[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Proposed Rules]
[Pages 20522-20557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06884]



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Vol. 87

Thursday,

No. 67

April 7, 2022

Part II





 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  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter 1


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 Oral Fluid (OFMG) which 
published in the Federal Register of October 25, 2019.

DATES: Submit comments on or before June 6, 2022.

ADDRESSES: In commenting, please refer to file code SAMHSA 2022-001. 
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):
     Electronically. You may submit electronic comments on this 
document to https://www.regulations.gov. Follow ``Submit a comment'' 
instructions.
     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.
     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.
     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: https://www.regulations.gov. 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 [email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

    This notification of proposed revisions to the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) 
includes revisions that will: Establish a process whereby the 
Department annually publishes the authorized drug testing panel (i.e., 
drugs, analytes, or cutoffs) to be used for Federal workplace drug 
testing programs; revise the definition of a substituted specimen to 
include specimens with a biomarker concentration inconsistent with that 
established for a human specimen, establish a process whereby the 
Department publishes an authorized biomarker testing panel (i.e., 
biomarker analytes and cutoffs) for Federal workplace drug testing 
programs; update and clarify the oral fluid collection procedures; 
revise the Medical Review Officer (MRO) verification process for 
positive codeine and morphine specimens; and require MROs to submit 
semiannual reports to the Secretary or designated HHS representative on 
Federal agency specimens that were reported as positive for a drug or 
drug metabolite by a laboratory and verified as negative by the MRO. In 
addition, some wording changes have been made for clarity and for 
consistency with the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Urine (UrMG), 82 FR 7920 (January 23, 2017), 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. No Federal agencies are testing oral fluid 
specimens at this time.
    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 notification 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 notification and comment,

[[Page 20523]]

and will continue to do so. In this revision, the Department is 
proposing to change the way a specific part of the Guidelines (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 an annual basis, including any 
revisions to the panel, without the need (perceived or otherwise) to 
undergo notification 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 OFMG will remain in effect until the effective date of 
a newly published 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, 
oral fluid collection device manufacturers) to develop or revise their 
products, and for HHS-certified laboratories to develop or revise 
assays, complete validation studies, and revise procedures. The prior 
version of the panel will remain in effect until the effective date of 
the panel changes.
    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 OFMG 
(effective January 1, 2020) allow additional specimen validity testing 
using biomarkers upon MRO request, to provide information to assist the 
MRO in the verification process. The current OFMG 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 oral fluid but does not allow these 
specimens to be reported as substituted. The Department proposes to 
revise the OFMG 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. 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 authorized biomarkers, with 
test analytes and cutoffs), in the FRN to be published each January (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 an oral fluid biomarker test is approved through this process, 
SAMHSA will authorize the individual HHS-certified laboratory 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 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 include 
measurands and decision points for other specimen validity tests in the 
OFMG (e.g., Section 11.17).
    Once a biomarker test has been added to the authorized biomarker 
panel published in the FRN, HHS-certified laboratories 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 OFMG section 3.5). The Department will continue to require NLCP 
review of biomarker assay validation records before allowing a 
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 20524]]

Medical Review Officer (MRO) Verification of Codeine and Morphine Test 
Results

    The MRO has an essential role in federally regulated workplace drug 
testing programs, which 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 13.5(c)(2) of the current OFMG, when a 
donor has no legitimate medical explanation for a positive codeine or 
morphine result equal to or greater than 150 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 
150 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. The 
Department is maintaining 150 ng/mL as a conservative decision point to 
rule out results that may have been due to poppy seed ingestion rather 
than illicit drug use. Because MROs routinely conduct donor interviews 
by telephone, rather than in-person, some MROs have expressed concern 
to the Department over the feasibility of the current requirement to 
make a clinical assessment (i.e., physical examination) of the donor. 
In light of this information, the Department reviewed the verification 
procedures and determined that the additional requirement for clinical 
evidence of illegal opioid use is no longer practical or effective. The 
Department proposes to revise the procedures, now in renumbered Section 
13.5(c)(3), to remove the requirement for the MRO to report specimens 
with morphine and/or codeine between the cutoff and 150 ng/mL as 
positive based on clinical evidence of illicit drug use. The MRO will 
verify such specimens as negative unless the donor admits to illegal 
opioid use that could have caused the positive result. The revised 
procedures will provide a reliable and objective basis for identifying 
illicit drug use, based on current scientific information and industry 
practice. Retaining the decision point may provide useful information 
on opioids, as the Department can use the semi-annual MRO reports 
(described below) to compare results of specimens with morphine and 
codeine concentrations between the cutoff and 150 ng/mL to results of 
other opioids, including 6-acetylmorphine.

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.
    MROs may also experience some savings because the removal of the 
clinical evaluation requirement for some codeine and morphine positive 
results will simplify the MRO verification process.

Proposed Revisions to the Guidelines

    This preamble describes the proposed revisions to the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid 
(OFMG), and the rationale for the changes.

Subpart A--Applicability

    Section 1.5 defines terms used in the OFMG. 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 oral fluid specimen reporting criteria for 
substitution in Section 3.7 of the UrMG. For clarity and for 
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''; revise definitions for 
Cutoff and Initial Specimen Validity Test to remove the ``(for urine)'' 
specification for identifying a substituted specimen; and revise the 
Invalid Result definition to mention both ``adulterated'' and 
``substituted'' as results that may be determined for an oral fluid 
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.
    The Department also revised Section 1.7(a)(7) to include a donor's 
refusal to wash their hands when directed to do so by the collector as 
an example of a refusal to test by failing to cooperate with the 
testing process. See also Section 8.4(a).
    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

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test, and the potential action for an applicant who refuses to take a 
pre-employment test.

Subpart C--Oral Fluid 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.
    The Department also revised item 3.1(c) to remove albumin or 
immunoglobulin G (IgG) tests as examples of biomarker tests, and to 
allow specimen validity tests that could be used to identify specimens 
that are not valid for testing. See also Sections 3.8 and 11.17(g).
    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 Section 3.4 of the OFMG to describe the 
proposed 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 laboratory and MRO reports. The annual 
notification will be posted on the SAMHSA website, https://www.samhsa.gov/workplace. The table in Section 3.4 of the final OFMG 
will remain in effect until the effective date of the new panels 
published in the separate FRN.
    The Department proposes to add a new Section 3.7 and revise Section 
3.8 to require specimens to be reported as substituted based on a 
biomarker concentration outside the range established for that 
biomarker in human oral fluid, rather than reporting such results as 
invalid. See also Section 1.5. Section 3.8 also addresses specimen 
validity tests that could be used to identify invalid specimens. See 
also Sections 3.1 and 11.17(g).

Subpart G--Oral Fluid Specimen Collection Devices

    The Department proposes to revise Section 7.2(b) to clarify that, 
depending on the device type, a collection device may include one or 
two specimen tubes for a split specimen collection. The Department also 
proposes to add two new requirements for collection devices in this 
section.
    In Section 7.2(b)(2), the Department added a requirement for oral 
fluid specimen tubes to be sufficiently transparent to enable a visual 
assessment of the contents without opening the tube. This will enable 
the collector to identify oral fluid specimens with abnormal physical 
characteristics and take action (e.g., recollection) to obtain an 
acceptable specimen. See also Section 8.5(a)(3).
    In Section 7.2(b)(3), the Department added a requirement for the 
collection device manufacturer to include the device lot expiration 
date on each specimen tube. The collector will check the expiration 
date of each device prior to use and document this action on the 
Federal Custody and Control Form (CCF), and the laboratory accessioner 
will check and document the expiration date on both A and B specimen 
tubes upon receipt. As described below regarding Section 15.1, 
laboratories must reject oral fluid specimens collected using an 
expired device.

Subpart H--Oral Fluid Specimen Collection Procedure

    The Department is proposing revisions to the oral fluid collection 
procedures as described below, for clarity and for consistency with the 
2020 Federal CCF and with the Oral Fluid Specimen Collection Handbook, 
which were both finalized following OFMG publication in 2019.
    Proposed revisions to Section 8.3 include reordering collection 
steps (e.g., item d, item h.4) and rewording for clarity (e.g., items g 
and h). The Department also added steps similar to those for urine 
collections, to deter donor attempts to adulterate or substitute the 
specimen. The added requirement for the collector to inspect the 
contents of the donor's pockets applies only when the collector does 
not keep the donor under direct observation until the end of the 
collection, including the 10-minute wait period described in section 
8.3(h). Unlike a urine collection, if the donor refuses to display the 
contents of their pockets, the collector will continue with the oral 
fluid collection, but will keep the donor under their direct 
observation. This is not a refusal to test. In Section 8.3(h)(4), 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 revised wording in Section 8.3(f) regarding how 
instructions for completing the Federal 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 also proposes to add steps in Section 8.4 to deter 
donor attempts to tamper with the specimen. Proposed revisions include 
a new item requiring the donor to wash their hands under the 
collector's observation, and to keep their hands within view and avoid 
touching items or surfaces after handwashing. A donor's refusal to wash 
their hands when instructed by the collector constitutes a refusal to 
test. In Section 8.4(b), the Department added a new item 1 specifying 
that the collector opens the package containing the specimen collection 
device, in the presence of the donor. In Section 8.4(d), the Department 
added ``an attempt to prevent the device from collecting sufficient 
oral fluid'' to the examples of donor attempts to tamper with a 
specimen. The Oral Fluid Specimen Collection Handbook includes 
additional examples of tampering attempts.
    In Section 8.5, the Department added a new item a.3 requiring the 
collector to check each collected specimen for abnormal physical 
characteristics. See also Section 7.2.
    The Department also revised the wording in Section 8.9(a)(3) for 
clarity.

Subpart I--HHS Certification of Laboratories

    Section 9.5 describes the qualitative and quantitative 
specifications for oral fluid performance test (PT) samples. In item 
a.2, the Department added that a PT sample may contain an adulterant or 
may satisfy the criteria for a substituted specimen or invalid result.
    Section 9.6 describes PT requirements for an applicant laboratory 
and Section 9.7 describes PT requirements for an HHS-certified 
laboratory. The Department has added requirements for specimen validity 
testing challenges in new items (a)(7) through (a)(10) in both 
sections. In addition, the Department is proposing to edit Section 
9.7(a)(5) to state clearly that quantitative values reported for drug 
tests are evaluated based on reported results for each PT cycle, not on 
cumulative results reported over two consecutive PT cycles. An HHS-
certified laboratory

[[Page 20526]]

must not obtain a quantitative value outside the specified range for a 
drug, based on the appropriate reference or peer group mean.

Subpart K--Laboratory

    Section 11.17 describes the requirements for an HHS-certified 
laboratory to report primary (A) specimen test results to an MRO. The 
Department proposes to add the requirements for reporting an oral fluid 
specimen as adulterated in item 11.17(d) and as substituted in item 
11.17(e). See also Section 1.5.
    Section 11.17(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. The 
Department has also reworded item 11.17(g) to allow laboratories to 
report specimens as invalid based on specimen validity tests. See also 
Sections 3.1 and 3.8.
    Section 11.17(i) and 11.17(p) includes requirements for the 
laboratory to report ``non-negative'' results for a specimen to the 
MRO. The Department is adding ``substituted'' to the list of non-
negative results in these sections.
    The Department also proposes to add a new item 11.17(l) 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.
    Section 11.18 addresses how long specimens must be retained by the 
laboratory. The Department proposes to edit item a to require HHS-
certified laboratories to retain specimens reported as substituted for 
at least one year (i.e., the same as specimens reported as positive, 
adulterated, or invalid). The Department is also revising item b of 
this section to require laboratories to maintain oral fluid specimens 
in accordance with the collection device manufacturer's instructions 
(i.e., frozen at -20 [deg]C or less, or refrigerated).
    Section 11.20 describes information that must be included on HHS-
certified laboratories statistical summary reports for oral fluid 
testing. The Department proposes to require laboratories to include the 
number of substituted specimens.
    Section 11.21 describes HHS-certified laboratory information that 
is available to a Federal agency. The Department proposes to add that 
an agency may request records of specimens reported as substituted.

Subpart M--Medical Review Officer (MRO)

    Section 13.5(b)(2) describes MRO actions when a laboratory reports 
an invalid result in conjunction with a positive, adulterated, or 
substituted result. The Department has revised this section to include 
substituted as well as positive or adulterated results. 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 e 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(c) 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(c)(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 drug use in the MRO records 
and in the MRO's report to the Federal agency. A donor's admission of 
unauthorized drug use corroborates the positive test.
    Currently, Section 13.5(c)(1) includes the policy of the Department 
that ingestion of food products containing marijuana is not an 
acceptable medical explanation for a positive drug test result. The 
Department proposes to reword this policy, now in item ii of Section 
13.5(c)(2), to clarify that the policy applies to any positive oral 
fluid drug test results, not just marijuana, with the exception of 
positive codeine and morphine results less than 150 ng/mL as described 
in Section 13.5(d). The 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'' as an 
example. 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 substance is not an acceptable medical 
explanation for a positive drug test. Under the Controlled Substances 
Act 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. 1) The Drug Enforcement 
Administration (DEA) maintains the current listing of controlled 
substances on their website.
    Section 13.5.(c)(3) describes MRO actions when the donor has no 
legitimate medical explanation for a positive drug test result, and 
includes exceptions for codeine and morphine results. As described 
above under Medical Review Officer (MRO) verification of codeine and 
morphine test results, the Department proposes to maintain the 150 ng/
mL decision point used to rule out codeine and morphine results that 
may have been due to poppy seed ingestion rather than illicit drug use, 
and remove the additional requirement for clinical evidence of illegal 
opioid use. MROs will verify positive codeine and morphine results less 
than 150 ng/mL as negative, and will include the specimen in the 
required report of verified negative specimens described under Section 
13.11 below. If the donor admits unauthorized drug use during their 
interview with the MRO that could have caused the positive result, the 
MRO verifies the result as positive.
    The Department also proposes to revise Section 13.5(c)(3) to 
address substituted oral fluid specimens where appropriate.
    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

[[Page 20527]]

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

    The Department proposes to add a new Section 14.4 describing how an 
HHS-certified laboratory reports a split (B) oral fluid 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. 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) oral fluid specimen result from an HHS-certified laboratory. 
The Department proposes to revise this section to address MRO 
verification of split (B) specimen results when the primary (A) 
specimen was reported as substituted, and when a B specimen was 
reported as substituted based on biomarker 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.

Subpart O--Criteria for Rejecting a Specimen for Testing

    The Department is proposing to add a new item c to Section 15.1, 
requiring the laboratory to reject oral fluid specimens collected using 
an expired device (i.e., when the expiration date on the specimen tube 
precedes the collection date), unless the split (B) specimen can be 
redesignated as the primary (A) specimen. See also Section 7.2.

General Revisions

    In addition to the proposed changes described by subpart and 
section above, the Department has edited the OFMG 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 UrMG.

Impact of These Guidelines on Government Regulated Industries

    The Department is aware that these proposed new Guidelines may 
impact the Department of Transportation (DOT) and Nuclear Regulatory 
Commission (NRC) regulated industries depending on these agencies' 
decisions to incorporate the final OFMG revisions into their programs 
under their own authority.

Costs and Benefits

Costs

    The proposed OFMG revision to publish the drug testing panel in a 
separate FRN each January (e.g., Section 3.4) may result in a cost 
increase for HHS-certified laboratories 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 require HHS-certified laboratories to 
implement authorized biomarker tests. Each laboratory 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 laboratories to 
test for a specific biomarker.
    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

[[Page 20528]]

products or develop new products to subvert drug and specimen validity 
tests in federally regulated workplace programs. (Ref. 2 and 3) When 
the Department added provisions for biomarker testing in the current 
OFMG, the intent was to identify non-human oral fluid samples that were 
submitted for testing in place of the donor's oral fluid. 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.
    MROs may also experience some savings, as the removal of the 
clinical evaluation requirement for some codeine and morphine positive 
results will simplify the MRO verification process.

Information Collection/Record Keeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines, which establish the 
scientific and technical guidelines for Federal workplace drug testing 
programs and establish standards for certification of laboratories 
engaged in oral fluid drug testing for Federal agencies under authority 
of 5 U.S.C. 7301 and Executive Order 12564, are approved by the Office 
of Management and Budget (OMB) under control number 0930-0158. The 
Federal Drug Testing Custody and Control Form (Federal CCF) used to 
document the collection and chain of custody of urine and oral fluid 
specimens at the collection site, for laboratories to report results, 
and for Medical Review Officers to make a determination; the National 
Laboratory Certification Program (NLCP) application; the NLCP 
Laboratory Information Checklist; and recordkeeping requirements in the 
current Guidelines, as approved under control number 0930-0158, will 
remain in effect.
    In support of the Government Paperwork Reduction Act (PRA), the 
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 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 Oral Fluid.
    Description: The Mandatory Guidelines establish the scientific and 
technical guidelines for Federal drug testing programs and establish 
standards for certification of laboratories engaged in drug testing for 
Federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301 
note, and Executive Order 12564. Federal drug testing programs test 
applicants to sensitive positions, individuals involved in accidents, 
individuals for cause, and random testing of persons in sensitive 
positions.
    Description of Respondents: Individuals or households, businesses, 
or other-for-profit and not-for-profit institutions.
    The burden estimates in the tables below are based on the following 
number of respondents: 10,500 donors who apply for employment or are 
employed in testing designated positions, 100 collectors, 10 oral fluid 
specimen testing laboratories, and 100 MROs.

                                                           Estimate of Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
9.2(a)(1)......................................  Laboratory or IITF required to submit                10               1               3              30
                                                  application for certification.
9.10(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.
11.20..........................................  Specifications for laboratory                        10               5             0.5              25
                                                  semiannual 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.

[[Page 20529]]

 
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......................................  .......................................             256  ..............  ..............             392
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 an oral fluid specimen. SAMHSA has not 
calculated a separate reporting burden for these requirements because 
they are included in the burden hours estimated for collectors to 
complete Federal CCFs and for MROs to report results to Federal 
agencies.

                                                          Estimate of Annual Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a), 8.6(b)(2)..............................  Collector must contact Federal agency               100               1    0.05 (3 min)               5
                                                  point of contact.
11.21, 11.22...................................  Information on drug test that                        25              10               3             750
                                                  laboratory must 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......................................  .......................................             225  ..............  ..............           4,955
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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(h)). SAMHSA believes having the collector explain the collection 
procedure to the donor and answer any questions is a standard business 
practice and not a disclosure burden.

                                                         Estimate of Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.4, 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) & 11.17................................  Laboratory completes Federal CCF upon                25           1,520    0.05 (3 min)           1,900
                                                  receipt 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.

[[Page 20530]]

 
14.1(b)........................................  MRO documents donor's request to have               100               2    0.05 (3 min)              10
                                                  split specimen tested.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................          38,325  ..............  ..............           9,510
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 (Section 
8.4(d)) requires collectors to enter any information on the Federal CCF 
of any unusual findings during the oral fluid specimen collection 
procedure. These recordkeeping requirements are an integral part of the 
collection procedure and are essential to documenting the chain of 
custody for the specimens collected. The burden for these entries is 
included in the recordkeeping burden estimated to complete the Federal 
CCF and is, therefore, not considered an additional recordkeeping 
burden. Subpart K describes a number of recordkeeping requirements for 
laboratories associated with their testing procedures, maintaining 
chain of custody, and keeping records (i.e., Sections 11.1(a) and (d); 
11.2(b), (c), and (d); 11.6(b); 11.7(c); 11.8; 11.10(a); 11.13(a); 
11.16; 11.19(a), (b), and (c); 11.20; 11.21(a); and 11.22). These 
recordkeeping requirements are necessary for any laboratory to conduct 
forensic drug testing and to ensure the scientific supportability of 
the test results. 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 oral fluid specimens by the laboratories and IITFs is estimated to 
be 14,857 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 oral fluid 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 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).

References

1. U.S. Department of Justice (DOJ), Drug Enforcement Agency (DEA), 
Diversion Control Division. Controlled Substance Schedules. https://www.deadiversion.usdoj.gov. Accessed June 9, 2021.
2. 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.
3. Quest Diagnostics, 2018. Workforce drug positivity at highest 
rate in a decade, finds analysis of more than 10 million drug test 
results. https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf. 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). There is no requirement for Federal agencies to use oral 
fluid as part of their drug testing program. A Federal agency may 
choose to use urine or oral fluid, or any combination of specimen types 
in accordance with the Mandatory Guidelines for each matrix in their 
program based on the agency's mission, its employees' duties, and the 
danger to the public health and safety or to national security that 
could result from an employee's failure to carry out the duties of his 
or her position. The Department believes that the proposed revisions to 
the Mandatory Guidelines save costs and improve the effectiveness of 
Federal workplace drug testing programs.


[[Page 20531]]


    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 
ORAL FLUID 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--Oral Fluid Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may an oral fluid specimen be 
collected?
2.3 How is each oral fluid specimen collected?
2.4 What volume of oral fluid is collected?
2.5 How is the split oral fluid specimen collected?
2.6 When may an entity or individual release an oral fluid specimen?
Subpart C--Oral Fluid Specimen Tests
3.1 Which tests are conducted on an oral fluid specimen?
3.2 May a specimen be tested for drugs other than those in the drug 
testing panel?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug and biomarker test analytes and cutoffs for 
undiluted (neat) oral fluid?
3.5 May an HHS-certified laboratory perform additional drug and/or 
specimen validity tests on a specimen at the request of the Medical 
Review Officer (MRO)?
3.6 What criteria are used to report an oral fluid specimen as 
adulterated?
3.7 What criteria are used to report an oral fluid specimen as 
substituted?
3.8 What criteria are used to report an invalid result for an oral 
fluid specimen?
Subpart D--Collectors
4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be a trainer for collectors?
4.5 What must a federal agency do before a collector is permitted to 
collect a specimen?
Subpart E--Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a 
specimen at the collection site?
5.6 What are the privacy requirements when collecting an oral fluid 
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?
Subpart G--Oral Fluid Specimen Collection Devices
7.1 What is used to collect an oral fluid specimen?
7.2 What are the requirements for an oral fluid collection device?
7.3 What are the minimum performance requirements for a collection 
device?
Subpart H--Oral Fluid Specimen Collection Procedure
8.1 What privacy must the donor be given when providing an oral 
fluid specimen?
8.2 What must the collector ensure at the collection site before 
starting an oral fluid specimen collection?
8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?
8.4 What steps does the collector take in the collection procedure 
before the donor provides an oral fluid specimen?
8.5 What steps does the collector take during and after the oral 
fluid specimen collection procedure?
8.6 What procedure is used when the donor states that they are 
unable to provide an oral fluid specimen?
8.7 If the donor is unable to provide an oral fluid specimen, may 
another specimen type be collected for testing?
8.8 How does the collector prepare the oral fluid specimens?
8.9 How does the collector report a donor's refusal to test?
8.10 What are a federal agency's responsibilities for a collection 
site?
Subpart I--HHS Certification of Laboratories
9.1 Who has the authority to certify laboratories to test oral fluid 
specimens for federal agencies?
9.2 What is the process for a laboratory to become HHS-certified?
9.3 What is the process for a laboratory to maintain HHS 
certification?
9.4 What is the process when a laboratory does not maintain its HHS 
certification?
9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory?
9.7 What are the PT requirements for an HHS-certified oral fluid 
laboratory?
9.8 What are the inspection requirements for an applicant 
laboratory?
9.9 What are the maintenance inspection requirements for an HHS-
certified laboratory?
9.10 Who can inspect an HHS-certified laboratory and when may the 
inspection be conducted?
9.11 What happens if an applicant laboratory does not satisfy the 
minimum requirements for either the PT program or the inspection 
program?
9.12 What happens if an HHS-certified laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?
9.13 What factors are considered in determining whether revocation 
of a laboratory's HHS certification is necessary?
9.14 What factors are considered in determining whether to suspend a 
laboratory's HHS certification?
9.15 How does the Secretary notify an HHS-certified laboratory that 
action is being taken against the laboratory?
9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?
9.17 Where is the list of HHS-certified laboratories published?
Subpart J--Blind Samples Submitted by an Agency
10.1 What are the requirements for federal agencies to submit blind 
samples to HHS-certified laboratories?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory?
10.4 What happens if an inconsistent result is reported for a blind 
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified 
laboratory?
11.5 What qualifications must an individual have to certify a result 
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an 
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory 
maintain?
11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?
11.9 What are the requirements for an initial drug test?
11.10 What must an HHS-certified laboratory do to validate an 
initial drug test?

[[Page 20532]]

11.11 What are the batch quality control requirements when 
conducting an initial drug test?
11.12 What are the requirements for a confirmatory drug test?
11.13 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
11.14 What are the batch quality control requirements when 
conducting a confirmatory drug test?
11.15 What are the analytical and quality control requirements for 
conducting specimen validity tests?
11.16 What must an HHS-certified laboratory do to validate a 
specimen validity test?
11.17 What are the requirements for an HHS-certified laboratory to 
report a test result?
11.18 How long must an HHS-certified laboratory retain specimens?
11.19 How long must an HHS-certified laboratory retain records?
11.20 What statistical summary reports must an HHS-certified 
laboratory provide for oral fluid testing?
11.21 What HHS-certified laboratory information is available to a 
federal agency?
11.22 What HHS-certified laboratory information is available to a 
federal employee?
11.23 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 May an IITF test oral fluid specimens for a federal agency's 
workplace drug testing program?
Subpart M--Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards 
that certify MROs approved?
13.3 What training is required before a physician may serve as an 
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing an oral fluid specimen's 
test results?
13.6 What action does the MRO take when the collector reports that 
the donor did not provide a sufficient amount of oral fluid for a 
drug test?
13.7 What happens when an individual is unable to provide a 
sufficient amount of oral fluid for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because 
of a permanent or long-term medical condition?
13.8 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?
13.11 What reports must an MRO provide to the Secretary for oral 
fluid testing?
13.12 What are a federal agency's responsibilities for designating 
an MRO?
Subpart N--Split Specimen Tests
14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen 
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported 
adulterated?
14.4 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported 
substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B) 
oral fluid specimen result from the second HHS-certified laboratory?
14.7 How does an MRO report a split (B) specimen test result to an 
agency?
14.8 How long must an HHS-certified laboratory retain a split (B) 
specimen?
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory to 
report an oral fluid specimen as rejected for testing?
15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject an oral fluid specimen for testing or 
an MRO to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?
Subpart P--Laboratory Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory be suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written 
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate 
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing 
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?

Subpart A--Applicability

Section 1.1 To whom do these Guidelines apply?

    (a) These Guidelines apply to:
    (1) Executive Agencies as defined in 5 U.S.C. 105;
    (2) The Uniformed Services, as defined in 5 U.S.C. 2101(3), but 
excluding the Armed Forces as defined in 5 U.S.C. 2101(2);
    (3) Any other employing unit or authority of the federal government 
except the United States Postal Service, the Postal Rate Commission, 
and employing units or authorities in the Judicial and Legislative 
Branches; and
    (4) The Intelligence Community, as defined by Executive Order 
12333, is subject to these Guidelines only to the extent agreed to by 
the head of the affected agency;
    (5) Laboratories that provide drug testing services to the federal 
agencies;
    (6) Collectors who provide specimen collection services to the 
federal agencies; and
    (7) Medical Review Officers (MROs) who provide drug testing review 
and interpretation of results services to the federal agencies.
    (b) These Guidelines do not apply to drug testing under authority 
other than Executive Order 12564, including testing of persons in the 
criminal justice system, such as arrestees, detainees, probationers, 
incarcerated persons, or parolees.

Section 1.2 Who is responsible for developing and implementing these 
Guidelines?

    (a) Executive Order 12564 and Public Law 100-71 require the 
Department of Health and Human Services (HHS) to establish scientific 
and technical guidelines for federal workplace drug testing programs.
    (b) The Secretary has the responsibility to implement these 
Guidelines.

Section 1.3 How does a federal agency request a change from these 
Guidelines?

    (a) Each federal agency must ensure that its workplace drug testing 
program complies with the provisions of these Guidelines unless a 
waiver has been obtained from the Secretary.
    (b) To obtain a waiver, a federal agency must submit a written 
request to the Secretary that describes the specific change for which a 
waiver is sought and a detailed justification for the change.

Section 1.4 How are these Guidelines revised?

    (a) To ensure the full reliability and accuracy of specimen tests, 
the accurate

[[Page 20533]]

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 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 Device. A product that is used to collect an oral fluid 
specimen and may include a buffer or diluent.
    Collection Site. The location where specimens are collected.
    Collector. A person trained to instruct and assist a donor in 
providing a specimen.
    Confirmatory Drug Test. A second analytical procedure performed on 
a separate aliquot of a specimen to identify and quantify a specific 
drug or drug metabolite.
    Confirmatory Specimen Validity Test. A second test performed on a 
separate aliquot of a specimen to further support 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.
    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.
    HHS. The Department of Health and Human Services.
    Initial Drug Test. An analysis used to differentiate negative 
specimens from those requiring further testing.
    Initial Specimen Validity Test. The first analysis used to 
determine if a specimen is adulterated, invalid, substituted, or (for 
urine) dilute.
    Instrumented Initial Test Facility (IITF). A permanent location 
where (for urine) initial testing, reporting of results, and 
recordkeeping are performed under the supervision of a responsible 
technician.
    Invalid Result. The result reported by an HHS-certified laboratory 
in accordance with the criteria established in Section 3.8 when a 
positive, negative, adulterated, or substituted result cannot be 
established for a specific drug or specimen validity test.
    Laboratory. A permanent location where initial and confirmatory 
drug testing, reporting of results, and recordkeeping are performed 
under the supervision of a responsible person.
    Limit of Detection. 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

[[Page 20534]]

or drug metabolite) can be accurately established.
    Lot. A number of units of an item (e.g., reagents, quality control 
material, oral fluid collection device) manufactured from the same 
starting materials within a specified period of time for which the 
manufacturer ensures that the items have essentially the same 
performance characteristics and expiration date.
    Medical Review Officer (MRO). A licensed physician who reviews, 
verifies, and reports a specimen test result to the federal agency.
    Negative Result. The result reported by an HHS-certified laboratory 
or (for urine) an HHS-certified IITF to an MRO when a specimen contains 
no drug and/or drug metabolite; or the concentration of the drug or 
drug metabolite is less than the cutoff for that drug or drug class.
    Oral Fluid Specimen. An oral fluid specimen is collected from the 
donor's oral cavity and is a combination of physiological fluids 
produced primarily by the salivary glands.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drug or drug metabolites to prevent 
the detection of the drugs or drug metabolites, or affects the reagents 
in either the initial or confirmatory drug test.
    Performance Testing (PT) Sample. A program-generated sample sent to 
a laboratory or (for urine) to an IITF to evaluate performance.
    Positive Result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the confirmatory test cutoff.
    Reconfirmed. The result reported for a split (B) specimen when the 
second HHS-certified laboratory corroborates the original result 
reported for the primary (A) specimen.
    Rejected for Testing. The result reported by an HHS-certified 
laboratory or (for urine) HHS-certified IITF when no tests are 
performed on a specimen because of a fatal flaw or an unrecovered 
correctable error (see Sections 15.1 and 15.2).
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of an HHS-certified laboratory.
    Sample. A performance testing sample, calibrator or control used 
during testing, or a representative portion of a donor's specimen.
    Secretary. The Secretary of the U.S. Department of Health and Human 
Services.
    Specimen. Fluid or material collected from a donor at the 
collection site for the purpose of a drug test.
    Split Specimen Collection (for Oral Fluid). A collection in which 
two specimens (primary [A] and split [B]) are collected, concurrently 
or serially, and independently sealed in the presence of the donor; or 
a collection in which a single specimen is collected using a single 
collection device and is subdivided into a primary (A) specimen and a 
split (B) specimen, which are independently sealed in the presence of 
the donor.
    Standard. Reference material of known purity or a solution 
containing a reference material at a known concentration.
    Substituted Specimen. A specimen that has been submitted in place 
of the donor's specimen, as evidenced by the absence of a biomarker or 
a biomarker concentration inconsistent with that established for a 
human specimen, as indicated in the biomarker testing panel, or (for 
urine) creatinine and specific gravity values that are outside the 
physiologically producible ranges of human urine, in accordance with 
the criteria to report a urine specimen as substituted in UrMG Section 
3.7.
    Undiluted (neat) oral fluid. An oral fluid specimen to which no 
other solid or liquid has been added. For example, see Section 2.4: a 
collection device that uses a diluent (or other component, process, or 
method that modifies the volume of the testable specimen) must collect 
at least 1 mL of undiluted (neat) oral fluid.

Section 1.6 What is an agency required to do to protect employee 
records?

    Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency 
contracts with laboratories, collectors, and MROs must require that 
they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the 
contracts must require compliance with employee access and 
confidentiality provisions of Section 503 of Public Law 100-71. Each 
federal agency must establish a Privacy Act System of Records or modify 
an existing system or use any applicable Government-wide system of 
records to cover the records of employee drug test results. All 
contracts and the Privacy Act System of Records must specifically 
require that employee records be maintained and used with the highest 
regard for employee privacy.
    The Health Insurance Portability and Accountability Act of 1996 
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and 
E, may be applicable to certain health care providers with whom a 
federal agency may contract. If a health care provider is a HIPAA 
covered entity, the provider must protect the individually identifiable 
health information it maintains in accordance with the requirements of 
the Rule, which includes not using or disclosing the information except 
as permitted by the Rule and ensuring there are reasonable safeguards 
in place to protect the privacy of the information. For more 
information regarding the HIPAA Privacy Rule, please visit https://www.hhs.gov/hipaa/index.html.

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., oral fluid or another 
authorized specimen type) for any drug test required by these 
Guidelines or federal agency regulations;
    (4) Fail to provide a sufficient amount of oral fluid when 
directed, and it has been determined, through a required medical 
evaluation, that there was no legitimate medical explanation for the 
failure as determined by the process described in Section 13.6;
    (5) Fail or decline to participate in an alternate specimen 
collection (e.g., urine) as directed by the federal agency or collector 
(i.e., as described in Section 8.6);
    (6) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification process (i.e., Section 
13.6) or as directed by the federal agency. In the case of a federal 
agency applicant/pre-employment drug test, the donor is deemed to have 
refused to test on this basis only if the federal agency applicant/pre-
employment test is conducted following a contingent offer of 
employment. If there was no contingent offer of employment, the MRO 
will cancel the test;
    (7) Fail to cooperate with any part of the testing process (e.g., 
disrupt the collection process, fail to rinse the mouth or wash hands 
after being directed to do so by the collector, refuse to provide a 
split specimen);
    (8) Bring materials to the collection site for the purpose of 
adulterating, substituting, or diluting the specimen;

[[Page 20535]]

    (9) Attempt to adulterate, substitute, or dilute the specimen; or
    (10) Admit to the collector or MRO that you have adulterated or 
substituted the specimen.

Section 1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?

    (a) A refusal to take a test may result in the initiation of 
disciplinary or adverse action for a federal employee, up to and 
including removal from federal employment. An applicant's refusal to 
take a pre-employment test may result in non-selection for federal 
employment.
    (b) When a donor has refused to participate in a part of the 
collection process, including failing to appear in a reasonable time 
for any test, the collector must terminate the collection process and 
take action as described in Section 8.9. Required action includes 
immediately notifying the federal agency's designated representative by 
any means (e.g., telephone or secure facsimile [fax] machine) that 
ensures that the refusal notification is immediately received and, if a 
Federal CCF has been initiated, documenting the refusal on the Federal 
CCF, signing and dating the Federal CCF, and sending all copies of the 
Federal CCF to the federal agency's designated representative.
    (c) When documenting a refusal to test during the verification 
process as described in Sections 13.4, 13.5, and 13.6, the MRO must 
complete the MRO copy of the Federal CCF to include:
    (1) Checking the refusal to test box;
    (2) Providing a reason for the refusal in the remarks line; and
    (3) Signing and dating the MRO copy of the Federal CCF.

Subpart B--Oral Fluid Specimens

Section 2.1 What type of specimen may be collected?

    A federal agency may collect oral fluid and/or an alternate 
specimen type for its workplace drug testing program. Only specimen 
types authorized by Mandatory Guidelines for Federal Workplace Drug 
Testing Programs may be collected. An agency using oral fluid must 
follow these Guidelines.

Section 2.2 Under what circumstances may an oral fluid specimen be 
collected?

    A federal agency may collect an oral fluid specimen for the 
following reasons:
    (a) Federal agency applicant/Pre-employment test;
    (b) Random test;
    (c) Reasonable suspicion/cause test;
    (d) Post accident test;
    (e) Return to duty test; or
    (f) Follow-up test.

Section 2.3 How is each oral fluid specimen collected?

    Each oral fluid specimen is collected as a split specimen (i.e., 
collected either simultaneously or serially) as described in Sections 
2.5 and 8.8.

Section 2.4 What volume of oral fluid is collected?

    A volume of at least 1 mL of undiluted (neat) oral fluid for each 
oral fluid specimen (designated ``Tube A'' and ``Tube B'') is collected 
using a collection device. If the device does not include a diluent (or 
other component, process, or method that modifies the volume of the 
testable specimen), the A and B tubes must have a volume marking 
clearly noting a level of 1 mL.

Section 2.5 How is the split oral fluid specimen collected?

    The collector collects at least 1 mL of undiluted (neat) oral fluid 
in a collection device designated as ``A'' (primary) and at least 1 mL 
of undiluted (neat) oral fluid in a collection device designated as 
``B'' (split) either simultaneously or serially (i.e., using two 
devices or using one device and subdividing the specimen), as described 
in Section 8.8.

Section 2.6 When may an entity or individual release an oral fluid 
specimen?

    Entities and individuals subject to these Guidelines under Section 
1.1 may not release specimens collected pursuant to Executive Order 
12564, Public Law 100-71, and these Guidelines to donors or their 
designees. Specimens also may not be released to any other entity or 
individual unless expressly authorized by these Guidelines or by 
applicable federal law. This section does not prohibit a donor's 
request to have a split (B) specimen tested in accordance with Section 
13.8.

Subpart C--Oral Fluid Specimen Tests

Section 3.1 Which tests are conducted on an oral fluid specimen?

    A federal agency:
    (a) Must ensure that each specimen is tested for marijuana and 
cocaine as provided in the drug testing panel described under Section 
3.4;
    (b) Is authorized to test each specimen for other Schedule I or II 
drugs as provided in the drug testing panel;
    (c) Is authorized upon a Medical Review Officer's request to test 
an oral fluid specimen to determine specimen validity using, for 
example, a test for a specific adulterant;
    (d) Is authorized to test each specimen for one or more biomarkers 
as provided in the biomarker testing panel described under Section 3.4; 
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.
    (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

[[Page 20536]]

their validity in accordance with Subpart C of these Guidelines. Use of 
specimens by donors, their designees, or any other entity, for other 
purposes (e.g., deoxyribonucleic acid, DNA, testing) is prohibited 
unless authorized in accordance with applicable federal law.
    (b) These Guidelines are not intended to prohibit federal agencies 
specifically authorized by law to test a specimen for additional 
classes of drugs in its workplace drug testing program.

Section 3.4 What are the drug and biomarker test analytes and cutoffs 
for undiluted (neat) oral fluid?

    The Secretary will publish the drug and biomarker test analytes and 
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing 
panel'') for initial and confirmatory drug and biomarker tests in the 
Federal Register each year. The drug and biomarker testing panels will 
also be available on the internet at https://www.samhsa.gov/workplace/drug-testing.
    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 cutoff
      Initial test analyte           Initial test cutoff \1\          analyte               concentration
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \2\.............  4 ng/mL \3\                   THC................  2 ng/mL
Cocaine/Benzoylecgonine.........  15 ng/mL                      Cocaine............  8 ng/mL
                                                                Benzoylecgonine....  8 ng/mL
Codeine/Morphine................  30 ng/mL                      Codeine............  15 ng/mL
                                                                Morphine...........  15 ng/mL
Hydrocodone/Hydromorphone.......  30 ng/mL                      Hydrocodone........  15 ng/mL
                                                                Hydromorphone......  15 ng/mL
Oxycodone/Oxymorphone...........  30 ng/mL                      Oxycodone..........  15 ng/mL
                                                                Oxymorphone........  15 ng/mL
6-Acetylmorphine................  4 ng/mL \3\                   6-Acetylmorphine...  2 ng/mL
Phencyclidine...................  10 ng/mL                      Phencyclidine......  10 ng/mL
Amphetamine/Methamphetamine.....  50 ng/mL                      Amphetamine........  25 ng/mL
                                                                Methamphetamine....  25 ng/mL
MDMA \4\/MDA \5\................  50 ng/mL                      MDMA...............  25 ng/mL
                                                                MDA................  25 ng/mL
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
  cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
  not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending
  on the technology. At least one analyte within the group must have a concentration equal to or greater than
  the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the
  laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol (THC).
\3\ Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology
  initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

    (a) The drug testing panel will include drugs authorized for 
testing in federal workplace drug testing programs, with the required 
test analytes and cutoffs;
    (b) The biomarker testing panel will include biomarkers authorized 
for testing in federal workplace drug testing programs, with the 
required test analytes and cutoffs; and
    (c) HHS-certified laboratories and Medical Review Officers must use 
the nomenclature (i.e., analyte names and abbreviations) published in 
the Federal Register with the drug and biomarker testing panels to 
report federal workplace drug test results.

Section 3.5 May an HHS-certified laboratory perform additional drug 
and/or specimen validity tests on a specimen at the request of the 
Medical Review Officer (MRO)?

    An HHS-certified laboratory is authorized to perform additional 
drug and/or specimen validity tests on a case-by-case basis as 
necessary to provide information that the MRO would use to report a 
verified drug test result (e.g., specimen validity tests). An HHS-
certified laboratory is not authorized to routinely perform additional 
drug and/or specimen validity tests at the request of an MRO without 
prior authorization from the Secretary or designated HHS 
representative, with the exception of the determination of D,L 
stereoisomers of amphetamine and methamphetamine. All tests must meet 
appropriate validation and quality control requirements in accordance 
with these Guidelines.

Section 3.6 What criteria are used to report an oral fluid specimen as 
adulterated?

    An HHS-certified laboratory reports a primary (A) specimen as 
adulterated when the presence of an adulterant is verified using an 
initial test on the first aliquot and a different confirmatory test on 
the second aliquot.

Section 3.7 What criteria are used to report an oral fluid specimen as 
substituted?

    An HHS-certified laboratory reports a primary (A) specimen as 
substituted when a biomarker is not detected or is present at a 
concentration inconsistent with that established for human oral fluid 
for both the initial (first) test and the confirmatory (second) test on 
two separate aliquots (i.e., using the test analytes and cutoffs listed 
in the biomarker testing panel).

Section 3.8 What criteria are used to report an invalid result for an 
oral fluid specimen?

    An HHS-certified laboratory reports a primary (A) oral fluid 
specimen as an invalid result when:
    (a) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid immunoassay or alternate technology initial drug 
test results cannot be obtained);
    (b) Interference with the drug confirmatory assay occurs on two 
separate aliquots of the specimen and

[[Page 20537]]

the laboratory is unable to identify the interfering substance;
    (c) The physical appearance of the specimen (e.g., viscosity) is 
such that testing the specimen may damage the laboratory's instruments;
    (d) The specimen has been tested and the appearances of the primary 
(A) and the split (B) specimens (e.g., color) are clearly different; or
    (e) A specimen validity test on two separate aliquots of the 
specimen indicates that the specimen is not valid for testing.

Subpart D--Collectors

Section 4.1 Who may collect a specimen?

    (a) A collector who has been trained to collect oral fluid 
specimens in accordance with these Guidelines and the manufacturer's 
procedures for the collection device.
    (b) The immediate supervisor of a federal employee donor may only 
collect that donor's specimen when no other collector is available. The 
supervisor must be a trained collector.
    (c) The hiring official of a federal agency applicant may only 
collect that federal agency applicant's specimen when no other 
collector is available. The hiring official must be a trained 
collector.

Section 4.2 Who may not collect a specimen?

    (a) A federal agency employee who is in a testing designated 
position and subject to the federal agency drug testing rules must not 
be a collector for co-workers in the same testing pool or who work with 
that employee on a daily basis.
    (b) A federal agency applicant or employee must not collect their 
own drug testing specimen.
    (c) An employee working for an HHS-certified laboratory must not 
act as a collector if the employee could link the identity of the donor 
to the donor's drug test result.
    (d) To avoid a potential conflict of interest, a collector must not 
be related to the employee (e.g., spouse, ex-spouse, relative) or 
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 use the specific oral fluid 
collection device. Training must include the following:
    (i) All steps necessary to complete an oral fluid collection;
    (ii) Completion and distribution of the Federal CCF;
    (iii) Problem collections;
    (iv) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (v) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of the donor, ensuring the 
security of the specimen, and avoiding conduct or statements that could 
be viewed as offensive or inappropriate.
    (4) Has demonstrated proficiency in collections by completing five 
consecutive error-free mock collections.
    (i) The five mock collections must include two uneventful 
collection scenarios, one insufficient specimen quantity scenario, one 
scenario in which the donor refuses to sign the Federal CCF, and one 
scenario in which the donor refuses to initial the specimen tube 
tamper-evident seal.
    (ii) A qualified trainer for collectors must monitor and evaluate 
the individual being trained, in person or by a means that provides 
real-time observation and interaction between the trainer and the 
trainee, and the trainer must attest in writing that the mock 
collections are error-free.
    (b) A trained collector must complete refresher training at least 
every five years that includes the requirements in 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 a trainer for collectors?

    (a) Individuals are considered qualified trainers for collectors 
for a specific oral fluid collection device and may train others to 
collect oral fluid specimens using that collection device when they 
have completed the following:
    (1) Qualified as a trained collector and regularly conducted oral 
fluid drug test collections using that collection device for a period 
of at least one year or
    (2) Completed a ``train the trainer'' course given by an 
organization (e.g., manufacturer, private entity, contractor, federal 
agency).
    (b) A qualified trainer for collectors must complete refresher 
training at least every five years in accordance with the collector 
requirements in Section 4.3(a).
    (c) A qualified trainer for collectors must maintain the 
documentation of the trainer's training and provide that documentation 
to a federal agency when requested.

Section 4.5 What must a federal agency do before a collector is 
permitted to collect a specimen?

    A federal agency must ensure the following:
    (a) The collector has satisfied the requirements described in 
Section 4.3;
    (b) The collector, who may be self-employed, or an organization 
(e.g., third party administrator that provides a collection service, 
collector training company, federal agency that employs its own 
collectors) maintains a copy of the training record(s); and
    (c) The collector has been provided the name and telephone number 
of the federal agency representative.

Subpart E--Collection Sites

Section 5.1 Where can a collection for a drug test take place?

    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) In the event that an agency-designated collection site is not 
accessible and there is an immediate requirement to collect an oral 
fluid specimen (e.g., an accident investigation), another site may be 
used for the collection, providing the collection is performed by a 
collector who has been trained to collect oral fluid specimens in 
accordance with these Guidelines and the manufacturer's procedures for 
the collection device.

Section 5.2 What are the requirements for a collection site?

    The facility used as a collection site must have the following:
    (a) Provisions to ensure donor privacy during the collection (as 
described in Section 8.1);
    (b) A suitable and clean surface area that is not accessible to the 
donor for handling the specimens and completing the required paperwork;
    (c) A secure temporary storage area to maintain specimens until the 
specimen is transferred to an HHS-certified laboratory;
    (d) A restricted access area where only authorized personnel may be 
present during the collection;

[[Page 20538]]

    (e) A restricted access area for the storage of collection 
supplies; and
    (f) The ability to store records securely.

Section 5.3 Where must collection site records be stored?

    Collection site records must be stored at a secure site designated 
by the collector or the collector's employer.

Section 5.4 How long must collection site records be stored?

    Collection site records (e.g., collector copies of the OMB-approved 
Federal CCF) must be stored securely for a minimum of 2 years. The 
collection site may convert hardcopy records to electronic records for 
storage and discard the hardcopy records after 6 months.

Section 5.5 How does the collector ensure the security and integrity of 
a specimen at the collection site?

    (a) A collector must do the following to maintain the security and 
integrity of a specimen:
    (1) Not allow unauthorized personnel to enter the collection area 
during the collection procedure;
    (2) Perform only one donor collection at a time;
    (3) Restrict access to collection supplies before, during, and 
after collection;
    (4) Ensure that only the collector and the donor are allowed to 
handle the unsealed specimen;
    (5) Ensure the chain of custody process is maintained and 
documented throughout the entire collection, storage, and transport 
procedures;
    (6) Ensure that the Federal CCF is completed and distributed as 
required; and
    (7) Ensure that specimens transported to an HHS-certified 
laboratory are sealed and placed in transport containers designed to 
minimize the possibility of damage during shipment (e.g., specimen 
boxes, padded mailers, or other suitable shipping container), and those 
containers are securely sealed to eliminate the possibility of 
undetected tampering;
    (b) Couriers, express carriers, and postal service personnel are 
not required to document chain of custody since specimens are sealed in 
packages that would indicate tampering during transit to the HHS-
certified laboratory.

Section 5.6 What are the privacy requirements when collecting an oral 
fluid specimen?

    Collections must be performed at a site that provides reasonable 
privacy (as described in Section 8.1).

Subpart F--Federal Drug Testing Custody and Control Form

Section 6.1 What federal form is used to document custody and control?

    The OMB-approved Federal CCF must be used to document custody and 
control of each specimen at the collection site.

Section 6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?

    (a) The use of a non-federal CCF or an expired Federal CCF is not, 
by itself, a reason for the HHS-certified laboratory to automatically 
reject the specimen for testing or for the MRO to cancel the test.
    (b) If the collector does not use the correct OMB-approved Federal 
CCF, the collector must document that it is a federal agency specimen 
collection and provide the reason that the incorrect form was used. 
Based on the information provided by the collector, the HHS-certified 
laboratory must handle and test the specimen as a federal agency 
specimen.
    (c) If the HHS-certified laboratory or MRO discovers that the 
collector used an incorrect form, the laboratory or MRO must obtain a 
memorandum for the record from the collector describing the reason the 
incorrect form was used. If a memorandum for the record cannot be 
obtained, the laboratory reports a rejected for testing result to the 
MRO and the MRO cancels the test. The HHS-certified laboratory must 
wait at least 5 business days while attempting to obtain the memorandum 
before reporting a rejected for testing result to the MRO.

Subpart G--Oral Fluid Specimen Collection Devices

Section 7.1 What is used to collect an oral fluid specimen?

    An FDA-cleared single-use collection device intended to collect an 
oral fluid specimen must be used. This collection device must maintain 
the integrity of such specimens during storage and transport so that 
the specimen contained therein can be tested in an HHS-certified 
laboratory for the presence of drugs or their metabolites.

Section 7.2 What are the requirements for an oral fluid collection 
device?

    An oral fluid specimen collection device must provide:
    (a) An indicator that demonstrates the adequacy of the volume of 
oral fluid specimen collected;
    (b) One or two sealable, non-leaking tubes [depending on the device 
type, as described in Section 8.8(a)] that:
    (1) Maintain the integrity of the specimen during storage and 
transport so that the specimen contained therein can be tested in an 
HHS-certified laboratory for the presence of drugs or their 
metabolites,
    (2) are sufficiently transparent to enable a visual assessment of 
the contents (i.e., oral fluid, buffer/diluent, collection pad) for 
identification of abnormal physical characteristics without opening the 
tube, and
    (3) include the device lot expiration date on each specimen tube 
(i.e., the expiration date of the buffer/diluent or, for devices 
without a buffer/diluent, the earliest expiration date of any device 
component);
    (c) Components that ensure pre-analytical drug and drug metabolite 
stability; and
    (d) Components that do not substantially affect the composition of 
drugs and/or drug metabolites in the oral fluid specimen.

Section 7.3 What are the minimum performance requirements for a 
collection device?

    An oral fluid collection device must meet the following minimum 
performance requirements.
    (a) Reliable collection of a minimum of 1 mL of undiluted (neat) 
oral fluid;
    (b) If the collection device contains a diluent (or other 
component, process, or method that modifies the volume of the testable 
specimen):
    (1) The volume of oral fluid collected should be at least 1.0 mL 
10 percent, and
    (2) The volume of diluent in the device should be within 2.5 percent of the diluent target volume;
    (c) Stability (recoverable concentrations >=80 percent of the 
concentration at the time of collection) of the drugs and/or drug 
metabolites for five days at room temperature (64- 77 [deg]F/18-25 
[deg]C) and under the manufacturer's intended shipping and storage 
conditions; and
    (d) Recover >=80 percent (but no more than 120 percent) of drug 
and/or drug metabolite in the undiluted (neat) oral fluid at (or near) 
the initial test cutoff listed in the drug testing panel.

Subpart H--Oral Fluid Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing an oral 
fluid specimen?

    The following privacy requirements apply when a donor is providing 
an oral fluid specimen:
    (a) Only authorized personnel and the donor may be present in the 
restricted

[[Page 20539]]

access area where the collection takes place.
    (b) The collector is not required to be the same gender as the 
donor.

Section 8.2 What must the collector ensure at the collection site 
before starting an oral fluid specimen collection?

    The collector must deter the adulteration or substitution of an 
oral fluid specimen at the collection site.

Section 8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?

    The collector must take the following steps before beginning an 
oral fluid specimen collection:
    (a) If a donor fails to arrive at the collection site at the 
assigned time, the collector must follow the federal agency policy or 
contact the federal agency representative to obtain guidance on action 
to be taken.
    (b) When the donor arrives at the collection site, the collector 
should begin the collection procedure without undue delay. For example, 
the collection should not be delayed because an authorized employer or 
employer representative is late in arriving.
    (c) The collector requests the donor to present photo 
identification (e.g., driver's license; employee badge issued by the 
employer; an alternative photo identification issued by a federal, 
state, or local government agency). If the donor does not have proper 
photo identification, the collector shall contact the supervisor of the 
donor or the federal agency representative who can positively identify 
the donor. If the donor's identity cannot be established, the collector 
must not proceed with the collection.
    (d) The collector must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (e) The collector asks the donor to remove any unnecessary outer 
garments (e.g., coat, jacket) that might conceal items or substances 
that could be used to adulterate or substitute the oral fluid specimen. 
The collector must ensure that all personal belongings (e.g., purse or 
briefcase) remain with the outer garments. The donor may retain the 
donor's wallet.
    (f) If the donor will remain under the collector's direct 
observation until the end of the collection, including the 10-minute 
wait period described in Section 8.3(h), the collector proceeds to 
Section 8.3(g). If the collector will not keep the donor under direct 
observation from this point until the end of the collection, the 
collector asks the donor to empty the donor's pockets and display the 
contents to ensure no items are present that could be used to 
adulterate or substitute the specimen.
    (1) If no items are present that can be used to adulterate or 
substitute the specimen, the collector instructs the donor to return 
the items to their pockets and continues the collection procedure.
    (2) If an item is present whose purpose is to adulterate or 
substitute the specimen (e.g., a commercial drug culture product or 
other substance for which the donor has no reasonable explanation), 
this is considered a refusal to test. The collector must stop the 
collection and report the refusal to test as described in Section 8.9.
    (3) If an item that could be used to adulterate or substitute the 
specimen (e.g., common personal care products such as mouthwash, 
lozenges, capsules) appears to have been inadvertently brought to the 
collection site, the collector must secure the item and continue with 
the normal collection procedure.
    (4) If the donor refuses to show the collector the items in their 
pockets, the collector must keep the donor under direct observation 
until the end of the oral fluid collection.
    (g) The collector requests that the donor open the donor's mouth, 
and the collector inspects the oral cavity to ensure that it is free of 
any items (e.g., candy, gum, food, tobacco) that could impede or 
interfere with the collection of an oral fluid specimen or items that 
could be used to adulterate, substitute, or dilute the specimen.
    (1) If an item is present that whose purpose is to adulterate or 
substitute the specimen (e.g., a commercial drug culture product or 
other item for which the donor has no reasonable explanation), this is 
considered a refusal to test. The collector must stop the collection 
and report the refusal to test as described in Section 8.9.
    (2) If an item is present that could impede or interfere with the 
collection of an oral fluid specimen (including abnormally colored 
saliva), or the donor claims to have ``dry mouth,'' the collector gives 
the donor water (e.g., up to 4 oz.) to rinse their mouth. The donor may 
drink the water. If the donor refuses to remove the item or refuses to 
rinse, this is a refusal to test.
    (3) If the donor claims that they have a medical condition that 
prevents opening their mouth for inspection, the collector follows the 
procedure in Section 8.6(b)(2).
    (h) The collector must initiate a 10-minute wait period prior to 
collecting the specimen. During these 10 minutes, the collector must:
    (1) Explain the basic collection procedure to the donor;
    (2) Provide the instructions for completing the Federal CCF for the 
donor's review, and informs the donor that these instructions and the 
collection device-specific instructions are available upon request.
    (3) Answer any reasonable and appropriate questions the donor may 
have regarding the collection procedure; and
    (4) Inform the donor that they must remain at the collection site 
(i.e., in the area designated by the collector) during the wait period, 
and that failure to follow these instructions will be reported as a 
refusal to test.

Section 8.4 What steps does the collector take in the collection 
procedure before the donor provides an oral fluid specimen?

    (a) The collector shall instruct the donor to wash and dry the 
donor's hands under the collector's observation, and to keep their 
hands within view and avoid touching items or surfaces after 
handwashing. If the donor refuses to wash their hands when instructed 
by the collector, this is a refusal to test.
    (b) The collector will provide or the donor may select the specimen 
collection device(s) to be used for the collection. The device(s) must 
be clean, unused, and wrapped/sealed in original packaging. See Section 
8.8(a) for types of specimen collection devices used for oral fluid 
split specimen collections.
    (1) The collector will open the package in view of the donor.
    (2) Both the collector and the donor must keep the unwrapped 
collection devices in view at all times until each collection device 
containing the donor's oral fluid specimen has been sealed and labeled.
    (c) The collector reviews with the donor the procedures required 
for a successful oral fluid specimen collection as stated in the 
manufacturer's instructions for the specimen collection device.
    (d) The collector notes any unusual behavior or appearance of the 
donor on the Federal CCF. If the collector detects any conduct that 
clearly indicates an attempt to tamper with a specimen (e.g., an 
attempt to prevent the device from collecting sufficient oral fluid; an 
attempt to bring into the collection site an adulterant or oral fluid 
substitute), the collector must report a refusal to test in accordance 
with Section 8.9.

[[Page 20540]]

Section 8.5 What steps does the collector take during and after the 
oral fluid specimen collection procedure?

    Integrity and Identity of the Specimen. The collector must take the 
following steps during and after the donor provides the oral fluid 
specimen:
    (a) The collector shall be present and maintain visual contact with 
the donor during the procedures outlined in this section.
    (1) Under the observation of the collector, the donor is 
responsible for positioning the specimen collection device for 
collection. The collector must ensure the collection is performed 
correctly and that the collection device is working properly. If there 
is a failure to collect the specimen, the collector must begin the 
process again, beginning with Step 8.4(b), using a new specimen 
collection device (for both A and B specimens) and notes the failed 
collection attempt on the Federal CCF. If the donor states that they 
are unable to provide an oral fluid specimen during the collection 
process or after multiple failures to collect the specimen, the 
collector follows the procedure in Section 8.6.
    (2) The donor and the collector must complete the collection in 
accordance with the manufacturer instructions for the collection 
device.
    (3) The collector must inspect the specimen to determine if there 
is any sign indicating that the specimen may not be a valid oral fluid 
specimen (e.g., unusual color, presence of foreign objects or 
material), documents any unusual findings on the Federal CCF, and takes 
action (e.g., recollection) to obtain an acceptable specimen.
    (b) If the donor fails to remain present through the completion of 
the collection, fails to follow the instructions for the collection 
device, refuses to begin the collection process after a failure to 
collect the specimen as required in step (a)(1) above, refuses to 
provide a split specimen as instructed by the collector, or refuses to 
provide an alternate specimen as authorized in Section 8.6, the 
collector stops the collection and reports the refusal to test in 
accordance with Section 8.9.

Section 8.6 What procedure is used when the donor states that they are 
unable to provide an oral fluid specimen?

    (a) If the donor states that they are unable to provide an oral 
fluid specimen during the collection process, the collector requests 
that the donor follow the collector instructions and attempt to provide 
an oral fluid specimen.
    (b) The donor demonstrates their inability to provide a specimen 
when, after 15 minutes of using the collection device, there is 
insufficient volume or no oral fluid collected using the device.
    (1) If the donor states that they could provide a specimen after 
drinking some fluids, the collector gives the donor a drink (up to 8 
ounces) and waits an additional 10 minutes before beginning the 
specimen collection (a period of 1 hour must be provided or until the 
donor has provided a sufficient oral fluid specimen). If the donor 
simply needs more time before attempting to provide an oral fluid 
specimen, the donor may choose not to drink any fluids during the 1 
hour wait time. The collector must inform the donor that the donor must 
remain at the collection site (i.e., in an area designated by the 
collector) during the wait period.
    (2) If the donor states that they are unable to provide an oral 
fluid specimen, the collector records the reason for not collecting an 
oral fluid specimen on the Federal CCF, notifies the federal agency's 
designated representative for authorization 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 an oral fluid specimen, 
may another specimen type be collected for testing?

    Yes, if the alternate specimen type is authorized by Mandatory 
Guidelines for Federal Workplace Drug Testing Programs and specifically 
authorized by the federal agency.

Section 8.8 How does the collector prepare the oral fluid specimens?

    (a) All federal agency collections are to be split specimen 
collections. An oral fluid split specimen collection may be:
    (1) Two specimens collected simultaneously with two separate 
collection devices;
    (2) Two specimens collected serially with two separate collection 
devices. The donor is not allowed to drink or rinse their mouth between 
the two collections. Collection of the second specimen must begin 
within two minutes after the completion of the first collection and 
recorded on the Federal CCF;
    (3) Two specimens collected simultaneously using a single 
collection device that directs the oral fluid into two separate 
collection tubes; or
    (4) A single specimen collected using a single collection device, 
that is subsequently subdivided into two specimens.
    (b) A volume of at least 1 mL of undiluted (neat) oral fluid is 
collected for the specimen designated as ``Tube A'' and a volume of at 
least 1 mL of undiluted (neat) oral fluid is collected for the specimen 
designated as ``Tube B''.
    (c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over the cap of each specimen 
tube. The collector records the date of the collection on the tamper-
evident labels/seals.
    (d) The collector instructs the donor to initial the tamper-evident 
labels/seals on each specimen tube. If the donor refuses to initial the 
labels/seals, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (e) The collector must ensure that all 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 (Tube A and Tube B) in a 
package and, within 24 hours or during the next business day, sends 
them to the HHS-certified laboratory that will be testing the Tube A 
oral fluid specimen.
    (i) If the specimen and Federal CCF are not immediately transported 
to an HHS-certified laboratory, they must remain under direct control 
of the collector or be appropriately secured under proper specimen 
storage conditions until transported.

Section 8.9 How does the collector report a donor's refusal to test?

    If there is a refusal to test as defined in Section 1.7, the 
collector stops the collection, discards any oral fluid specimen 
collected and reports the refusal to test by:

[[Page 20541]]

    (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 8.10 What are a federal agency's responsibilities for a 
collection site?

    (a) A federal agency must ensure that collectors and collection 
sites satisfy all requirements in subparts D, E, F, G, and H.
    (b) A federal agency (or only one federal agency when several 
agencies are using the same collection site) must inspect 5 percent or 
up to a maximum of 50 collection sites each year, selected randomly 
from those sites used to collect agency specimens (e.g., virtual, 
onsite, or self-evaluation).
    (c) A federal agency must investigate reported collection site 
deficiencies (e.g., specimens reported ``rejected for testing'' by an 
HHS-certified laboratory) and take appropriate action which may include 
a collection site self-assessment (i.e., using the Collection Site 
Checklist for the Collection of Oral Fluid Specimens for Federal Agency 
Workplace Drug Testing Programs) or an inspection of the collection 
site. The inspections of these additional collection sites may be 
included in the 5 percent or maximum of 50 collection sites inspected 
annually.

Subpart I--HHS Certification of Laboratories

Section 9.1 Who has the authority to certify laboratories to test oral 
fluid specimens for federal agencies?

    (a) The Secretary has broad discretion to take appropriate action 
to ensure the full reliability and accuracy of drug testing and 
reporting, to resolve problems related to drug testing, and to enforce 
all standards set forth in these Guidelines. The Secretary has the 
authority to issue directives to any HHS-certified laboratory, 
including suspending the use of certain analytical procedures when 
necessary to protect the integrity of the testing process; ordering any 
HHS-certified laboratory to undertake corrective actions to respond to 
material deficiencies identified by an inspection or through 
performance testing; ordering any HHS-certified laboratory to send 
specimens or specimen aliquots to another HHS-certified laboratory for 
retesting when necessary to ensure the accuracy of testing under these 
Guidelines; ordering the review of results for specimens tested under 
the Guidelines for private sector clients to the extent necessary to 
ensure the full reliability of drug testing for federal agencies; and 
ordering any other action necessary to address deficiencies in drug 
testing, analysis, specimen collection, chain of custody, reporting of 
results, or any other aspect of the certification program.
    (b) A laboratory is prohibited from stating or implying that it is 
certified by HHS under these Guidelines to test oral fluid specimens 
for federal agencies unless it holds such certification.

Section 9.2 What is the process for a laboratory to become HHS-
certified?

    (a) A laboratory seeking HHS certification must:
    (1) Submit a completed OMB-approved application form (i.e., the 
applicant laboratory provides detailed information on both the 
administrative and analytical procedures to be used for federally 
regulated specimens);
    (2) Have its application reviewed as complete and accepted by HHS;
    (3) Successfully complete the PT challenges in 3 consecutive sets 
of initial PT samples;
    (4) Satisfy all the requirements for an initial inspection; and
    (5) Receive notification of certification from the Secretary before 
testing specimens for federal agencies.

Section 9.3 What is the process for a laboratory to maintain HHS 
certification?

    (a) To maintain HHS certification, a laboratory must:
    (1) Successfully participate in both the maintenance PT and 
inspection programs (i.e., successfully test the required quarterly 
sets of maintenance PT samples, undergo an inspection 3 months after 
being certified, and undergo maintenance inspections at a minimum of 
every 6 months thereafter);
    (2) Respond in an appropriate, timely, and complete manner to 
required corrective action requests if deficiencies are identified in 
the maintenance PT performance, during the inspections, operations, or 
reporting; and
    (3) Satisfactorily complete corrective remedial actions, and 
undergo special inspection and special PT sets to maintain or restore 
certification when material deficiencies occur in either the PT 
program, inspection program, or in operations and reporting.

Section 9.4 What is the process when a laboratory does not maintain its 
HHS certification?

    (a) A laboratory that does not maintain its HHS certification must:
    (1) Stop testing federally regulated specimens;
    (2) Ensure the security of federally regulated specimens and 
records throughout the required storage period described in Sections 
11.18, 11.19, and 14.8;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.21 and 11.22 and Subpart P; 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 
may be sent to the laboratory as undiluted (neat) oral fluid. The PT 
samples must satisfy one of the following parameters:
    (i) The concentration of a drug or metabolite will be at least 20 
percent above the initial test cutoff for the drug or drug metabolite;
    (ii) The concentration of a drug or metabolite may be as low as 40 
percent of the confirmatory test cutoff when the PT sample is 
designated as a retest sample; or
    (iii) The concentration of drug or metabolite may differ from 
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 or invalid result.
    (3) A negative PT sample will not contain a measurable amount of a 
target analyte.
    (b) The laboratory must (to the greatest extent possible) handle, 
test, and report a PT sample in a manner identical to that used for a 
donor specimen, unless otherwise specified.

Section 9.6 What are the PT requirements for an applicant laboratory?

    (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;

[[Page 20542]]

    (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 20 percent or 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, must not obtain any drug 
concentration that differs by more than 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 20 percent 
or 2 standard deviations [whichever is larger] from the 
appropriate reference or peer group means) for at least 50 percent of 
the drug challenges for an individual drug over the three sets of PT 
samples;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over the three sets of PT samples;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over the three sets of PT 
samples;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over the three 
sets of PT samples that satisfy the specified criteria; and
    (10) Do not report any PT sample as adulterated with a compound 
that is not present in the sample or substituted when the appropriate 
reference or peer group mean for a biomarker is within the acceptable 
range.
    (b) Failure to satisfy these requirements will result in 
disqualification.

Section 9.7 What are the PT requirements for an HHS-certified oral 
fluid 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 20 percent or 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 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 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group means over two consecutive PT 
cycles;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over two consecutive PT cycles;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over two consecutive PT cycles;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over two 
consecutive PT cycles that satisfy the specified criteria; and
    (10) Do not report any PT sample as adulterated with a compound 
that is not present in the sample or substituted when the appropriate 
reference or peer group mean for a biomarker is within the acceptable 
range.
    (b) Failure to participate in all PT cycles or to satisfy these 
requirements may result in suspension or revocation of an HHS-certified 
laboratory's certification.

Section 9.8 What are the inspection requirements for an applicant 
laboratory?

    (a) An applicant laboratory is inspected by a team of two 
inspectors.
    (b) Each inspector conducts an independent review and evaluation of 
all aspects of the laboratory's testing procedures and facilities using 
an inspection checklist.

Section 9.9 What are the maintenance inspection requirements for an 
HHS-certified laboratory?

    (a) An HHS-certified laboratory must undergo an inspection 3 months 
after becoming certified and at least every 6 months thereafter.
    (b) An HHS-certified laboratory is inspected by 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 procedures, records, and facilities 
using guidance provided by the Secretary.
    (d) To remain certified, an HHS-certified laboratory must continue 
to satisfy the minimum requirements as stated in these Guidelines.

Section 9.10 Who can inspect an HHS-certified laboratory and when may 
the inspection be conducted?

    (a) An individual may be selected as an inspector for the Secretary 
if they satisfy the following criteria:
    (1) Has experience and an educational background similar to that 
required for either a responsible person or a certifying scientist for 
an HHS-certified laboratory as described in Subpart K;
    (2) Has read and thoroughly understands the policies and 
requirements contained in these Guidelines and in other guidance 
consistent with these Guidelines provided by the Secretary;
    (3) Submits a resume and documentation of qualifications to HHS;
    (4) Attends approved training; and
    (5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory.
    (b) The Secretary or a federal agency may conduct an inspection at 
any time.

Section 9.11 What happens if an applicant laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?

    If an applicant laboratory fails to satisfy the requirements 
established for the initial certification process, the laboratory must 
start the certification process from the beginning.

Section 9.12 What happens if an HHS-certified laboratory does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?

    (a) If an HHS-certified laboratory fails to satisfy the minimum 
requirements for certification, the laboratory is given a period of 
time (e.g., 5 or 30 working days depending on the nature of the 
deficiency) to provide any explanation for its performance and evidence 
that all deficiencies have been corrected.
    (b) A laboratory's HHS certification may be revoked, suspended, or 
no further action taken depending on the seriousness of the 
deficiencies and whether there is evidence that the deficiencies have 
been corrected and that current performance meets the requirements for 
certification.
    (c) An HHS-certified laboratory may be required to undergo a 
special inspection or to test additional PT samples to address 
deficiencies.
    (d) If an HHS-certified laboratory's certification is revoked or 
suspended in

[[Page 20543]]

accordance with the process described in Subpart P, the laboratory is 
not permitted to test federally regulated specimens until the 
suspension is lifted or the laboratory has successfully completed the 
certification requirements as a new applicant laboratory.

Section 9.13 What factors are considered in determining whether 
revocation of a laboratory's HHS certification is necessary?

    (a) The Secretary shall revoke certification of an HHS-certified 
laboratory in accordance with these Guidelines if the Secretary 
determines that revocation is necessary to ensure fully reliable and 
accurate drug test results and reports.
    (b) The Secretary shall consider the following factors in 
determining whether revocation is necessary:
    (1) Unsatisfactory performance in analyzing and reporting the 
results of drug tests (e.g., an HHS-certified laboratory reporting a 
false positive result for an employee's drug test);
    (2) Unsatisfactory participation in performance testing or 
inspections;
    (3) A material violation of a certification standard, contract 
term, or other condition imposed on the HHS-certified laboratory by a 
federal agency using the laboratory's services;
    (4) Conviction for any criminal offense committed as an incident to 
operation of the HHS-certified laboratory; or
    (5) Any other cause that materially affects the ability of the HHS-
certified laboratory to ensure fully reliable and accurate drug test 
results and reports.
    (c) The period and terms of revocation shall be determined by the 
Secretary and shall depend upon the facts and circumstances of the 
revocation and the need to ensure accurate and reliable drug testing.

Section 9.14 What factors are considered in determining whether to 
suspend a laboratory's HHS certification?

    (a) The Secretary may immediately suspend (either partially or 
fully) a laboratory's HHS certification to conduct drug testing for 
federal agencies if the Secretary has reason to believe that revocation 
may be required and that immediate action is necessary to protect the 
interests of the United States and its employees.
    (b) The Secretary shall determine the period and terms of 
suspension based upon the facts and circumstances of the suspension and 
the need to ensure accurate and reliable drug testing.

Section 9.15 How does the Secretary notify an HHS-certified laboratory 
that action is being taken against the laboratory?

    (a) When a laboratory's HHS certification is suspended or the 
Secretary seeks to revoke HHS certification, the Secretary shall 
immediately serve the HHS-certified laboratory with written notice of 
the suspension or proposed revocation by fax, mail, personal service, 
or registered or certified mail, return receipt requested. This 
notification 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 notification shall state that the laboratory will 
be afforded an opportunity for an informal review of the suspension or 
proposed revocation if it so requests in writing within 30 days of the 
date the laboratory received the notification, or if expedited review 
is requested, within 3 days of the date the laboratory received the 
notification. 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 must be effective 30 days after written notification is 
given or, if review is requested, upon the reviewing official's 
decision to uphold the proposed revocation. If the reviewing official 
decides not to uphold the suspension or proposed revocation, the 
suspension must terminate immediately and any proposed revocation shall 
not take effect.
    (d) The Secretary will publish in the Federal Register the name, 
address, and telephone number of any HHS-certified laboratory that has 
its certification revoked or suspended under Section 9.13 or Section 
9.14, respectively, and the name of any HHS-certified laboratory that 
has its suspension lifted. The Secretary shall provide to any member of 
the public upon request the written notification provided to a 
laboratory that has its HHS certification suspended or revoked, as well 
as the reviewing official's written decision which upholds or denies 
the suspension or proposed revocation under the procedures of Subpart 
P.

Section 9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?

    Following revocation, a laboratory may apply for recertification. 
Unless otherwise provided by the Secretary in the notification of 
revocation under Section 9.15 or the reviewing official's decision 
under Section 16.9(e) or 16.14(a), a laboratory which has had its 
certification revoked may reapply for HHS certification as an applicant 
laboratory.

Section 9.17 Where is the list of HHS-certified laboratories published?

    (a) The list of HHS-certified laboratories is published monthly in 
the Federal Register. This notification is also available on the 
internet at https://www.samhsa.gov/workplace.
    (b) An applicant laboratory is not included on the list.

Subpart J--Blind Samples Submitted by an Agency

Section 10.1 What are the requirements for federal agencies to submit 
blind samples to HHS-certified laboratories?

    (a) Each federal agency is required to submit blind samples for its 
workplace drug testing program. The collector must send the blind 
samples to the HHS-certified laboratory that the collector sends 
employee specimens.
    (b) Each federal agency must submit at least 3 percent blind 
samples along with its donor specimens based on the projected total 
number of donor specimens collected per year (up to a maximum of 400 
blind samples). Every effort should be made to ensure that blind 
samples are submitted quarterly.
    (c) Approximately 75 percent of the blind samples submitted each 
year by an agency must be negative and 25 percent must be positive for 
one or more drugs.

Section 10.2 What are the requirements for blind samples?

    (a) Drug positive blind samples must be validated by the supplier 
in the selected manufacturer's collection device as to their content 
using appropriate initial and confirmatory tests.
    (1) Drug positive blind samples must 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 in the selected manufacturer's 
collection device as negative using appropriate initial and 
confirmatory tests.

[[Page 20544]]

    (c) The supplier must provide information on the blind samples' 
content, validation, expected results, and stability to the collection 
site/collector sending the blind samples to the laboratory, and must 
provide the information upon request to the MRO, the federal agency for 
which the blind sample was submitted, or the Secretary.

Section 10.3 How is a blind sample submitted to an HHS-certified 
laboratory?

    (a) A blind sample must be submitted as a split specimen (specimens 
A and B) with the current Federal CCF that the HHS-certified laboratory 
uses for donor specimens. The collector provides the required 
information to ensure that the Federal CCF has been properly completed 
and provides fictitious initials on the specimen label/seal. The 
collector must indicate that the specimen is a blind sample on the MRO 
copy where a donor would normally provide a signature.
    (b) A collector should attempt to distribute the required number of 
blind samples randomly with donor specimens rather than submitting the 
full complement of blind samples as a single group.

Section 10.4 What happens if an inconsistent result is reported for a 
blind sample?

    If an HHS-certified laboratory reports a result for a blind sample 
that is inconsistent with the expected result (e.g., a laboratory 
reports a negative result for a blind sample that was supposed to be 
positive, a laboratory reports a positive result for a blind sample 
that was supposed to be negative):
    (a) The MRO must contact the laboratory and attempt to determine if 
the laboratory made an error during the testing or reporting of the 
sample;
    (b) The MRO must contact the blind sample supplier and attempt to 
determine if the supplier made an error during the preparation or 
transfer of the sample;
    (c) The MRO must contact the collector and determine if the 
collector made an error when preparing the blind sample for transfer to 
the HHS-certified laboratory;
    (d) If there is no obvious reason for the inconsistent result, the 
MRO must notify both the federal agency for which the blind sample was 
submitted and the Secretary; and
    (e) The Secretary shall investigate the blind sample error. A 
report of the Secretary's investigative findings and the corrective 
action taken in response to identified deficiencies must be sent to the 
federal agency. The Secretary shall ensure notification of the finding 
as appropriate to other federal agencies and coordinate any necessary 
actions to prevent the recurrence of the error.

Subpart K--Laboratory

Section 11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?

    (a) An HHS-certified laboratory must have a standard operating 
procedure (SOP) manual that describes, in detail, all HHS-certified 
laboratory operations. When followed, the SOP manual ensures that all 
specimens are tested using the same procedures.
    (b) The SOP manual must include at a minimum, but is not limited 
to, a detailed description of the following:
    (1) Chain of custody procedures;
    (2) Accessioning;
    (3) Security;
    (4) Quality control/quality assurance programs;
    (5) Analytical methods and procedures;
    (6) Equipment and maintenance programs;
    (7) Personnel training;
    (8) Reporting procedures; and
    (9) Computers, software, and laboratory information management 
systems.
    (c) All procedures in the SOP manual must be compliant with these 
Guidelines and all guidance provided by the Secretary.
    (d) A copy of all procedures that have been replaced or revised and 
the dates on which the procedures were in effect must be maintained for 
at least 2 years.

Section 11.2 What are the responsibilities of the responsible person 
(RP)?

    (a) Manage the day-to-day operations of the HHS-certified 
laboratory even if another individual has overall responsibility for 
alternate areas of a multi-specialty laboratory.
    (b) Ensure that there are sufficient personnel with adequate 
training and experience to supervise and conduct the work of the HHS-
certified laboratory. The RP must ensure the continued competency of 
laboratory staff by documenting their in-service training, reviewing 
their work performance, and verifying their skills.
    (c) Maintain a complete and current SOP manual that is available to 
all personnel of the HHS-certified laboratory and ensure that it is 
followed. The SOP manual must be reviewed, signed, and dated by the 
RP(s) when procedures are first placed into use and when changed or 
when a new individual assumes responsibility for the management of the 
HHS-certified laboratory. The SOP must be reviewed and documented by 
the RP annually.
    (d) Maintain a quality assurance program that ensures the proper 
performance and reporting of all test results; verify and monitor 
acceptable analytical performance for all controls and calibrators; 
monitor quality control testing; and document the validity, 
reliability, accuracy, precision, and performance characteristics of 
each test and test system.
    (e) Initiate and implement all remedial actions necessary to 
maintain satisfactory operation and performance of the HHS-certified 
laboratory in response to the following: Quality control systems not 
within performance specifications; errors in result reporting or in 
analysis of performance testing samples; and inspection deficiencies. 
The RP must ensure that specimen results are not reported until all 
corrective actions have been taken and that the results provided are 
accurate and reliable.

Section 11.3 What scientific qualifications must the RP have?

    The RP must have documented scientific qualifications in analytical 
toxicology. Minimum qualifications are:
    (a) Certification or licensure as a laboratory director by the 
state in forensic or clinical laboratory toxicology, a Ph.D. in one of 
the natural sciences, or training and experience comparable to a Ph.D. 
in one of the natural sciences with training and laboratory/research 
experience in biology, chemistry, and pharmacology or toxicology;
    (b) Experience in forensic toxicology with emphasis on the 
collection and analysis of biological specimens for drugs of abuse;
    (c) Experience in forensic applications of analytical toxicology 
(e.g., publications, court testimony, conducting research on the 
pharmacology and toxicology of drugs of abuse) or qualify as an expert 
witness in forensic toxicology;
    (d) Fulfillment of the RP responsibilities and qualifications, as 
demonstrated by the HHS-certified laboratory's performance and verified 
upon interview by HHS-trained inspectors during each on-site 
inspection; and
    (e) Qualify as a certifying scientist.

Section 11.4 What happens when the RP is absent or leaves an HHS-
certified laboratory?

    (a) HHS-certified laboratories must have multiple RPs or one RP and 
an

[[Page 20545]]

alternate RP. If the RP(s) are concurrently absent, an alternate RP 
must be present and qualified to fulfill the responsibilities of the 
RP.
    (1) If an HHS-certified laboratory is without the RP and alternate 
RP for 14 calendar days or less (e.g., temporary absence due to 
vacation, illness, or business trip), the HHS-certified laboratory may 
continue operations and testing of federal agency specimens under the 
direction of a certifying scientist.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all specimens if the 
laboratory does not have an RP or alternate RP for a period of more 
than 14 calendar days. The suspension will be lifted upon the 
Secretary's approval of a new permanent RP or alternate RP.
    (b) If the RP leaves an HHS-certified laboratory:
    (1) The HHS-certified laboratory may maintain certification and 
continue testing federally regulated specimens under the direction of 
an alternate RP for a period of up to 180 days while seeking to hire 
and receive the Secretary's approval of the RP's replacement.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all federally regulated 
specimens if the laboratory does not have a permanent RP within 180 
days. The suspension will be lifted upon the Secretary's approval of 
the new permanent RP.
    (c) To nominate an individual as an RP or alternate RP, the HHS-
certified laboratory must submit the following documents to the 
Secretary: The candidate's current resume or curriculum vitae, copies 
of diplomas and licensures, a training plan (not to exceed 90 days) to 
transition the candidate into the position, an itemized comparison of 
the candidate's qualifications to the minimum RP qualifications 
described in the Guidelines, and have official academic transcript(s) 
submitted from the candidate's institution(s) of higher learning. The 
candidate must be found qualified during an on-site inspection of the 
HHS-certified laboratory.
    (d) The HHS-certified laboratory must fulfill additional inspection 
and PT criteria as required prior to conducting federally regulated 
testing under a new RP.

Section 11.5 What qualifications must an individual have to certify a 
result reported by an HHS-certified laboratory?

    (a) A certifying scientist must have:
    (1) At least a bachelor's degree in the chemical or biological 
sciences or medical technology, or equivalent;
    (2) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (3) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.
    (b) A certifying technician must have:
    (1) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (2) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.

Section 11.6 What qualifications and training must other personnel of 
an HHS-certified laboratory have?

    (a) All HHS-certified laboratory staff (e.g., technicians, 
administrative staff) must have the appropriate training and skills for 
the tasks they perform.
    (b) Each individual working in an HHS-certified laboratory must be 
properly trained (i.e., receive training in each area of work that the 
individual will be performing, including training in forensic 
procedures related to their job duties) before they are permitted to 
work independently with federally regulated specimens. All training 
must be documented.

Section 11.7 What security measures must an HHS-certified laboratory 
maintain?

    (a) An HHS-certified laboratory must control access to the drug 
testing facility, specimens, aliquots, and records.
    (b) Authorized visitors must be escorted at all times, except for 
individuals conducting inspections (i.e., for the Department, a federal 
agency, a state, or other accrediting agency) or emergency personnel 
(e.g., firefighters and medical rescue teams).
    (c) An HHS-certified laboratory must maintain records documenting 
the identity of the visitor and escort, date, time of entry and exit, 
and purpose for access to the secured area.

Section 11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?

    (a) HHS-certified laboratories must use chain of custody procedures 
(internal and external) to maintain control and accountability of 
specimens from the time of receipt at the laboratory through completion 
of testing, reporting of results, during storage, and continuing until 
final disposition of the specimens.
    (b) HHS-certified laboratories must use chain of custody procedures 
to document the handling and transfer of aliquots throughout the 
testing process until final disposal.
    (c) The chain of custody must be documented using either paper copy 
or electronic procedures.
    (d) Each individual who handles a specimen or aliquot must sign and 
complete the appropriate entries on the chain of custody form when the 
specimen or aliquot is handled or transferred, and every individual in 
the chain must be identified.
    (e) The date and purpose must be recorded on an appropriate chain 
of custody form each time a specimen or aliquot is handled or 
transferred.

Section 11.9 What are the requirements for an initial drug test?

    (a) An initial drug test may be:
    (1) An immunoassay or
    (2) An alternate technology (e.g., spectrometry, spectroscopy).
    (b) An HHS-certified laboratory must validate an initial drug test 
before testing specimens.
    (c) Initial drug tests must be accurate and reliable for the 
testing of specimens when identifying drugs or their metabolites.
    (d) An HHS-certified laboratory may conduct a second initial drug 
test using a method with different specificity, to rule out cross-
reacting compounds. This second initial drug test must satisfy the 
batch quality control requirements specified in Section 11.11.

Section 11.10 What must an HHS-certified laboratory do to validate an 
initial drug test?

    (a) An HHS-certified laboratory must demonstrate and document the 
following for each initial drug test:
    (1) The ability to differentiate negative specimens from those 
requiring further testing;
    (2) The performance of the test around the cutoff, using samples at 
several concentrations between 0 and 150 percent of the cutoff;
    (3) The effective concentration range of the test (linearity);

[[Page 20546]]

    (4) The potential for carryover;
    (5) The potential for interfering substances; and
    (6) The potential matrix effects if using an alternate technology.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) Each initial drug test using an alternate technology must be 
re-verified periodically or at least annually.

Section 11.11 What are the batch quality control requirements when 
conducting an initial drug test?

    (a) Each batch of specimens must contain the following controls:
    (1) At least one control certified to contain no drug or drug 
metabolite;
    (2) At least one positive control with the drug or drug metabolite 
targeted at a concentration 25 percent above the cutoff;
    (3) At least one control with the drug or drug metabolite targeted 
at a concentration 75 percent of the cutoff; and
    (4) At least one control that appears as a donor specimen to the 
analysts.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.

Section 11.12 What are the requirements for a confirmatory drug test?

    (a) The analytical method must use mass spectrometric 
identification (e.g., gas chromatography-mass spectrometry [GC-MS], 
liquid chromatography-mass spectrometry [LC-MS], GC-MS/MS, LC-MS/MS) or 
equivalent.
    (b) A confirmatory drug test must be validated before it can be 
used to test federally regulated specimens.
    (c) Confirmatory drug tests must be accurate and reliable for the 
testing of an oral fluid specimen when identifying and quantifying 
drugs or their metabolites.

Section 11.13 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?

    (a) An HHS-certified laboratory must demonstrate and document the 
following for each confirmatory drug test:
    (1) The linear range of the analysis;
    (2) The limit of detection;
    (3) The limit of quantification;
    (4) The accuracy and precision at the cutoff;
    (5) The accuracy (bias) and precision at 40 percent of the cutoff;
    (6) The potential for interfering substances;
    (7) The potential for carryover; and
    (8) The potential matrix effects if using liquid chromatography 
coupled with mass spectrometry.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) HHS-certified laboratories must re-verify each confirmatory 
drug test method periodically or at least annually.

Section 11.14 What are the batch quality control requirements when 
conducting a confirmatory drug test?

    (a) At a minimum, each batch of specimens must contain the 
following calibrators and controls:
    (1) A calibrator at the cutoff;
    (2) At least one control certified to contain no drug or drug 
metabolite;
    (3) At least one positive control with the drug or drug metabolite 
targeted at 25 percent above the cutoff; and
    (4) At least one control targeted at or less than 40 percent of the 
cutoff.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.

Section 11.15 What are the analytical and quality control requirements 
for conducting specimen validity tests?

    (a) Each invalid, adulterated, or substituted specimen validity 
test result must be based on an initial specimen validity test on one 
aliquot and a confirmatory specimen validity test on a second aliquot;
    (b) The HHS-certified laboratory must establish acceptance criteria 
and analyze calibrators and controls as appropriate to verify and 
document the validity of the test results; and
    (c) Controls must be analyzed concurrently with specimens.

Section 11.16 What must an HHS-certified laboratory do to validate a 
specimen validity test?

    An HHS-certified laboratory must demonstrate and document for each 
specimen validity test the appropriate performance characteristics of 
the test, and must re-verify the test periodically, or at least 
annually. Each new lot of reagent must be verified prior to being 
placed into service.

Section 11.17 What are the requirements for an HHS-certified laboratory 
to report a test result?

    (a) Laboratories must report a test result to the agency's MRO 
within an average of 5 working days after receipt of the specimen. 
Reports must use the Federal CCF and/or an electronic report. Before 
any test result can be reported, it must be certified by a certifying 
scientist or a certifying technician (as appropriate).
    (b) A primary (A) specimen is reported negative when each initial 
drug test is negative or if the specimen is negative upon confirmatory 
drug testing, and the specimen does not meet invalid criteria as 
described in items (g)(1) through (g)(5) below.
    (c) A primary (A) specimen is reported positive for a specific drug 
or drug metabolite when both the initial drug test is positive and the 
confirmatory drug test is positive in accordance with the cutoffs 
listed in the drug testing panel.
    (d) A primary (A) oral fluid specimen is reported adulterated when 
the presence of an adulterant is verified using an initial test on the 
first aliquot and a different confirmatory test on the second aliquot.
    (e) A primary (A) oral fluid specimen is reported substituted when 
a biomarker is not present or is present at a concentration 
inconsistent with that established for human oral fluid.
    (f) For a specimen that has an invalid result for one of the 
reasons stated in items (g)(1) through (g)(5) below, the HHS-certified 
laboratory shall contact the MRO and both will decide if testing by 
another HHS-certified laboratory would be useful in being able to 
report a positive, adulterated, or substituted result. If no further 
testing is necessary, the HHS-certified laboratory then reports the 
invalid result to the MRO.
    (g) A primary (A) oral fluid specimen is reported as an invalid 
result when:
    (1) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (2) Interference with the confirmatory drug test occurs on at least 
two separate aliquots of the specimen and the HHS-certified laboratory 
is unable to identify the interfering substance;
    (3) The physical appearance of the specimen is such that testing 
the specimen may damage the laboratory's instruments;
    (4) The physical appearances of the A and B specimens are clearly 
different (note: A is tested); or
    (5) A specimen validity test on two separate aliquots of the 
specimen indicates that the specimen is not valid for testing.
    (h) An HHS-certified laboratory shall reject a primary (A) specimen 
for testing when a fatal flaw occurs as described in Section 15.1 or 
when a correctable flaw as described in Section 15.2 is not recovered. 
The HHS-certified laboratory will indicate on the Federal CCF that the 
specimen was rejected for testing and provide the reason for reporting 
the rejected for testing result.

[[Page 20547]]

    (i) An HHS-certified laboratory must report all positive, 
adulterated, substituted, and invalid test results for an oral fluid 
specimen. For example, a specimen can be positive for a specific drug 
and adulterated.
    (j) An HHS-certified laboratory must report the confirmatory 
concentration of each drug or drug metabolite reported for a positive 
result.
    (k) An HHS-certified laboratory must report numerical values of the 
specimen validity test results that support a specimen that is reported 
adulterated, substituted, or invalid (as appropriate).
    (l) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing 
panels.
    (m) When the concentration of a drug or drug metabolite exceeds the 
validated linear range of the confirmatory test, HHS-certified 
laboratories may report to the MRO that the quantitative value exceeds 
the linear range of the test or that the quantitative value is greater 
than ``insert the actual value for the upper limit of the linear 
range,'' or laboratories may report a quantitative value above the 
upper limit of the linear range that was obtained by diluting an 
aliquot of the specimen to achieve a result within the method's linear 
range and multiplying the result by the appropriate dilution factor.
    (n) HHS-certified laboratories may transmit test results to the MRO 
by various electronic means (e.g., teleprinter, fax, or computer). 
Transmissions of the reports must ensure confidentiality and the 
results may not be reported verbally by telephone. Laboratories and 
external service providers must ensure the confidentiality, integrity, 
and availability of the data and limit access to any data transmission, 
storage, and retrieval system.
    (o) HHS-certified laboratories must fax, courier, mail, or 
electronically transmit a legible image or copy of the completed 
Federal CCF and/or forward a computer-generated electronic report. The 
computer-generated report must contain sufficient information to ensure 
that the test results can accurately represent the content of the 
custody and control form that the MRO received from the collector.
    (p) For positive, adulterated, substituted, invalid, and rejected 
specimens, laboratories must fax, courier, mail, or electronically 
transmit a legible image or copy of the completed Federal CCF.

Section 11.18 How long must an HHS-certified laboratory retain 
specimens?

    (a) An HHS-certified laboratory must retain specimens that were 
reported as positive, adulterated, substituted, or as an invalid result 
for a minimum of 1 year.
    (b) Retained specimens must be kept in secured storage in 
accordance with the collection device manufacturer's specifications 
(i.e., frozen at -20 [deg]C or less, or refrigerated), to ensure their 
availability for retesting during an administrative or judicial 
proceeding.
    (c) Federal agencies may request that the HHS-certified laboratory 
retain a specimen for an additional specified period of time and must 
make that request within the 1-year period.

Section 11.19 How long must an HHS-certified laboratory retain records?

    (a) An HHS-certified laboratory must retain all records generated 
to support test results for at least 2 years. The laboratory may 
convert hardcopy records to electronic records for storage and then 
discard the hardcopy records after 6 months.
    (b) A federal agency may request the HHS-certified laboratory to 
maintain a documentation package (as described in Section 11.21) that 
supports the chain of custody, testing, and reporting of a donor's 
specimen that is under legal challenge by a donor. The federal agency's 
request to the laboratory must be in writing and must specify the 
period of time to maintain the documentation package.
    (c) An HHS-certified laboratory may retain records other than those 
included in the documentation package beyond the normal 2-year period 
of time.

Section 11.20 What statistical summary reports must an HHS-certified 
laboratory provide for oral fluid testing?

    (a) HHS-certified laboratories must provide to each federal agency 
for which they perform testing a semiannual statistical summary report 
that must be submitted by mail, fax, or email within 14 working days 
after the end of the semiannual period. The summary report must not 
include any personally identifiable information. A copy of the 
semiannual statistical summary report will also be sent to the 
Secretary or designated HHS representative. The semiannual statistical 
report contains the following information:
    (1) Reporting period (inclusive dates);
    (2) HHS-certified laboratory name and address;
    (3) Federal agency name;
    (4) Number of specimen results reported;
    (5) Number of specimens collected by reason for test;
    (6) Number of specimens reported negative;
    (7) Number of specimens rejected for testing because of a fatal 
flaw;
    (8) Number of specimens rejected for testing because of an 
uncorrected flaw;
    (9) Number of specimens tested positive by each initial drug test;
    (10) Number of specimens reported positive;
    (11) Number of specimens reported positive for each drug and drug 
metabolite;
    (12) Number of specimens reported adulterated;
    (13) Number of specimens reported substituted; and
    (14) Number of specimens reported as invalid result.
    (b) An HHS-certified laboratory must make copies of an agency's 
test results available when requested to do so by the Secretary or by 
the federal agency for which the laboratory is performing drug-testing 
services.
    (c) An HHS-certified laboratory must ensure that a qualified 
individual is available to testify in a proceeding against a federal 
employee when the proceeding is based on a test result reported by the 
laboratory.

Section 11.21 What HHS-certified laboratory information is available to 
a federal agency?

    (a) Following a federal agency's receipt of a positive, 
adulterated, or substituted drug test report, the federal agency may 
submit a written request for copies of the records relating to the drug 
test results or a documentation package or any relevant certification, 
review, or revocation of certification records.
    (b) Standard documentation packages provided by an HHS-certified 
laboratory must contain the following items:
    (1) A cover sheet providing a brief description of the procedures 
and tests performed on the donor's specimen;
    (2) A table of contents that lists all documents and materials in 
the package by page number;
    (3) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the HHS-certified laboratory, and a copy of the electronic report (if 
any) generated by the HHS-certified laboratory;
    (4) A brief description of the HHS-certified laboratory's initial 
drug (and specimen validity, if applicable) testing procedures, 
instrumentation, and batch quality control requirements;
    (5) Copies of the initial test data for the donor's specimen with 
all calibrators and controls and copies of all

[[Page 20548]]

internal chain of custody documents related to the initial tests;
    (6) A brief description of the HHS-certified laboratory's 
confirmatory drug (and specimen validity, if applicable) testing 
procedures, instrumentation, and batch quality control requirements;
    (7) Copies of the confirmatory test data for the donor's specimen 
with all calibrators and controls and copies of all internal chain of 
custody documents related to the confirmatory tests; and
    (8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the 
RP(s) and the certifying technician or certifying scientist of record.

Section 11.22 What HHS-certified laboratory information is available to 
a federal employee?

    A federal employee who is the subject of a workplace drug test may 
submit a written request through the MRO and/or the federal agency 
requesting copies of any records relating to the employee's drug test 
results or a documentation package as described in Section 11.21(b) and 
any relevant certification, review, or revocation of certification 
records. Federal employees, or their designees, are not permitted 
access to their specimens collected pursuant to Executive Order 12564, 
Public Law 100-71, and these Guidelines.

Section 11.23 What types of relationships are prohibited between an 
HHS-certified laboratory and an MRO?

    An HHS-certified laboratory must not enter into any relationship 
with a federal agency's MRO that may be construed as a potential 
conflict of interest or derive any financial benefit by having a 
federal agency use a specific MRO.
    This means an MRO may be an employee of the agency or a contractor 
for the agency; however, an MRO shall not be an employee or agent of or 
have any financial interest in the HHS-certified laboratory for which 
the MRO is reviewing drug testing results. Additionally, an MRO shall 
not derive any financial benefit by having an agency use a specific 
HHS-certified laboratory or have any agreement with an HHS-certified 
laboratory that may be construed as a potential conflict of interest.

Subpart L--Instrumented Initial Test Facility (IITF)

Section 12.1 May an IITF test oral fluid specimens for a federal 
agency's workplace drug testing program?

    No, only HHS-certified laboratories are authorized to test oral 
fluid specimens for federal agency workplace drug testing programs in 
accordance with these Guidelines.

Subpart M--Medical Review Officer (MRO)

Section 13.1 Who may serve as an MRO?

    (a) A currently licensed physician who has:
    (1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) 
degree;
    (2) Knowledge regarding the pharmacology and toxicology of illicit 
drugs;
    (3) The training necessary to serve as an MRO as set out in Section 
13.3;
    (4) Satisfactorily passed an initial examination administered by a 
nationally recognized entity or a subspecialty board that has been 
approved by the Secretary to certify MROs; and
    (5) At least every five years from initial certification, completed 
requalification training on the topics in Section 13.3 and 
satisfactorily passed a requalification examination administered by a 
nationally recognized entity or a subspecialty board that has been 
approved by the Secretary to certify MROs.

Section 13.2 How are nationally recognized entities or subspecialty 
boards that certify MROs approved?

    All nationally recognized entities or subspecialty boards which 
seek approval by the Secretary to certify physicians as MROs for 
federal workplace drug testing programs must submit their 
qualifications, a sample examination, and other necessary supporting 
examination materials (e.g., answers, previous examination statistics 
or other background examination information, if requested). Approval 
will be based on an objective review of qualifications that include a 
copy of the MRO applicant application form, documentation that the 
continuing education courses are accredited by a professional 
organization, and the delivery method and content of the examination. 
Each approved MRO certification entity must resubmit their 
qualifications for approval every two years. The Secretary shall 
publish at least every two years a notification in the Federal Register 
listing those entities and subspecialty boards that have been approved. 
This notification is also available on the internet at https://www.samhsa.gov/workplace/drug-testing.

Section 13.3 What training is required before a physician may serve as 
an MRO?

    (a) A physician must receive training that includes a thorough 
review of the following:
    (1) The collection procedures used to collect federal agency 
specimens;
    (2) How to interpret test results reported by HHS-certified IITFs 
and laboratories (e.g., negative, negative/dilute, positive, 
adulterated, substituted, rejected for testing, and invalid);
    (3) Chain of custody, reporting, and recordkeeping requirements for 
federal agency specimens;
    (4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing 
Programs for all authorized specimen types; and
    (5) Procedures for interpretation, review (e.g., donor interview 
for legitimate medical explanations, review of documentation provided 
by the donor to support a legitimate medical explanation), and 
reporting of results specified by any federal agency for which the 
individual may serve as an MRO;
    (b) Certified MROs must complete training on any revisions to these 
Guidelines prior to their effective date, to continue serving as an MRO 
for federal agency specimens.

Section 13.4 What are the responsibilities of an MRO?

    (a) The MRO must review all positive, adulterated, rejected for 
testing, invalid, and substituted test results.
    (b) Staff under the direct, personal supervision of the MRO may 
review and report negative and (for urine) negative/dilute test results 
to the agency's designated representative. The MRO must review at least 
5 percent of all negative results reported by the MRO staff to ensure 
that the MRO staff are properly performing the review process.
    (c) The MRO must discuss potential invalid results with the HHS-
certified laboratory, as addressed in Section 11.17(f) to determine 
whether testing at another HHS-certified laboratory may be warranted.
    (d) After receiving a report from an HHS-certified laboratory or 
(for urine) HHS-certified IITF, the MRO must:
    (1) Review the information on the MRO copy of the Federal CCF that 
was received from the collector and the report received from the HHS-
certified laboratory or HHS-certified IITF;
    (2) Interview the donor when required;
    (3) Make a determination regarding the test result; and
    (4) Report the verified result to the federal agency.

[[Page 20549]]

    (e) The MRO must maintain records for a minimum of two years while 
maintaining the confidentiality of the information. The MRO may convert 
hardcopy records to electronic records for storage and discard the 
hardcopy records after six months.
    (f) The MRO must conduct a medical examination or a review of the 
examining physician's findings and make a determination of refusal to 
test or cancelled test when a collector reports that the donor was 
unable to provide a specimen and an alternate specimen was not 
collected, as addressed in Sections 8.6 and 13.6.

Section 13.5 What must an MRO do when reviewing an oral fluid 
specimen's test results?

    (a) When the HHS-certified laboratory reports a negative result for 
the primary (A) specimen, the MRO reports a negative result to the 
agency.
    (b) When the HHS-certified laboratory reports multiple results for 
the primary (A) specimen, as the MRO, you must follow the verification 
procedures described in 13.5(c) through (f) and:
    (1) Report all verified positive and/or refusal to test results to 
the federal agency.
    (2) If an invalid result was reported in conjunction with a 
positive, adulterated, or substituted result, do not report the 
verified invalid result to the federal agency at this time. The MRO 
takes the action described in Section 13.5(e) for the verified invalid 
result(s) for the primary (A) specimen only when:
    (i) The MRO verifies the laboratory-reported positive, adulterated, 
or substituted result as negative based on a legitimate medical 
explanation as described in 13.5(c)(2) and 13.5(d)(1), or based on 
codeine and/or morphine concentrations less than 150 ng/mL as described 
in 13.5(c)(3)(i); or
    (ii) The split (B) specimen is tested and reported as a failure to 
reconfirm as described in Section 14.6(m).
    (c) When the HHS-certified laboratory reports a positive result for 
the primary (A) specimen, the MRO must contact the donor to determine 
if there is any legitimate medical explanation for the positive result.
    (1) If the donor admits unauthorized use of the drug(s) that caused 
the positive result, the MRO reports the test result as positive to the 
agency. The MRO must document the donor's admission of unauthorized 
drug use in the MRO records and in the MRO's report to the agency.
    (2) If the donor provides documentation (e.g., a valid 
prescription) to support a legitimate medical explanation for the 
positive result, the MRO reports the test result as negative to the 
agency.
    (i) Passive exposure to a drug (e.g., exposure to secondhand 
marijuana smoke) is not a legitimate medical explanation for a positive 
drug test result.
    (ii) Ingestion of food products containing a drug (e.g., products 
containing marijuana) is not a legitimate medical explanation for a 
positive drug test result. See exceptions for positive codeine and 
morphine results in item 3 below.
    (iii) A physician's authorization or medical recommendation for a 
Schedule 1 controlled substance is not a legitimate medical explanation 
for a positive drug test result.
    (3) If the donor is unable to provide a legitimate medical 
explanation for the positive result, the MRO reports the positive 
result to the agency, for all drugs except codeine and/or morphine as 
follows:
    (i) For codeine and/or morphine less than 150 ng/mL, the MRO must 
report the result as negative to the agency, unless the donor admits 
unauthorized use of the drug(s) that caused the positive result as 
described in item (c)(1) above.
    (ii) For codeine and/or morphine equal to or greater than 150 ng/mL 
and no legitimate medical explanation, the MRO shall report a positive 
result to the agency. Consumption of food products must not be 
considered a legitimate medical explanation for the donor having 
morphine or codeine at or above this concentration.
    (d) When the HHS-certified laboratory reports an adulterated or 
substituted result for the primary (A) oral fluid specimen, the MRO 
contacts the donor to determine if the donor has a legitimate medical 
explanation for the adulterated or substituted result.
    (1) If the donor provides a legitimate medical explanation, the MRO 
reports a negative result to the federal agency.
    (2) If the donor is unable to provide a legitimate medical 
explanation, the MRO reports a refusal to test to the federal agency 
because the oral fluid specimen was adulterated or substituted.
    (e) When the HHS-certified laboratory reports an invalid result for 
the primary (A) oral fluid specimen, the MRO must contact the donor to 
determine if there is a legitimate explanation for the invalid result.
    (1) If the donor provides a legitimate explanation (e.g., a 
prescription medication), the MRO reports a test cancelled result with 
the reason for the invalid result and informs the federal agency that a 
recollection is not required because there is a legitimate explanation 
for the invalid result.
    (2) If the donor is unable to provide a legitimate explanation, the 
MRO reports a test cancelled result with the reason for the invalid 
result and directs the federal agency to immediately collect another 
specimen from the donor.
    (i) If the second specimen collected provides a valid result, the 
MRO follows the procedures in 13.5(a) through (d).
    (ii) If the second specimen collected provides an invalid result, 
the MRO reports this specimen as test cancelled and recommends that the 
agency collect another authorized specimen type (e.g., urine).
    (f) When the HHS-certified laboratory reports a rejected for 
testing result for the primary (A) specimen, the MRO reports a test 
cancelled result to the agency and recommends that the agency collect 
another specimen from the donor.

13.6 What action does the MRO take when the collector reports that the 
donor did not provide a sufficient amount of oral fluid for a drug 
test?

    (a) When another specimen type (e.g., urine) was collected as 
authorized by the federal agency, the MRO reviews and reports the test 
result in accordance with the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using the alternative specimen.
    (b) When the federal agency did not authorize the collection of an 
alternative specimen, the MRO consults with the federal agency. The 
federal agency immediately directs the donor to obtain, within five 
days, an evaluation from a licensed physician, acceptable to the MRO, 
who has expertise in the medical issues raised by the donor's failure 
to provide a specimen. The MRO may perform this evaluation if the MRO 
has appropriate expertise.
    (1) For purposes of this section, a medical condition includes an 
ascertainable physiological condition. Permanent or long-term medical 
conditions are those physiological, anatomic, or psychological 
abnormalities documented as being present prior to the attempted 
collection, and considered not amenable to correction or cure for an 
extended period of time.
    (2) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the donor was required to take a federally regulated drug 
test, but was unable to provide a sufficient amount of oral fluid to 
complete the test;

[[Page 20550]]

    (ii) The consequences of the appropriate federal agency regulation 
for refusing to take the required drug test;
    (iii) That, after completing the evaluation, the referral physician 
must agree to provide a written statement to the MRO with a 
recommendation for one of the determinations described in paragraph 
(b)(3) of this section and the basis for the recommendation. The 
statement must not include detailed information on the employee's 
medical condition beyond what is necessary to explain the referral 
physician's conclusion.
    (3) As the MRO, if another physician performed the evaluation, you 
must consider and assess the referral physician's recommendations in 
making your determination. You must make one of the following 
determinations and report it to the federal agency in writing:
    (i) A medical condition as defined in paragraph (b)(1) of this 
section has, or with a high degree of probability could have, precluded 
the employee from providing a sufficient amount of oral fluid, but is 
not a permanent or long-term disability. As the MRO, you must report a 
test cancelled result to the federal agency.
    (ii) A permanent or long-term medical condition as defined in 
paragraph (b)(1) of this section has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of oral fluid and is highly likely to prevent the 
employee from providing a sufficient amount of oral fluid for a very 
long or indefinite period of time. As the MRO, you must follow the 
requirements of Section 13.7, as appropriate. If Section 13.7 is not 
applicable, you report a test cancelled result to the federal agency 
and recommend that the agency authorize collection of an alternate 
specimen type (e.g., urine) for any subsequent drug tests for the 
donor.
    (iii) There is not an adequate basis for determining that a medical 
condition has or, with a high degree of probability, could have 
precluded the employee from providing a sufficient amount of oral 
fluid. As the MRO, you must report a refusal to test to the federal 
agency.
    (4) When a federal agency receives a report from the MRO indicating 
that a test is cancelled as provided in paragraph (b)(3)(i) of this 
section, the agency takes no further action with respect to the donor. 
When a test is canceled as provided in paragraph (b)(3)(ii) of this 
section, the agency takes no further action with respect to the donor 
other than designating collection of an alternate specimen type (i.e., 
authorized by the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs) for any subsequent collections, in accordance with 
the federal agency plan. The donor remains in the random testing pool.

13.7 What happens when an individual is unable to provide a sufficient 
amount of oral fluid for a federal agency applicant/pre-employment 
test, a follow-up test, or a return-to-duty test because of a permanent 
or long-term medical condition?

    (a) This section concerns a situation in which the donor has a 
medical condition that precludes the donor from providing a sufficient 
specimen for a federal agency applicant/pre-employment test, a follow-
up test, or a return-to-duty test and the condition involves a 
permanent or long-term disability and the federal agency does not 
authorize collection of an alternative specimen. As the MRO in this 
situation, you must do the following:
    (1) You must determine if there is clinical evidence that the 
individual is an illicit drug user. You must make this determination by 
personally conducting, or causing to be conducted, a medical evaluation 
and through consultation with the donor's physician and/or the 
physician who conducted the evaluation under Section 13.6.
    (2) If you do not personally conduct the medical evaluation, you 
must ensure that one is conducted by a licensed physician acceptable to 
you.
    (b) If the medical evaluation reveals no clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
negative test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state the basis for the determination 
that a permanent or long-term medical condition exists, making 
provision of a sufficient oral fluid specimen impossible, and for the 
determination that no signs and symptoms of drug use exist. The MRO 
recommends that the agency authorize collection of an alternate 
specimen type (e.g., urine) for any subsequent collections.
    (c) If the medical evaluation reveals clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
cancelled test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state that a permanent or long-term 
medical condition [as defined in Section 13.6(b)(1)] exists, making 
provision of a sufficient oral fluid specimen impossible, and state the 
reason for the determination that signs and symptoms of drug use exist. 
Because this is a cancelled test, it does not serve the purposes of a 
negative test (e.g., the federal agency is not authorized to allow the 
donor to begin or resume performing official functions, because a 
negative test is needed for that purpose).

Section 13.8 Who may request a test of a split (B) specimen?

    (a) For a positive, adulterated, or substituted result reported on 
a primary (A) specimen, a donor may request through the MRO that the 
split (B) specimen be tested by a second HHS-certified laboratory to 
verify the result reported by the first HHS-certified laboratory.
    (b) The donor has 72 hours (from the time the MRO notified the 
donor that the donor's specimen was reported positive, adulterated, or 
substituted to request a test of the split (B) specimen. The MRO must 
inform the donor that the donor has the opportunity to request a test 
of the split (B) specimen when the MRO informs the donor that a 
positive, adulterated, or substituted result is being reported to the 
federal agency on the primary (A) specimen.

Section 13.9 How does an MRO report a primary (A) specimen test result 
to an agency?

    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, fax, or computer). Transmissions of the 
reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all 
positive, adulterated, and substituted results.
    (d) The MRO must not disclose numerical values of drug test results 
to the agency.
    (e) The MRO must report drug test results using the HHS-specified 
nomenclature published with the drug and biomarker testing panels.

[[Page 20551]]

Section 13.10 What types of relationships are prohibited between an MRO 
and an HHS-certified laboratory?

    An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory for which the MRO is reviewing 
drug test results.
    This means an MRO must not derive any financial benefit by having 
an agency use a specific HHS-certified laboratory, or have any 
agreement with the HHS-certified laboratory that may be construed as a 
potential conflict of interest.

Section 13.11 What reports must an MRO provide to the Secretary for 
oral fluid testing?

    (a) An MRO must send to the Secretary or designated HHS 
representative a semiannual report of federal agency specimens that 
were reported as positive for a drug or drug metabolite by a laboratory 
and verified as negative by the MRO. The report must not include any 
personally identifiable information for the donor and must be submitted 
by mail, fax, or other secure electronic transmission method within 14 
working days after the end of the semiannual period (i.e., in January 
and July). The semiannual report must contain the following 
information:
    (1) Reporting period (inclusive dates);
    (2) MRO name, company name, and address;
    (3) Federal agency name; and
    (4) For each laboratory-reported positive drug test result that was 
verified as negative by the MRO:
    (i) Specimen identification number;
    (ii) Laboratory name and address;
    (iii) Positive drug(s) or drug metabolite(s) verified as negative;
    (iv) MRO reason for verifying as negative (e.g., a donor 
prescription [the MRO must specify the prescribed drug]);
    (v) All results reported to the federal agency by the MRO for the 
specimen; and
    (vi) Date of the MRO report to the federal agency.
    (b) An MRO must provide copies of the drug test reports that the 
MRO sent to a federal agency available when requested to do so by the 
Secretary.
    (c) If an MRO did not verify any positive laboratory results as 
negative during the reporting period, the MRO should file a report that 
states that the MRO has no reportable results during the applicable 
reporting period.

Section 13.12 What are a federal agency's responsibilities for 
designating an MRO?

    (a) Before allowing an individual to serve as an MRO for the 
agency, a federal agency must verify and document the following:
    (1) That the individual satisfies all requirements in Section 13.1, 
including certification by an MRO certification organization that has 
been approved by the Secretary, as described in Section 13.2; and
    (2) that the individual is not an employee, agent of, or have any 
financial interest in an HHS-certified laboratory that tests the 
agency's specimens, as described in Section 13.10.
    (b) The federal agency must verify and document that each MRO 
reviewing and reporting results for the agency:
    (1) Completes training on any revisions to these Guidelines prior 
to their effective date;
    (2) at least every five years, maintains their certification by 
completing requalification training and passing a requalification 
examination; and
    (3) provides biannual reports to the Secretary or designated HHS 
representative as required in Section 13.11;
    (c) The federal agency must ensure that each MRO reports drug test 
results to the agency in accordance with Sections 13.9 and 14.7.
    (1) Before allowing an MRO to report results electronically, the 
agency must obtain documentation from the MRO to confirm that the MRO 
and any external service providers ensure the confidentiality, 
integrity, and availability of the data and limit access to any data 
transmission, storage, and retrieval system.

Subpart N--Split Specimen Tests

Section 14.1 When may a split (B) specimen be tested?

    (a) The donor may request, verbally or in writing, through the MRO 
that the split (B) specimen be tested at a different (i.e., second) 
HHS-certified oral fluid laboratory when the primary (A) specimen was 
determined by the MRO to be positive, adulterated, or substituted.
    (b) A donor has 72 hours to initiate the request after being 
informed of the result by the MRO. The MRO must document in the MRO's 
records the verbal request from the donor to have the split (B) 
specimen tested.
    (c) If a split (B) oral fluid specimen cannot be tested by a second 
HHS-certified laboratory (e.g., insufficient specimen, lost in transit, 
split not available, no second HHS-certified laboratory available to 
perform the test), the MRO reports to the federal agency that the test 
must be cancelled and the reason for the cancellation. The MRO directs 
the federal agency to ensure the immediate recollection of another oral 
fluid specimen from the donor, with no notification given to the donor 
of this collection requirement until immediately before the collection.
    (d) If a donor chooses not to have the split (B) specimen tested by 
a second HHS-certified oral fluid laboratory, a federal agency may have 
a split (B) specimen retested as part of a legal or administrative 
proceeding to defend an original positive, adulterated, or substituted 
result.

Section 14.2 How does an HHS-certified laboratory test a split (B) 
specimen when the primary (A) specimen was reported positive?

    (a) The testing of a split (B) specimen for a drug or metabolite is 
not subject to the testing cutoffs established.
    (b) The HHS-certified laboratory is only required to confirm the 
presence of the drug or metabolite that was reported positive in the 
primary (A) specimen.

Section 14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported adulterated?

    (a) The HHS-certified laboratory must use its confirmatory specimen 
validity test at an established LOQ to reconfirm the presence of the 
adulterant.
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
adulterated result reported by the first HHS-certified laboratory.

Section 14.4 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported substituted?

    (a) The HHS-certified laboratory must test for the biomarker using 
its confirmatory test (i.e., using the confirmatory test analytes and 
cutoffs listed in the biomarker testing panel).
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory biomarker test(s) needed to reconfirm the substituted 
result reported by the first HHS-certified laboratory.

Section 14.5 Who receives the split (B) specimen result?

    The second HHS-certified laboratory must report the result to the 
MRO using the HHS-specified nomenclature published with the drug and 
biomarker testing panels.

[[Page 20552]]

Section 14.6 What action(s) does an MRO take after receiving the split 
(B) oral fluid specimen result from the second HHS-certified 
laboratory?

    The MRO takes the following actions when the second HHS-certified 
laboratory reports the result for the split (B) oral fluid specimen as:
    (a) Reconfirmed the drug(s), adulteration, and/or substitution 
result. The MRO reports reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
the specimen was adulterated. If the donor provides a legitimate 
medical explanation for the adulteration result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and a refusal to 
test to the agency and indicates the adulterant that is present in the 
specimen. The MRO gives the donor 72 hours to request that Laboratory A 
retest the primary (A) specimen for the adulterant. If Laboratory A 
reconfirms the adulterant, the MRO reports refusal to test and 
indicates the adulterant present. If Laboratory A fails to reconfirm 
the adulterant, the MRO cancels both tests and directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure. The MRO shall notify the appropriate regulatory office about 
the failed to reconfirm and cancelled test.
    (c) Failed to reconfirm a single or all drug positive results and 
the specimen was substituted. If the donor provides a legitimate 
medical explanation for the substituted result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and a refusal to 
test (substituted) to the agency. The MRO gives the donor 72 hours to 
request that Laboratory A test the primary (A) specimen using its 
confirmatory test for the biomarker.
    (1) If the primary (A) specimen's test results confirm that the 
specimen was substituted, the MRO reports a refusal to test 
(substituted) to the agency.
    (2) If the primary (A) specimen's results fail to confirm that the 
specimen was substituted, the MRO cancels both tests and directs the 
agency to immediately collect another specimen using a direct observed 
collection procedure. The MRO shall notify the HHS office responsible 
for coordination of the drug-free workplace program about the failed to 
reconfirm and cancelled test.
    (d) Failed to reconfirm a single or all drug positive results and 
the specimen was not adulterated or substituted. The MRO reports to the 
agency a failed to reconfirm result (specifying the drug[s]), cancels 
both tests, and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (e) Failed to reconfirm a single or all drug positive results and 
the specimen had an invalid result. The MRO reports to the agency a 
failed to reconfirm result (specifying the drug[s]) and the reason for 
the invalid result, cancels both tests, directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was adulterated. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and found that the specimen was 
adulterated. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was substituted. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and found that the specimen was 
substituted. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (h) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was not adulterated or substituted. The MRO 
reports to the agency a reconfirmed result (specifying the drug[s]) and 
a failed to reconfirm result (specifying the drug[s]). The MRO tells 
the agency that it may take action based on the reconfirmed drug(s) 
although Laboratory B failed to reconfirm one or more drugs. The MRO 
shall notify the HHS office responsible for coordination of the drug-
free workplace program regarding the test results for the specimen.
    (i) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen had an invalid result. The MRO reports to the 
agency a reconfirmed result (specifying the drug[s]) and a failed to 
reconfirm result (specifying the drug[s]). The MRO tells the agency 
that it may take action based on the reconfirmed drug(s) although 
Laboratory B failed to reconfirm one or more drugs and reported an 
invalid result. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (j) Failed to reconfirm substitution or adulteration. The MRO 
reports to the agency a failed to reconfirm result (not adulterated: 
Specifying the adulterant or not substituted) and cancels both tests. 
The MRO shall notify the HHS office responsible for coordination of the 
drug-free workplace program regarding the test results for the 
specimen.
    (k) Failed to reconfirm substitution or adulteration and the 
specimen had an invalid result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: Specifying the adulterant or not 
substituted, and the reason for the invalid result), cancels both 
tests, directs the agency to immediately collect another specimen using 
a direct observed collection procedure and notifies the HHS office 
responsible for coordination of the drug-free workplace program.
    (l) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterated or substituted result. The MRO reports to 
the agency a reconfirmed result (adulterated or substituted) and a 
failed to reconfirm result (specifying the drug[s]). The MRO tells the 
agency that it may take action based on the reconfirmed result 
(adulterated or substituted) although Laboratory B failed to reconfirm 
the drug(s) result.
    (m) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterated or substituted result. The MRO 
reports to the agency a failed to reconfirm result (specifying the 
drug[s] and not adulterated: Specifying the adulterant or not 
substituted) and cancels both tests. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (n) Failed to reconfirm at least one drug and reconfirmed the 
adulterated result. The MRO reports to the agency a reconfirmed result 
(specifying the drug[s] and adulterated) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may

[[Page 20553]]

take action based on the reconfirmed drug(s) and the adulterated result 
although Laboratory B failed to reconfirm one or more drugs.
    (o) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterated result. The MRO reports to the agency a reconfirmed 
result (specifying the drug[s]) and a failed to reconfirm result 
(specifying the drug[s] and not adulterated: Specifying the 
adulterant). The MRO tells the agency that it may take action based on 
the reconfirmed drug(s) although Laboratory B failed to reconfirm one 
or more drugs and failed to reconfirm the adulterated result.
    (p) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: Specifying the adulterant, and 
not substituted), and cancels both tests. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (q) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (not adulterated: 
Specifying the adulterant). The MRO tells the agency that it may take 
action based on the substituted result although Laboratory B failed to 
reconfirm the adulterated result.
    (r) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.

Section 14.7 How does an MRO report a split (B) specimen test result to 
an agency?

    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, fax, or computer). Transmissions of the 
reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all split 
specimen results.
    (d) The MRO must not disclose the numerical values of the drug test 
results to the agency.
    (e) The MRO must report drug test results using the HHS-specified 
nomenclature published with the drug and biomarker testing panels.

Section 14.8 How long must an HHS-certified laboratory retain a split 
(B) specimen?

    A split (B) specimen is retained for the same period of time that a 
primary (A) specimen is retained and under the same storage conditions. 
This applies even for those cases when the split (B) specimen is tested 
by a second HHS-certified laboratory and the second HHS-certified 
laboratory does not confirm the original result reported by the first 
HHS-certified laboratory for the primary (A) specimen.

Subpart O--Criteria for Rejecting a Specimen for Testing

Section 15.1 What discrepancies require an HHS-certified laboratory to 
report an oral fluid specimen as rejected for testing?

    The following discrepancies are considered to be fatal flaws. The 
HHS-certified laboratory must stop the testing process, reject the 
specimen for testing, and indicate the reason for rejecting the 
specimen on the Federal CCF when:
    (a) The specimen ID number on the primary (A) or split (B) specimen 
label/seal does not match the ID number on the Federal CCF, or the ID 
number is missing either on the Federal CCF or on either specimen 
label/seal;
    (b) The primary (A) specimen label/seal is missing, misapplied, 
broken, or shows evidence of tampering and the split (B) specimen 
cannot be re-designated as the primary (A) specimen;
    (c) The primary (A) specimen was collected using an expired device 
(i.e., the device expiration date precedes the collection date) and the 
split (B) specimen cannot be re-designated as the primary (A) specimen;
    (d) The collector's printed name and signature are omitted on the 
Federal CCF;
    (e) There is an insufficient amount of specimen for analysis in the 
primary (A) specimen unless the split (B) specimen can be re-designated 
as the primary (A) specimen;
    (f) The accessioner failed to document the primary (A) specimen 
seal condition on the Federal CCF at the time of accessioning, and the 
split (B) specimen cannot be re-designated as the primary (A) specimen;
    (g) The specimen was received at the HHS-certified laboratory 
without a CCF;
    (h) The CCF was received at the HHS-certified laboratory without a 
specimen;
    (i) The collector performed two separate collections using one CCF; 
or
    (j) The HHS-certified laboratory identifies a flaw (other than 
those specified above) that prevents testing or affects the forensic 
defensibility of the drug test and cannot be corrected.

Section 15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?

    The following discrepancies are considered to be correctable:
    (a) If a collector failed to sign the Federal CCF, the HHS-
certified laboratory must attempt to recover the collector's signature 
before reporting the test result. If the collector can provide a 
memorandum for record recovering the signature, the HHS-certified 
laboratory may report the test result for the specimen. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot recover the collector's signature, the laboratory 
must report a rejected for testing result and indicate the reason for 
the rejected for testing result on the Federal CCF.
    (b) If a specimen is submitted using a non-federal form or an 
expired Federal CCF, the HHS-certified laboratory must test the 
specimen and also attempt to obtain a memorandum for record explaining 
why a non-federal form or an expired Federal CCF was used and ensure 
that the form used contains all the required information. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot obtain a memorandum for record from the collector, 
the laboratory must report a rejected for testing result and indicate 
the reason for the rejected for testing result on the report to the 
MRO.

Section 15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject an oral fluid specimen for testing or an 
MRO to cancel a test?

    (a) The following omissions and discrepancies on the Federal CCF 
that are received by the HHS-certified laboratory should not cause an 
HHS-certified laboratory to reject an oral fluid specimen or cause an 
MRO to cancel a test:
    (1) An incorrect laboratory name and address appearing at the top 
of the form;

[[Page 20554]]

    (2) Incomplete/incorrect/unreadable employer name or address;
    (3) MRO name is missing;
    (4) Incomplete/incorrect MRO address;
    (5) A transposition of numbers in the donor's Social Security 
Number or employee identification number;
    (6) A telephone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``reason for test'' box is not marked;
    (9) A ``drug tests to be performed'' box is not marked;
    (10) The specimen type box (Oral Fluid) is not marked (i.e., by the 
collector or laboratory);
    (11) A ``collection'' box is not marked;
    (12) The ``each device within expiration date'' box is not marked;
    (13) The collection site address is missing;
    (14) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (15) The time of collection is not indicated;
    (16) The date of collection is not indicated;
    (17) Incorrect name of delivery service;
    (18) The collector has changed or corrected information by crossing 
out the original information on either the Federal CCF or specimen 
label/seal without dating and initialing the change; or
    (19) The donor's name inadvertently appears on the HHS-certified 
laboratory copy of the Federal CCF or on the tamper-evident labels used 
to seal the specimens.
    (b) The following omissions and discrepancies on the Federal CCF 
that are made at the HHS-certified laboratory should not cause an MRO 
to cancel a test:
    (1) The testing laboratory fails to indicate the correct name and 
address in the results section when a different laboratory name and 
address is printed at the top of the Federal CCF;
    (2) The accessioner fails to print their name;
    (3) The certifying scientist or certifying technician fails to 
print their name;
    (4) The certifying scientist or certifying technician accidentally 
initials the Federal CCF rather than signing for a specimen reported as 
rejected for testing;
    (c) The above omissions and discrepancies should occur no more than 
once a month. The expectation is that each trained collector and HHS-
certified laboratory will make every effort to ensure that the Federal 
CCF is properly completed and that all the information is correct. When 
an error occurs more than once a month, the MRO must direct the 
collector or HHS-certified laboratory (whichever is responsible for the 
error) to immediately take corrective action to prevent the recurrence 
of the error.

Section 15.4 What discrepancies may require an MRO to cancel a test?

    (a) An MRO must attempt to correct the following errors:
    (1) The donor's signature is missing on the MRO copy of the Federal 
CCF and the collector failed to provide a comment that the donor 
refused to sign the form;
    (2) The certifying scientist failed to sign the Federal CCF for a 
specimen being reported drug positive, adulterated, invalid, or 
substituted; or
    (3) The electronic report provided by the HHS-certified laboratory 
does not contain all the data elements required for the HHS standard 
laboratory electronic report for a specimen being reported drug 
positive, adulterated, invalid result, or substituted.
    (b) If error (a)(1) occurs, the MRO must contact the collector to 
obtain a statement to verify that the donor refused to sign the MRO 
copy. If, after at least 5 business days, the collector cannot provide 
such a statement, the MRO must cancel the test.
    (c) If error (a)(2) occurs, the MRO must obtain a statement from 
the certifying scientist that they inadvertently forgot to sign the 
Federal CCF, but did, in fact, properly conduct the certification 
review. If, after at least 5 business days, the MRO cannot get a 
statement from the certifying scientist, the MRO must cancel the test.
    (d) If error (a)(3) occurs, the MRO must contact the HHS-certified 
laboratory. If, after at least 5 business days, the laboratory does not 
retransmit a corrected electronic report, the MRO must cancel the test.

Subpart P--Laboratory Suspension/Revocation Procedures

Section 16.1 When may the HHS certification of a laboratory be 
suspended?

    These procedures apply when:
    (a) The Secretary has notified an HHS-certified laboratory in 
writing that its certification to perform drug testing under these 
Guidelines has been suspended or that the Secretary proposes to revoke 
such certification.
    (b) The HHS-certified laboratory has, within 30 days of the date of 
such notification or within 3 days of the date of such notification 
when seeking an expedited review of a suspension, requested in writing 
an opportunity for an informal review of the suspension or proposed 
revocation.

Section 16.2 What definitions are used for this subpart?

    Appellant. Means the HHS-certified laboratory which has been 
notified of its suspension or proposed revocation of its certification 
to perform testing and has requested an informal review thereof.
    Respondent. Means the person or persons designated by the Secretary 
in implementing these Guidelines.
    Reviewing Official. Means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more of the official's 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.

Section 16.3 Are there any limitations on issues subject to review?

    The scope of review shall be limited to the facts relevant to any 
suspension or proposed revocation, the necessary interpretations of 
those facts, the relevant Mandatory Guidelines for Federal Workplace 
Drug Testing Programs, and other relevant law. The legal validity of 
these Guidelines shall not be subject to review under these procedures.

Section 16.4 Who represents the parties?

    The appellant's request for review shall specify the name, address, 
and telephone number of the appellant's representative. In its first 
written submission to the reviewing official, the respondent shall 
specify the name, address, and telephone number of the respondent's 
representative.

Section 16.5 When must a request for informal review be submitted?

    (a) Within 30 days of the date of the notification of the 
suspension or proposed revocation, the appellant must submit a written 
request to the reviewing official seeking review, unless some other 
time period is agreed to by the parties. A copy must also be sent to 
the respondent. The request for review must include a copy of the 
notification of suspension or proposed revocation, a brief statement of 
why the decision to suspend or propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired.

[[Page 20555]]

    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.

Section 16.6 What is an abeyance agreement?

    Upon mutual agreement of the parties to hold these procedures in 
abeyance, the reviewing official will stay these procedures for a 
reasonable time while the laboratory attempts to regain compliance with 
the Guidelines or the parties otherwise attempt to settle the dispute. 
As part of an abeyance agreement, the parties can agree to extend the 
time period for requesting review of the suspension or proposed 
revocation. If abeyance begins after a request for review has been 
filed, the appellant shall notify the reviewing official at the end of 
the abeyance period advising whether the dispute has been resolved. If 
the dispute has been resolved, the request for review will be 
dismissed. If the dispute has not been resolved, the review procedures 
will begin at the point at which they were interrupted by the abeyance 
agreement with such modifications to the procedures as the reviewing 
official deems appropriate.

Section 16.7 What procedures are used to prepare the review file and 
written argument?

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's Documents and Brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is wrong (appellant's brief).
    (b) Respondent's Documents and Brief. Within 15 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification to perform drug 
testing, which is tabbed and organized chronologically, and accompanied 
by an index identifying each document. Only essential documents should 
be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply Briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative Efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive Documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.

Section 16.8 When is there an opportunity for oral presentation?

    (a) Electing Oral Presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding Official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary Conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues, stipulations 
and admissions, limitations on evidence and witnesses that will be 
presented at the hearing, time allotted for each witness and the 
hearing altogether, scheduling the hearing, and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at their discretion, produce a written document 
summarizing the conference or transcribe the conference, either of 
which will be made a part of the record.
    (d) Time and Place of the Oral Presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date the appellant's request for review is received or within 10 days 
of submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the Oral Presentation.
    (1) General. The presiding official is responsible for conducting 
the oral presentation. The presiding official may be assisted by one or 
more of the official's employees or consultants in conducting the oral 
presentation and reviewing the evidence. While the oral presentation 
will be kept as informal as possible, the presiding official may take 
all necessary steps to ensure an orderly proceeding.
    (2) Burden of Proof/Standard of Proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
wrong.
    (3) Admission of Evidence. The Federal Rules of Evidence do not 
apply and the presiding official will generally admit all testimonial 
evidence unless it is clearly irrelevant, immaterial, or unduly 
repetitious. Each party may make an opening and closing statement, may 
present witnesses as agreed upon in the prehearing conference or 
otherwise, and may question the opposing party's witnesses. Since the 
parties have ample opportunity to prepare the review file, a party may 
introduce additional documentation during the oral presentation only 
with the permission of the presiding official. The presiding official 
may question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including

[[Page 20556]]

argument, must be in writing and be no more than 10 double-spaced pages 
in length. The presiding official will set a reasonable time for the 
party opposing the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At their discretion, the presiding 
official may require or permit the parties to submit post-hearing 
briefs or proposed findings and conclusions. Each party may submit 
comments on any major prejudicial errors in the transcript.

Section 16.9 Are there expedited procedures for review of immediate 
suspension?

    (a) Applicability. When the Secretary notifies an HHS-certified 
laboratory in writing that its certification to perform drug testing 
has been immediately suspended, the appellant may request an expedited 
review of the suspension and any proposed revocation. The appellant 
must submit this request in writing to the reviewing official within 3 
days of the date the HHS-certified laboratory received notification of 
the suspension. The request for review must include a copy of the 
suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing Official's Response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review File and Briefs. Within 7 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, which is tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral Presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official, the presiding 
official will attempt to schedule the oral presentation within 7-10 
days of the date of appellant's request for review at a time and place 
determined by the presiding official following consultation with the 
parties. The presiding official may hold a prehearing conference in 
accordance with Section 16.8(c) and will conduct the oral presentation 
in accordance with the procedures of Sections 16.8(e), (f), and (g).
    (e) Written Decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7-10 days of the date of the 
oral presentation or within 3 days of the date on which the transcript 
is received or the date of the last submission by either party, 
whichever is later. All other provisions set forth in Section 16.14 
will apply.
    (f) Transmission of Written Communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be by fax, secured electronic transmissions, 
or overnight mail.

Section 16.10 Are any types of communications prohibited?

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notification to the other party.

Section 16.11 How are communications transmitted by the reviewing 
official?

    (a) Because of the importance of a timely review, the reviewing 
official should normally transmit written communications to either 
party by fax, secured electronic transmissions, or overnight mail in 
which case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) In counting days, include Saturdays, Sundays, and federal 
holidays. However, if a due date falls on a Saturday, Sunday, or 
federal holiday, then the due date is the next federal working day.

Section 16.12 What are the authority and responsibilities of the 
reviewing official?

    In addition to any other authority specified in these procedures, 
the reviewing official and the presiding official, with respect to 
those authorities involving the oral presentation, shall have the 
authority to issue orders; examine witnesses; take all steps necessary 
for the conduct of an orderly hearing; rule on requests and motions; 
grant extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, 
usually with notification to the parties; reconsider a decision of the 
reviewing official where a party promptly alleges a clear error of fact 
or law; and to take any other action necessary to resolve disputes in 
accordance with the objectives of these procedures.

Section 16.13 What administrative records are maintained?

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.

Section 16.14 What are the requirements for a written decision?

    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefore in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
their decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of 
the date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public Notification. If the suspension and proposed revocation 
are

[[Page 20557]]

upheld, the revocation will become effective immediately and the public 
will be notified by publication of a notification in the Federal 
Register. If the suspension and proposed revocation are denied, the 
revocation will not take effect and the suspension will be lifted 
immediately. Public notification will be given by publication in the 
Federal Register.

Section 16.15 Is there a review of the final administrative action?

    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal Law. The reviewing official's decision, under 
Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe 
for judicial review as of the date of the decision.

[FR Doc. 2022-06884 Filed 4-6-22; 8:45 am]
BILLING CODE 4150-28-P