National Human Adipose
Tissue Survey
OPERATIONS MANUAL
NHATS
Nitlonil Human Adipose Tissue Survey
Exposure Evaluation Division
Office of Toxic Substances
U.S. Environmental Protection Agency
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National Human Adipose Tissue Survey
Operations Manual
For National Human Monitoring Program
Office of Toxic Substances
U.S. Environmental Protection Agency
EPA Prime Contract No.68-02-4252
MRI Project No. 8863-20
Revised
June 29,1990
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PREFACE
This is a revision of the National Human Adipose Tissue Survey
(NHATS) Operations Manual and replaces all previous versions. This operations
manual was prepared as a guide for personnel involved in the conduct of the
NHATS and to assist in maintaining consistency and thoroughness in the ongoing
activities. The manual describes in detail the activities involved in the
recruitment of cooperators, maintenance of the cooperator network, processing
of specimens, and reporting.
Examples of forms, labels, correspondence, and other items used by
NHATS personnel are included in the appendices. This manual was prepared by
Lori Bailey and Kay Turman for Work Assignment No. 20 of EPA Contract
No. 68-02-4252. The NHATS operates under the direction of Ms. Janet Remmers,
Work Assignment Manager, and Dr. Joseph Breen, Project Officer, Field Studies
Branch (TS-798), U.S. Environmental Protection Agency, 401 M Street, S.W.,
Washington, DC 20460.
Sincerely,
MIDWEST RESEARCH INSTITUTE
0
Kay Turman
Work Assignment Leader
Approved:
Paul Constant
Program Manager
n
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TABLE OF CONTENTS
Page
I. Introduct 1 on 1
II. Reference Information 2
A. Glossary 2
B. Files 2
C. Status Boards 4
III. Recruitment of Cooperators 5
A. Identification of Potential Cooperators 5
1. New MSA 5
2. Current or Previous MSA 7
B. Recruitment 8
1. Recruitment Packet 8
2. Recruitment Documentation 8
3. Phone Calls 8
C. Post-recruitment 9
1. Post-recruitment Letter and Supplies 10
2. File Setup 10
3. Paperwork 11
IV. Maintenance of Cooperator Network 12
A. New Fiscal year Activities 12
1. Design Plan Review 12
2. Purchase of Supplies 12
3. Shipment of Supplies 14
B. Ongoing Activities 14
1. Status Calls 15
2. Shipment Request 15
3. Cooperator Withdrawal 15
4. Travel 15
5. Additional Communication 16
V. Processing of Specimens 17
A. Receipt of Specimens 17
B. Check-in of Specimens 19
C. Storage of Specimens 21
D. Payment to Cooperator 22
E. Transfer of Information 22
F. Follow-up Activities 25
G. Analysis of Specimens 25
iii
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TABLE OF CONTENTS (continued)
Page
VI. Report i ng 26
A. Monthly Progress Report 26
B. Collection Quota Status Report 26
C. Recruitment Reports 26
D. Trip Reports 26
E. Additional Reports 26
F. Presentations 27
Appendix A Recruitment of Cooperators A-l
Appendix B Maintenance of Cooperator Network B-l
Appendix C Processing of Specimens C-l
Appendix D Reporting 0-1
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I. INTRODUCTION
The National Human Adipose Tissue Survey (NHATS) is responsible for
the collection of human adipose tissue based on demographic characteristics
(age, sex, and race) reflective of the population distribution in specific
areas of the United States. Researchers use the adipose tissue to monitor the
prevalence of selected toxic substances and to estimate the level of exposure
experienced by the general population. The results are used in evaluating
various factors and conditions pertaining to human health and effective envi-
ronmental regulations.
The EPA, through EPA Contract No. 68-02-4252, Work Assignment 20,
directs MRI to operate the collection network in support of the program
goals. Operation of the network includes recruitment of the cooperators,
maintenance of the cooperator network, processing of specimens, and reporting
to EPA. These activities are described in detail in this manual in order to
provide a guide for personnel involved in the operation of the NHATS.
Information needed for operation of the NHATS is contained in the
following sections:
II. Reference Information
III. Recruitment of Cooperators
IV. Maintenance of Cooperator Network
V. Processing of Specimens
VI. Reporting
Examples of letters, forms, tables, and other items used in the
operation of the NHATS are included in the following appendices:
Appendix A Recruitment of Cooperators
Appendix B Maintenance of Cooperator Network
Appendix C Processing of Specimens
Appendix D Reporting
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II. REFERENCE INFORMATION
To understand the sections on operation of the NHATS, reference
information is necessary. This section provides a glossary of terms used
throughout the manual, a list of the NHATS files, and a description of the
NHATS status boards.
A. Glossary
Table 1 is a glossary of terms used throughout this manual and in
the day-to-day operation of the NHATS.
B. Files
Several files are maintained and used routinely in the operation of
the NHATS.
1. Cooperator File--a separate file for each cooperator which
contains records of all contacts with the cooperator.
2. Quota Sheet File—an accordion file containing quota sheets for
the current fiscal year, alphabetically filed by cooperator
name.
3. Cooperator List Files—files containing the following lists:
a. All Cooperator List—database list of all cooperators who
have ever participated in NHATS (p. A-2).*
b. Current Cooperator List—database list of all cooperators
currently participating in NHATS (p. A-16).
c. Cooperator Recruitment List—database list of all
cooperators recruited for NHATS since 1983 (p. A-3).
4. Recruitment Files
a. Current Recruitment File—file containing information on
recruitment in progress.
b. "Finished" File—file containing information on previously
completed recruitments.
c. Possible Cooperator File—file containing information on
facilities which might be interested in future participa-
tion in NHATS.
5. Shipping File—an accordion file containing documentation of
shipments of supplies to cooperators.
Reference to page in an appendix.
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Table 1. Glossary of Terms
Term
Definition
Cooperator
Cooperator Network
Contact Person
Specimen
Fiscal Year (FY)
Facility at which collection of specimens takes
place
The more than 90 cooperators currently collecting
specimens
Person (pathologist, pathology assistant, diener,
secretary, etc.) who is contacted by telephone to
obtain information on collection
Adipose tissue collected by the cooperator
Period of collection which runs from October 1
through September 30
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6. Patient Summary Report (PSR) Files
a. "To Be Checked In" File—file of PSRs which corresponded
to specimens not yet checked in.
b. "Missing Information" File—file of incomplete or
questionable PSRs which correspond to specimens which have
been checked in.
c. "To Be Batched" File—file of completed PSRs which
correspond to specimens which have been checked in.
d. PSR File—file of PSR copies retained at MRI after
originals are mailed.
C. Status Boards
White, erasable boards (3 ft by 4 ft) are maintained with the
current status of collection for each cooperator, each region, and nationwide.
Each of three boards contains the following information for a portion of the
cooperator network:
1. Cooperator name
2. Geographic location
3. Cooperator quota
4. Number of design specimens received at MRI
5. Number of specimens collected but not shipped
6. Date of last contact by NHATS staff
7. Response rate for the previous FY
8. Percentages of quota achieved for each region
9. Comments on each cooperator
The boards provide an up-to-date summary of the status of the
collection in an easily readable, graphic manner. A diagram of the
information included on the status boards is shown on p. A-17.
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III. RECRUITMENT OF COOPERATORS
Recruitment activities are summarized in Figure 1. Described in
this section are identification of potential cooperators, recruitment
activities, and post-recruitment activities. Appendix A contains examples of
letters, forms, and other materials used in recruiting activities.
A. Identification of Prospective Cooperators
Prospective cooperators fall into two categories. Steps are listed
describing activities followed to recruit each of the two categories of
cooperators: New MSA and Current or Previous MSA. For all steps, documen-
tation of the activity and its outcome is essential for future reference.
1. New MSA
a. Consult the MSA list to identify cities and counties
included in the MSA.
b. Identify the city or county with the largest population.
c. Call directory assistance to get the phone number, if any,
for the county coroner or medical examiner. Get the
numbers for all counties included 1n the MSA. Try the
largest city in the county or the county seat.
d. Call the medical examiner's or coroner's office to get the
name of the medical examiner or coroner and the mailing
address.
e. If there is only one medical examiner's or coroner's
office to contact, continue with step g. If there are at
least two medical examiner's or coroner's offices to con-
tact, do not contact any hospitals unless the medical
examiner's or coroner's offices decline to participate.
f. If there is no listing for a medical examiner or coroner,
call the county offices or sheriff to determine who per-
forms the county autopsies. If autopsies are performed at
a hospital, see step g.
g. Consult the American Hospital Association (AHA) Guide for
cities/counties included in the MSA. Within the county,
look at general hospitals and children's hospitals. The
hospital should have a histopathology laboratory, and the
number of beds is preferred to be > 200. (Generally, the
larger the number of beds, the better.) If there is no
children's hospital, the hospital should have a pediatrics
unit and a newborn nursery. Select the three best choices
(if possible). If a hospital performs the coroner's
autopsies, include it in the "three best" category.
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NO
Identify Prospective
Facilities
Check Previous
Recruitment and
Cooperator Information
Figure 1. Recruitment of Cooperators.
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h. Call the selected hospitals (the phone number is in the
AHA Guide). Ask for anatomic pathology or the laboratory.
Introduce yourself and ask for the name of the chief
pathologist or the lab director. Ask for the direct phone
number and verify the hospital address. Thank them. If
necessary, explain that you want to send information
regarding a research program to the pathologist.
2. Current or Previous MSA
a. Replicate or Replacement Cooperators
When it has been decided that a replicate cooperator is needed
for a MSA (the current cooperator is performing poorly or is not able to
collect certain age groups, or the current cooperator drops out and must be
replaced):
(1) Consult the MSA list to identify the counties and
cities included in the MSA.
(2) Consult the "All Cooperators List" (p. A-2) to
determine previous Cooperators in the MSA.
(3) Check the recruitment list data bases (p. A-3) to
determine if any other recruitment activities have
occurred in the MSA during the last 3 to 4 years.
(4) If there are no previous Cooperators with previous
recruitment activities, treat as a new MSA.
(5) For previous Cooperators or Cooperators with previous
recruitment activities, recontact if:
It has been more than 3 years since they
participated.
It has been more than 2 years since any
recruitment activities occurred.
Many times a cooperator which previously declined to
participate, when recontacted, may have new staff
willing to participate, or other changes in circum-
stance which now allow them to participate.
b. Reinstated MSA
When a MSA which previously was dropped from the design is
reinstated, treat it like replicate or replacement Cooperators, but ignore the
criteria in Step 5. Previous performance should be considered, especially if
the former contact person is still working for a prospective cooperator.
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B. Recruitment
Activities are described which occur subsequent to identification of
prospective cooperators.
1. Recruitment Packet
a. Add the prospective cooperator's name to the recruitment
list (p. A-3) and request a recruitment letter (p. A-4).
b. Assemble remainder of packet:
Copy of quota sheet for that MSA (p. A-5)
NHATS info flyer (p. A-6)
• Guidelines for collection (p. A-8)
Patient summary report (PSR) (p. A-12)
Reprint of journal article of analysis results
c. Proofread the letter and recruitment list. Refile the
list, sign and photocopy the letter, add to the packet,
and ship.
d. Send the packet Federal Express Standard Overnight
(delivery by next business afternoon).
2. Recruitment Documentation
a. Make a call sheet (p. A-13) for each MSA and complete said
form. Use this sheet to document all phone calls to and
from the prospective cooperator. Document with date,
time, person contacted, and notes on conversation.
b. Put photocopy of letter, original quota sheet, delivery
notice, and call sheet in current recruitment file.
3. Phone Calls
After the prospective cooperator has had 2 to 3 days to read the
contents of the recruitment packet:
a. Call the prospective cooperator.
b. If he/she is not available, leave a message for them to
return the call collect. Try to find out when they will
be available.
c. If they are available and will speak to you, introduce
yourself and explain that you are calling in reference to
the information that was sent about the National Human
Adioose Tissue Survey.
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d. Ask if they received the information.
(1) If they have not received it, offer to send them a
duplicate recruitment packet and explain the program
briefly.
(2) If they have received it, ask if they have any
questions. If they have questions, answer them—most
of the time they missed something in the guidelines
or they have concerns about confidentiality.
e. Obtain participation.
(1) If the prospective cooperator declines to
participate, document the reason for refusal and go
to step g.
(2) If the prospective cooperator agrees to participate,
determine the contact person and go to post-
recruitment activities (Section C).
(3) If the prospective cooperator has to get department
or hospital approval, has to see if anyone on staff
is interested, needs more information, etc., find out
how long it should take to obtain a decision. State
that you will call back on a specified date. They
may say they will call; then give them a "deadline."
If they don't call back by that date, call them.
f. Be persistent and make follow-up calls. Leave messages if
necessary. Continue until you get a final decision.
g. If the prospective cooperator declines to participate,
staple all recruitment materials (photocopy of letter,
call sheet, shipping order, quota sheet, and any
correspondence) together and put in the "finished" file
for current fiscal year. If they might be interested in
the future, put photocopy of call sheet in Possible
Cooperator file.
h. If all prospective cooperators in a MSA have been
contacted and all declined to participate, document the
reasons and request a replacement MSA from the OTS Work
Assignment Manager.
C. Post-recruitment
Activities are described which occur subsequent to obtaining an
agreement to participate by a facility.
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1. Post-recruitment Letter and Supplies
a. Pull the post-recruitment letter (p. A-15) and the Current
Cooperators List (p. A-16). Request a letter, label, and
envelope for each new cooperator. The new cooperator will
be added to the Current Cooperator List when the letter is
printed.
b. Assemble supplies (Appendix B) for the new cooperator:
Shipping container, (Styrofoam in aluminum or
Styrofoam in cardboard)
Collection bottles (quota and 3 to 6 extra)
Bottle labels (quota and 3 to 6 extra)
Dry ice labels (2 large, 2 small)
Return label
Federal Express airbill—put facility name in block
with MRI charge number, record airbill number and
retain for future reference
Patient Summary Reports (PSRs)—make master by typing
facility name, city, and state on PSR, photocopy it
(make extras), and file master with other PSR masters
Instructions for completing PSR flyer
Helpful hints flyer
Guidelines for collection
Copy of latest newsletter
Quota sheet copy (fill in facility name, photocopy,
send one copy in box, one with letter)
Put all paperwork in a zip-lock plastic bag and place
bottles and paperwork in the shipping box.
Unless situation is urgent, send supplies UPS. If time is
critical, send supplies Federal Express Economy Service.
c. Proofread the post-recruitment letter and Current
Cooperator List and sign and photocopy the letter. Send
the letter and a copy of the quota sheet U.S. Mail (unless
time is critical, then add to the supplies in the shipping
box). Retain the copy of the post-recruitment letter in
the cooperator file.
2. File Setup
a. Photocopy the call sheet and staple a copy to the inside
cover of the cooperator file.
b. Add recruitment correspondence to file.
c. Type up red file label with facility name, city, and state
and label the file.
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d. All correspondence in file should be in sequential order,
by date, with the most recent on top.
3. Paperwork
a. Put original quota sheet in the quota sheet file.
b. When shipping papers are received, put in shipping file.
c. Put original call sheet in "finished" recruitment file.
d. Add facility to NHATS status board (p. A-17).
e. Complete facility add/change form (p. A-14). If a
previous cooperator, use the old ID number and mark
"rejoin survey." If a new cooperator, assign an ID number
from the "All Cooperator List." Mail the original
to Battelle Columbus Laboratories (the statistical
contractor) and a copy to OTS.
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IV. MAINTENANCE OF COOPERATOR NETWORK
Figure 2 summarizes activities necessary to maintain the cooperator
network. Details are described in Sections IV.A and IV.B. Examples of forms,
letters, and other materials used for maintenance of the cooperator network
are shown in Appendix B.
A. New Fiscal Year Activities
Approximately one month prior to the beginning of a new fiscal year
(FY), each cooperator is asked during a regular contact whether they will
continue to participate during the new year. If they decline, recruitment
activities are followed (Section III). For all continuing cooperators and any
newly recruited cooperators, the following new FY activities take place:
1. Design Plan Review
The design plan is supplied prior to the beginning of the fiscal
year. The plan consists of a list of the metropolitan statistical areas
(MSAs) and their collection quotas by number, age, sex, and race categories.
The plan is compared to the previous design plan to determine differences. If
any MSAs have been replaced, send the cooperators in the dropped MSA a letter
informing them of that fact and requesting the return of their supplies (pri-
marily the shipping box). Begin recruitment in the replacement MSA.
2. Purchase of Supplies
a. Collection Bottles
Bottles should be chemically clean, 1-oz glass containers with
Teflon-lined metal screw caps. Several suppliers such as I-Chem and
Scientific Specialities offer this type of bottle, cleaned by a specified
protocol (p. B-2).
b. Bar Code Labels
Bar code labels (p. B-3) are ordered from a local supplier
(Graphic Technology, Inc.) and include the bar code and the seven-digit
number. Six replicates of each label are ordered (one for inventory notebook,
one for bottle label, one for bottle cap, one for the Patient Summary Report,
two extras).
The labels are cold-resistant, durable, self-adhesive, white
laminated paper, applied at MRI as the specimens are processed. The first two
digits of the number are the FY, the next three digits are sequential numbers
from 0001 to 1900, and the seventh is a check digit. The procedure for
generating the check digit is included in Appendix B (p. B-4). The computer
program to generate the sequential numbers is also included (p. B-5). Prior
to final printing of the labels, a proof copy is received from the printer and
is verified against the computer-generated numbers printed at MRI. Approxi-
mately 10% of the numbers are verified manually. After the proof copy of
numbers is verified as being correct, enough labels for the FY are ordered
(total quota plus 400 to 500 extra).
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Call to
Verify Receipt
of Supplies
l
YES
Call Monthly
to Obtain
Collection
Status
NO t NO 1
Figure 2. Maintenance of cooperator network.
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c. Shipping Containers
There are two types of containers: an aluminum shipping
container with a Styrofoam insert and a "Freeze Safe" Styrofoam box contained
in an outer cardboard box. Each of these boxes is approximately 10 in x 10 in
x 10 in, large enough to hold up to 30 specimens on dry ice. The aluminum
shipping containers can be manufactured at MRI, and the "Freeze Safe"
Styrofoam shipping containers are available from local scientific supplies
(such as Baxter Scientific).
d. Bottle Labels
Bottle labels (p. B-6) are prepared and ordered through MRI's
graphic arts department. They are cold-resistant, self-adhesive labels which
are attached to the bottles at the collection site and include facility
information, patient ID number, and date of collection.
e. Other Supplies
Other supplies (dry ice labels, baggies, PSRs, etc.) are
ordered on an as-needed basis from local suppliers. No special order
Instructions are necessary for these supplies.
3. Shipment of Supplies
Collection supplies are shipped to each cooperator at the beginning
of the fiscal year. The following supplies (p. B-6 to B-13) are included in
the shipping container:
Collection bottles (quota and 3 to 6 extra)
Bottle labels (quota and 3 to 6 extra)
Dry ice labels (2 large, 2 small)
Return label
Federal Express airbill—put facility name in block with MRI
charge number, record airbill number, and retain for future
reference.
Patient Summary Reports (PSRs)—personalized with facility name
and location
Instructions for completing PSR flyer
Helpful hints flyer
Guidelines (p. A-8)
• Quota sheet copy
On the outside of the shipping container, apply a label which reads
"Open Immediately—Important Instructions are inside for the National Human
Adipose Tissue Survey" (p. B-14).
B. Ongoing Activities
Many activities occur regularly throughout the fiscal year. These
enable NHATS staff to maintain regular contact with the cooperators and stay
informed about collection status.
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1. Status Calls
Calls to each cooperator are completed at least once a month. The
calls are to obtain a status report on collection, answer questions, uncover
potential problems, and otherwise maintain a personal relationship with the
cooperator. Documentation of all calls is recorded in the cooperator file.
2. Shipment Request
If during status calls, a cooperator says they have several
specimens collected, shipment may be requested. At that time, an expected
shipment date is recorded on the status board. If the shipment is not
received, a follow-up phone call or a "please ship" written reminder may be
used to encourage shipment.
3. Cooperator Withdrawal
During status calls, the contact person may inform us that they no
longer wish to participate in the survey. After documenting their reason for
withdrawal, ask them to return their supplies, especially the shipping box.
Complete a facility add/change form and send one copy to Battelle Columbus
Laboratories and one copy to OTS.
If there are other cooperators in the MSA who are performing
adequately, it may not be necessary to begin recruitment of a replacement
cooperator. If there are no other cooperators in the MSA or the other(s) are
performing poorly, decisions must be made to either begin recruitment or
request a replacement MSA, if there are no other possible cooperators in the
MSA.
4. Travel
Travel, meaning a personal visit with a cooperator, may occur for
various reasons during the year.
a. New Cooperator
A cooperator may be visited shortly after being recruited,
especially if there are no other cooperators in the MSA or if the other
cooperators are not performing well. The purpose of this visit is to make
sure that the cooperator understands the requirements of the program, to train
the cooperator, and to ensure that the cooperator will collect specimens cor-
rectly. Specific questions and/or problems that the cooperator may have can
be answered during the visit.
b. Problem Cooperator
A cooperator may be visited if he is not collecting and/or
shipping specimens as expected. The purpose of the visit is to determine the
problem areas and to help remedy them. Specimens and PSRs will be picked up,
and missing PSR information will be gathered during the visit.
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c. Other
Cooperators may be visited in the course of a trip to see other
cooperators. These "piggy back" visits are advantageous both to save cost
dollars and to maintain personal contact for the enhancement of the program.
Cooperator response generally increases after a personal
visit. Also, the visits usually give MRI staff insight into how cooperators
perceive the program and what areas of the program need to be stressed or
explained further.
5. Additional Communication
In addition to status calls and visits, additional contact is
planned to encourage cooperation and teamwork among the participants in the
program.
NHATS newsletter—once a year.
• Status reports—usually halfway through FY.
"End of year" reminder—a letter sent near the end of the FY to
encourage collection and shipment.
Analysis results—copies are sent to the cooperators when
available, to promote a sense of purpose to the collection.
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V. PROCESSING OF SPECIMENS
The steps in processing specimens are described in the following
section. Included are receipt, check-in, payment, transfer of information,
follow-up activities, and analysis. Appendix C contains examples of forms,
letters, and other materials used to process the NHATS specimens.
A. Receipt of Specimens
This section describes activities associated with the receipt of
specimens. Figure 3 summarizes activities which occur after samples are
delivered to the laboratory by shipping personnel.
1. Pull forms—shipment log (p. C-2), bag insert (p. C-3), PSR
cover sheet (p. C-4).
2. Determine originating facility of shipment.
3. Record the number of the airbill that was used.
4. Open box and remove PSRs and specimens. Count number; they
should match.
5. Determine fiscal year(s) of specimens; use appropriate shipment
log(s).
6. Enter appropriate information into shipment log and assign
shipment number.
7. Inspect specimens (wear gloves).
a. Complete bag insert.
b. Visually inspect specimens for quality and condition.
(1) It should be > 1 g of good quality adipose tissue.
(2) Lids should be tight.
(3) Specimens should be frozen or at least cool (make
note in shipment log if they are warm and no dry ice
is visible in box).
(4) If any bottles are cracked or broken, transfer
specimen to a new bottle and label appropriately.
(If specimens are out of the bottles, reject and
dispose.)
(5) Dispose of broken bottles by rinsing them with a 1:1
solution of household bleach in water and then
dispose.
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Receive
Specimens
Pull Forms
I
Open Box
Remove
Specimens
and PSRs
Enter Information
into Shipment Log
and Assign
Shipment Number
PSRs
Complete Cover Sheet
Specimens
I
Sort PSRs and Check
for Completeness
andFY
Complete
Bag Insert
I
Visually Inspect
Specimens for
Quality and Condition
I
I
Complete Quota
Sheet and Photocopy
Place Specimens and
Bag Insert into a Bag
and Store in Freezer
Check In
Return Box
with Updated
Quota Sheet
and Airbill
File PSRs and
Cover Sheet in
To Be Checked
In' File
Figure 3. Receipt of specimens.
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(6) Place specimens and bag Insert In a bag and store In
the freezer until check-in.
8. Inspect PSRs.
a. Complete cover sheet.
b. Sort PSRs into the categories on the quota sheet.
c. Check for completeness and appropriateness of information.
Use colored clip to mark any PSRs that are incomplete or
have information that needs to be checked.
d. Clip any PSR for which there was an insufficient quantity
of specimen.
e. If any age, sex, or race is missing, make a note and
attach it on the cover sheet.
f. If any specimens have infectious diseases such as AIDS or
hepatitis, reject specimen, mark PSR, and put specimen in
labeled biohazard bag. Place bag in freezer for later
disposal.
g. Complete quota sheet for facility.
h. Attach a note to quota sheet with information regarding
missing age, sex, or race.
i. If the cooperator's quota has not been filled, return the
shipping box to the cooperator with a copy of the quota
sheet, return airbill, dry ice labels, and a return label.
j. Place PSRs and cover sheet (clipped together) in "To Be
Checked-in" file.
9. Update status boards.
B. Check-in of Specimens
Step-by-step instructions for check-in of specimens are shown in
Figure 4. The steps are described in this section.
1. Gather check-in supplies: (a) FY stamps and ink pad; (b) extra
bottle labels and PSRs; (c) top loader balance; (d) FY specimen
inventory notebook (p. C-5); and (e) bar code labels.
2. Remove PSRs and Quota sheet from "To Be Checked-in" file, stamp
PSRs with date received and correct FY, and write shipment
number on each PSR.
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Figure 4. Check-in of specimens.
20
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3. Remove specimens from freezer.
4. Match bottle labels to PSRs and place bottles in same order as
PSRs.
5. Do all match?
If not, identify problem and correct it, if possible, by
consulting cooperator and/or work assignment leader. If
problem is not correctable, reject the specimen and label PSR
and specimen bottle appropriately.
6. Weigh vial on top-loading balance.
Sufficient vial weight (> 2 g over bottle weight)
a. No—visually inspect, using standards in freezer.
If < 1 g of tissue, reject specimen, label PSR and bottle
appropriately.
If 2 1 g of tissue, accept specimen, write total weight
(rounded to nearest gram) on PSR and estimated tissue
weight with your initials and date.
b. Yes—write weight (rounded to nearest gram) on PSR.
7. Label vial (side and lid), PSR, and inventory notebook page
with EPA 10 number. Continue until all specimens in shipment
have been checked in.
8. Store specimens in freezer at -4°C in numerical order by EPA ID
number.
9. Verify totals on all documents (cover sheet, quota sheet, and
inventory page) and correct, if necessary.
10. Are the PSRs complete?
a. No—put in "Missing Information" file.
b. Yes-put in "To Be Batched" file.
C. Storage of Specimens
Specimens are stored at 0°F in the NHATS storage facility
(p. C-6). The facility consists of 11 manual defrost freezers equipped with
audible and visual alarms in case of freezer failure. All specimens are
stored upright in racks in numerical order by EPA ID Number or Sample
Number. The temperature of each freezer is manually checked once a week and
recorded on a temperature log attached to the door of the freeezer. Freezers
are defrosted periodically as needed.
21
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D. Payment to Cooperator
The cooperators are remunerated at the rate of $25 per acceptable
specimen for their collection services. Payment activities are described in
this section and shown in Figure 5.
1. Pull the quota sheet for the cooperator.
2. Complete two forms for payment.
a. Request for payment form (p. C-6)~includes payee, amount,
and hours (0.45 h/specimen).
b. Authorization for payment form (p. C-7)«includes date of
shipment, detail on number of design and surplus samples,
amounts, and reference number from the current cooperator
list database.
3. Photocopy both completed forms.
4. Request check.
5. Request a payment letter (p. C-8).
6. When the check and the payment letter have been received,
photocopy both.
7. Assemble the check, payment letter, and a copy of the
cooperator's quota sheet for mailing.
8. Prior to mailing, check the PSRs associated with the payment
for missing information.
a. If there is missing information, copy the PSRs and send a
request for the information along with the check and
payment letter. Be sure to include a postage-paid return
envelope.
b. If the PSRs are complete, mail the check, payment letter,
and copy of the quota sheet.
9. Mark "pd" in the shipment log next to the appropriate shipment
information.
E. Transfer of Information
Information on specimens received is transferred to the statistical
contractor and EPA via the patient summary reports. Steps in the transfer of
this information are given in this section and shown in Figure 6.
1. PSRs are removed from the "To be batched" file and grouped in
batches of 40 or less, by order of the shipment number. Do not
divide a shipment into separate batches.
22
-------
Gather Payment Forms
and Updated Quota Sheet
Do any of
the Specimens
Fit the
Design
Determine Amount of
Payment Based on Number
of Specimens Accepted
i.
Complete Check Authorization and
Check Request Forms, Photocopy,
and Submit to Accounting
Request
Payment Letter
Receive Check and
Payment Letter
I
Photocopy Check
and Payment Letter
tor File
Mail Check and
Payment Letter
to Cooperator
Photocopy PSRs with
Missing Information
I
Mail Check, Payment Letter
and Request for Missing
Information to Cooperator
Figure 5. Payment to cooperator.
23
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PSRs to Batch
Pull Forms (2)
1
Check Ust for
Next Available
Batch No.
Complete Transmitted
Forms (Maximum of
40 PSRs per Batch)
Review All PSRs
for Completeness,
Accuracy
All PSRs
Reviewed by 2
Additional Staff
Members
Make 2 Copies of
Each Batch of
PSRs
Verify Number and
Clarity of Both Sets
of Copies
Send Original PSRs
to BCL, One Copy
toOTS
Retain One Copy
of PSRs at MR)
Figure 6. Transfer of information.
24
-------
2. The log sheet of batch information transfer form (p. C-9) and
the PSR transmittal form (p. C-10) are pulled from the file and
completed.
3. Each batch of PSRs is reviewed by three separate NHATS staff
members for completeness and appropriateness.
4. Two copies are made of each transmittal form and corresponding
PSRs—all copies are counted and checked for readability.
5. The batches containing the original PSRs are sent to Battelle
Columbus Laboratories, one copy is sent to the OTS Design and
Development Branch, and the other copy is retained at MRI.
F. Follow-up Activities
Missing information or answers to questions on patient summary
reports must be obtained from the cooperator. Original requests (sent with
payments) may not be answered. A follow-up phone call to the cooperator
approximately 2 weeks following the original request should be made. Written
requests for the information should continue approximately once a month until
the information is received. If the necessary information cannot be obtained,
the corresponding specimen is rejected.
6. Analysis of Specimens
By request from OTS, specimens may need to be retrieved from the
repository for chemical analysis. If such a request is received, the
specimens will be pulled from the repository by EPA identification numbers (or
sample identification number if no EPA ID exists). The ID numbers will be
verified against the hardcopy inventory list. The specimens will be retrieved
from the freezer and shipped on dry ice to the analysis laboratory. Documen-
tation for all specimen ID numbers (such as date removed, new location, etc.),
will be made on the inventory list. Following analysis, any remaining speci-
mens will be returned to the repository and documentation of date returned,
location, etc., will be made on the inventory list. Any depleted specimens
will be removed from the inventory list.
25
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VI. REPORTING
This section describes reporting activities performed by NHATS
staff. Requested required reports are submitted to OTS. Additional reports
or information about the program are submitted or presented to current and
potential cooperators. Examples of these reports are in Appendix D.
A. Monthly Progress Report
A report on the current NHATS activities is included in the Monthly
Periodic Progress Report (p. D-2), submitted by the 15th of each month to
OTS. The report contains sections describing progress, QA/QC activity, and
problems which occurred during the reporting period. A copy of the current
Collection Quota Status Report is included in the monthly report of current
activity. Plans for the coming month are also given.
B. Collection Quota Status Report
The current fiscal year collection status is reported to OTS each
month. Two Collection Quota Status Reports (CQSRs) are prepared and
submitted. One includes collection status for each cooperator, each MSA, each
region, and overall; the second omits information regarding each individual
cooperator's status. The shorter version (p. D-3) is included in the Monthly
Periodic Progress Report. The longer version is submitted directly to the OTS
Work Assignment Manager by the 5th of each month.
Both CQSRs are generated on a PC using Multiplan spreadsheet
software.
C. Recruitment Reports
Recruitment reports (p. D-7) are submitted to OTS twice a month (by
the 5th and 20th) to summarize recruitment activity for the reporting
period. Information is included on the MSA and facility being recruited,
current activity, future activity, and any pertinent comments on specific
recruitments.
0. Trip Reports
A cooperator visit is summarized in a trip report (p. D-10). The
report includes who was visited, date of visit, person making the visit,
details of the visit, problem areas, conclusions, and future action items. A
copy is sent to OTS, and the original is placed in the cooperator file.
E. Additional Reports
Periodically, additional reports are prepared to present NHATS
information to the current cooperators. Examples are the NHATS newsletter
(p. D-ll) and status reports (p. D-12) halfway through or at the end of the
fiscal year. All these reports are reviewed and approved by the OTS Work
Assignment Manager.
26
-------
F. Presentations
Two NHATS exhibits are available for presentation at professional
meetings for the purpose of promoting the program to current and potential
cooperators.
27
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APPENDIX A
RECRUITMENT OF COOPERATORS
1. "All Cooperators List" Database A-2
2. Cooperator Recruitment Database A-3
3. Recruitment Letter A-4
4. Collection Quota Sheet A-5
5. Information Flyer A-6
6. Brochure A-7
7. Guidelines for Collection A-8
8. Patient Summary Report A-12
9. Recruitment Call Sheet A-13
10. Add/Change Form A-14
11. Post-recruitment Letter A-15
12. "Current Cooperator List" Database A-16
13. Diagram of Status Board A-17
A-l
-------
ALL COOPERATORS LIST DATABASE
Cooperator Codes - Numerical Order
Format
001 Facility E
002 Facility L
003 Facility P
004 Facility B
005 Facility I
006 Facility R
007 Facility Q
008 Facility D
009 Facility C
010 Facility K
Oil Facility M
012 Facility A
013 Facility G
014 Facility J
015 Facility H
016 Facility N
017 Facility F
018 Facility 0
nnn Facility _
Name, City, State
Cooperators - Alphabetical Order
Format
Facility A
Facility B
Facility C
Facility D
Facility
Facility
Facility G
Facility H
Facility
Facility
Facility
Facility
Facility
Facility
Facility
Facility
Facility Q
Facility R
Facility
Name, City, State
Code No.
002
004
009
008
001
017
013
015
005
014
010
002
Oil
016
018
003
007
006
nnn
A-2
-------
COOPERATOR RECRUITMENT DATABASE*
Format
Pathologist Name
Title
Organizational Name
Street Address
City, State Zip Code
Telephone Number
( 1)
Pathologist Name
Title
Organizational Name
Street Address
City, State Zip Code
Telephone Number
( 2)
Pathologist Name
Title
Organizational Name
Street Address
City, State Zip Code
Telephone Number
( n)
This list contains all contacts made since MRI assumed responsibility for
NHATS in 1983. The list is chronological (as indicated by the number
following each contact); however, it can be sorted by pathologist, or-
ganization, etc.
A-3
-------
RECRUITMENT LETTER
November 14, 1988
NO ITEM TO INSERT
Dear
NO ITEM TO INSERT
•
•
Midwest Research Institute operates the National Human Monitoring Program for
the Environmental Protection Agency. Through this program EPA is working to
determine incidences, levels, and trends of pesticide and other toxic residues
in the U.S. population. The program, which began in 1967, depends on the
cooperation and commitment of pathologists, medical examiners, and coroners
who agree to furnish the specimens for study.
NO ITEM TO INSERT
, has been selected as one of 47 cities representative of the general
populace. This letter is our invitation to you to participate in this
important program.
One activity conducted by the National Human Monitoring Program concerns the
analysis of human adipose tissue for residues of selected organic compounds
such as organochlorine insecticides and polychlorinated biphenyls (PCBs).
These samples are secured from previously excised surgical specimens and/or
postmortem examinations. Since the study is conducted in accord with
statistically based design, cooperators are requested to submit only specimens
conforming to the assigned demographic (age, sex, and race) quota reflective
of the population distribution in that area.
We have enclosed some background material, reprints, and guidelines for
collecting specimens. Note that the enclosed collection protocol discusses
some of the legal issues of tissue collections which are of concern to us
all. We will furnish all supplies (shipping containers, forms, bottles, etc.)
and will remunerate you or your designee at the rate of $25.00 per acceptable
specimen.
We hope that you will assist our continuing study by providing selected
adipose tissues obtained during routine pathological examination. I will
telephone you in a few days to answer any questions you may have and to
further discuss the project. If you prefer, you may contact us by calling
(collect) 816/753-7600.
Sincerely yours,
Kay Turman
Midwest Research Institute
Program Coordinator
National Human Adipose Tissue Survey
KT/lm
Enclosures A-4
-------
COLLECTION QUOTA
National Human Adipose Tissue Survey
National Human Monitoring Program
Fiscal Year 1990 Survey
(Oct. 1,1989 to Sept. 30,1990)
Cooperator:
Location: _
Total Quota:
ANNUAL
QUOTA
AGE
0-14
0-14
15-44
15-44
45 +
45 +
SEX
Male
Female
Male
Female
Male
Female
Totals
DATE
RECEIVED
NUMBER
ACCEPTED
NUMBER
SURPLUS
•NON-
CAUCASIAN
BALANCE
REMAINING
•NON-CAUCASIAN:.
. to be distributed among the Total Quota.
A-5
-------
INFORMATION FLYER
National Human Adipose
Tissue Survey
The National Human Adipose Tissue Survey (NHATS), establish-
ed in 1967, has been operated by the U.S. Environmental Protec-
tion Agency (USEPA) on an annual basis since 1970. The purpose
of the NHATS, the main operative program of the National Human
Monitoring Program (NHMP), is to monitor on a national scale the
prevalence of selected pesticides and toxic substances and the
level of exposure experienced by the general U.S. population. The
data collected are used to identify trends in this exposure and to
assess the effects of regulatory actions.
Pathologists and medical examiners throughout the conterminous
United States are cooperating in the collection of specimens for
NHATS. The nine geographic regions and 52 collection sites are
shown in Figure 1.
A-6
-------
BROCHURE
AN IMPORTANT STEP IN VALUABLE
HEALTH RESEARCH
WhatisNHATS?
The National Human Adipose Tissue
Survey (NHATS) is a statistically designed
national survey to collect human adipose
tissue for research purposes.
What is the purpose of NHATS?
The purpose is to collect human adipose
tissue based on demographic characteristics
(age, sex, and race) reflective of the
population distribution in specific areas of
the U.S. Researchers use the adipose tissue
to monitor the prevalence of selected toxic
substances and the level of exposure
experienced by the general U.S. population.
What toxic substances have been
investigated?
Baseline levels for pesticides, polychlorin-
ated biphenyls (PCBs), polychlonnated
dibenzo-p-dioxins (PCDDs), polychlorinated
dibenzofurans (PCDFs), volatile organic
compounds, and trace metals have been
determined for the U.S. population.
Who participates in NHATS?
Three groups participate in NHATS:
a management team, a collection team, and
an analysis team.
• The U.S. Environmental Protection
Agency Office of Toxic Substances,
Washington, D.C. manages NHATS.
Midwest Research Institute, Kansas
City, Mo., operates NHATS and main-
tains the repository of adipose speci-
mens.
• Approximately 90 pathologists and
medical examiners from 47 cities across
the U.S. are currently collecting human
adipose tissue from post-mortem ex-
aminations and previously excised
surgical specimens. Current and past par-
ticipants have collected more than
10,000 adipose specimens since NHATS
was established in 1967.
• Researchers composite, extract, and
analyze the adipose tissue for specific
toxic substances based on environ-
mental concerns determined by the U.S.
EPA. The data collected are statistically
examined to identify trends in exposure
to toxic substances and to assess the
effects of regulatory actions.
How can I learn more about NHATS?
If you are interested in participation, or if
you desire copies of analysis results, please
contact one of the persons listed on the
attached card.
A-7
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. Z0460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
Guidelines and General Information
Regarding the Collection of Adipose Tissue
for the National Human Adipose Tissue Survey
The National Human Adipose Tissue Survey is responsible for determining,
on a national basis, the prevalences, levels, and other evidence of exposure
to pesticides in the general population of the United States. At present, the
program collects adipose tissue and analyzes for selected pesticides and their
metabolites and other toxic chemicals stored in the lipid portion of these
tissues. The results are used in evaluating various factors and conditions
pertaining to human health and effective pesticide regulations.
The adipose tissue for this program is secured through the cooperation of
participating pathologists and medical examiners located throughout the con-
tinental United States. The tissue is obtained from surgical specimens previ-
ously excised for therapeutic or elective purposes and from postmortem
examinations. The specimens are sent to our laboratories in Kansas City,
Missouri for analysis. We will send periodic reports of results to partici-
pating physicians. Summaries that compare results among regions of the
country will also be provided as they become available.
In order to develop statistically valid information on a national basis,
collections must be made according to a survey design that dictates the number
of specimens required. The quotas of specimens reflect the demographic dis-
tribution of the population in the appropriate census division. As a
participant, you should have a copy of the annual quota of specimens expected
to be collected from your location on a fiscal year basis. All collections
should be made according to this aqe/sex/race distribution. You should have
no difficulty collecting the number of specimens required 1n each category.
Since our total sample is relatively small and the validity of the results
depends on a high response rate, your participation is particularly impor-
tant. If you feel that you will be unable to collect the number of specimens
required, please let us know.
Criteria for Selection of Patients to Be Sampled
Since the program objective is to reflect the prevalence and level of
exposure to selected pesticides experienced by the general (person-on-the-
street) population, a few suggestions are listed here for your guidance:
The highest priority should be given to satisfying the number and
demographic distribution of your annual quota. This quota should be
completed as soon after the start of the fiscal year as possible.
A-8
-------
Patients with known or suspected pesticide poisoning should not be
sampled, but if you are involved with a potential pesticide
poisoning, we would like to know about it. To repeat, specimens
should not be taken from such individuals for the National Human
Adipose Tissue Survey.
Patients who exhibit cachexia or who have been institutionalized for
long periods should not be sampled.
Patients with AIDS, hepatitis, or other infectious blood diseases
should not be sampled.
Legal Considerations
The National Human Adipose Tissue Survey staff is both interested in and
concerned about the legal ramifications of this human research project. Since
the program operates in about 40 states, it 1s not feasible for us to handle
the variety of local and state legal interpretations that may arise. There-
fore, as a matter of EPA policy, legal requirements, such as informed consent,
confidentiality, etc., are matters for your consideration and resolution. We
will, however, assist you in any way possible.
We have completed several studies on these matters and do not believe
that they present major obstacles to your participation. In most documents
authorizing postmortem examinations, there is a clause granting the examining
physician permission to remove tissues for research purposes. We consider
this project to be in that category. In the case of specimens recovered from
your surgical practice, the use of a small amount of tissue from a previously
excised specimen certainly does not place the patient at risk in any way what-
soever.
As you will notice in the discussion that follows regarding data needed
for each patient sampled, we do have mechanisms to assure confidentiality. In
fact, the disclosure or release of certain data is protected by several
Federal statutes, including the Privacy Act and the Freedom of Information
Act.
The fees paid to you by our program are intended solely to remunerate you
or your designee for professional services rendered.
Collection of Adipose Tissue
At least five grams (approximately equal to a rounded tablespoon) of good
quality, high lipid-containing adipose tissue, such as subcutaneous, peri-
renal, or mesenteric adipose tissue, should be collected each time. Avoid
fibrous or connective tissue and fascia (i.e., omentum). Such specimens will
not yield a satisfactory analysis.
A-9
-------
Adipose tissue should be taken dry and should not be rinsed before being
placed into the sample bottles. Many water supplies contain materials that
would interfere with chemical analysis. Instruments should be well-rinsed
with distilled water and dried before the adipose specimen is taken. Contact
with other chemicals, such as paraffin, disinfectants, preservatives, or
plastics, should be avoided. Take special care to keep specimens from dif-
ferent patients separate. Make certain that the specimens are correctly and
securely labeled.
Specimens of adipose tissue may be collected from unfixed surgical speci-
mens that have been excised for therapeutic or elective purposes. Avoid
cutting the tissue on paraffin.
Specimens of adipose tissue may also be collected during postmortem
examinations. These specimens must be obtained from unembalmed cadavers
only. The interval between death and the collection of tissue should be as
short as possible and in any case must not exceed 24 hours, assuming refriger-
ation during that interval.
The specimen of adipose tissue taken should be placed in the chemically
clean container provided, without any fixatives or preservatives. Complete
the self-adhesive bottle label legibly in ballpoint pen. Securely affix the
bottle label, wrap each bottle in gauze to prevent breakage, and freeze.
Specimens should be stored upright in the freezer at 14°F (-10°C) until
shipment.
Completion of the Patient Summary Report
A Patient Summary Report should be completed for each patient from whom a
specimen was taken. Special attention should be given to the completeness of
the data. First and last initials, in that order, should be used instead of
the complete name to ensure that confidentiality is maintained.
Confirmed diagnoses should be detailed in the spaces provided. Only the
major ones should be supplied. Other required information should be completed
as accurately as possible. The completed forms should be held and placed
under the outer lid of the insulated container when specimens are shipped.
Packing and Shipping
Tighten all lids on the specimen bottles carefully. This is important,
since we are required to use special aluminum foil cap liners that make
tightening somewhat difficult. Be certain that a completed bottle label is
firmly attached to each specimen bottle. Wrap each bottle in gauze or paper
to prevent breakage during shipment and to keep the label on the container.
Place the specimen bottles in a plastic bag in the insulated mailer. Add - 5
pounds dry ice to keep specimens frozen in transit.
A-10
-------
New transport regulations require any materials shipped in dry ice to be
specially labeled. Since frozen medical and/or diagnostic specimens are
exempt from some of these requirements, be sure that the contents of the ship-
ping containers are clearly indicated by ORM-A; FROZEN MEDICAL SPECIMENS. We
have provided a special label for this purpose. If, for some reason, you do
not have these labels, please attach a card or piece of wide adhesive tape
with ORM-A; FROZEN MEDICAL SPECIMENS indicated in indelible ink.
A Federal Express airbill and the local number for pickup is provided.
There is no cost to you because of the preaddressed airbill. All insulated
mailers should have a PERISHABLE - PACKED IN DRY ICE label, visible from all
sides, on the outside.
Specimens should be shipped on Monday, Tuesday, or Wednesday. This
ensures that they will arrive on or before Friday.
Patient Summary Reports should be sent in the carton with the specimens
whenever possible. They can be folded and placed on the top of the polyfoam
lid.
Only specimens which meet our criteria and are handled according to the
guidelines can be accepted. No substitute vials will be accepted.
For Further Information
If you have questions, problems, or comments, please contact either of us
by calling (collect):
Kay Turman Janet C. Remmers
Midwest Research Institute National Human Monitoring Program
425 Volker Boulevard Exposure Evaluation Division (TS-798)
Kansas City, MO 64110 U.S. Environmental Protection Agency
(816) 753-7600 Washington, DC 20460
(202) 382-3583
October 1988
A-ll
-------
MEDICAL RECORD: This form contains medical information the disclosure or release of which
is restricted by U.S.C 552, (bX6); 45 CFR Pan 5.
OMBML SOOtHUU
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF TOXIC SUBSTANCES
EXPOSURE EVALUATION DIVISION (TS-798)
FIELD STUDIES BRANCH
WASHINGTON DC 20460
NATIONAL HUMAN ADIPOSE TISSUE SURVEY
PATIENT SUMMARY REPORT (PSR)
INSTRUCTIONS
1. All unshaded questions for which information if available should be answered.
2. Date should be in the form of Month, Day and Year e.g., Nov. 19, 1988.
DO NOT WRITE W
SHADED AREA
Public rejonmi bu«u foe ttii tolkction of lafraittcB to «itim«»rt • mntt I ban p»r mpon, inclodinj cim>
for nmwini iBuncaou, MvcUif uiuaf fett imro», |iOnu( ia« nnnmni-g tin dua iMiid* IB* eoaplnat
tad nvuvini ita colleoioi of iafonaao& Sod f
-------
RECRUITMENT CALL SHEET
MSA:
Facility: - - First contact date:
Date packet sent
Address: - Date received: —
(department)
(street or box *)
(city, state, zip code)
Phone: ( )
Other: I I
Contact person:
Date called and result of call :
A-13
-------
NATIONAL HUMAN AIPOSE TISSUE SURVEY (NHATS)
FACILITY ADD/CHANGE FORM
To be filled in by MRI
Date completed
By
Facility ID
Facility Name
Street
City
County
State
Zip
1- New Cooperator: date joined survey
O2. Change of address:
Q3. Change in status: date _
leave survey
rejoin survey
To be filled in by Battelle
MSA
State FTPS Abbreviation
Date added/changed
By
June 1990
A-14
-------
POST-RECRUITMENT LETTER
INI
January 23, 1990
NO ITEM TO INSERT
Dear
NO ITEM TO INSERT
»
•
It was a pleasure talking with you about the National Human Adipose Tissue
Survey. I appreciate your willingness to cooperate in this survey.
Under separate cover I have sent you the following supplies:
»
Guidelines for specimen collection (extra copy)
Helpful Hints Flyer
Patient summary reports
"Instructions for Completing PSR" flyer
Collection bottles
Bottle labels
"Dry Ice" labels
Federal Express Airbill
Shipping container
Enclosed with this letter is the Collection Quota form that gives the number
of specimens required for each sex and age group. After collection, please
keep the specimens frozen until there is a sufficient number (about 10) for
shipment. Please be sure to add sufficient dry ice to keep the specimens
frozen during transit. We will return the shipping container to you as soon
as possible.
An updated Collection Quota form reflecting the number of acceptable specimens
received will be sent to you along with a check.
Thank you again for your participation. If you have any questions, please do
not hesitate to call me (collect) at (816) 753-7600, ext. 552.
Sincerely,
Lori Bailey
Regional Coordinator
National Human Adipose Tissue Survey
LB:lm
Enclosure
A-15
-------
CURRENT COOPERATOR LIST
Format
(1) Cooperator Name
Organizational Name
Street Address
City, State Zip Code
Payment Information
Contact Person
Payee
Phone Number of Cooperator and/or Contact Person
Organizational Name
City, State
(2) Cooperator Name
Organizational Name
Street Address
City, State Zip Code
Payment Information
Contact Person
Payee
Phone Number of Cooperator and/or Contact Person
Organizational Name
City, State
(3) Cooperator Name
Organizational Name
Street Address
City, State Zip Code
Payment Information
Contact Person
Payee
Phone Number of Cooperator and/or Contact Person
Organizational Name
City, State
A-16
-------
c
f— O
^? -S3*
•a "2
(TJ f±
UJ
-------
APPENDIX B
MAINTENANCE OF COOPERATOR NETWORK
1. Cleaning Protocol for Bottles B-2
2. Bar Code Labels B-3
3. Procedure for Generation of Check Digit B-4
4. Computer Program for Generation of
EPA ID Numbers B-5
5. Bottle Label B-6
6. Dry Ice Labels B-7
7. Return Label B-8
8. Federal Express Airbill B-9
9. Patient Summary Report B-10
10. Instructions for Completing PSR Flyer B-ll
11. Helpful Hints Flyer B-12
12. Quota Sheet Copy B-13
13. Outer Label for Shipping Container B-14
B-l
-------
CLEANING PROTOCOL FOR BOTTLES
- Protocol A™-
• Amber Glass Bottles • Gear Glass Bottles
• Wide Mouth Amber Glass Jars • Wide Mouth Gear Glass Jars*
* Also available cleaned according to Protocol fl™ - see below
Cleaning Protocol A™ specifications:
1. Laboratory Grade Detergent Wash and Rinse
2. Acid, Deionized Water, and Solvent Rinses
3. Oven Drying, Capping and Packing under quality controlled conditions
Sample Containers Prepared According to Protocol A™ Are Recommended For Use
In The Analysis Of:
Acidity/Alkalinity Hardness Settleable Residue/Suspended Solids
BOD (Biological Oxygen Demand) Mercury Silica
Chloride Metals Sulfate
COD (Chemical Oxygen Demand) OH & Grease Sulflde
Color pH Sulfite
Conductivity Phenols TOC (Total Organic Carbon)
Cyanide Phosphate Turbidity
Extractable Organics
™ Protocol is a trademark of I-Chem Research
B-2
-------
10/12/80
GRAPHIC TECHNOLOGY
MIDWEST RESEARCH INSTITUTE
900001-901800
L01258PAGE0001
CD ,
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70
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CD
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-------
PROCEDURE FOR GENERATION OF CHECK DIGIT
FOR EPA ID NUMBER
1. Multiply the EPA number by the special check number.
a. The EPA number is the six-digit number generated previously
(860001 - 861500).
b. The special check number is also a six-digit number which
is 121212.
c. The multiplication takes place along each digit.
d. Examples:
123
860001 860750 861500
121212 121212 121212
830002 830550 831100
Note: if the number generated from the multiplication
is two digits, subtract 9 from the two-digit
number and write down the result.
Example: 7 x 2 = 14, 14 - 9 = 5; so a five would be
written down as the result.
2. Add all the results together to obtain the resultant.
a. Examples: 1. 830002 = 13
2. 830550 = 21
3. 831100 = 13
3. The last digit of the resultant is subtracted from 10 to obtain
the check digit.
a. Examples: 1. 10 - 3 = 7
2. 10 - 1 = 9
3. 10 - 3 = 7
4. The check digit is then added to the EPA number to create a
seven-digit number called the EPA ID number.
a. Examples: 1. 8600017
2. 8607509
3. 8615007
B-4
-------
COMPUTER PROGRAM FOR GENERATION OF EPA ID NUMBERS
••» CLEPR, .2000: DIM R (6) :CLS: INPUT'Start ing label #":ST*:IF LEiM <> £ T
•> L.OCATE 3, 1 s PRINT" ":i_OCflTE 3, 1: INPL)T"Er.air,g
!<->
iaaei
•EN*7lF i_EN(EN*)<>6 THEN 20
-r, ST=VAL :EN=VAL
O FOR »-Bl TO S: R :NEXT L
^O FOR L=l TO 6:IF L=2 OR L=4 OR L=6 THEN R(L)=R>iIF £=10 THEN E=0
Oo"LPRINT ST*,-CHR*(4a*E) ;SPCO) ;ST*;CHR*(4e-»-E> ;SPC(7) ;
10 IF A/2=INT<0/2) THEN LPRINT" " :LPRINT :i_PRINT
12O A=ft-*-l:NEXT K:END
B-5
-------
BOTTLE LABEL
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
NATIONAL HUMAN MONITORING PROGRAM
NAME OF HOSPITAL
PATIENT'S INITIALS PATIENT'S IOENT NO
DATE COLLECTED
ADIPOSE
URINE
SERUM
BLOOD
OTHER ISoecily)
B-6
-------
DRY ICE LABELS
PLEASE RUSH
KEEP AWAY FROM HEAT
FROZEN MEDICAL SPECIMENS
WARNING
DO NOT store In closed containers or
unventilated spaces. DO NOT expose to
high temperatures. IF DELIVERY IS
DELAYED, please keep at freezing
temperatures, if possible.
o
o
x
FROZEN MEDICAL SPECIMENS
ORM-A DRY ICE
Packaging Conforms with Standards
in CFR 173.61S(e), 173. 387. 42 CFR
72.25
-------
RETURN LABEL
Ms. Kay Turnan
National Hunan Adipose Tissue Survey
Midwest Research Institute
425 Volker Boulevard
Kansas City, MO 64110
B-8
-------
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Company
MIDWEST RESEARCH
Street Address
425 VOLKER BLVD
Guy
KANSAS CITY
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(ReopwrtsName) Please Pert
KAY TURMAN |( )
Company
MIDWEST RESEARCH INSTITUTE
Enact Street Address fHkCamiMOTliFO teaorfO •ACofeJ
425 VOLKER BLVD.
C«y State
64110
Oepartment/Ftooi No
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Revisimio*fEi/a9
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FORMAT WI4
-------
MEDICAL RECORD: This form contains medical information (he disclosure or release of which
a restricted by U.S.C 552, (bX6): 45 CFR Part 5.
OMBM9L 29004319
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF TOXIC SUBSTANCES
EXPOSURE EVALUATION DIVISION (TS-798)
FIELD STUDIES BRANCH
WASHINGTON DC 20460
NATIONAL HUMAN ADIPOSE TISSUE SURVEY
PATIENT SUMMARY REPORT (PSR)
INSTRUCTIONS
1. All unshaded question! for which information is available should be answered.
2. Date should be in the form of Month, Day and Year e.g., Nov. 19. 1988.
DONOTWRfTEIN
SHADED AREA
Public reponwi Imrtia fot iti*. coBmaa of -m/aimuaa i» ———' a mnii I tear pit nipou*. mcladiii dm*
for revwwiat laimcaou. Mint»| «nuut to* inraM, |iitemt ad —~——»t ±m tta. uiM. io4 complnut
ind. nmewac thv coltuam of uframuKm. So4 -«-•••*-'» ngttrfuc to tanln uuamw at nj otter uput o( dB»
of lafenuBn. metadnn nueani» fot ndunt *» banton, a Otef. InfoBBUOB Policj Bnack. PM-I2J.
EnvmmmenaJ rtoacnon. Asncft «t M St. iW . WutanjtDB. DC 20*60: nd » a»vOffli» of lafannMoa ud
a. Offi» of Mui|am a< Bodpt, WubOfwa. DC 10J03.
8 9 1011 t213t4.ti 1817181980
HOSPITAL fWarn.. City and Statt)
21ZZ23
PATIENTS \B.NO.(HojpiUl. Acctutom. or
PATENTS INITIALS f/lr«
24 25 28 27 28 29 3tt 31 32 33 34 35 16 37 38
DATE COLLECTED (if on*. Day and fror)
BHTHDATEORAGE
W40
41 tt
emu-CD
PATHOLOGIST
sex
D
MALE
n
FEMALE
4HS 49 SO »t 52 53 5* 55 58 57
HHD-Liicm] n
HBGHTfCampl
-------
INSTRUCTIONS FOR COMPLETING PATIENT SUMMARY REPORT
Complete every box that is not shaded.
Please use black ink.
Please PRINT.
CLW-1
or sureties!
O
\s
!>
-------
NATIONAL HUMAN ADIPOSE TISSUE SURVEY
GUIDELINES AND HELPFUL HINTS
FOR COOPERATORS
COLLECTION AND STORAGE OF SPECIMENS
• Post quota sheet on wall in collection area.
• Mark off quota by age, sex and race as collected to
ensure complete collection of the specimens.
• Use only vials and labels that are provided.
• Complete label and affix securely to vial.
• Collect at least 5 g of high lipid-containing adipose tissue.
• Store specimens at 14°F (-10°C) or below until ready
to ship.
• Fill out patient summary reports (PSRs) as soon as
possible. One or two a week is easier than 20 or more
all at once.
SHIPMENT OF SPECIMENS
• Ship when 6-8 specimens have been collected.
• Check PSRs and vials for complete information.
Place PSRs under lid of shipping box.
• Tighten lids on vials and wrap vials with gauze
to prevent breakage. Place vials in plastic bag
for shipping.
• Include -5 Ib of dry ice to keep specimens frozen in transit.
• Ship on Monday, Tuesday, or Wednesday.
• Use Federal Express airbill provided for shipping.
IF YOU HAVE A PROBLEM OR QUESTION
• Call Kay Turman (x185) or Lori Bailey (x552) collect
at (816) 753-7600, from 8 am to 5 pm (CST).
6/90
B-12
-------
COLLECTION QUOTA
National Human Adipose Tissue Survey
National Human Monitoring Program
Fiscal Year 1990 Survey
(Oct. 1,1989 to Sept. 30,1990)
Cooperator:
Location: _
ST.
Total Quota:
ANNUAL
QUOTA
3
3
^
L
V
5
AGE
0-14
0-14
15-44
15-44
45-1-
4?+
SEX
Male
Female
Male
Female
Male
Female
Totals
DATE
RECEIVED
NUMBER
ACCEPTED
NUMBER
SURPLUS
•NON-
CAUCASIAN
BALANCE
REMAINING
•NON-CAUCASIAN
. to be distributed among the Total Quota.
B-13
-------
OUTER LABEL FOR SHIPPING CONTAINER
Important instructions
are inside for the
NATIONAL HUMAN ADIPOSE
TISSUE SURVEY
(NHATS)
B-14
-------
APPENDIX C
PROCESSING OF SPECIMENS
1. Shipment Log C-2
2. Bag Insert C-3
3. PSR Cover Sheet C-4
4. Specimen Inventory Page C-5
5. NHATS Storage Facility Diagram C-6
6. Request for Payment Form C-7
7. Authorization for Payment Form C-8
8. Payment Letter C-9
9. Log Sheet of Batch Information C-10
10. PSR Transmittal Form C-ll
C-l
-------
WATS SfWU RECEIPT AND PROCESSING - FY90
DA1E REC D
COOPERATQR
LOCATION
SHIPHEKT M3. NO. REC D/FV
COMCNTS
SUPPLIES CHECfED
REPLACED IN
"O
I
l\3
-------
BAG INSERT
National Human Adipose Tissue Survey
DATE SPECIMENS RECEIVED
COOPERATOR
LOCATION
NUMBER OF SPECIMENS
SHIPMENT NUMBER
C-3
-------
MIDWEST RESEARCH INSTITUTE
425 Volker Boulevard
Kansas City Missouri 64110
Telephone (816) 753-7600
COVER SHEET TO ACCOMPANY PSRS
National Human Adipose Tissue Survey
DATE SPECIMENS RECEIVED
COOPERATOR
LOCATION
NUMBER OF SPECIMENS
SHIPMENT NUMBER
Revised 10/89
C-4
-------
FY 90 INVENTORY
SHIPMENT * / BOX «
PATIENT ID *
1
2
3
4
5
6
7
8
9
10
11
12
13
14
CHECKED IN
BY:
DATE:
COOPERATOR
EPA ID *
VERIFIED
BY:
DATE:
CITY, STATE
PATIENT ID *
15
16
17
18
19
20
21
22
23
24
25
26
27
28
TOTAL « OF SPECIMENS
D S
DATE RECEIVED
EPA ID *
COMMENTS
•REJECTED
C-5
-------
NHATS STORAGE FACILITY
North
West
Freezer
1
Freezer
2
Freezer
3
Freezer
4
Freezer
5
Freezer
6
Alarm
Status
Board
Freezer
11
Desk
Freezer
10
Freezer
9
Processing
Area
Freezer
8
Freezer
7
Hood
East
Storage Files
\
Status
Board
^^^
Receipt
Area
Sink
South
C-6
-------
INTEROFFICE COMMUNICATION
MIDWEST RESEARCH INSTITUTE
To: Michael Limbocker
From: Kay Turman
Subject:
Check Request for Collection Services on Project
No. 8863-20-01
The following accounts payable are approved for payment. Please
notify me when the checks are ready. I will pick them up.
Payable To Payment Due Person Hours Charge
8863-20-01-6030
C-7
MRI2
-------
MIDWEST RESEARCH INSTITUTE
425 Volker Boulevard
Kansas City. Missouri 64110
Telephone (816) 753-7600
AUTHORIZATION FOR PAYMENT
NATIONAL HUMAN ADIPOSE TISSUE SURVEY
Payment is authorized in the amount of $ for ser-
vices provided in the collection of human adipose tissue for
diagnostic purposes to:
National Human Monitoring Program
Number of samples accepted x Rate = $
Word Processing:
Address #
Date Number Number Number
Received Received Accepted Surplus Payment Balance
C-8
-------
PAYMENT LETTER
//S//
April 25, 1990
NO ITEM TO INSERT
Dear
NO ITEM TO INSERT
Thank you for your recent shipment of tissue specimens to the National Human
Adipose Tissue Survey. Enclosed is payment for services provided in the
collection and shipment of human adipose tissue.
So that you are aware of the status of your collections, we have provided a
report on the specimens you sent and the current monetary balance remaining in
your account. You will also find enclosed a copy of your quota sheet indicat-
ing the number of specimens needed in each category for FY90.
Date
Shipment
Received
Total
Number
Received
Number
Accepted
Number
Surplus
Amount
of
Payment
Balance
in
Account
NO ITEM TO INSERT
Should you have any questions or comments, please feel free to telephone me
(collect) at (816) 753-7600.
Sincerely,
Kay Turman
Program Coordinator
National Human Adipose Tissue Survey
KTrlm
Enclosures
C-9
-------
L05 SHEET OF BATCH IIW--QRMATIGN TRANSFER TO BnTTFiL-LE
Batch Date Sent Patient Summary Report Analysis Report
No. To Battelle Initials Form No. tf o-f FSRs Form tt # ot ARs tt o-f QC
C-10
-------
NATIONAL HUMAN ADIPOSE TISSUE SURVEY
PSR TRANSMITTAL
Batch Number Form PSR
Shipped by MRI: Received at Battelle:
Date Date
Sent By ___^_ Reed By_
To Be Completed
To Be Completed By MRI By BMI
Package Beginning Ending Number Number Hosp
Number EPA ID EPA ID Shipped Received Code
Total
Incomplete PSR Forms
C-ll
-------
APPENDIX D
REPORTING
1. Monthly Progress Report D-2
2. Collection Quota Status Reports 0-3
3. Recruitment Report 0-7
4. Trip Report 0-10
5. Additional Reports 0-11
D-l
-------
EXAMPLE OF
MONTHLY PROGRESS REPORT
Work Assignment 20 (25% Complete); National Human Adipose Tissue Survey
(NHATSl
EPA Work Assignment Manager: Janet Returners
MRI Work Assignment Leader: Kay Turman
Progress: Two FY89 design specimens and 14 surplus specimens were
received* bringing the totals to date to 1111 design specimens received and
483 surplus received, as shown In Table 2. Two hundred twenty-two (222) FY90
design specimens and 12 surplus specimens have been received to date, as shown
1n Table 3.
All cooperators were contacted by phone for status reports on col-
lection efforts and to remind them to ship specimens.
Recruitment reports were submitted on December 19 and at the end of
the month.
Work continued on the NHATS newsletter, which will include the final
FY89 collection status.
Travel was completed to Salt Lake City, Utah, Sacramento,
California, and Paterson, New Jersey, to visit five cooperators.
QA/QC Activity; None.
Problems; None.
Plans for the Coming Month; Specimens will be processed as
received. PSRs will be batched and sent to BCL.
Calls to cooperators to request shipment and encourage collection
will continue.
Work will continue on the reorganization of the sample repository.
The newsletter will be submitted to the EPA WAN for final review,
and upon approval, will be distributed to all cooperators.
A brochure of the NHATS exhibit will be drafted and sent to the EPA
WAM for review. Work will begin on revisions to the NHATS operation manual.
D-2
-------
Table 2. Adipose Tissue Collection
Quota Status Report: fV1990
April 30. 1990
MSA and Census
Division
NEU ENGLAND
Springfield. NA
Ml DOLE ATLANTIC
AluAnjf ~5cncncctoQy % NY
Blngtetn-Elilra. NY
Mew York. NY
Paterson. HJ
frle. FA
Philadelphia. M
Pittsburgh. PA
EAST NORTH CENTRAL
Chicago. IL
Mollne. IL
Detroit. HI
Akron. OH
Cleveland. OH
Total Quota Samples accepted Surplus received
MSA 0-14 15-44 45* 0-14 15-44 45* 0-14 15-44 45*
quota HFHFNFNC MFNFNFNC NFHFNFNC
27 3366452 0000450 0000100
54 201388 -22 000010-1
27 3366455 1156454 0000470
54 6 6 12 12 8 10 10 2 3 3 12 8 10 7 0001000
27 3366455 1110011 0000000
27 3366453
27 3366453
27 3366453 0002440 0000000
216 4 5 9 20 16 20 • 74 0 0 0 1 4 7 • 12
54 6 6 12 12 8 10 8
27 3366454 1016452 0002220
54 66 12 12 8 10 8 2011 8 10 8 0000457
27 3366454 0004132 0000000
27 3366454 2020313 0000000
Sanples regaining
0-14 15-44 45*
H F H F H
3
4
3
2
4
2
3
3
3
20
6
2
4
1
3
6
3
2
3
2
3
3
3
19
6
3
6
3
6
11
6
1
9
5
6
6
6
39
12
5
11
4
6
9
6
0
0
6
6
6
4
28
12
0
11
6
0
0
4
0
0
4
4
4
0
16
8
0
0
1
F
0
2
5
0
0
4
5
5
1
20
10
0
0
4
NC
2
• 32
5
1
3
4
3
3
3
• 142
8
2
0
2
\
m
•3.
-o
m
o
CO T|
§0
co F
m
XJ 0
m__ i
~H
"^ i— i
00
TO Z
O
-------
Table 2 (continued)
NSA and Census
Division
Coliubus. OH
Dayton. OH
Madison. UI
WE SI NORTH CENTRAL
St. Louis. HO
Rochester. HN
Oaaha. NE
O
i Grand Forks. HO
•^
Wichita. KS
SOUTH ATLANTIC
Washington. OC
West Pain Beach. FL
MlMl. fl
Charlotte-Gastonia. KC
Taipa. FL
Atlanta. GA
Greenville. SC
Norfolk. VA
Total Quota
MSA 0-14 15-44 45*
quota H F M F N F NC
27 33664 54
27 3366454
270
27 3-366452
27 3366451
27 3366452
27 3366452
135
27 3366456
27 3366456
27 3366456
27 3367446
216
Sables accepted Surplus received
0-14 15-44 45* 0-14 15-44 45*
MFNFNFNC HFHFHFNC
3316153 0
1102400 0
12 7 10 24 24 28 • 105 0
0010100 0
3065451 0
0011000 0
0013440 0
6 3 IS 15 13 14 * 66 0
0000010 0
3263426 1
14 12 21 23 19 15 • 104 1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
0
0
0
0
0
0
0
0
0
1
0
0
1
0
0
1
3
0
0
0
0
0
0
0
0
0
1
0
0
1
0
0
1
7
0
0
0
0
0
0
0
2
0
1
2
0
5
0 0
0 0
2 0
9 • 20
0 0
0 0
0 0
0 0
0 0
0 • 0
0 0
1 3
0 0
1 4
2 4
0 1
4 - 12
Saaples retaining
0-14 15-44 45*
N F H F N
0
2
0
18
0
3
3
0
9
0
3
0
3
3
1
0
0
10
0
2
0
23
3
3
3
0
12
0
3
0
3
3
1
1
1
12
5
6
1
SO
0
5
5
0
IS
2
6
1
6
6
2
4
0
27
0
4
36
1
5
3
0
IS
1
6
0
6
6
2
2
4
27
3
0
1
16
0
4
0
0
7
0
4
1
4
4
0
0
0
13
F
0
5
1
22
0
5
1
0
11
0
5
2
4
5
3
2
2
23
NC
1
4
4
• 165
2
0
2
2
0
• 69
0
6
0
6
6
0
0
0
• 112
-------
Table 2 (continued)
NSA and Census
Division
EAST SOUTH CENTRAL
Nashville. TN
Leilngton. KV
Neaphls. TH
WEST SOUTH CENTRAL
Dallas. TX
New Orleans. LA
Houston. TX
Browisville-Hrlngn. TX
San Antonio. TX
MOUNTAIN
Denver, CO
Salt Lake City. UT
PACIFIC
Sacraaento. CA
San Francisco. CA
Los Angeles. CA
Portland. OR
Total Quota Staples accepted
MSA 0-14 15-44 45* 0-14 15-44 45*
quota NFMFHFNC MFMFHFNC
81 6 6 16 13 12 13 • 66
27 4366446 2266446
27 4366446 4311436
27 4366446 0165241
135 14 12 25 24 18 19 • 112
27 3377342 2131212
54 5 4 10 8 5 S • 37
27 3367447 2337445
27 3367447 0000410
54 66 12 14 8 8 14 6600104
27 337734? 0120122
Surplus received
0-14 15-44 45»
N F H F N F HC
0
0
0
0
0
0
6
0
0
6
0
3
3
0
0
0
0
1
0
0
1
0
0
1
0
0
1
0
0
0
0
0
0
0
3
0
0
3
0
0
0
3
0
3
2
9
11
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
6
6
0
0
0
1
0
4
5
0
0
5
0
0
5
2
3
S
S
0
0
0
1 1
0 0
4 4
S • 14
0 0
0 0
2 10
0 0
0 0
2 • 17
0 4
4 0
4 • 29
6 0
0 0
0 0
0 0
Staples remaining
0-14 15-44 45*
N F M F N
0 0
2 2
1 1
0 0
2 1
0 0
4 2
0 0
1 2
0 0
1 2
1 0
3 3
0 0
3 2
0
1
1
0
0
S
0
0
4
0
4
3
6
12
5
0
4
1
0
0
5
1
0
6
0
6
0
7
14
7
0
0
0
0
0
0
2
0
1
0
1
0
0
7
2
f HC
0 0
2 4
0 0
0 0
0 0
1 0
0 5
0 2
1 • 23
3 0
0 1
3 • 17
0 2
3 7
8 10
2 0
-------
Table 2 (concluded)
Total Quota Samlet accepted
NSA and Cenius MSA 0-14 15-44 45* 0-14 15-44 45*
Division quota NFHFHfNC NFMFNFNC
Seattle. UA 27 3 3 7 7 3 4 2
Spokane. UA 27 33773420022220
216 8 10 7 9 12 9 55
DCSIGN GWND TOTAL • 1.377 DESIGN COLLECTED • 641
Surplus received Saaples renaming
0-14 15-44 45t 0-14 15-44 45t
NFHFHFNC HFHFMFNC
3377342
0000000 3355122
000656 -17 16 14 45 47 16 23 • 161
SURPLUS • 122 TO BE COLLECTED • 736
Mote: NC • Non-caucasIan. Not Included in regional or grand totals.
O
en
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MIDWEST RESEARCH INSTITUTE
425 Volker Boulevard
Kansas City. Missouri 64110
Telephone (816) 753-7600
Telefax (816) 753-8420
EXAMPLE OF RECRUITMENT REPORT
February 5, 1990
Ms. Janet Remmers
Field Studies Branch, TS-798
Office of Toxic Substances
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Subject: NHATS Recruitment Report No. 78, Work Assignment No. 20,
EPA Contract No. 68-02-4252.
Dear Janet:
Attached is the recruitment report for January 16 through January 31, 1990.
If you have any questions or comments, please call me.
Sincerely,
AL
Kay Turman
Work Assignment Leader
KT/lro
cc: Lori Bailey
Carol ee King
8863-20 File (2 copies)
D-7
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RECRUITMENT ACTIVITIES
NHATS (8863-20-01)
January 16-31, 1990
oo
MSA/Target cooperator
Denver, CO
St. Joseph Hospital
Denver, CO
St. Anthony Hospital
Central
Denver, CO
AMI-Presbyter1an-
St. Luke's Medical
Center
Activities
Future activities
Remarks/comments
Identified prospective coopera-
tor (Dr. T1m Morgan) and
sent recruitment packet on
January 17. When contacted
January 23, Dr. Morgan declined
to participate, due to low
staffing.
Identified prospective coopera-
tor (Dr. Elwln Smith) and
sent recruitment packet on
January 17. When contacted
January 23, Dr. Smith said they
were still understaffed. He
passed the packet to Dr. Derek
Knopka, who was out of town
that day. When contacted
January 26, Dr. Knopka said
"no" to participation.
Identified prospective coopera-
tor (Dr. Kenneth Holloman) and
sent recruitment packet on
January 17. When contacted on
January 23, Dr. Holloman said .
"yes" to participation, after,
his questions on confidentiality
were answered. Post-recruitment
letter and supplies sent
January 24.
None.
Problems have arisen
with one of the
current cooperators.
None.
Previous "no" due to
low staffing (5/87).
they said to recon-
tact them 1n the
future.
New cooperator.
Previous cooperator.
dropped out when the
contact person (a
resident) left and
was not replaced
(6/88).
(continued)
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RECRUITMENT ACTIVITIES (CONTINUED)
NHATS (8863-20-01)
January 16-31. 1990
MSA/Target cooperator
R1chland-Kennew1ck-
Pasco, WA
Franklin County
Coroner's Office
R1chland-Kennew1ck-
Pasco, WA
Benton County Coroner
R1chland-Kennew1ck-
Pasco. WA
Kadlec Medical Center
Activities
Future activities
Identified prospective coopera-
tor (Ms. Mavis Williams) and
sent recruitment packet on
January 23. Left message
January 26. When contacted
January 29. Ms. Williams said
that they did very few actual
autopsies (only IB 1n 1989),
and would not be able to
participate. She said that
Benton County has a much
greater case load.
Identified prospective coopera-
tor (Mr. Floyd Johnson) and sent
recruitment packet on January 23.
Left message January 29 and
Mr. Johnson called back the same
day. He said that they hire a
different pathologist to do each
autopsy. If the case 1s In
Richland. 1t 1s performed at
the hospital and 1f the case 1s
1n Kennewlck, the autopsy 1s
performed at a mortuary. It
would be too hard to coordinate
collection, so he said "no" to
participation.
Identified prospective coopera-
tor (Dr. Thomas Mahony) and
sent recruitment packet on
January 31.
None.
Remarks/comments
Replacement MSA for
Medford, OR.
None.
Replacement MSA for
Nedford, OR.
Contact Dr. Mahony the
week of February 5 to
answer questions and
request participation.
No other possibili-
ties 1n this MSA.
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NHATS TRIP REPORT
Date of Visit 03-16-90
Cooperator Ohio State University
Hospital (Columbus)
NHATS Staff Kay Turman
SUMMARY OF VISIT
I met with Scott Jewell, the replacement for Karen Donovan,in their
new enlarged facilities. He had familiarized himself with the
program, and we briefly discussed the purpose and operation of the
program. He assured me that the people doing the collection will
continue. Also, he is enlisting the help of autopsy service to
collect more cases. We went over the missing information, and he
requested I send the PSRs by mail and he will obtain the
information and mail it to me. Scott introduced me to Teresa, one
of the contact people I have spoken with on the phone. Status
calls can be directed to Teresa or Scott. They would like copies
of results as they become available.
CONCLUSIONS
Collection is going well at this facility. Involvement of autopsy
service'should permit them to fill the guota. New contact person
appears very cooperative and willing to improve the collection at
his facility.
ACTION ITEMS
Continue regular contact. Send request for missing information on
previously received PSRs to Scott.
D-10
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&EPA
NEWSLETTER COVER
NHATS
National Human Adipose Tissue Survey
Newsletter
January 1990
Midwest Research Institute
425 Volker Boulevard
Kansas City, MO 64110
U.S. Environmental Protection Agency
National Human Monitoring Program
Exposure Evaluation Division (TS-798)
Field Studies Branch
401 M Street, S.W.
Washington, DC 20460
D-ll
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EXAMPLE OF STATUS REPORT
National
Tiss
ue
urvey
FY88 Summary
FY89 Outlook
S-EPA
D-12
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O
I
Last Year
Fiscal Year 1988
(October 1,1987 - September 30,1988)
With 95% of shipments received ...
approximately 70% of the FY88 goal has been
achieved:
60%
83%
73%
81%
68%
62%
64%
67%
69%
70%
Pacific Mountain West
North
West
South
East
North
East
South
South
Atlantic
Middle
Atlantic
New
England
Overall
Central Central Central Central
With all 47 cities in the survey contributing...
936 adipose tissue specimens have been
received for research purposes.
THANK YOU FOR YOUR CONTRIBUTION!
This Year
Fiscal Year 1989
(October 1,1988 - September 30,1989)
• With your help, the FY89 goal of 1377
adipose tissue specimens can be achieved!
Collection and shipment early in the fiscal
year helps us to process the specimens more
effectively and to identify and solve
problem areas quickly.
- Collect and ship at least 1/2 of your
quota by March 31.
- Use the Federal Express airbill supplied for
shipping your adipose tissue specimens to
Midwest Research Institute.
• Research Results Upcoming!
Final analysis reports are expected:
- Comparing Vietnam veterans' adipose tissue levels
of dioxins and furans with those of the U.S.
population.
- Summarizing baseline levels of pesticides, PCBs
and other semi-volatile compounds in the FY 86
specimens.
~ Summarizing baseline levels of dioxins and furans
in the FY 87 specimens.
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