2026 Instrumented Initial Test Facility (IITF) Application Form

Effective 1 April 2025

URINE
INSTRUMENTED INITIAL TEST FACILITY
(IITF)
APPLICATION FORM

RTI International
3040 Cornwallis Road
Durham, North Carolina 27713

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:

(____) ____ - _______

FAX: (____) ____ - ______

e-Mail:
2.

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
1. To be eligible for certification, the IITF must test for all drug test analytes in the Department
of Health and Human Services (HHS) Authorized Drug Test Panel. The IITF must also use
the test methods for screening and initial tests (i.e., drug tests and specimen validity tests)
specified by the Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Urine. 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 (i.e., at a minimum, tests
for creatinine, pH, specific gravity, and one or more oxidizing adulterants as required by
the Mandatory Guidelines)?
___
___

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 reference materials containing controlled substances are acquired: ___
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
3. Describe the relevant State licensure requirements for urine forensic toxicology for the State
in which the IITF is located:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

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4. List IITF certifications/licenses:
____ States (List):__________________________________________________________
____ CLIA/HCFA1 (List Specialties): ___________________________________________
____ CAP2 (List Specialties): _________________________________________________
____ Others (Specify): ______________________________________________________
Clinical Laboratory Improvement Amendments(CLIA)/Health Care Financing Administration (HCFA)
College of American Pathologists (CAP)

1
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 using Urine.
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 urine 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

_________ _________

Procedure for maintaining security
of specimen bottles

_________ _________

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TOPIC

SECTION

PAGE NO.

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

_________ _________

Procedure for automated aliquoting
equipment

_________ _________

Initial Drug Test
Note: For alternate technology initial drug tests [as applicable], provide the following
information based on the current Authorized Drug Testing Panel (i.e., list initial test
analytes below, either individually or grouped, appropriate for the topic).
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, acceptance
criteria (including partial batch acceptance
criteria) and corrective actions
_________ _________
Procedure for validation of initial drug test
methods

_________ _________

Procedure for verifying new lots of test
materials (including immunoassay
reagents)

_________ _________

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TOPIC

SECTION

PAGE NO.

Procedure for periodic re-verification of
alternate technology 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, acceptance criteria (including
partial batch acceptance criteria), and
corrective actions
_________ _________
Procedure for validation of second
initial drug test methods

_________ _________

Procedure for verifying new lots of test
materials (including immunoassay
reagents)

_________ _________

References

_________ _________

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TOPIC

SECTION

PAGE NO.

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

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

Procedure for assay calibration

_________ _________

Procedures for conducting creatinine tests _________ _________
QC procedure, acceptance criteria (including
partial batch acceptance criteria), and
corrective actions
_________ _________
Procedure for validation of creatinine
test methods

_________ _________

Procedure for periodic re-verification of
creatinine test methods

_________ _________

Special requirements, etc.

_________ _________

References

_________ _________

Specific Gravity
Principle of analysis

_________ _________

Preparation of calibrators and
and controls

_________ _________

Procedure for set-up and normal
operation of instruments

_________ _________

Procedure for instrument maintenance

_________ _________

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TOPIC

SECTION

PAGE NO.

Procedure for assay calibration

_________ _________

Procedures for conducting
specific gravity tests

_________ _________

QC procedure, acceptance criteria, and
corrective actions for specific gravity tests

_________ _________

Procedure for validation of specific gravity
test methods
_________ _________
Special requirements, etc.

_________ _________

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 procedure, acceptance criteria (including
partial batch acceptance 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 _________ _________

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TOPIC

SECTION

PAGE NO.

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 procedure, acceptance criteria (including
partial batch acceptance 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

_________ _________

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TOPIC

SECTION

PAGE NO.

Other Specimen Validity Tests
Note: Provide the following information for each specimen validity test
Measurand:
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 procedure, acceptance criteria (including
partial batch acceptance criteria, and
corrective action for the test
_________ _________
Criteria for identifying acceptable and
possible invalid, substituted, or adulterated
specimens based on the 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

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TOPIC

SECTION

PAGE NO.

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 action procedure when test material
verification results are unacceptable
_________ _________
Quality Assurance (QA) Procedures
Procedures for monitoring calibrator and
control results

_________ _________

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

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_________ _________
_________ _________

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TOPIC

SECTION

Procedure to detect and correct
clerical errors

PAGE NO.

_________ _________

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

_________ _________

Procedure for computer and software
validation

_________ _________

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

_________ _________

Procedure for LIMS records archival
and retrieval

_________ _________

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

_________ _________

System Security Plan (SSP)

_________ _________

Validation of second party software used
on mass spectral instruments

_________

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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 and 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. If the
laboratory plans to use an electronic Federal Custody and Control Form (ECCF), the
laboratory must submit supporting documentation separately to the NLCP. Requirements
for an ECCF Submission are in Section P of the NLCP Manual for Urine Laboratories.
1. Provide a description of the IITF's procedures for the following:
Specimen Receiving/Accessioning
-Receipt of specimen packages, how they are handled (if received outside the secured
forensic laboratory)
-Reviews of the Federal CCF and each specimen bottle
-Completing accessioner CCF entries, assembling specimen batch, assigning IITF
accession numbers
-Handling and resolution of problems with specimen bottles and/or Federal CCFs
-Description of collection kit to be used
-Location of all temporary storage area(s)
Aliquoting Procedures
-Aliquoting from the original specimen bottles (i.e., who and where)
-The aliquoting procedure (method, amounts, handling bottles and tubes, labeling) for initial
drug tests, screening specimen validity tests, and initial specimen validity tests
-Transfer of aliquots from the individuals performing the aliquoting to those who will be
testing the aliquots
-Transfer and storage of original specimen bottles after aliquoting is complete
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
-Location of all temporary storage areas
Specimen Validity Tests (Screening, Initial)
-Handling and testing of aliquots by IITF personnel
-Maintenance of chain of custody and aliquot identity during the testing
-Location of all temporary storage areas
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 → The IITF will be required to provide the items on the Electronic
CCF System Submission List (see Section P of the NLCP Manual for
Urine IITFs) after the IITF’s application has been approved
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 IITF will use more than one
technology for initial drug tests (e.g., immunoassay, LC-MS/MS) the IITF 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 the 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
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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

5. In the table below, enter the RT candidate’s education.
Education

Major and Minor
Fields of Study

Name of School

Diploma,
Certificate or
Degree Received

College or
University

Other Schools
Attended

6. How long has the RT candidate been associated with the IITF?
________ YEARS
7. Is the RT 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, describe the candidate’s relationship with the IITF:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
8. If approved as the RT for the certified IITF, how many hours per week would the candidate
work in the regulated forensic urine drug testing IITF?
________ HOURS PER WEEK

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9. If approved as the RT for the certified IITF, what additional duties (i.e., other than regulated
forensic urine drug testing) would the candidate perform for the company? (List here.)
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
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

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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
4. In the table below, enter the alt-RT 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. How long has the alt-RT candidate been associated with the IITF?
_______ YEARS
6. Is the alt-RT 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, describe the candidate’s relationship with the IITF:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
7. If approved as the alt-RT for the certified IITF, how many hours per week would the
candidate work in the regulated forensic urine drug testing IITF?
______ HOURS PER WEEK
8. If approved as the alt-RT for the certified IITF, what additional duties (i.e., other than
regulated forensic urine drug testing) would the candidate perform for the company? (List
here.)
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
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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 (QC)
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?
___
___

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 Technician Candidate?
___
___

Yes
No → CANDIDATE NOT ELIGIBLE AS RT

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?
___
___

Urine, IITF

Yes
No → IITF NOT ELIGIBLE TO APPLY
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April 2025

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 aliquoting 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, whether a batch
is constituted in one session or specimens are 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 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, whether a batch
is constituted in one session or specimens are 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 decision points for each test and what constitutes abnormal results
- 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.

Urine, IITF

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April 2025

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,
criteria for instrument flags):_________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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,
integrity, and availability of the data and to limit access to any data transmission, storage,
and retrieval system: ______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
4. Is the IITF’s Federal CCF identical to the OMB-approved Federal CCF to be used for all
specimens submitted for testing under the Mandatory Guidelines?
___
___

Urine, IITF

Yes→ ATTACH EXAMPLE OF IITF'S CUSTODY AND CONTROL FORM
No→ IITF NOT ELIGIBLE TO APPLY

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April 2025

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

Yes → ATTACH EXAMPLE REPORTS (SEE BELOW)
No

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):
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

Urine, IITF

24

April 2025

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 (and back-up computer system, if any) to be
used 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 onsite, provide
information on location and organizational control of each 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

Urine, IITF

25

April 2025

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,
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 (attached)?
___ Yes
___ No → IITF NOT ELIGIBLE TO APPLY
7. Does the IITF use data analysis software (in-house or third party) to process mass spectral
results?
___ Yes ® List the software and provide a description of its operation and use
in data processing and review
___ No
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Complete the NLCP Application Tables – Urine

Contact the NLCP for Application Tables focused on technologies other those in the tables.
Table 1-a-1.

Immunoassay Initial Drug Test Methods and Instruments

Table 1-a-2.

Alternate Technology 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 –Mass Spectrometry

Table 1-b.

Immunoassay First Initial Drug Test Calibrators and Controls

Table 1-c.

Immunoassay Second Initial Drug Test Calibrators and Controls

Urine, IITF

26

April 2025

Table 1-d.

Initial Drug Test Calibrators and Controls – Alternate Technology

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)

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

Tables 3-a
Through 3-d.

not applicable for an IITF

Tables 4-a
through 4-c.

not applicable for an IITF

Urine, IITF

27

April 2025

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 and records
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.

Urine, IITF

28

April 2025