Proposed Rule2026-22122
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG)
Primary source
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Published
October 29, 2026
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), published in the Federal Register on October 12, 2023).
Full Text
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[Federal Register Volume 91, Number 208 (Thursday, October 29, 2026)]
[Proposed Rules]
[Pages 68398-68445]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22122]
[[Page 68397]]
Vol. 91
Thursday,
No. 208
October 29, 2026
Part IV
Department of Health and Human Services
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42 CFR Chapter I
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Urine (UrMG); Proposed Rule
Federal Register / Vol. 91, No. 208 / Thursday, October 29, 2026 /
Proposed Rules
[[Page 68398]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Chapter I
RIN 0930-AA40
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Using Urine (UrMG)
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Proposed revisions to mandatory guidelines.
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SUMMARY: The Department of Health and Human Services (``HHS'' or
``Department'') is proposing to revise the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Urine (UrMG), published
in the Federal Register on October 12, 2023).
DATES: Submit comments on or before December 28, 2026.
ADDRESSES: In commenting, please refer to docket number SAMHSA-2026-
0002. Because of staff and resource limitations, SAMHSA cannot accept
comments by facsimile (fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
<bullet> Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow ``Submit a comment''
instructions.
<bullet> By regular mail. You may mail written comments to the
following address: SAMHSA, Center for Substance Abuse Prevention
(CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room
16N02, Rockville, MD 20857. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
<bullet> By express or overnight mail. You may send written
comments to the following address: SAMHSA, CSAP, DWP, 5600 Fishers
Lane, Room 16N02, Rockville, MD 20857.
<bullet> By hand or courier. You may deliver your written comments
by hand or courier to the following address prior to the close of the
comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02,
Rockville, MD 20857. If you intend to deliver your comments to the
Rockville address, please call (240) 276-2600 in advance to schedule
your arrival with one of our staff members. Because access to the
SAMHSA building is secure, persons without federal government
identification are encouraged to schedule their delivery or to leave
comments with the security guard at the front desk located in the main
lobby of the building.
All comments received before the close of the comment period will
be available for viewing by the public. Please note that all comments
are posted in their entirety, including personal or confidential
business information that is included in the comment. SAMHSA will post
all comments before the close of the comment period on the following
website: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the website's search function
to view the associated comments.
Comments received before the close of the comment period will also
be available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at
SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday
through Friday of each week, excluding federal holidays, from 8:30 a.m.
to 4:00 p.m. To schedule an appointment to view public comments, please
call (240) 276-2600.
FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA,
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by
telephone (240) 276-1459 or by email at <a href="/cdn-cgi/l/email-protection#387d4d5f5d565d167059415d4b784b5955504b591650504b165f574e"><span class="__cf_email__" data-cfemail="7d38081a18131853351c04180e3d0e1c10150e1c5315150e531a120b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Executive Summary
This notice of proposed revisions to the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using UrMG includes revisions
that will: clarify the types of laboratories that may be certified to
conduct testing for federal agency workplace drug testing programs,
change invalid specimen criteria (i.e., raise cutoff from pH 9.0 to
9.5), reflect the Department's decision to publish the Authorized Drug
Testing Panels only when revised rather than each year, revise the
initial test batch quality control requirements for laboratories and
instrumented initial test facilities (IITFs), allow a Medical Review
Officer (MRO) to authorize use of a biomarker test for a specimen with
an invalid result based on creatinine and specific gravity, and allow a
split testing laboratory to test for any HHS-authorized biomarker to
reconfirm substitution based on a biomarker test (i.e., may test for a
different biomarker). In addition, some wording changes have been made
for clarity and for consistency with the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) or to
apply to any authorized specimen type and to clarify direct observed
collection procedures.
The Department is concurrently publishing a separate Federal
Register Notice proposing revisions to the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using OFMG, including the same
or similar revisions proposed for the UrMG, where appropriate.
The current authorized drug testing panel and report nomenclature
table for urine and for oral fluid were published on January 16, 2025
(90 FR 4662).
Background
Pursuant to its authority under Section 503 of Public Law 100-71, 5
U.S.C. 7301, and Executive Order No. 12564, HHS establishes the
scientific and technical guidelines for Federal Workplace Drug Testing
Programs and establishes standards for certification of laboratories
engaged in drug testing for federal agencies. Using data obtained from
the Federal Workplace Drug Testing Programs and HHS-certified
laboratories, the Department estimates that 275,000 urine specimens are
tested annually by federal agencies.
As required, HHS originally published the Mandatory Guidelines for
Federal Workplace Drug Testing Programs (Guidelines) in the Federal
Register (FR) on April 11, 1988 (53 FR 11979). SAMHSA subsequently
revised the Guidelines on June 9, 1994 (59 FR 29908), September 30,
1997 (62 FR 51118), November 13, 1998 (63 FR 63483), April 13, 2004 (69
FR 19644), and November 25, 2008 (73 FR 71858). SAMHSA published the
renamed Mandatory Guidelines for Federal Workplace Drug Testing
Programs using UrMG on January 23, 2017 (82 FR 7920), and the first
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
OFMG on October 25, 2019 (84 FR 57754). SAMHSA published the current
UrMG (88 FR 70768) and current OFMG (88 FR 70814) on October 12, 2023.
Proposed Revisions to the Guidelines
This preamble describes the proposed revisions to the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using UrMG, and
the rationale for the changes.
Subpart A--Applicability
Section 1.5 defines terms used in the UrMG. The Department has
added terms and revised definitions in this section in accordance with
proposed changes to these Guidelines.
The Department has deleted ``Gender Identity'' (i.e., term and
definition) to
[[Page 68399]]
enhance the clarity of direct observed collection procedures.
The Department updated the definition of ``Laboratory'' clarifying
that, in addition to certifying laboratories to conduct all required
testing of primary (A) and split (B) specimens, the Department may
certify laboratories that test split (B) specimens only and/or conduct
additional drug or specimen validity tests for primary and split
specimens in accordance with these Mandatory Guidelines.
The Department edited the definition of ``Negative Result'' for
clarity.
The Department edited the definition of ``Substituted Specimen'' to
refer to a test for an HHS-authorized biomarker rather than
specifically referring to the Biomarker Testing Panel, to reflect the
Department's review and approval process for an HHS-certified test
facility to implement testing for a biomarker for use in Federal
workplace drug testing programs.
Section 1.7 describes the circumstances that constitute a refusal
to test. The Department provided additional examples for clarity.
Subpart B--Urine Specimens
Section 2.2 describes the circumstances under which a urine
specimen may be collected. The Department reviewed and revised Section
2.2(a) and other wording in the current UrMG to clarify that pre-
employment tests are performed for all individuals applying for a
testing designated position, including federal agency employees.
Subpart C--Urine Specimen Tests
Section 3.1 describes the tests that are conducted on a urine
specimen. The Department revised Section 3.2 to address when a specimen
may be tested for drugs other than those in the drug testing panel and
inserted a new Section 3.3 to describe the process for an HHS-certified
laboratory or IITF to obtain HHS approval to test for a biomarker other
than those in the biomarker testing panel. The Department renumbered
subsequent items in Section 3 accordingly.
Section 3.5 describes the publication of drug and biomarker testing
panels with analytes and cutoffs for urine. The Department removed the
drug testing panel from the UrMG and deleted the requirement to publish
the Authorized Drug Testing Panels annually. HHS will publish a FR
Notice when drug and/or biomarker testing panels are changed.
Subpart D--Collectors
Section 4.4 describes requirements for an observer for a direct
observed collection. The Department revised item b to refer to the sex
of the observer and donor to enhance the clarity of direct observed
collection procedures.
Subpart H--Urine Specimen Collection Procedure
Section 8.1 describes privacy requirements for urine collection.
The Department revised item b to refer to the sex of the observer and
donor to enhance the clarity of direct observed collection procedures.
The Department reworded item c in Section 8.8 for clarity and to
use the same wording in the UrMG and OFMG.
The Department revised the language in item 8.9(a)(2) to remove the
word ``medical,'' because there may be a legitimate non-medical
explanation for an invalid result.
Section 8.10 describes how a direct observed collection is
conducted and Section 8.12 describes how a monitored collection is
conducted. The Department revised wording in both sections to refer to
the sex of the observer and donor to clarify direct observation
collection procedures.
Subpart I--HHS Certification of Laboratories and IITFs
The Department revised the language in item 9.5(a)(1) to refer to
the drug testing panel rather than ``drug classes listed in the drug
testing panel.''
Section 9.6 describes National Laboratory Certification Program
(NLCP) performance testing (PT) requirements for an applicant urine
laboratory and Section 9.7 describes PT requirements for an HHS-
certified urine laboratory. The Department reworded item a.3 in both
sections to clarify that PT criteria for initial drug test results are
for applicant laboratories that will conduct initial drug tests.
Subpart K--Laboratory
Section 11.12 describes the initial drug test batch quality control
requirements for a urine laboratory. The Department revised item b to
apply to the controls in each initial drug test batch rather than to
calibrators and controls and reduced the required percentage of
controls from 10 percent to 4 percent of the total controls and
specimens in the batch. (The same changes were made for IITFs in
Section 12.)
Section 11.18 describes the requirements for urine laboratory
specimen validity tests. The Department added wording to this section
for clarity as follows: (1) added an introductory sentence referencing
the required urine specimen validity tests in Section 3.1(c) and
optional specimen validity tests in Sections 3.1(d) and 3.6; (2) added
an item a with the requirement for an invalid, adulterated, or
substituted result to be based on an initial specimen validity test on
one aliquot and a confirmatory specimen validity test on a second
aliquot, (3) added an item b with the current requirement for controls
to be analyzed concurrently with specimens, and (4) added an item h
with quality control requirements for specimen validity tests other
than those specified in preceding items. Other items were renamed or
renumbered accordingly.
Item 11.18(e)(4)(v) was edited to reflect the invalid cutoff change
from pH 9.0 to 9.5. As described below, the Department based this
change on a thorough review of current information.
Currently, specimens with pH >=9.0 must undergo laboratory
confirmatory testing for pH and those with reported pH results >=9.0
and <=9.5 must undergo MRO review for possible explanations for the
elevated pH. Specimens without a legitimate explanation and specimens
requiring a valid negative result (i.e., pre-employment, return-to-
duty, or follow-up test) must be recollected. The additional testing,
review, and recollections are a significant burden to HHS-certified
laboratories, MROs, and federal agencies that does not result in
identifying additional adulterated specimens.
Research on time and temperature changes in urine specimens and
effects of pH on drug concentrations in urine were presented at the
December 2024 meeting of SAMHSA's Drug Testing Advisory Board. The data
presented was sourced from HHS-certified laboratories' invalid pH
demographics, peer reviewed literature, and NLCP applied studies
presented at scientific meetings after peer review of the abstracts.
These data show that: (1) extended time at high temperature after
collection can cause urine pH in the acceptable range to rise to 9.1 to
9.3; (2) there is a cyclical nature to the incidence of specimens in
the pH range of 9.0 to 9.5 corresponding to summer months; (3) the
incidence of specimens in pH range 9.0 to 9.5 is ~0.2 percent (e.g.,
approximately 15,000 specimens/year); and (4) pH >9.5 does not occur
due to elevated temperature and increased shipping time.
Regarding the effect of elevated pH on positive drug
concentrations, three analytes (i.e., benzoylecgonine, phencyclidine,
and 6-acetylmorphine) were identified as susceptible to changes in
concentration due to elevated pH. Drug loss over a typical shipping
time (i.e., 1 to 3 days) ranged from 13 percent for benzoylecgonine to
58 percent for 6-acetylmorphine. There
[[Page 68400]]
was no difference in the loss of drug at pH 9.0 to 9.5 and pH of 9.5 to
10.0 for benzoylecgonine and phencyclidine; however, significant losses
of 6-acetylmorphine occurred at pH as low as 8.0. The Department also
reviewed information on primary (A) and split (B) specimens with
inconsistent concentrations of these three analytes. None of these
specimens had a pH >=9.0.
Section 11.19 describes requirements for an HHS-certified
laboratory to report a test result. The Department revised item
11.19(h)(1) to state that an MRO may authorize a specimen with an
invalid result based on creatinine and specific gravity to be tested
for an HHS-authorized biomarker to determine substitution. The
Department revised item 11.19(g) to require the laboratory to contact
the MRO for authorization before conducting testing for the additional
biomarker or sending the specimen to another certified laboratory for
the additional test.
Subpart L--IITF
Section 12.11 describes the initial drug test batch quality control
requirements for an IITF. The Department revised item b to apply to the
controls in each initial drug test batch rather than to calibrators and
controls and reduced the required percentage of controls from 10
percent to 4 percent of the total controls and specimen in the batch.
(The same changes were made for laboratories in Section 11.)
Section 12.14 describes the requirements for IITF specimen validity
tests.
The Department added wording to this section for clarity as
follows: (1) added an introductory sentence referencing the required
IITF specimen validity tests in Section 3.1(c) and optional specimen
validity tests in Sections 3.1(d); and (2) added an item a with the
current requirement for controls to be analyzed concurrently with
specimens. Other items were renamed accordingly.
The Department edited item 12.14(d)(1) and (2) consistent with the
revised invalid specimen criteria (i.e., cutoff change from pH 9.0 to
9.5).
The Department edited wording in item 12.21 regarding IITF records
available to a Federal applicant or employee to be the same as section
11.24 regarding laboratory records.
Subpart M--MRO
Section 13.5 describes MRO actions when reviewing a urine
specimen's test results.
The Department revised item f to delete MRO action for invalid
results based on a pH of 9.0 to 9.5, consistent with the revised
invalid specimen criteria (i.e., cutoff change from pH 9.0 to 9.5). The
Department also edited wording in this section to address different MRO
actions to be taken for invalid specimens depending on the reason for
the test.
Section 13.6 describes MRO action when the collector reports that
the donor did not provide a sufficient amount of urine for a drug test.
The Department has reviewed and revised the previous wording in Section
13.6(b) to clarify different MRO actions to be taken for invalid
specimens depending on the reason for the test.
Subpart N--Split Specimen Tests
Section 14.1 describes when a split (B) urine specimen may be
tested. The Department has revised item 14.1(c) to clarify MRO action
when a split specimen cannot be tested by a second laboratory because
(1) there is no split specimen or the specimen has insufficient volume
for testing), (2) the primary specimen was reported as adulterated and
there is no second HHS-certified laboratory to test the split specimen
for the same adulterant; or (3) the primary specimen was reported as
substituted based on a biomarker, and there is no second HHS-certified
laboratory to test the split specimen (i.e., using the same or a
different biomarker test).
Section 14.4 describes how an HHS-certified laboratory tests a
split (B) urine specimen when the primary (A) specimen was reported
substituted. The Department has renamed and renumbered items in this
section. Item 14.4(b) addresses testing of a split specimen when the
primary specimen was reported substituted based on biomarker testing.
The Department has revised this section to allow the split testing
laboratory to test for any HHS-authorized biomarker. It is not
necessary to test the split specimen for the same biomarker to
reconfirm the primary (A) specimen's substituted result.
Section 14.6 describes action an MRO takes after receiving the
split (B) urine specimen result from the split testing laboratory. The
Department has edited and reorganized this section for clarity and to
describe these revised requirements:
<bullet> When the split laboratory has failed to reconfirm a single
or all drug positive results and reported the specimen as adulterated
and the primary laboratory cannot perform the test for that adulterant:
the MRO directs testing at another HHS-certified laboratory.
<bullet> When the split laboratory has failed to reconfirm a single
or all drug positive results and reported the specimen as substituted
and the primary laboratory cannot perform a biomarker test: the MRO
directs testing at another HHS-certified laboratory. It is not
necessary to test the primary specimen for the same biomarker to
reconfirm the split specimen's substituted result.
The Department also removed the requirement for the MRO to contact
the HHS office responsible for coordination of the drug-free workplace
program regarding the test results throughout this section.
General Revisions
In addition to the proposed changes described by subpart and
section above, the Department has edited the UrMG to address proposed
changes and has reworded some items for clarity (e.g., referring to
``donors'' rather than ``employees'' or ``applicants'') and/or for
consistency with the OFMG or to apply to any authorized specimen type.
Impact of These Guidelines on Government Regulated Industries
The proposed revised Guidelines may impact the Department of
Transportation and Nuclear Regulatory Commission regulated industries
depending on these agencies' decisions to incorporate the final UrMG
revisions into their programs under their own authority.
Costs and Benefits
Costs
The proposed UrMG revisions are not expected to increase current
stakeholder costs. There will be some administrative costs for HHS-
certified laboratories and MROs associated with the change in invalid
specimen criteria (i.e., pH cutoff raised from 9.0 to 9.5; see Sections
11.18 and 12.14). However, the time and labor savings from this change
are expected to greatly exceed these one-time costs.
Benefits
As noted above, laboratories and MROs will incur some initial costs
for changing the pH invalid test cutoff; however, this change will
benefit laboratories, MROs, and Federal agencies. Currently, a large
number of specimens are reported as invalid based on pH between 9.0 and
9.5, especially in summer months. The reduction in invalid specimens
due to the cutoff change will reduce the numbers of required
confirmatory pH tests, MRO interviews and investigations, and specimen
recollections.
The proposed revision to quality control requirements for initial
drug test batches in Section 11.11(b) will reduce laboratory burden and
expense while
[[Page 68401]]
maintaining quality. The Department has lowered the percentage of
controls in each initial drug test batch from 10 percent to 4 percent
of the total controls and specimens in the batch. This will reduce
time, labor, and material costs (e.g., purchasing, initial
verification, batch review, monitoring control results). Initial drug
testing is used to report specimens as negative; specimens with a
positive initial drug test are reflexed to confirmatory testing. The
Department has maintained the 10 percent control requirement for
confirmatory test batches.
Other UrMG revisions that will reduce stakeholder burden include
those related to biomarker testing which are expected to lead to
definitive results and reduce the need for specimen recollection. These
include changes allowing an MRO to authorize testing for a biomarker
for a specimen with an invalid result based on creatinine and specific
gravity (Section 11.19) and allowing a split testing laboratory to use
any HHS-authorized biomarker test to reconfirm substitution based on a
biomarker test, rather than requiring the same biomarker test used for
the primary specimen (Section 14.1). These revisions also strengthen
the federal government's ability to identify illicit drug use and donor
attempts to subvert drug tests.
Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). The title and description of the collected
information and respondent description are shown in the following
paragraphs with an estimate of the annual reporting, disclosure, and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Comments on the information collection requirements are
specifically solicited in order to: (1) Evaluate whether the proposed
collection of information is necessary for the proper performance of
HHS's functions, including whether the information will have practical
utility; (2) evaluate the accuracy of HHS's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used; (3) enhance the quality, utility, and
clarity of the information to be collected; and (4) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
Title: The Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Urine
Information Collection/Record Keeping Requirements
The information collection requirements (i.e., reporting and
recordkeeping) in the current Guidelines, which establish the
scientific and technical guidelines for Federal Workplace Drug Testing
Programs and establish standards for certification of laboratories
engaged in urine drug testing for federal agencies under authority of 5
U.S.C. 7301 and Executive Order 12564, are approved by the Office of
Management and Budget (OMB) under control number 0930-0158. The Federal
Drug Testing Custody and Control Form (Federal CCF) used to document
the collection and chain of custody of urine and oral fluid specimens
at the collection site, for laboratories to report results, and for
Medical Review Officers to make a determination; the National
Laboratory Certification Program (NLCP) application; the NLCP
Laboratory Information Checklist; and recordkeeping requirements in the
current Guidelines, as approved under control number 0930-0158, will
remain in effect.
In support of the Government Paperwork Reduction Act, the
Department revised the Federal CCF to enable its use as an electronic
form (78 FR 42091, July 15, 2013) and developed requirements and
oversight procedures to ensure that HHS-certified test facilities and
other service providers (e.g., collection sites, MROs) using an
electronic version of the Federal CCF (ECCF) maintain the accuracy,
security, and confidentiality of electronic drug test information.
Before a Federal ECCF can be used for Federal agency specimens, HHS-
certified test facilities must submit detailed information and proposed
standard operating procedures (SOPs) to the NLCP for SAMHSA review and
approval and undergo an NLCP inspection focused on the proposed ECCF.
Since 2013, SAMHSA has encouraged the use of Federal ECCFs and
other electronic processes in HHS-certified test facilities, when
practicable, for federally regulated testing operations. In accordance
with Section 8108(a) of the SUPPORT for Patients and Communities Act,
SAMHSA has set a deadline of August 31, 2026, for all HHS-certified
laboratories to submit a request for approval of an electronic
(digital) Federal CCF. To assist all HHS-certified laboratories, SAMHSA
has implemented an ECCF Recognition Program to recognize ECCF systems
that meet program requirements and can be used by any HHS-certified
laboratory or IITF. This program is expected to facilitate the process
for HHS-certified test facilities seeking SAMHSA approval to use an
ECCF and enable all HHS-certified test facilities (regardless of size)
to meet the August 31, 2026, deadline for a digital ECCF submission.
Description: The Mandatory Guidelines establish the scientific and
technical guidelines for federal drug testing programs and establish
standards for certification of laboratories engaged in drug testing for
federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301
note, and Executive Order No. 12564. Federal drug testing programs test
applicants for safety-sensitive positions, individuals involved in
accidents, individuals tested for cause, and random testing of
employees in safety-sensitive positions.
Description of Respondents: Individuals or households, businesses,
or other-for-profit and not-for-profit institutions.
The burden estimates in the tables below are based on the following
number of respondents: 38,000 donors who apply for employment or are
employed in testing designated positions, 100 collectors, 20 urine
specimen testing laboratories, 1 IITF, and 100 MROs.
Estimate of Annual Reporting Burden
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The following reporting requirements are also in the proposed
Guidelines, but have not been addressed in the above reporting burden
table: collector must report any unusual donor behavior or refusal to
participate in the collection process on the Federal CCF (Sections 1.8,
8.9); collector annotates the Federal CCF when a sample is a blind
sample (Section 10.3(a)); MRO notifies the federal agency and HHS when
an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6
and 13.7 describe the actions an MRO takes for the medical evaluation
of a donor who cannot provide a urine specimen. SAMHSA has not
calculated a separate reporting burden for these requirements because
they are included in the burden hours estimated for collectors to
complete Federal CCFs and for MROs to report results to federal
agencies.
Estimate of Annual Disclosure Burden
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The following disclosure requirements are also included in the
proposed Guidelines but have not been addressed in the above disclosure
burden table: the collector must explain the basic collection procedure
to the donor and answer any questions (Section 8.3(e) and (g)). SAMHSA
believes having the collector explain the collection procedure to the
donor and answer any questions is a standard business practice and not
a disclosure burden.
Estimate of Annual Recordkeeping Burden
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BILLING CODE 4162-20-C
The proposed Guidelines contain several recordkeeping requirements
that SAMHSA considers not to be an additional recordkeeping burden. In
subpart D, a trainer is required to document the training of an
individual to be a collector (Section 4.3(a)(3)) and the documentation
must be maintained in the collector's training file (Section 4.3(c)).
SAMHSA believes this training documentation is common practice and is
not considered an additional burden. In subpart F, if a collector uses
an incorrect form to collect a federal agency specimen, the collector
is required to provide a statement (Section 6.2(b)) explaining why an
incorrect form was used to document collecting the specimen. SAMHSA
believes this is an extremely infrequent occurrence and does not create
a significant additional recordkeeping burden. Subpart H (Sections
8.4(c), 8.5(d)(2), 8.5 (e)(1) and (2)) requires collectors to enter any
information on the Federal CCF of any unusual findings during the urine
specimen collection procedure. These recordkeeping requirements are an
integral part of the collection procedure and are essential to
documenting the chain of custody for the specimens collected. The
burden for these entries is included in the recordkeeping burden
estimated to complete the Federal CCF and is, therefore, not considered
an additional recordkeeping burden. Subpart K describes a number of
recordkeeping requirements for laboratories associated with their
testing procedures, maintaining chain of custody, and keeping records
(i.e., Sections 11.1(a) and (d); 11.2(b), (c), and (d); 11.6(b);
11.7(c); 11.8; 11.11(a); 11.14(a); 11.17; 11.21(a), (b), and (c);
11.22; 11.23(a) and 11.24). These recordkeeping requirements are
necessary for any laboratory to conduct forensic drug testing and to
ensure the scientific supportability of the test results. Therefore,
they are considered to be standard business practice and are not
considered a burden for this analysis.
Thus, the total annual response burden associated with the testing
of urine specimens by the laboratories and IITFs is estimated to be
14,332 hours (that is, the sum of the total hours from the above
tables). This burden has decreased from the 2023 estimate of 14,862
hours. The estimated burden hours were also decreased for testing of
oral fluid specimens by laboratories, as described in the OFMG. The
final estimate after adjusting the total 1,686,483 hours currently
approved by OMB under control number 0930-0158 is 1,684,363 hours,
reflecting the decrease in burden hours required to perform the tasks
outlined in these updated mandatory guidelines. The Department requests
comments on the change in burden hours.
As required by section 3507(d) of the Paperwork Reduction Act, the
Secretary has submitted a copy of these proposed Guidelines to OMB for
its review.
OMB is required to make a decision concerning the collection of
information contained in these proposed Guidelines between 30 and 60
days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication. This does not affect
the deadline for the public to comment to HHS on the proposed
Guidelines.
Organizations and individuals desiring to submit comments on the
information collection requirements should direct them to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Building,
725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for
SAMHSA. Because of delays in receipt of mail, comments may also be sent
to 202-395-6974 (fax).
Robert F. Kennedy, Jr.,
Secretary.
For the reasons discussed above, the Department of Health and Human
Services proposes to amend the Mandatory Guideline to read as follows:
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Urine
Subpart A--Applicability
1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these
Guidelines?
1.3 How does a Federal agency request a change from these
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect workplace drug
testing records?
1.7 What is a refusal to take a federally regulated drug test?
1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
Subpart B--Urine Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may a urine specimen be collected?
2.3 How is each urine specimen collected?
2.4 What volume of urine is collected?
[[Page 68410]]
2.5 How does the collector split the urine specimen?
2.6 When may an entity or individual release a urine specimen?
Subpart C--Urine Specimen Tests
3.1 Which tests are conducted on a urine specimen?
3.2 May a specimen be tested for drugs other than those in the drug
testing panel?
3.3 May a specimen be tested for biomarkers other than those in the
biomarker testing panel?
3.4 May any of the specimens be used for other purposes?
3.5 What are the drug and biomarker test analytes and cutoffs for
urine?
3.6 May an HHS-certified laboratory perform additional drug and/or
specimen validity tests on a specimen at the request of the Medical
Review Officer (MRO)?
3.7 What criteria are used to report a urine specimen as
adulterated?
3.8 What criteria are used to report a urine specimen as
substituted?
3.9 What criteria are used to report a urine specimen as dilute?
3.10 What criteria are used to report an invalid result for a urine
specimen?
Subpart D--Collectors
4.1 Who may collect a urine specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be an observer for a direct
observed collection?
4.5 What are the requirements to be a trainer for collectors?
4.6 What must a Federal agency do before a collector is permitted to
collect a specimen?
Subpart E--Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a
specimen at the collection site?
5.6 What are the privacy requirements when collecting a urine
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What Federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not
available or is not used?
Subpart G--Urine Specimen Collection Containers and Bottles
7.1 What is used to collect a urine specimen?
7.2 What are the requirements for a urine collection container and
specimen bottles?
7.3 What are the minimum performance requirements for a urine
collection container and specimen bottles?
Subpart H--Urine Specimen Collection Procedure
8.1 What privacy must the donor be given when providing a urine
specimen?
8.2 What must the collector ensure at the collection site before
starting a urine specimen collection?
8.3 What are the preliminary steps in the urine specimen collection
procedure?
8.4 What steps does the collector take in the collection procedure
before the donor provides a urine specimen?
8.5 What steps does the collector take during and after the urine
specimen collection procedure?
8.6 What procedure is used when the donor states that they are
unable to provide a urine specimen?
8.7 If the donor is unable to provide a urine specimen, may another
specimen type be collected for testing?
8.8 How does the collector prepare the urine specimens?
8.9 When is a direct observed collection conducted?
8.10 How is a direct observed collection conducted?
8.11 When is a monitored collection conducted?
8.12 How is a monitored collection conducted?
8.13 How does the collector report a donor's refusal to test?
8.14 What are a federal agency's responsibilities for a collection
site?
Subpart I--HHS Certification of Laboratories and IITFs
9.1 Who has the authority to certify laboratories and IITFs to test
urine specimens for federal agencies?
9.2 What is the process for a laboratory or IITF to become HHS-
certified?
9.3 What is the process for a laboratory or IITF to maintain HHS
certification?
9.4 What is the process when a laboratory or IITF does not maintain
its HHS certification?
9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory that
seeks to perform urine testing?
9.7 What are the PT requirements for an HHS-certified urine
laboratory?
9.8 What are the PT requirements for an applicant IITF?
9.9 What are the PT requirements for an HHS-certified IITF?
9.10 What are the inspection requirements for an applicant
laboratory or IITF?
9.11 What are the maintenance inspection requirements for an HHS-
certified laboratory or IITF?
9.12 Who can inspect an HHS-certified laboratory or IITF and when
may the inspection be conducted?
9.13 What happens if an applicant laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
9.14 What happens if an HHS-certified laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
9.15 What factors are considered in determining whether revocation
of a laboratory's or IITF's HHS certification is necessary?
9.16 What factors are considered in determining whether to suspend a
laboratory's or an IITF's HHS certification?
9.17 How does the Secretary notify an HHS-certified laboratory or
IITF that action is being taken against the laboratory or IITF?
9.18 May a laboratory or IITF that had its HHS certification revoked
be recertified to test Federal agency specimens?
9.19 Where is the list of HHS-certified laboratories and IITFs
published?
Subpart J--Blind Samples Submitted by an Agency
10.1 What are the requirements for Federal agencies to submit blind
samples to HHS-certified laboratories or IITFs?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory
or IITF?
10.4 What happens if an inconsistent result is reported for a blind
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified
laboratory?
11.5 What qualifications must an individual have to certify a result
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory
maintain?
11.8 What are the laboratory chain of custody requirements for
specimens and aliquots?
11.9 What test(s) does an HHS-certified laboratory conduct on a
urine specimen received from an IITF?
11.10 What are the requirements for an initial drug test?
11.11 What must an HHS-certified laboratory do to validate an
initial drug test?
11.12 What are the batch quality control requirements when
conducting an initial drug test?
11.13 What are the requirements for a confirmatory drug test?
11.14 What must an HHS-certified laboratory do to validate a
confirmatory drug test?
11.15 What are the batch quality control requirements when
conducting a confirmatory drug test?
11.16 What are the analytical and quality control requirements for
conducting specimen validity tests?
[[Page 68411]]
11.17 What must an HHS-certified laboratory do to validate a
specimen validity test?
11.18 What are the requirements for conducting each specimen
validity test?
11.19 What are the requirements for an HHS-certified laboratory to
report a test result?
11.20 How long must an HHS-certified laboratory retain specimens?
11.21 How long must an HHS-certified laboratory retain records?
11.22 What statistical summary reports must an HHS-certified
laboratory provide for urine testing?
11.23 What HHS-certified laboratory information is available to a
federal agency?
11.24 What HHS-certified laboratory information is available to a
federal applicant or employee?
11.25 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
11.26 What type of relationship can exist between an HHS-certified
laboratory and an HHS-certified IITF?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 What must be included in the HHS-certified IITF's standard
operating procedure manual?
12.2 What are the responsibilities of the responsible technician
(RT)?
12.3 What qualifications must the RT have?
12.4 What happens when the RT is absent or leaves an HHS-certified
IITF?
12.5 What qualifications must an individual have to certify a result
reported by an HHS-certified IITF?
12.6 What qualifications and training must other personnel of an
HHS-certified IITF have?
12.7 What security measures must an HHS-certified IITF maintain?
12.8 What are the IITF chain of custody requirements for specimens
and aliquots?
12.9 What are the requirements for an initial drug test?
12.10 What must an HHS-certified IITF do to validate an initial drug
test?
12.11 What are the batch quality control requirements when
conducting an initial drug test?
12.12 What are the analytical and quality control requirements for
conducting specimen validity tests?
12.13 What must an HHS-certified IITF do to validate a specimen
validity test?
12.14 What are the requirements for conducting each specimen
validity test?
12.15 What are the requirements for an HHS-certified IITF to report
a test result?
12.16 How does an HHS-certified IITF handle a specimen that tested
positive, adulterated, substituted, or invalid at the IITF?
12.17 How long must an HHS-certified IITF retain a specimen?
12.18 How long must an HHS-certified IITF retain records?
12.19 What statistical summary reports must an HHS-certified IITF
provide?
12.20 What HHS-certified IITF information is available to a federal
agency?
12.21 What HHS-certified IITF information is available to a federal
applicant or employee?
12.22 What types of relationships are prohibited between an HHS-
certified IITF and an MRO?
12.23 What type of relationship can exist between an HHS-certified
IITF and an HHS-certified laboratory?
Subpart M--Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards
that certify MROs approved?
13.3 What training is required before a physician may serve as an
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing a urine specimen's test
results?
13.6 What action does the MRO take when the collector reports that
the donor did not provide a sufficient amount of urine for a drug
test?
13.7 What happens when an individual is unable to provide a
sufficient amount of urine for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because
of a permanent or long-term medical condition?
13.8 How does an MRO report a primary (A) specimen test result to an
agency?
13.9 Who may request a test of a split (B) specimen?
13.10 What types of relationships are prohibited between an MRO and
an HHS-certified laboratory or an HHS-certified IITF?
13.11 What reports must an MRO provide to the Secretary for urine
testing?
13.12 What are a federal agency's responsibilities for designating
an MRO?
Subpart N--Split Specimen Tests
14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) urine
specimen when the primary (A) specimen was reported adulterated?
14.4 How does an HHS-certified laboratory test a split (B) urine
specimen when the primary (A) specimen was reported substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B)
urine specimen result from the second HHS-certified urine
laboratory?
14.7 How does an MRO report a split (B) specimen test result to an
agency?
14.8 How long must an HHS-certified laboratory retain a split (B)
specimen?
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory or an
HHS-certified IITF to report a urine specimen as rejected for
testing?
15.2 What discrepancies require an HHS-certified laboratory or an
HHS-certified IITF to report a specimen as rejected for testing
unless the discrepancy is corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory or an HHS-certified IITF to reject a urine
specimen for testing or an MRO to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?
Subpart P--Laboratory or IITF Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory or IITF be
suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?
Subpart A--Applicability
Section 1.1 To whom do these Guidelines apply?
(a) These Guidelines apply to:
(1) Executive agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3), but
excluding the Armed Forces as defined in 5 U.S.C. 2101(2);
(3) Any other employing unit or authority of the federal government
except the United States Postal Service, the Postal Rate Commission,
and employing units or authorities in the Judicial and Legislative
Branches; and
(4) The Intelligence Community, as defined by Executive Order
12333, is subject to these Guidelines only to the extent agreed to by
the head of the affected agency;
(5) Laboratories and instrumented initial test facilities (IITF)
that provide drug testing services to the federal agencies;
[[Page 68412]]
(6) Collectors who provide specimen collection services to the
federal agencies; and
(7) Medical Review Officers (MRO) who provide drug testing reviews
and interpretation of results services to the federal agencies.
(b) These Guidelines do not apply to drug testing under authority
other than Executive Order 12564, including testing of persons in the
criminal justice system, such as arrestees, detainees, probationers,
incarcerated persons, or parolees.
Section 1.2 Who is responsible for developing and implementing these
Guidelines?
(a) Executive Order 12564 and Public Law 100-71 require the
Department of Health and Human Services (HHS) to establish scientific
and technical guidelines for federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these
Guidelines.
Section 1.3 How does a federal agency request a change from these
Guidelines?
(a) Each federal agency must ensure that its workplace drug testing
program complies with the provisions of these Guidelines unless a
waiver has been obtained from the Secretary.
(b) To obtain a waiver, a federal agency must submit a written
request to the Secretary that describes the specific change for which a
waiver is sought and a detailed justification for the change.
Section 1.4 How are these Guidelines revised?
(a) To ensure the full reliability and accuracy of specimen tests,
the accurate reporting of test results, and the integrity and efficacy
of federal drug testing programs, the Secretary may make changes to
these Guidelines to reflect improvements in the available science and
technology.
(b) Revisions to these Guidelines will be published in final as a
notification in the Federal Register.
Section 1.5 What do the terms used in these Guidelines mean?
The following definitions are adopted:
Accessioner. The individual who signs the Federal Drug Testing
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.
Adulterated Specimen. A specimen that has been altered, as
evidenced by test results showing either a substance that is not a
normal constituent for that type of specimen or showing an abnormal
concentration of a normal constituent (e.g., nitrite in urine).
Aliquot. A portion of a specimen used for testing.
Alternate Responsible Person. The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of the HHS-certified laboratory when the
responsible person is unable to fulfill these obligations.
Alternate Responsible Technician. The person who assumes
professional, organizational, educational, and administrative
responsibility for the day-to-day management of the HHS-certified IITF
when the responsible technician is unable to fulfill these obligations.
Alternate Technology Initial Drug Test. An initial drug test using
technology other than immunoassay to differentiate negative specimens
from those requiring further testing.
Batch. A number of specimens or aliquots handled concurrently as a
group.
Biomarker. An endogenous substance used to validate a biological
specimen.
Biomarker Testing Panel. The panel published in the Federal
Register that includes the biomarkers authorized for testing, with
analytes and cutoffs for initial and confirmatory biomarker tests, as
described under Section 3.5.
Blind Sample. A sample submitted to an HHS-certified test facility
for quality assurance purposes, with a fictitious identifier, so that
the test facility cannot distinguish it from a donor specimen.
Calibrator. A sample of known content and analyte concentration
prepared in the appropriate matrix used to define expected outcomes of
a testing procedure. The test result of the calibrator is verified to
be within established limits prior to use.
Cancelled Test. The result reported by the MRO to the federal
agency when a specimen has been reported to the MRO as an invalid
result (and the donor has no legitimate explanation) or the specimen
has been rejected for testing, when a split specimen fails to
reconfirm, or when the MRO determines that a fatal flaw or unrecovered
correctable flaw exists in the forensic records (as described in
Sections 15.1 and 15.2).
Carryover. The effect that occurs when a sample result (e.g., drug
concentration) is affected by a preceding sample during the preparation
or analysis of a sample.
Certifying Scientist (CS). The individual responsible for verifying
the chain of custody and scientific reliability of a test result
reported by an HHS-certified laboratory.
Certifying Technician (CT). The individual responsible for
verifying the chain of custody and scientific reliability of negative,
rejected for testing, and (for urine) negative/dilute results reported
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
Chain of Custody (COC) Procedures. Procedures that document the
integrity of each specimen or aliquot from the point of collection to
final disposition.
Chain of Custody Documents. Forms used to document the control and
security of the specimen and all aliquots. The document may account for
an individual specimen, aliquot, or batch of specimens/aliquots and
must include the name and signature of each individual who handled the
specimen(s) or aliquot(s) and the date and purpose of the handling.
Collection Container. A receptacle used to collect a donor's drug
test specimen.
Collection Site. The location where specimens are collected.
Collector. A person trained to instruct and assist a donor in
providing a specimen.
Confirmatory Drug Test. A second analytical procedure performed on
a separate aliquot of a specimen to identify and quantify a specific
drug or drug metabolite.
Confirmatory Specimen Validity Test. A second test performed on a
separate aliquot of a specimen to further support an initial specimen
validity test result.
Control. A sample used to evaluate whether an analytical procedure
or test is operating within predefined tolerance limits.
Cutoff. The analytical value (e.g., drug, drug metabolite, or
biomarker concentration) used as the decision point to determine a
result (e.g., negative, positive, adulterated, invalid, or substituted)
or the need for further testing.
Dilute Specimen. A urine specimen with creatinine and specific
gravity values that are lower than expected but are still within the
physiologically producible ranges of human urine.
Donor. The individual from whom a specimen is collected.
Drug Testing Panel. The panel published in the Federal Register
that includes the drugs authorized for testing, with analytes and
cutoffs for initial and confirmatory drug tests, as described under
Section 3.5.
External Service Provider. An independent entity that performs
services related to federal workplace drug testing on behalf of a
federal
[[Page 68413]]
agency, a collector/collection site, an HHS-certified laboratory, a
Medical Review Officer (MRO), or (for urine) an HHS-certified
Instrumented Initial Test Facility (IITF).
Failed to Reconfirm. The result reported for a split (B) specimen
when a second HHS-certified laboratory is unable to corroborate the
result reported for the primary (A) specimen.
Federal Drug Testing Custody and Control Form (Federal CCF). The
Office of Management and Budget (OMB) approved form that is used to
document the collection and chain of custody of a specimen from the
time the specimen is collected until it is received by the test
facility (i.e., HHS-certified laboratory or, for urine, HHS-certified
IITF). It may be a paper (hardcopy), electronic (digital), or
combination electronic and paper format (hybrid). The form may also be
used to report the test result to the Medical Review Officer.
HHS. The Department of Health and Human Services.
Initial Drug Test. An analysis used to differentiate negative
specimens from those requiring further testing.
Initial Specimen Validity Test. The first analysis used to
determine if a specimen is adulterated, invalid, substituted, or (for
urine) dilute.
Instrumented Initial Test Facility (IITF). A permanent location
where (for urine) initial testing, reporting of results, and
recordkeeping are performed under the supervision of a responsible
technician.
Invalid Result. The result reported by an HHS-certified laboratory
in accordance with the criteria established in Section 3.10 when a
positive, negative, adulterated, or substituted result cannot be
established for a specific drug or specimen validity test.
Laboratory. A permanent location where drug testing, reporting of
results, and recordkeeping are performed under the supervision of a
responsible person. In addition to certifying laboratories that conduct
all required testing of primary (A) and split (B) specimens, HHS may
certify a laboratory that tests split (B) specimens only and/or
conducts additional drug or specimen validity tests for primary and
split specimens in accordance with these Mandatory Guidelines.
Limit of Detection (LOD). The lowest concentration at which the
analyte (e.g., drug or drug metabolite) can be identified.
Limit of Quantification (LOQ). For quantitative assays, the lowest
concentration at which the identity and concentration of the analyte
(e.g., drug or drug metabolite) can be accurately established.
Lot. A number of units of an item (e.g., reagents, quality control
material) manufactured from the same starting materials within a
specified period of time for which the manufacturer ensures that the
items have essentially the same performance characteristics and
expiration date.
Medical Review Officer (MRO). A licensed physician who reviews,
verifies, and reports a specimen test result to the federal agency.
Negative Result. The result reported by an HHS-certified laboratory
or (for urine) an HHS-certified IITF when a specimen does not contain
the analyte of interest (i.e., drug and/or drug metabolite) or the
concentration is less than the cutoff for the test.
Oral Fluid Specimen. An oral fluid specimen is collected from the
donor's oral cavity and is a combination of physiological fluids
produced primarily by the salivary glands.
Oxidizing Adulterant. A substance that acts alone or in combination
with other substances to oxidize drug or drug metabolites to prevent
the detection of the drugs or drug metabolites, or affects the reagents
in either the initial or confirmatory drug test.
Performance Testing (PT) Sample. A program-generated sample sent to
a laboratory or (for urine) to an IITF to evaluate performance.
Positive Result. The result reported by an HHS-certified laboratory
when a specimen contains a drug or drug metabolite equal to or greater
than the confirmatory test cutoff.
Reconfirmed. The result reported for a split (B) specimen when the
second HHS-certified laboratory corroborates the original result
reported for the primary (A) specimen.
Rejected for Testing. The result reported by an HHS-certified
laboratory or (for urine) HHS-certified IITF when no tests are
performed on a specimen because of a fatal flaw or an unrecovered
correctable error (see Sections 15.1 and 15.2).
Responsible Person (RP). The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of an HHS-certified laboratory.
Responsible Technician (RT). The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of an HHS-certified IITF.
Sample. A performance testing sample, calibrator or control used
during testing, or a representative portion of a donor's specimen.
Secretary. The Secretary of the U.S. Department of Health and Human
Services.
Specimen. Fluid or material collected from a donor at the
collection site for the purpose of a drug test.
Split Specimen Collection (for Urine). A collection in which the
specimen collected is divided into a primary (A) specimen and a split
(B) specimen, which are independently sealed in the presence of the
donor.
Standard. Reference material of known purity or a solution
containing a reference material at a known concentration.
Substituted Specimen. A specimen that has been submitted in place
of the donor's specimen, as evidenced by the absence of a biomarker or
a biomarker concentration inconsistent with that established for a
human specimen based on testing for an HHS-authorized biomarker or (for
urine) creatinine and specific gravity values that are outside the
physiologically producible ranges of human urine, in accordance with
the criteria to report a specimen as substituted in Section 3.8.
Section 1.6 What is an agency required to do to protect workplace drug
testing records?
Consistent with 5 U.S.C. 552a and 48 CFR 24.101 through 24.104, all
agency contracts with laboratories, IITFs, collectors, and MROs must
require that they comply with the Privacy Act, 5 U.S.C. 552a. In
addition, the contracts must require compliance with employee access
and confidentiality provisions of section 503 of Public Law 100-71.
Each federal agency must establish a Privacy Act System of Records or
modify an existing system or use any applicable Government-wide system
of records to cover the records of workplace drug test results. All
contracts and the Privacy Act System of Records must specifically
require that workplace drug testing records be maintained and used with
the highest regard for individual privacy.
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and
E, may be applicable to certain health care providers with whom a
federal agency may contract. If a health care provider is a HIPAA
covered entity, the provider must protect the individually identifiable
health information it maintains in accordance with the requirements of
the Rule, which includes not using or disclosing the information except
as permitted by the Rule and ensuring there are reasonable
[[Page 68414]]
safeguards in place to protect the privacy of the information.
Section 1.7 What is a refusal to take a federally regulated drug test?
(a) A donor for a federally regulated drug test has refused to take
a federally regulated drug test when he/she:
(1) Fails to appear for any test within a reasonable time, as
determined by the federal agency, consistent with applicable agency
regulations, after being directed to do so by the federal agency;
(2) Fails to remain at the collection site until the collection
process is complete;
(3) Fails to provide a specimen (i.e., urine or another authorized
specimen type) for any drug test required by these Guidelines or
federal agency regulations;
(4) In the case of a direct observed or monitored collection, fails
to permit the observation or monitoring of his/her provision of a
specimen when required as described in Sections 8.9 and 8.10;
(5) Fails to provide a sufficient amount of urine when directed,
and it has been determined, through a required medical evaluation, that
there was no legitimate medical explanation for the failure as
determined by the process described in Section 13.6;
(6) Fails or declines to participate in an alternate specimen
collection (e.g., oral fluid) as directed by the federal agency or
collector (i.e., as described in Section 8.6);
(7) Fails to undergo a medical examination or evaluation, as
directed by the MRO as part of the verification process (i.e., Section
13.6) or as directed by the federal agency. In the case of a federal
agency applicant/pre-employment drug test, the donor is deemed to have
refused to test on this basis only if the Federal agency applicant/pre-
employment test is conducted following a contingent offer of
employment. If there was no contingent offer of employment, the MRO
will cancel the test;
(8) Fails to cooperate with any part of the testing process (e.g.,
refuses to empty pockets when directed by the collector, disrupts the
collection process, fails to wash hands after being directed to do so
by the collector, does not consent to testing or withdraws consent for
testing);
(9) For an observed collection, fails to follow the observer's
instructions related to the collection process;
(10) Brings materials to the collection site for the purpose of
adulterating, substituting, or diluting the specimen;
(11) Attempts to adulterate, substitute, or dilute the specimen;
(12) Possesses or wears a device intended to subvert or interfere
with the collection process; or
(13) Admits to the collector or MRO that he/she has adulterated or
substituted the specimen.
Section 1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
(a) A refusal to take a test may result in the initiation of
disciplinary or adverse action for a federal employee, up to and
including removal from federal employment. An applicant's refusal to
take a pre-employment test may result in non-selection for federal
employment.
(b) When a donor has refused to participate in a part of the
collection process, including failing to appear in a reasonable time
for any test, the collector must terminate the collection process and
take action as described in Section 8.13. Required action includes
immediately notifying the federal agency's designated representative by
any means (e.g., telephone, email, or secure facsimile [fax] machine)
that ensures that the refusal notification is immediately received and,
if a federal CCF has been initiated, documenting the refusal on the
federal CCF, signing and dating the federal CCF, and sending all copies
of the federal CCF to the federal agency's designated representative.
(c) When documenting a refusal to test during the verification
process as described in Sections 13.4, 13.5, and 13.6, the MRO must
complete the MRO copy of the federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the federal CCF.
Subpart B--Urine Specimens
Section 2.1 What type of specimen may be collected?
A federal agency may collect urine and/or an alternate specimen
type for its workplace drug testing program. Only specimen types
authorized by Mandatory Guidelines for Federal Workplace Drug Testing
Programs may be collected. An agency using urine must follow these
Guidelines.
Section 2.2 Under what circumstances may a urine specimen be collected?
A federal agency may collect a urine specimen for the following
reasons:
(a) Pre-employment test (i.e., for all applicants including federal
agency employees);
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post-accident test;
(e) Return to duty test; or
(f) Follow-up test.
Section 2.3 How is each urine specimen collected?
Each urine specimen is collected as a split specimen as described
in Section 2.5.
Section 2.4 What volume of urine is collected?
A donor is expected to provide at least 45 mL of urine for a
specimen.
Section 2.5 How does the collector split the urine specimen?
The collector pours at least 30 mL into a specimen bottle that is
designated as A (primary) and then pours at least 15 mL into a specimen
bottle that is designated as B (split).
Section 2.6 When may an entity or individual release a urine specimen?
Entities and individuals subject to these Guidelines under Section
1.1 may not release specimens collected pursuant to Executive Order
12564, Public Law 100-71, and these Guidelines to donors or their
designees. Specimens also may not be released to any other entity or
individual unless expressly authorized by these Guidelines or by
applicable federal law. This section does not prohibit a donor's
request to have a split (B) specimen tested in accordance with Section
13.9.
Subpart C--Urine Specimen Tests
Section 3.1 Which tests are conducted on a urine specimen?
A federal agency:
(a) Must ensure that each specimen is tested for marijuana and
cocaine metabolites as provided in the drug testing panel described
under Section 3.5;
(b) Is authorized to test each specimen for other Schedule I or II
drugs as provided in the drug testing panel;
(c) Must ensure that the following specimen validity tests are
conducted on each urine specimen:
(1) Determine the creatinine concentration on every specimen;
(2) Determine the specific gravity on every specimen for which the
creatinine concentration is less than 20 mg/dL;
(3) Determine the pH on every specimen; and
(4) Perform one or more specimen validity tests for oxidizing
adulterants on every specimen.
(d) Is authorized to test each specimen for one or more HHS-
authorized biomarkers; and
[[Page 68415]]
(e) May perform additional testing if a specimen exhibits abnormal
characteristics (e.g., unusual odor or color, semi-solid
characteristics), causes reactions or responses characteristic of an
adulterant during initial or confirmatory drug tests (e.g., non-
recovery of internal standard, unusual response), or contains an
unidentified substance that interferes with the confirmatory analysis.
Section 3.2 May a specimen be tested for drugs other than those in the
drug testing panel?
A federal agency covered by these Guidelines may test their
workplace specimens for the drugs listed in the drug testing panel and
any other drugs listed in Schedule I or II of the Controlled Substances
Act subject to the procedures listed in paragraphs (a) and (b) of this
section.
(a) A federal agency may test a reasonable suspicion or post-
accident specimen for additional Schedule I or II drugs not listed in
the drug testing panel on a case-by-case basis. The agency must request
the HHS-certified laboratory to test for the additional drug, include a
justification to test a specific specimen for the drug, and ensure that
the HHS-certified laboratory has the capability to test for the drug
and has established properly validated initial and confirmatory
analytical methods. If an initial test procedure is not available upon
request for a suspected Schedule I or Schedule II drug, the federal
agency can request an HHS-certified laboratory to test for the drug by
analyzing two separate aliquots of the specimen in two separate testing
batches using the confirmatory analytical method. Additionally, the
split (B) specimen will be available for testing if the donor requests
a retest at another HHS-certified laboratory.
(b) A federal agency must petition the Secretary in writing for
approval to routinely test for any drug not listed in the drug testing
panel described under Section 3.5. Such approval must be limited to the
use of the appropriate science and technology and must not otherwise
limit agency discretion to test for any drug tested under Section
3.2(a).
Section 3.3 May a specimen be tested for biomarkers other than those in
the biomarker testing panel?
An HHS-certified laboratory or (for urine) IITF must obtain
authorization from the Department before implementing testing for a
biomarker for federal agency drug testing specimens. The Department may
add the biomarker (i.e., initial and confirmatory test analytes and
cutoffs) to the subsequent biomarker testing panel published in the
Federal Register.
A federal agency covered by these Guidelines may test their
workplace specimens for any HHS-authorized biomarker routinely (see
Section 3.1.d) or on a case-by-case basis (see Section 3.6).
Section 3.4 May any of the specimens be used for other purposes?
(a) Specimens collected pursuant to Executive Order 12564, Public
Law 100-71, and these Guidelines must only be tested for drugs and to
determine their validity in accordance with subpart C of these
Guidelines. Use of specimens by donors, their designees, or any other
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing)
is prohibited unless authorized in accordance with applicable federal
law.
(b) These Guidelines are not intended to prohibit a federal agency
specifically authorized by law to test a specimen for additional drugs
in its workplace drug testing program.
Section 3.5 What are the drug and biomarker test analytes and cutoffs
for urine?
The Secretary publishes the drug and biomarker test analytes and
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing
panel'') for initial and confirmatory drug and biomarkers in the
Federal Register.
(a) The drug testing panel includes drugs authorized for testing in
federal workplace drug testing programs, with the required test
analytes and cutoffs.
(b) The biomarker testing panel includes biomarkers authorized for
testing in federal workplace drug testing programs, with the required
test analytes and cutoffs.
(c) HHS-certified IITFs, HHS-certified laboratories, and Medical
Review Officers must use the nomenclature (i.e., analyte names and
abbreviations) published in the Federal Register with the drug and
biomarker testing panels to report federal workplace drug test results.
Section 3.6 May an HHS-certified laboratory perform additional drug
and/or specimen validity tests on a specimen at the request of the
Medical Review Officer (MRO)?
An HHS-certified laboratory is authorized to perform additional
drug and/or specimen validity tests on a case-by-case basis as
necessary to provide information that the MRO would use to report a
verified drug test result (e.g., tetrahydrocannabivarin, specimen
validity tests). An HHS-certified laboratory is not authorized to
routinely perform additional drug and/or specimen validity tests at the
request of an MRO without prior authorization from the Secretary or
designated HHS representative, with the exception of the determination
of d,l stereoisomers of amphetamine and methamphetamine. All tests must
meet appropriate validation and quality control requirements in
accordance with these Guidelines.
Section 3.7 What criteria are used to report a urine specimen as
adulterated?
An HHS-certified laboratory reports a primary (A) specimen as
adulterated when:
(a) The pH is less than 4 or equal to or greater than 11 using
either a pH meter or a colorimetric pH test for the initial test on the
first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(b) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant
colorimetric test for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion chromatography, capillary electrophoresis) on the second aliquot;
(c) The presence of chromium (VI) is verified using either a
general oxidant colorimetric test (with an equal to or greater than 50
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric
test (chromium (VI) concentration equal to or greater than 50 mcg/mL)
for the initial test on the first aliquot and a different confirmatory
test (e.g., multi-wavelength spectrophotometry, ion chromatography,
atomic absorption spectrophotometry, capillary electrophoresis,
inductively coupled plasma-mass spectrometry) with the chromium (VI)
concentration equal to or greater than the LOQ of the confirmatory test
on the second aliquot;
(d) The presence of a halogen (e.g., chlorine from bleach, iodine,
fluoride) is verified using either a general oxidant colorimetric test
(with an equal to or great than 200 mcg/mL nitrite-equivalent cutoff or
an equal to or great than 50 mcg/mL chromium (VI)-equivalent cutoff) or
halogen colorimetric test (halogen concentration equal to or greater
than the LOQ) for the initial test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, inductively coupled plasma-mass spectrometry) with a
specific halogen concentration equal to or greater than the LOQ of the
confirmatory test on the second aliquot;
[[Page 68416]]
(e) The presence of glutaraldehyde is verified using either an
aldehyde test (aldehyde present) or the characteristic immunoassay
response on one or more drug immunoassay tests for the initial test on
the first aliquot and a different confirmatory test (e.g., GC/MS) for
the confirmatory test with the glutaraldehyde concentration equal to or
greater than the LOQ of the analysis on the second aliquot;
(f) The presence of pyridine (pyridinium chlorochromate) is
verified using either a general oxidant colorimetric test (with an
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or
a chromium (VI) colorimetric test (chromium (VI) concentration equal to
or greater than 50 mcg/mL) for the initial test on the first aliquot
and a different confirmatory test (e.g., GC/MS) for the confirmatory
test with the pyridine concentration equal to or greater than the LOQ
of the analysis on the second aliquot;
(g) The presence of a surfactant is verified by using a surfactant
colorimetric test with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the
first aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
(h) The presence of any other adulterant not specified in
paragraphs (b) through (g) of this section is verified using an initial
test on the first aliquot and a different confirmatory test on the
second aliquot.
Section 3.8 What criteria are used to report a urine specimen as
substituted?
An HHS-certified laboratory reports a primary (A) urine specimen as
substituted when:
(a) The creatinine concentration is less than 2 mg/dL on both the
initial and confirmatory creatinine tests on two separate aliquots
(i.e., the same colorimetric test may be used to test both aliquots)
and the specific gravity is less than or equal to 1.0010 or equal to or
greater than 1.0200 on both the initial and confirmatory specific
gravity tests on two separate aliquots (i.e., a refractometer is used
to test both aliquots), or
(b) A biomarker is not detected or is present at a concentration
inconsistent with that established for human urine for both the initial
(first) test and the confirmatory (second) test on two separate
aliquots (i.e., using the HHS-authorized test analytes and cutoffs).
Section 3.9 What criteria are used to report a urine specimen as
dilute?
A dilute result may be reported only in conjunction with the
positive or negative drug test results for a specimen.
(a) An HHS-certified laboratory or an HHS-certified IITF reports a
primary (A) specimen as dilute when the creatinine concentration is
greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is
equal to or greater than 1.002 but less than 1.003 on a single aliquot.
(b) In addition, an HHS-certified laboratory reports a primary (A)
specimen as dilute when the creatinine concentration is equal to or
greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is
greater than 1.0010 but less than 1.0030.
Section 3.10 What criteria are used to report an invalid result for a
urine specimen?
An HHS-certified laboratory reports a primary (A) specimen as an
invalid result when:
(a) Inconsistent creatinine concentration and specific gravity
results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the
specific gravity is greater than 1.0010 but less than 1.0200 on the
initial and/or confirmatory specific gravity test, the specific gravity
is less than or equal to 1.0010 on both the initial and confirmatory
specific gravity tests and the creatinine concentration is equal to or
greater than 2 mg/dL on either or both the initial or confirmatory
creatinine tests);
(b) The pH is equal to or greater than 4 and less than 4.5 or equal
to or greater than 9.5 and less than 11 using either a colorimetric pH
test or pH meter for the initial test and a pH meter for the
confirmatory test on two separate aliquots;
(c) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test or equal to or greater than the
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric
test for both the initial (first) test and the second test or using
either initial test and the nitrite concentration is equal to or
greater than 200 mcg/mL but less than 500 mcg/mL for a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, capillary electrophoresis) on two separate aliquots;
(d) The possible presence of chromium (VI) is determined using the
same chromium (VI) colorimetric test with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) for both the initial (first) test and the
second test on two separate aliquots;
(e) The possible presence of a halogen (e.g., chlorine from bleach,
iodine, fluoride) is determined using the same halogen colorimetric
test with a cutoff equal to or greater than the LOQ for both the
initial (first) test and the second test on two separate aliquots or
relying on the odor of the specimen as the initial test;
(f) The possible presence of glutaraldehyde is determined by using
the same aldehyde test (aldehyde present) or characteristic immunoassay
response on one or more drug immunoassay tests for both the initial
(first) test and the second test on two separate aliquots;
(g) The possible presence of an oxidizing adulterant is determined
by using the same general oxidant colorimetric test (with an equal to
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or
greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen
concentration is equal to or greater than the LOQ) for both the initial
(first) test and the second test on two separate aliquots;
(h) The possible presence of a surfactant is determined by using
the same surfactant colorimetric test with an equal to greater than 100
mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial
(first) test and the second test on two separate aliquots or a foam/
shake test for the initial test;
(i) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(j) Interference with the confirmatory drug test occurs on two
separate aliquots of the specimen and the laboratory is unable to
identify the interfering substance;
(k) The physical appearance of the specimen (e.g., viscosity) is
such that testing the specimen may damage the laboratory's instruments;
(l) The specimen has been tested and the appearances of the primary
(A) and the split (B) specimens (e.g., color) are clearly different; or
(m) A specimen validity test (i.e., other than the tests listed
above) on two separate aliquots of the specimen indicates that the
specimen is not valid for testing.
[[Page 68417]]
Subpart D--Collectors
Section 4.1 Who may collect a urine specimen?
(a) A collector who has been trained to collect urine specimens in
accordance with these Guidelines.
(b) The immediate supervisor of a federal employee may only collect
that employee's specimen when no other collector is available. The
supervisor must be a trained collector.
(c) The hiring official of an applicant may only collect that
applicant's specimen when no other collector is available. The hiring
official must be a trained collector.
Section 4.2 Who may not collect a specimen?
(a) A federal agency employee who is in a testing designated
position and subject to the federal agency drug testing rules must not
be a collector for co-workers in the same testing pool or who work with
that employee on a daily basis.
(b) A donor must not collect their own drug testing specimen.
(c) An employee working for an HHS-certified laboratory or IITF
must not act as a collector if the employee could link the identity of
the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not
be related to the donor (e.g., spouse, ex-spouse, relative) or be a
personal friend of the donor (e.g., fianc[eacute]e).
Section 4.3 What are the requirements to be a collector?
(a) An individual may serve as a collector if they fulfill the
following conditions:
(1) Is knowledgeable about the collection procedure described in
these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal
agency's drug-free workplace program and additional information
provided by the Secretary relating to the collection procedure
described in these Guidelines;
(3) Is trained and qualified to collect a urine specimen. Training
must include the following:
(i) All steps necessary to complete a urine collection;
(ii) Completion and distribution of the federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in
collections; and
(v) The collector's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of the donor, ensuring the
security of the specimen, and avoiding conduct or statements that could
be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five
consecutive error-free mock collections.
(i) The five mock collections must include one uneventful
collection scenario, one insufficient specimen quantity scenario, one
temperature out of range scenario, one scenario in which the donor
refuses to sign the federal CCF, and one scenario in which the donor
refuses to initial the specimen bottle tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate
the individual being trained, in person or by a means that provides
real-time observation and interaction between the trainer and the
trainee, and the trainer must attest in writing that the mock
collections are error-free.
(b) A trained collector must complete refresher training at least
every five years that includes the requirements in Section 4.3(a).
(c) The collector must maintain the documentation of their training
and provide that documentation to a federal agency when requested.
(d) An individual may not collect specimens for a federal agency
until the individual's training as a collector has been properly
documented.
Section 4.4 What are the requirements to be an observer for a direct
observed collection?
(a) An individual may serve as an observer for a direct observed
collection when the individual has satisfied the requirements:
(1) Is knowledgeable about the direct observed collection procedure
described in Section 8.9;
(2) Is knowledgeable about any guidance provided by the federal
agency's drug-free workplace program or additional information provided
by the Secretary relating to the direct observed collection procedure
described in these Guidelines;
(3) Has received training on the following subjects:
(i) All steps necessary to perform a direct observed collection;
and
(ii) The observer's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of individuals being
tested, ensuring that the observation is done in a professional manner
that minimizes the discomfort to the observed donor, ensuring the
security of the specimen by maintaining visual contact with the
collection container until it is delivered to the collector, and
avoiding conduct or statements that could be viewed as offensive or
inappropriate.
(b) The sex of the observer must be the same as the donor's sex.
The observer selection process is described in Section 8.10(b).
(c) The observer is not required to be a trained collector.
Section 4.5 What are the requirements to be a trainer for collectors?
(a) Individuals are considered qualified trainers for collectors
and may train others to collect urine specimens when they have
completed the following:
(1) Qualified as a trained collector and regularly conducted urine
drug test collections for a period of at least one year; or
(2) Completed a ``train the trainer'' course given by an
organization (e.g., manufacturer, private entity, contractor, federal
agency).
(b) A qualified trainer for collectors must complete refresher
training at least every five years in accordance with the collector
requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the
documentation of the trainer's training and provide that documentation
to a Federal agency when requested.
Section 4.6 What must a federal agency do before a collector is
permitted to collect a specimen?
A federal agency must ensure the following:
(a) The collector has satisfied the requirements described in
Section 4.3;
(b) The collector, who may be self-employed, or an organization
(e.g., third party administrator that provides a collection service,
collector training company, federal agency that employs its own
collectors) maintains a copy of the training record(s); and
(c) The collector has been provided the name and telephone number
of the federal agency representative.
Subpart E--Collection Sites
Section 5.1 Where can a collection for a drug test take place?
(a) A collection site may be a permanent or temporary facility
located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not
accessible and there is an immediate requirement to collect a urine
specimen (e.g., an accident investigation), a public restroom may be
used for the collection, using the procedures for a monitored
collection described in Section 8.12.
(c) In the event that an agency-designated collection site is not
[[Page 68418]]
accessible to a donor with a disability, another site may be used for
the collection, using the procedures for a monitored collection
described in Section 8.12.
Section 5.2 What are the requirements for a collection site?
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as
described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the
donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the
specimen is transferred to an HHS-certified laboratory or IITF;
(d) A restricted access area where only authorized personnel may be
present during the collection;
(e) A restricted access area for the storage of collection
supplies;
(f) A restricted access area for the secure storage of records; and
(g) The ability to restrict the donor access to potential diluents
in accordance with Section 8.2.
Section 5.3 Where must collection site records be stored?
Collection site records must be stored at a secure site designated
by the collector or the collector's employer.
Section 5.4 How long must collection site records be stored?
Collection site records (e.g., collector copies of the OMB-approved
federal CCF) must be stored securely for a minimum of 2 years. The
collection site may convert hardcopy records to electronic records for
storage and discard the hardcopy records after 6 months.
Section 5.5 How does the collector ensure the security and integrity of
a specimen at the collection site?
(a) A collector must do the following to maintain the security and
integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area
during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and
after collection;
(4) Ensure that only the collector and the donor are allowed to
handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and
documented throughout the entire collection, storage, and transport
procedures;
(6) Ensure that the federal CCF is completed and distributed as
required; and
(7) Ensure that specimens transported to an HHS-certified
laboratory or IITF are sealed and placed in transport containers
designed to minimize the possibility of damage during shipment (e.g.,
specimen boxes, padded mailers, or other suitable shipping container),
and those containers are securely sealed to eliminate the possibility
of undetected tampering;
(b) Couriers, express carriers, and postal service personnel are
not required to document chain of custody since specimens are sealed in
packages that would indicate tampering during transit to the HHS-
certified laboratory or IITF.
Section 5.6 What are the privacy requirements when collecting a urine
specimen?
Collections must be performed at a site that provides reasonable
privacy (as described in Section 8.1).
Subpart F--Federal Drug Testing Custody and Control Form
Section 6.1 What federal form is used to document custody and control?
The OMB-approved federal CCF must be used to document custody and
control of each specimen at the collection site.
Section 6.2 What happens if the correct OMB-approved federal CCF is not
available or is not used?
(a) The use of a non-federal CCF or an expired federal CCF is not,
by itself, a reason for the HHS-certified laboratory or IITF to
automatically reject the specimen for testing or for the MRO to cancel
the test.
(b) If the collector does not use the correct OMB-approved federal
CCF, the collector must document that it is a federal agency specimen
collection and provide the reason that the incorrect form was used.
Based on the information provided by the collector, the HHS-certified
laboratory or IITF must handle and test the specimen as a federal
agency specimen.
(c) If the HHS-certified laboratory, HHS-certified IITF, or MRO
discovers that the collector used an incorrect form, the laboratory,
IITF, or MRO must obtain a memorandum for the record from the collector
describing the reason the incorrect form was used. If a memorandum for
the record cannot be obtained, the laboratory or IITF reports a
rejected for testing result to the MRO and the MRO cancels the test.
The HHS-certified laboratory or IITF must wait at least 5 business days
while attempting to obtain the memorandum before reporting a rejected
for testing result to the MRO.
Subpart G--Urine Specimen Collection Containers and Bottles
Section 7.1 What is used to collect a urine specimen?
A single-use collection container with a means (i.e., thermometer)
to measure urine temperature and two specimen bottles must be used.
Section 7.2 What are the requirements for a urine collection container
and specimen bottles?
(a) The collection container, the thermometer, and the specimen
bottles must not substantially affect the composition of drugs and/or
metabolites in the urine specimen.
(b) The two specimen bottles must be sealable and non-leaking, and
must maintain the integrity of the specimen during storage and
transport so that the specimen contained therein can be tested in an
HHS-certified laboratory or IITF for the presence of drugs or their
metabolites.
(c) The two specimen bottles must be sufficiently transparent
(e.g., translucent) to enable an objective assessment of specimen
appearance and identification of abnormal physical characteristics
without opening the bottle.
Section 7.3 What are the minimum performance requirements for a urine
collection container and specimen bottles?
(a) The collection container must be capable of holding at least 55
mL and have a volume marking clearly noting a level of 45 mL.
(b) One of the two specimen bottles must be capable of holding at
least 35 mL and the other at least 20 mL, and each must have a volume
marking clearly noting the appropriate level (30 mL for the primary
specimen and 15 mL for the split specimen).
(c) The thermometer may be affixed to or built into the collection
container and must provide graduated temperature readings from 32-38
[deg]C/90-100 [deg]F. Alternatively, the collector may use another
technology to measure specimen temperature (e.g., thermal radiation
scanning), providing the thermometer does not come into contact with
the specimen.
[[Page 68419]]
Subpart H--Urine Specimen Collection Procedure
Section 8.1 What privacy must the donor be given when providing a urine
specimen?
The following privacy requirements apply when a donor is providing
a urine specimen:
(a) Only authorized personnel and the donor may be present in the
restricted access area where the collection takes place.
(b) The collector is not required to be the same sex as the donor.
The sex of the observer for purposes of a direct observed collection
(i.e., as described in Section 8.10) must be the same as the donor's
sex. The sex of the monitor for a monitored collection (i.e., as
described in Section 8.12) must be the same as the donor's sex, unless
the monitor is a medical professional (e.g., nurse, doctor, physician's
assistant, technologist, or technician licensed or certified to
practice in the jurisdiction in which the collection takes place).
(c) The collector must give the donor visual privacy while
providing the specimen. The donor is allowed to provide a urine
specimen in an enclosed stall within a multi-stall restroom or in a
single person restroom during a monitored collection.
Section 8.2 What must the collector ensure at the collection site
before starting a urine specimen collection?
The collector must deter the dilution or substitution of a specimen
at the collection site by:
(a) Placing a toilet bluing agent in a toilet bowl or toilet tank,
so the reservoir of water in the toilet bowl always remains blue. If no
bluing agent is available or if the toilet has an automatic flushing
system, the collector shall turn the water supply off to the toilet and
flush the toilet to remove the water in the toilet when possible.
(b) Secure other sources of water (e.g., shower or sink) in the
enclosure where urination occurs. If the enclosure has a source of
water that cannot be disabled or secured, a monitored collection must
be conducted in accordance with Section 8.11.
Section 8.3 What are the preliminary steps in the urine specimen
collection procedure?
The collector must take the following steps before beginning a
urine specimen collection:
(a) If a donor fails to arrive at the collection site at the
assigned time, the collector must follow the federal agency policy or
contact the federal agency representative to obtain guidance on action
to be taken.
(b) When the donor arrives at the collection site, the collector
should begin the collection procedure without undue delay. For example,
the collection should not be delayed because the donor states that they
are unable to urinate or an authorized employer or employer
representative is late in arriving.
(c) The collector requests the donor to present photo
identification (e.g., driver's license; employee badge issued by the
employer; an alternative photo identification issued by a federal,
state, or local government agency). If the donor does not have proper
photo identification, the collector shall contact the supervisor of the
donor or the federal agency representative who can positively identify
the donor. If the donor's identity cannot be established, the collector
must not proceed with the collection.
(d) The collector must provide identification (e.g., employee
badge, employee list) if requested by the donor.
(e) The collector explains the basic collection procedure to the
donor.
(f) The collector provides the instructions for completing the
federal CCF for the donor's review, and informs the donor that the
instructions are available upon request.
(g) The collector answers any reasonable and appropriate questions
the donor may have regarding the collection procedure.
(h) The collector asks the donor to remove any unnecessary outer
garments (e.g., coat, jacket) that might conceal items or substances
that could be used to adulterate or substitute the urine specimen. The
collector must ensure that all personal belongings (e.g., purse or
briefcase) remain with the outer garments. The donor may retain the
donor's wallet. The donor is not required to remove any items worn for
faith-based or disability reasons.
(i) The collector asks the donor to empty the donor's pockets and
display the contents to ensure no items are present that could be used
to adulterate or substitute the specimen.
(1) If no items are present that can be used to adulterate,
substitute, or dilute the specimen, the collector instructs the donor
to return the items to their pockets and continues the collection
procedure.
(2) If an item is present whose purpose is to adulterate,
substitute, or dilute the specimen (e.g., a commercial drug culture
product or other substance for which the donor has no reasonable
explanation), this is considered a refusal to test. The collector must
stop the collection and report the refusal to test as described in
Section 8.13.
(3) If an item that could be used to adulterate, substitute, or
dilute the specimen (e.g., common personal care products such as
eyedrops, mouthwash, or hand sanitizer) appears to have been
inadvertently brought to the collection site, the collector must secure
the item and continue with the normal collection procedure.
(4) If the donor refuses to show the collector the items in their
pockets, this is considered a refusal to test. The collector must stop
the collection and report the refusal to test as described in Section
8.13.
(j) The collector shall instruct the donor to wash and dry the
donor's hands prior to urination. After washing the donor's hands, the
donor must remain in the presence of the collector and must not have
access to any water fountain, faucet, soap dispenser, cleaning agent,
or any other materials which could be used to adulterate or substitute
the specimen.
(k) If the donor refuses to wash their hands when instructed by the
collector, this is considered a ``refusal to test.'' The collector must
stop the collection and report the refusal to test as described in
Section 8.13.
Section 8.4 What steps does the collector take in the collection
procedure before the donor provides a urine specimen?
(a) The collector will provide or the donor may select a specimen
collection container that is clean, unused, wrapped/sealed in original
packaging and compliant with subpart G of these Guidelines. The
specimen collection container package will be opened in view of the
donor.
(b) The collector instructs the donor to provide the specimen in
the privacy of a stall or otherwise partitioned area that allows for
individual privacy. The collector directs the donor to provide a
specimen of at least 45 mL, to not flush the toilet, and to return with
the specimen as soon as the donor has completed the void.
(1) Except in the case of a direct observed collection (i.e., as
described in Section 8.10) or a monitored collection (i.e., as
described in Section 8.12), neither the collector nor anyone else may
go into the room with the donor.
(2) The collector may set a reasonable time limit for specimen
collection.
(c) The collector notes any unusual behavior or appearance of the
donor on the federal CCF. If the collector detects any conduct that
clearly indicates an attempt to tamper with a specimen (e.g.,
substitute urine in plain view or an
[[Page 68420]]
attempt to bring into the collection site an adulterant or urine
substitute), the collector must report a refusal to test in accordance
with Section 8.13.
Section 8.5 What steps does the collector take during and after the
urine specimen collection procedure?
Integrity and Identity of the Specimen. The collector must take the
following steps during and after the donor provides the urine specimen:
(a) The collector must inform the donor that, once the collection
procedure has begun, the donor must remain at the collection site
(i.e., in an area designated by the collector) until the collection is
complete and that failure to follow these instructions will be reported
as a refusal to test. This includes the wait period (i.e., up to 3
hours) if needed to provide a sufficient specimen as described in
Sections 8.5(f)(2) and 8.6.
(b) After providing the specimen, the donor gives the specimen
collection container to the collector. Both the donor and the collector
must keep the specimen container in view at all times until the
collector seals the specimen bottles as described in Section 8.8.
(c) After the donor has given the specimen to the collector,
whenever practical, the donor shall be allowed to wash the donor's
hands and the donor may flush the toilet.
(d) The collector must measure the temperature of the specimen
within 4 minutes of receiving the specimen from the donor. The
collector records on the Federal CCF whether or not the temperature is
in the acceptable range of 32[deg]-38 [deg]C/90[deg]-100 [deg]F.
(1) The temperature measuring device must accurately reflect the
temperature of the specimen and not contaminate the specimen.
(2) If the temperature of the specimen is outside the range of
32[deg]-38 [deg]C/90[deg]-100 [deg]F, that is a reason to believe that
the donor may have adulterated or substituted the specimen. Another
specimen must be collected under direct observation in accordance with
Section 8.9. The collector must forward both specimens (i.e., from the
first and second collections) to an HHS-certified laboratory for
testing and record a comment on the federal CCF for each specimen.
(e) The collector must inspect the specimen to determine if there
is any sign indicating that the specimen may not be a valid urine
specimen (e.g., unusual color, presence of foreign objects or material,
unusual odor).
(1) The collector notes any unusual finding on the federal CCF. A
specimen suspected of not being a valid urine specimen must be
forwarded to an HHS-certified laboratory for testing.
(2) When there is any reason to believe that a donor may have
adulterated or substituted the specimen, another specimen must be
obtained as soon as possible under direct observation in accordance
with Section 8.10. The collector must forward both specimens (i.e.,
from the first and second collections) to an HHS-certified laboratory
for testing and record a comment on the federal CCF for each specimen.
(f) The collector must determine the volume of urine in the
specimen container. The collector must never combine urine collected
from separate voids to create a specimen.
(1) If the volume is at least 45 mL, the collector will proceed
with steps described in Section 8.8.
(2) If the volume is less than 45 mL, the collector discards the
specimen and immediately collects a second specimen using the same
procedures as for the first specimen (including steps in Section 8.5(c)
and (d)).
(i) The collector may give the donor a reasonable amount of liquid
to drink for this purpose (e.g., an 8 ounce glass of water every 30
minutes, but not to exceed a maximum of 40 ounces over a period of 3
hours or until the donor has provided a sufficient urine specimen).
However, the donor is not required to drink any fluids during this
waiting time.
(ii) If the donor provides a sufficient urine specimen (i.e., at
least 45 mL), the collector proceeds with steps described in Section
8.8.
(iii) If the donor has not provided a sufficient specimen (i.e., at
least 45 mL) within three hours of the first unsuccessful attempt to
provide the specimen, the collector records the reason for not
collecting a urine specimen on the federal CCF, notifies the federal
agency's designated representative for authorization to collect an
alternate specimen, and sends the appropriate copies of the federal CCF
to the MRO and to the federal agency's designated representative. The
federal agency may choose to provide the collection site with a
standard protocol to follow in lieu of requiring the collector to
notify the agency's designated representative for authorization in each
case. If an alternate specimen is authorized, the collector may begin
the collection procedure for the alternate specimen (see Section 8.7)
in accordance with the Mandatory Guidelines for Federal Workplace Drug
Testing Programs using the alternate specimen.
(g) If the donor fails to remain present through the completion of
the collection, declines to have a direct observed collection as
required in Section 8.5(d)(2) or (e)(2), refuses to provide a second
specimen as required in Section 8.5(f)(2), or refuses to provide an
alternate specimen as authorized in Section 8.5(f)(2)(iii), the
collector stops the collection and reports the refusal to test in
accordance with Section 8.13.
Section 8.6 What procedure is used when the donor states that they are
unable to provide a urine specimen?
(a) If the donor states that they are unable to provide a urine
specimen during the collection process, the collector requests that the
donor enter the restroom (stall) and attempt to provide a urine
specimen.
(b) The donor demonstrates their inability to provide a specimen
when he or she comes out of the stall with an empty collection
container.
(1) If the donor states that they could provide a specimen after
drinking some fluids, the collector gives the donor a reasonable amount
of liquid to drink for this purpose (e.g., an 8 ounce glass of water
every 30 minutes, but not to exceed a maximum of 40 ounces over a
period of 3 hours or until the donor has provided a sufficient urine
specimen). If the donor simply needs more time before attempting to
provide a urine specimen, the donor may choose not to drink any fluids
during the 3 hour wait time.
(2) If the donor states that they are unable to provide a urine
specimen, the collector records the reason for not collecting a urine
specimen on the federal CCF, notifies the federal agency's designated
representative for authorization to collect an alternate specimen, and
sends the appropriate copies of the federal CCF to the MRO and to the
federal agency's designated representative. The federal agency may
choose to provide the collection site with a standard protocol to
follow in lieu of requiring the collector to notify the agency's
designated representative for authorization in each case. If an
alternate specimen is authorized, the collector begins the collection
procedure for the alternate specimen (see Section 8.7) in accordance
with the Mandatory Guidelines for Federal Workplace Drug Testing
Programs using the alternate specimen.
Section 8.7 If the donor is unable to provide a urine specimen, may
another specimen type be collected for testing?
Yes, if the alternate specimen type is authorized by Mandatory
Guidelines for Federal Workplace Drug Testing
[[Page 68421]]
Programs and specifically authorized by the federal agency.
Section 8.8 How does the collector prepare the urine specimens?
(a) All federal agency collections are to be split specimen
collections.
(b) The collector, in the presence of the donor, pours the urine
from the collection container into two specimen bottles to be labeled
``A'' and ``B''. The collector pours at least 30 mL of urine into
Bottle A and at least 15 mL into Bottle B, and caps each bottle.
(c) In the presence of the donor, the collector places a tamper-
evident label/seal from the federal CCF over the cap of each specimen
bottle in a manner to ensure that any attempt to access the specimen
prior to receipt by the laboratory will be detected. The collector
records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident
labels/seals on each specimen bottle. If the donor refuses to initial
the labels/seals, the collector notes the refusal on the federal CCF
and continues with the collection process.
(e) The collector must ensure that all required information is
included on the federal CCF.
(f) The collector asks the donor to read and sign a statement on
the federal CCF certifying that the specimens identified were collected
from the donor. If the donor refuses to sign the certification
statement, the collector notes the refusal on the federal CCF and
continues with the collection process.
(g) The collector signs and prints their name on the federal CCF,
completes the federal CCF, and distributes the copies of the federal
CCF as required.
(h) The collector seals the specimens (A and B) in a package and,
within 24 hours or during the next business day, sends them to the HHS-
certified laboratory or IITF that will be testing the primary (A)
specimen.
(i) If the specimen and federal CCF are not immediately transported
to an HHS-certified laboratory or IITF, they must remain under direct
control of the collector or be appropriately secured under proper
specimen storage conditions until transported.
(j) The collector must discard any urine left over in the
collection container after both specimen bottles have been
appropriately filled and sealed. There is one exception to this
requirement: the collector may use excess urine to conduct clinical
tests (e.g., protein, glucose) if the collection was conducted in
conjunction with a physical examination required by federal agency
regulation. Neither the collector nor anyone else may conduct further
testing (such as specimen validity testing) on the excess urine.
Section 8.9 When is a direct observed collection conducted?
A direct observed collection procedure must be conducted when:
(a) The agency has authorized a direct observed collection because:
(1) The donor's previous drug test result was reported by an MRO as
positive, adulterated, or substituted; or
(2) The HHS-certified laboratory reports to the MRO that a specimen
is invalid, and the MRO reported to the agency that there was not a
legitimate explanation for the result; or
(3) The MRO reported to the agency that the primary (A) specimen
was positive, adulterated, or substituted but the test was cancelled
because the split (B) specimen could not be tested or the split
specimen failed to reconfirm the primary specimen result; or
(b) At the collection site, an immediate collection of a second
urine specimen is required because:
(1) The temperature of the specimen collected during a routine
collection is outside the acceptable temperature range; or
(2) The collector suspects that the donor has tampered with the
specimen during a routine collection (e.g., abnormal physical
characteristic such as unusual color and/or odor, and/or excessive
foaming when shaken).
(c) The collector must contact a collection site supervisor to
review and concur in advance with any decision by the collector to
obtain a specimen under direct observation.
(d) If the donor declines to have a direct observed collection, the
collector reports a refusal to test (i.e., as described in Section
8.13).
Section 8.10 How is a direct observed collection conducted?
(a) A direct observed collection procedure is the same as that for
a routine collection, except an observer watches the donor urinate into
the collection container. The observer's sex must be the same as the
donor's sex, with no exception to this requirement.
(b) Before an observer is selected, the collector informs the donor
that the sex of the observer will match the donor's sex. The collector
then selects the observer to conduct the observation.
(i) The collector asks the donor to identify the donor's sex on the
federal CCF and initial it.
(ii) The donor will then be provided an observer whose sex matches
the donor's sex.
(iii) The collector documents the observer's name and sex on the
federal CCF.
(c) If there is no trained collector available of the same sex as
the donor, the collector or collection site supervisor shall select an
observer of the same sex as the donor who has been trained in direct
observed specimen collection as described in Section 4.4. The observer
may be an individual that is not a trained collector.
(d) At the point in a routine collection where the donor enters the
restroom with the collection container, a direct observed collection
includes the following additional steps:
(1) The observer enters the restroom with the donor;
(2) The observer must directly watch the urine go from the donor's
body into the collection container (the use of mirrors or video cameras
is not permitted);
(3) The observer must not touch or handle the collection container
unless the observer is also serving as the collector;
(4) After the donor has completed urinating into the collection
container:
(i) If the same person serves as the observer and collector, that
person may receive the collection container from the donor while they
are both in the restroom;
(ii) If the observer is not serving as the collector, the donor and
observer leave the restroom and the donor hands the collection
container directly to the collector. The observer must maintain visual
contact of the collection container until the donor hands the container
to the collector.
(5) The collector checks the box for an observed collection on the
federal CCF and writes the name of the observer and the reason for an
observed collection on the federal CCF; and
(6) The collector then continues with the routine collection
procedure in Section 8.3.
Section 8.11 When is a monitored collection conducted?
(a) In the event that an agency-designated collection site is not
available and there is an immediate requirement to collect a specimen
(e.g., an accident investigation), a public restroom may be used for
the collection, using the procedures for a monitored collection
described in Section 8.12.
(b) If the enclosure used by the donor to provide a specimen has a
source of water that cannot be disabled or secured, a monitored
collection must be conducted.
(c) If the donor declines to permit a collection to be monitored
when
[[Page 68422]]
required, the collector reports a refusal to test (i.e., as described
in Section 8.13).
Section 8.12 How is a monitored collection conducted?
A monitored collection is the same as that for a routine
collection, except that a monitor accompanies the donor into the
restroom to check for signs that the donor may be tampering with the
specimen. The monitor remains in the restroom, but outside the stall,
while the donor is providing the specimen. A person of the same sex as
the donor shall serve as the monitor, unless the monitor is a medical
professional (e.g., nurse, doctor, physician's assistant, technologist,
or technician licensed or certified to practice in the jurisdiction in
which the collection takes place). The same procedures used for
selecting an observer of the appropriate sex in Section 8.10(b) must be
used to select the monitor for the purposes of Section 8.12, unless the
monitor is a medical professional as described above. The monitor may
be an individual other than the collector and need not be a qualified
collector.
(a) The collector secures the restroom being used for the monitored
collection so that no one except the donor and the monitor can enter
the restroom until after the collection has been completed.
(b) The monitor enters the restroom with the donor.
(c) The monitor must not watch the donor urinate into the
collection container. If the monitor hears sounds or makes other
observations indicating an attempt by the donor to tamper with a
specimen, there must be an additional collection under direct
observation in accordance with Section 8.9.
(d) The monitor must not touch or handle the collection container
unless the monitor is also the collector.
(e) After the donor has completed urinating into the collection
container:
(1) If the same person serves as the monitor and collector, that
person may receive the collection container from the donor while they
are both in the restroom;
(2) If the monitor is not serving as the collector, the donor and
monitor leave the restroom and the donor hands the collection container
directly to the collector. The monitor must ensure that the donor takes
the collection container directly to the collector as soon as the donor
has exited the enclosure.
(f) If the monitor is not serving as the collector, the collector
writes the name of the monitor on the federal CCF.
(g) The collector then continues with the routine collection
procedure in Section 8.3.
Section 8.13 How does the collector report a donor's refusal to test?
If there is a refusal to test as defined in Section 1.7, the
collector stops the collection, discards any urine collected and
reports the refusal to test by:
(a) Notifying the federal agency by means (e.g., telephone, email,
or secure fax) that ensures that the notification is immediately
received,
(b) Documenting the refusal to test including the reason on the
federal CCF, and
(c) Sending all copies of the federal CCF to the federal agency's
designated representative.
Section 8.14 What are a federal agency's responsibilities for a
collection site?
(a) A federal agency must ensure that collectors and collection
sites satisfy all requirements in subparts D, E, F, G, and H of these
Guidelines.
(b) A federal agency (or only one Federal agency when several
agencies are using the same collection site) must inspect 5 percent or
up to a maximum of 50 collection sites each year, selected randomly
from those sites used to collect agency specimens (e.g., virtual,
onsite, or self-evaluation).
(c) A federal agency must investigate reported collection site
deficiencies (e.g., specimens reported ``rejected for testing'' by an
HHS-certified laboratory or IITF) and take appropriate action which may
include a collection site self-assessment (i.e., using the Collection
Site Checklist for the Collection of Urine Specimens for Federal agency
Workplace Drug Testing Programs) or an inspection of the collection
site. The inspections of these additional collection sites may be
included in the 5 percent or maximum of 50 collection sites inspected
annually.
Subpart I--HHS Certification of Laboratories and IITFs
Section 9.1 Who has the authority to certify laboratories and IITFs to
test urine specimens for federal agencies?
(a) The Secretary has broad discretion to take appropriate action
to ensure the full reliability and accuracy of drug testing and
reporting, to resolve problems related to drug testing, and to enforce
all standards set forth in these Guidelines. The Secretary has the
authority to issue directives to any HHS-certified laboratory or IITF,
including suspending the use of certain analytical procedures when
necessary to protect the integrity of the testing process; ordering any
HHS-certified laboratory or IITF to undertake corrective actions to
respond to material deficiencies identified by an inspection or through
performance testing; ordering any HHS-certified laboratory or IITF to
send specimens or specimen aliquots to another HHS-certified laboratory
for retesting when necessary to ensure the accuracy of testing under
these Guidelines; ordering the review of results for specimens tested
under the Guidelines for private sector clients to the extent necessary
to ensure the full reliability of drug testing for federal agencies;
and ordering any other action necessary to address deficiencies in drug
testing, analysis, specimen collection, chain of custody, reporting of
results, or any other aspect of the certification program.
(b) A laboratory or IITF is prohibited from stating or implying
that it is certified by HHS under these Guidelines to test urine
specimens for federal agencies unless it holds such certification.
Section 9.2 What is the process for a laboratory or IITF to become HHS-
certified?
(a) A laboratory or IITF seeking HHS certification must:
(1) Submit a completed OMB-approved application form (i.e., the
applicant laboratory or IITF provides detailed information on both the
administrative and analytical procedures to be used for federally
regulated specimens);
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets
of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before
testing specimens for federal agencies.
Section 9.3 What is the process for a laboratory or IITF to maintain
HHS certification?
(a) To maintain HHS certification, a laboratory or IITF must:
(1) Successfully participate in both the maintenance PT and
inspection programs (i.e., successfully test the required quarterly
sets of maintenance PT samples, undergo an inspection 3 months after
being certified, and undergo maintenance inspections at a minimum of
every 6 months thereafter);
(2) Respond in an appropriate, timely, and complete manner to
required corrective action requests if deficiencies are identified in
the maintenance PT performance, during the inspections, operations, or
reporting; and
(3) Satisfactorily complete corrective remedial actions, and
undergo special
[[Page 68423]]
inspection and special PT sets to maintain or restore certification
when material deficiencies occur in either the PT program, inspection
program, or in operations and reporting.
Section 9.4 What is the process when a laboratory or IITF does not
maintain its HHS certification?
(a) A laboratory or IITF that does not maintain its HHS
certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and
records throughout the required storage period described in Sections
11.20, 11.21, 12.18, and 14.8;
(3) Ensure access to federally regulated specimens and records in
accordance with Sections 11.23, 11.24, 12.20, and 12.21 and subpart P
of these Guidelines; and
(4) Follow the HHS suspension and revocation procedures when
imposed by the Secretary, follow the HHS procedures in subpart P of
these Guidelines that will be used for all actions associated with the
suspension and/or revocation of HHS-certification.
Section 9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
(a) PT samples used to evaluate drug tests will be prepared using
the following specifications:
(1) PT samples may contain one or more of the drugs and drug
metabolites in the drug testing panel and must satisfy one of the
following parameters:
(i) The concentration of a drug or metabolite will be at least 20
percent above the initial test cutoff for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be as low as 40
percent of the confirmatory test cutoff when the PT sample is
designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from
Section 9.5(a)(1)(i) and (ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an
adulterant, or other substances for special purposes, or may satisfy
the criteria for a substituted specimen, dilute specimen, or invalid
result.
(3) A negative PT sample will not contain a measurable amount of a
target analyte.
(b) PT samples used to evaluate specimen validity tests shall
satisfy, but are not limited to, one of the following criteria:
(1) The nitrite concentration will be at least 20 percent above the
cutoff;
(2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5;
(3) The concentration of an oxidant will be at a level sufficient
to challenge a laboratory's ability to identify and confirm the
oxidant;
(4) The creatinine concentration will be between 0 and 20 mg/dL; or
(5) The specific gravity will be less than or equal to 1.0050 or
between 1.0170 and 1.0230.
(c) For each PT cycle, the set of PT samples going to each HHS-
certified laboratory or IITF will vary but, within each calendar year,
each HHS-certified laboratory or IITF will analyze essentially the same
total set of samples.
(d) The laboratory or IITF must (to the greatest extent possible)
handle, test, and report a PT sample in a manner identical to that used
for a donor specimen, unless otherwise specified.
Section 9.6 What are the PT requirements for an applicant laboratory
that seeks to perform urine testing?
(a) An applicant laboratory that seeks certification under these
Guidelines to perform urine testing must satisfy the following criteria
on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of
the total drug challenges over the three sets of PT samples;
(3) For laboratories that will test primary (A) specimens,
correctly identify at least 80 percent of the drug challenges for each
initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the
concentrations (i.e., no more than <plus-minus>20 percent or <plus-
minus>2 standard deviations [whichever is larger] from the appropriate
reference or peer group means) for at least 80 percent of the total
drug challenges over the three sets of PT samples;
(5) For the confirmatory drug tests, do not obtain any drug
concentration that differs by more than <plus-minus>50 percent from the
appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and
determine the concentrations (i.e., no more than <plus-minus>20 percent
or <plus-minus>2 standard deviations [whichever is larger] from the
appropriate reference or peer group means) for at least 50 percent of
the drug challenges for an individual drug over the three sets of PT
samples;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over the three sets of PT
samples;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over the three
sets of PT samples that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than <plus-
minus>20 percent or <plus-minus>2 standard deviations from the
appropriate reference or peer group mean; and
(ii) pH values are no more than <plus-minus>0.3 pH units from the
appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than <plus-minus>0.0003
specific gravity units from the appropriate reference or peer group
mean when the mean is less than 1.0100 and specific gravity values are
no more than <plus-minus>0.0004 specific gravity units from the
appropriate reference or peer group mean when the mean is equal to or
greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for nitrite and
creatinine concentrations, <plus-minus>0.8 pH units using a pH meter,
<plus-minus>0.0006 specific gravity units when the mean is less than
1.0100, or <plus-minus>0.0007 specific gravity units when the mean is
equal to or greater than 1.0100; and
(11) Do not report any sample as adulterated with a compound that
is not present in the sample, adulterated based on pH when the
appropriate reference or peer group mean is within the acceptable pH
range, substituted when the appropriate reference or peer group means
for both creatinine and specific gravity are within the acceptable
range, or substituted when the appropriate reference or peer group mean
for a biomarker is within the acceptable range.
(b) Failure to satisfy these requirements will result in the denial
of the laboratory's application for HHS certification to perform urine
testing.
Section 9.7 What are the PT requirements for an HHS-certified urine
laboratory?
(a) A laboratory certified under these Guidelines to perform urine
testing must satisfy the following criteria on the maintenance PT
samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of
the total drug challenges over two consecutive PT cycles;
(3) For laboratories that test primary (A) specimens, correctly
identify at least 80 percent of the drug challenges for
[[Page 68424]]
each initial drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the
concentrations for at least 80 percent of the total drug challenges are
no more than <plus-minus>20 percent or <plus-minus>2 standard
deviations (whichever is larger) from the appropriate reference or peer
group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, do not obtain any drug
concentration that differs by more than <plus-minus>50 percent from the
appropriate reference or peer group means;
(6) For each confirmatory drug test, correctly identify and
determine that the concentrations for at least 50 percent of the drug
challenges for an individual drug are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group means over two consecutive PT
cycles;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over two consecutive PT cycles;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over two
consecutive PT cycles that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than <plus-
minus>20 percent or <plus-minus>2 standard deviations from the
appropriate reference or peer group mean;
(ii) pH values are no more than <plus-minus>0.3 pH units from the
appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than <plus-minus>0.0003
specific gravity units from the appropriate reference or peer group
mean when the mean is less than 1.0100 and specific gravity values are
no more than <plus-minus>0.0004 specific gravity units from the
appropriate reference or peer group mean when the mean is equal to or
greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for nitrite and
creatinine concentrations, <plus-minus>0.8 pH units using a pH meter,
<plus-minus>0.0006 specific gravity units when the mean is less than
1.0100, or <plus-minus>0.0007 specific gravity units when the mean is
equal to or greater than 1.0100; and
(11) Do not report any PT sample as adulterated with a compound
that is not present in the sample, adulterated based on pH when the
appropriate reference or peer group mean is within the acceptable pH
range, substituted when the appropriate reference or peer group means
for both creatinine and specific gravity are within the acceptable
range, or substituted when the appropriate reference or peer group mean
for a biomarker is within the acceptable range.
(b) Failure to participate in all PT cycles or to satisfy these
requirements may result in suspension or revocation of an HHS-certified
laboratory's certification.
Section 9.8 What are the PT requirements for an applicant IITF?
(a) An applicant IITF that seeks certification under these
Guidelines must satisfy the following criteria on three consecutive
sets of PT samples:
(1) Correctly identify at least 90 percent of the total drug
challenges over the three sets of PT samples;
(2) Correctly identify at least 80 percent of the drug challenges
for each individual drug test over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the total specimen
validity test challenges over the three sets of PT samples;
(4) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over the three sets of PT
samples;
(5) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total specimen validity test
challenges over the three sets of PT samples that satisfy the following
criteria:
(i) Creatinine concentrations are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than <plus-minus>0.001
specific gravity units from the appropriate reference or peer group
mean; and
(6) Must not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for creatinine
concentration or <plus-minus>0.002 specific gravity units for specific
gravity.
(b) Failure to satisfy these requirements will result in
disqualification.
Section 9.9 What are the PT requirements for an HHS-certified IITF?
(a) An IITF certified under these Guidelines must satisfy the
following criteria on the maintenance PT samples to maintain its
certification:
(1) Correctly identify at least 90 percent of the total drug
challenges over two consecutive PT cycles;
(2) Correctly identify at least 80 percent of the drug challenges
for each individual drug test over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the total specimen
validity test challenges over two consecutive PT cycles;
(4) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over two consecutive PT cycles;
(5) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total specimen validity test
challenges over two consecutive PT cycles that satisfy the following
criteria:
(i) Creatinine concentrations are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than <plus-minus>0.001
specific gravity units from the appropriate reference or peer group
mean; and
(6) Must not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for creatinine
concentration, or <plus-minus>0.002 specific gravity units for specific
gravity.
(b) Failure to participate in all PT cycles or to satisfy these
requirements may result in suspension or revocation of an HHS-certified
IITF's certification.
Section 9.10 What are the inspection requirements for an applicant
laboratory or IITF?
(a) An applicant laboratory or IITF is inspected by a team of two
inspectors.
(b) Each inspector conducts an independent review and evaluation of
all aspects of the laboratory's or IITF's testing procedures and
facilities using an inspection checklist.
Section 9.11 What are the maintenance inspection requirements for an
HHS-certified laboratory or IITF?
(a) An HHS-certified laboratory or IITF must undergo an inspection
3 months after becoming certified and at least every 6 months
thereafter.
(b) An HHS-certified laboratory or IITF is inspected by two or more
inspectors. The number of inspectors is determined according to the
number of specimens reviewed.
(c) Each inspector conducts an independent evaluation and review of
the HHS-certified laboratory's or IITF's procedures, records, and
facilities using guidance provided by the Secretary.
[[Page 68425]]
(d) To remain certified, an HHS-certified laboratory or IITF must
continue to satisfy the minimum requirements as stated in these
Guidelines.
Section 9.12 Who can inspect an HHS-certified laboratory or IITF and
when may the inspection be conducted?
(a) An individual may be selected as an inspector for the Secretary
if they satisfy the following criteria:
(1) Has experience and an educational background similar to that
required for either a responsible person or a certifying scientist for
an HHS-certified laboratory as described in subpart K of these
Guidelines or as a responsible technician for an HHS-certified IITF as
described in subpart L of these Guidelines;
(2) Has read and thoroughly understands the policies and
requirements contained in these Guidelines and in other guidance
consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory or IITF.
(b) The Secretary or a federal agency may conduct an inspection at
any time.
Section 9.13 What happens if an applicant laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
If an applicant laboratory or IITF fails to satisfy the
requirements established for the initial certification process, the
laboratory or IITF must start the certification process from the
beginning.
Section 9.14 What happens if an HHS-certified laboratory or IITF does
not satisfy the minimum requirements for either the PT program or the
inspection program?
(a) If an HHS-certified laboratory or IITF fails to satisfy the
minimum requirements for certification, the laboratory or IITF is given
a period of time (e.g., 5 or 30 working days depending on the nature of
the deficiency) to provide any explanation for its performance and
evidence that all deficiencies have been corrected.
(b) A laboratory's or IITF's HHS certification may be revoked,
suspended, or no further action taken depending on the seriousness of
the deficiencies and whether there is evidence that the deficiencies
have been corrected and that current performance meets the requirements
for certification.
(c) An HHS-certified laboratory or IITF may be required to undergo
a special inspection or to test additional PT samples to address
deficiencies.
(d) If an HHS-certified laboratory's or IITF's certification is
revoked or suspended in accordance with the process described in
subpart P of these Guidelines, the laboratory or IITF is not permitted
to test federally regulated specimens until the suspension is lifted or
the laboratory or IITF has successfully completed the certification
requirements as a new applicant laboratory or IITF.
Section 9.15 What factors are considered in determining whether
revocation of a laboratory's or IITF's HHS certification is necessary?
(a) The Secretary shall revoke certification of an HHS-certified
laboratory or IITF in accordance with these Guidelines if the Secretary
determines that revocation is necessary to ensure fully reliable and
accurate drug and specimen validity test results and reports.
(b) The Secretary shall consider the following factors in
determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the
results of drug and specimen validity tests (e.g., an HHS-certified
laboratory reporting a false positive result for a drug test);
(2) Unsatisfactory participation in performance testing or
inspections;
(3) A material violation of a certification standard, contract
term, or other condition imposed on the HHS-certified laboratory or
IITF by a federal agency using the laboratory's or IITF's services;
(4) Conviction for any criminal offense committed as an incident to
operation of the HHS-certified laboratory or IITF; or
(5) Any other cause that materially affects the ability of the HHS-
certified laboratory or IITF to ensure fully reliable and accurate drug
test results and reports.
(c) The period and terms of revocation shall be determined by the
Secretary and shall depend upon the facts and circumstances of the
revocation and the need to ensure accurate and reliable drug testing.
Section 9.16 What factors are considered in determining whether to
suspend a laboratory's or IITF's HHS certification?
(a) The Secretary may immediately suspend (either partially or
fully) a laboratory's or IITF's HHS certification to conduct drug
testing for federal agencies if the Secretary has reason to believe
that revocation may be required and that immediate action is necessary
to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of
suspension based upon the facts and circumstances of the suspension and
the need to ensure accurate and reliable drug testing.
Section 9.17 How does the Secretary notify an HHS-certified laboratory
or IITF that action is being taken against the laboratory or IITF?
(a) When laboratory's or IITF's HHS certification is suspended or
the Secretary seeks to revoke HHS certification, the Secretary shall
immediately serve the HHS-certified laboratory or IITF with written
notice of the suspension or proposed revocation by fax, mail, personal
service, or registered or certified mail, return receipt requested.
This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory or IITF will
be afforded an opportunity for an informal review of the suspension or
proposed revocation if it so requests in writing within 30 days of the
date the laboratory or IITF received the notice, or if expedited review
is requested, within 3 days of the date the laboratory or IITF received
the notice. Subpart P of these Guidelines contains detailed procedures
to be followed for an informal review of the suspension or proposed
revocation.
(c) A suspension must be effective immediately. A proposed
revocation must be effective 30 days after written notice is given or,
if review is requested, upon the reviewing official's decision to
uphold the proposed revocation. If the reviewing official decides not
to uphold the suspension or proposed revocation, the suspension must
terminate immediately and any proposed revocation shall not take
effect.
(d) The Secretary will publish in the Federal Register the name,
address, and telephone number of any HHS-certified laboratory or IITF
that has its certification revoked or suspended under Section 9.13 or
9.14, respectively, and the name of any HHS-certified laboratory or
IITF that has its suspension lifted. The Secretary shall provide to any
member of the public upon request the written notice provided to a
laboratory or IITF that has its HHS certification suspended or revoked,
as well as the reviewing
[[Page 68426]]
official's written decision which upholds or denies the suspension or
proposed revocation under the procedures of subpart P of these
Guidelines.
Section 9.18 May a laboratory or IITF that had its HHS certification
revoked be recertified to test Federal Agency specimens?
Following revocation, a laboratory or IITF may apply for
recertification. Unless otherwise provided by the Secretary in the
notice of revocation under Section 9.17 or the reviewing official's
decision under Section 16.9(e) or 16.14(a), a laboratory or IITF which
has had its certification revoked may reapply for HHS certification as
an applicant laboratory or IITF.
Section 9.19 Where is the list of HHS-certified laboratories and IITFs
published?
(a) The list of HHS-certified laboratories and IITFs is published
monthly in the Federal Register.
(b) An applicant laboratory or IITF is not included on the list.
Subpart J--Blind Samples Submitted by an Agency
Section 10.1 What are the requirements for Federal agencies to submit
blind samples to HHS-certified laboratories or IITFs?
(a) Each federal agency is required to submit blind samples for its
workplace drug testing program. The collector must send the blind
samples to the HHS-certified laboratory or IITF that the collector
sends donor specimens.
(b) Each federal agency must submit at least 3 percent blind
samples along with its donor specimens based on the projected total
number of donor specimens collected per year (up to a maximum of 400
blind samples). Every effort should be made to ensure that blind
samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each
year by an agency must be negative, 15 percent must be positive for one
or more drugs, and 10 percent must either be adulterated or
substituted.
Section 10.2 What are the requirements for blind samples?
(a) Drug positive blind samples must be validated by the supplier
as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must contain one or more of the
drugs or metabolites listed in the drug testing panel.
(2) Drug positive blind samples must contain concentrations of
drugs between 1.5 and 2 times the initial drug test cutoff.
(b) Drug negative blind samples (i.e., certified to contain no
drugs) must be validated by the supplier as negative using appropriate
initial and confirmatory tests.
(c) A blind sample that is adulterated must be validated using
appropriate initial and confirmatory specimen validity tests, and have
the characteristics to clearly show that it is an adulterated sample at
the time of validation.
(d) A blind sample that is substituted must be validated using
appropriate initial and confirmatory specimen validity tests, and have
the characteristics to clearly show that it is a substituted sample at
the time of validation.
(e) The supplier must provide information on the blind samples'
content, validation, expected results, and stability to the collection
site/collector sending the blind samples to the laboratory or IITF, and
must provide the information upon request to the MRO, the federal
agency for which the blind sample was submitted, or the Secretary.
Section 10.3 How is a blind sample submitted to an HHS-certified
laboratory or IITF?
(a) A blind sample must be submitted as a split specimen (specimens
A and B) with the current federal CCF that the HHS-certified laboratory
or IITF uses for donor specimens. The collector provides the required
information to ensure that the federal CCF has been properly completed
and provides fictitious initials on the specimen label/seal. The
collector must indicate that the specimen is a blind sample on the MRO
copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of
blind samples randomly with donor specimens rather than submitting the
full complement of blind samples as a single group.
Section 10.4 What happens if an inconsistent result is reported for a
blind sample?
If an HHS-certified laboratory or IITF reports a result for a blind
sample that is inconsistent with the expected result (e.g., a
laboratory or IITF reports a negative result for a blind sample that
was supposed to be positive, a laboratory reports a positive result for
a blind sample that was supposed to be negative):
(a) The MRO must contact the laboratory or IITF and attempt to
determine if the laboratory or IITF made an error during the testing or
reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to
determine if the supplier made an error during the preparation or
transfer of the sample;
(c) The MRO must contact the collector and determine if the
collector made an error when preparing the blind sample for transfer to
the HHS-certified laboratory or IITF;
(d) If there is no obvious reason for the inconsistent result, the
MRO must notify both the federal agency for which the blind sample was
submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A
report of the Secretary's investigative findings and the corrective
action taken in response to identified deficiencies must be sent to the
federal agency. The Secretary shall ensure notification of the finding
as appropriate to other federal agencies and coordinate any necessary
actions to prevent the recurrence of the error.
Subpart K--Laboratory
Section 11.1 What must be included in the HHS-certified laboratory's
standard operating procedure manual?
(a) An HHS-certified laboratory must have a standard operating
procedure (SOP) manual that describes, in detail, all HHS-certified
laboratory operations. When followed, the SOP manual ensures that all
specimens are tested using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited
to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management
systems.
(c) All procedures in the SOP manual must be compliant with these
Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and
the dates on which the procedures were in effect must be maintained for
at least 2 years.
[[Page 68427]]
Section 11.2 What are the responsibilities of the responsible person
(RP)?
(a) Manage the day-to-day operations of the HHS-certified
laboratory even if another individual has overall responsibility for
alternate areas of a multi-specialty laboratory.
(b) Ensure that there are sufficient personnel with adequate
training and experience to supervise and conduct the work of the HHS-
certified laboratory. The RP must ensure the continued competency of
laboratory staff by documenting their in-service training, reviewing
their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to
all personnel of the HHS-certified laboratory and ensure that it is
followed. The SOP manual must be reviewed, signed, and dated by the
RP(s) when procedures are first placed into use and when changed or
when a new individual assumes responsibility for the management of the
HHS-certified laboratory. The SOP must be reviewed and documented by
the RP annually.
(d) Maintain a quality assurance program that ensures the proper
performance and reporting of all test results; verify and monitor
acceptable analytical performance for all controls and calibrators;
monitor quality control testing; and document the validity,
reliability, accuracy, precision, and performance characteristics of
each test and test system.
(e) Initiate and implement all remedial actions necessary to
maintain satisfactory operation and performance of the HHS-certified
laboratory in response to the following: quality control systems not
within performance specifications; errors in result reporting or in
analysis of performance testing samples; and inspection deficiencies.
The RP must ensure that specimen results are not reported until all
corrective actions have been taken and that the results provided are
accurate and reliable.
Section 11.3 What scientific qualifications must the RP have?
The RP must have documented scientific qualifications in analytical
toxicology.
Minimum qualifications are:
(a) Certification or licensure as a laboratory director by the
state in forensic or clinical laboratory toxicology, a Ph.D. in one of
the natural sciences, or training and experience comparable to a Ph.D.
in one of the natural sciences with training and laboratory/research
experience in biology, chemistry, and pharmacology or toxicology;
(b) Experience in forensic toxicology with emphasis on the
collection and analysis of biological specimens for drugs of abuse;
(c) Experience in forensic applications of analytical toxicology
(e.g., publications, court testimony, conducting research on the
pharmacology and toxicology of drugs of abuse) or qualify as an expert
witness in forensic toxicology;
(d) Fulfillment of the RP responsibilities and qualifications, as
demonstrated by the HHS-certified laboratory's performance and verified
upon interview by HHS-trained inspectors during each on-site
inspection; and
(e) Qualify as a certifying scientist.
Section 11.4 What happens when the RP is absent or leaves an HHS-
certified laboratory?
(a) HHS-certified laboratories must have multiple RPs or one RP and
an alternate RP. If the RP(s) are concurrently absent, an alternate RP
must be present and qualified to fulfill the responsibilities of the
RP.
(1) If an HHS-certified laboratory is without the RP and alternate
RP for 14 calendar days or less (e.g., temporary absence due to
vacation, illness, or business trip), the HHS-certified laboratory may
continue operations and testing of Federal agency specimens under the
direction of a certifying scientist.
(2) The Secretary, in accordance with these Guidelines, will
suspend a laboratory's HHS certification for all specimens if the
laboratory does not have an RP or alternate RP for a period of more
than 14 calendar days. The suspension will be lifted upon the
Secretary's approval of a new permanent RP or alternate RP.
(b) If the RP leaves an HHS-certified laboratory:
(1) The HHS-certified laboratory may maintain certification and
continue testing federally regulated specimens under the direction of
an alternate RP for a period of up to 180 days while seeking to hire
and receive the Secretary's approval of the RP's replacement.
(2) The Secretary, in accordance with these Guidelines, will
suspend a laboratory's HHS certification for all federally regulated
specimens if the laboratory does not have a permanent RP within 180
days. The suspension will be lifted upon the Secretary's approval of
the new permanent RP.
(c) To nominate an individual as an RP or alternate RP, the HHS-
certified laboratory must submit the following documents to the
Secretary: the candidate's current resume or curriculum vitae, copies
of diplomas and licensures, a training plan (not to exceed 90 days) to
transition the candidate into the position, an itemized comparison of
the candidate's qualifications to the minimum RP qualifications
described in the Guidelines, and have official academic transcript(s)
submitted from the candidate's institution(s) of higher learning. The
candidate must be found qualified during an on-site inspection of the
HHS-certified laboratory.
(d) The HHS-certified laboratory must fulfill additional inspection
and PT criteria as required prior to conducting federally regulated
testing under a new RP.
Section 11.5 What qualifications must an individual have to certify a
result reported by an HHS-certified laboratory?
(a) A certifying scientist must have:
(1) At least a bachelor's degree in the chemical or biological
sciences or medical technology, or equivalent;
(2) Training and experience in the analytical methods and forensic
procedures used by the HHS-certified laboratory relevant to the results
that the individual certifies; and
(3) Training and experience in reviewing and reporting forensic
test results and maintaining chain of custody, and an understanding of
appropriate remedial actions in response to problems that may arise.
(b) A certifying technician must have:
(1) Training and experience in the analytical methods and forensic
procedures used by the HHS-certified laboratory relevant to the results
that the individual certifies; and
(2) Training and experience in reviewing and reporting forensic
test results and maintaining chain of custody, and an understanding of
appropriate remedial actions in response to problems that may arise.
Section 11.6 What qualifications and training must other personnel of
an HHS-certified laboratory have?
(a) All HHS-certified laboratory staff (e.g., technicians,
administrative staff) must have the appropriate training and skills for
the tasks they perform.
(b) Each individual working in an HHS-certified laboratory must be
properly trained (i.e., receive training in each area of work that the
individual will be performing, including training in forensic
procedures related to their job duties) before they are permitted to
work independently with federally
[[Page 68428]]
regulated specimens. All training must be documented.
Section 11.7 What security measures must an HHS-certified laboratory
maintain?
(a) An HHS-certified laboratory must control access to the drug
testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times, except for
individuals conducting inspections (i.e., for the Department, a federal
agency, a state, or other accrediting agency) or emergency personnel
(e.g., firefighters and medical rescue teams).
(c) An HHS-certified laboratory must maintain records documenting
the identity of the visitor and escort, date, time of entry and exit,
and purpose for access to the secured area.
Section 11.8 What are the laboratory chain of custody requirements for
specimens and aliquots?
(a) HHS-certified laboratories must use chain of custody procedures
(internal and external) to maintain control and accountability of
specimens from the time of receipt at the laboratory through completion
of testing, reporting of results, during storage, and continuing until
final disposition of the specimens.
(b) HHS-certified laboratories must use chain of custody procedures
to document the handling and transfer of aliquots throughout the
testing process until final disposal.
(c) The chain of custody must be documented using either paper copy
or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and
complete the appropriate entries on the chain of custody form when the
specimen or aliquot is handled or transferred, and every individual in
the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain
of custody form each time a specimen or aliquot is handled or
transferred.
Section 11.9 What test(s) does an HHS-certified laboratory conduct on a
urine specimen received from an IITF?
An HHS-certified laboratory must test the specimen in the same
manner as a specimen that had not been previously tested.
Section 11.10 What are the requirements for an initial drug test?
(a) An initial drug test may be:
(1) An immunoassay; or
(2) An alternate technology (e.g., spectrometry, spectroscopy).
(b) An HHS-certified laboratory must validate an initial drug test
before testing specimens.
(c) Initial drug tests must be accurate and reliable for the
testing of specimens when identifying drugs or their metabolites.
(d) An HHS-certified laboratory may conduct a second initial drug
test using a method with different specificity, to rule out cross-
reacting compounds. This second initial drug test must satisfy the
batch quality control requirements specified in Section 11.12.
Section 11.11 What must an HHS-certified laboratory do to validate an
initial drug test?
(a) An HHS-certified laboratory must demonstrate and document the
following for each initial drug test:
(1) The ability to differentiate negative specimens from those
requiring further testing;
(2) The performance of the test around the cutoff, using samples at
several concentrations between 0 and 150 percent of the cutoff;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed
into service.
(c) Each initial drug test using an alternate technology must be
re-verified periodically or at least annually.
Section 11.12 What are the batch quality control requirements when
conducting an initial drug test?
(a) Each batch of specimens must contain the following controls:
(1) At least one control certified to contain no drug or drug
metabolite;
(2) At least one positive control with the drug or drug metabolite
targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted
at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the
analysts.
(b) Controls must total at least 4 percent of the controls and
specimens analyzed in each batch.
Section 11.13 What are the requirements for a confirmatory drug test?
(a) The analytical method must use mass spectrometric
identification (e.g., gas chromatography-mass spectrometry [GC-MS],
liquid chromatography-mass spectrometry [LC-MS], GC-MS/MS, LC-MS/MS) or
equivalent.
(b) A confirmatory drug test must be validated before it can be
used to test federally regulated specimens.
(c) Confirmatory drug tests must be accurate and reliable for the
testing of a urine specimen when identifying and quantifying drugs or
their metabolites.
Section 11.14 What must an HHS-certified laboratory do to validate a
confirmatory drug test?
(a) An HHS-certified laboratory must demonstrate and document the
following for each confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantification;
(4) The accuracy and precision at the cutoff;
(5) The accuracy (bias) and precision at 40 percent of the cutoff;
(6) The potential for interfering substances;
(7) The potential for carryover; and
(8) The potential matrix effects if using liquid chromatography
coupled with mass spectrometry.
(b) Each new lot of reagent must be verified prior to being placed
into service.
(c) HHS-certified laboratories must re-verify each confirmatory
drug test method periodically or at least annually.
Section 11.15 What are the batch quality control requirements when
conducting a confirmatory drug test?
(a) At a minimum, each batch of specimens must contain the
following calibrators and controls:
(1) A calibrator at the cutoff;
(2) At least one control certified to contain no drug or drug
metabolite;
(3) At least one positive control with the drug or drug metabolite
targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the
cutoff.
(b) Calibrators and controls must total at least 10 percent of the
aliquots analyzed in each batch.
Section 11.16 What are the analytical and quality control requirements
for conducting specimen validity tests?
(a) Each invalid, adulterated, or substituted specimen validity
test result must be based on an initial specimen validity test on one
aliquot and a confirmatory specimen validity test on a second aliquot;
(b) The HHS-certified laboratory must establish acceptance criteria
and analyze calibrators and controls as appropriate to verify and
document the
[[Page 68429]]
validity of the test results (required specimen validity tests are
addressed in Section 11.18); and
(c) Controls must be analyzed concurrently with specimens.
Section 11.17 What must an HHS-certified laboratory do to validate a
specimen validity test?
An HHS-certified laboratory must demonstrate and document for each
specimen validity test the appropriate performance characteristics of
the test, and must re-verify the test periodically, or at least
annually. Each new lot of reagent must be verified prior to being
placed into service.
Section 11.18 What are the requirements for conducting urine specimen
validity tests?
An HHS-certified urine laboratory must perform the specimen
validity tests specified in Section 3.1(c) and may also perform
specimen validity tests in accordance with Section 3.1(d) and Section
3.6.
(a) Each invalid, adulterated, or substituted specimen validity
test result must be based on an initial specimen validity test on one
aliquot and a confirmatory specimen validity test on a second aliquot.
(b) Controls must be analyzed concurrently with specimens.
(c) The requirements for measuring creatinine concentration are as
follows:
(1) The creatinine concentration must be measured to one decimal
place on both the initial creatinine test and the confirmatory
creatinine test;
(2) The initial creatinine test must have the following calibrators
and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
(iii) A control in the range of 3 mg/dL to 20 mg/dL; and
(iv) A control in the range of 21 mg/dL to 25 mg/dL.
(3) The confirmatory creatinine test (performed on those specimens
with a creatinine concentration less than 2 mg/dL on the initial test)
must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL; and
(iii) A control in the range of 3 mg/dL to 4 mg/dL.
(d) The requirements for measuring specific gravity are as follows:
(1) For specimens with initial creatinine test results greater than
5 mg/dL and less than 20 mg/dL, laboratories may perform a screening
test using a refractometer that measures urine specific gravity to at
least three decimal places to identify specific gravity values that are
acceptable (equal to or greater than 1.003) or dilute (equal to or
greater than 1.002 and less than 1.003). Specimens must be subjected to
an initial specific gravity test using a four decimal place
refractometer when the initial creatinine test result is less than or
equal to 5 mg/dL or when the screening specific gravity test result
using a three decimal place refractometer is less than 1.002.
(2) The screening specific gravity test must have the following
calibrators and controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002;
(iii) One control in the range of 1.004 to 1.018.
(3) For the initial and confirmatory specific gravity tests, the
refractometer must report and display specific gravity to four decimal
places. The refractometer must be interfaced with a laboratory
information management system (LIMS), computer, and/or generate a paper
copy of the digital electronic display to document the numerical values
of the specific gravity test results;
(4) The initial and confirmatory specific gravity tests must have
the following calibrators and controls:
(i) A calibrator or control at 1.0000;
(ii) One control targeted at 1.0020;
(iii) One control in the range of 1.0040 to 1.0180; and
(iv) One control equal to or greater than 1.0200 but not greater
than 1.0250.
(e) Requirements for measuring pH are as follows:
(1) Colorimetric pH tests that have the dynamic range of 3 to 12 to
support the 4 and 11 pH cutoffs and pH meters must be capable of
measuring pH to one decimal place. Colorimetric pH tests, dipsticks,
and pH paper (i.e., screening tests) that have a narrow dynamic range
and do not support the cutoffs may be used only to determine if an
initial pH specimen validity test must be performed;
(2) For the initial and confirmatory pH tests, the pH meter must
report and display pH to at least one decimal place. The pH meter must
be interfaced with a LIMS, computer, and/or generate a paper copy of
the digital electronic display to document the numerical values of the
pH test results;
(3) pH screening tests must have, at a minimum, the following
controls:
(i) One control below the lower decision point in use;
(ii) One control between the decision points in use; and
(iii) One control above the upper decision point in use;
(4) An initial colorimetric pH test must have the following
calibrators and controls:
(i) One calibrator at 4.0;
(ii) One calibrator at 11.0;
(iii) One control in the range of 3.0 to 3.8;
(iv) One control in the range 4.2 to 5.0;
(v) One control in the range of 5.0 to 9.5;
(vi) One control in the range of 10.0 to 10.8; and
(vii) One control in the range of 11.2 to 12.0;
(5) An initial pH meter test, if a pH screening test is not used,
must have the following calibrators and controls:
(i) One calibrator at 3.0;
(ii) One calibrator at 7.0;
(iii) One calibrator at 10.0;
(iv) One control in the range of 3.0 to 3.8;
(v) One control in the range 4.2 to 5.0;
(vi) One control in the range of 10.0 to 10.8; and
(vii) One control in the range of 11.2 to 12.0;
(6) An initial pH meter test (if a pH screening test is used) or
confirmatory pH meter test must have the following calibrators and
controls when the result of the preceding pH test indicates that the pH
is below the lower decision point in use:
(i) One calibrator at 4.0;
(ii) One calibrator at 7.0;
(iii) One control in the range of 3.0 to 3.8; and
(iv) One control in the range 4.2 to 5.0; and
(7) An initial pH meter test (if a pH screening test is used) or
confirmatory pH meter test must have the following calibrators and
controls when the result of the preceding pH test indicates that the pH
is above the upper decision point in use:
(i) One calibrator at 7.0;
(ii) One calibrator at 10.0;
(iii) One control in the range of 10.0 to 10.8; and
(iv) One control in the range of 11.2 to 12.0.
(f) Requirements for performing oxidizing adulterant tests are as
follows:
(1) The initial test must include an appropriate calibrator at the
cutoff specified in Section 11.19(d)(2), (3), or (4) for the compound
of interest, a control without the compound of interest (i.e., a
certified negative control), and at least one control with one of the
compounds of interest at a measurable concentration; and
(2) A confirmatory test for a specific oxidizing adulterant must
use a different analytical method than that used for the initial test.
Each
[[Page 68430]]
confirmatory test batch must include an appropriate calibrator, a
control without the compound of interest (i.e., a certified negative
control), and a control with the compound of interest at a measurable
concentration.
(g) The requirements for measuring the nitrite concentration are
that the initial and confirmatory nitrite tests must have a calibrator
at the cutoff, a control without nitrite (i.e., certified negative
urine), one control in the range of 200 mcg/mL to 250 mcg/mL, and one
control in the range of 500 mcg/mL to 625 mcg/mL.
(h) For specimen validity tests other than those above, the
laboratory must establish acceptance criteria and analyze calibrators
and controls as appropriate to verify and document the validity of the
test results.
Section 11.19 What are the requirements for an HHS-certified laboratory
to report a test result?
(a) Laboratories must report a test result to the agency's MRO
within an average of 5 working days after receipt of the specimen.
Reports must use the Federal CCF and/or an electronic report, as
described in items p and q below. Before any test result can be
reported, it must be certified by a certifying scientist or a
certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial
drug test is negative or if the specimen is negative upon confirmatory
drug testing, and the specimen does not meet invalid criteria as
described in Section 11.19(h)(1) through (13).
(c) A primary (A) specimen is reported positive for a specific drug
or drug metabolite when both the initial drug test is positive and the
confirmatory drug test is positive in accordance with the cutoffs
listed in the drug testing panel.
(d) A primary (A) urine specimen is reported adulterated when:
(1) The pH is less than 4 or equal to or greater than 11 using
either a pH meter or a colorimetric pH test for the initial test on the
first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(2) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant
colorimetric test for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion chromatography, capillary electrophoresis) on the second aliquot;
(3) The presence of chromium (VI) is verified using either a
general oxidant colorimetric test (with an equal to or greater than 50
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric
test (chromium (VI) concentration equal to or greater than 50 mcg/mL)
for the initial test on the first aliquot and a different confirmatory
test (e.g., multi-wavelength spectrophotometry, ion chromatography,
atomic absorption spectrophotometry, capillary electrophoresis,
inductively coupled plasma-mass spectrometry) with the chromium (VI)
concentration equal to or greater than the LOQ of the confirmatory test
on the second aliquot;
(4) The presence of halogen (e.g., chlorine from bleach, iodine,
fluoride) is verified using either a general oxidant colorimetric test
(with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff
or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent
cutoff) or halogen colorimetric test (halogen concentration equal to or
greater than the LOQ) for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion chromatography, inductively coupled plasma-mass spectrometry) with
a specific halogen concentration equal to or greater than the LOQ of
the confirmatory test on the second aliquot;
(5) The presence of glutaraldehyde is verified using either an
aldehyde test (aldehyde present) or the characteristic immunoassay
response on one or more drug immunoassay tests for the initial test on
the first aliquot and a different confirmatory method (e.g., GC/MS) for
the confirmatory test with the glutaraldehyde concentration equal to or
greater than the LOQ of the analysis on the second aliquot;
(6) The presence of pyridine (pyridinium chlorochromate) is
verified using either a general oxidant colorimetric test (with an
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or
a chromium (VI) colorimetric test (chromium (VI) concentration equal to
or greater than 50 mcg/mL) for the initial test on the first aliquot
and a different confirmatory method (e.g., GC/MS) for the confirmatory
test with the pyridine concentration equal to or greater than the LOQ
of the analysis on the second aliquot;
(7) The presence of a surfactant is verified by using a surfactant
colorimetric test with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the
first aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
(8) The presence of any other adulterant not specified in Section
11.19(d)(2) through (7) is verified using an initial test on the first
aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) urine specimen is reported substituted when:
(1) The creatinine concentration is less than 2 mg/dL and the
specific gravity is less than or equal to 1.0010 or equal to or greater
than 1.0200 on both the initial and confirmatory creatinine tests
(i.e., the same colorimetric test may be used to test both aliquots)
and on both the initial and confirmatory specific gravity tests (i.e.,
a refractometer is used to test both aliquots) on two separate
aliquots; or
(2) A biomarker is not present or is present at a concentration
inconsistent with that established for human urine.
(f) A primary (A) urine specimen is reported dilute when the
creatinine concentration is equal to or greater than 2 mg/dL but less
than 20 mg/dL and the specific gravity is greater than 1.0010 but less
than 1.0030 on a single aliquot.
(g) For a specimen that has an invalid result for one of the
reasons stated in Section 11.19(h)(1) and (4) through (13), the HHS-
certified laboratory shall contact the MRO and both will decide if
testing by another HHS-certified laboratory would be useful in being
able to report a positive, adulterated, or substituted result. If no
further testing is necessary, the HHS-certified laboratory then reports
the invalid result to the MRO.
(h) A primary (A) urine specimen is reported as an invalid result
when:
(1) Inconsistent creatinine concentration and specific gravity
results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the
specific gravity is greater than 1.0010 but less than 1.0200 on the
initial and/or confirmatory specific gravity test, the specific gravity
is less than or equal to 1.0010 on both the initial and confirmatory
specific gravity tests and the creatinine concentration is equal to or
greater than 2 mg/dL on either or both the initial or confirmatory
creatinine tests). A specimen meeting these criteria may be tested for
an HHS-authorized biomarker to determine substitution (see Section
3.8);
(2) The pH is equal to or greater than 4 and less than 4.5 or equal
to or greater than 9.5 and less than 11 using either a colorimetric pH
test or pH meter for the
[[Page 68431]]
initial test and a pH meter for the confirmatory test on two separate
aliquots;
(3) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test or equal to or greater than the
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric
test for both the initial (first) test and the second test or using
either initial test and the nitrite concentration is equal to or
greater than 200 mcg/mL but less than 500 mcg/mL for a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, capillary electrophoresis) on two separate aliquots;
(4) The possible presence of chromium (VI) is determined using the
same chromium (VI) colorimetric test with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) for both the initial (first) test and the
second test on two separate aliquots;
(5) The possible presence of a halogen (e.g., chlorine from bleach,
iodine, fluoride) is determined using the same halogen colorimetric
test with a cutoff equal to or greater than the LOQ for both the
initial (first) test and the second test on two separate aliquots or
relying on the odor of the specimen as the initial test;
(6) The possible presence of glutaraldehyde is determined by using
the same aldehyde test (aldehyde present) or characteristic immunoassay
response on one or more drug immunoassay tests for both the initial
(first) test and the second test on two separate aliquots;
(7) The possible presence of an oxidizing adulterant is determined
by using the same general oxidant colorimetric test (with an equal to
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or
greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen
concentration is equal to or greater than the LOQ) for both the initial
(first) test and the second test on two separate aliquots;
(8) The possible presence of a surfactant is determined by using
the same surfactant colorimetric test with an equal to or greater than
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the
initial (first) test and the second test on two separate aliquots or a
foam/shake test for the initial test;
(9) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(10) Interference with the confirmatory drug test occurs on at
least two separate aliquots of the specimen and the HHS-certified
laboratory is unable to identify the interfering substance;
(11) The physical appearance of the specimen is such that testing
the specimen may damage the laboratory's instruments;
(12) The physical appearances of the A and B specimens are clearly
different (note: A is tested); or
(13) A specimen validity test (i.e., other than the tests listed
above) on two separate aliquots of the specimen indicates that the
specimen is not valid for testing.
(i) An HHS-certified laboratory shall reject a primary (A) specimen
for testing when a fatal flaw occurs as described in Section 15.1 or
when a correctable flaw as described in Section 15.2 is not recovered.
The HHS-certified laboratory will indicate on the federal CCF that the
specimen was rejected for testing and provide the reason for reporting
the rejected for testing result.
(j) An HHS-certified laboratory must report all positive,
adulterated, substituted, and invalid test results for a urine
specimen. For example, a specimen can be positive for a drug and
adulterated.
(k) An HHS-certified laboratory must report the confirmatory
concentration of each drug or drug metabolite reported for a positive
result.
(l) An HHS-certified laboratory must report numerical values of the
specimen validity test results that support an adulterated,
substituted, or invalid result (as appropriate).
(m) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing
panels.
(n) When the concentration of a drug or drug metabolite exceeds the
validated linear range of the confirmatory test, HHS-certified
laboratories may report to the MRO that the quantitative value exceeds
the linear range of the test or that the quantitative value is greater
than ``insert the actual value for the upper limit of the linear
range,'' or laboratories may report a quantitative value above the
upper limit of the linear range that was obtained by diluting an
aliquot of the specimen to achieve a result within the method's linear
range and multiplying the result by the appropriate dilution factor.
(o) HHS-certified laboratories may transmit test results to the MRO
by various electronic means (e.g., fax, computer). Transmissions of the
reports must ensure confidentiality and the results may not be reported
verbally by telephone. Laboratories and external service providers must
ensure the confidentiality, integrity, and availability of the data and
limit access to any data transmission, storage, and retrieval system.
(p) HHS-certified laboratories must fax, courier, mail, or
electronically transmit a legible image or copy of the completed
federal CCF and/or forward a computer-generated electronic report. The
computer-generated report must contain sufficient information to ensure
that the test results can accurately represent the content of the
custody and control form that the MRO received from the collector.
(q) For positive, adulterated, substituted, invalid, and rejected
specimens, laboratories must fax, courier, mail, or electronically
transmit a legible image or copy of the completed federal CCF.
Section 11.20 How long must an HHS-certified laboratory retain
specimens?
(a) An HHS-certified laboratory must retain specimens that were
reported as positive, adulterated, substituted, or as an invalid result
for a minimum of 1 year.
(b) Retained urine specimens must be kept in secured frozen storage
(-20 [deg]C or less) to ensure their availability for retesting during
an administrative or judicial proceeding.
(c) Federal agencies may request that the HHS-certified laboratory
retain a specimen for an additional specified period of time and must
make that request within the 1-year period following the laboratory's
reporting of the specimen.
Section 11.21 How long must an HHS-certified laboratory retain records?
(a) An HHS-certified laboratory must retain all records generated
to support test results for at least 2 years. The laboratory may
convert hardcopy records to electronic records for storage and then
discard the hardcopy records after 6 months.
(b) A federal agency may request the HHS-certified laboratory to
maintain a documentation package (as described in Section 11.23) that
supports the chain of custody, testing, and reporting of a donor's
specimen that is under legal challenge by a donor. The federal agency's
request to the laboratory must be in writing and must specify the
period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those
included in the documentation package beyond the normal 2-year period
of time.
[[Page 68432]]
Section 11.22 What statistical summary reports must an HHS-certified
laboratory provide for urine testing?
(a) HHS-certified laboratories must provide to each federal agency
for which they perform testing a semiannual statistical summary report
that must be submitted by mail, fax, or email within 14 working days
after the end of the semiannual period. The summary report must not
include any personally identifiable information. A copy of the
semiannual statistical summary report will also be sent to the
Secretary or designated HHS representative. The semiannual statistical
report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative and the number reported
negative/dilute;
(7) Number of specimens rejected for testing because of a fatal
flaw;
(8) Number of specimens rejected for testing because of an
uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug
metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's
test results available when requested to do so by the Secretary or by
the federal agency for which the laboratory is performing drug-testing
services.
(c) An HHS-certified laboratory must ensure that a qualified
individual is available to testify in a proceeding against a Federal
employee when the proceeding is based on a test result reported by the
laboratory.
Section 11.23 What HHS-certified laboratory information is available to
a federal agency?
(a) Following a federal agency's receipt of a positive,
adulterated, or substituted drug test report, the federal agency may
submit a written request for copies of the records relating to the drug
test results or a documentation package or any relevant certification,
review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified
laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures
and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in
the package by page number;
(3) A copy of the federal CCF with any attachments, internal chain
of custody records for the specimen, memoranda (if any) generated by
the HHS-certified laboratory, and a copy of the electronic report (if
any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial
drug and specimen validity testing procedures, instrumentation, and
batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with
all calibrators and controls and copies of all internal chain of
custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's
confirmatory drug (and specimen validity, if applicable) testing
procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen
with all calibrators and controls and copies of all internal chain of
custody documents related to the confirmatory tests; and
(8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the
RP(s) and the certifying technician or certifying scientist of record.
Section 11.24 What HHS-certified laboratory information is available to
a federal applicant or employee?
Federal applicants or employees who are subject to a workplace drug
test may submit a written request through the MRO and/or the federal
agency requesting copies of any records relating to their drug test
results or a documentation package as described in Section 11.23(b) and
any relevant certification, review, or revocation of certification
records. Federal applicants or employees, or their designees, are not
permitted access to their specimens collected pursuant to Executive
Order 12564, Public Law 100-71, and these Guidelines.
Section 11.25 What types of relationships are prohibited between an
HHS-certified laboratory and an MRO?
An HHS-certified laboratory must not enter into any relationship
with a federal agency's MRO that may be construed as a potential
conflict of interest or derive any financial benefit by having a
federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor
for the agency; however, an MRO shall not be an employee or agent of or
have any financial interest in the HHS-certified laboratory for which
the MRO is reviewing drug testing results. Additionally, an MRO shall
not derive any financial benefit by having an agency use a specific
HHS-certified laboratory or have any agreement with an HHS-certified
laboratory that may be construed as a potential conflict of interest.
Section 11.26 What type of relationship can exist between an HHS-
certified laboratory and an HHS-certified IITF?
An HHS-certified laboratory can enter into any relationship with an
HHS-certified IITF.
Subpart L--Instrumented Initial Test Facility (IITF)
Section 12.1 What must be included in the HHS-certified IITF's standard
operating procedure manual?
(a) An HHS-certified IITF must have a standard operating procedure
(SOP) manual that describes, in detail, all HHS-certified IITF
operations. When followed, the SOP manual ensures that all specimens
are tested consistently using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited
to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software,
[…truncated; see source link]Indexed from Federal Register on October 29, 2026.
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