Form Urine Lab App Form Urine Lab App Form Urine Lab App Form

Effective 1 October 2010

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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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
Methamphetamine5
250 ng/mL
MDMA6
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

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October 2010

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

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.

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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

_________

_________

_________

_________

_________

_________

Procedure for problem/rejected specimens _________

_________

Accessioning (Specimen receipt)
Procedure for receipt and processing
of specimens
Procedure for accessioning specimens
received from another laboratory

Chain-of-Custody
Procedure for documenting all transfers
of specimens
Procedure for documenting all
transfers of aliquots

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_________

_________

_________

_________

October 2010

TOPIC

SECTION

PAGE NO.

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

_________

_________

_________

_________

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

_________

_________

_________

_________

Preparation of reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Aliquot Preparation
Procedure for preparing initial drug test
aliquots

Initial Drug Test
Principle of analysis

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October 2010

TOPIC

SECTION

PAGE NO.

_________

_________

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 reagents, 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

_________

_________

References

_________

_________

Procedure for calculating results

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October 2010

TOPIC

SECTION

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 reagents, 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

_________

_________

_________

_________

Preparation of calibrators and
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Specific Gravity
Principle of analysis

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October 2010

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

_________

_________

_________

_________

Preparation of reagents, 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

_________

_________

pH
Principle of analysis

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October 2010

TOPIC

SECTION

PAGE NO.

_________

_________

Procedure for validation of pH test methods _________

_________

Special requirements, etc.

_________

_________

References

_________

_________

_________

_________

Preparation of reagents, 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

_________

_________

Procedure for designating reconfirmed
results for split specimens as adulterated
based on pH

Oxidants
Principle of analysis

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TOPIC

SECTION

PAGE NO.

Other Adulterants
Adulterant:__________________ ___________________________
Principle of analysis

_________

_________

Preparation of reagents, 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
6-Acetylmorphine
Urine, Laboratory

_________ _________
_________ _________
_________ _________
_________ _________
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October 2010

TOPIC

SECTION

Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA/MDEA
Amphetamines enantiomers

PAGE NO.

_________ _________
_________ _________
_________ _________
_________ _________

Preparation of reagents, 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 tuning instruments

_________

_________

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
6-Acetylmorphine
Phencyclidine
Urine, Laboratory

_________ _________
_________ _________
_________ _________
_________ _________
_________ _________
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October 2010

TOPIC

SECTION

PAGE NO.

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
_________ _________
Amphetamines enantiomers
_________ _________

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TOPIC

SECTION

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 Materials and Reagents
Procedures for preparing stock
standards, etc.
Procedures for preparing and verifying
calibrators

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October 2010

TOPIC

SECTION

PAGE NO.

_________

_________

Corrective procedure when QC verification
results are out of control limits
_________

_________

Procedures for preparing and verifying
reagents

_________

_________

Corrective procedure when reagent
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)
_________

_________

Procedures for preparing and verifying
controls

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

_________

_________

_________

_________

Procedure for reporting the test result(s)
of a primary specimen

_________

_________

Procedure for reviewing/certifying the
test result(s) of a split specimen

_________

_________

Administrative/Reporting Procedures
Procedure for reviewing/certifying the
test result(s) of a primary specimen

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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 Computer System 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

_________

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October 2010

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
-Location of temporary storage area(s)
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
Note: (1) Insert here.
(2) Do not exceed a total of 4 pages.
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2. 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).
3. Will regulated specimens be accessioned in a limited access, secure area?
___
___

Yes
No → LABORATORY NOT ELIGIBLE TO APPLY

4. Will regulated specimens be tested in a limited access, secure area?
___
___

Yes
No → LABORATORY NOT ELIGIBLE TO APPLY

5. 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).
6. Will the original specimens be maintained in a limited access, secured area at all times?
___
___

Yes
No → LABORATORY NOT ELIGIBLE TO APPLY

6a. Where will the original specimens be stored?
Before testing? ________________________________________________________
During testing? _______________________________________________________
After testing is complete? ________________________________________________
6b. Who will have access to the specimen storage areas?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________
7. 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?
___

Yes → # of days to be stored: __________

___

No → LABORATORY NOT ELIGIBLE TO APPLY

7a. How will specimens (A and B Bottles) and split specimens be stored? ____________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________

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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 two 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.

Urine, Laboratory

19

October 2010

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

20

October 2010

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

Urine, Laboratory

21

October 2010

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

22

October 2010

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

Urine, Laboratory

23

October 2010

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:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Urine, Laboratory

24

October 2010

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

25

October 2010

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.

Urine, Laboratory

26

October 2010

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: ___________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Urine, Laboratory

27

October 2010

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

Urine, Laboratory

28

October 2010

I. Laboratory Computer 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
Urine, Laboratory

29

October 2010

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

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.

Alternate Confirmatory Drug Test QC Samples

Urine, Laboratory

30

October 2010

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 = Δ9-tetrahydrocannabinol-9-carboxylic acid
BZE = benzoylecgonine

MOR = morphine
PCP = phencyclidine

6-AM = 6-acetylmorphine
MAMP = methamphetamine

Laboratory_Application_Tables_Oct2010.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

Control 2

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

Laboratory_Application_Tables_Oct2010.xls

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

Control 2

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:

Laboratory_Application_Tables_Oct2010.xls

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
Ca
yo e Limitt
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

Laboratory_Application_Tables_Oct2010.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:

Laboratory_Application_Tables_Oct2010.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:

Laboratory_Application_Tables_Oct2010.xls

Other:

Other:

Other:

Confirmatory Specimen Validity Test
Methods and Instruments

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

Other:

Other:

Other:

Other:

Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size

*If "Other" is selected, please specify:

Laboratory_Application_Tables_Oct2010.xls

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:

Laboratory_Application_Tables_Oct2010.xls

Other:

Other:

Table 2-c-2

Screening/Differential
SVT cont.
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

Screening/Differential Specimen Validity Test
Methods and Instruments
Other:

Other:

Other:

*If "Other" is selected, please specify:

Laboratory_Application_Tables_Oct2010.xls

Other:

Other:

Table 2-d-1

Initial SVT QC

Initial Specimen Validity Test
QC Samples
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:

Laboratory_Application_Tables_Oct2010.xls

Control 1

Control 2

Control 3

Control 4

Control 5

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):

Initial Specimen Validity Test
QC Samples
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:

Laboratory_Application_Tables_Oct2010.xls

Control 2

Control 3

Control 4

Control 5

Table 2-d-3

Confirmatory SVT

Confirmatory Specimen Validity Test
QC Samples
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:

Laboratory_Application_Tables_Oct2010.xls

Control 2

Control 3

Control 4

Control 5

Table 2-d-4

Confirmatory SVT QC cont.

Confirmatory Specimen Validity Test
QC Samples
Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value

Other (enter name): Matrix

Source
Target Value
Other (enter name): Matrix
Source

*If "Other" is selected, please specify:

Laboratory_Application_Tables_Oct2010.xls

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

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:

Laboratory_Application_Tables_Oct2010.xls

Control 2

Control 3

Control 4

Control 5

Table 3-a

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
T
dN
b
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

Laboratory_Application_Tables_Oct2010.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

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

Laboratory_Application_Tables_Oct2010.xls

AMPHETAMINES (select analytes from dropdown lists below)

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

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

Laboratory_Application_Tables_Oct2010.xls

AMPHETAMINES (select analytes from dropdown lists below)

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

6-AM

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

Laboratory_Application_Tables_Oct2010.xls

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

6-AM

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

Laboratory_Application_Tables_Oct2010.xls

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

Laboratory_Application_Tables_Oct2010.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

Laboratory_Application_Tables_Oct2010.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

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

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

Laboratory_Application_Tables_Oct2010.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

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

Æ

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

Laboratory_Application_Tables_Oct2010.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

Control 1

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

Laboratory_Application_Tables_Oct2010.xls

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

Laboratory_Application_Tables_Oct2010.xls

Control 1

Control 2

Control 3

Control 4

Control 5