Urine Lab App form 2018 Urine Lab App form

Effective 1 November 2018

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 3 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, 5600 Fishers Lane, Room 15E57-B, 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

1

November 2018

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, 82 FR 7920, 23 January 2017, effective 1
October 2017):

Initial Test Analyte

Initial Test
Cutoff1

Confirmatory Test
Analyte

Confirmatory Test
Cutoff
Concentration
15 ng/mL

Marijuana metabolites (THCA)2

50 ng/mL3

Cocaine metabolites (Benzoylecgonine)

150 ng/mL3 Benzoylecgonine

Codeine/Morphine

2000 ng/mL

Codeine
Morphine

2000 ng/mL
2000 ng/mL

Hydrocodone/Hydromorphone

300 ng/mL

Hydrocodone
Hydromorphone

100 ng/mL
100 ng/mL

Oxycodone/Oxymorphone

100 ng/mL

Oxycodone
Oxymorphone

100 ng/mL
100 ng/mL

6-Acetylmorphine

10 ng/mL

6-Acetylmorphine

10 ng/mL

Phencyclidine

25 ng/mL

Phencyclidine

25 ng/mL

Amphetamine/Methamphetamine

500 ng/mL

Amphetamine
Methamphetamine

250 ng/mL
250 ng/mL

THCA

100 ng/mL

MDMA
250 ng/mL
MDA
250 ng/mL
1For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same
initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target
analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80
percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration,
depending on the technology. At least one analyte within the group must have a concentration equal to
or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or
greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial
test cutoff.
2An immunoassay must be calibrated with the target analyte, ∆-9-tetrahydrocannabinol-9-carboxylic acid
(THCA).
3Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for
an alternate technology initial test that is specific for the target analyte (i.e., 15 ng/mL for THCA, 100
ng/mL for benzoylecgonine).
4Methylenedioxymethamphetamine (MDMA)
5Methylenedioxyamphetamine (MDA)
MDMA4/MDA5

500 ng/mL

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, 82 FR 7920, 23 January 2017, effective 1 October
2017). The laboratory must use the test methods specified by the Mandatory Guidelines for
Urine, Laboratory

2

November 2018

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 analytes
required by the Mandatory Guidelines?
___
___

Yes
No → LABORATORY NOT ELIGIBLE TO APPLY

1b. 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

1c. 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

1d. 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

1e. 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

3

November 2018

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): _____________________________________________________
1Clinical
2College

Laboratory Improvement Amendments(CLIA)/Health Care Financing Administration (HCFA)
of American Pathologists (CAP)

4a. ATTACH PHOTOCOPIES OF ALL LICENSES AND CERTIFICATIONS INDICATED
ABOVE.

Urine, Laboratory

4

November 2018

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, 82 FR 7920, 23 January 2017, effective 1 October
2017).
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

Urine, Laboratory

5

_________ _________

November 2018

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

Urine, Laboratory

6

_________ _________

November 2018

TOPIC

SECTION

PAGE NO.

Initial Drug Test
Note: For alternate technology initial drug tests (as applicable), provide the following
information for each drug analyte
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

_________ _________

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

_________ _________

Urine, Laboratory

7

November 2018

TOPIC

SECTION

PAGE NO.

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

_________ _________

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

_________ _________

Urine, Laboratory

8

November 2018

TOPIC

SECTION

Specific Gravity
Principle of analysis

PAGE NO.

_________ _________

Preparation of calibrators and
and controls

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

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

_________ _________

Urine, Laboratory

9

November 2018

TOPIC

SECTION

PAGE NO.

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

_________ _________

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

_________ _________

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

_________ _________

Urine, Laboratory

10

November 2018

TOPIC

SECTION

PAGE NO.

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

_________ _________

Other Adulterants
Note: Provide the following information for each adulterant
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

_________ _________

Urine, Laboratory

11

November 2018

TOPIC

SECTION

Procedure for validation of the test
methods

PAGE NO.

_________ _________

Procedure for periodic re-verification of the
test methods
_________ _________
Special requirements, etc.

_________ _________

References

_________ _________

Confirmatory Drug Tests
Principle of each analysis
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Preparation of test materials, calibrators,
and controls
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Extraction procedures
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine

_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________

Urine, Laboratory

12

November 2018

TOPIC

SECTION

PAGE NO.

Amphetamine/Methamphetamine

_________ _________

MDMA/MDA
Amphetamines enantiomers

_________ _________
_________ _________

Procedure for instrument maintenance

_________ _________

Procedure for verifying the performance
of the mass spectrometer(s)

_________ _________

Procedure for instrument set-up and operation
THCA
_________
Benzoylecgonine
_________
Codeine/Morphine
_________
Hydrocodone/Hydromorphone
_________
Oxycodone/Oxymorphone
_________
6-Acetylmorphine
_________
Phencyclidine
_________
Amphetamine/Methamphetamine
_________
MDMA/MDA
_________
Amphetamines enantiomers
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Procedure for assay calibration
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Procedure for calculating results
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Urine, Laboratory

13

November 2018

TOPIC

SECTION

PAGE NO.

Procedure when results exceed linearity
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Procedure for designating positive results
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

Procedure for designating reconfirmed
results for split specimens
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

QC procedure and QC acceptance criteria
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine

_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________

Urine, Laboratory

14

November 2018

TOPIC

SECTION

PAGE NO.

Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________

_________
_________
_________
_________

Special requirements, etc.
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
Amphetamines enantiomers

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

_________
_________
_________
_________
_________
_________
_________
_________
_________
_________

References
THCA
Benzoylecgonine
Codeine/Morphine
Hydrocodone/Hydromorphone
Oxycodone/Oxymorphone
6-Acetylmorphine
Phencyclidine
Amphetamine/Methamphetamine
MDMA/MDA
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

_________ _________

Procedures for preparing and verifying
controls

_________ _________

Urine, Laboratory

15

November 2018

TOPIC

SECTION

PAGE NO.

Corrective procedure when calibrator
and control 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 calibrator and
control results

_________ _________

Corrective procedure when QA review of
calibrator and 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

_________ _________

Urine, Laboratory

16

November 2018

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 preparing data packages

_________ _________

Procedure for preparing 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)

_________ _________

Urine, Laboratory

17

November 2018

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

18

November 2018

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? ________________________________________________

Urine, Laboratory

19

November 2018

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?
___

Yes → # of days to be stored: __________

___

No → LABORATORY NOT ELIGIBLE TO APPLY

8a. How will specimens (A and B Bottles) and split specimens be stored? ____________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________

Urine, Laboratory

20

November 2018

E. Records
The laboratory must maintain records to support test results (i.e., including but not limited to all
associated calibrator and control 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 for initial drug tests (e.g., immunoassay, LC-MS/MS) or confirmatory drug tests
(e.g., GC-MS, GC-MS/MS, LC-MS/MS) the laboratory must also provide drug test batch
data and associated documents for a drug positive sample tested using each technology.

Urine, Laboratory

21

November 2018

F. Personnel
To be eligible to apply for certification a laboratory must have a Responsible Person (RP)
Candidate that meets all eligibility requirements listed in Section 11.3 of the Mandatory
Guidelines. A laboratory may not apply for certification unless they can affirmatively answer
questions 2 and 3 below regarding their RP Candidate.
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?
___
Urine, Laboratory

Yes → Describe: _____________________________________________
22

November 2018

_________________________________________________________________
_________________________________________________________________
___

Urine, Laboratory

No → CANDIDATE NOT ELIGIBLE AS RP

23

November 2018

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

24

November 2018

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

25

November 2018

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

26

November 2018

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

27

November 2018

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 calibrators/controls, instrument responses, etc., fail
defined acceptance criteria?
___
___

Yes
No → LABORATORY NOT ELIGIBLE TO APPLY

3. Are all calibrator and control 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
controls. At a minimum, these must include the number and type of calibrators and controls
described in the Mandatory Guidelines for drug and specimen validity tests.
Urine, Laboratory

28

November 2018

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, calibrators and controls within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented and (as applicable for alternate
technologies) criteria for exclusion of unsatisfactory calibrators
- The acceptance criteria for calibration and 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
- For alternate technologies (as applicable), the criteria for accepting, re-extracting, or
reinjecting a specimen
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, calibrators, and controls 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 specimen
validity test measurand, 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, calibrators, and controls 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

29

November 2018

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

30

November 2018

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/Codeine/Morphine Positive
Hydrocodone/Hydromorphone Positive
Oxycodone/Oxymorphone Positive
Amphetamine/Methamphetamine Positive
d-Methamphetamine (if applicable)
MDMA/MDA 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?
___
___

Urine, Laboratory

Yes → ATTACH EXAMPLE DATA FILE REPORTS (reflecting what will be
sent)
No

31

November 2018

9.

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.
___
___

Yes
No

If YES, specify the CCF type(s) and supplier(s):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

Urine, Laboratory

32

November 2018

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
Urine, Laboratory

33

November 2018

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-1.

Immunoassay Initial Drug Test Methods and Instruments

Table 1-a-2.

LC-MS/MS Initial Drug Test Methods

Table 1-a-3.

Initial Drug Test Methods and Instruments – Liquid Chromatography

Table 1-a-4.

Initial Drug Test Methods and Instruments – Tandem Mass Spectrometry

Table 1-b.

Immunoassay First Initial Drug Test Calibrators and Controls

Table 1-c.

Immunoassay Second Initial Drug Test Calibrators and Controls

Table 1-d.

Initial Drug Test Calibrators and Controls – LC-MS/MS

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)

Urine, Laboratory

34

November 2018

Table 2-d-1.

Initial Specimen Validity Test Calibrators and Controls
(continued on Table 2-d-2 as needed)

Table 2-d-3.

Confirmatory Specimen Validity Test Calibrators and Controls
(continued on Table 2-d-4 as needed)

Table 2-d-5.

Screening/Differential Specimen Validity Test Calibrators and Controls

Table 3-a.

Confirmatory Drug Test Methods

Table 3-b-1.

Primary Confirmatory Drug Test Methods and Instruments – Gas
Chromatography

Table 3-b-2.

Alternate Confirmatory Drug Test Methods and Instruments – Gas
Chromatography

Table 3-b-3.

Primary Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography

Table 3-b-4.

Alternate Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography

Table 3-c-1.

Primary Confirmatory Drug Test Methods and Instruments – Mass
Spectrometry

Table 3-c-2.

Alternate Confirmatory Drug Test Methods and Instruments – Mass
Spectrometry

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 Calibrators and Controls

Table 3-d-2.

Alternate Confirmatory Drug Test Calibrators and Controls

Table 4-a.

AMPS Enantiomer Test Methods

Table 4-b.

AMPS Enantiomer Calibrators and Controls

Table 4-c.

AMPS Enantiomer Result Calculation

Urine, Laboratory

35

November 2018

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

35

November 2018

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

Urine, Laboratory

36

November 2018

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
Urine, Laboratory

37

November 2018

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 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

38

November 2018