Dorevitch IPCB Testimony rev_7-25-08.pdf
Dorevitch CV 7-24-08.pdf
CHEERS recruitment to date.pdf
CAWS Use survey summary.pdf
Complete QAPP.pdf

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF:

)

WATER QUALITY STANDARDS AND

)

EFFLUENT LIMITATIONS FOR THE

)

R08-9

CHICAGO AREA WATERWAY SYSTEM

)

(Rulemaking - Water)

AND THE LOWER DES PLAINES RIVER:

)

PROPOSED AMENDMENTS TO 35 Ill.

)

Adm. Code Parts 301, 302, 303 and 304

)

PRE-FILED TESTIMONY OF SAMUEL DOREVITCH

My name is Samuel Dorevitch and I am an environmental health researcher at the

University of Illinois at Chicago School of Public Health. I am a medical doctor, with training

and board certification in Emergency Medicine and also in Preventive Medicine, with

specialization in Occupational Medicine. Over the last six years, I’ve conducted research on

local environmental health issues, such as the effects of public housing demolition and the

reconstruction of the Dan Ryan expressway on air quality. In addition to being a scientist, I have

been an advocate for reducing pollution and improving the environment. Over the years, I have

testified at U.S. EPA hearings in favor of setting more stringent regulatory standards for ozone,

particulate matter air pollution, and off-road diesel emissions. I have also spoken out in the

media about the impact of coal-fired power plants on local air quality. I have added my name to

the National Resources Defense Council’s list of those opposed to the U.S. EPA’s recent effort

to stop regulating lead as an air pollutant.

I have advocated for tighter regulations in the above contexts because there is an

overwhelming body of public health research that demonstrates negative consequences of air

pollution. For ozone, particulate matter, lead and other air pollutants, a solid scientific

foundation exists for setting a regulatory standard. Just as I support improvements in air quality

as a means of promoting public health, I recognize the critical role that improvements in drinking

water quality have played in promoting the health of the public. The scientific basis for

improving air quality and drinking water quality are well-established, strong, and based on

thousands of scientific studies. However, in the case of water recreation, and limited contact

recreation in particular, we are just beginning to develop the scientific data that will help define

what regulatory measures are appropriate for protecting the health of public.

In contrast with the thousands of scientific papers that have addressed the health effects

of air pollution, less than 20 observational epidemiologic studies of primary contact recreation in

the US have been published. For limited contact recreation, no studies have been done in the

US, less than 5 have been done in Europe, and those looked primarily at whitewater canoeing, an

activity that does not take place on the Chicago Area Waterway System, or CAWS. No research

has ever characterized the health risks of activities observed on the CAWS, namely boating,

paddling, rowing and fishing. We do not know if people who engage in limited contact

recreational activities develop illnesses, such as gastroenteritis or eye infections or skin

infections or respiratory problems at higher risk than the general population.

Because the scientific literature does not provide guidance for establishing health-based

regulations for CAWS recreation, one would want to know the following in developing efforts to

improve water quality on the CAWS:

•

Are rates of illness higher among CAWS recreators compared to recreators doing the

same activities on waters that do not receive treated wastewater?

•

If so, how frequently do such cases of illnesses occur above background rates?

•

Are the pathogens responsible for illness bacteria, viruses or parasites, which may require

different water quality treatment strategies?

•

Are people who engage in specific recreational activities at increased risk while those

who engage in other activities are not?

•

Are there differences in risk on different CAWS reaches?

•

How does the contribution of water reclamation plants to microbial measures of water

quality compare to the contributions of runoff and sewer overflows?

•

If the Pollution Control Board were to establish a disinfection requirement rather than a

microbial water quality standard, how would risk to the public be determined along

various CAWS reaches?

•

Following rainfall and other events that are unrelated to wastewater treatment, what

microbes should be measured in the water to evaluate and communicate risk to the

public?

•

If the Pollution Control Board were to establish a water quality standard, rather than a

disinfection requirement, is there a microbial water quality level above which risk is

unacceptable and below which risk is acceptable?

If there were known outbreaks of disease linked to CAWS recreation, I would suggest

public health action now, rather than research. However, I am not aware of epidemics attributed

to CAWS recreation. Since 1978, the U.S. Centers for Disease Control and Prevention has

monitored disease outbreaks linked to water recreation. Using “WBDOSS,” the Waterborne

Disease Outbreak Surveillance System, the CDC compiles information about outbreaks due to

treated and untreated recreational waters. Hundreds of outbreaks and thousands of cases of

illness have been identified, described, and in varying degrees, investigated over the years.

Outbreaks from Illinois – including a recent outbreak of

Cryptosporidiosis

in Tazewell County –

have been reported. To the best of my knowledge, local health departments, the Illinois

Department of Public Health, and the CDC have not identified outbreaks of disease attributed to

CAWS recreation.

This does not mean that people haven’t gotten sick after using the CAWS. It is possible

that such cases fly beneath the radar of the public health monitoring system. That is why it is

important to identify such cases, to determine the microbes responsible for illness, to evaluate the

locations where water contact took place, to characterize the water quality at that location, and to

estimate the frequency with which such illness occurs. The fact that outbreaks linked to CAWS

recreation have not been identified does suggest that we have the opportunity to define the scope

and specifics of the problem before developing a potential solution. This lack of known

outbreaks of disease is consistent with the finding of the recent quantitative microbial risk

assessment. That study used hundreds of measurements of water quality on the CAWS and

estimated that rates of illness among limited contact recreators are about 1-2 cases per 1,000

uses.

Although risk assessment can be very useful in comparing various risk scenarios, such

analyses do not involve direct measurement of risk in populations. That type of research – the

study of the distribution and determinants of states of health and disease in population – is

epidemiology. Because epidemiologic studies involve the direct measurement, rather than the

statistical modeling of risk, they are of great importance in developing plans to protect the health

of the public. I am directing the epidemiologic study of CAWS recreation known as CHEERS,

which stands for the Chicago Health, Environmental Exposure, and Recreation Study. This is

the first epidemiologic study of the health risks of fishing, boating, rowing and paddling. This

research uses the gold standard of observational epidemiologic studies, the prospective cohort

design, and has been developed by a multi-disciplinary team of experienced researchers, with

backgrounds in infectious disease medicine, environmental medicine, epidemiology,

biostatistics, industrial hygiene and environmental science. A panel of recognized leaders in the

fields of water microbiology and health from the U.S. Centers for Disease Control and

Prevention, the U.S. Environmental Protection Agency, and other universities has reviewed and

endorsed the design and protocols of the research, and continues to monitor the quality of data

collected. A copy of the review panel’s endorsement has been submitted by Mr. Daniel

Woltering of the Water Environment Research Foundation and is Public Comment Number 63 in

the docket for this rulemaking.

I would like to give you a broad brushstroke view of the CHEERS research. A copy of

the epidemiologic study protocol has been submitted as an attachment to my written testimony

for anyone who wishes to see the details of this research. We recruit people into one of three

study groups. The CAWS Group is composed of people who row, paddle, fish or go boating on

the CAWS. The General Use Waters Group consists of people who do these same activities on a

number of area lakes, rivers and lagoons not including the CAWS. The Unexposed Group

includes people who do outdoor activities that do not involve water (such as jogging or biking) at

about the same time and about the same place as the recruitment of participants into the other

two groups. Individuals in all three groups undergo interviews on the day of recreation, and

then are contacted for three telephone interviews over the following three weeks. All interviews

are conducted using computer assisted methods, which ensure that participants are asked the

same questions in a neutral fashion. Field interviews address current health, and for those who

engage in water recreation, the extent of their contact with the water. Telephone interviews

address changes in health status and additional water exposure since recruitment. While the

participants are on the water, samples of water are collected and sent for analyses of bacteria,

viruses and parasites. If a participant develops illness, clinical specimens are collected so that

the pathogen responsible for illness may be identified. The study uses state-of-the-art methods,

which in several respects, surpass the U.S. EPA’s ongoing research about primary contact

recreation known as the National Epidemiological and Environmental Assessment of

Recreational Water (NEEAR) study.

Additionally, a module of CHEERS known as the exposure study seeks to answer

important questions regarding water contact among recreators. Rowers, paddlers, boaters and

fishers may be exposed to water microbes via several routes: ingestion, inhalation, and skin

contact. Ingestion may result from getting water on ones hands and then touching ones mouth, it

could result from a splash to the mouth, or it could occur in the unlikely event of capsizing or

falling into the water. The exposure study will allow us to describe for the first time how much

water exposure occurs by each route for specific recreational activities. These results may be

useful in establishing whether some activities pose lower levels of risk (due to lower exposure)

than others. We will also have the opportunity to evaluate the assumptions of risk assessments

regarding exposure, dose, and risk. Preliminary analyses of 2007 data show that assumptions

regarding the duration of various recreational activities were quite accurate. The conduct of an

epidemiologic and a risk assessment in tandem is unusual and this opportunity to evaluate the

strengths and limitations of risk assessment methods is one reason that there is considerable

national interest in applying the final results of this research to the development of water quality

regulation.

Epidemiologic studies provide an opportunity to directly measure, rather than model,

risk. For this reason the U.S. EPA places considerable weight on epidemiologic studies when

establishing environmental standards. A well-designed epidemiologic study seeks to minimize

the possibility that the research will fail to identify a real risk that may exist (a “false negative

result”) and to minimize the possibility that a risk will be identified when none exists (a “false

positive result”). Early in the development of CHEERS, the research team evaluated numerous

approaches for minimizing the possibility of a false positive or a false negative result. In

calculating our necessary number of study participants, we used typical values of a 1 in 20

chance of a false positive result and a 1 in 5 chance of a false negative result. We made

numerous conservative assumptions in that sample size calculation, and it is becoming apparent

that we will have more statistical power than originally anticipated because the rate of drop out

by study participants is less than a third of the 15% we had projected. Thus, the chances of

failing to identify a real risk are likely less than one in five.

We calculated that a total of 9,330 people should be enrolled in the three recreational

categories (i.e. approximately 3,110 people per recreational category as described above). Last

summer and fall – the first year of the study – over the first 800 participants signed up for the

study. CHEERS has been scaled up substantially this summer, and for the months of May, June

and July, an average of more than 1,000 participants were enrolled per month. A breakdown of

recruitment by group, by month is included as an appendix to this testimony. By the date of this

hearing, we project that 5,500 participants will have been enrolled in CHEERS. We collected

data about use of the CAWS, for specific activities at specific locations. A summary of the

findings of CAWS recreational use survey in 2007 has been submitted as an appendix to this

testimony. Highlights of that summary include the observation that the dominant uses on the

North Branch and North Shore Channel are rowing and paddling while the dominant use on the

Cal-Sag Channel is motor boating. Fishing from shore is relatively uncommon, and jet skiing is

rarer still. Swimming and water skiing were never observed. Data obtained from field

interviews of study participants demonstrates that several dozen individuals on rowing team each

use the CAWS more 100 times per year. Similarly, some boaters at the Worth and Alsip

launches use the Cal-Sag Channel dozens of times per season. Thus, a small number of users

account for a large proportion of uses. These observations add detail to the picture sketched out

by the assessment of current uses reported in the UAA. Inconsistencies between our

observations and those of the UAA regarding the frequency of specific recreational activities and

the distinction between uses and users are likely due to difference in methodologies.

Over 5,000 water samples have been analyzed and more than 150 stool samples have

been obtained for analysis by the UIC laboratory and the Illinois Department of Public Health.

We are well on our way to completing data collection and moving on to data analyses. The

results of those analyses will provide answers to the critical questions about risk, the

determinants of risk, exposure, sources of microbes, and causes of illness. The final report will

serve as the basis for establishing standards to protect limited contact uses. Preliminary analysis

of the 2007 data identifies no difference in rates of gastrointestinal symptoms among recreators

in the three study groups. Because that analysis involved less than 10% of the total number of

participants who will have been enrolled at the completion of this research, firm conclusions are

premature. However, consistent with the lack of reports by public health departments of

outbreaks of disease linked to CAWS recreation, our preliminary observations suggest no danger

to the health of the population of limited contact recreators on the CAWS.

I favor strong, science-based environmental regulation as a means of protecting public

health. Reducing the potential risks of limited contact recreation on the CAWS is an important

and complex public health goal. From a policy perspective, one would want to know what the

benefits and risks are of current wastewater management and recreation practices, and what the

Testimony Attachments

1. Curriculum vitae

2. Recruitment by month, by group

3. Use survey summary

4. CHEERS Protocol (Quality Assurance Project Plan documents)

CURRICULUM VITAE

Samuel Dorevitch, M.D., M.P.H.

University of Illinois at Chicago - School of Public Health

Division of Epidemiology and Biostatistics

Division of Environmental and Occupational Health Science

1603 W. Taylor, M/C 923

(312) 355-3629

sdorevit@uic.edu

Education and Training

July 1999-June 2001 Resident, Occupational Medicine, UIC Medical Center

Aug 1999-May 2001 Environmental and Occupational Health Sciences, UIC School of

Public Health; Degree awarded: Masters in Public Health

July 1990-June 1993 Resident, Emergency Medicine, Cook County Hospital

July 1989-June 1990 Intern, Internal Medicine, Northwestern University-Evanston Hospital

Sept 1985-June 1989 University of Chicago, Pritzer School of Medicine;

Degree Awarded: MD

Sept 1981-June 1985 University of Illinois at Chicago

Degrees awarded: B.S. with honors, Biological Sciences, B.A.,

Psychology, with honors

Employment

2001-present

Assistant Professor, Research, Division of Environmental and

Occupational Health Sciences, University of Illinois at Chicago

Assistant Professor, Research, Division of Epidemiology and

Biostatistics, School of Public Health, University of Illinois at Chicago

Faculty Occupational Medicine Residency Program

2007-present

Clinical Physician, Department of Emergency Medicine, UIC O’Hare

Clinic, University of Illinois at Chicago Medical Center

1995-present

Staff physician, Emergency Medicine and Occupational Health Services,

Lake Forest Hospital, Lake Forest, IL

1993-2002

Clinical Instructor, Emergency Medicine, Cook County Hospital,

Chicago, Illinois

1993-1995

Emergency Medicine and Occupational Medicine, Westlake Community

Hospital, Melrose Park, Illinois

Academic Honors

Edmund C. James Scholar, University of Illinois, Chicago, 1983-1985

Phi Beta Kappa

Chief Resident, Emergency Medicine, Cook County Hospital, Chicago, IL, 1992-1993

NIOSH Trainee in Occupational and Environmental Medicine, 1999-2001

Central States Occupational Medicine Association, Scientific Session 2000. Award for

presentation by a resident.

Publications

(*refereed journal)

1. Westfall MD, Price KR, Lambert M, Himmelman R, Kacey D, DOREVITCH S,

Mathews J. "Intravenous access in the critically injured trauma patient: a multicentered,

prospective randomized trial of saphenous cutdown and percutaneous femoral access."

Annals of Emergency Medicine, 23:541-545, 1994.*

2. DOREVITCH S, Forst L. "Occupational hazards of emergency physicians" American

Journal of Emergency Medicine, 18:300-311, 2000*

3. DOREVITCH S, Marder D. "Occupational hazards of municipal solid waste workers".

State of the Art Reviews in Occupational Medicine, 16:125-133, 2001.

4. DOREVITCH S, Babbin A. "Ceramics: Hazards, health effects, and prevention". State

of the Art Reviews in Occupational Medicine, Oct-Dec;16(4):563-75.2001.

5. Geller RJ, DOREVITCH S, Gummin DD. "Air and Water Pollution" in Toxicology

Secrets, Ling LJ, Clark RF, Erickson TB and Trestrail JH (Eds). Hanley & Belfus,

Philadelphia, PA. 2001.

6. DOREVITCH S, Forst L, Conroy L, Levy P. "Toxic inhalation fatalities of US

construction workers, 1990-1999." Journal of Occupational and Environmental

Medicine, 44(7):657-62, 2002.*

7. Krantz A, DOREVITCH S. “Metal Exposures and Common Chronic Diseases: A

Guide for the Clinician”.

Disease-a-Month,50(5):220-62, 2004.

8. DOREVITCH S, Demirtas H, Persky VW, Erdal S, Conroy L, Schoonover T, Scheff P:

“Demolition of high-rise public housing increases particulate matter air pollution in

communities of high-risk asthmatics.” J Air Waste Management Assoc. 2006

Jul;56(7):1022-32.*

9. Martinez O,Gangi E, Mordi D, Gupta S, DOREVITCH S, Lefranc MP, Prabhakar BS:

Diversity in the complementarity determining region 3 (CDR3) of antibodies from mice

with evolving anti-TSHR antibody responses.” Endocrinology, Endocrinology. 2007

Feb;148(2):752-61.*

10. DOREVITCH S, Demirtas H, Scheff P, Persky VW: “Bias and confounding in

longitudinal measures of exhaled monoxides.” Journal of Exposure Science and

Environmental Epidemiology, Sep;17(6):583-90 *

11. DOREVITCH S, Tharenos L, Demirtas H, Persky VW, Artwohl J, Fortman J: “Inverse

association between rural environment in infancy and sensitization to rodents in

adulthood.” Annals of Allergy Asthma and Immunology. 2007 May;98(5):440-6.*

12. Patel M, DOREVITCH S, Williamson R, Buchanan S: Pilot study investigating the

effect of the static magnetic field from a 9.4 Tesla MRI on the vestibular system.

Journal of Occupational and Environmental Medicine. 2008 May 50(5):576-583.*

13. DOREVITCH S, Karandikar A, Washing GF, Walton GP, Anderson R, Nickels S:

Efficacy of an air pollution education program in a community at risk for asthma

morbidity. In press, J Asthma.

14. Wei H, Turyk M, Cali S, DOREVITCH S, Erdal S, Li A: Polybrominated Diphenyl

Ethers in Dust: Particle size fractionation, evidence of debromination and human

exposure. In revision, Environmental Science and Technology.

Research Funding

Principal Investigator: NIOSH Pilot Project Research Training Award “Immunologic Risk

Factors for Laboratory Animal Allergy,” 2001-2002. Total award $15,844.

Principal Investigator: NIOSH Pilot Project Research Training Award “Immunologic Risk

Factors for Laboratory Animal Allergy.” Renewed, 2002-2003

PI: NIEHS, NIH Research Career Award ES-K08ES011302 “Asthma and Demolition in

Chicago Public Housing” Total award $641,527 2002-2007.

Co-investigator: Laboratory Animal Allergen Production and Transport in a Working

Animal Research Facility, PI: J. Artwohl,

Co-investigator: NIOSH/CDC, ERC Training Grant, T42/CCT522954-01, 07/01/03-

06/30/08, $5,552,668. (Conroy PI)

Co-investigator (UIC PI): Grand Boulevard Federation: Reducing air pollution impacts of

Dan Ryan Expressway Reconstruction. USEPA NE96586801. Total award, $49,515.

Principal Investigator: Asthma, Obesity and Airway Oxidative Stress. American Lung

Association/Respiratory Health Association of Metropolitan Chicago. $80,000. Funding

period July 2007-June 2009.

Principal Investigator: Epidemiologic Study of Chicago Area Waterways. Metropolitan

Water Reclamation District of Greater Chicago. Funding period May 2007-December

2009.

Teaching

Course director, Occupational Medicine Weekly Conference

Lecturer, Environmental and Occupational Health Sciences Course, “Air Quality”

Presentations at National Meetings

2003 American Public Health Association Annual Meeting, San Francisco, CA. Housing

Demolition and Air Pollution: Working with a local public housing environmental task

force to minimize exposure. Poster Presentation.

May, 2005, American Thoracic Society International Conference, San Diego, CA.

Particulate matter exposure adjacent to demolition of public housing.

May, 2006, American Thoracic Society International Conference, San Diego, CA.

Elemental and organic carbon in PM2.5 are associated with exhaled nitric oxide and

exhaled carbon monoxide in inner-city asthmatics

May, 2006, American Thoracic Society International Conference, San Diego, CA. Exhaled

carbon monoxide in inner-city asthmatics is associated with ambient ozone concentrations

two days earlier.

November, 2006, American Public Health Association, Boston, MA. Science, Politics and

Air Quality Policy.

May, 2007, American Thoracic Society International Conference, San Diego, CA

Elemental Carbon and Organic Carbon in PM2.5 Are Associated with Exhaled Nitric

Oxide and Exhaled Carbon Monoxide in Inner-City Asthmatics

May, 2007, American Thoracic Society International Conference, San Diego, CA Exhaled

Carbon Monoxide in Inner-City Asthmatics Increases 1-2 Days after Ambient Ozone

Exposure

Presentation at State and Local Meetings

May, 2004, Illinois Public Health Association “Beat Asthma in Illinois”, Springfield, IL.

Community health educators as key personnel in inner city asthma research.

November, 2006, Chicago Asthma Consortium Data Conference, Chicago, IL. Air

pollution and lung inflammation among public housing residents.

February, 2007, UIC Medical Center Pulmonary Medicine, Air Pollution and Health: Epidemiologic

Methods

Other

Reviewer,

International Journal of Occupational and Environmental Health

, 2000

Reviewer,

Journal of Occupational and Environmental Medicine

, 2002

Reviewer,

American Journal of Public Health

, 2004

Reviewer,

Archives of Occupational and Environmental Health

, 2006-7.

Scientist Reviewer, CDC/ASTPM/ASPH/AAMC Special Emphasis Panel, Atlanta,

Georgia June 7-8, 2004

Testimony at public hearings: OSHA proposed ergonomics standard hearings, 2000.

Testimony at public hearings: US EPA proposed offroad diesel hearings, June, 2004.

Testimony at public hearings: US EPA proposed PM2.5 standard, March, 2006

Testimony at public hearing: US EPA proposed ozone standard, September, 2007

Member, Illinois Department of Transportation “Dan Ryan Health and Environmental

Focus Group”, 2004-present.

Testimony before Chicago City Council Transportation Committee regarding the Dan Ryan

Expressway reconstruction, May 15, 2006.

Invited member, Governor’s Blagojevich’s Illinois Climate Change Advisory Group,

January-October, 2007.

Licensure and Certification

Medical license, State of Illinois, 1990-present

Board Certified, Emergency Medicine, 1994-present

Board Certified, Preventive Medicine/Occupational Medicine, 2002-present

Instructor, Advanced Cardiac Life Support, 1994-2006

CHEERS

monthly

enrollment

4,402

participants,

group,

through

July,

2008

This figure displays monthly recruitment of participants, by group, by month who

complete the second field interview. CAWS: Chicago Area Waterways System group;

GUW: General Use Waters group.

U N I V E R S I T Y O F I L L I N O I S

A T C H I C A G O

Division of Environmental and Occupational Health Sciences (MC 922)

School of Public Health

2121 West Taylor Street

Chicago, IL 60612

Phone (312) 996-8855 . Fax (312) 413-9898

Dr. Tom Granato

Assistant Director, Research and Development Department

Metropolitan Water Reclamation District of Great Chicago

6001 W. Pershing Road

Stickney, IL

Dear Dr. Granato,

An element of the Epidemiologic Study of Recreational Use of the Chicago Area

Waterways, also known as CHEERS, has been a characterization of usage of the waterway. This

letter reports our work, to date.

Methods of Characterizing Water Usage

Over the course of the 2007 data collection season, UIC staff has recorded rates of recreational

use of the waterways at various locations. The methodology for the use survey involved

counting the number of new users on given day, at a given location, for a specific activity. Thus,

a boat carrying three people would be counted as three users rather than one event. An

individual who boated and then fished would be counted twice, once for each recreational

activity. In order to prevent counting the same user twice for the same activity on a given day,

and to estimate the number of new users per unit of time, we did not count people passing by a

launch point. Thus, users who were observed passing or exiting a launch point were not

counted, to ensure that individuals were not counted both at launch and again while they were

engaged in (or finishing) their water recreational activity.

Results of Observations

Data were collected on a total of twenty-two days of observation. Generally, study

personnel conducted the usage survey at one to two locations per day. This generally occurred

on days and at times that participants were being recruited into the CHEERS study. The average

duration of observation per site per day was 4.7 hours. This data includes participants at the

Chicago River Flatwater Classic, which were recorded as using the waterways at Clark Park.

Table 1 summarizes the amount of time spent collecting use data, by site.

Location

Days of

observation

Total

hours of

obs.

Avg.

hrs/day

of obs.

Avg.

start

time

Avg.

end

time

103.5

4.7

Table 1: Summary of amount of time spent collecting use data, by site

Tables 2 and 3 present usage by category, by location, and Table 4 summarizes overall usage by

location. Figure 1 presents the overall distribution of recreational users.

Kayakers

Total

(per hour) Total (per hour) Total

(per hour)

Total

(per hour)

364

(3.5)

461

(4.5)

607

(5.9)

247

(2.4)

Table 2: Observed uses and hourly usage rates for boaters, rowers and paddlers, by category and

location. Clark Park data includes the Flatwater Classic.

Swimmers

Total

(per

hour)

Total

(per

hour)

Total

(per

hour)

Total

(per

hour)

Total

(per

hour)

(0.1)

(0.0)

Table 3: Observed uses and hourly usage rates, for fishers, waders, jet skiers, water skiers and

swimmers.

All uses

Location

Total

(per hour)

Table 4: Observed uses and hourly usage rate, all recreational categories

Page 2

Figure 1: Overall use, by recreational category

In addition to the uses recorded on the twenty-two days that the use survey was conducted,

study personnel surveyed numerous other potential access points in two ways. One was by land-

based site visits. The other was on a survey of the North Branch of the Chicago River and lower

North Shore Channel by boat. Paddling, rowing and boating were observed on these surveys;

however, swimming, jet skiing, and water skiing were not.

Interpretation of Data

Several factors should be taken into consideration when interpreting the above data. First, the

dates and times of observation were not randomly selected. Surveys were generally conducted

when usage was expected to be relatively heavy--on weekends, when rowing teams and clubs

used the waterways, and during a major rowing/paddling event. Thus, multiplying hourly usage

rates by the number of hours in a recreation season would grossly overestimate actual usage.

Second, recreational users of the waterways were counted regardless of their eligibility to enroll

in CHEERS. For example, rowers who would enroll in the CHEERS study on Monday would

not be eligible to enroll on Tuesday (there is a 21 day period of follow-up during which current

participants are not eligible to re-enroll). Nevertheless, they would have been counted on both

days of the use survey. Members of rowing teams typically practice or compete 4-7 days per

week on the waterways for as many as 8 months per year. Thus, the number of uses greatly

exceeds the number of users and the number of users eligible to enroll in CHEERS.

The data summarized in the above tables contrasts with data summarized in the Use

Attainability Analysis (UAA), conducted for the Illinois Environmental Protection Agency.

Notably, fishing accounted for 73% of the activity observed on the North Shore Channel, 25% of

the activity on the North Branch of the Chicago River, 34% of the activity on the Cal-Sag

Channel, and 64% of the activity of the Little Calumet River. By contrast, fishing accounted for

less than 1% of all activity noted in our use survey. Power boating accounted for 32% of activity

on the North Branch in the UAA while it is observed infrequently in our study at North Brach

locations. Differences in the findings of the two studies are likely due to differences in

Page 3

Table of Contents

Organization of this protocol

Background

1. Chicago Area Waterways

2. Water Quality Regulation

3. Scientific Background

4. Limitations

5. Epidemiologic Study

Study Objectives

Field study overview and design considerations

1. Field study summary

2. Approach to choice of study methods

3. Rationale for prospective cohort design

4. Study groups

5. Estimating background rates for sample size calculations

6. Study name

7. Participant recruitment strategies

8. Study enrollment and locations

9. Survey data

10. Clinical microbiology

11. Human research subject protections

12. Overview of water sampling

13. Field team organization

14. Project management

15. Communications plan

List of Appendices

Terms used to describe water recreational activities based

on degree of contact

Table 2

Summary of 2007 recruitment efforts, projected 2008

recruitment efforts

Table 3

Study participant recruitment achieved during 2007,

targets for 2008

Table 4

Pathogens to be detected in stool samples

Table 5

Primary purposes of water sampling, by location

Table 6

Locations for water sampling on the CAWS other than

recruitment sites

Table 7

Water sampling locations, by site of participation

Chicago Area Waterways (CAWS) map

Figure 2

Overview of study components

Figure 3

Recruitment locations, 2007 and 2008 seasons

Figure 4

Usual Incubation Period ranges for selected etiologic agents

Figure 5

Shedding period and optimal collection period for select agents

List of Appendices

Information for clubs, teams organizers and vendors

Overview 4

Water Quality FAQ Sheet

Overview 5

Recruitment sites – CAWS

Overview 6

Recruitment sties – GUW

Overview 7

2007 recruitment schedule

Overview 8

2008 recruitment schedule

List of Acronyms

AGI

Acute Gastrointestinal Illness

A-SPM

Assistant Survey Project Manager

CAI

Computer Assisted Interview

CAPI

Computer Assisted Personal Interviewing

CATI

Computer Assisted Telephone Interviewing

CAWS

Chicago Area Waterways System

CDC

Centers for Disease Control and Prevention

CFC

Continuous Flow Centrifugation

CFU

Colony Forming Units

CHEERS

Chicago Health, Environmental Exposure, and Recreation Study

COC

Chain of Custody

CPM

Clinical Project Manager

CSOs

Combined Sewer Overflows

DQO

Data Quality Objective

EPA

Environmental Protection Agency

FCR

Friends of the Chicago River

Illinois Department of Public Health

CHEERS Overview

July 2008

IEPA

Illinois Environmental Protection Agency

IPCB

Illinois Pollution Control Board

IPR

Initial Precision and Recovery

IRB

Institutional Review Board

Method Blank

Matrix Spike

MSD

Matrix Spike Duplicate

MWRDGC Metropolitan Water Reclamation District of Greater Chicago

NBCR

North Branch Chicago River

NEEAR

National Epidemiological and Environmental Assessment of

Recreational waters study

NGI

Non-gastrointestinal Illness

NSC

North Shore Channel

OPR

Ongoing Precision and Recovery

OSS

Office of Survey Systems

Quality Assurance Project Plan

Quality Control

QMP

Quality Management Plan

QRC

Questionnaire Review Committee

Relative Risk

SAS

Statistical Analysis Software

SMI

Scientific Methods Incorporated

SPH

School of Public Health

SPM

Survey Project Manager

SRL

Survey Research Laboratory

TNTC

Colonies Too Numerous to Count

UAA

Use attainability analysis

UIC

University of Illinois at Chicago

UIH

University of Illinois Hospital

USEPA

United States Environmental Protection Agency

WERF

Water Environment Research Foundation

WRP

Water Reclamation Plant

ORGANIZATION OF THIS PROTOCOL

The Chicago Health, Environmental Exposure, and Recreation Study, or “CHEERS,” is a multi-

year, multi-site, interdisciplinary epidemiologic study being conducted by a research team at the

University of Illinois at Chicago (UIC) for the Metropolitan Water Reclamation District of

Greater Chicago (MWRDGC).

When initially proposed, this study was called the

“Epidemiologic Study of Recreational Use of the Chicago Area Waterways.” It consists of three

distinct but interrelated data-collecting activities, which are organized as separate projects within

the larger study. Each project has its own Quality Assurance Project Plan (QAPP). The study

protocol is organized into six major sections:

•

Study Overview (this document)

•

Organization-wide Quality Management Plan (QMP)

•

QAPP #1: Water Sampling and Analysis

•

QAPP #2: Survey Methods

•

QAPP #3: Clinical microbiology

•

Statistical Analyses

The Study Overview and Organization-wide QMP are referred to throughout the individual

QAPPs and should be read first. Key analyses will involve data generated by two or more

individual projects within the larger study, therefore, the approach to statistical analyses are

presented in a separate document. Numbering of pages, tables, figures, and appendices is

specific to each of the six documents (in other words, numbering begins at 1 for each of these

major components of the overall study protocol).

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July 2008

BACKGROUND

1. The Chicago Area Waterways System (CAWS)

The Chicago Area Waterways System (CAWS) is a 78-mile-long, primarily man-made series of

channels and rivers. It is partly natural but irreversibly modified. The CAWS includes the North

Shore Channel, the North and South Branches of the Chicago River, the Chicago River, the

South Fork of the Chicago River (Bubbly Creek), the Chicago Sanitary and Ship Canal, the

Calumet-Sag Channel, the Calumet River, the Little Calumet River, the Grand Calumet River,

and Lake Calumet (Figure 1). The primary purpose of the system is to provide an outlet for urban

drainage in order to protect Lake Michigan, the source of drinking water for Chicago and many

nearby communities. Other purposes include transportation, commerce, and recreation. The

waterways also provide aquatic wildlife habitat. Four water reclamation plants (WRPs) of the

Metropolitan Water Reclamation District of Greater Chicago (MWRDGC) release secondary-

treated effluent (i.e., non-disinfected sewage) into the CAWS. It has been estimated that 70% of

the annual flow in the system is effluent from the WRPs (UAA). Storm runoff and combined

sewer overflows (CSOs) during and immediately after significant rainfall introduce water and

contaminants into the CAWS.

2. CAWS water quality regulation

2.1. Current CAWS use designations

The Illinois Pollution Control Board (IPCB) establishes use designations for bodies of water

in Illinois. Most of the CAWS is designated Secondary Contact and Indigenous Aquatic Life.

This designation allows recreational activities during which water contact is incidental or

accidental and for which the probability of ingesting appreciable quantities of water is

minimal, including canoeing, kayaking, and fishing, but not jet skiing or swimming. Three

relatively small portions of the system (the upper North Shore Channel, the Chicago River,

and Calumet River) are designated for general use. These use designation are not associated

with a microbial water quality standard.

2.2. Proposed changes to CAWS use designations

Because of water quality improvements in recent years, the Illinois Environmental Protection

Agency (IEPA) has recommended a use upgrade for parts of the CAWS that are now

designated Secondary Contact Recreation and Limited Aquatic Life. These improvements

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July 2008

stem from efforts by the State of Illinois to meet the goal of the Clean Water Act to make all

bodies of water “fishable and swimmable.” A change in use designation generally requires a

Use Attainability Analysis (UAA), thus, the IEPA had a UAA for the CAWS performed by a

contractor. The UAA included a review of current water quality, biodiversity, and uses of the

CAWS. After convening a stakeholder advisory committee and summarizing CAWS water

quality, current uses, and other data, the CAWS UAA recommended the creation of two

CAWS use designation subcategories, which differentiate recreational uses from aquatic life

uses.

Two recreational uses were proposed in draft form and posted on the UAA website in 2004

1) Recreational Navigation, which would apply to the Chicago Sanitary and Ship Canal, and

2) Limited Contact Recreation, which would apply to the other reaches of the CAWS that are

currently designated Secondary Contact and Indigenous Aquatic Life. Under the Limited

Contact Recreation use designation, canoeing, kayaking, fishing, jet skiing, and wading

would have been permitted. This designation would have applied from March 1 to November

30 and required the attainment of a water quality standard intended to limit excess illness to

10 cases per thousand contacts (a 30-day geometric mean of 1,030

E. coli

colony-forming

units (cfu) per 100 mL). The Recreational Navigation microbial standard would have

required the attainment of a standard meant to limit excess illness to 14 cases per thousand

contacts (a 30-day geometric mean of 2,740

E. coli

cfu per 100mL). Revisions to the Illinois

Pollution Control Board regulations were proposed in draft form on January 18, 2007. In that

document, the proposed recreational use designations were called “Incidental Contact

Recreation” and “Non-contact Recreation,” and had the same bacterial water quality

requirements, 1,030 and 2,740 geometric mean

E. coli

cfu per 100mL, as the “Limited

Contact Recreation” and “Recreational Navigation,” respectively. Ultimately, the IEPA

proposed one of three use designations for each segment, or reach, of the CAWS. These are

non-recreational use, non-contact recreation, and incidental contact recreation. Microbial

water quality standards to protect these use designations were not proposed; rather the IEPA

recommended the disinfection of effluent discharged into the reaches of the CAWS

designated for incidental contact and non-contact recreation.

A variety of terms have been used to categorize the degree of water contact expected to occur

during water recreation activities (Table 1). In order to simplify the terminology used in this

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July 2008

protocol, and to be consistent with other publications, we use the term “secondary,” rather

than “limited” or “incidental” contact recreation. For the purposes of this study, “secondary

contact recreation” is defined as any recreational water activity in which water contact is

limited to accidental or incidental contact, and precludes activities in which head immersion

is likely to occur. Secondary contact recreational activities include non-motorized boating

(paddling canoes or kayaks; rowing,) motor boating, and fishing (from a boat or from shore).

Because head immersion is expected in activities such as water skiing, jet skiing, and boogie

boarding, these activities are not considered part of our definition of secondary contact

recreation. Kayaking or canoeing on the low-flow waters of the CAWS are not expected to

result in head immersion. Again, the distinction between secondary contact recreational

activities and primary contact recreational activities such as swimming and water skiing is

that head immersion is not expected to not typically occur among secondary contact

recreators, while it is expect to occur among primary contact recreators.

Key elements of definition

Incidental contact

recreation

IEPA

Human contact with water is incidental and

the probability of ingesting appreciable

quantities of water is minimal, such as

fishing, commercial boating, small craft

recreational boating, shoreline activities.

Non-contact recreation

IEPA

Human contact with water is unlikely such

recreational navigation

Limited contact

recreation

UAA

Incidental or accidental body contact,

during which the ingestion of appreciable

quantities of water is minimal, such as

recreational boating (hand powered boating

activity, canoeing, jet skiing) and any

limited contact incident to shoreline

activity, such as wading and fishing.

Recreational navigation

UAA

Non-contact activities including, but not

limited to, pleasure boating and commercial

boating traffic operations.

Table 1. Terms used to describe water recreational activities based on degree of contact

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July 2008

Figure 1. The Chicago Area Waterways (CAWS). Map produced by the MWRDGC

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July 2008

3. Scientific background for a CAWS microbial water quality standard

Four sources of information are useful for estimating health risks attributable to secondary

contact recreation on the CAWS. These are: 1) prior epidemiologic studies of secondary contact

recreation in other settings, 2) prior primary contact recreation studies, 3) the MWRDGC Expert

Panel Report, and 4) the CAWS risk assessment produced for the MWRDGC.

3.1.Prior epidemiologic studies of secondary contact recreation

Three studies have characterized rates or relative odds of illness among secondary contact

recreators in other settings.

3.1.1. Fewtrell 1992

This investigation was conducted at two freshwater canoeing courses in the United

Kingdom, one of which was downstream of several sewage treatment facilities, and the

other of which was on a “pristine” waterway.

Demographic information and risk factors

for acute gastrointestinal symptoms were recorded at baseline. Water exposure while

canoeing was assessed immediately following the event. Five to seven days later,

symptoms were recorded by telephone survey and recorded again by self-administered

postal survey 28 days after the event. Unexposed individuals were enrolled at each site as

a reference group. Fecal coliforms, fecal streptococci, total staphylococci, and enterovirus

concentrations were measured in water samples taken during the event. A total of 561

participants, 90% of those initially enrolled, completed the 5-7 day follow-up. The risk of

developing gastrointestinal symptoms at 5-7 day follow-up was 4.25 times greater among

those who canoed downstream of the sewage treatment facility than among those in the

unexposed reference group. In other words, the relative risk (RR) of GI symptoms was

4.25, with a 95% confidence interval [CI] of 2.60, 6.94. Among recreators downstream of

the sewage treatment facilities, the incidence of respiratory symptoms was also higher

than among those without exposure (RR 2.42; 95%CI 1.55, 3.79), as were “flu”

symptoms (RR 2.41; 95%CI 1.68, 3.45). Event participants on the cleaner body of water

were more likely to develop respiratory symptoms than the reference group (RR 1.61; CI

1.01, 2.55), but not other symptoms. Between the 5-7 day follow-up and the 28-day

postal questionnaire, 40 of 109 (37%) participants on the contaminated course reported

the development of gastrointestinal symptoms. This rate was more than 50% higher than

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July 2008

that observed among those who canoed on the other body of water. The authors speculate

that the development of symptoms between the first and third week post-event may have

been due to infection by

Giardia

Cryptosporidium

. Because stool sample collection

and analysis was not part of the study protocol, it was not possible to identify the

pathogens responsible for acute illness.

3.1.2. Fewtrell 1994

Following up on the previous work, a prospective cohort study was conducted in which

study subjects were enrolled at two rowing regattas and two canoe marathons in the

United Kingdom.

A total of 591 event participants and unexposed spectators were

enrolled in the study. A variety of demographic and behavioral characteristics were

recorded prior to recreation. Five to seven days after the event, subjects were contacted

by phone and postal survey, and asked about water exposure during the event; the

subsequent development of symptoms was recorded. Water quality measures included

fecal coliforms, fecal streptococci, staphylococci,

Pseudomonas auruginosa, Salmonella

spp.

, and

Cryptosporidium spp.

, as well as enteroviruses. Those who ingested water were

more likely to develop gastrointestinal symptoms (RR 2.20; CI confidence interval 1.35,

3.58) or any symptom (RR 1.35; CI 1.32, 2.32) compared to combined group of

spectators and participants who did not ingest water. Actual rates of illness were not

reported, nor were associations between rates of illness and measures of water quality.

Another limitation of this study is that participants were asked five to seven days after the

event about water exposure during the event. Recall bias may have occurred. For

example, having become ill, those who developed symptoms may have been more likely

to remember or report swallowing water during the event than those who did not become

ill.

3.1.3. Lee 1997

A third study of 473 paddlers was conducted in the United Kingdom on a whitewater

course

. Participants in whitewater events were given questionnaires and asked to mail in

their responses one week after the event. Water quality measures included

E. coli

enterococci, and F-specific RNA bacteriophages. The authors found that specific

exposure variables predicted the development of symptoms. For example, the risk of

illness was increased among those who reported swallowing water two or more times

CHEERS Overview

July 2008

compared to those who did not (RR 1.9; CI 1.0, 3.6). Accidentally falling in the course

and swimming (RR 2.3; CI 1.2, 4.3), and eating or drinking before changing out of

clothing worn during the event (RR 2.1; CI 1.1-4.0) were also risk factors for the

subsequent development of symptoms. The risk was lower among those who used the

slalom course seven or more times in the past year compared to less frequent users (RR

0.3; CI 0.1, 0.7) . The absence of a reference (i.e., unexposed) group precludes estimating

the risks of illness attributable to paddling in this setting.

3.1.4. Other prior studies of secondary contact recreation

Several other papers have been published on related topics, though they do not help

characterize the risks of secondary contact recreation. These include a characterization of

the RNA of a norovirus-like pathogen that was isolated from stool samples of several

canoeists, but did not include measures of water quality.

Illness rates among canoeists in

South Africa have been described,

8, 9

though the pathogen of interest in those studies,

Schistosoma hematobium

, is not a pathogen of concern in North America.

3.2. Prior primary contact recreation studies

Recreational water quality standards have been based on epidemiologic studies of swimmers

and bathers. The literature has been summarized in a review article

and a meta-analysis.

Many of the relevant primary contact research studies included in those reviews,

12-15

as well

as three published since,

16-18

were prospective cohort studies, while several were randomized

controlled trials.

19-22

Additionally, a case-control design was used in one study.

Furthermore, outbreaks of illness linked to recreational water exposure, generally involving

primary contact recreation, have been reported through the ongoing Waterborne Disease and

Outbreak Surveillance System of the US Centers for Disease Control and Prevention

(CDC).

24, 25

The above studies generally address marine water or freshwater lakes, with very

little known about health risks of primary contact in rivers. The above studies are fairly

consistent in documenting an increased risk of illness with increasing indicator organism

concentrations in recreational waters.

3.3. The MWRDGC Expert Panel Report

The MWRDGC convened an expert panel to evaluate the scientific basis for establishing a

microbial water quality standard for the CAWS.

After reviewing the literature and relevant

CHEERS Overview

July 2008

proposed and established regulatory standards, the expert panel noted that “there are virtually

no data available on which to rationally base criteria for secondary contact recreational

exposure, either in freshwater or marine situations.” Given the paucity of knowledge about

the risks of limited contact recreation, the Expert Panel recommended that “…studies to

ascertain risk from secondary contact in freshwater and the relationship between any such

risk and indicator levels need to be conducted. These may be epidemiological studies

designed with sufficient statistical power to detect risks at levels deemed to be acceptable for

regulatory purposes. Alternatively, a formal microbial risk assessment can be conducted…”

3.4. The CAWS risk assessment produced for the MWRDGC.

A CAWS recreation risk assessment was conducted for the MWRDGC by GeoSyntech

Consultants to compare the estimated health consequences of the current practice of not

disinfecting WRP effluent to a scenario of disinfection.

That study involved sampling water

at locations upstream and downstream on three CAWS WRPs. Samples were analyzed for a

variety of bacteria, viruses and protozoa. Rates of illness were then modeled using risk

established quantitative microbial risk assessment methods. The risk model is based on

several assumptions and estimates, including waterway usage rates, distribution and duration

of specific recreational activities, water ingestion rates for specific activities, and the

infectious dose of specific pathogens. Environmental sampling was conducted in wet and dry

weather. The risk assessment projected a low probability of developing gastrointestinal

illness attributable to recreation (about 1 to 2 per thousand exposures) even for the most

recreational users in areas of the CAWS in close proximity to the District’s WRPs.

4. Limitations of the literature for establishing a CAWS bacterial water quality standard

4.1. Limitations of prior secondary contact studies

The studies of secondary contact discussed above have limitations, including (in one or more

studies) the lack of a comparison of rates of illness to those in a group of unexposed

individuals, the possibility of recall bias, and the fact that rates of illness were not reported.

The dominant activities on the Calumet system of the CAWS are boating and fishing,

which

CHEERS Overview

July 2008

were not evaluated in the UK river studies. Even the risks for CAWS canoeing can not be

predicted with any precision based on the UK studies of canoeing, because exposure was

likely much greater on a whitewater slalom course than on the low-flow conditions of the

CAWS.

4.2. Limitations of prior primary contact studies

The relevance of studies of primary contact exposure to the establishment of secondary

contact standards is questionable.

4.2.1 The exposures are not comparable given the assumption that smaller quantities of

water ingested (the presumed route of pathogen exposure) during secondary contact

recreation than during primary contact recreation. Risk estimates derived from primary

contact studies would be relevant to modeling risks for secondary contact activities if the

amount of water ingested by swimmers could be compared to that of paddlers or fishers.

Ingestion rates for swimmers have been determined among adults and children swimming

in a pool.

If similar estimates were available for secondary contact recreation,

extrapolation of risks from primary to secondary contact could be made, but such

estimates have not been determined.

4.2.2 Additionally, there are no studies comparing rates of illness among swimmers to

those among paddlers, boaters, or fishers in the same body of water. The National

Epidemiological and Environmental Assessment of Recreation (NEEAR) study reported

higher odds of illness among beachgoers who had head-immersion, body immersion, and

any water contact, compared to those who had no water contact.

Because water quality

at Great Lakes beaches is so different than at many CAWS locations, and because wading

is so different than kayaking, extrapolating from other surface waters to the CAWS may

not be justified.

5. The epidemiologic study of recreational use of the CAWS

As discussed, the existing literature of risk of illness following primary and secondary contact

water recreation is insufficient for establishing a microbial water quality standard for the CAWS.

Although the GeoSyntech risk assessment suggested a low risk, many of the assumptions used in

the analysis have yet to be validated. In order to develop a scientific basis for establishing a

CHEERS Overview

July 2008

standard, on April 19, 2007 the MWRDGC Board of Commissioners voted to contract with the

University of Illinois at Chicago (UIC) to conduct an epidemiologic study of recreational use of

the CAWS. That study is CHEERS, and the remainder of this overview document describes its

The overall objective of CHEERS is to investigate illness associated with secondary contact

recreation on the CAWS. Specific aims are:

1) To determine rates of acute gastrointestinal and non-gastrointestinal illness attributable

to CAWS recreation.

2) To characterize the relationship between concentrations of microbes in the CAWS and

rates of illness among recreators.

3) To identify pathogens responsible for acute infections among recreators, and to

explore sources of those pathogens on the CAWS.

The purpose of this study is not to develop regulatory standards. The findings of this research

may provide a scientific basis for the establishment of state or federal water quality standards.

CHEERS Overview

July 2008

FIELD STUDY OVERVIEW AND DESIGN CONSIDERATIONS

1. Field Study Summary

A prospective cohort study design is being conducted in which the health of research participants

is evaluated both prior to and following recreation. Three groups of participants are being

enrolled: 1) CAWS recreators (the “CAWS group”), 2) recreators on Lake Michigan and other

general use waters (GUW) (the “GUW group”), and 3) outdoor recreators without water

exposure, such as joggers and cyclists (the “unexposed group”). An overview of study

components is presented in Figure 2. After completing an eligibility screen and an informed

consent process, participants complete two interviewers in the field. The first interview collects

basic demographic information, while the second, administered after recreation to the water-

exposed groups, inquires about water contact. Participants also provide information regarding

their health in general, and about risk factors for acute illness that are unrelated to water

exposure. They are also asked about any open skin wounds and pre-existing infections of the

eyes, ears, and skin. Water is sampled at the location of and on the same days as subject

enrollment; rates of illness will be analyzed as a function of water microbe concentration.

Clinical specimens for microbial analyses are obtained from participants who develop symptoms

of acute gastrointestinal illness (AGI) and non-gastrointestinal illness (NGI). Subjects are

contacted for follow-up telephone interviews at 2, 5, and approximately 21 days after enrollment.

The major study elements are discussed in greater detail in each specific QAPP document.

2. Approach to Choice of Study Methods

The use of well-established methods was strongly preferred over innovation for the

epidemiologic study design. The central components – a prospective cohort design, pre- and

post-recreation evaluations of health, post-recreation evaluations of exposure, the content and

methods of administering surveys, measures of water quality, and the enrollment of a reference

group – are based on the methods employed by the previously discussed studies by Fewtrell,

Water sampling – direct grab samples and with mechanized large

volume sampling – is being conducted using US EPA-approved methods. Novel statistical

methods will not be developed. Rather, the approaches used in the NEEAR and other studies will

be utilized, and analyses will be conducted using SAS, a widely accepted and thoroughly tested

statistical software package.

Pre-recreation survey

(Field Interview A)

Study participant

____activities___

Laboratory

__analyses_

Day of recreation

Recreation

Post-recreation survey

(Field Interview B)

Water sampling for

indicators, pathogens

Environmental

sampling

Consent

Figure 2. Overview of study components

3. Rationale for Prospective Cohort Design

While randomized controlled trial designs, such as that used in European primary contact

studies,

19-22

have the advantage of the ability to equalize levels of confounders among study

groups, such a design could not be effectively implemented in our setting. Almost all of the

kayakers, canoeists, and boaters who come to the CAWS – particularly for events such as the

Chicago River Flatwater Classic – will have planned in advance and brought their watercraft

CHEERS Overview

July 2008

with them. Such individuals would be unwilling to be randomized to a non-water-recreator

group. Rather than addressing confounding by randomization, we will collect data about a

variety of potential confounders and statistically adjust for the confounders in analyses. The

prospective design will minimize recall bias because we will ask participants about water

exposure immediately after recreation, rather than after some become ill.

4. Study groups

Conceptually, there are three possible sources of risk for acute gastrointestinal and non-

gastrointestinal illness among CAWS recreators:

•

“Background” factors that result in AGI and NGI symptoms. For AGI these

include existing population risks of food-borne illness, fecal-orally transmitted

gastrointestinal infections, medication side effects, and lactose intolerance. For

NGI, the relevant factors are population rates of acute respiratory, skin, eye, and

ear symptoms.

•

Acute illness due to recreational contact with water itself. Water can be aspirated,

causing acute respiratory symptoms. Acute respiratory symptom rates have been

noted to be higher among secondary contact recreators on a pristine whitewater

course than among unexposed individuals, suggesting that water contact, rather

than pathogen contact, is responsible for some symptoms (Fewtrell et al. 1992).

Direct water contact promotes breakdown of the protective layer of the skin,

increasing the risk of dermatitis and otitis externa (“swimmers ear”).

•

Infections caused by waterborne pathogens that are acquired through recreational

activities.

AGI is the best-studied health endpoint in studies of water recreation. There are substantial rates

of AGI in the general population. Failure to account for background rates could result in some

cases of AGI in water-exposed recreators to be attributed to water contact or pathogens, rather

than to background factors. Such erroneous attribution would inflate estimated risks of illness

due to microbial pathogen or water contact.

Data from the three groups of recreators will allow us to meet study objective 1,

determining rates of illness attributable to CAWS recreation. We will differentiate the risk of

acute illness following CAWS recreation from the risk attributable to microbial exposure on the

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July 2008

CAWS by enrolling three groups of study participants: CAWS recreators, GUW recreators, and

unexposed (non-water) recreators. CAWS recreators have all three sources of risk. At

recruitment locations which are not immediately downstream of wastewater treatment facilities,

recreators in the GUW group have risks due to background factors and water contact, but will be

exposed to much lower concentrations of waterborne microbes. The inclusion of the GUW group

will allow the evaluation of a dose-response relationship between water quality and illness rates

that will include a broader range of water quality measures than if only CAWS recreators were

included. Risk for acute illness in the unexposed group, enrolled at the same times and areas as

participants in the two water-exposed groups, will be due to “background” factors only. The

fact that all three groups will consist of people engaging in outdoor recreational activities should

reduce demographic and general health variables from confounding possible associations

observed between illness rates and study group. Additionally, we will be able to examine self-

reported measures of water exposure for various recreational activities, and to use this

information in to help understand the variability of risk among study participants.

5. Estimating background rates for sample size calculations

We estimate that background rates of AGI in the population are approximately 50-75 per 1,000

per month. This estimate is based upon rates of AGI in groups of unexposed individuals in the

primary contact recreation studies

16-18

noted above that employed study designs and methods of

defining health endpoints that are similar to those that will be used in the present study. In the

NEEAR study, the overall rate of AGI among those without water contact was 80/1,000 during

the 10-12 days following the beach visit.

However, in that study, the rate of AGI among

unexposed beachgoers at the Indiana Dunes (located near Chicago) was 50/1,000. At the Lake

Erie beach, the rate among the unexposed was also approximately 50/1,000, with the exception

of one day when it exceeded 100/1,000 (personnel communication, T. Wade). In the Mission

Bay, CA study, the rate among the unexposed was again approximately 75/1,000/month.

Another estimate of background rates for acute gastrointestinal symptoms comes from a large

hepatitis A post-marketing surveillance study of US adults and children. In that study the rate of

“diarrhea/gastroenteritis” requiring emergency department evaluation was 50/1,000 over a thirty

Although the name of this study when originally proposed to the MWRDGC was the

“Epidemiologic Study of Recreational Use of the Chicago Area Waterways,” for the purposes of

study publicity and recruitment, the study will be known as “CHEERS,” the Chicago Health

Environmental Exposure and Recreation Study. We wish to avoid biasing potential study

participants regarding the study’s hypotheses, and we will not identify the Chicago River (or

other parts of the CAWS) as the primary focus of the research. Additionally, our promotional

materials and recruitment scripts do not identify those who have no water contact as being a

“control group,” so that all participants perceive that the information that they provide is no less

important than that provided by individuals in the CAWS and GUW groups.

7. Participant recruitment strategies

Three general approaches will be employed to promote enrollment: day-of-recruitment efforts,

advance coordination with organizers of special events, and advance coordination with teams or

clubs. Study participants are also offered financial incentives for their time and effort. The

efforts to recruit study participants are the responsibility of a recruitment manager.

7.1 Recruitment manager

Beginning in 2008, a member of the CHEERS team now functions as a recruitment manager

and has primary responsibility for identification and contact of relevant organizations, and

for the development of plans to work with clubs,/ teams, and organizers of secondary contact

water recreation events in the Chicago area. In January, 2008, a dinner meeting was held

with 25 representatives of yacht clubs, organizers of secondary contact water recreation

events in the Chicago area, and high-school, collegiate, and private rowing and paddling

clubs. The meeting was successful in allowing the research group to form new working

relationships with organizations and to solidify existing relationships in order to promote

recruitment of club/team members in the study. If recruitment goals are not met in 2008, a

similar meeting will be held during the winter of 2009. In order to introduce the study to the

target audience, the recruitment coordinators will also staff a CHEERS booth at non-

recreation events that are attended by water recreation enthusiasts, such as conventions and

sales conferences for water sports equipment.

CHEERS Overview

July 2008

7.2 Recruitment strategies

During the 2007 season, participants were recruited using three approaches. The “intercept

interview” was the most frequently used. A recruiting station would be established at a

location at which recreators were expected to be and recreators were approached by staff and

invited to participate in the study. The second approach, event oriented recruiting, was used

on two occasions: The Chicago River Flatwater Classic (a rowing and paddling event) and

the Chicago Shoreline Marathon (a lake kayaking race). This approach involved the

coordination of publicity and recruitment with event organizers. The third approach, club

and team recruiting, was used several times in 2007 to recruit members of three rowing

teams, a kayaking club, and a club that bicycles along Lake Michigan and the North Branch

of the Chicago River.

In the 2008 season we will vary the balance of the recruiting

approaches over the course of the season in an effort to maximize recruitment.

7.2.1 Intercept interviews

In 2007, we relied primarily on intercept interviews at locations on Lake Michigan and

the CAWS.

These efforts were most successful on weekends. The number of

participants recruited was related to the number of recruiting locations that could be

staffed on a given day, and the number of staff available. In 2007, the number of staff

available limited such recruiting to about 4-6 hours per day, generally on either Saturday

or Sunday (but frequently not both on the same weekend) and generally at one location

per day. In 2008, we are have increased duration and staffing of intercept interview

recruitment on dates when large numbers of participants are likely to be recruited, such as

summer weekends and holidays, and have extended the length of the recruiting day from

about five hours to between ten and twelve hours. Separate morning and

afternoon/evening shifts are be staffed by approximately 4-5 people at each of three to

four locations.

The composition of a team (data manager, interviewer/recruiters,

incentives/publicity, and use survey recorder [CAWS locations only]) remains

unchanged. The positions are described in QAPP 2: Survey Methods. These eight teams

(four locations, two shifts per location) are supervised by a field supervisor, one of the

project managers.

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July 2008

7.2.2 Event-oriented recruiting

It is far more efficient to enroll participants at one large event than fewer participants on

multiple dates. Our recruitment coordinator has identified at least number additional

major events that will allow us to enroll participants at CAWS and general use waters

locations. We will provide the organization hosting the event between $50-$250 to assist

with publicity and distribution of information, such as links to our website and study

information sheets. Several large rowing and paddling events will be held on CAWS and

general use waters in 2008 and canoe/kayak vendors host smaller group outings on a

regular basis. The amount of money provided to the organizers will vary based on the

number of participants in the event, not the number who choose to enroll in the research

study.

7.2.3 Club and team recruiting

Unlike events, in which several hundred people participate a single time, clubs and teams

generally consist of 10-100 members, and have multiple outings per season. A problem

with this type of recruitment is that members are often ineligible to enroll; many of the

clubs and teams row 6-7 days per week and, to meet study eligibility requirements,

participants must not have engaged in water activities 48 hours prior to enrollment. To

address this issue, the recruitment manager works with coaches to set a date for CHEERS

recruiting on which we can sign up team members on their first day out on the water, as

well as on their first time back after spring and summer breaks. We have also simplified

the process of enrolling members of high school rowing teams. Parents will have the

option of providing consent once during the season for enrolling their children in the

study as many times as they are eligible. As will be the case for event organizers, we will

compensate clubs and teams for the time they put into helping coordinate recruitment.

Teams will receive $100 for their participation, regardless of the number of team

members who enroll in CHEERS. If a school has four teams (men’s and women’s,

varsity and novice) the school would receive $400. Additionally, participants will have

the option to donate the $50 incentive to the team or club.

7.3 Participation incentives

Research participants will receive a CHEERS T-shirt and $15 Target gift card on the day of

field evaluation. Following the completion of the third and final telephone follow-up, they

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July 2008

will be sent a check for $35. CHEERS participants recruited as members of a rowing or

paddling team or club have the option to donate their incentive to the team, or to Friends of

the Chicago River, a UIC research partner. Those who are asked to provide a stool or other

clinical specimen for analysis (based on the presence of specific symptoms on telephone

follow-up) will receive an additional $75. These amounts were established based on the

experience of UIC investigators in prior occupational and environmental epidemiologic

studies. For example, in a study conducted by members of this research team about possible

Helicobacter

transmission in an occupational setting, offering a $25 incentive resulted in 28

out of the 45 eligible workers (62%) providing stool samples and 28 of the 30 who enrolled

in the study (93%).

7.4 Study awareness and publicity

Various efforts have been undertaken to increase awareness of the study among potential

participants.

7.4.1 Logo

A logo has been developed to promote awareness of the study among local water

recreation enthusiasts (Appendix 1). The logo was designed to convey messages of

“outdoors” and “sports” without indicating that a specific body of water or regulatory

issue is the focus of this research, so as not to bias study participants. The CHEERS

study logo is displayed on the banners, T-shirts, and a recruitment flyer (Appendix 2) that

is distributed in advance of group- and event-oriented recruiting, and during other

recruitment.

7.4.2 Informative handouts

7.4.2.1 Recruitment flier

Like the logo, the recruitment flyer (Appendix 2) was designed to interest potential

participants without communicating information that could result in biased enrollment (in

other words, we do not wish to promote enrollment into the study in way that appeals

more to those who perceive water quality to be particularly poor or particularly good).

For example, although it is clear that this research is about water, outdoor recreation, and

health, no message is communicated to suggest that CAWS recreation is either hazardous

or risk-free. Similarly, the flyer does not state that some participants who enrolled to be

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July 2008

part of a “control group” rather than being in a group of primary interest. Additionally,

although the financial compensation is presented as a range, $50-$125, but no mention is

made of the fact that if participants note specific symptoms, they will receive a $125

rather than $50.

7.4.2.2 General information about CHEERS

The “General Information about CHEERS: For clubs, teams, organizers, and vendors”

sheet Appendix 3) was developed to provide information to people contacted by the

recruitment manager about the possibility of coordinating recruitment efforts. The flier

outlines the basic goal of the study and what participation entails.

7.4.2.3 Water Quality FAQ

Anticipating that our presence will prompt inquiries from the public regarding the quality

of the waterways, we compiled a “Water Quality Frequently Asked Questions” sheet

(Overview Appendix 4), based on information from publicly available government

websites, including the Illinois EPA. The sheet allows study staff to provide standard,

unbiased responses to common questions without offering opinions on water quality or

health risks.

7.4.3 Day of event publicity

On the day of recruitment multi-disciplinary field teams will set up a tent and banners at

the site of recruitment. All CHEERS field team members will wear the CHEERS t-shirt

which, like the banners and flyers, will display the study logo. After their participation in

the field study, each research subject will receive a CHEERS T-shirts. To the degree that

participants subsequently wear the T-shirts, they will be promoting recognition of the

study “brand,” potentially facilitating recruitment of new participants.

7.4.4 Recruitment assistance by Friends of the Chicago River

Friends of the Chicago River (FCR) is a non-profit organization that promotes the health

and use of the Chicago River. FCR is an important partner in this research, helping to

publicize the study, promote recruitment, and provide space at events for enrollment.

FCR estimates that through its newsletter, website, special events, event promotion, club

outreach, and other methods, it will promote awareness of the CHEERS study among

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July 2008

several thousand area residents. FCR organizes several urban canoe trips per season at

various locations, as well as the “Chicago River Flatwater Classic,” a popular canoeing

and kayaking event. FCR provides information to its members about the CHEERS study,

and will provide specific enrollment information to those who register for the Flatwater

Classic and selected other events.

7.4.5 Website

In July, 2008, a website was launched to inform the public about this research. A goal of

the website is to provide information about the study, and how one might enroll in it.

The web address of the site is www.cheerschicago.org.

8. Study enrollment and locations

8.1 Enrollment locations

8.1.1 CAWS locations

The November 2004 Draft UAA report includes profiles of CAWS use by recreational

activity and by waterway reach. Based on information in that report, the most heavily

used access points on the Cal-Sag Chanel are the boat launches of Alsip and Worth, from

which approximately 7,000 and 4,000 launches occur per season respectively, making

them by far the most active sites of recreation on the Calumet river system downstream

of the Calumet WRP. At Clark Park on the North Branch of the Chicago River and at the

Skokie Rowing Center Boat Launch on the North Shore Channel, the Chicago River

Canoe & Kayak Rental Company estimates that a total of approximately 5,000 launches

occurred in 2004. That number has reportedly increased to over 7,000 launches per year.

Additionally, approximately 200 rowers per week use the CAWS as members of rowing

clubs and school teams. After assessing these and twelve less frequently used access

points on the CAWS in May 2007, we finalized the list of sites for the enrollment of

study participants for the 2007 season. For the 2008 season, we will recruit at two new

locations of the South Branch of the Chicago River (one for rowers, one for fishers), and

at a second location at North Avenue on the west side of the turning basin. On the Cal-

Sag Channel recruiting will also take place at new locations in 2008: Riverdale Marina,

and at an aeration station near the Village of Worth boat launch.

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July 2008

8.1.2 GUW locations

We will expand the number of “general use waters” locations where recruitment will take

place. In 2007 such recruitment took place at Lake Michigan harbors and beaches, the

Skokie Lagoons, and Crystal Lake.

In 2008 this has been expanded to include

potentially the Fox, Des Plaines, Kankakee, and Du Page Rivers as well as two boating

centers within the Cook County Forest Preserves: Busse Woods and Tampier Lake. The

recruitment manager will work throughout the season to identify additional locations.

8.1.3 Study Area

All 2007 enrollment sites will be included in the 2008 season. The 2008 season will also

incorporate additional CAWS and GUW sites. Enrollment sites visited during the 2007

and 2008 seasons are shown in Figure 3. Site specifications, including geographic

coordinates and the occurrence of water and non-water activities can be found in

Appendix 5 (CAWS locations) and Appendix 6 (GUW locations).

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July 2008

Figure 3. Recruitment locations 2007, 2008 seasons

CAWS North (NSC, NBCR, MS, SBCR)

BR: Bridge Street, Evanston, IL

SK: Skokie Rowing Center, Skokie, IL

RP: River Park, Chicago, IL

CP: Clark Park, Chicago, IL

NA: North Avenue, Chicago, IL

MS: Main Stem, Chicago, IL

PT: Ping Tom Park, Chicago, IL

CAWS South (Cal-Sag)

WO: Worth Boat Launch, Worth, IL

AL: Alsip Boat Launch, Alsip, IL

RM: Riverdale Marina, Riverdale, IL

General Use Waterways

UDP: Upper Des Plaines River, Wadsworth, IL

DS: Des Plaines River, Libertyville, IL

CL: Cystal Lake, Crystal Lake, IL

SL: Skokie Lagoons, near Winnetka, IL

BS: Busse Woods Boating Center, Elk Grove Village, IL

FR: Fox River, St. Charles, IL

LB: Leone Beach, Chicago, IL

MB: Montrose Beach, Chicago, IL

BH: Belmont Harbor, Chicago, IL

DH: Diversey Harbor, Chicago, IL

SD: Solidarity Dr., Chicago, IL

BN: Burnham Harbor, Chicago, IL

JP: Jackson Park Harbor, Chicago, IL

TL: Tampier Lake Boating Center, near Palos Park, IL

HW: Hammel Woods, Shorewood, IL

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July 2008

8.2 Scheduling enrollment by location

8.2.1 Theoretical considerations

Field study locations were selected based on the following principles relevant to data

analysis and interpretation: 1) the activities and locations of enrollment of participants in

the CAWS group should reflect actual CAWS usage patterns, by recreational activity and

location; 2) the distribution of recreational activities among GUW group participants

should reflect that observed in the CAWS group; and 3) the demographic characteristics

of unexposed group participants should reflect that of the other two groups. The unit of

“sampling” the population of recreators is done at the level of the recruitment site. At a

given recruiting site, efforts are made to approach every water recreator and every non-

water recreator within the pre-defined “recruitment area” (Appendices 5 and 6) at that

site to avoid any potential selection bias on the part of the recruiters.

In order to ensure that the activities and locations of enrollment into the CAWS group

reflect actual use, we will track enrollment and use by location on the CAWS. Several

locations are relatively busy (Skokie Rowing Center, the east and west sides of the

turning basin at North Avenue, Alsip, and Worth), while others are intermediate (Clark

Park, River/Ronan Park), and others see relatively little use (Riverdale Marina, the Cal-

Sag SEPAs and South Branch locations). We schedule recruitment at these locations in

relation to actual use. In general, recruitment will take place at all busy locations every

week of the summer (in 2008).

The study’s statistical power will be maximized if the participants are evenly distributed

among the CAWS, GUW, and unexposed groups. Given that this is a dynamic cohort

study into which new participants are enrolled every week, we have the opportunity to

increase or decrease the frequency of recruitment of participants into the three groups in

order to produce groups of equivalent size. If recruitment of one group of participants is

lagging far behind the other two, the frequency of scheduling recruitment targeting that

group will be increased.

Maintaining three groups of equivalent size throughout the

study is desirable for two reasons. First, it will produce a sample size that has higher

statistical power. Second, if a community-wide outbreak were to occur (unrelated to

water quality), all three groups would have a similar likelihood of capturing this outbreak

if the groups are of comparable size. For these reasons, after each block of 1,000

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July 2008

participants is enrolled, the distribution of participants among the three groups is

reviewed. If one or two groups are lagging significantly behind the other(s) (by more

than 15%), the frequency of recruitment efforts targeting those groups are adjusted for the

following month so that the lagging group(s) can catch up in enrollment to the largest

group. This is done based strictly on recruitment rates per site (by group) and not based

on measures of water quality or health events (such data is not available at the time of

schedule revision).

8.2.2 Logistical considerations

Additionally, logistical considerations in the selection of study sites are: 1) waterway

access; 2) the presence of nearby sites of recreational activities that do not involve water,

which would allow the recruitment of participants into the unexposed group on the same

days and at the same approximate location as the recruitment of participants in the

CAWS or lake group; and 3) the physical safety of study personnel.

In the 2007 season, CHEERS enrollment was designed to progress from smaller to larger

enrollment targets during the summer, and from enrolling participants from one access

point per day to two access points per day (by two teams) during periods of anticipated

heavy usage. In 2007, participant recruitment generally took place for 4-6 hours per day.

In 2008, teams will work at four or five recruiting sites per day, with two shifts per site

allowing up to 12 hours of recruitment. Based on the patterns of CAWS usage noted in

the 2007 season, recruitment in 2008 will focus on recruiting rowing teams in clubs in the

early morning or late afternoon, generally on weekdays during the academic year.

Between Memorial Day and Labor Day, recruiting will take place every Friday, Saturday

and Sunday, as well as on holidays at multiple sites per day.

The priorities for setting the recruitment calendar are: 1) organized races or events which

often result in the greatest number of enrolled participants per hour, 2) availability and

eligibility of clubs and teams, 3) more active recruitment sites over less active sites, and

4) increasing frequency of recruitment at sites where enrollment of participants into the

“lagging” group is likely.

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July 2008

A summary of recruiting efforts during the 2007 season and proposed efforts for the 2008

season are listed in Table 8. The recruiting calendar for 2007 and the current calendar for

2008 can be found in appendices 7 and 8, respectively.

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July 2008

Table 2. Summary of 2007 recruitment efforts, projected 2008 recruitment efforts

2008

9 (Flatwater Classic, Chicago Shoreline Marathon,

DesPlaines River Canoe Marathon, Kane County Canoe

Marathon, Mid-America Canoe Race, Fox River Dragon

Boat Race, Chicago River Dragon Boat Race,

Chicagoland Bass Tournament, canoers and kayakers in

11 (New Trier, LPJ, Crystal Lake, St. Ignatius,

Northwestern U., U of Chicago, Chicago River Rowing

and Paddling Club, Chicago Rowing Club, Evanston

Ecology Center, Lincoln Park Boat Club, North Park

8.3 Enrollment targets by exposure group and study year

We plan to enroll a total of 9330 participants, based on considerations outlined in the

Statistical Analysis document (which is not part of this “Overview” document). While we

projected enrollment of 2,010 participants during the 2007 season, we successfully enrolled

886 study participants during the brief 2007 season, of whom 811 were eligible for telephone

follow-up. The recruiting effort has been substantially increased in 2008, with the goal of

recruiting the remaining 8,442 participants. Table 2 displays the overall recruiting targets by

CAWS

Annual Total

9330

Table 3. Study participant recruitment achieved during 2007 and targets for 2008

9. Survey data

9.1 The survey questionnaires being used in this study are derived from those used in the

NEEAR study, conducted by the US EPA and CDC. Like the NEEAR study, we will use

surveys to conduct pre-exposure enrollment, post-recreation exposure assessments, and post

recreation health follow-up by telephone. Modifications to the NEEAR approach are: 1) the

unit of recruitment (and interviewing) will be individuals, rather than family groups, and 2)

exposure questions specific to secondary contact recreational activities have been added. The

study was initially designed to conduct a pre-exposure health assessment questionnaire and a

field clinical exam, and the first 130 participants were enrolled following this protocol.

However, because the physical examination in the field by a clinician was considered a

potential disincentive to participation and little information was gained from it, it was

dropped from the protocol. The survey questionnaires were developed for this study in

conjunction with the University of Illinois at Chicago (UIC) Survey Research Laboratory

(SRL), a national leader in survey development, administration, and analysis. Elements of

the survey portion of CHEERS are described briefly below. Detailed information is

presented in QAPP 2: Survey Methods.

9.2 Questionnaires

A total of four questionnaires will be administered to all study participants:

9.2.1 An eligibility screen

9.2.2 A pre-recreation field questionnaire

9.2.4 A post-recreation field questionnaire

9.2.5 A telephone follow-up questionnaire

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July 2008

9.3 Questionnaire administration

Questionnaires will be administered in face-to-face interviews, with the exception of the

follow-up questionnaire, which will be administered by telephone. The questionnaires will be

administered using computer assisted interview (CAI) methods, with the exception of the

eligibility screen. The CAIs conducted in the field will be administered used computer-

assisted personal interviewing (CAPI) methods, while the telephone follow-up questionnaire

will be administered using computer assisted telephone interview (CATI) methods. Field

interviews will be conducted using laptop computers and the telephone interview will be

conducted at UIC using desktop computers.

For children under the age of 7, parents will be required to provide proxy responses for the

child; for children ages 8 through 17, parents have the option to serve as the proxy

respondent. In both cases, parents are encouraged to accompany the child during the

interview.

9.4. Health end-points

Using survey methods, we will determine whether each participant does or does not develop

specific health endpoints. Key health endpoints to be identified are acute gastrointestinal

illness and non-gastrointestinal illness:

Acute gastrointestinal illness (AGI)

We will use two of definitions of AGI. One is based on the presence or absence of single

symptoms (such as vomiting or diarrhea). The other is based on a syndrome of two or

more symptoms. Prior studies have defined specific syndromes, and our study

questionnaires and data analyses have been planned to allow comparisons of rates of such

syndromes determined in our study to those in other studies. These definitions include

Cabelli’s “Highly Credible Gastrointestinal Illness”

and the definitions used the primary

contact studies.

16-18

Non gastrointestinal illness (NGI)

Definitions for otitis externa, conjunctivitis, acute respiratory tract infections, and skin

infections will be based on responses to questionnaire items. In addition to the above

definitions, “culture positive AGI” will be defined as cases of AGI in which a pathogen is

identified on stool analysis. Similar categories for culture-positive conjunctivitis and

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July 2008

skin/wound infection will be created though we expect few individuals to have such

infections.

10. Clinical microbiology

10.1 Prior health studies of recreational water contact have relied upon telephone or postal

questionnaires to define health endpoints (such as AGI). In other words, objective measures

of health endpoints have been lacking. One exception is a primary contact study conducted in

the United Kingdom conducted by Jones, et al.

In that randomized controlled trial of

exposure to seawater, both water-exposed and unexposed participants were asked to bring

stool samples three days before, three days after, and three weeks after the trial date. A total

of 781 specimens were obtained from 276 participants, the vast majority of whom had no

gastrointestinal symptoms. Two samples tested positive for

Salmonella spp,. (

one sample was

obtained prior to the trial date), one for

Campylobacter spp.

(again, obtained prior to the trial

, and five for enterovirus. Because of the

small numbers of positive stool specimens, differences in the rates of infection by study

group (exposed vs. unexposed) were not presented. In part because of the lack of positive

findings in this study, investigations of the pathogens responsible for endemic (as opposed to

outbreak-associated) recreational water illness were not conducted.

Based on the experience of Jones, we intend to only collect stool samples 1) after recreational

activities, 2) from individuals with symptoms, and 3) by dispatching study personnel to pick

up samples from the participants’ homes. After participants who report specific symptoms at

telephone follow-up are asked to provde a stool specimen, they will be told that they will

receive an extra $75 for their efforts. This is expected to provide additional motivation for the

collection of samples.

10.2 Selection of pathogens

Pathogens of interest have been identified by reviewing recent publications by the

Waterborne Disease and Outbreak Surveillance System of the US Centers for Disease

Control and Prevention.

24,25

Additionally, data on pathogens in the CAWS have been

physician/epidemiologists and the director of a university hospital microbiology laboratory,

have assisted in defining the pathogens of interest, as presented in Table 3.

Parasites

Table 4: Pathogens to be detected in stool samples

Entamoeba histolytica

Giardia lamblia

Cryptosporidium spp.

Cyclorospora

10.3 Timing of follow-up phone interviews

Based on information from an authoritative textbook of infectious diseases,

we devised a

chart of the latency between exposure and AGI onset (Figure 4) and well as the optimal

timing for collecting stool samples, given the period of shedding organisms in stool (Figure

5). This information was used to select days 2, 5 and 21 following recreation to conduct

telephone follow-up and collect stool samples.

11. Human Research Subject Protections

This research study has been approved by the UIC Office for Protection of Research Subjects,

Institutional Review Board (IRB). The UIC IRB protocol number is 2007-0436. Human

research protection issues and the IRB process are described in detail in QAPP #2: Survey

methods.

Further details about clinical sample collection analyses are described in QAPP #3: Clinical

Microbiology and Evaluations.

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July 2008

Figure 4: Usual incubation period ranges for selected etiologic agents

Figure 5: Shedding period and optimal collection period for select etiologic agents

CHEERS Overview

July 2008

12. Overview of Water Sampling

12.1 Purpose and types of water sampling

Water sampling and analysis will support study objectives 2 (characterizing the relationship

between concentrations of water microbes and rates of illness) and study objective 3 (exploring

sources of pathogens on the waterways). What follows is an overview of water sampling and

analysis. Detailed information is provided in QAPP 1: Water sampling and Analysis.

Two types of water sampling will take place: direct sampling and large volume sampling. The

large volumes samples will be collected by the use of pumps which will collect water for

continuous flow centrifugation (CFC) and for viral filtration . Direct sampling will be used to

collect water for analyses of densities of indicator micrboes

E. coli,

enterococci, and coliphages.

CFC will be employed to collect water samples for analyses of

Giardia

and

Cryptosporidium

Filtration samples will be analyzed for norovirus. Samples will be archived for potential future

analyses.

12.2 Locations for Water Sampling

Water sampling locations will depend upon enrollment locations on any given date. For each

enrollment location we will sample water every two hours at the approximate site of water entry

(“access point sampling”). CAWS water will also be sampled upstream and downstream of the

nearest upstream WRP, at the beginning and end of the enrollment day (“WRP sampling”).

Additionally, for locations on the North Branch of the Chicago River, water samples will also be

taken from the North Branch upstream of the North Branch dam. This location is important

because at this location water that does not have an upstream WRP enters the CAWS from the

North Branch of the Chicago River.

Categories of sampling locations were developed to support the analyses required for meeting

specific study objectives. Table 5 presents the primary uses of water quality measures collected

by location category. Health outcomes will be modeled using access point indicator densities,

and also (separately) using downstream sampling site indicator organism densities. While access

point measures may prove to be better predictors of health outcomes, sampling from a variety of

access points will likely not prove practical in establishing water quality standards for the

CAWS. Microbe densities measured in sampling collected at the fixed “downstream” sites could

be a convenient measure used to define a sampling plan to comply with possible regulatory

CHEERS Overview

July 2008

requirements in the future. This distinction parallels the ongoing debate in recreational water

illness epidemiology over whether the “ecologic exposure” or “personal exposure model” is

preferable. Recent work indicates that in the primary contact setting any difference between the

two approaches is small,

though it is not clear whether this will prove to be true for CAWS

Predicting health events

√

Regulatory

√

Illness-source linkage

√

Table 5. Primary purpose of water sampling, by location.

The collection of water samples both upstream and downstream of the WRPs, as well as above

the North Branch Dam (for North Branch access points) will allow the exploration of sources of

pathogens responsible for illness among CAWS recreators. Table 6 presents locations for CAWS

water sampling at sites other than participant recruitment locations.

Table 6. Locations for water sampling on the CAWS other than recruitment sites.

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July 2008

On each day of participant enrollment and field evaluation, water will be sampled at the locations

Table 7. Water sampling locations, by site of participant enrollment.

13. Field Team Organization

The management structure of the overall epidemiologic study is described in a separate

document, the “Quality Management Plan.” Each field team consists of approximately twelve

UIC personnel, who perform logistical, water sampling, participant recruitment, and evaluation

functions. The staffing level varies with daily recruiting targets. On days on which participants

will be enrolled at two locations, two teams are simultaneously in the field. On those days, the

water sampling and survey supervisors, water sampling staff, and equipment courier serve both

locations. Each site has a dedicated data manager plus survey personnel and recruiters..For the

2008 season, twelve-hour recruiting efforts will employ 2 six-hour shifts of recruiters and

interviewers.

Position (number in this capacity)

Water sampling supervisor (1 per day)

Direct method water sampling staff (2-4 per shift)

Filtration method water sampling staff (2 per shift)

Water chemistry and quality monitoring (1 per shift)

Courier/driver (1 per shift)

Survey supervisor (1 per day)

Recruiter/interviewer (2-4 per site)

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July 2008

Field data manager (1 per site per shift)

14. Project management

The management structure of CHEERS reflects the need to coordinate and ensure the quality of

the diverse and interdependent elements of this project. Figure 6 outlines the positions and roles

of members of the project management team. All work will be done at UIC, with the exception

of the microbial measures of water quality, certain elements of study publicity performed by

Friends of the Chicago River and some stool analyses to be performed by the Illinois Department

of Public Health (IDPH). The study director, project coordinator, project managers, quality

manager, and field coordinator comprise the leadership team of the project and have direct

responsibility for its execution. Additionally, several UIC SPH faculty members have played

critical roles in protocol development and will continue to provide ongoing consultation. All

personnel are employed by the UIC School of Public Health unless otherwise indicated. Other

important members of the research team and the roles that they play are included in the project-

specific QAPP documents.

14.1 Study director

The study director, Samuel Dorevitch, MD, MPH, will have overall responsibility for the

development and implementation of the CHEERS study, as well as providing deliverables to the

MWRDGC. Specific responsibilities of the study director include the hiring and supervising of

project managers, establishing subcontracts with entities external to UIC, complying with human

subjects research protection requirements, and communicating with the MWRDGC.

14.2 Quality Manager

Peter Scheff, PhD, is the CHEERS quality manager. His responsibilities will include the

development of the organization-wide QMP, as well as the four individual Quality Assurance

Project Plans (QAPPs) for each component of the overall study. He has worked with the study

director and assistant study directors to establish data quality objectives for individual projects.

He will review the quality control data of the laboratories conducting water and medical sample

analyses, conduct quality audits, and communicate with quality managers of the Survey Research

Laboratory (SRL), UIC microbiology laboratory, IDPH microbiology, and microbial water

quality laboratories.

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July 2008

14.3 CHEERS Project Manager

Sara Wuellner, MS, is the CHEERS project manager. The CHEERS project manager will have

field, administrative, data management and quality monitoring functions. The CHEERS project

manager will serve as a field supervisor and coordinate the three primary field data collection

activities (water, survey, and clinical). The program manager will be responsible for ensuring

that sufficient staff are available to conduct the field study, and will manages an online

scheduling and staffing system. She will also track and consolidate incoming data from the

laboratories and ensure the timely addition of the data to the central CHEERS database. The

project manager will have responsibilities for organizing and maintain study related documents

(laboratory reports, data, IRB documents) and for report writing.

14.4 Survey Data Manager

The survey data manager will ensure the training of field team members and develop survey

questionnaires based upon those used by the US EPA/CDC NEEAR study. Preethi Pratap, PhD,

serving in this capacity, will also coordinate the review and programming of the questionnaires

to be performed by SRL. She will also be responsible for training the field and telephone survey

staff. Dr. Pratap will ensure the smooth transfer of data from field surveys to SRL, and from

SRL to the telephone follow-up team. At field study events, she will serve as field data

coordinator, and will ensure the accurate compilation of consent documents, the assignment of

case ID’s, unique identifiers for study participants, and the smooth flow of participants through

the study process. Throughout data collection periods, the Survey Project Manager will track

study enrollment, study completion by participants, and attrition from the study. The Survey

Project Manager will coordinate staffing of the survey teams with the field coordinator.

14.5 Clinical Project Manager

Jacqueline Wuellner, RN, MPH, as the Clinical Project Manager will be responsible for the

staffing and training of clinicians who will conduct field and home clinical evaluations, and the

staff who will collect stool samples from homes of study participants. The Clinical Project

Manager will be responsible for communications with the managers of the microbiology

laboratories that will analyze medical samples. Together with the study Quality Manager, she

will be responsible for establishing the identification and tracking procedures for medical

samples.

CHEERS Overview

July 2008

14.6 Water Project Manager

Margit Javor, MS, is the Water Project Manager, and will be responsible for the development of

the water sampling protocol, standard operating procedures (SOPs), and the training of field staff

to implement the protocol and SOPs. The water data manager will work closely with the field

manager and quality manager to review data from the analytic laboratories to identify and

promptly address deviations from the data quality objectives for water quality measurements.

The water data manager will be responsible for staff that performs quality monitoring and water

chemistry measures, as well as the training of all water sampling staff. The Water Project

Manager will communicate with the laboratories that analyze water samples to ensure the prompt

delivery of chain of custody forms and laboratory results.

14.7 Field manager

The field manager will be responsible for the logistics of fieldwork. Todd Schoonover, MS,

CIH, will ensure the smooth functioning of the water sampling portion of the study, and will be

responsible for procuring and maintaining major study pieces of equipment, such as vehicles,

boats, pumps, centrifuges, and refrigerators. He will ensure the transport of water samples to the

commercial analytic laboratories. The field manager works closely with the Water Project

Manager to ensure the implementation of the water sampling protocol by field staff. This will

involve preparing all necessary timetables, labels, materials, and equipment for each day of field

sampling. Mr. Schoonover will provide the water sampling schedule to the analytic laboratories

and provide timely notification regarding any modifications to that schedule. The decision to

cancel a day of field work due to a high probability (80% chance) of thunderstorms will be made

by the field manager.

14.8 Supply manager

Nicholas “Buck” Hanson, MPH, will be the project supply manager. He will be responsible for

training and supervising staff who prepare the equipment and supplies for the field study. He

will send mailings (including stool sample collection kits, when indicated) to study participants.

He will monitor study supply inventories, order additional supplies as needed, and ensure

delivery of supplies to the field. He will also have certain data management responsibilities.

CHEERS Overview

July 2008

14.9 Biostatistician

Li Liu, PhD, will be responsible for merging study data from diverse sources into a single dataset

for analysis Dr. Liu will perform interim analyses following each recreation season, as well as a

final analysis after all health data has been collected. She will review data analysis plans

developed by members of the research team who will conduct parts of the data analysis, and

provide consultation.

14.10 Fiscal management

Anita Shaperd, of the Division of Epidemiology and Biostatistics at the UIC SPH, will

coordinate the fiscal aspects of the study, including purchasing, accounting, and subcontracting.

The fiscal manager will work closely with the personnel/human resources manager in the

Division to hire and pay study personnel.

14.11 Internal Consultants

Daniel Hryhorczuk, MD, MPH; Mark Dworkin, MD, MPH; Ronald Hershow, MD, MPH; and

Leslie Stayner, PhD, have all assisted with the development of the study protocol. They will

continue to advise on the implementation, analysis, and interpretation of results of the study.

14.12 WERF Science Advisory Board

A group of independent, nationally-recognized experts on water microbiology, the epidemiology

of recreational water-borne illness, infectious diseases, waste water treatment, and related fields,

was convened by the Water Environment Research Foundation (WERF) to conduct peer review

of the study before it was launched in the field. The same group now functions as a science

advisory board, reviewing study progress, quality data and proposed changes to the study

protocol. Lola Olabode of WERF coordinates the review/science advisory group.

14.13 Friends of the Chicago River

Friends of the Chicago River (FCR) works to preserve, protect and foster the vitality of the

Chicago River. FCR is trusted and respected by users of the Chicago River and will work to

promote publicity about the CHEERS study among river users. Margaret Frisbie, Executive

Director of FCR, will be responsible for working with UIC to disseminate the publicity message

Thomas Granato, PhD, will be the MWRDGC’s contact for communications with UIC. He will

coordinate the MWRDGC’s review of this protocol and QAPPs, the external scientific review, a

local stakeholder review, and WERF/Science Advisory Board-UIC meetings. Dr. Granato will

ensure the transfer of data collected by the MWRDGC, such as water quality measures

monitored along the CAWs, the CSOs, water flow through the controlling works and pumping

stations, and effluent discharge from the WRPs.

CHEERS Overview

July 2008

Study director

S. Dorevitch, MD, MPH

Field study support

manager

manager

Water project

manager

M. Javor, MS

Fiscal Management

A. Shaperd

Data Analysis

L. Liu, PhD

UIC SPH

consultants

MWRDGC liaison

T. Granato, PhD

CHEERS Project Manager

S. Wuellner, MS

Field manager

T. Schoonover,

MS, CIH

Recruitment

manager

WERF Science

Personnel Manager

K. Fodor

Figure 6: CHEERS project management

15. Communications Plan

15.1 General

The study director, quality manager, project managers, field manager, and their assistants

meet each week to discuss the data quality objectives and any issues or concerns regarding

field work and logistics. The study maintains an internal website for sharing documents,

housing training materials, and posting schedules. All study managers have access to the

website. In addition to this meeting of the core leadership team, “water group” meetings and

“interview group” meetings will be held on a weekly basis, with the project coordinator and

assistant study directors planning upcoming events and reviewing quality data (such as

unusual occurrence reports) with project staff. Communications between the project

managers and the project staff is supported by a “Shiftboard” website. That site is used for

scheduling and general communications purposes. A central element of the CHEERS

training manual includes lines of communications and all personnel are aware of whom to

contact with questions.

15.2 Field work

Pre-paid cellular phone cards are provided to field supervisors and onsite survey data

managers to facilitate field communications and to allow supervisors to coordinate activities

and address problems as quickly as possible. Members of the interview/recruitment team

bring questions or concerns to the enrollment onsite data manager. In the event that the data

managers have questions or concerns, they contact the day’s field interview supervisor.

Members of the water sampling team bring concerns to the field water supervisor. Questions

from the field supervisors re brought to the project coordinator, who consults with the study

director when necessary. All field staff are provided with a list of contact names and phone

numbers that includes daily field supervisor and study director contact information, as well as

contact Information for laboratories and municipalities with which we work. Before each

shift, a briefing is conducted by the field supervisor to address any new or ongoing issues.

CHEERS Overview

July 2008

References

CDM. Use Attainability Analsysis (Draft). 2004.

Illinois EPA. Pre-filed testimony of Rob Sulski. 2007.

CDM. Chicago Area Waterway Use Attainability Analysis. 2007.

Fewtrell L, Godfree AF, Jones F, Kay D, Salmon RL, Wyer MD. Health effects of white-

water canoeing. Lancet 1992; 339:1587-9.

Fewtrell L, Kay D, Salmon RL, Wyer MD, Newman G, Bowering G. The health effects

of low-contact water activities in fresh and estuarine waters. Journal of the Institute of

Water and Environmental Management 1994; 81:97-101.

Lee JV, Dawson SR, Ward S, Surman SB, Neal KR. Bacteriophages are a better indicator

of illness rates than bacteria amongst users of a white water course fed by a lowland

river. Water Sci Technol 1997; 35:165-70.

Gray JJ, Green J, Cunliffe C, Gallimore C, Lee JV, Neal K, et al. Mixed genogroup

SRSV infections among a party of canoeists exposed to contaminated recreational water.

J Med Virol 1997; 52:425-9.

Appleton CC, Bailey IW. Canoeists and waterborne diseases in South Africa. S Afr Med

J 1990; 78:323-6.

Taylor MB, Becker PJ, Van Rensburg EJ, Harris BN, Bailey IW, Grabow WO. A

serosurvey of water-borne pathogens amongst canoeists in South Africa. Epidemiol

Infect 1995; 115:299-307.

10.

Pruss A. Review of epidemiological studies on health effects from exposure to

recreational water. Int J Epidemiol 1998; 27:1-9.

11.

Wade TJ, Pai N, Eisenberg JN, Colford JM, Jr. Do U.S. Environmental Protection

Agency water quality guidelines for recreational waters prevent gastrointestinal illness?

A systematic review and meta-analysis. Environ Health Perspect 2003; 111:1102-9.

12.

Stevenson AH. Studies of bathing water quality and health. Am J Public Health 1953;

43:529-38.

13.

Cabelli VJ, Dufour AP, Levin MA, McCabe LJ, Haberman PW. Relationship of

microbial indicators to health effects at marine bathing beaches. Am J Public Health

Cabelli VJ, Dufour AP, McCabe LJ, Levin MA. Swimming-associated gastroenteritis and

water quality. Am J Epidemiol 1982; 115:606-16.

15.

Dufour AP. Bacterial indicators of recreational water quality. Can J Public Health 1984;

75:49-56.

16.

Colford JM, Jr., Wade TJ, Schiff KC, Wright CC, Griffith JF, Sandhu SK, et al. Water

quality indicators and the risk of illness at beaches with nonpoint sources of fecal

contamination. Epidemiology 2007; 18:27-35.

17.

Wade TJ, Calderon RL, Brenner KP, Sams E, Beach M, Haugland R, et al. High

sensitivity of children to swimming-associated gastrointestinal illness: results using a

rapid assay of recreational water quality. Epidemiology 2008; 19:375-83.

18.

Wade TJ, Calderon RL, Sams E, Beach M, Brenner KP, Williams AH, et al. Rapidly

measured indicators of recreational water quality are predictive of swimming-associated

gastrointestinal illness. Environ Health Perspect 2006; 114:24-8.

19.

Fleisher JM, Jones F, Kay D, Stanwell-Smith R, Wyer M, Morano R. Water and non-

water-related risk factors for gastroenteritis among bathers exposed to sewage-

contaminated marine waters. Int J Epidemiol 1993; 22:698-708.

20.

Fleisher JM, Kay D, Salmon RL, Jones F, Wyer MD, Godfree AF. Marine waters

contaminated with domestic sewage: nonenteric illnesses associated with bather exposure

in the United Kingdom. Am J Public Health 1996; 86:1228-34.

21.

Kay D, Fleisher JM, Salmon RL, Jones F, Wyer MD, Godfree AF, et al. Predicting

likelihood of gastroenteritis from sea bathing: results from randomised exposure. Lancet

1994; 344:905-9.

22.

Wiedenmann A, Kruger P, Dietz K, Lopez-Pila JM, Szewzyk R, Botzenhart K. A

randomized controlled trial assessing infectious disease risks from bathing in fresh

recreational waters in relation to the concentration of Escherichia coli, intestinal

enterococci, Clostridium perfringens, and somatic coliphages. Environ Health Perspect

2006; 114:228-36.

23.

Jessop EG, Horsley SD, Wood L. Recreational use of inland water and health: are

Windermere and Coniston water a health hazard? Public Health 1985; 99:338-42.

CHEERS Overview

July 2008

24.

Dziuban EJ, Liang JL, Craun GF, Hill V, Yu PA, Painter J, et al. Surveillance for

waterborne disease and outbreaks associated with recreational water--United States,

2003-2004. MMWR Surveill Summ 2006; 55:1-30.

25.

Yoder JS, Blackburn BG, Craun GF, Hill V, Levy DA, Chen N, et al. Surveillance for

waterborne-disease outbreaks associated with recreational water--United States, 2001-

2002. MMWR Surveill Summ 2004; 53:1-22.

26.

MWRDGC. Expert review report regarding United States Enviornmental Protection

Agency's water quality criteria for bacteria - applicaiton to secondary contact criteria.

Chicago, IL, 2006.

27.

GeosyntechConsultants. Dry and wet weather risk assessment of human health impacts of

disinfection versus no disinfection of the Chicago Area Waterways System (CWS). 2008.

28.

Dufour AP, Evans O, Behymer TD, Cantu R. Water ingestion during swimming activities

in a pool: a pilot study. J Water Health 2006; 4:425-30.

29.

Black S, Shinefield H, Hansen J, Lewis E, Su L, Coplan P. A post-licensure evaluation of

the safety of inactivated hepatitis A vaccine (VAQTA, Merck) in children and adults.

Vaccine 2004; 22:766-72.

30.

Jones F, Kay D, Stanwell-Smith R, Wyer M. Results of the first pilot scale controlled

cohort epidemiological observation into the possible health effects of bathing in seawater

and Landland Bay, Swansea. J Inst Water Env Management 1991:91-8.

31.

Mandell G, Bennet J, Dolin R. Principles and Syndromes of Enteric Infections. In:

Principles and Practices of Infectious Diseases 6ed. Philadelphia, PA: Elsevier Inc.; 2005.

32.

Wymer LJ, Dufour AP, Calderon RL, Wade TJ, Beach M. Comment on "Derivation of

numerical values for the World Health Organization guidelines for recreational waters".

Water Res 2005; 39:2774-7.

CHEERS Overview

July 2008

CHEERS Overview Document

Appendix 1: Study Logo

CHEERS Overview Document

Appendix 2: Recruitment Flier

CHEERS Overview Document

Appendix 3: Information for clubs, team

organizers and vendors

CHEE Ca Ha a E Ea

and it is being conducted by

Dr. Sam Dorevitch of The University of Illinois at Chicago (UIC) School of Public Health.

This study is being funded by the Metropolitan Water Reclamation District of Greater Chicago.

CHEERS is a research study about the health of people in the Chicago area who participate in outdoor

activities. We are interested in canoers, kayakers, rowers and fishermen on waters in the Chicago area, as

well as, people engaging in outdoor activities

a ’ a

(such as bicycling and jogging) near

local lakes, lagoons and rivers.

Our goal is to assess the health of people who participate in different outdoor activities on and around local

lakes, lagoons, rivers and channels.

We want to know if health is linked with water quality, especially among people like you who participate in

outdoor recreational activities in and around the Chicago waterways.

The results of this study could be used for developing better environmental water quality standards to

improve public health.

The study does not involve swimmers because many research studies have evaluated the link between water

quality and swimming. This study addresses other forms of water recreation.

No information provided by research participants during the research will be disclosed to non-research staff.

We respect the privacy of research participants. All computer files with will be password-protected. When

the results of the research are published or discussed in conferences, no information will be included that

would reveal the identity of study participants.

The research study will last about 3 years. Individuals who will enroll will answer a few questions in person

when they enroll in the

. W’ a

them by phone 2, 5 and 21 days from the date of enrollment to

check on their health. When they have completed the last telephone interview, 21 days later they will be

eligible to partake in the study again.

We will explain the study to potential participants in detail. Any questions they may have will be answered.

Then, we will ask them a few questions to see if they are eligible to be in this study.

Anyone who participates will be given a free CHEERS T-shirt and a $15 Target gift card after finishing the

surveys. At the end of 21 days of participation we will send participants a $35 check for their time and effort.

Some people will be selected for an optional home visit. We will provide those selected with an extra $75.

This is not an official recruiting document. Anyone who wants to be in the study will be given a consent

form, and we will answer any questions they may have about this research.

We look forward to the opportunity to work with your organization on this environmental health study! For

any questions, please contact Amelia DeLaquil at adelaquil@gmail.com.

General information about CHEERS: For

clubs, teams, organizations, and vendors

CHEERS Overview Document

Appendix 4: Water Quality Frequently Asked

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managed by the Metropolitan

rowiug are allowed. For

more inforrnatiott about the

waterways.

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For

more infbrrnation

about the Metropolitan

Water

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rseactiorti

inclefC.ltU/-fqWaglj-Q.-niir-v-ig*-1q-p-Q$jlgn-Q

For

information about beach

the Illinois Department

Public

Health Beach

Information

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jslr-dstilir-1s.p-sljaskrqrl$d&$A!vrisvZ"elQ0?.Q2.-0j+:-df

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CHEERS Overview Document

Appendix 5

Recruitment sites: CAWS

CHEERS Overview: CAWS recruiting locations

2008 Recruiting Site Specifications-CAWS

Water Activity

Non-water Activity

Site

GPS

Coordinates

Recruitment Area and Tent

Location

CAWS: Calumet System

CAWS: North Branch Chicago

River

North Ave, East

N: 41°54.607’

W: 87°93.283’

CHEERS Overview: CAWS recruiting locations

CAWS: South Branch Chicago

River

CHEERS Overview: CAWS recruiting locations

CHEERS Overview Document

Appendix 6

Recruitment sites: GUW

CHEERS Overview: GUW recruiting sites

Water Activity

Non-water Activity

Site

GPS

Coordinates

Recruitment Area and Tent

Location

GUW: Lake Michigan

CHEERS Overview: GUW recruiting sites

GUW: Area Waterways

CHEERS Overview: GUW recruiting sites

CHEERS Overview: GUW recruiting sites

CHEERS Overview Document

Appendix 7

2007 Recruiting Schedule

DATE

SITE

8/4/2007

CAWS: Alsip Boat Launch

8/11/2007

GUW: Skokie Lagoons

8/12/2007

CAWS: Skokie Rowing Center

8/17/2007

CAWS: Worth Boat Launch

8/18/2007

GUW: Skokie Lagoons

8/19/2007

CAWS: Skokie Rowing Center

CAWS: Skokie Rowing Center

9/9/2007

CAWS: Skokie Rowing Center

CAWS: Clark Park - Ping Tom (Flatwater Classic)

9/22/2007

CAWS: Worth Boat Launch

9/22/2007

CAWS: Alsip Boat Launch

9/23/2007

GUW: Jackson Park Harbor

9/24/2007

CAWS: Skokie Rowing Center

CAWS: Skokie Rowing Center

10/6/2007

GUW: Montrose Beach

10/7/2007

GUW: Jackson Park Harbor

10/9/2007

CAWS: Skokie Rowing Center

CAWS: North Ave @ Kingsbury

11/5/2007

CAWS: North Ave @ Kingsbury

CHEERS Overview Document

Appendix 8

2008 Recruiting Schedule

CHEERS Overview-Appendix 8

Date

Location

Notes

3/10/2008 CAWS: North Ave @ Kingsbury

3/18/2008 CAWS: North Ave @ Magnolia

3/22/2008 CAWS: North Ave @ Magnolia

team canceled

3/24/2008 CAWS: Skokie Rowing Center

3/26/2008 CAWS: North Ave @ Magnolia

3/31/2008 CAWS: Skokie Rowing Center

4/1/2008 CAWS: Skokie Rowing Center

4/5/2008 GUW: Diversey Harbor

4/7/2008 CAWS: North Ave @ Kingsbury

4/13/2008 GUW: Diversey Harbor

4/14/2008 CAWS: North Ave @ Magnolia

4/19/2008 GUW: DuPage River - Hammel Woods

4/20/2008 GUW: Skokie Lagoons

4/21/2008 CAWS: Skokie Rowing Center

4/22/2008 CAWS: Skokie Rowing Center

4/23/2008 GUW: Crystal Lake

4/26/2008 GUW: Diversey Harbor

4/27/2008 GUW: Upper Des Plaines River

5/3/2008 GUW: Skokie Lagoons

5/4/2008 GUW: Montrose Beach

5/10/2008 GUW: Jackso Park Harbor

5/11/2008 GUW: Burnham Harbor

rain cancellation

5/12/2008 CAWS: North Ave @ Magnolia

5/13/2008 CAWS: North Ave @ Magnolia

canceled

5/17/2008 GUW: Skokie Lagoons

5/18/2008 GUW: Des Plaines River - Libertyville

5/22/2008 CAWS: North Ave @ Magnolia

5/22/2008 GUW: Jackso Park Harbor

5/24/2008 CAWS: Skokie Rowing Center

5/24/2008 CAWS: River Park

5/24/2008 CAWS: Clark Park

5/24/2008 CAWS: North Ave @ Magnolia

5/25/2008 CAWS: Alsip Boat Launch

5/25/2008 CAWS: Riverdale Marina

5/25/2008 CAWS: Worth Boat Launch

5/26/2008 GUW: Montrose Beach

5/26/2008 GUW: Diversey Harbor

5/26/2008 GUW: Jackso Park Harbor

5/30/2008 CAWS: Alsip Boat Launch

rain cancellation

5/30/2008 CAWS: Riverdale Marina

rain cancellation

5/30/2008 CAWS: Worth Boat Launch

rain cancellation

5/31/2008 GUW: Busse Lake Boating Center

5/31/2008 GUW: Diversey Harbor

CHEERS Overview-Appendix 8

5/31/2008 GUW: Leone Beach

5/31/2008 GUW: Montrose Beach

6/1/2008 GUW: Crystal Lake

6/1/2008 GUW: Skokie Lagoons

6/6/2008 CAWS: Clark Park

rain cancellation

6/6/2008 CAWS: Skokie Rowing Center

rain cancellation

6/7/2008 GUW: Fox River - St. Charles

6/7/2008 GUW: Tampier Lake Boating Center

6/8/2008 GUW: Busse Lake Boating Center

6/8/2008 GUW: Fox River - St. Charles

6/9/2008 CAWS: Skokie Rowing Center

6/10/2008 CAWS: Skokie Rowing Center

6/13/2008 CAWS: Alsip Boat Launch

6/13/2008 CAWS: Riverdale Marina

6/13/2008 CAWS: Worth Boat Launch

6/14/2008 GUW: Belmont Harbor

6/14/2008 GUW: Diversey Harbor

6/14/2008 GUW: Montrose Beach

6/14/2008 GUW: Skokie Lagoons

6/15/2008 CAWS: Clark Park

6/15/2008 CAWS: North Ave @ Magnolia

6/15/2008 CAWS: River Park

6/15/2008 CAWS: Skokie Rowing Center

6/17/2008 CAWS: North Ave @ Kingsbury

6/20/2008 CAWS: Alsip Boat Launch

6/20/2008 CAWS: Riverdale Marina

6/20/2008 CAWS: Worth Boat Launch

6/21/2008 CAWS: Clark Park

6/21/2008 CAWS: Evanston Ecology Center

6/21/2008 CAWS: North Ave @ Magnolia

6/21/2008 CAWS: River Park

6/21/2008 CAWS: Skokie Rowing Center

6/22/2008 CAWS: Alsip Boat Launch

6/22/2008 CAWS: Riverdale Marina

6/22/2008 CAWS: Worth Boat Launch

6/22/2008 GUW: Tampier Lake Boating Center

6/27/2008 CAWS: Clark Park

6/27/2008 CAWS: River Fishing Festival

6/27/2008 CAWS: Skokie Rowing Center

6/28/2008 CAWS: Alsip Boat Launch

6/28/2008 CAWS: Riverdale Marina

6/28/2008 CAWS: Worth Boat Launch

6/28/2008 GUW: Busse Lake Boating Center

6/29/2008 CAWS: Clark Park

6/29/2008 CAWS: North Ave @ Magnolia

6/29/2008 CAWS: Skokie Rowing Center

CHEERS Overview-Appendix 8

6/29/2008 GUW: Skokie Lagoons

7/4/2008 GUW: Burnham Harbor

7/4/2008 GUW: Leone Beach

7/4/2008 GUW: Montrose Beach

7/4/2008 GUW: Solidarity Drive

7/5/2008 CAWS: Clark Park

7/5/2008 CAWS: North Ave @ Magnolia

7/5/2008 CAWS: River Park

7/5/2008 CAWS: Skokie Rowing Center

7/5/2008 GUW: Lincoln Park Boat Club

7/6/2008 CAWS: Alsip Boat Launch

7/6/2008 CAWS: Riverdale Marina

7/6/2008 CAWS: Worth Boat Launch

7/6/2008 GUW: Busse Lake Boating Center

7/7/2008 CAWS: River Fishing Festival

7/11/2008 CAWS: Clark Park

7/11/2008 CAWS: North Ave @ Magnolia

7/11/2008 CAWS: River Fishing Festival

7/11/2008 CAWS: Skokie Rowing Center

7/12/2008 GUW: Lake Arlington

rain cancellation

7/12/2008 GUW: Diversey Harbor

rain cancellation

7/12/2008 GUW: Lincoln Park Boat Club

7/12/2008 GUW: Montrose Beach

rain cancellation

7/13/2008 CAWS: Clark Park

7/13/2008 CAWS: North Ave @ Magnolia

7/13/2008 CAWS: Skokie Rowing Center

7/13/2008 GUW: Skokie Lagoons

7/18/2008 GUW: Belmont Harbor

7/18/2008 GUW: Busse Lake Boating Center

7/18/2008 GUW: Diversey Harbor

7/18/2008 GUW: Montrose Beach

7/19/2008 CAWS: Alsip Boat Launch

rain cancellation

7/19/2008 CAWS: Worth Boat Launch

rain cancellation

7/19/2008 GUW: Tampier Lake Boating Center

rain cancellation

7/20/2008 CAWS: Clark Park

7/20/2008 CAWS: North Ave @ Magnolia

7/20/2008 CAWS: River Park

7/20/2008 CAWS: Skokie Rowing Center

7/20/2008 GUW: Skokie Lagoons

7/25/2008 CAWS: Clark Park

7/25/2008 GUW: Diversey Harbor

7/25/2008 GUW: Montrose Beach

7/25/2008 GUW: Solidarity Drive

7/26/2008 CAWS: Clark Park

7/26/2008 CAWS: North Ave @ Magnolia

7/26/2008 CAWS: Ping Tom Park

CHEERS Overview-Appendix 8

7/27/2008 CAWS: Alsip Boat Launch

7/27/2008 CAWS: Worth Boat Launch

7/27/2008 GUW: Tampier Lake Boating Center

Overview Appendix 8: 2008 CHEERS recruiting schedule

CHEERS Overview-Appendix 8

CHEERS: The Chicago Health, Environmental

Exposure and Recreation Study

QUALITY MANAGEMENT PLAN

Samuel Dorevitch, MD, MPH

Division of Environmental and Occupational Health Sciences

Division of Epidemiology and Biostatistics

University of Illinois at Chicago School of Public Health

2121 W. Taylor, M/C 922

Chicago, IL 60612

__________________________________

______________

Samuel Dorevitch, Study Director

Date

__________________________________

_______________

Peter A. Scheff, Project Quality Manager

Date

Table of Contents

Section

Page

I. INTRODUCTION

II. MANAGEMENT AND ORGANIZATION

III. QUALITY SYSTEM COMPONENTS

IV. PERSONNEL QUALIFICATION AND TRAINING

V. PROCUREMENT OF ITEMS AND SERVICES

VI. DOCUMENTS AND RECORDS

VII. COMPUTER HARDWARE AND SOFTWARE

VIII. PLANNING

IX. IMPLEMENTATION OF WORK PROCESSES

X. ASSESSMENT AND RESPONSE

XI. QUALITY IMPROVEMENT

List of Acronyms

CAWs

Chicago Area Waterways

CDC

Centers for Disease Control and Prevention

CSOs

Combined Sewer Overflows

DQO

Data quality objective

FCR

Friends of the Chicago River

IEPA

Illinois Environmental Protection Agency

IRB

Institutional Review Board

MWRDGC

Metropolitan Water Reclamation District of Greater Chicago

NEEAR

National Environmental and Epidemiological Assessment of

Recreational Water

Quality assurance

QAPP

Quality Assurance Project Plan

Quality Control

Quality manager

QMP

Quality Management Plan

SPH

School of Public Health

SRL

Survey Research Laboratory

UAA

Use attainability analysis

UIC

University of Illinois at Chicago

USEPA

United States Environmental Protection Agency

WRP

Water Reclamation Plant

INTRODUCTION

This document was designed to conform with US Environmental Protection

Agency (EPA) quality requirements, which are in turn based on ANSI/ASQC E4-1994,

Specifications and Guidelines for Environmental Data Collection and Environmental

Technology Programs

. The QMP is designed to conform with EPA Requirements for

Quality Management Plans, EPA QA/R-2, which is based upon Part A of the ANSI

standard. The QMP provides a system-wide framework for conducting the three projects

described in their respective Quality Assurance Projects Plan (QAPP) documents. The

QAPPs, in turn are designed to conform with EPA Requirements for Quality Assurance

Project Plans, EPA QA/R-5, which is based upon Part B of the ANSI standard. Each

QAPP, in turn, is grounded in the principle of obtaining data of sufficient quality and

quantity to achieve the objectives of that particular project. Data quality objectives were

developed for each project using the EPA’s Guidance on Systematic Planning Using the

Data Quality Objectives Process, EPA QA/G4.

II.

MANAGEMENT and ORGANIZATION

Organization’s policy on quality assurance

This Quality Management Plan (QMP) describes the systematic approach to

addressing quality developed by the UIC team for the conduct of the CAWs

epidemiologic study. This QMP documents the management practices, including quality

assurance (QA) and quality control (QC) activities, used to ensure that the results of

technical work are of the type and quality needed for their intended use. The University

of Illinois at Chicago School of Public Health, in general, and this research group in

particular, embrace the principles and practices of quality management, recognizing that

the data collected for this study are only of value to the degree that they meet quality

objectives. The systematic approach to quality is outlined below.

The overall objective of the quality system is to ensure that each of the three

component “projects” of the epidemiologic study produce data that will achieve their

specific objectives. The quality of data obtained by the three individual projects will be

promoted by establishing and implementing organization-wide practices for quality

control, personnel training, procurement of supplies and equipment, contracting to

extramural entities elements of the study, documentation, data management, work

process implementation, assessment, and quality improvement. Furthermore, this will

promote a culture of attention to quality and adherence to protocol throughout the

organization.

It is with the recognition that this research could potentially impact

environmental regulation, that we use US EPA quality guidelines to achieve quality

objectives.

Resources have been committed to support quality management at both

organization and project levels. On the organization level, the salary of the Quality

Manager and other staff who perform quality monitoring functions will be supported by

this project. Additionally, the directors of each of the three projects and the director of

the epidemiologic study will commit a substantial portion of their time addressing quality

on organization- and project-levels. Space, resources and personnel will be available for

all quality practices needed for data management, record keeping, procurement, and

personnel. Within individual projects, the budget will support all necessary training,

documentation, performance evaluations (such as use of field blanks, replicate samples,

positive controls, monitoring telephone survey staff), and instruments necessary to

monitor and enhance data quality.

Organization of the research team

The organizational chart and description of responsibilities are presented in the CHEERS

Overview document.

3. Authorities of the Quality Manager and other QA staff

The Quality Manager (QM) will have authority to evaluate quality aspects of all data

generating activities. Project Managers will review all quality data with the QM, whether

the data were generated by UIC personnel or by subcontractors. The quality manager

will be independent of those who generate, compile and evaluate environmental data.

The Project Managers, as well as the QC manager of UIC’s subcontractors, know that

they will be asked to provide quality monitoring data to the UIC QM. Their work with

UIC is contingent on their compliance with requests from the QM additional quality data.

Likewise, they will be required to respond to quality improvement plans proposed by the

UIC QM. QM will have authority to conduct quality audits, review training and

documentation practices, and recommend modifications to the study protocols.

4. Technical activities supported by the QA system

4.1. Specific programs that require quality management controls

4.1.1. Analyses of water samples for

E. coli

and enterococci

4.1.2. Analyses of water samples for pathogens and coliphages

4.1.3. Participant enrollment and attrition

4.1.4. Survey data collection

4.1.5. Clinical evaluations of participants

4.1.6. Microbiologic evaluations of clinical specimens

4.1.7. Data management practices

4.2. Oversight of delegated, contracted or other extramural programs needed to assure

quality data

Extramural laboratories will produce data for this study. Those laboratories

include:

4.2.1. A commercial laboratory that will analyze water samples for

E. coli

and

enterococci (described in QAPP #1: Water sampling and analysis).

4.2.2. A commercial laboratory that will analyze water filtrate for pathogens and

coliphages (described in QAPP #1: Water sampling and analysis).

4.2.3. The Illinois Department of Public Health will analyze stool samples for

norovirus. (described in QAPP #3: Clinical examinations and microbial

evaluations)

4.3. Where and how internal coordination of QA and QC activities among the group’s

organization units needs to occur

Internal QA and QC activities among the organization’s units will be coordinated by

the QM through regular quality assurance meetings held in room 210 of the UIC SPH

West (the CHEERS study center). During the initial weeks of the field study, such

meetings will occur following each day of data collection. The frequency of quality

assurance meetings will subsequently decrease to once per week if ongoing quality

monitoring indicates that data quality objectives are being met. Such meetings will

be held during the data collection season only.

At weekly meetings, the QA staff, the study director, the Project Managers, and

the Field Manager will review the number of participants enrolled, by site; the

number of telephone follow-up calls completed, the number of home visits, the

number of positive cultures obtained from clinical specimens. Any problems with

equipment calibration or performance will be discussed. Additionally, unusual

occurrence reports will reviewed, and results of performance evaluations that did not

meet data quality objectives will be discussed. The performance of the system of

using notebook computers in the field, and the transfer of data from the field, to the

UIC Survey Research Laboratory (SRL), to the telephone call center, and back to

SRL will be reviewed.

At monthly reviews, quantitative summaries of water quality data will be presented,

as will results of positive clinical specimen cultures, and numbers of participants

enrolled by location, by study group. Results of QC data from water and clinical

microbiology laboratories will be presented.

Annual reviews are discussed on the following page under “Quality System

Components.”

5. Assuring implementation of quality system in all environmental programs

All management and staff of the epidemiologic study will undergo an orientation session

that addresses the importance of the quality system to this research. In that session,

either the study director, the project coordinator or the Quality Manager will explain now

critical it is that all activities in the study be conducted by protocol. Staff will be

encouraged to either contact a manager for help, or to refer to the relevant protocol or

operating procedure, rather than “guessing” or improvising about how to handle

uncertainty. All Project Managers and assistant project managers will receive a copy of

this quality management system. Personnel will be told that quality audits will occur

regularly, and that their practices and documentation will be reviewed. By providing

timely feedback to study staff about ongoing quality monitoring, a culture of quality will

be promoted.

6. Processes for solving disputes

The QM, rather than the study director, will be final authority for any disputes regarding

quality system requirements, procedures, assessments or corrective actions.

III.

QUALITY SYSTEM COMPONENTS

1. Principal components of the system and roles and implementation responsibilities for:

1.1. Documentation

Each project supported by this QMP will have its own QAPP which establishes

project-specific documentation requirements.

System-wide quality documentation

will include reports of weekly project managers’ meetings with the QM in attendance,

as well as annual summaries of quality monitoring. Copies of the QMP and QAPP

will be made available to all study personnel, and will be posted on a secure internal

website using UIC’s BlackBoard system.

1.2. Annual reviews and planning

Following the completion of data collection for the 2007 water recreation season, data

quality will be comprehensively reviewed. Participant recruitment, water sampling

and analysis, clinical microbiology results, and survey data, as well as the QC data

compiled by internal (UIC) and external laboratories will be reviewed. Results of

performance evaluation sample analyses (replicates, field blanks, positive controls),

holding times, and other project-specific quality benchmarks will be summarized.

Trends and deviations from data quality objectives will be reviewed. Quality

improvements for the 2008 water recreation season will be based on the annual

quality reviews. The QM and his staff will be responsible for the quality reviews,

which will be presented to the study director, the Project Managers, the quality

managers of laboratories within and external to UIC, to the study’s internal

consultants, and to the MWRDGC liaison. In addition to study managers and staff,

internal consultants, quality personnel of internal and external laboratories, internal

consultants, and the MWRDGC liaison will be invited to participate in the annual

reviews.

1.3. Management assessments

For each major data stream (water, survey and clinical), an “Unusual Occurrence

Report” will be completed each day of field data collection. Completing the form will

be the responsibility of the individual serving as a field data manager (for survey

data), the Field Manager (for water collection data), or the Clinical Project Manager

(for clinical microbiology data). The unusual occurrence report will be completed

after discussions with each member of the study team at the end of the day.

Qualitative information regarding possible deviations from protocol, unexpected

events, or problems in documentation, data collection, handling, transport will be

recorded. Additionally, Project Manages and the study director will meet with the

QM and the study director to identify and address system-wide and project-specific

quality problems. They will also participate in annual quality reviews and in quality

improvement planning.

1.4. Training

Job descriptions for study positions will define eligibility for hire. Subsequent to

hire, additional training will be required. Job descriptions and subsequent training

requirements will be developed by the study director, Project Managers, and will be

reviewed by the QM.

1.5. Systematic planning of projects

Projects within the larger study have been developed using the EPA “Guidance on

systematic planning using the data quality objective process” and the “EPA

Requirements for Quality Assurance Project Plans.” Additionally, input has been

sought from the MWRDGC, UIC consultants, and environmental researchers external

to this project. Additionally, during the design phase of the epidemiologic study,

overviews of the research were presented to Mr. Ephraim King of US EPA, Director

of the Office of Science and Technology in the Office Water, and his staff; to the

Science Advisory Board coordinated by the Water Environment Research

Foundation; at an Illinois EPA’s Use Attainability Analysis stakeholder meeting; at a

local advisory group on July 9, 2007; at the initial Science Advisory Board meeting

(“initial peer review”) organized by WERF on July 17-18, 2007; and at a follow-up

Science Advisory Board meeting on February, 27, 2008.

1.6. Project-specific quality documentation

Each QAPP supported by this Quality Management Plan includes documentation

requirements. Accurate and secure documentation is necessary to ensure the validity,

accuracy, precision, and integrity of the data.

Each Project Manager will be

responsible for ensuring compliance with documentation requirements of their

projects. Documentation requirements common to all projects will include chain of

custody documentation, storage of the results of laboratory analyses, and ensuring the

confidentiality of study participants. The QM will be responsible for regularly

reviewing compliance with documentation and other requirements of each project. .

1.7. Project and data assessments

All projects, as well as the study overall will be the subject of weekly, monthly and

annual assessments. The comparison of actual data quality to data quality objectives

will be assessed at these evaluations.

2. Tools for implementing each component of the quality system

2.1. This system-wide Quality Management Plan will be the basis for establishing and

reviewing quality management practices throughout each project within the larger

epidemiologic study.

2.2. Audits

2.2.1. Quality system audits will be performed by the QM and the project

coordinator. These audits will include qualitative evaluations of the field

and laboratory quality control systems. During the system audit, the quality

control activities actually performed or scheduled will be compared with

those specified in the three

2.2.2. QAPPs. The results of the system audits will include the reviews of the

following:

•

Completeness of the field records,

•

Completeness of the Chain-of-Custodian forms,

•

Safe storage the documents and backup of the computer files,

•

Adherence to training requirements

•

Instrument status and calibration records,

•

The status of other relevant laboratory equipment,

•

Identification of invalid data based on the specified accuracy, precision,

and comparability,

•

Any corrective actions and the results.

2.2.2. Performance Audits

A performance audit is a quantitative evaluation of the data collection and analysis

aspects of the project. For the projects involving microbial analyses of water samples and

microbial analyses of clinical specimens, data from performance evaluation samples

(such as replicates, blanks, and positive control or spike samples) will be analyzed. For

survey data, “mock subjects” will be enrolled in the study and will provide pre-

determined answers to specific questions, and the way such responses are recorded by

survey staff will be reviewed. The results will be used to evaluate the performance of the

data generation system.

2.3. Training plans

The training plans for staff will be reviewed by the QM. Documentation of the

implementation of training within the overall study will be reviewed by the QM. Any

deficits in training will be identified and brought to the attention of the Quality Manager

and the appropriate Project Manager.

2.4. QA Project Plans

One QAPP has been developed for each of the following major study elements:

•

Water sampling and analysis

•

Survey methods

•

Clinical examinations and microbiologic evaluations

These QAPPs will describe project management, data generation and acquisition,

assessment and oversight, and data validation and usability. The key function of each

QAPP is to ensure that data quality and quantity generated within each project will be

sufficient to meet study objectives. Each Project Manager will be responsible for

ensuring implementation of the QAPP specific to their project. The QA manager will

review each QAPP, and conduct the necessary reviews to ensure that data quality

objectives for each QAPP are being met.

2.5. Data verification and validation

Each QAPP includes plans to ensure data verification and validation. The Project

Managers and quality management staff will review all data generated or acquired to

determine if validation rules have been violated, and if so, to identify factors that may

have resulted in invalid data. Corrective actions will then be identified by the Quality

Manager in conjunction with the Project Manager and project coordinator.

Components of the organization that develop Quality Plans

Project Managers, the study director, and the QM develop quality plans, in collaboration

with quality managers of internal and extramural laboratories that will provide services to

the study.

IV.

PERSONNEL QUALIFICATIONS AND TRAINING

1. Policy regarding training for management and staff

All personnel performing work for the Epidemiologic Study of Recreational Use of the

Chicago Area Waterways study will be qualified for all assigned tasks and will be given

appropriate training to ensure proper performance of all duties.

2. Processes for ensuring appropriate qualifications and training

All personnel must be qualified for the roles they will perform in this study. Each role in

the project will have a job description that will include the necessary knowledge, skill,

certification, accreditation, licenses or other formal qualification. These job descriptions

will be developed for project staff by each Project Manager for their personnel. Job

descriptions for personnel for whom more than one Project Manager will have authority,

will be developed by the relevant Project Managers. Job descriptions for managers in

this project will be developed by the study director. Job descriptions will be developed

using a template that will include the necessary knowledge, skills, and certification. In

addition to the skills required for hire in a position, a list of training requirements for each

role in the project will specify the necessary training following hire.

3. Retraining needs

Project specific training requirements for all CHEERS staff is outlined in the individual

QAPPS. Retraining will be required for staff that, on performance evaluations are

deficient. The performance evaluations will vary from project to project. For the survey

project (QAPP 2) this will involve mock interviews and interview monitoring. For the

water sampling and analysis project (QAPP 1) this will involve evaluations of split

samples and observations of sampling technique. For the clinical evaluations, it will

involve classifying photos of conjunctivitis by severity grade. For all projects, problems

noted on unusual occurrence reports (such as breaches in protocol, chain of custody

problems, etc) either retraining or disciplinary action or both will be initiated.

PROCUREMENT OF ITEMS AND SERVICES

In order to ensure high quality data, the projects with the epidemiologic study will

procure items and services after determining whether performance standards or

certifications exist for a particular purchase that are relevant to data quality. We have:

- selected EPA certified laboratories to conduct water analysis

- selected clinical laboratories that are CLIA-certified

- selected equipment such as GPS devices, bar-code scanners, instruments to

measure basic water quality parameters after reviewing EPA and other Federal

guidelines.

- evaluated tablet and laptop computers to be used in the field surveys will be tested

during the pilot study. We will assess battery life, screen visibility in bright

outdoor light, field performance, including portability and ease of use

- field tested the bar-code printing and reading technology

VI.

DOCUMENTS AND RECORDS

Study-wide we have a uniform that requires appropriate storage of documents. Each

QAPP has listed the personnel responsible for the development, storage and distribution

of project specific documents and records. For example, consent form that will have Case

IDs and names of study participants will require special storage and restricted access. In

general paper-based records will have more than 1 copy that will be stored in binders in

two different places. We will maintain copies of documents that are free of personal

identifiers and raw data in the CHEERS study center (room 210, UIC SPHW). This

would include protocols, references, literature, and quality monitoring reports. Paper-

based data will be kept in a locked study storage room (room 417, UIC SPHW) and a

second copy will be maintained in the office of the manager of the project that generated

the data. We will use the UIC Blackboard system which insures multiple CHEERS staff

members can work with, or discuss, the same version of a document at the same time.

All computer files with identifiers will be password protected. All computer files,

databases, reports will be backed up on a secure UIC server.

VII. COMPUTER HARDWARE AND SOFTWARE

The University of Illinois, Chicago (UIC) has selected high quality hardware from

reputable manufactures that we will purchase centrally through the UIC system. Software

used for data analysis, the SAS system, has been extensively tested and is widely used

in environmental and epidemiologic research conducted by and for the US EPA.

VIII. PLANNING

The initial planning for this project began in February, 2007 when MWDGC personnel

and UIC faculty first communicated about this study. The initial weeks of planning

involved defining study objectives and selecting an appropriate study design to meet

those objectives. Over the subsequent weeks, in consultation with MWRDG personnel,

UIC faculty and staff, and external resources, the specific projects of the study were

developed. Planning of individual projects used the EPA’s systematic planning process

called the Data Quality Objectives (DQO) Process mentioned in the

EPA Guidance for

the Data Quality Objectives Process (QA/G-4)

(EPA 2000).

The study objectives, study sites, study timetable are presented in the “Overview”

document, as are considerations that went into the design of the study.

IX. IMPLEMENTATION OF WORK PRCESSES

The QM and each Project Manager will be responsible for ensuring implementation of

the QAPP as written. After new personnel are trained, the Project Managers will

supervise their field activities and monitoring adherence to protocol. The QM will

review QC data that will identify possible breaches in adherence to protocol, or needs to

modify the protocol. Each Project Manager, with QM have identified processes within

each project that will require review. Any modification to the protocol will require the

approval of the study director and quality manager, as well the notification of the

MWRDGC liaison.

X. ASSESSMENT AND RESPONSE

Project specific assessment plans and response actions are outlined in the individual

QAPPS. In addition, Section III discusses the overall quality system components

including audits and response actions for each QAPP. In addition, any unusual

occurrence report will be submitted by the responsible Project Manager to the QM within

24 hours. These reports will be reviewed and an appropriate response action will be

decided by the QM and/or the study director.

At weekly meetings, the QA staff, the study director, the Project Managers, and the

field coordinator will review any problems with equipment calibration or performance,

unusual occurrence reports, and results of performance evaluations that did not meet data

quality objectives will be discussed.

At monthly reviews, quantitative summaries of water quality data will be presented, as

will results of positive clinical specimen cultures, and numbers of participants enrolled by

location, by recreational group. Results of QC data from water and clinical microbiology

laboratories will be presented. All available study personnel and will be present at

monthly reviews.

Annual reviews are discussed in Section III.

XI.

QUALITY IMPROVEMENT

The QM and each Project Manager and program manager will be responsible for

identifying, planning, implementing, and evaluating the effectiveness of quality

improvement activities as described in each QAPP. At all quality reviews, potential

threats to data quality will be identified and addressed. The range of responses will be

determined and efforts will be made to improve quality through system-wide

improvements.

Thus, a quality issue identified in the water project may prompt

improvements in that project, and also in the survey or clinical evaluation project.

CHEERS QAPP-1

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July 2008

Table of Contents

A. PROJECT MANAGEMENT

1. Distribution List

2. Project/Task Organization

3. Problem Definition/Background

4. Project Task/Description

5. Quality Objectives and Criteria

6. Special Training/Certification

7. Documents and Records

B. DATA GENERATION AND ACQUISITION

1. Sampling Process Design (Experimental Design)

2. Sampling Methods

3. Sample Handling and Custody

4. Analytical Methods

5. Quality Control

6. Instrument/Equipment Testing, Inspection, and Maintenance

7. Instrument/Equipment Calibration and Frequency

8. Inspection/Acceptance of Supplies and Consumables

9. Non-direct Measurements

10. Data Management

C. ASSESSMENT AND OVERSIGHT

1. Assessments and Response Actions

D. DATA VALIDATION AND USABILITY

1. Data Review, Verification, and Validation

2. Verification and Validation Methods

Contact information for water sampling project

Table 2

Table 3

Table 4

List of microbes and their quantifying methods

Summary of sample collection on days of participant

enrollment for two years of data collection

Spike levels, by location

Table 5

Summary table for QA/QC Requirements for methods 1600

and 1603 (Enterococci & E.coli)

Table 6

Summary table for QA/QC Requirements for method 1602:

Male-specific (F+) and Somatic Coliphage in water

Table 7

Summary table for QA/QC Requirements for method 1623:

Cryptosporidium and Giardia

Table 8

Locations of water sampling by participant enrollment site;

CAWS sites

Table 9

Size of direct sampling bottles

Table 10

Suggested range of sample volumes (mL) for fecal coliform

tests using the membrane Filter Method

Table 11

Dilution volumes, by sampling location, weather condition,

and indicator

Table 12

Microbiology lab equipment monitoring

Table 13

Quality of reagent water used for microbiology testing

Water sampling organization

CHEERS QAPP-1

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July 2008

List of Appendices

Appendix

Description

Laboratory certification, EnviroTest/Perry

Laboratory certification, SMI

EPA reference method 1603;

E. coli

in water by membrane

filtration

EPA reference method 1600; Enterococci in Water by

Membrane Filtration

EPA reference method 1602; Male–specific (F+) and

Somatic Coliphage in Water by Single Agar Layer (SAL)

Procedure

Method for serotyping F(+)RNA coliphages (Hsu, 1995)

EPA’s Reference Method 1623 (

Cryptosporidium, Giardia

)

Method for detection of Norovirus

Properties of continuous fluid centrifugation (Zuckerman

2006)

EPA approval of CFC for Method 1623

Matrix spiking materials

Water Quality Sampling Field Data Sheets (FDS)

Field Log Book

Continuous flow centrifugation (CFC) system

SMI Virus sampling kit

SMI SOP for CFC

Chain-of-Custody records (EnviroTest/Perry)

Chain-of-Custody records (SMI)

Water sampling location codes

CHEERS QAPP-1

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July 2008

A. PROJECT MANGAMENT

1. Distribution list

Current and revised versions of the Water Sampling and Analysis QAPP are to be distributed to

the following individuals:

i. Samuel Dorevitch, UIC

ii. Peter Scheff, UIC

iii. Margit Javor, UIC

iv. Sara Wuellner, UIC

v. Todd Schoonover, UIC

vi. Thomas Granato, MWRDGC

2. Project/Task Organization

Key personnel participating in the water sampling and analysis for the epidemiology study and

their specific roles/responsibilities are listed below. The organization chart indicating the lines of

communication is included in Figure 1.

Figure 1: Water sampling organization

Enviro-Test/Perry Laboratories

M. Lenos

Water project

manager assistants

Scientific Methods, Inc.

Project Title or Role

Water Project Manager

Enviro-Test/Perry Lab contact

(630) 734-9530

Fu-Chih Hsu

Scientific Methods, Inc.

(574) 277-4078

Matt Hayes

Scientific Methods, Inc.

(574) 277-4078

Table 1: Contact information for water sampling project

Responsibilities

1. Study Director: Samuel Dorevitch, MD, MPH

The Study Director will have overall responsibility for the development and implementation of

the CHEERS study, as well as providing deliverables to the MWRDGC. Specific responsibilities

of the Study Director include the hiring of project staff, establishing subcontracts with entities

external to UIC, complying with human subject research protection requirements, and

communicating with the MWRDGC and with the public as needed.

2. Water Project Manager: Margit Javor, MS

The Water Project Manager will be responsible for developing the water sampling protocol and

selecting, based on performance data, laboratories that will analyze water samples. The Water

Project Manager will work with the Field Manager to ensure implementation of protocols and

will also be responsible for developing training materials, observing field sampling as needed,

and monitoring the field sampling procedures. If deviations from the data quality objectives for

water analysis are noted, the Water Project Manager will collaborate with the Quality Manager

and Field Manager to identify field practices or protocol elements responsible for such deviations

and to develop solutions.

CHEERS QAPP-1

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July 2008

3. Quality Manager: Peter Scheff, PhD

The responsibilities of the Study Quality Manager will include assisting with the development of

the Quality Assurance Project Plan (QAPP), establishing data quality objectives, reviewing the

quality control data of laboratories conducting water analyses, conducting quality audits, and

communicating with laboratory Quality Managers.

4. Field Manager: Todd Schoonover, MS, CIH, CSP

The responsibilities of the Field Manager will include field training of water samplers, oversight

of the surface-water collection, and ensuring that sampling occurs according to written standard

operating procedures by trained personnel. The Field Manager will plan and prepare paperwork

for each field sampling event and ensure that samples arrive at the lab within the holding-time

specified in the relevant analytic methods. The Field Manager will provide updated information

to the commercial laboratories regarding the water sampling schedule, including the anticipated

number of samples for each analytic method and the expected date and time of sample receipt.

5. Commercial Water Quality Laboratory for indicator bacteria: Enviro-Test/Perry Laboratory

(contact: Mirka Lenos).

This commercial water quality laboratory will perform analyses of the water samples for

E. coli

and enterococci. The laboratory will be responsible for adhering to US EPA protocols and

maintaining Illinois Department of Public Health certification (Appendix 1) as an analytic

laboratory for microbial water quality in drinking water. The laboratory will provide results of

microbial water quality measures to the Water Project Manager and invoices to the Fiscal

Manager.

6. Commercial Water Quality Laboratory for pathogens and coliphages: Scientific Methods

Incorporated (SMI)

6.1 Laboratory and technical issues (contact: Fu-Chih Hsu, PhD)

Dr. Hsu will be responsible for maintaining Indiana State Department of Health laboratory

certification (Appendix 2). He will also be responsible for teaching the Water Project Manager

CHEERS QAPP-1

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July 2008

and the Field Manager to operate the continuous fluid centrifugation (CFC) and virus sampling

systems, and also for water pathogen and coliphage analyses conducted by SMI. He will provide

results of microbial water quality measures and of internal QC analyses to the Water Project

Manager.

6.2 Coordination of sample receiving and reporting of results (contact: Matt Hayes)

Mr. Hayes will prepare for laboratory analyses based on the schedule received by the Field

Manager. Mr. Hayes will send laboratory results to the Water Project Manager and invoices to

the Fiscal Manager.

7. Water sampling staff

7.1 Water Sampling Specialists

Water Sampling Specialists will be responsible for implementing matrix spike sampling on an

ongoing basis. This function may also be performed by the Field Manager or by personnel with

responsibility for filtration sampling. Water Sampling Specialists will also maintain and use

instruments for measuring water chemistry parameters, such as dissolved oxygen, pH,

conductivity, turbidity, and temperature.

7.2 Water Sampling Technicians

Water Sampling Technicians will be responsible for collecting samples in accordance with SOPs

and documenting any deviations from the SOPs.

3. Problem Definition/Background

The primary purpose of the research study’s water sampling activities is to provide a measure of

concentration of microbes in the water to which study participants may be exposed. By

collecting water samples at the approximate times and locations of water recreation, we aim to

identify and characterize water quality measures that predict the risk of illness among people

engaging in secondary contact water recreational activities. Samples will be analyzed both for

conventional indicators of water quality, as well as for pathogens that may cause recreational

and enterococci are commonly used as indicators of water

quality and samples will be collected and analyzed for these bacteria as part of the study.

However, there are limits to the information gained from measurements of

E. coli

and

enterococci. First, recreational waterborne illness is not thought to be caused by enterococci and

is rarely caused by specific pathogenic strains of

E. coli

. Rather, disease is caused by pathogens

such as enteric viruses

Giardia spp.

and

Cryptosporidium spp.,

and bacteria such as

Salomnella

spp., Shigella spp.,

and

Aeromonas spp.

Second, the CAWS risk assessment (1) found that

bacterial indicators and pathogens were, at best, weakly associated with one another. In one of

the few epidemiologic studies of paddlers, measures of coliphages were shown to be better

predictors of acute illness than were bacterial indicators.(2) Additionally, coliphage typing

allows the tracking of sources of fecal contamination and the differentiation of human from non-

human sources of water microbes.(3, 4) To characterize exposure, we will collect water samples

throughout each day of participant enrollment at various locations using EPA-approved methods

to analyze for indicator bacteria, coliphages, and waterborne pathogens. Samples taken using

filtration methods will be archived (frozen) for possible future analyses that can provide a

molecular link between pathogens obtained from clinical and water samples.

4. Project/Task Description

4.1 Overview of water sampling

As discussed in the “Overview” document, the objective of the water sampling is to provide

accurate and precise measures of microbe concentrations in the CAWS and general-use

waterways (GUW) to address study objectives 2 and 3. In order to characterize the relationship

between recreator illness and microbe concentrations in the CAWS (study objective 2), it is

necessary to estimate exposure to waterborne microbes among recreators. This will be

accomplished by analyzing water samples collected along the waterways at multiple time points

throughout the day of participant enrollment. To meet study objective 3 (identifying pathogens

responsible for illness and exploring their sources on the CAWS), we will measure three

pathogens;

Giardia, Cryptosporidium,

and norovirus. Potential future analyses of archived water

samples collected upstream and downstream of WRPs may permit testing water samples for

specific pathogens (at a species or genotype level) responsible for acute infections among

CHEERS QAPP-1

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July 2008

recreators. Moreover, if a water quality standard were to be applied to the CAWS, compliance

with such a standard may require sampling water at specific fixed locations. The results of spatial

and temporal variability of water quality on the CAWS, to be established by intensive sampling

on a limited number of occasions and by ongoing “standard” sampling during participant

enrollment, will provide information that could be translated into regulatory requirements.

Two categories of microbial analyses will be performed: 1) those for indicator microbes and 2)

those for pathogens. Samples will be collected by the direct method for indicator bacteria,

E. coli

and enterococci, as well as for male-specific and somatic coliphages. Coliphages will be

serotyped (Groups I-IV) to identify the relative contribution of human and non-human sources of

coliform bacteria at various locations along the waterways. Pathogen analyses will be performed

on samples collected using continuous flow centrifugation (CFC) and with a viral sampling kit.

The pathogens to be analyzed are:

Giardia

spp.

, Cryptosporidium

spp., and norovirus. In 2007,

samples were also analyzed for

discontinued in 2008 based on questions about the precision, accuracy and validity of the 2007

analyses of these bacteria. Following discussions with the CHEERS Science Advisory Board in

February 2008, large volume sampling for these pathogens was discontinued. The pairing of

indicator and pathogen sampling will build on the risk assessment’s analysis of the relationship

between these two categories of microbes on the CAWS.

Method

Appendix

Indicators

Male specific colipahge

EPA 1602

Appendix 5

Male specific RNA coliphage serotyping

Pathogens

discontinued after 2007

Salmonella

EPA 1682

discontinued after 2007

Shigella

SM 9260E

discontinued after 2007

Table 2. List of microbes and their quantifying methods

Water sampling will occur at two categories of locations; Access points and WRP-oriented

locations. Access points are the locations at which water recreators (research subjects) begin

their water recreation. For boaters, paddlers and rowers, this is the “put in” or launch location.

For streamside fishers, the access point is where they are fishing. Access point sampling will

take place on the CAWS and general use waters. WRP-oriented sampling will take place

upstream and downstream of the WRPs. This will occur at CAWS locations only.

Table 3 provides an overview of the sampling schedule for indicators and pathogens at access

points and at WRP-related sites on the CAWS, and at general use access points. The differences

between 2007 and 2008 sampling strategies are described below.

In addition to microbial evaluations, environmental observations and water chemistry measures

will be recorded, as described below (Sections B 2.3 and B 2.4).

2008

Indicator

sampling

Pathogen

sampling

Indicator

sampling

Pathogen

sampling

3 every 2 hrs 1-2 per 12-hr

2 every 2 hrs 1-2 per 12-hr

Table 3. Summary of sample collection on days of participant enrollment for two years of

data collection

4.2 Frequency and location of water sampling

An overview of sampling intensity (number of samples per round, frequency of sampling) is

presented in Table 3, which contrasts the 2008 methods and those employed in 2007.

4.2.1 CAWS sampling

4.2.1.1 Access points: Number of samples collected by direct method for indicator

microbes.

During the 2007 enrollment season, samples were collected at 5 points near each access point:

left, right, and center stream at the access point plus center stream 0.5 mile upstream and center

stream 0.5 mile downstream of the access point. The results of “Preliminary Water Sampling

Study 2: Spatial and temporal variability of CAWS indicator organisms” (described in detail in

the July, 2007 QAPP: Water Sampling and Analysis), suggested that sampling at one cross-

sectional location is sufficient to characterize concentrations across the waterway. Analyses of

CHEERS QAPP-1

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July 2008

the entire 2007 dataset demonstrated that concentrations of all indicator microbes were

statistically indistinguishable whether collected at left, center or right sampling sites across

cross-sections of CAWS locations. After discussion with the CHEERS Science Advisory Board

in February, 2008, sampling was revised to collecting two samples per single cross-sectional

location (left, center or right) at each time point of sampling. Analysis of the 2007 data also

suggests that, for most locations, concentrations do not differ significantly within a mile of each

other along the length of the waterway with one exception; The Skokie Rowing Center, which is

immediately upstream of the North Side WRP.

With the exception of the Skokie Rowing

Center site, the upstream and downstream sampling points were omitted from the 2008 sampling

strategy. This allowed us to refine our sampling strategy for the 2008 season and collect samples

from a single cross-section at the access point, using a telescopic pole with a sample collection

cup secured to the end of the pole. Since the 2007 data suggest that concentrations may vary by

time of day, we will continue collecting samples at the access point every two hours.

4.2.1.2 CAWS Sampling: Water reclamation plant-oriented sampling

Samples will be collected once during each 6-hour shift of fieldwork at locations upstream and

downstream of the nearest upstream WRP. Because results from the preliminary water study

examining the spatial and temporal variability of the indicator organisms in the CAWS showed

no statistically significant differences in river cross-sectional concentrations of the indicator

microbes, access point samples will be collected from a single cross-sectional location.

4.2.1.3 CAWS Sampling: Large volume sampling for pathogens

Large volume sampling for pathogens will be performed by two methods: continuous flow

centrifugation (CFC) and viral filtration sampling. Large volume water samples will be collected

at the access point, as well as upstream and downstream of the nearest upstream WRP. These

samples will be collected from the cross-sectional location used for recreator access at access

points. At WRP-oriented sampling locations, these samples will be collected at either the left-

stream or right-stream shore, depending on logistical considerations. Pathogen samples will be

collected at each of these three points at least once each day of CAWS participant enrollment.

Three options for the collection of water samples for filtration during the 2008 season were

identified: A) Bringing the CFC into the field to sample the water directly from the shore of the

river, B) Pumping water into a 20L cubitainer to be brought back to the UIC water quality lab

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July 2008

and processed by the CFC, and C) transporting the cubitainer to the analytic laboratory,

approximately 100 miles away, for CFC processing and analysis. Option A was not viable

because there were not enough CFC available for use at multiple field locations. After

discussing these options with the Scientific Advisory Board, it was decided that during the 2008

season, water would be collected in a 20L cubitainer and brought back to the UIC Water lab for

processing in the CFC.

4.2.2 Sampling at general-use waters

Water will be sampled every two hours at access points using a telescopic pole. There will be no

WRP-oriented samples as there are no water reclamation plants operating on these waterways.

At lake and lagoon locations, two samples will be collected every two hours by telescopic pole

from shore. Large volume water samples for pathogens will be collected at access points at least

once each day of general use participant enrollment. When possible, a second set of pathogen

samples will be collected 6-12 hours later.

The exact locations of water sampling, with GPS coordinates, are found in the Overview

document.

4.3 Water analysis

4.3.1 Grab samples

4.3.1.1 Analysis for E. coli

Escherichia coli

will be analyzed at the commercial laboratory using US EPA Method 1603, a

single-step membrane filter procedure which uses the modified membrane-Thermotolerant E.

coli (mTEC) agar. The red or magenta colonies that grow on the surface of the membrane filter,

after a two-stage incubation period, provide a direct count of E. coli in water. The EPA

reference method for E. coli analyses can be found in Appendix 3 of this QAPP document.

4.3.1.2 Analysis for enterococci

Enterococci indicator bacteria will be analyzed at the commercial laboratory using US EPA

Method 1600, a single-step membrane filter procedure which uses the membrane-Enterococcus

Indoxyl-b-D-Glucoside (mEI) Agar. All colonies greater than or equal to 0.5mm in diameter

with a blue halo are counted in the surface water samples. The EPA reference method for

enterococci analyses can be found in Appendix 4 of this QAPP document.

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July 2008

4.3.1.3 Analysis for coliphage

Male-specific (F+) and somatic coliphages will be analyzed at the commercial laboratory using

US EPA Method 1602, a single agar layer procedure in which magnesium chloride, log-phase

host bacteria, and molten tryptic soy agar are added to the sample. Circular lysis zones (plaques)

are counted after an overnight incubation period, allowing for enumeration of coliphage in water.

The EPA reference method for coliphage analyses can be found in Appendix 5 of this QAPP

document. Serotyping of F(+) RNA coliphages will be performed according to the method of

Hsu 1995, which can be found in Appendix 6 of this QAPP document.

4.3.2 Large volume sampling for pathogens

Large volume sampling methods will be used to collect samples for analysis of pathogens.

Continuous flow centrifugation (CFC) will be used to collect samples for detection of

Giardia

spp

. and

Cryptosporidium spp.

The performance of this method has been previously reported to

yield good recoveries (Zuckerman 2006), as detailed in Appendix 9. CFC sampling has received

US EPA approval for use (Appendix 10). In 2007 this method was also used fo

r Shigella spp.,

Salmonella spp, and Pseudomonas

. The CFC system allows for automated sampling of large

volumes by drawing water through an inlet tube using a peristaltic pump at a specified sample

flow rate. As the sampled water passes through the continuous flow centrifuge, the pathogens

are concentrated in the CFC bowl. We compared two methods of sampling large volumes of

water, and the CFC system was chosen as the preferred method of pathogen sampling because of

its ease of use in the field and because it is an EPA approved method for Cryptosporidium (see

appendix 10). A second filtering system will be used to collect water samples for analysis of

norovirus and potentially other waterborne viruses.

Samples will be analyzed for

Cryptosporidium

and

Giardia

using US EPA Method 1623,

utilizing filtration, immunomagnetic separation, and immunofluorescence assay microscopy.

The samples are filtered and the filtered materials are centrifuged, resulting in pellets containing

cysts and oocysts which are magnetized to allow for separation from the extraneous materials.

The cysts and oocysts are stained on slide wells with antibodies able to be detected using

fluorescence and differential interference contrast microscopy. Oocysts and cysts are then

identified qualitatively based on size, shape, color, and morphology. The total number of objects

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July 2008

on the slide provides a count of the pathogens present in the water samples. The EPA reference

method for Giardia and Cryptosoporidum analyses can be found in Appendix 7 of this QAPP.

4.3.2.2 Analysis for

Salmonella

In 2007 samples were analyzed for

Salmonella

spp. using US EPA Method 1682:

Salmonella

Sewage Sludge (Biosolids) by Modified Semisolid Rappaport-Vassiliadis (MSRV) Medium.

4.3.2.3 Analysis for

Shigella

In 2007 samples were analyzed for

Shigella

spp. using standard method 9260E, (APHA, 2005)

4.3.2.4 Analysis for

Pseudomonas aeruginosa

In 2007 samples were analyzed for

Pseudomonas

using standard method 9213E, Membrane filter

Technique for

Pseudomonas aeruginosa

(APHA, 2005)

4.3.3 Selection of commercial laboratories

Based on the results of a head-to-head comparison of two commercial laboratories that included

evaluation of the performances (described in detail in the July 2007 QAPP: Water and Sampling

Analysis document), up-to-date laboratory SOPs, capacity, turnaround time, data product,

accessibility (weekends, holidays), distance and cost, Enviro-Test/Perry Laboratories was

selected as the commercial lab to analyze samples for enterococci and

E. coli

using US EPA

Methods 1600 and 1603, respectively. Scientific Methods, Inc. will conduct the analyses for

coliphages (Method 1602) with serotyping of F+ RNA coliphages;

Cryptosporidium

and

Giardia

(Method 1623), and norovirus. In 2007, CFC samples were also analyzed for

Pseudomonas aeruginosa

(SM 9213E). Additionally, SMI

will make available the CFC and virus sampling kits required for this study, and will archive

water samples for potential future analyses.

4.4 Quantitative polymerase chain reaction pilot study

4.4.1 Overview

A qPCR pilot study has been designed to address the following objectives: 1) to establish the

precision and accuracy of qPCR for CAWS samples collected at areas of high and low

enterococci concentration, 2) to characterize the relationship between qPCR and USEPA method

1600 for enterococci and 3) to evaluate the impact of freezing CAWS samples on pPCR results.

Because measures of enterococci by qPCR are thought to correlate with viral pathogens in

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July 2008

surface waters, we will also measure other indicators and pathogens at the same times and places

where samples are collected for qPCR measurement of enterococci .

qPCR enterococci testing does not address the needs of the Illinois EPA and, for that reason, will

not be part of the basic set of tests for indicator microbes (namely

E. coli

, enterococci, and

coliphages) performed on all water samples. However, it would increase the relevance of the

epidemiology study if it were possible to compare results obtained in this study to those which

use qPCR testing. A small scale study is in development that would allow us to meet the

objectives listed above. A commercial laboratory (Mycometrics) that has experience in

analyzing surface water sampling for enterococci by aPCR and has worked closely with the US

EPA in developing draft methods for such analyses, will analyze our samples. qPCR testing will

not become part of the basic package of indicator analyses performed as part of the ongoing

epidemiologic study.

5. Quality Objectives and Criteria

In order to monitor laboratory performance, study personnel will send to the lab performance

evaluation samples such as method blanks, matrix spikes and sample splits. The laboratories are

required to adhere to the quality control procedures provided in the US EPA Methods 1600,

1602, 1603, and 1623 documents. These procedures include initial and ongoing precision and

recovery tests, media sterility checks, and record maintenance.

5.1 Indicator bacteria water samples

5.1.1 Method Blanks

For each method of analysis, at least one field blank will be included with every 20 samples sent

to the laboratory. Blanks consisting of sterile buffer solution will be prepared by the water

sampling technicians at the end of the first round of sampling every day of sampling.

5.1.2 Replicate Samples

For each method of analysis, at least one sample for every 20 samples collected will be split in

the field among three bottles, two of which will be sent to the lab to evaluate precision, the third

will be prepared with the matrix spike material (see section 5.1.3).

For each method of analysis, the third bottle of the split sample (see section 5.1.2) will be

prepared with the matrix spike material by the water sampling technician. This will occur for at

least 5% of the samples collected each day. See Appendix 11A-C for spike materials details.

(Somatic: 10,00pfu/mL;

Table 4: Spiking levels by location.

5.1.4 Method Performance

Laboratories are required to meet (or exceed) all method performance specifications of EPA

Methods 1600, 1602 and 1603. Performance requirements of Methods 1600 and 1603 are

described in detail in the method documents and are summarized in Table 5. Performance

requirements of Methods 1602 is described in detail in the method document is summarized in

Method 1603 (E.coli)

Both Methods

QC Measures

Method 1600 (Enterococci)

Procedure

Criteria (BioBall)

Note

Frequency

Procedure

Criteria (BioBall)

IPR

Detect-144%

collection start (once)

85-106%

OPR

Detect-

144%

78-113%

1xXXmL +spike ATCC#11775

17-117%

63-110%

1x50mL PBS or dilution

W>>mTEC

Absence of growth

Every day when sample

1xXXmL diluted E. coli

(ATCC#11775)

Growth

Count

Every day when sample

analyzed (+ new batch

of media)

1xXXmL diluted

Enterococci (ATCC#19433)

Growth

Negative Control

1xXXmL diluted E. faecalis

(ATCC#19433)

Absence of growth

Every day when sample

analyzed (+ new batch

1 filter placed on TSA

plate>incubate

Absence of growth

Every day when sample

analyses

1 filter placed on TSA

plate>incubate

Absence of growth

Filtration Blank

1x50mL PBS filtered >TSA

1x50mL PBS filtered >TSA

1 from each batch of medium

Absence of growth

Every day when sample

All 4 media tested with positive

and negative controls

Absence of growth

When new batch or

reagents used

All 3 media tested with

positive and negative

1 typical colony/ 10 positive

samples

1 atypical colony/10 positive

samples

E. coli

Verify

1/10 positive samples

(or 10/month) for both

typical and atypical

colonies

1 typical colony/ 10 positive

samples

1 atypical colony/10 positive

samples

E. faecalis

Table 5. Summary table for QA/QC Requirements for methods 1600 and 1603 (Enterococci & E.coli)

Both Methods

Procedure (both separately)

Male-specific

Somatic

Note

Frequency

IPR (Init. Precision

& Recovery)

4x100mL Reag W +spike 80PFU

collection start (once)

OPR (Ongoing

Precision &

Recovery

1x100mL Reag W +spike 80PFU

1x50mL MB

%Recovery: 4-135%

%Recovery: 79-183%

Control chart after 5

value;Ave R% &s (Stdev);

% R interval plot R-2s;

R+2s; update on a reg.

%Recovery: Detect-120%

Precision (RPD) 57%

%Recovery: 48-291%

Precision (RPD) 28%

Control chart for matrices

and update on a reg. basis

First received source

and 1/20 sample (5%)

MB (Method

Blank)

1x100mL Reagent W > same anal

Table 6. Summary table for QA/QC Requirements for method 1602: Male-specific (F+) and Somatic Coliphage in water

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5.2 Filtration samples for pathogens

5.2.1 Method blanks

Sterile buffer solutions prepared in the UIC SPH laboratories will be used to process virus and

CFC blanks. To ensure that at least one field blank will be included with every 20 samples sent

to the laboratory, blanks will be prepared by the water sampling technicians immediately upon

collection of the final sample in a group to be sent to the lab. Thus, each shipment of samples

will include one field blank.

5.2.2 Matrix spikes

Study personnel will spike one sample aliquot for

approximately every 10 samples sent to the laboratory for analysis. In 2007, BioBalls spikes

were used. In 2008 spike materials from the Wisconsin State Hygiene Laboratory will be used.

For coliphage analyses spike material provided by the Scientific Methods, Inc. was found in

2007 to produce more consistent results than those obtained as BioBalls from BTF, Inc. In 2008

only Scientific Methods, Inc. material will be used. The target concentration of the male-specific

coliphage spike material is 10,000 pfu/mL and for somatic coliphages, 1,000 pfu/mL. A volume

of 1mL from both male-specific and somatic coliphages spike material is pipetted into the

specified samples. Once each week, 60 liters of water will be collected for matrix spiking,

completed in the UIC laboratory. The matrix to be spiked will rotate weekly from among the

following four groups: CAWS-North, CAWS-South, Lake Michigan, and other general use

waters. Samples from CAWS-North, CAWS-South, Lake Michigan, and other general use

waters are spiked at a frequency of approximately one spike per 10 samples for each of 1600,

1602, and 1603 methods.

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July 2008

Spiking 1600 / 1603 samples (Indicator bacteria)

Identify spike samples from FDS

•

Match sample method with correct spike material from above

•

Open sample

•

Adjust volume to 170ml line if necessary

•

Open correct BTF bioball vial

•

Insert ball into sample

Circle sample in the FDS, write # of vials added and your initials

Spiking 1602 samples (Indicator viruses, coliphages)

•

Identify spike sample from FDS

•

Take “Coliphages” label container from refrigerator and put it in the chemical hood

•

Open container, identify 2 test tubes inside (MS2 male specific and somatic coliphages)

•

Open sample

•

Adjust volume to 450ml if possible (compare to the empty bottle in hood with volume lines)

•

Attach a 1mL pipette to pipetter

•

Open the MS2 male specific test tube, mix material with the pipette and pipette exactly 1mL

material into the sample (touch the pipette tip to the upper neck of sample bottle to remove

the remaining material in the pipette)

•

Cap the spike material

•

Repeat the procedure with the somatic coliphage using clean pipette

•

Close sample bottle lid tightly

•

Agitate sample

•

Circle sample in the FDS, write down sample volume, number of coliphages from the test

tubes and your initials

•

Put spike material back to refrigerator

Spiking CFC samples

Take “Parasites” label container from refrigerator and remove one vial from it

•

Agitate vial with circular movement for ~30seconds and remove parafilm

•

Identify spike sample (20L container) from FDS

•

Empty contents of vial into sample and rinse vial at least 3 times with sterile buffer (pour

buffer to tube, cap and shake, repeat)

•

Close sample and agitate by rolling it from one side to the other

•

Circle sample in the FDS, write down spike tube number and your initials

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July 2008

5.2.3 Method Performance

Laboratories are required to meet (or exceed) all method performance specifications of EPA

Methods 1623. These are described in detail in the method document and summarized in Table

Procedure

Giardia

Note

Frequency

IPR (Init. Precision

& Recovery)

4x20L ReagW +spike ~100-500

Cryptooocysts and ~100-500

Examine & doc slides for each sample;

3 Crypto & 1

3 Gia ID, characterize

(size, shape, DAPI, DIC cat.)

50%Undamaged, morf. intact oocysts

&cysts (200x;400x magnification)

Examination form fill

Before sample collection

start (once if meet criteria)

1x20L ReagW +spike ~100-500

Crypto oocysts and ~100-500

Examine & doc slide; 1

3 Crypto & 1

Gia ID, characterize (size, shape, FITC,

DAPI, DIC cat.) 50%Undamaged, morf.

intact oocysts &cysts (200x;400x

magnification)

Report form must be filled

1 each week or 1 for every

20 sample if more than 20

1 or 2x20L (split) sample

+spike ~100-500 Crypto

oocysts and ~100-500 Gia cysts

1x20L Un-spike sample matrix

Control chart for matrices when 5 sample

available and update on a reg. basis

P-2s to P+2s (mean recov: P; std: s)

First received source and

1/20 sample (5%) for

source

1-2 spikes + 1 un-spike

MB (Method Blank;

negative control)

1x20L Reagent W > same anal

as samples

No interfering organisms

with Crypto oocysts

No interfering organisms

with Giardia cysts

If criteria meets, acceptable MB

1 with IPR; 1 with OPR

Table 7. Summary table for QA/QC Requirements for method 1623: Cryptosporidium and Giardia

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July 2008

5.3 Basic water quality parameters

Conductivity, turbidity, dissolved oxygen, pH and temperature will be measured by field

sampling personnel at the time of microbial sampling using portable instruments.

Parameters will be measured at least once per day at each sampling location.

5.3.1 Turbidity

Turbidity will be measured with an HP Scientific MicroTPW portable turbidimeter. This

instrument uses a white light (tungsten) source and conforms to USEPA Method 180.1.

Resolution is 1% of full-scale (10, 100 or 1100 NTU) with an accuracy of ±2%.

Conductivity/TDS/Temperature portable field meter, which measures conductivity from

0.0μS/cm to 200mS/cm with resolutions of 0.1μS, 1μS and 0.01mS and relative accuracy

of ±1% full scale.

5.3.3 DO, pH, temperature

Dissolved oxygen, pH and temperature will be measured with an Accumet AP84 portable

pH/dissolved oxygen meter. The DO range is 0.00 to 20.00mg/L with a resolution of

1.5% of saturation and an accuracy of 1.5% of full scale. The pH range is -2.00 to

16.00pH with a resolution of ±0.01pH and an accuracy of ±0.01pH. The temperature

probe will be calibrated against a NIST standard. These instruments will be used and

calibrated per the manufacturer’s instructions.

5.4 QA/QC Procedures

Implementation of the QA/QC procedures for surface water evaluation will be

established through the following steps:

5.4.1 Ensure that each field team member is familiar with the provisions of the

QAPP. The Water Project Manager will ensure that each field team member is familiar

with the field sampling SOPs and QAPP prior to implementation of field activities.

5.4.2 The Data Quality Manager, with the assistance of the Water Project Manager,

will regularly perform a QA review of field activities and field data sheets to ensure that

all procedures are followed.

5.4.3 The Data Quality Manager will verify that all contracted laboratories have a

written description of their QA activities and a QA plan describing the QA management

CHEERS QAPP-1

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July 2008

of day-to-day routine operations. UIC personnel will conduct telephone interviews and

visit the laboratories before any project samples can be evaluated.

5.4.4 The laboratories contracted to evaluate samples are required to adhere to

defined quality assurance procedures to ensure that generated analytical data are

scientifically valid and are of known and acceptable precision and specificity.

5.4.5 Quality control charts will be maintained for every parameter measured for the

study including blanks, calibration factors, and measures of precision for each parameter.

The Data Quality Manager will initially perform weekly reviews and specify corrective

action as needed. Once acceptable performance is established, this review will be

conducted monthly or more often if needed.

6. Special Training/Certification

6.1 Surface water sampler qualification

A high school diploma and one year of college level laboratory course work is required.

Samplers should be physically fit and not afraid of water (know how to swim).

Medications causing dizziness are unadvisable.

6.2 Description of Training

Surface water samplers must participate in a 2-hr in-class training and a 2-hr field

training conducted by the Assistant Project Director, Water Data.

6.2.1 Laboratory Training

During the in-class training section, water samplers are instructed about the surface water

sample collection technique and handling of sample containers for microbiological

analysis following the protocol. Health effects of possible pathogens and techniques for

safely handling contaminated water are emphasized. Water samplers learn the use and

calibration of portable meters to measure basic water quality parameters (principle of

operations is included). The parameters to be measured are: water and air temperature;

dissolved oxygen, pH; turbidity and conductivity.

6.2.2 Field Training

Field training will be held at one of the sampling sites. Samplers will learn to sample for

microbes, prepare sample bottles for transportation, measure water quality parameters

and record all data on Field Data Sheets. Safety on waterways will be emphasized.

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July 2008

6.2.3 Performance Evaluation

The performance of trainees will be evaluated visually after repeating sampling and

sample handling five times. Water quality parameters are measured and documented five

times by each sampler and calibration of meters before and after the measurements.

Relative standard deviation should be within 5%. Sampler’s performance will be

evaluated. If he or she used proper sampling technique and demonstrated satisfactory

variability of basic water quality parameters, he or she will be approved for field

sampling. The performance of trainees will be documented in a Training Log-book.

6.2.4 Frequency of Training

Initial training will occur at the time of hire. Refresher training will take place if quality

monitoring identifies potential problems (positive field blanks, high variability in split

samples).

7. Documents and Records

7.1 Water quality sampling Field Data Sheets (FDS) must be completed on-site at the

time sampling occurs. Appendix 12 presents a sample FDS. The FDS has been

developed to facilitate both completion in the field and the subsequent merging of

laboratory results with data regarding the time, place, and conditions of water sampling.

Identification of site sample number, date of collection, sample volume analysis required

and sample type (blank, split, spike) will be pre-printed on the FDS. The time of sample

collection, sample volume, sampler’s name, water quality parameters, and environmental

conditions will be recorded by the field technician at the time of sample collection.

Special notes about unusual observations require documentation. Completed FDS must

be submitted to the Assistant Project Director promptly (within one day). FDS will be

maintained for 5 years after completion of the project.

7.2 A separate Field Log Book (Appendix 13) is maintained for each site and filled in

by the Water Project Manager using information in the FDS. The Field Log Book is kept

in a safe place and not allowed to be taken to the field where it could be

damaged/destroyed (rain, wind, dropped in river). It is maintained for 5 years after

7.3 The custody of water samples is documented when the sampler and the sample

courier sign the Chain of Custody (COC) record at the time of transfer. A copy of the

COC will be faxed to the Water Project Manager and the Project Coordinator within 48

hours of sample receipt.

7.4 The contracted laboratories send results of lab analyses electronically that are then

maintained by the Water Project Manager. Results will be sent as both an Excel file and

as a PDF document bearing the laboratory letterhead and signature of the commercial lab

manager. Upon receiving results, hard copies are printed out, computer back-up disks

made, and copies distributed to the Project Coordinator. Laboratory results will be

maintained for at least 5 years after completion of the project.

B. DATA GENERATION AND ACQUISITION

1. Sampling Process Design (Experimental Design)

1.1 CAWS sample locations

The location(s) for enrolling participants into this epidemiologic research study on a

given date will determine the locations of water sampling at the CAWS and will reflect

the frequency of actual CAWS usage, by recreational activity and location.

For each enrollment location we will sample water at the approximate location of water

entry every 2 hours. Additionally, water will be sampled upstream and downstream of the

nearest upstream WRP twice a day (before the beginning of event and at the end). For

research participant enrollment locations on the North Branch of the Chicago River,

water samples will also be taken from the North Branch upstream of the North Branch

Dam. Exact locations of water sampling are presented in Appendix 5 and Appendix 6 of

the Overview document. Table 8 presents a summary of water sampling locations by

CAWS enrollment sites.

Water sampling locations

At access point

Upstream of

WRP

Downstream of

WRP

Dam

Bubbly Creek, Ping Tom

Table 8: Locations of water sampling, by participant enrollment site, CAWS sites

1.2 General Use sampling locations

For enrollment sites of the GUW group (Lake Michigan, the Skokie Lagoons, Crystal

Lake, and the Des Plaines, Fox, and Kankakee Rivers), water sampling locations will be

determined by the site and type of study participants’ recreational activities. Samples

will be taken at the launch site for boaters and paddlers except for beach-launch paddlers.

Water sampling for fishing subjects will happen at the point of recruitment (where they

are fishing).

The interval between sample collection at a given site on a given date will be every two

hours, the same as the interval between CAWS sampling. Samples will be collected

using a telescopic pole at launch sites (for boaters and paddlers) and near the study

participants (in the setting of fishers from shore).

2. Sampling Methods

2.1 Collection of Surface Water Samples for Indicator Organisms

2.1.1 A grab sample (discrete aliquot representative of a specific location/time) will

be collected using a telescopic pole fitted with a bottle holder, collecting the surface layer

only (up to 10 cm of depth) directly into sterile high-density polyethylene sampling

Size of sample bottle

Table 9: Size of direct sampling bottles

The volumes (Table 9) were chosen based on the suggestion from literature that [6] “the

minimum volume collected should be three to four times the amount required for the

analysis”.

2.1.3 Preservation of surface water samples will not be required for the indicator

organism analyses as none of the sources contain residual chlorine. (None of the

Wastewater Treatments Plants chlorinate effluents and Lake Michigan has no detectable

level of chlorine residual.) Sampling bottles will be used without preservative (e.g.

sodium thiosulfate or other).

2.1.4 Samples will be collected from the channel/river cross-section (left-stream or

right-stream, facing upstream) location nearest the access point. In addition, sampling

approximately ¼ mile upstream and ¼ mile downstream of Skokie Rowing Center will

be collected in conjunction with access point sampling at that location. Sampling sites

will be mapped for each event and provided to the sampler with the Field Data Sheets.

2.1.5 Method blanks, field splits, and matrix spikes will be prepared at every access

point where samples are being collected. Details are provided in section B.5. Five

percent of samples sent to the lab for analysis will be field blanks. The number of field

blanks collected will be determined by the total number of samples collected. On days

when more than one field blank will be collected, blanks will be collected at more than

one sampling site.

2.1.6 At least 5 percent of samples or 1 per method per day, whichever is greater,

sent to the lab for analysis will be matrix spike samples. The number of matrix spike

samples will be determined by the total number of samples collected. All samples will be

spiked at a single location each day; locations will vary by day.

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2.2 Water sampling by field filtration

Scientific Methods, Inc. (SMI) of Granger, IN has made available to the research team a

continuous flow centrifugation (CFC) system for use in the field or laboratory (Appendix

14). This system has Tier 2 EPA approval for use in Cryptosporidium analyses

(Appendix 10). Additionally, SMI has developed a “Virus Sampling Kit” consisting of a

2L per minute pump and a ViroCap 5-inch filter (Appendix 15). SMI will train UIC

personnel to use the CFC and virus sampling systems according to each system’s

Standard Operating Procedures (SOP) (see Appendix 16 for CFC SOP).

CFC samples are collected with non-filtering diaphragm water sampling pumps at each

location. Samples are collected into 20 liter sterile cubitainers using new tubing for each

sample. Samples are either processed by centrifugation upon delivery to the laboratory or

refrigerated until processed. Following processing, CFC bowls are refrigerated and

shipped cold.

All analyses will be performed by SMI as follows: Aliquots from the CFC bowl will be

Direct method, CFC, and simple filtration samples will be analyzed for E. coli and

enterococci by EPA reference methods 1603 and 1600, respectively. CFC and simple

filtration samples will be analyzed for microbes using methods listed in Table 2.

2.2.1 SMI will perform all QA and QC procedures required for each method and

follow internal QA practices required for certification by the Indiana Department of

Public Health for analyses of drinking water sources.

2.2.2 Laboratory results will be transmitted electronically to the director of the Water

Sampling and Analysis project by e-mail.

2.2.3 CFC and virus sampling in the epidemiologic study

2.2.3.1 Water samples for the analysis of pathogens will be collected every day

that direct method water sampling will take place (in other words, on days that CAWS

group and Lake group participants are enrolled). For WRP-oriented sampling, water will

be collected first upstream of the WRP, and approximately 30 minutes later from the

downstream location. One access point sample, one sample upstream of the WRP, and

one sample downstream of the WRP will be collected for pathogen analysis, in parallel

with the direct method sampling. Throughout the 2007 season, samples were filtered

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directly from the waterway by the CFC. Because of a nation-wide limited supply of CFC

systems, for the 2008 season samples are collected in 20L cubitainers and then

transported to the UIC lab to be filtered through the CFC. This method of collection was

chosen in consultation with the scientific review committee. The CFC sampling will take

place streamside/lakeside, as close as possible to water as permitted by safety

considerations. Study staff will monitor the filter systems to ensure that the pumps are

functioning properly and that the sampling tubing extends at least 10 feet from the

water’s edge.

2.2.4 Quality monitoring

2.2.4.1 Blank samples

Sterile, buffered water samples from the UIC SPH laboratories will be used to prepare

virus and CFC blanks for analysis.

2.2.4.2 Virus replicates

Every other week, 1 set of replicate virus samples will be created by filling a 200L drum

with water, at either a CAWS or general use location. Two 100L samples for viral

analyses will be collected, one right after the other.

2.2.4.3 CFC replicates

Every other week, two aliquots from the same CFC bowl will be sent for bacterial and

protozoal analyses.

2.2.4.4 Aliquoting of CFC samples will be as described in the SOP. One aliquot

will be kept at SMI -80°C.

2.2.4.5 Sample handling and transport will be as outlined in Section B.3, below.

2.3 Water Quality Parameters for Field Data Sheets

At each sampling location basic water quality parameters will be measured and recorded

on the FDS (Appendix 12). Turbidity will be measured with an HP Scientific MicroTPW

portable turbidimeter. DO (dissolved oxygen), pH and temperature will be measured with

an Accumet AP84 portable pH/dissolved oxygen meter. Conductivity will be measured

using an Oakton Acorn CON6 conductivity meter. All meters will be operated and

maintained according to the manufacturer’s instructions. Meters will be calibrated in the

UIC lab with certified standard materials before readings are taken for pH and DO

(Accumet AP84 pH/DO/mV meter) and turbidity (Micro TPW) and conductivity (Oakton

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July 2008

Acorn CON6) at the site. During a full day of sampling recalibration is necessary.

Calibrations are documented in the log books for equipment maintenance and calibration.

2.4 Meteorology Data for Field Data Sheet

Cloud cover, current precipitation and precipitation in the preceding 72 hours will be

recorded on the FDS (Appendix 12).

2.5 Equipment/Materials

The checklist of equipment and materials necessary for water sampling and safety is

listed below:

•

20 Liter sterile LDPE cubitainer

•

New 0.5” ID sample transfer tubing

•

Shurflo non-filtering viton diaphragm sampling pumps

•

Safety gloves, powder-free

• Sterile sample bottles (plastic, high-density polyethylene (HDPE), 250-mL)

• Sterile sample bottles (plastic, high-density polyethylene (HDPE), 1-L)

• 500-mL sterile water (pyrogen-free) for field blank at each site and each day

• Ziploc bags (7 in x 8 in for holding sample bottles)

• Paper towel

• Coolers (at least two for two different laboratories)

• Ice Packs

• Duct Tape

• Waterproof pen (several)

• Sample-bottle labels (waterproof, preprinted with data available)

• Accumet AP84 portable pH/dissolved oxygen meter

• HP Scientific MicroTPW portable turbidimeter

•

Oakton Acorn CON6 conductivity meter

• Field Logbook

• Chain-of-Custody Records (from laboratories, Appendices 7-9)

• (Water Quality Sampling) Field Data Sheets

• Clipboard with plastic cover (protect from water splash)

• Site location information, including maps and photographs

• Insect repellent/sunscreen (optional)

• Small first aid kit (optional)

• Whistle (to summon help in emergency,optional)

• Refreshments/drinking water (optional)

• Rope

• Camera/film (optional)

• Bottle of tap water (for rinsing exposed skin)

• Trash bag (to collect used safety gloves and other trash)

• CHEERS study contact list

• Cellular telephone

2.6 Collection of Surface Water Samples using Telescopic Pole

2.6.1 Select a bottle with a pre-printed label. Labels are coded based on the type and

location of sample being collected. Make sure that you are choosing the correct type and

location for sampling.

2.6.2 Verify that the bottle looks clean and remains sealed before starting to sample.

If sterility is questionable, deface the label and do not use the bottle.

2.6.3 Write the time and sampler's initials on the label with a waterproof pen

2.6.4 Put safety gloves on and remove the bottle cap carefully, ensuring that you do

not touch the inside of the cap or bottle.

2.6.5 Position the bottle in the holder at the end of the telescopic pole. Ensure that the

bottle is secure in holder and holder is tightly affixed to pole.

2.6.6 While standing at the access point, extend the pole making sure that all sections

are fully extended and tight fitting.

2.6.7 Immerse bottle (holding it about 45 degree) facing upstream so that water

surface and the upper 10 centimeter (~4 inches) layer are included in the sample (avoid

surface debris if possible).

2.6.8 Raise bottle out of water, retract pole.

2.6.9 Remove bottle from holder.

2.6.10 Pour off excess water until the water level is at the fill line or leave about 1-in

air space (for proper mixing purpose before analysis).

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2.6.11 Recap the bottle (tight enough) and dry off the bottle with paper towel.

2.6.12 Place sample in zip-lock bag and put it in insulated cooler.

2.6.13 Fill in the Field Data Sheet with times and initials (same as on bottle).

2.6.14 Fill in the Chain-of-Custody (COC) record (Appendix 17,18).

2.6.15 Turn over the coolers to the assigned custodian for transportation to the

analyzing laboratory. He/she must sign the Chain-of-Custody record.

2.6.16 Wait until the cooler is sealed with tamper proof tape.

2.6.17 Return Field Data Sheets to Water Project Manager as soon as possible.

2.7 Collection of Field Split samples

2.7.1 Field splits are used to estimate sampling and laboratory analysis precision.

Field split samples are to be collected the same way as the regular samples except that a

higher volume sterile sample container (1-liter) will be used for sampling. The 1-liter

container is used to collect water and split between three regular sterile sample

containers. Regular sample bottles must be labeled and ready for filling by the time of

sampling. All bottles must be kept closed, to be opened for sample filling only and using

aseptic technique. Before splitting, the sample must be shaken up. One staff member will

open the sample bottle and the other one will fill them (from the 1-liter container).

2.7.2 Collect a minimum of two sets of field replicate samples every day of field

sampling. A minimum of 5% of all samples will include a split. Preferably, this should

take place at the access point closest downstream to a WRP.

2.7.3 When sampling will take place at a given access point more the once, the splits

will be prepared at the end of the sampling day.

2.7.5 Follow the steps of “Collection of surface water samples” (from 2.5.1.1 to

2.5.1.11) for the collection of field split samples. They are to be processed the same way

as regular samples sent to the laboratory.

2.8 Preparation of Field Blanks

2.8.1 Sterile buffer will be available for the preparation of field blanks.

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July 2008

2.8.2 At least one field blank for every 20 samples of each method will be prepared

on each day of sampling, the total number to be determined by the number of samples

collected. If more than one blank is needed, then blanks will be prepared at more than

one location.

2.8.3 Field blanks will be prepared at the end of the sampling day.

2.8.4 Procedure for preparing field blanks:

2.8.4.1 Locate the sterile bottle of water and the “field blank” coded sample bottles.

2.8.4.2 Initial and note the time on the sample bottle label.

2.8.4.3 Uncap the sample bottles and fill them up with the sterile water until fill-line.

2.8.4.4 Continue the procedure from the 13th step of the “Collection of surface water

samples” (these are handled like regular samples)

2.9 Procedures for 20 liter cubitainer sample collection

2.9.1 Wear new gloves

2.9.2 Connect new sample transfer tubing to sample pump

2.9.3 Position inlet tubing ~6” below surface of source water but not in bottom or

debris

2.9.4 Open pre-labeled 20 Liter cubitainer

2.9.5 Insert tubing into cubitainer

2.9.6 Fill cubitainer near full and cap

2.9.7 Record sample time, volume, and sampler initials on label and data sheet

2.9.1 Transfer to UIC laboratory

2.10 Virus sample collection

2.10.1 Wear new gloves

2.10.2 Remove inlet and outlet caps from pre–labeled filter

2.10.3 Connect new sample transfer tubing to filter inlet

2.10.4 Position inlet tubing ~6” below surface of source water but not in bottom or

debris

2.10.5 Connect tubing from filter outlet to sample pump

2.10.6 Turn pump on and filter 100 liters from water source

2.10.7 Replace filter inlet and outlet covers after sample collection

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July 2008

2.10.8 Record sample time, volume, and sampler initials on label and data sheet

2.10.9 Store in cooler and transfer to UIC laboratory

2.11 Safety Precautions for Samplers

2.11.1 Rivers are under the direct influence of treated wastewater discharge. Fecal

contamination or pathogens may be present.

2.11.2 Use disposable safety gloves when collecting samples (have a bag with you

for collecting contaminated ones)

2.11.3 Wash your hands thoroughly after sampling; use hand sanitizer when hand

washing facilities are unavailable.

2.11.4 Do not touch your eyes, ears, nose, or mouth until you’ve washed your hands

2.11.5 Operating in and around bodies of water carries the inherent risk of drowning.

Collecting samples in cold weather, especially around cold water bodies, carries the risk

of hypothermia and collecting samples in extremely hot and humid weather carries the

risk of dehydration and heat stroke. Sampling team members should wear adequate

clothing for protection in cold weather and should carry an adequate supply of water or

other liquids for protection against dehydration in hot weather.

3. Sample Handling and Custody

3.1 Sample Handling

All requirements for methods 1600 and 1603 for sample containers, preservation

techniques, sample volumes and holding times will be met. Specifically, all bacteria

samples will be held at 1-4°C during transit to the laboratory, and the time between

sample collection and the initiation of analysis will not exceed 6 hours. The laboratory

will provide certified-clean sample containers. Separate sample containers for QC

samples will also be provided by the analytical laboratory.

3.2 Sample Identification

Samples are to be identified on the sample container with a separate identification label.

All labeling will be done in indelible/waterproof ink. Any errors will be crossed out with

a single line, dated, and initialed.

After collection and identification, samples will be maintained under chain-of-custody

procedures specified by the analytical laboratory. Proper sample custody procedures will

be used to ensure that samples have been obtained from the locations stated and that they

have reached the laboratory without alteration. A sample is considered to be in a person's

custody if the sample is:

• in a person's actual possession;

• in view after being in a person's possession;

• locked so that no one can tamper with it after having been in physical custody; or

• in a secured area, restricted to authorized personnel

All samples will be accompanied by a Chain-of-Custody Record. When transferring

samples, the individuals relinquishing and receiving the sample will sign and date the

record. Once the samples have been received by the laboratory, a designated laboratory

person will check all incoming samples for integrity and note any observations on the

original Chain-of-Custody Record. Each sample will be logged into the laboratory system

by assigning it a unique laboratory sample number. This number and the field sample

identification number will be recorded on the laboratory report. The laboratory will

maintain a file of all the documents (e.g., Chain-of-Custody forms) pertinent to sample

custody and sample analysis protocol. For Chain-of-Custody forms, the laboratory

maintains a file copy and the completed original will be returned to the Water Project

Manager as part of the final analytical report. This record will be used to document

sample custody transfer from the sampler to other personnel or the laboratory.

3.4 Sample Packaging, Shipment, and Tracking

All samples will be delivered directly to the analytical laboratories by study staff, lab

staff, or commercial courier service.

3.5 Labeling/Identifying Water Samples

3.5.1 Samples will be identified on the sample container with pre-printed waterproof

identification labels. Sampling times and initials will be added with waterproof ink. After

securely affixing them, labels will be covered with transparent tape.

3.5.2 Sample identification code on the labels will code for location, sample type,

required analysis, sample number, required procedure, date and time.

3.5.3 Sampling location codes are listed in Appendix 19.

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July 2008

3.5.4 Sample Type Code

• Blank (sterile water): BK

• Sample (regular sample): SP

• Field replicate (duplicate): FR

• Matrix spike sample: MS

• Matrix spike Sterile Water (blank spike): BS

3.5.6 Sample number code

This number will be given to each sample starting from 1111 based on the Field Log

Book’s serial number

3.5.7 Required procedure with the sample:

• No filtration performed in field: N

• Simple filtration performed in field: F

• Centrifugation performed: C

3.5.8 Date and time of sample collection

• Date will be preprinted on label: month-day-year

• Write time using military time (e.g. 3:08 PM would be 1508)

3.5.9 Example of coding:

Sampling at Alsip, for indicator bacteria, 15th sample in the Field Log Book, directly

sampled (no procedure), and collected on June 12th, 2:45PM;

Code: AL-SP-IB-15N-06-12-07-1445

3.5.10 Necessary information and appearance of label

3.5.10.1 Sample Identification Code

3.5.10.2 Name or initials of samplers (if initials shown on the label, a separate

sheet should be maintained showing the sampler’s full name and initials (to be able to

identify him/her)

3.5.10.3 Date and time of sampling

3.5.10.4 Requested Analyses (fully printed, no abbreviation)

3.5.10.5 Analysis method numbers (e.g. 1600, 1602, 1603)

4. Analytical Methods

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July 2008

Water samples will be transported to a commercial EPA-certified analytical laboratory

for measurement of indicator organisms. Based on the results of the first preliminary

water sampling study (detailed in the 2007 QAPP: Water Sampling and Analysis

document), Enviro-Test/Perry Laboratories was chosen as the commercial lab to analyze

samples for E. coli and enterococci, using US EPA Methods 1603 and 1600, respectively.

SMI will analyze samples for coliphages using US EPA Method 1602 as they are the

only lab in the Chicago area able to perform the analysis. Laboratory certification and

initial sample receipt protocols are found in Appendices 18-19.

The analytic laboratories will dilute samples using specific sample volumes using

membrane filtration method for indicator organisms. We developed a series of 5 dilution

volumes to be performed for all samples, based on sampling site (CAWS vs. lake/lagoon)

for the following reasons:

1) For E. coli, the recommendations of “Microbiology Methods” text [3] are shown

below in Table 10. Although this provides information about fecal coliforms,

approximately 80-90% of the coliforms in the CAWS are E. coli. The “Range Covered”

is consistent with Dry Weather Risk Assessment values for the dry season, with higher

densities anticipated in the wet season.

2) For Enterococci analyses, we have chosen a lower dilution range based on the

expectations that densities will be at least ten-fold lower than the E. coli density, as noted

in the Dry Weather Risk Assessment.

Sample

Source

100

0.3

0.1

0.03

0.01

* “CFU range covered” is calculated using membranes with 20-60 colonies (acceptable

range)

CFU/100-mL = # of colonies counted x 100 / Volume of sample filtered, in mL

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July 2008

Table 10. Suggested range of sample volumes (mL) for fecal coliform tests using the

membrane Filter Method

Based on the knowledge of the pollution level of indicator organisms in CAWS, we have

decided to request the analyses of 5 dilution levels from each river samples.

The dilutions to be performed on samples in this study, based on location of sampling are

presented in Table 11 below. If filter clogging or interference is found to occur with the

100mL dilution volumes, that dilution volume will require reduction.

100; 30; 10; 3; 1 mL 100; 30; 10; 3; 1 mL

Dry weather

Skokie Lagoons

100; 30; 10; 3; 1 mL 100; 30; 10; 3; 1 mL

Wet weather

30; 10; 3; 1; 0.3 mL 30; 10; 3; 1; 0.3 mL

Dry weather

North Shore

30; 10; 3; 1; 0.3 mL 100; 30; 10; 3; 1 mL

Channel – Bridge St

Wet weather

10; 3; 1; 0.3; 0.1 mL 30; 10; 3; 1; 0.3 mL

Dry weather

CAWS – North Side

10; 3; 1; 0.3; 0.1 mL 30; 10; 3; 1; 0.3 mL

Wet weather

3; 1; 0.3; 0.1; 0.03

10; 3; 1; 0.3; 0.1 mL

Dry weather

CAWS – South Side

100; 30; 10; 3; 1 mL 100; 30; 10; 3; 1 mL

Wet weather

30; 10; 3; 1; 0.3 mL 30; 10; 3; 1; 0.3 mL

Table 11: Dilution volumes, by sampling location, weather condition, and indicator

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July 2008

5. Quality Control

5.1 Interference and Potential Problems for Sampling

5.1.1 Two main sources of possible interference and problems during surface water

sampling can involve cross-contamination and improper sampling.

5.1.2 Improper sampling arises from unclean and non-sterile sample containers,

improper sampling technique or improper shipment procedures. Improper sampling can

be reduced by using standardized procedures for collecting, handling and shipping

samples and following the procedures of the SOP step-by-step. The commercial

laboratories will provide certified sterile sample bottles. If bottle sterility is questionable,

the sampler must deface the label or write on the bottle “non-sterile” when no label is

attached and put it aside. When temperature of sample measured at the lab is above 20°C,

sample analysis will be refused by the laboratory. Improper sampling technique may be

detectable from too high standard deviation between replicates. Statistical evaluation will

be used to examine the data for outliers.

5.1.3. Cross-contamination from sampling equipment is greatly reduced by using the

direct sampling method (collection of samples directly into the sterile container). If the

sampler accidentally touched the inside of the bottle, he/she must not use it.

5.2 Quality Assurance/Quality Control Samples

5.2.1 “Field Blanks” will be processed at every sampling day along with the regular

samples. For that purpose, sterile buffered water is taken into the field in a sealed

container. Two sterile sampling containers will be filled with it at the sampling site. They

will be marked according to the code of “Field Blank” and sent to the laboratory to be

analyzed with the regular samples. Analysis should result in "0" bacteria counts for

blanks (errors, contamination). See procedure under 2.7. Field blanks will be processed

close to the end of sampling events for the day.

5.2.2 “Field Replicates” and “Matrix Spikes” will be prepared for each method

during every sampling day, which will produce a minimum of one replicate and one

matrix spike for every 20 samples. Water will be collected in a 1 liter bottle and then

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July 2008

distributed among four 250mL bottles. Two of the four bottles will be spiked, the other

two will serve as field replicates. Field replicates and matrix spikes will be analyzed with

the regular samples. Replicates should have comparable bacteria counts (precision of

sampling and analysis). See procedure under 2.6 for field replicate sampling.

5.2.3 Temperature will be checked and documented upon arrival at the laboratory.

Pistol-grip infrared thermometers are used in both laboratories that allow for touch-free

measurement of cooler and bottle temperature. Their accuracies are 1% what is ±2°F or

±1°C. Once releasing the button, readings display for 7 seconds which allows time to

record data.

5.3 QA/QC Procedures: Implementation of the QA/QC procedures for surface water

evaluation will be established through the following steps:

5.3.1 Ensure that each field team member is familiar with the provisions of the

QAPP. The Water Project Manager will ensure that each field team member is familiar

with the field sampling SOPs and QAPP prior to implementation of field activities.

5.3.2 The Data Quality Manager, with the assistance of the Water Project Manager,

will regularly perform a QA review of field activities, field data sheets and forms to

ensure that all procedures are followed.

5.3.3 The Data Quality Manager will verify that all laboratories contracted have a

written description of their QA activities and a QA plan describing the QA management

of day-to-day routine operations.

5.3.4 The laboratories contracted to evaluate samples are required to adhere to

defined quality assurance procedures to ensure that generated analytical data is

scientifically valid and are of known and acceptable precision and specificity.

5.3.5 Quality control charts will be maintained for every parameter measured for the

study including blanks, calibration factors, and measures of precision for each parameter.

The Data Quality Manager will initially perform weekly reviews and specify corrective

action as needed. Once acceptable performance is established, this review will be

conducted monthly or more often if needed.

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July 2008

6. Instrument/Equipment Testing, Inspection, and Maintenance

Equipment maintenance and repair will be performed as required for each instrument.

Preventive maintenance for all equipment includes inspection before use, cleaning as

necessary during use, and thorough cleaning and inspection after use. Rechargeable

batteries are checked before use and recharged after use. For equipment using disposable

batteries, replacement batteries will always be stocked. Maintenance and repairs will also

occur when corrective action needs are identified. If the instrument cannot be repaired or

recalibrated, the instrument will be replaced.

6.1 Corrective Actions

Corrective actions involving field instruments, including pH, turbidity, DO and

temperature will be implemented by the UIC field personnel and documented in field

logs. Corrective actions for the analytical laboratory may include the following:

6.1.1 Reanalyzing the samples if holding time criteria permits;

6.1.2 Re-sampling and re-analyzing;

6.1.3 Evaluating and amending sampling procedures, and/or evaluating and

amending analytical procedures; and

6.1.4 Accepting the data and acknowledging the level of uncertainty.

7. Instrument/Equipment Calibration and Frequency

Each instrument will be calibrated following the specific manufacturer's

recommendations. Laboratory instruments should be calibrated prior to each use or on a

scheduled, periodic basis as specified in the analytical methods. Analyzing laboratories

both provided documentation of their equipment/instrument calibration data.

Typical microbiology lab instruments/equipment:

Accuracy

Service and recalibrate

Monitor bacterial density Monthly

Dilution water bottle

Check pH and volume

Each use

Table 12: Microbiology lab equipment monitoring

8. Inspection/Acceptance of Supplies and Consumables

Commercial water quality laboratories (EnviroTest/Perry and SMI) have established

rigorous QA/QC systems for all aspects of microbiologic analyses. Copies of their log-

books for rinse/dilution water sterility and quality (pH, conductivity, chlorine residual)

checks, media storage and preparation, media performance check, membrane filter

acceptance QA and copies of other documentation are available for us (and we have

copies of pages from those log books)

8.1 Dilution/Rinse Water Sterility Check

Prepared rinse water needs to be checked for sterility on a per lot basis prior to use. The

sterility check is accomplished by adding 50ml water to 50ml of a non-selective broth

and incubating the mixture. The absence of growth indicates sterility. Water failing the

sterility check is re-sterilized (and re-checked) or disposed. Table 13 below presents

information about the sterility checks, their monitoring frequency, and their acceptable

Heterotrophic Plate Count

Monthly or for new source

<1000cFU/mL,

Student’s t≤2.78

Conductivity

Continuous or each use

>0.5megohm resistance

or <2μmhos/cm @

Each use

5.5-7.5

Total Organic Carbon (TOC)

Monthly

< 1.0 mg/L

Heavy metals, single (Cd, Cr,

Cu, Ni, Pb, Zn)

Annually (more frequently if

problematic)

< 0.05 mg/L

Heavy metals, total

Annually (more frequently if

problematic)

< 0.1 mg/L

Ammonia/organic nitrogen

Monthly

< 0.1 mg/L

Total Chlorine Residual

Monthly or with each use

< 0.01 mg/l

Table 13: Quality of reagent water used for microbiology testing [8]

8.2 Media Sterility Check

New lots of media received from the vendor as well as new batches of media prepared in

the lab need to be evaluated prior to use. Positive and negative controls are analyzed. The

positive control uses a culture that is intended to be the detected analyte of the procedure.

The negative control uses a culture that is not intended to be the detected analyte of the

procedure. Unacceptable lots/batches cannot be used for the analysis of samples.

8.3 Positive/Negative Controls

The method blank is a negative control that goes through all applicable analytical steps

and is used to document non-contamination of the analytical process. This control uses

sterile buffered dilution water to verify the sterility of the media, equipment and

techniques used to process environmental samples in a particular batch. The method

blank is considered a batch control parameter. Samples associated with a method blank

indicating high bias must be re-prepared and analyzed (if possible).

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July 2008

The lab control sample is a positive control that goes through all applicable analytical

steps. This control uses a known culture to verify the ability of the entire analytical

procedure (i.e. media, equipment and techniques) to properly identify the presence of the

target organism in a particular batch of environmental samples. The lab control sample is

considered a batch control parameter. Samples associated with a failing lab control

sample must be re-prepared and analyzed (if possible). Where reanalysis is unavailable,

the data reported to client is associated with a narrative explaining the QC failure.

8.4 Media Storage

All opened containers of dehydrated media are stored at room temperature in a desiccator

unless otherwise recommended by the manufacturer. All prepared media is stored at 4

degrees C in an appropriate container until expiration date.

8.5 Filtration Unit Sterilization

Filtration units are sterilized using an autoclave. A thermometer is used to verify the

appropriate temperature of the autoclave environment. Additionally, sterilization tape is

used to indicate proper operation of the autoclave. Method Blanks (MBLKs) are

processed on each filtration unit prior to the first client-submitted sample as well as after

every 10 samples and the last sample. The results from these blanks are used to assess

and indicate clean filtration units prior to use on samples as well as throughout an in-

going run.

9. Non-Direct Measurements

Meteorology data will be obtained for the sampling sites from the closest stations.

10. Data Management

Field data sheets need to be inspected by the sampler for completion/correct information

and given to the Water Project Manager at the end of sampling day or on the following

day in case of late afternoon sampling. The Water Project Manager will review it for

errors and store them in a locked room. Water quality parameters will be entered in an

excel spreadsheet.

Laboratory analyses data for indicator organism will be received by the Water Project

C. ASSESMENT AND OVERSIGHT

1. Assessments and Response Actions

Reviews of data quality will be performed regularly, as outlined in the system-wide

quality management plan (QMP). This project includes several streams of quality

monitoring data, and we will use a graded approach to review them.

1.1 At weekly quality reviews, we will note and develop ways to prevent deviations in

the protocol that have occurred in the preceding week. This could include:

• rejection of samples by analytic laboratories

• intervals between sample collection and analysis that exceed 6 hours

• field blanks with quantifiable amounts of E. coli or enterococci

• Failure to collect samples at the correct locations or other breaches in protocol

1.2 At monthly quality reviews, summary statistics of field blanks, split samples, and

internal laboratory QC data will be reviewed. Summaries of mean densities of indicator

organisms by sampling location (CAWS vs. general use waters) will be reviewed and

outliers will be identified and reviewed.

1.3 At annual quality reviews, all quality data will be reviewed, as will summaries of

indicator and pathogen measures. Emphasis will be placed on system-wide quality issues,

with the goal of developing quality improvement strategies for the next recreation season.

D. DATA VALIDATION AND USABILITY

1. Data Review, Verification and Validation

Reduction of analytical results will be done using calculations recorded on analytical data

sheets. The laboratory QA manager will verify that the appropriate analytical method is

followed and the data are calculated properly. The laboratory QA Manager or his/her

designee will validate the data by comparing the raw data to the reported results. In

addition, the results of calibration and internal QA/QC checks will be compared with the

project acceptance criteria to assess the usefulness of the data. The laboratory analytical

reports will contain the following information:

1.1 Raw data, including results of calibration and internal QC checks;

1.2 Analytical data results;

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July 2008

1.3 Units of measurement;

1.4 Client and sample identification;

1.5 Sample analysis dates;

1.6 Summary of any problems encountered;

1.7 QC data (matrix spikes, blanks,

ORPs); and

1.8 QA reviewer’s signature

2. Verification and Validation Methods

Upon receipt of hardcopy sample results for a monitoring sample, the Water Project

Manager will verify that the following information is included:

2.1 Sample result summary sheet, which should include the following:

2.1.1 Sample identification information

2.1.2 Sample result

2.1.3 Laboratory quality control checklist (or other verification from the laboratory

that all QC specifications were met)

2.1.4 Method Bench Sheet completed by the laboratory with primary sample

processing and analysis data associated with the sample

2.1.5 Laboratory comments. Comments may include any applicable data qualifiers.

The following is a list of potential data qualifiers:

2.1.5.1 Sample arrived at the laboratory in unacceptable condition (i.e., leaking)

2.1.5.2 Sample holding time exceeded

2.1.5.3 Sample holding temperature not within acceptable range

2.1.5.4 Unacceptable blank sample result

2.1.5.5 Unacceptable positive or negative control result

2.1.5.6 Media sterility checks were not acceptable

2.1.5.7 Method incubation times or temperatures were not within acceptable range

2.1.5.8 Membrane filtration: Too much sediment on the filter

2.1.5.9 Membrane filtration: Confluent growth of non-target organism

2.1.5.10 Membrane filtration: Colonies too numerous to count (TNTC)

2.1.5.11. Membrane filtration: Pre- or post- filtration series sterility check not

If laboratory forms are missing, incomplete, or incorrect, the Water Project Manager will

contact the laboratory project manager immediately to discuss and request resubmission

of the missing forms and/or spreadsheets.

CHEERS QAPP-1

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July 2008

References

Geosyntech Consultants. 2008. Dry and wet weather risk assessment of human

health impacts of disinfection versus no disinfection of the Chicago Area Waterways

System (CWS).

Lee, J. V., S. R. Dawson, S. Ward, S. B. Surman, and K. R. Neal. 1997.

Bacteriophages are a better indicator of illness rates than bacteria amongst users of a

white water course fed by a lowland river.

Water Sci Technol

35(11-12):165-170.

Love, D. C., and M. D. Sobsey. 2007. Simple and rapid F+ coliphage culture,

latex agglutination, and typing assay to detect and source track fecal contamination.

Appl

Environ Microbiol

73(13):4110-8.

Noble, R. T., S. M. Allen, A. D. Blackwood, W. Chu, S. C. Jiang, G. L. Lovelace,

M. D. Sobsey, J. R. Stewart, and D. A. Wait. 2003. Use of viral pathogens and indicators

to differentiate between human and non-human fecal contamination in a microbial source

tracking comparison study.

J Water Health

1(4):195-207.

4. U.S. Environmental Protection Agency, ERT, 1994. Surface Water Sampling, SOP#:

2013 (11/17/94)

5 U.S. Environmental Protection Agency, ERT, 1994. General Field Sampling

Guidelines, SOP#: 2001 (08/11/94)

6 U.S. Environmental Protection Agency, R&D, 1978. Microbial Methods for

Monitoring the Environment, Water and Wastes, EPA-600/8-78-017 (Edited by R.

Bordner and J. Winter)

7 U.S. Environmental Protection Agency, ERT, 1992. Performance Evaluation (PE)

Samples, Quality Assurance Technical Information Bulletin (May 1992)

8. U.S. Environmental Protection Agency, ERT, 1992. Quality Assurance/Quality

Control Samples, Quality Assurance Technical Information Bulletin (May 1992)

9. U.S. Environmental Protection Agency, ERT, 1995. Superfund Program,

Representative Sampling Guidance, Volume 5: Water and Sediment, Part I; Surface

Water and Sediment, December 1995

CHEERS QAPP-1

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July 2008

10. U.S. Environmental Protection Agency, NRMRL, 2007. EPA 625/R02/017: Time

Relevant Beach/Recreational Water Quality Monitoring and Modeling, January 19th,

2007

11. APHA-AWWA-WPCF: Standard Methods for the Examination of Water and

Wastewater, 21st Edition, 2005: Part 9000: Microbiological Examination

12. U.S. Environmental Protection Agency, OWOW, 1997. Monitoring and Assessing

Water Quality, Volunteer Stream Monitoring: A Methods Manual EPA 841-B-97-003

13. U.S. Geological Survey. 2003: National Field Manual for the Collection of Water-

Quality Data: Chapter A7: Biological Indicators (7.1.2A: Surface Water collection

11/2003)

14. MWRDGC R&D Department (Report No. 05-15) Interim Report, Fecal Coliform

Densities in Chicago area Waterways during dry and Wet Weather 2004

15. MWRDGC: Interim Phase I Dry Weather Risk Assessment of Human Health Impacts

of Disinfection vs. No Disinfection of the Chicago Area Waterways System (Project No.

CHE8188) 2006 November

16. Prepared by Research Triangle Institute, U.S.EPA Contract 68-D4-0091 (August 24,

1999): Data Quality Objectives and Statistical Design Support for Development of a

Monitoring Protocol for Recreational Waters, Final Report.

Table of Contents

A. PROJECT MANAGEMENT

1. Distribution List

2. Project/Task Organization

3. Problem Definition/Background

4. Project Task/Description

5. Quality Objectives and Criteria

6. Special Training/Certification

7. Documents and Records

B. DATA GENERATION AND ACQUISITION

1. Sampling Process Design (Experimental Design)

2. Sampling Methods

3. Sample Handling and Custody

4. Analytical Methods

5. Quality Control

6. Instrument/Equipment Testing, Inspection, and Maintenance

7. Instrument/Equipment Calibration and Frequency

8. Inspection/Acceptance of Supplies and Consumables

9. Non-direct Measurements

10. Data Management

C. ASSESSMENT AND OVERSIGHT

1. Assessments and Response Actions

2. Reports to Management

D. DATA VALIDATION AND USABILITY

References

List of Tables

List of Figures

List of Appendices

Page

Table 1 Index of Documents and Records, Storage and Distribution

Table 2 Composition of Field teams

Page

Overall Project Management Structure for Survey Methods

Figure 2

Field Team Management Structure

CHEERS QAPP 2

July, 2008

List of Appendices

Appendix

Description

1A-P

CHEERS Survey Training Manual

EPA/CDC NEEAR Study Beach Survey

EPA/CDC NEEAR Telephone Interview

4A-B

Eligibility Screener & Refusal Tally

Field Survey A

Field Survey B

Follow-up Telephone Interview

8A-E

CHEERS Pilot Study protocol and IRB approval

letter

Use Survey Data Sheet

IRB Exemption for user survey

IRB approval for CHEERS Survey Methods

Protocol

Thermal wristband bar coding technology

CHEERS Survey Methods Field Report

14A-U

Maps of recruitment areas

CHEERS Location Specific Flyer

Adult Consent Form

Parental Consent Form

Assent Form

Questionnaire Variables for Data Analysis

CHEERS QAPP 2

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July, 2008

A. Project Management

1. Distribution List

UIC: S. Dorevitch, P. Scheff, M. Javor, P. Pratap, S. Wuellner, A. DeLaquil, J.

Wuellner, T. Schoonover and all other CHEERS staff.

MWRDGC: T. Granato

2. Project/ task organization

Figure 1 outlines the lines of authority linking key members of the CHEERS study

involved in the questionnaire development and project implementation. The study director will

have overall authority in the development and implementation of the study questionnaires and

hiring of project managers involved in recruiting and survey administration. The quality

manager will establish overall data quality objectives for the CHEERS study and will be in

charge of reviewing the quality of the data and the questionnaire data collection process. The

detailed organizational structure is provided in the Study Overview.

The Survey Project Manager (SPM), Preethi Pratap, PhD, has primary responsibility for

the development and implementation of the study survey questionnaires, hiring and monitoring

of field interviewers and recruiters, communicating with the Survey Research Laboratory (SRL),

and maintaining the overall quality of the field data collection and management process. The

Survey Project Manager, with assistance from the Assistant Survey Project Manager (A-SPM), is

responsible for the following project related tasks:

2.1. Develop the study questionnaires and conduct necessary pilot tests and reviews in

order to improve and ensure quality of these questionnaires and the field data

collection methods.

2.2. Obtain Institutional Research Board (IRB) approval for the use of the study

questionnaires in the field and data collection methods.

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July, 2008

2.3. Work with the University of Illinois at Chicago (UIC) Survey Research Laboratory

(SRL) to program and review the study questionnaires.

2.4. Work with the project manager to recruit and hire data managers and interviewer-

recruiters.

2.5. Develop, implement, and evaluate training programs for field data managers and

interview-recruiters.

2.6. Ensure all field team members involved in recruiting and survey administration are

certified (and maintain certification) by the UIC IRB for Human Subjects Research.

2.7. Work with the SRL to develop and conduct the appropriate training methods to

administer the questionnaires.

2.8. Ensure all field team members involved in recruiting and survey administration are

trained in questionnaire administration and interviewing techniques before they

begin recruiting in the field.

2.9. Implement adequate quality control methods during field events to ensure accurate

compilation of consent documents, assignment of Case IDs for study participants,

and the smooth flow of participants through the study process.

2.10. Meet regularly with survey data managers to review and, when possible, improve

the field work conducted by the interviewer/recruiters.

2.11. Securely transfer data to SRL after each field event.

2.12. Assist the Project Manager to staff the field events. Assist the Clinical Manager,

when necessary, to ensure timely clinical specimen collection or pickup.

2.13. On a weekly basis track study enrollment and data collection of the CHEERS

study, including study completion by participants, and attrition from the study.

2.14. Provide timely feedback and reports to the CHEERS study quality manager and

study director throughout the data collection process.

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Study Director

S. Dorevitch, MD, MPH

Quality Manager

P. Scheff, PhD

Survey Project Manager

P. Pratap, PhD

Survey Research Lab

Project Manager

I. Farrar

- Questionnaire design

Survey Research Lab

Data Manager

Interviewer/recruiters

(Approximately 50)

Field Data Managers

(Approximately 12)

Participant

Recruitment Manager

A. DeLaquil, BS

Figure 1: Overall Project Management Structure for Survey Methods.

CHEERS QAPP 2

July, 2008

3. Problem Definition/Background

The overall scientific background and goals of the CHEERS study are outlined in the

Study Overview document. The following sections will focus on the development,

implementation and use of the CHEERS questionnaire data collection methods.

In order to meet the following study objectives:

3.1 To determine rates of acute gastrointestinal and non-gastrointestinal illness

attributable to recreation on the Chicago Area Waterways System (CAWS)

3.2 To define the relationship between concentrations of microbes in the water and

rates of water illness among recreators

It is necessary to:

•

define participant demographics, non-water-related risk factors for illness, other

water exposures, and health end-points

•

ensure that the survey questionnaires are easy to follow and complete

•

characterize usage at CAWS recruiting locations

•

use available technology for reliable recording of responses in a timely fashion

•

develop a system for assigning unique participant ID and be able to track their

progress throughout the study

•

develop a secure and reliable method for transferring data from the field to SRL

•

have a system in place for tracking participant completion of study elements and

attrition rates

•

construct a database of the survey data

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July, 2008

4. Project/Task Description

The overall project objectives are:

4.1. To develop CHEERS study questionnaires

4.2. Work with SRL to program the questionnaires into portable computers and desktop

computers

4.3. Ensure all project staff are IRB certified, and trained in survey administration and

interviewing techniques

4.4. Conduct a pilot study in order to evaluate and refine the study questionnaires prior to

use in the field

4.5. Conduct a user survey to identify potential sampling locations for CHEERS study

recruitment

4.6. Obtain IRB approval (pilot and final epidemiologic study) for use of study

questionnaires and the data collection methods involving human subjects

4.7. Establish the field study base of operations on day of event

4.8. Provide advance and day-of-event publicity

4.9. Screen interested individuals for eligibility

4.10. Enroll those who are eligible through the informed consent process

4.11. Administer survey questionnaires prior to and after recreation

4.12. Transfer and receive data through secure channels to/from SRL at the end of each event

4.13. Conduct follow-up telephone interviews

4.14. Coordinate the above with clinical specimen collection and collection of water samples

4.15. Implement QA/QC methods throughout the data collection and management process

4.16. Provide field reports and quality reports to the study director and quality manager on a

regular basis

4.17. Track progress of participant enrollment and completion of study

4.18. Analyze data to improve and refine the data collection process and recruiting methods

The proposed dates and locations of various recruiting events are outlined in Study Overview.

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July, 2008

5. Quality Objectives and Criteria

The overall quality objectives are:

5.1. To develop appropriate data collection methods to gather high quality data that can be

used to test the hypotheses of the study described in the Study Overview

5.2. To ensure all CHEERS personnel will receive proper training and oversight

5.3. To maintain integrity of data at all times during data collection and data transfer from

field/phone to final dataset

5.4. To ensure that 100% of the participants who complete the field surveys will receive a

follow-up telephone call on days 2, 5 and 21 of the study

6. Special Training/Certification

As per the University of Illinois at Chicago (UIC) Institutional Review Board (IRB) all

UIC Investigators and key research personnel in the CHEERS study are required to meet the

training requirements in human subjects protections before their involvement in any research

involving interactions with human subjects (including the publicity and recruitment process,

consent process, administration of surveys and telephone interviews). No CHEERS study

personnel will be allowed to participate in research activities involving human subjects until they

have, and maintain, IRB certification.

All CHEERS personnel involved in recruiting and survey administration or any human

subject interaction in the field will be required to obtain IRB certification in Biomedical

Research at UIC. The SPM is responsible for maintaining a log of the IRB certification status of

all CHEERS study personnel at all times during the study. Study personnel will be reminded

about the expiration of their IRB certification status at least 2 months in advance, and if

necessary, provide information as to how to take the online training. Any study personnel with

an expired IRB certification status will not be allowed to participate in field activities involving

human subjects.

CHEERS QAPP 2

July, 2008

In order to be eligible to recruit participants, administer survey questionnaires, and

conduct telephone interviews all CHEERS study personnel will also be required to complete an

in class training session designed and conducted by the SPM with assistance from SRL.

The training will cover all documents included in the training manual (Appendix 1).

Many training documents from the EPA/CDC NEEAR study were adopted and revised. In

addition CHEERS study personnel will also complete the following:

•

An on-line general recruiting and interviewing training session designed by SRL

•

A power-point presentation of the CHEERS study overview

•

A power-point presentation outlining a day in the field, including:

o

An introduction to survey questionnaires

o

An introduction to interviewing techniques, “Do’s” and “Don’ts”

o

How to approach participants and recruit them

o

How to check participant eligibility

o

How to conduct the consent process

o

How to administer the CHEERS survey questionnaires (including use of

hand-held computers in the field and telephone interviews on a desktop

computer)

o

How to hand out incentives in the field

•

Mock interviews - These are conducted in groups or one-on-one. The SPM, SRL

staff, and/or A-SPM will conduct these mock interviews. We will go through each of

the surveys question by question. The mock interviews will focus on:

o

Probing methods

o

Recording the answers correctly

o

What to do if problems arise

The SRL Project Manager and the SPM will plan and conduct an in-class training session

prior to each recreation season.

CHEERS QAPP 2

July, 2008

All new CHEERS personnel hired for the study will complete an in-class training session

(including the mock interviews) under the guidance of the SPM or any other staff member

identified by the SPM. When the new hire is conducting a mock interview, the SPM or other

designated staff member will note any problems with the administration of the questionnaire, as

well as any misclassification of responses.

7. Documents and Records

The development and use of all CHEERS documents and records related to Survey

Methods has been outlined in Section B of this document. The following Table 1 identifies these

documents and records, the personnel responsible for record keeping and the study personnel

who will receive copies of these documents.

Only the study director, the SPM, and SRL project staff will have access to raw data.

Study personnel will be IRB trained to treat data confidentially. Several levels of protection

minimize risks of disclosure to others in order to protect confidentiality of participants. The

consent forms which will contain both the name and unique Case ID for each participant will be

kept in a locked cabinet in a pre-assigned CHEERS office. De-identified data (only with Case

ID) will be stored in a computer at the study director’s office, SPM office, and SRL. Only de-

identified datasets will be made available to CHEERS staff (such as the study biostatisticians)

involved in data analysis. All computer data files will be password protected during transfer.

Only consent documents and contact-tracing forms will contain participants' names and

Case ID. All other study-related forms/data will contain the Case IDs only. A master file linking

the Case ID and participant names will be stored in a password protected computer file. Nothing

in this file will indicate participant characteristics, responses or results.

All data without personal identifiers will be retained for an indefinite period. The master

files linking names and Case IDs will be destroyed 6 years after completion of the study. No

audio or video tapes will be made of research subjects.

CHEERS QAPP 2

July, 2008

Table 1. Index of Documents and Records, Storage and Distribution

CHEERS Study Documents

and Records

Personnel Responsible

for developing and

storage

Storage Type

Distribution List

QAPP # 2 with appendices.

SPM

Computer file

Hard copy

All CHEERS study personnel

MWRDGC liaison

IRB certification/Training

completion status for

CHEERS survey training

Interviewer/recruiters

SRL phone/ call center

BLAISE technical manual

All CHEERS Field personnel

Field Supply Checklists

Project Supply Manager

file folder

SPM

All Field event coordinators

Equipment Maintenance

stored in a file folder

will be stored in a file

Field Recruitment/Attrition

stored in a file folder

Paper-based forms (consents)

SPM/A-SPM

Copied and stored in a

secure file folder or

locked cabinet

SPM

Study Director

Gift card receipt book/ T-shirt

checklist

SPM/ Project Manager/

Project Supply Manager

Stored in the Program

Coordinators Office

Project Manager

SPM

Project Supply Manager

B. Data Generation and Acquisition

1. Sampling Process Design

The study design, sample size calculations, sampling locations and rationale for design

are outlined in the Study Overview document. The following sections will focus on the

development, implementation and use of the CHEERS questionnaire data collection methods.

2. Sampling Methods

2.1. Development of CHEERS study questionnaires

The CHEERS study questionnaires developed for this study are derived from those used

in the National Epidemiological and Environmental Assessment of Recreational Water

(NEEAR) study, conducted by the US EPA and CDC (NEEAR Study Beach Survey and

Telephone Interview, Appendix 2 and 3). Like the NEEAR study, we will use surveys to

conduct pre-exposure health assessments, post-recreation exposure assessments, and post

recreation health follow-up by telephone. Modifications to the NEEAR approach are: 1) the unit

of recruitment (and interviewing) will be individuals, rather than family groups, and 2) exposure

questions specific to secondary contact recreational activities have been added.

A total of five CHEERS study questionnaires will be administered:

2.1.1 Eligibility screener and refusal tally sheet (Appendix 4)

2.1.2 Field Survey A (Appendix 5)

2.1.3 Field Survey B (Appendix 6)

2.1.4 Follow-up Telephone Interview (Appendix 7)

2.1.5 Home Clinical Evaluation Form (Described in QAPP# 3, Clinical Evaluation)

CHEERS QAPP 2

July, 2008

2.2 Survey Research Laboratory Computer Assisted Interviewing System

The CHEERS study questionnaires have been developed in conjunction with the

University of Illinois at Chicago (UIC) Survey Research Laboratory (SRL), a national leader in

survey development, administration, and analysis. Field Surveys A and B will be administered as

face-to-face interviews, with the exception of the telephone follow-up interview, which will be

administered by telephone. The questionnaires will be administered using computer assisted

interviewing (CAI) methods, with the exception of the eligibility screener and the home clinical

evaluation, which will use paper forms. The CAIs conducted in the field will be administered

using computer assisted personal interviewing (CAPI) methods, while the telephone follow-up

questionnaire will be administered using computer assisted telephone interview (CATI) methods.

Field interviews will be conducted using tablet computers and the telephone interview will be

conducted in a call center at UIC SRL using desktop computers.

We have chosen to use CAI methods for administering the questionnaires rather than

traditional paper and pencil techniques as CAI methods are known to enhance the quality of

survey data in a number of ways:

•

Routing problems (or skip patterns) within the questionnaire are eliminated.

•

Interviewers cannot miss questions or ask the wrong questions.

•

Questions are 'customized' correctly for each individual. For example, if a

participant’s recreational activity is “fishing,” questions will be asked about number

of fish caught, type of bait used, etc.

•

Information from one question can be carried out within the program or dates can be

populated for one question using information from a previous question.

•

The computer checks for inadmissible or inconsistent responses.

•

Data is entered one time, rather than two (in the field on paper and manually entered

into a into a computer site at the study center). This elimination of a data entry step

prevents errors.

•

Facilitate the fast turn around of data for the follow-up telephone interviews and

home visits.

CHEERS QAPP 2

July, 2008

SRL uses the Blaise CAI system developed by the Statistics Netherlands. Version 4.7

will be used for this study. This system functions on a Novell Network and is based on a

shareable storage device. It also works on notebooks and tablet computers for on-site

interviewing needs. Computing power and random access memory are located at each

“intelligent” interviewing station. The CAI software (a) simplifies the sign-off or start-up

procedures between the interviewing station and the network; (b) provides temporary back-up

storage for the data produced by an interview, in the event that the connection to the network

fails, is busy, or malfunctions or in the event of power and operating system errors on notebooks;

and (c) stores and executes the questionnaire text and administration logic per programmed

specifications.

The system also facilitates recoding of closed- or open-end text answers, execution of

real-time and post data collection consistency and range checks, complex branching and

calculations, and production of data files formatted for use with several popular statistical

analysis packages.

SRL’s Office of Survey Systems (OSS) works with the computer-related aspects of

interviewing. OSS contributes to the design and programming of software to schedule, screen,

track, and conduct computer assisted interviews. After the data collection period, staff members

will produce and run cleaning programs on closed-ended variables and produce composite

variables as necessary. They will also produce a final dataset in SAS format.

CHEERS QAPP 2

July, 2008

2.3 Evaluation of study questionnaires

The overall objective is to evaluate and refine the field and telephone questionnaires to

be used in the CHEERS Study. Specific aims are to:

- Evaluate question wording for problems of comprehension and sensitivity

- Estimate the time and difficulty of completing the questionnaires

- Evaluate question order to minimize potential satiation and or non-response

- Identify potential problems with the administration of the questionnaires

- Identify improved methods for recruiting study participants

- Identify improved methods for evaluating water contact for several water recreational

activities

2.3.1. SRL Questionnaire Review Committee

In order to produce high quality data it is necessary to make sure that the questionnaires

ask the right questions in the right way, and are user friendly. The CHEERS study questionnaires

were reviewed by an infectious disease epidemiologist, an environmental epidemiologist, and an

industrial hygienist at the UIC School of Public Health.

Following questionnaire development, each questionnaire was reviewed by members of

SRL’s Questionnaire Review Committee (QRC). This committee, composed of technical experts

within SRL, reviews all survey instruments at their pretest and final stages to ensure that

approved ethical practices are maintained and that basic principles of questionnaire construction

are followed. No instrument is administered to respondents before approval is obtained from this

committee.

CHEERS QAPP 2

July, 2008

The QRC members have extensive experience related to questionnaire construction. The

QRC review ensures that this expertise is applied to each SRL instrument regardless of which

staff member has drafted it. To this end the committee reviews each instrument with the

following kinds of concerns in mind:

•

Is the ordering of the questions appropriate?

•

Does the ordering present any possible problems of context effect?

•

Does the ordering meet the needs of the science while minimizing respondent burden

and optimizing cooperation?

•

Are all of the questions necessary? Should any be added?

•

Are the response options appropriate?

•

If response categories are given, are they consistent with the question, understandable

to the respondent, and least likely to invoke socially desirable answers?

•

Are the vocabulary and constructs in the questions comprehensible to the

respondents?

•

Is it reasonable to expect that the respondents have the knowledge or memory

required to answer the questions?

•

Are sensitive questions constructed to limit, as much as possible, less-than-truthful

responses because of social desirability?

•

Are there design or format questions remaining that might require the use of

cognitive methodologies, such as focus groups or think-aloud interviews prior to

typical pretesting?

Before instruments are used in the field, they are tested in-house. In the case of

computer-assisted telephone interviews like the proposed study, the CHEERS field staff will

conduct extensive testing of the computer programming to test the questionnaire logic during the

SRL training session and pilot study. This allows for evaluation of all skip patterns and

contingencies that are programmed into the questionnaire and avoids the awkward situation that

occurs when an interviewer encounters a problem while trying to keep a respondent on the

telephone.

CHEERS QAPP 2

July, 2008

2.3.2. Pilot Field Testing

In addition to expert review of the study questionnaires, pilot field testing is highly

recommended to maximize the ability to refine the questionnaires for validity. Although the

CHEERS questionnaires were developed using the EPA/CDC NEEAR study survey, the

modifications had not been tested in the field. Additionally, the study wants to avoid asking

potentially troubling or uncomfortable questions.

Prior to the field launch of the epidemiologic study, a pilot study was conducted to solicit

reactions from respondents on the questionnaire length, difficulty in comprehension, sensitivity

of questions asked, any wording problems, gauge the appropriateness of the questions and the

validity of the responses. In addition, the pilot work also assisted in debugging the questionnaire

administration process. The pilot data helped refine the final version of the questionnaires to be

used in a larger field study.

The CHEERS Pilot study protocol was submitted to the UIC IRB, along with a copy of

all the study questionnaires. The IRB approved the CHEERS pilot study. The field pilot study

was conducted from July 21- 30, 2007. A detailed description of the pilot study methods, IRB

approval letter, and evaluation forms used is found in the 2007 QAPP 2 document (Appendix 8).

2.4 Use Survey

This section will describe the use survey that we will undertake to characterize usage so

that the activities and locations of recreation among participants enrolled in the CHEERS study

can be compared with actual usage patterns. If users who enrolled in the study tend to engage in

low-exposure activities, or recreated in areas of relatively low microbe densities, the true risk

among users in general may be underestimated. By working to ensure the comparability of the

study subjects to the larger population of users, findings about risks of illness due to recreational

exposure on the waterways will provide a more accurate estimate of risk among the population

of users.

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July, 2008

Specific aims of the use survey are to determine:

- Usage, in terms of numbers of users, and types of recreational activities at various

access points

- To identify differences in usage between locations

- To identify differences in usage at the same location at different times of day, and

different days of the week

- To identify use at informal access points

The procedure of the usage survey will be as follows:

a. At CAWS recruiting events staff will select a clear view of the access point of

interest, preferably in a shaded location. They will fill out the top half of the Use

Survey Data Sheet (Appendix 9).

b. Using the datasheet, staff will tally the number of individuals who begin recreation,

by recreational activity. The tally will be done in 10-minute intervals. The first

interval will begin at 0, 10, 20, 30, 40, or 50 minutes past the hour. Staff will write

into the chart the hour (clock time) for each interval.

c. In order to avoid counting the same individual more than once, individuals will be

counted only when they begin a recreational activity. Those recreating at the time

that counting begins will be identified by circling the tally marks for those

individuals.

d. After a datasheet has been completed, staff will begin a second sheet, taking care to

again complete the top portion, including the page number.

e. Safety of the researchers will be maintained at all times. The field study will not be

done without adequate light and will be terminated in the event of inclement weather.

Researchers will also be instructed to leave the area and seek a safe location in the

event that the feel that their safety is threatened in any way.

f. At the completion of data collection, data sheets will be brought to the UIC School of

Pubic Health and photocopied. One copy will be placed in the mailbox of the SPM,

and the other in the mailbox of the study director.

g. Data will be entered into an excel file.

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h. On two dates per month during the summer months, while the team is at the primary

access points at which the study will take place, another pair of staff members will

follow the same protocol for one-hour intervals at public access points that are not

designated as recruitment sites for the CHEERS study.

i. Two surveys by boat will be conducted, one on the North Shore Channel / North

Branch of the Chicago River and a second survey on the Little Calumet River/ Cal-

Sag Channel to identify use at areas not identified on the Public Access Inventory

compiled by the MWRDGC.

j. Schedule and locations: When field teams are conducting the CHEERS study at

various locations, one staff member will monitor use.

k. Consent: Because this is a study of the behavior of anonymous individuals in a public

space this study has been granted exempt status by the UIC IRB for the protection of

research subjects (Appendix 10). Thus no consent process for the recreational use

study is necessary and none will be performed.

l. Only field staff trained in this protocol will conduct this use survey. When the

survey is conducted in isolation (i.e., on days or at locations that participants are not

being enrolled in the CHEERS study), staff members will work in pairs. When the

survey is conducted at the time and place of the CHEERS study, staff may conduct

the survey without a partner.

m. Data management: Following the field survey, copies of the datasheet will be used to

enter the tallies by category into an Excel spreadsheet, which will be converted to

SAS format for analyses. These analyses will include:

1. Frequency of each activity

2. Frequency of use by location

3. Frequency of use by activity, by location

4. Differences in use within a location, weekend vs. weekday

5. Differences in use within a location, morning vs. afternoon

These analyses will be conducted by a CHEERS staff member, and data will be

stored in a computer file on a desktop computer in the study director or SPM’s office.

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2.5 Field Health Measures Protocol

The pre-event study publicity methods and organizations involved have been outlined in

the Study Overview. The CHEERS survey methods protocol, outlined below, was approved by

the UIC IRB, (this includes all the study questionnaires, recruitment materials) (Appendix 11).

The following section outlines the steps involved in day of event staffing, publicity, recruitment

and data collection using the study questionnaires.

2.5.1 Day of Event Staffing

The expanded recruiting schedule will require significant increases in staff, including

managers of the field teams. The proposed management structure for the field work is presented

in Figure 2. At each location (A-D), a morning team and an afternoon team (teams 1 and 2) will

operate. The composition of each team is described in Table 2. While each member of the field

team will have a primary responsibility, they will be cross-trained, and data managers and

recruiters will be able to function as interviewers as need. Likewise, interviewers will be able to

recruit potential participants. The structure of teams for large events will be similar, though 2-4

teams may be in the same location.

Responsibilities of field team managers are:

•

Project Manager (Sara Wuellner, MS): Responsible for staffing and scheduling

field events.

•

Survey Project Manager (Preethi Pratap, PhD): Responsible for recruiting and

training survey staff, developing and using questionnaires, ensuring the transfer of

field survey data to the call center, working with SRL to track completion rates at

all phases of the study, and ensuring the collection of high-quality survey data.

•

Field supervisors: Assist the SPM in monitoring field work, training field

personnel, tracking quality of field data collection, and serve as a resource to field

team. Supervisors are responsible for transferring data to SRL at the end of each

Daily field supervisor A/B

Project Manager

Daily field supervisor C/D

Figure 2. Field team management structure

Table 2. Composition of field teams

Position

Primary responsibilities

Number per team

Data manager Consent form tracking,

ID/wrist band assignment,

tracks return for survey B,

downloading data

Recruiter

Approaches recreators, passes

out fliers, evaluates eligibility

1-2

Interviewer

Conducts field interviews A

and B; distributes T-shirts, gift

cards, obtains signature on cash

receipt, provides stool

collection instructions.

1-4

Note:

Detailed job descriptions of the above positions are provided in the CHEERS survey

training manual (Appendix 1)

Use survey

Records the number of

On the day of the event study personnel will wear CHEERS T-shirts and identification

badges. Teams of CHEERS study staff members will work together in a coordinated fashion to

conduct the water sampling and questionnaire administration. The field base of operations will

be based around a tent prominently displaying the CHEERS study banner. With the cooperation

of the MWRDGC, UIC will work with local municipalities and other government entities to

arrange all necessary permits for this field work.

The publicity and screening will take place outside of the tent, with study personnel

speaking with potential participants nearby. The consent process and administration of surveys

will generally take place in the tent. A typical day in the field can range from 8-12 hours.

CHEERS staff will work in shifts, at multiple sites. In addition to conducting interviews in the

CHEERS tent, we may conduct some mobile recruiting and interviewing. The composition and

responsibilities of the field teams will be as follows:

a. A field manager, who will have overall responsibility for establishing the sites;

coordinating the field logistics; allocating vehicles; and the collection and transport

of water samples.

b. A supply manager, who will ensure that all supplies and equipment necessary for

recruiting and interviewing study participants arrive on time to each location of field

work.

c. A field supervisor, who will be responsible for the overall administration of surveys,

management and security of consent forms and other field documents. The field

supervisor is the final authority in making decisions regarding questionnaire

administration and assigning interviewer duties. The field supervisor will have

responsibility for teams working over two shifts (AM/PM) at two locations. The field

supervisor will be in cell phone contact with data managers as needed. The field

supervisor will also assist in recruiting, interviewing and managing data as needed.

d. A data manager, who will receive the paper eligibility and consent forms. The data

manager will maintain a log of study participants, assign and record their Case ID

(unique identifiers), and place a wristband with that ID number and a bar code

version of that ID number, printed in waterproof ink (Appendix 12). The data

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July, 2008

manager will also track participant progress through interview process, and will

ensure the efficient flow of participants through the process. The data manager will

ensure that all computer data files are consolidated and downloaded onto a flash

drive following each day of field data collection. The flash drive will be transferred

to the supervisor at the end of the day. The data manager will also ensure the proper

flow of research participants through each phase of the data collection process. The

data manager will work under the direction of the field supervisor and report any

unusual events or staff issues to the supervisor as and when they come up. The data

manager is responsible to download the data and transfer the files to the supervisor at

the end of the day. The data manager will also complete a field report (Appendix 11)

at the end of each day. The data manager will hold a briefing prior to each field work

shift during which time the recruitment area for the site will be defined and displayed

on a map. Interviewer-recruiters, both stationary and mobile (where applicable) will

be reminded to approach all individuals recreating within the sampling area.

e. The field supervisor will collect all the flash drives from the data mangers at the end

of each day. The data from these flash drives will be secured in a password protected

zipped file and emailed to the SRL staff. In addition an email with the details of

number of participants recruited for the day will also be sent to SRL.

f. Two to four interviewers, who will perform event day publicity, evaluate eligibility,

take potential study participants through the consent process, and administer Field

Surveys A and B. The interviewers may take turns to recruit and interview. In

addition some interviewers may work in mobile teams of 2 to recruit participants

away from the CHEERS tent. This increases our radius for recruitment.

g. Water sampling personnel, as described in QAPP # 1.

h. Many staff members will be cross-trained so that survey staff will be able to

participate in recruitment and consent. Similarly, some water sampling staff will be

able to conduct surveys. At the beginning of each field session, all staff trained in

recruitment and consenting will conduct such activities, and will then assume their

other roles (such as survey administration) as participants enroll. Likewise, when a

staff member assigned to administer surveys has no participant to interview, they will

conduct recruiting.

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i. An incentive provider will be assigned to hand out the T-shirts and gifts cards at each

site. All participants will have to sign a receipt book as and when they receive their

gift cards. In addition a checklist will be used to record t-shirt distribution. It is the

responsibility of the incentive provider to report the final number of receipts to the

supervisor on site at the end of each day.

2.5.2 Recruitment areas

Recruiting locations are chosen with the goal of efficiently recruiting 9,330 study

participants distributed approximately equally among the three groups (CAWS, GUW and

unexposed) at locations that provide a range of water quality measures. At a given field site,

however, interviewer-recruiters are to approach all recreators within the recruitment area. This

is to avoid any bias, conscious or otherwise, that recruiters may have. Within a recruitment area,

all recreators (regardless of age, gender, ethnicity, or race) are approached, engaged by study

personnel, and if interested, screened for eligibility. Maps of the recruitment areas for specific

sites are included in Appendix 14.

2.5.3 Day of event publicity

Study personnel will approach individuals within the recruitment area of each site, and

work to interest them in participating in this research using a specified recruiting script and a

FAQ sheet outlined in the CHEERS survey training manual (See Appendix 1) outlining

responses to commonly asked questions. CHEERS team members will approach individuals

within the pre-defined recruitment area at the launch sites at access points, piers, harbors,

beaches (for lake kayakers), and at nearby running/biking trails, tennis courts, and sports fields.

Individuals will be provided with a location specific CHEERS flyer (See example in Appendix

15) before they begin their recreational activity and those interested in learning about the

research will be told more about the purpose of the study and what their participation in this

research would involve. They will also be given an opportunity to ask any questions. Any

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vendors (water-activities or food/water) on site will be requested to pass along the flyers to

customers.

2.5.4 Eligibility

Individuals interested in participating in the CHEERS study will answer a series of

questions from the paper-based Eligibility Screener, which will determine their inclusion in to or

exclusion from the study.

Inclusion criteria are:

•

Will be engaging in outdoor recreational activities and will be available for

telephone follow-up over the next three weeks

•

Intend to return for interview B prior to that day’s departure of CHEERS

personnel, the time of which will be specified (generally before 8 PM)

•

Prior participant who has completed the 21- day telephone survey

Exclusion criteria are:

•

Recreational activity on day of enrollment will be swimming, water skiing or

tubing

•

Are currently participating in the CHEERS study (have not completed day-21

telephone survey)

•

Have participated in water recreation in the past 48 hours (not including

swimming pools, but including wading in beaches)

•

Are not able to complete Survey B in the field, or not willing to participate in

telephone follow-up

After the eligibility screener has been completed, individuals who are interested in

participating but are not eligible will be notified. Those who are eligible will begin the consent

process. Any reasons for ineligibility of participants or refusals will be recorded in the refusal

tally sheet (Appendix 4) section of the eligibility screener.

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2.5.5 Consent

Study personnel will explain to eligible participants 1) what would be asked of them if

they agree to participate, 2) that participation is voluntary, and 3) the potential benefits and risks

of participation. They will provide a consent document which provides this information in

greater detail. After reading the consent document, participants will be given an opportunity to

ask any questions they may have about the study. All eligible participants 18 years or older who

choose to enroll in this research will sign the consent form (Appendix 16). A parent or guardian

will complete a parental consent form on the child’s behalf for all participants under the age of

18 years (Appendix 17). All children 7-17 years of age will also be given an assent form

(Appendix 18) to complete. All consent forms will be paper-based. Participants in group events

organized by Friends of the Chicago River who express interest in participating in the CHEERS

study in advance of the event will receive study information and consent documents by e-mail

prior to the event.

Eligible participants can enroll in this research as often as every 21 days. Each time they

would receive the same set of financial incentives (gift cards and checks) as well as a CHEERS

T-shirt. This research study will seek to recruit members of rowing teams and other sports

team/clubs several times during the 2008 season. If a child is on a team/club, the parent can

check a box on the signature page of the parental consent form that would allow the child to

enroll and re-enroll into the study even if a parent is not present. Parents can withdraw their

permission at any point by contacting the CHEERS team.

All CHEERS team members involved in recruiting will be certified by the UIC

Institutional Review Board (IRB) and all human-subjects research will take place with the

approval of the IRB (Appendix 11).

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July, 2008

2.5.6 Unique identifiers (“Case ID”)

Upon completing the consent process participants will be directed to the field data

coordinator, who will take the consent forms, and apply a bar-coded wrist band with a unique

Case ID to the wrist of each participant. A second copy will be attached to that particular

participant’s consent form. In addition the participants case ID will be logged into a field book.

At each survey station a CHEERS staff member will scan the bar-code on the wrist band into a

laptop computer (the scanner will be connected through a USB port) and enter the participants

name into the form before beginning the surveys. At the end of the data download process each

day, SRL will be able to link the data from individual forms by Case ID and name for each

participant.

Bar-coding, a form of keyless data entry will allow automatic identification and data

collection is commonly referred to as Auto ID (Appendix 12). The motivation to use bar coding

is to improve data management and reduce errors related to data entry and tracking. The benefits

of bar coding for our study include:

•

Improved data accuracy: Scanning a bar-code rather than typing a number is over

99% accurate. With data entry playing such a critical role in this study, it is

absolutely necessary for each participant to have a unique ID and for us to be able to

link their data from individual forms in the field.

•

In addition, it is easier for a participant to have a bar-coded wrist band with their

unique case ID than to have a participant remember a case ID number, or to carry a

piece of paper with their Case ID when they are recreating.

•

The wristbands are durable and water proof and will have to be cut in order to be

released. In addition they will serve as a colorful reminder to the participant to return

to the tent to complete the survey after their activity.

•

Bar-coding reduces the impact of human error and enables users to work faster,

without sacrificing accuracy.

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July, 2008

2.5.7 Field Survey A

Field Survey A (Appendix 5) will be administered in a face-to-face interview by trained

personnel. This will take approximately 2-3 minutes.

2.5.8 Field Clinical Evaluation

The 2007 QAPP included a plan for conducting a clinical evaluation of study participants

in the field on the day of enrollment. After conducting the field clinical evaluation on first 130

participants in August, 2007, little useful information was gleaned (findings were limited to bug

bites and allergic conjunctivitis). Given the low yield of this component of the study and the

recommendations of the WERF peer review panel, the field clinical exam was deleted from the

CHEERS protocol in September, 2007.

2.5.9 Field Survey B and exit protocol

a. After participants finish their recreational activity and return to the CHEERS

tent, study personnel will administer Field Survey B (Appendix 6). This will take

approximately 8-10 minutes.

b. Subjects will be reminded that in the three weeks following the field interviews,

they may be asked to provide a stool sample. They will be told that if they are

asked to provide a stool sample, they will receive all necessary materials by

FedEx delivery.

c. Participants who swam, jet-skied, went tubing or intentionally fell into the water

as part of their recreational activity will be disqualified from participating in the

follow-up phone surveys. However, participants who accidently fell into water

will still be allowed to complete Survey B and the phone follow-ups.

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July, 2008

2.5.10 Incentives

After completing Field Survey B participants will be given a T-shirt that displays the

CHEERS study logo and a $15 Target gift card. They will be reminded that they will receive a

check for $35 after they complete all three follow-up telephone surveys. They will be told that if

they are selected for a home visit or provide a stool sample they will receive an additional $75.

2.5.11 Special Events

As noted in the Overview document, participants will be recruited using one of three

general approaches: intercept interviews, planning recruiting of teams and clubs, and special

events. In 2007 recruiting participants in two special events was arranged: the Chicago

Shoreline Marathon and the Chicago River Flatwater Classic. In 2008, Friends of the Chicago

River will again hold the Chicago River Flatwater Classic. Canoeists and kayakers will begin on

the North Branch of the Chicago River, and paddle downstream approximately 7.5 miles. This

will be an opportunity to enroll as many as several hundred research participants.

At the Flatwater Classic and other large events, approximately 30 CHEERS personnel

will staff the event to maximize participant enrollment. In addition to the larger number of staff

performing the various functions listed above, two individuals will be “team captains” who will

help ensure the smooth flow of participants through the enrollment and evaluation process.

Additionally extra supply management staff will ensure that all necessary supplies are readily

available to field staff. For events such as the Flatwater Classic and the Des Plaines River Canoe

Marathon, which have separate put-in and take-out locations, the bulk of the research team will

relocate from the site of initial recruiting/Survey A (put-in location) to the site where Survey B

will be administered (take-out location).

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2.6 Telephone interview protocol

2.6.1 Location and facilities

The SRL call center will be used for the CHEERS follow-up telephone surveys. All call

center telephone follow-up instruments will be programmed in the SRL Blaise software for

CATI (Computer-Assisted-Telephone-Interviewing) administration. The call center computers

will be networked and have access to the call management software in order to track and

complete the telephone follow-ups in a timely manner. Staffing of the call center at a given time

will depend on the number of participants in the sample list. The call center staff will be

supervised by the SRL call center supervisor, and the SPM.

2.6.2 Methods

Once the field data is received by SRL they will send an email confirming the number of

cases they received that day. SRL will then set up a file including a list of individuals to follow-

up, their case IDs, and their telephone numbers in the call management system at the call center.

This turnaround of data will require roughly 24 hours (or one SRL day). Using the sample list

the call center staff will contact participants by telephone on days 2, 5, and 21 following

recreation. Participants who could not be reached as scheduled will be called later that day and

again over the following days. Participants will also be given a contact phone number to call

back if necessary. On establishing phone contact with the participant the Follow-up Telephone

Interview (Appendix 7) will be administered. This interview addresses the development of

symptoms of AGI and NGI during the interval since the date of recreation, or last phone contact.

Other questions address water recreation subsequent to the date of enrollment, and non-water

related risk factors for illness. The telephone interview process may take about 10

minutes

depending on the participant symptoms.

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July, 2008

2.6.3 Triggers for the collection of clinical specimens

At the end of the telephone interview a list of all study participants, who on telephone

follow-up interview indicate that they have had, in the last 24 hours, symptoms of AGI,

conjunctivitis or skin infections, will be generated. The criteria for clinical specimen collection

will be:

Any one or more of the following gastrointestinal symptoms:

o

Diarrhea

o

Vomiting

o

Abdominal pain or cramps ( that for adult female participants is reported as

being different than menstrual cramps)

o

Nausea accompanied by Fever

The following eye symptoms

o

Eye drainage or crusting

Skin symptoms

o

Any draining area on the skin

Acute respiratory symptoms will not prompt a home visit, given the limited value

that such a visit would have in either identifying pathogens or establishing

objectively the presence of infection.

At the completion of the third and final telephone interview, participants will be

thanked and notified that they will receive a check for $35 in the mail.

The protocol for specimen collection is described in QAPP # 3.

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3. Sample Handling and Custody

Described in sections B 2 (sampling methods), and section B 9 (data management) of this

document.

4. Analytical Methods

4.1. Health end-points, predictors, and confounders/effect modifiers for overall study

Health end-points of interest in this study are based on previous research studies of

water-related GI and Non-GI illnesses. A review of literature is presented in the Study Overview.

Therefore, results of our study can be compared to other studies that have used similar end-points

or definitions for GI illness (Wade, 2006; Cabelli, 1982) and non-GI illnesses (Colford 2007).

The data analysis methods for the CHEERS study have been outlined in the Biostatistics section.

This includes the data collected from QAPP # 1 AND # 3.

Responses to questions from the CHEERS study questionnaires (QAPP #2) will be

categorized as described in Appendix 19.

4.2. Interim data analysis

Apart from the overall data analysis, the study director, biostatistician and SPM will also

create interim reports of process measures (recruitment by site, attrition through the phases of the

study) that will be used to modify the recruitment strategy, staffing and training involved in the

Following the 2007 season we will review the kind of recreators (by activity) that we

have been able to recruit in the GUW and CAWS groups of participants. For example, if we have

recruited more fishers along the CAWS, compared to the GUW group, we will increase the

frequency with which recruiting teams are stationed at locations where GUW fishing occurs.

4.2.2. Demographics

All through the 2008 season we will also review the demographic similarities between

the exposed and unexposed groups, and by activity. We want all three recreator groups to be as

similar as possible in age and race/ethnicity. The 2007 data will assist in modifying the

recruitment strategy for the 2008 season to ensure equal demographic representation. For

example, if a large number of rowers are high school and college aged, we will seek to work with

high school and college sports teams that engage in non-water recreational activities.

In addition, enrollment and attrition rates will also be followed to make necessary

modifications to the study recruitment or data collection protocol.

4.2.3. Interviewer bias

All forms will include the name of the interviewer. We will identify interviewers that

have above average rates of incomplete “refused” or “don’t know” responses, as well as very

brief or prolonged average duration of interviews. Retraining of an interviewer maybe required,

based on the results.

4.2.4. Health end-points

We will also analyze the data to see if there is a discrepancy between reports of

symptoms and findings in clinical examination and culture. We do expect a number of

participants to have negative stool cultures in spite of having symptoms.

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July, 2008

5. Quality control

Quality assurance methods have been employed throughout the questionnaire design,

development, programming and administration. These have been outlined in section 2. The main

goal of the questionnaire implementation process is to ensure that all data collected in the field

follows a systematic process, and all data is securely and accurately transferred to SRL. This

involves smooth operating of the equipment and tracking of participant progress through each

station, so that at the end of the day the data for each participant is complete and all this is

correctly transferred to SRL. This will lead to the compilation of a complete and usable dataset

of the study analysis. The following section describes the appropriate quality control methods

that will be employed before, during and after a field event.

Prior to each field event all equipment and supplies will be checked by the SPM, A-SPM,

Project Supply Manager and/or the field supervisor. Any monitoring will be more heavily

concentrated during the early phases of data collection and for newly-hired interviewers so that

any problems in performance can be detected immediately. The monitor (who could be the field

supervisor, SPM, quality manager, study director, or other designated CHEERS staff) will be

instructed regarding whom and when to monitor based on random selection of interviewing

stations and times during each field shift, or as a result of problems noted from previous

monitoring sessions.

The ongoing monitoring of field and CATI interview permits interviewer skills to be

evaluated in a number of key areas, including the ability to follow instructions correctly and the

ability to probe for clear and complete answers. Through monitoring, additional factors,

including the interviewer’s skills in eliciting cooperation and maintaining neutrality, are

routinely evaluated. Errors detected during these reviews will be recorded by the SPM to help

give feedback to interviewers and to identify the need to retrain as necessary. Positive as well as

negative feedback is given to ensure that the interviewers maintain a high level of commitment

to quality.

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July, 2008

The quality control checks will include (but not be limited to):

Check field event supplies (outlined in Section B7)

Check all study equipment- tablets, flash drives, bar-code scanners, printers

etc. (outlined in Section B 6)

Availability of paper-based forms (this includes the eligibility screeners, and

consent forms). Any paper-based materials with participant names or Case

IDs will be stored in a locking file cabinet. Only the SPM, field supervisor

and data manager will have access to this box/folder. All consent forms will

be counted periodically to make sure the numbers tally with the log book.

Once the consent form is complete and a Case ID has been assigned (that is a

bar-coded wrist band is placed on the participant’s wrist) a second wrist band

with the participants ID number is stapled to their consent form. This creates

a paper-based record of the CaseIDs assigned to each participant. The

consent forms will be stored in a secure folder on site.

The data manager will record details of each Case ID and the surveys

completed in field data log book.

In order to assess interviewer performance, a “mock subject” will be assigned

to an event during different times of the data collection process. The location,

date and time will be selected randomly by the quality manager/study

director. This “mock subject” will behave and participate, throughout the

field event, just like any other participant, and neither field nor telephone

survey staff will be aware that this individual represents a “performance

evaluation” interview. The “mock subject” would have already been told to

answer certain questions in a certain way. The data collected for this “mock

subject” will be reviewed after the event to check if the interviewer recorded

the responses correctly i.e., if the responses were coded correctly. Based on

this review, the SPM will sit down with the “mock subject” and the

interviewer to discuss any issues with the survey administration.

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At the end of each field data collection day all the tablets and files will be

checked and secured by the field supervisor. The data manager will also

ensure that all computer data files are consolidated and downloaded onto a

flash drive following each day of field data collection. The flash drive will be

transferred to the supervisor at the end of the day. The field supervisor will

collect all the flash drives from the data mangers at the end of each day. The

data from these flash drives will be secured in a password protected zipped

file and emailed to the SRL staff. In addition, an email including the details

of number of participants recruited for the day will be sent to SRL.

The downloaded raw data from the field will be stored in a password

protected files at UIC as a back-up to the data transferred at SRL.

We will track all data transmissions to and from SRL with an email. SRL

staff will send an email acknowledging the number of files they received.

Any discrepancies in the number of files uploaded or downloaded will be

resolved immediately.

A field report (Appendix 13) will be completed (See Section C) after each

field data collection event.

Upon receiving the files at the end of each field event SRL will create a

sample list of all participant Case IDs, name and telephone numbers by date

of telephone follow-up. SRL will upload the sample list to programmed call

management software that will be used to track the progress of the telephone

follow-up. Telephone interviewers at the call center will have access to the

sample list, and can pick a Case ID to call. Once this Case ID is picked by

one caller it is removed from the list until it is complete. After completion of

the telephone interview, the interviewer will answer a set of pre-programmed

questions that will track disconnected numbers, appointments, unreachable

participants etc. After completion of the call the Case ID gets released to the

call management document, that will update the status and display the status

of the call, including the date and time for the next call. This assists in

tracking the telephone follow-up which is critical for this study. Disposition

codes will be created by SRL for use with the call management document.

CHEERS QAPP 2

July, 2008

The SPM will receive the call management reports at various points during

the telephone interview process to track the progress of the telephone follow-

ups.

To receive effective feedback on the performance of telephone interviewers,

it is standard SRL practice to monitor approximately ten percent of each

telephone interviewer’s work. Interviewers will not know when they are

being monitored, since telephone monitoring is done using specially

equipped extension telephones. Monitoring will be done by Interviewer

Supervisors or the SPM. In addition we may use “mock participants” like we

did in the field.

Data integrity/ Field devices: data collected on notebooks are password

protected. In addition we will use full disk encryption software to further

secure all data and programs stored on the notebooks’ hard disk.

SRL network: The network servers use Microsoft Windows 2000, Windows

2003, and Novell IntraNetWare operating systems. These servers provide

data storage, dialup data transfer, e-mail, Web services, and data backups.

The Backup EXEC from Veritas is used to perform nightly backups on all

network servers on the network.

Weekly quality meetings will review any issues with data collection/transfer.

Each week a different quality assurance procedure will be reviewed with the

interviewer-recruiters.

CHEERS QAPP 2

July, 2008

6. Instrument/Equipment Testing, Inspection, and Maintenance

SRL will develop a BLAISE CHEERS study technical manual that will address how to

run/troubleshoot the field and telephone interviewing programs, how to evaluate tablet

performance and conduct maintenance (including battery and key board checks), and perform

bar code scanner maintenance. This manual will be made available to all CHEERS survey staff

at the initial training (Appendix 1).

•

Prior to a field event the Project Supply Manager and/or the assistants will check each

laptop to make sure they are powered up and have 2 additional battery packs ready for

use in the field. Check the tablet key boards and screens as well.

•

External battery charging stations will be used to charge additional batteries.

•

It will be ensured that the bar-code printer and scanners are working and the bar-coded

wrist bands are prepared for the event.

•

At the end of each field event (after the data is downloaded at UIC), the Project Supply

Manager and/or the assistants will securely store all the tablets, printers and scanners in

a locked room at UIC.

7. Instrument/Equipment Calibration and Frequency

Not Applicable

8. Inspection/Acceptance of Supplies and Consumables

The SPM, Project Supply Manager and/ or the assistants are responsible for making sure

that all supplies outlined in the following sections are available during any field event and the

telephone interviews. A supply checklist will be used to record this information before and after

each event.

CHEERS QAPP 2

July, 2008

8.1 Supplies for use survey

Supplies for the use survey field study will be prepared at least one day prior to the

planned activity, and stored in plastic crates in the CHEERS storage space at the UIC SPH.

Supplies to be brought to the field are:

Clipboards

Sunblock

Pens

Watches or equivalent

Folders

Stapler

Identification Badges

Use survey forms

Cell phone

CHEERS telephone contact directory

Cooler with beverages

First Aid Kits

8.2 Supplies for day of event

Supplies for the day of event field study will be prepared at least one day prior to the

planned activity, and stored in plastic crates in the CHEERS storage space at the UIC SPH.

Supplies to be brought to the field, in addition to those listed as part of the water sampling

protocol are included (Described in QAPP# 1).

Spare laptop batteries

Publicity flyers (250)

Consent Document-adult (100)

Consent Document-parental, for child (100)

Consent Document-assent for child (100)

Field data log book

Bar-coded wrist bands with Case IDs

Bar-code scanner with USB ports

Clipboards

Pens

Markers

Accordion files for signed consent documents

USB flash memory drives

CHEERS telephone contact directory

T-shirts (50 XL, 50 L, 50M, 50 S, 20 kids-L, 20 kids-S, 20 kids junior)

Target Gift cards

Exit packets: contact information

Cooler and beverages for study staff

9. Non-direct Measurement

Not Applicable

CHEERS QAPP 2

July, 2008

10. Data Management

10.1. Transfer of field data

10.1.1.

Electronic data copies

In the field, data obtained from Field Surveys A and B will be copied from each laptop

onto a flash memory device, which will used by the field data coordinator.

10.1.2.

Data file transmission

These data files will be transmitted to UIC Survey Research Laboratory (SRL) via email

using password protected zip files. Once the files are transmitted, we will send the SRL staff an

email with the number of cases that we transmitted, including the data transmittal form.

10.2.

Survey Research Laboratory data handling

SRL personnel will follow this process in reverse to send to the SPM an email

confirming the number of files they received. SRL will create a list of individuals to contact,

their case IDs, and their telephone numbers for the call center. This turnaround of data will

require roughly 24 hours (or one SRL day). For data that is transmitted over the weekend, SRL

call center supervisors will run the necessary programs to create the phone list. These sample

files will be loaded onto a desktop with the call management software, to use as our telephone

follow-up sample list. SRL will create a field report after each event. This will be reviewed by

the SPM or A-SPM to track recruitment/attrition rates on a weekly basis.

CHEERS QAPP 2

July, 2008

10.3. Transfer of telephone data

At the end of each day all telephone interview forms will be saved on the desktop and

uploaded to the SRL server. SRL will create reports through the call management system. These

reports will be monitored on a weekly basis by the SPM, or the A-SPM.

10.4. Paper forms

Consent documents, any paper based forms and Case ID logs will be placed into locked

boxes/ folders on site. The originals will be stored in a locked file cabinet in an assigned

CHEERS office.

10.5. CHEERS study datasets

The SRL Office of Survey Systems (OSS) will be responsible for creating the final

datasets for the CHEERS study. Because all responses are entered directly into the computer at

the point of interview, the time consuming and potentially error prone process of converting raw

data responses to machine readable form is largely eliminated. To create an output file ready for

analysis, the data processing component creates a blank rectangular file and fills in codes from

closed-ended questions (and open-ended questions that have been coded), using the skip logic

programmed into the survey questionnaire. This process can be executed concurrently with data

collection (and is done at regular intervals as another quality control point).

The processing component is also used to test and edit the data while producing clean

computer files. When clean files are available, the system also produces documentation. This

includes code books, record layouts, and SAS, SPSS or STATA control cards (with both variable

and value labels). These code books can be used to produce absolute and percentage frequencies

and/or cross-tabulations for every coded variable at any time during the study and routinely used

as part of the quality control procedures.

CHEERS QAPP 2

July, 2008

SRL will deliver one preliminary and one final dataset at the end of each season for each

time-point/instrument prepared in SAS. These deliveries will contain lists of open-ended

responses, too. The SPM will be responsible for all coding and back coding of data at that point.

A final methodological report that summarizes the study design, questionnaire development

process, and programming and data processing procedures will be submitted by SRL.

All datasets will be saved in password- protected computer files. The datasets will not

contain any participant names or contact information. Access to the datasets will be restricted to

the study director, SPM, biostatistician and other personnel involved in the data analysis and

report writing process.

C. ASSESSMENTS AND OVERSIGHT

1. Assessments and Response Actions

a. IRB certification tracking: CHEERS staff will not be allowed to participate in any

field work involving human subjects without current IRB certification.

b. All CHEERS staff must complete the CHEERS survey training on interviewing

techniques that will be conducted by the SPM. This training will also include the

mock interview. Only after the SPM has observed and signed off on the mock

interview and training process and verified the IRB certification status, will a

CHEERS staff member be allowed to recruit participants in the field.

c. The SPM, A-SPM, or field supervisor will be in charge of observing the process in

the field on any given day. The field report completed at the end of each field event

will include any information on unusual occurrences, staffing problems, staff

concerns, and equipment issues. In the event of any trouble that cannot be resolved in

the field, it is the responsibility of the SPM to submit the field report to the Study

Director and the Quality Manager, who will have the final authority to make any

decisions regarding staffing, equipment changes or other participant issues.

CHEERS QAPP 2

July, 2008

d. The SRL call management document will track the telephone follow-up process (See

Section B5).

e. Any field and telephone interviewing issues specific to an interviewer in the field or

during the telephone interview process will be identified using “mock subjects” and

CATI interview screening methods. Steps will be taken to assist/retrain the

interviewer, or the interviewer may be reassigned to other appropriate tasks (See

Section B5).

f. Any equipment that does not work will be fixed before the next field event. For

example, if we have trouble with a tablet key, the SRL- CHEERS study technical

manual will be used to resolve the issue, failing which, SRL will be contacted to

service the tablet before taking it to the field. All equipment failure will also be

reported to the Study Director and Quality Manager (see Section B6).

2. Reports to management

All CHEERS questionnaire related documents described in the preceding sections (See

List in Section A9) will be stored by the SPM. It is the responsibility of the SPM to make these

available to the CHEERS Quality Manager and study director at all times. Any unusual

occurrence reports will be submitted within 24 hours to the quality manager. Any recruitment

issues, staff related issues or equipment trouble will be reported within 24 hours to the Study

Director.

In addition the interim data analysis reports (as described in Section 4) will be submitted

to the study director as outlined in Project Quality Management Plan document, or as and when

requested.

CHEERS QAPP 2

July, 2008

D. DATA VALIDATION AND USABILITY

Data review, verification, and validation methods have been employed during the

development, programming and implementation of the survey methods. These are outlined in

Section B and include:

•

Questionnaire review and validation process (including internal/external reviews,

IRB clearance, and pilot evaluations of survey questions)

•

Use of CAI (Computer Assisted Interviewing Techniques) and limited open-ended

questions to ensure accurate data entry. The questionnaires have been developed with

pre-determined acceptable response options. This prevents the entry of unacceptable

or out of range responses.

•

Data will be deemed unusable if the transmission of data files introduces errors in the

dataset. There are control in place to prevent this (back up data files on desktops,

transmission reports etc), and an error could be identified by a mismatch in the

encrypted emails (generated at the time of uploading data to SRL) and the

number/type of files received by SRL. Any mismatch will prompt a review of the

status of that particular Case ID awaiting upload, and/or the Case ID’s forms received

by SRL.

CHEERS QAPP 2

July, 2008

References

Cabelli VJ, Dufour AP, McCabe LJ, Levin MA. 1982. Swimming-associated gastroenteritis and

water quality. American journal of epidemiology 115(4): 606-616.

Wade TJ, Calderon RL, Sams E, Beach M, Brenner KP, Williams AH, et al. 2006. Rapidly

measured indicators of recreational water quality are predictive of swimming-associated

gastrointestinal illness. Environmental health perspectives 114(1): 24-28.

Colford JM, Jr., Wade TJ, Schiff KC, Wright CC, Griffith JF, Sandhu SK, et al. 2007. Water

quality indicators and the risk of illness at beaches with nonpoint sources of fecal

contamination. Epidemiology 18(1): 27-35.

CHEERS QAPP 2

July, 2008

QAPP 2

Appendix 1: CHEERS Survey Training Manual

QAPP 2

Appendix 1A

CHEERS Survey Training Manual

Gaining Cooperation

GAINING COOPERATION

Let’s start out by talking about the role of the interviewer. This part of the

discussion will be brief because we will talk about each of the points in more detail later. The

following discussion will highlight the role of the interviewer.

1. It is important for interviewers to gain cooperation from recreators.

The percentage of people who answer our questions is critical. A high response rate

means greater confidence in the results of the study. You all know about response rates from

watching the nightly news. How many times have you heard a report of the outcome of a poll

that states 57% surveyed support something (+/-3%)? That means that between 54% and 60%

support the issue. The (+/- 3%) is the confidence interval.

A low response rate means a greater chance of error. We need to avoid getting a low

response rate.

2. It is critical for interviewers to communicate that we are doing scientific

surveys.

You are now all professional interviewers and researchers.

The key to

communicating that is to practice good techniques.

Know the answers to the CHEERS FAQ Sheet inside and out, backwards and

forwards.

Use your voice. Don’t try to sound like someone else.

Be confident and professional.

3. It is important to practice your delivery.

Throughout this training use every opportunity you get to read as a chance to

improve your ability to communicate that you are a professional interviewer.

4. True or False: People don’t want to do surveys?

This is a myth. People don’t want to talk with a telemarketer. We do scientific

research. People will answer our questions because they are posed by researchers, and it gives

them a chance to be heard.

How we are different from telemarketers:

We are not selling anything.

We are not asking for any money.

We will provide written information about the survey.

5. It is important to be prepared to answer respondents’ questions.

Respondents are likely to ask questions before you even get started with an

interview. For each survey, we anticipate these questions and provide you with answers. You

each have a copy of the CHEERS FAQ Sheet, which you should always keep available for quick

reference. Practice the answers to these questions. It is necessary for you to be able to answer

them with correct information in a confident and natural manner.

6. Turning a “No” into a “Yes!”

Listen carefully to the respondent's question, answer briefly and to the point, and

then continue with gaining their cooperation.

Your interest in the survey is communicated to the respondent by your voice, body

language, and appearance. There should be a pleasant and professional tone to your voice. You

should display open or neutral body language. Do not stand too close to the respondent.

You need to listen to the respondent's tone and watch his/her face and body

language. At what point did s/he become hesitant or uncomfortable? Is it possible s/he

misunderstood something you said? You must be prepared at all times to answer his/her

questions and you need to speak to him/her at his/her level of comprehension, without sounding

condescending.

Most respondents do not refuse outright; rather they express some hesitancy,

reservation or initial hostility. You will soon become sensitive to the firmness of the "no"

conveyed by the respondent's tone of voice and the wording of his/her comments. You will also

learn to sense the reasons behind a respondent's hesitancy and develop ways of dealing with

those "hidden" concerns. Listen very carefully to what the respondent has to say, and then

address your remarks to the respondent's concerns.

7. Common Reasons Given for Refusing

The reasons why respondents refuse are varied, and the approaches for handling

them will vary from respondent to respondent and Interviewer to Interviewer. There will be

times when a refusal cannot be avoided.

Listed below are some common reasons respondents give for refusing:

Too busy; don't have the time;

Not interested in the survey;

If I participate, you'll ask me to do more interviews later.

Don't want to be bothered/ don't want to be involved.

Afraid of being involved;

Waste of time and money;

Government interference;

"Nothing in it for me."

Too ill; don't feel well enough;

I don't give out that type of information, and

How do I know who you are/this survey is legitimate?

These reasons reflect the broad types of concerns respondents may have about the

time you are asking him/her to give and/or about surveys in general, as well as specific concerns

about the survey itself. When a respondent refuses, it is important that you listen carefully and if

possible, clarify the reason for the refusal.

Your responses should emphasize the importance of the survey and assure the

respondents that we appreciate their contribution to the project.

REMEMBER: Remind them that their participation is really important to the Cheers

Study and all information they provide to us will be kept confidential.

Factors Affecting Respondents' Participation

There are factors, both positive and negative, that may affect a respondent's decision

to participate in any survey. Let's look at some of the negative factors involved and how they

can be used to gain completed interviews.

Fear of the survey, the interviewer or the use of the data;

Hostility toward the interviewer or the sponsor;

Perceived invasion of privacy;

Assumed threatening subject matter; and

Cost to them in terms of time and energy.

A knowledgeable interviewer who is LISTENING to the respondent and answering

the respondent's objections directly can counter all of these factors.

The following are some of the problems you may encounter as you start doing interviews. Let's

look at the negative factor involved in each problem and talk about the ways to avoid or lessen

the problem.

Respondent is suspicious or expresses doubt about the legitimacy of the survey

and your role.

This factor is sometimes expressed by the respondent by asking, "What are you

selling?" "Why did you pick me?" What are you going to do with the data?" or "If I participate,

you'll keep coming back to me for more information."

To counter the concern, you can:

Let your respondent know you are not selling anything.

Show him/her your badge.

Restate confidentiality.

Restate the purpose of the survey.

Let the respondent know the information will only be released in statistical

form--that we will take everyone’s' results and average them together, and that

no one outside of the survey will be able to put his/her responses with his/her

name.

Tell him/her that his/her name will be separated from his/her data before it is

analyzed and his/her data can be traced back to him/her; or

Offer to let him/her speak to your Field Manager/Data Manager/Supervisor.

Respondent refuses outright without listening to any information about the

project or without listening to your entire introduction.

You may hear, "I'm not interested," or "I can't be bothered." You can:

In response to "I'm not interested" or "I can't be bothered," your first response

should always be, "May I ask why not?" You want to be very careful how you

say this and to not sound rude, abrupt, or unsure of yourself. If the question is

asked sincerely and there is a look of concern on your face, the respondent

should not object to you asking. This question can open up a dialogue with the

respondent, so that you will be able to provide him with more information and

help him become more comfortable with the survey. In addition, this is

something you can record on your tracking log.

Be sure to ask him/her if there is any more information you can give him/her,

and restate that you are not selling anything.

Respondent expresses concern about the survey or the use of the data.

You may hear, "I don't give out personal information" or "I don't want to give out my

information because of what you may do with it." You can:

Let your respondent know what will happen to the information/data s/he gives

us;

Reassure him/her of the confidentiality of the data;

Restate the purpose of the survey;

Let him/her know s/he can refuse to answer any question that makes him/her

uncomfortable; or

Offer to let him speak to your Field Manager/Data Manager/Supervisor.

Respondent is concerned about costs in terms of time and energy.

You may hear, "I'm too busy," or "Are you going to pay me for my time?" or maybe

you will hear, "What's in it for me?"

You need to let the respondent know that each questionnaire will take about 15

minutes. Also inform them that they will receive a $15 gift card and a t-shirt in

the field, followed by a $35 check in the mail after the 3 telephone interviews.

Restate the purpose of the survey.

Respondent expresses distrust of government studies.

This may be expressed as "The government never listens," "This is a waste of

taxpayer's money," or "The decisions have already been made."

These objections often just need to be heard--then the respondent is willing to

cooperate. You should just listen and accept his/her feelings in a neutral

manner.

Assure him/her that his/her views and experiences are important.

Tell him/her that we don't want his/her experiences to be overlooked.

Restate the purpose of the survey. Also tell them- we are the UIC School of

Public Health and this is a scientific study.

Other Questions and Concerns Respondents May Have About the Survey

How was I selected for the survey?

Explain that anyone who recreates in or

around these waterways is eligible to complete the survey.

How will the results be used?

The results of this survey will be used to help

us learn more about water quality and health of people who recreate in these

waterways.

Other Ways to Avoid Refusals

Listen carefully to what the respondent is saying.

What is the reason for his objection? If it is not clear to you, ask the

respondent to explain further. Probe as necessary but not to the point of

annoyance. Then you should respond to his/her stated reason (s).

Acknowledge that you have heard and understood the respondent's objections.

Be sympathetic, using phrases like, "I understand how you might feel that

way," or "That's very interesting." These phrases express in a neutral way that

you have heard the respondent's objections. You want to avoid too brief an

acknowledgement like "Yes, but…" that may be seen by the respondent as a

dismissal of his feelings.

Be direct, answer only what is asked and get right back to the business at hand-

-getting the respondent to complete the questionnaire. You can tell the

respondent s/he can start the questionnaire and see how it goes, and that s/he

can skip any questions s/he does not want to answer.

Do not volunteer additional information--which will only lead to more

questions on the respondent's part.

If you do not know the answer to a question, be honest and tell the respondent

that you do not know, but will find out. Then see your Field Manager/Data

Manager/Supervisor on site and get the answer for the respondent. This shows

the respondent that your actions match your words and will help convince

him/her that the other information you are giving him/her (the survey sponsor,

use of the data, confidentiality, etc.) is true.

Tips for Gaining Participant Cooperation

Carefully prepare for your interviewing day. A knowledgeable and enthusiastic

interviewer is the best defense against a refusal. Review your manual as often

as necessary, so you can answer respondents' questions without hesitation.

Be thoroughly familiar with all the survey materials so you can readily answer

a respondent's questions about the survey.

Make sure the respondent knows exactly who you are and why you are asking

him/her to be in the survey.

Make sure your respondent feels s/he is valuable to the survey and knows how

important his/her participation is.

Approach the respondent confidently and calmly. If you are not confident in

what you are doing, the respondent will quickly pick up on your nervousness.

Listen very carefully to the respondent's voice and watch his/her face and body

language. Knowing how to put the respondent at ease is one of the most

important refusal avoidance tools you can utilize in your efforts to gain

cooperation. Regardless of your respondent's mood or attitude, you must

always remain calm, confident, and pleasant.

Try to establish a good rapport as quickly as you possibly can. Getting the

respondent to start (and finish) the survey is the purpose of your efforts as an

Interviewer. Avoid unnecessary conversation with respondents.

Never take a refusal personally. No matter how good an interviewer you are,

you are going to get refusals.

Results of Your Efforts

What will happen when you are successful in answering respondents'

questions?

Your respondent will cooperate and the respondent will complete the survey.

What happens if you are not successful at convincing them to continue with the

survey?

It is important that you know when to stop. If you feel your respondent is becoming

annoyed instead of just hesitant you should discontinue your efforts.

If you get a couple of refusals, and it is starting to get you down, speak with your

Field Manager/Data Manager/Supervisor. They can help get you “back on track.”

QAPP 2

Appendix 1B

CHEERS Survey Training Manual

Probing

Section 11. Probing

When you finish this section, you should:

Know how to probe initial ‘don’t knows’ and refusals

Know how to probe for amounts, dates, and numbers

Understand how to probe on precoded and open-ended questions

and the difference between them

Know the correct way to record probes on open-ended questions

Know what it means to probe to the point of the question

Understand how to probe for additional ideas

Be able to successfully probe for occupation

Ideally, respondents would answer most or all questions using the response

categories provided. In reality, that doesn’t always happen.

Probing

is an interviewing

technique used to obtain specific, complete and relevant answers from a respondent. It is

one of the most difficult skills used in interviewing, but can also be one of the most

rewarding.

An interviewer who probes well is natural and friendly and shows a real interest

in the respondent while maintaining his or her neutrality regarding the respondent's

answers. Without being overly aggressive or seeming to cross-examine the respondent,

the interviewer works

with

the respondent to obtain specific information for the

researcher. Remember that the purpose of many studies is to help researchers make

decisions about programs or services for the public. This cannot be done unless specific

likes, dislikes, problems or experiences are known. You act as a "reporter" for the people

you interview, trying to get all the details possible for the story.

11.1 Probing Initial "Don't Knows" and Refusals

When a respondent answers "I don't know" to a question, it may mean one of

several things:

He is in a hurry to get the interview over with and

doesn't want to take the time to think about an answer;

The subject of the question is something the

respondent has never thought about before;

3. The respondent does not feel he is expert or

knowledgeable enough to give the "correct" answer; or

4. The respondent really has no idea of the answer.

In the first two situations, a remark such as, "I wonder if you could take a moment

to think about it" is appropriate. In the third situation, reassure the respondent that there

are no right or wrong answers and that we are only interested in his opinions. In the

fourth situation, encourage the respondent to give his impressions or, if the question asks

for a number, help him or her arrive at an estimate.

When a respondent refuses to answer a particular question, remind him of the

confidentiality of the information and opinions he gives.

Probe initial "don't know" responses and refusals

once

in an effort to obtain an

answer. Do not, however, badger the respondent to answer or convey the impression that

you are annoyed by his inability or refusal to answer.

11.2 Probing for Amounts, Dates and Numbers

When a question requires a numerical answer, the respondent may answer with a

range rather than a single number, or in units different than those asked for, or he may

initially say, "I don't know." In each of these situations, it is necessary to probe for the

specific information required in the question.

If the question asks for a dollar amount and

1. the answer is given as a range, probe with "I need (or would like to

record) an exact figure if possible." This tells the respondent that you

are interested in exact amounts. The same probe should be used for

responses such as "Oh, around $200."

2. the respondent says, "I don't know," probe with "Just your best estimate

is fine."

If the question asks for a date and

the respondent answers with a time reference, such as "a year or so

ago," probe by asking the calendar information that you need: "What

was the actual date?" or "What month and year would that be?"

the respondent gives only part of the information you need to record,

for instance, only the month or only the year. Again, probe by asking

for the missing piece(s) of information.

the respondent says "I don't know," begin by asking the respondent to

try to remember the time of year or the season. If he can't remember,

ask him to think about anything else that may have been happening at

that time which would help him pinpoint the date more exactly.

If the question asks for a number and

1. the respondent gives a range such as "two or three," probe with "I need to

record a single number; which would you say is correct?" or "Which

would you say would be most likely; 2 or 3?"

the respondent answers in units that are different from those required by

the question (hours instead of minutes, weeks instead of months), probe

by asking for the answer in the units needed: "How many months would

that be?" The same method should be used if he replies with a time

reference instead of a number: "Once a week," when you have asked for

the number of times per month.

3. the respondent says, "It depends," probe with "On the average" or

"Usually . . ."

the respondent says, "I don't know," probe with "Just your best

estimate."

11.3 Probing on Precoded Questions

Remember that precoded questions are used when researchers want the

respondent to place himself or his opinions in one of several predetermined categories.

Let's look at our examples of precoded questions again:

Would you say your health is excellent, very good, good, fair or poor?

Have you never been married?

<9>

REFUSED

In precoded questions, probing is used to focus the respondent's attention on the

question and/or to direct the respondent's attention to the existing code categories. You

must indicate to the respondent that his job is to choose one of the existing code

categories

without

biasing his response or leading him to a particular category. You

should repeat all categories to the respondent without narrowing down his choices for

him. Always preface a repetition of the code categories with an appropriate

acknowledging remark. If the respondent answers in his own words instead of using an

answer category, a prefacing remark such as, "Well then, would you say . . . ?" or "Would

that be . . . ?" is appropriate. If the respondent says, "It depends," a remark such as, "In

general, would you say . . . " or "Overall, . . . " will let him know that we want him to

generalize on the subject.

If, after probing, the respondent does not choose an existing category, record his

answer verbatim and go on to the next question. On PAPI questionnaires, record

verbatims that do not fit into existing code categories in the left-hand margin. On CAPI

studies, record this type of verbatim using the NOTE command before entering the code

for "No coded response applicable."

11.4 Probing on Open-Ended Questions

On open-ended questions there are no precoded answer categories. The

respondent is allowed to answer in a free-flowing manner, in his own words. The

interviewer records the responses(s) as the respondent speaks, in his own words. Let's

look at our examples of open-ended questions again:

Why did you choose to live in this location?

What do you like about your HMO?

Because open-ended questions tend to be very general, respondents tend to

answer in a general way and to use general adjectives when describing situations and

opinions. Respondents also tend to give brief or single answers without going into much

detail. For this reason, two types of probing are used in conjunction with open-ended

questions--

probing for clarification,

which is always used, and

probing for additional

ideas

, used when you are instructed to do so in the questionnaire.

11.5 Probing for Clarification

Probing for clarification

is often a matter of asking for specifics or an

explanation. Never assume that a respondent is using a vague or general word or phrase

in the same way you would. The same general word can mean many different things to

different people.

There are many general words or phrases used in everyday conversation that

should automatically suggest to an interviewer that probing for clarification is needed.

Below is a list of some of the more common words that should always be probed.

Negative

(poor, bad) reputation

(good) appearance

(poor, bad) appearance

not effective, ineffective

works

doesn't work

Can Be Positive or Negative

Probing for clarification should encourage the respondent to speak

without

influencing his answer

. The potential for introducing bias while probing is great. Under

pressure of the interview situation, an interviewer may imply quite unintentionally that

some responses are more acceptable than others or that a respondent may want to

consider certain things in formulating his answer. Many respondents wish to be helpful; if

they can tell how you as an interviewer feel about the subject, they may answer in a way

they think would please you. Be careful not to encourage the respondent with your

reaction to his answers. Avoid saying, "That's good," "That's true," or "That's right." Also

be careful not to suggest possible meanings or specific connotations to the respondent.

Remember that you must remain impartial during every moment of the interview.

In short, the best probes for clarification are those that tell the respondent exactly

what kind of information or response you want from him without leading him toward a

specific possible response. Some examples of neutral probes that can be used are:

What, specifically, do you mean by (__________)?

What, exactly, was (__________)?

In what way was it (__________)?

What about the (__________) do you (like/dislike)?

Would you explain that please?

Would you describe that for me?

Tell me a little more about that.

Often a respondent will volunteer more than one general word or idea that needs

to be clarified,

he may answer a probe with just another general word. You are

expected to

probe each word or idea that needs clarifying

and to

probe each as many

times as necessary

until it is clarified. If the respondent is unable to clarify or be more

specific in response to your probe, move on.

QAPP 2

Appendix 1C

CHEERS Survey Training Manual

A Typical Day for the CHEERS Staff

A TYPICAL DAY FOR THE CHEERS RECRUITER

This is a general overview of a typical data collection day for a CHEERS

recruiter/ interviewer/incentive person. Please note you can be assigned to do one or all of

these jobs on any given day.

Arrive at the pre-designated site at the given time. Please inform the on-

site Data Manager or the CHEERS Field Supervisor (for that

day/location) if there are any unforeseeable delays.

Wear your CHEERS study T-shirt; and

Wear appropriate pants and shoes.

Report to the on-site Data Manager. He/She will record your arrival on a

time sheet.

Listen to changes/location specific details/ additional instructions and for

any adjustments; and

Ask any questions, if necessary. There will always be copies of

CHEERS Study FAQ sheets and Water quality info. sheets available to

help you prepare for the day.

Please discuss your lunch time/break times before you start work

Pick-up recruiting material and place on clip-board. This includes:

Location specific flyers

Eligibility Screener (Make sure you know what time the CHEERS

study will wrap up that day)

We are interested in water recreators before they start their activity

of the day.

We are interested in non-water recreators at any time

before/during/after their activity.

Participants must be able to return to the CHEERS tent to complete

Survey B before we end the CHEERS event for that day.

Refusal Tally sheet

Commence recruiting.

Check Recruiting script, CHEERS FAQ Sheet,

and slides for more help

Return all recruiting material at the end of the day.

De-brief with the on-site Data Manager.

Ask questions/get clarification, if necessary

Discuss any problems you encountered during the day;

Discuss any positive elements of the day; and

Listen for general instructions.

Checkout for the day. Data Manger will complete your time sheet.

A TYPICAL DAY FOR THE CHEERS INTERVIEWER

Arrive at the pre-designated site at the given time. Please inform the on-

site Data Manager or the CHEERS Field Supervisor (for that

day/location) if there are any unforeseeable delays.

Wear your CHEERS study T-shirt; and

Wear appropriate pants and shoes.

Report to the on-site Data Manager. He/She will record your arrival on a

time sheet.

Listen to changes/location specific details/ additional instructions and for

any adjustments; and

Ask any questions, if necessary. There will always be copies of

CHEERS Study FAQ sheets and Water quality info. sheets available to

help you prepare for the day.

Please discuss your lunch time/break times before you start work

Pick-up your laptop and scanner. Commence interviewing.

See the

slides for more help

. The following items are of most importance:

Don’t Be in A Hurry: Slow down, be patient, and be observant.

Record the CASE ID number very carefully. Double check Case ID

entries.

Be Accurate: Listen intensely to what the respondent is saying to

you. Capture the respondent responses exactly as they give them

to you.

Repeat: Repeat back to the respondent all names, addresses and

phone numbers. This is the method that is used to accurately

match the two parts of the survey.

Report any data/laptop troubles to the on-site Data Manager

immediately.

Check to make sure each participant has completed Survey A

before they do Survey B.

All water recreators will receive Survey A before their activity

and Survey B after their activity.

All non-water recreators will receive Survey A and B at the

same time.

If you enter the wrong case IDs or you start the wrong survey,

or you lose power and restart the survey on a new laptop-

PLEASE ENTER ALL THIS IN A REMARK and inform the DM.

Check the laptop battery power every now and then. If power is 25%

or less then please swap the battery and inform the on-site data

manager.

Always close all surveys before placing laptops on stand-by or

powering off. We need to protect the data and save battery power

in the field.

Protect laptops from sun/rain/physical damage. They are your

responsibility.

Return all laptops and scanners at the end of the day. The on-site

Data Manager will download all the data before you pack them in

their bags.

De-brief with the on-site Data Manager.

Ask questions/get clarification, if necessary

Discuss any problems you encountered during the day;

Discuss any positive elements of the day; and

Listen for general instructions.

Checkout for the day. Data Manger will complete your time sheet.

Please note: You may be asked to go out and do some mobile

interviewing- if so, you will be a recruiter/mini- data manager/

interviewer. This means:

You will approach participants and recruit them

You will complete the consent process and assign a Case ID.

You will do the surveys.

You will record this data on a log and return to the tent for

incentives.

You will report all data to the on-site Data Manager.

A TYPICAL DAY FOR THE CHEERS INCENTIVE PERSON

Arrive at the pre-designated site at the given time. Please inform the on-

site Data Manager or the CHEERS Field Supervisor (for that

day/location) if there are any unforeseeable delays.

Wear your CHEERS study T-shirt; and

Wear appropriate pants and shoes.

Report to the on-site Data Manager. He/She will record your arrival on a

time sheet.

Listen to changes/location specific details/ additional instructions and for

any adjustments; and

Ask any questions, if necessary. There will always be copies of

CHEERS Study FAQ sheets and Water quality info. sheets available to

help you prepare for the day.

Please discuss your lunch time/break times before you start work

Pick-up the incentive material. This includes:

The incentive check list on a clipboard.

The gift-cards/receipt book.

Stool flyers.

T-shirts

Commence incentive distribution.

See slides for more help

. Please be

aware:

Count all gift cards at the beginning of your shift and enter the

number on the white form provided in the gift-card box.

Record the date/location and start/end gift card count on the

incentive sheet before you start your day and at the end of the day

again.

You will be stationed at a table close to the on-site Data Manager.

Please make sure all participants have completed Survey A and

Survey B- before they take their incentives

Take their wrist bands before they leave. Please collect as trash.

Participants can choose to donate their cash ($50) incentive. They

will sign the consent form. The on-site Data Manager can help you

track this. If someone says they are donating their cash incentive

to any club/team/group then-

DO NOT GIVE THEM A GIFT CARD.

Enter “

DONATE

” next to their

case ID. This data is very important as we track donations every

week.

If you run out of t-shirt sizes you can record details of the participant

NAME, ADDRESS AND T-SHIRT SIZE. We can mail it out to

them. Please give details to the on-site Data Manager.

Once again, count all gift- cards and enter the number on the white

form provided in the gift-card box at the end of your shift/day. You

are responsible for an accurate account of the gift cards. This is as

good as cash.

De-brief with the on-site Data Manager.

Ask questions/get clarification, if necessary

Discuss any problems you encountered during the day;

Discuss any positive elements of the day; and

Listen for general instructions.

Checkout for the day. Data Manger will complete your time sheet.

QAPP 2

Appendix 1D

CHEERS Survey Training Manual

BLAISE Field Interviewer Training

Blaise Manual for study 1027 CHEERS

(7/19/07)

Logging in to your laptop

After you turn the computer on, you will be prompted for your user name and password.

Select the user name “user” (not “admin”), and enter the password you were given to use

during training. If you bypass the sign-in dialog by closing the window or pressing the

Escape key, the programs will not work.

Password: survey

Checking the time and date

After you’ve logged in, you will be presented with a time/date window. You should

verify that both are correct, and fix them if not. (The time and date are used by the

instrument in various calculations.) After you are done, press the “OK” button to

continue.

Figure 2

Verifying that you are running off of a wall plug rather than the battery

It’s very important that interviews be carried out while the laptop is plugged in, if at all

possible. The battery is intended as backup, to prevent the loss of data in the case of a

power outage; it’s unlikely that you will be able to complete an entire interview on

battery power alone. PLEASE CONDUCT A BATTERY CHECK- IF YOU HAVE 25%

OR LESS POER THEN YOU NEED TO SWAP THE BATTERY.

There are two kinds of laptops used for the 1057 study: IBM and ACER. The laptops

have been set up so that an icon in the system tray (at the bottom of the screen, on the

right) shows you whether you are operating on “full” or “battery” power, and, if you are

operating on battery power, tells you what percentage battery power you are operating

on. The icons for the two kinds of laptops are different.

For the laptops:

1) An icon that looks like a plug with a blue lightning bolt over it indicates you are

running on full power. If you rest your mouse on the icon, it will give you a

message like “92% remaining (charging)”, indicating that your battery is “92%”

charged and that the laptop is in the process of further charging the battery. You

should double-click on the icon to get a display like the following, confirming you

are plugged in and giving you additional details.

Figure 5

2) If the icon appears as a blue battery, with a red plus and minus sign on it, this

indicates that you are running on battery power. If you rest your mouse on the

icon, it will give you a message like “96% remaining”, indicating that your

battery is “96%” charged. You should double-click on the icon to get a display

like the following, confirming you are running off the battery and giving you

additional details.

Figure 6

3) You can also tell that the laptop is running on full power from a small indicator

light on the laptop itself: above the left-hand corner of the keyboard. If the laptop

is plugged in to a working outlet, the light under the image of a plug will be on,

otherwise not.

“CHEERS” desktop folder

Icons for data collection

1) “Run Part A”, “Run Part B” : used for data collection with actual respondents; for

further instructions see the section on “Accessing the Blaise instrument for data

collection”, below.

2) “Salvage”: used to recover if your case locks or you get other error messages

indicating a problem with the database; for further instructions see the section on

“Salvaging a case after data problems”, below.

“Training” directory (for training/review)

1) “Joint” sub-directory:

a) “Run Training” will allow you to go through the entire questionnaire using

a training case. (Do

not

use this icon for actual data collection.)

b) “Salvage Training” is a training version of the “Salvage” icon.

c) “Training Sample.xls” = copy of test sample file, which you will need in

order to run through a case in the “Joint” directory; it lists the CaseID and

associated Randno values which you will need to type in when prompted

by the program.

2) “Section1” – “Section9” and “Post” sub-directories:

Each of these sub-directories has a “Run Training” icon which will allow

you to practice on just that particular section of the questionnaire. (Click

to start.) You will not need to enter a CaseID and Randno to go through

these.

Accessing the Blaise instrument for data collection

1) Click onto desktop folder CHEERS.

2) Click on the appropriate icon for the phase of the study or training you are

working on.

3) Click on the “Main Laptop” folder.

4) Click on the “Part A. bat” or Part B. bat” file icon- This will bring up the study

instrument in the Blaise data entry program.

5) To access a particular case, see instructions under the “Accessing a case (‘form’)”

section below.

Troubleshooting

You click on your “Run” icon and nothing happens

– Try clicking on it several

times. All icons should be working but sometimes you have to click on them

several times before they will kick in. (NOTE: the “Salvage” icon discussed

below will run a program very quickly in the background; you may see only a

flash on your screen, and you should test before clicking on “Salvage” again.)

Salvaging a case after data problems

1) You may need to salvage a case if it locks (freezes on a particular screen and will

not let you go backwards or forwards), or if you get an error message that refers

to the data or database being corrupt or unusable.

2) The very first thing you should do is to write down the error message (if you get

an error message), and a description of what went wrong.

3) Then exit Blaise and attempt to re-enter the case regularly (without using

“Salvage”). Only if that fails should you proceed to salvage.

4) To salvage start by clicking onto desktop folder ST1057 Patient and then click on

the “Salvage” icon (right beside the “Run Production” icon). This will cause the

salvage program to run very quickly in the back-ground (you may see just a flash

on your screen).

5) Now attempt to re-enter the case you were in.

6) If you still cannot access the case, run salvage one more time and attempt to re-

enter the case.

7) If you still cannot re-enter the case, you can call one of the SRL staff members

listed in your manual, and we will attempt to address the problem over the phone

with you.

8) If none of the above works, you will need to reschedule your appointment with

the respondent and return as soon as possible to SRL so that we can take a look at

your computer.

Blaise screen layout

Each Blaise screen consists of 5 basic sections:

Figure 7

1) The menu bar – The bar consists of 5 drop down menus; Forms, Answer,

Navigate, Options, and Help. Clicking on any one of these titles will display a list

of options that you may need/want to use during the interview session. Any option

grayed-out is not activated for use on that particular screen. Active options may

change from screen to screen (for example, the DK/RF options, which are

available on most but not all screens).

2) The speed buttons – The second bar consists of several speed buttons that you

may need/want to use during the interview session. Resting your mouse pointer

on the speed button will display a description of what it does. Buttons include

Get

form

Don’t know answer

Refuse answer

Make Remark

Goto previous

page

Goto next page

Goto first page

Goto last page, Search tag,

and

Form

Language

3) The info pane – This is the portion of the screen shaded pale yellow. It will

display the question text, interviewer instructions (in blue, and usually in all

capital letters), and answer choices. The text should be read/used as instructed in

general and study specific training.

4) The form pane – This is the pale gray area at the bottom of the window. It

contains one or more field panes or fields where the data is entered. Each field has

a field name or variable name. On fields which display numbered response

options, after you enter an answer a variable label will be displayed to the right of

the entry for that field for reference as you view a page. (Numeric and string

fields don’t have such variable labels.) These labels can be useful when checking

previous answers without having to scroll back through all fields one by one.

Each form pane also corresponds to one page. You can use the mouse pointer or

arrow keys to navigate one field at a time or use the “previous page” and “next

page” speed buttons or the “page up” and “page down” keys to move backward

and forward one screen/page at a time. NOTE: You will not be allowed to move

past fields that are required to be answered (and that have not been answered yet).

5) The status bar – This is the last line on the screen that contains some information

about the case. The three sections of particular interest are the second, which

displays the current page/total pages involved in the interview (ex = “6/259) and

the last two, which display the current CaseID number (ex = “100001) and the

name of the field that the cursor is currently on (ex = “Section1.PD1_intro”).

Accessing a case (“form”)

1) After entering the Blaise system you will be brought to a screen that asks for

CaseID number.

2) Enter the 6-digit CaseID number to access the form.

Figure 8

Entering answers

You can use the keyboard to enter the answer to any question in the form. Simply enter

the appropriate number(s) or letter(s) into the field pane and press the “Enter” key. This

will take you to the next appropriate question.

Alternatively, questions such as those with radio buttons or check boxes, can be entered

by clicking on the appropriate response. Clicking on the text of the response itself is the

best way to ensure that the correct response is selected.

Whether using the keyboard or using the mouse to select answers it is always advisable to

quickly glance at the screen to ensure that the correct response was selected.

Closed ended (numbered response) questions:

For those with radio buttons you use the keyboard to enter the number of the response

and press the “Enter” key to move on to the next question. Or you can click once on the

response to select it and press the “Enter” key to move on. Or you can double-click on

the response to both select it and move to the next screen; but this is dangerous because

it’s hard to catch any mistakes caused by double-clicking on a different response than the

one you were aiming at.

Figure 12

CAUTION: if there are 2 or 3 columns of responses presented onscreen, and you use the

mouse to select an option in the 2

or 3

column, you have to be careful not to click to

the

left

of the radio button, or you may end up selecting the answer to the left of the one

that you intended. This can be a hard error to catch if you are double-clicking in order to

both select the response and move to the next screen. Clicking on the answer text just to

the

right

of the radio button (that is, on the response number or label itself) may be the

best way to avoid this error.

For those close ended questions with check all that apply boxes you can check the boxes

in any order by clicking on each box in the order the response is given by the respondent.

Or you can use the keyboard to enter each response separated by a dash. For example,

1-3-2-10

would indicate that the first, third, second and tenth answer categories from the list were

named by the respondent in that order.

CAUTION: If you are using the keyboard instead of the mouse to enter responses the

program will allow you to enter the same option twice (for example “1-3

-1

”, entering

option “1” twice), but you will get an error message when you try to proceed.

Figure 13

CAUTION: For “check all that apply” questions a “don’t know” response or a “refusal”

response is intended to be used as the only answer to the question. It may not be used in

conjunction with checking other responses shown on the screen. If other responses have

been entered followed by the don’t know or refusal option, the previous entries will be

erased, so if you want to preserve those other answers you should enter the don’t know or

refusal answer as a “SOMETHING ELSE” of “OTHER” answer with an appropriate

message in the follow-up field (“Refused to say what the other illness was”, or whatever).

CAUTION: For “check all that apply” questions be careful when backing up to edit or

append to an answer. When you back up the entire answer field will be highlighted.

1-3-2-10

Typing in any answer while the field is highlighted will overwrite the previous answer(s).

To edit or append to the field you can press the “Insert” key or click with the mouse on

the answer field and then edit as desired.

CAUTION: as with radio button responses, check boxes that are arrayed in 2 or 3

columns can result in data entry errors when you click to the

left

of the item you intended

to select. Clicking on the answer text just to the

right

of the radio button may be the best

way to avoid this error.

“Don’t know” answers:

“Don’t know” is not displayed on-screen as a potential answer category but it is available

for use on most questions. It can be selected by entering the key combination “Ctrl” +

“k”, or by clicking the “Don’t know answer” speed button, or by choosing “Don’t Know”

from the “Answer” menu on the menu bar. The answer is displayed on-screen in the field

pane as a yellow circle with a question mark in the middle.

If “don’t know” is not available for a particular item, you will be notified by an onscreen

interviewer instruction indicating “(NODK)”. If you try to use the Ctrl-K shortcut, or the

speed button, on such items, you won’t get an error message; instead nothing will

happen. You can also tell that the option is unavailable because both the “Answer” menu

option and the speed button will be grayed out.

If “don’t know” is not available for an item, you can assume that this was intentional and

that you should probe further to get the R to choose one of the other precodes.

If the R gives an answer that doesn’t fit into one of the existing codes, and when probed,

can’t pick one of those pre-codes, do not code this as a “don’t know” answer but instead

select a precode and leave a remark.

You can review all of your “don’t know” answers by selecting the “Show DontKnow and

Refusal” option on the “Navigate” menu. (It displays both “don’t know” and “refusal”

answers by default, but you can uncheck the “Show refusal” check-box.) To go to an

item answered with a “don’t know” (if for example the respondent now has an answer),

select that item in the left screen of the dialog box and then click on the “Goto” button.

Figure 14

Figure 15

“Refusal” answers:

“Refusal” is not displayed on-screen as a potential answer category but it is available for

use on most questions. It can be selected by entering the key combination “Ctrl” + “r”, or

by clicking the “Refuse answer” speed button, or by choosing “Refuse” from the

“Answer” menu on the menu bar. The answer is displayed on-screen in the field pane as a

blue circle with an exclamation point in the middle.

If “refusal” is not available for a particular item, you will be notified by an onscreen

interviewer instruction indicating “(NORF)”. If you try to use the Ctrl-R shortcut on

such items, you won’t get an error message; instead nothing will happen. You can also

tell that the option is unavailable because both the “Answer” menu option and the speed

button will be grayed out.

If “refusal” is not available for an item, you can assume that this was intentional and that

you should probe further to get the R to choose one of the other precodes, emphasizing

the confidentiality of the information as appropriate.

If the R gives an answer that doesn’t fit into one of the existing codes, and when probed,

refuses to pick one of those pre-codes, do not code this as a “refusal” answer but instead

select a precode and leave a remark.

You can review all of your “refusal” answers by selecting the “Show DontKnow and

Refusal” option on the “Navigate” menu. (It displays both “don’t know” and “refusal”

answers by default, but you can uncheck the “Show don’t know” check-box.) To go to

an item answered with a “refusal” (if for example the respondent now has an answer),

select that item in the left screen of the dialog box and then click on the “Goto” button.

Entering a note/remark:

You can enter an interviewer note on any item by entering the key combination “Ctrl” +

“m”, or by clicking the “Make remark” speed button, or by choosing the “Make Remark”

option from the “Answer” menu. This will bring up a “Remark” box for you to type into.

Figure 16

CAUTION: Be sure to click on the “save” button to save your text. If you press the

“cancel” button, or otherwise close the Remark box without saving (by, for example,

clicking on the “X” in the corner), any text you just entered will be erased.

Once you have saved the remark a paper clip symbol will appear on the screen to the left

of the field pane. To view and edit your saved answer, you can open the remark the same

way you did before (from shortcut keys, speed button, or menu), or you can double-click

on the paper clip icon beside the question. To delete a remark you have to delete all of

the remark’s text (open the remark, delete all of the text

, then click on the “Save”

button); once the remark has been deleted the paper clip symbol for that remark will

disappear.

You can review all of your remarks by selecting the “Show All Remarks” option on the

“Navigate” menu. To go to an item that has a remarks attached to it (if for example the

respondent’s current answer requires editing a previous note), select that item in the left

screen of the dialog box and then click on the “Goto” button. Once you’re at the item,

open the remark in order to view and edit it.

Please note: It may be appropriate at times to make a remark in conjunction with

precodes other than “NO CODED RESPONSE APPLICABLE”. A remark can be left on

any screen where you feel a remark is needed based on instruction you received in

general or study specific training.

String questions:

These are limited-text-entry questions (unlike the “open ended” questions mentioned

often used for names and addresses, and usually provide between 40

nd 80 characters for data entry.

r than 80 characters on an 80-character string question).

those cases you can enter the rest of the data in a remark attached to the string

dress in

below). They are

You may occasionally run out of space to record your answer on a string question (if for

example you get an address longe

question. For something like an address, you might want to start the remark by indicating

that you ran out of space to record it; then copy the text already entered for the string

question and paste it into the remark

, before continuing to enter the rest of the ad

You can delete the text in any of several different ways (and the list below is not exhaustive):

a) From the end of the text (arrived at by pressing the “Ctrl” + “End” keys), press the

“BkSp” key

ted text by pressing the

“Del” key

Del”

ng, left-clicking, and then, with the mouse left pad held down, moving the mouse pointer to

To copy

until you’ve deleted the text all the way to the beginning.

b) Or, from the start of the text (arrived at by pressing the “Ctrl” + “Home” keys), press the

“Del”

key

until you’ve deleted the text all the way to the end.

c) Or, from the start of the text (press “Ctrl” + “Home”), select all of the text to the end by pressing

the

“Shift” + “Ctrl” + “End” keys

, and delete the selec

d) Or, from the end of the text (press “Ctrl” + “End”), select all of the text to the beginning by

pressing the

“Shift” + “Ctrl” + “Home” keys

, and delete the selected text by pressing the

“

key

Or, use the mouse

to select text starting from either the beginning or the end of the text by

pointi

the other end of the text. Then delete the selected text by pressing the

“Del” key

and paste the string answer into the remark:

Select the text already entered for the string question, in any of the following ways…

ote that the entry of “don’t know” and “refusal” answers for string questions is done in

pen ended (memo) questions:

ese are

unlimited

-text-entry questions (unlike the “string” questions mentioned

hey

o enter data, you can either just begin typing, or double-click, or press the “Insert” key.

s.)

igure 17

the remark. (Do

not

manually re-type the string answer into the remark, since any

differences between the two will create a puzzle as to which is the correct version; u

copy-paste as described in the footnote.)

the same way as for close-ended questions.

above), although they look just like a string question until you start to enter data. T

are used in places where the respondent might give us an entire story (for example, when

we ask “what did the doctor tell you to do next?”).

The system will bring up a memo box that allows you to enter a virtually unlimited

amount of text. (The box looks and acts much like the one that comes up for remark

1) Back up to previous item (using up arrow key), then go forward again to string question

(using down arrow key), which will automatically highlight (select) all of the text you’ve

entered for that string question.

2) Or, from from the start of the string question text (arrived at by pressing the “Home”

key), select all of the text to the end in one step by pressing the

“Shift” + “End” keys

3) Or, from the end of the text (arrived at by pressing the “End” key), select all of the text to

the beginning in one step by pressing the

“Shift” + “Home” keys

4) Or, from the start of the text (press “Home”), select all of the text to the end, character by

character, by pressing the

“Shift” key and

continuing to press the

right arrow key

till

you’ve arrived at the end.

5) Or, from the end of the text (press “End”), select all of the text to the beginning, character

by character, by pressing the

“Shift” key

and continuing to press the

left arrow key

till

you’ve arrived at the beginning.

6) Or,

use the mouse

to select text starting from either the beginning or the end of the text

by pointing, left-clicking, and then, with the mouse left button held down, moving the

mouse pointer to the other end of the text.

b) After selecting the text, copy it to the clipboard by right-clicking and selecting “Copy” from the

menu, or by pressing the “Ctrl” + ”C” shortcut keys.

c) To paste the selected text, open the Remark and either right-click and select “Paste” from the

menu, or press the “Ctrl” + “V” shortcut keys.

CAUTION: Be sure to click on the “save” button to save your text. If you press the

“cancel” button, or otherwise close the Memo box without saving (by, for example,

clicking on the “X” in the corner), any text you just entered will be erased.

You can back up to this open ended question at any time to view and edit your saved

answer (but see the “CAUTION” below). You can also review all of your answers to

open ended questions by selecting the “Show All Open Answers” option on the

“Navigate” menu. To go to one of these open ended questions (if for example the

respondent’s current answer requires editing a previous answer), select that item in the

left screen of the dialog box and then click on the “Goto” button.

CAUTION: To edit an existing Memo-type (open ended) answer, you need to double

click on it or press the “Insert” key after your cursor is on the answer. If instead you

typing, or click

once

in the answer and start typing, you will end up deleting the text

Note that the entry of “don’t know” and “refusal” answers for open ended questions is

done in the same way as for close-ended questions.

Introduction screens:

These are screens on which some introductory text is read to the res

instructed to “PRESS ENTER TO CONTINUE” after you are done, without having to

enter any data. The screens will

accept

a single character of data if you enter it, but this

will not be stored in the final dataset, so it’s not a problem.

Edit check screens:

Edit check screens wil

hard” error which req

l pop up either when a data entry error has clearly been made (a

uires a change to an answer entered), or when an error is suspected

r last live birth must have

een at a later age than her first live birth, and this is therefore an example of a hard error.

he edit check programmed to catch such an error would bring up a popup window like

“

(a “signal” which can be suppressed by the interviewer).

For example, an interviewer may record that the respondent’s first live birth was at age

“18” (DM21c1=18), and that her last live birth was at age “17” (DM21c2 = 17)…perhaps

because of a typo of “17” when “27” was meant. Clearly he

the following:

Figure 24

Notice that the “Suppress” button is greyed out. This popup will only go away when the

interviewer returns to one of the two questions and changes the answer so that the

inconsistency is eliminated. (For example, by selecting the “Section9.DM21c2” item,

clicking on the “Goto” button, and changing that answer from “17” to “27” before

proceeding to the next question.)

On the other hand, an interviewer

can

suppress a “signal” generated by an edit check of a

suspicious answer. Suppressing a “signal” confirms that the suspicious answer is in fact

correct; the “signal” popup window therefore goes away and the interviewer is allowed to

proceed to the next question.

For example, an interviewer may record that the respondent spends “0” hours awake with

her spouse on an average weekday (NT5a=0). This is an unusual answer, but not

impossible (since some spouses live apart for work reasons during the week, and get

together only on weekends). The edit check programmed to query interviewers about

such an unusual but possible answer would bring up a popup window like the following:

Figure 25

Note that such an interviewer “signal” can be suppressed if the answer entered was

indeed the correct one (by clicking on the “Suppress” button). If on the other hand the

answer entered turns out to be incorrect (due perhaps to a typo of “0” when “10” was

meant), the interviewer can return to the question by clicking on the “Goto” or the

“Close” button, and then change the answer before proceeding to the next question.

Exiting and saving a form

You can exit a form in several ways at any point in the interview for a partial interview or

at the end.

After the last question in the questionnaire is asked and answered you will be asked if

you want to save the form or cancel. If you click on the “cancel” button you will be put

back in the questionnaire form. If you click on the “Yes” button your form will be saved

and closed.

You can also exit a form at any point by selecting the “Forms” menu option “Close” (to

close the form but remain in Blaise) or “Exit” (to both close the form and exit Blaise).

Clicking on the “x” box in the upper corner of the Blaise window has the same effect as

choosing “Exit” (it closes the form and exits Blaise). In all cases, you will be prompted

with the same options as when you complete a form: to either save and exit the form or

cancel the exit procedure and return to the form.

CAUTION:

You must enter a “1” on the last “End_All” item (as it tells you to) before exiting. If

instead you get to the “End_All” item and just exit the program, the case will not be

treated as a completion but as a partial. So the safest way to exit a completed case is to

answer all of the questions, including “End_All”, and press enter so that the program

prompts you to save the form.

QAPP 2

Appendix 1E

CHEERS Survey Training Manual

How to do a CAWs Use Survey

HOW TO DO A CAWs USE SURVEY?

Specific aims of the CAWs usage survey are to determine:

•

CAWs usage, in terms of numbers of users and types of recreational activities at

various access points.

•

To identify differences in usage between locations

•

To identify differences in usage at the same location at different times of day, and

different days of the week.

•

To identify use at informal access points.

The procedure of the CAWs usage survey will be as follows:

a. The CHEERS Field Manager/Supervisor or the on-site Data Manager will have

overall responsibility for identifying sites and times to start sampling as well as

for conducting user counts. Only field staff trained in this protocol will conduct

this CAWs use survey.

b. Staff will select a clear view of the access point of interest, preferably in a shaded

location. They will fill out the top half of the CAWs Use Survey Data Sheet.

c. Using the datasheet, staff will tally the number of individuals who begin

recreation, by recreational activity. The tally will be done in 10-minute intervals.

The first interval will begin at 0, 10, 20, 30, 40, or 50 minutes past the hour. Staff

will write into the chart the hour (clock time) for each interval.

d. In order to avoid counting the same individual more than once, individuals will

be counted only when they begin a recreational activity. Those recreating at the

time that counting begins will be identified by circling the tally marks for those

individuals.

e. After a datasheet has been completed, staff will begin a second sheet, taking care

to again complete the top portion, including the page number.

f. Consent: Because this is a study of the behavior of anonymous individuals in a

public space this study has been granted exempt status by the UIC Institutional

Review Board (IRB) for the protection of research subjects. Thus no consent

process for the CAWs recreational use study is necessary and none will be

performed.

g. Safety of the researchers will be maintained at all times. The field study will not

be done without adequate light and will be terminated in the event of inclement

weather. Researchers will also be instructed to leave the area and seek a safe

location in the event that the feel that their safety is threatened in anyway.

h. At the completion of data collection, data sheets will be given to the on-site Data

Manager.

QAPP 2

Appendix 1F

CHEERS Survey Training Manual

Know Your Job

KNOW YOUR JOB

Scheduling

Your schedule is planned around your availability, classes and activities and within the

framework of our study. Some schedules may stay the same during the entire season, while

others may change on a regular basis. You will be scheduled to work Fri/Sat or Sun. We

require you to sign up for a minimum of 12 hours of work each week. You may work as many

hours as allowed by the university and at the discretion of the study coordinators. Please ask

your supervisor for further details. If you have a conflict due to vacation, classes, activities or

any other reason, please see Sara and let her know in advance. We will assist you in

resolving conflicts with your work schedule. Due to the nature of this study you will probably

be required to work holidays and during exam periods. Every effort will be made to

accommodate course work and other activities, however a definite commitment in time and

availability will be required during the periods of active sampling in the study.

Pay Day

All employees are paid on a bi-monthly basis. Earnings are directly deposited into the bank

account you designated on the NESSIE new hire forms.

Employees are responsible for filling out a time card after each shift which will be signed by

the immediate supervisor. If you believe there is an error in your paycheck, please bring it to

the attention of the project coordinator immediately.

Evaluations

Your work performance will be evaluated periodically throughout the season. You will also be

given an opportunity to give us feedback.

Resignations

In the unfortunate event that you have to leave your position, please see Amelia/Preethi or

Sara BEFORE you resign. We may be able to help you work out the conflict. If you are sure

that you must resign, however, we ask that you give us at least two (2) weeks advance notice.

This will allow you to remain eligible for future employment. In addition, this courtesy will give

supervisors and coworkers time to replace your shifts.

YOUR WORK DAY

Rest Periods

You can ask for two (15) minute rest periods when you work at least six consecutive hours.

This includes a meal/rest room/phone call break (and smoking breaks too). Your

supervisor/field manager/data manager will determine when your breaks may be taken. We

encourage you to eat prior to, or at the end of your shifts. Also note, many of the recruiting

sites are in relatively remote areas and do not have restaurants or food establishments

nearby. Plan to bring food if you need to eat during your workday.

Training and Supervision

You will be trained in all aspects of your job prior to be sent into the field. Our supervisors/field

managers/data managers will then provide further assistance when in the field. We will teach

you the proper techniques and safety procedures to ensure that you will be successful in your

job. If you are not sure of something during the course of your work day, please see your

supervisor/field manager/data manager.

Reporting for your shift

1. You are expected to report to work on time as scheduled. Please do not arrive late.

2. Arrive at work wearing your CHEERS T-shirt and ready to work.

3. Please be prepared to work your entire shift

4. Complete your time card and submit to the immediate supervisor at the end of each

shift. Over reporting of time worked will require disciplinary action.

EMPLOYMENT POLICIES

Every job is important and yours is no exception. It is necessary that you report to work

according to your schedule.

• If you are scheduled to work and are unable to do so (for example: you become ill or there is

a schedule conflict), you are responsible for finding a substitute who is capable of performing

your job. A list of coworkers’ phone numbers is posted on the CHEERS website (blackboard).

• If you fail to report to work without finding a substitute, the absence will be unexcused.

Unexcused absences may result in termination and a negative evaluation.

• If you are ill and unable to work, we may require you to provide verification from your doctor.

• If you might be late for work, inform your supervisor/field manager/data manager on the

schedule for that day. Failure to do so may result in disciplinary action.

• Major emergencies or illnesses will be taken into consideration on an individual basis.

Discuss such situation with us.

• Remember, we try to be FLEXIBLE. Keep us informed and you will remain in good standing.

• You will be provided with two CHEERS T-shirts which should be worn during every shift. We

expect you to look clean, neat and professional at all times. You can always ask for

replacement T-shirts and for any questions about what is appropriate to keep yourself looking

great!

• It is unlawful to manufacture, distribute or possess a controlled substance while working for

UIC. Working while under the influence of drugs or alcohol is prohibited and will result in

termination. All employees are prohibited from carrying out any box, package or container

from their workplace without prior consent. Those employees who do not follow this policy

will be subject to appropriate discipline, which may include termination. Lost and abandoned

items should be reported to your supervisor.

• As a member of the CHEERS study team, your success during the course of your

employment is important to us. Work rules are established and are expected to be followed.

Your unit will also express additional expectations to you.

Safety Rules / Regulations

As an employee, you share in the responsibility for the health and safety of yourself, your

coworkers, study participants, and other members of the community.

• Follow the Cheers study safety plan at all times.

• Wash your hands or use hand sanitizer after using the rest room, coughing, sneezing,

touching your hair, eating or wiping your face.

• Report unsafe working conditions to a supervisor/field manager/data manager.

• If you are injured on the job, regardless of the degree of severity, notify us immediately. Your

supervisor will see that you get medical attention if necessary.

Quality Control

A lot of information will be presented during the training period. All this information is

designed to provide to you the tools, knowledge and experience necessary to be the best

interviewer that you can be. The study relies on the accuracy of the data collected during all

parts of the survey. It is very important that data collected is not biased or accidentally

misrepresented at any time.

The Assistant Study Director- Surveys, CHEERS Assistant Research Specialists, Study

Director, Program Coordinator and field supervisors will monitor each interviewer in the field

to receive effective feedback on the performance. Interviewers may not know when or how

they are being monitored. Monitoring is done in the field while an interviewer is recruiting

participants and administering questionnaires or through the data collected in a survey. The

CHEERS surveys have certain built-in checks that help us monitor the data quality by

interviewer.

Monitoring is more heavily concentrated during the early phases of data collection and for

newly-hired interviewers so that any problems in performance can be detected immediately.

The monitor is instructed regarding whom and when to monitor based on random selection of

interviewing stations and times during each field shift or as a result of problems noted from

previous monitoring sessions.

This ongoing monitoring of CATI interview files permits interviewer skills to be evaluated in a

number of key areas, including the ability to follow instructions correctly and the ability to

probe for clear and complete answers. Through monitoring, additional factors, including the

interviewer’s skills in eliciting cooperation and maintaining neutrality, are routinely evaluated.

Errors detected during these reviews are recorded on a standardized form to help supervisors

give feedback to interviewers and retrain as necessary. Positive as well as negative feedback

is given to ensure that the interviewers maintain a high level of commitment to quality.

Falsifying Data Collection

Intentionally falsifying data collection is illegal and unethical and will compromise the reliability

of the study. All of your work is to be performed in a faithful, industrious, and professional

manner in accordance with the code of conduct specifically established for the CHEERS

study. Your work must be authentic. CHEERS may validate your work by contacting

respondents and you are expected to cooperate with these validation efforts. CHEERS used

internal and external checks to validate data collection in 2007 and will continue to do so in

2008.

It is unethical and fraudulent to submit any work that you represent as data that you have

collected from sample respondents, when you have not, in fact, done so. Any violation may

result in termination of employment and may violate IRB rules regarding scientific integrity. A

violation may also lead to other actions by CHEERS, such as criminal court action and claims

for money damages.

Interacting with the Media Press

We are not the experts on this survey. We are their means of acquiring data and are not the

spokespersons of CHEERS. The CHEERS representatives are the scientists involved with

this study. Dr. Samuel Dorevitch (Study Director), Dr. Preethi Pratap (Assistant Study Director

- Surveys), Sara Wuellner (Program Coordinator), Amelia DeLaquil (Assistant Research

Specialist) and Todd Schoonover (Field Logistics Coordinator) are the CHEERS staff

authorized and prepared to answer any and all questions any representative of the media

should have.

Tips for Handling the Press

Don’t Panic: The media are people too. Be calm, if you’re in the middle of an

interview finish the interview and politely speak with the media person.

Be Polite: Politely explain to the media person that you’re job is to conduct

interviews and that the principal investigator or a supervisor will be able to

more accurately answer their questions. Direct the media person to Sam or to

the supervisor available at your location.

Be Proactive: If you see a media person looking for someone to interview,

direct them to either Sam or to a supervisor.

QAPP 2

Appendix 1G

CHEERS Survey Training Manual

Professionalism Policy

CHEERS Professionalism Policy

It is the study’s expectation that all employees will conduct themselves according to high

standards of conduct and performance. Our work takes place in the public arena, and

unprofessional behavior can impair our ability to collect high quality data, damage to the

study’s image in the eyes of public, and promote discord within the project team. When

employees do not behave professionally, it is the immediate supervisor's responsibility to

act in a timely manner and initiate a program of disciplinary steps to address the problem.

This policy presents the basic principles and procedures of a system of progressive

discipline which is intended to ensure that all employees are treated as consistently and

fairly as possible. The disciplinary program has four major purposes:

To ensure that the employee knows what the problem is

To communicate what the supervisor's expectations are in order for the employee

to correct the problem

To provide appropriate penalties for improper work conduct

To provide a record of corrective action taken by supervisors in such problem

situations.

Progressive Discipline

Progressive discipline is a formal process which includes several steps or levels of

discipline, each of which provides the employee with the opportunity to correct the

problem or inadequacy.

A. Preliminary Actions. Prior to moving to formal discipline the supervisor should do the

following:

1. Do a thorough fact-finding which includes collection of all information and

applicable records. This will be done by the Field supervisor and Survey

Managers.

Hold a discussion in private with the employee. During the discussion the

supervisor should state the problem clearly and allow the employee to respond.

Follow up with the employee after the meeting and after all information has been

gathered, to report the findings. If the supervisor intends to move to formal

discipline, the employee should be told at the conclusion of the follow-up meeting

or as soon after as possible. It should be made clear to the employee which level

or step of the discipline process is being applied.

4. Provide a follow up letter as soon after the meeting as possible. The letter should

include the date and time of the follow-up meeting, a brief statement of the

problem, the supervisor's expectations, and the conclusion reached in the meeting.

The stage of discipline must be clearly noted and a statement made that lack of

improvement will result in further discipline.

The Steps of Progressive Discipline. There are

four steps

in the progressive discipline

process; however, in cases of misconduct or repeated infractions, the process may be

shortened and the supervisor, in consultation with the Principal investigator, may move

directly to a later step in the process, including termination.

All disciplinary action should be taken within a reasonable time frame it is recommended

that no more than two days elapse between the time the supervisor learns or has

knowledge of the offense and the action is taken.

The standards of professionalism differentiate between minor and significant violations.

Examples of minor violations of standards of professionalism include:

•

Not wearing the CHEERS t-shirt while working

•

Speaking on a cell phone while working (meaning, while not on a break

scheduled by a supervisor)

•

Arriving more than 15 minutes late to the study location

•

Smoking at or adjacent to the study location

Examples of significant violations of standards of professionalisms include:

•

Failure to show-up to work without arranging a shift swap or notifying the

supervisor the day before

•

Arguing with or making inappropriate comment to study participants

•

Insulting study participants

•

Theft

•

Refusal to perform work

•

Falsifying data collection

1. Oral Warning

Oral warnings are appropriate for minor first offenses. It is important that supervisors not

overuse the oral warning for the same type of offense; no more than two oral warnings

should be given.

The supervisor should have a full discussion with the employee before giving the

warning to ensure that the employee has the opportunity to respond or to give additional

information. If the supervisor believes that an oral warning is appropriate, it should be

made clear to the employee that the oral warning is the first step in the progressive

discipline process. The oral warning should be

documented

for the supervisor's record

and it is recommended that a note summarizing the warning be given to the employee.

The record and note should record the date, time and reason for the warning. This will be

done by the Field Supervisor or Survey Manager.

Note: The oral warning remains in effect for 2 months

2. Written Warning

After an employee has received an oral warning, a subsequent minor offense should be

addressed by a written reprimand as appropriate. Arriving more than 30 minutes late

will also results in a written warning. When a field supervisor notes such an offence,

his/her manager (survey manager, field manager) must review the draft of the written

reprimand with the Principal Investigator. The supervisor and employee first meet to

discuss the problem. In the discussion, the supervisor must review the incident or

performance problem which requires the reprimand and the supervisor and employee

should exchange ideas and information regarding solution(s) to the problem. The written

reprimand should be given to the employee directly following the discussion. Employees

can provide a written response to the warning within two (2) days of receiving the

warning and both documents will be placed in the employee's official personnel file.

The written warning should:

Be identified as a disciplinary warning

Describe as specifically as possible the situation which prompted the warning.

including day, date, time, location, and what the supervisor saw or heard

Indicate why the behavior or performance is unacceptable

Review the decisions that were reached during the discussion regarding how the

employee would correct the problem

State that if the behavior continues or other problems occur, additional corrective

measures may be taken, which may result in termination of employment.

The supervisor should discuss the matter with the employee when giving the

employee the warning.

Note: The written warning can be given without a prior discussion regarding the incident

between the supervisor and employee.

Written warnings are retained in the employee's formal record.

3. Suspension

Suspension is the third step of the disciplinary procedure. It is intended to indicate to the

employee the seriousness of the infraction and that the employee can reasonably expect

that the next step is termination of employment. Suspension is an appropriate response

to arguing with study participants, engaging in unsafe or illegal activities, intoxication, or

more than one failure to show up for work.

Before determining if an employee should be suspended,

the supervisor must meet with

the employee

to discuss the incident or problem and consult with the Principal

Investigator.

The employee should be notified in writing of the suspension as soon as

possible and given two (2) days to respond. The letter should outline the reason for the

suspension and the dates of the suspension. Suspensions are normally for three (3) to five

(5) consecutive work days and the dates are determined by the supervisor in consultation

with the Principal investigator and program coordinator. Longer suspensions because of

severe infractions may be given and scheduled at the convenience of management. The

employee should be warned that continuation of the behavior may result in termination of

employment.

Suspensions are without pay. There may be instances when a final written warning may

be more appropriate, and may, upon consultation with the Principal Investigator,

substitute for a suspension (for example when discipline is for a pattern of absenteeism).

4.Termination

Termination of employment is the culmination of the progressive discipline process or

the penalty for very serious offenses such as theft or violence. Whenever possible, the

Principal Investigator, Field Manager, Project Manager, Survey Manager, or Quality

Control Manager should conduct a

pre-termination

hearing. The purpose of the hearing is

to review with the employee's supervisor and the employee, the past record and any new

circumstances leading to the supervisor's request to terminate.

Termination Procedure:

The Supervisor or Survey Manager will provide the pre-termination panel and the

employee with any oral warning(s), any written warning(s), and a written statement

outlining the reason for termination. A Minimum of two (2) days should be given to the

employee to provide a written response to the panel. The panel may then either schedule

a meeting or provide an immediate decision as to the appropriate course of action. In

either case an action should be taken within fourteen (5) days of the initiation of the

procedure.

Note: Typically the employee will be suspended without pay during the time of this review

QAPP 2

Appendix 1H

CHEERS Survey Training Manual

Survey Training Manual

CHEERS Survey Training Manual Documents (2008)

1. CHEERS Survey Methods power-point presentation

2. Professionalism Policy

3. Know your job

4. Standards and Ethics in research

5. Survey Research Lab (SRL) CD

6. Recruiting:

a. Script,

b. FAQ sheet

c. Water Quality info. sheet

d. Mobile recruiting

7. Eligibility screener and Refusal Tally

8. Informed Consent:

a. Consent/Assent/Parental Consent

b. How to consent document

9. CAWs Use Survey:

a. How to conduct a use survey

10. Field surveys:

a. Refusal Aversion Exercise

b. Probing

c. Gaining Cooperation

11. BLAISE Manual

12. Mock Interviews (using laptops)

13. CHEERS job descriptions:

QAPP 2

Appendix 1I

CHEERS Survey Training Manual

Consent Process

HOW TO CONSENT A CHEERS STUDY PARTICIPANT?

Please do take some time to read the consent/ assent and parental consent forms. If a

participant is eligible to enroll in the study then you take them through the consent

process.

1. All adults

18 years or older

will need to sign and date a CONSENT FORM.

2. All children

8-17 years old

will need a signed/dated PARENTAL CONSENT and

also need to sign and date an ASSENT FORM.

3. All children

7 years and below

will need a PARENTAL CONSENT ONLY.

4. Please highlight the 5 main points in the consent form-

a. CHEERS is a voluntary research study. You can choose to quit any time

you want. This will not affect your relationship with UIC at anytime.

You will complete a 3 minute Survey A, and a 5-7 minute Survey B. For

this you will receive a $15 Target gift card and a T-shirt. (Note: Water-

recreators will need to return (mention time) before we leave for the day

and complete Survey B. Only then will they receive the incentives). Tell

them about the follow-up phone surveys 2, 5 and 21 days later. The phone

surveys take about 6-8 minutes. We will ask them about their health. They

will receive a $35 check in the mail after the final phone call.

PARTICIPANTS CAN CHOOSE TO DONATE THE $50( $15 gift card

+ $ 35 check) CASH INCENTIVE TO ANY CLUB/ORGANIZATION

THAT HAS AN MoU WITH UIC. IF WE ARE NOT WORKING WITH

A CLUB OR TEAM THEN PARTICIPANTS CAN ONLY DONATE

TO: CHEERS STUDY OR FRIENDS OF THE CHICAGO RIVER.

c. Participants may require a home visit if they do experience any skin, eye

symptoms. A clinician will visit them at home and we may request a skin

or eye swab. OR if participant experiences certain GI symptoms (stomach

cramps, vomiting, diarrhea) they may be requested to provide a stool

sample. If this happens they will receive an additional $75.

d. The only risk to them is that we ask for their name, phone number and

address. We will not share this information with anyone else. This

information is used to contact them for the phone surveys and to send

them their check. Once their participation is complete- we will only use

the case id number (from the wristband) for the data analysis. Show them

the wristband.

e. Finally, tell them page 4 of the consent form has a number where they can

5. Participants will need to sign and date the consent form. Ensure you sign it and

date it and store it in the black folder.

Strap one copy of the wrist band on their wrist and staple the other to the consent

form.

Participants who lose their wrist bands cannot receive any incentives.

7. Ensure you give them the first 4 pages of the consent forms.

Health and Environment

unlK$',+[[85{A[H[?lEfiLH'$[qr

Chicago, School of Public Health,

Chicago River and other waterways,

Results from this study

could be used for developing

is being funded by the

Many research studies have

current health status,

telephone survey we will ask

input included in an important

in recreationalwaters

across the country and to

You can impact environmental

will receive a t-shirt and

check in the mail when

for different waterways

Crystal Lake, Fox River,

enroll in the research,

day. You will answer a

can reach us at this number on the flyer. We will be at different

eligible to be in this

to sign a consent form to

participate

this study for the next

take about 3 minutes.

health. This will take

take about 6-8 minutes.

selected for a home visit by a clinician in next

them to a senior research

and effort. We will also

don't want to do this study and

is kept strictly confidential.

will not be disclosed or

required to sign a statement of confidentiality

from the water, and this

welcome a cross-section

of answers and opinions.

This is what we are trying to

THEY HAVE NOT REFUSED

typically takes around

selects the appropriate

(CLIENTS)/INFORMATIONAL

Public Health. The School of Public Health conducts

studies and

evaluations

many different topics

opinions because they

However, in the event of any

QAPP 2

Appendix 1K

CHEERS Survey Training Manual

For Mobile Recruiting

For mobile recruiting:

1. Organize the mobile folders-

a. Consents ( All adults 18+)

b. Assents +Parental Consents (All children between 8-17 years)

c. Parental Consents only (All children 0-7 years)

d. Location flyers

e. Case IDs

f. Laptop and scanner

g. Stapler

2. Clipboard-

a. Eligibility screener and Refusal Tally sheet

b. Mobile Log (just a sheet of paper)- to track Case IDs with survey A and B

3. What to do?

a. Approach people (make sure fishermen are yet to start fishing)

i. Recruit

ii. Eligibility screener

iii. Record in refusal tally if ineligible or refused to participate

b. If eligible to participate

i. Consent participant

ii. Give Case ID number- one on the wrist and one on the consent form.

Make sure participant gets first 4 pages of consent form. Secure

signed consent with ID in the folder.

iii. Record Case ID given out in a log (JUST A SHEET OF PAPER)

iv. Administer survey

1. Non-water recreators get both survey A and B

2. Water recreators will get only survey A and will be asked to

return to the CHEERS tent for Survey B.

c. Incentives- please note that all participants will have to return to the

CHEERS tent to collect their incentives. Incentive person will have to make

sure that participant has done Survey A and B before they hand out the gift

card/t-shirt and stool flyer.

d. DM- You can send them out in groups of 2-3 (please monitor the process

the first time). These are new interviewers and have minimal interview

experience.

e. DM- Please review the consent process with them.

f. DM- Make sure all interviewers return the log (sheet of paper) with case IDs

given out and the corresponding consent forms.

QAPP 2

Appendix 1L

CHEERS Survey Training Manual

Instructions for Data Managers

Instructions for data manager

DM responsibilities:

You will receive your assignment by time/location and date from Sara. There will be an

option for you to sign-up as DM for each event.

Remember you are the immediate field supervisor in the field for the CHEERS staff.

•

Arrive at the location at least 15 minutes before your schedule.

•

Receive the supplies from the CHEERS Supply Manager/Driver for that

day/location.

•

Use the supplies checklist to ensure you have everything you need for that

day/location.

•

Fill out the time sheets for all staff.

•

Each member is allowed 2 fifteen minute breaks in a 6-hour shift. Staff doing a

12-hour shift may take one 30 minute break and 2 fifteen minute breaks. Please

read the ‘CHEERS professionalism’ and ‘know-your-job’ document to be familiar

with the field rules for staff.

•

Ensure all supplies are in place and safe.

•

Count and account for the signed consent forms.

•

Monitor the incentive process- count and account for the gift cards.

•

Monitor the recruiting/interview process.

•

Assign the CAWs use survey task to a CHEERS staff each time we visit a CAWS

location.

•

Ensure safe and accurate transfer/download of the data from the laptop to the

flash drive.

•

Complete the CHEERS field report form (see the sample form)

•

Complete the DM task checklist (see sample checklist)

•

Hand-over the following to the CHEERS Supply Manager/Drive at the end of the

shift:

o

laptops,

o

flash drive,

o

used refusal tally sheets,

o

used incentive forms,

o

signed consents,

o

completed field report form

o

completed DM task checklist

o

completed CAWS use survey

•

You can always call the CHEERS on-call senior staff if you have any questions or

concerns.

Data Manager Survey Supplies List:

The CHEERS Supplies Driver/Manager will give you the following supplies-

1. A paper rack

2. Data Manager Accordion file

a. Permits

b. CAWs Use Survey Forms

c. CHEERS Field Report form

d. Time sheets

e. FAQ sheet and Recruiting script of interviewers

f. CHEERS staff job description document

3. Black plastic “Signed consents” folder for storing consents and other documents.

4. A Log book to record Case ID, and status of Survey A/ B

5. A box of scanners

6. A box of pens, staplers/pins, bungee cords

7. A box of UNUSED back-up batteries for the laptops

8. An empty box to store DEAD/USED batteries.

9. Set of laptops

10. One flash drive

11. A roll of wrist band case IDs.

12. A box of gift cards

13. Boxes of t-shirts

14. Clipboards

15. Plastics file folders

a. Consents ( All adults 18+)

b. Assents +Parental Consents (All children between 8-17 years)

c. Parental Consents only (All children 0-7 years)

d. Water Quality Information sheets

e. Location specific flyers

f. Eligibility/Refusal Tally sheet

g. Incentive sheets

h. Stool flyers

16. Mobile recruiting folders (if necessary for that event or location)

In addition- each location will have a set of tables, chairs, tents, water cooler, and a

CHEERS Study banner.

When you reach the site:

1. Set up the tent and supplies

a. Arrange the papers and laptops on the table

b. Put up the CHEERS banner

2. Fill-out time sheets.

3. Announce the location to all CHEERS staff: for example, tell them ‘we are at the

CAWs location: Alsip or General Use Waterway location: Crystal Lake today’.

This will ensure everybody enters the correct location in survey A and B.

4. Offer CHEERS staff a copy of the recruiting script/FAQ sheet, if they want to

brush up on what to say.

5. Offer the CHEERS staff job description documents, if they want to better

understand their task for the day.

6. You can also brief the staff about any previous experiences at this location.

7. Assign tasks to CHEERS staff (you can rotate these assignments)

Recruiters- Each recruiter will have a clipboard with flyers, eligibility and

refusal tally sheet. Recruiters will use eligibility and refusal tally sheet as

and when they approach people. Participants must be able to return to

finish Survey B before the CHEERS event for the day ends. They will

then direct the participants to the CHEERS tent.

We do not need

recruiters when we work with clubs/teams.

b. DMs will consent participants and assign Case IDs. Please ensure all case

IDs are in duplicate.

You will have rolls of Case IDs in your survey

supplies. Please start from where the previous DM ended.

Read the

instructions on how to consent.

c. DMs will record location, date of event, and participant progress by case

IDs in the field data log book. Store signed consents in the black plastic

file. Please count them on a regular basis.

d. DMs can direct the participants to the interviewers. You can also advice

the interviewers as to whether the participant is a water or non-water

recreator.

e. Participants returning to complete Survey B must check-in with the

DM first. If participant has lost/misplaced their wrist band- then find

their consent form so that the correct Case ID can be used to finish

the survey B.

f. Interviewers- Each interviewer will have a laptop and scanner.

Interviewers doing surveys must check with the participant if they are

water recreators or non-water recreators before they start the surveys.

g. Interviewers will always open the CHEERS folder on the desktop.

Followed by the “MAIN LAPTOP-X” folder. Please use “Part A.bat” file

for survey A and “Part B.bat” file for survey B.

h. Interviewers close out all interviews – answer all questions

(

including

proxy question). If you enter the wrong case ID or start a wrong

survey- then please leave a “Remark” before you start a new survey.

This is also the case when you lose power and start a survey on a new

laptop. The remarks you leave helps the SRL staff reconcile the data

for the phone surveys.

i. DM and Interviewers will check laptops batteries every 2 hours and swap

batteries, if necessary. Place USED batteries in the USED/DEAD battery

box.

j. Incentive person- Please position yourself close to the DM. You can help

the DM when he/she gets swamped. Always direct the participant to the

DM when they return for their Survey B and incentives.

k. Incentive person will always ask participants:

i. Have you completed both surveys today?

ii. Have you consented to donate incentives today?

l. Incentive person will use the incentive sheets to record the date/location

and start/end count of gift cards along with the participant’s incentive

status by case ID.

m. Each participant will receive a t-shirt, gift card and stool flyer. Record

“DONATE” if they donated incentives.

Please inform the DM if you run

out of t-shirts or gift cards. You will need to record the participants

cased ID, name and address so that we can mail it to them

n. Monitor the CAWs use survey (see instructions for use survey).

o. DM back-up the files onto the flash drive at the end of the shift. Copy the

“

Main Laptop- X

” folder from each laptop.

p. Complete CHEERS field report Note any problems in the field, including

interviewer issues.

q. Return all laptops, signed consents (in the black file), refusal tally sheets,

and incentive sheets, time sheets, FLASH DRIVES WITH DATA, CAWs

use survey and field report to the CHEERS supply manager/driver. The

black log book can stay in the same box. Please count consents again.

For mobile recruiting:

1. Organize the mobile folders-

a. Consents ( All adults 18+)

b. Assents +Parental Consents (All children between 8-17 years)

c. Parental Consents only (All children 0-7 years)

d. Location flyers

e. Case IDs

f. Laptop and scanner

g. Stapler

2. Clipboard-

a. Eligibility screener and Refusal Tally sheet

b. Mobile Log (just a sheet of paper)- to track Case IDs with survey A and B

3. What to do?

a. Approach people (make sure fishermen are yet to start fishing)

i. Recruit

ii. Eligibility screener

iii. Record in refusal tally if ineligible or refused to participate

b. If eligible to participate

i. Consent participant

ii. Give Case ID number- one on the wrist and one on the consent

form. Make sure participant gets first 4 pages of consent form.

Secure signed consent with ID in the folder.

iii. Record Case ID given out in a log (JUST A SHEET OF PAPER)

iv. Administer survey

1. Non-water recreators get both survey A and B

2. Water recreators will get only survey A and will be asked

to return to the CHEERS tent for Survey B.

c. Incentives- please note that all participants will have to return to the

CHEERS tent to collect their incentives. Make sure they check-in with the

DM and then follow the same incentive procedures.

d. DM- You can send them out in groups of 2-3 (please monitor the process

the first time). These are new interviewers and have minimal interview

experience.

e. DM- Please review the consent process with all mobile interviewers.

f. DM- Make sure all interviewers return the log (sheet of paper) with case

IDs given out and the corresponding consent forms.

QAPP 2

Appendix 1M

CHEERS Survey Training Manual

Mobile Recruiting Log

For mobile recruiting:

CASE ID

Survey A

Survey B

QAPP 2

Appendix 1N

CHEERS Survey Training Manual

Recruiting Script

unlYt$Tf+IT'8[li.S?iE6!6X,,?d"o

Greeting: Good morning,

QAPP 2

Appendix 1-O

CHEERS Survey Training Manual

Standard Ethics

Standards and Ethics

in Survey Research

CHEERS Survey Training

Handout

2008 Season

STANDARDS AND ETHICS IN SURVEY RESEARCH

CHEERS is committed to the collection of high-quality, independent and unbiased

data. We are also committed to following ethical principles and practices in the collection of

these data. This commitment assures our clients, researchers, educators, business leaders, and

policymakers that they can have confidence in the data we collect.

The material in this handout will help you to:

Understand the importance of ethical principles and practices in survey research.

Provide you with historical information related to the development of ethical practices in

research.

Raise your awareness of the process of informed consent and the importance of

confidentiality.

Help you understand your ethical responsibilities during the performance of your job as a

data collector.

How to apply the training to field work.

You WILL fill out this survey!

You WILL do it NOW!

You have NO choice!

What is at the core of ethical principles and practices in survey research?

At the core of ethics in data collection is that researchers have responsibilities to the

public, to their clients, to study participants, and to you—data collectors.

Researchers have a responsibility to the public to ensure that the survey

findings released/published are an accurate portrayal of survey data. This

includes conducting mandatory checks on the accuracy of the information

collected.

Researchers have a responsibility to clients to conduct work as agreed upon (in

their contracts) and to maintain all proprietary information in a confidential

manner.

Researchers have a responsibility to study participants (1) to inform them

about the basic elements of participation; (2) to maintain participant data

confidentiality; and (3) to avoid using practices or methods that may harm,

humiliate, or seriously mislead participants.

Researchers have a responsibility to you—data collectors. Researchers cannot

ask you to engage in any activity during the performance of your job as a data

collector that does not follow the general principles specified above with

regard to the public, our clients, and study participants.

What are the key international and national events surrounding the development of

standards and ethics in research?

Following World War II, the allies convened the Nuremberg Court to try Nazi war

criminals and expose Nazi medical war crimes. These crimes included medical testing on

unsuspecting human subjects.

In 1949, the court published the

Nuremberg Code

that:

Formed the basis of global ethics codes for medical researchers.

Emphasized the importance of voluntary consent for research participants.

Stated that risks to research participants should be minimized.

Stressed that participants must be allowed to withdraw from research.

During the years following the publication of the Nuremberg Code, the World

Medical Association continued to work on ethics in research, and in 1964 they issued a landmark

document called the

Declaration of Helsinki

. This document expanded on the principles laid

out in the Nuremberg Code and, most importantly, made “informed consent” a requirement for

medical research. It stipulated that study participants must “formally” consent to participation in

a study after being fully informed about the basic elements of the study.

At the same time, ethical problems were being uncovered in medical experiments

and testing in U.S. research.

Three of the most famous or infamous examples of a lack of oversight were the:

Tuskegee Alabama Syphilis Study.

Jewish Chronic Disease Hospital Study.

Willowbrook Study.

The

Tuskegee Alabama Syphilis Study

tracked the progression of syphilis in

African American males. Study researchers “knowingly” did not treat study participants who

had syphilis with penicillin even though it was known to be an effective treatment for syphilis.

In the

Jewish Chronic Disease Hospital Study

of 1963, live cancer cells were

injected into chronically ill patients without informed consent. The researchers believed that the

cancer cells would be rejected. They rationalized their actions by stating that they didn’t want to

“alarm” the patients.

The

Willowbrook Study

ran from 1963 through 1966. In this study, live hepatitis

was injected into children labeled mentally impaired. The researchers rationalized that the

majority of the children would have acquired the infection in the future anyway. In this study,

the parents of the children did give consent.

These and other studies raised important questions about ethical practices in our

country. The result was that, beginning in 1966, Congress and Federal agencies implemented

legislation and developed regulations to protect human subjects—also referred to as study

participants.

1966

, the U.S. Surgeon General and the head of the National Institutes of Health

(NIH) decreed that to conduct research sponsored or subsidized by the Federal Government,

researchers would have to submit their research plans for prior review and approval to an

independent committee. Today these committees are called

Institutional Review Boards or

IRBs

. All Westat studies dealing with human subjects must be reviewed and approved by

Westat and client IRBs.

1974

, Congress passed the

Privacy Act

. This act focused on restricting the

disclosure of personally identifiable records by establishing a code of “fair information

practices” to protect study participants.

1979

, the Federal Government published the

Belmont Report

, which is

considered to be the foundation of ethical research in the United States. It stipulates that study

participants must be treated with respect, with beneficence (i.e., protection of participant well-

being), and with justice (i.e., in a fair manner).

1981

, the

Code of Federal Regulation of Research with Human Subjects

was

issued and a Federal office to monitor and support the code was established. By 1991 17 Federal

departments and agencies had adopted these regulations—often referred to as the

“Common

Rule.”

1995

, another important piece of legislation was passed—the

Paper Work

Reduction Act

. It mandated that each Federal agency must review the collection of information

in terms of its need, the burden on the respondent, and the plans for using the information

collected. It also reinforced the informed consent process and stipulated that authorized studies

cannot be fielded or implemented without a valid control number assigned by the Office of

Management and Budget displayed on printed material.

What is informed consent?

Informed consent

is a process where the researchers explain both the risks and the

benefits of the research study to the potential human subjects and obtain the subject's

permission/consent, whether verbal or written, for them to participate in the study.

Participants must agree or consent to take part in a study before the start of their

participation. Their agreement or consent to participate must be an informed one. “Informed

participants” are those knowledgeable about the basic elements of study participation.

3a)

What are the basic elements of informed consent that participants must know?

Study participants must:

Know who the sponsor is and what the purpose and duration of the research

are.

Understand the procedures of the study—the tasks they will be asked to

participate in.

Know that their participation is voluntary.

Understand the expected risks and benefits of participating in the study.

Know if and what compensation exists.

Know that the information they provide will be maintained following the rules

and laws pertaining to confidentiality.

Understand that they can withdraw from the study at any time.

Know who to contact if they have questions.

Every study has an informed consent process. The process can vary.

At a minimum, the study must include a

verbal introduction

which specifies all of

the basic elements of informed consent we just reviewed. Some studies have

prepared

materials

such as advance letters and brochures that must be given to the participant and again

include the basic elements of informed consent.

Other studies have an actual

consent form

that must be read and signed by the

participant. Studies can have some or all of the above procedures. Data collectors must follow

the informed consent procedures of the study they are working on “to the letter.”

3b)

What is confidentiality?

Confidentiality involves:

The appropriate treatment of information disclosed in a relationship of trust.

Meeting the expectation that such information will not be disclosed to others

without permission.

Confidentiality includes information collected during an interview and information

gleaned from observation, such as observations of the interview setting, the condition of a

respondent’s home, interpersonal communications observed among family members, etc.

3c)

Why is confidentiality important to survey participants?

Survey participants must be assured:

That information provided in confidence will not be used outside the stated

purposes of the study.

That they cannot be uniquely identified based on any study information

distributed for public and/or private use.

3d)

Why is confidentiality important to CHEERS?

CHEERS staff are ethically bound to follow the confidentiality requirements

set forth by our UIC IRB.

A major breach in data confidentiality procedures could affect our ability to

obtain contracts and/or gain respondent cooperation in the future.

3e)

Who must maintain study data confidentiality?

All project staff must maintain study data confidentiality. This includes:

CHEERS interviewers

CHEERS water staff

CHEERS home visit staff

CHEERS consultants and subcontractors

Field supervisors and data collectors

Field translators, interpreters, and escorts (if used)

Study Director, Assistant Directors, Coordinators, etc.

3f)

What are your responsibilities with regard to confidentiality?

You are the front line of the data collection process—data confidentiality in the

field begins with you.

You cannot disclose anything learned during data collection to anyone except

project team members or supervisors.

You cannot discuss information collected or observed with anyone outside the

project staff (i.e., other data collectors not on the project, family members, or

friends).

Unless a special exception is made by project managers, you should not

interview anyone you know.

All data you collect must be submitted through secure electronic transmission

and/or other hard-copy submission procedures established for the project.

CHEERS Data Security

CHEERS has established a quality assurance plan to ensure data security

confidentiality. Our plan is based on the following principles:

Study data must be protected from unauthorized access;

Every step of data collection, from design to data release and distribution, must

be reviewed.

Study protocols for maintaining confidentiality and data security must be based

on documented and proven procedures. This is outlined in the Quality

Assurance Protocol.

All project staff, even volunteer staff and/or short-term staff (e.g., interpreters,

escorts), must make every effort to protect data and ensure quality.

All project staff must be trained to follow the quality assurance plan and

maintain confidentiality.

The quality assurance plan is implemented when the study design phase begins and

ends with the release of the data to the public.

The key elements of the security plan are:

Substituting participant codes for participant identifiers (e.g., using an ID#

versus the name of participant).

Separating participant identifiers from survey data. For example, a list with

participant name, phone number, and case ID must be destroyed after use or

handed over to a supervisor.

Limiting access to identifiable data.

Minimizing hard-copy materials kept.

Storing paper records and materials with identifiers in a secure place in offices,

homes, hotel rooms, cars, airplanes, etc.—any place where the records may be

at a given point in the data collection process.

Shredding “unneeded” survey documents with identifiers ASAP.

Providing security codes (user IDs and passwords) for computerized records.

Training staff to keep laptops secure in participant homes, offices, hotel rooms,

cars, airports, etc.

When necessary, emailing only data “without” identifiers via the Internet. Or

sharing password protected files.

Storing study data on secure network drives.

Restricting access to network directories.

Avoiding the production of analysis files and reports with small cells (e.g.,

single, female, Ph.D. statistician in small fishing village in Maine).

Including respondent identification information only as necessary in analysis

files and reports.

Avoiding the production of public-release files with identifying information

and data that can be matched against publicly available databases.

The CHEERS study expects data collectors, to follow during their employment on a

project, all codes from ethics, to technical performance, to work style, and confidentiality.

What to do while conducting interviews.

Make sure that you ask the potential respondent if they want to participate in

the survey or study. Wait for a verbal yes or no.

Give the potential respondent time to make a decision.

If they respond with a verbal “yes” provide the participant with the

informational pamphlet/consent form.

Children under 7 are allowed to participate in this study with the signed

consent of the legal guardian, but no assent is needed from the child. Children

8 to 17 years are allowed to participate in the study with the signed consent of

the legal guardian and a signed assent from the child. Anyone 18 and older

requires only eligibility and a signed consent to participate.

Approach all potential respondents with respect. Do not argue with the

participant. If the potential respondent is rude to you, thank him or her for his

or her time and terminate the interview.

Answer all participants basic questions with knowledge provided to you during

training. However, for extended or hard to answer questions, refer him or her

to the CHEERS supervisor on site.

If an individual appears incompetent to participate, do not ask them to

participate. Thank him or her for his or her time and walk away.

State, “No physical risks are involved in participating in this survey.”

You must inform all possible respondents of the incentives: CHEERS t-shirt,

$15 Target gift card and $35 for completing the telephone interviews. Do not

bribe potential respondents. Simply inform them of the incentives and the

benefits of participating in the study, and always thank them for their time,

even if they choose not to participate.

Approach all groups of potential respondents fairly. Do not exclude

respondents based on sex, race, ethnicity, language, physical disability, or age.

Exceptions are persons under the age of 18 and persons that appear

incompetent to make the decision to participate and answer questions.

We will have bilingual interviewers that speak Spanish. Always attempt

to conduct the interview in English. If the potential participant needs the

interview conducted in Spanish, request one of the bilingual interviewers

to conduct the interview in Spanish. If the respondent understands or

speaks another language besides Spanish and English, we will have to

exclude the respondent from the study. Code the as ineligible.

Do not discuss the respondents’ answers with anyone. In the extreme instance

that a surveyor must discuss a participant’s responses, do so only with

individuals associated with the survey and make certain not to identify the

respondent. These discussions should normally be between the interviewer

and a field supervisor or field manager or data manager on site.

Do not take

ANY

questionnaires home. Edit all questionnaires at the field

location. Questionnaires will always be monitored by supervisory personnel

except during the times when they are secured in a locked receptacle.

QAPP 2

Appendix 1P

CHEERS Survey Training Manual

Water Quality Flier

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managed by the Metropolitan

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more inforrnatiott about the

waterways.

visit:[1p1rryWy.$_!-r._LSi]gaA!:qa\$lC1L4y1qg

For

more infbrrnation

about the Metropolitan

Water

Reclamatiou District,

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rseactiorti

inclefC.ltU/-fqWaglj-Q.-niir-v-ig*-1q-p-Q$jlgn-Q

For

information about beach

the Illinois Department

Public

Health Beach

Information

Irttl,rr.uruujdurlo!.

jslr-dstilir-1s.p-sljaskrqrl$d&$A!vrisvZ"elQ0?.Q2.-0j+:-df

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QAPP 2

Appendix 2

NEEAR Study Beach Survey

PRIMARY RESPONDENT’S LAST NAME_________________________________________

Study for Beaches Program

Interview status (circle one)

Complete (Part A & B)

Refused

Ineligible

Incomplete

Leaving Late (after 6pm)

Language (circle if in Spanish)

Given in Spanish

Gift received (circle one):

COOLER

TOTE BAG

U.S. Environmental Protection Agency

Centers For Disease Control and Prevention

Research Triangle Park, North Carolina 27711

1600 Clifton Rd

Atlanta, GA 30333

Westat, Inc.

1650 Research Boulevard

Rockville, Maryland 20850-3195

OMB: 2080.0068

Part A data verified (sign) ______________

Expires: 09/30/2008

Part B data verified (sign) ______________

Questionnaire #: ___ ___ ___

Version 1, 1/26/2007

BEACH INTERVIEW

Interviewer Name (Part A): ...............................

...................................................

Last

First

Site ID: ........................

Saturday: ______ Sunday: ______ Monday: _______ Friday: ________

Date: ____ / ____ /____

Time: ...........................AM PM (circle one)

X1. Latitude: _________

X2.

Longitude: __________

X3.

Transect Area: ________

Hi, my name is___________________________. I am conducting the

National Beaches Survey

Q1.

Have you been interviewed by the National Beaches Survey in the last 28 (4weeks) days?

YES......................................................... 1

TERMINATE INTERVIEW

NO...........................................................

Q1a.

INTERVIEWER BY OBSERVATION: IS THE RESPONDENT 18 OR OLDER?

YES.........................................................

NO...........................................................

Here is a pamphlet describing the study.

(GIVE RESPONDENT THE CONSENT TRI-FOLD PAMPHLET)

INTERVIEWER:

The federal government is conducting a nationwide research study on the health of swimmers at

marine and Great Lakes beaches. The Environmental Protection Agency (EPA) and the Centers for Disease

Control and Prevention (CDC) are the two agencies that are supporting the study. The study involves a two-part

questionnaire that you complete today and a telephone interview 10-12 days from now. Your participation today

will greatly assist the government in developing better guidelines for safe beach water quality and may improve

beachgoer’s health. Your participation is voluntary and you may stop the interview at any time. There are no risks

involved from participating in this survey. It will take about 10 to 15 minutes of your time for these beach questions

and about the same time for an exit interview at the bath house. At the bathhouse we have a gift for you, when you

leave to go home. After completing the beach and telephone interview, you will also receive a check for the total of

$25. Your responses to the questions will be confidential and your address and other contact information will be

destroyed after you complete the telephone interview and we send you your

YES....................................................... 1

START INTERVIEW

REFUSAL, GO TO 5.a.

INTERVIEWER

: Collect GPS coordinates for participants and nonparticipants.

Version 1, 1/26/2007

Q2a.

Our survey is primarily for households of one or more persons that live together at the same

address. Do you all live at the same address?

(INTERVIEWER PROBE TO IDENTIFY

HOUSEHOLD. IF MORE THAN ONE HOUSEHOLD WITH A DIFFERENT ADDRESS,

INTERVIEW EACH SEPARATELY.)

YES....................................................... 1

NO......................................................... 2

Q3.

How many members in your household are at the beach today including yourself?

__________ MEMBERS

For the rest of this interview, I will be asking questions mostly about those people in your household who

are here today at the beach.

Q4.

What time did you and your household arrive at the beach today?

(CIRCLE AM OR PM)

___________ AM PM

Q5.

We are interested in asking about the health of your household during the few weeks following your beach

visit. Could you please give me your telephone number so we can get in touch with you in 10-12 days from

now?

YES......................................................... 1

GO TO Q5B

NO........................................................... 2

GO TO Q5A

Q5a.

IF “NO,”

Is it for one of the following reasons?

Too busy .................................................

No longer interested ...............................

Will not be available................................

Other reason?.........................................

Please specify: .......................................

INTERVIEWER:

Collect GPS Coordinates all persons on beach regardless of participation.

INTERVIEWER:

We will end the interview here since a contact telephone number is required to

complete the telephone interview that I mentioned. Thank you for speaking with us.

Q5b.

10-12 days from now which phone number(s) should we call?

___________________________________________

Q5c.

Is this your home, vacation, or cell phone number?

Home Phone...........................................

Vacation Phone.......................................

Cell Phone ..............................................

Specify other...........................................

Version 1, 1/26/2007

Q6.

What are the best times to reach you during week days?

(INTERVIEWER: MARK WITH AN “X” ALL DAYS THAT APPLY AND APPROXIMATE TIME SPAN.)

Mon.

Tues.

Wed.

Thurs.

Fri.

INTERVIEWER:

We’ll try to reach you during that (those) time(s).

Q6a.

Can I please have your mailing address so that we can send you your $25

Thank You

check?

First Name: ____________________ ....

Last Name ______________________

Address: ......................................................................................................................

City: ..........................................

State: ....................

Zip: ............................

INTERVIEWER:

We will destroy your identifying information after we mail the check.

Q7.

Please tell me the first name of the members of your household at the beach today, their birth dates,

gender, race, ethnicity, and whether they are in diapers.

[INTERVIEWER: IF 8 OR MORE PEOPLE, USE SUPPLEMENTAL QUESTIONNAIRES.]

First Name

Date of Birth

mm/dd/yyyy

Gender

Hispanic

In Diapers

5. Native Hawaiian or Other Pacific Islander

2. Black or African American

6. Other

3. Asian

7. Refused

4. American Indian or Alaska Native

8. Don’t Know

Version 1, 1/26/2007

Q8.

Will (you/all these people at the beach with you today) be living (with you) at the same address(es) during

the next two weeks?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

Q9.

Have any of these household members at the beach today been ill in the past 3 days with . . .

Person

Y N RF DK

Y N RF

Y N RF DK

a. Diarrhea or loose

bowels? ..................

cough?....................

f. Eye infection?............ 1 2 7 8

1 2 7 8

g. Rash or itchy skin?.... 1 2 7 8

1 2 7 8

h. Sunburn?................... 1 2 7 8

1 2 7 8

Q10.

Are there any household members

not

present at the beach today?

YES......................................................... 1

GO TO Q10a

NO........................................................... 2

GO TO Q11

REFUSED............................................... 7

GO TO Q11

DON’T KNOW......................................... 8

GO TO Q11

Q10a. Have any household members

not

present at the beach today been ill in the past 3 days

with . . .

Y N RF DK

a. Diarrhea or loose bowels?.....................

1 2 7 8

b. Urinary tract infection or burning

sensation when urinating? ..................

1 2 7 8

c. Throwing up or vomiting? ......................

1 2 7 8

d. Sore throat or cough?............................

1 2 7 8

e. Earache, ear infection or runny ears? ...

1 2 7 8

Eye infection?........................................

1 2 7 8

g. Rash or itchy skin? ................................

1 2 7 8

Version 1, 1/26/2007

Q11.

Do you or any household members at the beach today, not including any one that stayed at home, suffer

from any of the following chronic, long-term conditions?

Person

Y N RF DK

b. Chronic respiratory

How many times do you usually come to this beach each year?

................................................... TIMES

REFUSED...............................................

DON’T KNOW.........................................

Q13.

How many miles did you travel to the beach today?

__________________________ MILES

REFUSED...............................................

DON’T KNOW.........................................

Q14.

During the past two weeks, did you (anyone in your household at the beach today) go bathing or swimming

anywhere - at this or some other beach, pool or lake?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

IF NO TO PERSON 1 THROUGH PERSON 8, GO 14c

Version 1, 1/26/2007

Q14a. Did you {PERSON} go bathing or swimming anywhere in the past one week (Monday through

Friday) at this or some other beach, pool or lake ?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

Q14b. Did you {PERSON} actually get their head or face wet?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

Q14c. During the past 2 weeks, did you (person) get a sunburn that lasted more than 12 hours?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

ENTER HERE IF NO TO Q14

INTERVIEWER: DID YOU RECORD THE

LONGITUDE AND LATITUDE COORDINATES ON PAGE 1?

THE FOLLOWING IS ENTERED BY THE INTERVIEWER:

X4.

HOW COOPERATIVE WAS THIS HOUSEHOLD?

Very.........................................................

Somewhat ...............................................

Not at all..................................................

X5.

WAS INTERVIEW CONDUCTED IN SPANISH?

YES.........................................................

NO...........................................................

INTERVIEWER: END OF PART A. PLEASE RETURN QUESTIONNAIRE TO THE BATH HOUSE.

Version 1, 1/26/2007

End A

Please go to the exit stations when you leave the beach today, before 5:30

PM, to complete Part B of the Beach Interview and to pick-up your beach

gift. Thank you for participating in this portion of the survey.

Version 1, 1/26/2007

Interviewer Part A: __________________

Date: ___ / ___ / ____

Questionnaire #: ___ ___ ___

Interviewer Part B

: ____________________

Part B

Beach Survey

Thank you for returning to complete the beach interview. We will have your gift ready for you after we complete the

interview. Some of the questions will be repetitive to ensure accuracy. May we have your name to link it to your

previous answers?

Q15.

Were you the person that we interviewed on the beach or earlier today?

YES.........................................................

NO...........................................................

Q15a. INTERVIEWER: IF NO, CHECK Q7 TO DETERMINE THE PERSON YOU ARE INTERVIEWING.

Person ___________________________

Q16.

Did you or anyone in your household wade, swim, or play in the water today?

Name Droplist

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

IF NO TO PERSON 1 THROUGH PERSON 8, GO TO Q17

Person

Y N RF DK

Q16a.1. Did {PERSON}

immerse their body, not

necessarily {PERSON’s}

head, in water today?.......

1 2 7 8

Q16a.2. Did {PERSON}

put their face in water or

submerge head in water

today? ..............................

1 2 7 8

Q16a.3. Did {Person} get

water in the mouth today?

1 2 7 8

IF NO TO PERSON 1 THROUGH PERSON 8 FOR THE ABOVE QUESTION, Q16a.3, GO TO Q16b.

Version 1, 1/26/2007

Q16.a. Did {PERSON} swallow the water?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

[PROGRAMMER NOTE: PUT IN POP UP ASSIST TO SHOW TIME OF QUESTION 4.]

Q16b. Was {PERSON} in the water at the following times today?

READ ONLY FOR TIME PERIODS

THEY WERE AT THE BEACH BASED ON THE ANSWER FROM Q4 ABOVE.

If “Yes,” what part

of the beach did {PERSON} swim in?

INDICATE AREA ON THE MAP

[PROGRAMMER NOTE: PREASSIGNED AREA DESIGNATIONS FOR EACH BEACH.]

Person

Times

Y N

Area

INTERVIEWER: MARK AREA WHERE PERSON SWAM MOST OF THE TIME.

Q16c. What total time did {PERSON} stay in the water? We are only interested in time actually in the

water, not the total time at the beach.

(CIRCLE TIME UNITS)

Person 1 ................ ____ MINUTES

_____.__ HOURS 7

Person 2 ................ ____ MINUTES

_____.__ HOURS 7

Person 3 ................ ____ MINUTES

_____.__ HOURS 7

Person 4 ................ ____ MINUTES

_____.__ HOURS 7

Person 5 ................ ____ MINUTES

_____.__ HOURS 7

Person 6 ................ ____ MINUTES

_____.__ HOURS 7

Person 7 ................ ____ MINUTES

_____.__ HOURS 7

Person 8 ................ ____ MINUTES

_____.__ HOURS 7

Version 1, 1/26/2007

Q16d. Did {PERSON} engage in any of the following water-related activities while at the beach today?

(Circle all that apply)

Person

Y N RF DK

Placemarker for sport

1 2 7 8

Placemarker for sport

1 2 7 8

Did {person} have

contact with water in

a non-circulating pool

or tidal pool?

1 2 7 8

INTERVIEWER:

We would like to ask a few questions about things that may help protect swimmers from becoming

ill.

Q17.

What would {PERSON} estimate (your/his/her) total time in direct sunlight was? This does not include

being indoors or under umbrellas, etc.

(CIRCLE TIME UNITS)

Explain to participant that cloudy day is not

considered

Person 1 ................ ____ MINUTES

_____.__ HOURS 7

Person 2 ................ ____ MINUTES

_____.__ HOURS 7

Person 3 ................ ____ MINUTES

_____.__ HOURS 7

Person 4 ................ ____ MINUTES

_____.__ HOURS 7

Person 5 ................ ____ MINUTES

_____.__ HOURS 7

Person 6 ................ ____ MINUTES

_____.__ HOURS 7

Person 7 ................ ____ MINUTES

_____.__ HOURS 7

Person 8 ................ ____ MINUTES

_____.__ HOURS 7

Version 1, 1/26/2007

Q18.

Did {PERSON} engage in any of the following activities while at the beach today?

Person

Y N RF DK

collecting sea shells,

rocks, feathers, etc? .....

1 2 7 8

digging in sand or

building sand castles.

1 2 7 8

had their body buried

in sand............................

c.1.

c.1.a.

the sand, or building

sand castles…did

{person} wash their

hands before eating?

(washing of hands may

playing with algae or

seaweed ....................

d.1

IF YES TO d

d.1.a

. After playing with

algae…did {person}

wash their hands before

eating? (washing of

hands may include the

use of personal water-

free hand sanitizer.)

1 2 7 8

18.e

Was the sand you dug in or played with dry or wet? (interviewer to read the responses)

1) All dry

2) Mostly dry, some wet

3) Mostly wet, some dry

4) All wet

Version 1, 1/26/2007

Q19.

Did {PERSON} cut themselves today or have an open cut when they came to the beach today?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

Q20.

Did {PERSON} wear sunscreen/sunblock today?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

If No, Q23, Otherwise GOTO Q21

Q21.

What was the SPF rating of the sunscreen/sunblock you used most often today?

Enter SPF Level ______________

Q21a. When you used sunscreen/sunblock today, how did you apply it?

Only to certain areas of my body (for example, head and shoulders)

All exposed skin

Q22.

Did you reapply at least once today?

Person

Y N RF DK

Did {PERSON} wear a hat today?

YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

Version 1, 1/26/2007

Q23.

If yes, Did the hat have a wide brim or another way to shade face, ears, and back of the neck from the sun?

.............................................................................................................. YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

Q23a.1

Did {PERSON} use protective equipment such as a canopy, umbrella or other type of sunshade today?

................................................................................................

YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 .................................................................................

Q23b. Did {PERSON} wear protective clothing, such as a long-sleeved shirt or cover-up?

YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

Version 1, 1/26/2007

Q24.

During the summer, if you/(PERSON) go(es) out in the sun repeatedly without sunscreen or protective clothing which

one of these things most usually happens to your/his/her/skin? READ RESPONSES SLOWLY (Choose only one):

First Name

03 No tan, maybe some freckles

04 Repeated sunburns

05 OTHER (Specify)

96 NEVER GO OUT IN THE SUN

97 REFUSE

98 DON’T KNOW

Q25.

Did {PERSON} wear insect repellant today?

YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

Q26.

Did you or any member of your household consume food while at the beach today?

YES

NO RF

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

Version 1, 1/26/2007

IF NO, GO to Q27

Was the food . . .

(Circle all that apply)

Person

Y N RF DK

a. brought from home?

1 2 7 8

b. purchased from

vending machines or a

Did you or any member of your household consume any drinks while at the beach today?

YES

Person 1 ........................................................ 1...................2 .................. 7 .................... 8

Person 2 ........................................................ 1...................2 .................. 7 .................... 8

Person 3 ........................................................ 1...................2 .................. 7 .................... 8

Person 4 ........................................................ 1...................2 .................. 7 .................... 8

Person 5 ........................................................ 1...................2 .................. 7 .................... 8

Person 6 ........................................................ 1...................2 .................. 7 .................... 8

Person 7 ........................................................ 1...................2 .................. 7 .................... 8

Person 8 ........................................................ 1...................2 .................. 7 .................... 8

IF NO, GO to Q28

Was the drink . . .

(Circle all that apply)

Person

Y N RF DK

a. brought from home?

1 2 7 8

b. purchased from

vending machines or a

beach? (Ex. Restaurant,

In the last 48 hours has anyone done the following . . .

Person

Y N RF DK

complained of diarrhea,

(Crab, oyster, mussel)

1 2 7 8

d. Consumed

rare/raw/undercooked

or meat that is pink in

center?

(Fish, beef, chicken)

1 2 7 8

e. Consumed runny or

raw eggs?

...........................

1 2 7 8

Thank you for your assistance on this national survey of marine and Great Lake beaches. You can contact us

regarding information about the study at the toll-free number or e-mail address in the pamphlet. We will phone you

in the next 10-12 days with some brief questions about your health. After completing the telephone interview, your

household will receive a $25 check within 30 days of completing the telephone interview.

Gift received (circle one):

COOLER

TOTE BAG

Version 1, 1/26/2007

QAPP 2

Appendix 3

NEEAR Telephone Interview

NATIONAL EPIDEMIOLOGICAL AND ENVIRONMENTAL ASSESSMENT OF RECREATIONAL

(NEEAR) WATER STUDY:

BEACHES SURVEY

1/30/2007

INTRO 1

Hello, my name is ____________. May I speak to _______________?

{IF NEEDED: I am calling about a study for the Environmental Protection Agency (EPA). Recently, we

spoke to [BEACH RESPONDENT] at {BEACH}, and we’re calling back to complete the interview.}

AVAILABLE – GO TO INTRO 4

NOT AVAILABLE – GO TO INTRO 2

NEVER HEARD OF PERSON – GO TO INTRO 3

REFUSED – GO TO INTRO 2

INTRO 2

[My name is ____________and] I am calling about a follow-up study for the Environmental Protection

Agency (EPA). Recently, we spoke to (BEACH RESPONDENT) at {BEACH}, and we’re calling to

complete the interview. If s/he isn’t available, I can talk to someone else. Are you a household member

18 years of age or older?

YES -- GO TO AINTRO

NO – May I speak to an adult 18 years of age or older?

REFUSED – COMPLETE NIRF

INTRO 3

Is this number (___) ___ ____ (Verify the number on the call record sheet)?

YES – COMPLETE NIRF

NO -- REDIAL THE NUMBER

INTRO 4

[Hello, my name is _____________, and] I’m calling about a study for the Environmental Protection

Agency (EPA). Recently, we spoke to you at {BEACH} {IF NEEDED: Indiana National Dunes Park

(National Lakeshore)}; and we’re calling back to complete the interview.

CONTINUE

SCHEDULE APPOINTMENT

REFUSED – COMPLETE NIRF

IF ASKED TO CALL BACK OR SCHEDULE APPOINTMENT, SAY: The interview needs to be

completed by [LAST DATE]. When would be the best time to call you before then?

Aintro.

[This is ________________ with the NEEAR Water Study calling.] I’m going to ask some

questions about any swimming or bathing during your initial beach visit or other visits you may have had

in the last 10-12 days and about illnesses that have been experienced in the last week. I will be asking

about the following members of your household …

[READ NAMES OF HH MEMBERS AT THE BEACH.]

{display list of persons showing first name/age/sex.}

[IS RESPONDENT SAME PERSON INTERVIEWED AT THE BEACH?]

A1a

A1. RespName

[May I have just your first name, please?]

_________________

During Beach Visit where you enrolled in this study on {date}

(For the persons that were swimmers in the beach interview) Did {PERSON} wear ear plugs while in the

A3.

Did {PERSON} wear nose plugs while in the water?

A4.

Did {PERSON} wear eye goggles or use a face mask while in the water?

A5.

During the beach interview, {PERSON} had contact with an animal?

Person 1

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 2

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 3

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 4

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 5

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 6

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 7

Drop down list

Were they unfamiliar to you? Yes No RF DK

Person 8

Drop down list

Were they unfamiliar to you? Yes No RF DK

NEXT QUESTION FOR FEMALE PARTICIPANTS ONLY

A6. Between your beach visit on XXXX date and today were you menstruating (or some other word) or

pregnant?

Y N

1 2

We are now going to switch and ask you questions about activities that have occurred since the

Beach Interview.

B1. AnyoneSwim

................................................................

Have you or any of the people I just mentioned gone bathing or swimming

anywhere since we

talked to [you/ORIGINAL RESPONDENT] at the beach interview on {BEACH INTERVIEW

DATE}? Please include

any bathing or swimming such as at a beach, waterpark, public pool,

private pool, or wading pool.

B2. WhoSwam

Who was it that went bathing or swimming? _______________

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

ASK B3

THROUGH B5 ABOUT EACH PERSON WHO WAS MARKED IN B2. BEGIN WITH THE FIRST

PERSON IN THE LIST WHO WAS MARKED AND CONTINUE WITH ALL OTHER MARKED

PERSONS.

B3a. SameBeach

Did [PERSON] go bathing or swimming at {BEACH} since the beach interview on {BEACH

B3b. DifferentBeach

Did [PERSON] go bathing or swimming at any other beach?

Did [PERSON] go bathing or swimming at a waterpark?

[Did {PERSON} go bathing or swimming …] at a public pool?

[Did {PERSON} go bathing or swimming …] at a private pool?

[Did {PERSON} go bathing or swimming …] in a wading pool?

[NOTE TO INT: THIS COULD BE A BACKYARD INFLATED POOL.]

YES

REFUSED

DON’T KNOW

B3h. AnyOtherSwimming

[Did {PERSON} go bathing or swimming …] any other place?

CATI EDIT CHECK: IF R ANSWERED YES TO B3a, BUT NO TO B3b THROUGH B3h, ASK, “You’ve

said that (PERSON) went bathing or swimming sometime since (BEACH INTERVIEW DATE). Where

did (you/s/he) go swimming?” CODA B3b-B3h

B3i. OtherSwimLocation

[SPECIFY:] _______________________________

B4. GetFaceWet

Did [you/{PERSON}] actually get [your/{his/her}] face wet while bathing or swimming?

YES

REFUSED

DON’T KNOW

B5. DaysSwam

On which days did [you/{PERSON}] go bathing or swimming? [since {BEACH INTERVIEW

DATE}]

____________________

[CODE ALL THAT APPLY]

INTERVIEWER WILL REFER TO HARD-COPY CALENDAR FOR ALL DATES.

PROG. NOTE: Do not allow a date prior to the BEACH INTERVIEW DATE. Do not allow a date later

than today.

SymptomIntro

I’m going to go through a list of symptoms. Please tell me if anyone has had any of these

symptoms since the interview at {BEACH} on {BEACH INTERVIEW DATE}. Again, the people I

am asking about are…

[

Questions

B6 to B23 are asked about all household members who were at the beach on the

BEACH INTERVIEW DATE.]

B6. AnyStomachAche

Have you or anyone else had a stomachache or abdominal cramping since the interview at

{BEACH} on {BEACH INTERVIEW DATE}?

Who? [had a stomachache or abdominal cramps since the interview at {BEACH} on {BEACH

INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons (first name/age/sex).}

REFUSED

DON’T KNOW

B7. AnyDiarrhea

Has anyone had diarrhea or loose bowels since the interview at {BEACH} on {BEACH INTERVIEW

DATE}? By diarrhea we mean, three or more loose or watery stools in a 24-hour period.

B7a. DiarrheaList

Who [had diarrhea or loose bowels since the interview at {BEACH} on {BEACH INTERVIEW

DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons (PERSON).}

REFUSED

DON’T KNOW

B8. AnyNausea

Has anyone had nausea since the interview at {BEACH} on {BEACH INTERVIEW DATE}?

Who? [had nausea since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons (first name/age/sex).}

REFUSED

DON’T KNOW

B9. AnyVomiting

Has anyone had throwing up or vomiting? [since the interview at {BEACH} on {BEACH INTERVIEW

B9a. VomitingList

Who had throwing up or vomiting [since the interview at {BEACH} on {BEACH INTERVIEW

DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons (first name/age/sex).}

REFUSED

DON’T KNOW

B10. AnyUTI

Has anyone had a urinary tract infection or burning sensation when urinating since the interview at

{BEACH} on {BEACH INTERVIEW DATE}?

B10a. UTIList

Who? [had a urinary tract infection or burning sensation when urinating since the interview at

{BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons (first name/age/sex).}

REFUSED

DON’T KNOW

B11. AnyFever

[Has anyone had …] a fever? [since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

Who? [had a fever since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B12. AnyHeadache

[Has anyone had …] a headache lasting more than a few hours? [since the interview at {BEACH}

on {BEACH INTERVIEW DATE}?]

B12a. HeadacheList

Who? [had a headache since the interview at {BEACH} on {beach interview

date}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B13. AnySoreThroat

[Has anyone had …] a sore throat? [since the interview at {BEACH} on {beach interview date}?]

B13a. SoreThroatList

Who? [had a sore throat since the interview at {BEACH} on {beach interview date}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B14. AnyCough

[Has anyone had ] a bad cough? [since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

Who? [had a cough since the interview at {BEACH} on {beach interview date}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B15. AnyCold

[Has anyone had …] a cold? [since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

Who? [had a cold since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B16. AnyRunnyNose

[Has anyone had…] a runny or stuffy nose? [since the interview at {BEACH} on {BEACH

B16a. RunnyNoseList

Who? [had a runny nose since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B17. AnyEarache

[Has anyone had …] an earache, ear infection, or runny ears? [since the interview at {BEACH} on

{BEACH INTERVIEW DATE}?]

B17a. EaracheList

[Who? [ had an earache since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B18. AnyWateryEyes

[Has anyone had …] watery eyes? [since the interview at {BEACH} on {BEACH INTERVIEW

B18a. WateryEyesList

Who? [ had watery eyes since the interview at {BEACH} on {beach interview

date}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B19. AnyEyeInfection

[Has anyone had …] an eye infection? [since the interview at {BEACH} on {BEACH INTERVIEW

B19a. EyeList

Who? [ had any eye infection since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B20. AnyCuts

(We need to know if the cut became infected after the visit to the beach; When did the cut occur,

it could have occurred after they were at the beach. Check to make sure the information is

conveyed correctly from Beach Interview) [Has anyone had …] an infected cut? [since the

interview at {BEACH} on {BEACH INTERVIEW DATE}?]

B20a. CutList

Who? [Had an infected cut since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B21. AnyRash

[Has anyone had …] a rash or itchy skin? [since the interview at {BEACH} on {BEACH

[Who? [Had a rash since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B22. AnySunburn

[Has anyone had …] a sunburn? [since the interview at {BEACH} on {beach interview date}?]

B22a. AnySunburnList

Who? [ had sunburn since the interview at {BEACH} on {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B23. ActivitiesIntro

I’d like to ask you about some activities people may have done since the day of the beach interview on

(BEACH INTERVIEW DATE).

B23a. AnyContactAni

[Since the day of the beach interview] Has anyone come into contact with any animals?

B23b. AnimalContactList

Who? [ came into contact with animals since {BEACH INTERVIEW DATE}?]

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B23c. ASK FOR EACH PERSON IN A23a:

(Was this animal/Were any of these animals) unfamiliar to

B23d. What kind of animal or animals were they?

DROP-DOWN MENU WILL ALLOW FOR CHECKING ALL THAT APPLY

1. FISH (AQUARIUM)

2. CATS

3. DOGS

4. POULTRY (CHICKENS, TURKEYS)

9. AMPHIBIANS (FROGS, SALAMANDERS)

10. REPTILES (SNAKES, TURTLES, LIZARDS)

11. BIRDS (PETS)

12. OTHER, SPECIFY: ________________________

B24a. (Since the day of the beach interview) Has anyone come into contact with someone who

has complained of diarrhea, vomiting, or stomach illness?

B24b. PeopleContactList

Who? [had contact with someone complaining of diarrhea, vomiting or stomach illness since

(BEACH INTERVIEW DATE)?

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B25a. (Since the day of the beach interview) Has anyone eaten raw shell fish, such as oysters,

clams, mussels, crabs?

B25b. ShellfishList

Who? [has eaten raw shellfish since (BEACH INTERVIEW DATE)?

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B26a.

(Since the day of the beach interview) Has anyone eaten rare or raw meat? This includes pink in

B26b. RawMeatList

Who? [has eaten rare (pink in center) or raw meat since (BEACH INTERVIEW DATE)?

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

B27a. (Since the day of the beach interview) Has anyone eaten runny or raw

eggs?

Who? [has eaten runny or raw eggs since (BEACH INTERVIEW DATE)?

[CODE ALL THAT APPLY.]

{response options are the names of all persons}

REFUSED

DON’T KNOW

IF ANY PERSON WAS MARKED AS HAVING ANY SYMPTOM (B6-B22), ASK ALL PERTINENT

SYMPTOM QUESTIONS FOR THAT PERSON.

BEGIN WITH THE FIRST PERSON IN THE

ENUMERATION WHO WAS MARKED AS HAVING HAD A SYMPTOM, THEN CONTINUE WITH

EACH OTHER PERSON MARKED.

IF NO PERSON WAS MARKED AS HAVING ANY SYMPTOMS, GO TO QUESTION E1.

SECTION C.

C INTRO.

You said that {you/PERSON} experienced some symptoms since {BEACH INTERVIEW DATE}.

Now I would like to ask you about those symptoms.

IF THIS PERSON HAD A STOMACHACHE, GO TO C1 OR ELSE, GO TO C2.

C1. StomachStartDay

On what day did {name/age/sex}’s stomachache or abdominal cramping start?

DATE: ________________________________

INTERVIEWER WILL REFER TO HARD-COPY CALENDAR FOR ALL DATES.

PROG. NOTE: Do not allow a date prior to the BEACH INTERVIEW DATE. Do not allow a date later

than today.

C1a. StomachStill

Does {name/age/sex} still have a stomachache or abdominal cramping?

YES

REFUSED

DON’T KNOW

INTERVIEWER WILL REFER TO HARD-COPY CALENDAR TO NEGOTIATE DATES.

IF THIS PERSON STILL HAS A STOMACHACHE, GO TO C2.

C1b. StomachDays

For how many days did {name/age/sex}’s stomachache or abdominal cramping last?

|__|__|__|

REFUSED

DON’T KNOW

NOTE: FOR SYMPTOMS LASTING A HALF DAY OR LESS, CODE “00”.

IF THIS PERSON HAD DIARRHEA, GO TO C2. OR ELSE, GO TO C3.

C2. DiarrheaStartDay

On what day did {name/age/sex}’s diarrhea or loose bowels start?

DATE: ________________________________

C2a. DiarrheaStill

Does {name/age/sex} still have diarrhea?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS DIARRHEA, GO TO C2c

C2b. DiarrheaDays

For how many days did {name/age/sex}’s diarrhea last?

|__|__|__|

REFUSED

DON’T KNOW

C2c. DiarrheaNumber

What was the maximum number of bouts or episodes of diarrhea {name/age/sex} experienced in

a 24-hour period?

[NUMBER PER DAY:] |__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD NAUSEA, GO TO C3. OR ELSE, GO TO C4.

C3. NauseaStartDay

On what day did {name/age/sex}’s nausea start?

DATE: ________________________________

Does {name/age/sex} still have nausea?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS NAUSEA, GO TO C4.

C3b. NauseaDays

For how many days did {name/age/sex}’s nausea last?

|__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD VOMITING, GO TO C4. OR ELSE, GO TO C5.

C4. VomitingStartDay

On what day did {name/age/sex}’s throwing up or vomiting start?

DATE: ________________________________

C4a. VomitingStill

Is {name/age/sex} still vomiting?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL IS VOMITING, GO TO C4c.

C4b. VomitingDays

For how many days did {name/age/sex}’s vomiting last?

[NUMBER] |__|__|__|

REFUSED

DON’T KNOW

C4c. VomitingNumber

What was the maximum number of times that {name/age/sex} vomited during a 24-hour period?

[NUMBER] |__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD A UTI, GO TO C5. OR ELSE, GO TO C6.

C5. UrinaryTractInfectionStartDay

On what day did {name/age/sex}’s urinary tract infection or burning start?

DATE: ________________________________

C5a. UrinaryTractInfectionStill

Does {name/age/sex} still have a urinary tract infection or burning sensation?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A UTI, GO TO C6.

C5b. UrinaryTractInfectionDays

For how many days did {name/age/sex}’s urinary tract infection or burning sensation?

|__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD A FEVER, GO TO C6. OR ELSE, GO TO C7.

C6. FeverStartDay

On what day did {name/age/sex}’s fever start?

DATE: ________________________________

Does {name/age/sex} still have a fever?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A FEVER, GO TO C6c.

C6b. FeverDays

For how many days did {name/age/sex}’s fever last?

|__|__|__|

REFUSED

DON’T KNOW

C6c. FeverTempTaken

Was {name/age/sex}’s temperature taken using a thermometer?

What is the highest temperature that {name/age/sex} has had since {BEACH

___

IF THIS PERSON HAD A HEADACHE, GO TO C7. OR ELSE, GO TO C8.

C7. HeadacheStartDay

On what day did {name/age/sex}’s headache start?

DATE: ________________________________

C7a. HeadacheStill

Does {name/age/sex} still have a headache?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A HEADACHE, GO TO C8.

C7b. HeadacheDays

For how many days did {name/age/sex}’s headache last?

|__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD A SORE THROAT, GO TO C8. OR ELSE, GO TO C9.

C8. SoreThroatStartDay

On what day did {name/age/sex}’s sore throat start?

DATE: ________________________________

C8a. SoreThroatStill

Does {name/age/sex} still have a sore throat?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A SORE THROAT, GO TO C8c.

C8b. SoreThroatDays

For how many days did {name/age/sex}’s sore throat last?

|__|__|__|

REFUSED

DON’T KNOW

C8c. SoreThroatAllergy

Was this sore throat related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD A BAD COUGH, GO TO C9. OR ELSE, GO TO C10.

C9. CoughStartDay

On what day did {name/age/sex}’s bad cough start?

DATE: ________________________________

Does {name/age/sex} still have a bad cough?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A BAD COUGH, GO TO C9c.

C9b. CoughDays

For how many days did {name/age/sex}’s cough last?

|__|__|__|

REFUSED

DON’T KNOW

C9c. CoughAllergy

Was this bad cough related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD A COLD, GO TO C10. OR ELSE, GO TO C11.

C10. ColdStartDay

On what day did {name/age/sex}’s cold start?

DATE: ________________________________

Does {name/age/sex} still have a cold?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A COLD STILL, GO TO C10c.

C10b. ColdDays

For how many days did {name/age/sex}’s cold last?

|__|__|__|

REFUSED

DON’T KNOW

C10c. ColdAllergy

Was this cold related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD A RUNNY OR STUFFY NOSE, GO TO C11, OR ELSE, GO TO C12.

C11. RunnyNoseStartDay

On what day did {name/age/sex}’s runny or stuffy nose start?

DATE: ________________________________

C11a. RunnyNoseStill

Does {name/age/sex} still have a runny or stuffy nose?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS A RUNNY NOSE, GO TO C11c.

C11b. RunnyNoseDays

For how many days did {name/age/sex}’s runny or stuff nose last?

|__|__|__|

REFUSED

DON’T KNOW

C11c. RunnyNoseAllergy

Was this runny or stuffy nose related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD A EARACHE, GO TO C12. OR ELSE, GO TO C13.

C12. EaracheStartDay

On what day did {name/age/sex}’s earache, ear infection or runny ears start?

DATE: ________________________________

C12a. EaracheStill

Does {name/age/sex} still have an earache, ear infection or runny ears?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS AN EARACHE, GO TO C12c.

C12b. EaracheDays

For how many days did {name/age/sex}’s earache, ear infection or runny ears last?

|__|__|__|

REFUSED

DON’T KNOW

C12c. EaracheAllergy

Was this earache, ear infection or runny ears related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD WATERY EYES, GO TO C13. OR ELSE, GO TO C14.

C13. WateryEyesStartDay

On what day did {name/age/sex}’s watery eyes start?

DATE: ________________________________

C13a. WaterEyesStill

Does {name/age/sex} still have watery eyes?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS WATERY EYES, GO TO C13c.

C13b. WateryEyesDays

For how many days did {name/age/sex}’s watery eyes last?

|__|__|__|

REFUSED

DON’T KNOW

C13c. WateryEyesAllergy

Were the watery eyes related to allergies?

YES

REFUSED

DON’T KNOW

IF THIS PERSON HAD AN EYE INFECTION, GO TO C14. OR ELSE, GO TO C15.

C14. EyeInfectionStartDay

On what day did {name/age/sex}’s eye infection start?

DATE: ________________________________

C14a. EyeInfectionStill

Does {name/age/sex} still have the eye infection?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS AN EYE INFECTION, GO TO C15.

C14b. EyeInfectionDays

For how many days did {name/age/sex}’s eye infection last?

|__|__|__|

REFUSED

DON’T KNOW

IF THIS PERSON HAD AN INFECTED CUT, GO TO C15. OR ELSE, GO TO C16.

(Make sure information about the cut date is being relayed)

C15. CutStartDay (Maybe CutInfectDay)

On what day did {name/age/sex}’s cut first get infected?

DATE: ________________________________

Does {name/age/sex} still have an infected cut?

YES

REFUSED

DON’T KNOW

IF THIS PERSON STILL HAS AN INFECTED CUT, GO TO C15c.

C15b. CutDays

For how many days did {name/age/sex}’s infected cut last?

|__|__|__|

REFUSED

DON’T KNOW

C15c. Where were [you/PERSON#n] cut?

[Mark all that apply.]

Location

Check if positive

4a. Was that the upper or lower back?

10a. Was it on the soles or the top of the feet/foot?

11. genitalia

12. groin

13. hands

13a. Was it on the back of the hand, the palm, or the fingers?

IF THIS PERSON HAD RASH, GO TO C16. OR ELSE, GO TO C17.

C16. RashStartDay

On what day did {name/age/sex}’s rash, itchy skin, or skin infection start?

DATE: ________________________________

Does {name/age/sex} still have the rash, itchy skin, or skin infection?

IF THIS PERSON STILL HAS SKIN PROBLEM, GO TO C16c.

C16b. RashDays

For how many days did {name/age/sex}’s rash, itchy skin, or skin infection last?

|__|__|__|

REFUSED

DON’T KNOW

C16c. Where were/was your/{name/age/sex}’s rash?

[Mark all that apply.]

Location

Check if positive

4a. Was that the upper or lower back?

10a. Was that on the sole or the top of the foot?

13a. Was that on the back of the hand, the fingers or the palm?

IF THIS PERSON HAD SUNBURN, GO TO C17. OR ELSE, GO TO QUESTION D1.

(When did they get sunburned. Was the information relayed)

C17. Sunburn

On which parts of the body was {name/age/sex} sunburned?

[Mark all that apply.]

Location

Check if positive

ASK D1 ONLY ONCE FOR EACH PERSON REPORTING SYMPTOMS (C1-C172). START WITH

PERSON #1.

D1.

When (your/PERSON’s) (illness/condition) began, (were you/was s/he)

working for pay either inside or outside the home? Please include jobs for which (you

were/s/he was) self-employed.

YES

REFUSED

DON’T KNOW

[PROG NOTE: Remaining Section D questions will be asked for all household members (1-12)

reporting symptoms of the following syndromes:

Gastrointestinal/Diarrhea (symptoms – stomach ache, diarrhea, nausea, vomiting)

Eye Infection (symptoms – watery eyes, eye infection)

Upper Respiratory (symptoms – sore throat, cough, runny nose, cold)

Ear Infection (symptom – earache)

Urinary Tract Infection (symptom – urinary tract infection)

Skin (symptom – cuts, rash, sunburn)

Data will not be collected on headache and fever if they occur in isolation and are not linked to

specific syndromes.]

(Do this for each symptom for each person)

DINTRO

You said [you/PERSON] had [LIST OF SYMPTOMS MAKING UP SYNDROME].

[READ FOR FIRST SYNDROME FOR FIRST PERSON: We would now like to discuss how

this (illness/condition) affected (your/his/her) daily activities

DOES D1=01 (Working for pay/business)

Yesgo to D2

No go to D4

D2.

During (your/his/her) illness, did (you/s/he) miss any time from work, for example because

(you/s/he) called in sick or took time off to see a doctor?

D3.

How many days? |__|__|__| days (IF IN HOURS, i.e. <1 DAY, THEN CODE AS ZERO)

REFUSED

DON’T KNOW

D4.

Did this illness prevent (you/him/her) from performing daily activities such as school, recreation, or

vacation activities, or work around the home?

D5.

|__|__|__|

days (IF IN HOURS, i.e. <1 DAY, THEN CODE AS ZERO)

REFUSED

DON’T KNOW

. Did (your/his/her) illness cause other household members to lose time at work?

D7.

IF Yes: How many days?

|__|__|__| days (IF IN HOURS, i.e. <1 DAY, THEN CODE AS ZERO)

REFUSED

DON’T KNOW

Next, I am going to ask you some questions about the treatment and diagnosis of (your/his/her) illness.

You said that (you/PERSON) suffered from (SYMPTOMS MAKING UP EACH ILLNESS).

D8a.

Did (you/s/he) consult a healthcare provider over the phone about this (illness/condition)?

D8b.

visit

a health care provider?

D8c

D8d

. What illness did the health care provider say (you/s/he) had?

D8e.

visit

D8f.

D8g.

Were you admitted to the hospital?

D8h.

How many days (were you/was s/he) hospitalized?

_______ # DAYS

REFUSED

DON’T KNOW

D8i.

(Were you /Was s/he) given intravenous fluids?

YES

REFUSED

DON’T KNOW

D9a.

Did (you/s/he) receive a prescription for an antibiotic or other drug for this (illness/condition)?

D9b.

About how much of your own or your household’s money was spent altogether for these

prescription medicines?

Amount $ ______________________

Amount to nearest dollar

D10a

. Did (you/s/he) use any over-the-counter medications, including things like special drinks, only

because of this (illness/condition)?

D10b

About how much of your own or your household’s money was spent altogether for over-

the-counter medicines?

Amount $ ________________________

Amount to nearest dollar

EXIT STATEMENT

IF THERE IS ANOTHER PERSON IN THE ENUMERATION WHO WAS MARKED AS HAVING ANY

SYNDROME, GO BACK TO D1 FOR THAT PERSON AND ASK APPROPRIATE QUESTIONS FROM

THROUGH

D10b

OR ELSE, IF THERE IS NO OTHER PERSON IN THE ENUMERATION WHO NEEDS TO BE ASKED ABOUT,

GO TO

E1.

Before today, were you aware that people could become ill by swimming at the beach?

YES

REFUSED

DON’T KNOW

E2.

After today, will you change the way you use the water at the beach? Or Will you change your recreational

use of water/activities at the beach?

YES

REFUSED

DON’T KNOW

(We might want to move this to the front. Might make more sense. Moving it may bias)

Q1.

Did you or anyone in your household wade, swim, or play in the water on ___/___/___?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

IF NO TO PERSON 1 THROUGH PERSON 8, GO TO Q20

Person

Y N RF DK

Q1a.1

. Did {PERSON}

immerse their body, not

necessarily {PERSON’s}

head, in water today? ..........

1 2 7 8

Q1a.2.

Did {PERSON} put

their face in water or

submerge head in water

today?..................................

1 2 7 8

CONTINUE

Person

Y N RF DK

Q1a.3.

Did {Person} get

water in the mouth today?

1 2 7 8

IF NO TO THE ABOVE QUESTION, GO TO QUESTION Q2..

Q1a.4

.Did {PERSON} gag or cough after getting water in their mouth?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

IF NO TO PERSON 1 THROUGH PERSON 8, GO TO Q16d

Q1a.5. Did {PERSON} swallow the water?

YES

Person 1.................................................. 1 .................2 ................ 7.................. 8

Person 2.................................................. 1 .................2 ................ 7.................. 8

Person 3.................................................. 1 .................2 ................ 7.................. 8

Person 4.................................................. 1 .................2 ................ 7.................. 8

Person 5.................................................. 1 .................2 ................ 7.................. 8

Person 6.................................................. 1 .................2 ................ 7.................. 8

Person 7.................................................. 1 .................2 ................ 7.................. 8

Person 8.................................................. 1 .................2 ................ 7.................. 8

Q2.

What total time did {PERSON} stay in the water? We are only interested in time actually in the water, not

the total time at the beach.

(CIRCLE TIME UNITS)

Person 1 ................ ____ MINUTES

_____.__ HOURS 7

Person 2 ................ ____ MINUTES

_____.__ HOURS 7

Person 3 ................ ____ MINUTES

_____.__ HOURS 7

Person 4 ................ ____ MINUTES

_____.__ HOURS 7

Person 5 ................ ____ MINUTES

_____.__ HOURS 7

Person 6 ................ ____ MINUTES

_____.__ HOURS 7

Person 7 ................ ____ MINUTES

_____.__ HOURS 7

Person 8 ................ ____ MINUTES

_____.__ HOURS 7

This completes our telephone interview and your participation. I’d like to verify your address so we can mail a

check for $25 to {BEACH RESPONDENT}. (VERIFY ADDRESS ON CALL SHEET.) You will receive your

check in 30 days and thank you for your participation in this study. Thank you for taking the time to talk with me.

Goodbye.

IF RESP DOESN’T HAVE BROCHURE:

You can call 1-888-422-3072, from 8 am to 4:30 pm, Monday through Friday, Eastern time; mention you

are calling about the NEEAR study.

Website: NEEAR Water Study

You can also e-mail

neear_water_study@epa.gov

QAPP 2

Appendix 4A

Eligibility Screener

University of lllinois, Chicago

CHEERS Study

Eligibility

Screener & Refusal Tally sheet 2008

of our research study.

What

outdoor activity will

terminste recruiting. NO PRIMARY

child) enrolled in the

in any water recreational

activity

(such

swimming. skiing, kayaking, fishing,

boating etc) at a lake, river

or beach in

the

past

hours? SWIMMING IN A POOL

in the water with their dogs, they are ineligible.

OK for us to contact

you

phone

3 times over the next three weeks and ask

enrolling in the study

QAPP 2

Appendix 4B

Refusal Tally Sheet

Confidentiality concerns:

Currently Enrolled= CE

APPENDIX 6: FIELD SURVEY B

--------------------------------------------------------------------------------

IF RIVER:

PB_S2

Enter River Location:

1 = Skokie Rowing Center

7 = Little Calumet River

--------------------------------------------------------------------------------

IF LAKE:

PB_S3

Enter General Area Waterways Location:

6 = Jackson Park Harbor

7 = Skokie Lagoons

8 = Des Plaines River

--------------------------------------------------------------------------------

PB_Intro

"Thank you for returning to complete the survey. We will have your t-shirt

and gift-card ready for you after we complete the survey. May I have your name

so that we can link it to your previous answers?

--------------------------------------------------------------------------------

PB_Q1First

"What is your first name?"

--------------------------------------------------------------------------------

PB_Q1Last

"What is your last name?"

--------------------------------------------------------------------------------

PB_Q9

"Did you engage in any water recreational activities at the <location> today?":

--------------------------------------------------------------------------------

IF YES TO PB_Q9:

PB_Q9a

"What water recreational activities did you engage in while at the <location> today?”

Check All That Apply. If 'NONE' be sure no others are checked.

6 = Fishing on a boat

7 = Fishing at the pier, shore or dock

8 = None of the above

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

PB_Q9b

"Did you (read activities from list) also while at the <location> today?

Check All That Apply.

5 = Use a waverunner?

6 = Swim?

7 = Go sailing?

8 = None of the above?

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF PB_Q9b RESPONSE IS “SWIM”:

PB_Q9c

"You said you swam today. Was it accidental or intentional?":

--------------------------------------------------------------------------------

IF PB_Q9b RESPONSE IS “INTENTIONAL”

INEL

"Thank you for participating in the CHEERS study.

We will not be calling you for the follow-up telephone survey.”

(INTERVIEWER): Be sure they receive their t-shirt and $15 gift card.

--------------------------------------------------------------------------------

ASK Q10 SERIES FOR EACH ACTIVITY:

PB_Q10SAIL.i_H

"For how long did you <FILL ACTIVITY>?

Enter in hours and minutes.

Enter a number between 0 and 18 for hours.

Enter a number between 0 and 59 for minutes

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.ii

"Where did you launch with your <FILL ACTIVITY>?"

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.iii

"Where did you exit with your <FILL ACTIVITY>?"

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.iv

"Did you travel upstream or downstream?"

--------------------------------------------------------------------------------

PB_Q10SAIL.v

"Did any part of your body get wet at all today?"

1 = Yes

2 = No

SKIP TO PB_Q10SAIL.vii

DON’T KNOW

SKIP TO PB_Q10SAIL.vii

REFUSAL

SKIP TO PB_Q10SAIL.vii

--------------------------------------------------------------------------------

IF YES TO PB_10SAIL.v:

PB_Q10SAIL.vi

"How wet did you get? Would you say..."

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q10SAIL.vi_feet

"How wet did your feet or legs get? Would you say..."

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q10SAIL.vi_hands

"How wet did your hands or arms get? Would you say...":

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q10SAIL.vi_torso

"How wet did your torso (that is your stomach or back) get? Would you say...":

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q10SAIL.vii

"Did your face or head get wet?":

1 = Yes

2 = No

SKIP TO PB_Q10SAIL.xvii

DON’T KNOW

SKIP TO PB_Q10SAIL.xvii

REFUSAL

SKIP TO PB_Q10SAIL.xvii

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.vii:

PB_Q10SAIL.viii

"How wet did your face or head get? Would you say..."

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q10SAIL.ix

"Did you get any water in your mouth today?"

--------------------------------------------------------------------------------

PB_Q10SAIL.xv

"Did you swallow any water while <FILL ACTIVITY> today?"

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xv:

PB_Q10SAIL.xvi

"Would you say it was...

(PROBE): Your best estimate is fine."

1 = A drop or two,

2 = A teaspoon, or,

3 = One or more mouthfuls?

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.xvii

"Did you get wet while launching the <FILL ACTIVITY>?"

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.xviii

"Did your <FILL ACTIVITY> flip over or capsize today?"

1 = Yes

2 = No

SKIP TO PB_Q10SAIL.xxiii_A

DON’T KNOW

SKIP TO PB_Q10SAIL.xxiii_A

REFUSAL

SKIP TO PB_Q10SAIL.xxiii_A

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xviii:

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xviii:

PB_Q10SAIL.xix_H

"How long did you stay in the water after capsizing?”

Enter in hours and minutes.

Enter a number between 0 and 18 for hours.

Enter a number between 0 and 59 for minutes.

--------------------------------------------------------------------------------

PB_Q10SAIL.xxiii_A

"Did you wade into the water or stand in the water while <FILL ACTIVITY> today?"

1 = Yes

2 = No

SKIP TO PB_Q10SAIL.Rubeyes

DON’T KNOW

SKIP TO PB_Q10SAIL.Rubeyes

REFUSAL

SKIP TO PB_Q10SAIL.Rubeyes

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xxiii_A:

PB_Q10SAIL.xxiii_B

"Did you wear waders or hip boots?"

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xxiii_A:

PB_Q10SAIL.xxiii_CH

"How long did you stay in the water?”

Enter in hours and minutes.

Enter a number between 0 and 18 for hours.

Enter a number between 0 and 59 for minutes.

--------------------------------------------------------------------------------

PB_Q10SAIL.Rubeyes

"Did you rub your eyes while <FILL ACTIVITY> today?"

--------------------------------------------------------------------------------

PB_Q10SAIL.xxiv

"You said you were boating. Was it on a power boat?"

--------------------------------------------------------------------------------

IF YES TO PB_Q10SAIL.xxiv:

PB_Q10SAIL.xxv

"How long is your boat?”

Enter a number in feet from 1 to 100.

(PROBE): Approximately how many feet?"

--------------------------------------------------------------------------------

ASK ONLY FOR BOAT ACTIVITIES:

PB_Q10SAIL.xxvi

"How many people, not including yourself, were on the boat with you today?”

Enter a number from 0 to 97.

--------------------------------------------------------------------------------

ASK IF RESPONSE TO PB_Q10SAIL.xxvi IS MORE THAN “1”:

PB_Q10SAIL.xxvii

"How many of these people, not including yourself, are enrolled in the CHEERS study?”

Enter a number from 0 to 97.

--------------------------------------------------------------------------------

ASK FOR EACH PERSON:

PB_Q10SAIL.Roster.Person[01].Q1cName

"What is the full name of the (first/next) person who was on the boat with you,

who is also enrolled in the CHEERS study?":

--------------------------------------------------------------------------------

ASK FOR EACH PERSON:

PB_Q10SAIL.Roster.Person[01].Q1cGender

"What is their gender?"

--------------------------------------------------------------------------------

ASK ONLY FOR FISHING ACTIVITIES:

PB_Q10SAIL.xxviii

"How many fish did you catch while <FILL ACTIVITY> today?"

--------------------------------------------------------------------------------

ASK ONLY FOR FISHING ACTIVITIES:

PB_Q10SAIL.xxvix

"What kind of bait did you use <FILL ACTIVITY> today? Did you use...

Check All That Apply.

1 = Live bait such as worms or minnows?,

2 = Artificial lures?,

3 = Natural lures such as corn, fish eggs or meat?,

4 = Some other type of bait? (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

ASK ONLY FOR FISHING ACTIVITIES:

PB_Q10SAIL.xxx

"Do you plan on eating any of the fish you caught today?"

--------------------------------------------------------------------------------

PB_Q11.a

"Did you eat during or after your activities at the <LOCATION>?

(NOTE): Only record any eating before they left the location.

--------------------------------------------------------------------------------

IF YES TO PB_Q11a:

PB_Q11.b

"Did you clean your hands before eating?"

--------------------------------------------------------------------------------

IF YES TO PB_Q11b:

PB_Q11.c

"Did you use...

Read All Choices. Check All That Apply.

(NOTE): <LOCATION> water doesn't count.

1 = Soap,

2 = A hand sanitizer,

3 = Hand wipes, or,

4 = Just rinse your hands?

5 = Other (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

PB_Q11.d

"Did you drink anything during or after your activities at the <LOCATION> today?

(NOTE): Only record any drinking before they left the location.

--------------------------------------------------------------------------------

IF YES TO PB_Q11d:

PB_Q11.e

"Did you clean your hands before drinking?"

--------------------------------------------------------------------------------

IF YES OR SOMETIMES TO PB_Q11e:

PB_Q11.f

"Did you use...

Read All Choices. Check All That Apply.

(NOTE): <LOCATION> water doesn't count."

1 = Soap,

2 = A hand sanitizer,

3 = Hand wipes, or,

4 = Just rinse your hands?

5 = Other (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF YES TO PB_Q11d:

PB_Q11.g

"How many ounces did you drink at the <LOCATION> today?

(PROBE): Your best estimate is fine.

Use Visual Aids As Appropriate:

Can = 12 ounces

Small bottle = 8 ounces

Regular bottle = 16 ounces

Or Check their water bottle.

Enter a number from 1 to 500.

--------------------------------------------------------------------------------

ASK THE Q12 SERIES AND Q13 SERIES FOR RESPONDENTS WHO DID NOT DO ANY

WATER REC ACTIVITIES TODAY:

PB_Q12[

"What activity did you participate in today? Did you...

Read All Categories. Check All That Apply.":

11 = Do any other activity? (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

PB_Q13

"Did you at any point in time today come in contact with the <LOCATION> water?"

--------------------------------------------------------------------------------

PB_Q13a

"Did any part of your body get wet at all today?"

--------------------------------------------------------------------------------

PB_Q13b

"Did your face or head get wet?"

--------------------------------------------------------------------------------

IF YES TO PB_Q13b:

PB_Q13c

"How wet did your face or head get?"

1 = Sprinkle or few drops,

--------------------------------------------------------------------------------

PB_Q13d

"Did you get any <LOCATION> water in your mouth today?"

--------------------------------------------------------------------------------

PB_Q13e

"Did you swallow any <LOCATION> water today?"

--------------------------------------------------------------------------------

IF YES TO Q13e:

PB_Q13f

"Would you say it was...

(IF NECESSARY): Your best estimate is fine."

1 = A drop or two,

2 = A teaspoon, or,

3 = One or more mouthfuls?

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

CE_1Intro

"Now I am going to ask you a few questions about your current health status.

--------------------------------------------------------------------------------

CE_1a1

"Do you have any ongoing stomach or intestinal problems,

otherwise known as gastrointestinal problems?"

--------------------------------------------------------------------------------

IF YES TO CE_1a1:

CE_1a2

"Which of the following do you have? Do you have...

Check All That Apply.

1 = Crohn's disease?,

2 = Inflammatory bowel disease?,

3 = Irritable bowel syndrome?,

4 = Ulcers?,

5 = Gastritis?,

6 = Acid Reflux?,

7 = Lactose intolerance?,

8 = OTHER (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

CE_1b

"Do you have any ongoing respiratory problems such as asthma,

bronchitis or emphysema?":

--------------------------------------------------------------------------------

CE_1c

"Do you have diabetes?"

--------------------------------------------------------------------------------

CE_1d

"In the past 7 days, have you taken oral antibiotics?"

--------------------------------------------------------------------------------

CE_1e

"Do you have any condition that makes you more likely to get infections?"

--------------------------------------------------------------------------------

CE_1f

"In the past 48 hours, have you taken any antacids such as Tums, Rolaids and Mylanta?

(NOTE): Also includes Pepsid AC, Zantac, Prilosec."

--------------------------------------------------------------------------------

CE_2

"On average, how many bowel movements do you have in a day?

(PROBE): By bowel movements we mean pooping.

--------------------------------------------------------------------------------

CE_2a

"Do you wear contact lenses?"

--------------------------------------------------------------------------------

CE_3a

"Now I am going to ask you a few questions about how you are feeling today.

Are you currently experiencing any of the following symptoms?

Abdominal cramps or stomach ache?

--------------------------------------------------------------------------------

CE_3b

"Diarrhea or loose bowels?

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

CE_3h

"A bad or persistent cough?

--------------------------------------------------------------------------------

CE_3i

"A cold, or a runny or stuffy nose?

--------------------------------------------------------------------------------

CE_3j

"Ear ache or ear infection?

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

CE_3l

"Drainage or crusting in your eyes?

--------------------------------------------------------------------------------

CE_3cut

"Any areas on your skin where there are cuts?

--------------------------------------------------------------------------------

CE_3bug

"Any areas on your skin where there are bug bites?

--------------------------------------------------------------------------------

CE_3m

"Any areas on your skin that are sore or draining?

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

CE_cut[

"Where are the cuts located? Check All That Apply."

1 = RIGHT SIDE, HEAD/FACE,

2 = RIGHT SIDE, NECK,

3 = RIGHT SIDE, UPPER ARM,

4 = RIGHT SIDE, ELBOW,

5 = RIGHT SIDE, FORE ARM,

6 = RIGHT SIDE, HAND,

7 = RIGHT SIDE, FINGERS,

8 = RIGHT SIDE, THIGH,

9 = RIGHT SIDE, KNEE,

10 = RIGHT SIDE, LOWER LEG,

11 = RIGHT SIDE, ANKLE/FOOT,

12 = RIGHT SIDE, TOES,

13 = RIGHT SIDE, ABDOMEN,

14 = RIGHT SIDE, CHEST,

15 = RIGHT SIDE, BACK,

16 = RIGHT SIDE, (SPECIFY),

17 = LEFT SIDE, HEAD/FACE,

18 = LEFT SIDE, NECK,

19 = LEFT SIDE, UPPER ARM,

20 = LEFT SIDE, ELBOW,

21 = LEFT SIDE, FORE ARM,

22 = LEFT SIDE, HAND,

23 = LEFT SIDE, FINGERS,

24 = LEFT SIDE, THIGH,

25 = RIGHT SIDE, KNEE,

26 = LEFT SIDE, LOWER LEG,

27 = LEFT SIDE, ANKLE/FOOT,

28 = LEFT SIDE, TOES,

29 = LEFT SIDE, ABDOMEN,

30 = LEFT SIDE, CHEST,

31 = LEFT SIDE, BACK,

32 = LEFT SIDE, (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF CUT ON RIGHT SIDE AT OTHER LOCATION:

CE_cutRO_text

"Where else on your right side did you cut yourself?"

--------------------------------------------------------------------------------

IF CUT ON LEFT SIDE AT OTHER LOCATION:

CE_cutLO_text

"Where else on your left side did you cut yourself?"

--------------------------------------------------------------------------------

CE_bug[

"Where are the bug bites or cuts located? Check All That Apply."

1 = RIGHT SIDE, HEAD/FACE,

2 = RIGHT SIDE, NECK,

3 = RIGHT SIDE, UPPER ARM,

4 = RIGHT SIDE, ELBOW,

5 = RIGHT SIDE, FORE ARM,

6 = RIGHT SIDE, HAND,

7 = RIGHT SIDE, FINGERS,

8 = RIGHT SIDE, THIGH,

9 = RIGHT SIDE, KNEE,

10 = RIGHT SIDE, LOWER LEG,

11 = RIGHT SIDE, ANKLE/FOOT,

12 = RIGHT SIDE, TOES,

13 = RIGHT SIDE, ABDOMEN,

14 = RIGHT SIDE, CHEST,

15 = RIGHT SIDE, BACK,

16 = RIGHT SIDE, (SPECIFY),

17 = LEFT SIDE, HEAD/FACE,

18 = LEFT SIDE, NECK,

19 = LEFT SIDE, UPPER ARM,

20 = LEFT SIDE, ELBOW,

21 = LEFT SIDE, FORE ARM,

22 = LEFT SIDE, HAND,

23 = LEFT SIDE, FINGERS,

24 = LEFT SIDE, THIGH,

25 = RIGHT SIDE, KNEE,

26 = LEFT SIDE, LOWER LEG,

27 = LEFT SIDE, ANKLE/FOOT,

28 = LEFT SIDE, TOES,

29 = LEFT SIDE, ABDOMEN,

30 = LEFT SIDE, CHEST,

31 = LEFT SIDE, BACK,

32 = LEFT SIDE, (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF BUG BITES ON RIGHT SIDE ON OTHER LOCATION:

CE_bugRO_text

"Where else on your right side did you have bug bites?"

--------------------------------------------------------------------------------

IF BUG BITES ON LEFT SIDE ON OTHER LOCATION:

CE_bugLO_text

"Where else on your left side did you have bug bites?"

--------------------------------------------------------------------------------

CE_sore[

"Where are the sores or draining skin located? Check All That Apply."

1 = RIGHT SIDE, HEAD/FACE,

2 = RIGHT SIDE, NECK,

3 = RIGHT SIDE, UPPER ARM,

4 = RIGHT SIDE, ELBOW,

5 = RIGHT SIDE, FORE ARM,

6 = RIGHT SIDE, HAND,

7 = RIGHT SIDE, FINGERS,

8 = RIGHT SIDE, THIGH,

9 = RIGHT SIDE, KNEE,

10 = RIGHT SIDE, LOWER LEG,

11 = RIGHT SIDE, ANKLE/FOOT,

12 = RIGHT SIDE, TOES,

13 = RIGHT SIDE, ABDOMEN,

14 = RIGHT SIDE, CHEST,

15 = RIGHT SIDE, BACK,

16 = RIGHT SIDE, OTHER (SPECIFY),

17 = LEFT SIDE, HEAD/FACE,

18 = LEFT SIDE, NECK,

19 = LEFT SIDE, UPPER ARM,

20 = LEFT SIDE, ELBOW,

21 = LEFT SIDE, FORE ARM,

22 = LEFT SIDE, HAND,

23 = LEFT SIDE, FINGERS,

24 = LEFT SIDE, THIGH,

25 = LEFT SIDE, KNEE,

26 = LEFT SIDE, LOWER LEG,

27 = LEFT SIDE, ANKLE/FOOT,

28 = LEFT SIDE, TOES,

29 = LEFT SIDE, ABDOMEN,

30 = LEFT SIDE, CHEST,

31 = LEFT SIDE, BACK,

32 = LEFT SIDE, OTHER (SPECIFY)

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF SORES / DRAINING SIDE ON RIGHT SIDE ON OTHER LOCATION:

CE_soreRO_text

"List other sites on right side where R has sores or draining skin."

--------------------------------------------------------------------------------

IF SORES / DRAINING SIDE ON LEFT SIDE ON OTHER LOCATION:

CE_soreLO_text

"List other sites on left side where R has sores or draining skin."

--------------------------------------------------------------------------------

CE_rash[

"Where is the rash located? Check All That Apply."

1 = RIGHT SIDE, HEAD/FACE,

2 = RIGHT SIDE, NECK,

3 = RIGHT SIDE, UPPER ARM,

4 = RIGHT SIDE, ELBOW,

5 = RIGHT SIDE, FORE ARM,

6 = RIGHT SIDE, HAND,

7 = RIGHT SIDE, FINGERS,

8 = RIGHT SIDE, THIGH,

9 = RIGHT SIDE, KNEE,

10 = RIGHT SIDE, LOWER LEG,

11 = RIGHT SIDE, ANKLE/FOOT,

12 = RIGHT SIDE, TOES,

13 = RIGHT SIDE, ABDOMEN,

14 = RIGHT SIDE, CHEST,

15 = RIGHT SIDE, BACK,

16 = RIGHT SIDE, (SPECIFY),

17 = LEFT SIDE, HEAD/FACE,

18 = LEFT SIDE, NECK,

19 = LEFT SIDE, UPPER ARM,

20 = LEFT SIDE, ELBOW,

21 = LEFT SIDE, FORE ARM,

22 = LEFT SIDE, HAND,

23 = LEFT SIDE, FINGERS,

24 = LEFT SIDE, THIGH,

25 = RIGHT SIDE, KNEE,

26 = LEFT SIDE, LOWER LEG,

27 = LEFT SIDE, ANKLE/FOOT,

28 = LEFT SIDE, TOES,

29 = LEFT SIDE, ABDOMEN,

30 = LEFT SIDE, CHEST,

31 = LEFT SIDE, BACK,

32 = LEFT SIDE, (SPECIFY),

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

IF RASH ON RIGHT SIDE ON OTHER LOCATION:

CE_rashRO_text

"Where else on your right side do you have a rash?"

--------------------------------------------------------------------------------

IF RASH ON LEFT SIDE ON OTHER LOCATION:

CE_rashLO_text

"Where else on your left side do you have a rash?"

--------------------------------------------------------------------------------

PB_Q15

"Are you currently sunburned?"

--------------------------------------------------------------------------------

PB_Q2a

"In the past 72 hours have you come in contact with someone who had

vomiting or diarrhea?"

--------------------------------------------------------------------------------

IF YES TO PB_Q2a:

PB_Q2a1

"Were any of those contacts with people who live with you, such as family members or

--------------------------------------------------------------------------------

PB_Q2b

"In the past 72 hours have you come in contact with someone who had

a cold, cough or sore throat?"

--------------------------------------------------------------------------------

IF YES TO PB_Q2b:

PB_Q2b1

"Were any of those contacts with people who live with you, such as family members or

--------------------------------------------------------------------------------

PB_Q2c

"In the past 72 hours have you come in contact with someone who had

--------------------------------------------------------------------------------

PB_Q3a

"In the last 48 hours have you touched a cat or dog?"

--------------------------------------------------------------------------------

PB_Q3b

"In the last 48 hours have you touched any animals other than cats or dogs,

including farm animals or animals at a petting zoo?"

--------------------------------------------------------------------------------

PB_Q3c

"In the last 48 hours have you

Eaten any sushi or raw shell fish such as crab, oyster, or mussels?"

--------------------------------------------------------------------------------

PB_Q3d

"In the last 48 hours have you eaten any rare, raw, or undercooked meat?"

--------------------------------------------------------------------------------

PB_Q3e

"In the last 48 hours have you eaten any runny or raw eggs?"

--------------------------------------------------------------------------------

PB_Q3f

"In the last 48 hours have you eaten a prepackaged sandwich?"

NOTE: Please do not include any home-made sandwiches or hot sandwiches.

--------------------------------------------------------------------------------

PB_Q3g

"In the last 48 hours have you eaten any fresh fruit, vegetables, or salad greens?"

--------------------------------------------------------------------------------

PB_Q3h

"In the last 48 hours have you eaten a hamburger?"

--------------------------------------------------------------------------------

PB_Q16

"When was the last time you were involved in any water activity before today?"

1 = Past 3 days,

2 = 4-7 days,

3 = More than 7 days ago but less than 30 days (one month),

4 = 30 days(one month) or more ago

DON’T KNOW

REFUSAL

--------------------------------------------------------------------------------

PB_Q17

"Approximately how many miles did you travel today to get here today?

Enter a number between 0 and 500.

Enter 0 for less than a mile.

--------------------------------------------------------------------------------

PB_Q18a

"(INTERVIEWER): Do not ask children this question.

Did you use any tobacco while at the <LOCATION> today?"

--------------------------------------------------------------------------------

IF YES TO PB_Q18a:

PB_Q18b

"Was that cigarettes, cigars, a pipe, or chewing tobacco?"

--------------------------------------------------------------------------------

IF YES TO PB_Q18a:

PB_Q18c

"How much did you use?

(PROBE): How many cigarettes, cigars, pipes did you smoke or pinches of tobacco did you

chew?

Enter a number from 1 to 100.

--------------------------------------------------------------------------------

PB_Q19River

"In the past 12 months, how many times have you used the Chicago River for any

water

recreational activities?”

Enter a number from 0 to 365.

(PROBE): Your best estimate is fine."

--------------------------------------------------------------------------------

PB_Q19Lake

"In the past 12 months, how many times have you used Lake Michigan for any

water recreational

activities?”

Enter a number from 0 to 365.

(PROBE): Your best estimate is fine."

--------------------------------------------------------------------------------

PB_Q19Lagoon

IF PBS2loc = SKOKIE LAGOON, DES PLAINES RIVER, KANKAKEE RIVER, FOX RIVER OR

OTHER GENERAL AREA WATERWAY:

"In the past 12 months, how many times have you used the (SPECIFY GENERAL AREA

WATERWAY LOCATION) for any

water recreational activities?”

Enter a number from 0 to 365.

(PROBE): Your best estimate is fine."

--------------------------------------------------------------------------------

PB_Q19

"On a scale from 0 to 10 where 0 is not at all risky and 10 is very risky, can you tell me how

much of a health risk you think it is to do water sports on the Chicago River?

(PROBE): We are not asking about safety,

only health."

--------------------------------------------------------------------------------

PB_Q8Addr

"May I please have your mailing address so that we can send you

your $35 'Thank You' check once you have completed the final telephone interview? You should

receive your check in about 6-8 weeks.

Enter Street Address. Verify Spelling."

--------------------------------------------------------------------------------

PB_Q8City

Enter City. Verify Spelling."

--------------------------------------------------------------------------------

PB_Q8State

Enter State. Use Standard 2-Letter Abbreviation."

--------------------------------------------------------------------------------

PB_Q8Zip

Enter 5-Digit Zip Code."

--------------------------------------------------------------------------------

PB_Thanks

"Thank you for your assistance on this survey. We will call you 2, 5 and 21 days

from today. If you have any questions or concerns you can reach us at the numbers

provided in the consent document.

--------------------------------------------------------------------------------

IF RESPONDENT DECLINED TO GIVE ADDRESS:

PB_InelA

"I'm sorry. In order to be eligible to participate in the rest of the

survey we would need your mailing address to mail your 'Thank you' check.

Thank you for your time."

--------------------------------------------------------------------------------

PB_Phone

(INTERVIEWER): Was the interview completed in person or over the phone?

1 = In person

2 = Over the phone

--------------------------------------------------------------------------------

PB_Proxy

Was this interview completed by a proxy respondent?

--------------------------------------------------------------------------------

QAPP 2

Appendix 5

Field Survey A

UNIVERSITY OF ILLINOIS, CHICAGO

CHEERS FIELD SURVEY

PART A

Interviewer Name (Part A): ...............................

...................................................

Last

First

CAWs: Location…

…………….Drop down menu: Skokie Rowing Center, Clark Park, North Avenue, Alsip, Worth,

Little Calumet River, 28 street, other

If other: Free text

General Area Waterways: Location

…………..Drop down menu: Leone Beach, Montrose Harbor, Wilson Beach,

Belmont Harbor, Diversey Harbor, Jackson Park Harbor, Skokie Lagoons, Des Plaines River, Kankakee River, Fox

River, other

If other: Free text

ENTER 6-digit Case Identification Number: _____________

Date: ____ / ____ /____

Start Time OF Field Survey A:

AM / PM

(computer to populate this field)

Hi, my name is___________________________. In order for us to find out more about people like you who

participate in outdoor activities, I will ask you a few questions about yourself.

Q1. Please tell me your first name, last name and birth month/year. (INTERVIEWER: CODE GENDER.)

First Name

Last Name

Date of Birth

mm/yyyy

Gender

__ / ___ RF DK

M F RF DK

Note: PROGRAM decides if this is proxy interview, based on child’s age. If child is below 7 years of age

interviewer is prompted to request parent to answer the

questions.

Q1a. Do you consider yourself to be … SELECT ALL THAT APPLY.

1. White,

5. Native Hawaiian or Other Pacific Islander, or

2. Black or African American,

6. Asian?

3. Hispanic,

7. Other: Specify ________________________

8. Refused

4. American Indian or Alaska Native, 9. Don’t Know

Q1b. Are you here

today

with any people who live with you, such as family members or roommates? Y N RF DK,

or If No (Skip to Q2)

Q1c. How many people who you live with are here today? Enter Number. (Please do not include yourself)

Q1d. How many of those people are enrolled or enrolling in the CHEERS study today? Enter Number. (Please do

not include yourself)

Field Survey A, Version 10, January 2008

Q2.

Some people swim, canoe, kayak, fish, SCUBA dive, or participate in water recreational activities at

places such as beaches, water parks, public pools, private pools, or wading pools. During the past

7 days, have

you participated in any water recreational activities anywhere?

Q3. Where did you engage in these water recreational activity/ activities? Check all that apply.

PROBE: If BEACH,

ask – was that an ocean, lake or river?

Location

Lake

Y N RF DK

If YES , Were any of these activities at Lake

Michigan

River

Y N RF DK

If YES , Were any of these activities at

Chicago River or Calumet-Sag channel

Lagoon

Y N RF DK

If YES, Were any of these activities at

Skokie Lagoon

Q4. During any of these water recreational activities………

a. Did any part of your body get wet at all?

If NO, GoTo Q5

b. If YES, did your face/head get wet?

Y N RF DK

c. Did you get any water in your mouth?

If NO, GoTo Q5

d. If YES, did you swallow any water?

Y N RF DK

Field Survey A, Version 10, January 2008

Q5. As mentioned earlier we are interested in asking about your health in the next 3 weeks

. May I please have

the best phone number where we can reach you at over the next

3 weeks?

YES.........................................................

GO TO Q6a

NO...........................................................

terminate survey

(IF NECESSARY): As mentioned earlier we will be calling 2,5, and 21 days from today to ask you a few

questions about your health.

INTERVIEWER:

We will end the interview here since a contact telephone number is required to complete the

telephone interview that I mentioned. Thank you for speaking with us.

Q6a.

Which

is the best

phone number(s)

to reach you at during this time

? INTERVIEWER: COLLECT AS

MANY

PHONE NUMBERS AND EXTENTIONS AS

INTERVIEWER: Thank you

. We’ll try to reach you during that (those) time(s).

End A

IF non-water recreator proceed directly to Survey B.

IF water recreator ask: Will you be returning by (mention time) to complete Survey B?

IF “YES”- remind them to return to the CHEERS tent by (mention time) to complete Survey B and collect

their gift card and t-shirt.

Interviewer make sure the data manager has the list of participants who will return to complete survey B.

End Time for Field Survey A________AM /PM

(computer to populate this field)

Field Survey A, Version 10, January 2008

QAPP 2

Appendix 7

Telephone Follow-up Interview

Follow up Telephone Interview, Version 7, January 2008

UNIVERSITY OF IILINOIS, CHICAGO

CHEERS

FOLLOW-UP TELEPHONE SURVEY

ENTER 6-digit Case Identification Number:_____________________

A1. Hello, my name is ____________. May I speak to (RESPONDENT NAME: _______________)?

AVAILABLE – GO TO A4

NOT AVAILABLE – GO TO A2

NEVER HEARD OF PERSON – GO TO A3

REFUSED – Too busy ................................................

No longer interested ...............................

Will not be available................................

Other reason?.........................................

Please specify: .......................................

A2. Recently, we spoke to (RESPONDENT) at [fill River/Lake location], and we’re calling to complete the interview.

If s/he isn’t available- Could you please tell us what is the best time to reach him/her?

DATE:

TIME:

A3. Is this number (___) ___ ____ ? (VERIFY THE NUMBER ON THE CALL RECORD SHEET)

YES – COMPLETE NIRF

NO -- REDIAL THE NUMBER

A4. I’m calling about a follow-up health survey for the CHEERS study. Recently, we spoke to you at [fill River/Lake

location]{IF NEEDED: Specify the location and date}; and we’re calling back to complete the interview.

YES- CONTINUE Goto Section B

NO- SCHEDULE APPOINTMENT

NO- REFUSED - Too busy

No longer interested ...........................

Will not be available............................

Other reason?.....................................

Please specify: ...................................

IF ASKED TO CALL BACK OR SCHEDULE APPOINTMENT, SAY: The interview needs to be completed by

[LAST DATE]. When would be the best time to call you before then?

DATE:

TIME:

Follow up Telephone Interview, Version 7, January 2008

Symptom Intro

Now I am going to ask you a few questions about how you have been feeling since we last spoke.

Since we last spoke on (fill Date of survey or last telephone interview) [fill number of days] days

ago.

Note: Go through each symptom. If YES to any symptom, then Go to symptom detail questions. If NO to

any symptom, Go to next symptom on the list. If NO to all symptoms, then skip to Section D.

Symptom

Y N RF DK

Symptom Detail

B1. Abdominal cramps or stomach ache

Y N RF DK

If Yes, Complete B1a- B1d.

B2. Diarrhea or loose bowels

Y N RF DK

If Yes, Complete B2a- B2d

B3. Nausea

Y N RF DK

If Yes, Complete B3a- B3d

B4. Vomiting

Y N RF DK

If Yes, Complete B4a- B4d

B5. Fever

Y N RF DK

If Yes, Complete B5a- B5e

B6. Headache

Y N RF DK

If Yes, Complete B6a- B6c

B7. Sore throat

Y N RF DK

If Yes, Complete B7a-B7d

B8. Cough

Y N RF DK

If Yes, Complete B8a-Be

B9. A Cold or a runny or stuffy nose

Y N RF DK

If Yes, Complete B9a-B9d

B10. Earache or ear infection

Y N RF DK

If Yes, Complete B10a-B10d

B11. Eye irritation

Y N RF DK

If Yes, Complete B11a-B11d

B12. Drainage or crusting in eyes

Y N RF DK

If Yes, Complete B12a-B12d

B13. Any areas on your skin that are sore or

draining

Y N RF DK

If Yes, Complete B13a-B13h

B14. Rash or Itchy skin

Y N RF DK

If Yes, Complete B14a-B14f

B. Symptom Detail

INTERVIEWER WILL REFER TO HARD-COPY CALENDAR TO NEGOTIATE DATES.

B1a. On what date did the abdominal cramping or stomach ache start?

DATE: ______ / _____ /

Do you still have the abdominal cramping or stomach ache?

YES

NO Go to B1c.

REFUSED Go to B1c.

DON’T KNOW Go to B1c.

B1c.

On what date did the abdominal cramps or stomach ache end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B1d. Was this menstrual cramps? Ask only for female participants 12 years or older.

Follow up Telephone Interview, Version 7, January 2008

YES

REFUSED

DON’T KNOW

B2a. On what date did the diarrhea or loose bowels start?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B2b. Do you still have diarrhea or loose bowels?

YES

NO Go to B2c.

REFUSED Go to B2c.

DON’T KNOW Go to B2c.

B2c. On what date did the diarrhea or loose bowels end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B2d. What is the maximum number of times you had diarrhea in a 24-hour period?

[NUMBER PER DAY:] |__|__|__|

REFUSED

DON’T KNOW

B3a. On what date did the nausea start?

DATE: ______ / _____ /

Do you still have nausea?

YES

NO Go to B3c.

REFUSED Go to B3c.

DON’T KNOW Go to B3c.

B3c. On what date did the nausea end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

B3d. Are you pregnant? Ask only adult females.

YES

REFUSED

DON’T KNOW

B4a. On what date did you start vomiting?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B4b. Do you still have the vomiting?

YES

NO Go to B4c.

REFUSED Go to B4c.

DON’T KNOW Go to B4c.

B4c. On what date did the vomiting end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B4d. Are you pregnant? Ask only adult females.

YES

REFUSED

DON’T KNOW

B5a. On what date did the fever start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B5b. Do you still have fever?

YES

NO Go to B5c.

REFUSED Go to B5c.

DON’T KNOW Go to B5c.

B5c. On what date did the fever end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

B5d. Was your temperature taken using a thermometer?

B5e. What is the highest temperature that you had?

B6a. On what date did the headache start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B6b. Do you still have a headache?

YES

NO Go to B6.

REFUSED Go to B6c.

DON’T KNOW Go to B6c.

B6c. On what date did the headache end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B7a. On what date did the sore throat start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B7b. Do you still have a sore throat?

YES

NO Go to B7c.

REFUSED Go to B7c.

DON’T KNOW Go to B7c.

Follow up Telephone Interview, Version 7, January 2008

B7c. On what date did the sore throat end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B7d. Do you think this sore throat was related to allergies?

YES

REFUSED

DON’T KNOW

B8a. On what date did the cough start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B8b. Do you still have a cough?

YES

NO Go to B8c.

REFUSED Go to B8c.

DON’T KNOW Go to B8c.

B8c. Did you cough up phlegm?

YES

REFUSED

DON’T KNOW

B8d. On what date did the cough end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B8e. Do you think this cough was related to allergies?

YES

REFUSED

DON’T KNOW

B9a. On what date did your cold or runny or stuffy nose start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

B9b. Do you still have a cold or runny or stuffy nose?

YES

NO Go to B9c.

REFUSED Go to B9c.

DON’T KNOW Go to B9c.

B9c.

On what date did the cold or runny or stuffy nose end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B9d. Do you think was this cold or runny or stuffy nose was related to allergies?

YES

REFUSED

DON’T KNOW

B10a. On what date did the earache/ear infection start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B10b. Do you still have an earache?

YES

NO Go to B10c

REFUSED Go to B10c

DON’T KNOW Go to B10c

B10c. On what date did the earache end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B10d. Was this earache or ear infection in your……..

B11a. On what date did the eye irritation start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

B11b. Do still have eye irritation?

YES

NO Go to B11c

REFUSED Go to B11c

DON’T KNOW Go to B11c

B11c. On what date did the eye irritation end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B11d. Was the irritation in your…

B12a. On what day did the eye drainage or crusting start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B12b. Do you still have eye drainage or crusting?

YES

NO Go to B12c

REFUSED Go to B12c

DON’T KNOW Go to B12c

B12c.

On what date did the eye drainage or crusting end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B12d. Was this drainage or crusting in your…..

Follow up Telephone Interview, Version 7, January 2008

B13a. Where

is the soreness or drainage located?

Left side

On what day did you first notice soreness or drainage?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

B13e. Do you still have the soreness or drainage?

YES

NO Go to B13f

REFUSED Go to B13f

DON’T KNOW Go to B13f

B13f. On what date did the soreness or drainage end?

DATE: ______ / _____ /

200_

REFUSED

DON’T KNOW

B13g. Do you think this soreness or drainage was related to insect bites?

B13h. Do you think this soreness or drainage was related to allergies?

B14a. On what day did the rash or itchy skin start?

DATE: ______ / _____ /

2007

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

B14b. Do you still have the rash or itchy skin?

YES

NO Go to B14c

REFUSED Go to B14c

DON’T KNOW Go to B14c

B14c. On what date did the rash or itchy skin end?

DATE: ______ / _____ /

200_

REFUSED

B14d. Where is the rash located?

Left side

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Abdomen

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

Y N RF DK

B14e. Do you think this rash or itchy skin was related to insect bites?

B14f. Do you think this rash or itchy skin was related to allergies?

NOTE: IF ANY OF THE SYMPTOMS (B1-B14) WERE REPORTED IN THE FIELD SURVEY B OR PREVIOUS

PHONE SURVEY, THEN ASK QB15 –

B15. Have you had a 48 hour symptom free period since you reported the (symptom) during the field

survey B or previous telephone interview on (enter date)?

Follow up Telephone Interview, Version 7, January 2008

C. You said you had [LIST OF SYMPTOMS FROM B1-B14]. We would now like to discuss how this illness or

these symptoms affected your daily activities

C1. Did these symptoms prevent you from performing daily activities such as school, work or

recreation?

YES

REFUSED

DON’T KNOW

C2 For how long were you prevented from performing daily activities?

|__|__|__|

days (IF IN HOURS, i.e. <1 DAY, THEN CODE AS ZERO)

REFUSED

DON’T KNOW

C3.

Did you consult a healthcare provider over the phone or in person about any of these symptoms?

YES

REFUSED

DON’T KNOW

If YES to C3 then ask C4-C8

What illness did the health care provider say (you) had, if any?

_______________

NONE

REFUSED

DON’T KNOW

Did you visit an emergency room for this illness?

YES

REFUSED

DON’T KNOW

Were you admitted in the hospital for this illness?

YES

REFUSED

DON’T KNOW

Follow up Telephone Interview, Version 7, January 2008

Did you receive a prescription for an antibiotic or other drug to treat this illness?

YES

REFUSED

DON’T KNOW

Did you use any over-the-counter medications, including things like special drinks, for these

symptoms?

YES

REFUSED

DON’T KNOW

D. Now I am going to ask you a few questions about your recent water recreational activities .

D1. Since we last spoke on (Fill date of last interview) x days ago, have

you participated in any water

recreational activities

anywhere?

YES

1 D2

2 Go to E1

REFUSED

7 Go to E1

DON’T KNOW

8 Go to E1

D2.

Since we last spoke on (Fill date of last interview) x days ago, on how many days have

you participated

in these water recreational activities ?

Enter number: _____________

D3. Record date of water recreational activities since last interview. Enter dates: _________________---

D4. Where did you engage in these water recreational activity/activities? Check all that apply. If Beach,

ask – Was it ocean, lake or river?

Location

Lake

Y N RF DK

If YES , ask if Lake Michigan

River

Y N RF DK

If YES , ask if Chicago River or Calumet-Sag

channel

Lagoon

Y N RF DK

If YES, ask if Skokie Lagoon

Other

Specify:______________

Follow up Telephone Interview, Version 7, January 2008

D5.

During any of these water recreational activities………

a. Did any part of your body get wet at all?

b. If YES, Did your face or head get wet?

Y N RF DK

c. Did you get any water in your mouth?

If NO, Go to D6

d. If YES, did you swallow any water?

Y N RF DK

E. I’d like to ask you about some other exposures you may have had since we last spoke [fill date of survey

or last telephone interview].

E1. Since we last spoke on [fill date of survey or last telephone interview]……………..

a. Have you touched any cat or dog?

Y N RF DK

b. Have you touched any other animals, other than cats or

dogs, including farm animals or animals at a petting zoo?

Y N RF DK

d. Have you eaten any sushi or raw shell fish (such as crab,

oyster, or mussels)?

Y N RF DK

d. Have you eaten any rare/raw/undercooked meat?

Y N RF DK

e. Have you eaten any runny or raw eggs?

Y N RF DK

f. Have you eaten a pre-packaged sandwich?

Y N RF DK

h. Have you eaten any fresh fruit, vegetables, or salad

greens?

Y N RF DK

i. Have you eaten a hamburger?

Y N RF DK

Follow up Telephone Interview, Version 7, January 2008

E2.

Since we last spoke [fill date of survey or last telephone interview], have you come into contact with someone

who had ……………

a. Vomiting or diarrhea?

Y N RF DK

IF YES Goto E3

b. A cold or sore throat or cough?

Y N RF DK

IF YES Goto E3

c. An eye infection?

Y N RF DK

IF YES Goto E3

E3. Were any of those contacts with people who live with you, such as family members or roommates?

Yes GOTO E3a

No GOTO F

E3a. How many of those people were enrolled in this CHEERS study?

ENTER NUMBER:____________________

E3b. And what are their names?

First and Last Name

Gender

RF DK

M F RF DK

RF DK

M F RF DK

RF DK

M F RF DK

RF DK

M F RF DK

Follow up Telephone Interview, Version 7, January 2008

F. INTERVIEWER: Reconfirm phone numbers and call back times.

F1. Which is the best phone number(s) to reach you at during this time? INTERVIEWER: COLLECT AS

MANY PHONE NUMBERS AND EXTENTIONS AS POSSIBLE.

Home phone

Vacation phone

cell phone

Morning

8:00 AM-12:00

noon

Afternoon

12:01 PM-5:00 PM

other

Evening

5:01 PM- 9:00 PM

Home phone

Vacation phone

cell phone

Morning

8:00 AM-12:00

noon

Afternoon

12:01 PM-5:00 PM

other

Evening

5:01 PM- 9:00 PM

Home phone

Vacation phone

cell phone

Morning

8:00 AM-12:00

noon

Afternoon

12:01 PM-5:00 PM

Evening

5:01 PM- 9:00 PM

other

EXIT STATEMENT

Note: If this is the Day 2 or Day 5 interview then ask for a date and time to schedule next telephone interview. Make sure to

inform the participant that interview must be completed within a certain period.

Note: Schedule appointment for home

visit by the nurse if any symptoms need clinical evaluation.

INTERVIEWER: Thank you for your assistance on this survey. We will call you again in about (x) days to

complete the next telephone interview. After completing the final telephone interview, you will receive a $35

check within 30 days.

At the end of day 21 telephone interview. This completes our telephone interview and your participation. I’d like to verify

your address so we can mail a check for

$35

to you. (VERIFY ADDRESS ON CALL SHEET.) You will receive your check

in 30 days. Thank you for your participation in this study. Goodbye.

F2. INTERVIEWER: Was this interview with a proxy respondent?

YES

F3. INTERVIEWER: Is there anything you want to add about respondent comprehension, any issues with the

answers to specific items, or anything else that affects data quality?

YES Specify:_____________________________

INTERVIEWER NAME: FIRST______________LAST________________________

Follow up Telephone Interview, Version 7, January 2008

PROGRAM: Home visit triggers.

If YES to 1 or more of the following symptoms –

B1. Abdominal cramps or stomach ache

Stool sample (ONLY IF THIS IS

NOT

MENSTURAL

CRAMPS)

GOTO G1

B2. Diarrhea or loose bowels

Stool sample Goto G1

B4. Vomiting

Stool sample Goto G1

B3. Nausea

Stool sample. Only if present

along with symptoms B1, B2 or

B4. OR with FEVER. Goto G1

B12. Drainage from eyes or crusting in

eyes. Please ask if there is any discharge

from the eyes? If YES, only then get a

sample. If it is only a sore area we do not

want a sample.

Eye discharge sample. Goto G2

Obtain sample only if there is any

eye discharge.

B13. Any areas on your skin that are sore

or sore or draining

Skin discharge sample. Goto G2

Decision tree for home visits and stool collection: This is followed when the survey triggers the home visit

or stool sample collection.

G1. INTERVIEWER: We will need a stool sample from you.

Have you already collected a stool sample? Y N (Goto G9 )

If YES, When did you collect it? (How many hours back?)

Have you called the courier service to schedule a pick-up? Y N (Goto G5)

If YES- Thank participant. Continue to finish survey.

If participant has collected the stool sample in the past 6 hours, but not called the courier

service then- Will you be at home in the next 2 hours? Y N (Goto G8 )

If YES, may I send the courier service home to pick-up the sample? Y N (Goto G8)

If YES, confirm address and contact courier service to pick-up sample in the next 2 hours.

Thank participant and continue to finish the survey.

If NO, Ok- will you call the courier service to set up a convenient time to pick-up the sample.

(The interviewer will have all details of the courier service and how samples need to be collected and

stored- if needed by the participant)

Do you have a stool kit available? Y N (Goto G13)

10.

If YES, Do you understand how to use the kit? Y N (Goto G12)

11.

If YES, please follow the instructions on the stool kit and collect the sample. Kindly contact

the courier service using the number on the kit for a pick-up. (The interviewer will have all details of

the courier service and how samples need to be collected and stored- if needed by the participant)

12.

If NO, The interviewer will have all details of the courier service and how samples need to be

collected and stored- if needed by the participant.

Follow up Telephone Interview, Version 7, January 2008

13.

OK- We will send you a stool kit. After that please follow the instructions on the stool kit and

collect the sample. Kindly contact the courier service using the number on the kit for a pick-up.

END: Is there any other question or concern regarding the stool collection that I can answer? If YES,

Specify:________________________________

G2. INTERVIEWER: A CHEERS study clinician will call you to schedule a home visit. The clinician may

examine your eyes and take an eye swab, or swab your skin (depending on the symptom). Interviewer has

to confirm the address and pass on details to the CHEERS nurse.

If a participant calls in with symptoms in between their day 2, 5 and 21 survey then we follow the same

decision tree. However, in addition we collect other case details too:

1. Case ID

2. Participant First and Last Name

3. Symptom experienced

4. Start date

5. Does symptom still persist? If NO- then end date.

6. Go through G1 or G2 based on home visit or stool collection trigger.

QAPP 2

Appendix 8: CHEERS Pilot Study Protocol

& IRB Approval Letter

QAPP 2

Appendix 8A

CHEERS Pilot Study Protocol and IRB Approval Letter

Pilot Consent Document

Flesch-Kincaid Grade level 8.9

Leave box empty - For office use only

University of Illinois at Chicago

CONSENT FOR PARTICIPATION IN RESEARCH

“

PILOT STUDY FOR EVALUATING THE CHICAGO WATER RECREATION STUDY

FIELD AND TELEPHONE QUESTIONNAIRES”

(To be administered in English)

Why am I being asked?

The University of Illinois at Chicago (UIC) School of Public Health is planning a research study

on the health of people in the Chicago area who take part in outdoor recreation. You are being

asked to be in this pilot study because you are active in outdoor recreation in or around Lake

Michigan and the Chicago River. We ask that you read this form and ask any questions you may

have before agreeing to be in the research.

Your taking part in this research is voluntary. Your decision whether or not to be in the study

will not affect your current or future relationship with the University of Illinois at Chicago

(UIC). If you decide to be part of the research, you may withdraw at any time without affecting

that relationship.

Why is this research being done?

We want to know if the questionnaires developed for a research study are user friendly. Results

could be used for improving the quality of the questionnaires to be used in a larger study.

What is the purpose of this research?

The main purpose of this pilot study is to evaluate and refine the field and telephone

questionnaires developed for a larger study on outdoor recreators in the Chicago area.

What procedures are involved?

If you agree to be in this pilot study, we would ask you to do the following things:

We will first ask you to read and sign this consent form.

2 of 5

Chicago Water Recreation Study Pilot Consent, June 2007

Then we will ask you a few questions, about your current health and your recreational

activity today. This will take about 8-12 minutes.

We then will ask for your feedback about the questionnaire. This will take about 10 to 15

minutes.

We will ask you for your address and phone number, as we will try to contact you.

We will call you 1 or 2 days from today to ask you about how you feel. This will take

about 10 minutes.

We then will ask your feedback on the telephone questionnaire that will take about 10-15

minutes.

What are the potential risks and discomforts?

The research has no major physical risks or discomforts other than the time involved. You may

feel uncomfortable while answering certain questions during the survey/interview. You have the

right to refuse to answer any questions at any time. We will do the telephone follow-up at a time

that you tell us is convenient for you.

You may be concerned about how we will store/protect your data. We will protect your

confidentiality and to keep your answers private.

When the results of the research are

published or discussed in conferences, no information will be included that would reveal

your identity.

Are there benefits to taking part in the research?

There are no direct benefits to the participant from being in this pilot study.

The results from this pilot study may help future research subjects better understand the survey

questions being asked

Will I be told about new information that may affect my decision to participate?

During the course of the pilot study, you will be informed of any significant new findings (either

good or bad), such as changes in the risks or benefits resulting from participation in the research

or new alternatives to participation that might cause you to change your mind about continuing

in the study. If new information is provided to you, your consent to continue participating in this

study will be re-obtained.

What about privacy and confidentiality?

The only people who will know that you are a research subject are members of the research

team. No information about you, or provided by you during the research will be disclosed to

others without your written permission, except:

- If necessary to protect your rights or welfare (for example, if you are injured and need

emergency care or when the UIC Institutional Review Board monitors the research or

consent process); or

3 of 5

Chicago Water Recreation Study Pilot Consent, June 2007

- If required by law.

We respect your privacy. All computer files with identifiers will be password-protected. Any

hard copies of the forms/files will be stored in locked cabinets and will be destroyed as soon as

data collection is complete. When the results of the research are published or discussed in

conferences, no information will be included that would reveal your identity.

What if I am injured as a result of my participation?

No injury is expected to occur as a result of your participation in this research. In the event

Injury related to this research, treatment would be available through the UIC Medical Center.

However, you or your third party payer, if any, will be responsible for payment of this treatment.

If you feel you have been injured, you may contact Jacqueline Wuellner at 312-996-3395.

What are the costs for participating in this research?

There are no costs to you for participating in this research.

Will I be reimbursed for any of my expenses or paid for my participation in this research?

You will receive a total of up to $ 25 in gift certificates for participating in this research

according to the following schedule:

If you decide to participate, we will give you a $15 gift card after you have answered the

questions today.

After completing the survey and final telephone interview: a $10 check will be sent to you in the

mail.

Can I withdraw or be removed from the study?

Your participation in this research is VOLUNTARY. If you choose not to participate, that will

not affect your relationship with UIC or your right to health care or other services to which you

are otherwise entitled. If you decide to participate, you are free to withdraw your consent and

discontinue participation at any time without affecting your future care at UIC.

Who should I contact if I have questions?

The research contact for this study is Dr. Sam Dorevitch. You may ask any questions you have

now. If you have questions later, you may contact the Dr.Dorevitch at: 312-355-3629 or 312-

413-1739.

What are my rights as a research subject?

If you feel you have not been treated according to the descriptions in this form, or you have any

questions about your rights as a research subject, you may call the Office for the Protection of

4 of 5

Chicago Water Recreation Study Pilot Consent, June 2007

Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll-free) or e-mail

OPRS at uicirb@uic.edu

Remember:

Your participation in this research is voluntary. Your decision whether or not to participate will

not affect your current or future relations with the University. If you decide to participate, you

are free to withdraw at any time without affecting that relationship. You will be given a copy of

this form for your information and to keep for your records.

Signature of Subject or Legally Authorized Representative

I have read (or someone has read to me) the above information. I have been given an opportunity

to ask questions and my questions have been answered to my satisfaction. I agree to participate

in this research. I have been given a copy of this form.

Signature

Date

Printed Name

Signature of Researcher

Date (must be same as subject’s)

Printed name of Researcher

Signature of Witness (if appropriate)

Date (must be same as subject’s)

Printed name of Witness (if appropriate)

5 of 5

Chicago Water Recreation Study Pilot Consent, June 2007

QAPP 2

Appendix 8B

CHEERS Pilot Study Protocol and IRB Approval Letter

Field Pilot Survey Evaluation Form

PILOT FIELD SURVEY EVALUATION FORM

Interviewer Name_______________________________

Participant Name _______________________________

Date of interview _______________________________

Time of interview_______________________________

Were there any questions that may be confusing for other people who will take this

survey?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

How difficult was it to answer all of the questions?

Notes:__________________________________________________________________

________________________________________________________________________

Is there anything that you think would be helpful to add to or take out of the

questionnaire?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Field questionnaire evaluation, June 2007

Which questions were confusing or difficult to answer?

Notes:__________________________________________________________________

________________________________________________________________________

What do you think about the length of the questionnaire?

Notes:

________________________________________________________________________

Did any of the questions make you feel uncomfortable? If so, which ones?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

How would you feel if a nurse or doctor would examine your eyes, skin and ears

after you took the survey?

Notes:__________________________________________________________________

________________________________________________________________________

Field questionnaire evaluation, June 2007

8. What do you think would be good ways to recruit people who (mention activity of

participant) for this study?

Notes:__________________________________________________________________

________________________________________________________________________

We want to know how wet people get when they (mention the participant’s water-

recreational activity). What would be good questions to ask people in order to find

that out?

Notes:__________________________________________________________________

________________________________________________________________________

10. Do you have any other suggestions for us when we do a research study about water

contact, outdoor recreation, and health?

Notes:__________________________________________________________________

________________________________________________________________________

Field questionnaire evaluation, June 2007

QAPP 2

Appendix 8C

CHEERS Pilot Study Protocol and IRB Approval Letter

Pilot Study Telephone Evaluation Form

PILOT TELEPHONE QUESTIONNAIRE EVALUATION FORM

Interviewer Name_______________________________

Participant Name _______________________________

Date of call ___________________________________

Time of call ___________________________________

Were there any questions that you think may be confusing for other people who

will take this survey?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

How difficult was it to answer the questions?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Is there anything that you think would be helpful to add or take out of the

questionnaire?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Telephone questionnaire evaluation form, June 2007

Which questions were confusing or difficult to answer?

Notes:__________________________________________________________________

________________________________________________________________________

What do you think about the amount it took to finish the interview ?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Did any of the questions about your health make you uncomfortable?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Would you have any concerns if a nurse or physician came to your home to

collect a stool sample and or examine your eyes, skin or ears if you got sick after

your activity at the lake or river?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Telephone questionnaire evaluation form, June 2007

How would you feel about answering this telephone interview three times over a

three week period?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

On the whole, would you be willing or interested in participating in the CHEERS

study?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

10. If so, how much money do you think we should pay people for their time in

answering the questions at the lake or river, and by phone?

Y N RF DK

Notes:__________________________________________________________________

________________________________________________________________________

Telephone questionnaire evaluation form, June 2007

QAPP 2

Appendix 8D

CHEERS Pilot Study Protocol and IRB Approval Letter

Pilot Study IRB Approval Letter

Page 2 of 3

Approval Notice

Initial Review – Expedited Review

June 22, 2007

Samuel Dorevitch, MD, MPH

Environmental and Occupational Health

2121 W. Taylor St.

442 S.P.H.W., M/C 923

Chicago, IL 60612-0690

Phone: (312) 355-3629 / Fax: (312) 996-0064

RE:

Protocol # 2007-0420

“Pilot Study for Evaluating the Chicago Water Recreation Study Field and

Telephone Questionnaires”

Dear Dr. Dorevitch:

Members of Institutional Review Board (IRB) #3 reviewed and approved your research protocol

under expedited review procedures [45 CFR 46.110(b)(1) and 21 CFR 56.110(b)(1)] on June 19,

2007. You may now begin your research

Please note,

Jacqueline Wuellner’s

research training expired on 12/31/2006 and she may not

participate in the conduct of the research until an amendment (adding her key research

personnel) has been submitted and approved confirming that her continuing education

requirement has been completed. You may refer her to the OPRS website at

http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/education/continuing.shtml

where continuing education offerings are available."

Your research meets the requirement(s) for the following category - Expedited Review Approval

Category 45 CFR 46.110(b)(1) and /or 21 CFR 56.110(b)(1):

(7)

Research on individual or group characteristics or behavior (including but not limited to

research on perception, cognition, motivation, identity, language, communication, cultural beliefs

or practices and social behavior) or research employing survey, interview, oral history, focus

group, program evaluation, human factors evaluation, or quality assurance methodologies.

Please note the following information about your approved research protocol:

Protocol Approval Period:

June 19, 2007 - June 17, 2008

Approved Subject Enrollment #:

Page 3 of 3

Additional Determinations for Research Involving Minors:

These determinations have not

been made for this study since it has not been approved for enrollment of minors.

Performance Sites:

UIC

Sponsor:

Metropolitan Water Reclamation District of Greater

Chicago

Research Protocol(s):

a) Epidemiologic Study of Recreational Use of the Chicago Area Waterways; March 28,

2007

Informed Consent(s):

a) Chicago Water Recreation Study Pilot Consent, June_2007

Please note the Review History of this submission

:

Receipt Date

Submission Type Review Process

Use only the IRB-approved and stamped consent document(s) enclosed with this letter

when enrolling new subjects.

Use your

research protocol number

(2007-0420) on any documents or correspondence with

the IRB concerning your research protocol.

Review and comply with all requirements of the,

UIC Investigator Responsibilities, Protection of Human Research Subjects

Please note that the UIC IRB has the right to ask further questions, seek additional

information, or monitor the conduct of your research and the consent process.

We wish you the best as you conduct your research. If you have any questions or need further

help, please contact the OPRS office at (312) 996-1711 or me at (312) 355-2939. Please send any

correspondence about this protocol to OPRS at 203 AOB, M/C 672.

Sincerely,

Jewell Hamilton, MSW

IRB Coordinator, IRB # 3

Office for the Protection of Research Subjects

Enclosure(s):

1. UIC Investigator Responsibilities, Protection of Human Research Subjects

2. Informed Consent Document(s):

a) Chicago Water Recreation Study Pilot Consent, June_2007

cc:

Rosemary Sokas, MD, MOH, Environmental and Occupational Health, M/C 922

QAPP 2

Appendix 8E

CHEERS Pilot Study Protocol and IRB Approval Letter

Pilot Study Protocol

CHEERS Pilot Study Protocol 2007

The procedure for the pilot field testing is outlined below:

a. Participants will be enrolled at pre-determined sites along the Chicago River,

and Lake Michigan. Three groups of participants will be enrolled: 1)

recreators with water exposure at the Chicago Area Waterways (CAWs), 2)

recreators with water exposure at Lake Michigan and other general use

waterways, and 3) recreators without water exposure. We are interested in

administering the questionnaires to specific user groups such as (but not

limited to) kayakers, boaters, fishers, bikers and golfers or baseball players.

b. Approximately 50 participants will be recruited for the pilot study over a 1

week period.

c. CHEERS study personnel will approach individuals and explain the purpose

of the pilot study. Only English speaking adults (18 years or older) will be

eligible to participate in the pilot study. Interested individuals will be given a

consent form to read, and ask any questions necessary for clarification.

d. Individuals will be told that in order to participate in this pilot study they will

be required to:

•

Sign an informed consent for the pilot study (Appendix A)

•

Provide an address (so their stipend can be mailed to them) and

telephone number (for administering the telephone survey).

•

Complete an 8-12 minute questionnaire about their health, outdoor

activities and other exposures, and provide feedback on the

questionnaire. The whole process should take no more than 30

minutes.

•

Complete a 10-minute telephone questionnaire (after 1 or 2 days)

about their health after the outdoor activity, and give us some feedback

about the telephone questionnaire. The whole process should take no

more than 30 minutes.

•

Participants will be given a $15 gift card for completing the field

questionnaire and will be sent a $10 check in the mail after completing

the telephone questionnaires.

e. Following the consent process the Field Clinical Evaluation Form (described

in QAPP# 3), without the clinical assessment, Field Survey A (Appendix 5 of

QAPP 2) and Field Survey B (Appendix 6 of QAPP 2) will be administered.

The questionnaires will be administered by one CHEERS staff member, while

a second staff member will record the process by making notes on the paper

copy of the questionnaire. Questions that are followed by a long pause before

the respondent provides an answer (potentially indicating difficulties in

comprehension) will be noted. The observer will also note problems with

questions including but not limited to wording difficulties, confusing syntax,

question order, and ease of cognition. The observer will note any problems

with the administration of the questionnaire, as well as any clarifications

request by the participant. The administrators will also make notes of any

problems after the questionnaire has been completed. The total duration of

administering each survey will be recorded. The field pilot study will be

conducted using paper forms or a portable computer.

f. After the field questionnaires are administered, the participant will be asked to

evaluate any problems with the questionnaire using the field pilot survey

evaluation form (Appendix B). Specific questions will be asked to direct the

discussion. These questions, listed below, are not strict guidelines and should

facilitate discussion of the questionnaire. Researchers will be instructed to

allow subjects to converse freely about the questionnaire while covering

topics of difficulty, appropriateness, and areas of potential improvement of the

questionnaire.

g. At the end of the discussion participants will be given a $ 15 gift card for a

coffee shop or supermarket. The administrator will also make a note of the

best time to call in the next two days for telephone follow-up.

h. A CHEERS staff member will call the participant within 2 days of their field

interview. The day and time will be based on the convenience and availability

of the participant. The CHEERS member will administer a 10 minute

Telephone Follow-up Interview (Appendix 7 of QAAP 2). After completing

the interview participants will be asked to evaluate any problems with the

questionnaire. Specific questions, outlined in the field telephone interview

evaluation form (Appendix C) will be asked to prompt conversation. These

questions are not strict guidelines and are designed to promote discussion of

the questionnaire. Researchers will be instructed to allow subjects to converse

freely about the questionnaire while covering topics of difficulty,

appropriateness, and areas of potential improvement of the questionnaire.

i. At the end of the telephone interview participants will be thanked for their

time and told that a $10 check will be mailed to them within the next 2 weeks.

j. All data collected in the field and telephone interviews will be stored in a

locked file cabinet.

k. Evaluation of pilot data: The SPM will develop a list questions that were

associated with long pauses prior to response, clarifications requested by

participants, and responses to the evaluation questions that followed the

administration of the questionnaires. The SPM will also meet with CHEERS

personnel who conducted the pilot interviews within two days of the each

interview to discuss their impressions. Following the last pilot interview, the

SPM will present a summary of findings to the SRL project manager, staff

who participated in the pilot, and other CHEERS key personnel.

Opportunities to improve the clarity of the questionnaires, and the

incorporation of new questionnaires based on respondent suggestions will be

discussed.

l. Time-table for pilot study: The pilot study will be conducted by the SPM and

other CHEERS staff trained in the use of the BLAISE/CAPI software. The

evaluation meeting will take place in the third week of July, and an

amendment to the CHEERS study IRB protocol will be submitted listing these

modifications.

These changes will also be submitted to SRL for

programming. These questionnaires will only be used in the field study

following IRB approval.

m. Locations: The pilots study will be conducted at various Lake Michigan and

Chicago River locations. These sites and dates for conducting the pilot survey

have been selected to target specific groups of recreators: for example, CAWs

boaters at the Worth launch, paddlers at Clark Park, lake fishers and boaters at

Jackson Park Harbor and Montrose Harbor, and lake kayakers at Wilson

Beach. CAWs fishers are expected to be recruited at the River Park/Honan

Park site. Unexposed recreators engaging a variety of activities are found all

of the above locations.

n. Human research subjects protections: All members of CHEERS pilot study

team will be IRB trained/certified. The protocol will not be implemented until

IRB approval is obtained (Appendix D). All hard copies of forms with

identifiers will be stored in locked cabinets. All personal identifiers will be

removed from the dataset and destroyed following the completion of the pilot

study. Participants will not be identified individually in any of the discussions

or reports of this pilot study.

o. Staff: The field coordinator will have overall responsibility for identifying

sites and times to start the pilot study. The SPM will be responsible for

training staff to administer the questionnaire using the CAPI system, to

perform the pilot study evaluation, and to record findings on the pilot study

field data collection sheet. Staff members will work in groups of two or more.

p. The telephone pilot survey will be conduct at UIC using a computer

programmed in BLAISE for CATI, by landline telephone.

QAPP 2

Appendix 9

CAWs Use Survey Data Sheet

Page__of________

1. Location: _____________________________

2. Date:

______________

(MM / DD / YY)

3. CHEERS Staff Names:____________________

_______________________________________

3. Start Time of observation: ________________

(AM / PM)

4. Stop Time of observation: ________________

(AM / PM)

Tally of beginning of activity (launch, entry). If present at time of start of observation, then circle the tally mark.

Precipitation Present

Precipitation 24 Hour

Precipitation 24 Hour

Heavy

Light

Mist

QAPP 2

Appendix 10

IRB Exemption for Use Survey

2007-0386

Page 2 of 4

June 8, 2007

Exemption Granted

June 8, 2007

Samuel Dorevitch, MD, MPH

Environmental and Occupational Health

2121 W. Taylor St.

442 S.P.H.W., M/C 923

Chicago, IL 60612-0690

Phone: (312) 355-3629 / Fax: (312) 996-0064

RE:

Research Protocol # 2007-0386

“Recreational Use Profile of the Chicago Area Waterways”

Dear Dr. Dorevitch:

Your Claim of Exemption was reviewed on June 7, 2007 and it was determined that your

research protocol meets the criteria for exemption as defined in the U. S. Department of Health

and Human Services Regulations for the Protection of Human Subjects [(45 CFR 46.101(b)].

You may now begin your research

The specific exemption category under 45 CFR 46.101(b) is:

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,

interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a

manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any

disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of

criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

You are reminded that investigators whose research involving human subjects is determined to

be exempt from the federal regulations for the protection of human subjects still have

responsibilities for the ethical conduct of the research under state law and UIC policy. Please be

aware of the following UIC policies and responsibilities for investigators:

1. Amendments You are responsible for reporting any amendments to your research protocol

that may affect the determination of the exemption and may result in your research no

longer being eligible for the exemption that has been granted.

2. Record Keeping You are responsible for maintaining a copy all research related records in

a secure location in the event future verification is necessary, at a minimum these

documents include: the research protocol, the claim of exemption application, all

questionnaires, survey instruments, interview questions and/or data collection instruments

2007-0386

Page 3 of 4

June 8, 2007

associated with this research protocol, recruiting or advertising materials, any consent

forms or information sheets given to subjects, or any other pertinent documents.

Final Report When you have completed work on your research protocol, you should

submit a final report to the Office for Protection of Research Subjects (OPRS).

Information for Human Subjects UIC Policy requires investigators to provide information

about the research protocol to subjects and to obtain their permission prior to their

participating in the research. The information about the research protocol should be

presented to subjects in writing or orally from a written script. When appropriate, the

following information must be provided to all research subjects participating in exempt

studies:

a. The researchers affiliation; UIC, JBVMAC or other institutions,

b. The purpose of the research,

c. The extent of the subject’s involvement and an explanation of the procedures to be

followed,

d. Whether the information being collected will be used for any purposes other than the

proposed research,

e. A description of the procedures to protect the privacy of subjects and the

confidentiality of the research information and data,

f. Description of any reasonable foreseeable risks,

g. Description of anticipated benefit,

h. A statement that participation is voluntary and subjects can refuse to participate or can

stop at any time,

i. A statement that the researcher is available to answer any questions that the subject

may have and which includes the name and phone number of the investigator(s).

j. A statement that the UIC IRB/OPRS or JBVMAC Patient Advocate Office is available

if there are questions about subject’s rights, which includes the appropriate phone

numbers.

Please be sure to:

ÆUse

your research protocol number (listed above) on any documents or correspondence with

the IRB concerning your research protocol.

We wish you the best as you conduct your research. If you have any questions or need further

help, please contact me at (312) 355-2908 or the OPRS office at (312) 996-1711. Please send any

correspondence about this protocol to OPRS at 203 AOB, M/C 672.

Sincerely,

Charles W. Hoehne

Assistant Director, IRB # 2

Office for the Protection of Research Subjects

Enclosure(s): None

cc:

Rosemary Sokas, MD, MOH, Environmental and Occupational Health, M/C 922

2007-0386

Page 4 of 4

June 8, 2007

QAPP 2

Appendix 11

IRB Approval for Survey Methods Protocol

Page 2 of 4

Approval Notice

Initial Review – Expedited Review

June 26, 2007

Samuel Dorevitch, MD, MPH

Environmental and Occupational Health

2121 W. Taylor St.

442 S.P.H.W., M/C 923

Chicago, IL 60612-0690

Phone: (312) 355-3629 / Fax: (312) 996-0064

RE:

Protocol # 2007-0436

“Epidemiologic Study of Recreational Use of the Chicago Area Waterways”

Dear Dr. Dorevitch:

Members of Institutional Review Board (IRB) #3 reviewed and approved your research protocol

under expedited review procedures [45 CFR 46.110(b)(1) and 21 CFR 56.110(b)(1)] on June 22,

2007. You may now begin your research.

Your research meets the requirement(s) for the following categories - Expedited Review Approval

Category 45 CFR 46.110(b)(1) and /or 21 CFR 56.110(b)(1):

(3)

Prospective collection of biological specimens for research purposes by noninvasive means.

(7)

Research on individual or group characteristics or behavior (including but not limited to

research on perception, cognition, motivation, identity, language, communication, cultural beliefs

or practices and social behavior) or research employing survey, interview, oral history, focus

group, program evaluation, human factors evaluation, or quality assurance methodologies.

Please note the following information about your approved research protocol:

Protocol Approval Period:

June 22, 2007 - June 20, 2008

Approved Subject Enrollment #:

9330

Additional Determinations for Research Involving Minors:

These determinations have not

been made for this study since it has not been approved for enrollment of minors.

Performance Sites:

UIC

Sponsor:

Metropolitan Water Reclamation District of Greater

Chicago

Research Protocol(s):

a) Epidemiologic Study of Recreational Use of the Chicago Area Waterways; March 28,

2007

Page 3 of 4

Recruitment Material(s):

a) "Be part of a research study about water quality and your health!" Flyer; CHEERS

ver.1_June 18, 2007

Informed Consent(s):

a) CHEERS (Parental Permission), Ver. 1, June 18, 2007

b) CHEERS (Consent), Version. 1, June 18, 2007

Assent(s):

a) CHEERS_assent_ver.1 June 18, 2007

Please note the Review History of this submission

:

Receipt Date

Submission Type Review Process

Use only the IRB-approved and stamped consent document(s) enclosed with this letter

when enrolling new subjects.

Use your

research protocol number

(2007-0436) on any documents or correspondence with

the IRB concerning your research protocol.

Review and comply with all requirements of the,

UIC Investigator Responsibilities, Protection of Human Research Subjects

Please note that the UIC IRB has the right to ask further questions, seek additional

information, or monitor the conduct of your research and the consent process.

We wish you the best as you conduct your research. If you have any questions or need further

help, please contact the OPRS office at (312) 996-1711 or me at (312) 355-2939. Please send any

correspondence about this protocol to OPRS at 203 AOB, M/C 672.

Sincerely,

Jewell Hamilton, MSW

IRB Coordinator, IRB # 3

Office for the Protection of Research Subjects

Enclosure(s):

1. UIC Investigator Responsibilities, Protection of Human Research Subjects

2. Informed Consent Document(s):

a) CHEERS (Parental Permission), Ver. 1, June 18, 2007

b) CHEERS (Consent), Version. 1, June 18, 2007

3. Assent Document(s):

a) CHEERS_assent_ver.1 June 18, 2007

4. Recruiting Material(s):

a) "Be part of a research study about water quality and your health!" Flyer;

CHEERS ver.1_June 18, 2007

Page 4 of 4

cc:

Rosemary Sokas, MD, MOH, Environmental and Occupational Health, M/C 922

QAPP 2

Appendix 12

Thermal Wristband Barcoding Technology

Zebra Wrist Band Solutions

Web Link :http://healthcare.infologixsys.com/products/Products/Barcode/Patient-

Identification-Wristbands/Zebra-Wrist-Band-Solutions/default.asp

A premium direct thermal wristband that provides automated ID verification for

hospitals and other facilities seeking to boost efficiency and accuracy. Wrist band labels

are also available with UV varnish, which provides excellent chemical resistance for

printed information. Thermal wristbands are ideal for any environment where the

accuracy of information is critical to providers.

Zebra wristbands and thermal printers are designed to perform together as a

complete, optimal bar code wristband print solution -- ensuring the highest quality results

for uncompromised patient safety. Easy to operate and load, Zebra's all-in-one solution

makes it extremely simple for anyone to quickly create legible, accurate, reliable bar

coded wristbands. As a result, CHEERS team members can quickly print Case ID

wristbands for each subject with minimal instruction.

Zebra Z-Band Direct Wristbands

•

Direct thermal printing

•

Clinically proven antimicrobial coating

•

Pressure-sensitive adhesive tab

•

Six color options

•

Three sizes: adult, pediatric and infant

Z-Band QuickClip Wristbands

•

Direct thermal printing

•

Clinically proven antimicrobial coating

•

Secure, clip closure

•

Antimicrobial coating

•

Six color options

•

Two sizes: Adult (1 3/16" x 11") and infant (1" x 7")

The Z-Band Zebra direct thermal wristbands feature an inorganic ionic silver coating that

kills microorganisms that come into contact with it. As the silver ions are taken into the

microorganisms, they react and bond to the cellular enzyme. This inhibits the

microorganism enzyme activity and multiplication, which eliminates them.

Zebra’s antimicrobial coating has been clinically proven to prevent the growth and

survival of the following microorganisms on patient id wristbands:

Z-Band Zebra Direct Thermal Wristbands

•

Priners are easy to use

: within seconds you can print and secure the patient

identification wristband.

•

Highly durable

: they’re specially coated to resist water, soaps, chemicals and

other elements so the printed bar codes remain crisp and scannable for up to 14

days. Zebra patient wristbands are scannable after repeated exposure to water and

common solvents, including isopropyl alcohol, ethyl rubbing alcohol, Betadine,

and Purell.

•

Zebra patient wristbands offer superior tensile strength.

•

Zebra patient wristbands are unlikely to cause skin irritation.

Benefits with Zebra Patient Identification

Designed to work together to create a complete bar coded wristband solution, Zebra's

direct thermal printers and Z-Band direct thermal wristbands with antimicrobial coating:

•

Produce bar codes that remain legible and scannable for the duration of a subjects

participation in the field surveys.

•

Significantly reduce errors by automating access to accurate participant

information.

•

Satisfy participant safety and privacy standards set by IRB.

Zebra Barcode Printer - Model S4M

•

Affordable choice for high-volume wristband printing

•

Full 8" wristband roll capacity

•

Wide range of connectivity options

Zebra Barcode Thermal Printer - Model H 2824-Z

•

Economical and compact

•

Print on a variety of patient id wristband types and sizes

QAPP 2

Appendix 13

Survey Methods Field Report

CHEERS

Field Progress Report/Unusual Occurrence Report for Data Managers

Location:

Date:

Time:

Staff Members:

Shift 1:

Shift 2:

Data:

Consent

Forms

Field Survey A

Field Survey B

1. Equipment and Supplies Issues: (battery/scanner issues, start up etc)

2. Data Transfer Issues:

Case ID range given out today-

Laptop numbers used in the field today-

Data downloaded from all laptops: YES

3. Interviewer Issues: (absenteeism, non-compliance etc)

_________’W’ did not show up on time.

______________________________________________________________________________________

__________________________________________________

Was time sheet completed? YES

Was field supervisor informed about any interviewer issues? YES NO

4. Participant Issues: (Lost wrist bands, incomplete surveys etc)

John Doe lost his wrist band. We looked up his consent form and completed survey B.

Case ID 200902 and 200967 did not return to complete survey B.

5. Site Factors: (weather, set up site etc)

QAPP 2

Appendix 14: Field Maps of Recruitment Areas

QAPP 2

Appendix 14A

Maps of Recruitment Areas

Alsip Boat Launch

Alsip Boat Launch – CAWS

Tent & table set-up

(tack symbol)

1. Near Boat Launch and parking lot

**CAWS Use Survey Required**

Mobile recruiting: See circled area for recruiting area – use mobile unit as necessary.

Site Permission: Cook County Right of Entry Agreement (in emergency about site

permission, contact Vito Benignole at 708-906-1561 (cell))

Teams/Clubs: None

General Target Participants:

Bikers, walkers, runners and other non-water recreators

QAPP 2

Appendix 14B

Maps of Recruitment Areas

Belmont Harbor

Belmont Harbor – GUW

Tent & table set-up

(tack symbol)

1. 41/N. Lake Shore to parking lot on North side of harbor

2. Belmont Ave. to parking lot on South side of harbor

Mobile recruiting: See circled areas. Mobile recruiting necessary from each tent location.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

General Target Participants:

•

Boaters (not sailors)

•

Fishermen

•

Bikers, walkers and runners and other non-water recreators

QAPP 2

Appendix 14C

Maps of Recruitment Areas

Burnham Harbor

Burnham Harbor - GUW

Tent & table set-up

(tack symbol)

1. Near parking lot and paths

Mobile recruiting: See circled areas. Area on other side of harbor also possibility if there

are enough staff and someone is willing to walk all the way over there.

NOTE: Data manager – get 1 extra mobile recruiting folder from supply manager.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: None

General Target Participants:

•

Fishermen and boaters

•

Bikers, runners and other non-water recreators

QAPP 2

Appendix 14D

Maps of Recruitment Areas

Busse Lake Boating Center

Busse Lake Boating Center - GUW

Tent & table set-up

(tack symbol)

1. Near boat rental facility

Mobile recruiting: See circled areas.

NOTE: Data manager – get 1 extra mobile

recruiting folders from supply manager.

Site Permission

: Cook County Right of Entry Agreement (in emergency about site

permission, contact Vito Benignole at 708-906-1561 (cell))

General Target Participants:

•

Boaters, paddlers and rowers

•

Fishermen

•

Bikers, walkers and runners and other non-water recreators

QAPP 2

Appendix 14E

Maps of Recruitment Areas

Chicago Dragon Boat Race

Chicago Dragon Boat Race – CAWS

(

Ping Tom Park, 300 W. 19

St., Sat. 7/26)

Tent & table set-up

tack symbol)

1. On grass near main pavilion – location is flexible as long as it is in a visible place.

**CAWS Use Survey Required**

Supply Manager:

No vehicles are allowed on the park site between 7:00am - 4:00pm. All unloading of

equipment by car must be done strictly before 7:00am

on the day of the races. There

is only one entrance into the park and this pathway is relatively narrow. To navigate

vehicles whilst there is on foot traffic has been seen in the past to be incredibly dangerous

and hazardous. As a direct result of this, the Chicago Police is strongly enforcing this

rule this year. In addition, on the day of the event the park is still open to the general

public therefore increasing the amount of pedestrians in the park on this day. However,

should you wish to unload your equipment on foot and utilize hand trolleys, you are

welcome to do so. The event is scheduled to finish at approximately 4:00pm and again,

no vehicles are allowed before this time.

Parking:

In terms of parking facilities in Chinatown, there is street and metered parking as well as

2 Chinatown Parking Lots, both located on Wentworth Avenue (between 19th St. and

Cermak Road). Parking between 3-12 hours costs $16, whilst 12-24 hours costs $25. I

would strongly recommend you arrive early as possible as previous years have proven

that parking fills up by 9:00am. Parking in general on most days here in Chinatown is

limited, and it will be even more so on the day of the event. You have been warned!

Mobile recruiting: None. No extra mobile recruiting folders necessary.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office), and Chicago Dragon

Boat Race/ Chinatown Chamber of Commerce.

Teams/Clubs: None

General Target Participants:

•

Paddlers –

Dragon boat racers

•

Bikers, walkers, runners and other non-water recreators

QAPP 2

Appendix 14F

Maps of Recruitment Areas

Chicago Sprints

Chicago Sprints @ Lincoln Park Boat Club - GUW

Tent & table set-up: Near registration/ check-in tent (see LPBC staff for directions).

Time: 7:30am – 7pm

Parking: Supply manager –drop off supplies and park on street, either Canon or

Stockton. If you don't mind paying the zoo fees, just park in the zoo lot by the boathouse.

NOTE: let coaches and others who check in know about the study, they'll be the ones who

decide whether and when to send their athletes to you.

Mobile Recruiting: May be useful if team members do not want to come to table.

Site Permission: LPBC – Steve Neumann

Teams/Clubs: Lincoln Park Boat Club

Target Participants:

•

Rowers involved with the Chicago Sprints tournament –

ELIGIBILTY!

recreators

QAPP 2

Appendix 14G

Maps of Recruitment Areas

Clark Park

Clark Park – CAWS (

3400 N. Rockwell St., Chicago IL 60618)

Tent & table set-up

tack symbol)

1. Near Chicago River Canoe & Kayak rental facility

**CAWS Use Survey Required**

Mobile recruiting: See circled areas. No extra mobile recruiting folders necessary.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: None

General Target Participants:

Bikers, walkers, runners and other non-water recreators

QAPP 2

Appendix 14H

Maps of Recruitment Areas

Crystal Lake

Crystal Lake - GUW

Recruiting sites: Boat launch

Site Permission: Crystal Lake Rowing Club, contact Arne Arnesen, (815) 356-9215.

Teams/Clubs: Crystal Lake Rowing Club – only participants recruiting.

Recruiting Method: Tent and table set-up. No mobile recruiting necessary.

QAPP 2

Appendix 14I

Maps of Recruitment Areas

Diversey Harbor

Diversey Harbor - GUW

Tent & table set-up

(tack symbol)

1. Northern boat launch

Mobile recruiting: See circled areas. No extra mobile folders needed.

Site Permission

: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs

: none

General Target Participants:

•

Boaters (no sailboats)

•

fishermen

•

Bikers, walkers and runners and other non-water recreators

QAPP 2

Appendix 14J

Maps of Recruitment Areas

Lake Arlington

Lake Arlington – Sea Kayak Extravaganza - GUW

Tent & table set-up

(tack symbol)

1. In between both boat docks

Mobile recruiting: See circled area.

Site Permission: Lake County Forest Preserve Right of Entry Agreement.

Clubs/Teams: The Northwest Passage – Contact: Nancy Vedder.

General Target Participants:

•

Paddlers, rowers and boaters

•

Fishermen

•

Bikers, walkers and runners and other non-water recreators

QAPP 2

Appendix 14K

Maps of Recruitment Areas

Leone Beach

Leone Beach - GUW

Tent & table set-up

(tack symbol)

1. Next to Kayak Chicago rental facility at beach

Mobile recruiting: At DM’s discretion.

Site Permission

: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs:

None

General Target Participants:

Kayak Chicago

Non-water recreators at park south of rental facility – baseball diamonds and

basketball court

QAPP 2

Appendix 14L

Maps of Recruitment Areas

Lincoln Park Boat Club

Lincoln Park Boat Club - GUW

Tent & table set-up (

tack symbol)

1. Near Lincoln Park Boat Club boathouse - lagoon is between Lake Shore Drive and

Cannon Dr.

Mobile Recruiting: See circled areas. No extra mobile recruiting folders necessary.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: Lincoln Park Boat Club – events, classes, recreators. Contact: Steve

Neumann.

General Target Participants:

•

Paddlers and rowers at the boat club –

make sure to go through eligibility

screening!!

•

Bikers, walkers, runners and other non-water recreators

QAPP 2

Appendix 14M

Maps of Recruitment Areas

Mayor Daley’s Fishing Festival

Mayor Daley’s River Fishing Festival – CAWS

Tent & Table set-up

(tack symbol)

1. N. Columbus & East Wacker.

Directions for SM: Go Roosevelt to Columbus drive (just east of state and west of LSD). Go north on

Columbus. You'll drive underground at Randolph (near Frank Ghery Band Shell), keep going north (you're

now on lower columbus). Look out for 'CENTRAL AUTO POUND' signs, they will help to guide you. Pass

Lake. Take a left at 'South Water'... this is where it gets tricky. You want to turn onto the part of the street

that looks like a ramp heading downward (on the map it is called the 'service level' or something). Drive

down the ramp. Stetson should be the next street. Take a right. You're now on the 'service level' it is one

level below both lower wacker and lower columbus. Stetson deadends at the Wacker Service level. Take a

right. Go straight past the Columbus service level street and head straight for the autopound at the very end

of the street (if you look to your left, you'll see a gap in the concrete/fence that opens to the bikepath and a

grassy knoll w/ bike rental place -- that's your goal). The street (Wacker Service level) does a U-turn @

autopound, follow the turn. Pull up in front (or near) the gap in the gate/concrete. Look for your team...

unload... have a great CHEERS day.

**CAWS Use Survey Required**

Site Permission: Chicago Park District Right of Entry Agreement. In emergency concerning park officers,

contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: None

General Target Participants:

•

Fishermen

•

Non-water okay but not priority

Mobile recruiting ESSENTIAL! DM – get 2 extra mobile folders from SM

QAPP 2

Appendix 14N

Maps of Recruitment Areas

Montrose Beach

Montrose Beach - GUW

Tent & table set-up

(tack symbol)

1. Next to Kayak Chicago rental facility at beach

2. Near harbor – ONLY TABLES & CHAIRS IF AVAILABLE

Mobile recruiting: See circled areas.

NOTE: Data manager – get 2 extra mobile

recruiting folders from supply manager.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: None

General Target Participants:

Kayak Chicago

Fishermen and boaters at north and south sides of harbor

•

Bikers, runners and other non-water recreators

QAPP 2

Appendix 14O

Maps of Recruitment Areas

North Ave. at Kingsbury

North Ave. @ Kingsbury – CAWS

Tent & table set-up

(tack symbol)

1. On pavement/sidewalk down the hill past the parking lot by Old Navy.

**CAWS Use Survey Required**

Mobile recruiting: No mobile recruiting necessary. See circled area for general recruiting.

Site Permission: Private property, we’re there at the invitation of the rowing club.

Contact: Mike Wallin – head coach.

Teams/Clubs:

•

Lincoln Park Juniors (LPJ)

General Target Participants:

•

Rowers on LPJ team

•

Non-water recreators (sometimes rowers go to a gym to work out during practice

– they are still eligible as unexposed)

QAPP 2

Appendix 14P

Maps of Recruitment Areas

North Ave. at Magnolia

North Ave. @ Magnolia – CAWS

Tent & table set-up

(tack symbol)

1. On pavement/sidewalk outside of kayak/rowing facility (unless otherwise given

permission to come inside gates).

**CAWS Use Survey Required**

Mobile recruiting: Mobile recruiting not necessary. See circled area for general

recruiting.

Site Permission: Metropolitan Water Reclamation District

Teams/Clubs:

•

Kayak Chicago – rental facility & tours (contact: Dave Olsen)

•

University of Chicago

•

Ignatius Chicago Crew

•

Lincoln Park Boat Club men’s and women’s rowing teams (contact: Steve

Neumann)

General Target Participants:

QAPP 2

Appendix 14Q

Maps of Recruitment Areas

Skokie Lagoons

Skokie Lagoons - GUW

Tent & table set-up (

tack symbol)

1. Tower Rd. Boat launch

Mobile recruiting: See circled areas. No extra mobile recruiting folders necessary.

Site Permission: Cook County Right of Entry Agreement (in emergency about site

permission, contact Vito Benignole at 708-906-1561 (cell))

Teams/Clubs: Chicago Kayak Club, Chicago River Canoe & Kayak, and The Northwest

Passage.

NOTE: Classes given by Chicago Kayak and The Northwest Passage teach

rolling/rescuing; therefore, those people are not eligible for the study.

General Target Participants:

•

Kayakers and canoers put in at the boat launch, along with some boaters who are

usually fishing off their boats.

•

Fishermen need to be searched for – they are not usually near the boat launch.

•

Bikers – more of a priority here than at other sites, but all non-water recreators

eligible

QAPP 2

Appendix 14R

Maps of Recruitment Areas

Skokie Rowing Center

Skokie Rowing Center – CAWS

3220 Oakton St., Skokie IL 60076 (aka Dammrich Rowing Center)

Tent & table set-up

(tack symbol)

1. Next to pavilion where Chicago R. Canoe & Kayak sets up.

DO NOT

set up under the pavilion.

**CAWS Use Survey Required**

Mobile recruiting: See circled area. No extra folders needed, but recruit non-water recreators in rest of

the park north of tent.

Site Permission: Village of Skokie

Teams/Clubs:

•

Chicago River Canoe & Kayak has a rental facility (open 10am – 6pm) and hosts classes Sat. &

Sun. 10am and 1pm. Contact: Ryan Chew.

•

Northwestern University rowing club

•

North Park University Vikings (women’s crew),

note: cannot accept incentives

•

North Park University men’s club

•

New Trier High School Rowing

•

Loyola Academy – students

DO NOT

have permission to participate in study

•

Woodlands Academy – we do not have any agreement with them

General Target Participants:

•

Paddlers and rowers

•

Fishermen (occasionally)

•

Bikers, walkers and runners are okay but not priority.

QAPP 2

Appendix 14S

Maps of Recruitment Areas

Solidarity Drive

Solidarity Drive - GUW

Tent & table set-up

(tack symbol)

1. On E. Solidarity Dr. in between Aquarium and Planetarium

2. In front of Aquarium

Mobile recruiting: See circled areas. There is a lot of ground to cover so do what you can

with the staffing available.

NOTE: Data manager – get 2 extra mobile recruiting folders from supply manager.

Site Permission: Chicago Park District Right of Entry Agreement. In emergency

concerning park officers, contact Brian Loll, 773-761-8674 (office).

Teams/Clubs: None

General Target Participants:

•

Fishermen and boaters

•

Bikers, runners and other non-water recreators

QAPP 2

Appendix 14T

Maps of Recruitment Areas

Tampier Lake

Tampier Lake Boating Center - GUW

Tent & table set-up

(tack symbol)

1. Next to boat launch

Mobile recruiting: See circled areas. No extra mobile recruiting folders needed.

Site Permission: Cook County Right of Entry Agreement (in emergency about site

permission, contact Vito Benignole at 708-906-1561 (cell))

Teams/Clubs: None

General Target Participants:

•

Kayakers and canoers

•

Fishermen and boaters

•

Non-water recreators

QAPP 2

Appendix 14U

Maps of Recruitment Areas

Worth Boat Launch

Worth Boat Launch – CAWS

Table & tent set-up

(tack symbol)

1. Near Boat Launch

**CAWS Use Survey Required**

Mobile recruiting: See circled areas.

NOTE: Data manager – get 1 extra mobile

recruiting folder from supply manager.

Site Permission: Cook County Right of Entry Agreement (in emergency about site

permission, contact Vito Benignole at 708-906-1561 (cell))

Teams/Clubs: None

General Target Participants:

•

Boaters

•

Fishermen by aeration SEPA site

(star marker)

•

Bikers, walkers, runners and other non-water recreators

QAPP 2

Appendix 15:

Location Specific Flier for Lake

QAPP 2

Appendix 16: Adult Consent Form

The purpose of asking you questions is to learn more about any illness you may experience and

how you were exposed. It will take 8-10 minutes or less to complete. Answering the

questionnaire is voluntary. You may choose not to answer any question for any reason

In addition, some participants will be selected for a home visit by study staff. If you are selected,

this could involve collecting a sample (such as a stool sample or a “pink eye” sample) so the

laboratory can analyze any infection you may have. If a stool sample is required, we’ll need to

collect 3 samples over a one week period. The purpose of getting stool samples is to test for

bacteria, viruses, and parasites. This testing involves no risk to you. We will store your specimen

indefinitely and potentially test the samples for other microbes, or for chemicals related to health

or the environment, in the future.

What are the potential risks and discomforts?

The research has no major physical risks or discomforts other than the time involved and the

potential loss of privacy during the follow-up home visit. If you undergo the study nurse’s

examination of your eyes, ears or skin, you may feel a little uncomfortable, while you are being

checked. You may feel a little uncomfortable while answering certain questions during the

survey/interview. You have the right to refuse to answer any questions at any time. If you are

selected for a home visit, we will call to set up an appointment based on your convenience before

we make the visit.

You may be concerned about how we will store/protect your data. We will do our best to protect

your confidentiality and to keep the results of any test (in case we ask you for stool or eye/skin

discharge samples) private.

When the results of the research are published or discussed in

conferences, no information will be included that would reveal your identity.

Are there benefits to taking part in the research?

There are no direct benefits to you from being in this research. If a stool or other sample is

collected, you will be notified of the results, along with advice to share those results with your

physician. If you do not have a physician we will give you a directory of low cost clinics in the

Chicago area. We will also provide you with information sheets about this condition.

The results from this study may or may not benefit people who particiapte in outdoor activities

along Lake Michigan and Chicago River. Our findings could help establish a set of better water

quality standards.

Will I be told about new information that may affect my decision to participate?

During the course of the study, you will be informed of any significant new findings (either good

or bad), such as changes in the risks or benefits resulting from participation in the research or

new alternatives to participation, that might cause you to change your mind about continuing in

the study. If new information is provided to you, your consent to continue participating in this

study will be re-obtained.

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CHEERS Version 5, July, 2008

What about privacy and confidentiality?

The only people who will know that you are a research subject are members of the research

team. No information about you, or provided by you during the research will be disclosed to

others without your written permission, except:

- if necessary to protect your rights or welfare (for example, if you are injured and need

emergency care or when the UIC Institutional Review Board monitors the research or

consent process); or

- if required by law. This could happen if we collect a stool sample from you and we find

that you have an infection caused by certain germs (like Salmonella and several others).

We will be required by law to notify the Illinois Department of Public Health, which

helps track cases of infections. The Illinois Department of Public Health will not share

your personal information.

We respect your privacy. All computer files with identifiers will be password-protected. Any

hard copies of the forms/files will be stored in locked cabinets and will be destroyed as soon as

data collection is complete. When the results of the research are published or discussed in

conferences, no information will be included that would reveal your identity.

What if I am injured as a result of my participation?

No injury is expected to occur as a result of your participation in this research. In the event of

injury related to this research, treatment will be available through the UIC Medical Center.

However, you or your third party payer, if any, will be responsible for payment of this treatment.

If you feel you have been injured, you may contact Sara Wuellner at 312-996-2094.

What are the costs for participating in this research?

There are no costs to you for participating in this research.

Will I be reimbursed for any of my expenses or paid for my participation in this research?

You could receive a total of up to $125 in cash and gift cards for participating in this research

according to the following schedule:

If you decide to participate, we will give you a T-shirt plus a $15 gift card after you have

answered the questions before you go home today.

Six to eight weeks after completing the three follow-up telephone interviews: $35 (Remember

the final follow-up phone call will be 3 weeks from today)

If you are selected for a home visit, after providing an eye or skin drainage swab, or 3 separate

stool samples: $75

Money will be paid in the form of a check made out to you and mailed to your home address.

Alternately, if you are enrolling in the study as a member of a rowing, boating, cycling, running,

or other sports team/club, you have the option to donate part or all of your compensation to the

team.

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CHEERS Version 5, July, 2008

Can I withdraw or be removed from the study?

Your participation in this research is VOLUNTARY. If you choose not to participate, that will

not affect your relationship with UIC or your right to health care or other services to which you

are otherwise entitled. If you decide to participate, you are free to withdraw your consent and

discontinue participation at any time without affecting your future care at UIC.

Who should I contact if I have questions?

The researcher conducting this study is Dr. Sam Dorevitch. You may ask any questions you

have now. If you have questions later, you may contact the researchers at: 312-996-2094.

What are my rights as a research subject?

If you feel you have not been treated according to the descriptions in this form, or you have any

questions about your rights as a research subject, you may call the Office for the Protection of

Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll-free) or e-mail

OPRS at

uicirb@uic.edu

Remember:

Your participation in this research is voluntary. Your decision whether or not to participate will

not affect your current or future relations with the University. If you decide to participate, you

are free to withdraw at any time without affecting that relationship.

You will be given a copy of this form for your information and to keep for your records.

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CHEERS Version 5, July, 2008

Signature of Subject or Legally Authorized Representative

I have read (or someone has read to me) the above information. I have been given an opportunity

to ask questions and my questions have been answered to my satisfaction. I agree to participate

in this research. I have been given a copy of this form.

Signature

Date

Printed Name

Signature of Researcher

Date (must be same as subject’s)

Printed name of Researcher

Signature of Witness (if appropriate)

Date (must be same as subject’s)

Printed name of Witness (if appropriate)

OPTIONAL

I don’t want to receive any money for this research. Please donate my incentives to:

My team/club. The name of the team/club is___________________________________

Friends of the Chicago River

The CHEERS research study

Signature__________________________________

Date__________________

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CHEERS Version 5, July, 2008

QAPP 2

Appendix 17: Parental Consent Form

recreation on the day you child enrolls in the study and briefly about how the child is feeling and

their recent activities. Continuing in the study will involve you or your child answering a series

of telephone questions 2, 5 and 21 days from the day your child enrolls in the study.

The purpose of asking the questions is to learn more about any illness your child may experience

and how they were exposed. It will take 8-10 minutes to complete. Answering the questionnaire

is voluntary. You and your child may choose not to answer any question for any reason.

In addition, some participants will be selected for a home visit by study staff. If your child is

selected, this could involve collecting a sample (such as a stool sample or a “pink eye” sample)

so the laboratory can analyze any infection they may have. If a stool sample is required, we’ll

need to collect 3 samples over a one week period. The purpose of getting stool samples is to test

for bacteria, viruses and parasites. This testing involves no risk to your child. We will store

your child’s specimen indefinitely and potentially test the samples for other microbes, or for

chemicals related to health or the environment, in the future.

What are the potential risks and discomforts?

The research has no major physical risks or discomforts other than the time involved and the

potential loss of privacy during the follow-up home visit (if your child falls ill). If your child

undergoes the study nurse’s examination of his or her eyes, ears or skin, he or she may feel a

little uncomfortable while being checked. Your child may feel uncomfortable while answering

certain questions during the survey/interview. You and your child have the right to refuse to

answer any question at any time. We will call for follow-up phone interviews at a time

convenient for you and your child.

You may be concerned about how we will store/protect your child’s data. We will do our best to

protect your child’s confidentiality and to keep the results of any test (in case we ask your child

for stool or eye/skin discharge samples) private.

When the results of the research are

published or discussed in conferences, no information will be included that would reveal

your child’s identity.

Are there benefits to taking part in the research?

There are no direct benefits to your child from being in this research. If a stool or other sample is

collected, you will be notified of the results, along with advice to share those results with your

physician. If you do not have a physician will be given a directory of low cost clinics. You will

also be given a printed fact sheet about the condition.

The results of this study may or may not benefit people who particiapte in out door activities

along Lake Michigan and Chicago rivers and lakes. Our findings could help create a set of better

water quality standards.

Will I be told about new information that may affect my/ my child’s decision to

participate?

2 of 5

CHEERS Parental Consent, Version 5, July 9, 2008

During the course of the study, you and your child will be informed of any significant new

findings (either good or bad), such as changes in the risks or benefits resulting from participation

in the research or new alternatives to participation, that might cause you to change your mind

about continuing in the study. If new information is provided to you, you and your child will be

asked to consent again to continue participating in this study.

What about privacy and confidentiality?

The only people who will know that your child is a research subject are members of the research

team. No information about your child, or provided by you during the research will be disclosed

to others without written permission from you, except:

- if necessary to protect his/her rights or welfare (for example, if your child is injured and

need emergency care or when the UIC Institutional Review Board monitors the research

or consent process); or

- if required by law. This could happen if we collect a stool sample from your child and we

find that he or she has an infection caused by certain germs (like Salmonella and several

others). We will be required by law to notify the Illinois Department of Public Health,

which helps track cases of infections. The Illinois Department of Public Health will not

share your child’s personal information.

We respect your child’s privacy. All computer files with identifiers will be password-

protected. Any hard copies of the files will be stored in locked cabinets and will be destroyed as

soon as data collection is complete. When the results of the research are published or discussed

in conferences, no information will be included that would reveal you and your child’s identity.

What if my child is injured as a result of my participation?

No injury is expected to occur as a result of your participation in this research. In the event of

injury related to this research, treatment will be available through the UIC Medical Center.

However, you or your third party payer, if any, will be responsible for payment of this treatment.

If you feel your child has been injured, you may contact Sara Wuellner at 312-996-2094.

What are the costs for participating in this research?

There are no costs to you/your child for participating in this research.

Will my child be reimbursed for any of my expenses or paid for my participation in this

research?

Your child could receive a total of up to $125 in cash and gift cards for participating in this

research according to the following schedule:

If your child decides to participate, they will be given a T-shirt plus a $15 gift card after they

have answered the questions before they go home on the day they enroll in the study.

Six to eight weeks after completing the three follow-up telephone interviews: $35 (Remember

the final follow-up phone call will be 3 weeks from the day they enroll in the study)

3 of 5

CHEERS Parental Consent, Version 5, July 9, 2008

If your child is selected for a home visit, after providing an eye or skin drainage swab or 3

separate stool samples: $ 75

Money will be paid in the form of a check made out to your child and mailed to your home

address. Alternately, your child has the option to donate their compensation to the rowing team

to which they belong, if they so desire.

Can my child withdraw or be removed from the study?

Your child’s participation in this research is VOLUNTARY. If you/your child choose not to

participate, that will not affect your relationship with UIC or your right to health care or other

services to which you are otherwise entitled. If you decide to allow your child to participate, you

are free to withdraw your consent and discontinue participation at any time without affecting

your future care at UIC.

Advance consent

Children (and adults) can enroll in this research as often as every 21 days. Each time they would

receive the same set of financial incentives (gift cards and checks). This research study will seek

to recruit members of rowing teams and other sports team/clubs several times during the 2008

season. If your child is on a team/club, you can check a box on the signature page of this form,

that would allow your child to enroll and re-enroll into the study when the CHEERS research

staff are recruiting members of the team, even if you aren’t present. You can withdraw your

permission at any point by contacting the CHEERS team at (312)996-2094 or (312)355-3629.

Who should I contact if I have questions?

The researchers conducting this study are Dr. Sam Dorevitch and Dr. Preethi Pratap. You may

ask any questions you have now. If you have questions later, you may contact the researchers at:

312-996-2094.

What are my child’s rights as a research subject?

If you feel your child has not been treated according to the descriptions in this form, or you have

any questions about your child’s rights as a research subject, you may call the Office for the

Protection of Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll-free) or

e-mail OPRS at uicirb@uic.edu

Remember:

Your child’s participation in this research is voluntary. Your decision whether or not to allow

your child to participate will not affect your current or future relations with the University. If you

agree to participation, you and your child are free to withdraw at any time without affecting that

relationship.

You will be given a copy of this form for your information and to keep for your records.

4 of 5

CHEERS Parental Consent, Version 5, July 9, 2008

Signature of Subject or Legally Authorized Representative

I have read (or someone has read to me) the above information. I have been given an opportunity

to ask questions and my questions have been answered to my satisfaction. I agree to allow my

child to participate in this research. I have been given a copy of this form.

OPTION 1

My child may enroll in this research whenever they are eligible.

My child may only enroll within 21 days of the date I sign this form.

My child may only enroll on the date I sign this form.

OPTION 2

I don’t want my child to receive any money for this research. Please donate his/her incentive

gift card and check(s) to:

His/her team/club. The name of the team/club is_______________________________

Friends of the Chicago River

The CHEERS research study

_________________________

Child’s Printed Name

Signature of parent or guardian

Date

Printed name of parent or guardian

Signature of Researcher

Date

Printed name of Researcher

5 of 5

CHEERS Parental Consent, Version 5, July 9, 2008

QAPP 2

Appendix 18: Assent Form

-.-if,Sii&1,$[it'S$l!#'*3T#$

QAPP 2

Appendix 19: Study Questionnaire Variables for Data Analysis

Appendix: Questionnaire Variable for Data Analysis

1. Health End-points: Acute Gastrointestinal Illness

Health-end points

AGI – Acute GI illness

1. Single symptom definition: the presence of any one of the following symptoms, as determined by telephone follow-up on day 2, 5

or 21 + No symptoms at baseline.

i. Abdominal cramps or stomach ache

2. Syndrome definitions :

i. Any two or more of the following symptoms + No symptoms at baseline

Vomiting

Diarrhea

Nausea

Stomach ache/abdominal cramps

ii. Highly credible GI illness (HCGI): in accordance with the definition posited by Cabelli et al (1982) + No symptoms at baseline

vomiting, or

ii.

diarrhea associated with fever, or

iii. stomach ache with fever, or

iv. nausea with fever, or

diarrhea with impact on daily activities

iii. EPA study GI illness definitions + No symptoms at baseline (Wade et al, 2006)

≥3

loose stools/24 hours, or

ii.

vomiting+ stomachache, or

iii. nausea + stomachache, or

iv. nausea with impact on activity, or

stomachache with impact on activity

2. Health End-point: Ear and Eye Illness

Health endpoints

Non-GI Illness Ear

1. Single symptom definition: the presence of any one of the following symptoms, as determined by telephone follow-up on day 2, 5 or 21

+ No symptoms at baseline

i. Earache or ear infection

2. Clinically proven: the presence of any one of the following symptoms, as determined by clinical evaluation during home visits (could be

left or right ear for each symptom)

i. Earache or pain with traction

v. Diagnosed with ear infection

vi. Antibiotic treatment

Non-GI Illness Eyes

1. Single symptom definition: the presence of any one of the following symptoms, as determined by telephone follow-up on day 2, 5 or 21

+ No symptoms at baseline

i. Eye irritation

ii. Drainage or crusty eyes

3. Health End-point: Dermal

Non-GI Illness Dermal

1. Single symptom definition: the presence of any one of the following symptoms, as determined by telephone follow-up on day 2, 5 or 21 +

No symptoms at baseline

i. Any area on the skin that are red, or sore, or draining

ii. Rash or Itchy skin

2. Clinically proven: the presence of any one of the following symptoms, as determined by clinical evaluation during home visits (could be

left or right ear for each symptom)

i. Warmth around the wound

ii. Tenderness

iii. Erythema

iv. Discharge

v. Antibiotic treatment (including type of antibiotic)

4. Health End-point: Upper Respiratory

Health endpoints

Non-GI Illness Upper Respiratory Illness

1. Single symptom definition: the presence of any one of the following symptoms, as determined by telephone follow-up on day 2, 5

or 21 + No symptoms at baseline

i. Sore throat

ii. Cough

iii. Cold/ Runny or stuffy nose

2. Syndrome definitions:

i. Any two or more of the following symptoms + No symptoms at baseline

Headache

Sore throat

Cough

Cold or runny or stuffy nose

Fever

Note: Only fever or headache with out any other symptoms is not considered an upper respiratory illness

ii. Respiratory illness in accordance with the definition posited by Colford et al (2007)

Cough with phlegm

5. Potential Confounder and/or Effect Modifiers: Demographics and others

Demographics and other

Distance traveled to the lake/river for outdoor activity

6. Concern about doing water sports in the Chicago River

6.Effect Modifiers and/or confounders: Pre-exposure Non-water-related GI factors

Effect Modifiers

A. Pre-exposure and health

1. Non-water related GI illness exposures

Animal contact

dog/cat

other animal (petting zoo/farm)

d. Store bought cold sandwich

e. Store bought cold salad

d. Fresh produce

Hamburger

Exposure to someone ill

at home

outside home

2. Environmental exposures

1. Recreational water exposure in past 7 days

2. Location of exposure- lake, river, beach, pool (Chicago river/lake/lagoon vs other places)

3. Get wet during water-recreational activity

3. Pre-existing health conditions

Chronic stomach illness/GI illness

vi. Inflammatory bowel syndrome

vii. Irritable bowel syndrome

viii. Other: Specify

Asthma/emphysema

diabetes

5. Antibiotic use in past 7 days

prone to infections

5. Average daily bowel movements

Effect modifiers and/or confounders: Post-exposure Non-water related GI factors

Effect Modifiers

B. Post-exposure and health

1. Non-water related GI illness exposures

Animal contact

dog/cat

other animal (petting zoo/farm)

d. Store bought cold sandwich

e. Store bought cold salad

d. Fresh produce

Hamburger

Exposure to someone ill

at home

outside home

2. Environmental exposures

1. Recreational water exposure since last contact

2. Location of exposure- lake, river, beach, pool (Chicago river/lake/lagoon vs other places)

3. Get wet during water-recreational activity

8. Behavioral Predictors of Illness: Activity-based indicators of exposure

Predictors

A. Activity 3 study groups.

1. Water- recreational activity (exposed groups)

1a. Type of water-recreational activity

1b. Location for launch and exit

1c. Duration of activity

1d. Wet while launching OR wade while fishing

2a. Non-water recreational activities (unexposed)

2b. Type of non-water recreational activity

B. Water exposure by activity

Canoeing or Kayaking or Rowing or Rafting or boating or sailing or fishing on a boat or fishing at the pier

Flip over (by accident)

ate/drank during or after activity on the water

2. washed hands before eating

Rubbing of eyes with hands

For fishermen

Type of bait (for handling exposure)

ii.

No: of fish 0, 1, 2,3, >3

iii. Will they eat the fish they caught

Table of Contents

A. PROJECT MANAGEMENT

Page

1. Distribution List

2. Project/Task Organization

3. Problem Definition/Background

4. Project Task/Description

5. Quality Objectives and Criteria

6. Special Training/Certification

7. Documents and Records

B. DATA GENERATION AND ACQUISITION

1. Sampling Process Design (Experimental Design)

2. Sampling Methods

3. Sample Handling and Custody

4. Analytical Methods

5. Quality Control

6. Instrument/Equipment Testing, Inspection, and Maintenance

7. Instrument/Equipment Calibration and Frequency

8. Inspection/Acceptance of Supplies and Consumables

9. Non-direct Measurements

10. Data Management

11. Archiving Clinical Specimens

12. Disease Reporting

C. ASSESSMENT AND OVERSIGHT

1. Assessments and Response Actions

2. Reports to Management

D. DATA VALIDATION AND USABILITY

1. Data Review, Verification, and Validation

2. Verification and Validation Methods

3. Reconciliation with User Requirements

Overall Project Management Structure for Survey Methods

Index of Documents and Records, Storage and Distribution

Table 2

Index of Analytic Methods for Clinical Specimens

CHEERS QAPP 3

iii

July 2008

List of Appendices

Appendix

Description

CHEERS Home Clinical Evaluation Form

Specimen Collection System

Letter to Study Participants

Conjunctivitis Rating Scale

Positive Culture Letter: Stool

Positive Culture Letter: Eye/Wound

Fact Sheets

Low Cost Clinics in Chicago

11A-C

Chain of Custody Log

UIH Laboratory: Stool Culture

UIH Laboratory: Stool Viral Culture

UIH Laboratory Protocol: Cryptosporidium

UIH Laboratory Protocol: Rotavirus

UIH Laboratory Protocol: Eye

UIH Laboratory Protocol: Wound

IDPH Laboratory Protocol: Shigatoxin

IDPH Laboratory Protocol: Norovirus

UIH Laboratory Details

UIH CLIA Certification

IDPH CLIA Certification

IDPH QA

UIH Laboratory Protocol: Archiving Samples and Long-term Storage

IDPH Laboratory Protocol: Archiving Samples and Long-term Storage

Unusual Occurrence Log

CHEERS QAPP 3

July 2008

Quality Assurance Project Plan 3: Clinical Evaluations and Microbial Analyses

A. PROJECT MANAGEMENT

1. Distribution List

UIC: S. Dorevitch, P. Scheff, M. Javor, P. Pratap, J. Wuellner, S. Wuellner,

T. Schoonover and all clinicians

MWRDGC: T. Granato

2. Project/Task Organization

The key members of the CHEERS study team involved in the clinical

evaluations and microbial analyses include the Study Director, Quality Manager,

Clinical Project Manager as well as the clinical staff. The Study Director will have

overall authority for the development and implementation of the study, hiring of

clinical staff involved in assessments and obtaining biologic samples for analyses,

and communicating with CHEERS study stakeholders. The Quality Manager will

establish overall data quality objectives for the CHEERS study and will be

responsible for reviewing the quality control data of the data collection process. The

detailed organizational structure is provided in the Study Overview.

The Clinical Project Manager (CPM), Jacqueline Wuellner, MPH, RN, is

responsible for maintaining the overall quality of the clinical evaluations and

specimen collection. The Project Manager is responsible for the following project

related tasks:

2.1 Assist in writing the application to University of Illinois at Chicago (UIC)

Institutional Review Board (IRB) for Human Subjects Research approval.

2.2 Develop protocols for obtaining and transporting clinical specimens.

2.3 Work with the University of Illinois Hospital (UIH) Microbiology Laboratory

and the Illinois Department of Public Health (IDPH) Microbiology Laboratory

to ensure proper protocols for specimen chain of custody are followed.

2.4 Ensure all clinical team members performing home visits to obtain culture

specimens are certified (and maintain certification) by the UIC IRB.

CHEERS QAPP 3

- 1 -

July 2008

2.5 Work with the Study Director to develop and conduct the appropriate training

methods for the clinical team.

2.6 Work with the UIC Survey Research laboratory (SRL) to identify all study

participants from whom clinical specimens are required for culture.

2.7 Work with a commercial courier service to ensure the prompt transport of stool

specimens from the home of the study participant to the UIH Microbiology Lab.

2.8 Train staff how to prepare for shipping Fisherbrand Commode Specimen

Collection kits (Fisher Health Catalog # 02-544-208) with instructions for use to

study participants identified during telephone interviews as candidates for stool

sample analysis.

2.9 Ensure that clinical specimens are archived for potential future analysis at the

IDPH microbiology lab.

2.10 Ensure that pathogens isolated in the UIH microbiology lab are archived for

potential future analysis.

2.11 Ensure all clinical team members are trained in assessment techniques and

proper specimen handling techniques before they begin working in the field.

2.12 Ensure availability of stool collection kits for distribution as needed.

2.13 Ensure all study participants are mailed project reminders within 5 days of

enrollment to promote phoning the CHEERS study nurse if gastrointestinal, eye

or skin symptoms develop at anytime during the 21-day active study period.

2.14 Implement adequate quality control methods to ensure accurate documentation

of clinical data and home visit data.

2.15 Work with the Survey Project Manager to ensure smooth flow of participants

through the phases of field, phone and clinical data collection.

2.16 Receive and properly store laboratory reports from the UIH Microbiology

laboratory and IDPH microbiology laboratory.

2.17 Notify the study participant by telephone within 24 hours of receipt of positive

results and provide via U.S. Postal Service health information sheets specific to

the participant’s infection.

2.18 Provide a directory of low-cost clinics to study participants who do not have a

personal health care provider as needed.

CHEERS QAPP 3

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July 2008

2.19 Provide timely feedback and reports to the CHEERS Study Quality Manager and

Study Director throughout the clinical data collection process.

The clinical staff will be responsible for completing home visits to collect the appropriate

specimens from those participants reporting eye drainage, wound drainage, or redness.

During the home visit, the clinician will complete an assessment, document findings and

obtain any clinical specimens required. Further staff duties include arranging home visits

with participants as required, transporting specimens to the UIC microbiology laboratory,

and communicating with the Clinical Project Manager daily, following any home visits

completed the previous evening. Also, the clinical staff will maintain an unusual

occurrence log to document and communicate any unexpected events that arise during a

S. Dorevitch, MD, MPH

CHEERS Clinical Staff

Clinical

IDPH Microbiology

G. Dizikes, PhD

Figure 1:

Overall Project Management Structure for Clinical Evaluations and Microbial

3. Problem Definition/Background

The overall scientific background and goals of the CHEERS study are outlined in

the Study Overview. The following sections will focus on development and

implementation of the CHEERS clinical data collection and microbial analyses

methods.

Problems specifically related to clinical evaluations and microbial analyses are:

3.1 Prior studies of recreational waterborne illness generally did not confirm

acute gastrointestinal illness and other infectious diseases by culture.

3.2 Prior studies had no basis for identifying the pathogens responsible for illness

among recreators.

4. Project/Task Description

The overall clinical project objectives are:

4.1 Develop CHEERS home visit clinical evaluation forms.

4.2 Ensure all clinicians are licensed health care professionals.

4.3 Develop a system for specimen collection from study participants and document

specific clinical findings at the time the culture specimen is obtained.

4.4 Provide specific training to clinical staff to evaluate conjunctivitis using the

conjunctiva grading scale, and assess as well as measure skin lesions.

4.5 Train all clinical staff how to collect, label and transport a biologic specimen,

maintaining sample integrity at all times.

4.6 Perform follow-up home visits and sample collection as per protocol based on

participants’ answers to the follow-up telephone surveys.

4.7 Contract with courier service to pick up stool specimens from participants’

homes as needed and deliver the samples to UIC microbiology lab.

4.8 Work with the UIH and IDPH labs to develop a system to deliver and record

biologic specimens collected, and maintain a record of all results.

4.8.1 List of microbes of interest that we will be able to identify

Salmonella, Shigella, Yersinia, Plesiomonas,

Campylobacter, Aeromonas, Edwardsiella, E. Coli

0157:H7

Virus: norovirus, rotavirus, enteric adenovirus, enterovirus

Parasites:

Cryptosporidium spp., Giardia labmlia, Cyclospora,

Entamoeba histolytica

5. Quality Objectives and Criteria

5.1 Provide stool specimen collection kits to participants identified on follow-up

survey as needing such an evaluation, within 24 hours.

5.2 Transport 90% of stool samples to the UIH laboratory within 8 hours of sample

collection.

5.3 Make telephone contact with participants potentially requiring home visits for

evaluations of eye and skin symptoms, within 12 hours of notification by SRL

that a home visit may be warranted, based on participants’ symptoms.

5.4 Require 100% accuracy in sample handling/labeling/transport and receipt

in lab. The Clinical Project Manager will train all clinical staff in proper

handling and labeling of specimens and will maintain an unsatisfactory

specimen log to assure immediate correction of problems/inconsistencies.

5.5 Conduct consistent clinical assessments among clinical personnel.

6. Special Training/Certification

All clinical personnel will be licensed health professionals and therefore,

will only require specific training focused on documenting conjunctivitis using the

conjunctiva grading scale, and assessing and measuring skin lesions for accuracy and

consistency. Training will be conducted using didactic and interactive teaching

methods. Members of the clinical team will be required to verbalize standard procedure

protocols and perform return demonstrations indicating an acceptable mastery of the

7. Documents and Records

CHEERS Study

Clinical Documents

and Records

Personnel Responsible

for Developing and

Storage

Storage Type

Distribution List

QAPP # 3 with

appendices.

Clinical Project Manager

Computer file

Hard copy

All CHEERS study personnel

Clinical project manager

Computer file

Log book

Survey Project Manager

Clinical Project Manager

SRL training

completion

SRL/ ASD-Q

Computer file Training log

Survey Project Manager

Field Data Coordinator

Hard copy

All CHEERS clinical personnel

Clinical Project Manager

Clinical Project Manager

Paper-based forms

(logs)

Clinical project manager

Copied and stored in a

secure file folder

Clinical Project Manager

Clinical project manager

Computer file

Clinical Project Manager

Hard copy kept in Room 210

All CHEERS field personnel

Reminder mailing

Clinical project manager

Computer file

Hard copy kept in Room 210

Table 1: Index of Documents and Records, Storage and Distribution

Clinical Project Manager

A copy of the QAPP 3 will be stored in a binder with all other study-related QAPP

documents in the study office: Room 210, School of Public Health West. An additional

print copy will be with the Clinical Project Manager. An electronic copy will be stored

on the UIC Blackboard site, accessible to all clinical personnel.

CHEERS QAPP 3

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July 2008

B. DATA GENERATION AND ACQUISITION

1. Sampling Process Design

The study design, sample size calculations, sampling locations and rationale for the

design are outlined in the “Overview” document. The following sections will focus

on the development of sampling methods for the follow-up, home visit clinical

evaluations, and the collection/transport/analyses of biologic specimens.

1.1 Clinical evaluations for skin and eye symptoms

1.1.1 Home visits can be triggered by answers given during the follow-up

telephone surveys indicating the participant has eye crusting or drainage,

or has wound or skin drainage, or by the participant calling the study nurse

anytime during the 21-day active study participation period and reporting

symptoms of eye crusting or drainage, or wound or skin lesions or

drainage. Acute respiratory symptoms will not prompt a home visit, given

the limited value that such a visit would have in either identifying

pathogens or objectively establishing the presence of infection.

1.1.2 The clinician will contact the participant within 12 hours of notification to

determine the best time within the next 24 hours, for the home visit to

occur. The clinician will confirm the participant’s home address at this

time.

1.1.3 One member of the home visit team will confirm the appointment

with the participant, ideally 1 hour prior to the appointment, and

complete the visit at the appointed hour.

1.1.4 Wearing gloves, the clinician will complete an exam of the eyes, ears, and

skin. The clinician will also obtain swabs of any discharge. Culturette

tubes will be labeled and placed in a laboratory transport bag with the

appropriate requisition.

1.1.4.1 Conjunctivitis: Two swabs of the palpebral conjunctiva will be

obtained, one swab for bacterial culture and one swab for viral

culture obtained on a Dacron swab and placed in viral transport

1.1.4.2 Wound: Only wound discharge will be cultured. Scabbed-

over lesions or dry areas (such as cellulitis or a skin abscess) will not

be cultured, nor will study personnel attempt wound drainage.

1.1.5 The clinician will complete the Home Clinical Evaluation Form

(Appendix #1) prior to leaving the participant’s home.

1.1.6 The swabs obtained during the home visit will be delivered to the UIC

laboratory within 12 hours, either by the clinician or by courier.

1.2 Clinical Evaluations for Acute Gastrointestinal Symptoms

1.2.1 Reports of acute gastrointestinal (AGI) symptoms (diarrhea, vomiting,

acute abdominal cramping, unrelated to menstrual cramps), either during

follow-up telephone survey or by participant-initiated phone call will

trigger request for stool sample collection.

1.2.2 If AGI symptoms are reported during a routine follow-up telephone

survey, the participant will be sent (via FedEx) a package containing 3

Fisherbrand Commode Specimen Collection Systems (Appendix #2),

printed instructions for collection, and the courier service telephone

number for the participant to call when there is a sample for delivery to the

UIC laboratory. The interviewer will confirm the participant’s address for

delivery.

1.2.3 If a participant experiences AGI symptoms anytime during the 21-day

active study participation period they are encouraged to report those

symptoms to the Clinical Project Manager who will arrange for overnight

FedEx delivery of the stool collection kits (as noted in 1.2.2 above). All

participants are mailed a magnet with the nurse’s phone number and a

letter encouraging them to report any symptoms immediately (Appendix

#3).

1.2.4 The Survey Research Lab call center will generate a list of participants

reporting AGI symptoms to the Clinical Project Manager for follow-up the

1.2.5 Stool specimens will be collected three times on alternating days over a 5

day period from those reporting AGI symptoms to increase the likelihood

of detecting infection caused by

Giardia

1.3 Home Visit Protocol

1.3.1 Overview

Participants who report on telephone follow-up symptoms of eye drainage or

crusting, skin lesion or wound drainage will require a home visit conducted by a

licensed clinician (RN or MD). Additionally, participants may call the Clinical

Project Manager directly if they develop specific symptoms which would trigger a

home visit anytime during the 21 days of active study participation.

Based on the symptoms reported, the staff clinician will obtain specimens for

culture from the participant’s eye(s) or skin discharge. The clinician will also

document relevant physical findings on the paper-based Home Clinical

Evaluation form (Appendix #1).

The steps to be followed before and during a home visit include:

a. Telephone interviewer will inform the study participant that based on the

answers to the survey, a home visit, by a nurse or doctor for a brief follow-up

exam and to obtain eye or wound drainage samples, is required. Interviewer will

confirm the best telephone number to reach the study participant and indicate that

they will be getting a call from a member of the clinical staff within 12 hours.

b. Every two hours, the interviewer will notify the staff clinician via telephone or

e-mail, of any participants requiring a home visit who were identified in the

preceding 2 hours.

c. The staff clinician will consult the on-call list of project team members to

identify the appropriate team member that a home visit will occur within 24

hours, although preferably within 12 hours.

d. Each home visit team member will carry a cell phone and wear UIC

CHEERS study identification. The clinician will bring the home visit bag. The

CHEERS QAPP 3

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July 2008

clinician will follow study protocol for examining eyes (Appendix #4): obtaining

necessary samples, conducting a thorough evaluation, and completing required

documentation. Samples will be labeled and specimens will be entered into the

transport log.

e. One member of the home visit team will deliver the specimen to the UIC

Microbiology laboratory at 820 S. Wood Street, Room 215 or will contact the

courier for specimen delivery. .

f. The clinician will fax the Home Clinical Evaluation Form to the office of the

Project Manager - Questionnaire Data or personally deliver the form to that

manager.

g. The Survey Project Manager will be responsible for entering the data into a

desktop computer. Project Manager - Questionnaire Data will work with

CHEERS staff to complete the data entry and upload the files to the SRL server

(see transmittal procedures for all computer files in QAPP #2)

1.3.2 Technique for obtaining swab for culture of wound exudate

•

Wash hands and don gloves.

•

Explain procedure to subject.

•

Cleanse wound with sterile saline rinse.

•

Using aseptic technique, twirl the end of the sterile-tipped applicator stick on

one square centimeter area of the open wound for five seconds.

•

Insert the swab into the gel tube.

•

Label specimen and requisition form. Place in plastic specimen transport bag.

•

Transport immediately to the UIC laboratory for processing.

1.3.3 Technique for obtaining swab culture of eye drainage.

•

Wash hands and don gloves.

•

Explain procedure to subject.

•

Using aseptic technique, pull down the lower eyelid. Roll the swab along the

inside of the lower eyelid. Do not swab over the globe of the eye.

•

Replace the swab in the gel tube.

Label specimen and requisition form. Place in plastic specimen transport bag.

•

Transport immediately to the UIC laboratory for processing.

1.3.4 Protocol for arranging for courier pick up:

When the call center is notified of a sample ready for delivery, the call center

will either confirm that the participant has the courier contact information or the

call center will call the courier with name, address, and phone number of

participant. Specimen will be picked up and delivered to the UIC microbiology

lab within 3 hours of notification.

1.3.5 Subject notification of positive sample results:

If stool or other specimens collected are culture positive, participants will be

notified of the results via telephone and US mail, along with advice to share

those results with their physician (Appendices #5, #6). CDC fact sheets

pertaining to the particular microbe identified will be included with the

notification letter (Appendix #7). If the participant does not have a physician,

he/she will be given a directory with phone numbers of low cost clinics in the

Chicago area (Appendix #8).

2. Sampling Methods

There is no randomization or statistical approach for obtaining health information

from subsets of study participants. Clinical questions are asked of all study participants in

the field and telephone interviews. Clinical specimen collection is triggered by specific

responses to those questions among all study participants.

3. Sample Handling and Custody

3.1 Before concluding the home visit, the clinician will label the wound and eye

drainage specimens with subject’s Case ID number, date and clinician’s initials.

Afterwards, the clinician will place the samples in a plastic specimen transport

bag with the UIC requisition form.

3.2 The clinician will then complete the specimen chain of custody log (Appendix

#9) and terminate the home visit.

CHEERS QAPP 3

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July 2008

3.3 Immediately following the home visit, the clinician will deliver the specimens

to the UIC Microbiology lab, Room 215. The person receiving the specimens in

the lab will sign and date the specimen log. The clinician may elect to use the

courier service to deliver the specimen to the UIC lab. In which case, the courier

service would be called immediately upon termination of the home visit and

have the specimen delivered within 3 hours of notification.

3.4 Lab access – With building “swipe” access, specimens can be delivered

between 7:00 AM and 9:00 PM from Monday through Friday, 7:00 AM and

6:00 PM on Saturday, and 7:00 AM and 3:00 PM Sundays.

3.5 If the subject reports acute gastrointestinal illness and has already obtained and

labeled the stool sample, the courier will pick up the specimen. If

pick-up occurs after normal business hours, lab specimens can be delivered to

the UIH Microbiology laboratory’s loading dock via the “FED EX” bell.

4. Analytical Methods

4.1 Stool samples

Upon receipt of the sample in the UIC microbiology laboratory, an aliquot

of the sample will be removed from the stool sample container, placed in transport

medium, labeled, and then transferred to the IDPH microbiology laboratory by

courier for Norovirus and Shiga toxin analysis. The sample will be received and

tracked in the IDPH laboratory by established protocol, analyzing the samples by

real-time reverse transcriptase polymerase chain reaction.

Pathogen/

Lab and Analytical Method

Appendix #

Stool culture

UIC hospital microbiology lab

Stool culture

Stool viral culture

UIC hospital microbiology lab

Virus isolation specimens

Virus identification

Virus isolation identification

UIC hospital microbiology lab

Enteric protozoa by direct immunofluorescence

Rotavirus

UIC hospital microbiology lab

Rotavirus by enzyme immunoassay

Eye discharge

UIC hospital microbiology lab

Eye cultures

Wound discharge

UIC hospital microbiology lab

Wound Culture

Enterovirus

IDPH microbiology lab: Shigatoxin protocol

Norovirus

Table 2. Index of Analytic Methods for Clinical Specimens

IDPH microbiology lab: Norovirus by real-time reverse

transcriptase polymerase chain reaction

CHEERS QAPP 3

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July 2008

At the UIC hospital microbiology laboratory, stool samples will be analyzed for

enteric pathogens and protozoa, including Cryptosporidium and Giardia, following the

laboratory’s standard operating procedures by direct immunofluorescence. Stool

specimens will also be analyzed for rotavirus by enzyme immunoassay. Additionally,

specimens will be analyzed for the presence of enteroviruses by cell culture.

4.2 Eye swabs

Eye swabs will be analyzed by the UIC Hospital Microbiology Laboratory by

culture following the laboratory’s standard protocol (Appendix #14).

4.3 Wound swabs

Wound swabs will be analyzed by the UIC Hospital Microbiology Laboratory

by culture following the laboratory’s standard protocol (Appendix #15).

5. Quality Control

5.1 Quality Control Measures for Clinical Data Analysis

a. The UIC laboratory and IDPH laboratory are fully certified and have their own

internal QA/QC protocols (Appendices 18-21).

b. The laboratory’s QA manager will provide the Clinical Project Manager their

laboratory’s internal QC data on a quarterly basis for review.

5.2 Quality Control for Clinical Data Collection

5.2.1 The Clinical Project Manager will be responsible for ensuring the clinical

staff conforms to the study protocols.

5.2.2 Quality of the health assessment and sampling procedures will be assured

by consistent training of clinical staff and periodic review of home visit

evaluation forms and unusual occurrence logs.

5.2.3 Accuracy of the data entry will be ensured by staff training, before the start

of each year’s recreation season, and also through random quality

assurance checks throughout the season.

5.2.4 The unsatisfactory specimen log will indicate the frequency of incomplete,

poorly prepared, or incompletely identified specimens and the final

disposition of these samples (identified, unable to analyze due to lack of

proper identification, etc.).

CHEERS QAPP 3

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July 2008

5.2.5 The Clinical Project Manager will review the log, analyze for problem

areas, and report unsatisfactory outcomes. Clinical staff will be re-trained

as deemed necessary to maintain quality data outcomes.

6. Instrument/Equipment Testing, Inspection, and Maintenance

The UIC Hospital and IDPH laboratories are both certified laboratories with their

own QA/QC protocols. Instrument testing, inspection, and maintenance will be

conducted per their respective protocols. There are no instruments specific to

handling or analyzing CHEERS clinical specimens.

7. Instrument/Equipment Calibration and Frequency

The UIC Hospital and IDPH laboratories are both certified laboratories with their own

QA/QC protocols. Instrument calibration and frequency will be conducted per their

respective protocols. There are no instruments specific to handling or analyzing

CHEERS clinical specimens.

8. Inspection/Acceptance of Supplies and Consumables

The RN on call is responsible for inspection and maintenance of the home visit bag.

Contents will be listed on a checklist, stored in the bag. Missing items can be

replenished from the CHEERS stockroom.

Contents of the “Home Visit Bag”

1. Culturette tubes

2. Latex exam gloves

3. Biohazard (‘red”) bags for disposal

4. Otoscope

5. Disposable measuring tape

6. Clipboard and pen

7. Notebook

8. Home visit data forms

9. Sample ID labels

9. Non-Direct Measurements

Does not apply to this protocol.

CHEERS QAPP 3

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July 2008

10. Data Management

Home evaluation data will be uploaded by the Survey Project Manager and sent to

the SRL for analysis. All sample data will remain stripped of personal identifiers.

Logs of laboratory data will be kept by the Clinical Project Manager in a password-

protected computer file. All paper copies will be stored in a locked cabinet.

IDPH provides paper copies of all lab results directly to the Principal Investigator.

UIH provides paper copies of all lab results to the Clinical Project Manager. UIH

lab notifies the Clinical Project Manager by telephone immediately when an

abnormal result is obtained.

11. Archiving Clinical Specimens

When pathogens are identified in stool samples, both the UIH and IDPH

laboratories will freeze an aliquot of the sample in the sub-zero freezer for possible

future investigation. Additionally, IDPH lab will freeze a sample of all raw stool

received (Appendices # 22 and 23).

12. Disease Reporting

11.1 Notifiable Disease Reporting will comply with Illinois requirements.

In the context of this research, it is possible the cases of Giardiasis,

Cryptosporidiosis, Salmonellosis, Shigellosis will be identified. Less likely

cases of Yersiniosis, Shigatoxin-positive enteritis and Cyclosporiasis may be

reported. The Clinical Project manager will contact the Illinois Department of

Public Health and provide any information required by law.

CHEERS QAPP 3

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July 2008

C. ASSESSMENT AND OVERSIGHT

1. Assessments and Response Actions

Reviews of the data quality will be performed regularly, as outlined in the

system wide quality management plan (QMP). This project includes several streams

of data quality monitoring and we will use a graded approach to review them.

At weekly reviews, we will note, revise and develop ways to prevent unusual

occurrences that have been reported in the preceding week, which could include:

a. The rejection of samples by the microbiology labs for various reasons.

b. Improper or incomplete data entry during field clinical assessment

c. Incomplete data entry during home visit.

d. Failure to complete home visit within the timeframe prescribed per

protocol.

At monthly quality reviews, summary statistics of laboratory results and UIH

internal laboratory QC data will be reviewed.

At annual quality reviews, all quality data will be reviewed. Emphasis will be

placed on system-wide quality issues with the goal of developing quality

improvement strategies for the next recreation season.

2. Reports to Management

The Clinical Project Manager will receive hard copy reports daily from the UIH and

IDPH microbiology laboratories. All data will be entered a CHEERS clinical

microbiology data file, devoid of all personal identifiers. The study director will be

notified of all positive cultures. A summary data report will be generated monthly

by the Clinical Project Manager and shared with the Study Director and Quality

Manager.

The Clinical Project Manager will also maintain an Unusual Occurrence log to

document any unexpected occurrence with personnel, subjects, data

collection/handling, or data reporting. (Appendix #24)

CHEERS QAPP 3

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July 2008

D. DATA VALIDATION AND USABILITY

1. Data Review, Verification, and Validation

Data review, verification, and validation methods have been employed during the

development, programming and implementation of the clinical data gathering process.

These include questionnaire review and validation processes, including internal/external

reviews, IRB clearance, and pilot evaluations of survey questions. Specifically:

•

The computer assisted surveys have been developed with pre-determined

acceptable response options. This prevents the entry of unacceptable or out-of-

range responses.

•

Data will be deemed unusable if a laboratory reports a specimen as unusable.

2. Verification and Validation Methods

Novel methods are not employed for data collection or analysis. Validation of

methods will not be necessary.

3. Reconciliation with User Requirements

The clinical data collected were selected specifically for this research. Clinical

microbiology data reported by laboratories as having been obtained from acceptable

specimens will be used without any reconciliation.

CHEERS QAPP 3

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July 2008

CHEERS QAPP 3

Appendix 1: Home clinical evaluation form

UNIVERSITY OF ILLINOIS, CHICAGO

CHEERS HOME VISIT CLINICAL EVALUATION

Clinician Name

: ____________________

You said you had a red, or sore, or draining area on your skin when we last spoke

to you on (fill date of late telephone interview). I will examine your skin now.

(Fill location of skin wound/cut/bruise/bug bite from telephone survey Q 13a).

Observation:

a. Warmth around the wound?

Y N RF DK

b. Is there any tenderness/pain? Y N RF DK

c. Any surrounding erythema (measure diameter in mm)? Y ___mm N RF DK

d. Any discharge from the wound? Y N RF DK

e. Are you currently being treated with any antibiotics or prescription

medications for this? Y N RF DK

f. IF Yes, Is this topical or oral?

Topical/ Oral RF

I will examine your skin for any other similar cuts, bruises, bug bites, or wounds.

Note: Nurse/Physician records observations. Look for infected cuts, bruises, insect bites.

Check all that apply.

Note: For each “Yes”- then observe wound-

You have an open cut/wound/insect bite/ scrape. I am going to briefly examine this now.

Observation:

a. Warmth around the wound?

Y N RF DK

b. Is there any tenderness/pain? Y N RF DK

c. Any surrounding erythema (measure diameter in mm)? Y ___mm N RF DK

d. Any discharge from the wound? Y N RF DK

e. Are you currently being treated with any antibiotics or prescription

medications for this? Y N RF DK

f. IF Yes, Is this topical or oral?

Topical/ Oral RF

You said you had eye irritation or draining and crusting in your eyes when we last

spoke to you on (fill date of late telephone interview). I am going to examine your

3d. Have you been diagnosed with an eye infection since we last spoke to you on (fill

Date of survey or last telephone interview)? Y N RF DK

3e. If YES, was it the ….

3f. Are you currently being treated with any antibiotics or prescription eye drops? Y N

RF DK

You said you ear ache or an ear infection when we last spoke to you on (fill date of late

telephone interview). I am going to examine your ears now.

4e. Have you been diagnosed with an ear infection since we last spoke to you on (fill

Date of survey or last telephone interview)? Y N RF DK

4f. If yes, was it the …

4g. Are you currently being treated with any antibiotics or prescription ear drops? Y N

RF DK

4h. If Yes, is this oral or drops? Oral/ Drops RF DK

5. Specimen collection

5a. If YES-

Stool sample Day 1 / 2 / 3

Skin discharge

Eye discharge

CHEERS QAPP 3

Appendix 2: Specimen Collection System

Fisherbrand* Commode Specimen Collection System

Fisher Health Catalog # 02-544-208

.Stool need not be handled

.Sturdy frame enables container to fit securely under any toilet seat

.Lid is snapped on, and support frame is easily removed by snapping it down for transportation

to lab

.Doubles for female urine output

.Easy-to-read graduations on container

.Directions are printed on container lid in both English and Spanish

CHEERS QAPP 3

Appendix 3: Letter to study participants

CHEERS Thank You letter

v1. 04/03/2008

Thank you for participating in the

CHEERS study.

Remember, we want to know about your

health over the next 21 days of the study

period.

If you have any:

abdominal pain,

vomiting, or diarrhea

1. Please collect a stool sample using the stool kit provided.

2. Call the courier service at

1.888.333.9112

to schedule a pick-

up of your specimen (just tell them that you’re in the UIC

CHEERS project).

3. Be sure to have the gold lab requisition form with your ID

number in the bag with the collected specimen.

4. Call the

CHEERS call center at 1.800.688.0582

to report

your symptoms.

If you have any:

eye crusting or drainage, or any skin wounds

with drainage

Please call the

CHEERS call center at 1.800.688.0582

report your symptoms.

If you need a stool kit or a gold requisition form -

Please call the

CHEERS call center at 1.800.688.0582

If you have any other questions or concerns regarding the stool

collection procedure or the home visit-

Please call the

CHEERS nurse at 312-996-3395

Note: You will receive an additional $ 75 for providing any of the

CHEERS Thank You letter

v1. 04/03/2008

CHEERS QAPP 3

Appendix 4: Conjunctivitis Rating Scale

Conjunctivitis Rating Scale of Lichtenstein, et. J AOPPS, 2003

CHEERS QAPP 3

Appendix 5: Positive Culture Letter

Stool

Date, Month, 2008

Dear First, Last Name,

On (Month, Date,) 2008 we obtained a stool sample from you. Testing

showed that you have an infection known as (pathogen). Please contact

your doctor and let him/her know that you have this infection. Your doctor

can contact the CHEERS study clinical director for further details. Jackee

Wuellner, RN can be reached at (312) 996-3395.

Enclosed is an information sheet for you about this condition. Be sure

to follow-up soon with your doctor, and if your condition is worsening, be

sure to seek treatment right away.

Thank you for your participation in CHEERS.

Sam Dorevitch, MD, MPH

Study Director

UIC School of Public Health

CHEERS QAPP 3

Appendix 6: Positive Culture Letter

Eye/Wound

Date

Dear ______________,

On _____________ we obtained a (wound/eye) swab from you.

Testing showed that you have an infection known as ___________. Please

contact your doctor and let him/her know that you have this infection.

Your doctor can contact the CHEERS study clinical director for further

details by calling the Clinical Director of the CHEERS study, Jackee

Wuellner, at (312) 996-3395.

Enclosed is an information sheet for you about this condition. Be sure

to follow-up soon with your doctor, and if your condition is worsening, be

sure to seek treatment right away.

Thank you for your participation in CHEERS.

Sam Dorevitch, MD, MPH

Study Director

UIC School of Public Health

CHEERS QAPP 3

Appendix 7: Fact Sheets

Fact Sheet

for the general public

Division of Parasitic Diseases 1 of 4

Cryptosporidium

Infection

Cryptosporidiosis (KRIP-toe-spo-rid-ee-OH-sis)

What is cryptosporidiosis?

Cryptosporidiosis is a diarrheal disease caused by microscopic parasites of the genus

Cryptosporidium

. Once an animal or person is infected, the parasite lives in the

intestine and passes in the stool. The parasite is protected by an outer shell that

allows

it to survive outside the body for long periods of time and makes it very resistant to

chlorine-based disinfectants. Both the disease and the parasite are commonly known

as "crypto."

During the past two decades, crypto has become recognized as one of the most

common causes of waterborne disease within humans in the United States. The

parasite may be found in drinking water and recreational water in every region of the

United States and throughout the world.

How is cryptosporidiosis spread?

Cryptosporidium

lives in the intestine of infected humans or animals. Millions of

crypto

germs can be released in a bowel movement from an infected human or animal.

Consequently,

Cryptosporidium

is found in soil, food, water, or surfaces that have

been

contaminated with infected human or animal feces. If a person swallows the parasite

they become infected. You

cannot

become infected through contact with blood. The

parasite can be spread by

• Accidentally putting something into your mouth or swallowing something that has

come into contact with feces of a person or animal infected with

Cryptosporidium

• Swallowing recreational water contaminated with

Cryptosporidium

(Recreational

water includes water in swimming pools, hot tubs, jacuzzis, fountains, lakes, rivers,

springs, ponds, or streams that can be contaminated with sewage or feces from

humans or animals.)

Note:

Cryptosporidium

can survive for days in swimming

pools with adequate chlorine levels.

• Eating uncooked food contaminated with

Cryptosporidium

. Thoroughly wash with

clean, safe water all vegetables and fruits you plan to eat raw. See below for

information on making water safe.

• Accidentally swallowing

Cryptosporidium

picked up from surfaces (such as

bathroom fixtures, changing tables, diaper pails, or toys) contaminated with feces

from an infected person.

What are the symptoms of cryptosporidiosis?

2 of 4

The most common symptom of cryptosporidiosis is watery diarrhea. Other symptoms

include:

• Dehydration

• Weight loss

• Stomach cramps or pain

• Fever

• Nausea

• Vomiting

Some people with crypto will have no symptoms at all. While the small intestine is

the site most commonly affected,

Cryptosporidium

infections could possibly affect

other areas of the digestive or the respiratory tract.

How long after infection do symptoms appear?

Symptoms of cryptosporidiosis generally begin 2 to 10 days (average 7 days) after

becoming infected with the parasite.

How long will symptoms last?

In persons with healthy immune systems, symptoms usually last about 1 to 2 weeks.

The symptoms may go in cycles in which you may seem to get better for a few days,

then feel worse again before the illness ends.

If I have been diagnosed with

Cryptosporidium

, should I worry about

spreading the infection to others?

Yes,

Cryptosporidium

can be very contagious. Follow these guidelines to avoid

spreading the disease to others:

1. Wash your hands with soap and water after using the toilet, changing diapers,

and before eating or preparing food.

2. Do not swim in recreational water (pools, hot tubs, lakes or rivers, the ocean,

etc.) if you have cryptosporidiosis and for at least 2 weeks after diarrhea stops.

You can pass

Cryptosporidium

in your stool and contaminate water for several

weeks after your symptoms have ended. This has resulted in outbreaks of

cryptosporidiosis among recreational water users.

Note:

Cryptosporidium can be

spread in a chlorinated pool because it is resistant to chlorine and, therefore, can

live for days in chlorine-treated swimming pools.

3. Avoid fecal exposure during sexual activity.

Who is most at risk for cryptosporidiosis?

People who are most likely to become infected with

Cryptosporidium

include:

• Children who attend day care centers, including diaper-aged children

• Child care workers

• Parents of infected children

• International travelers

• Backpackers, hikers, and campers who drink unfiltered, untreated water

• Swimmers who swallow water while swimming in swimming pools, lakes, rivers,

ponds, and streams

• People who drink from shallow, unprotected wells

• People who swallow water from contaminated sources.

Contaminated water includes water that has not been boiled or filtered. Several

community-wide outbreaks of cryptosporidiosis have been linked to drinking

municipal

water or recreational water contaminated with

Cryptosporidium.

Who is most at risk for getting seriously ill with

cryptosporidiosis?

3 of 4

Although Crypto can infect all people, some groups are more likely to develop more

serious illness.

• Young children and pregnant women may be more susceptible to the dehydration

resulting from diarrhea and should drink plenty of fluids while ill.

• If you have a severely weakened immune system, you are at risk for more serious

disease. Your symptoms may be more severe and could lead to serious or

lifethreatening illness. Examples of persons with weakened immune systems include

those with HIV/AIDS; cancer and transplant patients who are taking certain

immunosuppressive drugs; and those with inherited diseases that affect the immune

system.

If you have a severely weakened immune system, talk to your health

care provider for additional guidance.

You can also call the CDC AIDS HOTLINE toll-free at 1-800- 342-2437. Ask for more information

on cryptosporidiosis, or go to the CDC fact sheet

Preventing Cryptosporidiosis:

A Guide for People with Compromised Immune Systems

available by visiting

What should I do if I think I may have cryptosporidiosis?

If you suspect that you have cryptosporidiosis, see your health care provider.

How is a cryptosporidiosis diagnosed?

Your health care provider will ask you to submit stool samples to see if you are

infected.

Because testing for Crypto can be difficult, you may be asked to submit several stool

specimens over several days. Tests for Crypto are not routinely done in most

laboratories;therefore, your health care provider should specifically request testing

for the parasite.

What is the treatment for cryptosporidiosis?

A new drug, nitazoxanide, has been approved for treatment of diarrhea caused by

Cryptosporidium

in people with healthy immune systems. Consult with your health

care provider for more information. Most people who have a healthy immune system

will recover without treatment. The symptoms of diarrhea can be treated. If you

have diarrhea, drink plenty of fluids to prevent dehydration. Rapid loss of fluids from

diarrhea may be especially life threatening to babies; therefore, parents should talk

to their health care provider about fluid replacement therapy options for infants.

Anti-diarrheal medicine may help slow down diarrhea, but talk to your health care

provider before taking it.

People who are in poor health or who have a weakened immune system are at

higher risk for more severe and more prolonged illness. The effectiveness of

nitazoxanide in immunosuppressed individuals is unclear. For persons with AIDS,

anti-retroviral therapy that improves immune status will also decrease or eliminate

symptoms of Crypto. However, even if symptoms disappear, cryptosporidiosis is

usually not curable and the symptoms may return if the immune status worsens. See

your health care provider to discuss anti-retroviral therapy used to improve your

immune status.

How can I prevent cryptosporidiosis?

Practice good hygiene.

1. Wash hands thoroughly with soap and water. a. Wash hands after using the toilet

and before handling or eating food (especially for persons with diarrhea). b. Wash

hands after every diaper change, especially if you work with diaper-aged children,

even if you are wearing gloves.

4 of 4

Protect others by not swimming if you are experiencing diarrhea (essential for

children in diapers).

Avoid water that might be contaminated.

1. Do not swallow recreational water.

2. Do not drink untreated water from shallow wells, lakes, rivers, springs, ponds,

and streams.

3. Do not drink untreated water during community-wide outbreaks of disease caused

by contaminated drinking water.

4. Do not use untreated ice or drinking water when traveling in countries where the

water supply might be unsafe. In the United States, nationally distributed brands of

bottled or canned carbonated soft drinks are safe to drink. Commercially packaged

non-carbonated soft drinks and fruit juices that do not require refrigeration until

after they are opened (those that are stored unrefrigerated on grocery shelves) also

are safe. If you are unable to avoid using or drinking water that might be

contaminated, then you can make the water safe to drink by doing one of the

following:

• Heat the water to a rolling boil for at least 1 minute. OR

• Use a filter that has an absolute pore size of at least 1 micron or one that has been

NSF rated for "cyst removal."

Do not rely on chemicals to disinfect water and kill

Cryptosporidium.

Because it has a

thick outer shell, this particular parasite is highly resistant to disinfectants such as

chlorine and iodine.

Avoid food that might be contaminated.

1. Wash and/or peel all raw vegetables and fruits before eating.

2. Use safe, uncontaminated water to wash all food that is to be eaten raw.

3. Avoid eating uncooked foods when traveling in countries with minimal water

treatment and sanitation systems.

Take extra care when traveling.

If you travel to developing nations, you may be at a greater risk for

Cryptosporidium

infection because of poorer water treatment and food sanitation.

Warnings about food, drinks, and swimming are even more important when

visiting developing countries. Avoid foods and drinks, in particular raw fruits and

vegetables, tap water, or ice made from tap water, unpasteurized milk or dairy

products, and items purchased from street vendors. These items may be

contaminated with

Cryptosporidium.

Steaming-hot foods, fruits you peel yourself,

bottled and canned processed drinks, and hot coffee or hot tea are probably safe.

Talk with your health care provider about other guidelines for travel abroad.

Avoid fecal exposure during sexual activity.

This fact sheet is for information only and is not meant to be used for self-diagnosis or as a substitute for

consultation with a health care provider.

For information on choosing safe bottled water, see the CDC fact sheet entitled

“Preventing Cryptosporidiosis: A Guide to Water Filters and Bottled Water,”

available by visiting http://www.cdc.gov/ncidod/dpd/parasites/cryptosporidiosis/

For information on choosing a water filter, see the CDC fact sheet entitled “Preventing Cryptosporidiosis:

A Guide to Water Filters and Bottled Water,” available by visiting

http://www.cdc.gov/ncidod/dpd/parasites/cryptosporidiosis/

Salmonella

What is salmonellosis?

Salmonellosis is an infection with a bacteria called Salmonella. Most persons infected

with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after

infection. The illness usually lasts 4 to 7 days, and most persons recover without

treatment. However, in some persons the diarrhea may be so severe that the patient needs

to be hospitalized. In these patients, the Salmonella infection may spread from the

intestines to the blood stream, and then to other body sites and can cause death unless the

person is treated promptly with antibiotics. The elderly, infants, and those with impaired

immune systems are more likely to have a severe illness.

What sort of germ is Salmonella?

The Salmonella germ is actually a group of bacteria that can cause diarrheal illness in

humans. They are microscopic living creatures that pass from the feces of people or

animals, to other people or other animals. There are many different kinds of Salmonella

bacteria. Salmonella serotype Typhimurium and Salmonella serotype Enteritidis are the

most common in the United States. Salmonella has been known to cause illness for over

100 years. They were discovered by a American scientist named Salmon, for whom they

are named.

How can Salmonella infections be diagnosed?

Many different kinds of illnesses can cause diarrhea, fever, or abdominal cramps.

Determining that Salmonella is the cause of the illness depends on laboratory tests that

identify Salmonella in the stools of an infected person. These tests are sometimes not

performed unless the laboratory is instructed specifically to look for the organism. Once

Salmonella has been identified, further testing can determine its specific type, and which

antibiotics could be used to treat it.

How can Salmonella infections be treated?

Salmonella infections usually resolve in 5-7 days and often do not require treatment

unless the patient becomes severely dehydrated or the infection spreads from the

intestines. Persons with severe diarrhea may require rehydration, often with intravenous

fluids. Antibiotics are not usually necessary unless the infection spreads from the

intestines, then it can be treated with ampicillin, gentamicin,

trimethoprim/sulfamethoxazole, or ciprofloxacin. Unfortunately, some Salmonella

Salmonella p. 2

bacteria have become resistant to antibiotics, largely as a result of the use of antibiotics to

promote the growth of feed animals.

Are there long term consequences to a Salmonella infection?

Persons with diarrhea usually recover completely, although it may be several months

before their bowel habits are entirely normal. A small number of persons who are

infected with Salmonella, will go on to develop pains in their joints, irritation of the eyes,

and painful urination. This is called Reiter's syndrome. It can last for months or years,

and can lead to chronic arthritis which is difficult to treat. Antibiotic treatment does not

make a difference in whether or not the person later develops arthritis.

How do people catch Salmonella?

Salmonella live in the intestinal tracts of humans and other animals, including birds.

Salmonella are usually transmitted to humans by eating foods contaminated with animal

feces. Contaminated foods usually look and smell normal. Contaminated foods are often

of animal origin, such as beef, poultry, milk, or eggs, but all foods, including vegetables

may become contaminated. Many raw foods of animal origin are frequently

contaminated, but fortunately, thorough cooking kills Salmonella. Food may also become

contaminated by the unwashed hands of an infected food handler, who forgot to wash his

or her hands with soap after using the bathroom.

Salmonella may also be found in the feces of some pets, especially those with diarrhea,

and people can become infected if they do not wash their hands after contact with these

feces. Reptiles are particularly likely to harbor Salmonella and people should always

wash their hands immediately after handling a reptile, even if the reptile is healthy.

Adults should also be careful that children wash their hands after handling a reptile.

What can I do to prevent salmonellosis?

•

Cook poultry, ground beef, and eggs thoroughly before eating. Do not eat or drink

foods containing raw eggs, or raw unpasteurized milk.

•

If you are served undercooked meat, poultry or eggs in a restaurant, don't hesitate

to send it back to the kitchen for further cooking.

•

Wash hands, kitchen work surfaces, and utensils with soap and water immediately

after they have been in contact with raw meat or poultry.

•

Be particularly careful with foods prepared for infants, the elderly, and the

immunocompromised.

•

Wash hands with soap after handling reptiles or birds, or after contact with pet

feces.

•

Avoid direct or even indirect contact between reptiles (turtles, iguanas, other

lizards, snakes) and infants or immunocompromised persons.

Salmonella p. 3

•

Don't work with raw poultry or meat, and an infant (e.g., feed, change diaper) at

the same time.

•

Mother's milk is the safest food for young infants. Breast-feeding prevents

salmonellosis and many other health problems.

Date: November 4, 2006

Content source: Coordinating Center for Infectious Diseases / Division of Bacterial and

Mycotic Diseases

Adapted from: http://www.cdc.gov/ncidod/dbmd/diseaseinfo/salmonellosis_g.htm

CDC Answers Your Questions About

Noroviruses:

What are noroviruses?

Noroviruses are a group of viruses that cause the “stomach flu,” or gastroenteritis (GAS-tro-

enter- I-tis), in people. The term norovirus was recently approved as the official name for this

group of viruses. Several other names have been used for noroviruses, including:

•

Norwalk-like viruses (NLVs)

•

caliciviruses (because they belong to the virus family

Caliciviridae

)

•

small round structured viruses.

Viruses are very different from bacteria and parasites, some of which can cause illnesses

similar to norvirus infection. Viruses are much smaller, are not affected by treatment with

antibiotics, and cannot grow outside of a person’s body.

What are the symptoms of illness caused by noroviruses?

The symptoms of norovirus illness usually include nausea, vomiting, diarrhea, and some

stomach cramping. Sometimes people additionally have a low-grade fever, chills, headache,

muscle aches, and a general sense of tiredness. The illness often begins suddenly, and the

infected person may feel very sick. The illness is usually brief, with symptoms lasting only

about 1 or 2 days. In general, children experience more vomiting than adults. Most people

with norovirus illness have both of these symptoms.

What is the name of the illness caused by noroviruses?

Illness caused by norovirus infection has several names, including:

•

stomach flu – this “stomach flu” is

not

related to the flu (or influenza), which is a

respiratory illness caused by influenza virus.

•

viral gastroenteritis – the most common name for illness caused by norovirus.

Gastroenteritis refers to an inflammation of the stomach and intestines.

•

acute gastroenteritis

•

non-bacterial gastroenteritis

•

food poisoning (although there are other causes of food poisoning)

•

calicivirus infection

How serious is norovirus disease?

Norovirus disease is usually not serious, although people may feel very sick and vomit many

times a day. Most people get better within 1 or 2 days, and they have no long-term health

effects related to their illness. However, sometimes people are unable to drink enough liquids

to replace the liquids they lost because of vomiting and diarrhea. These persons can become

dehydrated and may need special medical attention. This problem with dehydration is usually

only seen among the very young, the elderly, and persons with weakened immune systems.

There is no evidence to suggest that an infected person can become a long-term carrier of

norovirus.

How do people become infected with noroviruses?

Noroviruses are found in the stool or vomit of infected people. People can become infected

with the virus in several ways, including:

CDC Answers Your Questions About Norovirus

•

eating food (see food handler fact sheet) or drinking liquids that are contaminated with

norovirus;

•

touching surfaces or objects contaminated with norovirus, and then placing their hand in

their mouth;

•

having direct contact with another person who is infected and showing symptoms (for

example, when caring for someone with illness, or sharing foods or eating utensils with

someone who is ill).

Persons working in day-care centers or nursing homes should pay special attention to

children or residents who have norovirus illness. This virus is very contagious and can spread

rapidly throughout such environments.

When do symptoms appear?

Symptoms of norovirus illness usually begin about 24 to 48 hours after ingestion of the virus,

but they can appear as early as 12 hours after exposure.

Are noroviruses contagious?

Noroviruses are very contagious and can spread easily from person to person. Both stool and

vomit are infectious. Particular care should be taken with young children in diapers who may

have diarrhea.

How long are people contagious?

People infected with norovirus are contagious from the moment they begin feeling ill to at

least 3 days after recovery. Some people may be contagious for as long as 2 weeks after

recovery. Therefore, it is particularly important for people to use good handwashing and

other hygienic practices after they have recently recovered from norovirus illness.

Who gets norovirus infection?

Anyone can become infected with these viruses. There are many different strains of

norovirus, which makes it difficult for a person’s body to develop long-lasting immunity.

Therefore, norovirus illness can recur throughout a person’s lifetime. In addition, because of

differences in genetic factors, some people are more likely to become infected and develop

more severe illness than others.

What treatment is available for people with norovirus infection?

Currently, there is no antiviral medication that works against norovirus and there is no

vaccine to prevent infection. Norovirus infection cannot be treated with antibiotics. This is

because antibiotics work to fight bacteria and not viruses. Norovirus illness is usually brief in

healthy individuals. When people are ill with vomiting and diarrhea, they should drink plenty

of fluids to prevent dehydration. Dehydration among young children, the elderly, the sick,

can be common, and it is the most serious health effect that can result from norovirus

infection. By drinking oral rehydration fluids (ORF), juice, or water, people can reduce their

chance of becoming dehydrated. Sports drinks do not replace the nutrients and minerals lost

during this illness.

Can norovirus infections be prevented?

Yes. You can decrease your chance of coming in contact with noroviruses by following these

CDC Answers Your Questions About Norovirus

preventive steps:

•

Frequently wash your hands, especially after toilet visits and changing diapers and before

eating or preparing food.

•

Carefully wash fruits and vegetables, and steam oysters before eating them.

•

Thoroughly clean and disinfect contaminated surfaces immediately after an episode of

illness by using a bleach-based household cleaner.

•

Immediately remove and wash clothing or linens that may be contaminated with virus

after an episode of illness (use hot water and soap).

•

Flush or discard any vomitus and/or stool in the toilet and make sure that the surrounding

area is kept clean.

Persons who are infected with norovirus should not prepare food while they have symptoms

and for 3 days after they recover from their illness (see food handler information sheet)

. Food

that may have been contaminated by an ill person should be disposed of properly.

Diarrhea

Alternative names

Stools - watery; Frequent bowel movements; Loose bowel movements

Definition

Diarrhea is loose, watery, and frequent stool. Diarrhea is considered chronic (long-term)

when you have had loose or frequent stools for more than 4 weeks.

Considerations

Diarrhea in adults is usually mild and goes away quickly without complications. In

infants and children (especially under age 3), diarrhea can cause dehydration fairly

quickly.

Common Causes

The most common cause of diarrhea is viral gastroenteritis, a mild viral infection that

goes away on its own within a few days. This condition is often called the stomach flu.

Viral gastroenteritis often occurs in mini-epidemics in schools, neighborhoods, or

families.

Food poisoning and traveler's diarrhea are two other common causes of diarrhea. They

occur as a result of eating food or drinking water contaminated with bacteria or parasites.

Medications, especially antibiotics, laxatives containing magnesium, and chemotherapy

for cancer treatment, can also cause diarrhea.

The following medical conditions can also lead to diarrhea:

•

Malabsorption syndromes such as lactose intolerance

•

Inflammatory bowel diseases (Crohn's disease and ulcerative colitis)

•

Irritable bowel syndrome (IBS)

•

Celiac disease

Other less common causes of diarrhea include:

•

Zollinger-Ellison syndrome

•

Nerve disorders like autonomic neuropathy or diabetic neuropathy

•

Carcinoid syndrome

•

Gastrectomy (partial removal of the stomach)

•

High dose radiation therapy

Diarrhea p. 2

Home Care

•

Drink plenty of fluid to avoid becoming dehydrated. Start with sips of any fluid

other than caffeinated beverages. Milk may prolong loose stools, but also

provides needed fluids and nourishment. Drinking milk may be fine for mild

diarrhea. For moderate and severe diarrhea, electrolyte solutions available in

drugstores are usually best.

•

Active cultures of beneficial bacteria (probiotics) make diarrhea less severe and

shorten its duration. Probiotics can be found in yogurt with active or live cultures

and in supplements.

•

Foods like rice, dry toast, and bananas can sometimes help with diarrhea.

•

Avoid over-the-counter anti-diarrhea medications unless specifically instructed to

use one by your doctor. Certain infections can be made worse by these drugs.

When you have diarrhea, your body is trying to get rid of whatever food, virus, or

other bug is causing it. The medicine interferes with this process.

•

Rest.

If you have a chronic form of diarrhea, like the one caused by irritable bowel syndrome,

try adding bulk to your diet -- to thicken the stool and regulate bowel movements. Such

foods include rice, bananas, and fiber from whole-wheat grains and bran. Psyllium-

containing products such as Metamucil or similar products can also add bulk to stools.

Call your health care provider if :

•

You have blood or pus in your stools or your stool is black

•

You have abdominal pain that is not relieved by a bowel movement

•

You have symptoms of dehydration

•

You have a fever above 101°F, or your child has a fever above 100.4°F, along

with diarrhea

•

You have foul smelling or oily-looking stools

•

You have recently traveled to a foreign country

•

You have eaten with other people who also have diarrhea

•

You have started on a new medication

•

Your diarrhea does not get better in 5 days (2 days for an infant or child), or

worsens before that

•

Your child has been vomiting for more than 12 hours (in a newborn under 3

months you should call as soon as vomiting or diarrhea begins)

Prevention

•

Wash your hands often, especially after going to the bathroom and before eating.

•

Teach children to not put objects in their mouth.

Diarrhea p. 3

•

When taking antibiotics, try eating food with Lactobacillus acidophilus, a healthy

bacteria. This helps replenish the good bacteria that antibiotics can kill. Yogurt

with active or live cultures is a good source of this good bacteria.

•

Use alcohol-based hand gel frequently

References

Yates J. Traveler's diarrhea. Am Fam Physician. 2005; 71(11): 2095-2100.

Guerrant RL. Practice guidelines for the management of infectious diarrhea. Clin Infect

Dis. 2001; 32(3): 331-351.

Update Date: 5/8/2006

Updated by: Jenifer K. Lehrer, MD, Department of Gastroenterology, Frankford-

Torresdale Hospital, Jefferson Health System, Philadelphia, PA. Review provided by

VeriMed Healthcare Network.

Swimmer's ear

Alternative names

Ear infection - outer ear - acute; Otitis externa - acute

Definition

Swimmer's ear is an inflammation, irritation, or infection of the outer ear and ear canal.

Causes, incidence, and risk factors

Swimmer's ear (otitis externa) is fairly common, especially among teenagers and young

adults. Swimming in polluted water is one way to contract swimmer's ear. The condition

also can be caused by scratching (in) the ear or by an object stuck in it. Trying to clean

wax from the ear canal, especially with cotton swabs or small objects, can irritate or

damage the skin.

Swimmer's ear is occasionally associated with middle ear infection (otitis media) or

upper respiratory infections such as colds. Moisture in the ear makes the ear susceptible

to infection from water-loving bacteria such as Pseudomonas. Other bacteria, and rarely,

fungus, can also cause infection.

Symptoms

•

Ear pain -- may worsen when pulling the outer ear

•

Itching of the ear or ear canal

•

Drainage from the ear -- yellow, yellow-green, pus-like, or foul smelling

Signs and tests

When the doctor looks in the ear, it appears red and swollen, including the ear canal. The

ear canal may appear eczema-like, with scaly shedding of skin. Touching or moving the

outer ear increases the pain. The eardrum may be difficult for the doctor to see with an

otoscope because of the swollen outer canal. Taking some of the ear's drainage and doing

a culture on it may identify bacteria or fungus.

Treatment

The goal of treatment is to cure the infection. The ear canal should be cleaned of drainage

to allow topical medications to work effectively.

Swimmer's ear p. 2

Effective medications include ear drops containing antibiotics to fight infection, and

corticosteroids to reduce itching and inflammation. Ear drops should be used abundantly

(four or five drops at a time) in order to penetrate the end of the ear canal. If the ear canal

is very swollen, a wick may be applied in the ear to allow the drops to travel to the end of

the canal.

Occasionally, pills may be used in addition to the topical medications. Analgesics may be

used if pain is severe. Putting something warm against the ears may reduce pain.

Protect ears from further damage. Do not scratch the ears or insert cotton swabs or other

objects in the ears. Keep ears clean and dry, and do not let water enter the ears when

showering, shampooing, or bathing.

Expectations (prognosis)

Swimmer's ear responds well to treatment, but complications may occur if it is not

treated. Some individuals with underlying medical problems, such as diabetes, may be

more likely to get complications such as malignant otitis externa.

Complications

•

Chronic otitis externa

•

Malignant otitis externa

•

Spread of infection to other areas of the body

Calling your health care provider

Call for an appointment with your doctor if you develop any symptoms of swimmer's ear.

Call your doctor if the symptoms worsen or persist despite treatment, or if new symptoms

appear, including pain and redness of the skull behind the ear or persistent fever.

Prevention

•

Dry the ear thoroughly after exposure to moisture.

•

Avoid swimming in polluted water.

•

Use earplugs when swimming.

•

Consider putting a few drops of a 1:1 mixture of alcohol and white vinegar in the

ears after they get wet. The alcohol and acetic acid prevent bacterial growth.

Update Date: 6/15/2005

Updated by: Monica Gandhi, MD, MPH, Assistant Professor, Division of Infectious Diseases, UCSF, San

Francisco, CA. Review provided by VeriMed Healthcare Network.

http://www.nlm.nih.gov/medlineplus/ency/article/000622.htm

Fact Sheet

for the general public

Division of Parasitic Diseases

Giardia

Infection

Giardiasis (GEE-are-DYE-uh-sis)

1 of 4

What is giardiasis?

Giardiasis (GEE-are-DYE-uh-sis) is a diarrheal illness caused by a one-celled,

microscopic parasite,

Giardia intestinalis

(also known as

Giardia lamblia

). Once an

animal or person has been infected with

Giardia intestinalis

, the parasite lives in the

intestine and is passed in the stool. Because the parasite is protected by an outer

shell, it can survive outside the body and in the environment for long periods of

time.

During the past 2 decades,

Giardia

infection has become recognized as one of the

most common causes of waterborne disease (found in both drinking and recreational

water) in humans in the United States.

Giardia

are found worldwide and within every

region of the United States.

How do you get giardiasis and how is it spread?

The

Giardia

parasite lives in the intestine of infected humans or animals. Millions of

germs can be released in a bowel movement from an infected human or animal.

Giardia

is found in soil, food, water, or surfaces that have been contaminated with

the feces from infected humans or animals. You

can

become infected after

accidentally swallowing the parasite; you

cannot

become infected through contact

Accidentally putting something into your mouth or swallowing something that has

come into contact with feces of a person or animal infected with

Giardia

•

Swallowing recreational water contaminated with

Giardia

. Recreational water

includes water in swimming pools, hot tubs, jacuzzis, fountains, lakes, rivers,

springs, ponds, or streams that can be contaminated with sewage or feces from

humans or animals.

•

Eating uncooked food contaminated with

Giardia

•

Accidentally swallowing

Giardia

picked up from surfaces (such as bathroom

fixtures, changing tables, diaper pails, or toys) contaminated with feces from an

infected person.

What are the symptoms of giardiasis?

Giardia

infection can cause a variety of intestinal symptoms, which include

Greasy stools that tend to float

•

Stomach cramps

•

Upset stomach or nausea.

These symptoms may lead to weight loss and dehydration. Some people with

giardiasis have no symptoms at all.

How long after infection do symptoms appear?

Symptoms of giardiasis normally begin 1 to 2 weeks (average 7 days) after

becoming infected.

D i v i s i o n o f P a r a s i t i c

D i s e a s e s

2 of 4

How long will symptoms last?

In otherwise healthy persons, symptoms of giardiasis may last 2 to 6 weeks.

Occasionally, symptoms last longer.

Who is most likely to get giardiasis?

Anyone can get giardiasis. Persons more likely to become infected include

•

Children who attend day care centers, including diaper-aged children

•

Child care workers

•

Parents of infected children

•

International travelers

•

People who swallow water from contaminated sources.

•

Backpackers, hikers, and campers who drink unfiltered, untreated water

•

Swimmers who swallow water while swimming in lakes, rivers, ponds, and streams

•

People who drink from shallow wells

Contaminated water includes water that has not been boiled, filtered, or disinfected

with chemicals. Several community-wide outbreaks of giardiasis have been linked to

drinking municipal water or recreational water contaminated with

Giardia

What should I do if I think I may have giardiasis?

See your health care provider.

How is a

Giardia

infection diagnosed?

Your health care provider will likely ask you to submit stool samples to check for the

parasite. Because

Giardia

can be difficult to diagnose, your provider may ask you to

submit several stool specimens over several days.

What is the treatment for giardiasis?

Several prescription drugs are available to treat

all people, young children and pregnant women may be more susceptible to

dehydration resulting from diarrhea and should, therefore, drink plenty of fluids while

ill.

My child does not have diarrhea, but was recently diagnosed as

having giardiasis. My health care provider says treatment is not

necessary. Is this true?

Treatment is not necessary when the child has no symptoms. However, there are a

few exceptions. If your child does not have diarrhea, but is having nausea, fatigue

(very tired), weight loss, or a poor appetite, you and your health care provider may

wish to consider treatment. If your child attends a day care center where an

outbreak is continuing to occur despite efforts to control it, screening and treating

children who have no obvious symptoms may be a good idea. The same is true if

several family members are ill, or if a family member is pregnant and therefore not

able to take the most effective anti-

Giardia

medications.

If I have been diagnosed with giardiasis, should I worry about

spreading the infection to others?

D i v i s i o n o f P a r a s i t i c

infection can be very contagious. Follow these guidelines to avoid

spreading giardiasis to others:

1. Wash your hands with soap and water after using the toilet, changing diapers, and

before eating or preparing food.

2. Do not swim in recreational water (pools, hot tubs, lakes or rivers, the ocean, etc.)

if you have

Giardia

and for at least 2 weeks after diarrhea stops. You can pass

Giardia

in your stool and contaminate water for several weeks after your symptoms

have ended. This has resulted in outbreaks of

Giardia

among recreational water

users.

3. Avoid fecal exposure during sexual activity.

How can I prevent a

Giardia

infection?

Practice good hygiene.

1. Wash hands thoroughly with soap and water.

a. Wash hands after using the toilet and before handling or eating food

(especially for persons with diarrhea).

b. Wash hands after every diaper change, especially if you work with diaper-

aged children, even if you are wearing gloves.

2. Protect others by not swimming if you are experiencing diarrhea (essential for

children in diapers).

Avoid water that might be contaminated.

1. Do not swallow recreational water.

2. Do not drink untreated water from shallow wells, lakes, rivers, springs, ponds, and

streams.

3. Do not drink untreated water during community-wide outbreaks of disease

caused by contaminated drinking water.

4. Do not use untreated ice or drinking water when traveling in countries where

the water supply might be unsafe.

In the United States, nationally distributed brands of bottled or canned carbonated

soft drinks are safe to drink. Commercially packaged non-carbonated soft drinks and

fruit juices that do not require refrigeration until after they are opened (those that

are stored unrefrigerated on grocery shelves) also are safe.

If you are unable to avoid using or drinking water that might be

contaminated, then you can make the water safe to drink by doing one of

the following:

•

Heat the water to a rolling boil for at least 1 minute, OR

•

Use a filter that has an absolute pore size of at least 1 micron or one that has been

NSF rated for "cyst removal."

•

If you cannot heat the water to a rolling boil or use a recommended filter, then try

chemically treating the water by chlorination or iodination.

For information on recreational waterrelated illnesses, visit CDC’s Healthy Swimming website at http://

www.cdc.gov/healthyswimming.

For information on choosing safe bottled water, see the CDC fact sheet entitled

“Preventing Cryptosporidiosis: A Guide to Water Filters and Bottled Water,”

available by visiting http://

www.cdc.gov/ncidod/dpd/parasites/ cryptosporidiosis/

D i v i s i o n o f P a r a s i t i c D i

s e a s e s

4 of 4

Using chemicals may be less effective than boiling or filtering because the amount of

chemical required to make the water safe is highly dependent on the temperature,

pH, and cloudiness of the water.

Avoid food that might be contaminated.

1. Wash and/or peel all raw vegetables and fruits before eating.

2. Use safe, uncontaminated water to wash all food that is to be eaten raw.

3. Avoid eating uncooked foods when traveling in countries with minimal water

treatment and sanitation systems.

Avoid fecal exposure during sexual activity.

If my water comes from a well, should I have my well water tested?

You should consider having your well water tested if you can answer “yes” to any of

the following questions:

•

Are members of your family or others who use your well water becoming

ill?

If yes, your well may be the source of infection.

•

Is your well located at the bottom of a hill or is it considered shallow?

If so, runoff from rain or flood water may be draining directly into your well causing

contamination.

•

Is your well in a rural area where animals graze?

Well water can become

contaminated with feces if animal waste seepage contaminates the ground water.

This can occur if your well has cracked casings, is poorly constructed, or is too

shallow. Tests used to specifically identify

Giardia

are often expensive, difficult, and

usually require hundreds of gallons of water to be pumped through a filter. If you

answered “yes” to the above questions, consider generally testing your well for fecal

contamination by testing it for the presence of coliforms or

E. coli

instead of

Giardia

Although tests for fecal coliforms or

E. coli

do not specifically tell you whether

Giardia

is present, these tests will show whether your well water has been contaminated by

fecal matter. These tests are only useful if your well is not routinely disinfected with

chlorine, since chlorine kills fecal coliforms and

E. coli

. If the tests are positive, it is

possible that the water may also be contaminated with

Giardia

or other harmful

bacteria and viruses.

Contact your county health department, your county cooperative extension service,

or a local laboratory to find out who offers water testing in your area. If the fecal

coliform test comes back positive, indicating that your well is fecally contaminated,

discontinue drinking the well water and contact your local water authority for

instructions on how to disinfect your well.

This fact sheet is for information only and is not meant to be used for self-diagnosis or as a substitute for

consultation with a health care provider. If you have any questions about the disease described above or

think that you may have a parasitic infection, consult a health care provider.

For information on choosing a water filter, see the CDC fact sheet entitled

“Preventing Cryptosporidiosis: A Guide to Water Filters and Bottled Water,” available by visiting

http://www.cdc.gov/ncidod/dpd/parasites/cryptosporidiosis/factsht_crypto_prevent_water.htm.

CHEERS QAPP 3

Appendix 8: Low Cost Clinics in Chicago

Low Cost Health-Care Providers

Chicago, IL

Name

Location

Phone #

South/Southwest Chicago

Access Ashland Family Health Center

5256 S. Ashland Avenue

773-434-9216

Access Auburn-Gresham Family

Health Center

8234 S. Ashland Avenue

773-874-1400

Access Booker Family Health Center

747 E. 47th Street

773-624-4800

Access Brandon Family Health Center

8300 S. Brandon Avenue

773-721-7600

Access Grand Family Health Center

5401 S. Wentworth Avenue

773-288-6900

Access Ideal Family Health Center

2413 S. State Street

312-225-6800

Access South State Family Health

Center

5050 S. State Street

773-624-2700

Access Southwest Family Health

Center

4839 W. 47th Street

773-735-2345

Access Taylor Family Health Center

4501 S. State Street

773-548-0800

Access Wells Family Health Center

3747 S. Cottage Grove

773-536-1000

CDPH Englewood Family Health

Center

641 W. 63rd Street

312-747-7831

CDPH Roseland Neighborhood Health

Chicago Family Health Center -

Roseland

556 E. 115th Street

773-785-6800

Chicago Family Health Center- South

Chicago

9119 S. Exchange Avenue

773-768-5000

Christian Community Health Center

9718 S. Halsted Street

773-233-4100

Cook County Woodlawn Health Center 6337 S. Woodlawn

312-747-7700

Cook County Englewood Health Center 1135 W. 69th Street

773-483-5090

Friend Family Health Center - East

800 E. 55th Street

773-702-0660

Friend Family Health Center - West

5843 S. Western Avenue

773-434-8600

Holy Cross Family Medical Center

2701 W. 68th Street

773-884-3400

John Sengstacke Health Center

450 E. 51st

312-572-2900

Komed/Holman Health Center

4259 S. Berkeley Avenue

University of Chicago Friend & Family

Center

800 E. 55th Street

773-702-0660

West Chicago

Access Armitage Family Health Center 2957 W. Armitage Avenue

773-772-4319

Access Austin Family Health Center

5835 W. North Avenue

773-745-1200

Access Cabrini Family Health Center

Access Centro Medico San Rafael

3204 W. 26th Street

773-927-3100

Access Doctors Medical Group

6240 W. 55th Street

773-284-2200

Access Dr. James West Clinic at

Haymarket Center

120 N. Sangamon Street

312-226-7984

x408

Access Humboldt Park Family Health

Center

3202 W. North Avenue

773-489-6333

Access Jackson Family Health Center

2450 W. Jackson Boulevard

773-829-7650

Access Kedzie Family Health Center

3213-21 W. 47th Place

773-254-6044

Access Lawndale Family Health Center 1108 S. Kedzie Avenue

773-722-2712

Access Madison Family Health Center

3800 W. Madison

773-826-6600

Access Near West Family Health

Center

1158 W. Taylor Street

312-455-8640

Access Pilsen Family Health

1817 S. Loomis Street

312-666-6511

Access Plaza Medical Center

2507 W. Cermak Road

773-523-0900

Access Servicios Medicos La Villita

3303 W. 26th Street

773-277-6589

Access Warren Family Health Center

2409 W. Warren Boulevard

312-733-4475

Access West Division Family Health

Center

4401 W. Division Street

773-252-3122

Access Westside Family Health Center

3606 W. 16th Street

773-762-2435

Alivio Medical Center

966 W. 21st Street

312-829-6304

Alivio Medical Center

2355 S. Western Avenue

773- 254-1400

Logan Square Health Center

4909 W. Division Street

773-921-8100

Cook County Austin Health Center

4800 W. Chicago Ave.

773-826-9600

Cook County Cicero Health Center

5912 W. Cermak

708-783-9800

Cook County Fantus Health Center

621 S. Winchester

312-864-6224

Erie West Side Family Health Center

646 N. Lawndale Avenue

312-666-3494

Lawndale Christian Health Center -

Arthington

3517 W. Arthington Street

773-843-3000

Lawndale Christian Health Center -

Farragut

2345 S. Christiana Avenue

773-843-3000

Lawndale Christian Health Center -

Ogden

3860 W. Ogden Avenue

773-843-3000

Louise Landau Health Center

3645 W. Chicago Avenue

773-826-3450

North/Northwest Chicago

Access Anixter Center

2020 N. Clybourn Avenue

773-404-5277

Access Evanston-Rogers Park Family

Health Center

1555 W. Howard Street

773-764-3425

Access Humboldt Park Family Health

Center

3202 W. North Avenue

773-278-1880

Access Near North Family Health

Center

361 W. Chestnut Street

312-751-4080

Access Peterson Family Health Center

2655 W. Peterson Avenue

773-271-8880

CDPH Lakeview Neighborhood Health

Center

2849 N. Clark Street

(773) 528-1188

CDPH Uptown Neighborhood Health

Center

845 W. Wilson

312-744-1938

CDPH West Town Neighborhood

Health Center

2418 W. Division Street

312-744-0943

Chicago Health Outreach

1015 W. Lawrence Avenue

773-275-2586

Circle Family Care

118 N. Central Avenue

773-921-1446

Erie Helping Hands Health Center

4759 N. Kedzie

773-588-9640

Erie Humboldt Park Family Health

Center

2750 W. North Avenue

312-666-3494

Erie West Town Family Health Center

1701 W. Superior Street

312-666-3494

Health Service Center

4909 W. Division Street

773-921-8100

James Jordan Family Life Center

2102 W. Madison Street

312-226-2323

Miles Square Health Center

2045 W. Washington

Boulevard

312-413-7810

Near West Family Health Center

2310 W. Roosevelt Road

773-432-4087

PCC Austin Family Health Center

355 N. Mason Avenue

773-378-3347

PCC Lake Street Family Health Center

14 Lake Street

773-921-8100

PCC Salud Family Health Center

5359 W. Fullerton Avenue

773-836-2785

PrimeCare Community Wellness -

Northwest

4235 W. North Avenue

773-278-6868

PrimeCare Community Wellness -

West Logan Square

3924 W. Fullerton Avenue

773-276-2229

PrimeCare Community Wellness -

West Town

1431 N. Western Avenue

312-633-5841

Winfield Moody Health Center

1276 N. Clybourn Avenue

312-337-1073

Chicago Suburbs

Access Alma Family Health Center

318 Madison Street

Maywood, IL 60153

708-344-5300

Access Blue Island Family Health

Center

13000 Maple Avenue

Blue Island, IL 60406

708-385-6100

Access Cicero Family Health Center

5817 W. Cermak Road

Cicero, IL 60804

708-458-0757

Access Des Plaines Valley Health

Access Family Health Society

152 W. Lincoln Highway

Chicago Heights, IL 60411

708-754-9687

Access Genesis

1 N. Broadway Street

Des Plaines, IL 60440

847-298-3150

Access Hawthorne Family Health

Center

2307-09 S. Cicero Avenue

Cicero, IL 60804

708-780-9777

Access Maywood Family Health

Access Melrose Park Family Health

Center

8321 W. North Avenue

Melrose Park, IL 60160

708-681-2298

Belvidere Medical Building

2400 Belvidere Road

Waukegan, IL 60085

847-360-6500

Medical Services Northeast Satellite

1819 27th Street

Zion, IL 60099

847-872-1918

Vincennes Health Center

1644 Vincennes Avenue

Chicago Heights, IL 60411

708-756-2001

CHEERS QAPP 3

Appendix 9: Specimen Chain of Custody Log

SPECIMEN TRACKING LOG/ CHAIN of CUSTODY

LABORATORY PERSONNEL SIGNATURE & DATE

CHEERS QAPP 3

Appendix 10: UIC Laboratory: Stool Culture

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 11

STOOL CULTURE

PRINCIPLE:

Acute infectious diarrhea is caused by a number of different agents: bacteria, viruses, and

protozoa. The laboratory routinely searches for the bacteria that are most likely to cause diarrhea.

Stool specimens are cultured in order to isolate one or more of the following pathogens:

Salmonella, Shigella, Edwardsiella, Yersinia, Aeromonas, Plesiomonas, Vibrio, Campylobacter,

and

E. coli

0157:H7.

Campylobacter jejuni

is the most important species of

Campylobacter

terms of human disease, usually causing diarrhea (sometimes with blood in the stool), abdominal

pain, nausea, fever, and sometimes vomiting. The most common sources of infection are

unpasteurized milk, and rare or partially cooked poultry. Several new

Campylobacter

species have

been discovered and are associated with new clinical syndromes. In addition, a predominance of

yeast,

Staphylococcus aureus

, beta streptococci, or

Pseudomonas aeruginosa

may be clinically

significant.

Normal stool flora consists of a variety of gram positive and gram negative organisms. In

order to isolate and identify pathogens, a combination of selective and differential media,

biochemical tests, and serological typing are employed. Isolation of

Campylobacter jejuni/coli

depends on the use of selective media, a microaerophilic atmosphere (5% O

, 10% CO

, 85% N

)

and growth optimally at 42

C. One selective media used is Campy BAP which is a brucella agar

base with 10 % sheep blood. The agar contains a variety of antibiotics which prevent or retard the

growth of competing enteric flora. A selective enrichment broth is also used to recover low

numbers of organisms. The organisms are slender, spirally curved gram negative rods which

appear as non-hemolytic clear or gray colonies on the media. Colonies may appear at 24 to 72

hours of incubation.

SPECIMEN:

Acceptable Specimens:

Freshly passed stool. For optimal recovery of organisms, collect specimen during

the

Acute stage (first 3 days) of diahrreal disease, prior to antibiotic therapy.

Rectal swabs. Swabs will not yield maximal number or positive cultures. Should be

primarily used to sample feces flora from persons ill in an epidemic or from infants.

Single rectal swabs are of little value in examination of convalescent patients.

Acceptable containers: Plastic stool container, Cairy Blair Transport, Culturette

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 2 of 11

Unacceptable Specimens:

More than one specimen per day

Specimen collected after 3 hospital day

Specimens received in diapers

Specimens received >24 in transit. Specimens received in Cary Blair can be held

for up to 3 days at room temperature.

Dried specimens

EQUIPMENT AND MATERIALS:

Equipment:

Campy jar

Campy gas generator

C incubator

Materials:

Blood Agar Plate (BAP)

Hektoen Enteric Agar Plate (HE)

MacConkey Agar Plate (MAC)

Campylobacter BAP (CVA)

Campylobacter Thioglycollate

QUALITY CONTROL:

Materials:

3 CVA agar plates

2 Campylobacter Thioglycollate

Tryptic Soy Broth (TSB)

Sterile swabs

Sterile tubes

Sterile saline

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Pathology Laboratories

Clinical Microbiology Laboratory

Page 3 of 11

10 ul loops

Quality control is to be performed on each new shipment of CVA and Campylobacter

Thioglycollate. The organisms to be used for Quality Control testing are the following:

Campylobacter jejuni

ATCC 33291

Staphylococcus epidermidis

These isolates are frozen at -70

C. These organisms are subcultured to a blood agar plate

when quality control testing is to be performed. The organisms are streaked for isolation

and incubated at 35 - 37

C or 42

C. The organisms are to be subcultured at least three times

prior to testing. The organisms may then be set up for testing using the following

instructions:

Designate plates and inoculate as follows:

To perform QC for the CVA prepare the following suspension:

Obtain fresh stock cultures. Suspend several isolated colonies in TSB to match the

turbidity of a 0.5 McFarland standard.

Dilute the basic cell suspension 1:10 in sterile normal saline (9 ml saline with 1 ml

of the cell suspension added).

Inoculate each organism suspension to the CVA using a 10 ul loop (0.01 ml

disposable blue loop) or 10 ul MLA pipette.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 4 of 11

Incubate as described in Campy gas at 42

Examine plates at 24 and 48 hours. Record reactions in the appropriate log sheets,

initial and date.

To perform QC for the

Campylobacter

Thioglycollate prepare the following suspension:

Obtain a fresh subculture of

C. jejuni

. Suspend several isolated colonies in TSB to

match the turbidity of a 0.5 McFarland Standard.

Dilute the basic cell suspension 1:10 in sterile normal saline (9 ml saline with 1 ml

cell suspension added).

***If QC is performed in conjunction with the CVA procedure, the same

C. jejuni

suspension can be used ***

Inoculate the suspension to the Campylobacter Thioglycollate using a 10 ul loop or

10 ul MLA pipette.

Refrigerate at 2 – 8

C for 18 to 24 hours.

After 18-24 hours refrigeration, subculture to a CVA, as described in

PROCEDURE

Subculture of Campy Thioglycollate

Examine subcultured plates after 24 and 48 hours. Record reactions in appropriate

log sheets, initial and date.

Expected Reactions for CVA and

Campylobacter

Thioglycollate are as follows:

If any deficiencies are observed, notify supervisor for appropriate action. Any corrective action

taken should be noted on the QC worksheet.

STORAGE REQUIREMENTS:

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 5 of 11

All media is to be stored at 2 to 8

PROCEDURE - STEPWISE:

Culture Examination and Interpretation of Aerobic Cultures (non-campylobacter)

Examine original BAP, MAC, and HE plates at both 24 and 48 hours incubation.

Look for "suspicious colonies" on each plate as follows:

PLATE

SUSPICIOUS COLONIES

BAP

Predominance of yeast,

Staphylococcus aureus

, beta streptococci, or

Pseudomonas aeruginosa,

hemolytic gram negative rods (screen

with oxidase)

MAC

Lactose negative colonies (clear to pink colonies)

Lactose negative and/or H

S positive colonies (clear colonies with

without black centers, or black colonies)

Work up suspicious colonies as follows:

Yeast - gram stain only

S. aureus

- staphaurex

Beta streptococci - slidex

Lactose negative - inoculate Kliglers and LIA

S positive - inoculate Kliglers and LIA

Refer to appropriate procedure for instructions on these tests.

Interpretation of Kligler’s iron agar and LIA reactions for stool cultures

Read reactions of Kliglers and LIA as described in their procedures.

Using Stool Cultures Flow Chart, incorporate KL and LIA reactions. Follow

directions on flowchart, and perform tests indicated. (Refer to appropriate

procedures for information on performing tests.)

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 6 of 11

Cultures positive for

Salmonella

and

Shigella

All isolates must be sent to IDPH for further serological differentiation.

Streak organisms to a trypic soy agar slant and refer to procedure for

sending specimens to IDPH.

It is not necessary to retype multiple identical isolates on the same culture if

one has already typed positive. Do not send multiple isolates to IDPH.

Culture Examination and Interpretation of

Campylobacter

Cultures

Examination of Direct Plates:

Examine direct plates at 24, 48, and 72 hours of incubation. Examine the Campy

thioglycollate subculture plates at 24 hours and 48 hours. Look for gray or

colorless, nonhemolytic colonies that may be either flat and watery with irregular

edges, or round and convex with entire edges. The colonies may range in size from

pinpoint to large and spready.

Treat these organisms like anaerobes. Examine plates quickly and place them back

into special gas mixture.

Gram stain any suspicious colonies, leave safranin on slide for about 3 minutes.

Campylobacter

organisms may appear as:

If gram stain correlates, perform oxidase and catalase test on suspicious colony.

Campylobacter jejuni/coli

will be oxidase and catalase positive (reactions may be

weak).

If colony has typical morphology on plate, appropriate gram stain, and is oxidase

and catalase positive, report as presumptive

Campylobacter

species. Notify floor or

clinic.

Obtain a blood agar plate. Inoculate plate and streak for isolation.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 7 of 11

Place a Nalidixic acid disk on the first quadrant of the plate.

Place the plate a Campy jar. Open Campy generator and place inside jar. Quickly

close top.

Incubate plates at 42

Examine plate at 24 and 48 hours.

10.

From the subculture plate, perform a rapid Sodium Hippurate (See Aerobic

Procedure Manual for procedure).

Subculture of Campy Thioglycollate:

MATERIALS:

Sterile plastic pasteur pipette (with bulb attached)

After 18-24 hours refrigeration at 2 - 8

C, remove Campylobacter Thioglycollate.

Place the tip of a sterile plastic pasteur pipette approximately one inch below the

surface of thioglycollate

Withdraw an aliquot towards the surface the tube.

Invert pipette and mix contents in bulb.

Place 2-3 drops of specimen on CVA and streak for isolation.

Place plate in Campy Jar. Place Campy generator in jar and quickly close the top.

Incubate at 42

Place only 6 - 8 plates per jar.

Interpretation of Positive Campylobacter Cultures

Campylobacter jejuni

will produce the following reactions:

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Pathology Laboratories

Clinical Microbiology Laboratory

Page 8 of 11

will produce the following reactions:

If any other results occur or the organism grows at 35

only

, bring to the attention of the

supervisor or lab rounds.

REPORTING RESULTS:

The workup and reporting of Stool Cultures is to include the reporting of (or absence of) normal

stool flora, reporting of no growth, reporting of the absence of coliforms as part of sparse normal

stool flora, and the exclusion of workup for gram positive stool flora. When reporting stool flora

and negative for enteric pathogens, use to precoded statements in Mysis.

The precoded results are:

Normal Stool Flora, Negative for Enteric Pathogens including Campylobacter, Salmonella,

Shigella, Yersinia, Edwardsiella, Aeromonas, and Pleiomonas

. Use this result when the

following conditions have been met:

absence of pathogens

moderate to many lactose positive gram negative rods

no beta hemolytic oxidase positive gram negative rods

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 9 of 11

Presence or absence of any one of the following: rare to few yeast, rare to few

Staphylococcus aureus

, any amount of gram positive organisms (not yeast or

aureus

No growth.

Use this result for no growth cultures.

Sparse Normal Stool Flora, Negative for Enteric Pathogens including Campylobacter,

Salmonella, Shigella, Yersinia, Edwardsiella, Aeromonas, and Pleiomonas

. Use this result

when the following conditions have been met:

absence of pathogens

rare to few lactose positive gram negative rods rare to few yeast, rare to few

Staphylococcus aureus

no beta hemolytic oxidase positive gram negative rods

Presence or absence of any one of the following: rare to few yeast, rare to few

Staphylococcus aureus

, any amount of gram positive organisms (not yeast or

aureus

Sparse Normal Stool Flora, No Coliforms Present, Negative for Enteric Pathogens

including Campylobacter, Salmonella, Shigella, Yersinia, Edwardsiella, Aeromonas, and

Pleisiomonas

. Use this result when the following conditions have been met:

absence of pathogens

absence of fermenting gram negative rods

no beta hemolytic oxidase positive gram negative rods

Presence or absence of any one of the following: rare to few yeast, rare to few

Staphylococcus aureus,

any amount of gram positive organisms (not yeast or

aureus

5. Yeast and

Staphylococcus aureus

are part of stool flora and will be reported using the

criteria:

Yeast will be reported if it is found to be in pure culture or the predominating organism. No

germ tube or further workup is required unless a physician requests identification. If yeast

is found in pure culture, none of the precoded results can be used. Report the absence of

stool flora, the quantity of yeast, and negative for enteric pathogens. If yeast is the

predominant organism, use one of the precoded results to report the type of normal flora,

then report the quantity of yeast.

Staphylococcus aureus

will be reported if it is found to be in pure culture or the

predominating organism. No susceptibility is required. If

S. aureus

is found in pure culture,

none of the precoded results can be used. Report the absence of stool flora, quantity of

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 10 of 11

staph, and negative for enteric pathogens. If

S. aureus

is the predominant organism, use one

of the precoded results to report the type of normal flora, then report the quantity of staph.

Pseudomonas aeruginosa

is identified when found to be the predominant gram negative

rod. No susceptibility is required. When reporting, use one of the precoded results to report

the type of normal flora, then report the quantity of pseudo.

8. When reporting a stool pathogen, DO NOT use any of the precoded results. There is no

reason to report the presence of stool flora.

Organism identifications done by IDPH or CDC must be stated on the CULTURE

report

. There are precoded comments for IDPH and CDC in Mysis. These precoded

comments must be used along with the confirmed identification of an organism. Example:

Salmonella serotype enteritidis

. Identification confirmed by the Illinois Department of

Health Lab, Chicago, Illinois.

REFERENCES:

Murray et al. 2007.

Manual of Clinical Microbiology

, 9th ed. American Society for Microbiology,

Washington D.C.

Isenberg, Henry D. 1992.

Clinical Microbiology Procedures Handbook

. American Society for

Microbiology, Washington, D.C.

Winn et al. 2006. Koneman’s

Color Atlas and Textbook of Diagnostic Microbiology

, 6th ed.

Lippincott-Raven, Philadelphia, PA.

NCCLS: Quality Assurance for Commercially Prepared Microbiological Culture Media.

(Approved Standard, Third Edition, M22-A3). NCCLS, Villanova, Pa, 2004.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 11 of 11

DISCARD

DISCARD

Rounds

DISCARD

Rounds

. (Send to IDPH. Save all plates

on desk until report comes back from IDPH.)

Positive

Cont’d from Page 1, H2S neg, Oxidase neg, Glucose pos or weak

DISCARD

DISCARD

DISCARD

Yersinia ID

Rounds

, Call Dr, Send to IDPH. Save all plates on desk until report comes bac

CHEERS QAPP 3

Appendix 11: UIC Laboratory: Stool Viral

Culture

A: Virus isolation and identification procedures

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 5

VIRUS ISOLATION AND IDENTIFICATION

PROCEDURES

INTRODUCTION:

A variety of methods are used for the laboratory diagnosis of viral infections. These include

isolation in cell culture; direct examination of clinical material to detect viral particles, antigens,

or nucleic acids; cytohistological evidence of infection; and serologic assays to assess the

individual’s antibody response to infection. No single approach can meet the needs of the

diagnostic virology laboratory. Instead, a combination of methods must be implemented. The

choice of methods involves several factors, including knowledge of the pathogenesis of the

suspected agent(s), the stage of illness, and the availability and utility of various methods for the

particular infection in question.

The field of clinical virology is changing rapidly and a wide variety of testing methodologies are

now available for virus detection. Cell culture isolation, the backbone of the virology laboratory,

has also changed significantly in the past 10 years. The introduction of the centrifugation-

enhanced (shell vial) technique has for the first time, allowed laboratories to provide culture

confirmation within a clinically relevant time frame for many slow-growing viruses.

Rapid identification of viral agents is becoming increasingly important because of the

development and use of antiviral agents. Unfortunately, the conventional method of virus

isolation in standard tube culture can take up to 21 days. The shell vial technique which

combines centrifugation with monoclonal antibody staining has further reduced the time for virus

detection. However, due to the limited optimum sensitivity of a single cell line preparation for

different viral pathogens, several cell lines along with primary monkey kidney cells are often

included for conventional tube or shell vial culture. This practice is both costly and time

consuming. Recently mixed cell cultures have come on the market that ultimately can save time

and money.

PRINCIPLE:

Viruses are obligate intracellular parasites and require a suitable cell culture substrate for

propagation. Since there is no one cell type that will support the replication of all viruses, a

spectrum of different cell types is used to cultivate the medically important viruses. Certain

viruses, including Ebstein-Barr virus and human immunodeficiency virus type 1 are not

culturable in traditional mono-layered cell cultures and require the use of blood WBCs. Several

other viruses remain unculturable or require specialized cell cultures or alternative hosts that are

not generally available in the diagnostic setting. Several Coxsackie A viruses, rabies virus, and

arbovirus are best isolated in mice. In some instances, noninfectious subviral particles may be

present in cells. These are not recoverable by conventional isolation procedures. For example,

the recovery of measles virus from the brain tissue of patients with subacute sclerosing

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 2 of 5

panencephalitis was achieved by co-cultivation involving the fusion of brain cells with cell

cultures.

Once a specimen is received in the laboratory, it is processed to yield material suitable for the

inoculation into shell vial cultures. Specimen preparation depends on the specimen type. Swabs

are vortexed in viral transport medium, tissue samples are homogenized, and fluid specimens

usually require only the addition of antimicrobial agents. After specimens are inoculated into the

appropriate cell cultures, the cultures are incubated at 35 – 37ºC. A major emphasis in recent

years has been on providing culture results within the shortest possible time.

SPECIMEN COLLECTION:

Successful laboratory diagnosis of viral infections requires an understanding of the pathogenesis

of the suspected organism and knowledge regarding the stage of infection and the age and

immunocompetence of the infected individual. The success of culture depends on several factors

including the proper choice of specimens, careful collection to optimize recovery of the agent,

and transport of specimens in a manner that maintains viability and minimizes overgrowth with

contaminating organisms. For best correlation with a particular disease, the specimen should

reflect the target organ whenever possible.

A) Special transport media is available for specimen collection.

B) All specimens are processed immediately upon receipt.

C) Those specimens received outside normal working hours are kept at 2 – 8ºC until

processed.

D) All handling and processing of virology specimens must be done under a class II

biological safety cabinet in accordance with the universal precautions for blood-borne

pathogens. Refer to the Laboratory Safety Manual for specific details.

E) Specimen Rejection Criteria

1. All specimens received without an attached identifying label, or label that does

not correspond with the information provided on the accompanying requisition

or transmittal form, will not be tested until the requesting physician is contacted

and asked to either personally identify and label the specimen or submit a new

specimen.

If the physician requests that the test be performed on the

improperly labeled specimen, all subsequent reports will include a comment to

the effect.

2. All specimens submitted for viral isolation must be collected according to

instructions outlined in the Laboratory Users Guide

. All requests for viral

isolation must include the source of specimen and if possible the type of

infection and/or the virus expected. Dry swabs will not be accepted by the

virology lab. All virology specimen transport kits contain detailed instructions

for each type of patient specimen that needs to be collected. The clinician is

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Pathology Laboratories

Clinical Microbiology Laboratory

Page 3 of 5

also encouraged to contact the laboratory if any additional instruction is needed.

The requesting physician will be notified and asked to submit a properly

collected specimen if necessary.

3. Grossly contaminated specimen containers and/or soiled requisition will not be

accepted.

Any spillage is treated with the proper disinfectant and all

contaminated materials disposed in an appropriate biohazard bag. If possible,

another specimen should be submitted following notification of the requesting

physician. The head nurse on the patient’s unit will be notified of all

improperly collected and/or transported specimens.

4. “QNS” specimens: The requesting physician will be notified by telephone and

a canceled test report will be sent out in the computer. If more than one test is

requested, the tests to be performed will be prioritized in consultation with the

requesting physician.

PROCEDURE:

A) Collection and Processing of Clinical Specimens—See Specimen Collection section.

B) Inoculation and Examination of Cell Cultures

1) All routine specimens are inoculated into a cell spectrum of at least two (unless

otherwise specified) cell types to ensure cell susceptibility and virus recovery.

2) Uninoculated cell culture controls from each new lot are incubated along with the

patients. When new cells are checked into the laboratory, a record is kept of cell

type, passage number, and source. Observe the gross and microscopic conditions

of the cultures.

Inspect the cultures for leaking, breakage, pH extremes,

contamination, etc. Microscopically examine representative monolayer to assess

the quality and extent of development (sparse, sub confluent, confluent,

overgrown). Record any problems and if necessary, notify the technical service

of the manufacturer.

3) Patient and control cell cultures are incubated at 35 – 37ºC in exactly the same

manner as patients.

All cultures, including controls, are examined every working day for the

appearance of cytopathic effects (CPE).

The cultures are held 1 – 7 days prior

to issuing a negative report. Preliminary positive results are entered in the

computer and are also reported by telephone (except for HSV request from the

clinics) to the requesting physician. Final computer results are submitted after

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 4 of 5

definitive identification has been completed and reviewed and signed out by the

section supervisor.

5) All viral identifications are confirmed with monoclonal antibodies when

available

Probable Enteroviruses are sent to IDPH for confirmation.

6) Viral isolates are stored at -70ºC for future reference.

C) Virus Detection and Identification

1) Viral Cytopathogenic Effects

a) A table describing typical viral CPE, inclusion body formation, viral

hemadsorption, virus susceptibility, cell spectrum and other

characteristics helpful in identification procedures is available (Table I).

b) A pictorial atlas of typical virus CPE in stained and unstained cell

cultures has been compiled for the laboratory staff as an additional aid.

c) Representative virus cultures (formalin preserved monolayer)

demonstrating viral CPE is also available for reference.

2) Immunological Methods

a) Neutralization—Enteroviruses. Sent to the state lab per M.D.’s request.

b) Fluorescent Antibody—CMV, HSV, VZV, Adeno group, RSV,

Influenza A/B, and Parainfluenza 1, 2, 3.

INTERPRETATION:

The occurrence of viruses in various clinical specimens is shown in Table II. The significance of

a viral isolate depends upon the nature of the illness and pathogenesis of the virus. For example:

Isolation of a viral agent from the nasopharynx and stool specimens may not be related to the

suspected clinical syndrome and must be interpreted with caution. However, isolation of a viral

agent from the blood, CSF, and/or vesicle fluid provides direct evidence of its involvement in the

disease process.

QUALITY CONTROL:

A) Media and Media Components

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 5 of 5

1) Only reagents quality control tested by suppliers to ensure freedom from

Mycoplasma, endogenous viruses, bacteria and other extraneous agents are

used in isolation procedures. Sufficient quantities of the same lot number are

kept in stock supply to ensure uniform and reproducible results.

2) All new lots of media are labeled with receipt date and used within their

specified expiration time.

B) Cell culture Substrates

1) Primary cell cultures (PRMK) and continuous cell cultures (MRC-5, A549) are

obtained from reliable commercial sources and certified to be free of

mycoplasma and endemic viruses.

2) The laboratory staff is trained to be aware and to recognize latent virus

contaminants which may be present in “normal” cell cultures, especially

primary cells of Simian origin.

REFERENCES:

Clark, L.M. “Viruses, Rickettsiae, Chlamydiae, and Mycoplasmas.” ASM Clinical Microbiology

Handbook. Washington, D.C.: ASM Press, 1992.

Evans, Alfred S. Viral Infections of Humans: Epidemiology and Control. New Haven: Plenum

Medical Book co., 1991.

Winn, W. et al. Koneman’s Color Atlas and Textbook of Diagnostic Microbiology, 6

edition.

Philadelphia: J.B. Lippincott Co., 2006.

Murray, Patrick R. Manual of Clinical Microbiology,9

ed. Washington D.C.: ASM Press, 2007.

CHEERS QAPP 3

Appendix 11: UIC Laboratory: Stool Viral

Culture

B: Specimen collection for virus isolation

SPECIMEN COLLECTION FOR VIRUS ISOLATION

Please use the swab provided in the kit and break it so that it fits into the tube

containing the transport media. Then securely fasten the cap to prevent unwanted media

leakage. Be sure to specify the source of the specimen on the requisition before sending

it to the lab.

Routine and HSV Isolation

Throat swabs:

Rub the tonsils and posterior nasal passages.

Throat wash:

Have patient gargle several times with 5-10ml saline.

Collect in sterile container, transfer to transport tube.

Nasopharyngeal swabs:

Use small wire swab, insert gently into nose and down into

pharyngeal area.

Nasopharyngeal wash:

Using 5-10ml saline in syringe with plastic tubing attached

or bulb syringe, expel and withdraw several times.

Transfer to transfer tube.

Sputum/Bronchial wash/

Tracheal Aspirate:

Collect in sterile container and transfer approx. 2ml to

transport tube.

Eye:

Rub conjunctiva and any visible exudate.

Lesion or open vesicle:

Rub lesion or absorb vesicle fluid with swab.

Rectal swabs:

Insert swab 2-3cm into anal canal and rotate. An adequate

(nonrotavirus testing)

sample should have visible fecal material attached to swab.

Transfer to transport tube.

Tissue:

Place tissue in transport tube.

For autopsy specimens, separate sets of sterile instruments

should be used to prevent cross contamination. Sections of

each tissue should be placed in separate labeled transport

tubes.

NO FIXATIVE SHOULD BE USED.

Non-Routine Virus Isolation

These types of specimens do not require viral transport media. Send as instructed with

requisition.

Urine:

Collect 10-20ml sterile screw cap jar.

Feces:

Collect in sterile container aprrox. 5grams in screw cap jar

or container with tight lid.

CSF/Pericardial

or other sterile body fluid:

Collect at least 2ml in sterile tube.

Direct Detection

Rsv EIA:

Nasopharyngeal wash or swab are specimens of choice and

may be sent in viral transport medium.

Rotavirus EIA:

Feces in the specimen of choice. 1 gram or 1ml of stool is

required.

Note:

ALL SPECIMENS SHOULD BE PROCESSED IMMEDIATELY. IF

THER IS A DELAY IN TRANSPORT OR SPECIMEN AFTER NORMAL

LABORATORY HOURS, STORE AT 4

CHEERS QAPP 3

Appendix 11: UIC Laboratory: Stool Viral

Culture

C: CPE produced by viruses in monolayer cell

cultures

Table 1.

Description of CPE produced by viruses in monolayer cell cultures

Virus

Characteristic CPE

Devolp

ment

(days)

Progression

Comments

Adenovirus

Enlarged, rounded cells in tighly

associated grapelike clusters. Some

isolates may produce lattice-type

arrangement of rounded cells.

4 - 7

Moderate

CPE is less characteristic in diploid

fibroblasts and may initially resemble

that of CMV.

Enterovirus

Rounded highly refractile cells in

loose clusters or dispersed

CPE is similar for most enteroviruses

(coxsackie A and B, echoviruses, polio,

and enteroviruses 68 to 71).

Herpes

viruses CMV

Plump, rounded cells in elongated

foci parallel to long axis of host cells

5 - 10

Slow

Some isolates may not progress

beyond a few patches of CPE, while

high-titered urine specimens may yield

extensive CPE within 24 h.

Herpes

simplex

Clusters of rounded, ballooned cells

with or without syncytia. Early CPE

is focal but progresses throughout

CPE may develop more slowly and be

less characteristic in human bibroblasts.

Simian B virus produces similar CPE in

simian cells, including primary rhesus

kidney.

VZV

Foci of enlarged, rounded, refractile

cells with or without syncytia.

Cytoplasmic strands between

infected cells and granularity may be

prominent as CPE progresses.

Variable. No CPE may be produced

or may include granular and

vacuolated appearance or

nonspecific degeneration. Rounded

refractile cells are more frequently

associated with type B.

3 - 5

Moderate

HAd is independent of presence or

degree of CPE

Orthopoxviru

s Vaccinia

Syncytia and clusters of rounded,

enlarged, refractile cells with

cytoplasmic strands bridging foci of

Infected cells hemadsorb chicken

Variable, with increased rounding,

granularity, and progressive

degeneration. Syncytia are

associated with mumps and

parainfluenza type 2 and 3 viruses.

3 - 7

Moderate

HAd is independent of presence or

degree of CPE

Measles

(rubeola)

Syncytia appear as large

multnucleated refractile areas.

Nuclei may encircle granular mass of

giant cell. Extensive vacuolization

Infected cells may hemadsorb simian

RBCs.

Respiratory

syncytial

Syncytia appear as large

multinucleated refractile areas.

3 - 5

Moderate

CPE in human bibroblasts is less

characteristic and may resemble

nonspecific cellular degneration.

Reoviruses

Noncharacteristic granular

appearance with progressive

degeneration and detaching of

CPE may be difficult to distinguish from

nonspecific degeneration of monolayer.

CHEERS QAPP 3

Appendix 12: UIH Laboratory Protocol:

Cryptosporidium/Giardia

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

MERIDIAN CRYPTOSPORIDIUM/GIARDIA DIRECT

IMMUNOFLUORESCENT DETECTION

INTRODUCTION:

Protozoans of the genus Cryptosporidium are encountered worldwide and produce a self

limiting gastroenteritis in immunocompetent individuals. The primary symptoms include

explosive, watery diarrhea, accompanied by vomiting, abdominal cramping and low

grade fever lasting two to fourteen days. In immunocompromised patients, symptoms are

more severe and persistent and may result in mortality particularly in patients with

Acquired Immune Deficiency Syndrome. Attempts to find effective chemotherapeutic

agents have been unsuccessful thus far.

Giardia lamblia is the etiologic agent of giardiasis, an important worldwide intestinal

disease. Infections in the Unites States were initially reported from hikers, campers and

fisherman who drank stream water. The incidence of giardiasis has steadily increased

over the last two decades and has become an urban parasite. There has been an increase

in the prevalence of giardiasis children in day care centers, institutionalized individuals

and the homosexual population. In symptomatic cases there may be irritation of the

mucosal lining, dehydration, epigastric pain, flatulence, diarrhea with increased fat and

mucus and anorexia lasting from several weeks to several months.

An association between Cryptosporidium and Giardia infection has not been

demonstrated. However, numerous incidents of coinfection with both organisms has

been documented. The immunofluorescent technique is simple to perform and has been

demonstrated to have a higher sensitivity than traditional staining procedures.

PRINCIPLE:

The Meridian Cryptosporidium/Giardia test utilizes the principle of direct

immunofluorescence. The Detection Reagent contains a mixture of FITC labeled

monoclonal antibodies directed against cell wall antigens of Cryptosporidium

oocysts and

Giardia

cysts. A prepared fecal specimen is treated with the Detection Reagent a

counterstain. The monoclonal antibodies attach to Cryptosporidium

or Giardia antigens

present in the specimen. The slides are rinsed to remove unbound antibodies. A

coverslip is affixed with mounting medium and the slides are examined for apple green

color and characteristic morphology of Cryptosporidium oocysts and Giardia cysts using

a fluorescent microscope. Background material in the specimen is counterstained dull

yellow to red.

SPECIMEN REQUIREMENTS:

Formalinized preserved stool that has been concentrated by the formalin – ethyl acetate

method.

Page 1 of 5

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MATERIALS:

Detection Reagent:

FITC labeled anti- Cryptosporidium and anti-Giardia

monoclonal antibodies in a buffered solution containing a

protein stabilizer and 0.1% sodium azide

Counterstain:

Eriochrome Black solution

20X Wash Buffer:

Concentrated wash buffer with a preservative

Positive Control-

Formalinized stool preparation of Cryptosporidium oocysts

and Giardia cysts

Mounting Medium:

Buffered glycerol containing formalin, an anitquencher and

0.1% sodium azide

Transfer Loops

Treated Slides

Distilled or deionized water

Wash bottle

Humidity chamber

Microscope coverslips 22 x 50 mm

Applicator sticks

EQUIPMENT:

Fluorescent microscope

PROCEDURE:

Specimen Preparation

To increase the probability of detection in stools with low numbers of

cysts or oocysts, the specimen should be concentrated by the formalin –

ethyl acetate procedure prior to processing. (Refer to procedure manual)

The removal of fecal lipids by ethyl acetate may be particularly beneficial

if the fecal specimen is mucoid. Delipidation will facilitate the adherence

of fecal material to the treated microscope slide.

Allow the slide to air dry completely at room temperature (usually

requires 15-30 minutes).

Place one drop of Detection Reagent in each well.

Page 2 of 5

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Place one drop of Counterstain in each well.

Mix the reagents with an applicator stick and spread over the entire well.

Do not scratch the treated surface of the slide.

Incubate the slide in a humidified chamber for 30 minutes at room

temperature.

Use a wash bottle to rinse the slide with a gentle stream of 1X Wash

Buffer until excess

Detection Reagent and Counterstain is removed.

NOT SUBMERGE THE SLIDE DURING RINSING.

Avoid

disturbing the specimen or causing cross contamination of the specimens.

Remove excess buffer by tapping the long edge of the slide on a clean

paper towel.

DO NOT ALLOW THE SLIDE TO DRY.

10.

Add one drop of Mounting Medium to each well and apply a coverslip.

11.

Scan each well thoroughly using 100 – 200X magnification. The presence

of Cryptosporidium

oocysts should be confirmed at higher magnification.

INTERPRETATION:

Control Reactions

Cryptosporidium oocysts are round to slightly oval in shape, 2 – 6 microns

in diameter. The oocyst wall will stain bright apple green. A suture line

may also be visible.

Giradia

cysts are oval shaped organisms 8 -12 microns long. The cyst

wall will stain bright apple green.

Background material should counterstain dull yellow to red.

Test Reactions

Cryptosporidium positive test result: Any stool specimen exhibiting one

or more oocysts with an apple green color and characteristic morphology

should be considered positive for the presence of Cryptosporiduim

sp…

Giardia positive test result: Any stool specimen exhibiting one or more

cysts with an apple green color and characteristic morphology should be

considered positive for the presence of Giardia.

Page 3 of 5

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Negative test result: A stool specimen with no apple green fluorescence

should be considered negative for the presence of Cryptosporiduim

oocysts and Giardia cysts. Background fluorescence debris which does

not exhibit vibrant apple green color or characteristic morphology should

also be considered negative.

NOTES:

Protect the Detection Reagent and Counterstain from exposure to light.

Patient specimens may contain HIV or other infectious agents and should be

handled by properly trained personnel and disposed of as potential biohazards.

Follow universal precautions and utilized appropriate barrier protection.

Specimens preserved in PVA or MF/MIF are not suitable for use with this assay.

Formalin and SAF preserved specimens may be used.

If stool material is not seen upon scanning the slide wells, loss of sample may

have occurred. This is usually due to an overly vigorous wash procedure or

insufficient specimen drying time.

QUALITY CONTROL:

A Positive and negative control should be evaluated each time patient specimens

are tested.

At the time of each use, the kit components should be visually examined for

obvious signs of contamination, freezing or leakage.

The results of each quality control check must be recorded on the appropriate log.

Do Not Report Patient Results if QC Fails.

REFERENCES

Fayer, R., and B. L. Ungar, 1986. Cryptosporidium spp. and Cryptosporidiosis.

Microbiol. Rev. 50:458-483.

MERIFLUOR Crptosporidium/Giardia Direct Immunofluorescent Detection

Procedure, Package Insert, 1991, Meridain Diagnostics, Inc. Cincinnati, OH

45244.

Clinical Microbiology Procedures Handbook

, American Society for

Microbiology, Washington, D. C., 1992.

Page 4 of 5

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Pathology Laboratories

Clinical Microbiology Laboratory

Garcia, L.S., D.A. Bruckner,

Diagnostic Medical Parasitology 4

edition

American Society for Microbiology, Washington, D. C., 2001.

Page 5 of 5

CHEERS QAPP 3

Appendix 13: UIH Laboratory Protocol:

Rotavirus

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 6

MERIDIAN

IMMUNO-CARD STAT ROTAVIRUS

EIA

INTENDED USE:

The

ImmunoCard STAT!

Rotavirus

immunoassay is a rapid

in vitro

qualitative procedure for

the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of

rotavirus associated gastroenteritis.

PRINCIPLE:

Rotavirus is a major cause of acute gastroenteritis, especially in children 6 to 24 months in age.

In addition, rotavirus infections can produce severe illness as well as asymptomatic infection in

adults. The incubation period of rotavirus infection is usually one to three days, followed by

gastroenteritis with an average duration of five to eight days. Virus titers in stool reach a

maximum shortly after the onset of illness, then decline.

Due to inadequacies in existing culture methods, human rotavirus infection is not routinely

isolated from rotavirus-containing specimens. For many years, electron microscopy has been the

standard method for rotavirus detection. However, newly introduced enzyme immunoassays and

latex agglutination assays with increased sensitivities and specificities are now the methods of

choice. The

ImmunoCard STAT!

Rotavirus

test offers a simple, rapid method for detecting

rotavirus antigen in patient stool.

The

Meridian

ImmunoCard Stat!

Rotavirus

assay detects the presence of rotavirus antigen in

stool. Patient specimen is diluted in Sample Diluent and then added to the sample port of the

device. The sample mobilizes gold particles coated with monoclonal antibody to rotavirus and

migrates along the membrane through the

Test

(polyclonal anti-rotavirus antibody) and

Control

zones. After ten minutes, the

Test

and

Control

zones are observed for the presence of

red/purple line in the

Test

zone. No red/purple line in the

Test

zone indicates a negative result.

The

Control

line serves as a procedural control to assure that the sample has migrated the

appropriate distance along the membrane.

SPECIMEN:

For the best results, specimens should be collected after onset of symptoms. Several authors

have reported declining numbers of rotavirus particles after day eight or nine, with peak counts

occurring on days three through five. Samples collected after day eight or nine may be less

reactive than those collected earlier in the course of the disease. Specimens containing high

levels of blood may fail to flow in the

ImmunoCard STAT!

Rotavirus

device, resulting in an

invalid test result. Testing of an additional specimen is recommended under such circumstances.

Stool specimens must be collected into a clean, dry container free of detergent residue. One

gram of stool (about the size of a pea) or one mL of liquid stool is required for test.

Swabs are

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Page 2 of 6

not acceptable

. Any request for Rotavirus collected on a swab is to be canceled and called to

the floor or clinic.

Handling Conditions:

The specimen should be tested as soon as possible, but may be

stored up to 72 hours at 2 – 8ºC prior to testing. If the test cannot be performed within this

time frame, the specimen should be frozen at -20ºC or lower.

EQUIPMENT AND MATERIALS:

Materials Provided:

ImmunoCard STAT! Rotavirus

device

Positive Control-Inactivated rotavirus (SA-11) in a buffer containing 0.02%

thimerosal

Sample Diluent-Buffer containing 0.1% sodium azide as a preservative

Transfer pipets

Materials Not Provided:

12x75 mm test tubes

Applicator sticks

Timer

Preparation:

Allow kit components to reach 21 – 25ºC prior to use.

Gently mix liquid reagents prior to use.

PRECAUTIONS:

1. All reagents are for

in vitro

diagnostic use only.

2. All reagent concentration, incubation times and temperatures (21 – 25ºC) have been

optimized for sensitivity and specificity. Best results are obtained by adhering to these

specifications. Once the assay has been started, complete all subsequent steps without

interruption.

3. Patient specimens and used

ImmunoCard STAT!

Rotavirus

devices may contain

infectious agents and should be handled at Biosafety Level 2 as recommended in the

CDC/NIH manual “Biosafety in Microbiology and Biomedical laboratories” 1988.

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Page 3 of 6

4. Positive Control reagent contains inactivated rotavirus. However, it should be handled

as potential biohazard.

5. All reagents should be gently mixed and at 21 – 25ºC before use.

6. Do not interchange reagents from different kit lot numbers, or use expired reagents.

7. Hold Positive Control vial vertically to insure proper drop size and delivery. Do not

allow the tips of the vial or pipet to touch the sample port.

8. Use only one transfer pipet per control or specimen. Discard after use.

9. Stool must be mixed thoroughly (regardless of consistency) to insure a representative

sample prior to pipetting. Do not use stools that have dried out.

10. Dilution of stool as described in the

PROCEDURE

section is important. Over-

inoculation of stool into the Sample Diluent may restrict movement within the

ImmunoCard STAT!

Rotavirus

device so as to produce an invalid result.

QUALITY CONTROL:

The Positive and Negative Controls should be assayed along with patients and performed each

day test is performed. Patient tests are invalid if controls do not perform to specifications.

1. Add three drops of Positive control directly to

Sample

Port of appropriate device (do

not dilute Positive Control).

2. Using a transfer pipet, add 150 μL Sample Diluent (Negative Control) directly to

Sample

port of appropriate device.

Interpretation of Control Results:

1. The Positive Control should yield a visually detectable red/purple

Test

and

Control

lines.

2. The Negative control should yield a visually detectable red/purple

Control

line. No

Test

line should be present.

STORAGE REQUIREMENTS:

All components must be at 21 – 25ºC prior to use.

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Page 4 of 6

PROCEDURE - STEPWISE:

1. Sample dilution

a. Add 350 μL Sample Diluent to one 12x75 mm test tube for each specimen to be

tested.

b. Mix stool thoroughly, regardless of consistency.

c. Liquid or semi-solid stool: Using a transfer pipet, draw stool to the 25 μL

calibration point (first mark from tip of pipet). Dispense the stool into the Sample

Diluent in appropriate 12.75 mm tube. Using the same pipet, gently withdraw and

expel the stool suspension several times, then vortex ten seconds. Leave transfer

pipet in tube for further use. Note: Do not pipet more than 25 μL of stool. Over-

inoculation with stool may produce invalid results. Proceed to Step 2 within 30

minutes.

d. Solid stool: using a wooden applicator stick, transfer a 2 mm diameter portion of

stool into the Sample Diluent in the appropriate 12.75 mm tube. Emulsify the

stool thoroughly using the applicator stick, then vortex ten seconds. Place transfer

pipet in the tube. Proceed to Step 2 within 30 minutes.

2. Remove appropriate number of

ImmunoCard STAT!

Rotavirus

devices from their

pouches. Label appropriately. Use one device per control or sample.

3. Vortex each diluted specimen for ten seconds. Using the original specimen transfer pipet,

draw diluted sample to the 150 μL calibration point (second mark from the tip of the

pipet) and add to

Sample

port.

4. Incubate ten minutes at 21 – 25ºC. Note: During the ten minute incubation, diluted

specimen must move past the

Control

zone.

5. Visually read

Control

and

Test

zones for the presence of absence of a red/purple line at

the end of the incubation period.

INTERPRETATION OF RESULTS:

Positive Test Result:

Visually detectable red/purple

Test

and

Control

lines. A positive result

indicates the presence of rotavirus antigen.

Negative Test Result:

Visually detectable red/purple

Control

line. No red/purple

Test

line

present. A negative result indicates that rotavirus antigen is absent or below the level of

detection.

Invalid Test Result:

No visually detectable red/purple

Control

line, with or without a visually

detectable red/purple

Test

line. An invalid test result may be due to a Reagent/Device problem,

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Clinical Microbiology Laboratory

Page 5 of 6

a procedural error, or over-inoculation of stool into Sample Diluent during specimen dilution.

Re-dilute stool and repeat test. Stools containing high levels of blood may fail to flow properly,

resulting in an invalid result. Testing with an additional specimen is recommended. On

occasion, a stool may have very high levels of rotavirus antigen and will yield a visible

Test

line

and no visible

Control

line. In such cases, the specimen may be diluted two-fold or greater,

beyond original 1:15 dilution (ex. 25 μL stool + 750 μL Sample Diluent) and retested.

REPORTING RESULTS:

Positive Test Result:

All positive test results must be called to the floor or clinic. Under the

function MEH enter the code PROTA with the name, date, and time of the person notified of the

result.

Negative Test Result:

Under the function MEH enter the code NROTA.

Invalid Test Result:

Under the function MEH enter the code IND and free text the comment

“please recollect sample”.

LIMITATIONS OF THE PROCEDURE:

1. The

ImmunoCard STAT!

Rotavirus

test does not define the presence of rotavirus

associated gastroenteritis, but only demonstrates the presence of the antigen in stool. As

with all

in vitro

diagnostic procedures, test results should be interpreted by a physician in

conjunction with other clinical information.

2. Limit of detection in stool specimens is 1.8 – 3.7x10

rotavirus particles per test volume.

3. The use of meconium stools in this assay is not recommended as their performance

characteristics have not been evaluated.

4. A positive result does not preclude the presence of other infectious organisms.

REFERENCES:

Meridian

ImmunoCard Stat!

Rotavirus

package insert 12/01. Meridian Diagnostics, Inc.,

Cincinnati, OH.

Winn, W. et al., Koneman’s Color Atlas of Diagnostic Microbiology, 6

Ed., Philadelphia, PA

Lippincott, 2006.

CHEERS QAPP 3

Appendix 14: UIH Laboratory Protocol:

Eye Cultures

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 8

EYE CULTURES

PRINCIPLE:

Inflammatory eye conditions may be due to a variety of diseases, and microorganisms play a major

role in both acute and chronic eye diseases. The detection of infectious agents depends on the

knowledge of the site of infection and the severity of the process, because a variety of organisms

cause infections of the eye. Unlike the procedures with other specimen types, it may be important

for the physician to inoculate culture media at the bedside rather than transport the specimen to the

laboratory for processing.

This procedure describes the clinical syndromes associated with bacterial infections of the

eye, the organisms associated with these syndromes, and the procedure for isolation of these

infections.

MICROORGANISMS ENCOUNTERED IN EYE INFECTIONS

Conjunctivitis

Description of syndrome

Conjunctivitis is an acute or chronic inflammation of the conjunctiva, the mucous

membrane covering of the anterior surface (sclera) of the eye. The symptoms

include reddening of the surface, tearing, and a purulent discharge. The source of

the involved bacterial organism is usually direct inoculation of exogenous

organisms from formites, and the environment, etc, but hematogenous spread from

another focus can occur.

Common causes of infection

Haemophilus influenzae

Staphylococcus aureus

Streptococcus pneumoniae

Neisseria gonorrhoeae

Causes of infections in immunocompromised patients

Members of the family

Enterobacteriaceae

Pseudomonas aeruginosa

Bacterial keratitis

Description of the syndrome

Keratitis is defined as an inflammation of the cornea. It may present with a wide

range of symptoms extending from a superficial infection of the corneal epithelium

to deep stromal ulceration that may lead to perforation and/or loss of the eye. It is a

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Page 2 of 8

serious condition requiring prompt and meticulous investigation. Predisposing

factors for corneal ulceration include prior eye disease, contact lens wear, and use

of topical corticosteriods. Other individuals at risk include alcoholics, burn patient

and other immunocompromised patient.

Symptoms of keratitis include redness of the eye, inflammation of the conjunctiva,

increased pain, decreased vision, and photophobia. Patients feel a foreign-body

sensation in the eye that results in tearing and exudate formation.

Common causes of infection

Pseudomonas aeruginosa

(often progresses rapidly and may result in

corneal perforation in a few hours)

Streptococcus pneumoniae

Moraxella sp.

Alpha hemolytic streptococci

Staphylococcus aureus

Coagulase negative staphylococci

Less common bacterial causes of infection

Enterobacteriaceae

Neisseria gonorrhoeae

Neisseria meningitidis

Haemophilus influenzae

Rapidly growing mycobacteria

Actinomyces sp.

Propionibacterium acnes

Clostridium perfringens

Contact lens associated causes of infection

Bacillus sp.

Serratia sp.

Bacterial endophthalmitis

Description of the syndrome

Endophthalmitis is the most serious and sight-threatening infection of the eye. It is

an inflammation of the ocular cavities and intraocular tissue resulting from trauma

to the eye, including surgery, injury, or corneal suppuration and perforation

following keratitis. Endogenous endophthalmitis as a result of bacterial sepsis or

from a contagious site, ie.,

cellulitis, may also occur. The infection following

surgery will often manifest within 72 hours of surgery, presenting with decreased

vision, pain, lid edema, conjunctival hyperemia, sever iridocyclitis, and hypopyon.

Chronic endophthalmitis may follow.

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Common causes of infection

Postsurgical endophthalmitis

Staphylococcus aureus

Coagulase negative staphylococcus

Streptococcus pneumoniae

Streptococcus sp.

Pseudomonas aeruginosa

Other gram-negative bacilli

Postcataract surgery (chronic, occurring months to years after surgery)

Propionibacterium acnes

Posttraumatic endophthalmitis

Bacillus cereus

Bacillus licheniformis

Bacillus subtilis

Clostridium sp.

Endogenous endophthalmitis

Staphylococcus aureus

Streptococcus pneumoniae

Haemophilus influenzae

Neisseria meningitidis

Description of the syndrome

Preseptal cellulitis is an inflammation of the periorbital tissue resulting from

traumatic injury, laceration, or a puncture wound. It may also result from an

extension of impetigo or erysipelas. Symptoms are a warm erythematous eyelid

with conjunctival edema. The condition needs to be differentiated from orbital

cellulitis, a more-systemic, severe infection of the orbit itself.

Common causes of infection

Staphylococcus aureus

Streptococcus pyogenes

other streptococci

Haemophilus influenzae

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Traumatic injury with foreign body contamination

Clostridium sp.

may be involved alone or mixed with aerobes

Uncommon causes of infection

Pseudomonas sp.

Other gram-negative bacilli

Orbital cellulitis

Description of the syndrome

Orbital cellulitis is an infection of the orbital tissue resulting from trauma, surgery,

or an extension of paranasal infection or panophthalmitis. It is a serious, systemic

infection and may cause blindness, septic thrombosis of the cavernous sinus, or

intracranial infections. Symptoms include fever, leukocytosis, lid edema, and

limitation of ocular motility.

Common causes of infection

Postsurgical infection

Staphylococcus aureus

Trauma

Mixed anaerobic and aerobic infections may occur.

Extension from panophthalmitis

Staphylococcus aureus

Streptococcus pneumoniae

Pseudomonas aeruginosa

Extension of a paranasal infection

Haemophilus influenzae

(especially in children less than 5 years old)

Staphylococcus aureus

Streptococcus pyogenes

Streptococcus pneumoniae

Gram-negative bacilli

Miscellaneous eye infections

Dacryoadenitis

Description of the syndrome

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Dacryoadenitis is an infection of the lacrimal glands. Symptoms include

pain and tenderness in the upper lid.

Common causes of infection

Staphylococcus aureus

Streptococcus pyogenes

Streptococcus pneumoniae

Dacryocystitis

Description of the syndrome

Dacryocystitis is an infection of the lacrimal sac that usually follow

obstruction of the nasolacrimal duct. Symptoms include pain, swelling,

redness, and tenderness of the lacrimal gland. A fistula may form.

Common cause of infection

Streptococcus pneumoniae

Staphylococcus aureus

Streptococcus pyogenes

Haemophilus influenzae

Canaliculitis

Description of the syndrome

Canaliculitis is an inflammation of the canaliculus, the passage that

connects the punctum to the lacrimal sac. Symptoms include swelling, pain,

and tenderness at the corner of the eye. The infection may be accompanied

by unilateral conjunctivitis and hyperemia of the eyelid.

Common causes of infection

Actinomyces israelii

Propionibacterium propionicus

Moraxella sp.

Diphtheroids

Alpha hemolytic streptococci

SPECIMEN:

Acceptable Specimens:

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Sterile tubes: Fluids can be transported in sterile vacutainer tubes without

preservatives

Swabs

Cornea or lens

Specimen received on plates and broth

Unacceptable Specimens:

Mislabelled and unlabelled specimens

Dried swabs, or swabs with ampules not crushed

Specimens received >24 hours after collection

Specimens received in citrate or EDTA tubes

B) Specimens sent on swabs

C) Specimens sent on plates and broth:

Handling Conditions:

All specimens must be sent to the laboratory as soon as they are collected.

Once the specimen is in the laboratory, it must be processed promptly. If there is a delay in

the processing, eye specimens must be place in the CO2 incubator.

The type of container the specimen came in must be entered into the computer under

SREQ for each test ordered.

EQUIPMENT AND MATERIALS:

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Page 7 of 8

Equipment:

C CO

Incubator

Laminar Flow Hood

C ambient air incubator

Materials:

Chocolate Agar Plate (CHOC)

Blood Agar Plate (BAP)

Eugonic Broth

Glass microscope slides (for requested Gram Stains)

Sterile pipette

Sterile forceps

QUALITY CONTROL:

Quality control on all commercially prepared culture media adheres to CLSI (NCCLS) M22-A3

standards. Refer to Protocol for QC on Media procedure.

PROCEDURE - STEPWISE:

Gram Stains

Gram stains are performed upon request only.

Reporting of Gram Stain results: refer to Gram Stain/Direct Exam Procedure

Culture Examination and Interpretation

Initial examination of plates is made 18-24 hours after specimen is processed.

Preliminary reports are updated daily until report is final.

No growth plates are incubated for 72 hours before final report is sent out. No

growth Eugonic broths are incubated for 72 before final report and held for 10 days

before being discarded.

On cultures with growth, Chocolate plate must be incubated for 72 hours (for

Neisseria gonorrhoeae

) before being discarded. Subculture positive Eugonic

broths which have no growth on original plates or no plates were received.

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Report the quantity and organism identity for each morphological type observed on

culture media. Conjunctive and eye lid cultures which grow few to moderate

numbers of multiple

organisms including Coagulase negative staphylococci,

diphtheroids, alpha Strep, Gram negative rods,

Bacillus sp.

, etc. do not identify,

report the relative quantity and type of organisms only, i.e. "4 colonies Staph." Hold

plates on bench a few days in case physician questions report.

Any organisms found in corneal ulcer, vitreous fluid, other sterile site is considered

significant and should be worked up with sensitivities. If these cultures are mixed

with multiple organisms bring up at rounds.

Antimicrobial Susceptibility Testing

For general policy, follow Antimicrobial Susceptibility Testing Protocol.

Haemophilus influenzae

is isolated, beta lactamase testing is done.

REPORTING RESULTS:

Report the quantity and organism identity for each morphological type observed

The appropriate physician is informed by phone about possible

Neisseria gonorrhoeae

Pseudomonas aeruginosa

, any growth in vitreous fluid cultures.

Eye bank should be notified on any growth found in eye bank cultures.

NOTE

The date and name of the person the report is given to must be recorded in the

CULTURE

field of the Mysis report.

REFERENCES:

Isenberg, Henry D. 1992.

Clinical Microbiology Procedures Handbook

. American Society for

Microbiology, Washington, D.C.

Winn, W. et al. 2006

Koneman’s Color Atlas and Textbook of Diagnostic Microbiology

, 6th ed.

Lippincott-Raven, Philadelphia, PA.

CHEERS QAPP 3

Appendix 15: UIH Laboratory Protocol:

Wound Culures

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 5

WOUND CULTURES

PRINCIPLE:

The accumulation of pus, either within an abscess or exuding from a sinus tract or from a

mucocutaneous surface, is one of the indicators of local sepsis. Varying degrees of redness, pain,

and swelling may also be present. Exogenous wound infections may also be present. Exogenous

wound infections include those associated with traumatic injury wounds or decubitus ulcers,

animal or human bites, burns, or foreign bodies in the skin or mucous membranes.

Endogenous wounds and abscesses may be associated with appendicitis, cholecystitis, cellulitis,

dental infections, osteomyelitis, empyema, septic arthritis, sinusitis, or many other internal

infections. Many of these infections are nosocomial, secondary to invasive procedures, surgical

manipulations, or placement of prostheses. Others originate from hematogenous spread from other

primary sites of infection or by direct extension of bacterial contaminants from ruptured viscera,

particularly the large intestine.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 2 of 5

SPECIMEN:

Acceptable Specimens:

1. Specimens received on aerobic swabs, gel swabs or anaerobic transport media.

Swabs specimens are the least desirable for culture, as the quantity of the sample

may not be sufficient to ensure adequate recovery of the infectious agent.

2. Stool or rectal swabs sent to rule out VRE.

3. Any source that is not a fluid (the source dictates the order). For example,

•

Pus (from any site)

•

Fluid (from any site)

•

Abscess drainage

•

Abscess (from any site)

Unacceptable Specimens:

1. Mislabeled or unlabeled specimens.

2. Specimens received >24 hours after collection.

3. Specimens received without appropriate source documentation.

4. Specimens received on dried swabs, or swabs with ampules not crushed.

5. Specimens received on expired BBL plus swabs/anaerobic transport media.

Type:

Surface wounds are more often than not colonized with environmental bacteria, and

swab samples often do not reflect the true cause of the infectious process.

Aspiration of fluid or pus from the depths of pustular or vesicular wounds and

abscesses with a sterile needle and syringe is the most desirable method for

collecting material for culture. Ideally, a biopsy specimen of the leading edge of the

wound is the best specimen for culture. The site from which the culture is to be

obtained should first be decontaminated with surgical soap and 70% ethyl or

isopropyl alcohol.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 3 of 5

Handling Conditions:

All specimens must be sent to the laboratory as soon as they are collected.

Once the specimen is in the microbiology laboratory, it must be processed promptly.

If there is a delay in specimen processing, fluid specimens must be placed in the

incubator and swab specimens must be left at room temperature.

EQUIPMENT AND MATERIALS:

Equipment:

Materials:

Chocolate agar plate (CHOC)

Blood agar plate (BAP)

MacConkey agar plate (MAC)

Colisitin-Naladixic acid agar plate (CNA)*

Modified Thayer-Martin agar plate (MTM)**

Sterile loops

Glass Microscope slide

Gram stain slip***

* CNA agar is the only media used if the source of the specimen is rectal swab or

stool and the special request is R/O VRE (vancomycin resistant enterococci). This

order is usually from the Stem Cell floor (8WST). No gram stain should be prepared

for this type of order.

** MTM agar should only be used if the source of the specimen is in a genital region

(penile, labial, perineum, rectal, groin, etc.).

*** Gram stain slip should be prepared for those wound cultures accompanied by a

GRAM STAIN ONLY order. Please note the site of the wound under source on the

Gram stain slip. Gram stains should be read before the end of the shift, unless it is

ordered STAT then it should be read within 1 hour.

QUALITY CONTROL:

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 4 of 5

Quality control on all commercially prepared culture media adheres to CLSI (formerly NCCLS)

M22-A2

Standards. Refer to Protocol for QC on Media procedure.

PROCEDURE - STEPWISE:

For the fluid specimen:

1. Label specimen, plates, and a glass slide with patient's name and accession number (use the

SunQuest labels).

*NOTE: All of the following steps must be performed inside a laminar flow hood.

2. Mix specimen very well before inoculating plates. Aspirate approximately 1 ml of specimen

using a sterile transfer pipette. Inoculate media by dropping 1 to 2 drops of the specimen

onto each plate.

3. Place one drop of the specimen on a glass slide for a Gram stain (Do not touch slide with the

pipette). If no Gram stain was ordered, label the slide WDCT and place slide on heating

block to dry. If a Gram stain was ordered, label a Gram stain slip with a GRAM STAIN

ONLY label and place slide on heating block to dry.

4. Using a sterile loop, streak each plate to obtain well isolated colonies. Make sure to use a

different loop for each plate.

5. Make a few small stab marks with the loop into the surface of the BAP for demonstration of

subsurface hemolysis.

6. Incubate plates in the CO

incubator.

For the swab specimen:

1. If the specimen is received on a double swab or Port-a-Cul transport system, roll one swab

over a small area at the edge of each plate.

2. Take the second swab and roll it over a small area on the glass slide for Gram stain, and

discard swab. If no Gram stain was ordered, label the slide WDCT and place slide on heating

block to dry. If a Gram stain was ordered, label a Gram stain slip with a GRAM STAIN

ONLY label and place slide on heating block to dry.

3. Using a sterile loop, streak each plate to obtain well isolated colonies. Make sure to use a

different loop for each plate.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 5 of 5

4. Make a few small stab marks with the loop into the surface of the BAP for demonstration of

subsurface hemolysis.

5. Incubate plates in the CO

incubator.

If the specimen is received in an anaerobic transport system and both an aerobic and

anaerobic culture is ordered it will be necessary to use both the swabs carefully. Use one

swab to setup plates for the cultures and the second swab to setup the two Gram stains

necessary for both cultures (refer to Anaerobic Specimen Processing procedure for further

instructions on processing the anaerobic cultures).

CHEERS QAPP 3

Appendix 16: IDPH Laboratory Protocol:

Shigatoxin

CHEERS QAPP 3

Appendix 17: IDPH Laboratory Protocol:

Norovirus

CHEERS QAPP 3

Appendix 18: UIH Laboratory Description

UNIVERSITY OF ILLINOIS MEDICAL CENTER

CLINICAL MICROBIOLOGY LABORATORY

The Clinical Microbiology Laboratory is a full-service laboratory offering

diagnostic bacteriology, mycology, parasitology, virology, and mycobacteriology. The

laboratory receives specimens from in-patients at the University of Illinois Hospital and

the University’s out-patient clinics, as well as from several outreach sites throughout

Illinois and the United States. The Microbiology Laboratory is composed of several

sections including Aerobic and Anaerobic Bacteriology, Mycology, Parasitology,

Mycobacteriology.

The Aerobic Bacteriology Section isolates and identifies clinically significant

microorganisms from clinical specimens and performs antimicrobial susceptibility testing

on these bacterial pathogens. These functions are performed with the Vitek-2 automated

instrument. Additional reference identification and susceptibility testing methods for

other, more fastidious bacterial agents are also available. Blood culturesare performed

using the cultures using the BactiAlert system, which provides continuous monitoring of

blood cultures for the entire 7-day incubation period. The Aerobic Bacteriology

Laboratory performs amplified probe tests for detection of

Neisseria gonorrhoeae

and

Chlamydia trachomatis

in urogenital specimens and also has the capability to perform

“real-time” PCR on nares swab specimens and other specimen types for rapid

detection/identification of methicillin-resistant strains of

Staphylococcus aureus (MRSA).

This lab section also p

erforms isolation and characterization of clinically significant

anaerobic bacteria. For these purposes, the laboratory is equipped with a glove box, a

gas-liguid chromatograph, and other methods to provide accurate identification of

anaerobes.

The Mycology Section of the Laboratory performs identification and anti-fungal

susceptibility testing on clinically significant yeast isolates and provides identification of

pathogenic moulds recovered from clinical specimens, including dermatophytes, moulds

causing wound and systemic infections, and systemic mycotic agents such as

Histoplamsa capsulatum and Blastomyces dermatiditis

The Parasitology Section provides services for the diagnosis of various parasitic

infections and has a great deal of expertise in providing diagnostic parasitology services

to several other local hospitals and clinics. Specimens submitted for parasitology include

stool specimens for the detection of pathogenic amoebae, and flagellates, and for

detection/identification of the ova belonging to various nematode (roundworms), cestode

(tapeworms), and trematode (flukes) species. Blood specimens are also submitted for the

diagnosis and species identification of malarial parasites.

The Virology/STD Section provides laboratory services to aid in the diagnosis of

viral infections. Culture methods are available for several viral agents, and enzyme

immunoassay tests are used for detection of several non-cultivable viral agents such as

rotavirus. The Virology Section also performs “real-time” molecular detection assays for

influenza A and B viruses, and, in cooperation with Molecular Pathology, offers

multiplex molecular detection of several other respiratory viruses. This laboratory section

also performs HIV-1 antibody enzyme immunoassays, syphilis serology, and cultures for

Trichomonas vaginalis

The Mycobacteriology Section receives specimens for the isolation and

identification of acid-fast organisms including

Mycobacterium tuberculosis

Mycobacterium avium

complex, and other important mycobacterial pathogens. The

laboratory utilizes state-of-the-art methods to detect growth and to confirm the identities

of mycobacterial isolates, including the use of chemiluminescent ribosomal RNA probes

for species identification. This laboratory section also performs the new FDA-approved

Quantiferon TB-Golod blood test for diagnosis of active and latent tuberculosis.

The staff of the Clinical Microbiology Laboratory includes over 22 FTE’s.

Technical staff participate in teaching Medical Students, Pathology Residents, and

Infectious Diseases Fellows. Continuing education is eagerly encouraged and promoted

through weekly/monthly teleconferences, seminars, and ongoing lectures. Staff are also

encouraged to avail themselves of the many other educational opportunities that exist on

the University campus for further education and academic advancement.

The Clinical Microbiology Laboratory is certified by the College of American

Pathologists (CAP). The Laboratory subscribes to the CAP Proficiency Testing Program

and currently receives the following Proficiency Surveys from CAP (dates in parentheses

indicate the lab receipt date of surverys from CAP for the year 2007):

Proficiency Test Area

Surveys Received

Receipt Dates

(if known)

Blood Parasite Identification

Chlamydia IF Antigen Detection

Survey HC1-A

Survey HC1-B

Survey HC1-C

Chlamydia trachomatis/Neisseria gonorrhoeae

by Nucleic Acid Amplification

Survey HC6-A

Survey HC6-B

Survey HC-6-C

Helicobacter pylori Antigen Detection

Bioterrorism Laboratory Preparedness

Rapid Anti-HIV-1 Antibody

Infectious Mononucleosis

Virology-Antigen by Immunofluorescence

Survey VR2-A

Survey VR2-B

Survey VR2-C

Virology-Antigen Detection by eia

Survey VR4-A

Survey VR4-B

Survey VR4-C

Director of Clinical Microbiology:

William M. Janda, Ph.D., D(ABMM)

Phone:

312-996-56o8

Laboratory Manager:

Linda Bruno, M.A., MT(ASCP)

Phone:

312-996-3635

Bacteriology/Blood Culture Section Supervisor:

Kathy Ristow, M.S., MT(ASCP)SM

Phone:

312-996-3175

Virology/STD Section Supervisor:

Jo-Ann Curry, B.A., MT(HEW)

Phone: 312-996-5377

Mycology Supervisor:

Molecular Pathology & Genetics

SUBSPECIALTY

Percent corrected of total graded challenges tested

Bacteriology Hematology

PATHOLOGY LABORATORIES

SUBSPECIALTY PROFICIENCY TESTING OVERVIEW

2ND QTR - 4TH QTR, 2006

CHEERS QAPP 3

Appendix 19: UIH Laboratory CLIA

Certification

CHEERS QAPP 3

Appendix 20: IDPH Laboratory CLIA

Certification

CENTERS FOR MEDICARE

MEDICATD SERVICES

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS

CER TIFICA TE OF COMPUNCE

I.'

LABORATORY NAME AND ADDRESS

CLLA ID NUMBER

&byl

14D0691828

ILLINOIS DEPT OF PUBLIC HEALTH LABS

This

date

shall 

be valid until

the

expiration

date

abave, 

but

subject to temcation, suspension, Limitation, or other sanctions

for

violation of the

Act

or the replations pmmnlgated thereunder.

Judith

A. Yost, Director

Division of Laboratory Services

Survey and Certification Group

Center for Medicaid and State Operations

If you currently hold a Certificate of Compliance or Certificate of Accreditation, below is a list of the laboratory

specialtieslsubspecialties 

you are certified to perform and their effective date:

LAB CERTIFICATION (CODE)

EFFECTIVE DATE

BACTERIOLOGY (1 10)

MYCOBACTERIOLOGY (1 15)

MYCOLOGY (1 20)

PARASITOLOGY (130)

VIROLOGY (140)

SYPHILIS SEROLOGY (210)

GENERAL IMMUNOLOGY (220)

ROUTINE CHEMISTRY (310)

ENDOCRINOLOGY (330)

TOXICOLOGY (340)

FOR MORE INFORMATION ABOUT CLLA, VISIT OUR WEBSITE AT WWW.CMS.HHS.GOV1CLJ.A

OR CONTACT YOUR LOCAL STATE AGENCY. PLEASE SEE THE REVERSE FOR

YOUR STATE

AGENCY'S ADDRESS AND PHONE NUMBER.

PLEASE CONTACT YOUR STATE AGENCY FOR ANY CHANGES TO YOUR CURRENT CERTIFICATE.

CHEERS QAPP 3

Appendix 21: IDPH Laboratory Clinical

Quality Manual

DCA001-06-1105

Page 1 of 65

IDENTIFICATION INFORMATION

Document Title:

Illinois Department of Public Health, Division of

Laboratories (DOL), Clinical Quality Manual, DCA001-06-

1105

Effective Date:

12-08-2005

Organizational Title:

Illinois Department of Public Health, Division of Laboratories

Addresses:

1155 S. Oakland St., P.O. Box 2797

Springfield, IL 62794

Phone: 618-457-5131

Phone: 213-793-4760

217-782-6562

Responsible Officials:

Bernard Johnson, MS, Chief, Division of Laboratories

Karen Meier, Manager, Carbondale Laboratory

George Dizikes, Ph.D., Manager, Chicago Laboratory

David L. Maserang, Ph. D., CLIA Director, Division of Laboratories

Division of Laboratory Quality Administrator:

Maria Kaminski

Scope of this Document:

This Quality Manual has been developed to address the data

quality needs of the Illinois Department of Public Health, Division of Laboratories, in the clinical

area. This Document reflects the overall QA program framework and the management systems

to ensure that clinical data generated by the Division of Laboratories is of acceptable quality to

meet the needs of users and decision-makers. It also describes the delegation of quality

assurance responsibilities within the DOL. This document meets the requirements for a Quality

Manual for the following laboratory certification program:

Medicare, Medicaid and CLIA Programs;

Laboratory Requirements Relating to Quality

Systems and Certain Personnel Qualifications;

Final Rule, January 24, 2003

APPROVALS*:

Carbondale Laboratory Manager

Date

George Dizikes, Ph.D.

11/14/2005

Chicago Laboratory Manager

Date

David L Maserang, Ph.D.

12/01/2005

CLIA Laboratory Director

Date

Maria Kaminski

11/30/2005

Division QA Administrator

Date

Bernard T. Johnson

12/08/2005

Chief, Division of Laboratories

Date

* Original signatures – LIS file.

Quality Assurance Policy

1.1

Scope of the DOL Clinical Quality Manual

2.0

Organization and Responsibilities

2.1

Carbondale Laboratory Organization

2.2

Chicago Laboratory Organization

2.3

Springfield Laboratory Organization

2.4

Laboratory Key Personnel

2.5

Training Procedures

3.0

Laboratory Physical Facilities

3.1

Carbondale Laboratory Physical Facility

3.2

Chicago Laboratory Physical Facility

3.3

Springfield Laboratory Physical Facility

3.4

Laboratory Improvement Section

4.0

General Laboratory System

Specimen Identification and Integrity

4.4

Customer Complaints and Communication

4.5

Personnel Competency Assessment

4.6

Evaluation of Proficiency Testing Performance

5.0

Quality Assurance Objectives

5.1

Test Variability/Reproducibility

Specimen Management Protocol

6.2

Specimen Collection

6.3

Established Procedures

6.4

New Work or Procedures

6.5

Specimen Receipt and Logging

6.6

Test Requisition Form

6.7

Specimen Submission, Handling, and Referral

6.8

Purchase and Handling of Consumables and Services

7.0

Analytical System

7.1

Standard Operation Procedurs

Test Systems, Equipment, Instruments, Reagents, Materials and Supplies

7.3

Establishment and Verification of Performance Specification

7.4

Maintenance and Function Checks

7.5

Calibration and Calibration Verification

7.6

Control Procedures

7.7

Comparison of Test Results

Post Analytical System

8.1

Data Review Procedure

Corrective Action Report

8.5

Specimen Retention

9.0

Documentation Management

9.1

CLIA Documents

9.2

Routine QA Operating Documents and Analytical Records

9.3

Administrative Records

9.4

Record Storage Procedure

Scope and Frequency of Audits

10.2

Types of Audits

10.3

Managerial Review Procedure

Administrative Operating Procedures

Appendix 3

Personnel Training Record

Appendix 4

Calibration/Verification of Laboratory Support Equipment

Appendix 5

Comparison of Test Results

Appendix 6

CLIA Personnel File Documentation

Appendix 7

Quarterly Managerial Review Forms

Appendix 8

Semi-Annual Managerial Review Forms

Appendix 9

Quarterly Quality Assurance Report

DCA001-06-1105

Page 5 of 65

QUALITY ASSURANCE POLICY

The mission of the Illinois Department of Public Health (IDPH) is to promote the health of the

people of Illinois through the prevention and control of disease and injury. The IDPH Division

of Laboratories participates in the fulfillment of this mission by providing data of exceptional

quality. Figure 1-1 shows the placement of the Division of Laboratories in IDPH. The high

level of data quality is maintained by an established quality assurance program that provides a

mechanism to evaluate and monitor work quality, identify and correct non-conformities, validate

accuracy, precision, sensitivity and timeliness of analytical results, and provide personnel

training.

Adherence to the quality assurance program requirements is the responsibility of all laboratory

personnel. This responsibility is stated in Directive 01-01,

Quality Assurance/Quality Control

dated October 1, 2002, and signed by the Chief of the Division of Laboratories. In addition,

employees participate in the Division’s continuous quality improvement efforts. Through the

process of continuous quality improvement, the services of the Division are constantly being

examined and improved.

1.1

SCOPE OF THE DOL CLINICAL QUALITY MANUAL

This Quality Manual summarizes the policies and administrative procedures associated with the

Illinois Department of Public Health, Division of Laboratories Clinical Laboratories and

establishes a structured quality system for all phases of the total process; that is, preanalytic,

analytic, and postanalytic, as well as general laboratory systems. All policies and procedures

have been structured in accordance with the Clinical Laboratory Improvement Act (CLIA). This

manual has been prepared in accordance with the documents listed in Section 12. Further details

of the Division’s administrative procedures are contained in directives listed in Appendix 1 and

standard operating procedures listed in Appendix 2.

All laboratory activities performed by the Illinois Department of Public Health, Division of

Laboratories, Clinical Laboratories, are performed in accordance with this document. The

laboratories provide services and assistance to referring physicians, public health care providers,

federal and local law enforcement agencies, other approved providers, and State of Illinois

agencies.

The IDPH Clinical Laboratories analyze clinical specimens in the specialties and sub-specialties

of Microbiology, Serology, Virology, Molecular Diagnostics, Chemistry, and metabolic/genetic

diseases. The laboratories also perform animal rabies testing.

Occasionally, the Division will find it necessary to allow a departure from approved procedures

due to unusual circumstances or specimens. The procedure for this departure is contained in

SOP DXX011 (draft),

Exceptions Permitting Departures from Documented Policies or

Procedures.

The procedure in this SOP provides the only authorized means by which departures

from required procedures and policies can occur.

Office of Health Protection

Division of Environmental Health

Division of Infectious Disease

Division of

Laboratories

DCA001-06-1105

Page 7 of 65

ORGANIZATION AND RESPONSIBILITIES

The Division of Laboratories is a division of the Illinois Department of Public Health and is thus

legally identifiable as a State of Illinois agency. For the purpose of clinical analyses, the

Division of Laboratories is divided into three separate organizational units, all under the

supervision of the Chief, Division of Laboratories. They are the Carbondale Laboratory, the

Chicago Laboratory, and the Springfield Laboratory. The Division of Laboratories, Laboratory

Improvement Section is responsible for the overall management of the laboratory quality system

and its implementation. Figure 2-1 is a divisional organizational chart as it relates to clinical

testing. The Laboratory Improvement Section maintains a record of employee’s name, initials,

and signature for all individuals who are responsible for signing or initialing any laboratory

record.

2.1

CARBONDALE LABORATORY ORGANIZATION

The Carbondale Laboratory is headed by the Carbondale Laboratory Manager and the Clinical

Supervisor. The laboratory is organized and operates in such a way that it meets the

requirements of all appropriate standards. The laboratory specifies and documents the

responsibility, authority, and interrelationships of all personnel who manage, perform or verify

work affecting the quality of testing.

2.2

CHICAGO LABORATORY ORGANIZATION

The Chicago Laboratory is headed by the Chicago Laboratory Manager. The Chicago Laboratory

consists of four sections: Microbiology, Virus-Serology, Metabolic/Genetic Diseases and

Molecular Diagnostics, all under the supervision of the Laboratory Manager. These sections are

headed by the technical supervisors (section chiefs). The laboratory is organized and operates in

such a way that it meets the requirements of all appropriate standards. The laboratory specifies

and documents the responsibility, authority, and interrelationships of all personnel who manage,

perform or verify work affecting the quality of testing.

2.3

SPRINGFIELD LABORATORY ORGANIZATION

The Springfield Laboratory consists of two sections: Diagnostic and Molecular, all under the

supervision of the Laboratory Manager. Both sections are headed by a supervisor. The

laboratory is organized and operates in such a way that it meets the requirements of all

appropriate standards. The laboratory specifies and documents the responsibility, authority, and

interrelationships of all personnel who manage, perform or verify work affecting the quality of

testing.

2.4

LABORATORY KEY PERSONNEL

2.4.1

MANAGEMENT

Laboratory management is responsible for defining the minimum level of qualification,

experience, and basic laboratory skills necessary for all positions within the laboratory.

DCA001-06-1105

Page 8 of 65

Laboratory managerial staff and their specific responsibilities are listed here. Each managerial

staff member is provided with the authority and resources needed to discharge his/her duties.

2.4.1.1

CHIEF, DIVISION OF LABORATORIES

The Chief, Division of Laboratories, is responsible for the coordination of analytical services

between the three laboratories. He/she is responsible for ensuring that standardized laboratory

systems are used at each laboratory so that the data generated is similar in format, content, and

quality; providing budgetary oversight of laboratory operations to verify that required financial

controls and accounting procedures are in place; formulating long-term goals in facilities,

staffing, equipment, and analytical capabilities. Specific responsibilities include the following:

Delegating authority and responsibilities to the laboratory managers/directors to

implement their duties;

Being accessible to the laboratory to provide consultation either on site or by phone or

pager;

Developing, establishing and maintaining written laboratory policies.

2.4.1.2

CLIA LABORATORY DIRECTOR

The laboratory director is responsible for the overall operation and administration of the

laboratory, including the employment of personnel who are competent to perform test

procedures, record and report test results promptly, accurately and proficiently, and for assuring

compliance with the applicable regulations. The laboratory director, if qualified, may perform

the duties of the technical supervisor, clinical consultant, general supervisor, and testing

personnel, or delegate these responsibilities to personnel meeting the qualifications. If the

laboratory director reapportions performance of his or her responsibilities, he or she remains

responsible for ensuring that all duties are properly performed. The laboratory director must be

accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.

The laboratory director must:

Ensure that testing systems developed and used for each of the tests performed in the

laboratory provide quality laboratory services for all aspect of test performance, which

includes the preanalytic, analytic, and postanalytic phases of testing;

Ensure that the physical plant and environmental conditions of the laboratory are

appropriate for the testing performed and provide a safe environment in which employees

are protected from physical, chemical, and biological hazards;

Ensure that test methodologies selected have the capability of providing the quality of

results required for patient care;

DCA001-06-1105

Page 9 of 65

Verifies that procedures used are adequate to determine the accuracy, precision, and other

pertinent performance characteristics of the method and that laboratory personnel are

performing the test methods as required for accurate and reliable results;

Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program

for the testing performed and that the proficiency testing samples are tested as routine

specimens; the results are returned within the timeframes established by the proficiency

testing program; all proficiency testing reports received are reviewed by appropriate staff

to evaluate the laboratory’s performance and to identify any problems that require

corrective action; and an approved corrective action plan is followed when any

proficiency testing result is found to be unacceptable or unsatisfactory as outlined in the

proficiency testing SOP, DAA017;

Ensure that the quality control and quality assessment programs are established and

maintained to assure the quality of laboratory services provided and to identify failures in

quality as they occur;

Ensure the establishment and maintenance of acceptable levels of analytical performance

for each test system;

Ensure that all necessary remedial actions are taken and documented whenever

significant deviations from the laboratory’s established performance characteristics are

identified, and that patient test results are reported only when the system is functioning

properly;

Ensure that reports of test results include pertinent information required for

interpretation;

Ensure that consultation is available to the laboratory’s clients on matters relating to the

quality of the test results reported and their interpretation concerning specific patient

conditions;

Ensure that a general supervisor provides on-site supervision of non-waived test

performance by qualified testing personnel;

Employ a sufficient number of laboratory personnel with the appropriate education and

either experience or training to provide appropriate consultation, properly supervise and

accurately perform tests and report test results;

Ensure that prior to testing patients’ specimens, all personnel have the appropriate

education and experience, receive the appropriate training for the type and complexity of

the services offered, and have demonstrated that they can perform all testing operations

reliably to provide and report accurate results;

Ensure that policies and procedures are established for monitoring individuals who

conduct preanalytic, analytic, and postanalytic phases of testing to assure that they are

DCA001-06-1105

Page 10 of 65

competent and maintain their competency to process specimens, perform test procedures

and report test results promptly and proficiently, and whenever necessary, identify needs

for remedial training or continuing education to improve skills;

Ensure that an approved procedure manual is available to all personnel responsible for

any aspect of the testing process; and

Specify, in writing, the responsibilities and duties of each consultant and each supervisor,

as well as each person engaged in the performance of the preanalytic, analytic, and

postanalytic phases of testing, that identifies which examinations and procedures each

individual is authorized to perform, whether supervision is required for specimen

processing, test performance or result reporting and whether supervisory or director

review is required prior to reporting patient test results.

2.4.1.3

CLINICAL CONSULTANT, DIVISION OF LABORATORIES

The Clinical Consultant, Division of Laboratories is responsible for providing consultation.

Specific responsibilities include the following:

Be available to clients and to the laboratories via phone or e-mail;

Provide consultation regarding the appropriateness of the testing ordered and

interpretation of test results;

Assist the laboratory’s clients in ensuring that appropriate tests are ordered to meet

clinical expectations;

Ensure that reports of test results include pertinent information required for specific

patient test interpretation;

Ensure that consultation is available and communicated to the laboratory’s clients on

matters related to the quality of the test results reported and their interpretation

concerning specific patient conditions.

2.4.1.4

DIVISION OF LABORATORIES MANAGERS / SECTION CHIEFS –

TECHNICAL SUPERVISORS

The technical supervisor is responsible for the technical and scientific oversight of the

laboratory. The technical supervisors must be available to the laboratory to provide on-site,

telephone or electronic consultation. The technical supervisor’s responsibilities include:

Approve test methodology that is appropriate for the clinical use of the test results

according to the latest version/revision of DAA005,

Standard Operating Procedure for

Technical and Standard Operations Implementation and/or Change

;

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Verify the test procedures performed and establishment of the laboratory’s test

performance characteristics, including the precision and accuracy of each test and test

system and document such activity as described in SOP DAA005,

Standard Operating

Procedure for Technical and Standard Operations Implementation and/or Change

;

Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program

for the testing performed and that the proficiency testing samples are tested as routine

specimens; the results are returned within the timeframes established by the proficiency

testing program; all proficiency testing reports received are reviewed by appropriate staff

to evaluate the laboratory’s performance and to identify any problems that require

corrective action; and an approved corrective action plan is followed when any

proficiency testing result is found to be unacceptable or unsatisfactory as outlined in the

latest version/revision of SOP, DAA017,

Standard Operating Procedure for Handling,

Analysis, and Reporting of Proficiency Testing Samples

;

Establish a quality control program appropriate for the testing performed and the

parameters for acceptable levels of analytical performance and ensure that these levels

are maintained throughout the entire testing process from the initial receipt of the

specimen, through sample analysis and reporting of test results;

Ensure that all necessary corrective actions are taken and documented whenever

significant deviations from the laboratory’s established performance characteristics are

identified, and that patient test results are reported only when the system is functioning

properly as outlined in SOP 015,

Standard Operating Procedure for Quality

Improvement Actions

;

Ensure that patient test results are not reported until all corrective actions have been taken

and the test system is functioning properly;

Evaluate the competency of all testing personnel and assuring that the staff maintain their

competency to perform test procedures and report test results properly, accurately, and

proficiently. See Appendix 6.

Conduct quality improvement studies that include the following: identify and monitor

important quality indicators; define and select thresholds in data generated; analyze data

and recommend corrective action to the Director; and, conduct follow-up assessments.

Perform Management System Reviews - See Appendices 7 and 8.

The technical supervisor is familiar with the calibration of tests and procedures, the objective of

the calibration or test, and the assessment of results. The technical supervisor reports to the

Laboratory Manager/Laboratory Director and may act as a deputy in the absence of the

Laboratory Manager/Director. The technical supervisor must have a minimum of a bachelor’s

degree in a natural or physical science course work and a minimum of four years laboratory

experience with six months experience in the designated area of responsibility. The technical

supervisor inform the Laboratory Improvement Section of changes in technical supervision.

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2.4.1.5

DIVISION OF LABORATORIES SUPERVISOR – GENERAL SUPERVISOR

The general supervisor is responsible for day-to-day supervision or oversight of the laboratory

operation and personnel performing testing and reporting test results.

The general supervisor must be accessible to testing personnel at all times testing is

performed to provide on-site, telephone or electronic consultation to resolve technical

problems in accordance with policies and procedures established either by the laboratory

director or technical supervisor;

Is responsible for providing day-to-day supervision of non-waived test performance by

qualified testing personnel;

Except as listed below, must be on site to provide direct supervision when non waived

testing is performed by qualified personnel;

Exception: For individuals qualified, who were performing non waived testing on

or before January 19, 1993, the requirements provide that all non waived testing

performed by the individual in the absence of a general supervisor is reviewed

within 24 hours by a qualified general supervisor;

Is responsible for monitoring test analyses and specimen examinations to ensure that

acceptable levels of analytical performance are maintained;

The director or technical supervisor may delegate to the general supervisor the

responsibility for:

* Assuring that all remedial actions are taken whenever test systems deviate from the

laboratory’s established performance specification following the procedure in the

latest version/revision of SOP DAA015,

Standard Operating Procedure for Quality

Improvement Action

The general supervisor is familiar with the calibration of test methods and procedures, the

objective of the calibration or test and the assessment of results. The supervisor reports to the

section chief – technical supervisor and may act as a deputy in the absence of the Section Chief.

The supervisor must have a minimum of a bachelor’s degree in a natural or physical science or

medical technology with course work relative to the area of supervision, and one-year experience

in the analysis of clinical specimens in the area of supervision.

2.4.2 LABORATORY IMPROVEMENT SECTION

The Laboratory Improvement Section is responsible for the overall management of the

laboratory quality system and its implementation. For the purpose of clinical testing, the section

consists of the Laboratory Quality Specialists (LQS) who report directly to the Laboratory

Quality Supervisor in the Chicago Laboratory and the Laboratory Quality Specialists (LQS) who

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report directly to the Laboratory Quality Administrator in the Springfield Laboratory. The

Laboratory Improvement Section in Springfield also works with the Carbondale Laboratory.

2.4.1.2 LABORATORY QUALITY ADMINISTRATOR

The Laboratory Quality Administrator is responsible for the overall management of the Division

of Laboratories’ quality operations. The Laboratory Quality Administrator has direct access to

technical supervisors, Laboratory Director(s), and the Chief, Division of Laboratories. The

Laboratory Quality Administrator also functions as a quality manager as defined in ISO 15189.

In addition, the Laboratory Quality Administrator does/has the following:

Conducts internal audits of the entire technical operation annually, notifies laboratory

management of deficiencies in the quality system, and monitors corrective action;

Has documented training and/or experience in QA procedures and is knowledgeable in

the quality systems defined by CLIA;

Has a general knowledge of the analytical procedures;

Notifies the regulatory agencies of changes in technical supervision and directorship;

Prepares and presents administrative laboratory training, such as general safety, ethics,

general security, and regulation updates;

Oversees the Division’s quality documentation.

2.4.2.2 LABORATORY QUALITY SUPERVISOR

The Laboratory Quality Supervisor is responsible for the overall management of the Chicago

Laboratory’s quality operations and assists the Laboratory Quality Administrator with the

resolution of regulatory compliance issues. For CLIA compliance issues, the Laboratory Quality

Supervisor reports directly to the Laboratory Quality Administrator and has direct access to the

technical supervisors and division management.

The Laboratory Quality Supervisor functions as a quality manager as defined in ISO 15189. The

Laboratory Quality Supervisor in the Chicago Laboratory performs those functions listed under

the Laboratory Quality Administrator, Section 2.4.1.2.

2.4.2.3 CLINICAL LABORATORY QUALITY SPECIALIST (LQS)

The Clinical LQS is responsible for assisting the Laboratory Quality Administrator and

Laboratory Quality Supervisor in coordinating the quality system, its implementation, and

certification programs for clinical laboratories. The clinical LQS reports directly to the

Laboratory Quality Administrator or Laboratory Quality Supervisor, has direct access to division

management and the technical supervisors, and can discuss with them any questions or concerns

about the laboratory quality system.

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2.4.3 SAFETY COMMITTEE/OFFICER

The laboratory has a designated safety committee/officer. The safety committee/officer assists

laboratory supervisors in the implementation of the safety program. The safety

committee/officer provides, and/or makes available, safety training for all employees, reviews

the laboratory safety manual and safety standard operating procedures, performs safety

inspections of the facility, and reviews maintenance documentation for laboratory safety

equipment to determine compliance with safety regulations. Areas of noncompliance are

reported to the supervisor, and Director and to the Chief, Division of Laboratories. See the

laboratory Safety Manual for further details.

2.4.4 DIVISION OF LABORATORIES TESTING PERSONNEL

Testing personnel are responsible for sample analysis and identification of corrective actions.

The testing personnel report directly to the designated general supervisor. All testing personnel

are responsible for complying with all quality assurance requirements that pertain to their

organizational/technical function. The testing personnel are responsible for specimen

processing, test performance and reporting test results. Each individual performs only those tests

that are authorized by the laboratory director and require a degree of skill commensurate with the

individual’s education, training or experience, and technical abilities. Each testing personnel

must:

Follow the laboratory procedures for specimen handling and processing, test analyses,

reporting and maintaining records of patient test results;

Maintain records that demonstrate that proficiency testing samples are tested in the same

manner as patient specimens;

Adhere to the laboratory’s quality control policies, document all quality control activities,

instrument and procedural calibrations and maintenance performed;

Follow the laboratory’s established policies and procedures whenever test systems are not

within the laboratory’s established acceptable levels of performance;

Be capable of identifying problems that may adversely affect test performance or

reporting of test results and either must correct the problems or immediately notify the

general supervisor, technical supervisor, or director;

Document all corrective actions taken when test systems deviate from the laboratory’s

established performance specifications.

2.5

TRAINING PROCEDURES

Laboratory personnel are internally trained in health and safety, security, QA procedures, and the

laboratory management system. Laboratory personnel are also required to attend regular health

and safety and laboratory QA procedures refresher courses. New testing staff is trained for a

sufficient number of days by experienced testing personnel prior to performing any laboratory

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work on clinical specimens. The length of training is determined by the technical supervisor.

This training will include basic laboratory skills, as appropriate. Content and dates of training

that each laboratory staff member receives are documented by the immediate supervisor in the

personnel training records. Employee review of the Quality Manual and other administrative

procedures are documented through the use of signed read receipts. This read receipt verifies

that each employee has read, understood, and is using the latest version of the laboratory’s SOPs

that relate to his/her job responsibilities.

2.5.1 GENERAL TRAINING

The employee reviews the current versions of the appropriate method SOPs. This review is

documented by a signed and dated read receipt. Training is provided and documented in the

following areas for specimen preparation if applicable:

Glassware cleaning;

Specimen logging;

Analytical balance;

Use of pipets and other liquid handling systems;

Quality Control Procedures;

Reagent preparation techniques;

Testing procedures (SOP).

The form for training documentation is contained in Appendix 3. The documentation of training

is maintained in the employee CLIA personnel file. When a regulatory agency requires

additional training certification such as required by the Select Agent Rule, the detailed process

will be outlined in the corresponding procedure. Records must be maintained accordingly.

2.5.2 CLINICAL SPECIMEN ANALYSES

Upon assignment to testing, the testing personnel will be trained and assessed to verify

capabilities; the personnel assessment will be conducted upon completion of training (initial),

after six months, and yearly, thereafter. Testing personnel are also required to participate in a

blind sample testing program at least yearly. See Appendix 6.

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Figure 2-1

FIGURE 2.1 DIVISION OF LABORATORIES, CLINICAL ORGANIZATIONAL CHART

David Maserang, Ph. D.,

CLIA Director

Maria Kaminski,

Division of Laboratories

George Dizikes,Ph.D.,

Technical/General Supervisor

LABORATORY PHYSICAL FACILITIES

3.1

CARBONDALE LABORATORY PHYSICAL FACILITY

3.1.1 ACCOMMODATION AND ENVIRONMENT

The Carbondale Laboratory is located at only one site as listed in the beginning of this manual. The

Carbondale Laboratory is maintained so that the test areas, energy sources, lighting, heating, and

ventilation are adequate to facilitate proper performance of testing. The environment of the laboratory

is such that it does not invalidate the results or adversely affect the required accuracy of measurements.

In instances where monitoring or control of any environmental condition is specified in the test

procedure or by regulation, the laboratory will meet and document adherence to the specification. The

facility is owned by the Illinois Department of Public Health. Problems with environmental conditions

are brought to the attention of the laboratory manager who is then responsible for adjustments and

maintenance. A pest and rodent control program is available. The floor plan of the Carbondale

Laboratory can be found in the

Carbondale Laboratory Emergency Procedure Manual.

3.1.2 WORK AREAS

The laboratory maintains effective separation between neighboring areas when the activities are

incompatible. The contamination of specimens, equipment, instruments, reagents, materials and

supplies is minimized. Molecular amplification procedures that are not contained in closed systems

have a uni-directional workflow including separate areas for specimen preparation, amplification, and

product detection, and, as applicable, reagent preparation. Good housekeeping is practiced in the

laboratory to ensure that contamination does not adversely affect data quality. Enough work space is

available to ensure an unencumbered work area.

3.2

CHICAGO LABORATORY PHYSICAL FACILITY

3.2.1 ACCOMMODATION AND ENVIRONMENT

The Chicago Laboratory is located at only one site as listed in the beginning of this manual. The

Chicago Laboratory is maintained so that the test areas, energy sources, lighting, heating, and

ventilation are adequate to facilitate proper performance of testing. The environment of the laboratory

is such that it does not invalidate the results or adversely affect the required accuracy of measurements.

In instances where monitoring or control of any environmental condition is specified in the test

procedure or by regulation, the laboratory will meet and document adherence to the specification.

Environmental conditions are monitored by the building owner, State of Illinois, Central Management

Services. Problems with environmental conditions are brought to the attention of the building owner

through the building manager who is then responsible for adjustments and maintenance. A pest and

rodent control program is available. The floor plan for the Chicago laboratory can be found in the

Chicago Laboratory Emergency Procedure Manual

3.2.2

WORK AREAS

The laboratory maintains effective separation between neighboring areas when the activities are

incompatible. The contamination of specimens, equipment, instruments, reagents, materials and

supplies is minimized. Molecular amplification procedures that are not contained in closed systems

have a uni-directional workflow including separate areas for specimen preparation, amplification, and

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product detection, and, as applicable, reagent preparation. Good housekeeping is practiced in the

laboratory to ensure that contamination does not adversely affect data quality. Enough work space is

available to ensure an unencumbered work area.

3.3

SPRINGFIELD LABORATORY PHYSICAL FACILITY

3.3.1

ACCOMMODATION AND ENVIRONMENT

The Springfield Laboratory is located at only one site as listed in the beginning of this manual. The

Springfield Laboratory is maintained so that the test areas, energy sources, lighting, heating, and

ventilation are adequate to facilitate proper performance of testing. The environment of the laboratory

is such that it does not invalidate the results or adversely affect the required accuracy of measurements.

In instances where monitoring or control of any environmental condition is specified in the test

procedure or by regulation, the laboratory will meet and document adherence to the specification.

Environmental conditions are monitored by the building owner, Southern Illinois University School of

Medicine. Problems with environmental conditions are brought to the attention of the building owner

through the building manager who is then responsible for adjustments and maintenance. A pest and

rodent control program is available. The floor plan for the Springfield laboratory can be found in the

Springfield Laboratory Emergency Procedure Manual

3.3.2

WORK AREAS

The laboratory maintains effective separation between neighboring areas when the activities are

incompatible. The contamination of specimens, equipment, instruments, reagents, materials and

supplies is minimized. Molecular amplification procedures that are not contained in closed systems

have a uni-directional workflow including separate areas for specimen preparation, amplification, and

product detection, and, as applicable, reagent preparation. Good housekeeping is practiced in the

laboratory to ensure that contamination does not adversely affect data quality. Enough work space is

available to ensure an unencumbered work area.

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4.0

GENERAL LABORATORY SYSTEM

4.1

ETHICS

In committing to a standard of excellence, the Illinois Department of Public Health Laboratories

expects high ethical standards from all personnel. The management of the IDPH and the Division of

Laboratories has stressed the importance of high ethical standards to the employees through a number

of documents distributed to all employees. These documents include the following:

Directive 88-03, “Personnel Conduct”;

Directive 97-01, “Professional Conduct”;

SOP DAA003, “Standard Operating Procedure for Data Integrity”;

Through the distribution of the above documents, employees agree to abide by these directives and

procedures. Any data reporting errors are to be reported to the appropriate laboratory supervisor in a

timely manner. The supervisor will then take appropriate action.

4.2

CONFIDENTIALITY

All information about clients/patients, specimens, results, and proprietary rights must be considered

confidential. Disclosure of any such information is restricted. Only authorized personnel will be

allowed access to such information. All records, including those pertaining to calibration and test

equipment, certificates and reports are safetly stored, held secure and reported in confidence to the

client. The confidentiality of information is communicated to all employees through the distribution of

Directive 01-04, “Confidentiality of Test Results”. Refer to Section 9.4 concerning storage

requirements.

4.2.2 REPORTS BY FAX

The same limitations apply to Faxed reports as to those by mail. In addition, the following statement

must appear on the fax cover page:

“CONFIDENTIAL REPORTS”

This message is intended for the use of the individual or entity to which it has been addressed and may

contain information that is Privileged, Confidential, and exempt from Disclosure under Applicable

Law. If the reader of this message is not the intended recipient, or the employee or agent responsible

for delivering the message to the intended recipient, you are hereby notified that any dissemination,

distribution or copying of this document is strictly prohibited. If you have received this message in

error, please notify us by telephone to arrange for returning the faxed document to us.

4.2.3 REPORTS BY PHONE

When requests are received to report results by telephone, the person reporting the data must document

the verbal transmission of results either on the work sheet/test requisition form or in a telephone

logbook. The telephone call to report results must either originate from the laboratory to a number

verified to belong to the appropriate agency or be from an individual clearly identifiable by voice to

the person reporting data. Any verbally transmitted data is to be followed up by sending a written

report at the earliest convenience unless a report has been sent or is in transit.

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4.3

SPECIMEN IDENTIFICATION AND INTEGRITY

The Division of Laboratories offers to the submitters a manual of services either as hard copy or an

electronic file. The manual of services includes instructions for the labeling and handling (storage,

shipment) of specimens to maintain the specimen integrity. Upon receipt of the specimen by the

Division of Laboratories, the specimen will enter a control system as described in sections 6, 7, and 8.

4.4

CUSTOMER COMPLAINTS AND COMMUNICATIONS

All customer complaints concerning laboratory test data, whether internal or external to the division,

are handled according to the procedure contained in SOP DAA016,

Service Improvement Actions

The

completed resolution of complaints form is retained by both, the laboratory section involved and the

Laboratory Improvement Section and becomes part of the laboratory records.

4.5

PERSONNEL COMPETENCY ASSESSMENT

Evaluation and documentation of the performance of individuals responsible for testing must be done

at six months during the first year the individual tests patient specimens. Thereafter, evaluations must

be performed at least annually unless test methodology or instrumentation changes. If changes to

methodology or instrumentation do occur, the individual’s performance must be reevaluated to include

the use of the new test methodology or instrumentation prior to reporting patient test results.

The procedures for evaluation of the competency of the staff are the responsibility of the technical

supervisors and must include, but are not limited to the following:

Direct observation of routine patient test performance, including patient preparation, if

applicable, specimen handling, processing and testing;

Monitoring the recording and reporting of test results;

Review of intermediate test results or worksheets, quality control records, proficiency testing

results, and preventive maintenance records;

Direct observation of performance of instrument maintenance and function checks;

Assessment of test performance through testing previously analyzed specimens, internal blind

testing samples or external proficiency testing samples;

Assessment of problem solving skills.

Each laboratory unit may expand the personnel assessment form to suit individual unit needs.

Supervisor’s remarks must include employee’s testing status, remedial training, and follow-up as

required. See Appendix 6.

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4.6

EVALUATION OF PROFICIENCY TESTING PERFORMANCE

The laboratory will review and evaluate the results obtained on proficiency testing samples as detailed

in the latest version/revision of SOP DAA017,

Standard Operating Procedure for the Handling,

Analysis, and Reporting of Proficiency Testing Samples.

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5.0

QUALITY ASSURANCE OBJECTIVES

The overall Quality Assurance objectives for the Illinois Department of Public Health, Division of

Laboratories are to develop and implement procedures for laboratory analyses, chain-of-custody (when

appropriate), and reporting that will provide results that are of known and acceptable documented

quality. Below is a general discussion of data quality indicators (DQIs) used in the laboratory. See

specific procedure SOPs for more specific information concerning quality control parameters.

5.1

TEST VARIABILITY/REPRODUCIBILITY

For test procedures that specify parameters for reproducibility, duplicate (or other multiple) analyses

are performed and must meet acceptance limits as required by the technical procedure.

5.2

ACCURACY

Accuracy is the degree of agreement between an observed value and an accepted reference value. It is

the degree of agreement between a specimen’s target (positive or negative) and the actual measured

value. Laboratory accuracy is assessed with the use of positive and negative controls at the time of

media preparation and during analysis. Negative controls are analyzed to demonstrate that equipment,

containers, media and reagents are not contaminated because of improper handling or preparation,

inadequate sterilization, or environmental exposure. Positive controls demonstrate that the medium

can support the growth of the target organism(s), and the medium produces the specified or expected

reaction to target organism(s). Positive controls also are used to determine that the analytical system is

functioning correctly for example: antibiotic testing.

5.3

PRECISION

Precision is the degree to which a set of observations or measurements of the same property, obtained

under similar conditions, conform to themselves. Precision is usually expressed as standard deviation,

variance or range, in either absolute or relative terms.

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6.0

PREANALYTIC SYSTEM

6.1

SPECIMEN MANAGEMENT PROTOCOL

With the exception of Metabolic/Genetic Diseases, Clinical testing is not directly available to

individuals but must be requested through approved Local Health Department, Regional Offices of the

Illinois Department of Public Health, or other public agencies. Requests for special or non-routine

analyses must be coordinated through the laboratory in conjunction with a public agency. The

Division of Laboratories routinely analyzes blood and body fluids specimens for Microbiology,

Serology, Virology, Molecular Diagnostics, Chemistry, and Metabolic/Genetic Diseases. The

laboratories also perform animal rabies testing.

6.2

SPECIMEN COLLECTION

Collection of specimens is performed by the appropriate local health department, clinical laboratory,

hospital laboratory, IDPH program personnel or other authorized health care provider/individual. The

Division of Laboratories personnel do not collect specimens. Testing for public health clinics is

coordinated through the Division of Infectious Diseases. The Division of Infectious Diseases will pre-

approve facilities for laboratory testing. The request for testing for private laboratories can be made by

an individual through the local health department or IDPH regional office. For a detailed list of

procedures and specimen collection instructions, refer to the current manual of services.

6.3

ESTABLISHED PROCEDURES

Microbiology Analyses:

The microbiology specimens are accepted from pre-approved submitters.

Microbiology testing includes bacteriology, enterics, parasitology, mycobacteriology, and mycology.

Serology Analyses:

Serology specimens are accepted only from pre-approved submitters. Serology

testing includes testing for Syphilis, HIV, Encephalitic panel, and Hepatitis.

Virology Analyses:

Virology analyses include viral isolation for enterovirus, respiratory virus and

herpes simplex; viral serology for Measles, Rubella, IgM, IgG, and West Nile Virus.

Molecular Diagnostics:

Molecular diagnostics include testing for Chlamydia and Gonorrhea,

viral load for HIV-1,

Mycobacterium tuberculosis

, Pertussis, molecular strain typing, Norwalk-like

virus, Leptosporosis, Enterohaemorrhagic E. coli (EHEC), and Rabies

Chemistry:

Chemistry testing includes blood lead.

Metabolic/Genetic Diseases :

Metabolic/Genetic Diseases include testing for Congenital

Hypothyriodism, Biotinidase Deficiency, Congenital Adrenal Hyperplasia, Galactosemia, Amino Acid

Disorders, Organic Acid Disorders, Fatty Acid Oxidation Disorders, Sickle Cell and other

Hemoglobinopathies.

Rabies:

Rabies specimens are accepted only from regional, veterinary, animal control, county,

or city sanitarian personnel. The sanitarian contacts the epidemiologist of the IDPH Infectious Disease

Division to receive assistance in determining the type of symptoms experienced by the victims. After

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consulting with the Division of Infectious Disease, the veterinarian or qualified animal control officer

should contact the laboratory with specifics of the time and method for shipment.

6.4

NEW WORK OR PROCEDURES

The laboratories will occasionally receive request for analyses not included in the list of established

procedures or beyond the normal workload. Such requests are first discussed by the Chief, Division of

Laboratories and program to determine the exact nature of the test, the data quality objectives, the

expected sample load, and any regulatory or legal issues. Refer to the following documents:

Standard Operating Procedure Implementation/Change,

Directive 01-02, October 1, 2001

;

Standard Operating Procedure for Proposals for Technical and Standard Operating Procedure

Implementation and/or Change,

DAA005.

New procedures must be reported to the regulatory agency within six months of implementation.

6.5

SPECIMEN RECEIPT AND LOG-IN

Details of the specimen receipt and acceptance policies can be found in the latest version/revision of

the Standard Operating Procedure for specific testing. These standard operating procedures (SOP)

contain information on the following sample handling issues:

Specimen collection kits;

Litigation specimens;

Recording of specimen information;

Specimen preservation, container, storage, and holding times;

Specimen acceptance policy;

Specimen log-in sheets or electronic log-in.

6.6

TEST REQUISITION FORM

Specimens submitted for testing must be accompanied by an Illinois form approved by the Division of

Communications. The laboratory must have a written or electronic request for a patient test from an

authorized person/facility. The laboratory may accept a verbal request for laboratory tests if it solicits

a written electronic authorization within 30 days of the verbal request and maintains the authorization

of documentation of its efforts to obtain authorization. See memo from the Chief, Division of

Laboratories dated April 29, 2003. The memo is available through the Laboratory Improvement

Section.

Test requisition forms must solicit the following information:

Submitter identification (name and address of facility or submitter code);

Patient’s name or unique patient identifier;

Sex and age or date of birth of the patient;

Test(s) to be performed;

Source of specimen, when appropriate;

Date, and if appropriate, time of specimen collection;

Any additional information relevant and necessary for a specific test.

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6.7

SPECIMEN SUBMISSION, HANDLING AND REFERRAL

6.7.1 WRITTEN INSTRUCTIONS

The Division of Laboratories will have available to submitters of specimens either written or electronic

instructions for:

Patient preparation;

Specimen collection;

Specimen labeling, including patient name or unique identification and, when appropriate,

specimen source;

Specimen storage and preservation;

Conditions for specimen transportation;

Specimen processing;

Specimen acceptability and rejection;

Specimen referral.

6.7.2 DOCUMENTATION

The laboratory must document the date and time it receives a specimen. This documentation can be

performed by manually writing the date and time on the test requisition form, using a mechanical or

electronic device to stamp the date and time or by placing the date and time into the database during

the scanning of optical character recognition forms.

6.7.3 SPECIMEN REFERRAL

The laboratory must refer a specimen for testing to a CLIA certified laboratory or a laboratory meeting

equivalent requirements as determined by the regulatory entity.

6.8

PURCHASE AND HANDLING OF CONSUMABLES AND SERVICES

6.8.1 PURCHASE OF REAGENTS AND STANDARDS

The purchasing of reagents and standards is usually performed by the supervisor or designee of each

unit.

6.8.2 INSPECTION/ACCEPTANCE REQUIREMENTS FOR SUPPLIES AND

CONSUMABLES UPON RECEIPT

Labels indicating the following information on receipt and testing are to be used for critical supplies

and consumables:

Unique identification name or number (if not clearly shown);

Date received;

Date opened;

Date tested (if applicable);

Date to be retested (if applicable);

Expiration date (if not clearly shown)

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Initials

6.8.3 OUTSIDE SUPPORT SERVICES AND SUPPLIES

Only those outside support services and supplies that are of adequate quality to sustain confidence in

the quality of testing are to be used. Where no assurance of the quality of equipment and supplies is

available, the purchased equipment or supplies are not used until they have been inspected, calibrated

or otherwise verified as complying with any standard specifications relevant to the calibration or tests

concerned. Work performed by outside support services must be verified to be of adequate quality

before any testing dependent on that work is done.

Where applicable, such as in the purchase of specimen collection tubes or specimen collection kits,

supplies will be purchased with a certificate or statement indicating suitability for their intended use

and those certificates/statement retained. Where no indication of a material’s suitability for its

intended use is available, a representative batch of that material is tested by using it to prepare test

blanks and/or standards and the testing records retained.

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7.0

ANALYTIC SYSTEM

7.1

STANDARD OPERATING PROCEDURES (SOPs)

Standard Operating Procedures (SOPS) developed within the Division of Laboratories are reviewed by

the technical staff, management, Laboratory Improvement Section, and other designated personnel.

SOP development and revisions are initiated by management or Laboratory Improvement staff and

approved by the Laboratory Director and the Chief, Division of Laboratories. The DOL SOPs

encompass laboratory activities, and quality control practices. SOP documents will be issued and

maintained on file in either hard copy or electronically by the pertinent laboratory section, and SOP

recipients. The Laboratory Improvement Section maintains on file the historical folders for all SOPs.

The procedures for SOPs are detailed in the following documents and SOPs:

Standard Operating Procedure Implementation/change,

Directive 01-02, October1, 2001;

Standard Operation Procedure for Proposals for Technical and Standard Operations Procedure

Implementation and/or Change,

DAA005;

Standard Operating Procedure for the Initiation, Draft, Approval, and Distribution of Standard

Operating Procedures, DAA021

7.1.1 SOP DISTRIBUTION

Copies of SOPs will be distributed to all signatories. Other laboratory personnel will receive copies of

SOPs based on their job functions. A distribution list will be generated and maintained by the

Laboratory Improvement Section for each SOP as determined by the Chief, Division of Laboratories.

7.2.

TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENTS, MATERIALS AND

SUPPLIES

Laboratory testing must be performed following the manufacturer’s instructions and Standard

Operating Procedures in a manner that provides test results within the laboratory’s stated performance

specification for each test system.

7.2.1 REAGENT, STANDARD AND SPECIMEN STORAGE

All reagents and commercial kits are marked with initials, date received, date opened, and expiration

date. If reagents are prepared, the concentration and content of the solution must also be marked on

the container. Standards are stored in each section’s designated location for standards and reagents

only. Storage of reagents and standards must be consistent with the manufacturer’s instructions, if

provided. Storage of specimens must be consistent with test manufacturer’s instructions, if provided.

Specimens must be stored in conditions that support accurate, reliable test operation and results. These

conditions must be monitored and documented and, if applicable, include the following:

Protection of equipment and instruments from fluctuation and interruptions of electrical current.

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7.2.2

DOCUMENTATION AND LABELS OF STANDARDS AND REAGENTS

Label and maintain records for all reagents, solution, culture media, control materials, calibration

materials, standards, reference cultures, and other supplies including the following:

Manufacturer/vendor;

The manufacturer’s Certificate of Analysis or purity (if supplied);

Identity and, when significant, titer, strength or concentration;

The date of receipt;

Initials;

Recommended storage conditions;

Preparation and expiration date;

An expiration date after which the material must not be used;

Other pertinent information required for proper use.

Components of reagent kits of different lot numbers must not be interchanged unless otherwise

specified by the manufacturer. Original containers must be labeled with in expiration date unless

labeled by the commercial manufacturer. Records are maintained on reagent and standard preparation.

These records contain the following, where applicable:

Traceability to purchased stocks, or reagents;

Reference to the method of preparation;

This information is recorded in a standards/reagent preparation logbook(s), appropriate quality control

form, or electronic record. All containers of prepared reagents and standards bear a unique identifier

and expiration date that links the reagent or standard to the documentation requirements recorded in

the logbook.

Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not

be used after their expiration date has been exceeded, they have deteriorated, or they are found to be of

substandard quality.

7.3 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE SPECIFICATION

Any new method that is being considered for routine testing and is FDA-cleared and approved must be

subject to a verification of performance specifications study including accuracy, precision, and

reportable range. Any FDA-cleared and approved method that has been modified or any test system

that is developed by the laboratory must be subject to an establishment of performance specifications

study including accuracy, precision, analytical sensitivity, analytical specificity to interfering

substances, reportable range, reference intervals, and other performance characteristics. See SOP

DAA005,

Standard Operation Procedure for Proposals for Technical and Standard Operations

Procedure Implementation and/or Change.

7.4

MAINTENANCE AND FUNCTION CHECKS

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7.4.1 ANALYTICAL SUPPORT EQUIPMENT

Analytical support equipment includes the following: balances, incubators, laboratory reagent water

dispensors, refrigerators, freezers, temperature measuring devices, pH meters, conductivity meters and

volumetric dispensing devices. All such support equipment is maintained in proper working order and

the records of all activities including service calls are retained. Support equipment is calibrated or

verified at least annually, using NIST traceable references, when available, over the entire range of use.

The results of the calibration or verification must be within the specifications required of the

application for which the equipment is used or the equipment is removed from service until repaired.

Refer to the corresponding Preventive Maintenance manual.

Prior to use on each day of use, refrigerators, incubators (day of use), and freezers are checked with

NIST traceable references (where possible) in the expected range of use. The acceptability for use or

continued use is according to the needs of the analysis or application for which the equipment is being

used. Mechanical volumetric dispensing devices (except Class A glassware) are checked for accuracy

quarterly. See Appendix 4 for a minimum schedule for the calibration/verification of laboratory

support equipment.

7.4.2 LABORATORY INSTRUMENT MAINTENANCE

All laboratory instruments are maintained in proper working order, and the records of all routine and

non-routine maintenance activities including service calls are retained. A record of maintenance is

maintained for each instrument to record the date and details of each maintenance activity.

Manufacturer’s instructions and manuals for the operation of the instruments are stored in an area

readily accessible to the instrument operator. Function checks are performed as defined by the

manufacturer and with at least the frequency specified by the manufacturer. Function checks must be

within the manufacturer’s established limits before patient testing is conducted. Function checks must

be documented.

7.4.3 LABORATORY INSTRUMENT CALIBRATION

All laboratory instruments are calibrated in a manner consistent with the appropriate reference method

protocols and/or the laboratory’s standard operating procedures. In cases where the laboratory needs

to use equipment outside its permanent control, the laboratory assures that all requirements for the

equipment are met by establishing and maintaining a protocol that ensures performance necessary for

accurate and reliable test results and test results reporting. The laboratory must also define a function

check protocol that ensures equipment, instrument, and test system performance necessary for accurate

and reliable test results and test result reporting. The laboratory must perform and document the

function checks, including background or baseline checks specified in the respective procedure

manual. Function checks must be within the laboratory’s established limits before patient testing is

conducted. The results of instrument calibration must meet acceptance criteria. If the calibration

acceptance criteria are not met, the instrument is removed from service until repaired or a deviation

curve prepared, and all measurements corrected for the deviation. Raw data for all calibrations are

retained, as either electronic or hard copy, so that the conditions of the calibration can be

reconstructed.

The SOP for each analysis performed in the laboratory describes the calibration procedures, their

frequency, acceptance criteria and the conditions that will require re-calibration. When calibration is

performed, sufficient raw data is retained to permit reconstruction of the instrument calibration

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including the following when appropriate: date, test method, instrument test name, analyst’s initials,

concentration and response, calibration or response factor, or unique equation or coefficient used to

reduce instrument responses to concentration.

7.5 CALIBRATION AND CALIBRATION VERIFICATION

Calibration and calibration verification procedures are required to substantiate the continued accuracy

of the test method throughout the laboratory’s reportable range for patient test results. Calibration

verification is the assaying of calibration materials in the same manner as patient specimens to confirm

that calibration has remained stable throughout the laboratory’s reportable range for patient test results.

7.5.1 CALIBRATION PROCEDURE AND FREQUENCY

The laboratory will perform and document calibration procedures following the manufacture’s test

system instructions, using calibration materials provided or specified, and at least the frequency

recommended by the manufacturer. All analytical instruments are calibrated with a standard or series

of standards, or equivalent materials. These standards are either purchased from various vendors in

premixed solutions or prepared directly from neat compounds. The preparation of all standard

solutions is documented in standard preparation logbooks. All stock standards are labeled with date

received, date opened, date prepared (if prepared in the laboratory), and expiration date. The standards

are stored in designated areas and checked for expiration on a regular schedule and prior to use. The

laboratory must also perform and document calibration procedures whenever calibration verification

fails to meet the laboratory’s acceptable limits for calibration verification; at least once every 6

months, and whenever any of the following occur:

A complete change of reagents for a procedure is introduced, unless the laboratory can

demonstrate that changing reagent lot numbers does not affect the range used to report patient

test results, and control values are not adversely affected by reagent lot number changes.

There is a major preventive maintenance or replacement of critical parts that may influence test

performance.

Control materials reflect an unusual trend or shift, or are outside of the laboratory’s acceptable

limits, and other means of assessing and correcting unacceptable control values fail to identify

and correct the problem.

The laboratory’s established schedule for verifying the reportable range for patient test results

requires more frequent calibration verification.

Specific calibration requirements for major classes of analytical procedures are described in the

following sections.

7.5.2 STANDARD RECEIPT AND TRACEABILITY

A standard (including reference cultures) is a solution or culture containing the organism or test

analyte of interest with verifiable accuracy that is used to evaluate that constituent in the specimen or

the performance of the test process in the presence of that organism or material. The purity of a

material, or an organism/culture must be verified and the accuracy requirements for its measurement

available from the source through certification and traceability statements that are kept on file in the

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laboratory. All laboratory standards and reference cultures must be traceable to a national standard

such as NIST, ATCC, or other documented source. Where traceability to national standards is not

possible, the laboratory participates in inter-laboratory testing programs to ensure the quality of the

results. Other reagents must have the purity specifications (grades) required by the method. The

safety requirements are checked with the material safety data sheets (MSDS) supplied by the

manufacturer. Information concerning specific grades of materials used in reagent and standard

preparation, appropriate glassware and container for preparation and storage, and labeling and record

keeping for all reagents are detailed in the procedure SOPs.

7.5.3 VERIFICATION

Select a minimum of three solutions spanning the reportable range (minimum or 0, mid-point,

and maximum), to be run in replicate (recommend two to three times);

Using appropriate, validated software, plot the assigned value (x axis) versus the mean of the

replicates for each level, the observed value (y axis). Draw a line through zero at 45 degree

angle where y=x.

Compare the observed values with the assigned in terms of the laboratory defined

tolerance limits for acceptability. These limits may be specific for each analyte, or may vary

with concentration.

Visually inspect the data for linearity or use linear regression analysis.

Note:

For calibration verification, CLIA requires at a minimum that observed values fall within the

laboratory's acceptable limits, having no regard for linearity.

If all the points are within the laboratory’s tolerance limits then calibration verification is acceptable. If

calibration verification is unacceptable, then recalibrate and repeat calibration verification. If still

unacceptable, then check reagents, troubleshoot the instrument, seek manufacturer technical assistance,

etc. until verification is acceptable. Document all corrective actions.

7.6

CONTROL PROCEDURES

7.6.1 GENERAL REQUIREMENTS

The data acquired from quality control (QC) procedures are used to evaluate the quality of analytical

data, to determine the need for corrective action in response to identified deficiencies, and to interpret

results after corrective action procedures are implemented. Each SOP includes a QC section that

addresses the QC requirements for the procedure. Internal QC requirements are specific for each

method but are summarized in this section. The frequency, acceptance limits, and corrective action for

QC checks are also described in each SOP. The requirements and procedures for initiating and

implementing corrective action are detailed in the following documents:

Remedial Action, Directive 01-03,

October 1, 2001;

Standard Operating Procedure for Corrective Action,

DAA015.

For quality control purposes the laboratory will measure and assure constant and consistent test

conditions (both instrumental and environmental) where required by the test method such as

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temperature, humidity, light, or specific instrument conditions. Figure 7-1 contains examples of the

minimum frequency of quality control samples. Figure 7-2 contains examples of the test quality

control requirements. Each procedure SOP details the required, minimum quality control specimens,

the minimum frequency, and acceptance criteria.

FIGURE 7-1 QUALITY CONTROL SAMPLE SUMMARY

QC Sample

Frequency

Sterility checks

Each new lot number of media, sample bottles,

membrane filters, etc

Positive control

Each new lot of media, supplies, each day patient

specimens are tested

Negative control

Each new lot of media (where available), media,

supplies; each day patient specimens are tested.

Two control materials, positive and negative

Each day patient specimens are tested, extraction

phase, molecular amplification

Comparison testing

Each new lot of reagents, new lot of media, new

controls

Two control materials of different concentration Each quantitative procedure

Negative and positive controls

Each qualitative procedure

Negative control and control material with

graded or titered reactivity

Each procedure producing graded or titered results

Two control materials including one that is

capable of detecting errors in the extraction

process

Each test system that has an extraction phase

FIGURE 7-2 MINIMUM QUALITY CONTROL REQUIREMENTS SUMMARY

Test

Quality Control Requirement

Frequency

Beta-lactamase

Positive and negative organisms

Each day of use

Gram stain

Positive and negative organisms

Each week of use

Media

Positive and negative organisms

Each batch or each lot

Bact-antiserum

Positive and negative organisms

Upon preparation /open;

every six months thereafter

Antimicrobial Susceptibility Appropriate control organisms

Each day test performed

Acid-fast

Positive and negative organisms

Each day of use

TB susceptibility

Positive and negative organisms

Each week test is performed

Lactphenol Cotton Blue

Positive and negative organisms

Each batch or lot

Fungal susceptibility

Appropriate control organisms

Each day of test

Parasitology

Collection of slides or

photographs

Each day of testing

Permanent stain

Sample control material

Each month of use

Virus Isolation

Cell substrate control, bland

Simultaneously with test

Chemistry

Low and high value controls

Each 8 hours

Staining materials

Positive and negative controls

Each day of use

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7.7 COMPARISON OF TEST RESULTS

Laboratories performing the same test using different methodologies (distinct analytical, chemical,

biochemical, molecular etc. techniques or kits) or instruments, must have a system that, twice a year,

evaluates and defines the relationship between test results using different methodologies or

instruments. Previously tested proficiency test samples or patient specimens may be used. If all

samples used to compare test results are within the laboratory’s established acceptable range, the test

comparison exercise is acceptable. If the test comparison is unacceptable, then calibrate and repeat

calibration verification. If still unacceptable, then check reagents, troubleshoot the instrument, etc.

until comparison of test results is acceptable. The comparison of test results must be documented

using “Comparison of Test Results Report” (Appendix 5).

The laboratory must have a system to identify and assess patient test results that appear inconsistent

with the following relevant criteria, when available: patient age, sex, diagnosis or pertinent clinical

data, and distribution of patient test results relationship with other parameters.

7.8 CORRECTIVE ACTIONS

The laboratory must document all corrective actions taken, including test systems not meeting the

established verification specifications as specified in the procedure; equipment and methodology

perform outside parameters; patient test values are outside reportable range; or when the laboratory

determines that the reference intervals for a test procedure are inappropriate. Corrective action must be

taken any time the results of controls or calibration fail to meet the established criteria. Patient test

results obtained in the unacceptable test run and since the last acceptable test run must be evaluated.

Any time the criteria for proper storage of reagents and specimens is not met, a corrective action must

be implemented and documented. See DAA015,

SOP for Quality Improvement Actions.

7.9 TEST RECORDS

The laboratory must maintain an informational record system that includes:

Positive identification of specimens which initiates an audit trail;

The test requisition form bearing the date and time the specimen was received. When an

optical character form is used, a date/ time record will be recorded upon scanning in an

electronic file;

Worksheets documenting the condition and disposition of specimens that do not meet

acceptable criteria;

Dates of all specimen testing;

Identity of the personnel who performed the test;

Records of testing including, if applicable, instrument printouts or electronic equivalents.

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8.0

POSTANALYTIC SYSTEM

8.1

DATA REVIEW PROCEDURE

Data resulting from the analysis of specimens are calculated according to protocols described in the

laboratory procedure. Computer programs used for data calculation are validated before use. All

information used in the calculations (e.g., raw data) is recorded in order to enable reconstruction of the

final result at a later date. Information on the preparation of the specimen (e.g., weight or volume of

specimen used, dilution factor used) is maintained in order to enable reconstruction of the final result

at a later date. All specimen results are reviewed by the unit supervisor or designee before being

released.

8.2

FINAL TEST REPORTS

The results of each test, or series of tests, are contained in a final laboratory report and include all the

information necessary for the interpretation of the results. Final results may be reported to an

interfaced system or manually transcribed or electronically transmitted by the analyst for all

specimens. Final reports must be sent promptly only to the authorized person, and if applicable, the

individual responsible for using the test results and the laboratory that initially requested the test. Test

results are reported according to the specific test SOP. Each final report sent to the customer includes

information to interpret the results. The report will include some or all of the following information as

required by the accrediting authority:

Name, and address of the laboratory where the test was performed;

Unique identification number of the report and all pages numbered. The report identification

number and specimen number are equivalent;

Outbreak number. Outbreak specimens are collected in groups. The group of specimens is

reported on one form that is identified with the outbreak number, date and time of collection,

and specimen numbers;

Name and address of test requesting facility or submitter code number;

Test report date;

Test performed;

Specimen source, when appropriate;

Test results and, if applicable, the units of measurement or interpretation, or both;

Any information regarding the condition and disposition of specimens that do not meet the

laboratory’s criteria for acceptability.

After issuance of the report, the report must remain unchanged. Any material amendments to a report

after issue are to be made in the form of a further document with the statement “Corrected Report,

serial number” or “Amended report, serial number”. Amendments will meet all relevant requirements

as the original report. In the event that anything is discovered after the issuance of a report that casts

doubt on the validity of that report, the authorized person ordering the test and, if applicable the

individual using the test results is to be notified promptly. Issue a corrected report and maintain

duplicates of the original report, as well as the corrected report.

The laboratory must have available pertinent “reference intervals” or “normal” values. Upon request,

the laboratory will make available a list of methods employed and the performance specifications

established or verified. Pertinent updates on testing information must be provided to clients whenever

changes occur that affect the test results or interpretation of test results.

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When the laboratory cannot report test results within its established time frame, the laboratory must

determine, based on the urgency of the patient test requested, the need to notify the appropriate

individual of the delay.

When the laboratory refers patient specimens for testing, the laboratory must not revise results or

information related to the test interpretation; the referring laboratory may send test results directly to

the authorized person who initiated the test request. In that case, the laboratory must maintain an exact

duplicate of each testing laboratory’s report. The laboratory initiating the test request must be notified

by the referring laboratory of the name and address of each laboratory where the test was performed.

When test results are submitted to clients by telephone, telex, fax, or other electronic or

electromagnetic means, all requirements stated in this section and those in the Section 4.2,

“Confidentiality”, must be followed.

8.3

RECORDS

Accurate records provide the direct evidence, support, and documentation for the necessary technical

interpretations, judgments, and discussions concerning laboratory results. These records, particularly

those that are anticipated to be used as evidentiary data, provide the historical evidence needed for later

reviews and analyses. Records should be legible, identifiable, and retrievable, and protected against

damage, deterioration, or loss. All records referenced in this section are retained for a total of six

years; Metabolic/Genetic Diseases will keep records for 21 years. All records will be made available

to the accrediting authority upon request. All records are maintained on site and thus immediately

available for a period of 2 years.

Electronic or hard copy data is stored securely in each of the laboratories or in the off-site

storage/archive facility. Original laboratory logbooks, analyst logbooks, and laboratory worksheets are

changed at the beginning of the year or as determined by the technical supervisor, replaced with new

ones, and the old logbook stored. Logbooks are also replaced if they show signs of deterioration or as

determined by the technical supervisor.

8.4

CORRECTIVE ACTION REPORTS

The process of corrective action is detailed in each method SOP and in SOP DAA015,

Standard

Operating Quality Improvement Actions.

Corrective action reports and all pertinent information are

retained by the Laboratory Improvement Section.

8.5

SPECIMEN RETENTION

Most specimens and specimen products are discarded shortly after the analysis has been completed and

the sample results are reported. The specimens and specimen products are disposed of by the

laboratory in accordance with federal and state laws and regulations. Figure 8-1 summarizes the

minimum specimen retention schedule. All documents pertaining to specimen storage and tracking are

retained, including shipping receipts, transmittal forms, and internal routing and assignment records.

If the specimen is part of litigation, disposal of the physical specimen occurs only with the concurrence

of the affected legal authority, specimen data user and/or submitter of the specimen. All conditions of

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disposal and all correspondence between all parties concerning the final disposition of the physical

specimen are recorded and retained.

Records indicate the date of disposal, nature of disposal (such as specimen depleted, specimen

disposed in hazardous waste facility, or specimen returned to submitter), and the name of the

individual who performed the task.

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Figure 8-1

IDPH Specimen Retention Schedule

UNSATS

Clinical specimens (enteric) /

Referred cultures (enteric)

1 year

6 months

Reference culture (misc.)

1 month/final

Till report

MTB RFLP Testing (mail-out)

2 years (frozen)

N/A

Bacteriology culture ID / susceptibility

Subculture 1 week

10 days

TB clinical specimens

5 weeks or until final

Specimen & isolates 2

24 hours or until final

Metabolic/Genetic Diseases

Negative/Unsat

Positives

BDL*s and Unsats

Biotinidase Deficiency

1 wk refrigerated

2 months @ rm. temp.

Frozen indefinitely

4 months refrigerated

balance of year @ rm. temp.

Congenital Adrenal Hyperplasia

1 wk refrigerated

2 months @ rm. temp.

Frozen indefinitely

4 months refrigerated

balance of year @ rm. temp.

4 months refrigerated

balance of year @ rm. temp.

4 months refrigerated

balance of year @ rm. temp.

4 months refrigerated

balance of year @ rm. temp.

Sickle Cell Disease and other

4 months refrigerated

balance of year @ rm. temp.

*Borderline

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DOCUMENTATION MANAGEMENT AND RECORD RETENTION

Managing quality documents is the responsibility of the Laboratory Improvement Section with

assistance from the laboratory supervisors. The process of document management serves to assure that

records are accessible, reviewed and revised on a regular schedule, and protected in storage from

damage and deterioration. The IDPH Division of Laboratories follows the provision of the State

Records Act (5ILCS 160/1) and the rules established by the State Records Commission to implement

this act.

9.1

CLIA DOCUMENTS

Copies of national guidance or requirements document issued by the CLIA’s Quality Assurance

Division and all HHS documents are maintained by the Laboratory Improvement Section in

Springfield. They are distributed by the Laboratory Improvement Section to Division personnel upon

request and when documents are updated or changed.

9.2

ROUTINE QA OPERATING DOCUMENTS AND ANALYTICAL RECORDS

All routine QA documents (logbooks, temperature charts, balance checks, specimen receipt logs, etc.)

and specimen analysis records are used, properly maintained and stored by the laboratories. All

documents and records are maintained on site for a period of three years either as hard copy or

electronic equivalents. At the end of on site storage period, documents are inventoried, boxed up and

sent to the Secretary of State Records Retention Center and are kept for the appropriate time. See

Guideline Record management 91-02 and DAA010,

SOP for Record management.

See section 8 for detailed information on final reports and laboratory records. Allowing for specific

requirements of the analytical process, quality assurance forms established by the Division of

Laboratories may be revised by the technical supervisor in order to more accurately reflect the

documentation required. The revised forms must contain at a minimum the criteria set by the Division.

The revised forms must be reviewed by the Laboratory Improvement staff and be approved by the

Laboratory Director and Chief, Division of Laboratories, prior to implementation. Electronic records

are considered equivalent to hard copy.

9.2.1 QUALITY MANUAL

This Quality Manual was developed by the Division of Laboratories and is reviewed by the Division’s

management and Laboratory Improvement Section. The Division’s Quality Manual is a controlled

document that is distributed to all employees in the clinical and research sections/units in the DOL.

Receipt will be documented with signed read receipts.

9.2.2 DOCUMENT TRACKING

A master list of controlled documents for the Quality Manual, SOPs, and QA policies will be

developed and maintained by the Laboratory Improvement Section. All controlled documents and

subsequent approved revisions will be entered into the system by the LQS. The master list of

controlled documents includes the title, revision number, effective date, and retirement date of all

SOPs. The LQS will monitor the status of all documents to assure timely drafting, review, and

approval or revisions.

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9.2.3 RETIREMENT OF DOCUMENTS

The LQS will ensure that all DOL quality documents are current. Should one of these documents

become outdated, the LQS will initiate a revision of the document. Copies of all quality documents,

both current and retired, will be maintained in the Laboratory Improvement Section in a centrally

located file area under secure conditions for a minimum of six years.

9.2.4 MAINTAINING SENSITIVE DOCUMENT INTEGRITY

The DOL will take special care to preserve the integrity of all sensitive documents such as audit

reports, performance evaluation reports, personnel assessments, and service improvement forms. At

the Springfield and Chicago laboratories, these records are in the Laboratory Improvement Office.

This office is locked when the Laboratory Quality Specialist/Manager is absent. Access to these

records is by permission of the Division Chief, Laboratory Director, and/or the Laboratory

Improvement Section only. In Carbondale, these records are located and kept secure in the Laboratory

Manager’s office.

Analysts have access to those specimen records that are currently being completed. After the records

are completed and submitted to the unit supervisor, they are accessible to analysts only with

permission of the supervisor. Records that have entered permanent storage are accessible only to the

Division Chief, Laboratory Director, Section Chief, Laboratory Improvement Section, or the

designated supervisor. If sensitive (confidential, proprietary, evidentiary) documents are used at a

workstation, due care and document control processes are used in order to maintain integrity of the

data or records. No data or records identified as, or deemed to be confidential, proprietary or

evidentiary documents will be distributed outside the Division of Laboratories workstation where they

are being used without specific written or verbal permission by the appropriate laboratory technical

supervisor. Any issues or questions concerning the internal Division of Laboratories distribution of

such documents must be brought promptly to the attention of the applicable section or unit supervisor.

All records will follow the departmental requirements of the Health Insurance Portability and

Accountability Act of 1996 (HIPPA).

9.2.5 STANDARD OPERATING PROCEDURES

All methods performed in the Division of Laboratories will have a standard operating procedure that

details the procedure and requirements of the method. See SOP DEA021,

The Initiation, Draft,

Approval, Distribution, and Revision of Standard Operating Procedures (SOPs).

9.2.6 EQUIPMENT MAINTENANCE DOCUMENTATION

Documents detailing the receipt and specification of analytical equipment are retained. A history of

the maintenance record of each instrument serves as an indication of the adequacy of maintenance

schedules and parts inventory. The performance of all instrument maintenance, either regular or

emergency, will be recorded in a logbook, electronic record, or log sheet. The information recorded

will include date and initials, the maintenance performed, and the reason for the maintenance.

9.2.7 TEST REQUISITIONS AND AUTHORIZATIONS

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Records of test requisitions and test authorizations must be retained including documentation of the

laboratory’s efforts to obtain authorization to perform the test when a verbal request for test and/or

patient demographics has been made. See memorandum dated April 29, 2003,

Operational Change –

CLIA Request.

A copy of this memorandum can be obtained from the Laboratory Improvement

Section.

9.2.8 SPECIMEN ANALYSIS LOGBOOKS/LOGSHEETS

Specimen analysis logbooks/logsheets/worksheets are used to document the conditions and date of

specimen analysis. The information in these logbooks includes specimen numbers and the date of

analysis, the method used, and any instrument or specimen information that may be relevant.

9.2.9 ORIGINAL DATA

The raw data and calculated results for all specimens are maintained in laboratory notebooks, logs,

bench sheets, files or other sample tracking or data entry forms or electronic equivalents. Instrumental

output is stored in a computer file or hard copy report. These records include the following:

Laboratory specimen ID code;

Date of analysis;

All specimen handling and analysis logbook/logsheets or electronic equivalents;

Instrumentation identification and instrument operating condition/parameters (if appropriate);

Analysis type and specimen preparation information;

All manual, automated, or statistical calculations;

All data system reports including instrument printouts or electronic equivalents;

Confirmatory analysis data, when required;

Review history of specimen data; and,

Analyst’s or operator’s initials/signature.

9.2.10 QC DATA

The raw data and calculated results for all QC specimens and standards are maintained in the manner

described in the preceding paragraph. Documentation allows correlation of sample results with

associated QC data. Documentation also includes the source and lot numbers of standards for

traceability. QC specimens include, but are not limited to, sterility checks, positive and negative

controls and multiple level controls.

9.2.11 SYSTEM PERFORMANCE

Systems performance includes specification that the laboratory has established and verified the test

performance specification including verification studies and calibration verification.

9.2.12 FINAL REPORT

A copy of any report issued and any supporting documentation is retained by the laboratory, either in

hard copy or retrievable electronic form for a minimum of 6 years (per HIPPA requirements). Reports

issued by Metabolic/Genetic Diseases must be retained for 21 years.

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9.2.13 CORRESPONDENCE

Correspondence related to specific specimens is retained along with the specimen test requisition form.

Correspondence and/or records of conversations concerning the final disposition of rejected specimens

are maintained.

9.3 ADMINISTRATIVE RECORDS

Each analyst performing testing must be qualified to perform laboratory testing in accordance with the

accrediting agency. The laboratory supervisor assigns the performance of testing to each analyst. The

technical supervisor or his/her designee upon staff assignment to that laboratory initiates CLIA

personnel files. CLIA personnel files include educational background, initial and continuing

demonstrations of capability or personnel assessments, and record of training. CLIA personnel files

are maintained in the Laboratory Improvement Section. See Appendix 6.

9.3.1 CORRECTIVE ACTION REPORTS

The process of corrective action is detailed in each method SOP and in SOP DAA015,

Standard

Operating Quality improvement Actions.

Corrective action reports and all pertinent information are

retained at a minimum by the Laboratory Improvement Section.

9.3.2 AUDIT INFORMATION

Files of audits (internal and external), as well as the responses and corrective actions associated with

them including, but not limited to checklists, correspondence, and follow up are retained at a minimum

by the Laboratory Improvement Section. Internal audits will be conducted according to SOP DAA022,

Standard Operating procedures for Internal Audits.

9.3.3 PERFORMANCE EVALUATION DATA

These records include but are not limited to the following: all proficiency test raw data, results,

corrective action and follow-up (if any). The files are arranged chronologically by survey and retained

by the Laboratory Improvement Section and/or the unit supervisor.

9.3.4 SUPPLIER AND SUPPLIES RECORDS

All documentation from suppliers of services is retained. These documents include, but are not limited

to the following: records of service contracts, copies of certifications, schedules of services provided.

All records associated with goods received are also retained. These records include, but are not limited

to instrument manuals and certifications and certificates of analysis for standards and reagents.

9.4

RECORD STORAGE PROCEDURE

All records, including all information necessary for the historical reconstruction of data, must be stored

for a minimum of 6 years from the date of completion of analysis; 21 years for Metabolic/Genetic

Diseases. For the first two years the records are stored in-house. The data is then stored at the State

Records Center in Springfield, Illinois under the authority of the Secretary of State for the remainder of

the required time. Stored documentation includes all raw analytical data (computer print-outs, etc),

test requisition forms, logbooks, maintenance records, quality control records, controlled documents,

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etc. In the event of the closure of the laboratory or when a test is discontinued, the records will be

transferred to the State Records Center in Springfield, Illinois. The department programs will be

notified in writing of the closure and procedures for obtaining records.

9.5

DATA SECURITY

Analog data from the instruments is converted to digital information by vendor supplied software

installed on the laboratory’s computers. Consistent, correct analyses of the QC specimens indicate that

the data is being received and calculated correctly.

Data from the laboratory’s computers is backed up on a regular basis. A copy of this back up is

maintained by the Division of Information Technology. Records stored only on electronic media are

supported by the hardware and software necessary for their retrieval.

Data is further protected by physical methods. Access to the laboratory is restricted. A series of

passwords are also required for entry into any database. Access is restricted to authorized personnel.

Computer and automated equipment are maintained to ensure proper functioning and provided with the

environmental and operating condition necessary to maintain the integrity of calibration and test data.

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10.0 SYSTEMS AUDITS

10.1 SCOPE AND FREQUENCY OF AUDITS

The Laboratory Improvement Section (LIS) will, on an annual basis, audit all laboratory operations to

verify compliance with the requirements of the quality system: preanalytic, analytic, and postanalytic.

These audits form the basis of quality improvement action requirements and constitute a permanent

record of the conformity of laboratory operations to quality requirements. When audit findings suggest

that further investigation may be necessary, the laboratory will investigate and when deemed

necessary, take immediate corrective action and immediately notify, in writing, any client whose work

may have been affected.

10.2 TYPES OF AUDITS

10.2.1 QUALITY SYSTEM AUDITS

The quality system audits are based on the quality system elements, activities, and requirements

contained in a quality manual. The activities subject to quality system audits are those activities that

have a significant effect on the quality of DOL services. The laboratory must monitor and evaluate the

overall quality of the preanalytic, analytic, and postanalytic system. Audit procedures and scheduling

are detailed in the latest version/revision of SOP DAA022,

Standard Operating Procedure for Internal

Audits

10.2.2 GENERAL LABORATORY AUDITS

The general laboratory systems audit must include a review of the effectiveness of improvement

actions taken to correct problems, revisions of policies and procedures necessary to prevent recurrence

of problems, and discussion of general laboratory systems audit reviews with appropriate staff.

10.2.3 PREANALYTIC SYSTEMS AUDITS

The preanalytic systems audit must include a review of the effectiveness of improvement actions taken

to correct problems, revisions of policies and procedures necessary to prevent recurrence of problems,

and discussion of preanalytic systems audit reviews with appropriate staff.

10.2.4 ANALYTIC SYSTEMS AUDITS

The analytic systems audit must include a review of the effectiveness of improvement actions taken to

correct problems, revision of policies and procedures necessary to prevent recurrence of problems, and

discussion of analytic systems audit reviews with appropriate staff.

10.2.4 POSTANALYTIC SYSTEMS AUDIT

The postanalytic systems audit must include a review of the effectiveness of improvement actions

taken to correct problems, revision of policies and procedures necessary to prevent recurrence of

problems, and discussion of postanalytic systems audit reviews with appropriate staff.

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10.2.5 PERFORMANCE AUDITS – PROFICIENCY TESTING SPECIMENS

Performance audits are periodic audits to ensure the quality of results provided to clients by

implementing checks to monitor the quality of the laboratory’s analytical activities. The audits provide

assessment of laboratory performance through the analysis of proficiency testing specimens. The

specimens are to be handled, analyzed, and reported according to the procedure in SOP DAA017,

Standard Operation Procedure for Handling, Analysis, and Reporting of Proficiency Testing Samples

The Division of Laboratories, clinical units, participate in the following programs:

CAP – College of American Pathology;

WSLH – Wisconsin State Laboratory of Hygiene;

CDC – Centers for Disease Control and Prevention;

AAB – American Association of Bioanalysts.

Other programs may be added as they become available.

10.2.6 EXTERNAL AUDITS

External audits are conducted to verify compliance with rules, regulations, or certification criteria.

External audits are conducted with a high degree of formality upon notification and scheduling with

the auditing agency. The laboratories are surveyed during the renewal period by the US Department of

Health and Human Service, Centers for Medicare and Medicaid Services for Disease Control and

Prevention (CMS) for all clinical analyses.

10.3 MANAGERIAL REVIEW PROCEDURE

10.3.1 QUARTERLY SUPERVISOR’S REVIEW OF LABORATORY TESTING

Each laboratory supervisor must quarterly review its policies and procedures for sample and results

management, quality control, the relationship of sample information to test results, corrective action,

and customer complaints. See Appendix 7 for the form to be used for this review.

10.3.2 SEMI-ANNUAL QUALITY ASSURANCE REVIEW AND REPORT

Each laboratory supervisor must perform a semi-annual review of its QA program including the

outcome of recent internal audits and assessment by external organizations. The supervisor must then

submit a report to the Laboratory Director and the Laboratory Improvement Section using the forms in

Appendix 8. This report summarizes all quality assurance activities for the six-month period.

10.4 DOCUMENTATION

The laboratory must document all preanalytic, analytic, and postanalytic systems audit activities.

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11.0 DEFINITIONS

Accuracy:

the degree of agreement between an observed value and an accepted reference value.

Arithmetic Mean (Mean X):

the number obtained by dividing the sum of a set of quantities by the

number of quantities in the set; average. The mean is an arithmetical measure of central tendency.

The mean is commonly referred to as the “average”. The mean may be used to indicate the accuracy

of a test or analysis.

Audit

: a formal examination of an organization's or individual's accounts or financial situation; an

assessment.

Calibration:

to determine, by measurement or comparison with a standard, the correct value of each

scale reading on a meter, instrument, or other device.

Calibrator or Standard:

any material that meets established identity, labeling and performance

criteria and is used or recommended for use in a calibration process to establish the basis by which

specimen values are determined.

Chain-of-Custody

: a record that documents the possession of the sample from the time of collection

to receipt in the laboratory through the analytical testing process, and storage or retention; This record

generally includes the number and types of containers, the mode of collection, collector, time of

collection, preservation, and requested analysis.

Coefficient of Variation – CV

: a relative measure of variation, sometimes referred to as the Relative

Standard Deviation, RSD; The CV is expressed as percent by the follow formula: (standard deviation

divided by the mean) times 100.

CMS

: US Department of Health and Human Services, Centers for Medicare and Medicaid Services

for Disease Control and Prevention.

Corrective action

: the action taken to eliminate the causes of an existing conformity, defect, or other

undesirable situation in order to prevent recurrence.

Data audit

: a qualitative and quantitative evaluation of the documentation and procedures associated

with environmental measurements to verify that the resulting data are of acceptable quality.

Deficiency:

an unauthorized deviation from acceptable procedure or practices, or a defect in an item

or system.

DOL

: Division of Laboratories

Holding times (maximum allowable holding time):

the maximum times that samples may be held

prior to analysis and still be considered valid or not compromised. Holding time measurement begins

with the time of specimen collection.

ISO:

the International Organization for Standardization; ISO standards are developed by technical

committees comprising experts on loan from the industrial, technical, and business sectors that asked

for the standards and will subsequently put them to use.

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LQS

: Laboratory Quality Specialist

May

: denotes permitted action, but not required action.

Median

: the middle-ranking number in a set of numbers.

Must

: denotes a requirement that must be met.

Negative Control – media:

an analysis consisting of the inoculation of media using an organism that

should not grow in the media or should not respond in a specific way.

Negative Control – analytical testing

: an analysis consisting of a sample that does not contain the

analyte(s) of interest. A negative control is performed in an analytical test to ensure the test is

responding appropriately.

NIOSH

: National Institute of Occupational Safety and Health

NIST

: National Institute of Standards and Technology, US Department of Commerce

: Proficiency Test

Parallel Testing:

the system used to compare lots and/or shipments of diagnostic reagents/kits or

methods. Parallel testing uses identical controls and specimens/samples to determine the consistency

of the test system being evaluated (i.e., the only variable is the reagent/kit/test material being

evaluated). All reagents are parallel tested prior to use for diagnostic purposes or as screening tests.

Performance Audit

: the routine comparison of independently obtained qualitative and quantitative

measurement system data with routinely obtained data in order to evaluate the proficiency of an

analytical system.

Positive Control – media

: an analysis consisting of the inoculation of media using an organism that

should grow in the media or should respond in a specific way.

Positive Control – analytical testing:

a sample containing the analyte(s) of interest. A positive

control is performed in an analytical test to ensure the test is responding appropriately.

Predictive Value

: the expression of the likelihood that a test result reflects the disease or condition

status of an individual; Predictive values may be applied to either positive or negative results.

Predictive value is especially useful when screening for diseases or conditions in a population with a

low prevalence of the disease or condition.

Preventive Maintenance – PM:

upkeep, repairs, or maintenance that prevents or impedes breakdown

or loss of function in equipment, machinery, or complex systems.

Precision

: the degree to which a set of observations or measurements of the same property, obtained

under similar conditions, conform to themselves. Precision is usually expressed as standard deviation,

variance or range, in either absolute or relative terms.

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Preservation

: the act of preserving or controlling the conditions (e.g., environmental, chemical,

temperature, etc.) at the time of sample collection (or later) to maintain the chemical and/or biological

integrity of the sample.

Proficiency Testing

: a means of evaluating a laboratory’s performance under controlled conditions

relative to a given set of criteria through analysis of unknown samples provided by an external source.

Quality Assurance (QA):

an integrated system of activities involving planning, quality control,

quality assessment, reporting and quality improvement to ensure that a product or service meets

defined standards of quality with a stated level of confidence.

Quality Control (QC):

the overall system of technical activities whose purpose is to measure and

control the quality of a product or service so that it meets the needs of the users.

Quality Manager

– ISO 15189 – has delegated responsibility and authority to oversee compliance

with the requirements of the quality management system and reports directly to the level of laboratory

management at which decisions are made on laboratory policy and procedures.

Regression:

a statistical measure of the strength of linear association of X and Y; Complete linear

association equals unity, while no linear association equals zero.

Relative Standard Deviation – RSD:

see Coefficient of Variation – CV

Screening:

the presumptive identification of unrecognized disease or defect by the application of tests,

examinations, or other procedures which can be applied rapidly to sort out apparently well persons

who probably have a disease from those who probably do not.

Should:

denotes a guideline or recommendation

Slope

: the slope is the rate of change of Y for a unit change of X.

Standard Deviation (SD):

a statistical tool used as a measure of dispersion in a distribution; The SD

is the square root of the variance. The standard deviation is a measure of dispersion of results about

the mean value of the frequency distribution of the observation. Standard deviation may be used to

indicate the precision of a test or analysis.

Traceability:

the property of a result or a measurement where by it can be related to appropriate

standards, generally international or national standards, through an unbroken chain of comparison.

Validation:

the process of substantiating specified performance criteria.

Verification

: the confirmation by examination and provision of evidence that specified requirements

Health Care Financing Administration 42 CFR Part 493

Medicare, Medicaid, and CLIA

Programs: Laboratory Requirements Relating to Quality Systems and Certain Personnel

Qualification;

Final Rule January 24, 2003.

12.2

General Requirements for the Competence of Testing and Calibration Laboratories,

ISP/IEC17025, International Standard, 1999.

12.3

Laboratory Procedure Manuals,

National Committee for Clinical Laboratory Standards,

Volume 4, Number 2.

12.4 James P. Rux, Ph. D.,

Handbook of Quality Assurance for the Analytical Chemistry

Laboratory,

Van Nostrand Reinhold Company, N.Y., 1986.

12.5 Stanley L. Inhorn, M.D., Editor,

Quality Assurance Practices for Health Laboratories,

American Public Health Association, Washington, D.C., 1978.

12.6 John Keenan Taylor,

Quality Assurance of Chemical Measurements,

Lewis Publishers.,

Chelsea, MI, 1988.

12.7 Health Care Financing Administration, 42 CFR Part 405, et. al.,

Clinical Laboratory

Improvement Amendments of 1988,

Final Rule, February 28, 1992.

12.8 J. S. Mausner and A. K. Bahn,

Epidemiology: An Introductory Text,

W. B. Saunders Co.,

Philadelphia, 1974.

12.9 P.E. Leaverton,

A Review of Biostatistics,

Little, Brown & Co., Boston, 1978.

12.10 B. L. Therrell, Jr., Editor,

Laboratory Methods for Neonatal Screening,

American Public

Health Association, 1993.

12.11 ISO15189,

Medical Laboratories – Particular Requirements for Quality and Competence,

ISO

15189:2003(E), ISO 2003

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13.0 APPENDICES:

13.1 Appendix 1 – Directives

13.2 Appendix 2 – Standard Operating Procedures

13.3 Appendix 3 – Training Documentation

13.4 Appendix 4 - Calibration/Verification of Laboratory Support Equipment

13.5 Appendix 5 – Comparison of Results

13.6 Appendix 6 – CLIA Personnel File Documentation

13.7 Appendix 7 – Quarterly Managerial Review Forms

13.8 Appendix 8 – Semi-Annual Managerial Review Forms

Quality Assurance/Quality Control

October 1, 2001

01-02

Standard Operating Procedure

Implementation/Change

Confidentiality of Laboratory Test

SOP for Data Integrity

11/05/2001

DAA005

SOP for Technical and Standard Operation

Implementation/Change

11/01/2001

DAA007

Information Technology Procedure Manual

01/03/2005

DAA0010

Standard Operating Procedure for Record

Management

02/10/2004

DAA015

SOP for Quality Improvement Actions

12/12/2003

DAA016

SOP for Service Improvement Actions

12/12/2003

DAA017

Standard Operating Procedure for Handling,

Analysis, and Reporting of Proficiency Testing

Samples

12/12/2003

DAA018

Chemical Hygiene Plan

12/05/2004

DAA021

SOP for Initiation, Draft, Approval, and

Distribution of Standard Operating Procedures

12/12/2003

DAA022

Standard Operating Procedure for Internal Audits

01/07/2004

DAA023

SOP for Risk Assessment

3/28/2005

DAA025

SOP for Fiscal Ordering

8/16/2005

DAA028

SOP for Exposure Control to Blood borne

Pathogens

1/03/2005

DAS001

SOP for Specimen/Sample Log-In and Receipt

01/01/2004

DCS001

SOP for Preventive Maintenance

Illinois Department of Public Health – Division of Laboratories

Personnel Training Record

Employee Name: _____________________

Supervisor: __________________

I understand that by initialing, I acknowledge having been instructed and evaluated on each time

below. Furthermore, I agree to follow the laboratory’s procedures and policies for the items below.

Employee signature: ___________________

Date: ________________________

Items

Date of Evaluation

Employee

Initials

Supervisor

Initials

Emergency Response Plan

Safety Manual

Reagent preparation techniques

Testing procedures (SOP number)

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Appendix 4

Calibration/Verification of Laboratory Support Equipment

Equipment

Activity

Minimum

Frequency

Acceptance

Check with three weights

Temperature monitoring

devices

Verification at temperature

of use against a NIST

Illinois Department of Public Health – Division of Laboratories

Comparison of Test Results Report

Specimen

Method/Instrument

Result

Acceptable

Initials/Date

Summary:

Corrective Action:

Follow-up action to be taken to document that the problem has been solved:

Prepared by: _______________________________________

Date: __________________

General/Tech Supervisor: ____________________________

Date: __________________

Reviewed by QA Staff: ______________________________

Date: __________________

Approved by Laboratory Director: _____________________

Date: __________________

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Appendix 6

Illinois Department of Public Health – Division of Laboratories

CLIA Personnel File

Checklist

Employee Name:

Position:

Date Hired

Certificate, license, registry number

Foreign education equivalency

High school diploma, degrees, certificates

Job responsibilities (copy of job description)

Appendix 6 – continued

Illinois Department of Public Health – Division of Laboratories

CLIA Personnel File

Laboratory Qualification Appraisal

Employee Name

Section assigned:

Hours:

Name of College, University, or Professional School

Attach any copies of license, transcript evaluation,

certification or diplomas

Dates

Major

Degree/Cert.

Experience: Facility’s name

Dates

Position

Test: Extension of test procedures

Eval Date/ Emp. Initials

Supervisor Init.

Signature: General/Technical/Supervisor:

Date:

Director’s Signature:

Date:

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Appendix 6 – continued

Illinois Department of Public Health – Division of Laboratories

CLIA Personnel File

Personnel Assessment

Assessment

Date _____________________

Monitoring, reporting

& recording of results

Sat.

Un-sat.

Comment

Monitoring, reporting

& recording of results

Problem solving skills

General supervisor’s remarks

General supervisor’s signature:

Date

Technical supervisor’s remarks (if applicable):

Technical supervisor’s signature:

Appendix 7

Illinois Department of Public Health – Division of Laboratories

Supervisor’s Review of Laboratory Testing

Month(s) of _____________________________ Date of Review:________________________________Reviewed by:_________

The laboratory must perform a quarterly review of its policies and procedures for patient test management, quality control, proficiency testing, relationship of

patient information to test results, communications and complaint investigations. To comply with this requirement, review a representative number of specimens

for compliance in the indicated headings. Indicate Sat

, if satisfactory, Unsat, if unsatisfactory. Use the comment/corrective action space to document

unsatisfactory findings and corresponding corrective action.

Test

Specimens

reviewed

Requisitions Reports Worksheets

Calibration

Storage

Corrective

action

%TAT Communications

Requisitions: Review specimen processing for accuracy: Specimen identification, test ordered, correct specimen type, appropriate handling, appropriate storage.

Reports:

Assure that requisition information has been accurately transferred to test report; test ordered was performed and reported to authorized person.

Worksheets: Has all required information including lot #, results from worksheets, instrument printout or electronic transmission been accurately reported.

: Control samples are tested in the dame manner as patients, meet established criteria, corrective action is followed when controls are out of limits.

: Records of all instruments requiring preventive maintenance, including corrective action and proper labeling, assure PM schedule is observed.

Calibration: Records of all instruments requiring calibration to assure that calibration and/or verification is performed at least every 6 months, review for

compliance.

Storage

: Specimens, records, and reagents are stored according to schedule or corresponding expiration date.

Corrective Action

: Evaluate corrective actions for effectiveness and follow up.

: PT samples are treated as patients, if unsat participation, review patients’ specimens, review corrective action and follow-up.

% TAT: Indicate the % of specimens that meet the established TAT for the review period.

Communications

: Review documents that resolve communication problems and complaints, effectiveness of solutions.

Comments: Findings/ Corrective Action:

Quality Assurance Semi-Annual Report

Lab. Section/Unit:

Date:

PT results/Deviances:

QC Reports:

Personnel Assessment reports:

Lab investigation reports:

Preventive maintenance records:

Safety:

Other Quality Assurance Issues:

Technical supervisor:

Appendix 8 - continued

Illinois Department of Public Health – Division of Laboratories

Quality Assessment Semi-Annual Managerial Review

Performed by: _________________________Date: ___________________Test(s): _______________

The technical supervisor or his/her designee must review the level of compliance in his/her area(s) of

responsibility with the Division’s quality assurance policies and procedures semiannually. Indicate Y,

N, or NA in the findings box. Use the comments/corrective action space to documented the proposed

corrective action, where appropriate.

ASSESSMENT REQUIREMENTS

Finding

Comments/ corrective action

FACILITY

Work area arranged to minimize problems in

specimen handling, examination and testing of

specimens, and reporting of test results

Workbench space is sufficient for test performance, is

well lit, and has water, gas, suction, and electrical

outlets as necessary

Instruments, equipment, and computer systems are

placed in locations where their operation is not

affected adversely by physical or chemical factors

such as heat, direct sunlight, vibrations, power

fluctuations, or fumes from acid or alkaline solutions

Equipment tops are not used as workbench space

Stable electrical source is maintained, e.g. outlets, not

extension cords, and meets the power requirements

for each piece of equipment

Follows contamination prevention practices to

minimize contamination of patient specimens,

equipment, instruments, reagents, materials, and

supplies

Performs wipe test of areas where radioactive

material or amplification procedures are used in order

to monitor and prevent contamination

Processing of mycobacteriology cultures is performed

in a manner that prevents contamination of the

environment

Molecular amplification procedures have a

mechanism to detect cross contamination of patient

specimens

Molecular amplification procedures have a uni-

directional workflow – separate areas for reagent

preparation, pre-amplification, and post-amplification

Has equipment and/or instruments capable of

producing results within the stated test performance

specifications

Has test systems, equipment and/or instruments

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ASSESSMENT REQUIREMENTS

Finding

Comments/ corrective action

necessary to perform the laboratory’s volume of

testing within established turnaround times

Data capacity in the laboratory information system is

sufficient for current data entry and reporting

Safety procedures are established, accessible, and

observed

Has clean up spill kits (chemical, biological,

radiological)

Has determine the amount of waste that can be safely

contained and precautions are taken to ensure that

liquid waste does not spill or splash while in travel

status

Maintains records in a secure area

Records are stored according to the established

schedule

Maintains copies of the original test requisition or

electronic equivalents

Retains copies of all reports including original,

preliminary, corrected, and final reports

GENERAL LABORATORY SYSTEMS –

CONFIDENTIALITY

Controls visitor access to the laboratory areas

Has safeguards to ensure confidentiality of patient

information and test reports

GENERAL LABORATORY SYSTEMS –

IDENTIFICATION & INTEGRITY

Ensures positive specimen identification from

specimen receiving to the reporting of results

Maintains optimum integrity of patient’s specimen,

follows instructions for performance of each test

method and analyzes the specimen within the

limitations of the test methodology

GENERAL LABORATORY SYSTEMS –

COMPLAINT INVESTIGATION and

COMMUNICATION

Documents all complaints and problems reported to

the laboratory

Investigates all complaints and implement corrective

action when applicable

GENERAL LABORATORY SYSTEMS –

PERSONNEL ASSESSMENT

Monitors each individual’s competency and identify

remedial training or continuing educational needs

GENERAL LABORATORY SYSTEMS – PT

Reviews and evaluates laboratory’s PT results

Reviews its menu to determine if it tests for any

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ASSESSMENT REQUIREMENTS

Finding

Comments/ corrective action

analyte for which there is no PT

Twice annually verifies the accuracy of the test

without PT

Documents review of PT score and corrective action

taken

PREANALYTIC SYSTEM

Retains all laboratory test requests

Documents attempts to collect written lab orders

following a verbal request

Uniquely identifies patient specimens

Ensures that individuals who entered data including

clerical staff correctly match patient information

Provides written instructions or electronic equivalents

to submitters to ensure that patient preparation

requirements have been followed

Specimens are properly stored

Follows referral laboratory’s instructions, as

appropriate, for transport specimens

Notifies submitter when specimen meets its

unsatisfactory criteria and it is unsuitable for testing

Has a current service manual for each reference

laboratory

Documents the date and time it receives specimens

Maintains copy of CLIA certificate of reference

laboratory

ANALYTIC SYSTEM

Has current and approved SOP’s

SOP includes calibration and calibration verification

procedures

SOP includes quality control procedures and

corrective action

Laboratory information system SOP are available to

operators

Follows manufacturer’s instructions for the use of

equipment, instruments, reagents, materials and

supplies

Assesses water quality (may include pH, silicate

content, particular matter, bacterial and organic

content)

Monitors and documents results for acceptable

temperature range on temperature controlled spaces,

equipment, and instruments

Documents dates for expiration of kits/ reagents and

date opened

Uses reagents, solutions, control materials, within

their expiration date, free of contamination, or other

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ASSESSMENT REQUIREMENTS

Finding

Comments/ corrective action

signs of deterioration

Uses components of reagents kits with the same lot

number unless otherwise approved by the

manufacturer/supplier

Verifies or establishes performance specifications for

any new test/ major change to the procedure (SOP

DAA005)

Verifies or establishes performance specifications for

each instrument when multiple instruments are used

Performs maintenance and function checks as defined

in the preventive maintenance manual

Maintains instrument / equipment maintenance

service records

Follows and documents the necessary function checks

as stated by the laboratory information system for the

computer and devices such as monitors, printers and

modems

For instruments that automatically perform function

checks and flag problems, the laboratory documents

the corrective actions in response to the flagged

problem

Fluorescent light source has not exceeded the

manufacturer’s established optimal timeframe

Autodiluters, microdiluters and/or pipettors are

checked for adequate and consistent delivery

For systems that perform simultaneous fluid delivery

to multi well plates or tubes, the laboratory checks for

uniform deliver of reagents or washing solutions to all

wells or tubes

The laboratory monitors the accuracy and precision of

each phase of the analytical testing process by using

control procedures

Control procedures to the test system includes

checking for reagent contamination or deterioration,

reagent lot variation, reaction temperature fluctuation,

inadequate sampling, improper loss of calibration,

electronic or mechanical failure, power supply

variances

Controls procedures that affect the test environment

include checking for temperature, airflow, light

intensity, humidity

Testing personnel are trained prior to testing on the

test performed (SOP)

Uses control samples, at a minimum, as frequent as

specified by the manufacturer

Each quantitative procedure include 2 controls of

different concentration

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ASSESSMENT REQUIREMENTS

Finding

Comments/ corrective action

Each qualitative procedure includes a negative and

positive control

Each procedure producing graded or titered results

include a negative control and a control with graded

or titered reactivity

Verifies acceptable ranges for control materials

Media are checked for sterility, ability to support

growth

Maintains QC documentation from manufacturer and

documents receipt and condition of each batch, lot, or

shipment

Uses ATCC controls or have established reactivity for

each organism

Investigates QC failures and document all corrective

action taken

POSTANALYTIC SYSTEM

Test reports indicate the location where the test was

performed

Test report dates are not changed

Test report corrected copies leave an audit trail

Test results are released to authorized persons

Laboratory documents the date, time test results, and

person’s name to whom test results were given

verbally to alert of panic values

Laboratory maintains an “exact duplicate “ test report

or electronic equivalent

PERSONNEL

A current CLIA file is maintained for each testing

staff member and supervisor.

Personnel assessments are performed for each testing

staff member for each test performed

Monitors each individual’s competency and identifies

remedial training or continuing educational needs

CHEERS QAPP 3

Appendix 22: UIH Procedures for Archiving

Cultures

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 1 of 11

Procedure: Maintenance of Stock Bacteriology Cultures

Prepared by

Date Adopted

Supersedes Procedure

Kathy Ristow

Review Date

Revision Date

Signature

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 2 of 11

PRINCIPLE:

Long term storage of isolates may be achieved by freezing in a storage medium at -70

Isolates may be obtained from commercial sources (i.e. ATCC) or prepared from in-house

isolates. The storage medium used is Remel Pras Milk (skim milk) which is dispensed into 2 ml

cryovials. The cryobox used for freezing the cryovials contains 81 positions. The cryobox is

given the name of the type of organisms to be stored (i.e. ATCC strains) and a sequential

number. Information about the organisms stored in each of the 81 cryobox positions is written on

the cryobox logsheet. There are two type of logsheets used, one for VRE isolates (Appendix A),

and the other is for all other isolates (Appendix B). The data or pedigree of particular isolate is

maintained in a data binder by including the Sunquest worksheet.

SPECIMEN:

Pure culture from overnight growth on an appropriate medium

EQUIPMENT AND MATERIALS:

Equipment:

-70

C Freezer

35 – 37

C Incubator (ambient or CO

Materials:

Sterile applicator stick

Appropriate culture media

PROCEDURE - STEPWISE:

Freezing of Stock Strains

Obtain the binder of the organism type to freeze (i.e. ATCC strains, VRE strains, etc). On

the cryobox logsheet locate a vacant location. Write the name of the organism on the

logsheet. Include the ATCC number and/or Sunquest accession number where appropriate.

Note the location to be used.

Label cryovial with organism name and location in cryobox, i.e.

S. aureus

Box 1 #23.

University o

Pathology L

Clinical Microbiology Laboratory

f Illinois Medical Center at Chicago

aboratories

Page 3 of 11

Using a sterile disposable pipet, dispense approximately 2 ml of Remel Pras milk into

cryovial.

Using a sterile swab or loop, suspend a heavy inoculum into the vial and cap tightly.

Label the Sunquest workup printout with the cryovial box used and location. Insert sheet

into binder in numerical order.

Place vial in proper cryobox location in the -70

C freezer located in Room 241.

Retreival of Frozen Stock Strains

Locate required isolate in stock culture binders

Retrieve cryobox from -70

C freezer located in Room 241.

Remove cryovial from cryobox. Slightly warm vial so the top portion of skin milk may be

removed using a sterile applicator stick or loop. DO NOT COMPLETELY THAW VIAL.

Subculture to appropriate culture media.

REFERENCES:

Isenberg, Henry D, et al. 2006.

Clinical Microbiology Procedures

Handbook

, 2

ed. American Society for Microbiology, Washington, D.C.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 4 of 11

Appendix A

Linezolid Results

MIC Results: S, I, or R.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 5 of 11

Linezolid Results

MIC Results: S, I, or R.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 6 of 11

Linezolid Results

MIC Results: S, I, or R.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 7 of 11

Linezolid Results

MIC Results: S, I, or R.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 8 of 11

Linezolid Results

MIC Results: S, I, or R.

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

Page 9 of 11

Linezolid Results

MIC Results: S, I, or R.

f Illinois Medical Center at Chicago

aboratories

Page 10 of 11

Linezolid Results

MIC Results: S, I, or R.

University o

Pathology L

Clinical Microbiology Laboratory

University of Illinois Medical Center at Chicago

Pathology Laboratories

Clinical Microbiology Laboratory

CRYO BOX NUMBER ______

Appendix B

Page 11 of 11

CHEERS QAPP 3

Appendix 23: IDPH Procedures for

Archiving Cultures for PCR

IDPH Protocol for archiving stool specimens for later extraction of nucleic acids and

viral identification by PCR

As part of the Norovirus identification procedure, stool specimens are prepared for RNA

extraction by adding 0.5 mL of buffer to a small amount of stool and 10 glass beads in a

1.5 mL microfuge tube. After vortexing to disrupt the stool matrix, the suspension is

clarified by centrifugation. One-third of the supernatant is used to prepare RNA, and the

remaining supernatant (over the disrupted stool and glass beads) is frozen at -70

C for

long-term storage (archiving).

Note: Bacterial cultures are set up from the raw stool when it is received in the lab, but

raw stool is not frozen/archived. Consequently, in the future, only viral identification

(including other molecular manipulations – e.g., sequencing or cloning) would be

possible from the archived material. We have been able to successfully amplify

Norovirus RNA from supernatants that have been frozen for several years.

CHEERS QAPP 3

Appendix 24: Unusual Occurrence Log

CHEERS

LOG OF SPECIMENS UNSATISFACTORY FOR TESTING

CHEERS: THE CHICAGO HEALTH,

ENVIRONMENTAL EXPOSURE, AND

RECREATION STUDY

STATISTICAL ANALYSES

Project Statistician: Li Liu, PhD

Division of Epidemiology and Biostatistics

University of Illinois at Chicago

School of Public Health

1. Power/sample size calculation

1.1. The sample size calculations and data analyses are based upon the two primary

aims of this research study, namely, 1) to determine rates of acute gastrointestinal

and non-gastrointestinal illness attributable to recreation on the CAWs, and 2) to

define the relationship between concentrations of microbes and rates of illness

among individuals with limited recreational water contact. As noted in the

District’s Expert Review Report (2006-038), should an epidemiologic study be

conducted, it would require “sufficient statistical power to detect risks at levels

deemed to be acceptable for regulatory purposes.”

1.1.1. For Aim 1, we need to make sure that the number of participants is big

enough in the study in order to detect with confidence, differences that

may exist between the groups. The subtler the difference between groups

(e.g., in rates of AGI), the larger the requisite sample size (e.g., the

number of participants). Given that the background rate of AGI may be

approximately 75 cases/1,000 people, detecting an excess risk in one

group of 10/1,000 would mean differentiating rates of 75/1,000 in the

“background rate” group, from a rate of 85/1,000 in an exposed group.

Mathematical formulas allow the calculation of the required sample size

for the comparison of rates between groups, and a given level of

confidence desired in the conclusion that differences in rates are not due to

chance alone.(Fleiss 1981) Using this formula, given an anticipated

background rate of 75 cases of AGI/1,000 participants in the unexposed

recreator group, in order to identify with confidence a rate of

97cases/1,000 in the CAWs group (a 22 cases/1,000 increase in rates), a

sample size of 2,644 participants per group is required. Larger samples

sizes would allow the detection of more subtle differences. Detecting an

increase of 10 cases/1,000 exposures would require recruiting more than

40,000 participants, which would not be feasible.

1.1.2. For Aim 2, the calculation of the required number of study participants

would be based on the development of a mathematical relationship

between concentrations of microbes in the water and rates of illness. With

data obtained in such a study, it would be possible to model rates of illness

as a function of water quality, allowing the prediction of rates of illness for

a given concentration of microbes in the water. The sample size required

for such a study can be calculated if one specifies 1) an estimated slope of

the concentration-disease rate line, 2) an estimated background rate, and 3)

the desired level of statistical confidence desired (Tosteson et al. 2003).

Therefore, given that a 10-fold increase in microbe concentrations in

freshwater increases the risk of AGI by approximately 60% among

swimmers,(Wade et al. 2003) we will assume, for the purpose of sample

size calculation, that the risk of illness among non-swimming recreators is

one-fourth that of swimmers. In order to detect a 15% increase in risk of

illness for a 10-fold increase in microbe concentrations, assuming a

background rate of 75 cases of AGI/1,000, a sample size of 5,028

participants in the water-recreation groups (CAWs and general use waters)

is required.

1.2. Given the above calculations for Aims 1 and 2, we will seek complete data on

2,644 subjects in each of the three groups or a final sample size of 7,932.

Assuming a projected attrition rate of 15% (those who do not complete follow-

up), a total of 9,330 participants will be recruited in order to obtain a final dataset

for analysis with records of 7,932 individuals.

2. Health outcomes, Non-water related and Water Quality Measures

Potential outcome variables, effect modifiers and non-water related confounders, as well

as water exposure and water-quality related predictors are presented in the tables at the

end of this section.

Health outcomes of interest include Acute GI illness and Non-GI illness such as ear,

eyes, skin, and upper respiratory illness. GI symptoms include abdominal cramps or

stomach ache, diarrhea, nausea, and vomiting. Three syndromic definitions (any two or

more of the symptoms; Highly Credible Gastroinsteinal Illness; or the definition used in

the NEEAR study, as outlined in the QAPP 2: Survey Methods) will be explored. Two GI

illness outcome variables will be considered in modeling stage: 0/1 indicator of illness

and an ordinal variable of number of symptom items presented. For non-GI illness, a 0/1

indicator for any non-GI illness, indicators for ear, eyes, skin, and respiratory illness, and

an ordinal variable of number of illness presented will be used in logistic regression

models.

In evaluation of the overall risk, potential non-water related confounders include

participant demographics, recent exposures (animal, food, someone ill) prior to

recreation, pre-existing health conditions (such as chronic gastrointestinal illness, asthma,

diabetes), and post-recreation exposures. In assessing the relationship between water

quality and health outcomes, potential behavioral predictors include type and duration of

activity, get wet at all, food/water during or after activity, sanitary measures, and other

activity-specific exposure measures. Water-quality related predictors include

E. coli

enterococcus, and coliphage concentrations, concentrations of coliphage serotypes linked

to human sources; recent combined sewer overflow events and rainfall conditions.

3. Data Analysis

3.1. After data is collected, descriptive statistics will be conducted. This will include:

3.1.1. Descriptive statistics of study participant demographics (age,

gender, race, distance traveled, and socioeconomic characteristics).

Demographic distributions for all participants, as well as

distributions by study group, location site, and year of enrollment

will be examined.

3.1.2. Descriptive statistics of participant pre-existing health conditions

and pre- and post-exposures. Overall distributions as well as

distributions by study group, location site, and year of enrollment

will be examined.

3.1.3. Summary statistics of all potential behavioral predictors, including

type and duration of activity, water exposure measures, sanitary

conditions, and food/water intake during or after activity, etc.

3.1.4. Summary statistics of indicator organism concentration (

E. coli,

enterococci, coliphages and coliphage serotpyes) in water, by

location and year.

3.1.5. A correlation matrix of concentrations of indicators and pathogens,

measured in samples collected at the same location, at the same

point in time.

3.1.6. Rates of all illness, including acute GI illness and Non-GI illness

such as ear, eyes, skin, and upper respiratory illness. For GI illness,

distributions of the number of GI symptoms presented (abdominal

cramps or stomach ache, diarrhea, nausea, and vomiting) will be

examined. For Non-GI illness, number of illness presented will

also be examined. All rates and distributions of the ordinal

outcomes will be presented by study group, location, and year.

3.1.7. Descriptive statistics of organisms identified in clinical specimens,

by study group.

3.2. Formal statistical analysis for this data includes:

3.2.1. Crude tests of equality of rates among the three study groups for all

acute GI and non-GI illnesses. For these overall tests, chi-square

test of homogeneity of proportions will be performed for all illness

and symptoms of interest. Chi-square test for comparisons of

proportions has the advantage of allowing for more than two

groups. These tests are the first step in revealing whether the rates

of illness are significantly different for the three study groups

without considerations of other effect modifiers or confounders.

3.2.2. Evaluation of the overall risk associated with the study groups. At

this stage, the water-quality related measures are not included. For

each illness of interest, logistic regression models will be used to

estimate the study group effect on illness rate while adjusting for

non-water related covariates such as participant demographics, pre-

existing health conditions, pre- and post-activity exposures.

Interactions between covariates and study groups will also be

examined. Model selections will be performed for all logistic

models. Once a final model is selected for an outcome of interest,

adjusted odds ratios for each group from the logistic regression

model can be obtain by holding covariates constant at reasonable

values. For ordinal outcomes of number of GI symptoms presented

and number of Non-GI illness presented, proportional odds models

in logistic regression will be applied, and common odds ratios will

be reported. In fitting the logistic models for ordinal outcomes, the

proportional odds assumption can be examined by the Score test in

SAS.

3.2.3. Modeling the relationship between water quality and health

outcomes. Since water-quality measures are often approximately

log-normally distributed (El-Shaarawi 1989; El-Shaarawi and

Viveros 1997; Noble et al. 2003), base 10 log (log

)

transformation of the count is likely to be done for all organism

densities. Different types of water quality measures will be

explored as predictor of the health outcomes. At participant level,

since the time of entering and exit of water will be recorded, water

qualities measured after (or close to) entering time and before (or

close to) the exit time can be averaged to obtain measures that are

subject specific. At access site level, average of measures specific

to the activity location can be obtained. And overall daily water

quality, such as the average of all measures of the day, and one-

time down-stream measure, can be used as well. In the modeling

stage, water-related covariates including behavioral factors,

activity-specific exposure measures, and water quality indicators

will be added into the logistic regression models. A model with

nested interaction terms between water exposures and water

quality measures will be included. These nested interaction models

effectively assign zero exposure values by the use of indicators for

water-related activities and water exposures. For instance, in

modeling the probability of illness

, the covariates of interest are:

= 1 if participant engaged in water-related activities, 0

otherwise; X

= 1 if participant got wet during the activity; and X

is the water organism density measure. The nested interaction

model is parameterized as follows:

Model selections will be done, and adjusted odds ratios for unit

increase in indicator organisms will be reported to reflect the effect

of water quality on illness.

4.0 Overview of analyses to be performed using final datasets

Prior to reaching conclusions from CHEERS regarding rates of illness, risk factors

for illness, and causes of illness, numerous data analyses will be performed. These

include:

4.1 Water data: quality monitoring

4.1.1 Quality monitoring: indicator microbes

4.1.1.1

E. coli

: splits, blanks, recoveries (multi-level and single-

level spiking)

4.1.1.2 Enterococci: splits, blanks, recoveries (multi-level and

single-level spiking)

4.1.1.3 EPA dilution/plate concentration requirements for E. coli

and Enterococci

4.1.1.4 F+ coliphages: splits, blanks, recoveries (multi-level and

single-level spiking)/method 1602 validation for surface

waters

4.1.1.5 Somatic coliphages: splits, blanks, recoveries (multi-level

and single-level spiking) /method 1602 validation for

surface waters

4.1.2 Quality monitoring: pathogens

4.1.2.1

Giardia

: splits, blanks, recoveries (multi-level and single-

level spiking)

4.1.2.2

Crytposporidium

: splits, blanks, recoveries (multi-level and

single-level spiking)

4.2 Quality monitoring: sampling strategy

4.2.1 Analyses of spatial and temporal predictors of microbe

concentration

4.2.1.1 Location (access point)

4.2.1.2 Cross-section

4.2.1.3 Upstream/downstream

4.2.1.4 Date

4.2.1.5 Time within day

4.2.2 Holding time

4.2.3 Sample temperature

4.3 Descriptive measures of water quality

4.3.1 Microbiology

4.3.1.1 Concentrations of indicator microbes by location, overall

and by year

4.3.1.1.1 E. coli

4.3.1.1.2 Enterococci

4.3.1.1.3 F+ coliphages

4.3.1.1.4 Somatic coliphages

4.3.1.2 Concentrations of pathogens by location, overall and by

year:

4.3.1.2.1 Giardia

4.3.1.2.2 Cryptosporidium

4.3.2 Water chemistry, by location, by year

4.3.2.1 pH

4.3.2.2 temperature

4.3.2.3 dissolved oxygen

4.3.2.4 conductivity

4.3.2.5 turbidity

4.4 Environmental observations, by location, by year

4.5.1 By month, by year:

4.5.1.1 air temperature

4.5.1.2 precipitation

4.5.2 By time of day, by month: cloud cover

4.6 Analyses of water quality

4.6.1 correlations among indicators, with factor analysis

4.6.1.1 Overall

4.6.1.2 By location

4.6.1.3 By group of locations

4.6.1.4 GUW

4.6.1.4.1 Overall

4.6.1.4.2 Small lakes + lagoons

4.6.1.4.3 Rivers

4.6.1.4.4 Lake Michigan

4.6.1.5 CAWS

4.6.1.5.1 Overall

4.6.1.5.2 Locations above WRPs vs. below

4.6.1.5.3 Locations below WRPs overall

4.6.1.5.4 Locations below WRPs, North vs. South

4.6.2 Correlations among indicators (with factors) and pathogens

4.6.2.3 By group of locations

4.6.3 GUW

4.6.3.1.1 Overall

4.6.3.1.2 Small lakes + lagoons

4.6.3.1.3 Rivers

4.6.3.1.4 Lake Michigan

4.6.3.2 CAWS

4.6.3.2.1 Overall

4.6.3.2.2 Locations above WRPs vs. below

4.6.3.2.3 Locations below WPRs overall

4.6.3.2.4 Locations below WRPs, North vs. South

4.6.4 Correlations among indicators and water chemistry

4.6.4.1 Overall

4.6.4.2 By location

4.6.4.2.1 By group of locations

4.6.5 GUW

4.6.5.1.1 Overall

4.6.5.1.2 Small lakes + lagoons

4.6.5.1.3 Rivers

4.6.5.1.4 Lake Michigan

4.6.5.2 CAWS

4.6.5.2.1 Overall

4.6.5.2.2 Locations above WRPs vs. below

4.6.5.2.3 Locations below WPRs overall

4.6.5.2.4 Locations below WRPs, North vs. South

4.6.6 Correlations among indicators and environmental observations

4.6.6.1 Overall

4.6.6.2 By location

4.6.6.3 By group of locations

4.6.6.4 GUW

4.6.6.4.1 Overall

4.6.6.4.2 Small lakes + lagoons

4.6.6.4.3 Rivers

4.6.6.4.4 Lake Michigan

4.6.6.5 CAWS

4.6.6.5.1 Overall

4.6.6.5.2 Locations above WRPs vs. below

4.6.6.5.3 Locations below WPRs overall

4.6.6.5.4 Locations below WRPs, North vs. South

4.6.7 Effect of rainfall, overall and by location

4.6.7.1 Rainfall (≥0.1 inch, present vs absent) for indicators

4.6.7.1.1 on day of sampling

4.6.7.1.2 24 hours prior

4.6.7.1.3 48 hours prior

4.6.7.1.4 72 hours prior

4.6.7.2 Rainfall (≥0.1 inch, present vs absent) for pathogens

4.6.7.2.1 on day of sampling

4.6.7.2.2 24 hours prior

4.6.7.2.3 48 hours prior

4.6.7.2.4 72 hours prior

4.6.8 Effect of rainfall, overall and by location

4.6.8.1 Rainfall (≥0.5 inch, present vs absent) for indicators

4.6.8.1.1 on day of sampling

4.6.8.1.2 24 hours prior

4.6.8.1.3 48 hours prior

4.6.8.1.4 72 hours prior

4.6.8.2 Rainfall (≥0.5 inch, present vs absent) for pathogens

4.6.8.2.1 on day of sampling

4.6.8.2.2 24 hours prior

4.6.8.2.3 48 hours prior

4.6.8.2.4 72 hours prior

4.6.8.3 CAWS locations only: effect of CSOs on day of sampling,

24 hours prior, 48 hours prior, 72 hours prior on:

4.6.8.3.1 Indicators

4.6.8.3.2 Pathogens

4.7 Effect of WRP

4.7.1 Concentrations above vs below WRP on same day: both plants,

North Side, Calumet:

4.7.1.1 Indicators:

E. coli,

enterococci, F+ coliphage, somatic

coliphage total and for each serotype; factors

4.7.1.2

Pathogens:

Giardia, Cryptosporidium

4.7.1.3 Water chemistry parameters: pH, temperature, DO,

conductivity, turbidity

4.8 Participants

4.8.1 Total participant recruitment, by date by location by group

4.8.2 Summary of recruitment by location by group by study year

4.8.3 Participants recruitment: without telephone follow-up, by reason

(no interview A, no interview B, disqualified by swimming)

4.8.4 Loss to telephone follow-up: overall, by group

4.8.5 Demographic, location, activity differences for those with vs. those

without telephone follow-up

4.8.6 Demographics of study participants: participants in phone follow-

up total, and by group: age (mean, median, SD; <5, 5-<10,10-<20;

20-<40; 40-<65;>=65), gender, race, ethnicity

4.8.7 Recreational activity, by group, by year

4.9 Non-water-related risk factors for illness (potential confounders)

4.9.1 Underlying GI illness: total and by group

4.9.2 Underlying respiratory illness: total and by group

4.9.3 Contact with someone who is sick

4.9.4 Contact with animals

4.9.5 Recent ingestion of raw fish, undercooked meat, hamburger, salad

4.10 Water exposure

4.10.1 Recreational activity by location, by group

4.10.2 Duration of recreational activity by activity by location

4.10.3 Recreational activity by age, gender, by group

4.10.4 Did you get wet at all? overall, by group

4.10.5 Did you get wet all? by activity by group

4.10.6 How wet did your feet/legs get: overall, by group

4.10.7 How wet did your feet/legs get by activity by group

4.10.8 How wet did your hands/arms get: overall, by group

4.10.9 How wet did your hands/arms get: by activity by group

4.10.10 How wet did your torso get: overall, by group

4.10.11 How wet did your torso get: by activity by group

4.10.12 How wet did your face/head get: overall, by group

4.10.13 How wet did your face/head get: by activity by group

4.10.14 How much water did you swallow: overall, by group

4.10.15 How much water did you swallow: by activity by group

4.10.16 Eating, drinking and hand washing during/after recreation

4.10.17 Last water contact prior to enrollment

4.10.18 Water contact since enrollment

Launch from pier/dock/shore?

From shore: use of hip boots/waders?

4.11 Recreation, risk perception

4.11.1 Frequency of water recreation at CAWS, other sites

4.11.2 Distance traveled

4.11.3 Leichert scale risk perception

4.12 Health measures

4.12.1 Frequency of symptoms at baseline: GI, respiratory, skin, eye, and

AGI symptom complex definitions

4.12.2 Rates of onset of symptoms following recreation: Kaplan-Meier

curves and survival rates: overall and by group:

4.12.2.1

for each symptom (GI, respiratory, skin, eye)

4.12.2.2

for symptom complexes (specific definitions of

AGI)

4.13 Clinical Microbiology

4.13.1 Frequency of specimen collection vs. frequency of symptoms

4.13.2 Results of stool cultures

4.14 Predictors of health events (individual symptoms and symptom complexes)

4.14.1 Demographic variables

4.14.2 Temporal factors

4.14.3 Non-water related risk factors

4.14.4 General water exposure factors

4.14.4.1

Study group

4.14.4.2

Recreational activity

4.14.4.3

Duration of recreational activity

4.14.4.4

Self-reported water exposure variables during

recreation

4.14.4.5

Water recreation prior to enrollment

4.14.4.6

Water recreation subsequent to enrollment

4.14.4.7

Eat/drink during recreation

4.14.5 Specific exposure factors (CAWS and GUW groups only)

4.14.5.1

Did you get wet at all?

4.14.5.2

How wet did your feet/legs get?

4.14.5.3

How wet did your hands/arms get?

4.14.5.4

How wet did your torso get?

4.14.5.5

How wet did your face/head get?

4.14.5.6

How much water did you swallow?

4.14.5.7

Boaters: Capsize? Wet at launch? Launch from

pier/dock/shore?

4.14.5.8

Fishers: Catch fish? Type of bait? Fish from shore or

boat? Use hip boot/waders?

4.14.6 Microbial measures of water quality

4.14.6.1

Indicator concentrations, principal component factors

at launch:

4.14.6.1.1 At time point closest to launch/start

4.14.6.1.2 At time point closest to return/end

4.14.6.1.3 Average concentration during period of water

recreation

4.14.6.2

Pathogen concentrations at launch:

4.14.6.2.1 At time point closest to launch/start

4.14.6.2.2 At time point closest to return/end

4.14.6.2.3 Average concentration during period of water

recreation

4.14.6.3 CAWS locations: Indicator concentrations, principal

component factors at sites above vs. below WRP

4.14.6.3.1 At time point closest to launch/start

4.14.6.3.2 At time point closest to return/end

4.14.6.3.3 Average concentration during period of water

recreation

4.14.6.4 CAWS locations: pathogen concentrations, principal

component factors at sites above vs.below WRP

4.14.6.4.1 At time point closest to launch/start

4.14.6.4.2 At time point closest to return/end

4.14.6.4.3 Average concentration during period of water

recreation

4.14.6.5 CAWS locations: indicator and pathogen

concentrations at non-WRP locations upstream of

recreation

4.14.7 Non-microbial measures of water quality

4.14.7.1

Water chemistry

4.14.7.2

Environmental observations

4.14.7.3

Rain and CSO

4.14.8 Exploration of propensity scores

4.14.9 Modeled integrated microbial exposure

4.14.10 Spatial-temporal model of integrated exposure

4.14.11 Final model selection using predictors identified in steps 4.14.1-

4.14.10.

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Tosteson TD, Buzas JS, Demidenko E, Karagas M. 2003. Power and sample size

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Wade TJ, Pai N, Eisenberg JN, Colford JM, Jr. 2003. Do U.S. Environmental Protection

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A systematic review and meta-analysis. Environ Health Perspect 111(8): 1102-

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