Rule2023-21735
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
October 10, 2023
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 Oral Fluid (OFMG) which published in the Federal Register of October 25, 2019.
Full Text
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Rules and Regulations]
[Pages 70814-70850]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21735]
[[Page 70813]]
Vol. 88
Thursday,
No. 196
October 12, 2023
Part V
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 70814]]
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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 Oral Fluid (OFMG) which published
in the Federal Register of October 25, 2019.
DATES: The mandatory guidelines are effective October 10, 2023.
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#87c2f2e0e2e9e2a9cfe6fee2f4c7f4e6eaeff4e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="793c0c1e1c171c573118001c0a390a1814110a185711110a571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Executive Summary
These revised Mandatory Guidelines for Federal Workplace Drug
Testing Programs using Oral Fluid (OFMG) 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 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 Urine (UrMG) 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 UrMG, which include the same or similar revisions as the
OFMG, 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 OFMG, during which 53 commenters submitted 204 comments on
the OFMG. 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 OFMG 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.
Some submitted comments were specific to transportation industry
drug testing which is regulated by the Department of Transportation
(DOT). The Department has noted these comments below, but responded
only to comments that are relevant to these Guidelines. DOT issued a
notice of proposed rulemaking (NPRM) on February 28, 2022 (87 FR
11156). Subsequently, DOT extended the comment period to April 29, 2022
(87 FR 16160), and published the final rule on May 2, 2023 (88 FR
27596).
Authorized Drug Testing Panel
The Department requested comments on its proposal to publish the
drug testing panel separately from the OFMG in a Federal Register\[[[[p
Notification (FRN) each year. Fifteen commenters submitted a total of
40 comments on this topic for the OFMG.
Nine 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,
[[Page 70815]]
manufacturers of collection devices and/or immunoassay kits, as well as
Federal partners such as 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.
Information regarding any proposed changes to the drug 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 Notice, 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.
Three commenters specifically agreed with the need to streamline
and improve processes for making changes to the testing panels, but
expressed concern over the process for testing panel review and who
would be involved. These commenters 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 have opportunities to review and provide input.
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 has reviewed these
comments 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 OFMG (84 FR
57554) and has repeated the same information in that section below.
Two commenters suggested that the Department limit changes to every
few years (e.g., four to five years). The Department will not set such
time limits for panel changes. The need for more timely testing panel
changes was clearly explained in the preamble to the proposed
Guidelines.
Eight commenters were concerned that the Department will not allow
sufficient time for stakeholders to implement changes (e.g., time for
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 for implementation of all changes (e.g., 90 days, six
months) 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 multiple sources to assist in decision making.
In regard to the use of FDA-cleared collection devices and
immunoassay initial tests, four 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. Because the
Department does not address FDA clearance requirements for test systems
in the Mandatory Guidelines, the reference to FDA clearance for oral
fluid collection devices has been removed from Section 7.1. Applicant
and HHS-certified laboratories must verify that oral fluid collection
devices and test systems subject to FDA regulations are approved or
otherwise cleared by FDA and, in addition, must validate the oral fluid
collection devices and test systems prior to use in accordance with
requirements specified in the National Laboratory Certification Program
(NLCP) Manual for Oral Fluid Laboratories.
Two commenters 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
Notice 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.
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 OFMG in a Federal Register
Notification each year. Seven commenters submitted a total of 14
comments on this topic for the OFMG.
One commenter disagreed with specimen validity or biomarker testing
for oral fluid specimens, because all collections are observed and
collection devices are required to have volume indicators. The
commenter stated these tests would be unnecessary and increase costs.
The commenter also noted that the observed collections and required
inspection of the oral fluid reduced the risk of adulteration or
substitution. Four 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. The Department agrees that
there are no known effective subversion products for oral fluid
specimens at this time; however, such products may be available in the
future. The Department has also included examples in the HHS Oral Fluid
Specimen Handbook (posted on SAMHSA's website, <a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>) to assist trained collectors in identifying donor attempts
to tamper with the collection of their oral fluid specimen. The
Department is not requiring all certified laboratories to conduct oral
fluid specimen validity testing or 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 them to their
regulated clients, the Department will ensure that the tests provide
scientifically valid and forensically defensible results and will
revisit the
[[Page 70816]]
need for requiring the tests on all specimens.
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. 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.
Three commenters specifically agreed with the need to streamline
and improve processes for making changes to the testing panels. One of
these commenters noted that since there are no currently agreed-upon
analytes to assess OF validity and there may be differences in buffered
collection devices, determining a biomarker panel may be complex. The
other two commenters suggested involving other stakeholders (e.g., HHS-
certified laboratories, DTAB). A different commenter recommended that
the Department consult with immunoassay manufacturers and OF testing
laboratories to understand the scope of making proposed changes,
availability of materials/reagents, etc. As noted under Authorized drug
testing panel 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. Federal partners
will also have opportunities to review and provide input.
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 OFMG (84 FR 57554) and has repeated the
same information in that section below.
Medical Review Officer (MRO) Verification of Codeine and Morphine Test
Results
In Section 13.5, the Department removed the requirement for the MRO
to report specimens with morphine and/or codeine between the cutoff and
150 ng/mL as positive based on clinical evidence of illicit drug use
and, instead, directed the MRO to verify such specimens as negative
unless the donor admits to illegal opioid use that could have caused
the positive result. Four commenters agreed with this change.
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 eight comments on this topic for the
OFMG.
Three 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
stated that it was unclear what actions would be taken if the
Department disagreed with the MRO report. The third 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.
Two commenters disagreed on the basis of added costs and burden to
MROs. One claimed that this would result in MROs tracking and reporting
all results sent by the laboratory, as they are already required to
report positive results to the Federal Motor Carrier Safety
Administration (FMCSA) Clearinghouse. The other claimed that this would
require documentation and report generation for each non-negative
result, and expressed concern that smaller MRO practices could find the
process too time-consuming and costly to continue in the program.
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 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 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 OFMG in regard to
marijuana testing, but received comments from 21 commenters: 20
disagreed and one agreed with the current requirements. Seventeen
commenters supported medical use of marijuana. Some of these noted that
many doctors and medical professionals support the use of medical
marijuana and that many States have legalized marijuana for medical
use. Commenters expressed concern that Federal employees using
marijuana for health reasons could lose their jobs or benefits or that
Federal employees without access to medical marijuana may use other
drugs such as opioids. Three commenters supported legalization of
marijuana in general. One commenter stated that marijuana testing
should be removed from the Guidelines until research can establish
reliable levels to distinguish marijuana use from use of a legal hemp
product (i.e., as defined by the 2018 Farm Bill).
One commenter agreed with continuing to recognize marijuana as a
Schedule I drug, with zero tolerance for safety-sensitive positions.
The commenter stated that the liability and risk are not worth allowing
employees in safety-sensitive positions to use medical marijuana.
Current Federal law requires Federal agencies to test for marijuana
under E.O. 12564 in their workplace drug testing
[[Page 70817]]
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.
General Comments
Five commenters submitted general comments concerning the OFMG.
Three agreed with the use of oral fluid testing, citing benefits of
oral fluid as a testing matrix compared to urine (e.g., less invasive
collection is preferable for body/gender issues and the need to respect
donor privacy; reduces specimen tampering; eliminates need for same
gender observers; saves time). Two commenters disagreed with making any
changes to the previous OFMG (published October 25, 2019).
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 two disagreed with the Department's
proposed revision to the Substituted Specimen definition in Section 1.5
to include specimens tested for a biomarker.
Of the two commenters who disagreed, one 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 other commenter stated that there should be clear notice
and the opportunity to comment on specific biomarkers and criteria for
substitution and that HHS should continue to require laboratories to
report specimens as invalid based on normally occurring endogenous
substances that appear unusual but do not violate standards for
identified validity tests. The Department has reviewed the comments 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. Nine commenters
submitted a total of 16 comments on this proposal. Many of the
commenters referenced DOT drug testing requirements and/or
transportation industry issues that are not relevant to these
Guidelines.
Eight 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, specifies the time
consistent with 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.
Three commenters noted that the Guidelines should state that the
designated employer representative (DER) makes the determination of a
refusal to test. A fourth commenter noted that the employer, not the
collector, should determine whether a failure to appear for a pre-
employment test should be considered a refusal, as the collection site
may not know that a donor is coming or how much time the employer
allows the donor to complete a test. The Department has reviewed the
comments and determined that no change is needed. As stated in this
section, the Federal agency takes action consistent with applicable
agency regulations. Corresponding wording in Section 8.3 specifies that
the collector follows the Federal agency policy or contacts the Federal
agency representative to obtain guidance on action to be taken before
reporting a refusal to test because a donor does not arrive at an
assigned time.
One commenter suggested that the Department add procedures to
follow when the collection site cannot collect a specimen (e.g.,
collection site closed early, collection site ran out of supplies). The
Department disagrees with this suggestion. The applicant and/or the
collector should contact the Federal agency representative when a
situation beyond the applicant's control prevents completing a drug
test within the specified time.
Subpart B--Oral Fluid Specimens
Section 2.2 Under what circumstances may an oral fluid specimen be
collected?
In Section 2.2, the Department allows oral fluid to be used for any
type of testing conducted in Federal agency drug testing programs, and
had not proposed any changes. Six commenters submitted comments in
response to DOT's February 28, 2022 NPRM, regarding whether oral fluid
should be allowed for all or only some testing reasons.
Section 2.5 How is the split oral fluid specimen collected?
The Department did not propose any changes to the requirements for
split oral fluid collections in Sections 2.5 and 8.8 (How does the
collector prepare the oral fluid specimens?). In its February 28, 2022
NPRM, DOT prohibits serial or simultaneous collections of A and B oral
fluid specimens using two separate devices, which are allowed under the
OFMG. Four commenters requested that HHS and DOT harmonize their
requirements.
Three of the commenters requested a clear definition of ``single
device'' and the fourth commenter recommended that both HHS and DOT
specifically allow a device that collects a specimen that is then split
or divided into the primary (A) and split (B) specimens. HHS and DOT
have discussed oral fluid collection requirements. The Department will
retain the split specimen collection requirements in the current OFMG
which are based on current devices used in non-regulated drug testing
and also allow for development of additional device types validated to
meet program requirements. HHS-certified laboratories must ensure
compliance with DOT regulations for specimens collected and tested
under their regulations.
[[Page 70818]]
Subpart C--Oral Fluid Specimen Tests
Section 3.4 What are the drug and biomarker test analytes and cutoffs
for undiluted (neat) oral fluid?
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. Seven commenters
submitted 10 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 Notice, four commenters noted it is difficult and
requires substantial effort for stakeholders to make such changes to
their information technology (IT) systems. Three of 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. The other commenter stated that
``industry consensus'' should determine how analytes are identified.
This commenter also stated that standardizing nomenclature for urine
and oral fluid testing is not practical. 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. Two commenters recommended a
minimum of one-year implementation period after nomenclature changes
are published. Another commenter agreed with specifying nomenclature,
but noted that clear instructions will be needed for training and
updating databases. 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.
One commenter disagreed with requiring both cocaine and
benzoylecgonine as confirmatory test analytes, and recommended testing
oral fluid specimens for benzoylecgonine only. The commentor cited
their experience in testing for cocaine and metabolites in oral fluid;
however, the commentor did not provide a scientific literature citation
for their recommendation. SAMHSA has reviewed the literature and
disagrees that testing for benzoylecgonine alone yields the same
results as testing for both analytes. A 2010 dosing study showed that
testing for both cocaine and benzoylecgonine increases detection rates
in the periods 0.08-0.25 hours and 24-48 hours post-dosing as compared
to testing for cocaine or benzoylecgonine alone.\1\
The annual Federal Register Notification will be posted on the
SAMHSA website, <a href="https://www.samhsa.gov/workplace">https://www.samhsa.gov/workplace</a>. The table in Section
3.4 of these final Guidelines will remain in effect until the effective
date of the new panels published in the separate FRN.
Section 4.1 Who may collect a specimen?
One commenter submitted suggested rewording Section 4.1(a) to
require the collector to be trained on ``each manufacturer's procedures
for the collection device.'' The Department disagrees with the
suggested edit, which may be misconstrued as requiring a collector to
be trained on all devices. The current OFMG wording (i.e., ``the
manufacturer's procedures for the collection device'') is clear and
consistent with the Oral Fluid Specimen Collection Handbook.
Five commenters submitted comments in response to DOT's February
28, 2022 NPRM, regarding who may collect an oral fluid specimen.
Subpart F--Federal Drug Testing Custody and Control Form
Section 6.1 What Federal form is used to document custody and control?
The Department did not propose any changes to this section. One
commenter submitted a comment in response to DOT's February 28, 2022
NPRM, regarding maintaining a fax number on the Federal Custody and
Control Form (CCF).
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 G--Oral Fluid Specimen Collection Devices
Section 7.2 What are the requirements for an oral fluid collection
device?
In Section 7.2(b)(2), the Department added a requirement for oral
fluid specimen tubes to be sufficiently transparent to enable a visual
assessment of the contents without opening the tube. See also Section
8.5(a)(3). Two commenters disagreed with the term ``sufficiently
transparent,'' noting that opaque tubes would enable visual assessment.
The Department did not intend that all tubes must be entirely clear
(thus, the term ``sufficiently transparent''). An opaque tube would not
allow visual assessment of the contents. For clarity, the Department
has added ``(e.g., translucent)''.
In Section 7.2(b)(3), the Department added a requirement for the
collection device manufacturer to include the device lot expiration
date on each specimen tube, to enable the collector to verify that each
tube is within its expiration date prior to use. This is consistent
with the current Federal CCF and associated documents (i.e.,
Instructions for Completing the Federal CCF for Oral Fluid Specimen
Collection, Guidance for Using the Federal CCF) which require the
collector to verify the expiration date and mark the checkbox in Step 2
of the Federal CCF. The collector may, but is not required to, document
the expiration date on each tube in Step 4 of the CCF. Four commenters
disagreed with current requirements, stating that it is sufficient for
the collector and not the laboratory to document the expiration date of
each device on the Federal CCF. These commenters suggested that failure
of the collector to record the date could be recovered with a signed
memorandum for the record (MFR). Three of the four commenters also
stated that the expiration date would likely be covered by the label/
seal applied by the collector and noted changing to a transparent label
would incur additional costs, while the fourth noted that even a
partially transparent label would take time to develop and would not
eliminate concerns about label/seal placement. The Department has
[[Page 70819]]
reviewed the comments and determined that no change is needed to the
proposed OFMG. The expiration date is critical information supporting
the scientific and forensic defensibility of the test result, and the
laboratory must not test the specimen if it is unable to verify that
the device was within its expiration date at the time of collection. A
trained collector should avoid covering this information when placing
the label on the tube. If the collector records an incorrect expiration
date on the CCF, the laboratory corrects the information and is not
required to obtain an MFR from the collector to recover the error.
One commenter agreed that the manufacturer should include the lot
number and expiration date on each collection tube. The Department has
provided additional guidance to laboratories noting that if the
expiration date is not visible on the tube upon receipt and the device
lot number is visible, the laboratory may use that information to
recover the expiration date.
One of the commenters noted that the expiration date could be a
required field on an ECCF, preventing the collector from continuing the
collection without entering an expiration date. The Department agrees
that ECCF system providers could implement this safeguard, but this
does not obviate the need for the laboratory to verify the expiration
date on each tube, just as the laboratory must verify the specimen
identification number on each tube and the CCF.
Subpart H--Oral Fluid Specimen Collection Procedure
Section 8.3 What are the preliminary steps in the oral fluid specimen
collection procedure?
The Department proposed revisions to Section 8.3 consistent with
removal of refusal to test exceptions for pre-employment collections
(see Section 1.7), reordered collection steps (e.g., item d, item h.4),
and reworded items for clarity (e.g., items g and h). The Department
also added steps similar to those for urine collections to deter donor
attempts to adulterate or substitute the specimen. Eight commenters
submitted comments concerning this section.
In regard to determining a refusal to test, one commenter suggested
that the Department establish the beginning of the collection by
specifying that the collection begins when the collector has checked
the donor's identification. Another commenter who suggested the
Department retain exceptions for pre-employment drug test collections
(see Section 1.7) also suggested that this step be specified as the
beginning of a pre-employment collection. The Department has determined
that no revision is needed. The Guidelines clearly describe the
preliminary collection steps and specify that the collector reports a
refusal to test when a donor leaves the collection site before the
collection is complete.
To deter donor attempts to adulterate or substitute the specimen,
the Department proposed that the collector inspect the contents of the
donor's pockets only when the collector does not keep the donor under
direct observation until the end of the collection, including the 10-
minute wait period described in Section 8.3(h). If the donor refuses to
display the contents of their pockets, the collector will continue with
the oral fluid collection, but will keep the donor under their direct
observation and will not report this as a refusal to test. Five
commenters disagreed, stating that a donor's refusal to empty their
pockets should be reported as a refusal to test, for consistency with
requirements for a urine collection. The Department has considered
these comments and decided that no change is needed. The proposed
procedures facilitate the collection process and prevent specimen
tampering while maintaining donor privacy. There were no comments on
this topic; however, the Department added a sentence in item e 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.
One commenter expressed concern over the requirement in Section
8.3(h)(4) for the collector to direct the donor to remain at the
collection site until the end of the collection, stating that the
refusal to test could be cancelled if the donor claimed that the
collector did not mention this. The Department has determined that no
revision is needed. It is incumbent upon the collector to instruct the
donor throughout the collection process, including the instruction to
remain through the end of the collection, and to inform the donor of
the consequences for leaving early.
Section 8.4 What steps does the collector take in the collection
procedure before the donor provides an oral fluid specimen?
The Department added steps in Section 8.4 to deter donor attempts
to tamper with the specimen. Added item a requires the donor to wash
their hands under the collector's observation and to keep their hands
within view and avoid touching items or surfaces after handwashing.
Added Section 8.4(b)(1) specifies that the collector opens the package
containing the collection device in the presence of the donor. Five
commenters submitted comments on this section.
Two commenters stated that requiring the donor to wash their hands
was unnecessary and could cause a problem when the oral fluid
collection site has no sink or water. The commenters suggested allowing
the donor to wear gloves or use hand wipes as an alternative. The
Department has reviewed these comments and determined that no changes
are needed to the Guidelines. The instruction does not preclude the use
of other means of handwashing. The Department has included examples of
alternate means (e.g., alcohol-free hand wipes, moist towelette, or
hand sanitizer) in the Oral Fluid Specimen Collection Handbook.
The same two commenters suggested that the donor be instructed not
to touch the collection pad. The Department does not agree that this
added instruction is needed. The OFMG require the collector to be
present and maintain visual contact with the donor throughout the
collection, and specifically require the collector to go over the
manufacturer's instructions for use of the device with the donor,
observe the donor washing their hands before handling the device, and
observe the donor positioning the device in their mouth. If the
collector detects any conduct that clearly indicates an attempt to
tamper with the specimen, the collector reports a refusal to test.
One commenter stated that requiring the donor to avoid touching
items or surfaces was unnecessary and unreasonable. Two others agreed
that the donor should not touch items that they brought with them after
washing their hands, but stated that it may be difficult for the donor
to avoid touching surfaces at the collection site. The Department has
reviewed the comments and determined that no changes are needed to the
Guidelines. The instruction to not touch items or surfaces at the
collection site is a reasonable precaution, and compliance should not
be difficult for the donor.
Another commenter specifically agreed with added Section 8.4(a)(1),
noting this would eliminate errors and attempts to subvert the test.
In regard to added Section 8.4(b)(1), three commenters disagreed
with the collector opening the package containing the collection
device. Two recommended that the donor open the package, because some
devices that are
[[Page 70820]]
inserted into the donor's mouth may not be separately wrapped. A third
commenter disagreed, stating that a donor could argue that the
collector contaminated the device when opening the package. This
commenter also noted that remote collections would not be possible if
the collector was required to open the package. The Department has
reviewed the comments and determined that no change is needed to the
Guidelines. Collectors must be trained to maintain the integrity of the
specimen (per Section 4.4), and remotely viewed collections are not
allowed (i.e., the collector must be present).
Another commenter suggested adding the instruction for the
collector to verify and record the device expiration date in Section
8.4(b)(1). The Department agrees with the commenter in part, and has
edited Section 8.4(b) to state that each device used must be within the
manufacturer's expiration date and inserted a new Section 8.4(c)
requiring the collector to verify that each device is within its
expiration date prior to use and to document the action on the Federal
CCF. As discussed under Section 7.2 above, the Department disagrees
with requiring the collector and not the laboratory to record the
expiration date.
Section 8.6 What procedure is used when the donor states that they are
unable to provide an oral fluid specimen?
One commenter suggested that the Department clarify how many
collection attempts should be allowed when a donor is unable to provide
a sufficient specimen and recommended that only one additional attempt
be allowed to limit costs. The Department reviewed the comment and
determined that no change is needed to the proposed Guidelines. As
noted in the preamble to the current OFMG, the Department set the time
limit but did not set a limit for the number of attempts because there
may be different reasons for failing to collect the specimen from the
donor.
Section 8.8 How does the collector prepare the oral fluid specimens?
Comments relating to Section 8.8 are addressed under Section 2.5
above.
Section 8.9 How does the collector report a donor's refusal to test?
One commenter disagreed with the requirement for the collector to
send all copies of the Federal CCF to the Federal agency's designated
representative, and stated that the collector should keep the Collector
Copy and give the Donor Copy to the donor. The Department has reviewed
the comment and determined that no change is needed. The current
wording reflects HHS requirements.
Subpart M--Medical Review Officer (MRO)
Section 13.3 What training is required before a physician may serve as
an MRO?
Two commenters submitted comments on this section. One commenter
stated that the requirements for additional MRO training in the section
are unclear and should be revised to clarify requirements (e.g., what
must training consist of, must the MRO take another certification exam,
would training be required for annual panel changes). This commenter
also suggested that MROs register with SAMHSA to get updates/
announcements and acknowledge review of that information. A second
commenter indicated that new and existing MROs should receive
additional training for oral fluid testing (e.g., collection procedures
and documentation; differences in drug detection times for oral fluid
and urine; urine and oral fluid cutoffs; criteria for substituted,
adulterated, and refusal to test results; dry mouth scenarios; and
effect of pre-existing conditions on ability to provide oral fluid).
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 Oral Fluid 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 an oral fluid
specimen's test results?
The Department received three comments on its proposed revisions to
Section 13.5.
One commenter agreed with the Department's proposed revision to
item 13.5(b)(2) clarifying that the MRO acts on an invalid result only
when the MRO has verified the other results for the specimen as
negative or when the split specimen was reported as a failure to
reconfirm.
The Department revised Section 13.5(c)(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 clarified existing item ii regarding ingestion of food
products containing a drug and added a new item iii. Although an
increased number of States have authorized marijuana use for medical
purposes, marijuana remains a Schedule 1 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, so 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 OFMG 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).
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory to report
an oral fluid specimen as rejected for testing?
As noted in Section 7.2(b), an oral fluid collection device must
have an indicator that demonstrates the adequacy of the volume of oral
fluid specimen collected. Because the oral fluid specimen volume is
critical for determining the specimen concentration, the collector must
document that they observed the volume indicator(s) at the time of
collection. The Department has revised Section 15.1 (i.e., new
paragraph (e)) specifying that the laboratory must reject the specimen
when the collector failed to document observation of the volume
indicator at the time of collection. This is consistent with current
program documents (e.g., Oral Fluid Specimen Collection Handbook for
Federal Agency Workplace Drug
[[Page 70821]]
Testing Programs, Collection Site Manual, and Medical Review Officer
Guidance Manual) posted on the SAMSHSA website, as well as the NLCP
Manual for Oral Fluid Laboratories.
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 depend on the extent to which these agencies
incorporate the OFMG 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, a ``significant regulatory action'' is 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 OFMG (87 FR 20522),
and requested public comment on all estimates and assumptions. Three
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.
One commenter stated that the Department did not consider costs to
MROs for training and education to bring MROs and MRO staff up to date
on new drug panels and reporting methods. This commenter requested that
the MRO community be allowed input to testing panel and nomenclature
changes to enable adequate staffing and preparation. Another commenter
disagreed with the Department's statement in the preamble to the
proposed OFMG 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 OFMG. 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 oral fluid drug testing for Federal agencies under authority
of 5 U.S.C. 7301 and Executive Order 12564, are approved by the Office
of Management and Budget (OMB) under control number 0930-0158. The
Federal Drug Testing Custody and Control Form (Federal CCF) used to
document the collection and chain of custody of urine and oral fluid
specimens at the collection site, for laboratories to report results,
and for Medical Review Officers to make a determination; the National
Laboratory Certification Program (NLCP) application; the NLCP
Laboratory Information Checklist; and recordkeeping requirements in the
current Guidelines, as approved under control number 0930-0158, will
remain in effect.
In support of the Government Paperwork Reduction Act (PRA), the
[[Page 70822]]
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 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 Oral Fluid
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: 10,500 donors who apply for employment or are
employed in testing designated positions, 100 collectors, 10 oral fluid
specimen testing laboratories, 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 10 1 3 30
required to submit
application for
certification.
9.10(a)(3)........... Materials to submit to 10 1 2 20
become an HHS inspector.
11.3................. Laboratory submits 10 1 2 20
qualifications of
responsible person (RP)
to HHS.
11.4(c).............. Laboratory submits 10 1 2 20
information to HHS on
new RP or alternate RP.
11.20................ Specifications for 10 5 0.5 25
laboratory semiannual
statistical report of
test results to each
Federal agency.
13.8 and 14.7........ Specifies that MRO must 100 14 0.05 (3 min) 70
report all verified
primary and split
specimen test results to
the Federal agency.
13.11................ Specifications for MRO 100 2 0.5 100
semiannual 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 1 1 3 3
request for informal
review of suspension/
proposed revocation of
certification.
16.4................. Specifies information 1 1 0.5 0.5
appellant provides in
first written submission
when laboratory
suspension/revocation is
proposed.
16.6................. Requires appellant to 1 1 0.5 0.5
notify reviewing
official of resolution
status at end of
abeyance period.
16.7(a).............. Specifies contents of 1 1 50 50
appellant submission for
review.
16.9(a).............. Specifies content of 1 1 3 3
appellant request for
expedited review of
suspension or proposed
revocation.
16.9(c).............. Specifies contents of 1 1 50 50
review file and briefs.
---------------------------------------------------------------
Total............ ......................... 256 .............. .............. 392
----------------------------------------------------------------------------------------------------------------
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 an oral fluid 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.
[[Page 70823]]
Estimate of Annual Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of Responses/
Section Purpose respondents respondent Hours/ response Total hours
----------------------------------------------------------------------------------------------------------------
8.3(a), 8.6(b)(2)....... Collector must 100 1 0.05 (3 min).... 5
contact Federal
agency point of
contact.
11.21, 11.22............ Information on drug 25 10 3............... 750
test that
laboratory must
provide to Federal
agency upon request
or to donor through
MRO.
13.9(b)................. MRO must inform 100 14 3............... 4,200
donor of right to
request split
specimen test when
a positive,
adulterated, or
substituted result
is reported.
-----------------------------------------------------------------
Total............... .................... 225 .............. ................ 4,955
----------------------------------------------------------------------------------------------------------------
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(h)). 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/
Section Purpose respondents respondent Hours/ response Total hours
----------------------------------------------------------------------------------------------------------------
8.3, 8.4, 8.5, 8.8...... Collector completes 100 380 0.07 (4 min).... 2,660
Federal CCF for
specimen collected.
8.8(d) & (f)............ Donor initials 38,000 1 0.08 (5 min).... 3,040
specimen labels/
seals and signs
statement on the
Federal CCF.
11.8(a) & 11.17......... Laboratory completes 25 1,520 0.05 (3 min).... 1,900
Federal CCF upon
receipt of specimen
and before
reporting result.
13.4(d)(4), 13.8(c), MRO completes 100 380 0.05 (3 min).... 1,900
14.7(c). Federal CCF before
reporting the
primary or split
specimen result.
14.1(b)................. MRO documents 100 2 0.05 (3 min).... 10
donor's request to
have split specimen
tested.
-----------------------------------------------------------------
Total............... .................... 38,325 .............. ................ 9,510
----------------------------------------------------------------------------------------------------------------
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 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 (Section
8.4(e)) requires collectors to enter any information on the Federal CCF
of any unusual findings during the oral fluid 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; 11.10(a); 11.13(a);
11.16; 11.19(a), (b), and (c); 11.20; 11.21(a) and 11.22). 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 oral fluid specimens by the laboratories is estimated to be 13,221
hours (that is, the sum of the total hours from the above tables).
Because of the expected transition from urine to oral fluid testing,
this number will replace some of 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.
References
1. Scheidweiler K.B., Spargo E.A., Kelly T.L., Cone E.J., Barnes
A.J., Huestis M.A., 2010. Pharmacokinetics of cocaine and
metabolites in human oral fluid and correlation with plasma
concentrations after controlled administration. Ther Drug Monit.,
32(5), 628-37.
Dated: September 27, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Oral Fluid Specimens
Subpart A--Applicability
1.1 To whom do these Guidelines apply?
[[Page 70824]]
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--Oral Fluid Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may an oral fluid specimen be collected?
2.3 How is each oral fluid specimen collected?
2.4 What volume of oral fluid is collected?
2.5 How is the split oral fluid specimen collected?
2.6 When may an entity or individual release an oral fluid specimen?
Subpart C--Oral Fluid Specimen Tests
3.1 Which tests are conducted on an oral fluid 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
undiluted (neat) oral fluid?
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 an oral fluid specimen as
adulterated?
3.7 What criteria are used to report an oral fluid specimen as
substituted?
3.8 What criteria are used to report an invalid result for an oral
fluid 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 a trainer for collectors?
4.5 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 an oral fluid
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--Oral Fluid Specimen Collection Devices
7.1 What is used to collect an oral fluid specimen?
7.2 What are the requirements for an oral fluid collection device?
7.3 What are the minimum performance requirements for a collection
device?
Subpart H--Oral Fluid Specimen Collection Procedure
8.1 What privacy must the donor be given when providing an oral fluid
specimen?
8.2 What must the collector ensure at the collection site before
starting an oral fluid specimen collection?
8.3 What are the preliminary steps in the oral fluid specimen
collection procedure?
8.4 What steps does the collector take in the collection procedure
before the donor provides an oral fluid specimen?
8.5 What steps does the collector take during and after the oral fluid
specimen collection procedure?
8.6 What procedure is used when the donor states that they are unable
to provide an oral fluid specimen?
8.7 If the donor is unable to provide an oral fluid specimen, may
another specimen type be collected for testing?
8.8 How does the collector prepare the oral fluid specimens?
8.9 How does the collector report a donor's refusal to test?
8.10 What are a Federal agency's responsibilities for a collection
site?
Subpart I--HHS Certification of Laboratories
9.1 Who has the authority to certify laboratories to test oral fluid
specimens for Federal agencies?
9.2 What is the process for a laboratory to become HHS-certified?
9.3 What is the process for a laboratory to maintain HHS certification?
9.4 What is the process when a laboratory 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 oral fluid testing?
9.7 What are the PT requirements for an HHS-certified oral fluid
laboratory?
9.8 What are the inspection requirements for an applicant laboratory?
9.9 What are the maintenance inspection requirements for an HHS-
certified laboratory?
9.10 Who can inspect an HHS-certified laboratory and when may the
inspection be conducted?
9.11 What happens if an applicant laboratory does not satisfy the
minimum requirements for either the PT program or the inspection
program?
9.12 What happens if an HHS-certified laboratory does not satisfy the
minimum requirements for either the PT program or the inspection
program?
9.13 What factors are considered in determining whether revocation of a
laboratory's HHS certification is necessary?
9.14 What factors are considered in determining whether to suspend a
laboratory's HHS certification?
9.15 How does the Secretary notify an HHS-certified laboratory that
action is being taken against the laboratory?
9.16 May a laboratory that had its HHS certification revoked be
recertified to test Federal agency specimens?
9.17 Where is the list of HHS-certified laboratories 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?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory?
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?
[[Page 70825]]
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 are the requirements for an initial drug test?
11.10 What must an HHS-certified laboratory do to validate an initial
drug test?
11.11 What are the batch quality control requirements when conducting
an initial drug test?
11.12 What are the requirements for a confirmatory drug test?
11.13 What must an HHS-certified laboratory do to validate a
confirmatory drug test?
11.14 What are the batch quality control requirements when conducting a
confirmatory drug test?
11.15 What are the analytical and quality control requirements for
conducting specimen validity tests?
11.16 What must an HHS-certified laboratory do to validate a specimen
validity test?
11.17 What are the requirements for an HHS-certified laboratory to
report a test result?
11.18 How long must an HHS-certified laboratory retain specimens?
11.19 How long must an HHS-certified laboratory retain records?
11.20 What statistical summary reports must an HHS-certified laboratory
provide for oral fluid testing?
11.21 What HHS-certified laboratory information is available to a
Federal agency?
11.22 What HHS-certified laboratory information is available to a
Federal employee?
11.23 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 May an IITF test oral fluid specimens for a Federal agency's
workplace drug testing program?
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 an oral fluid 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 oral fluid for a drug
test?
13.7 What happens when an individual is unable to provide a sufficient
amount of oral fluid 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?
13.11 What reports must an MRO provide to the Secretary for oral fluid
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) oral fluid
specimen when the primary (A) specimen was reported adulterated?
14.4 How does an HHS-certified laboratory test a split (B) oral fluid
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) oral
fluid 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 to report
an oral fluid specimen as rejected for testing?
15.2 What discrepancies require an HHS-certified laboratory 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 to reject an oral fluid 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 Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory 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 that provide drug testing services to the Federal
agencies;
[[Page 70826]]
(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 Technology Initial Drug Test. An initial drug test using
technology other than immunoassay to differentiate negative specimens
from those requiring further testing.
Batch. A number of specimens or aliquots handled concurrently as a
group.
Biomarker. An endogenous substance used to validate a biological
specimen.
Biomarker Testing Panel. The panel published in the Federal
Register that includes the biomarkers authorized for testing, with
analytes and cutoffs for initial and confirmatory biomarker tests, as
described under Section 3.4.
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 Device. A product that is used to collect an oral fluid
specimen and may include a buffer or diluent.
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.
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)
[[Page 70827]]
approved form that is used to document the collection and chain of
custody of a specimen from the time the specimen is collected until it
is received by the test facility (i.e., HHS-certified laboratory or,
for urine, HHS-certified IITF). It may be a paper (hardcopy),
electronic(digital), or combination electronic and paper format
(hybrid). The form may also be used to report the test result to the
Medical Review Officer.
HHS. The Department of Health and Human Services.
Initial Drug Test. An analysis used to differentiate negative
specimens from those requiring further testing.
Initial Specimen Validity Test. The first analysis used to
determine if a specimen is adulterated, invalid, substituted, or (for
urine) dilute.
Instrumented Initial Test Facility (IITF). A permanent location
where (for urine) initial testing, reporting of results, and
recordkeeping are performed under the supervision of a responsible
technician.
Invalid Result. The result reported by an HHS-certified laboratory
in accordance with the criteria established in Section 3.8 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, oral fluid collection device) 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.
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.
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 Oral Fluid). A collection in which
two specimens (primary [A] and split [B]) are collected, concurrently
or serially, and independently sealed in the presence of the donor; or
a collection in which a single specimen is collected using a single
collection device and is subdivided 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 urine specimen as substituted in the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Urine
(UrMG), Section 3.7.
Undiluted (neat) oral fluid. An oral fluid specimen to which no
other solid or liquid has been added. For example, see Section 2.4: a
collection device that uses a diluent (or other component, process, or
method that modifies the volume of the testable specimen) must collect
at least 1 mL of undiluted (neat) oral fluid.
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, 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:
[[Page 70828]]
(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 (e.g., oral fluid or another
authorized specimen type) for any drug test required by these
Guidelines or Federal agency regulations;
(4) Fail to provide a sufficient amount of oral fluid 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;
(5) Fail or decline to participate in an alternate specimen
collection (e.g., urine) as directed by the Federal agency or collector
(i.e., as described in Section 8.6);
(6) 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;
(7) Fail to cooperate with any part of the testing process (e.g.,
disrupt the collection process, fail to rinse the mouth or wash hands
after being directed to do so by the collector, refuse to provide a
split specimen);
(8) Bring materials to the collection site for the purpose of
adulterating, substituting, or diluting the specimen;
(9) Attempt to adulterate, substitute, or dilute the specimen; or
(10) 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 8.9. Required action includes
immediately notifying the Federal agency's designated representative by
any means (e.g., telephone, email, or secure facsimile [fax] machine)
that ensures that the refusal notification is immediately received and,
if a Federal CCF has been initiated, documenting the refusal on the
Federal CCF, signing and dating the Federal CCF, and sending all copies
of the Federal CCF to the Federal agency's designated representative.
(c) When documenting a refusal to test during the verification
process as described in Sections 13.4, 13.5, and 13.6, the MRO must
complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
Subpart B--Oral Fluid Specimens
Section 2.1 What type of specimen may be collected?
A Federal agency may collect oral fluid 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 oral fluid must
follow these Guidelines.
Section 2.2 Under what circumstances may an oral fluid specimen be
collected?
A Federal agency may collect an oral fluid 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 oral fluid specimen collected?
Each oral fluid specimen is collected as a split specimen (i.e.,
collected either simultaneously or serially) as described in Sections
2.5 and 8.8.
Section 2.4 What volume of oral fluid is collected?
A volume of at least 1 mL of undiluted (neat) oral fluid for each
oral fluid specimen (designated ``Tube A'' and ``Tube B'') is collected
using a collection device. If the device does not include a diluent (or
other component, process, or method that modifies the volume of the
testable specimen), the A and B tubes must have a volume marking
clearly noting a level of 1 mL.
Section 2.5 How is the split oral fluid specimen collected?
The collector collects at least 1 mL of undiluted (neat) oral fluid
in a collection device designated as ``A'' (primary) and at least 1 mL
of undiluted (neat) oral fluid in a collection device designated as
``B'' (split) either simultaneously or serially (i.e., using two
devices or using one device and subdividing the specimen), as described
in Section 8.8.
Section 2.6 When may an entity or individual release an oral fluid
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--Oral Fluid Specimen Tests
Section 3.1 Which tests are conducted on an oral fluid specimen?
A Federal agency:
(a) Must ensure that each specimen is tested for marijuana and
cocaine 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) Is authorized upon a Medical Review Officer's request to test
an oral fluid specimen to determine specimen validity using, for
example, a test for a specific adulterant;
(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
[[Page 70829]]
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 undiluted (neat) oral fluid?
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:
----------------------------------------------------------------------------------------------------------------
Confirmatory test Confirmatory test
Initial test analyte Initial test cutoff \1\ analyte cutoff
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\................. 4 ng/mL \3\............. THC.................... 2 ng/mL.
Cocaine/Benzoylecgonine............. 15 ng/mL................ Cocaine................ 8 ng/mL.
Benzoylecgonine........ 8 ng/mL.
Codeine/Morphine.................... 30 ng/mL................ Codeine................ 15 ng/mL.
Morphine............... 15 ng/mL.
Hydrocodone/Hydromorphone........... 30 ng/mL................ Hydrocodone............ 15 ng/mL.
Hydromorphone.......... 15 ng/mL.
Oxycodone/Oxymorphone............... 30 ng/mL................ Oxycodone.............. 15 ng/mL.
Oxymorphone............ 15 ng/mL.
6-Acetylmorphine.................... 4 ng/mL\3\.............. 6-Acetylmorphine....... 2 ng/mL.
Phencyclidine....................... 10 ng/mL................ Phencyclidine.......... 10 ng/mL.
Amphetamine/Methamphetamine......... 50 ng/mL................ Amphetamine............ 25 ng/mL.
Methamphetamine........ 25 ng/mL.
MDMA \4\/MDA \5\.................... 50 ng/mL................ MDMA................... 25 ng/mL.
MDA.................... 25 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 (THC).
\3\ Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology
initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
\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 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., 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.
[[Page 70830]]
Section 3.6 What criteria are used to report an oral fluid specimen as
adulterated?
An HHS-certified laboratory reports a primary (A) specimen as
adulterated when the presence of an adulterant 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 an oral fluid specimen as
substituted?
An HHS-certified laboratory reports a primary (A) specimen as
substituted when a biomarker is not detected or is present at a
concentration inconsistent with that established for human oral fluid
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 an invalid result for an
oral fluid specimen?
An HHS-certified laboratory reports a primary (A) oral fluid
specimen as an invalid result when:
(a) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(b) Interference with the confirmatory drug test occurs on two
separate aliquots of the specimen and the laboratory is unable to
identify the interfering substance;
(c) The physical appearance of the specimen (e.g., viscosity) is
such that testing the specimen may damage the laboratory's instruments;
(d) The specimen has been tested and the appearances of the primary
(A) and the split (B) specimens (e.g., color) are clearly different; or
(e) A specimen validity test 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 oral fluid
specimens in accordance with these Guidelines and the manufacturer's
procedures for the collection device.
(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 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 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 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 use the specific oral fluid
collection device. Training must include the following:
(i) All steps necessary to complete an oral fluid 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 two uneventful
collection scenarios, one insufficient specimen quantity 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 tube
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 a trainer for collectors?
(a) Individuals are considered qualified trainers for collectors
for a specific oral fluid collection device and may train others to
collect oral fluid specimens using that collection device when they
have completed the following:
(1) Qualified as a trained collector and regularly conducted oral
fluid drug test collections using that collection device 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 4.5 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.
[[Page 70831]]
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 an oral
fluid specimen (e.g., an accident investigation), another site may be
used for the collection, providing the collection is performed by a
collector who has been trained to collect oral fluid specimens in
accordance with these Guidelines and the manufacturer's procedures for
the collection device.
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;
(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; and
(f) A restricted access area for the secure storage of records.
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 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.
Section 5.6 What are the privacy requirements when collecting an oral
fluid 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 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 must handle and test the specimen as a Federal agency
specimen.
(c) If the HHS-certified laboratory or MRO discovers that the
collector used an incorrect form, the laboratory 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 reports a rejected for testing result to the
MRO and the MRO cancels the test. The HHS-certified laboratory 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--Oral Fluid Specimen Collection Devices
Section 7.1 What is used to collect an oral fluid specimen?
A single-use collection device intended to collect an oral fluid
specimen must be used. This collection device must maintain the
integrity of such specimens during storage and transport so that the
specimen contained therein can be tested in an HHS-certified laboratory
for the presence of drugs or their metabolites.
Section 7.2 What are the requirements for an oral fluid collection
device?
An oral fluid specimen collection device must provide:
(a) An indicator that demonstrates the adequacy of the volume of
oral fluid specimen collected;
(b) One or two sealable, non-leaking tubes [depending on the device
type, as described in Section 8.8(a)] that:
(1) maintain the integrity of the specimen during storage and
transport so that the specimen contained therein can be tested in an
HHS-certified laboratory for the presence of drugs or their
metabolites,
(2) are sufficiently transparent (e.g., translucent) to enable a
visual assessment of the contents (i.e., oral fluid, buffer/diluent,
collection pad) for identification of abnormal physical characteristics
without opening the tube, and
(3) include the device lot expiration date on each specimen tube
(i.e., the expiration date of the buffer/diluent or, for devices
without a buffer/diluent, the earliest expiration date of any device
component);
(c) Components that ensure pre-analytical drug and drug metabolite
stability; and
(d) Components that do not substantially affect the composition of
drugs and/or drug metabolites in the oral fluid specimen.
[[Page 70832]]
Section 7.3 What are the minimum performance requirements for a
collection device?
An oral fluid collection device must meet the following minimum
performance requirements.
(a) Reliable collection of a minimum of 1 mL of undiluted (neat)
oral fluid;
(b) If the collection device contains a diluent (or other
component, process, or method that modifies the volume of the testable
specimen):
(1) The volume of oral fluid collected should be at least 1.0 mL
<plus-minus>10 percent, and
(2) The volume of diluent in the device should be within <plus-
minus>2.5 percent of the diluent target volume;
(c) Stability (recoverable concentrations >=80 percent of the
concentration at the time of collection) of the drugs and/or drug
metabolites for five days at room temperature (64-77 [deg]F/18-25
[deg]C) and under the manufacturer's intended shipping and storage
conditions; and
(d) Recover >=80 percent (but no more than 120 percent) of drug
and/or drug metabolite in the undiluted (neat) oral fluid at (or near)
the initial test cutoff listed in the drug testing panel.
Subpart H--Oral Fluid Specimen Collection Procedure
Section 8.1 What privacy must the donor be given when providing an oral
fluid specimen?
The following privacy requirements apply when a donor is providing
an oral fluid 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.
Section 8.2 What must the collector ensure at the collection site
before starting an oral fluid specimen collection?
The collector must take all reasonable steps to prevent the
adulteration or substitution of an oral fluid specimen at the
collection site.
Section 8.3 What are the preliminary steps in the oral fluid specimen
collection procedure?
The collector must take the following steps before beginning an
oral fluid 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 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 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 oral fluid 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.
(f) If the donor will remain under the collector's direct
observation until the end of the collection, including the 10-minute
wait period described in Section 8.3(h), the collector proceeds to
Section 8.3(g). If the collector will not keep the donor under direct
observation from this point until the end of the collection, 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 or
substitute 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 or
substitute 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 8.9.
(3) If an item that could be used to adulterate or substitute the
specimen (e.g., common personal care products such as mouthwash,
lozenges, capsules) 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, the collector must keep the donor under direct observation
until the end of the oral fluid collection.
(g) The collector requests that the donor open the donor's mouth,
and the collector inspects the oral cavity to ensure that it is free of
any items (e.g., candy, gum, food, tobacco) that could impede or
interfere with the collection of an oral fluid specimen or items that
could be used to adulterate, substitute, or dilute the specimen.
(1) If an item is present that whose purpose is to adulterate or
substitute the specimen (e.g., a commercial drug culture product or
other item 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 8.9.
(2) If an item is present that could impede or interfere with the
collection of an oral fluid specimen (including abnormally colored
saliva), or the donor claims to have ``dry mouth,'' the collector gives
the donor water (e.g., up to 4 oz.) to rinse their mouth. The donor may
drink the water. If the donor refuses to remove the item or refuses to
rinse, this is a refusal to test.
(3) If the donor claims that they have a medical condition that
prevents opening their mouth for inspection, the collector follows the
procedure in Section 8.6(b)(2).
(h) The collector must initiate a 10-minute wait period prior to
collecting the specimen. During these 10 minutes, the collector must:
(1) Explain the basic collection procedure to the donor;
(2) Provide the instructions for completing the Federal CCF for the
donor's review, and informs the donor that these instructions and the
collection device-specific instructions are available upon request.
(3) Answer any reasonable and appropriate questions the donor may
have regarding the collection procedure; and
(4) Inform the donor that they must remain at the collection site
(i.e., in the area designated by the collector) during the wait period,
and that failure to follow these instructions will be reported as a
refusal to test.
[[Page 70833]]
Section 8.4 What steps does the collector take in the collection
procedure before the donor provides an oral fluid specimen?
(a) The collector shall instruct the donor to wash and dry the
donor's hands under the collector's observation, and to keep their
hands within view and avoid touching items or surfaces after
handwashing. If the donor refuses to wash their hands when instructed
by the collector, this is a refusal to test.
(b) The collector will provide or the donor may select the specimen
collection device(s) to be used for the collection. The device(s) must
be clean, unused, and wrapped/sealed in original packaging and must be
within the manufacturer's expiration date printed on the specimen tube.
See Section 8.8(a) for types of specimen collection devices used for
oral fluid split specimen collections.
(1) The collector will open the package in view of the donor.
(2) Both the collector and the donor must keep the unwrapped
collection devices in view at all times until each collection device
containing the donor's oral fluid specimen has been sealed and labeled.
(c) The collector verifies that each device is within the
manufacturer's expiration date, and documents this action on the
Federal CCF.
(d) The collector reviews with the donor the procedures required
for a successful oral fluid specimen collection as stated in the
manufacturer's instructions for the specimen collection device.
(e) 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., an
attempt to prevent the device from collecting sufficient oral fluid; an
attempt to bring into the collection site an adulterant or oral fluid
substitute), the collector must report a refusal to test in accordance
with Section 8.9.
Section 8.5 What steps does the collector take during and after the
oral fluid specimen collection procedure?
Integrity and Identity of the Specimen. The collector must take the
following steps during and after the donor provides the oral fluid
specimen:
(a) The collector shall be present and maintain visual contact with
the donor during the procedures outlined in this section.
(1) Under the observation of the collector, the donor is
responsible for positioning the specimen collection device for
collection. The collector must ensure the collection is performed
correctly and that the collection device is working properly. If there
is a failure to collect the specimen, the collector must begin the
process again, beginning with Step 8.4(b), using a new specimen
collection device (for both A and B specimens) and notes the failed
collection attempt on the Federal CCF. If the donor states that they
are unable to provide an oral fluid specimen during the collection
process or after multiple failures to collect the specimen, the
collector follows the procedure in Section 8.6.
(2) The donor and the collector must complete the collection in
accordance with the manufacturer instructions for the collection
device.
(3) The collector must inspect the specimen to determine if there
is any sign indicating that the specimen may not be a valid oral fluid
specimen (e.g., unusual color, presence of foreign objects or
material), documents any unusual findings on the Federal CCF, and takes
action (e.g., recollection) to obtain an acceptable specimen.
(b) If the donor fails to remain present through the completion of
the collection, fails to follow the instructions for the collection
device, refuses to begin the collection process after a failure to
collect the specimen as required in Section 8.5(a)(1), refuses to
provide a split specimen as instructed by the collector, or refuses to
provide an alternate specimen when directed to do so, the collector
stops the collection and reports the refusal to test in accordance with
Section 8.9.
Section 8.6 What procedure is used when the donor states that they are
unable to provide an oral fluid specimen?
(a) If the donor states that they are unable to provide an oral
fluid specimen during the collection process, the collector requests
that the donor follow the collector instructions and attempt to provide
an oral fluid specimen.
(b) The donor demonstrates their inability to provide a specimen
when, after 15 minutes of using the collection device, there is
insufficient volume or no oral fluid collected using the device.
(1) If the donor states that they could provide a specimen after
drinking some fluids, the collector gives the donor a drink (up to 8
ounces) and waits an additional 10 minutes before beginning the
specimen collection (a period of 1 hour must be provided or until the
donor has provided a sufficient oral fluid specimen). If the donor
simply needs more time before attempting to provide an oral fluid
specimen, the donor may choose not to drink any fluids during the 1
hour wait time. The collector must inform the donor that the donor must
remain at the collection site (i.e., in an area designated by the
collector) during the wait period.
(2) If the donor states that they are unable to provide an oral
fluid specimen, the collector records the reason for not collecting an
oral fluid 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 an oral fluid 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 oral fluid specimens?
(a) All Federal agency collections are to be split specimen
collections. An oral fluid split specimen collection may be:
(1) Two specimens collected simultaneously with two separate
collection devices;
(2) Two specimens collected serially with two separate collection
devices. The donor is not allowed to drink or rinse their mouth between
the two collections. Collection of the second specimen must begin
within two minutes after the completion of the first collection and
recorded on the Federal CCF;
(3) Two specimens collected simultaneously using a single
collection device that directs the oral fluid into two separate
collection tubes; or
(4) A single specimen collected using a single collection device,
that is subsequently subdivided into two specimens.
(b) A volume of at least 1 mL of undiluted (neat) oral fluid is
collected for the specimen designated as ``Tube
[[Page 70834]]
A'' and a volume of at least 1 mL of undiluted (neat) oral fluid is
collected for the specimen designated as ``Tube B''.
(c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over the cap of each specimen
tube. 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 tube. If the donor refuses to initial the
labels/seals, the collector notes the refusal on the Federal CCF and
continues with the collection process.
(e) The collector must ensure that all required information is
included on the Federal CCF.
(f) The collector asks the donor to read and sign a statement on
the Federal CCF certifying that the specimens identified were collected
from the donor. If the donor refuses to sign the certification
statement, the collector notes the refusal on the Federal CCF and
continues with the collection process.
(g) The collector signs and prints their name on the Federal CCF,
completes the Federal CCF, and distributes the copies of the Federal
CCF as required.
(h) The collector seals the specimens (Tube A and Tube B) in a
package and, within 24 hours or during the next business day, sends
them to the HHS-certified laboratory that will be testing the Tube A
oral fluid specimen.
(i) If the specimen and Federal CCF are not immediately transported
to an HHS-certified laboratory, they must remain under direct control
of the collector or be appropriately secured under proper specimen
storage conditions until transported.
Section 8.9 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 oral fluid specimen
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 8.10 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) and take appropriate action which may include
a collection site self-assessment (i.e., using the Collection Site
Checklist for the Collection of Oral Fluid 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
Section 9.1 Who has the authority to certify laboratories to test oral
fluid 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,
including suspending the use of certain analytical procedures when
necessary to protect the integrity of the testing process; ordering any
HHS-certified laboratory to undertake corrective actions to respond to
material deficiencies identified by an inspection or through
performance testing; ordering any HHS-certified laboratory 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 is prohibited from stating or implying that it is
certified by HHS under these Guidelines to test oral fluid specimens
for Federal agencies unless it holds such certification.
Section 9.2 What is the process for a laboratory to become HHS-
certified?
(a) A laboratory seeking HHS certification must:
(1) Submit a completed OMB-approved application form (i.e., the
applicant laboratory 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 to maintain HHS
certification?
(a) To maintain HHS certification, a laboratory 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 does not maintain its
HHS certification?
(a) A laboratory 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
11.18, 11.19, and 14.8;
(3) Ensure access to federally regulated specimens and records in
accordance with Sections 11.21 and 11.22 and subpart P of these
Guidelines; and
(4) Follow the HHS suspension and revocation procedures when
imposed by the Secretary, follow the HHS
[[Page 70835]]
procedures in subpart P of these Guidelines that will be used for all
actions associated with the suspension and/or revocation of HHS-
certification.
Section 9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
(a) PT samples used to evaluate drug tests will be prepared using
the following specifications:
(1) PT samples may contain one or more of the drugs and drug
metabolites in the drug classes listed in the drug testing panel and
may be sent to the laboratory as undiluted (neat) oral fluid. The PT
samples 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 or invalid result.
(3) A negative PT sample will not contain a measurable amount of a
target analyte.
(b) The laboratory 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 oral fluid testing?
(a) An applicant laboratory that seeks certification under these
Guidelines to perform oral fluid 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 specified criteria; and
(10) Do not report any PT sample as adulterated with a compound
that is not present in the sample 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 oral
fluid testing.
Section 9.7 What are the PT requirements for an HHS-certified oral
fluid laboratory?
(a) A laboratory certified under these Guidelines to perform oral
fluid 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 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 specified criteria; and
(10) Do not report any PT sample as adulterated with a compound
that is not present in the sample 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 inspection requirements for an applicant
laboratory?
(a) An applicant laboratory is inspected by a team of two
inspectors.
(b) Each inspector conducts an independent review and evaluation of
all aspects of the laboratory's testing procedures and facilities using
an inspection checklist.
Section 9.9 What are the maintenance inspection requirements for an
HHS-certified laboratory?
(a) An HHS-certified laboratory must undergo an inspection 3 months
after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory is inspected by two or more
inspectors. The number of inspectors is determined according to the
number of specimens to be reviewed. Additional information regarding
inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of
the HHS-certified laboratory's procedures, records, and facilities
using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory must continue
to satisfy the minimum requirements as stated in these Guidelines.
[[Page 70836]]
Section 9.10 Who can inspect an HHS-certified laboratory 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;
(2) Has read and thoroughly understands the policies and
requirements contained in these Guidelines and in other guidance
consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory.
(b) The Secretary or a Federal agency may conduct an inspection at
any time.
Section 9.11 What happens if an applicant laboratory does not satisfy
the minimum requirements for either the PT program or the inspection
program?
If an applicant laboratory fails to satisfy the requirements
established for the initial certification process, the laboratory must
start the certification process from the beginning.
Section 9.12 What happens if an HHS-certified laboratory does not
satisfy the minimum requirements for either the PT program or the
inspection program?
(a) If an HHS-certified laboratory fails to satisfy the minimum
requirements for certification, the laboratory 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 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 may be required to undergo a
special inspection or to test additional PT samples to address
deficiencies.
(d) If an HHS-certified laboratory's certification is revoked or
suspended in accordance with the process described in subpart P of
these Guidelines, the laboratory is not permitted to test federally
regulated specimens until the suspension is lifted or the laboratory
has successfully completed the certification requirements as a new
applicant laboratory.
Section 9.13 What factors are considered in determining whether
revocation of a laboratory's HHS certification is necessary?
(a) The Secretary shall revoke certification of an HHS-certified
laboratory in accordance with these Guidelines if the Secretary
determines that revocation is necessary to ensure fully reliable and
accurate drug 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 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 by a
Federal agency using the laboratory's services;
(4) Conviction for any criminal offense committed as an incident to
operation of the HHS-certified laboratory; or
(5) Any other cause that materially affects the ability of the HHS-
certified laboratory 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 9.14 What factors are considered in determining whether to
suspend a laboratory's HHS certification?
(a) The Secretary may immediately suspend (either partially or
fully) a laboratory'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 9.15 How does the Secretary notify an HHS-certified laboratory
that action is being taken against the laboratory?
(a) When a laboratory's HHS certification is suspended or the
Secretary seeks to revoke HHS certification, the Secretary shall
immediately serve the HHS-certified laboratory 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 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 received the notice, or if expedited review is
requested, within 3 days of the date the laboratory 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 that has
its certification revoked or suspended under Section 9.13 or 9.14,
respectively, and the name of any HHS-certified laboratory that has its
suspension lifted. The Secretary shall provide to any member of the
public upon request the written notice provided to a laboratory 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 9.16 May a laboratory that had its HHS certification revoked be
recertified to test Federal agency specimens?
Following revocation, a laboratory may apply for recertification.
Unless
[[Page 70837]]
otherwise provided by the Secretary in the notice of revocation under
Section 9.15 or the reviewing official's decision under Section 16.9(e)
or 16.14(a), a laboratory which has had its certification revoked may
reapply for HHS certification as an applicant laboratory.
Section 9.17 Where is the list of HHS-certified laboratories published?
(a) The list of HHS-certified laboratories 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 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?
(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 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 and 25 percent must be positive for
one or more drugs.
Section 10.2 What are the requirements for blind samples?
(a) Drug positive blind samples must be validated by the supplier
in the selected manufacturer's collection device 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 in the selected manufacturer's
collection device as negative using appropriate initial and
confirmatory tests.
(c) 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, 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?
(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
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 reports a result for a blind sample
that is inconsistent with the expected result (e.g., a laboratory
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 and attempt to determine if
the laboratory 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;
(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 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
[[Page 70838]]
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.
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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 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 11.11.
Section 11.10 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 11.11 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 11.12 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 an oral fluid specimen when identifying and quantifying
drugs or their metabolites.
Section 11.13 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 11.14 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 11.15 What are the analytical and quality control requirements
for conducting specimen validity tests?
An HHS-certified laboratory may perform specimen validity tests in
accordance with Sections 3.1 and 3.5.
(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; and
(c) Controls must be analyzed concurrently with specimens.
Section 11.16 What must an HHS-certified laboratory do to validate a
specimen validity test?
An HHS-certified laboratory must demonstrate and document for each
specimen validity test the appropriate performance characteristics of
the test, and must re-verify the test periodically, or at least
annually. Each new lot of reagent must be verified prior to being
placed into service.
Section 11.17 What are the requirements for an HHS-certified laboratory
to report a test result?
(a) Laboratories must report a test result to the agency's MRO
within an average of 5 working days after receipt of the specimen.
Reports must use the Federal CCF and/or an electronic report, as
described in items o and p below.
[[Page 70840]]
Before any test result can be reported, it must be certified by a
certifying scientist or a certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial
drug test is negative or if the specimen is negative upon confirmatory
drug testing, and the specimen does not meet invalid criteria as
described in Section 11.17(g)(1) through (5).
(c) A primary (A) specimen is reported positive for a specific drug
or drug metabolite when both the initial drug test is positive and the
confirmatory drug test is positive in accordance with the cutoffs
listed in the drug testing panel.
(d) A primary (A) oral fluid specimen is reported adulterated when
the presence of an adulterant is verified using an initial test on the
first aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) oral fluid specimen is reported substituted when
a biomarker is not present or is present at a concentration
inconsistent with that established for human oral fluid.
(f) For a specimen that has an invalid result for one of the
reasons stated in Section 11/17(g)(1) through (5), the HHS-certified
laboratory shall contact the MRO and both will decide if testing by
another HHS-certified laboratory would be useful in being able to
report a positive, adulterated, or substituted result. If no further
testing is necessary, the HHS-certified laboratory then reports the
invalid result to the MRO.
(g) A primary (A) oral fluid specimen is reported as an invalid
result when:
(1) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(2) Interference with the confirmatory drug test occurs on at least
two separate aliquots of the specimen and the HHS-certified laboratory
is unable to identify the interfering substance;
(3) The physical appearance of the specimen is such that testing
the specimen may damage the laboratory's instruments;
(4) The physical appearances of the A and B specimens are clearly
different (note: A is tested); or
(5) A specimen validity test on two separate aliquots of the
specimen indicates that the specimen is not valid for testing.
(h) An HHS-certified laboratory shall reject a primary (A) specimen
for testing when a fatal flaw occurs as described in Section 15.1 or
when a correctable flaw as described in Section 15.2 is not recovered.
The HHS-certified laboratory will indicate on the Federal CCF that the
specimen was rejected for testing and provide the reason for reporting
the rejected for testing result.
(i) An HHS-certified laboratory must report all positive,
adulterated, substituted, and invalid test results for an oral fluid
specimen. For example, a specimen can be positive for a drug and
adulterated.
(j) An HHS-certified laboratory must report the confirmatory
concentration of each drug or drug metabolite reported for a positive
result.
(k) An HHS-certified laboratory must report numerical values of the
specimen validity test results that support an adulterated,
substituted, or invalid result (as appropriate).
(l) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing
panels.
(m) When the concentration of a drug or drug metabolite exceeds the
validated linear range of the confirmatory test, HHS-certified
laboratories may report to the MRO that the quantitative value exceeds
the linear range of the test or that the quantitative value is greater
than ``insert the actual value for the upper limit of the linear
range,'' or laboratories may report a quantitative value above the
upper limit of the linear range that was obtained by diluting an
aliquot of the specimen to achieve a result within the method's linear
range and multiplying the result by the appropriate dilution factor.
(n) HHS-certified laboratories may transmit test results to the MRO
by various electronic means (e.g., fax, computer). Transmissions of the
reports must ensure confidentiality and the results may not be reported
verbally by telephone. Laboratories and external service providers must
ensure the confidentiality, integrity, and availability of the data and
limit access to any data transmission, storage, and retrieval system.
(o) HHS-certified laboratories must fax, courier, mail, or
electronically transmit a legible image or copy of the completed
Federal CCF and/or forward a computer-generated electronic report. The
computer-generated report must contain sufficient information to ensure
that the test results can accurately represent the content of the
custody and control form that the MRO received from the collector.
(p) For positive, adulterated, substituted, invalid, and rejected
specimens, laboratories must fax, courier, mail, or electronically
transmit a legible image or copy of the completed Federal CCF.
Section 11.18 How long must an HHS-certified laboratory retain
specimens?
(a) An HHS-certified laboratory must retain specimens that were
reported as positive, adulterated, substituted, or as an invalid result
for a minimum of 1 year.
(b) Retained oral fluid specimens must be kept in secured storage
in accordance with the collection device manufacturer's specifications
(i.e., frozen at -20 [deg]C or less, or refrigerated), to ensure their
availability for retesting during an administrative or judicial
proceeding.
(c) Federal agencies may request that the HHS-certified laboratory
retain a specimen for an additional specified period of time and must
make that request within the 1-year period following the laboratory's
reporting of the specimen.
Section 11.19 How long must an HHS-certified laboratory retain records?
(a) An HHS-certified laboratory must retain all records generated
to support test results for at least 2 years. The laboratory may
convert hardcopy records to electronic records for storage and then
discard the hardcopy records after 6 months.
(b) A Federal agency may request the HHS-certified laboratory to
maintain a documentation package (as described in Section 11.21) that
supports the chain of custody, testing, and reporting of a donor's
specimen that is under legal challenge by a donor. The Federal agency's
request to the laboratory must be in writing and must specify the
period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those
included in the documentation package beyond the normal 2-year period
of time.
Section 11.20 What statistical summary reports must an HHS-certified
laboratory provide for oral fluid testing?
(a) HHS-certified laboratories must provide to each Federal agency
for which they perform testing a semiannual statistical summary report
that must be submitted by mail, fax, or email within 14 working days
after the end of the semiannual period. The summary report must not
include any personally identifiable information. A copy of the
semiannual statistical summary report will also be sent to the
Secretary or designated HHS representative. The semiannual statistical
report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
[[Page 70841]]
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative;
(7) Number of specimens rejected for testing because of a fatal
flaw;
(8) Number of specimens rejected for testing because of an
uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug
metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's
test results available when requested to do so by the Secretary or by
the Federal agency for which the laboratory is performing drug-testing
services.
(c) An HHS-certified laboratory must ensure that a qualified
individual is available to testify in a proceeding against a Federal
employee when the proceeding is based on a test result reported by the
laboratory.
Section 11.21 What HHS-certified laboratory information is available to
a Federal agency?
(a) Following a Federal agency's receipt of a positive,
adulterated, or substituted drug test report, the Federal agency may
submit a written request for copies of the records relating to the drug
test results or a documentation package or any relevant certification,
review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified
laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures
and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in
the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain
of custody records for the specimen, memoranda (if any) generated by
the HHS-certified laboratory, and a copy of the electronic report (if
any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial
drug (and specimen validity, if applicable) testing procedures,
instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with
all calibrators and controls and copies of all internal chain of
custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's
confirmatory drug (and specimen validity, if applicable) testing
procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen
with all calibrators and controls and copies of all internal chain of
custody documents related to the confirmatory tests; and
(8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the
RP(s) and the certifying technician or certifying scientist of record.
Section 11.22 What HHS-certified laboratory information is available to
a Federal employee?
Federal applicants or employees who are subject to a workplace drug
test may submit a written request through the MRO and/or the Federal
agency requesting copies of any records relating to their drug test
results or a documentation package as described in Section 11.21(b) and
any relevant certification, review, or revocation of certification
records. Federal applicants or employees, or their designees, are not
permitted access to their specimens collected pursuant to Executive
Order 12564, Public Law 100-71, and these Guidelines.
Section 11.23 What types of relationships are prohibited between an
HHS-certified laboratory and an MRO?
An HHS-certified laboratory must not enter into any relationship
with a Federal agency's MRO that may be construed as a potential
conflict of interest or derive any financial benefit by having a
Federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor
for the agency; however, an MRO shall not be an employee or agent of or
have any financial interest in the HHS-certified laboratory for which
the MRO is reviewing drug testing results. Additionally, an MRO shall
not derive any financial benefit by having an agency use a specific
HHS-certified laboratory or have any agreement with an HHS-certified
laboratory that may be construed as a potential conflict of interest.
Subpart L--Instrumented Initial Test Facility (IITF)
Section 12.1 May an IITF test oral fluid specimens for a Federal
agency's workplace drug testing program?
No, only HHS-certified laboratories are authorized to test oral
fluid specimens for Federal agency workplace drug testing programs in
accordance with these Guidelines.
Subpart M--Medical Review Officer (MRO)
Section 13.1 Who may serve as an MRO?
(a) A currently licensed physician who has:
(1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.)
degree;
(2) Knowledge regarding the pharmacology and toxicology of illicit
drugs;
(3) The training necessary to serve as an MRO as set out in Section
13.3;
(4) Satisfactorily passed an initial examination administered by a
nationally recognized entity or a subspecialty board that has been
approved by the Secretary to certify MROs; and
(5) At least every five years from initial certification, completed
requalification training on the topics in Section 13.3 and
satisfactorily passed a requalification examination administered by a
nationally recognized entity or a subspecialty board that has been
approved by the Secretary to certify MROs.
Section 13.2 How are nationally recognized entities or subspecialty
boards that certify MROs approved?
All nationally recognized entities or subspecialty boards which
seek approval by the Secretary to certify physicians as MROs for
Federal workplace
[…truncated; see source link]Indexed from Federal Register on October 12, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.