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pdfEffective 1 October 2010
Revised November 2015
Urine Laboratory
Application Form
National Laboratory Certification Program
(NLCP)
RTI International
Center for Forensic Sciences
3040 Cornwallis Road
P.O. Box 12194
Research Triangle Park, North Carolina 27709
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. The OMB
control number for this project is 0930-0158. Public reporting burden for this collection of information is
estimated to average 4 hours per respondent per year, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA
Reports Clearance Officer, 1 Choke Cherry Road, Room 7-1044, Rockville, Maryland, 20857.
NATIONAL LABORATORY CERTIFICATION PROGRAM
URINE LABORATORY APPLICATION FORM
A. Applicant Laboratory
1. Name of Laboratory: _______________________________________
Address: ________________________________________________
City, State, ZIP: ___________________________________________
Telephone: (____) ____ - _______ FAX: _____ (____) ____ - ______
e-Mail: __________________________________________________
2. Express delivery address (if different from above)
Address: ________________________________________________
City, State, ZIP: ___________________________________________
3. Designated Responsible Person (RP): _________________________
Title/Position: ____________________________________________
Telephone: ___ (____) _____ - ________ Ext. ___________________
e-Mail: ___________________________________________________
If applicable:
Designated Alternate RP (Alt-RP): ____________________________
Title/Position: ____________________________________________
Telephone: ___ (____) _____ - ________ Ext. ___________________
e-Mail: ___________________________________________________
4.
I understand that the answers provided in this application will be
used to determine the applicant laboratory's potential eligibility
for the National Laboratory Certification Program. To the best of
my knowledge and belief, the answers recorded herein are true
and complete as of this date.
Signature, Designated RP
Date
NOTE: Any false, fictitious, or fraudulent statements or information presented in this application form could
subject you to prosecution, monetary penalties, or both. See Sec. 18 U.S.C. 1001; 31 U.S.C. 3801-812.
Urine, Laboratory
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October 2010, Rev. 1115
B. General Laboratory Information
The following table is excerpted from Section 3.4 of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs (Federal Register, 73 FR 71858, 25 November 2008,
effective 1 October 2010):
Initial Test Analyte
Marijuana metabolites
Initial Test Cutoff
Concentration
50 ng/mL
Confirmatory Test
Analyte
THCA1
Confirmatory Test
Cutoff Concentration
15 ng/mL
Cocaine metabolites
150 ng/mL
Benzoylecgonine
100 ng/mL
Opiate metabolites
Codeine/Morphine2
2000 ng/mL
10 ng/mL
Codeine
Morphine
6-Acetylmorphine
2000 ng/mL
2000 ng/mL
10 ng/mL
Phencyclidine
25 ng/mL
Phencyclidine
25 ng/mL
Amphetamines3
AMP/MAMP4
500 ng/mL
6-Acetylmorphine
Amphetamine
250 ng/mL
5
Methamphetamine
250 ng/mL
6
MDMA
500 ng/mL
MDMA
250 ng/mL
MDA7
250 ng/mL
MDEA8
250 ng/mL
1
Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
2
Morphine is the target analyte for codeine/morphine testing.
3
Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects
each target analyte independently at the specified cutoff.
4
Methamphetamine is the target analyte for amphetamine/methamphetamine testing.
5
To be reported positive for methamphetamine, a specimen must also contain amphetamine at a
concentration equal to or greater than 100 ng/mL.
6
Methylenedioxymethamphetamine (MDMA).
7
Methylenedioxyamphetamine (MDA).
8
Methylenedioxyethylamphetamine (MDEA).
1. To be eligible for certification, the laboratory must test for all drug analytes and specimen
validity test measurands required by the Mandatory Guidelines for Federal Workplace Drug
Testing Programs (Federal Register, 73 FR 71858, 25 November 2008, effective 1 October
2010). The laboratory must use the test methods specified by the Mandatory Guidelines for
screening, differential, initial, and confirmatory tests (i.e., drug tests and specimen validity
tests).
1a. Does the laboratory have validated initial drug test assays for the drug classes required
by the Mandatory Guidelines?
___
___
Urine, Laboratory
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
2
October 2010, Rev. 1115
1b. Does the laboratory use an immunoassay method approved, cleared, or otherwise
recognized as accurate and reliable by the U.S. Food and Drug Administration (FDA)
for the initial drug tests?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
1c. Does the laboratory have validated confirmatory test assays for the drug analytes
required by the Mandatory Guidelines? (Note: testing for amphetamine and
methamphetamine enantiomers is optional.)
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
1d. Does the laboratory use methods combining chromatographic separation and mass
spectrometric identification [e.g., gas chromatography/mass spectrometry (GC/MS),
liquid chromatography/mass spectrometry (LC/MS), GC/MS/MS, LC/MS/MS)] for the
confirmatory drug tests?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
1e. Does the laboratory have validated tests to assess specimen validity as required by the
Mandatory Guidelines (i.e., at a minimum, tests for creatinine, pH, specific gravity, and
one or more oxidizing adulterants)?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
1f. Does the laboratory perform testing for amphetamine and methamphetamine
enantiomers?
___
___
Yes COMMENT BELOW
No
Briefly describe the procedure for analysis and reporting of the enantiomers:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
2. Is the laboratory registered with the U.S. Drug Enforcement Agency (DEA)?
___
___
Urine, Laboratory
Yes ATTACH PHOTOCOPY OF REGISTRATION CERTIFICATE
No COMMENT BELOW
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October 2010, Rev. 1115
If YES, which schedules are covered by the registration?
___ 1 ___ 2 ___ 2N ___ 3 ___ 3N ___ 4 ___ 5
If NO, explain how controlled reference materials are
acquired: _______________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Describe the State licensure requirements for urine forensic toxicology for the State in which
the laboratory is located.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
4. List laboratory certifications/licenses:
____ States (List): ________________________________________________________
____ CLIA/HCFA1 (List Specialties): __________________________________________
____ CAP2 (List Specialties): ________________________________________________
____ Others (Specify): _____________________________________________________
1
Clinical Laboratory Improvement Amendments(CLIA)/Health Care Financing Administration (HCFA)
College of American Pathologists (CAP)
2
4a. ATTACH PHOTOCOPIES OF ALL LICENSES AND CERTIFICATIONS INDICATED
ABOVE.
Urine, Laboratory
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October 2010, Rev. 1115
C. Laboratory Standard Operating Procedures (SOP) Manual
1. For certification, the laboratory must have a complete SOP manual that will apply to testing
of regulated specimens under the Mandatory Guidelines for Federal Workplace Drug
Testing Programs (Federal Register, 73 FR 71858, 25 November 2008, effective 1 October
2010).
Note: Manufacturers’ package inserts or instrument manuals are not considered formal
procedures. A written SOP manual is required to be eligible to apply for certification and it
must be completed before the laboratory is eligible to receive NLCP performance testing
(PT) samples.
1a. Does the laboratory have a complete SOP manual for regulated drug testing?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
LABORATORY SOP MANUAL INDEX
Indicate the location for each of these topics in the laboratory's SOP manual:
TOPIC
SECTION
PAGE NO.
Security
Procedure for controlling access to the
drug testing facility
_________ _________
Procedure for controlling access to
individual secured areas
_________ _________
Procedure for documenting visitor access
_________ _________
Accessioning (Specimen receipt)
Procedure for receipt and processing
of specimens
_________ _________
Procedure for accessioning specimens
received from another laboratory
_________ _________
Procedure for problem/rejected specimens _________ _________
Chain-of-Custody
Procedure for documenting all transfers
of specimens
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_________ _________
October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
Procedure for documenting all
transfers of aliquots
_________ _________
Procedure for using an ECCF System
(if applicable)
_________ _________
Procedure for maintaining security
of specimen bottles
_________ _________
Procedure for maintaining security
of specimen aliquots
_________ _________
Procedure for sending a specimen
to another laboratory
_________ _________
Procedures for documenting all transfers
of specimens received from another
laboratory
_________ _________
Aliquot Preparation
Procedure for preparing initial drug test
aliquots
_________ _________
Procedure for preparing screening/differential
specimen validity test aliquots
_________ _________
Procedure for preparing initial specimen
validity test aliquots
_________ _________
Procedure for preparing confirmatory
specimen validity test aliquots
_________ _________
Procedure for preparing confirmatory drug
test aliquots
_________ _________
Procedures for automated aliquotting
equipment
Initial Drug Test
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
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_________ _________
6
_________ _________
October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedure for calculating results
_________ _________
Quality control (QC) procedure and criteria
for acceptable results and corrective
actions
_________ _________
Procedure for validation of initial drug test
methods
_________ _________
References
_________ _________
Second Initial Drug Test
Criteria for use
_________ _________
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedure for calculating results
_________ _________
QC procedure and criteria for acceptable
results and corrective actions
_________ _________
Procedure for validation of second
initial drug test methods
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
References
PAGE NO.
_________ _________
Specimen Validity Tests
Note: Provide the following information for each specimen validity test (Initial,
Confirmatory, Screening, Differential)
Creatinine
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting creatinine tests _________ _________
QC acceptance/rejection criteria and
corrective action for creatinine tests
_________ _________
Procedure for validation of creatinine
test methods
_________ _________
Procedure for periodic re-verification of
creatinine test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Specific Gravity
Principle of analysis
_________ _________
Preparation of calibrators and
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
Procedure for assay calibration
_________ _________
Procedures for conducting
specific gravity tests
_________ _________
QC acceptance/rejection criteria and
corrective action for specific gravity tests
_________ _________
Procedure for validation of specific gravity
test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Criteria for identifying acceptable,
dilute, invalid, and substituted specimens
based on creatinine and specific gravity
test results
_________ _________
Procedure for designating reconfirmed
results for split specimens as substituted
_________ _________
pH
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting pH tests
_________ _________
QC acceptance/rejection criteria
and corrective action for pH tests
_________ _________
Criteria for identifying acceptable,
invalid, and adulterated specimens based
on pH test results
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
Procedure for designating reconfirmed
results for split specimens as adulterated
based on pH
PAGE NO.
_________ _________
Procedure for validation of pH test methods _________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Oxidants
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting oxidant tests
_________ _________
QC acceptance/rejection criteria
and corrective action for oxidant tests
_________ _________
Criteria for identifying acceptable, invalid,
and adulterated specimens based on
oxidant test results
_________ _________
Procedure for designating reconfirmed
results for split specimens as adulterated
with a specific oxidant
_________ _________
Procedure for validation of oxidant test
methods
_________ _________
Procedure for periodic re-verification of
oxidant test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
Other Adulterants
Adulterant:__________________ ___________________________
Principle of analysis
_________ _________
Preparation of test materials, calibrators,
and controls
_________ _________
Procedure for set-up and normal
operation of instruments
_________ _________
Procedure for instrument maintenance
_________ _________
Procedure for assay calibration
_________ _________
Procedures for conducting
the test
_________ _________
QC acceptance/rejection criteria and
corrective action for the test
_________ _________
Criteria for identifying acceptable, invalid,
and adulterated specimens based on the
adulterant test results
_________ _________
Procedure for designating reconfirmed
results for split specimens as adulterated
_________ _________
Procedure for validation of the test
methods
_________ _________
Procedure for periodic re-verification of the
test methods
_________ _________
Special requirements, etc.
_________ _________
References
_________ _________
Confirmatory Drug Tests
Principle of each analysis
THCA
Benzoylecgonine
Codeine/Morphine
Urine, Laboratory
_________ _________
_________ _________
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Preparation of test materials, calibrators, and controls
THCA
_________
Benzoylecgonine
_________
Codeine/Morphine
_________
6-Acetylmorphine
_________
Phencyclidine
_________
Amphetamine/Methamphetamine
_________
MDMA/MDA/MDEA
_________
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
Extraction procedures
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure for instrument maintenance
_________ _________
Procedure for verifying the performance
of the mass spectrometer(s)
_________ _________
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
Procedure for instrument set-up and operation
THCA
_________
Benzoylecgonine
_________
Codeine/Morphine
_________
6-Acetylmorphine
_________
Phencyclidine
_________
Amphetamine/Methamphetamine
_________
MDMA/MDA/MDEA
_________
Amphetamines enantiomers
_________
Procedure for assay calibration
THCA
Benzoylecgonine
Codeine/Morphine
Urine, Laboratory
_________
_________
_________
_________
_________
_________
_________
_________
_________ _________
_________ _________
_________ _________
12
October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure for calculating results
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure when results exceed linearity
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure for designating positive results
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure for designating reconfirmed results for split specimens
THCA
_________ _________
Benzoylecgonine
_________ _________
Codeine/Morphine
_________ _________
6-Acetylmorphine
_________ _________
Phencyclidine
_________ _________
Amphetamine/Methamphetamine
_________ _________
MDMA/MDA/MDEA
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
Amphetamines enantiomers
PAGE NO.
_________ _________
QC procedure and QC acceptance criteria
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Special requirements, etc.
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
References
THCA
Benzoylecgonine
Codeine/Morphine
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
_________
Procedure for validation of confirmatory
drug test methods
_________ _________
Procedure for periodic re-verification
of confirmatory drug test methods
_________ _________
QC and Test Materials
Procedures for preparing stock
standards, etc.
_________ _________
Procedures for preparing and verifying
calibrators
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14
_________ _________
October 2010, Rev. 1115
TOPIC
SECTION
Procedures for preparing and verifying
controls
PAGE NO.
_________ _________
Corrective procedure when QC verification
results are out of control limits
_________ _________
Procedures for preparing and verifying
test materials
_________ _________
Corrective procedure when test materials
verification results are unacceptable
_________ _________
Quality Assurance (QA) Procedures
Procedures for monitoring control results
_________ _________
Corrective procedure when QA review of
control results shows problems or potential
problems (e.g., trends, shifts, bias)
_________ _________
Equipment and Maintenance
Wash procedure for labware
_________ _________
Procedure for determining accuracy
and precision of pipetting devices
_________ _________
Procedures for temperature-dependent
equipment
_________ _________
Procedures for centrifuges
_________ _________
Procedures for analytical balances
_________ _________
Safety procedures
_________ _________
Administrative/Reporting Procedures
Procedure for reviewing/certifying the
test result(s) of a primary specimen
_________ _________
Procedure for reporting the test result(s)
of a primary specimen
_________ _________
Procedure for reviewing/certifying the
test result(s) of a split specimen
_________ _________
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October 2010, Rev. 1115
TOPIC
SECTION
PAGE NO.
Procedure for reporting the test result(s)
of a split specimen
_________ _________
Procedure to detect and correct
clerical errors
_________ _________
Procedure for electronic reporting of results _________ _________
Procedure for preparing statistical
summary reports
_________ _________
Procedure for updating the SOP Manual
_________ _________
Procedure for preparation of
data packages
_________ _________
Procedure for preparation of the
Non-Negative Specimen List (NNSL)
_________ _________
Laboratory Computers and Information Systems Procedures
Computer and Laboratory Information
Management System (LIMS) security
procedures
_________ _________
Computer and LIMS maintenance
procedures
_________ _________
Procedure for computer and software
validation
_________ _________
Procedure for requesting, verifying, and
implementing software and configuration
changes
_________ _________
Procedure for LIMS records archiving
and retrieval
_________ _________
Procedures for system monitoring, incident
response, and disaster recovery
_________ _________
Procedure for obtaining audit trail reports
_________ _________
System Security Plan (SSP)
_________ _________
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October 2010, Rev. 1115
D. Chain of Custody, Accessioning, and Security
The laboratory must have chain of custody, accessioning, and security procedures that ensure
integrity is maintained for the original specimens and their aliquots. Procedures must address
specimens received from collectors, Instrumented Initial Test Facilities (IITFs), and other
laboratories. The chain of custody forms and procedures must account for all individuals who
handle the specimens and aliquots. The chain of custody forms and procedures should provide
a clear picture of the handling/transfers of specimens and aliquots from initial receipt to final
disposition. The laboratory must ensure the security of specimens and aliquots during
processing and placement in any storage locations.
1. Provide a description of the laboratory's chain of custody procedures for the following:
Specimen Receiving/Accessioning
-Receipt of specimen packages, how they are handled, who reviews the accuracy of the
information on the custody and control forms and how discrepancies are documented
-Assignment of laboratory accession numbers
-Handling and resolution of problems with specimen bottles and/or custody and control
forms
-Description of collection kit to be used
-Location of temporary storage area(s)
- Procedures for electronic (digital) or combination (electronic and paper) Federal CCF (if
applicable)
Aliquotting Procedures
-Aliquotting from the original specimen bottles (i.e., who and where)
-The aliquotting procedure (pouring or pipetting and amounts) used for preparing aliquots for
initial drug tests, screening/differential specimen validity tests, initial specimen validity tests,
confirmatory drug tests, and confirmatory specimen validity tests
-Transfer of aliquots from the individuals performing the aliquotting to those who will be
testing the aliquots
Initial Drug Tests (First and Second Tests)
-Handling and testing of aliquots by laboratory personnel
-Maintenance of chain of custody and aliquot identity during the testing
Specimen Validity Tests (Initial, Confirmatory, Screening, Differential)
-Handling and testing of aliquots by laboratory personnel
-Maintenance of chain of custody and aliquot identity during the testing
Confirmatory Drug Tests
-Handling and testing of aliquots by laboratory personnel
-Maintenance of chain of custody and aliquot identity during the testing
Disposition of Specimens and Aliquots
-Handling of original specimen bottles and aliquots after testing is completed
-Procedure for transferring positive, adulterated, substituted, and invalid specimens to longterm frozen storage
Urine, Laboratory
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October 2010, Rev. 1115
Note: (1) Insert here.
(2) Do not exceed a total of 4 pages.
2. Will the laboratory use an electronic (digital) or combination (electronic and paper) Federal
CCF?
___
___
Yes Provide the items on the Electronic CCF System Submission List
(attached)
No
3. Attach a flowchart and/or examples of chain of custody documents showing how regulated
specimens and aliquots will be processed and their custody documented (chain of custody
documents may be referenced and/or provided as examples for clarification).
4. Will regulated specimens be accessioned in a limited access, secure area?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
5. Will regulated specimens be tested in a limited access, secure area?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
6. Attach a floorplan of the laboratory indicating the areas to be used for accessioning, testing
of specimens, and storage of specimens, aliquots, and records. Include information to
describe how the areas are secured and what security devices are utilized (e.g., which walls
are outside walls; which are secured up to the ceiling; the location and type of security
devices such as magnetic key cards, cipher locks, padlocks; location of secured storage
areas such as refrigerators or freezers and how they are secured).
7. Will the original specimens be maintained in a limited access, secured area at all times?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
7a. Where will the original specimens be stored?
Before testing? ________________________________________________________
During testing? _______________________________________________________
After testing is complete? ________________________________________________
7b. Who will have access to the specimen storage areas?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________
8. When testing is complete, will all positive, adulterated, substituted, and invalid specimens (A
and B Bottles) and split specimens be retained in long-term frozen storage in their original
containers?
___
Urine, Laboratory
Yes # of days to be stored: __________
18
October 2010, Rev. 1115
___
No LABORATORY NOT ELIGIBLE TO APPLY
8a. How will specimens (A and B Bottles) and split specimens be stored? ____________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
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October 2010, Rev. 1115
E. Records
The laboratory must maintain records to support test results (i.e., including but not limited to all
associated QC results, analytical data, chain of custody documents and associated
administrative records) for at least two years. The laboratory must also maintain method
validation records for past and current procedures, instrument validation records, records
documenting the standard operating procedures used at any given time period, and records of
the education, training, and certification of all employees associated with regulated testing. The
laboratory must have security measures in place to limit access to electronic and hardcopy
records to essential authorized personnel.
1. Will the laboratory maintain records supporting specimen test results for at least two years?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
1a. Will there be a secured area for the storage of records supporting specimen test results?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
2. Will the laboratory limit records access to authorized personnel?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
3. Attach data packages using the format described in Section R of the NLCP Manual for Urine
Laboratories to support (1) a positive drug test result and (2) an adulterated, substituted, or
invalid result based on specimen validity testing.
4. In addition to the data packages described above: if the laboratory will use more than one
technology (e.g., GC/MS, GC/MS/MS, LC/MS/MS) for confirmatory drug tests, attach data
and documentation from a confirmatory drug test batch using each additional technology.
Urine, Laboratory
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October 2010, Rev. 1115
F. Personnel
Qualifications for a Responsible Person Candidate
1. RP Candidate's Name: _____________________________________________________
LAST
FIRST
MIDDLE
The candidate must provide the following for review of his/her eligibility:
(a) A detailed description of the experience and qualifications specifically addressing the RP
requirements as stated in the Mandatory Guidelines (Section 11.3);
(b) A current résumé or curriculum vitae; and
(c) Official copies with raised seal of all academic undergraduate and graduate transcripts.
2. To be eligible for review as an RP, at least one of the following questions must be answered
“yes”:
2a. Is the candidate certified/licensed by the State in which the laboratory is located and any
other State requiring personnel licensure as a Laboratory Director in forensic or clinical
laboratory toxicology?
___
___
Yes In which State(s)? _______________________________________
No
2b. Does the candidate have a Ph.D. in one of the natural sciences?
___
Yes In which field? __________________________________________
GO TO QUESTION 3.
___
No GO TO QUESTION 2C.
2c. Does the candidate have training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with additional training and
laboratory/research experience in biology, chemistry, and pharmacology or toxicology?
___ Yes Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
___
No
3. An RP must have extensive experience in forensic toxicology with emphasis on the
collection and analysis of biological specimens for drugs of abuse. To be eligible for review
as an RP, both of the following questions must be answered “yes”:
3a. Does the candidate have two years or more of postdoctoral experience or at least six
years of experience in forensic toxicology beyond any other degree?
___ Yes Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
___
Urine, Laboratory
No CANDIDATE NOT ELIGIBLE AS RP
21
October 2010, Rev. 1115
3b. Does the candidate have appropriate experience in forensic applications of analytical
toxicology (e.g., publications, court testimony, conducting research on the toxicology of
drugs of abuse) or qualify as an expert witness in forensic toxicology?
___ Yes Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
___
No CANDIDATE NOT ELIGIBLE AS RP
4. In the table below, enter the candidate’s education.
Education
Major and Minor
Fields of Study
Name of School
Diploma, Certificate
or Degree Received
College or
University
Other Schools
Attended
5. Is the candidate a full-time or part-time employee of the laboratory?
___
___
Full-time (at least 40 hours per week)
Part-time __________ hours per week
If not a full- or part-time employee, what is the relationship between the candidate and the
laboratory?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
6. How many hours per week will the candidate work in the forensic urine drug testing
laboratory?
______ HOURS PER WEEK
7. How long has the candidate been associated with the laboratory?
_______ YEARS
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October 2010, Rev. 1115
Qualifications for an Alternate Responsible Person Candidate
1. Alt-RP Candidate's Name: __________________________________________________
LAST
FIRST
MIDDLE
The candidate must provide the following for review of his/her eligibility:
(a) A detailed description of the experience and qualifications specifically addressing the RP
requirements as stated in the Mandatory Guidelines (Section 11.3);
(b) A current résumé or curriculum vitae; and
(c) Official copies with raised seal of all academic undergraduate and graduate transcripts.
2. An alt-RP must be capable of fulfilling RP duties for a limited time (i.e., up to 180 days). An
alt-RP candidate’s qualifications are compared to RP requirements as follows:
2a. Is the candidate certified/licensed by the State in which the laboratory is located and any
other State requiring personnel licensure as a Laboratory Director in forensic or clinical
laboratory toxicology?
___
___
Yes In which State(s)? ______________________________
No
2b. Does the candidate have a Ph.D. in one of the natural sciences?
___
Yes In which field? __________________________________________
GO TO QUESTION 3.
___
No GO TO QUESTION 2C.
2c. Does the candidate have training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with additional training and
laboratory/research experience in biology, chemistry, and pharmacology or toxicology?
___
Yes Describe: _____________________________________________
_________________________________________________________________
___
No
3. An alt-RP candidate must have appropriate experience in forensic toxicology.
3a. How many years of experience does the candidate have in forensic toxicology (including
experience with the collection and analysis of biological specimens for drugs of abuse)
beyond any degree?
_________ YEARS
3b. Does the candidate have appropriate training and/or experience in all operations of the
forensic drug testing laboratory (i.e., including training and experience as a certifying
scientist)?
___ Yes
___ No CANDIDATE NOT ELIGIBLE AS AN ALT-RP
Urine, Laboratory
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October 2010, Rev. 1115
4. In the table below, enter the candidate’s education.
Education
Major and Minor
Fields of Study
Name of School
Diploma, Certificate
or Degree Received
College or
University
Other Schools
Attended
5. Is the candidate a full-time or part-time employee of the laboratory?
___
___
Full-time (at least 40 hours per week)
Part-time __________ hours per week
If not a full- or part-time employee, what is the relationship between the candidate and the
laboratory?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
6. How many hours per week will the candidate work in the forensic urine drug testing
laboratory?
______ HOURS PER WEEK
7. How long has the candidate been associated with the laboratory?
_______ YEARS
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October 2010, Rev. 1115
Personnel Certifications and Licenses
1. List the name, job title, education, and licenses/certifications for the following key staff:
Note: (1) Attach a résumé for each individual listed below.
(2) Attach a separate sheet as needed to list all individuals in these positions.
Name
Job Title
Education
License/
Certification
Certifying
Technician(s)
Certifying
Scientist(s)
Supervisor(s)
Other Key
Staff
2. Is licensure and/or certification required for any of the above positions in the State in which
the laboratory is located?
___
___
Yes
No GO TO SECTION G
If YES, describe requirements:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
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October 2010, Rev. 1115
G. Quality Control
For certification, the laboratory must have clearly defined QC procedures that are consistently
applied, subject to review, and prompt appropriate corrective action upon failure to meet
established acceptance criteria.
1. Are instrument function checks reviewed prior to batch analysis?
___
___
Yes COMPLETE 1a
No
1a. What is the title and/or position of the person responsible for these checks?
Title/Position: ___________________________________________________________
2. Are corrective actions documented when controls, instrument responses, etc., fail defined
acceptance criteria?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
3. Are all QC results reviewed by the Certifying Technician/Scientist prior to the release of the
results?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
4. Is the QA/QC program under the direct supervision of a Quality Control Supervisor?
___
___
Yes
No COMPLETE 4a
4a. What is the title/position of the person responsible for the QA/QC program?
Title/Position: ___________________________________________________________
5. Is the QA/QC program reviewed periodically by the Responsible Person Candidate?
___
___
Yes
No CANDIDATE NOT ELIGIBLE AS RP
5a. What is the title/position of the person responsible for the periodic review?
Title/Position: ___________________________________________________________
6. Are there written procedures that are employed to routinely detect clerical and analytical
errors prior to reporting results?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
7. For certification, the laboratory must have a QC program that includes both blind and open
QC samples. At a minimum, these must include the number and type of QC samples
described in the Mandatory Guidelines for drug and specimen validity tests.
Urine, Laboratory
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October 2010, Rev. 1115
Provide a description of the laboratory's procedures for the following:
Specimen Accessioning
- Introduction and/or aliquotting of blind samples into the test batches by accessioners
- Content and concentration of each blind sample
- If applicable, preparation and submission of blind samples as donor specimens from
external sources
Initial Drug Tests (First and Second)
- How batches are constituted (e.g., how many specimens are in a batch, is it constituted in
one session or are specimens added to the batch throughout the day?)
- The distribution of the donor specimens and QC samples within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
Specimen Validity Tests (Initial, Confirmatory, Screening, Differential)
- How batches are constituted (e.g., how many specimens are in a batch, is it constituted in
one session or are specimens added to the batch throughout the day?)
- The distribution of the donor specimens and QC samples within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
- Include an outline or a legible flowchart that comprehensively describes the laboratory's
specimen validity testing. The laboratory’s submission must identify any “reflex” testing,
the use of two separate aliquots, the initial and confirmatory methods for each analytical
parameter, and any screening or differential tests.
Confirmatory Drug Tests
- How batches are constituted (e.g., how many specimens are in a batch, is it constituted in
one session or are specimens added to the batch throughout the day?)
- The distribution of the donor specimens and QC samples within each batch
- The procedure and acceptance criteria for calibration, including criteria for exclusion of
unsatisfactory calibrators
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting, re-extracting, or reinjecting a specimen
Note: (1) Insert here.
(2) Do not exceed a total of 3 pages.
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October 2010, Rev. 1115
H. Review and Reporting
The laboratory must have adequate procedures to ensure the thorough review and accurate
reporting of results.
1. Briefly describe the procedures for reviewing initial drug test data and certifying negative
results (i.e., title/position of reviewers, electronic/hardcopy documents reviewed, QC review):
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
2. Briefly describe the procedures for reviewing specimen validity test data/results (i.e.,
screening, differential, initial and confirmatory tests): _____________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Briefly describe the procedures for reviewing confirmatory drug test data and certifying
results (i.e., title/position of reviewers, electronic/hardcopy documents reviewed, QC review):
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
4. Briefly describe the procedures for the reporting of results. If the laboratory will use
electronic reporting for any regulated specimens, describe procedures to ensure
confidentiality: ___________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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October 2010, Rev. 1115
5. Is the laboratory’s custody and control form (CCF) identical to the OMB-approved Federal
CCF to be used for all specimens submitted for testing under the Mandatory Guidelines?
___
___
Yes ATTACH EXAMPLE OF LABORATORY'S CUSTODY AND
CONTROL FORM
No LABORATORY NOT ELIGIBLE TO APPLY
6. Does the laboratory’s report form for split specimens contain all required elements as
described in Section U of the NLCP Manual for Urine Laboratories?
___
___
Yes ATTACH EXAMPLE OF LABORATORY'S SPLIT SPECIMEN
REPORT FORM
No
7. Will the laboratory use computer-generated electronic reports for specimens submitted for
testing under the Mandatory Guidelines?
___
___
Yes ATTACH EXAMPLE REPORTS (SEE BELOW)
No
If YES, attach an example of the laboratory's computer-generated electronic report for each
of the following laboratory results:
Negative
Negative, Dilute
Rejected
Cocaine Metabolite Positive
6-AM/Morphine/Codeine Positive
Amphetamine/Methamphetamine Positive
d-Methamphetamine (if applicable)
MDMA/MDA/MDEA Positive
Substituted
Invalid Result
Specimen Adulterated: pH
Specimen Adulterated: Others as Pertinent
Split Specimen: Reconfirmed
Split Specimen: One or More Primary Specimen Results Not Reconfirmed
8. Will the laboratory send a data file report in lieu of a formatted electronic report?
___
___
9.
Yes ATTACH EXAMPLE DATA FILE REPORTS (reflecting what will be
sent)
No
Does the laboratory plan to use an electronic (digital) or combination (electronic and paper)
Federal CCF for reporting? Note: Section D of the NLCP Manual for Urine Laboratories
describes the allowable formats for the Federal CCF.
Urine, Laboratory
29
October 2010, Rev. 1115
___
___
Yes
No
If YES, specify the CCF type(s) and supplier(s):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
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30
October 2010, Rev. 1115
I. Laboratory Computers and Information Systems
Laboratory computer systems include any computer system used in processing regulated
specimens. Such systems are typically used for accessioning specimens, batch assignment
and scheduling, capturing test results, tabulating QC data, and reporting final results. HHScertified laboratories are prohibited from transmitting data to an IITF through a computer
interface. Any computer interface communicating any form of data from an HHS-certified IITF to
a laboratory must be approved by the NLCP prior to implementation. The applicant IITF and/or
laboratories must submit a detailed plan to the NLCP for review.
1. Give a brief description of the computer system to be utilized by the laboratory. Is it a “stand
alone” system used solely by the laboratory, part of a local system (e.g., a hospital system),
or part of a multi-laboratory corporate system? (If not on-site, provide information on its
location and organizational control of the system.)
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
2. Give a brief description of how the laboratory plans to use the computer system in regulated
specimen processing: _____________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Is the laboratory computer system maintained in a secure area?
___ Yes
___ No
Attach a floorplan identifying the laboratory computer system location. Include information
to describe how the area is secured and what security devices are utilized (e.g., which walls
are outside walls; which are secured up to the ceiling; the location and type of security
devices such as magnetic key cards, cipher locks, padlocks).
4. Does the laboratory limit functional access to the laboratory computer system?
___ Yes
___ No
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October 2010, Rev. 1115
5.
Does the laboratory have a System Security Plan (SSP) for each information system used
for regulated drug testing, including corporate systems and external service provider
systems?
___
___
Yes
No LABORATORY NOT ELIGIBLE TO APPLY
6. Will the laboratory use an external service provider (e.g., LIMS provider, software service
provider, ECCF provider, report provider) to perform services on the laboratory’s behalf
related to regulated drug testing?
___ Yes List the names of external service providers, and Complete 6a
___ No
_______________________________________________________________________
_______________________________________________________________________
6a. Does the laboratory have a signed contract/agreement with each external service
provider that includes the priority elements listed in the Priority Elements for
Contracts/Agreements with External Service Providers?
___ Yes
___ No LABORATORY NOT ELIGIBLE TO APPLY
Complete the NLCP Application Tables
Table 1-a.
First and Second Initial Drug Test Methods and Instruments
Table 1-b.
First Initial Drug Test QC Samples
Table 1-c.
Second Initial Drug Test QC Samples
Table 2-a-1.
Initial Specimen Validity Test Methods and Instruments
(continued on Table 2-a-2 as needed)
Table 2-b-1.
Confirmatory Specimen Validity Test Methods and Instruments
(continued on Table 2-b-2 as needed)
Table 2-c-1.
Screening/Differential Specimen Validity Test Methods and Instruments
(continued on Table 2-c-2 as needed)
Table 2-d-1.
Initial Specimen Validity Test QC Samples
(continued on Table 2-d-2 as needed)
Table 2-d-3.
Confirmatory Specimen Validity Test QC Samples
(continued on Table 2-d-4 as needed)
Table 2-d-5.
Screening/Differential Specimen Validity Test QC Samples
Table 3-a.
Primary and Alternate Confirmatory Drug Test Methods
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October 2010, Rev. 1115
Table 3-b-1.
Primary Confirmatory Drug Test Methods and Instruments – Gas
Chromatography (GC)
Table 3-b-2.
Alternate Confirmatory Drug Test Methods and Instruments – GC
Table 3-b-3.
Primary Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography (LC)
Table 3-b-4.
Alternate Confirmatory Drug Test Methods and Instruments – LC
Table 3-c-1.
Primary Confirmatory Drug Test Methods and Instruments – Mass
Spectrometry (MS)
Table 3-c-2.
Alternate Confirmatory Drug Test Methods and Instruments –MS
Table 3-c-3.
Primary Confirmatory Drug Test Methods and Instruments – Tandem Mass
Spectrometry
Table 3-c-4.
Alternate Confirmatory Drug Test Methods and Instruments – Tandem Mass
Spectrometry
Table 3-d-1.
Primary Confirmatory Drug Test QC Samples
Table 3-d-2.
Table 4-a.
Alternate Confirmatory Drug Test QC Samples
Amphetamines Enantiomer Test Methods
Table 4-b.
Amphetamines Enantiomer QC Samples
Table 4-c.
Description of Enantiomer Calculations
Urine, Laboratory
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October 2010, Rev. 1115
Priority Elements for Contracts/Agreements
with External Service Providers
1.
Limiting access to regulated specimen information
2.
Implementing appropriate safeguards to prevent unauthorized use or
disclosure of the information, including implementing applicable
federal requirements with regard to regulated specimen and drug test
information
3.
Reporting to the HHS-certified test facility any use or disclosure of the
information not provided for by the contract, including incidents that
constitute incidents that constitute data breaches of unsecured
regulated specimen and drug test information
4.
Disclosing information to HHS related to regulated specimens and
drug tests
5.
Arranging for disposition of regulated specimen data (i.e., disposal in
accordance with specified record retention periods; transfer of
records to the HHS-certified test facility upon termination of the
agreement)
6.
Notifying the HHS-certified test facility prior to allowing any
subcontractors to have access to regulated specimen and drug test
information
7.
Ensuring that any subcontractors agree to the same restrictions and
conditions that apply to the external service provider with respect to
regulated specimen and drug test information.
Urine, Laboratory
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October 2010, Rev. 1115
Electronic CCF System Submission List
Items to be submitted for review:
1. Process Overview. A detailed overview of all processes involving the Federal
ECCF from initiation until final disposition, including:
o
o
o
o
o
o
o
o
o
o
o
o
o
Assigning unique specimen identification numbers
Initiation of the ECCF
Collection
Specimen shipment (labels/seals for specimen bottles and bags)
CCF distribution at the end of collection
Collector/collection site records storage and disposal
Specimen tracking
Test facility accessioning
Test facility reporting
Test facility records storage and disposal
Medical Review Officer review and completion of the CCF
MRO reporting
MRO records storage and disposal
2. Topic Outline of Proposed SOPs An outline of topics to be addressed in:
o HHS-certified test facility standard operating procedures (SOPs) for
accessioning, certification, reporting
o Procedures/Instructions for other Federal ECCF users including collectors,
MROs, and MRO staff
Note: Proposed Federal ECCF instructions or proposed SOP Table of
Contents may be submitted
Examples: Screenshots, tables of contents
3. Training Plans Training for Federal ECCF system users, including:
o Federal ECCF system users (IITF staff, laboratory staff, collectors, MROs,
MRO staff as applicable)
o Other individuals given access to regulated specimen data (e.g., IT staff)
Security awareness training must address forensic records and
regulated specimen donor PII
Note: RP must document review and approval of training plans and materials
4. System/Network Diagram Logical network diagram including, at a minimum:
o
o
o
o
Firewalls
Network security devices
Servers
Workstations
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October 2010, Rev. 1115
Electronic CCF System Submission List
o Primary routers/switches
o Remote access devices
o Internet connection(s)
5. System Security Plan (SSP) Plan that reflects NIST 800-53 or other recognized
security standard, and provides an overview of the security requirements of the
system, describes the controls in place or planned for meeting those
requirements, and delineates responsibilities and expected behavior of all
individuals who access the system.
o The ability to generate accurate and complete copies of records in both
human readable and electronic form suitable for inspection, review, and
copying upon request of authorized parties (e.g., the MRO, federal agency,
or SAMHSA)
o Protection of records to enable accurate and ready retrieval through the
records retention period
o Limiting system access to authorized individuals
o Secure, computer-generated, time-stamped audit trails to independently
record the date and time of operator entries and actions that create,
modify, or delete records from the time of initiation of the Federal CCF
(changes should be evident when reviewing the original record, and any
electronic or paper copy of the original record)
o Use of authority checks to ensure that only authorized individuals can use
the system, electronically sign a record, access the operation or computer
system input or output device, alter a record, or perform the operation at
hand
6. System Validation Plan Plan for testing and evaluating information system
security controls to ensure effective implementation.
Note: The HHS-certified test facility must provide documentation of security
control testing and evaluation at NLCP inspections.
Examples of records to be provided include
o Periodic records checks
o Independent security monitoring by IITF/laboratory IT staff
o A report from an independent auditor regarding compliance with relevant
industry standards
7. External ECCF Provider Agreement with HHS-Certified Test Facility An
HHS-certified test facility that plans to use an external ECCF system must have a
contract/ agreement signed by each laboratory Responsible Person (RP)/IITF
Responsible Technician (RT) and an authorized representative of the ECCF
provider that:
o Specifies the responsibilities of the ECCF provider and states restrictions
and conditions that apply to the ECCF provider with respect to regulated
specimen and drug test information
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October 2010, Rev. 1115
Electronic CCF System Submission List
o Establishes the permitted and required uses and disclosures of regulated
specimen and drug test information by the ECCF provider
o Addresses, at a minimum, these priority elements:
Limiting access to regulated specimen information
Implementing appropriate safeguards to prevent unauthorized use
or disclosure of the information, including implementing applicable
federal requirements with regard to regulated specimen and drug
test information
Reporting to the HHS-certified test facility any use or disclosure of
the information not provided for by the contract, including incidents
that constitute incidents that constitute data breaches of unsecured
regulated specimen and drug test information
Disclosing information to HHS related to regulated specimens and
drug tests
Arranging for disposition of regulated specimen data (i.e., disposal
in accordance with specified record retention periods; transfer of
records to the HHS-certified test facility upon termination of the
agreement)
Notifying the HHS-certified test facility prior to allowing any
subcontractors to have access to regulated specimen and drug test
information
Ensuring that any subcontractors agree to the same restrictions
and conditions that apply to the ECCF provider with respect to
regulated specimen and drug test information.
Note: The agreement/contract must be provided for NLCP review with the
initial ECCF submission and with other ECCF system documentation at each
inspection.
Urine, Laboratory
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October 2010, Rev. 1115
Initial Drug Test
Methods and Instruments
Table 1-a
First Initial Drug Test Methods and Instruments
First Initial Drug
Test
THCA
(marijuana
metabolites)
BZE
(cocaine
metabolites)
MOR
(opiate
metabolites)
6-AM
PCP
MAMP
(amphetamines)
MDMA
MAMP
(amphetamines)
MDMA
Kit and
Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Calibration Method
Maximum Batch
Size
*If "Other" is selected, please specify:
Second Initial Drug Test Methods and Instruments
Second Initial Drug
Test
THCA
(marijuana
metabolites)
BZE
(cocaine
metabolites)
MOR
(opiate
metabolites)
6-AM
PCP
Kit and
Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Calibration Method
Maximum Batch
Size
*If "Other" is selected, please specify:
THCA = ∆9-tetrahydrocannabinol-9-carboxylic acid
BZE = benzoylecgonine
MOR = morphine
PCP = phencyclidine
6-AM = 6-acetylmorphine
MAMP = methamphetamine
LAB_Application_Tables_2015.xls
MDMA = methylenedioxymethamphetamine
First Initial Drug Test
QC Samples
Table 1-b
1st initial drug
test QC
THCA
BZE
MOR
6-AM
PCP
MAMP
MDMA
Cal 1
Cal 2
Cal 3
Cal 4
Control 1
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
*If "Other" is selected, please specify:
BQC = blind quality control sample
LAB_Application_Tables_2015.xls
Control 2
Control 3
Control 4
BQC 1
BQC 2
Second Initial Drug Test
QC Samples
Table 1-c
2nd initial drug
test QC
THCA
BZE
MOR
6-AM
PCP
MAMP
MDMA
Cal 1
Cal 2
Cal 3
Cal 4
Control 1
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
Conc.
Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 2
Control 3
Control 4
BQC 1
BQC 2
Initial Specimen Validity Test
Methods and Instruments
Table 2-a-1
Initial SVT
Creatinine
pH
Nitrite
4 dec. place
refractometer
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Unit of
Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator
SG
mg/dL
mcg/mL
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size
*If "Other" is selected, please specify:
SG = specific gravity
Gen. Oxid. = general oxidant
LOD = limit of detection
LOQ = limit of quantitation
ULOL= upper limit of linearity
LAB_Application_Tables_2015.xls
Gen.Oxid.
Other:
Other:
Initial Specimen Validity Test
Methods and Instruments
Table 2-a-2
Initial SVT cont.
Other:
Other:
Other:
Other:
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Unit of
Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Other:
Other:
Other:
Confirmatory Specimen Validity Test
Methods and Instruments
Table 2-b-1
Confirmatory SVT
Creatinine
SG
pH
Nitrite
4 dec. place
refractometer
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
mg/dL
mcg/mL
Target Analyte of
Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Other:
Other:
Other:
Table 2-b-2
Confirmatory SVT
cont.
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of
Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator
Confirmatory Specimen Validity Test
Methods and Instruments
Other:
Other:
Other:
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Other:
Other:
Other:
Table 2-c-1
Screening/Differential
SVT
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
Screening/Differential Specimen
Validity Test Methods and Instruments
SG
pH
Other:
Target Analyte of Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Other:
Other:
Table 2-c-2
Screening/Differential
SVT cont.
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
Screening/Differential Specimen Validity Test
Other:
Other:
Other:
Other:
Methods
and Instruments
Target Analyte of Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Other:
Initial Specimen Validity Test
QC Samples
Table 2-d-1
Initial SVT QC
Cal 1
Cal 2
Cal 3
Cal 4
Cal 5
Target value
Creatinine Matrix
Source
Target value
Matrix
SG
Source
Target value
Matrix
pH
Source
Target value
Matrix
Nitrite
Source
Target value
Gen Oxid Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 1
Control 2
Control 3
Control 4
Control 5
Initial Specimen Validity Test
QC Samples
Table 2-d-2
Initial SVT QC cont.
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Cal 1
Cal 2
Cal 3
Cal 4
Control 1
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 2
Control 3
Control 4
Control 5
Confirmatory Specimen Validity Test
QC Samples
Table 2-d-3
Confirmatory SVT
Cal 1
Cal 2
Cal 3
Cal 4
Control 1
Target Value
Creatinine Matrix
Source
Target Value
Matrix
SG
Source
Target Value
Matrix
pH
Source
Target Value
Matrix
Nitrite
Source
Target Value
Gen Oxid Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 2
Control 3
Control 4
Control 5
Confirmatory Specimen Validity Test
QC Samples
Table 2-d-4
Confirmatory SVT QC cont.
Cal 1
Cal 2
Cal 3
Cal 4
Target Value
Other (enter name): Matrix
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 1
Control 2
Control 3
Control 4
Control 5
Screening/Differential Specimen Validity Test
QC Samples
Table 2-d-5
Screening/Differential SVT
QC
Specific Gravity
pH
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Other (enter name):
Cal 1
Cal 2
Cal 3
Cal 4
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
*If "Other" is selected, please specify:
LAB_Application_Tables_2015.xls
Control 1
Control 2
Control 3
Control 4
Control 5
Table 3-a-1
Confirmatory Drug Test Methods
Primary Confirmatory Drug Test Methods
Primary
Confirmatory Drug
Test
Method
Internal Standard
Int. Std. Isotope
Type and Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*
Maximum Batch
Size
THCA
BZE
COD
MOR
6-AM
PCP
AMP
MAMP
MDMA
MDA
MDEA
MAMP
MDMA
MDA
MDEA
*If "Other" is selected, please specify:
Alternate Confirmatory Drug Test Methods
Alternate
Confirmatory Drug
Test
Method
Internal Standard
Int. Std. Isotope
Type and Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*
Maximum Batch
Size
THCA
BZE
COD
MOR
6-AM
PCP
*If "Other" is selected, please specify:
* ng/mL
COD = codeine
AMP = amphetamine
MDA = methylenedioxyamphetamine
MDEA = methylenedioxyethylamphetamine
LAB_Application_Tables_2015.xls
AMP
Table 3-b-1
Primary Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug
Test - Gas Chromatography
AMPHETAMINES (select analytes from dropdown lists below)
THCA
BZE
COD/MOR
6-AM
PCP
Extraction Method
Volume Used (mL)
Hydrolysis Method
Derivatizing Reagent
Split/Splitless Injection
Inj. Port Temp (°C)
Isothermal or Gradient
Column Type
Column Length (m)
Instrument Manufacturer
Number of Units
GC/GC Methods: provide additional information below
Cryotrapping (Y/N)
2nd GC Column Type
2nd GC Column Length
(m)
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
Table 3-b-2
Alternate Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Alternate Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug
Test - Gas Chromatography
AMPHETAMINES (select analytes from dropdown lists below)
THCA
BZE
COD/MOR
6-AM
PCP
Extraction Method
Volume Used (mL)
Hydrolysis Method
Derivatizing Reagent
Split/Splitless Injection
Inj. Port Temp (°C)
Isothermal or Gradient
Column Type
Column Length (m)
Instrument Manufacturer
Number of Units
GC/GC Methods: provide additional information below
Cryotrapping (Y/N)
2nd GC Column Type
2nd GC Column Length
(m)
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
Table 3-b-3
Primary Confirmatory Drug Test Methods and Instruments - Liquid Chromatography
Primary Confirmatory Drug Test Methods and Instruments - Liquid Chromatography
Primary Confirmatory Drug Test Liquid Chromatography
THCA
BZE
COD/MOR
Extraction Method
Volume Used (mL)
Hydrolysis Method
Injection Volume
Isocratic or Gradient
Guard Column (Y/N)
Flow Rate (mL/min)
Temperature (°C)
Column Type
Column Length (cm)
Column Diameter
Column Particle Size
A Solvent (Buffer)
Buffer Type
Molarity
pH
B Solvent (Organic)
Component 1
Component 2
Component 3
Component Ratio (1:2:3)
Instrument Manufacturer
Number of Units
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
6-AM
PCP
AMP/MAMP
MDMA/MDA/
MDEA
Table 3-b-4
Alternate Confirmatory Drug Test Methods and Instruments - Liquid Chromatography
Alternate Confirmatory Drug Test Methods and Instruments - Liquid Chromatography
Alternate Confirmatory Drug Test Liquid Chromatography
THCA
BZE
COD/MOR
Extraction Method
Volume Used (mL)
Hydrolysis Method
Injection Volume
Isocratic or Gradient
Guard Column (Y/N)
Flow Rate (mL/min)
Temperature (°C)
Column Type
Column Length (cm)
Column Diameter
Column Particle Size
A Solvent (Buffer)
Buffer Type
Molarity
pH
B Solvent (Organic)
Component 1
Component 2
Component 3
Component Ratio (1:2:3)
Instrument Manufacturer
Number of Units
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
6-AM
PCP
AMP/MAMP
MDMA/MDA/
MDEA
Table 3-c-1
Primary Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Primary Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Primary Confirmatory
Drug Test - Mass
Spectrometry
THCA
BZE
COD
MOR
6-AM
PCP
Instrument
Manufacturer
Number of Units
Inlet System
Ionization
Ion Focus
Full Scan Mass
Range
Calibration Type
Analyte Quantifier Ion
Analyte Qualifier Ion
1*
Analyte Qualifier Ion
2*
Analyte Qualifier Ion 3
Int. Std. Quantifier Ion
Int. Std. Qualifier Ion
1*
Int. Std. Qualifier Ion 2
*If "Other" is selected, please specify
*Minimum required
LAB_Application_Tables_2015.xls
AMP
MAMP
MDMA
MDA
MDEA
Table 3-c-2
Alternate Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Alternate Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Alternate Confirmatory
Drug Test - Mass
Spectrometry
THCA
BZE
COD
MOR
6-AM
PCP
Instrument
Manufacturer
Number of Units
Inlet System
Ionization
Ion Focus
Full Scan Mass Range
Calibration Type
Analyte Quantifier Ion
Analyte Qualifier Ion 1*
Analyte Qualifier Ion 2*
Analyte Qualifier Ion 3
Int. Std. Quantifier Ion
Int. Std. Qualifier Ion
1*
Int. Std. Qualifier ion 2
*If "Other" is selected, please specify
*Minimum required
LAB_Application_Tables_2015.xls
AMP
MAMP
MDMA
MDA
MDEA
Table 3-c-3
Primary Confirmatory Drug Test Methods and Instruments Tandem Mass Spectrometry
Primary Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Primary Confirmatory Drug
Test - Tandem Mass
Spectrometry
THCA
BZE
COD
MOR
6-AM
PCP
AMP
MAMP
MDMA
MDA
MDEA
Instrument Manufacturer
Number of Units
Ionization
Configuration
Calibration Type
Quantifier Transition*
Qualifier Transition 1*
Qualifier Transition 2
Qualifier Transition 3
Int. Std. Quantifier
Transition*
Int. Std. Qualifier
Transition 1*
Int. Std. Qualifier
Transition 2
Int. Std. Qualifier
Transition 3
*If "Other" is selected, please specify
*Minimum required
LAB_Application_Tables_2015.xls
Table 3-c-4
Alternate Confirmatory Drug Test Methods and Instruments Tandem Mass Spectrometry
Alternate Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Alternate Confirmatory Drug
Test - Tandem Mass
Spectrometry
THCA
BZE
COD
MOR
6-AM
PCP
AMP
MAMP
MDMA
MDA
MDEA
Instrument Manufacturer
Number of Units
Ionization
Configuration
Calibration Type
Quantifier Transition*
Qualifier Transition 1*
Qualifier Transition 2
Qualifier Transition 3
Int. Std. Quantifier
Transition*
Int. Std. Qualifier
Transition 1*
Int. Std. Qualifier
Transition 2
Int. Std. Qualifier
Transition 3
*If "Other" is selected, please specify
*Minimum required
LAB_Application_Tables_2015.xls
Table 3-d-1
Primary Confirmatory Drug Test
QC
THCA
BZE
COD
MOR
6-AM
PCP
AMP
MAMP
MDMA
MDA
MDEA
Primary Confirmatory Drug Test
QC Samples
Cal 1
Cal 2
Cal 3
Cal 4
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
Control 1
Control 2
Control 3
Control 4
Control 5
Table 3-d-2
Alternate Confirmatory Drug Test QC
THCA
BZE
COD
MOR
6-AM
PCP
AMP
MAMP
MDMA
MDA
MDEA
Alternate Confirmatory Drug Test
QC Samples
Cal 1
Cal 2
Cal 3
Cal 4
Cal 5
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
Concentration
Matrix
Source
*If "Other" is selected, please specify
LAB_Application_Tables_2015.xls
Control 1
Control 2
Control 3
Control 4
Control 5
Table C-4-a
AMPS Enantiomer Test Methods
Amphetamines Enantiomer
D-AMP
Drug Test
Method
Internal Standard
Int. Std. Isotope Type and
Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*
*If “Other” is selected, please specify:
Extraction Method
Volume Used (mL)
Derivatizing Reagent
Enantiomer Calculation
*If “Other” is selected, please specify:
Reflex ALL AMPs positive
specimens for DL testing?
* ng/mL
L-AMP
D-MAMP
L-MAMP
Table C-4-b
AMPS Enantiomer QC Samples
AMPS Enantiomer QCs
Cal 1
Concentration
D-AMP
Matrix
Source
Concentration
L-AMP
Matrix
Source
Concentration
D-MAMP
Matrix
Source
Concentration
L-MAMP
Matrix
Source
*If “Other” is selected, please specify:
* ng/mL
Cal 2
Cal 3
Cal 4
Control 1
Control 2
Control 3
Control 4
Control 5
AMPS Enantiomer Result Calculation
Describe in detail the method used to calculate the percentages of Dand L-enantiomers (e.g., use of peak abundances, concentrations,
use of an internal standard). Indicate if concentrations are
calculated that can be compared to the total methamphetamine
result obtained in the amphetamines method.
Type description below:
| File Type | application/pdf |
| File Title | Microsoft Word - LAB_NLCPUrineApplication_Oct2010_rev1115.docx |
| Author | lholliday |
| File Modified | 2016-11-08 |
| File Created | 2016-11-08 |