IITF App Form IITF App Form

Effective 1 October 2010

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 4 hours per respondent per year, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA
Reports Clearance Officer, 1 Choke Cherry Road, Room 7-1044, Rockville, Maryland, 20857.

NATIONAL LABORATORY CERTIFICATION PROGRAM
URINE 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, 73 FR 71858, 25 November 2008,
effective 1 October 2010). Note: confirmatory test information is not applicable for IITFs.

Marijuana metabolites

Initial Test Cutoff
Concentration
50 ng/mL

Confirmatory Test
Analyte
THCA1

Confirmatory Test
Cutoff Concentration
15 ng/mL

Cocaine metabolites

150 ng/mL

Benzoylecgonine

100 ng/mL

Opiate metabolites
Codeine/Morphine2

2000 ng/mL
10 ng/mL

Codeine
Morphine
6-Acetylmorphine

2000 ng/mL
2000 ng/mL
10 ng/mL

Phencyclidine

25 ng/mL

Phencyclidine

25 ng/mL

Amphetamines3
AMP/MAMP4

500 ng/mL

Initial Test Analyte

6-Acetylmorphine

Amphetamine
250 ng/mL
5
Methamphetamine
250 ng/mL
MDMA6
500 ng/mL
MDMA
250 ng/mL
MDA7
250 ng/mL
MDEA8
250 ng/mL
1
Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
2
Morphine is the target analyte for codeine/morphine testing.
3
Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects
each target analyte independently at the specified cutoff.
4
Methamphetamine is the target analyte for amphetamine/methamphetamine testing
5
To be reported positive for methamphetamine, a specimen must also contain amphetamine at a
concentration equal to or greater than 100 ng/mL.
6
Methylenedioxymethamphetamine (MDMA).
7
Methylenedioxyamphetamine (MDA).
8
Methylenedioxyethylamphetamine (MDEA).

1. To be eligible for certification, the 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, 73 FR 71858, 25 November 2008,
effective 1 October 2010). The IITF must use the test methods specified by the Mandatory
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 classes required by the
Mandatory Guidelines?
___
___

Urine, IITF

Yes
No → IITF NOT ELIGIBLE TO APPLY

2

October 2010

1b. Does the IITF use an immunoassay method approved, cleared, or otherwise recognized
as accurate and reliable by the U.S. Food and Drug Administration (FDA) for the initial
drug tests?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

1c. 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:
____ 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

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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?
___
___

Urine, IITF

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

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October 2010

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, 73 FR 71858, 25 November 2008, effective 1 October 2010).
Note: Manufacturers’ package inserts or instrument manuals are not considered formal
procedures. A written SOP manual is required to be eligible to apply for certification and it
must be completed before the 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

_________

_________

_________

_________

Procedure for problem/rejected specimens _________

_________

Accessioning (Specimen receipt)
Procedure for receipt and processing
of 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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October 2010

TOPIC

SECTION

PAGE NO.

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

_________

_________

_________

_________

Preparation of reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedure for calculating results

_________

_________

Quality control (QC) procedure and criteria
for acceptable results and corrective
actions
_________

_________

Procedure for validation of initial drug test
methods

_________

_________

References

_________

_________

Initial Drug Test
Principle of analysis

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October 2010

TOPIC

SECTION

PAGE NO.

Second Initial Drug Test
Criteria for use

_________

_________

Principle of analysis

_________

_________

Preparation of reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedure for calculating results

_________

_________

QC procedure and criteria for
acceptable results and corrective actions

_________

_________

Procedure for validation of second
initial drug test methods

_________

_________

References

_________

_________

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 reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedures for conducting creatinine tests _________

_________

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October 2010

TOPIC

SECTION

PAGE NO.

QC acceptance/rejection criteria and
corrective action for creatinine tests

_________

_________

Procedure for validation of creatinine
test methods

_________

_________

Procedure for periodic re-verification of
creatinine test methods

_________

_________

Special requirements, etc.

_________

_________

References

_________

_________

_________

_________

Preparation of calibrators and
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

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 method
_________

_________

Special requirements, etc.

_________

_________

References

_________

_________

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

_________

_________

Specific Gravity
Principle of analysis

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October 2010

TOPIC

SECTION

PAGE NO.

_________

_________

Preparation of reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedures for conducting pH tests

_________

_________

QC acceptance/rejection criteria
and corrective action for pH tests

_________

_________

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

_________

_________

Procedure for validation of pH test methods _________

_________

Special requirements, etc.

_________

_________

References

_________

_________

_________

_________

Preparation of reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedures for conducting oxidant tests

_________

_________

QC acceptance/rejection criteria
and corrective action for oxidant tests

_________

_________

pH
Principle of analysis

Oxidants
Principle of analysis

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October 2010

TOPIC

SECTION

PAGE NO.

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 reagents, calibrators,
and controls

_________

_________

Procedure for set-up and normal
operation of instruments

_________

_________

Procedure for instrument maintenance

_________

_________

Procedure for assay calibration

_________

_________

Procedures for conducting
the test

_________

_________

QC acceptance/rejection criteria and
corrective action for the test

_________

_________

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

_________

_________

Procedure for validation of the test
methods

_________

_________

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October 2010

SECTION

TOPIC
Procedure for periodic re-verification of the
test methods

PAGE NO.

_________

_________

Special requirements, etc.

_________

_________

References

_________

_________

_________

_________

Procedures for preparing and verifying
calibrators

_________

_________

Procedures for preparing and verifying
controls

_________

_________

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

_________

Procedures for preparing and verifying
reagents

_________

_________

Corrective procedure when reagent
verification results are unacceptable

_________

_________

Quality Assurance (QA) Procedures
Procedures for monitoring control results

_________

_________

Corrective procedure when QA review
of control results shows problems or potential
problems (e.g., trends, shifts, bias)
_________

_________

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

Equipment and Maintenance
Wash procedure for labware

_________

_________

Procedure for determining accuracy
and precision of pipetting devices

_________

_________

Procedures for temperature-dependent
equipment

_________

_________

Procedures for centrifuges

_________

_________

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October 2010

TOPIC

SECTION

PAGE NO.

Procedures for analytical balances

_________

_________

Safety procedures

_________

_________

_________

_________

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 Computer System Procedures
Computer and Laboratory Information
Management System (LIMS) security
procedures

_________

_________

Computer and LIMS maintenance
procedures

_________

_________

Procedure for computer and software
validation

_________

_________

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

_________

_________

Procedure for LIMS records archiving
and retrieval

_________

_________

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

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TOPIC

SECTION

PAGE NO.

Procedures for system monitoring, incident
response, and disaster recovery
_________

_________

Procedure for obtaining audit trail reports

_________

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_________

October 2010

D. Chain of Custody, Accessioning, and Security
The 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
-Location of temporary storage area(s)
Aliquotting Procedures
-Aliquotting from the original specimen bottles (i.e., who and where)
-The aliquotting procedure (pouring or pipetting and amounts) used for preparing aliquots
for initial drug tests, screening 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. Attach a flowchart and/or examples of chain of custody documents showing how regulated
specimens and aliquots will be processed and their custody documented (chain of custody
documents may be referenced and/or provided as examples for clarification).
3. Will regulated specimens be accessioned in a limited access, secure area?
___
___

Yes
No → IITF NOT ELIGIBLE TO APPLY

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

Yes
No → IITF NOT ELIGIBLE TO APPLY

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

Yes
No → IITF NOT ELIGIBLE TO APPLY

6a. Where will the original specimens be stored?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________

6b. Who will have access to the specimen storage areas?
Before testing? ________________________________________________________
During testing? ________________________________________________________
After testing is complete? ________________________________________________

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E. Records
The IITF must maintain records to support test results (i.e., including but not limited to all
associated QC results, analytical data, chain of custody documents and associated
administrative records) for at least two years. The 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 negative drug test result and (2) a
possible adulterated, substituted, or invalid result based on specimen validity testing.

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October 2010

F. Personnel
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;
(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: _____________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
___

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?

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October 2010

___ 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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October 2010

4. In the table below, enter the candidate’s education.

Education

Major and Minor
Fields of Study

Name of School

Diploma, Certificate
or Degree Received

College or
University

Other Schools
Attended

5. Is the candidate a full-time or part-time employee of the 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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October 2010

Personnel Certifications and Licenses
1. List the name, job title, education, and licenses/certifications for the following key staff:
Note: (1) Attach a résumé for each individual listed below.
(2) Attach a separate sheet as needed to list all individuals in these positions.

Name

Job Title

Education

License/
Certification

Certifying
Technician(s)

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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October 2010

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

Yes
No → IITF NOT ELIGIBLE TO APPLY

3. Are all QC 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

22

October 2010

7. For certification, the IITF must have a QC program that includes both blind and open QC
samples. At a minimum, these must include the number and type of QC samples described
in the Mandatory Guidelines for drug and specimen validity tests.
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 and QC samples within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
Specimen Validity Tests (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 and QC samples within each batch
- The procedure(s) and acceptance criteria for calibration and when and by whom the
calibration data are evaluated and documented
- The acceptance criteria for each control (open and blind) in each batch and when and by
whom these are evaluated and documented
- The criteria for accepting all donor specimen results or only a partial number of donor
specimens in a batch
- Include an outline or a legible flow chart 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

23

October 2010

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
24

October 2010

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

Urine, IITF

Negative
Negative, Dilute
Rejected

25

October 2010

I. IITF Computer 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
Urine, IITF

26

October 2010

Complete the NLCP Application Tables

Table 1-a.

First and Second Initial Drug Test Methods and Instruments

Table 1-b.

First Initial Drug Test QC samples

Table 1-c.

Second Initial Drug Test QC samples

Table 2-a-1.

Initial Specimen Validity Test Methods and Instruments (continued on Table
2-a-2 as needed)

Table 2-b-1.

not applicable for an IITF

Table 2-c-1.

Screening Specimen Validity Test Methods and Instruments (continued on
Table 2-c-2 as needed)

Table 2-d-1.

Initial Specimen Validity Test QC samples
(continued on Table 2-d-2 as needed)

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

not applicable for an IITF

Table 2-d-5.

Screening Specimen Validity Test QC samples

Urine, IITF

27

October 2010

Initial Drug Test
Methods and Instruments

Table 1-a

IITF

First Initial Drug Test Methods and Instruments
First Initial Drug
Test

THCA (marijuana
metabolites)

BZE (cocaine
metabolites)

MOR (opiate
metabolites)

6-AM

PCP

MAMP
(amphetamines)

MDMA

MAMP
(amphetamines)

MDMA

Kit and
Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Calibration Method
Maximum Batch
Size

*If “Other” is selected, please specify:

Second Initial Drug Test Methods and Instruments
Second Initial Drug
Test

THCA (marijuana
metabolites)

BZE (cocaine
metabolites)

MOR (opiate
metabolites)

6-AM

PCP

Kit and
M
f t
Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Calibration Method
Maximum Batch
Size

*If “Other” is selected, please specify:
THCA = Δ9-tetrahydrocannabinol-9-carboxylic acid
BZE = benzoylecgonine

MOR = morphine
PCP = phencyclidine

6-AM = 6-acetylmorphine
MAMP = methamphetamine

IITF_Applic_Tables_Oct2010.xls

MDMA = methylenedioxymethamphetamine

Table 1-b
1st initial drug
test QC

IITF

First Initial Drug Test QC Samples
Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Conc
Matrix
Source
Conc
Matrix
BZE
Source
Conc
MOR Matrix
Source
Conc
6-AM Matrix
Source
Conc
Matrix
PCP
Source
Conc
MAMP Matrix
Source
Conc
MDMA Matrix
Source

THCA

*If “Other” is selected, please specify:
BQC = blind quality control sample

IITF_Applic_Tables_Oct2010.xls

Control 2

Control 3

Control 4

BQC 1

BQC 2

Table 1-c

2nd initial drug
test QC

IITF

Second Initial Drug Test QC Samples

Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Conc
Matrix
Source
Conc
Matrix
BZE
Source
Conc
MOR Matrix
Source
Conc
6-AM Matrix
Source
Conc
Matrix
PCP
Source
Conc
MAMP Matrix
Source
Conc
MDMA Matrix
Source

THCA

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

Control 2

Control 3

Control 4

BQC 1

BQC 2

Initial Specimen Validity Test
Methods and Instruments

Table 2-a-1

Initial SVT
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Unit of
Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator

Creatinine

pH Meter*

Nitrite

mg/dL

Gen.Oxid.

IITF

Other:

Other:

mcg/mL

Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size

*If “Other” is selected, please specify:
SG = specific gravity

LOD = limit of detection

Gen. Oxid. = general oxidant

LOQ = limit of quantitation

ULOL= upper limit of linearity
*also applies to a colorimetric pH test with dynamic range of at least 2.0 to
12.0

IITF_Applic_Tables_Oct2010.xls

Initial Specimen Validity Test
Methods and Instruments

Table 2-a-2

Initial SVT cont.

Other:

Other:

Other:

Other:

Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of
Analyzer Units
Unit of
Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

IITF

Other:

Other:

Other:

Screening
Specimen Validity Test
Methods and Instruments

Table 2-c-1

Screening SVT

SG

pH

Other:

Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
Target Analyte of Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

IITF

Other:

Other:

Screening
Specimen Validity Test
Methods and Instruments

Table 2-c-2

Screening SVT cont.

Other:

Other:

Other:

Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
Target Analyte of Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

IITF

Other:

Other:

Initial Specimen Validity Test
QC Samples

Table 2-d-1

Initial SVT QC

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Target value

Creatinine Matrix
Source
Target value
pH Meter* Matrix
Source
Target value
Matrix
Nitrite
Source
Target value
Gen Oxid Matrix
Source

*If “Other” is selected, please specify:
*also applies to a colorimetric pH test with dynamic range of at least 2.0 to 12.0

IITF_Applic_Tables_Oct2010.xls

Control 1

IITF

Control 2

Control 3

Control 4

Control 5

Initial Specimen Validity Test
QC Samples

Table 2-d-2

Initial SVT QC cont.
Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

Control 1

IITF

Control 2

Control 3

Control 4

Control 5

Screening
Specimen Validity Test
QC Samples

Table 2-d-5

Screening SVT QC

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Target Value

Specific Gravity Matrix
pH
Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Other (enter name):

Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source
Target Value
Matrix
Source

*If “Other” is selected, please specify:

IITF_Applic_Tables_Oct2010.xls

IITF

Control 1

Control 2

Control 3

Control 4

Control 5