905R93010
REGION 5 STANDARD OPERATING
PROCEDURE FOR VALIDATION OF
CLP INORGANIC DATA
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION 5
CENTRAL REGIONAL LABORATORY
SEPTEMBER, 1993
U.S. Environmental Protection Agenc*
Region 5, Library (PL-12J)
77 West Jackson Boulevard, 12th Fkw
Chicago, II 60604-3590
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<\
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.p. J. Churilla, Chemist, TPO
United States Environmental Protection Agency
Region V
Environmental Sciences Division
Central Regional Laboratory/Laboratory Scientific Support Section
Chicago, Illinois
INDEX
CK 1. INTRODUCTION
t-O 2 . DATA REVIEW PACKAGE FORMAT
^ 3. INORGANIC DATA REVIEW NARRATIVE
^ 4. SAMPLE RE-ANALYSIS
5. DATA REJECTION
APPENDIX A: INORGANIC DATA REVIEW NARRATIVE FORMS
i. Region 5 Transmittal Form
ii. Data Review Narrative Cover Sheet
iii. Data Qualifier Sheet
iv. CLP Regional/Laboratory
Communication System Telephone
Record Log
v. CLP RAS/SAS Re-Analysis
Request/Approval Record
vi. Regional Response to Results of
Contract Compliance Screening (CCS)
vii. CLP TPO Communications Summary
APPENDIX B: SAMPLE/DATA TRACKING FORMS
i. Central Regional Laboratory Sample
Data Report Organics/Inorganics
ii. Inorganic Traffic Report (IRT)
iii. SAS Packing List
iv. Data Tracking Form for Contract
Samples
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1. INTRODUCTION .
Goals
The purpose of this document is to present guidelines to
Region 5 inorganic data reviewers for addressing technical
areas which are left open to interpretation in the "Laboratory
Data Validation Functional Guidelines for Evaluating
Inorganics Analysis", October 1989 revision. While this
standard operating procedure (SOP) will primarily focus on
samples analyzed through the Contract Laboratory Program (CLP)
Inorganic Routine Analytical Services (RAS), data obtained
through CLP Special Analytical Services (SAS) will be
discussed.
Several goals are sought to be achieved through this standard
operating procedure. These include:
o Review narratives of greater uniformity which address all
deficiencies and their impact on data usability.
o Review narratives which can be used to note problems with
laboratory performance and can be used by the CLP
Regional Technical Project Officers (CLP TPO) for
corrective action.
Guidance and Responsibility
This SOP provides technical guidance for qualification of
outliers in areas which the Functional Guidelines
characterizes as " professional judgement required".
The format for CLP Inorganic Data Review Narratives is
outlined for order and content. No deviation will be
permitted since this would increase the amount of time
required for both the Inorganic Data Review Coordinator and
the data users to examine results.
The SOP will also examine additional responsibilities of the
front line data reviewer including review of Contract
Compliance Screening (CCS) results/responses, recommendations
for rejection of data or reanalysis of sample fractions,
discussions with contractor laboratories, and identification
of special technical requirements as found in SAS or PRP
analyses.
This SOP cannot address every specific case situation but the
reviewer should bring to the attention of the Inorganic Data
Review Coordinator/Task Monitor problems which cannot be
resolved.
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Data Review Timeliness
The revised Memorandum of Agreement between Waste Management
Division and the Environmental Sciences Division dated
December 19, 1991 addresses timely data review. The standard
turn around time is 21 days for either RAS or SAS review.
This time can be shortened to 7 days for prioritized samples
on an exception basis.
All data review tracking is done by the Laboratory Scientific
Support Section within ESD. A weekly report is generated
showing due dates and the status of the review for all cases
received from contract laboratories. It is imperative that
all reviews are done within the turn around time given and
presented to the inorganic data review coordinator/task
monitor. This will allow time to overview and make any
recommendations for partial or non-payment of CLP
laboratories.
Data Acceptance/Rejection
The TPO has the responsibility to initiate any data rejection
or reduced useability actions for Region 5 based on the review
recommendations. Most of the data is acceptable for use or
acceptable for use with qualifications. For both acceptance
and rejection of data SMO is notified. Acceptance is
indicated through a copy of the Region 5 transmittal Form and
data review sent to SMO. Rejection is indicated through the
Regional Data Rejection/Reduced Value Form sent to SMO by the
TPO.
2. DATA REVIEW PACKAGE FORMAT
The following will outline the components of the data package
in the order that it must be returned to the USEPA Region 5
inorganic Data Review Coordinator/Task Monitor. The three
major components of the data review package are:
o Inorganic Data Review Narrative
o Laboratory QC and Results
o Additional case DeliverabLes
The Inorganic Data Review Narrative and the Laboratory QC and
Results comprise the data user package. The third component
is never sent to the data user unless a copy is specifically
requested (this does not apply to PRP data since the entire
data review package is returned to the data user requesting
assessment).
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These three major components are broken down into a number of
parts described below:
2.1 Inorganic Data Review Narrative
o Region 5 Transmittal Form
o Data Qualifier Sheet(s)
o Data Qualifier Definitions
o QC Exception Summary Report
o As applicable:
i. CLP Regional/Laboratory Communication System
Telephone Record Log initiated by the data
reviewer, laboratory, or TPO/RSCC.
ii. CLP RAS/SAS Re-analysis Request/Approval Form
iii. Regional Response to Results of Contract
Compliance Screen (CCS) with copy of
accompanying memo.
iv. CLP TPO Communication Summary
2.2 Laboratory QC and Results
o Central Regional Laboratory Sample Data Report
Organics/Inorganics
o Inorganic Traffic Reports (IRTs) or SAS Packing
Lists
o Case Narrative from the contractor laboratory
o Cover letters for resubmitted/additional/missing
data from the contractor laboratory
o Inorganic Data
i. Inorganic Analyses Data Sheet - Form I
(including undiluted, diluted and reanalyses)
ii. Method Blank Summary Form III
ii. Spike Sample Recovery Form V (part 1)
iii. Post Digest Spike Sample Recovery Form V
(part 2)
iv. Duplicates Form VI
v. Instrument Detection Limits Form X
o Data Tracking Form for Contract Samples
2.3 Additional case Deliverables
All other case deliverables should be in the required
order specified for the current CLP Statement of Work
(SOW) . The contractor laboratory is required to paginate
all deliverables and the data reviewer must restore the
data package (minus those items listed in section 2.1 and
2.2 above) to the original order. If the original order
is not restored, a great burden may be placed upon the
Inorganic Data Review Coordinator or anyone required to
examine the data at a later date. Please refer to
Exhibit B of the SOW concerning order of deliverables.
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Case deliverables also include additional submissions
such as Contract Compliance Screens, laboratory responses
to CCS, and additional or missing data. Case
deliverables should be in the following order:
o Contract Compliance Screen
o Laboratory Response to Contract Compliance Screen
(Blue Cover Sheet).
o Additional or Duplicate Data Submissions (Yellow
Cover Sheets).
o Remaining Case Deliverables restored to original
order according to the SOW.
The three components of the data package must be packaged
as follows to expedite review by the USEPA Inorganic Data
Review Coordinator and xeroxing by clerical staff:
o Inorganic Data Review Narrative - held together
with a paper clip.
o Laboratory QC and Results - held together with a
rubber band. Both the Inorganic Data Review
Narrative and Laboratory QC and Results are held
together with a rubber band.
o Additional Case Deliverables - held together with a
rubber band.
o Entire data review package is held together with a
rubber band (if too large, use a box).
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3. INORGANIC DATA REVIEW NARRATIVE
3.1 Outline
The Inorganic Data Review Narrative is the primary description
of outlier performance and reference point for all
qualifications of results. The purpose is to provide a clear
and concise narrative which addresses all technical and
contractual areas which the data reviewer has examined.
Supporting documentation such as telephone logs, reanalysis
requests, and memoranda for rejection of data will also be
included in this review package component.
The Inorganic Data Review Narrative consists of these major
elements:
o CRL Transmittal Form: The EPA data review task monitor
signs and dates this form and indicates the final
disposition of the case to the user.
o Data Qualifier Sheets: This provides discussion of the
technical and contractual points which each reviewer
examines in each Inorganic case. Each of these points
must be addressed for each sample fraction (TCP, GFAA,
Mercury and Cyanide) unless otherwise indicated:
i. Holding Time
ii. Calibration
iii. Blanks
iv. Interference Check Sample
v. Laboratory Control Sample
vi. Lab and Field Duplicate Sample Analysis
vii. Matrix Spike Analysis
viii.Furnace Atomic Absorption QC
ix. ICP Serial Dilution
x. Sample Result Verification
xi. Additional Case Specific Problems - only if
observed
The following items are also found in the Inorganic Data Review
Narrative if applicable:
o CLP Regional/Laboratory Communication System Telephone
Record Log
o CLP RAS/SAS Re-analysis Request/Approval Form
o Regional Response to Results of Contract Compliance
Screening (CCS). Copies of the completed green cover form
and supplementary memo are inserted if either:
i. Data has been determined to be non-compliant by CCS
but is determined to be usable by the region.
ii. Data is unusable by the Region and :s both
technically and contractually non-compliant.
o CLP TPO Communication Summary
Copies of communications between laboratories, CLP TPOs
and/or APOs are included if technical/contractual
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problems .of a potentially broad nature (i.e. internal lab
problem as opposed to a matrix problem) are observed.
These will be noted in the Data Qualifier Sheets for
outlier performance for the case at hand.
3.2 Detailed instructions for Completion of Inorganic Data
Review Narratives
The primary guidance for qualification of CLP RAS data
shall be the current edition of the Inorganic Functional
Guidelines. In addition to format and style, further
definition of qualifiers is discussed below under the
appropriate subject. Copies of all necessary forms may
be found in Appendices A and B.
3.2.1 CRL Transmittal Form
The reviewer should check off at least one of the four
statements on the bottom of the cover sheet which best
characterizes status of the data.
o Data are acceptable for use
o Data are acceptable for use with qualifications
referenced above. See Data Qualifier sheets and
Calibration Outlier forms for details.
o Data are preliminary - pending verification by
contractor laboratory. See case summary above.
o Data are unacceptable. See case summary above.
The first statement would be used rarely since any qualifier
would void its use. The second statement is the most common
in use since almost all cases will have some qualified
results. The third statement is used when a deliverable is
missing requires clarification, or reanalyzed/resubmitted data
is required but some preliminary results may be transmitted.
The fourth statement refers to samples or fractions which are
determined to be unusable. Data that has been found to be
both technically and contractually unusable will be returned
to the Sample Management Office (SMO). The details of data
rejection are described in Chapter 5.
3.2.2 Cover Sheet.
The cover sheet will present a brief summary of major case
problems and the status of the data. A major problem is
defined as situations where one or more sample fractions are
totally estimated or unusable.
The cover sheet will categorize the number of samples, matrix
type (i.e. water, soil), and analytical service (i.e. full RAS
inorganics, metals only, SAS). If the analytical service is
a SAS, the nature of the SAS must be described (i.e. fast
turnaround, low detection limits, additional/alternate
parameters, high hazard).
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The cover sheet shall reference other narrative sections such
as data qualifier sheets and calibration outlier forms which
detail outliers of performance. The reviewer should never
attempt to cram the full details on the cover sheet.
The hours required to complete the review should be noted.
3.2.3 Region 5 Data Qualifiers
This section details Region 5's variations from the inorganic
National Functional Guidelines and those areas where the
Region feels it can replace the "professional judgement"
criteria found in the National Functional Guidelines with more
definitive guidance.
3.2.3.1 Holding Times
The following table indicates the holding time criteria being
used in Region 5. Soil and sediment criteria are the same as
the criteria for water samples though they are not preserved.
METALS: >6 MONTHS UNUSABLE (R)
MERCURY: >28 DAYS ESTIMATED (J) >56 DAYS UNUSABLE (R)
CYANIDE >14 DAYS ESTIMATED (J) >28 DAYS UNUSABLE (R)
3.2.3.2 Calibration
The Regional guidance follows the National Functional Guidelines
with respect to %recovery for the ICV and CCV.
If the calibration curve coefficient is < 0.995, check to see if
the curve was generated using a computer assisted second degree
fit. If not, qualify sample results > IDL (> CRDL for CN and Hg)
as estimated (J) and results < IDL (< CRDL for CN and Hg) as
estimated (UJ).
3.2.3.3 Blanks
This criteria applies to all calibration blanks, preparation blanks
and field blanks.
For blanks with analytes having negative results whose absolute
value exceeds the CRDL, all associated sample results are qualified
as unusable (R).
For blanks with analytes > IDL but < 5X the CRDL, associated sample
results < 5X the blank level are reported as undetected (U); sample
results > 5X the blank level are qualified as estimated (J).
For blanks with analytes > 5X the CRDL, all associated samples are
unusable (R) and the system is considered out of control.
3.2.3.4 Interference Check Sample
The evaluation of the interference check sample follows the current
National Functional Guidelines for inorganic data validation.
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3.2.3.5 Laboratory Control Sample
The evaluation of the laboratory control sample follows the current
National Functional Guidelines for inorganic data validation.
3.2.3.6 Laboratory Duplicates and Field Duplicates
Field duplicates are evaluated with the same acceptance criteria as
the laboratory generated duplicates. If duplicate analysis results
for a particular analyte fall outside the appropriate control
limits, qualify the results for that analyte in all associated
samples of the same matrix as estimated (J). If a field blank was
used for duplicate analysis, all other QC data must be carefully
checked and professional judgement used to determine any
qualification of the data.
3.2.3.7 Matrix Spike Sample Analysis
The evaluation of the matrix spike sample follows the criteria
specified in the current National Functional Guidelines except with
regard to post digestion spikes. Post digestion spikes should be
evaluated with the same criteria as the other spike samples.
3.2.3.8 ICP Serial Dilution
The %Difference between the sample and the dilution should be
within 10%. If this criteria are not met the results for the
effected analyte are flagged as estimated (J) regardless of whether
positive interference or negative interference is indicated by the
serial dilution.
4. Sample Reanalysis
Under certain circumstances it is necessary to request a laboratory
to reanalyze samples. These circumstances generally fall into two
categories:
4.1 First, some reanalyses are automatically required by contract.
For example, when surrogate recoveries do not meet acceptance
criteria the lab must rerun the sample to determine if this is a
matrix problem or a lab problem.
4.2 Second, reanalysis may be necessary because of laboratory
error. For example, if a lab over diluted a sample or failed to
run a lab blank with that particular sample, reanalysis may be
required. In this case the reviewer first must discuss the problem
with the TPO and the data user to determine if reanalysis should be
done.
4.3 In both cases the TPO must sign a reanalysis request form
which is forwarded to the Sample Management Office and the APO in
Headquarters who approves the reanalysis and determines if the lab
can request payment for it. The Region can not directly request a
lab to do additional work.
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5. Data Rejection, and Reduced Value Determination
5.1 In some cases reanalysis can not fix the defective data. This
is often due to lack of sample or exceeded holding times. In these
instances the data may be rejected and payment withheld from the
laboratory. The decision not to use data is the sole decision of
the Region. If the Region recommends that the data be rejected the
rejection must be based on contractual requirements if there is to
be any reduced payment to the laboratory. There are two clauses in
the CLP contract that allow for reduced value and data rejection
determinations: The Inspection of Services clause and the Warranty
of Services clause.
5.2 Actions Under the Inspection of Services clause
This clause allows the Government to reduce the contract price to
reflect the value of the services performed. The evaluation of the
RAS services performed must be completed within the 30-day time
period following the EPA's receipt of the data. For SAS's this
time period is 45 days. Before any data is rejected the data user
is consulted by the Technical Project Officer (TPO) to confirm that
the data is unusable for the purpose it was collected. The TPO
prepares a memo to the Sample Management Office explaining the
contractual reasons for rejection or reduced payment which is sent
to SMO with any rejected data and a completed Data
Rejection/Reduced Value Form. The TPO's recommendation for the
reduced value of the data should attempt to answer the question,
"If this is the quality of the data I ordered, what would I have
paid for it?" The reduced value recommendation must be resolved by
EPA and the laboratory before the lab can be paid.
5.3 Actions Under the Warranty of Services Clause
The Warranty of Services clause is intended to provide protection
against problems with non-compliant data fund after acceptance has
occurred. This clause allows data rejection or reduced value
determinations by revoking acceptance of the data for the following
reasons:
o Latent defects (Detects which couldn't be discovered
using normal inspection techniques)
o Contractor Fraud
o Gross Mistakes
o Warranties not met by the contractor
Revocation of acceptance must be accomplished within 90 days
following the original acceptance of the data. Acceptance and the
beginning of the 90-day Warranty of Services Period occurs when the
Region transmits a copy of the completed data review to the Sample
Management Office or 30 days after the data package is received by
the Region; whichever occurs first.
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5.4 Under both clauses, whether the data is being rejected or
recommended for reduced value, the TPO's first action should be to
notify SMO by phone that a recommendation is going to be made
regarding payment for the data. This should prevent accidental
payment of the lab before usability has been determined. It should
also be noted that rejections under both the Inspection of Services
and Warranty of Services clauses do not have to be rejections of
the entire data package but may be limited to specific fractions
and samples.
6. Actual Damages
In some cases the laboratory does not deliver any data because it
did not analyze the samples. This may be due to sample loss or
destruction, instrument breakage or missed holding times. In such
cases, when the Government does not receive the data, it may pursue
actual damages under the Authority of the Risk of Loss to
Government Samples. To make a claim for actual damages the TPO
informs the Regional Project Manager (RPM) of the situation who
then submits a written claim to the APO in Headquarters detailing
the actual sampling costs that the Government will incur by
resampling. The APO will forward the request and documentation to
the CO who will then negotiate the actual damages amount with the
CLP laboratory.
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APPENDIX A
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. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION V
DATE:
SUBJECT: Review of Region V CLP Data
Received for Review on
FROM: Charles T. Elly, Director(5SCRL)
Central Regional Laboratory
TO: Data User:
We have reviewed the data for the following case(s).
SITE NAME: SMO Case No._
No. of DU/Activity
EPA Data Set No. Samples Numbers
CRL No.
SMO Traffic No.
CLP Laboratory: Hrs . for Review_
Following are our findings:
( ) Data are acceptable for use.
( ) Data are acceptable for use with qualifications.
( ) Data are preliminary - pending verification by laboratory
( ) Data are unacceptable.
cc: Elenor McLean, Sample Mgmt.Office
Edward Kantor, EMSL-Las Vegas
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DATA QUALIFIERS
PAGE OF
CONTRACTOR:
CASE
Below is a summary of the out-of-control audits and the
possible effect on the data for this case:
Reviewed by:
rbore:
Date:'
Hrs. Required
for Review:
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PAGE OF
DATA QUALIFIERS
Contractor: I Case
Below is a sun^a'y of the out-of-control audits and the possible effect on the
data for this case:
Reviewed by:
Phone:
Date:
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In Reference to Case No(s):
Contract Laboratory Program
REGIONAL/LABORATORY COMMUNICATION SYSTEM
Telephone Record Log
Date of Call:
Laboratory Name:
Lab Contact:
Region:
Regional Contact:
Call Initiated By: Laboratory Region
In reference to data for the following sample number(s):
Summary of Questions/Issues Discussed:
Summary of Resolution:
Signature Date
Distribution: (1) Lab Copy, (2) Region Copy, (3) SMO Copy
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CONTRACT LABORATORY PROGRAM
SAS RE-ANALYSIS REQUEST/APPROVAL RECORD
SECTION A
//I. SAS No. 112. DPOorRSCC
. Details of Re-Analysis Request:
o Laboratory Name:
o Sample No(s). «• Parameter(s):
o Reason for Re-Analvsis:
o Procedure for Re-Analysis:
//<». Name of SMO Contact: Date / /
REQUEST: Approved Not Approved
RE-ANALYSIS: Billable Not Billable
SECTION B (TO BE COMPLETED BY SMO)
ill. Date of Laboratory Notification (Verbal) / /
//2. Re-Analysis Start Date / / //3. Data Due Date / /
SECTION C (COORDINATOR CONCURRENCE)
Concurrence By \ Date / /
SMO Coordinator Signature
Return intact form to:
Sample Management Office
P.O. Box 818
Alexandria, Virginia 22313
Distribution: (1) DPO/RSCC Copy (2) SMO File Copy (3) Lab Copy
7/22/86
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COVER SHEET
REJECTED/REDUCED VALUE DATA FROM THE TECHNICAL REVIEW OF
ROUTINE ANALYTICAL SERVICES OF
THE NATIONAL CONTRACT LABORATORY PROGRAM
Response date USEPA Region
Data Rejected Reduced Value Considerations (check one)
Technical Project Officer •_
Technical Data Reviewer
Laboratory Name
Case Number
Affected SDGs and Sample Numbers
Data rejected or reduced value recommended for (check appropriate sections)
All OrganJcs Pesticides Cyanide
Volatiles All Inorganics
Semi-Voiatiles Metals
THIS IS A COVER SHEET ONLY. It is used to identify the Regional response to the
technical data review where datr is rejected or considered to have reduced value.
1. If data are rejected this cover sheet must be sent to SMO, CCS Section Leader
accompanied by:
a> A signed memo from the Regional TPO describing the rejection of the data
b) All rejected data
2. If data are recommended for reduced value, this cover sheet must be accompanied by a
signed memo from the Regional TPO describing the justification for reduced value
recommendation. DO NOT RETURN THIS DATA TO SMO.
3. SMO will check the Regional recommendations for reduced value considerations against
the results frorr. CCS.
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-CONTRACT LABORATORY PROGRAM
Deputy Project Officer Communication Summary
Date DPO Notified of Issue: DPO Notified By:
Subject Laboratory: Case/Sas No:
Contact for Resolution:
(Laboratory or PO)
Date of Contact: Call or Visit (Circle One)
Summary of Issues & Resolutions:
Document the issue(s), resolution(s), and action deadlines, if any.
Signature Date
Region
(1) DPO Copy (2) Project Officer Copy (3) SMO Copy (<0 Lab Copy
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APPENDIX B
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION V
ESD Central Regional Laboratory
Data Tracking Form for Contract Samples
Data Set No.__ CERCLIS No..
Case No. Site Nane Location:
Contractor or EPA Lab:. _Data User:
No. of Samples: Date Samples or Data Received:.
Have Chain-of-Custody records been received? YES NO
Have traffic reports or packing lists been received? YES NO
If no, are traffic report or packing list numbers written on the
chair.-cf-custody record? YES NO
If nc, which traffic report or packing list numbers are missing?-
Are basic data forms in? YES N0_
Nc. of samples claimed: No. of samples received:
Received by: Date:
Received by LESS: Date:
Review started: Reviewer Signature:.
Tc~al time spent en reviev;: Date review completed:.
Ccpied by; Date:
Mailed to user bv: Date:
DATA USERS:
Please fill in the blanks below and return this form to:
Sylvia Griffin, Data Kgmt. Coordinator, Region V, 5SCRL
Data received by: ; Date:
Data review received by: Date:
Inorganic Data Complete[ ] Suitable for Intended Purpose[ ] Vif OK
Organic Data Complete [ ] Suitable for Intended Purpose[ ] list
Dioxin Data Complete [ ] Suitable for Intended Purpose[ ] prblms
SAS Data Complete [ ] Suitable for Intended Purpose[ ] below.
PROBLEMS: Please indicate reasons why data are not suitable for
your uses.
Received by Data Kgr.r. Coordinator for Files Date:
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U.S. Eni/irormienlal Protection
Region 5, Library (PL-12J)
77 West Jackson Boulevard, 12th
Chicago, It 60604-3590
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