2019 IITF App Form

Effective 1 April 2019

Urine
Instrumented Initial Test Facility
(IITF)
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 IITF APPLICATION FORM
A. Applicant IITF
1.

Name of IITF: __________________________________________
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
Telephone:

(____) ____ - _______

e-Mail:
2.

FAX: (____) ____ - ______
___________________

Express delivery address (if different from above)
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________

3.

Designated Responsible Technician (RT): ___________________
Title/Position: _________________________________________
Telephone: (____) _____ - ________ Ext. ___________________
e-Mail:

________________________

If applicable:
Designated Alternate RT (Alt-RT): __________________________
Title/Position: _________________________________________
Telephone: (____) _____ - ________ Ext. ___________________
e-Mail:
4.

________________________

I understand that the answers provided in this application will be
used to determine the applicant IITF'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 RT

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.

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B. General IITF 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). Note: confirmatory test information is not applicable for IITFs.
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
1
For 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.
2
An immunoassay must be calibrated with the target analyte, ∆-9-tetrahydrocannabinol-9-carboxylic acid
(THCA).
3
Alternate 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).
4
Methylenedioxymethamphetamine (MDMA)
5
Methylenedioxyamphetamine (MDA)
MDMA4/MDA5

500 ng/mL

1. To be eligible for certification, the IITF must test for all initial drug test analytes and initial
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 IITF must use the test methods specified by the Mandatory

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Guidelines for screening and initial tests (i.e., drug tests and specimen validity tests). Note:
the terms “screening specimen validity test” and “initial specimen validity test” are defined in
Section J of the NLCP Manual for Urine IITFs.
1a. Does the IITF have validated initial drug test assays for the drug analytes required by
the Mandatory Guidelines?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

1b. Does the IITF 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 → IITF NOT ELIGIBLE TO APPLY

2. Is the IITF registered with the U.S. Drug Enforcement Agency (DEA)?
___
___

Yes → ATTACH PHOTOCOPY OF REGISTRATION CERTIFICATE
No → COMMENT BELOW

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 IITF is located. ________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

4. List IITF certifications/licenses:

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____ 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.

5. To be eligible for certification, the IITF must obtain a letter of commitment from one or more
HHS-certified laboratories stating that the laboratory will receive, test, and report specimens
from the certified IITF. The letter must be signed by each Responsible Person (RP) of the
laboratory and by the designated RT of the applicant IITF. The list of currently certified
laboratories is published by SAMHSA monthly in the Federal Register and is available on
the SAMHSA website, http://workplace.samhsa.gov/.
5a. Does the IITF have a letter of commitment from one or more HHS-certified
laboratories?
___
___

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Yes → ATTACH PHOTOCOPIES OF ALL LABORATORY
COMMITMENT LETTERS
No → IITF NOT ELIGIBLE TO APPLY

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C. IITF Standard Operating Procedures (SOP) Manual
1. For certification, the IITF 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 IITF is eligible to receive NLCP performance testing (PT)
samples.
1a. Does the IITF have a complete SOP manual for regulated drug testing?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

IITF SOP MANUAL INDEX
Indicate the location for each of these topics in the IITF'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 problem/rejected specimens _________ _________
Chain-of-Custody
Procedure for documenting all transfers
of specimens
Procedure for documenting all
transfers of aliquots

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_________ _________

_________ _________

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TOPIC

SECTION

PAGE NO.

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 a laboratory

_________ _________

Aliquot Preparation
Procedure for preparing initial drug test
aliquots

_________ _________

Procedure for preparing screening
specimen validity test aliquots

_________ _________

Procedure for preparing initial specimen
validity test aliquots

_________ _________

Procedures for automated aliquotting
equipment

_________ _________

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

_________ _________

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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 test materials, calibrators,
and controls

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

Procedure for assay calibration

_________ _________

Procedure for calculating results

_________ _________

QC procedure and criteria for
acceptable results and corrective actions

_________ _________

Procedure for validation of second
initial drug test methods

_________ _________

References

_________ _________

Specimen Validity Tests
Note: Provide the following information for each specimen validity test (Screening and
Initial tests are defined in Section J of the NLCP Manual for Urine IITFs)
Creatinine
Principle of analysis

_________ _________

Preparation of test materials, calibrators,
and controls

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_________ _________

April 2019

TOPIC

SECTION

PAGE NO.

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

Procedure for assay calibration

_________ _________

Procedures for conducting creatinine tests _________ _________
QC acceptance/rejection criteria and
corrective action for creatinine tests

_________ _________

Procedure for validation of creatinine
test methods

_________ _________

Procedure for periodic re-verification of
creatinine test methods

_________ _________

Special requirements, etc.

_________ _________

References

_________ _________

Specific Gravity
Principle of analysis

_________ _________

Preparation of calibrators and
and controls

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

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.

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_________ _________

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TOPIC

SECTION

PAGE NO.

References

_________ _________

Criteria for identifying acceptable,
dilute, and possible invalid or substituted
specimens based on creatinine and
specific gravity test results

_________ _________

pH
Principle of analysis

_________ _________

Preparation of test materials, calibrators,
and controls

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

Procedure for assay calibration

_________ _________

Procedures for conducting pH tests

_________ _________

QC acceptance/rejection criteria
and corrective action for pH tests

_________ _________

Criteria for identifying acceptable and
possible invalid or adulterated specimens
based on pH test results

_________ _________

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

_________ _________

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TOPIC

SECTION

PAGE NO.

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 and
possible invalid or adulterated specimens
based on oxidant test results

_________ _________

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

_________ _________

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TOPIC

SECTION

PAGE NO.

Criteria for identifying acceptable and
possible invalid or adulterated specimens
based on the adulterant test results

_________ _________

Procedure for validation of the test
methods

_________ _________

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

_________ _________

References

_________ _________

QC and Test Materials
Procedures for preparing stock
standards, etc.

_________ _________

Procedures for preparing and verifying
calibrators

_________ _________

Procedures for preparing and verifying
controls

_________ _________

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)

_________ _________

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TOPIC

SECTION

Equipment and Maintenance
Wash procedure for labware

PAGE NO.

_________ _________

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 specimen

_________ _________

Procedure for reporting the
test result(s) of a 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 Forwarded
and Rejected Specimen List (FRSL)

_________ _________

IITF Computers and Information Systems Procedures
Computer and Laboratory Information
Management System (LIMS) security
procedures
_________ _________
Computer and LIMS maintenance
procedures

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_________ _________

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TOPIC

SECTION

PAGE NO.

Procedure for computer and software
validation

_________ _________

Procedure for requesting, verifying, and
implementing software and configuration
changes

_________ _________

Procedure for LIMS records archiving
and retrieval

_________ _________

Procedures for system monitoring, incident
response, and disaster recovery
_________ _________
Procedure for obtaining audit trail reports

_________ _________

System Security Plan (SSP)

_________ _________

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D. Chain of Custody, Accessioning, and Security
The IITF must have chain of custody, accessioning, and security procedures that ensure
integrity is maintained for the original specimens and their aliquots. 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 IITF must ensure the
security of specimens and aliquots during processing and placement in any storage locations.
1. Provide a description of the IITF'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 IITF 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 specimen validity tests, and initial 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 IITF personnel
-Maintenance of chain of custody and aliquot identity during the testing
Specimen Validity Tests (Screening, Initial)
-Handling and testing of aliquots by IITF personnel
-Maintenance of chain of custody and aliquot identity during the testing
Note: the terms “screening specimen validity test” and “initial specimen validity test” are
defined in Section J of the NLCP Manual for Urine IITFs.
Disposition of Specimens and Aliquots
-Handling of original specimen bottles and aliquots after testing is completed
-Procedure for transferring specimens to an HHS-certified laboratory
Note: (1) Insert here.
(2) Do not exceed a total of 3 pages.

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2. Will the IITF 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 → IITF NOT ELIGIBLE TO APPLY

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

Yes
No → IITF NOT ELIGIBLE TO APPLY

6. Attach a floorplan of the IITF 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 → IITF 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? ________________________________________________

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E. Records
The IITF 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 IITF 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
IITF must have security measures in place to limit access to electronic and hardcopy records to
essential authorized personnel.
1. Will the IITF maintain records supporting specimen test results for at least two years?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

1a. Will there be a secured area for the storage of records supporting specimen test results?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

2. Will the IITF limit records access to authorized personnel?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

3. Attach two data packages using the format described in Section R of the NLCP Manual for
Urine Instrumented Initial Test Facilities to support (1) a specimen forwarded to a laboratory
based on initial drug test results and (2) a specimen forwarded to a laboratory based on
specimen validity test results.
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, GC-MS, GC-MS/MS, LC-MS/MS) the
laboratory must also provide drug test batch data and associated documents for a sample
tested using each technology.

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F. Personnel
To be eligible to apply for certification an IITF must have a Responsible Technician (RT)
candidate that meets all eligibility requirements listed in Section 12.3 of the Mandatory
Guidelines. An IITF may not apply for certification unless they can affirmatively answer
questions 2 and 3 below regarding their RT Candidate.
Qualifications for a Responsible Technician Candidate
1. RT 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 RT
requirements as stated in the Mandatory Guidelines (Section 12.3);
(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 RT, at least one of the following questions must be answered
“yes”:
2a. Does the candidate have a bachelor’s degree in the chemical or biological sciences or
medical technology?
___

Yes → In which field? __________________________________________
GO TO QUESTION 3.

___

No → GO TO QUESTION 2b.

2b. Does the candidate have training and experience comparable to a bachelor’s degree in
the chemical or biological sciences or medical technology, such as a scientific associate
degree or certificate, or at least 2 years of university courses in a science curriculum,
with additional training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___

No

3. Does the candidate have training and experience in the analytical methods and forensic
procedures used by the IITF that are relevant to the results?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________

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___

No→ CANDIDATE NOT ELIGIBLE AS RT

4. Does the candidate have appropriate training and experience in reviewing and reporting
forensic test results, maintenance of chain of custody, recordkeeping, and understanding
proper remedial action in response to problems that may arise?
___ Yes → Describe: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___

No→ CANDIDATE NOT ELIGIBLE AS RT

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 IITF?
___ 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
IITF?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
6. How many hours per week will the candidate work in the forensic urine drug testing IITF?
___________________ HOURS PER WEEK
7. How long has the candidate been associated with the IITF?
_________________________ YEARS

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Qualifications for an Alternate Responsible Technician Candidate
1. Alternate RT 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 RT
requirements as stated in the Mandatory Guidelines;
(b) A current résumé or curriculum vitae; and
(c) Official copies with raised seal of all academic undergraduate and graduate transcripts.
2. An alt-RT must be capable of fulfilling RT duties for a limited time (i.e., up to 180 days). An
alt-RT candidate’s qualifications are compared to RT requirements as follow:
2a. Does the candidate have a bachelor’s degree in the chemical or biological sciences or
medical technology?
___

Yes → In which field? __________________________________________
GO TO QUESTION 3.

___

No → GO TO QUESTION 2b.

2b. Does the candidate have training and experience comparable to a bachelor’s degree in
the chemical or biological sciences or medical technology, such as a scientific associate
degree or certificate, or at least 2 years of university courses in a science curriculum,
with additional training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology?
___ Yes → Describe: _____________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
___ No
3. An alt-RT candidate must have appropriate experience in analytical toxicology.
3a. How many years of experience does the candidate have in analytical forensic toxicology
(including experience with the analysis of biological material 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 IITF (i.e., including training and experience as a certifying
technician)?
___ Yes
___ No → CANDIDATE NOT ELIGIBLE AS AN ALT-RT

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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 IITF?
___ 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
IITF?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
6. How many hours per week will the candidate work in the forensic urine drug testing IITF?
______ HOURS PER WEEK
7. How long has the candidate been associated with the IITF?
_______ YEARS

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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)

Supervisor(s)

Other Key
Staff

2. Is licensure and/or certification required for any of the above positions in the State in which
the IITF is located?
___
___

Yes
No → GO TO SECTION G

If YES, describe requirements:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

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G. Quality Control
For certification, the IITF 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 → IITF NOT ELIGIBLE TO APPLY

3. Are all calibrator and control results reviewed by the Certifying Technician prior to the
release of the results?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

4. Is the QA/QC program under the direct supervision of a Quality Control Supervisor?
___
___
4a.

Yes
No → COMPLETE 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 Technician Candidate?
___
___
5a.

Yes
No → CANDIDATE NOT ELIGIBLE AS RT

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?
___
___

Urine, IITF

Yes
No → IITF NOT ELIGIBLE TO APPLY

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April 2019

7. For certification, the IITF 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.
Provide a description of the IITF'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 (Screening, Initial)
- 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 IITF's
specimen validity testing. The IITF’s submission must identify any “reflex” testing, the
initial test methods for each specimen validity test measurand, and any screening tests.
Note: (1) Insert here.
(2) Do not exceed a total of 2 pages.

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H. Review and Reporting
The IITF 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 and initial tests): _________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Briefly describe the procedures for the reporting of results. If the IITF will use electronic
reporting for any regulated specimens, describe procedures to ensure confidentiality: ___
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
4. Is the IITF’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 IITF'S CUSTODY AND CONTROL FORM
No→ IITF NOT ELIGIBLE TO APPLY

5. Will the IITF use computer-generated electronic reports for specimens submitted for testing
under the Mandatory Guidelines?
___
___

Urine, IITF

Yes → ATTACH EXAMPLE REPORTS (SEE BELOW)
No

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April 2019

If YES, attach an example of the IITF's computer-generated electronic report for each of the
following IITF results:
•
•
•

Negative
Negative, Dilute
Rejected

6. Will the IITF send a data file report in lieu of a formatted electronic report?
___
___

7.

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

Does the IITF plan to use an electronic (digital) or combination (electronic and paper)
Federal CCF for reporting? Note: Section D of the NLCP Manual for Urine IITFs describes
the allowable formats for the Federal CCF.
___ Yes
___ No
If YES, specify the CCF type(s) and supplier(s):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

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April 2019

I. IITF Computers and Information Systems
IITF 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. HHS-certified 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 IITF. Is it a “stand
alone” system used solely by the IITF, part of a local system (e.g., a hospital system), or part
of a multi-facility 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 IITF plans to use the computer system in regulated
specimen processing: _____________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Is the IITF computer system maintained in a secure area?
___ Yes
___ No
Attach a floorplan identifying the IITF 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 IITF limit functional access to the computer system?
___ Yes
___ No

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5. Does the IITF 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 → IITF NOT ELIGIBLE TO APPLY

6. Will the IITF use an external service provider (e.g., LIMS provider, software service provider,
ECCF provider, report provider) to perform services on the IITF’s behalf related to regulated
drug testing?
___
___

Yes → List the names of external service providers, and Complete 6a
No

_______________________________________________________________________
_______________________________________________________________________
6a. Does the IITF 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 → IITF 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.

not applicable for an IITF

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 Calibrators and Controls
(continued on Table 2-d-2 as needed)

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April 2019

Tables 2-d-3
and 2-d-4.

not applicable for an IITF

Table 2-d-5.

Screening/Differential Specimen Validity Test Calibrators and Controls

C-3 Tables.

not applicable for an IITF

Tables C-4-a
through C-4-c.

not applicable for an IITF

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April 2019

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 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.

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April 2019

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: RT must document review and approval of training plans and materials
4. System/Network Diagram Logical network diagram including, at a minimum:
o Firewalls
o Network security devices
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April 2019

Electronic CCF System Submission List
o
o
o
o
o

Servers
Workstations
Primary routers/switches
Remote access devices
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

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April 2019

Electronic CCF System Submission List
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
o Establishes the permitted and required uses and disclosures of regulated
specimen and drug test information by the ECCF provider
o Addresses, at a minimum, these priority elements:
 Limiting access to regulated specimen information
 Implementing appropriate safeguards to prevent unauthorized use
or disclosure of the information, including implementing applicable
federal requirements with regard to regulated specimen and drug
test information
 Reporting to the HHS-certified test facility any use or disclosure of
the information not provided for by the contract, including incidents
that constitute incidents that constitute data breaches of unsecured
regulated specimen and drug test information
 Disclosing information to HHS related to regulated specimens and
drug tests
 Arranging for disposition of regulated specimen data (i.e., disposal
in accordance with specified record retention periods; transfer of
records to the HHS-certified test facility upon termination of the
agreement)
 Notifying the HHS-certified test facility prior to allowing any
subcontractors to have access to regulated specimen and drug test
information
 Ensuring that any subcontractors agree to the same restrictions
and conditions that apply to the ECCF provider with respect to
regulated specimen and drug test information.
Note: The agreement/contract must be provided for NLCP review with the
initial ECCF submission and with other ECCF system documentation at each
inspection.

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