Rule2023-21734
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2023
Effective
February 1, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services ("HHS" or "Department") has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.
Full Text
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Rules and Regulations]
[Pages 70768-70811]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21734]
[[Page 70767]]
Vol. 88
Thursday,
No. 196
October 12, 2023
Part IV
Department of Health and Human Services
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42 CFR Chapter I
Mandatory Guidelines for Federal Workplace Drug Testing Programs; Final
Rule
Federal Register / Vol. 88 , No. 196 / Thursday, October 12, 2023 /
Rules and Regulations
[[Page 70768]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Chapter I
Mandatory Guidelines for Federal Workplace Drug Testing Programs
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Issuance of mandatory guidelines.
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SUMMARY: The Department of Health and Human Services (``HHS'' or
``Department'') has revised the Mandatory Guidelines for Federal
Workplace Drug Testing Programs using Urine (UrMG), which published in
the Federal Register of January 23, 2017.
DATES: The mandatory guidelines are effective February 1, 2024.
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#2b6e5e4c4e454e05634a524e586b584a4643584a05434358054c445d"><span class="__cf_email__" data-cfemail="a0e5d5c7c5cec58ee8c1d9c5d3e0d3c1cdc8d3c18ec8c8d38ec7cfd6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Executive Summary
These revised Mandatory Guidelines for Federal Workplace Drug
Testing Programs using Urine (UrMG) establish a process whereby the
Department annually publishes the authorized drug testing panel (i.e.,
drugs, analytes, or cutoffs) to be used for Federal workplace drug
testing programs; revise the definition of a substituted specimen to
include specimens with a biomarker concentration inconsistent with that
established for a human specimen, establish a process whereby the
Department publishes an authorized biomarker testing panel (i.e.,
biomarker analytes and cutoffs) for Federal workplace drug testing
programs; update and clarify the oral fluid collection procedures;
revise the confirmatory test cutoff for morphine; revise the Medical
Review Officer (MRO) verification process for positive codeine and
morphine specimens; and require MROs to submit semiannual reports to
the Secretary or designated HHS representative on Federal agency
specimens that were reported as positive for a drug or drug metabolite
by a laboratory and verified as negative by the MRO. 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.
The Department is publishing a separate Federal Register
Notification (FRN) elsewhere in this issue of the Federal Register with
the revised OFMG, which include the same or similar revisions as the
UrMG, where appropriate.
Background
Pursuant to its authority under section 503 of Public Law 100-71, 5
U.S.C. 7301, and Executive Order 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. No
Federal agencies are testing hair or oral fluid specimens at this time.
HHS originally published the Mandatory Guidelines for Federal
Workplace Drug Testing Programs (hereinafter referred to as Guidelines
or Mandatory Guidelines) in the Federal Register (FR) on April 11, 1988
(53 FR 11979). The Substance Abuse and Mental Health Services
Administration (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 current Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Urine (UrMG) on January
23, 2017 (82 FR 7920), and published the current Mandatory Guidelines
for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on
October 25, 2019 (84 FR 57554). SAMHSA published proposed Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Hair (HMG)
on September 10, 2020 (85 FR 56108), and proposed revisions to the UrMG
(87 FR 20560) and OFMG (87 FR 20522) on April 7, 2022.
There was a 60-day public comment period following publication of
the proposed UrMG, during which 22 commenters submitted 93 comments on
the UrMG. These commenters were comprised of individuals,
organizations, and private sector companies. The comments are available
for public view at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. All comments were
reviewed and taken into consideration in the preparation of the
Guidelines. The issues and concerns raised in the public comments for
the UrMG are set forth below. Similar comments are considered together
in the discussion.
Summary of Public Comments and HHS's Response
The following comments were directed to the information and
questions in the preamble.
Authorized Drug Testing Panel
The Department requested comments on its proposal to publish the
drug testing panel separately from the UrMG in a Federal Register
Notification (FRN) each year. Sixteen commenters submitted a total of
35 comments on this topic for the UrMG.
Eight commenters disagreed with publishing a revised drug testing
panel without a public comment period, expressing concerns that
stakeholders including individuals subject to federally regulated drug
testing would not be given the opportunity to provide comment and that
the Department would miss valuable input including information on costs
and burden. Some of these commenters suggested alternate ways to permit
public comment while enabling a quicker response to testing panel
changes (e.g., setting a shorter comment period, publishing the
Guidelines as an interim final rule or issuing an advance notice of
proposed rulemaking). The Department has reviewed these comments and
suggestions and determined that no changes to the proposed Guidelines
are needed. The Department has developed procedures which will allow
review and comment before testing panel changes are published, as
described below.
Consistent with current procedures, prior to making a change to the
drug or biomarker testing panel, the Department will conduct a thorough
review of the scientific and medical literature, and will solicit
review and input from subject matter experts such as Responsible
Persons (RPs) of HHS-certified laboratories, Medical Review Officers
(MROs), research scientists, manufacturers of collection devices and/or
immunoassay kits, as well as Federal partners such as the Department of
Transportation (DOT), the Food and Drug Administration (FDA), and the
Drug Enforcement Administration (DEA). Further, the Department plans to
provide notice and opportunity for public comment regarding any
proposed changes to the drug and biomarker testing panels as part of
Drug Testing Advisory Board (DTAB) meetings and procedures.
[[Page 70769]]
Information regarding any proposed changes to the drug analyte and
biomarker testing panels and a request for public comment will be
included in an advance notice of the DTAB meeting published in the
Federal Register, along with the timeframe and method(s) for comment
submission. During the meeting, the Department will present the basis
for adding or removing analytes (i.e., including technical and
scientific support for the proposed changes), as well as a discussion
of related costs and benefits. This information will be provided in
advance to DTAB members. The Department will review all submitted
public comments and will share information during a DTAB session prior
to DTAB's review of SAMHSA's recommendation to the Secretary regarding
each proposed change.
The Department will make the final decision on any panel changes
and include the effective date(s) in the annual Notification, to allow
time for drug testing service providers (e.g., immunoassay kit
manufacturers, oral fluid collection device manufacturers) to develop
or revise their products, and for HHS-certified laboratories to develop
or revise assays, complete validation studies, and revise procedures.
Four commenters disagreed that HHS is exempt from the
Administrative Procedure Act (APA) requirements. Two of these
specifically stated that the Guidelines are subject to APA requirements
because DOT is required to use the Guidelines for their transportation
industry drug testing programs. The Department explained why the APA
does not apply under the Regulatory Impact and Notices section of the
current UrMG (82 FR 7920) and has repeated the same information in that
section below.
Ten commenters were concerned that the Department will not allow
sufficient time for stakeholders to implement changes (e.g., time for
Food and Drug Administration [FDA] clearance for new or revised
products, information technology [IT] changes, process development and/
or changes, contractual changes, and training). Some of these
commenters suggested that the Department set a standard time period
(e.g., 90 days) for implementation of changes or based on the
complexity of the change (e.g., between 90 and 365 days). The
Department will establish a reasonable time for implementation based on
the change, rather than setting a standard time period for all changes.
As noted above, the Department will solicit information from
stakeholders to assist in decision making.
In regard to the use of FDA-cleared immunoassay initial tests, two
commenters suggested that federally regulated drug testing could fall
under what they referred to as the FDA's Employment and Insurance
exemption. The Department notes that, while some drugs of abuse test
systems intended for employment and insurance testing are, under
certain circumstances, exempt from the premarket notification
procedures in 21 CFR part 807, subpart E, such exemptions do not apply
to test systems intended for Federal drug testing programs. See 21 CFR
part 862, subpart D. Applicant and HHS-certified test facilities must
verify that test systems subject to FDA regulations are approved or
otherwise cleared by FDA and, in addition, must validate test systems
prior to use in accordance with requirements specified in the National
Laboratory Certification Program (NLCP) Manuals for Urine Laboratories
and Initial Instrumented Test Facilities (IITFs).
One commenter appeared to misinterpret the Department's testing
panel proposal, objecting to the Department making changes to the
testing panels each year. The Department plans to issue an annual
Notification with the current testing panels and required nomenclature,
but will make changes only when needed to ensure the continued
effectiveness of Federal workplace drug testing programs, which may not
be every year.
Four commenters specifically agreed with the need to streamline and
improve processes for making changes to the testing panels. Three of
these commenters expressed concern over the process for testing panel
review and who would be involved, and suggested involving other
stakeholders (e.g., HHS-certified laboratories, DTAB, FDA). As noted
above, the Department will use multiple methods and involve subject
matter experts from various stakeholder groups to determine testing
panel changes, and will provide opportunity for public review and
comment before changes are made. FDA, DOT, and other Federal partners
will also have opportunities to review and provide input.
The other commenter suggested that the Department include
additional prescriptive language in each annual Notification (e.g.,
street names, detection times, pharmacological information on added
drugs for MROs; Custody and Control Form (CCF) instructions for
collectors). The Department has determined that no changes to the
proposed Guidelines are needed. Relevant information and guidance will
be included in the MRO Guidance Manual, Case Studies, Guidance for
Using the Federal Custody and Control Form (CCF), and Specimen
Collection Handbook. These documents are posted on SAMHSA's website,
<a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>.
One commenter stated that testing panel changes would lead to an
increase in incorrect information on the Federal CCF. The Department
disagrees, noting that the Federal CCF does not include preprinted
analyte names.
One of the commenters agreed with posting a Notification without a
public comment period for added drugs, but disagreed with removing
drugs from the testing panel without public comment. The commenter
noted that entities (e.g., DOT, some states) are required by law to use
the Guidelines testing panel should be able to continue testing those
drugs, even if Federal agencies will not. The Department has determined
that no changes to the proposed Guidelines are needed to address these
concerns.
See additional comments under Section 3.4 below.
Authorized Biomarker Testing Panel
The Department requested comments on its proposal to publish the
biomarker testing panel separately from the UrMG in the Federal
Register each year. Five commenters submitted a total of 12 comments on
this topic for the UrMG.
Two commenters disagreed with publishing a biomarker testing panel
without a public comment period, expressing concerns that stakeholders
would not be given the opportunity to provide comment and that the
Department would miss valuable input including information on costs and
burden.
Two other commenters specifically agreed with the need to
streamline and improve processes for making changes to the testing
panels, but suggested involving other stakeholders (e.g., HHS-certified
laboratories, DTAB). The Department has reviewed these comments and
determined that no changes to the proposed Guidelines are needed. The
Department has developed procedures which will allow review and comment
before testing panel changes are published, as described under
Authorized drug testing panel above.
One commenter disagreed that HHS is exempt from the APA
requirements. The Department has reviewed the comment and determined
that no change is needed to the proposed Guidelines. The Department
explained why the APA does not apply under the Regulatory Impact and
Notices section of the current UrMG (82 FR 7920) and has repeated the
same information in that section below.
[[Page 70770]]
Two commenters were concerned that the Department will not allow
sufficient time for stakeholders to implement changes (e.g., time for
information technology [IT] changes, process development and/or
changes, training). The commenters suggested that the Department set a
standard time for implementation of all changes (e.g., 90 days, six
months). As noted under Authorized drug testing panel above, the
Department will establish a reasonable time for implementation based on
the change, rather than setting a standard time period for all changes,
and will solicit information from multiple sources to assist in
decision making.
Two commenters suggested that the Department require all HHS-
certified laboratories to perform standardized specimen validity and
biomarker tests on all federally regulated specimens, and allow
laboratories to choose whether to offer additional specialized tests
upon MRO request on a case-by-case basis. This is consistent with
current UrMG requirements for specimen validity testing. The Department
is not requiring all certified laboratories to conduct biomarker
testing at this time. However, if the drug testing industry identifies
a need for such tests and an HHS-certified laboratory chooses to offer
a biomarker test to their regulated clients, the Department will ensure
that the tests provide scientifically valid and forensically defensible
results and will revisit the need for requiring the test on all
specimens.
Medical Review Officer (MRO) Verification of Codeine and Morphine Test
Results
The Department removed the additional decision point for codeine
and morphine, adjusted the confirmatory test cutoff for morphine from
2,000 to 4,000 ng/mL, and removed the additional requirement for
clinical evidence of illegal opioid use. The Department received one
comment agreeing with these changes to the UrMG.
Medical Review Officer (MRO) Semiannual Reports
In Section 13.11, the Department added requirements for each MRO
performing medical review services for Federal agencies to submit
semiannual reports, in January and July of each year, of Federal agency
specimens that were reported as positive for a drug or drug metabolite
by the laboratory and verified as negative by the MRO, along with the
reason for the negative verification (e.g., a valid prescription for a
drug). Six commenters submitted six comments on this topic for the
UrMG.
Four commenters disagreed, stating that HHS had not clearly
described the reason and the process for such reports. One commenter
noted that the Department had not presented data documenting that MROs
were incorrectly reporting specimens, and it was unclear how the
reports could be matched to laboratory report information submitted to
the National Laboratory Certification Program (NLCP). Another commenter
was concerned that donors would be identifiable, and that ``a database
of legal drug use'' would violate donor privacy. One of the commenters
expressed concern over ``unintended consequences'' for DOT and state
workplace drug testing programs, without further explanation.
One commenter disagreed on the basis of added costs and burden to
MROs (e.g., system revisions, increased staff workload).
One commenter agreed that such reports could be beneficial, but
suggested that MROs provide the same information as provided by
laboratories to the NLCP. The commenter incorrectly stated that
laboratories do not provide specimen identification numbers to the
NLCP.
The Department has reviewed the comments and determined that no
change is needed to the proposed Guidelines. To clarify, this reporting
policy is only for Federal agency specimens, not DOT-regulated
specimens. Further, the reports are not for all positive specimens,
only for those specimens that were reported as positive by the
laboratory and verified as negative by the MRO. The requested MRO
information is sufficient to enable matching to HHS-certified
laboratory information provided to the NLCP without identifying the
donor. At this time, there is no system-wide mechanism for identifying
MRO verification practices for Federal agency specimens that are
inconsistent with the Mandatory Guidelines, so data on incorrect
reporting is not available. The Department is not planning to share
MRO-specific information, but may share statistical information and
deidentified examples of incorrect reporting by various means (e.g.,
DTAB meeting presentations, revisions to the MRO Guidance Manual and/or
Case Studies). The Department will also provide this information to
HHS-approved MRO certification organizations to share with their
certified MROs and to update training materials and examinations as
needed.
Marijuana Testing
The Department did not propose any changes to the UrMG in regard to
marijuana testing, but received three comments from three commenters
disagreeing with the current requirements. Two commenters supported
medical use of marijuana. One commenter supported legalization of
marijuana in general.
Current Federal law requires Federal agencies to test for marijuana
under E.O. 12564 in their workplace drug testing programs. The
Department also edited Section 13.5(c) to clarify that only
prescription medications can be offered as a legitimate medical
explanation for a positive drug test (as described under Section 13.5
below). No further edits are required at this time.
Discussion of Sections
The Department has not included a discussion in the preamble of any
sections for which public comments were not submitted or for minor
wording changes (e.g., edits for clarity, typographical or grammatical
corrections).
Subpart A--Applicability
Section 1.5 What do the terms used in these Guidelines mean?
Two commenters agreed and one disagreed with the Department's
proposed revision to the Substituted Specimen definition in Section 1.5
to include specimens tested for a biomarker. The commenter who
disagreed stated that there are situations in which a legitimate
specimen may be reported as outside the standards for human specimens,
and these should be reported as invalid. The Department has reviewed
the comment and determined that no change is needed to the proposed
Guidelines. The Department will follow the procedures summarized under
Authorized drug testing panel above to enable public comment and
review, and will ensure that a biomarker test is scientifically
supported and forensically sound to identify specimens as substituted
before allowing its use with federally regulated drug testing.
Specimens that do not meet established criteria for the biomarker test
will not be reported as substituted.
Section 1.7 What is a refusal to take a federally regulated drug test?
In Section 1.7(a), the Department proposed to remove two exceptions
for reporting a refusal to test for a pre-employment test: a donor who
fails to appear in a reasonable time and a donor who leaves the
collection site before the collection process begins. Seven
[[Page 70771]]
commenters submitted seven comments on this proposal.
Five commenters disagreed with the changes, noting that an
applicant may fail to appear because they have taken a different job
offer. The commenters noted that a refusal to test in the individual's
record could prevent individuals from taking other job offers and/or
require them to undergo unnecessary return-to-duty testing. The
Department has reviewed the comments and determined that no change is
needed. As stated in this section, the Federal agency determines a
reasonable time for the donor to take the test, consistent with
applicable agency regulations, and directs the individual accordingly.
At the time an applicant is scheduled for a pre-employment drug test,
or before, Federal agencies should provide the applicant with
instructions on how to notify the agency in the event that they decide
to withdraw their application or to not accept a job offer. Such
instructions will allow the agency to cancel the drug test and help
applicants avoid a refusal to test result.
One commenter noted that the Guidelines should state that the
designated employer representative (DER) makes the determination of a
refusal to test. The Department has reviewed the comment and determined
that no change is needed. As stated in this section, the Federal agency
takes action consistent with applicable agency regulations.
Subpart C--Urine Specimen Tests
Section 3.4 What are the drug and biomarker test analytes and cutoffs
for urine?
The Department revised Section 3.4 to describe the annual
publication of the drug testing and biomarker testing panels and the
nomenclature required for laboratory and MRO reports. Three commenters
submitted four comments on the required nomenclature required for
laboratory and MRO reports, which are addressed below. Comments on the
testing panels are addressed under Authorized drug testing panel and
Authorized biomarker testing panel above.
In regard to the required nomenclature specified in the annual
Federal Register Notification, two commenters noted it is difficult and
requires substantial effort for stakeholders to make such changes to
their information technology (IT) systems. These commenters suggested
that HHS convene a working group for review and input on nomenclature
changes, to include employers, third party administrators, providers of
electronic Federal Custody and Control Forms (ECCF providers),
laboratories, and MROs. One commenter agreed with publishing the
required nomenclature for each change to the testing panel, but
suggested that nomenclature not be changed after publication to avoid
increased costs and confusion. One commenter recommended a minimum of
one-year implementation period after nomenclature changes are
published.
The Department will establish required terminology based on correct
scientific nomenclature for added analytes. As described under
Authorized drug testing panel above, the Department has developed
procedures to allow public notice and comment on proposed drug analyte
changes through DTAB meetings and procedures. The Department will
publish separate nomenclature lists for urine and oral fluid analytes.
Subpart F--Federal Drug Testing Custody and Control Form
Section 6.2 What happens if the correct Office of Management and Budget
(OMB)-approved Federal CCF is not available or is not used?
One commenter stated that the Department should specify what
constitutes an incorrect form, how a collector's signed memorandum must
be submitted to correct submission of an incorrect CCF, and what
actions an HHS-certified laboratory must take in response to an
incorrect CCF. The Department has determined that no changes to the
Guidelines are needed. The Department issues Guidance for Using the
Federal CCF as part of the OMB-approved package and provides
information and guidance specific to the current and expired versions
of the Federal CCF, rather than including them in these Guidelines.
Subpart H--Urine Specimen Collection Procedure
8.3 What are the preliminary steps in the urine specimen collection
procedure?
There were no comments on this section; however, the Department
added a sentence in item h stating that a donor is not required to
remove any items worn for faith-based reasons. This requirement will be
specified for all authorized specimen types.
Subpart K--Laboratory
Section 11.20 How long must an HHS-certified laboratory retain
specimens?
The Department did not propose any changes to this section. One
commenter submitted a comment specifically agreeing with the existing
UrMG requirement for laboratories to maintain substituted urine
specimens for a period of one year after reporting. The comment
appeared to be in response to DOT's February 28, 2022 notice of
proposed rulemaking (NPRM) for transportation industry drug testing
programs.
Subpart M--Medical Review Officer (MRO)
Section 13.3 What training is required before a physician may serve as
an MRO?
The Department did not propose any changes to this section;
however, one commenter indicated that this section is unclear and needs
substantial clarification regarding additional MRO training (e.g., what
must training consist of, must the MRO take another certification exam,
would this be required for annual panel changes). The commenter also
suggested that MROs register with SAMHSA to get updates/announcements
and acknowledge review of that information.
The Department has reviewed these comments and edited item b of
this section to clarify that MROs must be trained on any revisions to
the drug and biomarker testing panels. In regard to training, SAMHSA
relies on the approved MRO certification entities to ensure that MROs
certified by their organizations meet Guidelines requirements. Current
documents on the SAMHSA website <a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>
include the HHS Medical Review Officer Guidance Manual, MRO Cases
Studies for Urine, and MRO Case Studies for Urine which address most of
the suggested topics. The Department does not maintain an email list,
but sends a notice through the NLCP to HHS-approved MRO certification
organizations for dissemination to their certified MROs. The Department
also sends additional guidance to HHS-certified laboratories to share
with MROs, clients, and collectors as applicable.
Section 13.5 What must an MRO do when reviewing a urine specimen's test
results?
The Department revised Section 13.5(d)(2) to clarify that passive
exposure to any drug (not just marijuana smoke) and ingestion of food
products containing a drug (not just those containing marijuana) are
not acceptable medical explanations for a positive drug test. The
Department also added Section 13.5(d)(2)(iii) to clarify that only
prescription medications can be offered as a legitimate medical
explanation for
[[Page 70772]]
a positive drug test. Two commenters disagreed with the addition of
Section 13.5(d)(2)(iii), maintaining that a physician's recommendation
for medical marijuana should be considered a legitimate medical
explanation for a positive test. The Department has evaluated these
comments and determined that no change is needed at this time. Although
an increased number of States have authorized marijuana use for medical
purposes, marijuana remains a Schedule I controlled substance and
cannot be prescribed under Federal law. For purposes of the Federal
drug free workplace program, Federal law pertaining to marijuana
control supersedes State marijuana laws, and therefore, a physician's
recommendation for marijuana use is not a legitimate medical
explanation for a positive marijuana test. Also see comments under
Marijuana testing above.
In addition to the changes described above, the Department
reordered UrMG Sections 13.8 and 13.9 to reflect the procedural order
(i.e., requirements for an MRO to report a primary specimen test result
are now in Section 13.8, and requests for a test of the split specimen
are addressed in Section 13.9).
Regulatory Impact and Notices
The potential impact that these Guidelines have on the Department
of Transportation (DOT) and/or Nuclear Regulatory Commission (NRC)
regulated industries depends on the extent to which these agencies
incorporate the UrMG revisions into their regulatory programs.
Therefore, analysis of the potential impact of these Guidelines on such
programs falls under the regulatory purview of DOT and NRC.
Executive Order 14094, 13563, and 12866
Executive Order 14094 of April 6, 2023 (Modernizing Regulatory
Review) reaffirms the statement set forth in 13563 of January 18, 2011
(Improving Regulation and Regulatory Review) that ``Our regulatory
system must protect public health, welfare, safety, and our environment
while promoting economic growth, innovation, competitiveness, and job
creation.'' Consistent with this mandate, Executive Order 13563
requires agencies to tailor ``regulations to impose the least burden on
society, consistent with obtaining regulatory objectives.'' Executive
Order 13563 also requires agencies to ``identify and consider
regulatory approaches that reduce burdens and maintain flexibility and
freedom of choice'' while selecting ``those approaches that maximize
net benefits.'' The regulatory approach in this document will reduce
burdens to providers and to consumers while continuing to provide
adequate protections for public health and welfare.
The Secretary has examined the impact of the Guidelines under
Executive Order 12866, as amended by Executive Order 14094, which
directs Federal agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity).
According to Executive Order 12866, as amended by Executive Order
14094, defines a ``significant regulatory action'' as one that is
likely to result in a rule that may meet any one of a number of
specified conditions, including: (1) have an annual effect on the
economy of $200 million or more in any one year (adjusted every 3 years
by the Administrator of the Office of Information and Regulatory
Affairs (OIRA) for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise legal or policy issues for which centralized review would
meaningfully further the President's priorities or the principles set
forth in the Executive order, as specifically authorized in a timely
manner by the Administrator of OIRA in each case. The Administrative
Procedure Act (APA) delineates an exception to its rulemaking
procedures for ``a matter relating to agency management or personnel''
5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary
govern Federal workplace drug testing programs, HHS has taken the
position that the Guidelines are a ``matter relating to agency
management or personnel'' and, thus, are not subject to the APA's
requirements for notice and comment rulemaking. This position is
consistent with Executive Order 12564 regarding Drug-Free Workplaces,
which directs the Secretary to promulgate scientific and technical
guidelines for executive agency drug testing programs.
Costs and Benefits
The Department included a Regulatory Impact and Notices section
with cost and benefits analysis and burden estimates in the April 7,
2022 Federal Register Notification for the proposed UrMG (87 FR 20560),
and requested public comment on all estimates and assumptions. Two
commenters submitted comments concerning the Department's costs and
benefits analysis.
One commenter noted that the Department did not consider the
application of the Guidelines to DOT testing, and recommended
reanalysis of the costs and burden of the proposed changes with
consideration of the impact on testing by the transportation industry.
Please see the first paragraph of the Regulatory Impact and Notices
section above.
The other commenter disagreed with the Department's statement in
the preamble to the proposed UrMG that ``implementation costs would be
lower for laboratories that already offer the drug test'' compared to
those laboratories that do not test for the added drug. The commenter
indicated that the list of cost impacts for any change should include
the laboratory's assay validation, materials management, and updates to
IT systems (e.g., laboratory information management system [LIMS],
recipient systems, and electronic ordering systems). This commenter
indicated that these additional costs should be considered, and that
they will be dependent on the complexity and adaptability of these
systems. The Department agrees that costs will depend on the change and
noted that in the preamble to the proposed UrMG. The Department will
continue to proactively solicit cost information from stakeholders when
conducting a cost analysis. As described under Authorized drug testing
panel above, the Department will include a discussion of related costs
and benefits when presenting a proposed panel change during a DTAB
meeting.
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
[[Page 70773]]
(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 (PRA), 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 originally set a deadline of August 31, 2023 for all HHS-
certified laboratories to submit a request for approval of a digital
(paperless) electronic Federal CCF. The Department subsequently
extended the deadline to August 31, 2026, to enable sufficient time for
all HHS-certified laboratories to identify and contract with an ECCF
supplier or to develop an ECCF.
The title and description of the information collected 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.
Title: The Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Urine.
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 12564. Federal drug testing programs test
applicants to sensitive positions, individuals involved in accidents,
individuals for cause, and random testing of persons in 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, 25 urine
specimen testing laboratories, 1 IITF, and 100 MROs.
Estimate of Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
9.2(a)(1)...................................... Laboratory or IITF required to submit 10 1 3 30
application for certification.
9.12(a)(3)..................................... Materials to submit to become an HHS 10 1 2 20
inspector.
11.3........................................... Laboratory submits qualifications of 10 1 2 20
responsible person (RP) to HHS.
11.4(c)........................................ Laboratory submits information to HHS 10 1 2 20
on new RP or alternate RP.
11.22.......................................... Specifications for laboratory 10 5 0.5 25
semiannual statistical report of test
results to each Federal agency.
12.3(a)........................................ IITF \1\ submits qualifications of RT 1 1 1 1
to HHS.
12.4(c)........................................ IITF \1\ submits information to HHS on 1 1 1 1
new RT or alternate RT.
12.19.......................................... Specifications for IITF \1\ semiannual 1 1 1 1
statistical report of test results to
each Federal agency.
13.8 and 14.7.................................. Specifies that MRO must report all 100 14 0.05 (3 min) 70
verified primary and split specimen
test results to the Federal agency.
13.11.......................................... Specifications for MRO semiannual 100 2 0.5 100
report to the Secretary or designated
representative for Federal agency
specimen results that were laboratory-
positive and MRO-verified negative.
16.1(b) & 16.5(a).............................. Specifies content of request for 1 1 3 3
informal review of suspension/proposed
revocation of certification.
16.4........................................... Specifies information appellant 1 1 0.5 0.5
provides in first written submission
when laboratory suspension/revocation
is proposed.
16.6........................................... Requires appellant to notify reviewing 1 1 0.5 0.5
official of resolution status at end
of abeyance period.
16.7(a)........................................ Specifies contents of appellant 1 1 50 50
submission for review.
[[Page 70774]]
16.9(a)........................................ Specifies content of appellant request 1 1 3 3
for expedited review of suspension or
proposed revocation.
16.9(c)........................................ Specifies contents of review file and 1 1 50 50
briefs.
---------------------------------------------------------------
Total...................................... ....................................... 259 .............. .............. 395
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application for certification to test federally regulated specimens.
IITF numbers are provided in this analysis as placeholders for administrative purposes.
The following reporting requirements are also in the 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a), 8.5(f)(2)(iii), 8.6(b)(2).............. Collector must contact Federal agency 100 1 0.05 (3 min) 5
point of contact.
11.23, 11.24................................... Information on drug test that 25 10 3 750
laboratory must provide to Federal
agency upon request or to donor
through MRO.
12.20, 12.21................................... Information on drug test that IITF must 1 1 1 1
provide to Federal agency upon request
or to donor through MRO.
13.9(b)........................................ MRO must inform donor of right to 100 14 3 4,200
request split specimen test when a
positive, adulterated, or substituted
result is reported.
---------------------------------------------------------------
Total...................................... ....................................... 226 .............. .............. 4956
--------------------------------------------------------------------------------------------------------------------------------------------------------
The following disclosure requirements are also included in the
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.5, 8.8.................................. Collector completes Federal CCF for 100 380 0.07 (4 min) 2,660
specimen collected.
8.8(d) & (f)................................... Donor initials specimen labels/seals 38,000 1 0.08 (5 min) 3,040
and signs statement on the Federal CCF.
11.8(a) & 11.19................................ Laboratory completes Federal CCF upon 25 1,520 0.05 (3 min) 1,900
receipt of specimen and before
reporting result.
12.8(a) & 12.15................................ IITF completes Federal CCF upon receipt 1 1 1 1
of specimen and before reporting
result.
13.4(d)(4), 13.8(c), 14.7(c)................... MRO completes Federal CCF before 100 380 0.05 (3 min) 1,900
reporting the primary or split
specimen result.
14.1(b)........................................ MRO documents donor's request to have 100 2 0.05 (3 min) 10
split specimen tested.
---------------------------------------------------------------
Total...................................... ....................................... 38,326 .............. .............. 9,511
--------------------------------------------------------------------------------------------------------------------------------------------------------
The 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
[[Page 70775]]
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) and (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. These
practices are integrated in the current processes and, therefore,
SAMHSA does not consider these standard business practices to be an
additional burden for disclosure. Thus, the total annual response
burden associated with the testing of urine specimens by the
laboratories and IITFs is estimated to be 14,862 hours (that is, the
sum of the total hours from the above tables). This is in addition to
the 1,788,809 hours currently approved by OMB under control number
0930-0158 for urine testing under the current Guidelines.
As required by section 3507(d) of the PRA, the Secretary submitted
a copy of the proposed Guidelines to OMB for its review. Comments on
the information collection requirements were 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.
Dated: September 27, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Urine Specimens
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 employee 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?
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 any of the specimens be used for other purposes?
3.4 What are the drug and biomarker test analytes and cutoffs for
urine?
3.5 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)?
3.6 What criteria are used to report a urine specimen as
adulterated?
3.7 What criteria are used to report a urine specimen as
substituted?
3.8 What criteria are used to report a urine specimen as dilute?
3.9 What criteria are used to report an invalid result for a urine
specimen?
Subpart D--Collectors
4.1 Who may collect a 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?
[[Page 70776]]
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?
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 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
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
[[Page 70777]]
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 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 (IITFs)
that provide drug testing services to the Federal agencies;
(6) Collectors who provide specimen collection services to the
Federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review
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.
[[Page 70778]]
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 3.4.
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 3.4.
External Service Provider. An independent entity that performs
services related to Federal workplace drug testing on behalf of a
Federal agency, a collector/collection site, an HHS[hyphen]certified
laboratory, a Medical Review Officer (MRO), or (for urine) an
HHS[hyphen]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.
Gender Identity. Gender identity means an individual's internal
sense of being male or female, which may be different from an
individual's sex assigned at birth.
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 3.9 when a
positive, negative, adulterated, or substituted result cannot be
established for a specific drug or specimen validity test.
Laboratory. A permanent location where initial and confirmatory
drug testing, reporting of results, and recordkeeping are performed
under the supervision of a responsible person.
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 to an MRO when a specimen contains
no drug and/or drug metabolite; or the concentration of the drug or
drug metabolite is less than the cutoff for that drug or drug class.
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.
[[Page 70779]]
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, as indicated in the biomarker testing panel, 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 3.7.
Section 1.6 What is an agency required to do to protect employee
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 employee drug test results. All
contracts and the Privacy Act System of Records must specifically
require that employee records be maintained and used with the highest
regard for employee 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 safeguards
in place to protect the privacy of the information. For more
information regarding the HIPAA Privacy Rule, please visit <a href="https://www.hhs.gov/hipaa/index.html">https://www.hhs.gov/hipaa/index.html</a>.
Section 1.7 What is a refusal to take a federally regulated drug test?
(a) As a donor for a federally regulated drug test, you have
refused to take a federally regulated drug test if you:
(1) Fail 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) Fail to remain at the collection site until the collection
process is complete;
(3) Fail 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, fail
to permit the observation or monitoring of your provision of a specimen
when required as described in Sections 8.9 and 8.10;
(5) Fail 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) Fail or decline 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) Fail 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) Fail to cooperate with any part of the testing process (e.g.,
refuse to empty pockets when directed by the collector, disrupt the
collection process, fail to wash hands after being directed to do so by
the collector);
(9) For an observed collection, fail to follow the observer's
instructions related to the collection process;
(10) Bring materials to the collection site for the purpose of
adulterating, substituting, or diluting the specimen;
(11) Attempt to adulterate, substitute, or dilute the specimen;
(12) Possess or wear a prosthetic or other device that could be
used to interfere with the collection process; or
(13) Admit to the collector or MRO that you have 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
[[Page 70780]]
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) Federal agency applicant/Pre-employment test;
(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 3.4;
(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 biomarkers
as provided in the biomarker testing panel; and
(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) On a case-by-case basis, a specimen may be tested for
additional drugs, if a Federal agency is conducting the collection for
reasonable suspicion or post accident testing. A specimen collected
from a Federal agency employee may be tested by the Federal agency for
any drugs listed in Schedule I or II of the Controlled Substances Act.
The Federal 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 covered by these Guidelines must petition the
Secretary in writing for approval to routinely test for any drug class
not listed in the drug testing panel described under Section 3.4. 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 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 Federal agencies
specifically authorized by law to test a specimen for additional
classes of drugs in its workplace drug testing program.
Section 3.4 What are the drug and biomarker test analytes and cutoffs
for urine?
The Secretary will publish the drug and biomarker test analytes and
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing
panel'') for initial and confirmatory drug and biomarker tests in the
Federal Register each year. The drug and biomarker testing panels will
also be available on the internet at <a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>.
This drug testing panel will remain in effect until the effective
date of a new drug testing panel published in the Federal Register:
[[Page 70781]]
----------------------------------------------------------------------------------------------------------------
Confirmatory test Confirmatory test
Initial test analyte Initial test cutoff \1\ analyte cutoff
----------------------------------------------------------------------------------------------------------------
Marijuana metabolite (THCA) \2\...... 50 ng/mL\3\............ THCA................... 15 ng/mL.
Cocaine metabolite (Benzoylecgonine). 150 ng/mL\3\........... Benzoylecgonine........ 100 ng/mL.
Codeine/Morphine..................... 2000 ng/mL............. Codeine................ 2000 ng/mL.
Morphine............... 4000 ng/mL.
Hydrocodone/Hydromorphone............ 300 ng/mL.............. Hydrocodone............ 100 ng/mL.
Hydromorphone.......... 100 ng/mL.
Oxycodone/Oxymorphone................ 100 ng/mL.............. Oxycodone.............. 100 ng/mL.
Oxymorphone............ 100 ng/mL.
6-Acetylmorphine..................... 10 ng/mL............... 6-Acetylmorphine....... 10 ng/mL.
Phencyclidine........................ 25 ng/mL............... Phencyclidine.......... 25 ng/mL.
Amphetamine/Methamphetamine.......... 500 ng/mL.............. Amphetamine............ 250 ng/mL.
Methamphetamine........ 250 ng/mL.
MDMA \4\/MDA \5\..................... 500 ng/mL.............. MDMA................... 250 ng/mL.
MDA.................... 250 ng/mL.
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
test cutoff): Immunoassay: The test must be calibrated with one analyte from the group identified as the
target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80
percent or greater; if not, separate immunoassays must be used for the analytes within the group. Alternate
technology: Either one analyte or all analytes from the group must be used for calibration, depending on the
technology. At least one analyte within the group must have a concentration equal to or greater than the
initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the
laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol-9-carboxylic acid
(THCA).
\3\ Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for an alternate
technology initial test that is specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL for
benzoylecgonine).
\4\Methylenedioxymethamphetamine (MDMA).
\5\Methylenedioxyamphetamine (MDA).
(a) The drug testing panel will include drugs authorized for
testing in Federal workplace drug testing programs, with the required
test analytes and cutoffs;
(b) The biomarker testing panel will include biomarkers authorized
for testing in Federal workplace drug testing programs, with the
required test analytes and cutoffs; and
(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 3.5 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 3.6 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;
(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;
[[Page 70782]]
(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 3.7 What criteria are used to report a urine specimen as
substituted?
An HHS-certified laboratory reports a primary (A) 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 test analytes and cutoffs listed in the
biomarker testing panel).
Section 3.8 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 3.9 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 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.
Subpart D--Collectors
Section 4.1 Who may collect a 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 donor may only
collect that donor's specimen when no other collector is available. The
supervisor must be a trained collector.
(c) The hiring official of a Federal agency applicant may only
collect that Federal agency 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
[[Page 70783]]
who work with that employee on a daily basis.
(b) A Federal agency applicant or employee 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 employee (e.g., spouse, ex-spouse, relative) or be a
personal friend of the employee (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 employee so observed, 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 gender of the observer must be the same as the donor's
gender, which is determined by the donor's gender identity. 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.
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.
[[Page 70784]]
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.
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 gender as the
donor. The gender 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 gender, which is determined by the donor's gender identity. The
gender of the monitor for a monitored collection (i.e., as described in
Section 8.12) must be the same as the donor's gender, 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
[[Page 70785]]
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 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 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.
[[Page 70786]]
(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 employee 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 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.
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 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 each specimen bottle cap.
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
[[Page 70787]]
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 (Bottle A and Bottle 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
Bottle A urine 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 medical 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 gender must be the same as the
donor's gender, which is determined by the donor's gender identity,
with no exception to this requirement.
(b) Before an observer is selected, the collector informs the donor
that the gender of the observer will match the donor's gender, which is
determined by the donor's gender identity (as defined in Section 1.5).
The collector then selects the observer to conduct the observation:
(i) The collector asks the donor to identify the donor's gender on
the Federal CCF and initial it.
(ii) The donor will then be provided an observer whose gender
matches the donor's gender.
(iii) The collector documents the observer's name and gender on the
Federal CCF.
(c) If there is no collector available of the same gender as the
donor's gender, the collector or collection site supervisor shall
select an observer 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 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 gender
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 gender 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 employee and
[[Page 70788]]
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 employee 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 employee
takes the collection container directly to the collector as soon as the
employee 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 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.
[[Page 70789]]
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 classes listed 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) 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) Correctly identify at least 80 percent of the drug challenges
for 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
[[Page 70790]]
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. Additional information regarding
inspections is available from SAMHSA.
(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.
(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
[[Page 70791]]
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 an employee's 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 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.
[[Page 70792]]
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. This notice is also available on the
internet at <a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>.
(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 employee 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.
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
[[Page 70793]]
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 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.
[[Page 70794]]
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) Calibrators and controls must total at least 10 percent of the
aliquots 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 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.
[[Page 70795]]
Section 11.18 What are the requirements for conducting each specimen
validity test?
(a) 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.
(b) 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.
(c) 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 contro
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