2018 IITF a_b_c Checklist

Effective 1 October 2017
Revised December 2018
Rev.1218

URINE
INSTRUMENTED INITIAL TEST FACILITY
(IITF)
INFORMATION CHECKLIST

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, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland, 20857.

NATIONAL LABORATORY CERTIFICATION PROGRAM
URINE IITF CHECKLIST
Table of Contents
I. URINE IITF INFORMATION CHECKLIST
Page
A.

Instructions for the IITF

A-1

B.

IITF Information

B-1

C.

IITF Procedures

C-1

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I.

URINE IITF INFORMATION CHECKLIST

A.

Instructions for the IITF

Pre-inspection Materials
Before each scheduled inspection, the NLCP sends instructions to the IITF listing the
required pre-inspection materials with due dates for provision. The required materials
depend on the inspection type (e.g., initial inspection, maintenance inspection, records
audit, special inspection). The following describes some items that may be required.
1. NLCP Urine IITF Information Checklist (Sections B and C)
The IITF provides up-to-date information to the NLCP on its drug testing operation
(i.e., staffing, facility, and procedures) using the NLCP Urine IITF Information
Checklist (Sections B and C). The information is maintained in NLCP records and is
verified by the inspection team (i.e., inspectors, records auditors) at each NLCP
inspection.
2. IITF Operation Schedule/Inspection Schedule
The IITF provides a schedule of its operations to the NLCP, listing the days and
hours for various processes (e.g., receiving, accessioning, initial testing,
certification). Using this schedule, NLCP staff prepare a tentative schedule for the
inspection team. To adequately assess operations on every shift, inspectors will
periodically inspect processes that occur during off-shifts. The lead inspector
determines the final schedule for the inspection team at most NLCP inspections. The
lead auditor determines the final schedule for a records audit. Inspectors should note
any changes to the schedule in their checklist submission.
3. Key Staff Interview List
The IITF provides a Staff Interviews List to the NLCP, listing key staff, their job titles,
and work schedules. NLCP staff select individuals from the list to be interviewed at
the inspection and return the list to the IITF, instructing the IITF to ensure that the
selected individuals are available for interview during the inspection. In addition to
interacting with IITF staff during the inspection, the inspection team conducts formal
interviews (i.e., 10 – 15 minutes each) with each selected staff member individually
to evaluate their knowledge and ability to fulfill job duties.
4. IITF Computers and Information Systems (Section P)
To facilitate the inspection of the IITF’s computer and information systems, the
NLCP directs the IITF to perform a self-assessment using Section P, IITF Computer
Systems. The IITF will answer Section P checklist questions and provide
explanatory comments (e.g., describe procedures and records) to support those
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answers. The IITF provides the completed Section P to the inspection team at the
beginning of the inspection.
5. Floor plan of the IITF
The floorplan must clearly identify areas (e.g., accessioning, testing, certification,
reporting), clearly indicate 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. IITF data packages
The IITF provides two data packages to the NLCP: one for a specimen forwarded to
a laboratory based on initial drug test results and one forwarded to a laboratory
based on specimen validity test results (i.e., pH, creatinine and specific gravity, or
oxidant tests). These data packages should contain all chain of custody forms,
worksheets, initial drug test data, screening specimen validity test data, initial
specimen validity test data, and reports pertaining to the specimen. The programrequired format for data packages is described in Section R of the NLCP Manual for
Urine IITFs. These must be recent specimens, processed since the last NLCP
inspection using the IITF’s current procedures. Note: the terms “screening specimen
validity test” and “initial specimen validity test” are defined in Section J of the NLCP
Manual for Urine IITFs. If the laboratory uses more than one technology for initial
drug tests (e.g., immunoassay, LC-MS/MS), the laboratory must also provide drug
test batch data and associated documents for a drug positive sample tested using
each technology.
7. Hotel list
The IITF provides a list of several hotels/motels located near the IITF and near the
airport. Hotels selected should ensure the safety and welfare of the inspectors
during the inspection. During the inspection, inspectors should notify the RT of
alternate hotel suggestions and notify the NLCP of suggestions after the inspection.
8. Directions
The IITF provides a clear, precise map with directions describing the routes from the
airport to the hotels and from the hotels to the IITF. Hotels selected should ensure
the safety and welfare of the inspectors during the inspection.
Forwarded and Rejected Specimen List (FRSL)
Prior to each NLCP inspection that includes a records audit, the NLCP notifies the IITF
of the specified audit period (e.g., the six-month period ending one month prior to the
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month of the inspection). The IITF is required to identify all regulated specimens that,
during that time, were reported as rejected or were forwarded to a certified laboratory
for testing. The IITF must submit to the NLCP a list of these specimens, with specific
information for each specimen. The IITF also provides a monthly summary for the
records audit period listing the numbers of regulated specimens reported as negative,
negative-dilute, and rejected.
The NLCP provides instructions for the FRSL to the IITF prior to the inspection. These
instructions include, but are not limited to, the following:
1. Format for FRSL spreadsheet
2. The IITF will provide information for each specimen (e.g., the reason for rejection,
the reason for forwarding to a laboratory and identification of the laboratory to which
the specimen was forwarded, receipt date, report date, forwarded date).
3. Specimens to be included on the FRSL:
• The IITF must list only specimens reported as rejected and specimens forwarded
to a certified laboratory for testing.
• The IITF must remove all known NLCP performance testing (PT) samples.
4. Requirements for records assembly
The NLCP selects specimens from the submitted FRSL for review during the
inspection and provides the selected list to the IITF and to the lead auditor. The IITF
must organize and assemble records for each of the selected specimens to facilitate
their review by the audit team during the inspection. At a minimum, records must be
assembled by reason (see item 2 above) and in chronological order, to facilitate their
location within labeled storage folders/boxes. Auditors must be able to retrieve all
records (excluding failed batches) pertaining to a specimen on the selected FRSL
with a minimum of assistance from the IITF staff.
During the inspection, the lead auditor and the Responsible Technician (RT) will
prepare an inventory of records for the selected specimens on the FRSL that were
not available for review. The RT must forward the missing records to the NLCP for
subsequent review and follow-up.
IITF Preparation Criteria List
Prior to each inspection, the NLCP sends an IITF Preparation Criteria List to the IITF,
listing materials that must be available for the inspection team upon their arrival at the
IITF. Materials include a copy of the standard operating procedures (SOP) manual for
each inspection team member, NLCP PT records, personnel files, quality assurance
(QA) records, calibrator and control records, reagent records, validation records, a
timeline of any changes in calibrator or control criteria and acceptance limits during the
records audit period, and documentation of security procedures (e.g., access rosters
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and visitor logs for each secured area). Other items may be requested for review prior
to or during the inspection.

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B.

IITF Information (completed by the IITF)

B-1.

Name of IITF: __________________________________________
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
Telephone: ( ___ ) _____-________
FAX: ( ___ ) ____ -______
e-Mail:
_____________________________________

B-2.

Responsible Technician(s)
RT’s name: ____________________________________________
RT’s title: _____________________________________________
RT’s name: ____________________________________________
RT’s title: _____________________________________________
RT’s name: ____________________________________________
RT’s title: _____________________________________________
Alternate Responsible Technician(s)
Alt-RT’s name: _________________________________________
Alt-RT’s title: ___________________________________________
Alt-RT’s name: _________________________________________
Alt-RT’s title: ___________________________________________

B-3.

I certify that the statements and information presented in Sections B and C
are true and correct as of this date. I affirm that the key staff have read and
are familiar with the current version of the NLCP Manual for Urine IITFs. I
also recognize my responsibility for providing amended Sections B and C to
the inspectors at the beginning of the inspection if changes are made
between the date of this submission and the inspection.

Note:

Any false, fictitious, or fraudulent statements or information presented in sections
B and C or misrepresentations relative thereto may violate Federal Law and could
subject you to prosecution, monetary penalties, or both (Sec 18 U.S.C. 1001; 31
U.S.C. 3801-812).

Signature, Responsible Technician

Date

Signature, Responsible Technician

Date

Signature, Responsible Technician

Date

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B-4.

List the changes made by the IITF (e.g., new instrumentation, new or
revised analytical procedures, new or revised software) since the last
NLCP inspection, and effective date of each change:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

B-5.

Days/hours of operation of the forensic urine drug testing IITF:
_________days per week; ________hours per day
If ≤ 6 days, indicate the day(s) that the IITF is routinely not operational:
_____________________________________________________

B-6.

Does the IITF have a U.S. Drug Enforcement Agency (DEA) registration? YES

NO

If YES, for which schedules?
___1 ___2 ___2N ___3 ___3N ___4 ___5
If NO, explain how controlled reference materials are acquired:
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-7.

Describe the State licensure requirements for urine forensic toxicology for
the State in which the IITF is located:
_____________________________________________________
_____________________________________________________
_____________________________________________________

B-8.

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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B-9.

List name, job title, education, and licenses/certifications for the following
key staff:
Note: (1)
(2)

May attach separate sheet listing additional key staff
Indicate (*) individuals new to the positions in the last 6 months
Name

Job Title

Education

License/
Certification

RT(s)

Alt-RT(s)

Certifying
Technician(s)

Supervisor(s)

Other Key
Staff

a.

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

YES

NO

If YES, describe requirements:____________________________
_____________________________________________________
_____________________________________________________

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B-10. If there is more than one RT, briefly describe how the RTs share the
responsibilities for the various IITF operations and procedures.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-11. Describe the administrative relationships that exist for the key staff of the
forensic drug testing IITF (see B-9 above):
a.

To whom does the RT(s) report? _____________________

b.

Who evaluates the performance of the RT(s)? ___________
________________________________________________

c.

What staff administratively report directly to the RT(s)? ____
________________________________________________
________________________________________________
________________________________________________
________________________________________________
________________________________________________

d.

The RT(s) evaluates the performance of which staff members?
________________________________________________
________________________________________________
________________________________________________
________________________________________________

e.

Which staff members do not report to the RT(s)? _________
________________________________________________
________________________________________________
________________________________________________
________________________________________________

B-12. Does the IITF test any federal agency specimens for drugs other than
those specified in the HHS Guidelines?

YES

NO

Does the IITF have a copy of the HHS waiver for a federal agency
to test the additional drug(s) on a routine basis?
YES

NO

Does the IITF maintain written authorization from federal agencies
to test the additional drug(s) on a case-by-case basis?
YES

NO

If YES, list the drug(s) and answer a and b below:
_____________________________________________________
_____________________________________________________
a.

b.

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B-13. Average number of specimens analyzed by the IITF each day for drugs of
abuse during the six months preceding submission of Sections B and
C (both regulated and non-regulated specimens):
Specify the months_________________________________
Total specimens/day ______
How was this number derived? ____________________________
_____________________________________________________
_____________________________________________________
B-14. The total number of staff who have authorized access to the secure
forensic drug testing IITF facility:
______

individuals

B-15. List the total numbers of staff who are trained and routinely perform the following
activities for regulated specimens:
No. of
Individuals

Activity
Accessioning
Initial drug testing
Screening/initial specimen validity testing
Certification
Specimen sendout to laboratory

B-16. List the name and location of each HHS-certified laboratory that has a legally binding
arrangement to receive, test, and report regulated specimens from the IITF. The
documentation of the arrangement (e.g., contract, written agreement between
corporate IITFs and laboratories) must outline the responsibilities of each party and
be signed by each Responsible Person (RP) of the laboratory and by each RT of the
ITF.
Laboratory Name

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Location (City, State)

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C.

IITF Procedures (completed by the IITF)

Any computer interface communicating any form of data from an HHS-certified IITF to
an HHS-certified laboratory must be approved by the NLCP prior to implementation.
The IITF and/or laboratories must submit a detailed plan to the NLCP for review.
Affected test facilities will be subject to inspection to verify compliance with NLCP
requirements. HHS-certified laboratories are prohibited from transmitting data to an
HHS-certified IITF through a computer interface.
NOTE: Before using an electronic Federal Custody and Control Form (ECCF) system for
regulated specimens, an HHS-certified test facility must submit a detailed plan and proposed
standard operating procedures (SOPs) for the ECCF system to the NLCP for review and
authorization, and undergo an onsite inspection.

C-1.

Provide a description of the IITF's procedures for the following:
Security
• Building
• Department
• Specimens
• Records

Note: (1)
(2)
C-2.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
Specimen Receiving/Accessioning
• Receipt of specimen packages, how they are handled, receipt of specimens
received with a paper custody and control form (CCF), receipt of specimens
received with an ECCF, who reviews the accuracy of the information on the
custody and control forms and how discrepancies are documented.
• Handling problems with specimen bottles and/or custody and control forms.
• Assignment of IITF accession numbers.
• Location of temporary storage area(s).

Note: (1)
(2)
C-3.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
Aliquotting Procedures
• Aliquotting of the original specimen bottles (i.e., who and where).
• The actual aliquotting procedure (pouring or pipetting and amounts) used for
preparing aliquots for initial drug tests and specimen validity tests.

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•

Transfer of aliquots from the individuals performing the aliquotting to those
who will be testing the aliquots.

Note: (1)
(2)
C-4.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
Specimen Sendout to Laboratory
• Retrieval of the original specimen bottles from storage and how they are
handled, including chain of custody documentation.
• Resealing the primary specimen bottle.
• Packaging the primary and split specimen bottles and the Federal Custody
and Control Form (CCF) for shipment.
• Maintaining records of forwarded specimens.

Note: (1)
(2)
C-5.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
Specimen Accessioning
• Introduction and/or aliquotting of blind controls into the test batches by
accessioning personnel.
• If applicable, preparation and submission of blind samples as donor
specimens from external sources.

Note: (1)
(2)
C-6.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
First and Second Initial Drug Tests
• Handling and testing of aliquots by IITF personnel.
• Maintenance of chain of custody during the testing.

Note: (1)
(2)
C-7.

Insert here.
Do not exceed a total of one page.

Provide a description of the IITF's procedures for the following:
First and Second Initial Drug Tests
• How batches are constituted (e.g., how many specimens are in a batch, is it
constituted in one session or are specimens added to the batch throughout

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•
•
•
•

the day, are regulated and non-regulated specimens tested in the same
batches).
The distribution of specimens, calibrators, and controls within each batch.
The acceptance criteria for calibration and for each control (open and blind) in
each batch and when and by whom these are evaluated and documented.
The criteria for accepting all donor specimen results or only a partial number
of donor specimens in a batch.
For an alternate technology (as applicable), the criteria for accepting a donor
specimen result, reextracting a specimen, or reinjecting a specimen.

Note: (1)
(2)
C-8.

Insert here.
Do not exceed a total of one page.

Provide the following information for the first and second Initial Drug Tests:
Describe the procedure(s) and acceptance criteria for calibration:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
Describe the method used to calculate the concentrations/ results of
analytes:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

C-9.

Provide a description of the IITF's procedures for the following:

Specimen Validity Tests (Screening and Initial)
• Handling and testing of aliquots by IITF personnel.
• Maintenance of chain of custody 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.
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Note: (1)
(2)

Insert here.
Do not exceed a total of one page.

C-10. Provide an outline or a legible flow chart that comprehensively describes the
IITF's Specimen Validity Testing.

Note: (1)
(2)

Insert here.
Do not exceed a total of one page.

a.

List any changes to the specimen validity testing
outline/flowchart during the time period of the FRSL audit, with
the effective date of each change.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

C-11. Provide a description of the IITF's procedures for the following:
Specimen Validity Tests (Screening and Initial)
• How batches are constituted.
• The distribution of specimens, calibrators and controls within each batch.
• 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.

Note: (1)
(2)

Insert here.
Do not exceed a total of one page.

C-12. Provide the following information for the Specimen Validity Tests (i.e., screening
and initial tests):
Describe the procedures and acceptance criteria for calibration:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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Describe the method used to calculate the concentrations/ responses
of measurands:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
C-13. Provide a description of the IITF's procedures for the following:
Certification/Reporting Procedures
• Review of all calibration and control data.
• Review of chain of custody forms.
• Review of specimen data.
• Documentation and certification of results (i.e., procedures for paper CCFs,
combination electronic/paper CCFs, and ECCFs, including use of electronic
signatures by certifying technicians)
• Release of specimens for sendout to a laboratory.
• Release/reporting of results.
• Verification of information (e.g., CCF and computer resident result).

Note: (1)
(2)

Insert here.
Do not exceed a total of one page.

C-14. Provide a description of the IITF's procedures for the following:
Electronic Reporting Procedures
• Reporting using an ECCF system: ECCF system provider(s) name and
address; ECCF reporting procedures (including how ECCF data are secured
(e.g., during transmission and storage); reporting methods; how MROs
access completed ECCFs
• Web-based reporting: where report data are sent (i.e., website addresses;
location and ownership of servers); file formats; external service provider(s)
name and address (including cloud-based service providers); how report data
are secured (i.e., during transmission and storage); how MROs access
reports
• Release of computer-generated electronic reports (i.e., methods other than
above).

Note: (1)
(2)
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Insert here.
Do not exceed a total of one page.
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C-15. Provide an example of the IITF's computer-generated electronic report for each
of the following IITF results:
•
•
•

Negative
Negative, Dilute
Rejected

C-16. Does the IITF use an off-site computer information system?

YES

NO

If YES,
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
C-17. Provide a description of the IITF's procedures for the following:
Disposition of Specimens and Aliquots
• Handling of original specimen bottles and aliquots after testing is completed.

Note: (1)
(2)

Insert here.
Do not exceed a total of one page.

Complete the C Tables:
Table C-1-a-1. Immunoassay Initial Drug Test Methods and Instruments
Table C-1-a-2. LC-MS/MS Initial Drug Test Methods
Table C-1-a-3. Initial Drug Test Methods and Instruments – Liquid Chromatography
Table C-1-a-4. Initial Drug Test Methods and Instruments – Tandem Mass
Spectrometry
Table C-1-b.

Immunoassay First Initial Drug Test Calibrators and Controls

Table C-1-c.

Immunoassay Second Initial Drug Test Calibrators and Controls

Table C-1-d.

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

Table C-2-a-1. Initial Specimen Validity Test Methods and Instruments (continued on
Table C-2-a-2 as needed)
Table C-2-b-1
and C-2-b-2.

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not applicable for an IITF

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Table C-2-c-1. Screening/Differential Specimen Validity Test Methods and
Instruments (continued on Table C-2-c-2 as needed)
Table C-2-d-1. Initial Specimen Validity Test Calibrators and Controls
(continued on Table C-2-d-2 as needed)
Table C-2-d-3
and C-2-d-4.

not applicable for an IITF

Table C-2-d-5. Screening/Differential Specimen Validity Test Calibrators and Controls
C-3 Tables.

not applicable for an IITF

Tables C-4-a
through C-4-c. not applicable for an IITF

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