-------
SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 2 of 9
2.10 HOUSEHOLD IDENTIFICATION NUMBER(HHID) = A unique number and character
combination which is assigned to each respondent household for
identification purposes. This number must be recorded on all data
(forms, samples, questionnaires and correspondence) generated by the
household.
2.11 MATERIALS TECHNICIAN = The employee of the research project who is
responsible for assembling and assigning field forms, questionnaires and
equipment for field use.
2.12 N/A = Not Applicable.
2.13 PACKET = A sturdy envelope-like container that can be fully closed and
is large enough to hold the physical data forms generated from sampling
and surveying a study household.
2.14 QUALITY ASSURANCE(QA) = All those planned and systematic actions
necessary for ensuring the accuracy, validity, integrity, preservation
and utility of collected data.
2.15 QUALITY CONTROL(QC) = Those quality assurance actions providing a means
to control and measure the characteristics of a datum, process, or the
adherence to established parameters.
2.16 SAMPLE = That piece of physical data which is collected from the study
participants for the purpose of scientific analysis.
2.17 TEAM LEADER = The member of the field team who is primarily responsible
for respondent contact, data collection, field form and questionnaire
completion, and site QC checks of all data.
2.18 TEAM MEMBER = The member of a field team responsible for assisting the
team leader in the collection of data and quality control checks in the
field.
2.19 TRACKING SYSTEM = A database system containing information about the
custody, transfer and storage of hard copy data, electronic data, field
samples, and field sample alloquats.
2.20 VISIT = A scheduled appointment with participating respondents at their
place of residence (HH) for the collection of samples, questionnaires
and other data.
3.0 REFERENCES
3.1 Lebowitz, M.D. 1993. Study Design (Revision of 31 Dec. 1993). EPA NHEXAS
Cooperative Agreement.
4.0 DISCUSSION
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 3 of 9
4.1 This SOP outlines generalities in the training of field team members.
Pre- and post-field visit activities and on-site data collection
standards. Data retrieval and handling are the primary job
responsibilities of all field team members. Team members are expected to
execute their responsibilities in an exhaustive and comprehensive
fashion in accordance with stated protocol.
4.2 Data collected in noncompliance with minimum quality control checks and
standards are considered questionable and of limited use to the research
endeavor. Proper sample collection, custody and handling must concern
all field staff.
5.0 RESPONSIBILITIES
5.1 The Field Coordinator is responsible for:
(a) overall quality of the data retrieved by the field teams,
(b) post-field QA checks of all data collected by the field teams,
(c) accepting custody of all data returned from the field.
5.2 The Team Leader is responsible for:
(a) overall quality of data collected from the HH,
(b) HH and Respondent interaction with the study,
(c) coordination and direction of team members in the field,
(d) quality assurance & control issues in the field,
(e) Chain of Custody procedures and records.
5.3 All Team Members are responsible for:
(a) obtaining all data according to protocol,
(b) properly labeling and storing the collected sample,
(c) fully completing all applicable fields on data form,
(d) quality control checks in the field.
6.0 MATERIALS AND REAGENTS
6.1 Materials
Materials required to successfully achieve the minimum standards
demanded by this protocol will vary according to the data collection
method employed.
6.2 Reagents - N/A
7.0 PROCEDURE
7.1 Preparation (Pre-Field Procedures)
(a) Pre-field standards expected of all team members include
punctuality, professionalism, safety and reliability.
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 4 of 9
(b) The particular equipment requirements for the preparation of field
visits and sampling are outlined in the appropriate sampling
protocol. Field kits must be adequately stocked and maintained at
all times.
(c) HH buckets will be maintained by the Team Leader for the duration
of sampling during each visit series or stage.
(d) Pre-field checks of equipment are required of all Team Members.
(e) The nature of this research project requires flexibility and team
members must be prepared to respond to a variety of sampling
environments. "Back-up" plans and necessary supplies to respond to
these different environments may become a key element in the
success of the sampling visit and the research project as a whole.
(f) The Team Leader will have access to the Confidential Home
Appointment Sheet (Fig. 2) which details confidential address and
last name information for the purpose of HH contact. This sheet is
produced through an interface of the Confidential database and the
NHEXAS tracking system.
(g) This confidential information is not to be revealed to anyone
without a critical need to know. No-one other than project
personnel directly involved with the field sampling component of
this research study would have any legitimate reason to inquire as
to the identity of persons participating in this project (see
UA-G-3.0).
1.1 Reagents - N/A
1.2 Standards & Blanks - N/A
2 In-Field Procedure
(a) Team Leader coordinates with Stage 1 interviewer and makes sure
informed consent has been obtained. If not, he or she obtains
consent to sampling from respondent(s) in each HH. The team leader
then assigns sampling tasks to team members.
(b) Sampling will proceed according to the appropriate SOPs. All team
members must adhere to accepted sample collection methods. Records
of sampling and data sheets must be completed comprehensively and
exhaustively.
(c) In-field QC checks of data and method are the responsibility of
all field personnel. Specific cross-check tasks will be assigned
by the Team Leader. Team members will double check each others
work to insure compliance with the appropriate protocol and
prevent error.
(d) Every form, questionnaire, sample and data item collected must be
labeled with the HHID, type of sample, date of collection, time of
collection and collecting Team Member's initials at a minimum.
(e) Before leaving the sampling environment all equipment and samples
will be inventoried and sampler placement verified by the Team
Leader. Arrangements for the follow-up visit will be made by the
Team Leader.
(f) Samples will be stored according to protocol for transport back to
the Field Office.
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 5 of 9
7.3 Post-Field
(a) Samples collected will be stored and processed upon return to the
Field Office as defined in the appropriate SOP. The original
completed Chain of Custody Record (Fig.l) will be secured with the
sample at all times.
(b) The Team Leader will review the visit with other team members to
promote a continual feedback process. The team will collectively
review data and forms collected to insure completeness of data
records.
(c) The Team Leader will forward the original forms to the Field
Coordinator within 24 hours of collection.
(d) Team Leader will report sampling accomplished and the follow-up
visit date to the Field Supervisor through the use of a Visit
Summary Sheet (Fig. 3).
7.4 Analyses - N/A
7.4.1 Standards/Blanks - N/A
7.4.2 Samples - N/A
7.5 Calculations - N/A
7.. 6 Quality Control
7.6.1 Tolerance Limits
All data collected will be 100% QA checked.
7.6.2 Detection Limits - N/A
7.6.3 Corrective Actions
Apparent mislabeling problems detected in the field may be corrected by
the Team Members when appropriate and in compliance with SOP #UA-C-2.0.
In the HH sampling site, the Team Leader supervises all work, assigns
cross-checking tasks, and QC checks all completed forms. Team members
work collectively and check each other's work for accuracy, precision
and compliance with the appropriate SOPs. The Team Leader must QC check
each form retrieved within 24 hours of collection at which time it is
forwarded to the Field Coordinator for QA check. The Field Coordinator
must QA check the data record within 24 hours of receipt from the Team
Leader, or within 48 hours of collection by the field team.
8.0 RECORDS
8.1 General
Specific records will vary according to procedure defined in the SOP.
All records will be completed exhaustively and comprehensively by
assigned field members. Without proper documentation, the data collected
by Team Members is not usable.
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 6 of 9
8.2 Data Sample
All sample containers will have HHID, date, time, sample type and Team
Member initials recorded upon it with indelible ink. Sample containers
will be processed for SOP-specified shipment and analysis upon return to
the Field Office.
8.3 Chain of Custody Record (Fig. 1).
This record will serve as the primary record of sample custody after
collection in the field. The Team Leader is responsible for the thorough
completion of this form. The completed original Chain of Custody Record
will remain with the data sample.
8.4 Confidential Home Appointment Sheet (Fig. 2).
This record is produced by a link between the confidential database and
the NHEXAS tracking system. It is one of the fundamental tracking
records of the NHEXAS Arizona project.
8.5 Visit Summary Sheet (Fig. 3).
This record is produced by the Team Leader at the conclusion of each HH
visit. It is then submitted with all data records which have been QC
checked by the Team Leader to the Field Coordinator within 24 hours of
visit completion. It provides a summary of the field sampling activities
by the field team on that visit.
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 7 of 9
Figure 1. Chain of Custody Record.
Chain of Custody Record
NHEXAS Arizona Project (CR-821560)
Respiratory Sciences
1435 N. Fremont Ave
Tucson, AZ 85719
(520) 626 - 4226
Sample. Tvpe: . . . page of
frpnprared hv: /
print name signature
Date
Generated
Time
Sample ID
# of
Containers
Remarks
/ /
History of Sample Handling and Custody
Relinquished
or
Received
Signature
Date
mo / day / yr
Time
Action
[Rell or |Rec[
/ /
I Re! I or |Rec|
/ /
j Rel' or I RecI
/ /
/ /
/ /
/ /
/ /
/ /
/ /
/ /
/ /
/ /
/ /
/ /
| j Rel I or IRccI
/ /
FORM = UA-G4 0 - 12 Attach Additional Pages as Necessary
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 8 of 9
Figure 2. Confidential Home Appointment Sheet
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SOP #UA-T-3.0
Revision # 0
14 Feb. 1995
Page: 9 of 9
Figure 3. Visit Summary Sheet
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-------
Appendix B: Household Summary & Packet Contents Form
-------
HOUSEHOLD SAMPLING SUMMARY
NHEXAS
Border
Stage # j
Collapsed?
FORM
ua 3 2.1
Y N
o o
8
o
Team
Leader;
Qc By:
Init.
Tech ID
Tech ID
HHID
F.S.
Init.
QC: ^ [ ]
MO
DAY
YR
MO
DAY
YR
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2 72 on:
/
/
/
/
or N/A [ ]
or N/A f 1
3. V3 on:
4. V4 on:
\n
/1
or N/A [ ]
or N/A [ ]
HOUSEHOLD
' impie
ype
PIT Indoors
PiL Outdoors
Sc tine!
) Metals
H2 ) Pests
^ vocs
H2 ) Carb
Collected
Y N N/A
G O O
O O O
O Q O
Y N N/A
o o o
' o o
o
OVM Indoors
C c..Outdoors
PP: Indoors
r: Outdoors
Ca;"bo Trap In
Carbo Trap Out
P" Indoors
Prr Outdoors
Y N N/A
o o o
Y N N/A
Sample
Status
QC:
LEVEL SAMPLES
Sample
Type
Yard Soil
Foundation Soil
Soil Thin Film
Floor Dust
Collected
Y N N/A
Sill Wipes
Sill Thin Film
o
Y N N/A
o o c
Y N N/A
O O G
G G: "
Y N N/A
Sample
Status
QC:
z'
Status Codes:
1 = Completed
2 = Not - Completed
3= Partially Completed
4 = Re-Collected
5 = Refused
7 = Destroyed
8 = N/A
9 = Missing
Data Use
Only:
0 1
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o o
4 5
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6 7
0 0
8 9
0 0
A B
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Form Id: UA-C-6.0-1.1 U 1 of 4 pages
-------
HOUSEHOLD LEVEL FORMS
PAGE 2
HP. Summary
Form
Type
Collected
Form
Status
^ ฐ
.9
PID Sheet
Y N N/A
O O O ฆ
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j
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i
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!
[ 1
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[ ]
Hi'O ' .irb
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[ ]
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[ ]
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o o o
[ ]
Y N N/A
PM Sheet
o o o
[ ]
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[ ]
F' .0! L us!
Y N N/A
r
i
[ ]
Form
Type
Tech QX
Descriptive QX
Collected
Y N N/A
Y N N/A
Status Codes:
1 = Completed
2 = Not - Completed
3= Partially Completed
4 = Re-Collected
5 = Refused
7 = Destroyed
Comments:
Form
Status
QC:
8 = N/A
9 = Missing
C^mrrv-ntS'
Data Use
0 1
2 3
0 0
4 5
0 0
6 7
0 o
8 9
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Form Id: UA-C-6.0-1.1 U 2 of 4 Pages
-------
ฆ i INDIVIDUAL LEVEL FORMS PAGE 3 ฆ
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-------
INDIVIDUAL LEVEL SAMPLES
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PAGE 4
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Comments
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iple
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o
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Comments
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MO
DAY
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DE:
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/
init.
DP Batch:
QXV:
F SIU M 1
Chain of custody initiated (sig.):
Consigned to packet on: [ ] /_
Box UA G4-2.0
Data Use
Only:
0 1 | 2 3
4 5
6 7
8 9
A
B
c
D
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7706
Form Id: UA-C-6.0-1.1 U 4 of 4 pages
-------