Urine Lab a_b_c Ch Urine Lab a_b_c Checklist

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Att E 2017 Urine Lab a_b_c checklist

Laboratory Application

OMB: 0930-0158

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Effective 1 October 2010
Revised November 2015

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

DATE
Rev. No.
November 1,
2015
Rev. 1115

CHANGE
Revisions to instructions as documented in separate file:
Summary of Changes - November 2015, NLCP Urine
Laboratory Checklist

QUESTION
NO.
Section A;
Section C;
C-15; C-16

SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland, 20857.

NLCP Urine Laboratory Information Checklist: Summary of Changes

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

Instructions for the Laboratory

A-1

Laboratory Information

B-1

Laboratory Procedures

C-1

Urine, Laboratory

October 2010, Rev.1115

URINE LABORATORY INFORMATION CHECKLIST

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 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. 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.
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 the selected staff members 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,
Laboratory Computer Systems. The laboratory provides the completed Section P to
the inspection team at the beginning of the inspection.
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October 2010, Rev.1115

5. Floor plan of the laboratory
6. Laboratory data packages
The laboratory provides two 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, invalidinconsistent 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 programrequired 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 specimens in the confirmatory drug test batch. Note: if the
laboratory performs any testing on regulated specimens using LC/MS/MS, the
laboratory must also provide LC/MS/MS batch data and associated documents (e.g.,
CCF, worksheets) for a drug positive specimen.

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.
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
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.

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October 2010, Rev.1115

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)/
methylenedioxyethylamphetamine (MDEA), benzoylecgonine, opiates,
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.
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 lead auditor and the Responsible Person (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,
Urine, Laboratory
A-3
October 2010, Rev.1115

quality assurance (QA)/quality control (QC) records, reagent records, validation records,
a timeline of any changes in QC criteria and control 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.

Urine, Laboratory

A-4

October 2010, Rev.1115

Laboratory Information (completed by the laboratory)

B-1.

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

B-2.

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

Urine, Laboratory

B-1

October 2010, Rev.1115

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 ≤ 6 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 controlled reference materials are acquired:
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-7.

Describe the 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): ________________________________________
____ Others (Specify):______________________________________________
1

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

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B-2

October 2010, Rev.1115

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)

Other Key
Staff

Urine, Laboratory

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October 2010, Rev.1115

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

YES

If YES, describe requirements:
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-10. If there is more than one RP, briefly describe how the RPs share the
responsibilities for the various laboratory operations and procedures.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
B-11. 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? _____________________

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

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

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

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

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

YES NO

If YES, list the drug(s) and answer a and b below:
_____________________________________________________
_____________________________________________________
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October 2010, Rev.1115

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

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

YES

B-13. Average number of 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 specimens/day ______
How was this number derived? ____________________________
_____________________________________________________
_____________________________________________________
B-14. The total number of staff who have authorized access to the secure
forensic drug testing laboratory 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
Confirmatory specimen validity testing
Extraction
Confirmatory drug testing
Certification

Urine, Laboratory

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October 2010, Rev.1115

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 temporary storage area(s).

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).
 The actual aliquotting procedure (pouring or pipetting and amounts) used for
preparing aliquots for initial drug tests, specimen validity tests, and confirmatory
drug tests.
 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

October 2010, Rev.1115

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, is it
constituted in one session or are specimens added to the batch throughout the
day, are regulated and non-regulated specimens tested in the same batch?).
 The distribution of specimens and QC samples 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)
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:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

Urine, Laboratory

C-2

October 2010, Rev.1115

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.

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.

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.
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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.
 The distribution of specimens and QC samples 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.
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October 2010, Rev.1115

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:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________

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:
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October 2010, Rev.1115

Confirmatory 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, are regulated
and non-regulated specimens tested in the same batch?).
 The distribution of the donor specimens and QC samples 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 a donor specimen result, reextracting a specimen, 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:
_____________________________________________________
_____________________________________________________
_____________________________________________________
_____________________________________________________
C-15. Provide a description of the laboratory's procedures for the following:
Certification/Reporting Procedures
 Review of all calibration data 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 and certifying scientists).
 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-16. Provide a description of the laboratory's procedures for the following:
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October 2010, Rev.1115

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)

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

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/Morphine/Codeine Positive
Amphetamine/ Methamphetamine Positive
d-Methamphetamine (if applicable)
MDMA/MDA/MDEA Positive
Substituted
Invalid Result
Specimen Adulterated: pH
Specimen Adulterated: Others as Pertinent
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.
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October 2010, Rev.1115



Procedure for transferring positive, adulterated, substituted, and invalid
specimens to long-term frozen storage.

Note: (1)
(2)

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

Complete the C Tables:
Table C-1-a.

First and Second Initial Drug Test Methods and Instruments

Table C-1-b.

First Initial Drug Test QC samples

Table C-1-c.

Second Initial Drug Test QC samples

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 QC samples
(continued on Table C-2-d-2 as needed)

Table C-2-d-3.

Confirmatory Specimen Validity Test QC samples
(continued on Table C-2-d-4 as needed)

Table C-2-d-5.

Screening/Differential Specimen Validity Test QC samples

Table C-3-a.

Primary and Alternate Confirmatory Drug Test Methods

Table C-3-b-1.

Primary Confirmatory Drug Test Methods and Instruments – Gas
Chromatography (GC)

Table C-3-b-2.

Alternate Confirmatory Drug Test Methods and Instruments – GC

Table C-3-b-3.

Primary Confirmatory Drug Test Methods and Instruments – Liquid
Chromatography (LC)

Table C-3-b-4.

Alternate Confirmatory Drug Test Methods and Instruments – LC

Table C-3-c-1.

Primary Confirmatory Drug Test Methods and Instruments – Mass Spectrometry
(MS)

Table C-3-c-2.

Alternate Confirmatory Drug Test Methods and Instruments –MS

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October 2010, Rev.1115

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 QC Samples

Table C-3-d-2.

Alternate Confirmatory Drug Test QC Samples

Table C-4-a.

Amphetamines Enantiomer Test Methods

Table C-4-b.

Amphetamines Enantiomer QC Samples

Table C-4-c.

Description of Enantiomer Calculation

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October 2010, Rev.1115

Initial Drug Test
Methods and Instruments

Table C-1-a

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
Average Number of
federally regulated
specimens tested
daily
Average Number of
Batches with
federally regulated
specimens tested
daily

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

*If "Other" is selected, please specify:
THCA = ∆9-tetrahydrocannabinol-9-carboxylic acid
BZE = benzoylecgonine

MOR = morphine
PCP = phencyclidine

6-AM = 6-acetylmorphine
MAMP = methamphetamine

LAB_Info_Checklist_CTables_October2010_rev1115.xls

MDMA = methylenedioxymethamphetamine

First Initial Drug Test
QC Samples

Table C-1-b

1st initial drug
test QC
THCA
BZE
MOR

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Control 1

Conc
Matrix
Source
Conc
Matrix
Source
Conc
Matrix
Source

Conc
Matrix
Source
Conc
PCP Matrix
Source
Conc
MAMP Matrix
Source
Conc
MDMA Matrix
Source

6-AM

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

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

BQC 1

BQC 2

Second Initial Drug Test
QC Samples

Table C-1-c

2nd initial drug
test QC
THCA
BZE
MOR

Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Control 2

Conc
Matrix
Source
Conc
Matrix
Source
Conc
Matrix
Source

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

*If "Other" is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 3

Control 4

BQC 1

BQC 2

Initial Specimen Validity Test
Methods and Instruments

Table C-2-a-1

Initial SVT

Creatinine

Nitrite

Gen.Oxid.

4 dec. place
refractometer

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

mg/dL

mcg/mL

Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch
Size

*If "Other" is selected, please specify:
SG = specific gravity
Gen. Oxid. = general oxidant

LOD = limit of detection
LOQ = limit of quantitation

ULOL= upper limit of linearity

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Initial Specimen Validity Test
Methods and Instruments

Table C-2-a-2

Initial SVT cont.

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:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Confirmatory Specimen Validity Test
Methods and Instruments

Table C-2-b-1

Confirmatory SVT

Creatinine

Nitrite

4 dec. place
refractometer

Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement

mg/dL

mcg/mL

Target Analyte of
Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover limit
Maximum Batch Size

*If "Other" is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Confirmatory Specimen Validity Test
Methods and Instruments

Table C-2-b-2

Confirmatory SVT
cont.

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:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Table C-2-c-1

Screening/Differential
SVT
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement

Screening/Differential Specimen Validity Test
Methods and Instruments
SG

Other:

Target Analyte of Assay
Target Analyte of
Calibrator
Calibration Method
LOD
LOQ
ULOL
Carryover Limit
Maximum Batch Size

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Table C-2-c-2

Screening/Differential
SVT cont.
Method
Kit Manufacturer
Analyzer and
Manufacturer
Number of Analyzer
Units
Unit of Measurement
Target Analyte of
Assay
Target Analyte of
Calibrator
Calibration Method
LOD

Screening/Differential Specimen Validity Test
Methods and Instruments
Other:

Other:

LOQ
ULOL
Carryover Limit
Maximum Batch Size

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Other:

Initial Specimen Validity Test
QC Samples

Table C-2-d-1

Initial SVT QC

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Control 1

Target value
Creatinine Matrix
Source
Target value
Matrix
SG
Source
Target value
Matrix
pH
Source
Target value
Nitrite Matrix
Source
Target value
Gen Oxid Matrix
Source

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Initial Specimen Validity Test
QC Samples

Table C-2-d-2

Initial SVT QC cont.
Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Control 1

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Confirmatory Specimen Validity Test
QC Samples

Table C-2-d-3

Confirmatory SVT QC

Creatinine

Target Value
Matrix
Source

Nitrite

Target Value
Matrix
Source

Gen Oxid

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Control 1

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Confirmatory Specimen Validity Test
QC Samples

Table C-2-d-4

Confirmatory SVT QC
cont.
Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Other (enter
name):

Target Value
Matrix
Source

Cal 1

Cal 2

Cal 3

Cal 4

Cal 5

Control 1

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Screening/Differential Specimen Validity Test
QC Samples

Table C-2-d-5

Screening/Differential SVT
QC
Specific Gravity
pH
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:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 1

Control 2

Control 3

Control 4

Control 5

Table C-3-a

Confirmatory Drug Test Methods

Primary Confirmatory Drug Test Methods
Primary
Confirmatory Drug
Test
Method
Internal Standard
Int. Std. Isotope
Type and Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*
Maximum Batch
Size
Average Number of
Batches with HHS
specimens tested
daily

THCA

BZE

COD

MOR

6-AM

PCP

AMP

MAMP

MDMA

MDA

MDEA

MAMP

MDMA

MDA

MDEA

*If “Other” is selected, please specify:

Alternate Confirmatory Drug Test Methods
Alternate
Confirmatory Drug
Test
Method
Internal Standard
Int. Std. Isotope
Type and Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*

THCA

BZE

COD

MOR

6-AM

PCP

Maximum Batch
Size

*If “Other” is selected, please specify:
* ng/mL
COD = codeine
AMP = amphetamine

MDA = methylenedioxyamphetamine
MDEA = methylenedioxyethylamphetamine

LAB_Info_Checklist_CTables_October2010_rev1115.xls

AMP

Table C-3-b-1

Primary Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug
Test - Gas Chromatography

THCA

BZE

COD/MOR

6-AM

PCP

Extraction Method
Volume Used (mL)
Hydrolysis Method
Derivatizing Reagent
Split/Splitless Injection
Inj. Port Temp (°C)
Isothermal or Gradient
Column type
Column length (m)
Instrument manufacturer
Number of units
GC/GC Methods: provide additional information below
Cryotrapping (Y/N)
2nd GC Column Type
2nd GC Column Length
(m)

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

AMPHETAMINES (select analytes from dropdown lists below)

Table C-3-b-2

Alternate Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Alternate Confirmatory Drug Test Methods and Instruments - Gas Chromatography
Primary Confirmatory Drug
Test - Gas Chromatography

AMPHETAMINES (select analytes from dropdown lists below)
THCA

BZE

COD/MOR

6-AM

PCP

Extraction Method
Volume Used (mL)
Hydrolysis Method
Derivatizing Reagent
Split/Splitless Injection
Inj. Port Temp (°C)
Isothermal or Gradient
Column Type
Column Length (m)
Instrument Manufacturer
Number of Units
GC/GC Methods: provide additional information below
Cryotrapping (Y/N)
2nd GC Column Type
2nd GC Column Length
(m)

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Table C-3-b-3

Primary Confirmatory Drug Test Methods and Instruments - Liquid Chromatography
Primary Confirmatory Drug Test Methods and Instruments- Liquid Chromatography
Primary Confirmatory Drug Test Liquid Chromatography

THCA

BZE

COD/MOR

6-AM

Extraction Method
Volume Used (mL)
Hydrolysis Method
Injection Volume
Isocratic or Gradient
Guard Column (Y/N)
Flow Rate (mL/min)
Temperature (°C)
Column Type
Column Length (cm)
Column Diameter
Column Particle Size
A Solvent (Buffer)
Buffer Type
Molarity
pH

B Solvent (Organic)
Component 1
Component 2
Component 3
Component Ratio (1:2:3)

Instrument Manufacturer
Number of Units

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

PCP

AMP/MAMP

MDMA/MDA/
MDEA

Table C-3-b-4

Alternate Confirmatory Drug Test Methods and Instruments- Liquid Chromatography
Alternate Confirmatory Drug Test Methods and Instruments- Liquid Chromatography
Alternate Confirmatory Drug Test Liquid Chromatography

THCA

BZE

COD/MOR

6-AM

B Solvent (Organic)
Component 1
Component 2
Component 3
Component Ratio (1:2:3)

Instrument Manufacturer
Number of Units

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

PCP

AMP/MAMP

MDMA/MDA/
MDEA

Table C-3-c-1

Primary Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)

Primary Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Primary Confirmatory Drug
Test - Mass Spectrometry

THCA

BZE

COD

MOR

6-AM

PCP

Instrument Manufacturer
Number of Units
Inlet System
Ionization
Ion Focus
Full Scan Mass Range
Calibration Type
Analyte Quantifier Ion
Analyte Qualifier Ion 1*
Analyte Qualifier Ion 2*
Analyte Qualifier Ion 3
Int. Std. Quantifier Ion
Int. Std. Qualifier Ion 1*
Int. Std. Qualifier Ion 2

*If “Other” is selected, please specify:
*Minimum required

LAB_Info_Checklist_CTables_October2010_rev1115.xls

AMP

MAMP

MDMA

MDA

MDEA

Table C-3-c-2

Alternate Confirmatory Drug Test Methods and Instruments - Mass Spectrometry

Alternate Confirmatory Drug Test Methods and Instruments - Mass Spectrometry (MS)
Alternate Confirmatory Drug
Test - Mass Spectrometry

THCA

BZE

COD

MOR

6-AM

PCP

*If “Other” is selected, please specify:
*Minimum required

LAB_Info_Checklist_CTables_October2010_rev1115.xls

AMP

MAMP

MDMA

MDA

MDEA

Table C-3-c-3

Primary Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Primary Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Primary Confirmatory
Drug Test - Tandem
Mass Spectrometry

THCA

BZE

COD

MOR

6-AM

PCP

AMP

MAMP

MDMA

MDA

MDEA

Quantifier Transition*



Qualifier Transition 1*



Qualifier Transition 2
Qualifier Transition 3
Int. Std. Quantifier
Transition*
Int. Std. Qualifier
Transition 1*
Int. Std. Qualifier
Transition 2
Int. Std. Qualifier
Transition 3






Instrument
Manufacturer
Number of Units
Ionization
Configuration
Calibration Type

*If “Other” is selected, please specify:
*Minimum required

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Table C-3-c-4

Alternate Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Alternate Confirmatory Drug Test Methods and Instruments - Tandem Mass Spectrometry
Alternate
Confirmatory Drug
Test - Tandem Mass
Spectrometry
Instrument
Manufacturer

THCA

BZE

COD

MOR

6-AM

PCP

AMP

MAMP

MDMA

MDA

MDEA

Quantifier Transition*



Qualifier Transition 1*



Qualifier Transition 2



Qualifier Transition 3



Int. Std. Quantifier
Transition*
Int. Std. Qualifier
Transition 1*
Int. Std. Qualifier
Transition 2
Int. Std. Qualifier
Transition 3



Number of Units
Ionization
Configuration
Calibration Type

*If “Other” is selected, please specify:
*Minimum required

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Table C-3-d-1

Primary Confirmatory Drug
Test QC

Primary Confirmatory Drug Test QC Samples

Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Concentration

THCA

Matrix
Source
Concentration

BZE

Matrix
Source
Concentration

COD

Matrix
Source
Concentration

MOR

Matrix
Source
Concentration

6-AM

Matrix
Source
Concentration

PCP

Matrix
Source
Concentration

AMP

Matrix
Source
Concentration

MAMP

Matrix
Source
Concentration

MDMA

Matrix
Source
Concentration

MDA

Matrix
Source
Concentration

MDEA

Matrix
Source

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Table C-3-d-2

Alternate Confirmatory Drug
Test QC

Alternate Confirmatory Drug Test QC Samples

Cal 1

Cal 2

Cal 3

Cal 4

Control 1

Concentration

THCA

Matrix
Source
Concentration

BZE

Matrix
Source
Concentration

COD

Matrix
Source
Concentration

MOR

Matrix
Source
Concentration

6-AM

Matrix
Source
Concentration

PCP

Matrix
Source
Concentration

AMP

Matrix
Source
Concentration

MAMP

Matrix
Source
Concentration

MDMA

Matrix
Source
Concentration

MDA

Matrix
Source
Concentration

MDEA

Matrix
Source

*If “Other” is selected, please specify:

LAB_Info_Checklist_CTables_October2010_rev1115.xls

Control 2

Control 3

Control 4

Control 5

Table C-4-a

AMPS Enantiomer Test Methods

Amphetamines Enantiomer
D-AMP
Drug Test
Method
Internal Standard
Int. Std. Isotope Type and
Number
Int. Std. Conc.*
LOD*
LOQ*
ULOL*
Carryover Limit*
*If “Other” is selected, please specify:
Extraction Method
Volume Used (mL)
Derivatizing Reagent
Enantiomer Calculation
*If “Other” is selected, please specify:
Reflex ALL AMPs positive
specimens for DL testing?
* ng/mL

L-AMP

D-MAMP

L-MAMP

Table C-4-b

AMPS Enantiomer QC Samples

AMPS Enantiomer QCs

Cal 1

Concentration
D-AMP

Matrix
Source
Concentration

L-AMP

Matrix
Source
Concentration

D-MAMP

Matrix
Source
Concentration

L-MAMP

Matrix

Source
*If “Other” is selected, please specify:
* ng/mL

Cal 2

Cal 3

Cal 4

Control 1

Control 2

Control 3

Control 4

Control 5

AMPS Enantiomer Result Calculation
Describe in detail the method used to calculate the percentages of Dand L-enantiomers (e.g., use of peak abundances, concentrations,
use of an internal standard). Indicate if concentrations are
calculated that can be compared to the total methamphetamine
result obtained in the amphetamines method.
Type description below:

File Type	application/pdf
File Title	Microsoft Word - LAB_Info_Checklist_AthruC_October2010_rev1115.docx
Author	lholliday
File Modified	2016-11-08
File Created	2016-11-08