Proposed Rule2022-06886
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Primary source
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Published
April 7, 2022
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Proposed Rules]
[Pages 20560-20605]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06886]
[[Page 20559]]
Vol. 87
Thursday,
No. 67
April 7, 2022
Part III
Department of Health and Human Services
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42 CFR Chapter I
Mandatory Guidelines for Federal Workplace Drug Testing Programs;
Proposed Rule
Federal Register / Vol. 87 , No. 67 / Thursday, April 7, 2022 /
Proposed Rules
[[Page 20560]]
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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: Notification of mandatory guidelines.
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SUMMARY: The Department of Health and Human Services (``HHS'' or
``Department'') is proposing to revise the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Urine (UrMG), which
published in the Federal Register of January 23, 2017.
DATES: Submit comments on or before June 6, 2022.
ADDRESSES: In commenting, please refer to file code SAMHSA 2022-0001.
Because of staff and resource limitations, SAMHSA cannot accept
comments by facsimile (fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
<bullet> Electronically. You may submit electronic comments on this
document to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow ``Submit a comment''
instructions.
<bullet> By regular mail. You may mail written comments to the
following address: SAMHSA, Center for Substance Abuse Prevention
(CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room
16N02, Rockville, MD 20857. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
<bullet> By express or overnight mail. You may send written
comments to the following address: SAMHSA, CSAP, DWP, 5600 Fishers
Lane, Room 16N02, Rockville, MD 20857.
<bullet> By hand or courier. You may deliver your written comments
by hand or courier to the following address prior to the close of the
comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02,
Rockville, MD 20857. If you intend to deliver your comments to the
Rockville address, please call (240) 276-2600 in advance to schedule
your arrival with one of our staff members. Because access to the
SAMHSA building is secure, persons without Federal Government
identification are encouraged to schedule their delivery or to leave
comments with the security guard at the front desk located in the main
lobby of the building.
All comments received before the close of the comment period will
be available for viewing by the public. Please note that all comments
are posted in their entirety, including personal or confidential
business information that is included in the comment. SAMHSA will post
all comments before the close of the comment period on the following
website: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the website's search function
to view the associated comments.
Comments received before the close of the comment period will also
be available for public inspection as they are received, generally
beginning approximately three weeks after publication of a document, at
SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday
through Friday of each week, excluding Federal holidays, from 8:30 a.m.
to 4:00 p.m. To schedule an appointment to view public comments, please
call (240) 276-2600.
FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA,
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by
telephone (240) 276-1459 or by email at <a href="/cdn-cgi/l/email-protection#50152537353e357e18312935231023313d3823317e3838237e373f26"><span class="__cf_email__" data-cfemail="42073725272c276c0a233b27310231232f2a31236c2a2a316c252d34">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Executive Summary
This notification of proposed revisions to the Mandatory Guidelines
for Federal Workplace Drug Testing Programs using Urine (UrMG) includes
revisions that will: Establish a process whereby the Department
annually publishes the authorized drug testing panel (i.e., drugs,
analytes, and 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.,
biomarkers, analytes, and cutoffs) for Federal workplace drug testing
programs; revise the confirmatory test cutoff for morphine; revise the
Medical Review Officer (MRO) verification process for positive codeine
and morphine specimens; and require MROs to submit semiannual reports
to the Secretary or designated HHS representative on Federal agency
specimens that were reported as positive for a drug or drug metabolite
by a laboratory and verified as negative by the MRO. In addition, some
wording changes have been made for clarity and for consistency with the
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Oral Fluid (OFMG), 84 FR 57554 (October 25, 2019), 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
proposing revisions to the OFMG, including the same or similar
revisions proposed for the UrMG, where appropriate.
Background
The Department of Health and Human Services, pursuant to the
Department's authority under Section 503 of Public Law 100-71, 5 U.S.C.
Section 7301, and Executive Order 12564, establishes the scientific and
technical guidelines for Federal workplace drug testing programs and
establishes standards for certification of laboratories engaged in drug
testing for Federal agencies. Using data obtained from the Federal
Workplace Drug Testing Programs and HHS-certified laboratories, the
Department estimates that 275,000 urine specimens are tested annually
by Federal agencies.
As required, HHS originally published the Mandatory Guidelines for
Federal Workplace Drug Testing Programs (Guidelines) in the Federal
Register (FR) on April 11, 1988 (53 FR 11979). 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 HHS published the
current Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554).
Proposed Revisions to the HHS Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Authorized Drug Testing Panel
The Guidelines pertain to a matter of Federal agency personnel and,
therefore, are not subject to the notice and comment procedures under
the Administrative Procedures Act. In light of the potential impact on
entities outside of the Federal Government, the Department has chosen
to submit the Guidelines to notice and comment, and will continue to do
so. In this revision, the Department is proposing to change the way a
specific part of the Guidelines
[[Page 20561]]
(i.e., the drug testing panel) is published and the frequency with
which it is published.
Since the original Guidelines were published in 1988, several
recommendations have been made for drugs to be added to or removed from
Federal workplace drug testing programs. The Department has revised the
Guidelines in the past to add or remove drugs from the authorized drug
testing panel and to revise test cutoffs (i.e., Section 3.4 of the
UrMG). The time required to revise the Guidelines through the Federal
review process has impeded the Department's ability to respond to drug
use trends. Individuals may change their drug use, and illicit drug
manufacturers may change their manufacturing methods, to avoid testing
positive for drugs included in proposed Guidelines, especially as the
number of new drugs and drug analogues increases. A less flexible drug
testing panel may delay needed drug analyte or cutoff changes based on
the state of the science (e.g., new technologies, research including
dosing studies). Therefore, the Department proposes to publish the drug
testing panel in the Federal Register on at least an annual basis,
including any revisions to the panel, without the need (perceived or
otherwise) to undergo notice and comment. Should the Department remove
a drug from the drug testing panel, a Federal agency may test specimens
for that drug in accordance with Section 3.2 (i.e., on a case-by-case
basis for reasonable suspicion or post accident testing, or routinely
with a waiver from the Secretary). This process is expected to improve
the effectiveness of Federal agency drug testing programs in support of
the Federal Drug-Free Workplace Program. The drug testing panel in
Section 3.4 of the final UrMG will remain in effect until the
Department publishes a separate FRN with the drug testing panel.
The Department will continue to monitor drug use trends and review
information on new drugs of abuse from sources such as Federal
regulators, researchers, the drug testing industry (including HHS-
certified laboratories), and public and private sector employers, to
determine whether drugs should be added or removed from the panel. Any
changes to analytes and cutoffs made in accordance with the newly
established drug testing panel publishing process will be based on a
thorough review of relevant information, including the current state of
the science, laboratory capabilities, cost associated with the change,
and benefits of the change to Federal agencies. The Department will set
a date for the panel changes to take effect and include the effective
date in the annual drug testing panel FRN in order to allow time for
drug testing service providers (e.g., immunoassay kit manufacturers) to
develop or revise their products, and for HHS-certified laboratories to
develop or revise assays, complete validation studies, and revise
procedures. The prior version of the panel will remain in effect until
the effective date of a newly published annual panel.
For consistency and to avoid misinterpretation of drug test
results, the Department is requiring HHS-certified laboratories and
HHS-certified instrumented initial test facilities (collectively
referred to hereafter as ``HHS-certified test facilities'') and Medical
Review Officers (MROs) to report results using the nomenclature (i.e.,
analyte names and abbreviations) published with the drug testing panel.
Authorized Biomarker Testing Panel
A biomarker is an endogenous substance used to validate a
biological specimen. The purpose of a biomarker test is to determine
whether a submitted specimen is a human specimen. The current UrMG
(effective October 1, 2017) allow additional specimen validity testing
using biomarkers upon MRO request, to provide information to assist the
MRO in the verification process. The current UrMG also require HHS-
certified laboratories to report a specimen as invalid when the
biomarker is not present or when its concentration is not consistent
with that established for human urine but does not allow these
specimens to be reported as substituted. The Department proposes to
revise the UrMG to define such specimens as substituted, and to allow
only biomarker tests that have been authorized by SAMHSA for use in
Federal agency workplace drug testing programs.
To ensure that scientifically valid biomarker tests, analytes, and
cutoffs are standardized for Federal workplace drug testing, the
Department will institute an approval process for biomarker tests,
based on review of data from the scientific and/or medical literature,
before authorizing the use of the biomarker test. This process is
equivalent to the approval process currently in use for testing
additional Schedule 1 and 2 drugs or adding new tests for a specific
adulterant. The Department will accept scientific information submitted
for review from various sources (e.g., HHS-certified test facilities,
drug testing industry stakeholders, researchers). The Department will
include the authorized biomarker testing panel (i.e., a table of
biomarkers authorized for testing, with test analytes and cutoffs), in
the FRN to be published annually (as described earlier in this
preamble). Federal agencies may choose to test some or all of their
workplace specimens for one or more authorized biomarkers.
An HHS-certified laboratory, or (for urine only) an HHS-certified
instrumented initial test facility (IITF), may request authorization
from SAMHSA to conduct a biomarker test that has not been included on
the list of authorized biomarkers. The test facility must submit
supporting documentation and assay validation records to the National
Laboratory Certification Program (NLCP) for SAMHSA review and approval.
When a urine biomarker test is approved through this process, SAMHSA
will authorize the individual HHS-certified test facility to perform
the biomarker test for federally regulated specimens only upon MRO
request (i.e., a blanket request for all specimens or a case-by-case
request for a specific specimen). A certified laboratory or IITF may
choose to begin the process by submitting supporting documentation for
review prior to assay validation, or may send supporting documentation
with completed validation records. The Department will continue to
include measurands and decision points for other specimen validity
tests in the UrMG (e.g., Sections 11.19 and 12.15).
Once a biomarker test has been added to the authorized biomarker
panel published in the FRN, any HHS-certified laboratory or IITF may
routinely conduct the test without requiring an MRO request, and only
require a signed MRO request for case-by-case biomarker testing (in
accordance with UrMG section 3.5). The Department will continue to
require NLCP review of biomarker assay validation records before
allowing an IITF or laboratory to use the test for federally regulated
workplace specimens.
This process will facilitate the identification of donors who
attempt to subvert their drug test, and ensure that biomarker tests
used for federally regulated workplace programs are scientifically
supportable and properly validated, and that all HHS-certified test
facilities use the same analytes and cutoffs.
For consistency and to avoid misinterpretation of biomarker test
results, the Department is requiring HHS-certified test facilities and
Medical Review Officers (MROs) to report results using the nomenclature
(i.e., analyte names and abbreviations) published with the biomarker
testing panel.
[[Page 20562]]
Medical Review Officer (MRO) Verification of Codeine and Morphine Test
Results
The MRO has an essential role in federally regulated workplace drug
testing programs that includes performing the review of laboratory
results and supporting documentation, interviewing the donor when
necessary, and making a final determination regarding the result. As
described in Section 13.5d(2) of the current UrMG, when a donor has no
legitimate medical explanation for a positive codeine or morphine
result equal to or greater than 15,000 ng/mL, the MRO reports the
specimen as positive to the agency. When a donor has no legitimate
medical explanation for a positive codeine or morphine result less than
15,000 ng/mL, the MRO must determine that there is clinical evidence of
illegal opioid use (in addition to the test results) to report such
specimens as positive. If the MRO finds no clinical evidence of illegal
opioid use, the MRO verifies the opiate results as negative. These
requirements were included in the UrMG to address positive codeine and/
or morphine results that may be due to poppy seed ingestion. The
Department proposes to remove the additional decision point for codeine
and morphine, to adjust the confirmatory test cutoff for morphine from
2,000 to 4,000 ng/mL, and to remove the additional requirement for
clinical evidence of illegal opioid use, as described above. The
confirmatory test cutoff for codeine will remain at 2,000 ng/mL. The
basis for the Department's proposed changes is described in the
following paragraphs.
A review of the scientific literature, as cited below, regarding
the role of poppy seed food products in producing positive urine drug
tests for the opiates, codeine and morphine, was undertaken to
ascertain whether the current decision point should be maintained or
changed. The Department focused on studies using analytical techniques
acceptable to modern forensic toxicology laboratories, for which the
researchers included information on poppy seed doses and adequately
described the analytical techniques. Because most common poppy variants
produce morphine in great excess to codeine, morphine concentrations
significantly exceeded codeine concentrations in all reviewed studies.
Studies of patients being tested for abstention from heroin use
suggest that urine concentrations of morphine are often below 15,000
ng/mL and the heroin metabolite, 6-acetylmorphine (6-AM) is absent,
indicating the heroin use was not within the short detection limit for
6-AM. A study by Colby et al. examined morphine concentrations in urine
specimens from chronic pain patients being monitored for medication
compliance. Patients with positive 6-AM results had morphine
concentrations averaging 85,000 ng/mL (<plus-minus>154,000 ng/mL), with
25% at or below 10,000 ng/mL and an additional 15% falling between
10,000 ng/mL and 20,000 ng/mL. (Ref. 1) However, it is well known that
6-AM is generally positive in only the first few urine specimens
following heroin dosing, making it the limiting factor in unequivocal
detection of heroin use. (Ref. 2 and 3) Further, in a study by Wang et
al., heroin metabolites including morphine were measured in subjects
seeking in-patient addiction treatment for heroin use. In 20 subjects
without 6-AM positive urine specimens, the total morphine concentration
ranged from 87 to 34,896 ng/mL and averaged 9,960 ng/mL. Only 30% of
the subjects had specimens above the 15,000 ng/mL decision point
specified by the current UrMG. Lowering the morphine cutoff to 4,000
ng/mL would identify another 30% of the heroin users in this type of
cohort. (Ref. 4)
In regard to poppy seed food products, the literature is consistent
in the conclusion that regular ingestion of poppy seed-containing foods
(bagels, cakes, curries, etc.) rarely results in urine opiate
concentrations above the 2,000 ng/mL cutoff specified in the current
UrMG, and that proper handling by pre-washing and cooking the poppy
seeds into food products causes loss of both morphine and codeine.
Studies attempting to characterize morphine and codeine results after
reasonable consumption of poppy seed food products on an acute and
chronic basis reported maximum morphine concentrations ranging between
160 and 3,000 ng/mL with codeine ranging between 11 and 390 ng/mL.
(Ref. 3 and 5-8) There is only one study in which the urine
concentration of morphine exceeded 4,000 ng/mL after ingestion of
regular prepared food containing poppy seeds, and the researchers
reported that some subjects became ill due to the large amount of poppy
seeds in the food product. (Ref. 9) The results of this study have not
been duplicated in subsequent studies involving prepared food products.
Other studies used extreme exposure protocols involving intolerable
or near intolerable amounts of raw and/or unwashed poppy seeds, which
are known to contain much more codeine and morphine than their washed
and cooked counterparts. In one such extreme study in 2015, the
researchers reported that participants felt that 15 g of raw, unwashed
poppy seeds was close to the bearable limit for ingestion, and the
maximum urine concentration was 4,200 ng/mL for morphine and 664 ng/mL
for codiene. (Ref. 7) Of note, this study also included the same dose
of poppy seeds baked in a roll and maximum morphine and codeine
concentrations were considerably lower at 1,400 and 194 ng/ml,
respectively. This research confirms the results of extreme ingestion
by three volunteers in a 2003 study by Rohrig and Moore, and the
experience in a 2014 study by Smith et al. in which only 19 of 22
participants could tolerate ingestion of all planned doses. (Ref. 10
and 11) Further, in the 2014 study, seven of the 19 subjects did not
produce a positive morphine result (i.e., >=2,000 ng/mL) until after
the second extreme dose of poppy seeds, approximately eight hours after
the first dose. At all times in this study, codeine results were below
the 2,000 ng/mL cutoff. The Department finds these studies relevant to
setting the cutoff limit of 4,000 ng/mL for morphine and sufficient for
eliminating positives due to poppy seeds because they confirm that
urine morphine concentrations exceeding 4,000 ng/mL would be very rare,
transient, and a consequence of unrealistic and extreme poppy seed
exposure (i.e., ingesting barely tolerable amounts of raw and/or
unwashed poppy seeds).
The Department also reviewed information on other sources of poppy
seed exposure. In reaction to at least 12 deaths reported in the
scientific literature associated with the use of tea prepared with
unwashed poppy seeds and the availability of unwashed poppy seeds from
online retailers, the Drug Enforcement Administration (DEA) issued a
warning in 2019 restating that unwashed poppy seeds are a danger to the
user, and their use and misuse may result in unpredictable outcomes
including death when used alone or in combination with other drugs. DEA
reiterated that the morphine and codeine, if present as contaminants on
poppy seed material, are not exempted from the Controlled Substances
Act (CSA) control. (Ref. 12)
In summary, the Department is not aware of any evidence that
reasonable or realistic consumption of poppy seed-containing food
products would cause a positive drug test using the codeine and
morphine cutoffs specified by these Guidelines. Only purposeful
consumption of large amounts (e.g., 15 g or more) of raw and/or
unwashed poppy seeds has been shown to result in codeine at or above
600 ng/mL or in morphine exceeding 4,000 ng/mL, and
[[Page 20563]]
the extreme amounts of poppy seeds in these studies, described by
subjects as intolerable or barely tolerable, do not represent a real-
world situation for donors in a Federal agency testing program.
Based on this information, the Department has decided that no
additional decision point is needed for MRO verification of codeine and
morphine results. Further, the Department has concluded that continued
use of the current 15,000 ng/mL decision point diminishes the deterrent
effect of the program by attributing codeine and morphine results
between the cutoff and 15,000 ng/mL to poppy seed ingestion in the
absence of a legitimate medical explanation. The Department proposes to
raise the confirmatory test cutoff for morphine to 4,000 ng/mL to rule
out any donor claims that consumption of poppy seed food products (on
an acute or chronic basis) was the reason for a positive morphine test
result. This cutoff change makes the Federal drug testing program
cutoffs for codeine and morphine the same as the Department of Defense
(DoD) program cutoffs, which were previously raised to these
concentrations to eliminate positive tests due to poppy seeds. (Ref.
14)
Medical Review Officer (MRO) Semiannual Reports
The Department, through the NLCP, obtains information from HHS-
certified laboratories that is reviewed to verify accurate reports and
compliance with Guidelines requirements. The NLCP conducts statistical
analysis and provides reports to the Department on federally regulated
workplace testing, although the data are limited to laboratory-reported
results and not the final, MRO-verified results. To obtain additional
information needed to assess compliance with the Mandatory Guidelines,
the Department proposes to require 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). The reports will
not contain any personally identifiable information of the donors.
This revision to the Guidelines will enable Department oversight of
MRO reporting practices and will enhance the Department's ability to
verify the accuracy of MRO reports and address areas of confusion about
Guidelines requirements. The information in the MRO reports will be
matched to information submitted to the NLCP by HHS-certified
laboratories for the same specimens. This additional information will
improve statistical analyses and provide a clearer picture of illicit
drug use by Federal job applicants and employees.
Proposed Revisions to the Guidelines
This preamble describes the proposed revisions to the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Urine
(UrMG), and the rationale for the changes.
Subpart A--Applicability
Section 1.5 defines terms used in the UrMG. The Department has
added terms and revised definitions in this section in accordance with
proposed changes to these Guidelines, and to standardize terms and
definitions, where possible, to apply to all authorized specimen types.
The Department proposes to revise the Substituted Specimen
definition to include specimens tested for a biomarker, when the
biomarker is absent or is present at a concentration inconsistent with
that established for a human specimen. For clarity, the Department also
added a reference to the reporting criteria for substitution in Section
3.7 of these Guidelines. For clarity and consistency with the revised
Substituted Specimen definition, the Department proposes to edit the
Adulterated Specimen definition to apply to specimens with ``an
abnormal concentration of a normal constituent (e.g., nitrite in
urine),'' rather than ``an abnormal concentration of an endogenous
substance,'' and to revise definitions for Cutoff and Initial Specimen
Validity Test to remove the ``(for urine)'' specification for
identifying a substituted specimen. The Department proposes to revise
the Collection Container definition to apply to all authorized specimen
types, by changing ``a urine specimen'' to ``a donor's drug test
specimen.'' The Department has also added definitions for ``Biomarker
Testing Panel'' and ``Drug Testing Panel'' consistent with the proposed
publication of these testing panels in a separate FRN each year.
Section 1.7 describes what constitutes a donor's refusal to take a
federally regulated drug test. Section 1.7(a) includes exceptions for a
donor who fails to appear in a reasonable time for a pre-employment
test and a donor who leaves the collection site before the collection
process begins for a pre-employment test. The Department finds that
there is no justification for altering a refusal to test based on
whether the test is being conducted in the employment or pre-employment
context and, therefore, proposes to remove these exceptions. The
collector will report a refusal to test for any donor who fails to
appear in a reasonable time or who leaves the collection site before
the collection is complete, regardless of the reason for the test.
Section 1.8(a) describes the potential consequences for a refusal
to test. The Department has reworded this section to clarify potential
actions for a Federal employee who refuses to take a drug test, and the
potential action for an applicant who refuses to take a pre-employment
test.
Subpart C--Urine Specimen Tests
The Department proposes to edit Section 3.1 to reflect the proposed
process for publishing drug and biomarker testing panels in an FRN each
year containing a list of authorized drug analytes and biomarkers that
can be tested. As described under Authorized drug testing panel and
Authorized biomarker testing panel above, the time required to revise
the Guidelines through the Federal review process has impeded the
Department's ability to respond to drug use trends, and to make drug
analyte or cutoff changes based on the state of the science (e.g., new
technologies, research including dosing studies). This new process is
expected to improve the effectiveness of Federal agency drug testing
programs in support of the Federal Drug-Free Workplace Program. See
also Section 3.4.
For clarity, the Department also revised the header for Section 3.2
to refer to ``drugs other than those in the drug testing panel'' (see
above) rather than ``additional drugs''.
The Department has revised the analytes and cutoffs table in
Section 3.4 of the UrMG to reflect the proposed change to the
confirmatory cutoff for morphine, and revised the section to describe
the publication of a final notification in the Federal Register each
year that will include the authorized drugs, test analytes, and
cutoffs; the authorized biomarkers, test analytes, and cutoffs; and the
nomenclature required for IITF, laboratory, and MRO reports. The annual
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 the final UrMG
will remain in effect until the effective date of the new panels
published in the separate FRN.
Section 3.7 describes the criteria used to report a specimen as
substituted and Section 3.9 describes the criteria used to report an
invalid result for a urine
[[Page 20564]]
specimen. The current sections require laboratories to report a
specimen as invalid when a biomarker is not present or its
concentration is outside the range established for that biomarker in
human urine. As described under Authorized biomarker testing panel
above, the purpose of a biomarker test is to determine whether a
submitted specimen is a human specimen. Therefore, the Department
proposes to revise these sections to require specimens to be reported
as substituted, rather than invalid, based on biomarker testing. See
also Section 1.5.
Subpart H--Urine Specimen Collection Procedure
The Department proposes to revise the wording in Section 8.3(f)
regarding how instructions for completing the Federal Custody and
Control Form (CCF) are provided to the donor. This is consistent with
changes made to the Federal CCF to enable its use with both urine and
oral fluid specimens.
The Department moved items under Section 8.3(h) into a new item
8.3(i) addressing the collector's request for the donor to display the
contents of their pockets and subsequent collector actions. The
required actions remain the same, but the Department revised wording in
new items 8.3(i)(1) through 8.3(i)(4) for clarity.
In Section 8.5(a), the Department clarified that the collector must
inform the donor that the donor's failure to remain at the collection
site until the collection is complete will be reported as a refusal to
test. This is consistent with Section 1.7.
The Department also revised wording in Section 8.9(a)(3) for
clarity.
Subpart I--HHS Certification of Laboratories and IITFs
Section 9.7 describes performance test (PT) requirements for an
HHS-certified laboratory and Section 9.9 describes PT requirements for
an HHS-certified IITF. PT error criteria will remain the same; however,
the Department is proposing to edit some items for clarity.
Specifically, the Department proposes to revise Sections 9.7(a)(5),
9.7(a)(10), and 9.9(a)(6) to state clearly that quantitative values
reported for drug and specimen validity tests are evaluated based on
reported results for each PT cycle, not on cumulative results reported
over two consecutive PT cycles. An HHS-certified test facility must not
obtain a quantitative value outside the specified range for a drug or
specimen validity test result, based on the appropriate reference or
peer group mean.
The Department also revised Section 9.6(a)(11) for an applicant
laboratory and Section 9.7(a)(10) for an HHS-certified laboratory to
address requirements for PT samples reported as substituted based on
biomarker test results, in addition to those reported as substituted
based on creatinine and specific gravity test results.
Subpart K--Laboratory
Section 11.19 describes the requirements for an HHS-certified
laboratory to report primary (A) specimen test results to an MRO. The
Department proposes to revise the requirements for reporting a specimen
as substituted in item 11.19(e) to include specimens with a biomarker
concentration inconsistent with that established for human urine, in
addition to those reported as substituted based on creatinine and
specific gravity test results (see also Sections 1.5, 3.7, and 3.9).
Section 11.19(g) addresses laboratory and MRO discussions to
determine whether additional testing may be useful for specimens with
certain invalid results. Because biomarker testing could be used to
identify substitution, the Department has revised this section to
indicate that additional testing may be useful in being able to report
a substituted result, as well as positive or adulterated results.
Section 11.19(g) describes the requirements for a laboratory to
report a specimen as invalid. The Department has added an item 13
addressing tests used to determine specimen validity, other than those
specifically listed in this section.
The Department also proposes to add a new item 11.19(m) stating
that the laboratory must use the HHS-specified nomenclature published
with the drug and biomarker testing panels on reports. This change is
to ensure consistency in reporting and interpretation of test results,
by requiring the results of each test performed to be reported using
clear and correct nomenclature for test analytes, with the same
terminology and units of measurement. See also Section 3.4.
Subpart L--Instrumented Initial Test Facility (IITF)
Section 12.15 describes the requirements for an HHS-certified IITF
to report primary (A) specimen test results to an MRO. The Department
proposes to add a new item 12.15(e) stating that the IITF must use the
HHS-specified nomenclature published with the drug and biomarker
testing panels on reports. See also Section 3.4.
Subpart M--Medical Review Officer (MRO)
Section 13.4(f) describes when an MRO must conduct a medical
examination or review an examining physician's findings when the
collector reported that the donor was unable to provide a specimen. The
Department has clarified that a medical examination is not required
when an alternate specimen was collected.
Section 13.5(c)(2) describes MRO actions when a laboratory reports
an invalid result in conjunction with a positive, adulterated, or
substituted result. The Department has added an item to this section to
clarify that the MRO takes the required action for the invalid result
(specified in item f of this section) only when the MRO has verified
the other result(s) for the specimen (i.e., positive, adulterated, or
substituted) as negative or when the split (B) specimen was tested and
reported as a failure to reconfirm.
Section 13.5(d) describes MRO actions to determine whether the
donor has a legitimate medical explanation for a positive specimen test
result. The Department added a new item Section 13.5(d)(1) to clarify
that the MRO reports a positive result when the donor admits
unauthorized use of the drug(s) that caused the positive test result,
and documents the admission of unauthorized use in the MRO records and
in the MRO's report to the Federal agency. A donor's admission of
unauthorized use corroborates the positive test.
Currently, Section 13.5(d)(2) includes the policies of the
Department that passive exposure to marijuana smoke and ingestion of
food products containing marijuana are not acceptable medical
explanations for a positive marijuana test result. The Department
proposes to reword this section to clarify that these policies apply to
any positive urine drug test results, not only positive marijuana
results. Item i of this section now states that passive exposure to any
drug is not an acceptable medical explanation for a positive drug test,
with ``exposure to secondhand marijuana smoke'' as an example of
passive exposure. Item ii of this section now states that ingestion of
food products containing a drug is not an acceptable medical
explanation for a positive drug test, with ``products containing
marijuana'' and ``poppy seeds containing codeine and/or morphine'' as
examples. The Department also proposes to add a new item iii to this
section stating that a physician's authorization or medical
recommendation for a Schedule I
[[Page 20565]]
substance is not an acceptable medical explanation for a positive drug
test. Under the CSA, a Schedule I substance is defined as a drug,
chemical, or other substance with no currently accepted medical use in
the United States, a lack of accepted safety for use under medical
supervision, and a high potential for abuse. (Ref. 13) The DEA
maintains the current listing of controlled substances on their
website.
Section 13.5(d)(3) describes MRO actions when the donor has no
legitimate medical explanation for a positive drug test result. The
Department has revised this section to remove the exceptions for
codeine and morphine. As described above under MRO verification of
codeine and morphine test results, the Department has removed the
additional 15,000 ng/mL decision point for codeine and morphine, as
well as the requirement for the MRO to report such specimens as
positive based on clinical evidence of illicit drug use (in addition to
the drug test results). The MRO will follow the same verification
procedures for all specimens with positive test results.
Section 13.9 describes how an MRO reports primary (A) drug test
results to an agency. The Department proposes to add a new item 13.9(e)
stating that the MRO must use the HHS-specified nomenclature published
with the drug and biomarker testing panels on reports. See also Section
3.4.
The Department has included a new Section 13.11 describing the
proposed requirement for an MRO to send semiannual reports to the
Secretary or designated HHS representative for Federal agency specimens
that were reported as positive by a laboratory and verified as negative
by the MRO. As described under Medical Review Officer (MRO) semiannual
reports above, this change will enable Department oversight of MRO
practices and will enhance the Department's ability to verify the
accuracy of MRO reports and address areas of confusion about Guidelines
requirements. In addition, the information in the MRO reports will be
matched to information submitted to the NLCP by HHS-certified
laboratories for the same specimens, thereby improving statistical
analyses and providing a clearer picture of illicit drug use by Federal
job applicants and employees. The reports must not include any
personally identifiable information for the donor, and must be
submitted within 14 working days after the end of the semiannual period
(i.e., in July and January). Section 13.11 lists the information that
must be included on the reports. To facilitate report preparation and
review, the Department will include a template for these MRO reports in
the MRO Guidance Manual and will arrange a secure method for MROs to
submit reports electronically.
The Department has included a new Section 13.12 describing the
Federal agency's responsibilities for designating an MRO. These
responsibilities include verifying and documenting that individuals
meet the MRO requirements in these Guidelines before allowing them to
serve as an MRO for the agency's drug testing program and on an ongoing
basis, and ensuring that each MRO reports drug test results in
accordance with the Guidelines. Further, the Federal agency must obtain
documentation from the MRO to confirm that the MRO and any external
service provider ensures the confidentiality integrity and availability
of the data and limits the access to any data transmission, storage,
and retrieval system.
Subpart N--Split Specimen Tests
Section 14.4 describes how an HHS-certified laboratory reports a
split (B) urine specimen when the primary (A) specimen was reported
substituted. The Department proposes to revise this section to address
primary (A) specimens reported as substituted based on biomarker test
results, in addition to those reported as substituted based on
creatinine and specific gravity test results. See also Section 1.5.
Section 14.5 states that the HHS-certified laboratory that tested a
split (B) specimen must report the results to the MRO. The Department
proposes to reword this section to require the laboratory to use the
HHS-specified nomenclature published with the drug and biomarker
testing panels on reports for split (B) specimens. See also Section
3.4.
Section 14.6 describes the actions an MRO takes after receiving a
split (B) urine specimen result from an HHS-certified laboratory.
Section 14.6(c) specifies MRO actions when the laboratory failed to
reconfirm one or more positive results and reported the split specimen
as substituted. The Department proposes to revise this item to address
actions when the B specimen was reported as substituted based on
biomarker test results, in addition to those reported as substituted
based on creatinine and specific gravity test results. See also Section
1.5. The Department also proposes to add a new item 14.6(k) to address
MRO verification of split (B) specimen results when the B specimen
fails to reconfirm adulteration or substitution and is invalid.
Section 14.7 describes how an MRO reports split (B) specimen test
results to an agency. The Department proposes to add a new item 14.7(e)
stating that the MRO must use the HHS-specified nomenclature published
with the drug and biomarker testing panels on reports. See also Section
3.4.
General Revisions
In addition to the proposed changes described by subpart and
section above, the Department has edited the UrMG to address proposed
changes (e.g., removing ``for urine'' when referring to substituted
specimens; referencing the proposed annual FRN with drug and biomarker
testing panels) and has reworded some items for clarity and/or for
consistency with the OFMG.
Impact of These Guidelines on Government Regulated Industries
The proposed revised Guidelines may impact the Department of
Transportation (DOT) and Nuclear Regulatory Commission (NRC) regulated
industries depending on these agencies' decisions to incorporate the
final UrMG revisions into their programs under their own authority.
Costs and Benefits
Costs
The proposed UrMG revision to publish the drug testing panel in a
separate FRN each year (e.g., Section 3.4) may result in a cost
increase for HHS-certified test facilities and MROs (e.g., costs for
test supplies, assay validation, administrative changes) when a new
drug is added to the panel or when analytes or cutoffs are changed for
current drugs. The added costs will depend on the change. For example,
implementation costs would be lower for laboratories that already offer
the drug test or use the different analyte or cutoff for their non-
regulated clients. MROs may experience increased costs when an agency
chooses to test their Federal job applicants and employees for a new
authorized drug with a high positivity rate or a Schedule II drug
requiring the MRO to review medical explanations. Additional costs for
testing and MRO review will be incorporated into the overall cost for
the Federal agency submitting the specimen to the laboratory. Added
costs to MROs would be expected to shift to Federal agencies over time,
as existing contracts expire and new contract terms are negotiated. As
noted earlier in this preamble, the Department will consider costs when
deciding whether to make a change to the authorized drug tests. At this
time, the Department will not
[[Page 20566]]
require HHS-certified test facilities to implement authorized biomarker
tests. Each laboratory and IITF should conduct their own cost analysis
when deciding whether to offer biomarker testing to federally regulated
clients. The Department will consider costs when deciding whether to
require all certified test facilities to test for a specific biomarker.
The proposed change to the morphine confirmatory test cutoff from
2,000 ng/mL to 4,000 ng/mL will result in some initial costs for HHS-
certified laboratories (e.g., to revalidate their opiate confirmatory
assays, revise opiate calibrators and controls, and revise review and
reporting procedures). However, there should also be some cost savings
as described below under Benefits.
There will be some administrative costs for MROs associated with
the generation and submission of the semiannual reports of verified-
negative results (see Section 13.11). The Department encourages the use
of electronic recordkeeping to facilitate information retrieval and
report generation, and will enable secure submission of electronic
information to reduce MRO costs to provide these reports.
Benefits
The potential benefits of more timely changes to the drug testing
panel will result in a healthier and more productive workforce, as well
as avoid the issues associated with addiction and rehabilitation. Since
the personnel tested under this program are in positions that are
safety sensitive, potential benefits include decreased risk of
transportation and workplace accidents, decreased risk of low-
probability high consequence events, a more responsible workforce in
positions of public trust, and potentially reducing individuals'
dependence or addiction and the personal benefits associated with those
conditions. Considering the potential health and performance costs of
drug misuse, the benefits to the Federal workplace and the individuals
within that workplace justify the more agile method of changing the
drug testing panel for the Federal workplace drug testing programs.
The number of commercial substitution and adulteration products
aimed at defeating a drug test continues to proliferate for both urine
and oral fluid. Manufacturers alter their existing products or develop
new products to subvert drug and specimen validity tests in federally
regulated workplace programs. (Ref. 15 and 16) When the Department
added provisions for biomarker testing in the current UrMG, the intent
was to identify non-human urine samples that were submitted for testing
in place of the donor's urine. The proposed revision to report a
specimen as substituted (not invalid) based on biomarker testing is
consistent with this intention. This revision, as well as the
Department review and approval of biomarker tests and the added
flexibility for making changes to the drug and biomarker testing
panels, will strengthen the Federal Government's ability to identify
illicit drug use and donor attempts to subvert drug tests.
The proposed requirement for semiannual MRO reports on laboratory-
positive/MRO-negative results will enable the Department to ensure
accurate reports and MRO compliance with Guidelines requirements. The
information in the MRO reports will be matched to information for the
same specimens that was submitted to the NLCP by the HHS-certified
laboratory, thereby improving statistical analyses and providing a
clearer picture of illicit drug use by Federal job applicants and
employees.
As noted above under Costs, HHS-certified laboratories will incur
some initial costs for changing the morphine confirmatory test cutoff;
however, laboratories will also experience some benefits in that the
removal of the 15,000 ng/mL decision points for codeine and morphine
will simplify codeine and morphine review and reporting procedures.
MROs may also experience some savings, as the removal of the decision
points and clinical evaluation requirement for some codeine and
morphine positive results will simplify the MRO verification process.
That is, codeine and morphine positive results will be reviewed and
verified using the same procedures as positive results for other drugs.
Information Collection/Record Keeping Requirements
The information collection requirements (i.e., reporting and
recordkeeping) in the current Guidelines, which establish the
scientific and technical guidelines for Federal workplace drug testing
programs and establish standards for certification of laboratories
engaged in urine drug testing for Federal agencies under authority of 5
U.S.C. 7301 and Executive Order 12564, are approved by the Office of
Management and Budget (OMB) under control number 0930-0158. The Federal
Drug Testing Custody and Control Form (Federal CCF) used to document
the collection and chain of custody of urine and oral fluid specimens
at the collection site, for laboratories to report results, and for
Medical Review Officers to make a determination; the National
Laboratory Certification Program (NLCP) application; the NLCP
Laboratory Information Checklist; and recordkeeping requirements in the
current Guidelines, as approved under control number 0930-0158, will
remain in effect.
In support of the Government Paperwork Reduction Act (PRA), the
Department revised the Federal CCF to enable its use as an electronic
form (78 FR 42091, July 15, 2013) and developed requirements and
oversight procedures to ensure that HHS-certified test facilities and
other service providers (e.g., collection sites, MROs) using an
electronic version of the Federal CCF (ECCF) maintain the accuracy,
security, and confidentiality of electronic drug test information.
Before a Federal ECCF can be used for Federal agency specimens, HHS-
certified test facilities must submit detailed information and proposed
standard operating procedures (SOPs) to the NLCP for SAMHSA review and
approval, and undergo an NLCP inspection focused on the proposed ECCF.
Since 2013, SAMHSA has encouraged the use of Federal ECCFs and
other electronic processes in HHS-certified test facilities, when
practicable, for federally regulated testing operations. In accordance
with Section 8108(a) of the SUPPORT for Patients and Communities Act,
SAMHSA has set a deadline of August 31, 2023, for all HHS-certified
laboratories to submit a request for approval of an electronic
(paperless) Federal CCF.
The title and description of the information collected and
respondent description are shown in the following paragraphs with an
estimate of the annual reporting, disclosure, and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Title: The Mandatory Guidelines for Federal Workplace Drug Testing
Programs Using Urine.
Description: The Mandatory Guidelines establish the scientific and
technical guidelines for Federal drug testing programs and establish
standards for certification of laboratories engaged in drug testing for
Federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301
note, and Executive Order 12564. Federal drug testing programs test
applicants to sensitive positions, individuals involved in accidents,
[[Page 20567]]
individuals for cause, and random testing of persons in sensitive
positions.
Description of Respondents: Individuals or households, businesses,
or other-for-profit and not-for-profit institutions.
The burden estimates in the tables below are based on the following
number of respondents: 38,000 donors who apply for employment or are
employed in testing designated positions, 100 collectors, 25 urine
specimen testing laboratories, 1 IITF, and 100 MROs.
Estimate of Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
9.2(a)(1)...................................... Laboratory or IITF required to submit 10 1 3 30
application for certification.
9.12(a)(3)..................................... Materials to submit to become an HHS 10 1 2 20
inspector.
11.3........................................... Laboratory submits qualifications of 10 1 2 20
responsible person (RP) to HHS.
11.4(c)........................................ Laboratory submits information to HHS 10 1 2 20
on new RP or alternate RP.
11.22.......................................... Specifications for laboratory 10 5 0.5 25
semiannual statistical report of test
results to each Federal agency.
12.3(a)........................................ IITF \1\ submits qualifications of RT 1 1 1 1
to HHS.
12.4(c)........................................ IITF \1\ submits information to HHS on 1 1 1 1
new RT or alternate RT.
12.19.......................................... Specifications for IITF \1\ semiannual 1 1 1 1
statistical report of test results to
each Federal agency.
13.9 and 14.7.................................. Specifies that MRO must report all 100 14 0.05 (3 min) 70
verified primary and split specimen
test results to the Federal agency.
13.11.......................................... Specifications for MRO semiannual 100 2 0.5 100
report to the Secretary or designated
representative for Federal agency
specimen results that were laboratory-
positive and MRO-verified negative.
16.1(b) & 16.5(a).............................. Specifies content of request for 1 1 3 3
informal review of suspension/proposed
revocation of certification.
16.4........................................... Specifies information appellant 1 1 0.5 0.5
provides in first written submission
when laboratory suspension/revocation
is proposed.
16.6........................................... Requires appellant to notify reviewing 1 1 0.5 0.5
official of resolution status at end
of abeyance period.
16.7(a)........................................ Specifies contents of appellant 1 1 50 50
submission for review.
16.9(a)........................................ Specifies content of appellant request 1 1 3 3
for expedited review of suspension or
proposed revocation.
16.9(c)........................................ Specifies contents of review file and 1 1 50 50
briefs.
---------------------------------------------------------------
Total...................................... ....................................... 259 .............. .............. 395
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application for certification to test federally regulated specimens.
IITF numbers are provided in this analysis as placeholders for administrative purposes.
The following reporting requirements are also in the proposed
Guidelines, but have not been addressed in the above reporting burden
table: Collector must report any unusual donor behavior or refusal to
participate in the collection process on the Federal CCF (Sections 1.8,
8.9); collector annotates the Federal CCF when a sample is a blind
sample (Section 10.3(a)); MRO notifies the Federal agency and HHS when
an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6
and 13.7 describe the actions an MRO takes for the medical evaluation
of a donor who cannot provide a urine specimen. SAMHSA has not
calculated a separate reporting burden for these requirements because
they are included in the burden hours estimated for collectors to
complete Federal CCFs and for MROs to report results to Federal
agencies.
Estimate of Annual Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a), 8.5(f)(2)(iii), 8.6(b)(2).............. Collector must contact Federal agency 100 1 0.05 (3 min) 5
point of contact.
11.23, 11.24................................... Information on drug test that 25 10 3 750
laboratory must provide to Federal
agency upon request or to donor
through MRO.
[[Page 20568]]
12.20, 12.21................................... Information on drug test that IITF must 1 1 1 1
provide to Federal agency upon request
or to donor through MRO.
13.8(b)........................................ MRO must inform donor of right to 100 14 3 4,200
request split specimen test when a
positive, adulterated, or substituted
result is reported.
---------------------------------------------------------------
Total...................................... ....................................... 226 .............. .............. 4956
--------------------------------------------------------------------------------------------------------------------------------------------------------
The following disclosure requirements are also included in the
proposed Guidelines, but have not been addressed in the above
disclosure burden table: The collector must explain the basic
collection procedure to the donor and answer any questions (Section
8.3(e) and (g)). SAMHSA believes having the collector explain the
collection procedure to the donor and answer any questions is a
standard business practice and not a disclosure burden.
Estimate of Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Section Purpose respondents respondent response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.5, 8.8.................................. Collector completes Federal CCF for 100 380 0.07 (4 min) 2,660
specimen collected.
8.8(d) & (f)................................... Donor initials specimen labels/seals 38,000 1 0.08 (5 min) 3,040
and signs statement on the Federal CCF.
11.8(a) & 11.19................................ Laboratory completes Federal CCF upon 25 1,520 0.05 (3 min) 1,900
receipt of specimen and before
reporting result.
12.8(a) & 12.15................................ IITF completes Federal CCF upon receipt 1 1 1 1
of specimen and before reporting
result.
13.4(d)(4),13.9(c),14.7(c)..................... MRO completes Federal CCF before 100 380 0.05 (3 min) 1,900
reporting the primary or split
specimen result.
14.1(b)........................................ MRO documents donor's request to have 100 2 0.05 (3 min) 10
split specimen tested.
---------------------------------------------------------------
Total...................................... ....................................... 38,326 .............. .............. 9,511
--------------------------------------------------------------------------------------------------------------------------------------------------------
The proposed Guidelines contain several recordkeeping requirements
that SAMHSA considers not to be an additional recordkeeping burden. In
subpart D, a trainer is required to document the training of an
individual to be a collector (Section 4.3(a)(3)) and the documentation
must be maintained in the collector's training file (Section 4.3(c)).
SAMHSA believes this training documentation is common practice and is
not considered an additional burden. In subpart F, if a collector uses
an incorrect form to collect a Federal agency specimen, the collector
is required to provide a statement (Section 6.2(b)) explaining why an
incorrect form was used to document collecting the specimen. SAMHSA
believes this is an extremely infrequent occurrence and does not create
a significant additional recordkeeping burden. Subpart H (Sections
8.4(c), 8.5(d)(2), 8.5(e)(1) and (2)) requires collectors to enter any
information on the Federal CCF of any unusual findings during the urine
specimen collection procedure. These recordkeeping requirements are an
integral part of the collection procedure and are essential to
documenting the chain of custody for the specimens collected. The
burden for these entries is included in the recordkeeping burden
estimated to complete the Federal CCF and is, therefore, not considered
an additional recordkeeping burden. Subpart K describes a number of
recordkeeping requirements for laboratories associated with their
testing procedures, maintaining chain of custody, and keeping records
(i.e., Sections 11.1(a) and (d); 11.2(b), (c), and (d); 11.6(b);
11.7(c); 11.8; 11.11(a); 11.14(a); 11.17; 11.21(a), (b), and (c);
11.22; 11.23(a); and 11.24). These recordkeeping requirements are
necessary for any laboratory to conduct forensic drug testing and to
ensure the scientific supportability of the test results. Therefore,
they are considered to be standard business practice and are not
considered a burden for this analysis.
Thus, the total annual response burden associated with the testing
of urine specimens by the laboratories and IITFs is estimated to be
14,862 hours (that is, the sum of the total hours from the above
tables). This is in addition to the 1,788,809 hours currently approved
by OMB under control number 0930-0158 for urine testing under the
current Guidelines.
As required by section 3507(d) of the PRA, the Secretary has
submitted a copy of these proposed Guidelines to OMB for its review.
Comments on the information collection requirements are specifically
solicited in order to: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of HHS's functions,
including whether the information will have practical utility; (2)
evaluate the accuracy of HHS's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) enhance the quality, utility, and clarity of
the information to be collected; and (4) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other
[[Page 20569]]
technological collection techniques or other forms of information
technology.
OMB is required to make a decision concerning the collection of
information contained in these proposed Guidelines between 30 and 60
days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication. This does not affect
the deadline for the public to comment to HHS on the proposed
Guidelines.
Organizations and individuals desiring to submit comments on the
information collection requirements should direct them to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Building,
725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for
SAMHSA. Because of delays in receipt of mail, comments may also be sent
to 202-395-6974 (fax).
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2019. DEA/DC/DO/DOE, DEA PRB 11-15-19-44.
13. U.S. Department of Justice (DOJ), Drug Enforcement Agency (DEA),
Diversion Control Division. Controlled Substance Schedules. <a href="https://www.deadiversion.usdoj.gov">https://www.deadiversion.usdoj.gov</a>. Accessed June 9, 2021.
14. U.S. Department of Defense (DoD). Instruction 1010.16, Technical
procedures for the military drug abuse testing program. <a href="https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf">https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf</a>.
Accessed June 9, 2021.
15. Kim, V.J., Okano, C.K., Osborne, C.R., Frank, D.M., Meana, C.T.,
Castaneto, M.S, 2018. Can synthetic urine replace authentic urine to
``beat'' workplace drug testing? Drug Test. Anal., 11(2), 331-335.
16. Quest Diagnostics, 2018. Workforce drug positivity at highest
rate in a decade, finds analysis of more than 10 million drug test
results. <a href="https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf">https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf</a>. Accessed October
19, 2018.
Summary
These proposed revisions are intended to simplify changes to the
authorized drug testing panel for Federal workplace drug testing
programs, facilitate the identification of substituted specimens using
biomarker testing, improve detection of illicit codeine and/or morphine
use, and provide the Department with information on Federal agency drug
test specimens that were reported as positive for a drug or drug
metabolite by a laboratory and verified negative by the Medical Review
Officer (MRO). The Department believes that the proposed revisions to
the Mandatory Guidelines save costs and improve the effectiveness of
Federal workplace drug testing programs.
Dated: March 22, 2022.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Substance
Abuse and Mental Health Services Administration.
Approved: March 22, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Urine Specimens
Subpart A--Applicability
1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these
Guidelines?
1.3 How does a federal agency request a change from these
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect employee records?
1.7 What is a refusal to take a federally regulated drug test?
1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
Subpart B--Urine Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may a urine specimen be collected?
2.3 How is each urine specimen collected?
2.4 What volume of urine is collected?
2.5 How does the collector split the urine specimen?
2.6 When may an entity or individual release a urine specimen?
Subpart C--Urine Specimen Tests
3.1 Which tests are conducted on a urine specimen?
3.2 May a specimen be tested for drugs other than those in the drug
testing panel?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug and biomarker test analytes and cutoffs for
urine?
3.5 May an HHS-certified laboratory perform additional drug and/or
specimen validity tests on a specimen at the request of the Medical
Review Officer (MRO)?
3.6 What criteria are used to report a urine specimen as
adulterated?
3.7 What criteria are used to report a urine specimen as
substituted?
3.8 What criteria are used to report a urine specimen as dilute?
3.9 What criteria are used to report an invalid result for a urine
specimen?
Subpart D--Collectors
4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?
[[Page 20570]]
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be an observer for a direct
observed collection?
4.5 What are the requirements to be a trainer for collectors?
4.6 What must a federal agency do before a collector is permitted to
collect a specimen?
Subpart E--Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a
specimen at the collection site?
5.6 What are the privacy requirements when collecting a urine
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not
available or is not used?
Subpart G--Urine Specimen Collection Containers and Bottles
7.1 What is used to collect a urine specimen?
7.2 What are the requirements for a urine collection container and
specimen bottles?
7.3 What are the minimum performance requirements for a urine
collection container and specimen bottles?
Subpart H--Urine Specimen Collection Procedure
8.1 What privacy must the donor be given when providing a urine
specimen?
8.2 What must the collector ensure at the collection site before
starting a urine specimen collection?
8.3 What are the preliminary steps in the urine specimen collection
procedure?
8.4 What steps does the collector take in the collection procedure
before the donor provides a urine specimen?
8.5 What steps does the collector take during and after the urine
specimen collection procedure?
8.6 What procedure is used when the donor states that they are
unable to provide a urine specimen?
8.7 If the donor is unable to provide a urine specimen, may another
specimen type be collected for testing?
8.8 How does the collector prepare the urine specimens?
8.9 When is a direct observed collection conducted?
8.10 How is a direct observed collection conducted?
8.11 When is a monitored collection conducted?
8.12 How is a monitored collection conducted?
8.13 How does the collector report a donor's refusal to test?
8.14 What are a federal agency's responsibilities for a collection
site?
Subpart I--HHS Certification of Laboratories and IITFs
9.1 Who has the authority to certify laboratories and IITFs to test
urine specimens for federal agencies?
9.2 What is the process for a laboratory or IITF to become HHS-
certified?
9.3 What is the process for a laboratory or IITF to maintain HHS
certification?
9.4 What is the process when a laboratory or IITF does not maintain
its HHS certification?
9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory?
9.7 What are the PT requirements for an HHS-certified urine
laboratory?
9.8 What are the PT requirements for an applicant IITF?
9.9 What are the PT requirements for an HHS-certified IITF?
9.10 What are the inspection requirements for an applicant
laboratory or IITF?
9.11 What are the maintenance inspection requirements for an HHS-
certified laboratory or IITF?
9.12 Who can inspect an HHS-certified laboratory or IITF and when
may the inspection be conducted?
9.13 What happens if an applicant laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
9.14 What happens if an HHS-certified laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
9.15 What factors are considered in determining whether revocation
of a laboratory's or IITF's HHS certification is necessary?
9.16 What factors are considered in determining whether to suspend a
laboratory's or an IITF's HHS certification?
9.17 How does the Secretary notify an HHS-certified laboratory or
IITF that action is being taken against the laboratory or IITF?
9.18 May a laboratory or IITF that had its HHS certification revoked
be recertified to test federal agency specimens?
9.19 Where is the list of HHS-certified laboratories and IITFs
published?
Subpart J--Blind Samples Submitted by an Agency
10.1 What are the requirements for federal agencies to submit blind
samples to HHS-certified laboratories or IITFs?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory
or IITF?
10.4 What happens if an inconsistent result is reported for a blind
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified
laboratory?
11.5 What qualifications must an individual have to certify a result
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory
maintain?
11.8 What are the laboratory chain of custody requirements for
specimens and aliquots?
11.9 What test(s) does an HHS-certified laboratory conduct on a
urine specimen received from an IITF?
11.10 What are the requirements for an initial drug test?
11.11 What must an HHS-certified laboratory do to validate an
initial drug test?
11.12 What are the batch quality control requirements when
conducting an initial drug test?
11.13 What are the requirements for a confirmatory drug test?
11.14 What must an HHS-certified laboratory do to validate a
confirmatory drug test?
11.15 What are the batch quality control requirements when
conducting a confirmatory drug test?
11.16 What are the analytical and quality control requirements for
conducting specimen validity tests?
11.17 What must an HHS-certified laboratory do to validate a
specimen validity test?
11.18 What are the requirements for conducting each specimen
validity test?
11.19 What are the requirements for an HHS-certified laboratory to
report a test result?
11.20 How long must an HHS-certified laboratory retain specimens?
11.21 How long must an HHS-certified laboratory retain records?
11.22 What statistical summary reports must an HHS-certified
laboratory provide for urine testing?
11.23 What HHS-certified laboratory information is available to a
federal agency?
11.24 What HHS-certified laboratory information is available to a
federal employee?
11.25 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
11.26 What type of relationship can exist between an HHS-certified
laboratory and an HHS-certified IITF?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 What must be included in the HHS-certified IITF's standard
operating procedure manual?
12.2 What are the responsibilities of the responsible technician
(RT)?
12.3 What qualifications must the RT have?
12.4 What happens when the RT is absent or leaves an HHS-certified
IITF?
[[Page 20571]]
12.5 What qualifications must an individual have to certify a result
reported by an HHS-certified IITF?
12.6 What qualifications and training must other personnel of an
HHS-certified IITF have?
12.7 What security measures must an HHS-certified IITF maintain?
12.8 What are the IITF chain of custody requirements for specimens
and aliquots?
12.9 What are the requirements for an initial drug test?
12.10 What must an HHS-certified IITF do to validate an initial drug
test?
12.11 What are the batch quality control requirements when
conducting an initial drug test?
12.12 What are the analytical and quality control requirements for
conducting specimen validity tests?
12.13 What must an HHS-certified IITF do to validate a specimen
validity test?
12.14 What are the requirements for conducting each specimen
validity test?
12.15 What are the requirements for an HHS-certified IITF to report
a test result?
12.16 How does an HHS-certified IITF handle a specimen that tested
positive, adulterated, substituted, or invalid at the IITF?
12.17 How long must an HHS-certified IITF retain a specimen?
12.18 How long must an HHS-certified IITF retain records?
12.19 What statistical summary reports must an HHS-certified IITF
provide?
12.20 What HHS-certified IITF information is available to a federal
agency?
12.21 What HHS-certified IITF information is available to a federal
employee?
12.22 What types of relationships are prohibited between an HHS-
certified IITF and an MRO?
12.23 What type of relationship can exist between an HHS-certified
IITF and an HHS-certified laboratory?
Subpart M--Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards
that certify MROs approved?
13.3 What training is required before a physician may serve as an
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing a urine specimen's test
results?
13.6 What action does the MRO take when the collector reports that
the donor did not provide a sufficient amount of urine for a drug
test?
13.7 What happens when an individual is unable to provide a
sufficient amount of urine for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because
of a permanent or long-term medical condition?
13.8 Who may request a test of a split (B) specimen?
13.9 How does an MRO report a primary (A) specimen test result to an
agency?
13.10 What types of relationships are prohibited between an MRO and
an HHS-certified laboratory or an HHS-certified IITF?
13.11 What reports must an MRO provide to the Secretary for urine
testing?
13.12 What are a federal agency's responsibilities for designating
an MRO?
Subpart N--Split Specimen Tests
14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) urine
specimen when the primary (A) specimen was reported adulterated?
14.4 How does an HHS-certified laboratory test a split (B) urine
specimen when the primary (A) specimen was reported substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B)
urine specimen result from the second HHS-certified laboratory?
14.7 How does an MRO report a split (B) specimen test result to an
agency?
14.8 How long must an HHS-certified laboratory retain a split (B)
specimen?
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory or an
HHS-certified IITF to report a urine specimen as rejected for
testing?
15.2 What discrepancies require an HHS-certified laboratory or an
HHS-certified IITF to report a specimen as rejected for testing
unless the discrepancy is corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory or an HHS-certified IITF to reject a urine
specimen for testing or an MRO to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?
Subpart P--Laboratory or IITF Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory or IITF be
suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?
Subpart A--Applicability
Section 1.1 To whom do these Guidelines apply?
(a) These Guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3), but
excluding the Armed Forces as defined in 5 U.S.C. 2101(2);
(3) Any other employing unit or authority of the federal government
except the United States Postal Service, the Postal Rate Commission,
and employing units or authorities in the Judicial and Legislative
Branches; and
(4) The Intelligence Community, as defined by Executive Order
12333, is subject to these Guidelines only to the extent agreed to by
the head of the affected agency;
(5) Laboratories and instrumented initial test facilities (IITFs)
that provide drug testing services to the federal agencies;
(6) Collectors who provide specimen collection services to the
federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review
and interpretation of results services to the federal agencies.
(b) These Guidelines do not apply to drug testing under authority
other than Executive Order 12564, including testing of persons in the
criminal justice system, such as arrestees, detainees, probationers,
incarcerated persons, or parolees.
Section 1.2 Who is responsible for developing and implementing these
Guidelines?
(a) Executive Order 12564 and Public Law 100-71 require the
Department of Health and Human Services (HHS) to establish scientific
and technical guidelines for federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these
Guidelines.
Section 1.3 How does a federal agency request a change from these
Guidelines?
(a) Each federal agency must ensure that its workplace drug testing
program complies with the provisions of these Guidelines unless a
waiver has been obtained from the Secretary.
(b) To obtain a waiver, a federal agency must submit a written
request to
[[Page 20572]]
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
notice in the Federal Register.
Section 1.5 What do the terms used in these Guidelines mean?
The following definitions are adopted:
Accessioner. The individual who signs the Federal Drug Testing
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.
Adulterated Specimen. A specimen that has been altered, as
evidenced by test results showing either a substance that is not a
normal constituent for that type of specimen or showing an abnormal
concentration of a normal constituent (e.g., nitrite in urine).
Aliquot. A portion of a specimen used for testing.
Alternate Responsible Person. The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of the HHS-certified laboratory when the
responsible person is unable to fulfill these obligations.
Alternate Responsible Technician. The person who assumes
professional, organizational, educational, and administrative
responsibility for the day-to-day management of the HHS-certified IITF
when the responsible technician is unable to fulfill these obligations.
Alternate Technology Initial Drug Test. An initial drug test using
technology other than immunoassay to differentiate negative specimens
from those requiring further testing.
Batch. A number of specimens or aliquots handled concurrently as a
group.
Biomarker. An endogenous substance used to validate a biological
specimen.
Biomarker Testing Panel. The panel published in the Federal
Register that includes the biomarkers authorized for testing, with
analytes and cutoffs for initial and confirmatory biomarker tests, as
described under Section 3.4.
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 rejected for
testing, when a split specimen fails to reconfirm, or when the MRO
determines that a fatal flaw or unrecovered correctable flaw exists in
the forensic records (as described in Sections 15.1 and 15.2).
Carryover. The effect that occurs when a sample result (e.g., drug
concentration) is affected by a preceding sample during the preparation
or analysis of a sample.
Certifying Scientist (CS). The individual responsible for verifying
the chain of custody and scientific reliability of a test result
reported by an HHS-certified laboratory.
Certifying Technician (CT). The individual responsible for
verifying the chain of custody and scientific reliability of negative,
rejected for testing, and (for urine) negative/dilute results reported
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
Chain of Custody (COC) Procedures. Procedures that document the
integrity of each specimen or aliquot from the point of collection to
final disposition.
Chain of Custody Documents. Forms used to document the control and
security of the specimen and all aliquots. The document may account for
an individual specimen, aliquot, or batch of specimens/aliquots and
must include the name and signature of each individual who handled the
specimen(s) or aliquot(s) and the date and purpose of the handling.
Collection Container. A receptacle used to collect a donor's drug
test specimen.
Collection Site. The location where specimens are collected.
Collector. A person trained to instruct and assist a donor in
providing a specimen.
Confirmatory Drug Test. A second analytical procedure performed on
a separate aliquot of a specimen to identify and quantify a specific
drug or drug metabolite.
Confirmatory Specimen Validity Test. A second test performed on a
separate aliquot of a specimen to further support a specimen validity
test result.
Control. A sample used to evaluate whether an analytical procedure
or test is operating within predefined tolerance limits.
Cutoff. The analytical value (e.g., drug, drug metabolite, or
biomarker concentration) used as the decision point to determine a
result (e.g., negative, positive, adulterated, invalid, or substituted)
or the need for further testing.
Dilute Specimen. A urine specimen with creatinine and specific
gravity values that are lower than expected but are still within the
physiologically producible ranges of human urine.
Donor. The individual from whom a specimen is collected.
Drug Testing Panel. The panel published in the Federal Register
that includes the drugs authorized for testing, with analytes and
cutoffs for initial and confirmatory drug tests, as described under
Section 3.4.
External Service Provider. An independent entity that performs
services related to federal workplace drug testing on behalf of a
federal agency, a collector/collection site, an HHS[hyphen]certified
laboratory, a Medical Review Officer (MRO), or (for urine) an
HHS[hyphen]certified Instrumented Initial Test Facility (IITF).
Failed to Reconfirm. The result reported for a split (B) specimen
when a second HHS-certified laboratory is unable to corroborate the
result reported for the primary (A) specimen.
Federal Drug Testing Custody and Control Form (Federal CCF). The
Office of Management and Budget (OMB) approved form that is used to
document the collection and chain of custody of a specimen from the
time the specimen is collected until it is received by the test
facility (i.e., HHS-certified laboratory or, for urine, HHS-certified
IITF). It may be a paper (hardcopy), electronic, or combination
electronic and paper format (hybrid). The form may also be used to
report the test result to the Medical Review Officer.
Gender Identity. Gender identity means an individual's internal
sense of being male or female, which may be different from an
individual's sex assigned at birth.
HHS. The Department of Health and Human Services.
Initial Drug Test. An analysis used to differentiate negative
specimens from those requiring further testing.
Initial Specimen Validity Test. The first analysis used to
determine if a specimen is adulterated, invalid, substituted, or (for
urine) dilute.
[[Page 20573]]
Instrumented Initial Test Facility (IITF). A permanent location
where (for urine) initial testing, reporting of results, and
recordkeeping are performed under the supervision of a responsible
technician.
Invalid Result. The result reported by an HHS-certified laboratory
in accordance with the criteria established in Section 3.9 when a
positive, negative, adulterated, or substituted result cannot be
established for a specific drug or specimen validity test.
Laboratory. A permanent location where initial and confirmatory
drug testing, reporting of results, and recordkeeping are performed
under the supervision of a responsible person.
Limit of Detection. The lowest concentration at which the analyte
(e.g., drug or drug metabolite) can be identified.
Limit of Quantification (LOQ). For quantitative assays, the lowest
concentration at which the identity and concentration of the analyte
(e.g., drug or drug metabolite) can be accurately established.
Lot. A number of units of an item (e.g., reagents, quality control
material) manufactured from the same starting materials within a
specified period of time for which the manufacturer ensures that the
items have essentially the same performance characteristics and
expiration date.
Medical Review Officer (MRO). A licensed physician who reviews,
verifies, and reports a specimen test result to the federal agency.
Negative Result. The result reported by an HHS-certified laboratory
or (for urine) an HHS-certified IITF to an MRO when a specimen contains
no drug and/or drug metabolite; or the concentration of the drug or
drug metabolite is less than the cutoff for that drug or drug class.
Oral Fluid Specimen. An oral fluid specimen is collected from the
donor's oral cavity and is a combination of physiological fluids
produced primarily by the salivary glands.
Oxidizing Adulterant. A substance that acts alone or in combination
with other substances to oxidize drug or drug metabolites to prevent
the detection of the drugs or drug metabolites, or affects the reagents
in either the initial or confirmatory drug test.
Performance Testing (PT) Sample. A program-generated sample sent to
a laboratory or (for urine) to an IITF to evaluate performance.
Positive Result. The result reported by an HHS-certified laboratory
when a specimen contains a drug or drug metabolite equal to or greater
than the confirmatory test cutoff.
Reconfirmed. The result reported for a split (B) specimen when the
second HHS-certified laboratory corroborates the original result
reported for the primary (A) specimen.
Rejected for Testing. The result reported by an HHS-certified
laboratory or (for urine) HHS-certified IITF when no tests are
performed on a specimen because of a fatal flaw or an unrecovered
correctable error (see Sections 15.1 and 15.2).
Responsible Person (RP). The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of an HHS-certified laboratory.
Responsible Technician (RT). The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of an HHS-certified IITF.
Sample. A performance testing sample, calibrator or control used
during testing, or a representative portion of a donor's specimen.
Secretary. The Secretary of the U.S. Department of Health and Human
Services.
Specimen. Fluid or material collected from a donor at the
collection site for the purpose of a drug test.
Split Specimen Collection (for Urine). A collection in which the
specimen collected is divided into a primary (A) specimen and a split
(B) specimen, which are independently sealed in the presence of the
donor.
Standard. Reference material of known purity or a solution
containing a reference material at a known concentration.
Substituted Specimen. A specimen that has been submitted in place
of the donor's specimen, as evidenced by the absence of a biomarker or
a biomarker concentration inconsistent with that established for a
human specimen, as indicated in the biomarker testing panel, or (for
urine) creatinine and specific gravity values that are outside the
physiologically producible ranges of human urine, in accordance with
the criteria to report a specimen as substituted in UrMG Section 3.7.
Section 1.6 What is an agency required to do to protect employee
records?
Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency
contracts with laboratories, IITFs, collectors, and MROs must require
that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the
contracts must require compliance with employee access and
confidentiality provisions of Section 503 of Public Law 100-71. Each
federal agency must establish a Privacy Act System of Records or modify
an existing system or use any applicable Government-wide system of
records to cover the records of employee drug test results. All
contracts and the Privacy Act System of Records must specifically
require that employee records be maintained and used with the highest
regard for employee privacy.
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and
E, may be applicable to certain health care providers with whom a
federal agency may contract. If a health care provider is a HIPAA
covered entity, the provider must protect the individually identifiable
health information it maintains in accordance with the requirements of
the Rule, which includes not using or disclosing the information except
as permitted by the Rule and ensuring there are reasonable safeguards
in place to protect the privacy of the information. For more
information regarding the HIPAA Privacy Rule, please visit <a href="https://www.hhs.gov/hipaa/index.html">https://www.hhs.gov/hipaa/index.html</a>.
Section 1.7 What is a refusal to take a federally regulated drug test?
(a) As a donor for a federally regulated drug test, you have
refused to take a federally regulated drug test if you:
(1) Fail to appear for any test within a reasonable time, as
determined by the federal agency, consistent with applicable agency
regulations, after being directed to do so by the federal agency;
(2) Fail to remain at the collection site until the collection
process is complete;
(3) Fail to provide a specimen (e.g., urine or another authorized
specimen type) for any drug test required by these Guidelines or
federal agency regulations;
(4) In the case of a direct observed or monitored collection, fail
to permit the observation or monitoring of your provision of a specimen
when required as described in Sections 8.9 and 8.10;
(5) Fail to provide a sufficient amount of urine when directed, and
it has been determined, through a required medical evaluation, that
there was no legitimate medical explanation for the failure as
determined by the process described in Section 13.6;
(6) Fail or decline to participate in an alternate specimen
collection (e.g., oral fluid) as directed by the federal agency or
collector (i.e., as described in Section 8.6);
(7) Fail to undergo a medical examination or evaluation, as
directed by the MRO as part of the verification
[[Page 20574]]
process (i.e., Section 13.6) or as directed by the federal agency. In
the case of a federal agency applicant/pre-employment drug test, the
donor is deemed to have refused to test on this basis only if the
federal agency applicant/pre-employment test is conducted following a
contingent offer of employment. If there was no contingent offer of
employment, the MRO will cancel the test;
(8) Fail to cooperate with any part of the testing process (e.g.,
refuse to empty pockets when directed by the collector, disrupt the
collection process, fail to wash hands after being directed to do so by
the collector);
(9) For an observed collection, fail to follow the observer's
instructions related to the collection process;
(10) Bring materials to the collection site for the purpose of
adulterating, substituting, or diluting the specimen;
(11) Attempt to adulterate, substitute, or dilute the specimen;
(12) Possess or wear a prosthetic or other device that could be
used to interfere with the collection process; or
(13) Admit to the collector or MRO that you have adulterated or
substituted the specimen.
Section 1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
(a) A refusal to take a test may result in the initiation of
disciplinary or adverse action for a federal employee, up to and
including removal from federal employment. An applicant's refusal to
take a pre-employment test may result in non-selection for federal
employment.
(b) When a donor has refused to participate in a part of the
collection process, including failing to appear in a reasonable time
for any test, the collector must terminate the collection process and
take action as described in Section 8.13. Required action includes
immediately notifying the federal agency's designated representative by
any means (e.g., telephone or secure facsimile [fax] machine) that
ensures that the refusal notification is immediately received and, if a
Federal CCF has been initiated, documenting the refusal on the Federal
CCF, signing and dating the Federal CCF, and sending all copies of the
Federal CCF to the federal agency's designated representative.
(c) When documenting a refusal to test during the verification
process as described in Sections 13.4, 13.5, and 13.6, the MRO must
complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
Subpart B--Urine Specimens
Section 2.1 What type of specimen may be collected?
A federal agency may collect urine and/or an alternate specimen
type for its workplace drug testing program. Only specimen types
authorized by Mandatory Guidelines for Federal Workplace Drug Testing
Programs may be collected. An agency using urine must follow these
Guidelines.
Section 2.2 Under what circumstances may a urine specimen be collected?
A federal agency may collect a urine specimen for the following
reasons:
(a) Federal agency applicant/Pre-employment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post accident test;
(e) Return to duty test; or
(f) Follow-up test.
Section 2.3 How is each urine specimen collected?
Each urine specimen is collected as a split specimen as described
in Section 2.5.
Section 2.4 What volume of urine is collected?
A donor is expected to provide at least 45 mL of urine for a
specimen.
Section 2.5 How does the collector split the urine specimen?
The collector pours at least 30 mL into a specimen bottle that is
designated as A (primary) and then pours at least 15 mL into a specimen
bottle that is designated as B (split).
Section 2.6 When may an entity or individual release a urine specimen?
Entities and individuals subject to these Guidelines under Section
1.1 may not release specimens collected pursuant to Executive Order
12564, Public Law 100-71, and these Guidelines to donors or their
designees. Specimens also may not be released to any other entity or
individual unless expressly authorized by these Guidelines or by
applicable federal law. This section does not prohibit a donor's
request to have a split (B) specimen tested in accordance with Section
13.8.
Subpart C--Urine Specimen Tests
Section 3.1 Which tests are conducted on a urine specimen?
A federal agency:
(a) Must ensure that each specimen is tested for marijuana and
cocaine metabolites as provided in the drug testing panel described
under Section 3.4;
(b) Is authorized to test each specimen for other Schedule I or II
drugs as provided in the drug testing panel;
(c) Must ensure that the following specimen validity tests are
conducted on each urine specimen:
(1) Determine the creatinine concentration on every specimen;
(2) Determine the specific gravity on every specimen for which the
creatinine concentration is less than 20 mg/dL;
(3) Determine the pH on every specimen; and
(4) Perform one or more specimen validity tests for oxidizing
adulterants on every specimen.
(d) Is authorized to test each specimen for one or more biomarkers
as provided in the biomarker testing panel; and
(e) 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, then additional testing may
be performed.
Section 3.2 May a specimen be tested for drugs other than those in the
drug testing panel?
(a) On a case-by-case basis, a specimen may be tested for
additional drugs, if a federal agency is conducting the collection for
reasonable suspicion or post accident testing. A specimen collected
from a federal agency employee may be tested by the federal agency for
any drugs listed in Schedule I or II of the Controlled Substances Act.
The federal agency must request the HHS-certified laboratory to test
for the additional drug, include a justification to test a specific
specimen for the drug, and ensure that the HHS-certified laboratory has
the capability to test for the drug and has established properly
validated initial and confirmatory analytical methods. If an initial
test procedure is not available upon request for a suspected Schedule I
or Schedule II drug, the federal agency can request an HHS-certified
laboratory to test for the drug by analyzing two separate aliquots of
the specimen in two separate testing batches using the confirmatory
analytical method. Additionally, the split (B) specimen will be
available for testing if the donor requests a retest at another HHS-
certified laboratory.
[[Page 20575]]
(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 paragraph (a) of this section.
Section 3.3 May any of the specimens be used for other purposes?
(a) Specimens collected pursuant to Executive Order 12564, Public
Law 100-71, and these Guidelines must only be tested for drugs and to
determine their validity in accordance with Subpart C of these
Guidelines. Use of specimens by donors, their designees, or any other
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing)
is prohibited unless authorized in accordance with applicable federal
law.
(b) These Guidelines are not intended to prohibit federal agencies
specifically authorized by law to test a specimen for additional
classes of drugs in its workplace drug testing program.
Section 3.4 What are the drug and biomarker test analytes and cutoffs
for urine?
The Secretary will publish the drug and biomarker test analytes and
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing
panel'') for initial and confirmatory drug and biomarker tests in the
Federal Register each year. The drug and biomarker testing panels will
also be available on the internet at <a href="http://www.samhsa.gov/workplace/drug-testing">http://www.samhsa.gov/workplace/drug-testing</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 concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolite (THCA) \2\...... 50 ng/mL \3\........... THCA................... 15 ng/mL
Cocaine metabolite (Benzoylecgonine). 150 ng/mL \3\.......... Benzoylecgonine........ 100 ng/mL
Codeine/Morphine..................... 2,000 ng/mL............ Codeine................ 2,000 ng/mL
Morphine............... 4,000 ng/mL
Hydrocodone/Hydromorphone............ 300 ng/mL.............. Hydrocodone............ 100 ng/mL
Hydromorphone.......... 100 ng/mL
Oxycodone/Oxymorphone................ 100 ng/mL.............. Oxycodone.............. 100 ng/mL
Oxymorphone............ 100 ng/mL
6-Acetylmorphine..................... 10 ng/mL............... 6-Acetylmorphine....... 10 ng/mL
Phencyclidine........................ 25 ng/mL............... Phencyclidine.......... 25 ng/mL
Amphetamine/Methamphetamine.......... 500 ng/mL.............. Amphetamine............ 250 ng/mL
Methamphetamine........ 250 ng/mL
MDMA \4\/MDA \5\..................... 500 ng/mL.............. MDMA................... 250 ng/mL
MDA.................... 250 ng/mL
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending
on the technology. At least one analyte within the group must have a concentration equal to or greater than
the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the
laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol-9-carboxylic acid
(THCA).
\3\ Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for an alternate
technology initial test that is specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL for
benzoylecgonine).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).
(a) The drug testing panel will include drugs authorized for
testing in federal workplace drug testing programs, with the required
test analytes and cutoffs;
(b) The biomarker testing panel will include biomarkers authorized
for testing in federal workplace drug testing programs, with the
required test analytes and cutoffs; and
(c) HHS-certified IITFs, HHS-certified laboratories, and Medical
Review Officers must use the nomenclature (i.e., analyte names and
abbreviations) published in the Federal Register with the drug and
biomarker testing panels to report federal workplace drug test results.
Section 3.5 May an HHS-certified laboratory perform additional drug
and/or specimen validity tests on a specimen at the request of the
Medical Review Officer (MRO)?
An HHS-certified laboratory is authorized to perform additional
drug and/or specimen validity tests on a case-by-case basis as
necessary to provide information that the MRO would use to report a
verified drug test result (e.g., tetrahydrocannabivarin, specimen
validity tests). An HHS-certified laboratory is not authorized to
routinely perform additional drug and/or specimen validity tests at the
request of an MRO without prior authorization from the Secretary or
designated HHS representative, with the exception of the determination
of D,L stereoisomers of amphetamine and methamphetamine. All tests must
meet appropriate validation and quality control requirements in
accordance with these Guidelines.
Section 3.6 What criteria are used to report a urine specimen as
adulterated?
An HHS-certified laboratory reports a primary (A) specimen as
adulterated when:
(a) The pH is less than 4 or equal to or greater than 11 using
either a pH meter or a colorimetric pH test for the initial test on the
first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(b) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant
colorimetric test for the initial test on the first aliquot and a
different confirmatory test (e.g., multi-wavelength spectrophotometry,
ion
[[Page 20576]]
chromatography, capillary electrophoresis) on the second aliquot;
(c) The presence of chromium (VI) is verified using either a
general oxidant colorimetric test (with an equal to or greater than 50
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric
test (chromium (VI) concentration equal to or greater than 50 mcg/mL)
for the initial test on the first aliquot and a different confirmatory
test (e.g., multi-wavelength spectrophotometry, ion chromatography,
atomic absorption spectrophotometry, capillary electrophoresis,
inductively coupled plasma-mass spectrometry) with the chromium (VI)
concentration equal to or greater than the LOQ of the confirmatory test
on the second aliquot;
(d) The presence of a halogen (e.g., chlorine from bleach, iodine,
fluoride) is verified using either a general oxidant colorimetric test
(with an equal to or great than 200 mcg/mL nitrite-equivalent cutoff or
an equal to or great than 50 mcg/mL chromium (VI)-equivalent cutoff) or
halogen colorimetric test (halogen concentration equal to or greater
than the LOQ) for the initial test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, inductively coupled plasma-mass spectrometry) with a
specific halogen concentration equal to or greater than the LOQ of the
confirmatory test on the second aliquot;
(e) The presence of glutaraldehyde is verified using either an
aldehyde test (aldehyde present) or the characteristic immunoassay
response on one or more drug immunoassay tests for the initial test on
the first aliquot and a different confirmatory test (e.g., GC/MS) for
the confirmatory test with the glutaraldehyde concentration equal to or
greater than the LOQ of the analysis on the second aliquot;
(f) The presence of pyridine (pyridinium chlorochromate) is
verified using either a general oxidant colorimetric test (with an
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or
a chromium (VI) colorimetric test (chromium (VI) concentration equal to
or greater than 50 mcg/mL) for the initial test on the first aliquot
and a different confirmatory test (e.g., GC/MS) for the confirmatory
test with the pyridine concentration equal to or greater than the LOQ
of the analysis on the second aliquot;
(g) The presence of a surfactant is verified by using a surfactant
colorimetric test with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the
first aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
(h) The presence of any other adulterant not specified in
paragraphs (b) through (g) of this section is verified using an initial
test on the first aliquot and a different confirmatory test on the
second aliquot.
Section 3.7 What criteria are used to report a urine specimen as
substituted?
An HHS-certified laboratory reports a primary (A) specimen as
substituted when:
(a) The creatinine concentration is less than 2 mg/dL on both the
initial and confirmatory creatinine tests on two separate aliquots
(i.e., the same colorimetric test may be used to test both aliquots)
and the specific gravity is less than or equal to 1.0010 or equal to or
greater than 1.0200 on both the initial and confirmatory specific
gravity tests on two separate aliquots (i.e., a refractometer is used
to test both aliquots), or
(b) A biomarker is not detected or is present at a concentration
inconsistent with that established for human urine for both the initial
(first) test and the confirmatory (second) test on two separate
aliquots (i.e., using the test analytes and cutoffs in the biomarker
testing panel).
Section 3.8 What criteria are used to report a urine specimen as
dilute?
A dilute result may be reported only in conjunction with the
positive or negative drug test results for a specimen.
(a) An HHS-certified laboratory or an HHS-certified IITF reports a
primary (A) specimen as dilute when the creatinine concentration is
greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is
equal to or greater than 1.002 but less than 1.003 on a single aliquot.
(b) In addition, an HHS-certified laboratory reports a primary (A)
specimen as dilute when the creatinine concentration is equal to or
greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is
greater than 1.0010 but less than 1.0030.
Section 3.9 What criteria are used to report an invalid result for a
urine specimen?
An HHS-certified laboratory reports a primary (A) specimen as an
invalid result when:
(a) Inconsistent creatinine concentration and specific gravity
results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the
specific gravity is greater than 1.0010 but less than 1.0200 on the
initial and/or confirmatory specific gravity test, the specific gravity
is less than or equal to 1.0010 on both the initial and confirmatory
specific gravity tests and the creatinine concentration is equal to or
greater than 2 mg/dL on either or both the initial or confirmatory
creatinine tests);
(b) The pH is equal to or greater than 4 and less than 4.5 or equal
to or greater than 9 and less than 11 using either a colorimetric pH
test or pH meter for the initial test and a pH meter for the
confirmatory test on two separate aliquots;
(c) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test or equal to or greater than the
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric
test for both the initial (first) test and the second test or using
either initial test and the nitrite concentration is equal to or
greater than 200 mcg/mL but less than 500 mcg/mL for a different
confirmatory test (e.g., multi-wavelength spectrophotometry, ion
chromatography, capillary electrophoresis) on two separate aliquots;
(d) The possible presence of chromium (VI) is determined using the
same chromium (VI) colorimetric test with a cutoff equal to or greater
than 50 mcg/mL chromium (VI) for both the initial (first) test and the
second test on two separate aliquots;
(e) The possible presence of a halogen (e.g., chlorine from bleach,
iodine, fluoride) is determined using the same halogen colorimetric
test with a cutoff equal to or greater than the LOQ for both the
initial (first) test and the second test on two separate aliquots or
relying on the odor of the specimen as the initial test;
(f) The possible presence of glutaraldehyde is determined by using
the same aldehyde test (aldehyde present) or characteristic immunoassay
response on one or more drug immunoassay tests for both the initial
(first) test and the second test on two separate aliquots;
(g) The possible presence of an oxidizing adulterant is determined
by using the same general oxidant colorimetric test (with an equal to
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or
greater than 50 mcg/mL chromium (VI)-
[[Page 20577]]
equivalent cutoff, or a halogen concentration is equal to or greater
than the LOQ) for both the initial (first) test and the second test on
two separate aliquots;
(h) The possible presence of a surfactant is determined by using
the same surfactant colorimetric test with an equal to greater than 100
mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial
(first) test and the second test on two separate aliquots or a foam/
shake test for the initial test;
(i) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid immunoassay or alternate technology initial drug
test results cannot be obtained);
(j) Interference with the drug confirmatory assay occurs on two
separate aliquots of the specimen and the laboratory is unable to
identify the interfering substance;
(k) The physical appearance of the specimen (e.g., viscosity) is
such that testing the specimen may damage the laboratory's instruments;
(l) The specimen has been tested and the appearances of the primary
(A) and the split (B) specimens (e.g., color) are clearly different; or
(m) A specimen validity test (i.e., other than the tests listed
above) on two separate aliquots of the specimen indicates that the
specimen is not valid for testing.
Subpart D--Collectors
Section 4.1 Who may collect a specimen?
(a) A collector who has been trained to collect urine specimens in
accordance with these Guidelines.
(b) The immediate supervisor of a federal employee donor may only
collect that donor's specimen when no other collector is available. The
supervisor must be a trained collector.
(c) The hiring official of a federal agency applicant may only
collect that federal agency applicant's specimen when no other
collector is available. The hiring official must be a trained
collector.
Section 4.2 Who may not collect a specimen?
(a) A federal agency employee who is in a testing designated
position and subject to the federal agency drug testing rules must not
be a collector for co-workers in the same testing pool or who work with
that employee on a daily basis.
(b) A federal agency applicant or employee must not collect their
own drug testing specimen.
(c) An employee working for an HHS-certified laboratory or IITF
must not act as a collector if the employee could link the identity of
the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not
be related to the employee (e.g., spouse, ex-spouse, relative) or
personal friend (e.g., fianc[eacute]e).
Section 4.3 What are the requirements to be a collector?
(a) An individual may serve as a collector if they fulfill the
following conditions:
(1) Is knowledgeable about the collection procedure described in
these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal
agency's Drug-Free Workplace Program and additional information
provided by the Secretary relating to the collection procedure
described in these Guidelines;
(3) Is trained and qualified to collect a urine specimen. Training
must include the following:
(i) All steps necessary to complete a urine collection;
(ii) Completion and distribution of the Federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in
collections; and
(v) The collector's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of the donor, ensuring the
security of the specimen, and avoiding conduct or statements that could
be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five
consecutive error-free mock collections.
(i) The five mock collections must include one uneventful
collection scenario, one insufficient specimen quantity scenario, one
temperature out of range scenario, one scenario in which the donor
refuses to sign the Federal CCF, and one scenario in which the donor
refuses to initial the specimen bottle tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate
the individual being trained, in person or by a means that provides
real-time observation and interaction between the trainer and the
trainee, and the trainer must attest in writing that the mock
collections are error-free.
(b) A trained collector must complete refresher training at least
every five years that includes the requirements in paragraph (a) of
this section.
(c) The collector must maintain the documentation of their training
and provide that documentation to a federal agency when requested.
(d) An individual may not collect specimens for a federal agency
until the individual's training as a collector has been properly
documented.
Section 4.4 What are the requirements to be an observer for a direct
observed collection?
(a) An individual may serve as an observer for a direct observed
collection when the individual has satisfied the requirements:
(1) Is knowledgeable about the direct observed collection procedure
described in Section 8.9 of these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal
agency's Drug-Free Workplace Program or additional information provided
by the Secretary relating to the direct observed collection procedure
described in these Guidelines;
(3) Has received training on the following subjects:
(i) All steps necessary to perform a direct observed collection;
and
(ii) The observer's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of individuals being
tested, ensuring that the observation is done in a professional manner
that minimizes the discomfort to the employee so observed, ensuring the
security of the specimen by maintaining visual contact with the
collection container until it is delivered to the collector, and
avoiding conduct or statements that could be viewed as offensive or
inappropriate.
(b) The gender of the observer must be the same as the donor's
gender, which is determined by the donor's gender identity. The
observer selection process is described in Section 8.10(b).
(c) The observer is not required to be a trained collector.
Section 4.5 What are the requirements to be a trainer for collectors?
(a) Individuals are considered qualified trainers for collectors
and may train others to collect urine specimens when they have
completed the following:
(1) Qualified as a trained collector and regularly conducted urine
drug test collections for a period of at least one year; or
(2) Completed a ``train the trainer'' course given by an
organization (e.g., manufacturer, private entity, contractor, federal
agency).
(b) A qualified trainer for collectors must complete refresher
training at least every five years in accordance with the collector
requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the
documentation of the trainer's training and provide that
[[Page 20578]]
documentation to a federal agency when requested.
Section 4.6 What must a federal agency do before a collector is
permitted to collect a specimen?
A federal agency must ensure the following:
(a) The collector has satisfied the requirements described in
Section 4.3;
(b) The collector, who may be self-employed, or an organization
(e.g., third party administrator that provides a collection service,
collector training company, federal agency that employs its own
collectors) maintains a copy of the training record(s); and
(c) The collector has been provided the name and telephone number
of the federal agency representative.
Subpart E--Collection Sites
Section 5.1 Where can a collection for a drug test take place?
(a) A collection site may be a permanent or temporary facility
located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not
accessible and there is an immediate requirement to collect a urine
specimen (e.g., an accident investigation), a public restroom may be
used for the collection, using the procedures for a monitored
collection described in Section 8.12.
Section 5.2 What are the requirements for a collection site?
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as
described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the
donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the
specimen is transferred to an HHS-certified laboratory or IITF;
(d) A restricted access area where only authorized personnel may be
present during the collection;
(e) A restricted access area for the storage of collection
supplies;
(f) The ability to store records securely; and
(g) The ability to restrict the donor access to potential diluents
in accordance with Section 8.2.
Section 5.3 Where must collection site records be stored?
Collection site records must be stored at a secure site designated
by the collector or the collector's employer.
Section 5.4 How long must collection site records be stored?
Collection site records (e.g., collector copies of the OMB-approved
Federal CCF) must be stored securely for a minimum of 2 years. The
collection site may convert hardcopy records to electronic records for
storage and discard the hardcopy records after 6 months.
Section 5.5 How does the collector ensure the security and integrity of
a specimen at the collection site?
(a) A collector must do the following to maintain the security and
integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area
during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and
after collection;
(4) Ensure that only the collector and the donor are allowed to
handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and
documented throughout the entire collection, storage, and transport
procedures;
(6) Ensure that the Federal CCF is completed and distributed as
required; and
(7) Ensure that specimens transported to an HHS-certified
laboratory or IITF are sealed and placed in transport containers
designed to minimize the possibility of damage during shipment (e.g.,
specimen boxes, padded mailers, or other suitable shipping container),
and those containers are securely sealed to eliminate the possibility
of undetected tampering;
(b) Couriers, express carriers, and postal service personnel are
not required to document chain of custody since specimens are sealed in
packages that would indicate tampering during transit to the HHS-
certified laboratory or IITF.
Section 5.6 What are the privacy requirements when collecting a urine
specimen?
Collections must be performed at a site that provides reasonable
privacy (as described in Section 8.1).
Subpart F--Federal Drug Testing Custody and Control Form
Section 6.1 What federal form is used to document custody and control?
The OMB-approved Federal CCF must be used to document custody and
control of each specimen at the collection site.
Section 6.2 What happens if the correct OMB-approved Federal CCF is not
available or is not used?
(a) The use of a non-federal CCF or an expired Federal CCF is not,
by itself, a reason for the HHS-certified laboratory or IITF to
automatically reject the specimen for testing or for the MRO to cancel
the test.
(b) If the collector does not use the correct OMB-approved Federal
CCF, the collector must document that it is a federal agency specimen
collection and provide the reason that the incorrect form was used.
Based on the information provided by the collector, the HHS-certified
laboratory or IITF must handle and test the specimen as a federal
agency specimen.
(c) If the HHS-certified laboratory, HHS-certified IITF, or MRO
discovers that the collector used an incorrect form, the laboratory,
IITF, or MRO must obtain a memorandum for the record from the collector
describing the reason the incorrect form was used. If a memorandum for
the record cannot be obtained, the laboratory or IITF reports a
rejected for testing result to the MRO and the MRO cancels the test.
The HHS-certified laboratory or IITF must wait at least 5 business days
while attempting to obtain the memorandum before reporting a rejected
for testing result to the MRO.
Subpart G--Urine Specimen Collection Containers and Bottles
Section 7.1 What is used to collect a urine specimen?
A single-use collection container with a means (i.e., thermometer)
to measure urine temperature and two specimen bottles must be used.
Section 7.2 What are the requirements for a urine collection container
and specimen bottles?
(a) The collection container, the thermometer, and the specimen
bottles must not substantially affect the composition of drugs and/or
metabolites in the urine specimen.
(b) The two specimen bottles must be sealable and non-leaking, and
must maintain the integrity of the specimen during storage and
transport so that the specimen contained therein can be tested in an
HHS-certified laboratory or IITF for the presence of drugs or their
metabolites.
(c) The two specimen bottles must be sufficiently transparent to
enable an objective assessment of specimen appearance and
identification of abnormal physical characteristics without opening the
bottle.
[[Page 20579]]
Section 7.3 What are the minimum performance requirements for a urine
collection container and specimen bottles?
(a) The collection container must be capable of holding at least 55
mL and have a volume marking clearly noting a level of 45 mL.
(b) One of the two specimen bottles must be capable of holding at
least 35 mL and the other at least 20 mL, and each must have a volume
marking clearly noting the appropriate level (30 mL for the primary
specimen and 15 mL for the split specimen).
(c) The thermometer may be affixed to or built into the collection
container and must provide graduated temperature readings from 32-38
[deg]C/90-100 [deg]F. Alternatively, the collector may use another
technology to measure specimen temperature (e.g., thermal radiation
scanning), providing the thermometer does not come into contact with
the specimen.
Subpart H--Urine Specimen Collection Procedure
Section 8.1 What privacy must the donor be given when providing a urine
specimen?
The following privacy requirements apply when a donor is providing
a urine specimen:
(a) Only authorized personnel and the donor may be present in the
restricted access area where the collection takes place.
(b) The collector is not required to be the same gender as the
donor. The gender of the observer for purposes of a direct observed
collection (i.e., as described in Section 8.10) must be the same as the
donor's gender, which is determined by the donor's gender identity. The
gender of the monitor for a monitored collection (i.e., as described in
Section 8.12) must be the same as the donor's gender, unless the
monitor is a medical professional (e.g., nurse, doctor, physician's
assistant, technologist, or technician licensed or certified to
practice in the jurisdiction in which the collection takes place).
(c) The collector must give the donor visual privacy while
providing the specimen. The donor is allowed to provide a urine
specimen in an enclosed stall within a multi-stall restroom or in a
single person restroom during a monitored collection.
Section 8.2 What must the collector ensure at the collection site
before starting a urine specimen collection?
The collector must deter the dilution or substitution of a specimen
at the collection site by:
(a) Placing a toilet bluing agent in a toilet bowl or toilet tank,
so the reservoir of water in the toilet bowl always remains blue. If no
bluing agent is available or if the toilet has an automatic flushing
system, the collector shall turn the water supply off to the toilet and
flush the toilet to remove the water in the toilet when possible.
(b) Secure other sources of water (e.g., shower or sink) in the
enclosure where urination occurs. If the enclosure has a source of
water that cannot be disabled or secured, a monitored collection must
be conducted in accordance with Section 8.11.
Section 8.3 What are the preliminary steps in the urine specimen
collection procedure?
The collector must take the following steps before beginning a
urine specimen collection:
(a) If a donor fails to arrive at the collection site at the
assigned time, the collector must follow the federal agency policy or
contact the federal agency representative to obtain guidance on action
to be taken.
(b) When the donor arrives at the collection site, the collector
should begin the collection procedure without undue delay. For example,
the collection should not be delayed because the donor states that they
are unable to urinate or an authorized employer or employer
representative is late in arriving.
(c) The collector requests the donor to present photo
identification (e.g., driver's license; employee badge issued by the
employer; an alternative photo identification issued by a federal,
state, or local government agency). If the donor does not have proper
photo identification, the collector shall contact the supervisor of the
donor or the federal agency representative who can positively identify
the donor. If the donor's identity cannot be established, the collector
must not proceed with the collection.
(d) The collector must provide identification (e.g., employee
badge, employee list) if requested by the donor.
(e) The collector explains the basic collection procedure to the
donor.
(f) The collector provides the instructions for completing the
Federal CCF for the donor's review, and informs the donor that the
instructions are available upon request.
(g) The collector answers any reasonable and appropriate questions
the donor may have regarding the collection procedure.
(h) The collector asks the donor to remove any unnecessary outer
garments (e.g., coat, jacket) that might conceal items or substances
that could be used to adulterate or substitute the urine specimen. The
collector must ensure that all personal belongings (e.g., purse or
briefcase) remain with the outer garments. The donor may retain the
donor's wallet.
(i) The collector asks the donor to empty the donor's pockets and
display the contents to ensure no items are present that could be used
to adulterate or substitute the specimen.
(1) If no items are present that can be used to adulterate,
substitute, or dilute the specimen, the collector instructs the donor
to return the items to their pockets and continues the collection
procedure.
(2) If an item is present whose purpose is to adulterate,
substitute, or dilute the specimen (e.g., a commercial drug culture
product or other substance for which the donor has no reasonable
explanation), this is considered a refusal to test. The collector must
stop the collection and report the refusal to test as described in
Section 8.13.
(3) If an item that could be used to adulterate, substitute, or
dilute the specimen (e.g., common personal care products such as
eyedrops, mouthwash, or hand sanitizer) appears to have been
inadvertently brought to the collection site, the collector must secure
the item and continue with the normal collection procedure.
(4) If the donor refuses to show the collector the items in their
pockets, this is considered a refusal to test. The collector must stop
the collection and report the refusal to test as described in Section
8.13.
(j) The collector shall instruct the donor to wash and dry the
donor's hands prior to urination. After washing the donor's hands, the
donor must remain in the presence of the collector and must not have
access to any water fountain, faucet, soap dispenser, cleaning agent,
or any other materials which could be used to adulterate or substitute
the specimen.
(k) If the donor refuses to wash their hands when instructed by the
collector, this is considered a ``refusal to test.'' The collector must
stop the collection and report the refusal to test as described in
Section 8.13.
Section 8.4 What steps does the collector take in the collection
procedure before the donor provides a urine specimen?
(a) The collector will provide or the donor may select a specimen
collection container that is clean, unused, wrapped/sealed in original
packaging and compliant with Subpart G. The
[[Page 20580]]
specimen collection container package will be opened in view of the
donor.
(b) The collector instructs the donor to provide the specimen in
the privacy of a stall or otherwise partitioned area that allows for
individual privacy. The collector directs the donor to provide a
specimen of at least 45 mL, to not flush the toilet, and to return with
the specimen as soon as the donor has completed the void.
(1) Except in the case of a direct observed collection (i.e., as
described in Section 8.10) or a monitored collection (i.e., as
described in Section 8.12), neither the collector nor anyone else may
go into the room with the donor.
(2) The collector may set a reasonable time limit for specimen
collection.
(c) The collector notes any unusual behavior or appearance of the
donor on the Federal CCF. If the collector detects any conduct that
clearly indicates an attempt to tamper with a specimen (e.g.,
substitute urine in plain view or an attempt to bring into the
collection site an adulterant or urine substitute), the collector must
report a refusal to test in accordance with Section 8.13.
Section 8.5 What steps does the collector take during and after the
urine specimen collection procedure?
Integrity and Identity of the Specimen. The collector must take the
following steps during and after the donor provides the urine specimen:
(a) The collector must inform the donor that, once the collection
procedure has begun, the donor must remain at the collection site
(i.e., in an area designated by the collector) until the collection is
complete and that failure to follow these instructions will be reported
as a refusal to test. This includes the wait period (i.e., up to 3
hours) if needed to provide a sufficient specimen as described in step
(f)(2) below and in Section 8.6.
(b) After providing the specimen, the donor gives the specimen
collection container to the collector. Both the donor and the collector
must keep the specimen container in view at all times until the
collector seals the specimen bottles as described in Section 8.8.
(c) After the donor has given the specimen to the collector,
whenever practical, the donor shall be allowed to wash the donor's
hands and the donor may flush the toilet.
(d) The collector must measure the temperature of the specimen
within 4 minutes of receiving the specimen from the donor. The
collector records on the Federal CCF whether or not the temperature is
in the acceptable range of 32[deg]-38 [deg]C/90[deg]-100 [deg]F.
(1) The temperature measuring device must accurately reflect the
temperature of the specimen and not contaminate the specimen.
(2) If the temperature of the specimen is outside the range of
32[deg]-38 [deg]C/90[deg]-100 [deg]F, that is a reason to believe that
the donor may have adulterated or substituted the specimen. Another
specimen must be collected under direct observation in accordance with
Section 8.9. The collector must forward both specimens (i.e., from the
first and second collections) to an HHS-certified laboratory for
testing and record a comment on the Federal CCF for each specimen.
(e) The collector must inspect the specimen to determine if there
is any sign indicating that the specimen may not be a valid urine
specimen (e.g., unusual color, presence of foreign objects or material,
unusual odor).
(1) The collector notes any unusual finding on the Federal CCF. A
specimen suspected of not being a valid urine specimen must be
forwarded to an HHS-certified laboratory for testing.
(2) When there is any reason to believe that a donor may have
adulterated or substituted the specimen, another specimen must be
obtained as soon as possible under direct observation in accordance
with Section 8.10. The collector must forward both specimens (i.e.,
from the first and second collections) to an HHS-certified laboratory
for testing and record a comment on the Federal CCF for each specimen.
(f) The collector must determine the volume of urine in the
specimen container. The collector must never combine urine collected
from separate voids to create a specimen.
(1) If the volume is at least 45 mL, the collector will proceed
with steps described in Section 8.8.
(2) If the volume is less than 45 mL, the collector discards the
specimen and immediately collects a second specimen using the same
procedures as for the first specimen (including steps in paragraphs c
and d of this section).
(i) The collector may give the donor a reasonable amount of liquid
to drink for this purpose (e.g., an 8 ounce glass of water every 30
minutes, but not to exceed a maximum of 40 ounces over a period of 3
hours or until the donor has provided a sufficient urine specimen).
However, the donor is not required to drink any fluids during this
waiting time.
(ii) If the donor provides a sufficient urine specimen (i.e., at
least 45 mL), the collector proceeds with steps described in Section
8.8.
(iii) If the employee has not provided a sufficient specimen (i.e.,
at least 45 mL) within three hours of the first unsuccessful attempt to
provide the specimen, the collector records the reason for not
collecting a urine specimen on the Federal CCF, notifies the federal
agency's designated representative for authorization of an alternate
specimen to be collected, 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 alternative specimen.
(g) If the donor fails to remain present through the completion of
the collection, declines to have a direct observed collection as
required in steps (d)(2) or (e)(2) above, refuses to provide a second
specimen as required in step (f)(2) above, or refuses to provide an
alternate specimen as authorized in step (f)(2)(iii) above, the
collector stops the collection and reports the refusal to test in
accordance with Section 8.13.
Section 8.6 What procedure is used when the donor states that they are
unable to provide a urine specimen?
(a) If the donor states that they are unable to provide a urine
specimen during the collection process, the collector requests that the
donor enter the restroom (stall) and attempt to provide a urine
specimen.
(b) The donor demonstrates their inability to provide a specimen
when he or she comes out of the stall with an empty collection
container.
(1) If the donor states that they could provide a specimen after
drinking some fluids, the collector gives the donor a reasonable amount
of liquid to drink for this purpose (e.g., an 8 ounce glass of water
every 30 minutes, but not to exceed a maximum of 40 ounces over a
period of 3 hours or until the donor has provided a sufficient urine
specimen). If the donor simply needs more time before attempting to
provide a urine specimen, the donor may choose not to drink any fluids
during the 3 hour wait time.
(2) If the donor states that they are unable to provide a urine
specimen, the collector records the reason for not collecting a urine
specimen on the
[[Page 20581]]
Federal CCF, notifies the federal agency's designated representative
for authorization of an alternate specimen to be collected, 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
alternative specimen.
Section 8.7 If the donor is unable to provide a urine specimen, may
another specimen type be collected for testing?
Yes, if the alternate specimen type is authorized by Mandatory
Guidelines for Federal Workplace Drug Testing Programs and specifically
authorized by the federal agency.
Section 8.8 How does the collector prepare the urine specimens?
(a) All federal agency collections are to be split specimen
collections.
(b) The collector, in the presence of the donor, pours the urine
from the collection container into two specimen bottles to be labeled
``A'' and ``B''. The collector pours at least 30 mL of urine into
Bottle A and at least 15 mL into Bottle B, and caps each bottle.
(c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over each specimen bottle cap.
The collector records the date of the collection on the tamper-evident
labels/seals.
(d) The collector instructs the donor to initial the tamper-evident
labels/seals on each specimen bottle. If the donor refuses to initial
the labels/seals, the collector notes the refusal on the Federal CCF
and continues with the collection process.
(e) The collector must ensure that all the information required on
the Federal CCF is provided.
(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 (Bottle A and Bottle B) in a
package and, within 24 hours or during the next business day, sends
them to the HHS-certified laboratory or IITF that will be testing the
Bottle A urine specimen.
(i) If the specimen and Federal CCF are not immediately transported
to an HHS-certified laboratory or IITF, they must remain under direct
control of the collector or be appropriately secured under proper
specimen storage conditions until transported.
(j) The collector must discard any urine left over in the
collection container after both specimen bottles have been
appropriately filled and sealed. There is one exception to this
requirement: The collector may use excess urine to conduct clinical
tests (e.g., protein, glucose) if the collection was conducted in
conjunction with a physical examination required by federal agency
regulation. Neither the collector nor anyone else may conduct further
testing (such as specimen validity testing) on the excess urine.
Section 8.9 When is a direct observed collection conducted?
A direct observed collection procedure must be conducted when:
(a) The agency has authorized a direct observed collection because:
(1) The donor's previous drug test result was reported by an MRO as
positive, adulterated, or substituted; or
(2) The HHS-certified laboratory reports to the MRO that a specimen
is invalid, and the MRO reported to the agency that there was not a
legitimate medical explanation for the result; or
(3) The MRO reported to the agency that the primary (A) specimen
was positive, adulterated, or substituted but the test was cancelled
because the split (B) specimen could not be tested or the split
specimen failed to reconfirm the primary specimen result; or
(b) At the collection site, an immediate collection of a second
urine specimen is required because:
(1) The temperature of the specimen collected during a routine
collection is outside the acceptable temperature range; or
(2) The collector suspects that the donor has tampered with the
specimen during a routine collection (e.g., abnormal physical
characteristic such as unusual color and/or odor, and/or excessive
foaming when shaken).
(c) The collector must contact a collection site supervisor to
review and concur in advance with any decision by the collector to
obtain a specimen under direct observation.
(d) If the donor declines to have a direct observed collection, the
collector reports a refusal to test (i.e., as described in Section
8.13).
Section 8.10 How is a direct observed collection conducted?
(a) A direct observed collection procedure is the same as that for
a routine collection, except an observer watches the donor urinate into
the collection container. The observer's gender must be the same as the
donor's gender, which is determined by the donor's gender identity,
with no exception to this requirement.
(b) Before an observer is selected, the collector informs the donor
that the gender of the observer will match the donor's gender, which is
determined by the donor's gender identity (as defined in Section 1.5).
The collector then selects the observer to conduct the observation:
(i) The collector asks the donor to identify the donor's gender on
the Federal CCF and initial it.
(ii) The donor will then be provided an observer whose gender
matches the donor's gender.
(iii) The collector documents the observer's name and gender on the
Federal CCF.
(c) If there is no collector available of the same gender as the
donor's gender, the collector or collection site supervisor shall
select an observer trained in direct observed specimen collection as
described in Section 4.4. The observer may be an individual that is not
a trained collector.
(d) At the point in a routine collection where the donor enters the
restroom with the collection container, a direct observed collection
includes the following additional steps:
(1) The observer enters the restroom with the donor;
(2) The observer must directly watch the urine go from the donor's
body into the collection container (the use of mirrors or video cameras
is not permitted);
(3) The observer must not touch or handle the collection container
unless the observer is also serving as the collector;
(4) After the donor has completed urinating into the collection
container:
(i) If the same person serves as the observer and collector, that
person may receive the collection container from the donor while they
are both in the restroom;
(ii) If the observer is not serving as the collector, the donor and
observer leave the restroom and the donor hands the collection
container directly to the collector. The observer must maintain visual
contact of the collection
[[Page 20582]]
container until the donor hands the container to the collector.
(5) The collector checks the box for an observed collection on the
Federal CCF and writes the name of the observer and the reason for an
observed collection on the Federal CCF; and
(6) The collector then continues with the routine collection
procedure in Section 8.3.
Section 8.11 When is a monitored collection conducted?
(a) In the event that an agency-designated collection site is not
available and there is an immediate requirement to collect a specimen
(e.g., an accident investigation), a public restroom may be used for
the collection, using the procedures for a monitored collection
described in Section 8.12.
(b) If the enclosure used by the donor to provide a specimen has a
source of water that cannot be disabled or secured, a monitored
collection must be conducted.
(c) If the donor declines to permit a collection to be monitored
when required, the collector reports a refusal to test (i.e., as
described in Section 8.13).
Section 8.12 How is a monitored collection conducted?
A monitored collection is the same as that for a routine
collection, except that a monitor accompanies the donor into the
restroom to check for signs that the donor may be tampering with the
specimen. The monitor remains in the restroom, but outside the stall,
while the donor is providing the specimen. A person of the same gender
as the donor shall serve as the monitor, unless the monitor is a
medical professional (e.g., nurse, doctor, physician's assistant,
technologist, or technician licensed or certified to practice in the
jurisdiction in which the collection takes place). The same procedures
used for selecting an observer of the appropriate gender in Section
8.10(b) must be used to select the monitor for the purposes of Section
8.12, unless the monitor is a medical professional as described above.
The monitor may be an individual other than the collector and need not
be a qualified collector.
(a) The collector secures the restroom being used for the monitored
collection so that no one except the employee and the monitor can enter
the restroom until after the collection has been completed.
(b) The monitor enters the restroom with the donor.
(c) The monitor must not watch the employee urinate into the
collection container. If the monitor hears sounds or makes other
observations indicating an attempt by the donor to tamper with a
specimen, there must be an additional collection under direct
observation in accordance with Section 8.9.
(d) The monitor must not touch or handle the collection container
unless the monitor is also the collector.
(e) After the donor has completed urinating into the collection
container:
(1) If the same person serves as the monitor and collector, that
person may receive the collection container from the donor while they
are both in the restroom;
(2) If the monitor is not serving as the collector, the donor and
monitor leave the restroom and the donor hands the collection container
directly to the collector. The monitor must ensure that the employee
takes the collection container directly to the collector as soon as the
employee has exited the enclosure.
(f) If the monitor is not serving as the collector, the collector
writes the name of the monitor on the Federal CCF.
(g) The collector then continues with the routine collection
procedure in Section 8.3.
Section 8.13 How does the collector report a donor's refusal to test?
If there is a refusal to test as defined in Section 1.7, the
collector stops the collection, discards any urine collected and
reports the refusal to test by:
(a) Notifying the federal agency by means (e.g., telephone, email,
or secure fax) that ensures that the notification is immediately
received,
(b) Documenting the refusal to test on the Federal CCF, and
(c) Sending all copies of the Federal CCF to the federal agency's
designated representative.
Section 8.14 What are a federal agency's responsibilities for a
collection site?
(a) A federal agency must ensure that collectors and collection
sites satisfy all requirements in subparts D, E, F, G, and H.
(b) A federal agency (or only one federal agency when several
agencies are using the same collection site) must inspect 5 percent or
up to a maximum of 50 collection sites each year, selected randomly
from those sites used to collect agency specimens (e.g., virtual,
onsite, or self-evaluation).
(c) A federal agency must investigate reported collection site
deficiencies (e.g., specimens reported ``rejected for testing'' by an
HHS-certified laboratory or IITF) and take appropriate action which may
include a collection site self-assessment (i.e., using the Collection
Site Checklist for the Collection of Urine Specimens for Federal Agency
Workplace Drug Testing Programs) or an inspection of the collection
site. The inspections of these additional collection sites may be
included in the 5 percent or maximum of 50 collection sites inspected
annually.
Subpart I--HHS Certification of Laboratories and IITFs
Section 9.1 Who has the authority to certify laboratories and IITFs to
test urine specimens for federal agencies?
(a) The Secretary has broad discretion to take appropriate action
to ensure the full reliability and accuracy of drug testing and
reporting, to resolve problems related to drug testing, and to enforce
all standards set forth in these Guidelines. The Secretary has the
authority to issue directives to any HHS-certified laboratory or IITF
including suspending the use of certain analytical procedures when
necessary to protect the integrity of the testing process; ordering any
HHS-certified laboratory or IITF to undertake corrective actions to
respond to material deficiencies identified by an inspection or through
performance testing; ordering any HHS-certified laboratory or IITF to
send specimens or specimen aliquots to another HHS-certified laboratory
for retesting when necessary to ensure the accuracy of testing under
these Guidelines; ordering the review of results for specimens tested
under the Guidelines for private sector clients to the extent necessary
to ensure the full reliability of drug testing for federal agencies;
and ordering any other action necessary to address deficiencies in drug
testing, analysis, specimen collection, chain of custody, reporting of
results, or any other aspect of the certification program.
(b) A laboratory or IITF is prohibited from stating or implying
that it is certified by HHS under these Guidelines to test urine
specimens for federal agencies unless it holds such certification.
Section 9.2 What is the process for a laboratory or IITF to become HHS-
certified?
(a) A laboratory or IITF seeking HHS certification must:
(1) Submit a completed OMB-approved application form (i.e., the
applicant laboratory or IITF provides detailed information on both the
administrative and analytical procedures to be used for federally
regulated specimens);
(2) Have its application reviewed as complete and accepted by HHS;
[[Page 20583]]
(3) Successfully complete the PT challenges in 3 consecutive sets
of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before
testing specimens for federal agencies.
Section 9.3 What is the process for a laboratory or IITF to maintain
HHS certification?
(a) To maintain HHS certification, a laboratory or IITF must:
(1) Successfully participate in both the maintenance PT and
inspection programs (i.e., successfully test the required quarterly
sets of maintenance PT samples, undergo an inspection 3 months after
being certified, and undergo maintenance inspections at a minimum of
every 6 months thereafter);
(2) Respond in an appropriate, timely, and complete manner to
required corrective action requests if deficiencies are identified in
the maintenance PT performance, during the inspections, operations, or
reporting; and
(3) Satisfactorily complete corrective remedial actions, and
undergo special inspection and special PT sets to maintain or restore
certification when material deficiencies occur in either the PT
program, inspection program, or in operations and reporting.
Section 9.4 What is the process when a laboratory or IITF does not
maintain its HHS certification?
(a) A laboratory or IITF that does not maintain its HHS
certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and
records throughout the required storage period described in Sections
11.20, 11.21, 12.18, and 14.8;
(3) Ensure access to federally regulated specimens and records in
accordance with Sections 11.23, 11.24, 12.20, 12.21, and Subpart P; and
(4) Follow the HHS suspension and revocation procedures when
imposed by the Secretary, follow the HHS procedures in Subpart P 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
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
9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an
adulterant, or other substances for special purposes, or may satisfy
the criteria for a substituted specimen, dilute specimen, or invalid
result.
(3) A negative PT sample will not contain a measurable amount of a
target analyte.
(b) PT samples used to evaluate specimen validity tests shall
satisfy, but are not limited to, one of the following criteria:
(1) The nitrite concentration will be at least 20 percent above the
cutoff;
(2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5;
(3) The concentration of an oxidant will be at a level sufficient
to challenge a laboratory's ability to identify and confirm the
oxidant;
(4) The creatinine concentration will be between 0 and 20 mg/dL; or
(5) The specific gravity will be less than or equal to 1.0050 or
between 1.0170 and 1.0230.
(c) For each PT cycle, the set of PT samples going to each HHS-
certified laboratory or IITF will vary but, within each calendar year,
each HHS-certified laboratory or IITF will analyze essentially the same
total set of samples.
(d) The laboratory or IITF must (to the greatest extent possible)
handle, test, and report a PT sample in a manner identical to that used
for a donor specimen, unless otherwise specified.
Section 9.6 What are the PT requirements for an applicant laboratory?
(a) An applicant laboratory that seeks certification under these
Guidelines must satisfy the following criteria on three consecutive
sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of
the total drug challenges over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the drug challenges
for each initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the
concentrations (i.e., no more than <plus-minus>20 percent or <plus-
minus>2 standard deviations [whichever is larger] from the appropriate
reference or peer group means) for at least 80 percent of the total
drug challenges over the three sets of PT samples;
(5) For the confirmatory drug tests, do not obtain any drug
concentration that differs by more than <plus-minus>50 percent from the
appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and
determine the concentrations (i.e., no more than <plus-minus>20 percent
or <plus-minus>2 standard deviations [whichever is larger] from the
appropriate reference or peer group means) for at least 50 percent of
the drug challenges for an individual drug over the three sets of PT
samples;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over the three sets of PT
samples;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over the three
sets of PT samples that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than <plus-
minus>20 percent or <plus-minus>2 standard deviations from the
appropriate reference or peer group mean; and
(ii) pH values are no more than <plus-minus>0.3 pH units from the
appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than <plus-minus>0.0003
specific gravity units from the appropriate reference or peer group
mean when the mean is less than 1.0100 and specific gravity values are
no more than <plus-minus>0.0004 specific gravity units from the
appropriate reference or peer group mean when the mean is equal to or
greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for nitrite and
creatinine concentrations, <plus-minus>0.8 pH units using a pH meter,
<plus-minus>0.0006 specific gravity units when the mean is less than
1.0100, or <plus-minus>0.0007 specific gravity units when the mean is
equal to or greater than 1.0100; and
(11) Do not report any sample as adulterated with a compound that
is not present in the sample, adulterated based on pH when the
appropriate reference or peer group mean is within the acceptable pH
range, substituted when the appropriate reference or peer group
[[Page 20584]]
means for both creatinine and specific gravity are within the
acceptable range, or substituted when the appropriate reference or peer
group mean for a biomarker is within the acceptable range.
(b) Failure to satisfy these requirements will result in
disqualification.
Section 9.7 What are the PT requirements for an HHS-certified urine
laboratory?
(a) A laboratory certified under these Guidelines 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 mean;
(6) For each confirmatory drug test, correctly identify and
determine that the concentrations for at least 50 percent of the drug
challenges for an individual drug are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group means over two consecutive PT
cycles;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over two consecutive PT cycles;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over two
consecutive PT cycles that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than <plus-
minus>20 percent or <plus-minus>2 standard deviations from the
appropriate reference or peer group mean;
(ii) pH values are no more than <plus-minus>0.3 pH units from the
appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than <plus-minus>0.0003
specific gravity units from the appropriate reference or peer group
mean when the mean is less than 1.0100 and specific gravity values are
no more than <plus-minus>0.0004 specific gravity units from the
appropriate reference or peer group mean when the mean is equal to or
greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for nitrite and
creatinine concentrations, <plus-minus>0.8 pH units using a pH meter,
<plus-minus>0.0006 specific gravity units when the mean is less than
1.0100, or <plus-minus>0.0007 specific gravity units when the mean is
equal to or greater than 1.0100; and
(11) Do not report any PT sample as adulterated with a compound
that is not present in the sample, adulterated based on pH when the
appropriate reference or peer group mean is within the acceptable pH
range, substituted when the appropriate reference or peer group means
for both creatinine and specific gravity are within the acceptable
range, or substituted when the appropriate reference or peer group mean
for a biomarker is within the acceptable range.
(b) Failure to participate in all PT cycles or to satisfy these
requirements may result in suspension or revocation of an HHS-certified
laboratory's certification.
Section 9.8 What are the PT requirements for an applicant IITF?
(a) An applicant IITF that seeks certification under these
Guidelines must satisfy the following criteria on three consecutive
sets of PT samples:
(1) Correctly identify at least 90 percent of the total drug
challenges over the three sets of PT samples;
(2) Correctly identify at least 80 percent of the drug challenges
for each individual drug test over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the total specimen
validity test challenges over the three sets of PT samples;
(4) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over the three sets of PT
samples;
(5) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total specimen validity test
challenges over the three sets of PT samples that satisfy the following
criteria:
(i) Creatinine concentrations are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than <plus-minus>0.001
specific gravity units from the appropriate reference or peer group
mean; and
(6) Must not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for creatinine
concentration or <plus-minus>0.002 specific gravity units for specific
gravity.
(b) Failure to satisfy these requirements will result in
disqualification.
Section 9.9 What are the PT requirements for an HHS-certified IITF?
(a) An IITF certified under these Guidelines must satisfy the
following criteria on the maintenance PT samples to maintain its
certification:
(1) Correctly identify at least 90 percent of the total drug
challenges over two consecutive PT cycles;
(2) Correctly identify at least 80 percent of the drug challenges
for each individual drug test over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the total specimen
validity test challenges over two consecutive PT cycles;
(4) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over two consecutive PT cycles;
(5) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total specimen validity test
challenges over two consecutive PT cycles that satisfy the following
criteria:
(i) Creatinine concentrations are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than <plus-minus>0.001
specific gravity units from the appropriate reference or peer group
mean; and
(6) Must not obtain any quantitative value on a specimen validity
test PT sample that differs from the appropriate reference or peer
group mean by more than <plus-minus>50 percent for creatinine
concentration, or <plus-minus>0.002 specific gravity units for specific
gravity.
(b) Failure to participate in all PT cycles or to satisfy these
requirements may result in suspension or revocation of an HHS-certified
IITF's certification.
Section 9.10 What are the inspection requirements for an applicant
laboratory or IITF?
(a) An applicant laboratory or IITF is inspected by a team of two
inspectors.
[[Page 20585]]
(b) Each inspector conducts an independent review and evaluation of
all aspects of the laboratory's or IITF's testing procedures and
facilities using an inspection checklist.
Section 9.11 What are the maintenance inspection requirements for an
HHS-certified laboratory or IITF?
(a) An HHS-certified laboratory or IITF must undergo an inspection
3 months after becoming certified and at least every 6 months
thereafter.
(b) An HHS-certified laboratory or IITF is inspected by one or more
inspectors. The number of inspectors is determined according to the
number of specimens reviewed. Additional information regarding
inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of
the HHS-certified laboratory's or IITF's procedures, records, and
facilities using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory or IITF must
continue to satisfy the minimum requirements as stated in these
Guidelines.
Section 9.12 Who can inspect an HHS-certified laboratory or IITF and
when may the inspection be conducted?
(a) An individual may be selected as an inspector for the Secretary
if they satisfy the following criteria:
(1) Has experience and an educational background similar to that
required for either a responsible person or a certifying scientist for
an HHS-certified laboratory as described in Subpart K or as a
responsible technician for an HHS-certified IITF as described in
Subpart L;
(2) Has read and thoroughly understands the policies and
requirements contained in these Guidelines and in other guidance
consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory or IITF.
(b) The Secretary or a federal agency may conduct an inspection at
any time.
Section 9.13 What happens if an applicant laboratory or IITF does not
satisfy the minimum requirements for either the PT program or the
inspection program?
If an applicant laboratory or IITF fails to satisfy the
requirements established for the initial certification process, the
laboratory or IITF must start the certification process from the
beginning.
Section 9.14 What happens if an HHS-certified laboratory or IITF does
not satisfy the minimum requirements for either the PT program or the
inspection program?
(a) If an HHS-certified laboratory or IITF fails to satisfy the
minimum requirements for certification, the laboratory or IITF is given
a period of time (e.g., 5 or 30 working days depending on the nature of
the deficiency) to provide any explanation for its performance and
evidence that all deficiencies have been corrected.
(b) A laboratory's or IITF's HHS certification may be revoked,
suspended, or no further action taken depending on the seriousness of
the deficiencies and whether there is evidence that the deficiencies
have been corrected and that current performance meets the requirements
for certification.
(c) An HHS-certified laboratory or IITF may be required to undergo
a special inspection or to test additional PT samples to address
deficiencies.
(d) If an HHS-certified laboratory's or IITF's certification is
revoked or suspended in accordance with the process described in
Subpart P, the laboratory or IITF is not permitted to test federally
regulated specimens until the suspension is lifted or the laboratory or
IITF has successfully completed the certification requirements as a new
applicant laboratory or IITF.
Section 9.15 What factors are considered in determining whether
revocation of a laboratory's or IITF's HHS certification is necessary?
(a) The Secretary shall revoke certification of an HHS-certified
laboratory or IITF in accordance with these Guidelines if the Secretary
determines that revocation is necessary to ensure fully reliable and
accurate drug and specimen validity test results and reports.
(b) The Secretary shall consider the following factors in
determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the
results of drug and specimen validity tests (e.g., an HHS-certified
laboratory reporting a false positive result for an employee's drug
test);
(2) Unsatisfactory participation in performance testing or
inspections;
(3) A material violation of a certification standard, contract
term, or other condition imposed on the HHS-certified laboratory or
IITF by a federal agency using the laboratory's or IITF's services;
(4) Conviction for any criminal offense committed as an incident to
operation of the HHS-certified laboratory or IITF; or
(5) Any other cause that materially affects the ability of the HHS-
certified laboratory or IITF to ensure fully reliable and accurate drug
test results and reports.
(c) The period and terms of revocation shall be determined by the
Secretary and shall depend upon the facts and circumstances of the
revocation and the need to ensure accurate and reliable drug testing.
Section 9.16 What factors are considered in determining whether to
suspend a laboratory's or IITF's HHS certification?
(a) The Secretary may immediately suspend (either partially or
fully) a laboratory's or IITF's HHS certification to conduct drug
testing for federal agencies if the Secretary has reason to believe
that revocation may be required and that immediate action is necessary
to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of
suspension based upon the facts and circumstances of the suspension and
the need to ensure accurate and reliable drug testing.
Section 9.17 How does the Secretary notify an HHS-certified laboratory
or IITF that action is being taken against the laboratory or IITF?
(a) When laboratory's or IITF's HHS certification is suspended or
the Secretary seeks to revoke HHS certification, the Secretary shall
immediately serve the HHS-certified laboratory or IITF with written
notice of the suspension or proposed revocation by fax, mail, personal
service, or registered or certified mail, return receipt requested.
This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory or IITF will
be afforded an opportunity for an informal review of the suspension or
proposed revocation if it so requests in writing within 30 days of the
date the laboratory or IITF received the notice, or if expedited review
is requested, within 3 days of the date the laboratory or IITF received
the notice. Subpart P 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
[[Page 20586]]
must be effective 30 days after written notice is given or, if review
is requested, upon the reviewing official's decision to uphold the
proposed revocation. If the reviewing official decides not to uphold
the suspension or proposed revocation, the suspension must terminate
immediately and any proposed revocation shall not take effect.
(d) The Secretary will publish in the Federal Register the name,
address, and telephone number of any HHS-certified laboratory or IITF
that has its certification revoked or suspended under Section 9.13 or
Section 9.14, respectively, and the name of any HHS-certified
laboratory or IITF that has its suspension lifted. The Secretary shall
provide to any member of the public upon request the written notice
provided to a laboratory or IITF that has its HHS certification
suspended or revoked, as well as the reviewing official's written
decision which upholds or denies the suspension or proposed revocation
under the procedures of Subpart P.
Section 9.18 May a laboratory or IITF that had its HHS certification
revoked be recertified to test federal agency specimens?
Following revocation, a laboratory or IITF may apply for
recertification. Unless otherwise provided by the Secretary in the
notice of revocation under Section 9.17 or the reviewing official's
decision under Section 16.9(e) or 16.14(a), a laboratory or IITF which
has had its certification revoked may reapply for HHS certification as
an applicant laboratory or IITF.
Section 9.19 Where is the list of HHS-certified laboratories and IITFs
published?
(a) The list of HHS-certified laboratories and IITFs is published
monthly in the Federal Register. This notification is also available on
the internet at <a href="http://www.samhsa.gov/workplace">http://www.samhsa.gov/workplace</a>.
(b) An applicant laboratory or IITF is not included on the list.
Subpart J--Blind Samples Submitted by an Agency
Section 10.1 What are the requirements for federal agencies to submit
blind samples to HHS-certified laboratories or IITFs?
(a) Each federal agency is required to submit blind samples for its
workplace drug testing program. The collector must send the blind
samples to the HHS-certified laboratory or IITF that the collector
sends employee specimens.
(b) Each federal agency must submit at least 3 percent blind
samples along with its donor specimens based on the projected total
number of donor specimens collected per year (up to a maximum of 400
blind samples). Every effort should be made to ensure that blind
samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each
year by an agency must be negative, 15 percent must be positive for one
or more drugs, and 10 percent must either be adulterated or
substituted.
Section 10.2 What are the requirements for blind samples?
(a) Drug positive blind samples must be validated by the supplier
as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must be fortified with one or more
of the drugs or metabolites listed in the drug testing panel.
(2) Drug positive blind samples must contain concentrations of
drugs between 1.5 and 2 times the initial drug test cutoff.
(b) Drug negative blind samples (i.e., certified to contain no
drugs) must be validated by the supplier as negative using appropriate
initial and confirmatory tests.
(c) A blind sample that is adulterated must be validated using
appropriate initial and confirmatory specimen validity tests, and have
the characteristics to clearly show that it is an adulterated sample at
the time of validation.
(d) A blind sample that is substituted must be validated using
appropriate initial and confirmatory specimen validity tests, and have
the characteristics to clearly show that it is a substituted sample at
the time of validation.
(e) The supplier must provide information on the blind samples'
content, validation, expected results, and stability to the collection
site/collector sending the blind samples to the laboratory or IITF, and
must provide the information upon request to the MRO, the federal
agency for which the blind sample was submitted, or the Secretary.
Section 10.3 How is a blind sample submitted to an HHS-certified
laboratory or IITF?
(a) A blind sample must be submitted as a split specimen (specimens
A and B) with the current Federal CCF that the HHS-certified laboratory
or IITF uses for donor specimens. The collector provides the required
information to ensure that the Federal CCF has been properly completed
and provides fictitious initials on the specimen label/seal. The
collector must indicate that the specimen is a blind sample on the MRO
copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of
blind samples randomly with donor specimens rather than submitting the
full complement of blind samples as a single group.
Section 10.4 What happens if an inconsistent result is reported for a
blind sample?
If an HHS-certified laboratory or IITF reports a result for a blind
sample that is inconsistent with the expected result (e.g., a
laboratory or IITF reports a negative result for a blind sample that
was supposed to be positive, a laboratory reports a positive result for
a blind sample that was supposed to be negative):
(a) The MRO must contact the laboratory or IITF and attempt to
determine if the laboratory or IITF made an error during the testing or
reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to
determine if the supplier made an error during the preparation or
transfer of the sample;
(c) The MRO must contact the collector and determine if the
collector made an error when preparing the blind sample for transfer to
the HHS-certified laboratory or IITF;
(d) If there is no obvious reason for the inconsistent result, the
MRO must notify both the federal agency for which the blind sample was
submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A
report of the Secretary's investigative findings and the corrective
action taken in response to identified deficiencies must be sent to the
federal agency. The Secretary shall ensure notification of the finding
as appropriate to other federal agencies and coordinate any necessary
actions to prevent the recurrence of the error.
Subpart K--Laboratory
Section 11.1 What must be included in the HHS-certified laboratory's
standard operating procedure manual?
(a) An HHS-certified laboratory must have a standard operating
procedure (SOP) manual that describes, in detail, all HHS-certified
laboratory operations. When followed, the SOP manual
[…truncated; see source link]Indexed from Federal Register on April 7, 2022.
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