Proposed Rule2026-22121
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG)
Primary source
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Published
October 29, 2026
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) published on October 12, 2023.
Full Text
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[Federal Register Volume 91, Number 208 (Thursday, October 29, 2026)]
[Proposed Rules]
[Pages 68364-68395]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22121]
[[Page 68363]]
Vol. 91
Thursday,
No. 208
October 29, 2026
Part III
Department of Health and Human Services
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42 CFR Chapter I
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using
Oral Fluid (OFMG); Proposed Rule
Federal Register / Vol. 91, No. 208 / Thursday, October 29, 2026 /
Proposed Rules
[[Page 68364]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Chapter I
RIN 0930-AA41
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Using Oral Fluid (OFMG)
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Proposed revisions to mandatory guidelines.
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SUMMARY: The Department of Health and Human Services (``HHS'' or
``Department'') is proposing to revise the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using Oral Fluid (OFMG)
published on October 12, 2023.
DATES: Submit comments on or before December 28, 2026.
ADDRESSES: In commenting, please refer to docket number SAMHSA-2026-
0001. Because of staff and resource limitations, SAMHSA cannot accept
comments by facsimile (fax) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
<bullet> Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow ``Submit a comment''
instructions.
<bullet> By regular mail. You may mail written comments to the
following address: SAMHSA, Center for Substance Abuse Prevention
(CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room
16N02, Rockville, MD 20857. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
<bullet> By express or overnight mail. You may send written
comments to the following address: SAMHSA, CSAP, DWP, 5600 Fishers
Lane, Room 16N02, Rockville, MD 20857.
<bullet> By hand or courier. You may deliver your written comments
by hand or courier to the following address prior to the close of the
comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02,
Rockville, MD 20857. If you intend to deliver your comments to the
Rockville address, please call (240) 276-2600 in advance to schedule
your arrival with one of our staff members. Because access to the
SAMHSA building is secure, people without federal government
identification are encouraged to schedule their delivery or to leave
comments with the security guard at the front desk located in the main
lobby of the building.
All comments received before the close of the comment period will
be available for viewing by the public. Please note that all comments
are posted in their entirety, including personal or confidential
business information that is included in the comment. SAMHSA will post
all comments before the close of the comment period on the following
website: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the website's search function
to view the associated comments.
Comments received before the close of the comment period will also
be available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, at
SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday
through Friday of each week, excluding federal holidays, from 8:30 a.m.
to 4:00 p.m. To schedule an appointment to view public comments, please
call (240) 276-2600.
FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA,
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by
telephone (240) 276-1459 or by email at <a href="/cdn-cgi/l/email-protection#692c1c0e0c070c472108100c1a291a0804011a084701011a470e061f"><span class="__cf_email__" data-cfemail="ade8d8cac8c3c883e5ccd4c8deeddeccc0c5decc83c5c5de83cac2db">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Executive Summary
This notice of proposed revisions to the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using OFMG includes revisions
that will: clarify the types of laboratories that may be certified to
conduct testing for federal agency workplace drug testing programs,
reflect the Department's decision to publish the Authorized Drug
Testing Panels only when revised rather than each year, revise the
initial test batch quality control requirements for laboratories, and
allow a split testing laboratory to test for any HHS-authorized
biomarker to reconfirm substitution based on a biomarker test (i.e.,
may test for a different biomarker). In addition, some wording changes
have been made for clarity and for consistency with the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Urine
(UrMG) or to apply to any authorized specimen type and to clarify
direct observed collection procedures.
The Department is concurrently publishing a separate Federal
Register Notice proposing revisions to the Mandatory Guidelines for
Federal Workplace Drug Testing Programs using UrMG, including the same
or similar revisions proposed for the OFMG, where appropriate.
The current authorized drug testing panel and report nomenclature
table for urine and for oral fluid were published on January 16, 2025
(90 FR 4662).
Background
Pursuant to its authority under Section 503 of Public Law 100-71, 5
U.S.C. 7301, and Executive Order No. 12564, HHS establishes the
scientific and technical guidelines for Federal Workplace Drug Testing
Programs and establishes standards for certification of laboratories
engaged in drug testing for federal agencies. Using data obtained from
the Federal Workplace Drug Testing Programs and HHS-certified
laboratories, the Department estimates that 275,000 urine specimens are
tested annually by federal agencies. No laboratories have been
certified to test oral fluid 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). SAMHSA subsequently
revised the Guidelines on June 9, 1994 (59 FR 29908), September 30,
1997 (62 FR 51118), November 13, 1998 (63 FR 63483), April 13, 2004 (69
FR 19644), and November 25, 2008 (73 FR 71858). SAMHSA published the
renamed Mandatory Guidelines for Federal Workplace Drug Testing
Programs using UrMG on January 23, 2017 (82 FR 7920), and the first
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
OFMG on October 25, 2019 (84 FR 57754). SAMHSA published the current
UrMG (88 FR 70768) and current OFMG (88 FR 70814) on October 12, 2023.
Proposed Revisions to the Guidelines
This preamble describes the proposed revisions to the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using 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.
The Department has deleted ``Gender Identity'' (i.e., term and
definition) to enhance the clarity of direct observed collection
procedures.
The Department updated the definition of ``Laboratory'' clarifying
that, in addition to certifying laboratories to conduct all required
testing of primary (A) and split (B)
[[Page 68365]]
specimens, the Department may certify laboratories that test split (B)
specimens only and/or conduct additional drug or specimen validity
tests for primary and split specimens in accordance with these
Mandatory Guidelines.
The Department edited the definition of ``Negative Result'' for
clarity.
The Department edited the definition of ``Substituted Specimen'' to
refer to a test for an HHS-authorized biomarker rather than
specifically referring to the Biomarker Testing Panel, to reflect the
Department's review and approval process for an HHS-certified test
facility to implement testing for biomarker for use in Federal
workplace drug testing programs.
Section 1.7 describes the circumstances that constitute a refusal
to test. The Department provided additional examples for clarity.
Subpart B--Oral Fluid Specimens
Section 2.2 describes the circumstances under which an oral fluid
specimen may be collected. The Department reviewed and revised Section
2.2(a) and other wording in the current OFMG to clarify that pre-
employment tests are performed for all individuals applying for a
testing designated position, including federal agency employees.
Subpart C--Oral Fluid Specimen Tests
Section 3.1 describes the tests that are conducted on an oral fluid
specimen. The Department revised Section 3.2 to address when a specimen
may be tested for drugs other than those in the drug testing panel and
inserted a new Section 3.3 to describe the process for an HHS-certified
laboratory or IITF to obtain HHS approval to test for a biomarker other
than those in the biomarker testing panel. The Department renumbered
subsequent items in Section 3 accordingly.
Section 3.5 describes the publication of drug and biomarker testing
panels with analytes and cutoffs for oral fluid. The Department removed
the drug testing panel from the OFMG and deleted the requirement to
publish the Authorized Drug Testing Panels annually. HHS will publish a
FR Notice when drug and/or biomarker testing panels are changed.
Subpart H--Oral Fluid Specimen Collection Procedure
Section 8.1 describes privacy requirements for oral fluid
collection. The Department revised item b to refer to the sex of the
collector and donor to enhance the clarity of direct observed
collection procedures.
Section 8.6(b) stated that a donor demonstrates their inability to
provide an oral fluid specimen when there is an insufficient volume or
no oral fluid after 15 minutes of using the collection device. Because
device manufacturers may establish different time limits for their
devices, the Department has replaced the 15-minute time limit with
``the time limit specified by the device manufacturer.''
The Department reworded item c in Section 8.8 for clarity and to
use the same wording in the UrMG and OFMG.
Subpart I--HHS Certification of Laboratories and IITFs
The Department revised the language in item 9.5(a)(1) to refer to
the drug testing panel rather than ``drug classes listed in the drug
testing panel.''
Section 9.6 describes National Laboratory Certification Program
(NLCP) performance testing (PT) requirements for an applicant oral
fluid laboratory and Section 9.7 describes PT requirements for an HHS-
certified oral fluid laboratory. The Department reworded item a.3 in
both sections to clarify that PT criteria for initial drug test results
are for laboratories that will conduct initial drug tests.
Subpart K--Laboratory
Section 11.11 describes the initial drug test batch quality control
requirements for an oral fluid laboratory. The Department revised item
b to apply to the controls in each initial drug test batch rather than
to calibrators and controls and reduced the required percentage of
controls from 10 percent to 4 percent of the total controls and
specimens in the batch.
Subpart M--Medical Review Officer (MRO)
Section 13.5 describes MRO actions when reviewing an oral fluid
specimen's test result. The Department edited wording in Section
13.5(e) to address different MRO actions to be taken for invalid
specimens depending on the reason for the test. The Department revised
Section 13.5(e)(1)(ii) to specify that the MRO may direct an unobserved
urine collection based on the reason for the invalid oral fluid result
if the agency allows urine testing. The Department also revised Section
13.5(e)(2)(ii) to require the MRO to recommend recollection of a urine
specimen under direct observation when the donor's first oral fluid
specimen and second recollected oral fluid specimen are invalid.
Section 13.6 describes MRO action when the collector reports that
the donor did not provide a sufficient amount of oral fluid for a drug
test. The Department has reviewed and revised the previous wording in
Section 13.6(b) to clarify different MRO actions to be taken for
invalid specimens depending on the reason for the test.
Subpart N--Split Specimen Tests
Section 14.1 describes when a split (B) oral fluid specimen may be
tested. The Department has revised item 14.1(c) to clarify MRO action
when a split specimen cannot be tested by a second laboratory because
(1) there is no split specimen or the specimen has insufficient volume
for testing); (2) the primary specimen was reported as adulterated and
there is no second HHS-certified laboratory to test the split specimen
for the same adulterant; or (3) the primary specimen was reported as
substituted based on a biomarker and there is no second HHS-certified
laboratory to test the split specimen (i.e., using the same or a
different biomarker test).
Section 14.4 describes how an HHS-certified laboratory tests a
split (B) oral fluid specimen when the primary (A) specimen was
reported substituted. This section addresses testing of a split
specimen when the primary specimen was reported substituted based on
biomarker testing. The Department has revised this section to allow the
split testing laboratory to test for any HHS-authorized biomarker. It
is not necessary to test the split specimen for the same biomarker to
reconfirm the primary (A) specimen's substituted result.
Section 14.6 describes action an MRO takes after receiving the
split (B) oral fluid specimen result from the split testing laboratory.
The Department has edited and reorganized this section for clarity and
to describe these revised requirements:
<bullet> When the split laboratory has failed to reconfirm a single
or all drug positive results and reported the specimen as adulterated
and the primary laboratory cannot perform the test for that adulterant:
the MRO directs testing at another HHS-certified laboratory.
<bullet> When the split laboratory has failed to reconfirm a single
or all drug positive results and reported the specimen as substituted
and the primary laboratory cannot perform a biomarker test: the MRO
directs testing at another HHS-certified laboratory. It is not
necessary to test the primary specimen for the same biomarker to
reconfirm the split specimen's substituted result.
<bullet> The Department has maintained the current requirement for
immediate recollection of ``another specimen using a direct observed
collection procedure'' but added that the MRO recommends an
[[Page 68366]]
observed urine collection if the agency allows urine testing.
The Department also removed the requirement for the MRO to contact
the HHS office responsible for coordination of the drug-free workplace
program regarding the test results throughout this section.
General Revisions
In addition to the proposed changes described by subpart and
section above, the Department has edited the OFMG to address proposed
changes and has reworded some items for clarity (e.g., referring to
``donors'' rather than ``employees'' or ``applicants'') and/or for
consistency with the UrMG or to apply to any authorized specimen type.
Impact of These Guidelines on Government Regulated Industries
The Department is aware that these proposed new Guidelines may
impact the Department of Transportation and Nuclear Regulatory
Commission 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 revisions are not expected to increase current
stakeholder costs.
Benefits
The proposed revision to quality control requirements for initial
drug test batches in Section 11.11(b) will reduce laboratory burden and
expense while maintaining quality. The Department has lowered the
percentage of controls in each initial drug test batch from 10 percent
to 4 percent of the total controls and specimens in the batch. This
will reduce time, labor, and material costs (e.g., purchasing, initial
verification, batch review, monitoring control results). Initial drug
testing is used to report specimens as negative; specimens with a
positive initial drug test are reflexed to confirmatory testing. The
Department has maintained the 10 percent control requirement for
confirmatory test batches.
Other OFMG revisions that will reduce stakeholder burden include
those related to biomarker testing which are expected to lead to
definitive results and reduce the need for specimen recollection. For
example, Section 14.4 has been revised to allow a split testing
laboratory to test for any HHS-authorized biomarker to reconfirm
substitution, rather than requiring the same biomarker test used for
the primary specimen. This revision also strengthens the federal
government's ability to identify illicit drug use and donor attempts to
subvert drug tests.
Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). The title and description of the 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.
Comments on the information collection requirements are
specifically solicited in order to: (1) Evaluate whether the proposed
collection of information is necessary for the proper performance of
HHS's functions, including whether the information will have practical
utility; (2) evaluate the accuracy of HHS's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used; (3) enhance the quality, utility, and
clarity of the information to be collected; and (4) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
Title: The Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid.
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; NLCP
application; the NLCP Laboratory Information Checklist; and
recordkeeping requirements in the current Guidelines, as approved under
control number 0930-0158, will remain in effect.
In support of the Government Paperwork Reduction Act, the
Department revised the federal CCF to enable its use as an electronic
form (78 FR 42091, July 15, 2013) and developed requirements and
oversight procedures to ensure that HHS-certified test facilities and
other service providers (e.g., collection sites, MROs) using an
electronic federal CCF (ECCF) maintain the accuracy, security, and
confidentiality of electronic drug test information. Before a federal
ECCF can be used for federal agency specimens, HHS-certified test
facilities must submit detailed information and proposed standard
operating procedures (SOPs) to the NLCP for SAMHSA review and approval
and undergo an NLCP inspection focused on the proposed ECCF.
Since 2013, SAMHSA has encouraged the use of federal ECCFs and
other electronic processes in HHS-certified test facilities, when
practicable, for federally regulated testing operations. In accordance
with Section 8108(a) of the SUPPORT for Patients and Communities Act,
SAMHSA has set a deadline of August 31, 2026, for all HHS-certified
laboratories to submit a request for approval of an electronic
(digital) federal CCF. To assist all HHS-certified laboratories, SAMHSA
has implemented an ECCF Recognition Program to recognize ECCF systems
that meet program requirements and can be used by any HHS-certified
laboratory or IITF. This program is expected to facilitate the process
for HHS-certified test facilities seeking SAMHSA approval to use an
ECCF and enable all HHS-certified test facilities (regardless of size)
to meet the August 31, 2026, deadline for a digital ECCF submission.
Description: The Mandatory Guidelines establish the scientific and
technical guidelines for federal drug testing programs and establish
standards for certification of laboratories engaged in drug testing for
federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301
note, and Executive Order No. 12564. Federal drug testing programs test
applicants for safety-sensitive positions, individuals involved in
accidents, individuals tested for cause, and random testing of
employees in safety-sensitive positions.
Description of Respondents: Individuals or households, businesses,
or other-for-profit and not-for-profit institutions.
[[Page 68367]]
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/ Total
Section Purpose respondents respondent Hours/ response hours
----------------------------------------------------------------------------------------------------------------
9.2(a)(1)................... Laboratory or IITF 10 1 3............... 30
required to submit
application for
certification.
9.10(a)(3).................. Materials to submit 10 1 2............... 20
to become an HHS
inspector.
11.3........................ Laboratory submits 10 1 2............... 20
qualifications of
responsible person
(RP) to HHS.
11.4(c)..................... Laboratory submits 10 1 2............... 20
information to HHS
on new RP or
alternate RP.
11.20....................... Specifications for 10 5 0.5............. 25
laboratory
semiannual
statistical report
of test results to
each federal agency.
13.8 and 14.7............... Specifies that MRO 100 14 0.05 (3 min).... 70
must report all
verified primary
and split specimen
results to the
federal agency.
13.11....................... Specifications for 100 2 0.5............. 100
MRO semiannual
report to the
Secretary or
designated
representative for
federal agency
specimen results
that were
laboratory-positive
and MRO-verified
negative.
16.1(b) and 16.5(a)......... Specifies content of 1 1 3............... 3
request for
informal review of
suspension/proposed
revocation of
certification.
16.4........................ Specifies 1 1 0.5............. 0.5
information
appellant provides
in first written
submission when
laboratory
suspension/
revocation is
proposed.
16.6........................ Requires appellant 1 1 0.5............. 0.5
to notify reviewing
official of
resolution status
at end of abeyance
period.
16.7(a)..................... Specifies contents 1 1 50.............. 50
of appellant
submission for
review.
16.9(a)..................... Specifies content of 1 1 3............... 3
appellant request
for expedited
review of
suspension or
proposed revocation.
16.9(c)..................... Specifies contents 1 1 50.............. 50
of review file and
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/ Total
Section Purpose respondents respondent Hours/ response hours
----------------------------------------------------------------------------------------------------------------
8.3(a), 8.6(b)(2)........... Collector must 100 1 0.05 (3 min).... 5
contact federal
agency's point of
contact.
11.21, 11.22................ Information on drug 10 10 3............... 300
test that
laboratory must
provide to federal
agency upon request
or to donor through
MRO.
13.8(b)..................... MRO must inform 100 14 3............... 4,200
donor of right to
request split
specimen test when
a positive,
adulterated, or
substituted result
is reported.
-------------------------------------------------------------
Total................... .................... 210 .............. ................ 4,505
----------------------------------------------------------------------------------------------------------------
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.
[[Page 68368]]
Estimate of Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total
Section Purpose respondents respondent Hours/ response hours
----------------------------------------------------------------------------------------------------------------
8.3, 8.4, 8.5, 8.8.......... Collector completes 100 380 0.07 (4 min).... 2,660
federal CCF for
specimen collected.
8.8(d) and (f).............. Donor initials 38,000 1 0.08 (5 min).... 3,040
specimen labels/
seals and signs
statement on the
federal CCF.
11.8(a) and 11.17........... Laboratory completes 10 1,520 0.05 (3 min).... 760
federal CCF upon
receipt of specimen
and before
reporting result.
13.4(d) (4),13.9 (c),14.7 MRO completes 100 380 0.05 (3 min).... 1,900
(c). federal CCF before
reporting the
primary or split
specimen result.
14.1(b)..................... MRO documents 100 2 0.05 (3 min).... 10
donor's request to
have split specimen
tested.
-------------------------------------------------------------
Total................... .................... 38,310 .............. ................ 8,370
----------------------------------------------------------------------------------------------------------------
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 13,267 hours (that is, the sum of the total hours from the above
tables). The estimated burden hours were also decreased for testing of
urine specimens by laboratories, as described in the UrMG. The final
estimate after adjusting the total 1,686,483 hours currently approved
by OMB under control number 0930-0158 is 1,684,363 hours, reflecting
the decrease in burden hours required to perform the tasks outlined in
these updated mandatory guidelines. The Department requests comments on
the change in burden hours.
As required by section 3507(d) of the Paperwork Reduction Act, the
Secretary has submitted a copy of these proposed Guidelines to OMB for
its review.
OMB is required to make a decision concerning the collection of
information contained in these proposed Guidelines between 30 and 60
days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication. This does not affect
the deadline for the public to comment to HHS on the proposed
Guidelines.
Organizations and individuals desiring to submit comments on the
information collection requirements should direct them to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Building,
725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for
SAMHSA. Because of delays in receipt of mail, comments may also be sent
to 202-395-6974 (fax).
Robert F. Kennedy, Jr.,
Secretary.
For the reasons discussed above, the Department of Health and Human
Services proposes to amend the Mandatory Guideline to read as follows:
Mandatory Guidelines For Federal Workplace Drug Testing Programs Using
Oral Fluid
Subpart A--Applicability
1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these
Guidelines?
1.3 How does a federal agency request a change from these
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect workplace drug
testing records?
1.7 What is a refusal to take a federally regulated drug test?
1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
Subpart B--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 a specimen be tested for biomarkers other than those in the
biomarker testing panel?
3.4 May any of the specimens be
[[Page 68369]]
used for other purposes?
3.5 What are the drug and biomarker test analytes and cutoffs for
undiluted (neat) oral fluid?
3.6 May an HHS-certified laboratory perform additional drug and/or
specimen validity tests on a specimen at the request of the Medical
Review Officer (MRO)?
3.7 What criteria are used to report an oral fluid specimen as
adulterated?
3.8 What criteria are used to report an oral fluid specimen as
substituted?
3.9 What criteria are used to report an invalid result for an oral
fluid specimen?
Subpart D--Collectors
4.1 Who may collect an oral fluid specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be a trainer for collectors?
4.5 What must a federal agency do before a collector is permitted
to collect a specimen?
Subpart E--Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a
specimen at the collection site?
5.6 What are the privacy requirements when collecting an oral fluid
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What Federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not
available or is not used?
Subpart G--Oral Fluid Specimen Collection Devices
7.1 What is used to collect an oral fluid specimen?
7.2 What are the requirements for an oral fluid collection device?
7.3 What are the minimum performance requirements for a collection
device?
Subpart H--Oral Fluid Specimen Collection Procedure
8.1 What privacy must the donor be given when providing an oral
fluid specimen?
8.2 What must the collector ensure at the collection site before
starting an oral fluid specimen collection?
8.3 What are the preliminary steps in the oral fluid specimen
collection procedure?
8.4 What steps does the collector take in the collection procedure
before the donor provides an oral fluid specimen?
8.5 What steps does the collector take during and after the oral
fluid specimen collection procedure?
8.6 What procedure is used when the donor states that they are
unable to provide an oral fluid specimen?
8.7 If the donor is unable to provide an oral fluid specimen, may
another specimen type be collected for testing?
8.8 How does the collector prepare the oral fluid specimens?
8.9 How does the collector report a donor's refusal to test?
8.10 What are a federal agency's responsibilities for a collection
site?
Subpart I--HHS Certification of Laboratories
9.1 Who has the authority to certify laboratories to test oral
fluid specimens for Federal agencies?
9.2 What is the process for a laboratory to become HHS-certified?
9.3 What is the process for a laboratory to maintain HHS
certification?
9.4 What is the process when a laboratory does not maintain its HHS
certification?
9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory that
seeks to perform oral fluid testing?
9.7 What are the PT requirements for an HHS-certified oral fluid
laboratory?
9.8 What are the inspection requirements for an applicant
laboratory?
9.9 What are the maintenance inspection requirements for an HHS-
certified laboratory?
9.10 Who can inspect an HHS-certified laboratory and when may the
inspection be conducted?
9.11 What happens if an applicant laboratory does not satisfy the
minimum requirements for either the PT program or the inspection
program?
9.12 What happens if an HHS-certified laboratory does not satisfy
the minimum requirements for either the PT program or the inspection
program?
9.13 What factors are considered in determining whether revocation
of a laboratory's HHS certification is necessary?
9.14 What factors are considered in determining whether to suspend
a laboratory's HHS certification?
9.15 How does the Secretary notify an HHS-certified laboratory that
action is being taken against the laboratory?
9.16 May a laboratory that had its HHS certification revoked be
recertified to test Federal agency specimens?
9.17 Where is the list of HHS-certified laboratories published?
Subpart J--Blind Samples Submitted by an Agency
10.1 What are the requirements for Federal agencies to submit blind
samples to HHS-certified laboratories?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified
laboratory?
10.4 What happens if an inconsistent result is reported for a blind
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified
laboratory?
11.5 What qualifications must an individual have to certify a
result reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory
maintain?
11.8 What are the laboratory chain of custody requirements for
specimens and aliquots?
11.9 What are the requirements for an initial drug test?
11.10 What must an HHS-certified laboratory do to validate an
initial drug test?
11.11 What are the batch quality control requirements when
conducting an initial drug test?
11.12 What are the requirements for a confirmatory drug test?
11.13 What must an HHS-certified laboratory do to validate a
confirmatory drug test?
11.14 What are the batch quality control requirements when
conducting a confirmatory drug test?
11.15 What are the analytical and quality control requirements for
[[Page 68370]]
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 applicant or 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 result?
13.6 What action does the MRO take when the collector reports that
the donor did not provide a sufficient amount of oral fluid for a drug
test?
13.7 What happens when an individual is unable to provide a
sufficient amount of oral fluid for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because of
a permanent or long-term medical condition?
13.8 How does an MRO report a primary (A) specimen test result to
an agency?
13.9 Who may request a test of a split (B) specimen?
13.10 What types of relationships are prohibited between an MRO and
an HHS-certified laboratory?
13.11 What reports must an MRO provide to the Secretary for oral
fluid testing?
13.12 What are a federal agency's responsibilities for designating
an MRO?
Subpart N--Split Specimen Tests
14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) oral
fluid specimen when the primary (A) specimen was reported adulterated?
14.4 How does an HHS-certified laboratory test a split (B) oral
fluid specimen when the primary (A) specimen was reported substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B)
oral fluid specimen result from the second HHS-certified oral fluid
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 communication 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
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complies with the provisions of these Guidelines unless a waiver has
been obtained from the Secretary.
(b) To obtain a waiver, a federal agency must submit a written
request to the Secretary that describes the specific change for which a
waiver is sought and a detailed justification for the change.
Section 1.4 How are these Guidelines revised?
(a) To ensure the full reliability and accuracy of specimen tests,
the accurate reporting of test results, and the integrity and efficacy
of Federal drug testing programs, the Secretary may make changes to
these Guidelines to reflect improvements in the available science and
technology.
(b) Revisions to these Guidelines will be published in final as a
notification in the Federal Register.
Section 1.5 What do the terms used in these Guidelines mean?
The following definitions are adopted:
Accessioner. The individual who signs the Federal Drug Testing
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.
Adulterated Specimen. A specimen that has been altered, as
evidenced by test results showing either a substance that is not a
normal constituent for that type of specimen or shows 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 RP is
unable to fulfill these obligations.
Alternate Technology Initial Drug Test. An initial drug test using
technology other than immunoassay to differentiate negative specimens
from those requiring further testing.
Batch. A number of specimens or aliquots handled concurrently as a
group.
Biomarker. An endogenous substance used to validate a biological
specimen.
Biomarker Testing Panel. The panel published in the Federal
Register that includes the biomarkers authorized for testing, with
analytes and cutoffs for initial and confirmatory biomarker tests, as
described under Section 3.5.
Blind Sample. A sample submitted to an HHS-certified test facility
for quality assurance purposes, with a fictitious identifier, so that
the test facility cannot distinguish it from a donor specimen.
Calibrator. A sample of known content and analyte concentration
prepared in the appropriate matrix used to define expected outcomes of
a testing procedure. The test result of the calibrator is verified to
be within established limits prior to use.
Cancelled Test. The result reported by the MRO to the Federal
agency when a specimen has been reported to the MRO as an invalid
result (and the donor has no legitimate explanation) or the specimen
has been rejected for testing, when a split specimen fails to
reconfirm, or when the MRO determines that a fatal flaw or unrecovered
correctable flaw exists in the forensic records (as described in
Sections 15.1 and 15.2).
Carryover. The effect that occurs when a sample result (e.g., drug
concentration) is affected by a preceding sample during the preparation
or analysis of a sample.
Certifying Scientist (CS). The individual responsible for verifying
the chain of custody and scientific reliability of a test result
reported by an HHS-certified laboratory.
Certifying Technician (CT). The individual responsible for
verifying the chain of custody and scientific reliability of negative,
rejected for testing, and (for urine) negative/dilute results reported
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
Chain of Custody (COC) Procedures. Procedures that document the
integrity of each specimen or aliquot from the point of collection to
final disposition.
Chain of Custody Documents. Forms used to document the control and
security of the specimen and all aliquots. The document may account for
an individual specimen, aliquot, or batch of specimens/aliquots and
must include the name and signature of each individual who handled the
specimen(s) or aliquot(s) and the date and purpose of the handling.
Collection Device. A product that is used to collect an oral fluid
specimen and may include a buffer or diluent.
Collection Site. The location where specimens are collected.
Collector. A person trained to instruct and assist a donor in
providing a specimen.
Confirmatory Drug Test. A second analytical procedure performed on
a separate aliquot of a specimen to identify and quantify a specific
drug or drug metabolite.
Confirmatory Specimen Validity Test. A second test performed on a
separate aliquot of a specimen to further support an initial specimen
validity test result.
Control. A sample used to evaluate whether an analytical procedure
or test is operating within predefined tolerance limits.
Cutoff. The analytical value (e.g., drug, drug metabolite, or
biomarker concentration) used as the decision point to determine a
result (e.g., negative, positive, adulterated, invalid, or substituted)
or the need for further testing.
Donor. The individual from whom a specimen is collected.
Drug Testing Panel. The panel published in the Federal Register
that includes the drugs authorized for testing, with analytes and
cutoffs for initial and confirmatory drug tests, as described under
Section 3.5.
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-certified
laboratory, a MRO, or (for urine) an HHS-certified Instrumented Initial
Test Facility (IITF).
Failed to Reconfirm. The result reported for a split (B) specimen
when a second HHS-certified laboratory is unable to corroborate the
result reported for the primary (A) specimen.
Federal Drug Testing Custody and Control Form (Federal CCF). The
OMB approved form that is used to document the collection and chain of
custody of a specimen from the time the specimen is collected until it
is received by the test facility (i.e., HHS-certified laboratory or,
for urine, HHS-certified IITF). It may be a paper (hardcopy),
electronic (digital), or combination electronic and paper format
(hybrid). The form may also be used to report the test result to the
Medical Review Officer.
HHS. The Department of Health and Human Services.
Initial Drug Test. An analysis used to differentiate negative
specimens from those requiring further testing.
Initial Specimen Validity Test. The first analysis is used to
determine if a specimen is adulterated, invalid, substituted, or (for
urine) dilute.
Instrumented Initial Test Facility (IITF). A permanent location
where (for urine) initial testing, reporting of results, and
recordkeeping are performed under the supervision of a responsible
technician.
Invalid Result. The result reported by an HHS-certified laboratory
in accordance with the criteria established in Section 3.9 when a
positive, negative, adulterated, or substituted result cannot be
established for a specific drug or specimen validity test.
Laboratory. A permanent location where drug testing, reporting of
results,
[[Page 68372]]
and recordkeeping are performed under the supervision of a responsible
person. In addition to certifying laboratories that conduct all
required testing of primary (A) and split (B) specimens, HHS may
certify a laboratory that tests split (B) specimens only and/or
conducts additional drug or specimen validity tests for primary and
split specimens in accordance with these Mandatory Guidelines.
Limit of Detection (LOD). The lowest concentration at which the
analyte (e.g., drug or drug metabolite) can be identified.
Limit of Quantification (LOQ). For quantitative assays, the lowest
concentration at which the identity and concentration of the analyte
(e.g., drug or drug metabolite) can be accurately established.
Lot. A number of units of an item (e.g., reagents, quality control
material, 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 when a specimen does not contain
the analyte of interest (i.e., drug and/or drug metabolite) or the
concentration is less than the cutoff for the test.
Oral Fluid Specimen. An oral fluid specimen is collected from the
donor's oral cavity and is a combination of physiological fluids
produced primarily by the salivary glands.
Oxidizing Adulterant. A substance that acts alone or in combination
with other substances to oxidize drug or drug metabolites to prevent
the detection of the drugs or drug metabolites or affects the reagents
in either the initial or confirmatory drug test.
Performance Testing (PT) Sample. A program-generated sample sent to
a laboratory or (for urine) to an IITF to evaluate performance.
Positive Result. The result reported by an HHS-certified laboratory
when a specimen contains a drug or drug metabolite equal to or greater
than the confirmatory test cutoff.
Reconfirmed. The result reported for a split (B) specimen when the
second HHS-certified laboratory corroborates the original result
reported for the primary (A) specimen.
Rejected for Testing. The result reported by an HHS-certified
laboratory or (for urine) HHS-certified IITF when no tests are
performed on a specimen because of a fatal flaw or an unrecovered
correctable error (see Sections 15.1 and 15.2).
Responsible Person (RP). The person who assumes professional,
organizational, educational, and administrative responsibility for the
day-to-day management of an HHS-certified laboratory.
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 based on testing for an HHS-authorized biomarker or (for
urine) creatinine and specific gravity values that are outside the
physiologically producible ranges of human urine, in accordance with
the criteria to report a urine specimen as substituted in the Mandatory
Guidelines for Federal Workplace Drug Testing Programs using Urine
(UrMG).
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 workplace drug
testing records?
Consistent with 5 U.S.C. 552a and 48 CFR 24.101 through 24.104, all
agency contracts with laboratories, collectors, and MROs must require
that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the
contracts must require compliance with employee access and
confidentiality provisions of section 503 of Public Law 100-71. Each
Federal agency must establish a Privacy Act System of Records or modify
an existing system or use any applicable Government-wide system of
records to cover the records of workplace drug test results. All
contracts and the Privacy Act System of Records must specifically
require that workplace drug testing records be maintained and used with
the highest regard for individual privacy.
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and
E, may be applicable to certain health care providers with whom a
federal agency may contract. If a health care provider is a HIPAA
covered entity, the provider must protect the individually identifiable
health information it maintains in accordance with the requirements of
the Rule, which includes not using or disclosing the information except
as permitted by the Rule and ensuring there are reasonable safeguards
in place to protect the privacy of the information.
Section 1.7 What is a refusal to take a federally regulated drug test?
(a) A donor for a federally regulated drug test, has refused to
take a federally regulated drug test when he/she:
(1) Fails to appear for any test within a reasonable time, as
determined by the Federal agency, consistent with applicable agency
regulations, after being directed to do so by the Federal agency;
(2) Fails to remain at the collection site until the collection
process is complete;
(3) Fails to provide a specimen (e.g., oral fluid or another
authorized specimen type) for any drug test required by these
Guidelines or Federal agency regulations;
(4) Fails 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) Fails or declines 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) Fails to undergo a medical examination or evaluation, as
directed by the MRO as part of the verification process (i.e., Section
13.6) or as directed
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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) Fails to cooperate with any part of the testing process (e.g.,
disrupts the collection process, fails to rinse the mouth or wash hands
after being directed to do so by the collector, refuses to provide a
split specimen, does not consent to testing or withdraws consent for
testing);
(8) Brings materials to the collection site for the purpose of
adulterating, substituting, or diluting the specimen;
(9) Attempts to adulterate, substitute, or dilute the specimen;
(10) Admits to the collector or MRO that he/she has adulterated or
substituted the specimen;
Section 1.8 What are the potential consequences for refusing to take a
federally regulated drug test?
(a) A refusal to take a test may result in the initiation of
disciplinary or adverse action for a federal employee, up to and
including removal from Federal employment. An applicant's refusal to
take a pre-employment test may result in non-selection for Federal
employment.
(b) When a donor has refused to participate in a part of the
collection process, including failing to appear at a reasonable time
for any test, the collector must terminate the collection process and
take action as described in Section 8.9. Required action includes
immediately notifying the federal agency's designated representative by
any means (e.g., telephone, email, or secure facsimile [fax] machine)
that ensures that the refusal notification is immediately received and,
if a Federal CCF has been initiated, documenting the refusal on the
Federal CCF, signing and dating the Federal CCF, and sending all copies
of the Federal CCF to the Federal agency's designated representative.
(c) When documenting a refusal to test during the verification
process as described in Sections 13.4, 13.5, and 13.6, the MRO must
complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
Subpart B--Oral Fluid Specimens
Section 2.1 What type of specimen may be collected?
A federal agency may collect oral fluid and/or an alternate
specimen type for its workplace drug testing program. Only specimen
types authorized by Mandatory Guidelines for Federal Workplace Drug
Testing Programs may be collected. An agency using oral fluid must
follow these Guidelines.
Section 2.2 Under what circumstances may an oral fluid specimen be
collected?
A Federal agency may collect an oral fluid specimen for the
following reasons:
(a) Pre-employment test (i.e., for all applicants including Federal
agency employees);
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post-accident test;
(e) Return to duty test; or
(f) Follow-up test.
Section 2.3 How is each oral fluid specimen collected?
Each oral fluid specimen is collected as a split specimen (i.e.,
collected either simultaneously or serially) as described in Sections
2.5 and 8.8.
Section 2.4 What volume of oral fluid is collected?
A volume of at least 1 mL of undiluted (neat) oral fluid for each
oral fluid specimen (designated ``Tube A'' and ``Tube B'') is collected
using a collection device. If the device does not include a diluent (or
other component, process, or method that modifies the volume of the
testable specimen), the A and B tubes must have a volume marking
clearly noting a level of 1 mL.
Section 2.5 How is the split oral fluid specimen collected?
The collector collects at least 1 mL of undiluted (neat) oral fluid
in a collection device designated as ``A'' (primary) and at least 1 mL
of undiluted (neat) oral fluid in a collection device designated as
``B'' (split) either simultaneously or serially (i.e., using two
devices or using one device and subdividing the specimen), as described
in Section 8.8.
Section 2.6 When may an entity or individual release an oral fluid
specimen?
Entities and individuals subject to these Guidelines under Section
1.1 may not release specimens collected pursuant to Executive Order
12564, Public Law 100-71, and these Guidelines to donors or their
designees. Specimens also may not be released to any other entity or
individual unless expressly authorized by these Guidelines or by
applicable Federal law. This section does not prohibit a donor's
request to have a split (B) specimen tested in accordance with Section
13.9.
Subpart C--Oral Fluid Specimen Tests
Section 3.1 Which tests are conducted on an oral fluid specimen?
A Federal agency:
(a) Must ensure that each specimen is tested for marijuana and
cocaine as provided in the drug testing panel described under Section
3.5;
(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 HHS-
authorized biomarkers; and
(e) May perform additional testing if a specimen exhibits abnormal
characteristics (e.g., unusual odor or color, semi-solid
characteristics), causes reactions or responses characteristic of an
adulterant during initial or confirmatory drug tests (e.g., non-
recovery of internal standard, unusual response), or contains an
unidentified substance that interferes with the confirmatory analysis.
Section 3.2 May a specimen be tested for drugs other than those in the
drug testing panel?
A Federal agency covered by these Guidelines may test their
workplace specimens for the drugs listed in the drug testing panel and
any other drugs listed in Schedule I or II of the Controlled Substances
Act subject to the procedures listed in paragraphs (a) and (b) of this
section.
(a) A Federal agency may test a reasonable suspicion or post-
accident specimen for additional Schedule I or II drugs not listed in
the drug testing panel on a case-by-case basis. The agency must request
the HHS-certified laboratory to test for the additional drug, include a
justification to test a specific specimen for the drug, and ensure that
the HHS-certified laboratory has the capability to test for the drug
and has established properly validated initial and confirmatory
analytical methods. If an initial test procedure is not available upon
request for a suspected Schedule I or Schedule II drug, the Federal
agency can request an HHS-certified laboratory
[[Page 68374]]
to test for the drug by analyzing two separate aliquots of the specimen
in two separate testing batches using the confirmatory analytical
method. Additionally, the split (B) specimen will be available for
testing if the donor requests a retest at another HHS-certified
laboratory.
(b) A Federal agency must petition the Secretary in writing for
approval to routinely test for any drug not listed in the drug testing
panel described under Section 3.5. Such approval must be limited to the
use of appropriate science and technology and must not otherwise limit
agency discretion to test for any drug tested under Section 3.2(a).
Section 3.3 May a specimen be tested for biomarkers other than those in
the biomarker testing panel?
An HHS-certified laboratory or (for urine) IITF must obtain
authorization from the Department before implementing a biomarker test
for Federal agency drug testing specimens. The Department may add the
biomarker (i.e., initial, and confirmatory test analytes and cutoffs)
to the subsequent biomarker testing panel published in the Federal
Register.
A Federal agency covered by these Guidelines may test their
workplace specimens for any HHS-authorized biomarker routinely (see
Section 3.1.d) or on a case-by-case basis (see Section 3.6).
Section 3.4 May any of the specimens be used for other purposes?
(a) Specimens collected pursuant to Executive Order 12564, Public
Law 100-71, and these Guidelines must only be tested for drugs and to
determine their validity in accordance with subpart C of these
Guidelines. Use of specimens by donors, their designees, or any other
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing)
is prohibited unless authorized in accordance with applicable Federal
law.
(b) These Guidelines are not intended to prohibit a federal agency
specifically authorized by law to test a specimen for additional drugs
in its workplace drug testing program.
Section 3.5 What are the drug and biomarker test analytes and cutoffs
for undiluted (neat) oral fluid?
The Secretary publishes the drug and biomarker test analytes and
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing
panel'') for initial and confirmatory drug and biomarker tests in the
Federal Register.
(a) The drug testing panel includes drugs authorized for testing in
federal workplace drug testing programs, with the required test
analytes and cutoffs.
(b) The biomarker testing panel includes biomarkers authorized for
testing in federal workplace drug testing programs, with the required
test analytes and cutoffs.
(c) HHS-certified laboratories and Medical Review Officers must use
the nomenclature (i.e., analyte names and abbreviations) published in
the Federal Register with the drug and biomarker testing panels to
report federal workplace drug test results.
Section 3.6 May an HHS-certified laboratory perform additional drug
and/or specimen validity tests on a specimen at the request of the
Medical Review Officer (MRO)?
An HHS-certified laboratory is authorized to perform additional
drug and/or specimen validity tests on a case-by-case basis as
necessary to provide information that the MRO would use to report a
verified drug test result (e.g., specimen validity tests). An HHS-
certified laboratory is not authorized to routinely perform additional
drug and/or specimen validity tests at the request of an MRO without
prior authorization from the Secretary or designated HHS
representative, with the exception of the determination of d,l
stereoisomers of amphetamine and methamphetamine. All tests must meet
appropriate validation and quality control requirements in accordance
with these Guidelines.
Section 3.7 What criteria are used to report 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 3.8 What criteria are used to report an oral fluid specimen as
substituted?
An HHS-certified laboratory reports a primary (A) oral fluid
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 HHS-authorized test
analytes and cutoffs).
Section 3.9 What criteria are used to report an invalid result for an
oral fluid specimen?
An HHS-certified laboratory reports a primary (A) oral fluid
specimen as an invalid result when:
(a) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(b) Interference with the confirmatory drug test occurs on two
separate aliquots of the specimen and the laboratory is unable to
identify the interfering substance;
(c) The physical appearance of the specimen (e.g., viscosity) is
such that testing the specimen may damage the laboratory's instruments;
(d) The specimen has been tested, and the appearances of the
primary (A) and the split (B) specimens (e.g., color) are clearly
different; or
(e) A specimen validity test on two separate aliquots of the
specimen indicates that the specimen is not valid for testing.
Subpart D--Collectors
Section 4.1 Who may collect an oral fluid 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 may only collect
that employee's specimen when no other collector is available. The
supervisor must be a trained collector.
(c) The hiring official of an applicant may only collect that
applicant's specimen when no other collector is available. The hiring
official must be a trained collector.
Section 4.2 Who may not collect a specimen?
(a) A Federal agency employee who is in a testing designated
position and subject to the Federal agency drug testing rules must not
be a collector for co-workers in the same testing pool or who work with
that employee on a daily basis.
(b) A donor must not collect their own drug testing specimen.
(c) An employee working for an HHS-certified laboratory must not
act as a collector if the employee could link the identity of the donor
to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not
be related to the donor (e.g., spouse, ex-spouse, relative) or be a
personal friend of the donor (e.g., fianc[eacute]e).
[[Page 68375]]
Section 4.3 What are the requirements to be a collector?
(a) An individual may serve as a collector if they fulfill the
following conditions:
(1) Is knowledgeable about the collection procedure described in
these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal
agency's drug-free workplace program and additional information
provided by the Secretary relating to the collection procedure
described in these Guidelines;
(3) Is trained and qualified to use the specific oral fluid
collection device. Training must include the following:
(i) All steps necessary to complete an oral fluid collection;
(ii) Completion and distribution of the federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in
collections; and
(v) The collector's responsibility for maintaining the integrity of
the collection process, ensuring the privacy of the donor, ensuring the
security of the specimen, and avoiding conduct or statements that could
be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five
consecutive error-free mock collections.
(i) The five mock collections must include two uneventful
collection scenarios, one insufficient specimen quantity scenario, one
scenario in which the donor refuses to sign the federal CCF, and one
scenario in which the donor refuses to initial the specimen tube
tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate
the individual being trained in person or by a means that provides
real-time observation and interaction between the trainer and the
trainee, and the trainer must attest in writing that the mock
collections are error-free.
(b) A trained collector must complete refresher training at least
every five years that includes the requirements in Section 4.3(a).
(c) The collector must maintain the documentation of their training
and provide that documentation to a federal agency when requested.
(d) An individual may not collect specimens for a federal agency
until the individual's training as a collector has been properly
documented.
Section 4.4 What are the requirements to be a trainer for collectors?
(a) Individuals are considered qualified trainers for collectors
for a specific oral fluid collection device and may train others to
collect oral fluid specimens using that collection device when they
have completed the following:
(1) Qualified as a trained collector and regularly conduct 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 for 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 with 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;
(e) A restricted access area for the storage of collection
supplies; and
(f) A restricted access area for the secure storage of records.
Section 5.3 Where must collection site records be stored?
Collection site records must be stored at a secure site designated
by the collector or the collector's employer.
Section 5.4 How long must collection site records be stored?
Collection site records (e.g., collector copies of the OMB-approved
federal CCF) must be stored securely for a minimum of 2 years. The
collection site may convert hardcopy records to electronic records for
storage and discard the hardcopy records after 6 months.
Section 5.5 How does the collector ensure the security and integrity of
a specimen at the collection site?
(a) A collector must do the following to maintain the security and
integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area
during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and
after collection;
(4) Ensure that only the collector and the donor are allowed to
handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and
documented throughout the entire collection, storage, and transport
procedures;
(6) Ensure that the federal CCF is completed and distributed as
required; and
(7) Ensure that specimens transported to an HHS-certified
laboratory are sealed and placed in transport containers designed to
minimize the possibility of damage during shipment (e.g., specimen
boxes, padded mailers, or other suitable shipping containers), and
those containers are securely sealed to eliminate the possibility of
undetected tampering;
(b) Couriers, express carriers, and postal service personnel are
not
[[Page 68376]]
required to document chain of custody since specimens are sealed in
packages that would indicate tampering during transit to the HHS-
certified laboratory.
Section 5.6 What are the privacy requirements when collecting an oral
fluid specimen?
Collections must be performed at a site that provides reasonable
privacy (as described in Section 8.1).
Subpart F--Federal Drug Testing Custody and Control Form
Section 6.1 What federal form is used to document custody and control?
The OMB-approved Federal CCF must be used to document custody and
control of each specimen at the collection site.
Section 6.2 What happens if the correct OMB-approved federal CCF is not
available or is not used?
(a) The use of a non-federal CCF or an expired federal CCF is not,
by itself, a reason for the HHS-certified laboratory to automatically
reject the specimen for testing or for the MRO to cancel the test.
(b) If the collector does not use the correct OMB-approved federal
CCF, the collector must document that it is a federal agency specimen
collection and provide the reason that the incorrect form was used.
Based on the information provided by the collector, the HHS-certified
laboratory must handle and test the specimen as a federal agency
specimen.
(c) If the HHS-certified laboratory or MRO discovers that the
collector used an incorrect form, the laboratory or MRO must obtain a
memorandum for the record from the collector describing the reason the
incorrect form was used. If a memorandum for the record cannot be
obtained, the laboratory reports a rejected for testing result to the
MRO and the MRO cancels the test. The HHS-certified laboratory must
wait at least 5 business days while attempting to obtain the memorandum
before reporting a rejected for testing result to the MRO.
Subpart G--Oral Fluid Specimen Collection Devices
Section 7.1 What is used to collect an oral fluid specimen?
A single-use collection device intended to collect an oral fluid
specimen must be used. This collection device must maintain the
integrity of such specimens during storage and transport so that the
specimen contained therein can be tested in an HHS-certified laboratory
for the presence of drugs or their metabolites.
Section 7.2 What are the requirements for an oral fluid collection
device?
An oral fluid specimen collection device must provide:
(a) An indicator that demonstrates the adequacy of the volume of
oral fluid specimen collected;
(b) One or two sealable, non-leaking tubes [depending on the device
type, as described in Section 8.8(a)] that:
(1) maintain the integrity of the specimen during storage and
transport so that the specimen contained therein can be tested in an
HHS-certified laboratory for the presence of drugs or their
metabolites,
(2) are sufficiently transparent (e.g., translucent) to enable a
visual assessment of the contents (i.e., oral fluid, buffer/diluent,
collection pad) for identification of abnormal physical characteristics
without opening the tube, and
(3) include the device lot expiration date on each specimen tube
(i.e., the expiration date of the buffer/diluent or, for devices
without a buffer/diluent, the earliest expiration date of any device
component);
(c) Components that ensure pre-analytical drug and drug metabolite
stability; and
(d) Components that do not substantially affect the composition of
drugs and/or drug metabolites in the oral fluid specimen.
Section 7.3 What are the minimum performance requirements for a
collection device?
An oral fluid collection device must meet the following minimum
performance requirements.
(a) Reliable collection of a minimum of 1 mL of undiluted (neat)
oral fluid;
(b) If the collection device contains a diluent (or other
component, process, or method that modifies the volume of the testable
specimen):
(1) The volume of oral fluid collected should be at least 1.0 mL
<plus-minus>10 percent, and
(2) The volume of diluent in the device should be within <plus-
minus>2.5 percent of the diluent target volume;
(c) Stability (recoverable concentrations >=80 percent of the
concentration at the time of collection) of the drugs and/or drug
metabolites for five days at room temperature (64-77 [deg]F/18-25
[deg]C) and under the manufacturer's intended shipping and storage
conditions; and
(d) Recover >=80 percent (but no more than 120 percent) of drug
and/or drug metabolite in the undiluted (neat) oral fluid at (or near)
the initial test cutoff listed in the drug testing panel.
Subpart H--Oral Fluid Specimen Collection Procedure
Section 8.1 What privacy must the donor be given when providing an oral
fluid specimen?
The following privacy requirements apply when a donor is providing
an oral fluid specimen:
(a) Only authorized personnel and the donor may be present in the
restricted access area where the collection takes place.
(b) The collector is not required to be the same sex as the donor.
Section 8.2 What must the collector ensure at the collection site
before starting an oral fluid specimen collection?
The collector must take all reasonable steps to prevent the
adulteration or substitution of an oral fluid specimen at the
collection site.
Section 8.3 What are the preliminary steps in the oral fluid specimen
collection procedure?
The collector must take the following steps before beginning an
oral fluid specimen collection:
(a) If a donor fails to arrive at the collection site at the
assigned time, the collector must follow the Federal agency policy or
contact the federal agency representative to obtain guidance on action
to be taken.
(b) When the donor arrives at the collection site, the collector
should begin the collection procedure without undue delay. For example,
the collection should not be delayed because an authorized employer or
employer representative is late in arriving.
(c) The collector requests the donor to present photo
identification (e.g., driver's license; employee badge issued by the
employer; an alternative photo identification issued by a Federal,
state, or local government agency). If the donor does not have proper
photo identification, the collector shall contact the supervisor of the
donor or the federal agency representative who can positively identify
the donor. If the donor's identity cannot be established, the collector
must not proceed with the collection.
(d) The collector must provide identification (e.g., employee
badge, employee list) if requested by the donor.
(e) The collector asks the donor to remove any unnecessary outer
garments (e.g., coat, jacket) that might conceal items or substances
that could be used to adulterate or substitute the oral fluid specimen.
The collector must ensure that all personal belongings (e.g., purse
[[Page 68377]]
or briefcase) remain with the outer garments. The donor may retain the
donor's wallet. The donor is not required to remove any items worn for
faith-based or disability reasons.
(f) If the donor remains 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 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, wrapped/sealed in original packaging, and compliant
with Subpart G of these Guidelines; and must be within the
manufacturer's expiration date printed on the specimen tube. See
Section 8.8(a) for types of specimen collection devices used for oral
fluid split specimen collections.
(1) The collector will open the package in view of the donor.
(2) Both the collector and the donor must keep the unwrapped
collection devices in view at all times until each collection device
containing the donor's oral fluid specimen has been sealed and labeled.
(c) The collector verifies that each device is within the
manufacturer's expiration date and documents this action on the Federal
CCF.
(d) The collector reviews with the donor the procedures required
for a successful oral fluid specimen collection as stated in the
manufacturer's instructions for the specimen collection device.
(e) The collector notes any unusual behavior or appearance of the
donor on the federal CCF. If the collector detects any conduct that
clearly indicates an attempt to tamper with a specimen (e.g., an
attempt to prevent the device from collecting sufficient oral fluid; an
attempt to bring into the collection site an adulterant or oral fluid
substitute), the collector must report a refusal to test in accordance
with Section 8.9.
Section 8.5 What steps does the collector take during and after the
oral fluid specimen collection procedure?
Integrity and Identity of the Specimen. The collector must take the
following steps during and after the donor provides the oral fluid
specimen:
(a) The collector shall be present and maintain visual contact with
the donor during the procedures outlined in this section.
(1) Under the observation of the collector, the donor is
responsible for positioning the specimen collection device for
collection. The collector must ensure the collection is performed
correctly and that the collection device is working properly. If there
is a failure to collect the specimen, the collector must begin the
process again, beginning with Step 8.4(b), using a new specimen
collection device (for both A and B specimens) and notes the failed
collection attempt on the Federal CCF. If the donor states that they
are unable to provide an oral fluid specimen during the collection
process or after multiple failures to collect the specimen, the
collector follows the procedure in Section 8.6.
(2) The donor and the collector must complete the collection in
accordance with the manufacturer instructions for the collection
device.
(3) The collector must inspect the specimen to determine if there
is any sign indicating that the specimen may not be a valid oral fluid
specimen (e.g., unusual color, presence of foreign objects or
material), documents any unusual findings on the federal CCF, and takes
action (e.g., recollection) to obtain an acceptable specimen.
(b) If the donor fails to remain present through the completion of
the collection, fails to follow the instructions for the collection
device, refuses to begin the collection process after a failure to
collect the specimen as
[[Page 68378]]
required in Section 8.5(a)(1), refuses to provide a split specimen as
instructed by the collector, or refuses to provide an alternate
specimen when directed to do so, the collector stops the collection and
reports the refusal to test in accordance with Section 8.9.
Section 8.6 What procedure is used when the donor states that they are
unable to provide an oral fluid specimen?
(a) If the donor states that they are unable to provide an oral
fluid specimen during the collection process, the collector requests
that the donor follow the collector's instructions and attempt to
provide an oral fluid specimen.
(b) The donor demonstrates their inability to provide a specimen
when, after the time limit specified by the collection device
manufacturer, 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 waiting period.
(2) If the donor states that they are unable to provide an oral
fluid specimen, the collector records the reason for not collecting an
oral fluid specimen on the federal CCF, notifies the Federal agency's
designated representative for authorization to collect an alternate
specimen, and sends the appropriate copies of the federal CCF to the
MRO and to the federal agency's designated representative. The federal
agency may choose to provide the collection site with a standard
protocol to follow in lieu of requiring the collector to notify the
agency's designated representative for authorization in each case. If
an alternate specimen is authorized, the collector begins the
collection procedure for the alternate specimen (see Section 8.7) in
accordance with the Mandatory Guidelines for Federal Workplace Drug
Testing Programs using the alternate specimen.
Section 8.7 If the donor is unable to provide 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 be
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 in a manner to ensure that any attempt to access the specimen
prior to receipt by the laboratory will be detected. The collector
records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident
labels/seals on each specimen tube. If the donor refuses to initial the
labels/seals, the collector notes the refusal on the federal CCF and
continues with the collection process.
(e) The collector must ensure that all required information is
included in the federal CCF.
(f) The collector asks the donor to read and sign a statement on
the federal CCF certifying that the specimens identified were collected
from the donor. If the donor refuses to sign the certification
statement, the collector notes the refusal on the federal CCF and
continues with the collection process.
(g) The collector signs and prints their name on the federal CCF,
completes the federal CCF, and distributes the copies of the federal
CCF as required.
(h) The collector seals the specimens (A and B) in a package and,
within 24 hours or during the next business day, sends them to the HHS-
certified laboratory that will be testing the primary (A) specimen.
(i) If the specimen and federal CCF are not immediately transported
to an HHS-certified laboratory, they must remain under direct control
of the collector or be appropriately secured under proper specimen
storage conditions until transported.
Section 8.9 How does the collector report a donor's refusal to test?
If there is a refusal to test as defined in Section 1.7, the
collector stops the collection, discards any oral fluid specimen
collected and reports the refusal to test by:
(a) Notifying the federal agency by means (e.g., telephone, email,
or secure fax) that ensures that the notification is immediately
received,
(b) Documenting the refusal to test including the reason on the
federal CCF, and
(c) Sending all copies of the federal CCF to the Federal agency's
designated representative.
Section 8.10 What are a federal agency's responsibilities for a
collection site?
(a) A federal agency must ensure that collectors and collection
sites satisfy all requirements in subparts D, E, F, G, and H of these
Guidelines.
(b) A federal agency (or only one Federal agency when several
agencies are using the same collection site) must inspect 5 percent or
up to a maximum of 50 collection sites each year, selected randomly
from those sites used to collect agency specimens (e.g., virtual,
onsite, or self-evaluation).
(c) A federal agency must investigate reported collection site
deficiencies (e.g., specimens reported ``rejected for testing'' by an
HHS-certified laboratory) and take appropriate action which may include
a collection site self-assessment (i.e., using the Collection Site
Checklist for the Collection of Oral Fluid Specimens for Federal Agency
Workplace Drug Testing Programs) or an inspection of the collection
site. The inspections of these additional collection sites may be
included in the 5 percent or maximum of 50 collection sites inspected
annually.
[[Page 68379]]
Subpart I--HHS Certification of Laboratories
Section 9.1 Who has the authority to certify laboratories to test oral
fluid specimens for federal agencies?
(a) The Secretary has broad discretion to take appropriate action
to ensure the full reliability and accuracy of drug testing and
reporting, to resolve problems related to drug testing, and to enforce
all standards set forth in these Guidelines. The Secretary has the
authority to issue directives to any HHS-certified laboratory,
including suspending the use of certain analytical procedures when
necessary to protect the integrity of the testing process; ordering any
HHS-certified laboratory to undertake corrective actions to respond to
material deficiencies identified by an inspection or through
performance testing; ordering any HHS-certified laboratory to send
specimens or specimen aliquots to another HHS-certified laboratory for
retesting when necessary to ensure the accuracy of testing under these
Guidelines; ordering the review of results for specimens tested under
the Guidelines for private sector clients to the extent necessary to
ensure the full reliability of drug testing for federal agencies; and
ordering any other action necessary to address deficiencies in drug
testing, analysis, specimen collection, chain of custody, reporting of
results, or any other aspect of the certification program.
(b) A laboratory is prohibited from stating or implying that it is
certified by HHS under these Guidelines to test oral fluid specimens
for federal agencies unless it holds such certification.
Section 9.2 What is the process for a laboratory to become HHS-
certified?
(a) A laboratory seeking HHS certification must:
(1) Submit a completed OMB-approved application form (i.e., the
applicant laboratory provides detailed information on both the
administrative and analytical procedures to be used for federally
regulated specimens);
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets
of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before
testing specimens for Federal agencies.
Section 9.3 What is the process for a laboratory to maintain HHS
certification?
(a) To maintain HHS certification, a laboratory must:
(1) Successfully participate in both the maintenance PT and
inspection programs (i.e., successfully test the required quarterly
sets of maintenance PT samples, undergo an inspection 3 months after
being certified, and undergo maintenance inspections at a minimum of
every 6 months thereafter);
(2) Respond in an appropriate, timely, and complete manner to
required corrective action requests if deficiencies are identified in
the maintenance PT performance, during the inspections, operations, or
reporting; and
(3) Satisfactorily complete corrective remedial actions and undergo
special inspection and special PT sets to maintain or restore
certification when material deficiencies occur in either the PT
program, inspection program, or in operations and reporting.
Section 9.4 What is the process when a laboratory does not maintain its
HHS certification?
(a) A laboratory that does not maintain its HHS certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and
records throughout the required storage period described in Sections
11.18, 11.19, and 14.8;
(3) Ensure access to federally regulated specimens and records in
accordance with Sections 11.21 and 11.22 and subpart P of these
Guidelines; and
(4) Follow the HHS suspension and revocation procedures when
imposed by the Secretary, follow the HHS procedures in subpart P of
these Guidelines that will be used for all actions associated with the
suspension and/or revocation of HHS-certification.
Section 9.5 What are the qualitative and quantitative specifications of
performance testing (PT) samples?
(a) PT samples used to evaluate drug tests will be prepared using
the following specifications:
(1) PT samples may contain one or more of the drugs and drug
metabolites listed in the drug testing panel and may be sent to the
laboratory as undiluted (neat) oral fluid. The PT samples must satisfy
one of the following parameters:
(i) The concentration of a drug or metabolite will be at least 20
percent above the initial test cutoff for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be as low as 40
percent of the confirmatory test cutoff when the PT sample is
designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from
Section 9.5(a)(1)(i) and (ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an
adulterant, or other substances for special purposes, or may satisfy
the criteria for a substituted specimen or invalid result.
(3) A negative PT sample will not contain a measurable amount of a
target analyte.
(b) The laboratory must (to the greatest extent possible) handle,
test, and report a PT sample in a manner identical to that used for a
donor specimen, unless otherwise specified.
Section 9.6 What are the PT requirements for an applicant laboratory
that seeks to perform oral fluid testing?
(a) An applicant laboratory that seeks certification under these
Guidelines to perform oral fluid testing must satisfy the following
criteria on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of
the total drug challenges over the three sets of PT samples;
(3) For laboratories that will test primary (A) specimens,
correctly identify at least 80 percent of the drug challenges for each
initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the
concentrations (i.e., no more than <plus-minus>20 percent or <plus-
minus>2 standard deviations [whichever is larger] from the appropriate
reference or peer group means) for at least 80 percent of the total
drug challenges over the three sets of PT samples;
(5) For the confirmatory drug tests, do not obtain any drug
concentration that differs by more than <plus-minus>50 percent from the
appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and
determine the concentrations (i.e., no more than <plus-minus>20 percent
or <plus-minus>2 standard deviations [whichever is larger] from the
appropriate reference or peer group means) for at least 50 percent of
the drug challenges for an individual drug over the three sets of PT
samples;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for
each
[[Page 68380]]
individual specimen validity test over the three sets of PT samples;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over the three
sets of PT samples that satisfy the specified criteria; and
(10) Do not report any PT sample as adulterated with a compound
that is not present in the sample or substituted when the appropriate
reference or peer group mean for a biomarker is within the acceptable
range.
(b) Failure to satisfy these requirements will result in the denial
of the laboratory's application for HHS certification to perform oral
fluid testing.
Section 9.7 What are the PT requirements for an HHS-certified oral
fluid laboratory?
(a) A laboratory certified under these Guidelines to perform oral
fluid testing must satisfy the following criteria on the maintenance PT
samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of
the total drug challenges over two consecutive PT cycles;
(3) For laboratories that test primary (A) specimens, correctly
identify at least 80 percent of the drug challenges for each initial
drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the
concentrations for at least 80 percent of the total drug challenges are
no more than <plus-minus>20 percent or <plus-minus>2 standard
deviations (whichever is larger) from the appropriate reference or peer
group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, do not obtain any drug
concentration that differs by more than <plus-minus>50 percent from the
appropriate reference or peer group means;
(6) For each confirmatory drug test, correctly identify and
determine that the concentrations for at least 50 percent of the drug
challenges for an individual drug are no more than <plus-minus>20
percent or <plus-minus>2 standard deviations (whichever is larger) from
the appropriate reference or peer group means over two consecutive PT
cycles;
(7) Correctly identify at least 80 percent of the total specimen
validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for
each individual specimen validity test over two consecutive PT cycles;
(9) For quantitative specimen validity tests, obtain quantitative
values for at least 80 percent of the total challenges over two
consecutive PT cycles that satisfy the specified criteria; and
(10) Do not report any PT sample as adulterated with a compound
that is not present in the sample or substituted when the appropriate
reference or peer group mean for a biomarker is within the acceptable
range.
(b) Failure to participate in all PT cycles or to satisfy these
requirements may result in suspension or revocation of an HHS-certified
laboratory's certification.
Section 9.8 What are the inspection requirements for an applicant
laboratory?
(a) An applicant laboratory is inspected by a team of two
inspectors.
(b) Each inspector conducts an independent review and evaluation of
all aspects of the laboratory's testing procedures and facilities using
an inspection checklist.
Section 9.9 What are the maintenance inspection requirements for an
HHS-certified laboratory?
(a) An HHS-certified laboratory must undergo an inspection 3 months
after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory is inspected by two or more
inspectors. The number of inspectors is determined according to the
number of specimens to be reviewed.
(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 of these
Guidelines;
(2) Has read and thoroughly understands the policies and
requirements contained in these Guidelines and in other guidance
consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory.
(b) The Secretary or a federal agency may conduct an inspection at
any time.
Section 9.11 What happens if an applicant laboratory does not satisfy
the minimum requirements for either the PT program or the inspection
program?
If an applicant laboratory fails to satisfy the requirements
established for the initial certification process, the laboratory must
start the certification process from the beginning.
Section 9.12 What happens if an HHS-certified laboratory does not
satisfy the minimum requirements for either the PT program or the
inspection program?
(a) If an HHS-certified laboratory fails to satisfy the minimum
requirements for certification, the laboratory is given a period of
time (e.g., 5 or 30 working days depending on the nature of the
deficiency) to provide any explanation for its performance and evidence
that all deficiencies have been corrected.
(b) A laboratory's HHS certification may be revoked, suspended, or
no further action taken depending on the seriousness of the
deficiencies and whether there is evidence that the deficiencies have
been corrected and that current performance meets the requirements for
certification.
(c) An HHS-certified laboratory may be required to undergo a
special inspection or to test additional PT samples to address
deficiencies.
(d) If an HHS-certified laboratory's certification is revoked or
suspended in accordance with the process described in subpart P of
these Guidelines, the laboratory is not permitted to test federally
regulated specimens until the suspension is lifted or the laboratory
has successfully completed the certification requirements as a new
applicant laboratory.
Section 9.13 What factors are considered in determining whether
revocation of a laboratory's HHS certification is necessary?
(a) The Secretary shall revoke certification of an HHS-certified
laboratory in accordance with these Guidelines if the Secretary
determines that revocation is necessary to ensure fully reliable and
accurate drug test results and reports.
(b) The Secretary shall consider the following factors in
determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the
results of drug tests (e.g., an HHS-certified
[[Page 68381]]
laboratory reporting a false positive result for a drug test);
(2) Unsatisfactory participation in performance testing or
inspections;
(3) A material violation of a certification standard, contract
term, or other condition imposed on the HHS-certified laboratory by a
federal agency using the laboratory's services;
(4) Conviction for any criminal offense committed as an incident to
operation of the HHS-certified laboratory; or
(5) Any other cause that materially affects the ability of the HHS-
certified laboratory to ensure fully reliable and accurate drug test
results and reports.
(c) The period and terms of revocation shall be determined by the
Secretary and shall depend upon the facts and circumstances of the
revocation and the need to ensure accurate and reliable drug testing.
Section 9.14 What factors are considered in determining whether to
suspend a laboratory's HHS certification?
(a) The Secretary may immediately suspend (either partially or
fully) a laboratory's HHS certification to conduct drug testing for
Federal agencies if the Secretary has reason to believe that revocation
may be required and that immediate action is necessary to protect the
interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of
suspension based upon the facts and circumstances of the suspension and
the need to ensure accurate and reliable drug testing.
Section 9.15 How does the Secretary notify an HHS-certified laboratory
that action is being taken against the laboratory?
(a) When a laboratory's HHS certification is suspended or the
Secretary seeks to revoke HHS certification, the Secretary shall
immediately serve the HHS-certified laboratory with written notice of
the suspension or proposed revocation by fax, mail, personal service,
or registered or certified mail, return receipt requested. This notice
shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory will be
afforded an opportunity for an informal review of the suspension or
proposed revocation if it so requests in writing within 30 days of the
date the laboratory received the notice, or if expedited review is
requested, within 3 days of the date the laboratory received the
notice. Subpart P of these Guidelines contains detailed procedures to
be followed for an informal review of the suspension or proposed
revocation.
(c) A suspension must be effective immediately. A proposed
revocation must be effective 30 days after written notice is given or,
if review is requested, upon the reviewing official's decision to
uphold the proposed revocation. If the reviewing official decides not
to uphold the suspension or proposed revocation, the suspension must
terminate immediately, and any proposed revocation shall not take
effect.
(d) The Secretary will publish in the Federal Register the name,
address, and telephone number of any HHS-certified laboratory that has
its certification revoked or suspended under Section 9.13 or 9.14,
respectively, and the name of any HHS-certified laboratory that has its
suspension lifted. The Secretary shall provide any member of the public
upon request the written notice provided to a laboratory that has its
HHS certification suspended or revoked, as well as the reviewing
official's written decision which upholds or denies the suspension or
proposed revocation under the procedures of subpart P of these
Guidelines.
Section 9.16 May a laboratory that had its HHS certification revoked be
recertified to test Federal agency specimens?
Following revocation, a laboratory may apply for recertification.
Unless otherwise provided by the Secretary in the notice of revocation
under Section 9.15 or the reviewing official's decision under Section
16.9(e) or 16.14(a), a laboratory which has had its certification
revoked may reapply for HHS certification as an applicant laboratory.
Section 9.17 Where is the list of HHS-certified laboratories published?
(a) The list of HHS-certified laboratories is published monthly in
the Federal Register.
(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 donor
specimens.
(b) Each federal agency must submit at least 3 percent blind
samples along with its donor specimens based on the projected total
number of donor specimens collected per year (up to a maximum of 400
blind samples). Every effort should be made to ensure that blind
samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each
year by an agency must be negative and 25 percent must be positive for
one or more drugs.
Section 10.2 What are the requirements for blind samples?
(a) Drug positive blind samples must be validated by the supplier
in the selected manufacturer's collection device as to their content
using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must contain one or more of the
drugs or metabolites listed in the drug testing panel.
(2) Drug positive blind samples must contain concentrations of
drugs between 1.5 and 2 times the initial drug test cutoff.
(b) Drug negative blind samples (i.e., certified to contain no
drugs) must be validated by the supplier in the selected manufacturer's
collection device as negative using appropriate initial and
confirmatory tests.
(c) The supplier must provide information on the blind samples'
content, validation, expected results, and stability to the collection
site/collector sending the blind samples to the laboratory, and must
provide the information upon request to the MRO, the Federal agency for
which the blind sample was submitted, or the Secretary.
Section 10.3 How is a blind sample submitted to an HHS-certified
laboratory?
(a) A blind sample must be submitted as a split specimen (specimens
A and B) with the current Federal CCF that the HHS-certified laboratory
uses for donor specimens. The collector provides the required
information to ensure that the federal CCF has been properly completed
and provides fictitious initials on the specimen label/seal. The
collector must indicate that the specimen is a blind sample on the MRO
copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of
blind samples randomly with donor
[[Page 68382]]
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 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
[[Page 68383]]
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 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);
(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 reagents must be verified prior to being placed
into service.
(c) Each initial drug test using 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) Controls must total at least 4 percent of the controls and
specimens analyzed in each batch.
[[Page 68384]]
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 reagents must be verified prior to being placed
into service.
(c) HHS-certified laboratories must re-verify each confirmatory
drug test method periodically or at least annually.
Section 11.14 What are the batch quality control requirements when
conducting a confirmatory drug test?
(a) At a minimum, each batch of specimens must contain the
following calibrators and controls:
(1) A calibrator at the cutoff;
(2) At least one control certified to contain no drug or drug
metabolite;
(3) At least one positive control with the drug or drug metabolite
targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the
cutoff.
(b) Calibrators and controls must total at least 10 percent of the
aliquots analyzed in each batch.
Section 11.15 What are the analytical and quality control requirements
for conducting specimen validity tests?
An HHS-certified laboratory may perform specimen validity tests in
accordance with Sections 3.1 and 3.6.
(a) Each invalid, adulterated, or substituted specimen validity
test result must be based on an initial specimen validity test on one
aliquot and a confirmatory specimen validity test on a second aliquot;
(b) 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 reagents must be verified prior to being
placed into service.
Section 11.17 What are the requirements for an HHS-certified laboratory
to report a test result?
(a) Laboratories must report a test result to the agency's MRO
within an average of 5 working days after receipt of the specimen.
Reports must use the Federal CCF and/or an electronic report, as
described in items o and p below. Before any test result can be
reported, it must be certified by a certifying scientist or a
certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial
drug test is negative or if the specimen is negative upon confirmatory
drug testing, and the specimen does not meet invalid criteria as
described in Section 11.17(g)(1) through (5).
(c) A primary (A) specimen is reported positive for a specific drug
or drug metabolite when both the initial drug test is positive, and the
confirmatory drug test is positive in accordance with the cutoffs
listed in the drug testing panel.
(d) A primary (A) oral fluid specimen is reported adulterated when
the presence of an adulterant is verified using an initial test on the
first aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) oral fluid specimen is reported substituted when
a biomarker is not present or is present at a concentration
inconsistent with that established for human oral fluid.
(f) For a specimen that has an invalid result for one of the
reasons stated in Section 11/17(g)(1) through (5), the HHS-certified
laboratory shall contact the MRO and both will decide if testing by
another HHS-certified laboratory would be useful in being able to
report a positive, adulterated, or substituted result. If no further
testing is necessary, the HHS-certified laboratory then reports the
invalid result to the MRO.
(g) A primary (A) oral fluid specimen is reported as an invalid
result when:
(1) Interference occurs on the initial drug tests on two separate
aliquots (i.e., valid initial drug test results cannot be obtained);
(2) Interference with the confirmatory drug test occurs on at least
two separate aliquots of the specimen and the HHS-certified laboratory
is unable to identify the interfering substance;
(3) The physical appearance of the specimen is such that testing
the specimen may damage the laboratory's instruments;
(4) The physical appearances of the A and B specimens are clearly
different (note: A is tested); or
(5) A specimen validity test on two separate aliquots of the
specimen indicates that the specimen is not valid for testing.
(h) An HHS-certified laboratory shall reject a primary (A) specimen
for testing when a fatal flaw occurs as described in Section 15.1 or
when a correctable flaw as described in Section 15.2 is not recovered.
The HHS-certified laboratory will indicate on the Federal CCF that the
specimen was rejected for testing and provide the reason for reporting
the rejected for testing result.
(i) An HHS-certified laboratory must report all positive,
adulterated, substituted, and invalid test results for an oral fluid
specimen. For example, a specimen can be positive for a drug and
adulterated.
(j) An HHS-certified laboratory must report the confirmatory
concentration of each drug or drug metabolite reported for a positive
result.
(k) An HHS-certified laboratory must report numerical values of the
specimen validity test results that support an adulterated,
substituted, or invalid result (as appropriate).
(l) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing
panels.
(m) When the concentration of a drug or drug metabolite exceeds the
validated linear range of the confirmatory test, HHS-certified
laboratories may report to the MRO that the quantitative value exceeds
the linear range of the test or that the quantitative value is greater
than ``insert the actual value for the upper limit of the linear
range,'' or laboratories may report a quantitative value above the
upper limit of the linear range that was obtained by diluting an
[[Page 68385]]
aliquot of the specimen to achieve a result within the method's linear
range and multiplying the result by the appropriate dilution factor.
(n) HHS-certified laboratories may transmit test results to the MRO
by various electronic means (e.g., fax, computer). Transmissions of the
reports must ensure confidentiality and the results may not be reported
verbally by telephone. Laboratories and external service providers must
ensure the confidentiality, integrity, and availability of the data and
limit access to any data transmission, storage, and retrieval system.
(o) HHS-certified laboratories must fax, courier, mail, or
electronically transmit a legible image or copy of the completed
federal CCF and/or forward a computer-generated electronic report. The
computer-generated report must contain sufficient information to ensure
that the test results can accurately represent the content of the
custody and control form that the MRO received from the collector.
(p) For positive, adulterated, substituted, invalid, and rejected
specimens, laboratories must fax, courier, mail, or electronically
transmit a legible image or copy of the completed Federal CCF.
Section 11.18 How long must an HHS-certified laboratory retain
specimens?
(a) An HHS-certified laboratory must retain specimens that were
reported as positive, adulterated, substituted, or as an invalid result
for a minimum of 1 year.
(b) Retained oral fluid specimens must be kept in secured storage
in accordance with the collection device manufacturer's specifications
(i.e., frozen at -20 [deg]C or less, or refrigerated), to ensure their
availability for retesting during an administrative or judicial
proceeding.
(c) Federal agencies may request that the HHS-certified laboratory
retain a specimen for an additional specified period of time and must
make that request within the 1-year period following the laboratory's
reporting of the specimen.
Section 11.19 How long must an HHS-certified laboratory retain records?
(a) An HHS-certified laboratory must retain all records generated
to support test results for at least 2 years. The laboratory may
convert hardcopy records to electronic records for storage and then
discard the hardcopy records after 6 months.
(b) A Federal agency may request the HHS-certified laboratory to
maintain a documentation package (as described in Section 11.21) that
supports the chain of custody, testing, and reporting of a donor's
specimen that is under legal challenge by a donor. The Federal agency's
request to the laboratory must be in writing and must specify the
period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those
included in the documentation package beyond the normal 2-year period
of time.
Section 11.20 What statistical summary reports must an HHS-certified
laboratory provide for oral fluid testing?
(a) HHS-certified laboratories must provide to each Federal agency
for which they perform testing a semiannual statistical summary report
that must be submitted by mail, fax, or email within 14 working days
after the end of the semiannual period. The summary report must not
include any personally identifiable information. A copy of the
semiannual statistical summary report will also be sent to the
Secretary or designated HHS representative. The semiannual statistical
report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative;
(7) Number of specimens rejected for testing because of a fatal
flaw;
(8) Number of specimens rejected for testing because of an
uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug
metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's
test results available when requested to do so by the Secretary or by
the Federal agency for which the laboratory is performing drug-testing
services.
(c) An HHS-certified laboratory must ensure that a qualified
individual is available to testify in a proceeding against a federal
employee when the proceeding is based on a test result reported by the
laboratory.
Section 11.21 What HHS-certified laboratory information is available to
a federal agency?
(a) Following a federal agency's receipt of a positive,
adulterated, or substituted drug test report, the federal agency may
submit a written request for copies of the records relating to the drug
test results or a documentation package or any relevant certification,
review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified
laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures
and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in
the package by page number;
(3) A copy of the federal CCF with any attachments, internal chain
of custody records for the specimen, memoranda (if any) generated by
the HHS-certified laboratory, and a copy of the electronic report (if
any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial
drug (and specimen validity, if applicable) testing procedures,
instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with
all calibrators and controls and copies of all internal chain of
custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's
confirmatory drug (and specimen validity, if applicable) testing
procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen
with all calibrators and controls and copies of all internal chain of
custody documents related to the confirmatory tests; and
(8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the
RP(s) and the certifying technician or certifying scientist of record.
Section 11.22 What HHS-certified laboratory information is available to
a federal applicant or employee?
Federal applicants or employees who are subject to a workplace drug
test may submit a written request through the MRO and/or the federal
agency requesting copies of any records relating to their drug test
results or a documentation package as described in Section 11.21(b) and
any relevant certification, review, or revocation of certification
records. Federal applicants or employees, or their designees, are not
permitted access to their specimens collected pursuant to Executive
Order
[[Page 68386]]
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 includes 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.
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 including any changes to the drug and biomarker testing
panels 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.
(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, the MRO must follow the verification
procedures described in Section 13.5(c) through (f) and:
(1) The MRO reports 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,
[[Page 68387]]
or substituted result, the MRO does not report the verified invalid
result to the Federal agency at this time. The MRO takes action for the
verified invalid result(s) for the primary (A) specimen as described in
Section 13.5(e) only when:
(i) The MRO verifies the positive, adulterated, or substituted
result as negative based on a legitimate medical explanation as
described in Section 13.5(c)(2) and (d)(1), or based on codeine and/or
morphine concentrations less than 150 ng/mL as described in Section
13.5(c)(3)(i); or
(ii) The split (B) specimen is tested and reported as a failure to
reconfirm the positive, adulterated, or substituted result reported for
the primary (A) specimen 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 Federal
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 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 Section 13.5(c)(3).
(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 Section 13.5(c)(1).
(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 medicine), the MRO reports a test cancelled result with
the reason for the invalid result and informs the Federal agency that
there is a legitimate explanation for the invalid result.
(i) For a random, post-accident, or reasonable suspicion/cause
test, the MRO informs the agency that a recollection is not required.
(ii) If a negative result is required (i.e., for pre-employment,
return-to-duty, or follow-up test), the MRO directs the agency to
immediately collect another specimen from the donor. If the agency
allows urine collection, the MRO may direct an unobserved urine
collection, depending on the reason for the invalid result.
(2) If the donor is unable to provide a legitimate explanation for
an invalid result, 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 Section 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 a urine specimen under direct observation. If the
Federal agency does not authorize collection of another specimen type,
the MRO consults with the agency to arrange a clinical evaluation as
described in Section 13.7, to determine whether there is a legitimate
medical reason for the invalid result.
(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 in
accordance with Section 8.6, the MRO reviews and reports the test
result in accordance with the Mandatory Guidelines for Federal
Workplace Drug Testing Programs using the alternate specimen.
(b) When the Federal agency did not authorize the collection of an
alternate 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) If a physician other than the MRO performs the evaluation, the
MRO 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;
(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 Section
13.6(b)(3) and the basis for the recommendation. The statement must not
include detailed information on the donor's medical condition beyond
what
[[Page 68388]]
is necessary to explain the referral physician's conclusion.
(3) If a physician other than the MRO performed the evaluation, the
MRO must consider and assess the referral physician's recommendations
in making the determination. The MRO must make one of the following
determinations and report it to the federal agency in writing:
(i) A medical condition as defined in Section 13.6(b)(1) has, or
with a high degree of probability could have, precluded the donor from
providing a sufficient amount of oral fluid, but is not a permanent or
long-term disability. The MRO must report a test cancelled result to
the Federal agency. If a negative result is required (i.e., for pre-
employment, return-to-duty, or follow-up test), the MRO directs the
agency to immediately collect another oral fluid specimen from the
donor or recommends collection of a urine specimen, depending on the
medical condition.
(ii) A permanent or long-term medical condition as defined in
Section 13.6(b)(1) has, or with a high degree of probability could
have, precluded the donor from providing a sufficient amount of oral
fluid and is highly likely to prevent the donor from providing a
sufficient amount of oral fluid for a very long or indefinite period of
time. The MRO actions in this context will be dictated by the reason
for testing. For a pre-employment, return-to-duty, or a follow-up test,
the MRO consults with the federal agency and recommends that the agency
authorize collection of a urine specimen. If the agency does not
authorize the urine collection, the MRO follows the requirements of
Section 13.7. If the agency authorizes the urine collection, or if the
reason for testing is random, post-accident, or reasonable suspicion/
cause, the MRO reports the test as cancelled and directs the agency to
collect a urine specimen from the donor.
(iii) There is no adequate basis to conclude that a medical
condition has or, with a high degree of probability, could have
precluded the donor from providing a sufficient amount of oral fluid.
The MRO must report a refusal to test to the Federal agency.
(4) When a Federal agency receives a report from the MRO indicating
that a random, post-accident, or reasonable suspicion/cause test is
cancelled because of an acute or temporary medical condition as
provided in Section 13.6(b)(3)(i), the agency takes no further action
with respect to the donor. When the MRO reports that a random, post-
accident, or reasonable suspicion/cause test is canceled because of a
permanent or long-term medical condition as provided in Section
13.6(b)(3)(ii), the agency takes no further action with respect to the
donor other than authorizing 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.
Section 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 alternate specimen. The MRO must take the
following action:
(1) Determine if there is clinical evidence that the individual is
an illicit drug user. The MRO 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 the MRO does not personally conduct the medical evaluation,
the MRO must ensure that one is conducted by a licensed physician who
is acceptable to the MRO.
(b) If the medical evaluation reveals no clinical evidence of drug
use, the MRO 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, the MRO 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 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., fax, 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.
Section 13.9 Who may request a test of a split (B) specimen?
(a) For a positive, adulterated, or substituted result reported for
a primary (A) specimen, a donor may request through the MRO that the
split (B) specimen be tested by a second laboratory certified by HHS
for that specimen type 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
[[Page 68389]]
MRO informs the donor that a positive, adulterated, or substituted
result is being reported to the Federal agency on the primary (A)
specimen.
Section 13.10 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 (including 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 the positive drug(s) or drug
metabolite(s) 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 has sent to a federal agency 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 has 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,
including any changes to the drug and biomarker testing panels, 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 13.8 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) oral fluid specimen be tested?
(a) The donor may request, verbally or in writing, through the MRO
that the split (B) oral fluid 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 oral fluid laboratory, the MRO reports a cancelled test
to the Federal agency and the reason for the cancellation. The MRO
takes action based on the reason for cancellation as follows.
(1) No split (B) specimen (e.g., insufficient specimen, lost in
transit, split not available): The MRO directs the federal agency to
recollect another oral fluid specimen from the donor.
(2) No second HHS-certified laboratory to test the split (B)
specimen for the adulterant reported in the primary (A) specimen: The
MRO directs the federal agency to ensure the immediate collection of a
specimen from the donor under direct observation, with no notice given
to the donor until immediately before the collection. If urine testing
is allowed by the federal agency, the MRO recommends an observed urine
collection.
(3) No second HHS-certified laboratory to test a split (B) specimen
reported as substituted (i.e., for the same or a different HHS-
authorized biomarker): The MRO directs the federal agency to ensure the
immediate recollection of a specimen from the donor under direct
observation, with no notice given to the donor until immediately before
the collection. If urine testing is allowed by the federal agency, the
MRO recommends an observed urine 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 in the drug testing
panel.
(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 second HHS-certified oral fluid laboratory must use its
confirmatory specimen validity test at an established LOQ to reconfirm
the presence of the adulterant.
(b) The HHS-certified laboratory may only conduct the confirmatory
specimen
[[Page 68390]]
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?
An HHS-certified oral fluid laboratory must test the split (B)
specimen using its confirmatory biomarker test. Note: The laboratory
may test for any HHS-authorized biomarker for the split (B) specimen.
It is not necessary to test for the same biomarker to reconfirm the
primary (A) specimen's substituted result.
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.
Section 14.6 What action(s) does an MRO take after receiving the split
(B) oral fluid specimen result from the second HHS-certified oral fluid
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 positive drug(s), adulteration, and/or
substitution. The MRO reports were 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
failure 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
test the primary (A) specimen for the adulterant. If Laboratory A does
not perform the test, the MRO directs testing at another HHS-certified
oral fluid laboratory.
(1) If the laboratory reconfirms the adulterant in the primary (A)
specimen, the MRO reports a refusal to test and indicates the
adulterant present.
(2) If the laboratory fails to reconfirm the adulterant in the
primary (A) specimen, the MRO cancels both tests and directs the agency
to immediately collect a specimen using a direct observed collection
procedure. If urine testing is allowed by the Federal agency, the MRO
recommends an observed urine collection.
(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
failure 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 a second laboratory (Laboratory A or a different HHS-
certified laboratory) test the primary (A) specimen using its
confirmatory biomarker test. Note: The laboratory may test the primary
(A) specimen for a different HHS-authorized biomarker than tested for
the split (B) specimen.
(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 a specimen using a direct observed
collection procedure. If urine testing is allowed by the Federal
agency, the MRO recommends an observed urine collection.
(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]) and
cancels both tests.
(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, and directs the agency to
immediately collect a specimen using a direct observed collection
procedure. If urine testing is allowed by the federal agency, the MRO
recommends an observed urine collection.
(f) Reconfirmed one or more drugs, failed to reconfirm 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.
(g) Reconfirmed one or more drugs, failed to reconfirm 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.
(h) Reconfirmed one or more drugs, failed to reconfirm 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.
(i) Reconfirmed one or more drugs, failed to reconfirm 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.
(j) Failed to reconfirm substitution and/or adulteration. The MRO
reports to the agency a failed to reconfirm result (not substituted
and/or not adulterated: specifying the adulterant) and cancels both
tests.
(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 substituted or not adulterated: specifying the
adulterant, and the reason for the invalid result), cancels both tests,
and directs the agency to immediately collect a specimen using a direct
observed collection procedure. If urine testing is allowed by the
Federal agency, the MRO recommends an observed urine collection.
(l) Reconfirmed substitution or adulteration and failed to
reconfirm a single or all drug positive results. The MRO reports to the
agency a reconfirmed result (substituted or adulterated: specifying the
adulterant) 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 (substituted or adulterated) although Laboratory B
failed to reconfirm the drug result(s).
(m) Failed to reconfirm a single or all drug positive results and
failed to reconfirm substitution or adulteration. The MRO reports to
the agency a failed to reconfirm result (specifying the drug[s] and not
substituted or not
[[Page 68391]]
adulterated: specifying the adulterant) and cancels both tests.
(n) Reconfirmed one or more drugs, failed to reconfirm one or more
drugs, and reconfirmed adulteration. The MRO reports to the agency a
reconfirmed result (specifying the drug[s] and adulterated: specifying
the adulterant) 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) and adulterated result although Laboratory B failed
to reconfirm one or more drugs.
(o) Reconfirmed one or more drugs, failed to reconfirm one or more
drugs, and failed to reconfirm adulteration. 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) Reconfirmed substitution and failed to reconfirm adulteration.
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.
(q) Reconfirmed adulteration and failed to reconfirm substitution.
The MRO reports to the agency a reconfirmed result (adulterated:
specifying the adulterant) 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., fax, 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,
in accordance with Section 11.18. 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) The collector failed to document observation of the volume
indicator(s) at the time of collection for a collection device
containing a diluent.
(f) There is an insufficient amount of specimen for analysis in the
primary (A) specimen, and the split (B) specimen cannot be re-
designated as the primary (A) specimen;
(g) 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;
(h) The specimen was received at the HHS-certified laboratory
without a CCF;
(i) The CCF was received at the HHS-certified laboratory without a
specimen;
(j) The collector performed two separate collections using one CCF;
or
(k) 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 fails to sign the Federal CCF, the HHS-certified
laboratory must hold the specimen and attempt to obtain a memorandum
for record to recover the collector's signature. If, a
[…truncated; see source link]Indexed from Federal Register on October 29, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.