0930-0158 CCF_Urin 0930-0158 CCF_Urine_LAB_Info_Checklist

Effective 1 October 2017
Revised January 2020
Rev. 0120

URINE LABORATORY
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.

DATE
Rev. No.
December 12,
2018
Rev. 1218
January 1,
2020
Rev. 0120

CHANGE
Revisions to the urine laboratory information checklist are
documented in separate document: Summary of Changes December 2018, NLCP Manual for Urine Laboratories
Revisions made to the urine laboratory information checklist
for consistency with the oral fluid laboratory information
checklist

QUESTION
NO.
multiple
sections
multiple
sections

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

Instructions for the Laboratory

A-1

B.

Laboratory Information

B-1

C.

Laboratory Procedures

C-1

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I.

URINE LABORATORY INFORMATION CHECKLIST

A.

Instructions for the Laboratory

Pre-inspection Materials
Before each scheduled inspection, the NLCP sends instructions to the laboratory 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 Laboratory Information Checklist (Sections B and C)
The laboratory provides up-to-date information to the NLCP on its drug testing
operation (i.e., staffing, facility, and procedures) using the NLCP Urine Laboratory
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. Laboratory Operation Schedule/Inspection Schedule
The laboratory provides a schedule of its operations specific for urine to the NLCP,
listing the days and hours for various processes (e.g., receiving, accessioning, initial
testing, confirmation aliquotting, confirmatory drug test extractions, 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 laboratory 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 laboratory, instructing the
laboratory to ensure that the selected individuals are available for interview during
the inspection. In addition to interacting with laboratory staff in the course of 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. Laboratory Computers and Information Systems (Section P)
To facilitate the inspection of the laboratory’s computers and information systems,
the NLCP directs the laboratory to perform a self-assessment using Section P,
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Laboratory Computer Systems. The laboratory will answer Section P checklist
questions and provide explanatory comments (e.g., describe procedures and
records) to support those answers. The laboratory provides the completed Section P
to the inspection team at the beginning of the inspection.
5. Floor plan of the laboratory
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). The laboratory must indicate areas where regulated and
non-regulated testing, processing, and data review occur in the same area, and
where regulated and non-regulated specimens or records are stored in the same
area (i.e., short-term and long-term specimen and records storage areas).
6. Laboratory data packages
The laboratory provides data packages to the NLCP: one for a positive specimen
and one for a specimen that was reported as adulterated, substituted, or invalid
based on specimen validity testing (i.e., invalid-abnormal pH, invalid-inconsistent
creatinine and specific gravity results, or invalid-possible activity).
These data packages should contain all chain of custody forms, worksheets, initial
drug test data, screening/differential specimen validity test data, initial specimen
validity test data, confirmatory specimen validity test data, confirmatory drug test
data, and reports pertaining to the specimen. The program-required format for data
packages is described in Section R of the NLCP Manual for Urine Laboratories.
These must be recent specimens, processed since the last NLCP inspection using
the laboratory’s current procedures. The laboratory must provide test data for all
samples in the confirmatory drug test batch. Note: if the laboratory uses more than
one technology for initial drug tests (e.g., immunoassay, LC-MS/MS) or confirmatory
drug tests (e.g., GC-MS, GC-MS/MS, LC-MS/MS), the laboratory must also provide
drug test batch data and associated documents for a drug positive sample tested
using each technology.
7. Hotel list
The laboratory provides a list of several hotels/motels located in close proximity to
the laboratory and to the airport. Hotels selected should ensure the safety and
welfare of the inspectors during the inspection. During the inspection, inspectors
should notify the RP of alternate hotel suggestions and notify the NLCP of
suggestions after the inspection.

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8. Directions
The laboratory provides a clear, precise map with directions describing the routes
from the airport to the hotels and from the hotels to the laboratory.
Non-Negative Specimen List (NNSL)
Prior to each NLCP inspection that includes a records audit, the NLCP notifies the
laboratory of the specified audit period (e.g., the six-month period ending one month
prior to the month of the inspection). The laboratory is required to identify all regulated
urine specimens reported during that time period as positive, adulterated, substituted,
invalid, rejected, reconfirmed, or failed to reconfirm. In addition, the laboratory must
identify all specimens received for testing from an Instrumented Initial Test Facility
(IITF), including specimens reported as negative. The laboratory must submit to the
NLCP a list of these specimens, with specific information for each specimen. The
laboratory also provides a monthly summary for the records audit period listing the
numbers of regulated specimens reported as positive, adulterated, substituted, invalid,
negative, rejected, reconfirmed, or failed to reconfirm.
The NLCP provides instructions for the NNSL to the laboratory prior to the inspection.
These instructions include, but are not limited to, the following:
1. Format for NNSL spreadsheet
2. NNSL categories:
• The laboratory will provide information concerning results reported for the
following NNSL categories: amphetamine/methamphetamine/enantiomers,
methylenedioxymethamphetamine (MDMA)/methylenedioxyamphetamine (MDA),
benzoylecgonine, codeine/morphine, 6-acetylmorphine (6-AM),
hydrocodone/hydromorphone, oxycodone/oxymorphone, phencyclidine,
cannabinoids, adulterated, invalid, substituted, and rejected.
• If the laboratory has tested a regulated specimen for an additional Schedule I or
II drug upon request of a federal agency and reported the specimen as positive
(i.e., drug present at or above the cutoff used for the test), the laboratory must
submit a separate NNSL sheet for that drug.
• If no specimen is identified for a specific category, the laboratory must submit
that sheet indicating “None.”
3. Specimens to be included on the NNSL:
• Specimens reported positive, adulterated, substituted, invalid, rejected,
reconfirmed, and failed to reconfirm.
• Specimens received for testing from an IITF, including those reported negative.
The laboratory must remove all known NLCP performance testing (PT) samples.

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4. Requirements for records assembly
The NLCP selects specimens from the submitted NNSL for review during the
inspection and provides the selected list to the laboratory and to the lead auditor.
The laboratory 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 NNSL category 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 NNSL with a minimum of assistance from the laboratory staff.
During the inspection, the inspection team should alert the Responsible Person (RP)
when a record appears to be missing. The lead auditor and the RP will prepare an
inventory of records for the selected specimens on the NNSL that were not available
for review. The RP must forward the missing records to the NLCP for subsequent
review and follow-up.
Laboratory Preparation Criteria List
Prior to each inspection, the NLCP sends a Laboratory Preparation Criteria List to the
laboratory, listing materials that must be available for the inspection team upon their
arrival at the laboratory. 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 and visitor logs for each secured area). Other items
may be requested for review prior to or during the inspection.
All materials should be in the inspectors’ work area before the arrival of the team. The
laboratory must also take steps to ensure the security of these records when they are
unattended during the inspection. All inspectors and auditors should be given access to
the inspectors’ work area (e.g., each given their own key, access card, or code).

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B.

Laboratory Information (completed by the laboratory)

B-1.

Name of Laboratory: ____________________________________
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________
Telephone: ( ___ ) _____-________
e-Mail:

B-2.

FAX: ( ___ ) ____ -______

Responsible Person(s)
RP’s name: ___________________________________________
RP’s title: _____________________________________________
RP’s name: ___________________________________________
RP’s title: _____________________________________________
RP’s name: ___________________________________________
RP’s title: _____________________________________________
Alternate Responsible Person(s)
Alt-RP’s name: _________________________________________
Alt-RP’s title: __________________________________________
Alt-RP’s name: _________________________________________
Alt-RP’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
Laboratories. 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 Person

Date

Signature, Responsible Person

Date

Signature, Responsible Person

Date

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B-4.

List the changes made by the laboratory (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 laboratory:
_________days per week; ________hours per day
If < 7 days, indicate the day(s) that the laboratory is routinely not operational:
_____________________________________________________

B-6.

Does the laboratory 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 reference materials containing controlled substances
are acquired:
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-7.

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

B-8.

List laboratory certifications/licenses:
____ States (List): ________________________________________________
____ CLIA/HCFA1 (List Specialties): __________________________________
____ CAP2 (List Specialties): ________________________________________
____ NLCP (Specify Matrix):_________________________________________
____ Others (Specify):______________________________________________
1

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

2

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a.

Are any of the laboratory’s certifications and/or licenses for a
specialty that is not related to workplace drug testing based on the
qualifications of an RP or Alt-RP?
YES

NO

If YES, list each specialty with the department name, location, and the
name of the individual (i.e., RP or Alt-RP). Note: see also Question B-11
below.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
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

RP(s)

Alt-RP(s)

Certifying
Scientist(s)

Certifying
Technician(s)

Supervisor(s)

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Other Key
Staff

a.

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

YES

NO

If YES, describe requirements:
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-10. If there is more than one RP, briefly describe how the RPs share the
responsibilities for HHS-certified laboratory operations and procedures
for urine and for any other matrix for which the laboratory is certified,
and for non-regulated workplace drug testing.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-11. If an RP has any technical and administrative responsibilities that are
not related to workplace drug testing (e.g., in another laboratory
department or location), list the RP’s name, department name and
location, the individual’s responsibilities, and the amount of time spent
(hours/week) on those responsibilities.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-12. Describe the administrative relationships that exist for the key staff of the
forensic drug testing laboratory (see B-9 above):
a.

To whom does the RP(s) report? _____________________

b.

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

c.

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

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________________________________________________
________________________________________________
________________________________________________
________________________________________________
d.

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

e.

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

B-13. Does the laboratory test any federal agency specimens for drugs other
than those specified in the HHS authorized drug test panel?

YES

NO

Does the laboratory 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 laboratory 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.

B-14. Does the laboratory perform additional specimen validity testing for urine
specimens (e.g., for a biomarker or for a specific adulterant other than
those required by the HHS Guidelines)?
YES NO
If YES, list the measurand for each test and answer questions a and b
below:
______________________________________________________
______________________________________________________
a.

b.

Does the laboratory have approval from the NLCP to perform the
test(s)?

YES NO

Does the laboratory perform the tests on all regulated urine
specimens?

YES NO

If b is answered NO, list the conditions or clients for which specimen
validity testing is performed:
______________________________________________________
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______________________________________________________
______________________________________________________
______________________________________________________
B-15. Average number of urine specimens analyzed by the laboratory 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 urine specimens/day ______
How was this number derived? ____________________________
_____________________________________________________
_____________________________________________________
B-16. The total number of individuals who have authorized unescorted access to
the secure forensic drug testing laboratory facility:
______

individuals

The numbers of individuals with authorized unescorted access to secured
laboratory areas, by role:
______ Staff processing or testing workplace drug testing specimens
______ Support personnel (customer service, IT, maintenance)
______ Other. List each additional role/job title: ____________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
B-17. List the total numbers of staff who are trained and routinely perform the following
activities for regulated urine specimens:
No. of
Individuals

Activity
Accessioning
Initial drug testing
Screening/initial specimen validity testing
Confirmatory specimen validity testing
Specimen preparation (e.g., extraction)
Confirmatory drug testing
Certification

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C.

Laboratory Procedures (completed by the laboratory)

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 laboratory'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 laboratory'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 laboratory accession numbers.
• Location of all temporary storage areas.

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

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

Provide a description of the laboratory's procedures for the following:
Aliquotting Procedures
• Aliquotting of the original specimen bottles (i.e., who and where).
• Amount of specimen aliquoted for each test.
• Aliquotting procedure for initial and confirmatory drug and specimen validity tests
(including description of automated aliquoting equipment).
• Transfer of aliquots from the individuals performing the aliquotting to those who
will be testing the aliquots.

Note: (1)
(2)
Urine, Laboratory

Insert here.
Do not exceed a total of one page.
C-1

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C-4.

Provide a description of the laboratory'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-5.

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

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

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

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

Provide a description of the laboratory's procedures for the following:
First and Second Initial Drug Tests
• 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, whether regulated and non-regulated specimens are tested
in the same batch).
• 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 alternate technologies (as applicable), the criteria for accepting, re-preparing,
or reinjecting a specimen.

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

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:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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_____________________________________________________
_____________________________________________________
Describe the method used to calculate the concentrations/results of
analytes:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
C-8.

Provide a description of the laboratory's procedures for the following:
Specimen Validity Tests (Initial, Confirmatory and Screening/Differential)
• Handling and testing of aliquots by laboratory personnel.
• Maintenance of chain of custody during the testing.
• List additional specimen validity tests (e.g., for a biomarker or for a specific
adulterant in addition to those required by the HHS Guidelines).
• For each additional specimen validity test: the decision points and what
constitutes abnormal results.

Note: (1)
(2)
C-9.

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

Provide an outline or a legible flowchart that comprehensively describes the
laboratory'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 NNSL audit, with the effective date of
each change.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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C-10. Provide a description of the laboratory's procedures for the following:
Specimen Validity Tests (Initial, Confirmatory and Screening/Differential)
• How batches are constituted (e.g., whether a batch is constituted in one session
or specimens are added to the batch throughout the day, whether regulated and
non-regulated specimens are tested in the same batch).
• 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-11. Provide the following information for the Specimen Validity Tests (i.e., initial,
confirmatory, and screening/differential tests):
Describe the procedures and acceptance criteria for calibration:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
Describe the method used to calculate the concentrations/responses of
measurands:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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C-12. Provide a description of the laboratory's procedures for the following:
Confirmatory Drug Tests
• Handling and testing of aliquots by laboratory personnel.
• Maintenance of chain of custody during the testing.

Note: (1)
(2)

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

C-13. Provide a description of the laboratory's procedures for the following:
Confirmatory Drug Tests
• 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, whether regulated and non-regulated specimens are tested
in the same batch).
• The distribution of the donor 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, re-preparing, or reinjecting a specimen.

Note: (1)
(2)

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

C-14. Provide the following information for the Confirmatory Drug Tests:
Describe the requirements for calibration including criteria for exclusion of
unsatisfactory calibrators:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
Describe the method used to calculate the concentrations of analytes
for each calibration procedure used by the laboratory:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
Describe the procedures used to assess internal standard recovery
(i.e., the sample or samples used to establish the acceptance range
for the batch, any exclusion criteria).
_____________________________________________________
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_____________________________________________________
_____________________________________________________
_____________________________________________________
Describe the procedures used to calculate ion ratios and assess
acceptability (i.e., the sample or samples used to establish acceptance
ranges for the batch).
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
C-15. Provide a description of the laboratory's procedures for the following:
Certification/Reporting Procedures
• Review of all calibration and control data.
• Review of chain of custody forms for the specimen and for all aliquots.
• Review of specimen data.
• Documentation and certification of results (i.e., procedures for paper CCFs,
combination electronic/paper CCFs, and electronic CCFs, including use of
electronic signatures by certifying technicians and certifying scientists).
• Release/reporting of results.
• Verification of information (e.g., CCF and computer resident results).

Note: (1)
(2)

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

C-16. Provide a description of the laboratory’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-17. Provide an example of the laboratory's computer-generated electronic report for
each of the following laboratory results:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Negative
Negative, Dilute
Rejected
Cocaine Metabolite Positive
6-AM/Codeine/Morphine Positive
Hydrocodone/Hydromorphone Positive
Amphetamine/Methamphetamine Positive
D-Methamphetamine (if applicable)
Invalid Result
Substituted based on Creatinine and Specific Gravity
Substituted based on Biomarker (if applicable)
Specimen Adulterated: pH
Specimen Adulterated: Other (if applicable)
Split Specimen: Reconfirmed
Split Specimen: One or More Primary Specimen Results Not Reconfirmed

C-18. Does the laboratory use an off-site computer information system?

YES

NO

If YES,
Address: _____________________________________________
_____________________________________________________
City, State, ZIP: ________________________________________

C-19. Provide a description of the laboratory's procedures for the following:
Disposition of Specimens and Aliquots
• Handling of original specimen bottles and aliquots after testing is completed.
• Procedure for transferring positive, adulterated, substituted, and invalid
specimens to long-term frozen storage.

Note: (1)
(2)

Urine, Laboratory

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

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October 2017
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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.

Confirmatory Specimen Validity Test Methods and Instruments (continued on
Table C-2-b-2 as needed)

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.

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

Table C-2-d-5.

Screening/Differential Specimen Validity Test Calibrators and Controls

Table C-3-a.

Confirmatory Drug Test Methods

Table C-3-b-1.

Primary Confirmatory Drug Test Methods and Instruments – Gas
Chromatography

Table C-3-b-2.

Alternate Confirmatory Drug Test Methods and Instruments – Gas
Chromatography

Table C-3-b-3.

Primary Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography

Table C-3-b-4.

Alternate Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography

Table C-3-c-1.

Primary Confirmatory Drug Test Methods and Instruments – Mass Spectrometry

Table C-3-c-2.

Alternate Confirmatory Drug Test Methods and Instruments – Mass Spectrometry

Urine, Laboratory

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October 2017
Rev. 0120

Table C-3-c-3.

Primary Confirmatory Drug Test Methods and Instruments – Tandem Mass
Spectrometry

Table C-3-c-4.

Alternate Confirmatory Drug Test Methods and Instruments – Tandem Mass
Spectrometry

Table C-3-d-1.

Primary Confirmatory Drug Test Calibrators and Controls

Table C-3-d-2.

Alternate Confirmatory Drug Test Calibrators and Controls

Table C-4-a.

AMPS Enantiomer Test Methods

Table C-4-b.

AMPS Enantiomer Calibrators and Controls

Table C-4-c.

AMPS Enantiomer Result Calculation

Urine, Laboratory

C-9

October 2017
Rev. 0120