[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Proposed Rules]
[Pages 20560-20605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06886]



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Vol. 87

Thursday,

No. 67

April 7, 2022

Part III





Department of Health and Human Services





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42 CFR Chapter I





Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Proposed Rule

  Federal Register / Vol. 87 , No. 67 / Thursday, April 7, 2022 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter I


Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), Department of Health and Human Services (HHS).

ACTION: Notification of mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') is proposing to revise the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine (UrMG), which 
published in the Federal Register of January 23, 2017.

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

ADDRESSES: In commenting, please refer to file code SAMHSA 2022-0001. 
Because of staff and resource limitations, SAMHSA cannot accept 
comments by facsimile (fax) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
     Electronically. You may submit electronic comments on this 
document to https://www.regulations.gov. Follow ``Submit a comment'' 
instructions.
     By regular mail. You may mail written comments to the 
following address: SAMHSA, Center for Substance Abuse Prevention 
(CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room 
16N02, Rockville, MD 20857. Please allow sufficient time for mailed 
comments to be received before the close of the comment period.
     By express or overnight mail. You may send written 
comments to the following address: SAMHSA, CSAP, DWP, 5600 Fishers 
Lane, Room 16N02, Rockville, MD 20857.
     By hand or courier. You may deliver your written comments 
by hand or courier to the following address prior to the close of the 
comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02, 
Rockville, MD 20857. If you intend to deliver your comments to the 
Rockville address, please call (240) 276-2600 in advance to schedule 
your arrival with one of our staff members. Because access to the 
SAMHSA building is secure, persons without Federal Government 
identification are encouraged to schedule their delivery or to leave 
comments with the security guard at the front desk located in the main 
lobby of the building.
    All comments received before the close of the comment period will 
be available for viewing by the public. Please note that all comments 
are posted in their entirety, including personal or confidential 
business information that is included in the comment. SAMHSA will post 
all comments before the close of the comment period on the following 
website: https://www.regulations.gov. Use the website's search function 
to view the associated comments.
    Comments received before the close of the comment period will also 
be available for public inspection as they are received, generally 
beginning approximately three weeks after publication of a document, at 
SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday 
through Friday of each week, excluding Federal holidays, from 8:30 a.m. 
to 4:00 p.m. To schedule an appointment to view public comments, please 
call (240) 276-2600.

FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA, 
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by 
telephone (240) 276-1459 or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

    This notification of proposed revisions to the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs using Urine (UrMG) includes 
revisions that will: Establish a process whereby the Department 
annually publishes the authorized drug testing panel (i.e., drugs, 
analytes, and cutoffs) to be used for Federal workplace drug testing 
programs; revise the definition of a substituted specimen to include 
specimens with a biomarker concentration inconsistent with that 
established for a human specimen; establish a process whereby the 
Department publishes an authorized biomarker testing panel (i.e., 
biomarkers, analytes, and cutoffs) for Federal workplace drug testing 
programs; revise the confirmatory test cutoff for morphine; revise the 
Medical Review Officer (MRO) verification process for positive codeine 
and morphine specimens; and require MROs to submit semiannual reports 
to the Secretary or designated HHS representative on Federal agency 
specimens that were reported as positive for a drug or drug metabolite 
by a laboratory and verified as negative by the MRO. In addition, some 
wording changes have been made for clarity and for consistency with the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Oral Fluid (OFMG), 84 FR 57554 (October 25, 2019), or to apply to any 
authorized specimen type.
    The Department is publishing a separate Federal Register 
Notification (FRN) elsewhere in this issue of the Federal Register 
proposing revisions to the OFMG, including the same or similar 
revisions proposed for the UrMG, where appropriate.

Background

    The Department of Health and Human Services, pursuant to the 
Department's authority under Section 503 of Public Law 100-71, 5 U.S.C. 
Section 7301, and Executive Order 12564, establishes the scientific and 
technical guidelines for Federal workplace drug testing programs and 
establishes standards for certification of laboratories engaged in drug 
testing for Federal agencies. Using data obtained from the Federal 
Workplace Drug Testing Programs and HHS-certified laboratories, the 
Department estimates that 275,000 urine specimens are tested annually 
by Federal agencies.
    As required, HHS originally published the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs (Guidelines) in the Federal 
Register (FR) on April 11, 1988 (53 FR 11979). The Substance Abuse and 
Mental Health Services Administration (SAMHSA) subsequently revised the 
Guidelines on June 9, 1994 (59 FR 29908), September 30, 1997 (62 FR 
51118), November 13, 1998 (63 FR 63483), April 13, 2004 (69 FR 19644), 
and November 25, 2008 (73 FR 71858). SAMHSA published the current 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Urine (UrMG) on January 23, 2017 (82 FR 7920), and HHS published the 
current Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554).

Proposed Revisions to the HHS Mandatory Guidelines for Federal 
Workplace Drug Testing Programs

Authorized Drug Testing Panel

    The Guidelines pertain to a matter of Federal agency personnel and, 
therefore, are not subject to the notice and comment procedures under 
the Administrative Procedures Act. In light of the potential impact on 
entities outside of the Federal Government, the Department has chosen 
to submit the Guidelines to notice and comment, and will continue to do 
so. In this revision, the Department is proposing to change the way a 
specific part of the Guidelines

[[Page 20561]]

(i.e., the drug testing panel) is published and the frequency with 
which it is published.
    Since the original Guidelines were published in 1988, several 
recommendations have been made for drugs to be added to or removed from 
Federal workplace drug testing programs. The Department has revised the 
Guidelines in the past to add or remove drugs from the authorized drug 
testing panel and to revise test cutoffs (i.e., Section 3.4 of the 
UrMG). The time required to revise the Guidelines through the Federal 
review process has impeded the Department's ability to respond to drug 
use trends. Individuals may change their drug use, and illicit drug 
manufacturers may change their manufacturing methods, to avoid testing 
positive for drugs included in proposed Guidelines, especially as the 
number of new drugs and drug analogues increases. A less flexible drug 
testing panel may delay needed drug analyte or cutoff changes based on 
the state of the science (e.g., new technologies, research including 
dosing studies). Therefore, the Department proposes to publish the drug 
testing panel in the Federal Register on at least an annual basis, 
including any revisions to the panel, without the need (perceived or 
otherwise) to undergo notice and comment. Should the Department remove 
a drug from the drug testing panel, a Federal agency may test specimens 
for that drug in accordance with Section 3.2 (i.e., on a case-by-case 
basis for reasonable suspicion or post accident testing, or routinely 
with a waiver from the Secretary). This process is expected to improve 
the effectiveness of Federal agency drug testing programs in support of 
the Federal Drug-Free Workplace Program. The drug testing panel in 
Section 3.4 of the final UrMG will remain in effect until the 
Department publishes a separate FRN with the drug testing panel.
    The Department will continue to monitor drug use trends and review 
information on new drugs of abuse from sources such as Federal 
regulators, researchers, the drug testing industry (including HHS-
certified laboratories), and public and private sector employers, to 
determine whether drugs should be added or removed from the panel. Any 
changes to analytes and cutoffs made in accordance with the newly 
established drug testing panel publishing process will be based on a 
thorough review of relevant information, including the current state of 
the science, laboratory capabilities, cost associated with the change, 
and benefits of the change to Federal agencies. The Department will set 
a date for the panel changes to take effect and include the effective 
date in the annual drug testing panel FRN in order to allow time for 
drug testing service providers (e.g., immunoassay kit manufacturers) to 
develop or revise their products, and for HHS-certified laboratories to 
develop or revise assays, complete validation studies, and revise 
procedures. The prior version of the panel will remain in effect until 
the effective date of a newly published annual panel.
    For consistency and to avoid misinterpretation of drug test 
results, the Department is requiring HHS-certified laboratories and 
HHS-certified instrumented initial test facilities (collectively 
referred to hereafter as ``HHS-certified test facilities'') and Medical 
Review Officers (MROs) to report results using the nomenclature (i.e., 
analyte names and abbreviations) published with the drug testing panel.

Authorized Biomarker Testing Panel

    A biomarker is an endogenous substance used to validate a 
biological specimen. The purpose of a biomarker test is to determine 
whether a submitted specimen is a human specimen. The current UrMG 
(effective October 1, 2017) allow additional specimen validity testing 
using biomarkers upon MRO request, to provide information to assist the 
MRO in the verification process. The current UrMG also require HHS-
certified laboratories to report a specimen as invalid when the 
biomarker is not present or when its concentration is not consistent 
with that established for human urine but does not allow these 
specimens to be reported as substituted. The Department proposes to 
revise the UrMG to define such specimens as substituted, and to allow 
only biomarker tests that have been authorized by SAMHSA for use in 
Federal agency workplace drug testing programs.
    To ensure that scientifically valid biomarker tests, analytes, and 
cutoffs are standardized for Federal workplace drug testing, the 
Department will institute an approval process for biomarker tests, 
based on review of data from the scientific and/or medical literature, 
before authorizing the use of the biomarker test. This process is 
equivalent to the approval process currently in use for testing 
additional Schedule 1 and 2 drugs or adding new tests for a specific 
adulterant. The Department will accept scientific information submitted 
for review from various sources (e.g., HHS-certified test facilities, 
drug testing industry stakeholders, researchers). The Department will 
include the authorized biomarker testing panel (i.e., a table of 
biomarkers authorized for testing, with test analytes and cutoffs), in 
the FRN to be published annually (as described earlier in this 
preamble). Federal agencies may choose to test some or all of their 
workplace specimens for one or more authorized biomarkers.
    An HHS-certified laboratory, or (for urine only) an HHS-certified 
instrumented initial test facility (IITF), may request authorization 
from SAMHSA to conduct a biomarker test that has not been included on 
the list of authorized biomarkers. The test facility must submit 
supporting documentation and assay validation records to the National 
Laboratory Certification Program (NLCP) for SAMHSA review and approval. 
When a urine biomarker test is approved through this process, SAMHSA 
will authorize the individual HHS-certified test facility to perform 
the biomarker test for federally regulated specimens only upon MRO 
request (i.e., a blanket request for all specimens or a case-by-case 
request for a specific specimen). A certified laboratory or IITF may 
choose to begin the process by submitting supporting documentation for 
review prior to assay validation, or may send supporting documentation 
with completed validation records. The Department will continue to 
include measurands and decision points for other specimen validity 
tests in the UrMG (e.g., Sections 11.19 and 12.15).
    Once a biomarker test has been added to the authorized biomarker 
panel published in the FRN, any HHS-certified laboratory or IITF may 
routinely conduct the test without requiring an MRO request, and only 
require a signed MRO request for case-by-case biomarker testing (in 
accordance with UrMG section 3.5). The Department will continue to 
require NLCP review of biomarker assay validation records before 
allowing an IITF or laboratory to use the test for federally regulated 
workplace specimens.
    This process will facilitate the identification of donors who 
attempt to subvert their drug test, and ensure that biomarker tests 
used for federally regulated workplace programs are scientifically 
supportable and properly validated, and that all HHS-certified test 
facilities use the same analytes and cutoffs.
    For consistency and to avoid misinterpretation of biomarker test 
results, the Department is requiring HHS-certified test facilities and 
Medical Review Officers (MROs) to report results using the nomenclature 
(i.e., analyte names and abbreviations) published with the biomarker 
testing panel.

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

    The MRO has an essential role in federally regulated workplace drug 
testing programs that includes performing the review of laboratory 
results and supporting documentation, interviewing the donor when 
necessary, and making a final determination regarding the result. As 
described in Section 13.5d(2) of the current UrMG, when a donor has no 
legitimate medical explanation for a positive codeine or morphine 
result equal to or greater than 15,000 ng/mL, the MRO reports the 
specimen as positive to the agency. When a donor has no legitimate 
medical explanation for a positive codeine or morphine result less than 
15,000 ng/mL, the MRO must determine that there is clinical evidence of 
illegal opioid use (in addition to the test results) to report such 
specimens as positive. If the MRO finds no clinical evidence of illegal 
opioid use, the MRO verifies the opiate results as negative. These 
requirements were included in the UrMG to address positive codeine and/
or morphine results that may be due to poppy seed ingestion. The 
Department proposes to remove the additional decision point for codeine 
and morphine, to adjust the confirmatory test cutoff for morphine from 
2,000 to 4,000 ng/mL, and to remove the additional requirement for 
clinical evidence of illegal opioid use, as described above. The 
confirmatory test cutoff for codeine will remain at 2,000 ng/mL. The 
basis for the Department's proposed changes is described in the 
following paragraphs.
    A review of the scientific literature, as cited below, regarding 
the role of poppy seed food products in producing positive urine drug 
tests for the opiates, codeine and morphine, was undertaken to 
ascertain whether the current decision point should be maintained or 
changed. The Department focused on studies using analytical techniques 
acceptable to modern forensic toxicology laboratories, for which the 
researchers included information on poppy seed doses and adequately 
described the analytical techniques. Because most common poppy variants 
produce morphine in great excess to codeine, morphine concentrations 
significantly exceeded codeine concentrations in all reviewed studies.
    Studies of patients being tested for abstention from heroin use 
suggest that urine concentrations of morphine are often below 15,000 
ng/mL and the heroin metabolite, 6-acetylmorphine (6-AM) is absent, 
indicating the heroin use was not within the short detection limit for 
6-AM. A study by Colby et al. examined morphine concentrations in urine 
specimens from chronic pain patients being monitored for medication 
compliance. Patients with positive 6-AM results had morphine 
concentrations averaging 85,000 ng/mL (154,000 ng/mL), with 
25% at or below 10,000 ng/mL and an additional 15% falling between 
10,000 ng/mL and 20,000 ng/mL. (Ref. 1) However, it is well known that 
6-AM is generally positive in only the first few urine specimens 
following heroin dosing, making it the limiting factor in unequivocal 
detection of heroin use. (Ref. 2 and 3) Further, in a study by Wang et 
al., heroin metabolites including morphine were measured in subjects 
seeking in-patient addiction treatment for heroin use. In 20 subjects 
without 6-AM positive urine specimens, the total morphine concentration 
ranged from 87 to 34,896 ng/mL and averaged 9,960 ng/mL. Only 30% of 
the subjects had specimens above the 15,000 ng/mL decision point 
specified by the current UrMG. Lowering the morphine cutoff to 4,000 
ng/mL would identify another 30% of the heroin users in this type of 
cohort. (Ref. 4)
    In regard to poppy seed food products, the literature is consistent 
in the conclusion that regular ingestion of poppy seed-containing foods 
(bagels, cakes, curries, etc.) rarely results in urine opiate 
concentrations above the 2,000 ng/mL cutoff specified in the current 
UrMG, and that proper handling by pre-washing and cooking the poppy 
seeds into food products causes loss of both morphine and codeine. 
Studies attempting to characterize morphine and codeine results after 
reasonable consumption of poppy seed food products on an acute and 
chronic basis reported maximum morphine concentrations ranging between 
160 and 3,000 ng/mL with codeine ranging between 11 and 390 ng/mL. 
(Ref. 3 and 5-8) There is only one study in which the urine 
concentration of morphine exceeded 4,000 ng/mL after ingestion of 
regular prepared food containing poppy seeds, and the researchers 
reported that some subjects became ill due to the large amount of poppy 
seeds in the food product. (Ref. 9) The results of this study have not 
been duplicated in subsequent studies involving prepared food products.
    Other studies used extreme exposure protocols involving intolerable 
or near intolerable amounts of raw and/or unwashed poppy seeds, which 
are known to contain much more codeine and morphine than their washed 
and cooked counterparts. In one such extreme study in 2015, the 
researchers reported that participants felt that 15 g of raw, unwashed 
poppy seeds was close to the bearable limit for ingestion, and the 
maximum urine concentration was 4,200 ng/mL for morphine and 664 ng/mL 
for codiene. (Ref. 7) Of note, this study also included the same dose 
of poppy seeds baked in a roll and maximum morphine and codeine 
concentrations were considerably lower at 1,400 and 194 ng/ml, 
respectively. This research confirms the results of extreme ingestion 
by three volunteers in a 2003 study by Rohrig and Moore, and the 
experience in a 2014 study by Smith et al. in which only 19 of 22 
participants could tolerate ingestion of all planned doses. (Ref. 10 
and 11) Further, in the 2014 study, seven of the 19 subjects did not 
produce a positive morphine result (i.e., >=2,000 ng/mL) until after 
the second extreme dose of poppy seeds, approximately eight hours after 
the first dose. At all times in this study, codeine results were below 
the 2,000 ng/mL cutoff. The Department finds these studies relevant to 
setting the cutoff limit of 4,000 ng/mL for morphine and sufficient for 
eliminating positives due to poppy seeds because they confirm that 
urine morphine concentrations exceeding 4,000 ng/mL would be very rare, 
transient, and a consequence of unrealistic and extreme poppy seed 
exposure (i.e., ingesting barely tolerable amounts of raw and/or 
unwashed poppy seeds).
    The Department also reviewed information on other sources of poppy 
seed exposure. In reaction to at least 12 deaths reported in the 
scientific literature associated with the use of tea prepared with 
unwashed poppy seeds and the availability of unwashed poppy seeds from 
online retailers, the Drug Enforcement Administration (DEA) issued a 
warning in 2019 restating that unwashed poppy seeds are a danger to the 
user, and their use and misuse may result in unpredictable outcomes 
including death when used alone or in combination with other drugs. DEA 
reiterated that the morphine and codeine, if present as contaminants on 
poppy seed material, are not exempted from the Controlled Substances 
Act (CSA) control. (Ref. 12)
    In summary, the Department is not aware of any evidence that 
reasonable or realistic consumption of poppy seed-containing food 
products would cause a positive drug test using the codeine and 
morphine cutoffs specified by these Guidelines. Only purposeful 
consumption of large amounts (e.g., 15 g or more) of raw and/or 
unwashed poppy seeds has been shown to result in codeine at or above 
600 ng/mL or in morphine exceeding 4,000 ng/mL, and

[[Page 20563]]

the extreme amounts of poppy seeds in these studies, described by 
subjects as intolerable or barely tolerable, do not represent a real-
world situation for donors in a Federal agency testing program.
    Based on this information, the Department has decided that no 
additional decision point is needed for MRO verification of codeine and 
morphine results. Further, the Department has concluded that continued 
use of the current 15,000 ng/mL decision point diminishes the deterrent 
effect of the program by attributing codeine and morphine results 
between the cutoff and 15,000 ng/mL to poppy seed ingestion in the 
absence of a legitimate medical explanation. The Department proposes to 
raise the confirmatory test cutoff for morphine to 4,000 ng/mL to rule 
out any donor claims that consumption of poppy seed food products (on 
an acute or chronic basis) was the reason for a positive morphine test 
result. This cutoff change makes the Federal drug testing program 
cutoffs for codeine and morphine the same as the Department of Defense 
(DoD) program cutoffs, which were previously raised to these 
concentrations to eliminate positive tests due to poppy seeds. (Ref. 
14)

Medical Review Officer (MRO) Semiannual Reports

    The Department, through the NLCP, obtains information from HHS-
certified laboratories that is reviewed to verify accurate reports and 
compliance with Guidelines requirements. The NLCP conducts statistical 
analysis and provides reports to the Department on federally regulated 
workplace testing, although the data are limited to laboratory-reported 
results and not the final, MRO-verified results. To obtain additional 
information needed to assess compliance with the Mandatory Guidelines, 
the Department proposes to require each MRO performing medical review 
services for Federal agencies to submit semiannual reports, in January 
and July of each year, of Federal agency specimens that were reported 
as positive for a drug or drug metabolite by the laboratory, and 
verified as negative by the MRO, along with the reason for the negative 
verification (e.g., a valid prescription for a drug). The reports will 
not contain any personally identifiable information of the donors.
    This revision to the Guidelines will enable Department oversight of 
MRO reporting practices and will enhance the Department's ability to 
verify the accuracy of MRO reports and address areas of confusion about 
Guidelines requirements. The information in the MRO reports will be 
matched to information submitted to the NLCP by HHS-certified 
laboratories for the same specimens. This additional information will 
improve statistical analyses and provide a clearer picture of illicit 
drug use by Federal job applicants and employees.

Proposed Revisions to the Guidelines

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

Subpart A--Applicability

    Section 1.5 defines terms used in the UrMG. The Department has 
added terms and revised definitions in this section in accordance with 
proposed changes to these Guidelines, and to standardize terms and 
definitions, where possible, to apply to all authorized specimen types.
    The Department proposes to revise the Substituted Specimen 
definition to include specimens tested for a biomarker, when the 
biomarker is absent or is present at a concentration inconsistent with 
that established for a human specimen. For clarity, the Department also 
added a reference to the reporting criteria for substitution in Section 
3.7 of these Guidelines. For clarity and consistency with the revised 
Substituted Specimen definition, the Department proposes to edit the 
Adulterated Specimen definition to apply to specimens with ``an 
abnormal concentration of a normal constituent (e.g., nitrite in 
urine),'' rather than ``an abnormal concentration of an endogenous 
substance,'' and to revise definitions for Cutoff and Initial Specimen 
Validity Test to remove the ``(for urine)'' specification for 
identifying a substituted specimen. The Department proposes to revise 
the Collection Container definition to apply to all authorized specimen 
types, by changing ``a urine specimen'' to ``a donor's drug test 
specimen.'' The Department has also added definitions for ``Biomarker 
Testing Panel'' and ``Drug Testing Panel'' consistent with the proposed 
publication of these testing panels in a separate FRN each year.
    Section 1.7 describes what constitutes a donor's refusal to take a 
federally regulated drug test. Section 1.7(a) includes exceptions for a 
donor who fails to appear in a reasonable time for a pre-employment 
test and a donor who leaves the collection site before the collection 
process begins for a pre-employment test. The Department finds that 
there is no justification for altering a refusal to test based on 
whether the test is being conducted in the employment or pre-employment 
context and, therefore, proposes to remove these exceptions. The 
collector will report a refusal to test for any donor who fails to 
appear in a reasonable time or who leaves the collection site before 
the collection is complete, regardless of the reason for the test.
    Section 1.8(a) describes the potential consequences for a refusal 
to test. The Department has reworded this section to clarify potential 
actions for a Federal employee who refuses to take a drug test, and the 
potential action for an applicant who refuses to take a pre-employment 
test.

Subpart C--Urine Specimen Tests

    The Department proposes to edit Section 3.1 to reflect the proposed 
process for publishing drug and biomarker testing panels in an FRN each 
year containing a list of authorized drug analytes and biomarkers that 
can be tested. As described under Authorized drug testing panel and 
Authorized biomarker testing panel above, the time required to revise 
the Guidelines through the Federal review process has impeded the 
Department's ability to respond to drug use trends, and to make drug 
analyte or cutoff changes based on the state of the science (e.g., new 
technologies, research including dosing studies). This new process is 
expected to improve the effectiveness of Federal agency drug testing 
programs in support of the Federal Drug-Free Workplace Program. See 
also Section 3.4.
    For clarity, the Department also revised the header for Section 3.2 
to refer to ``drugs other than those in the drug testing panel'' (see 
above) rather than ``additional drugs''.
    The Department has revised the analytes and cutoffs table in 
Section 3.4 of the UrMG to reflect the proposed change to the 
confirmatory cutoff for morphine, and revised the section to describe 
the publication of a final notification in the Federal Register each 
year that will include the authorized drugs, test analytes, and 
cutoffs; the authorized biomarkers, test analytes, and cutoffs; and the 
nomenclature required for IITF, laboratory, and MRO reports. The annual 
notification will be posted on the SAMHSA website, https://www.samhsa.gov/workplace. The table in Section 3.4 of the final UrMG 
will remain in effect until the effective date of the new panels 
published in the separate FRN.
    Section 3.7 describes the criteria used to report a specimen as 
substituted and Section 3.9 describes the criteria used to report an 
invalid result for a urine

[[Page 20564]]

specimen. The current sections require laboratories to report a 
specimen as invalid when a biomarker is not present or its 
concentration is outside the range established for that biomarker in 
human urine. As described under Authorized biomarker testing panel 
above, the purpose of a biomarker test is to determine whether a 
submitted specimen is a human specimen. Therefore, the Department 
proposes to revise these sections to require specimens to be reported 
as substituted, rather than invalid, based on biomarker testing. See 
also Section 1.5.

Subpart H--Urine Specimen Collection Procedure

    The Department proposes to revise the wording in Section 8.3(f) 
regarding how instructions for completing the Federal Custody and 
Control Form (CCF) are provided to the donor. This is consistent with 
changes made to the Federal CCF to enable its use with both urine and 
oral fluid specimens.
    The Department moved items under Section 8.3(h) into a new item 
8.3(i) addressing the collector's request for the donor to display the 
contents of their pockets and subsequent collector actions. The 
required actions remain the same, but the Department revised wording in 
new items 8.3(i)(1) through 8.3(i)(4) for clarity.
    In Section 8.5(a), the Department clarified that the collector must 
inform the donor that the donor's failure to remain at the collection 
site until the collection is complete will be reported as a refusal to 
test. This is consistent with Section 1.7.
    The Department also revised wording in Section 8.9(a)(3) for 
clarity.

Subpart I--HHS Certification of Laboratories and IITFs

    Section 9.7 describes performance test (PT) requirements for an 
HHS-certified laboratory and Section 9.9 describes PT requirements for 
an HHS-certified IITF. PT error criteria will remain the same; however, 
the Department is proposing to edit some items for clarity. 
Specifically, the Department proposes to revise Sections 9.7(a)(5), 
9.7(a)(10), and 9.9(a)(6) to state clearly that quantitative values 
reported for drug and specimen validity tests are evaluated based on 
reported results for each PT cycle, not on cumulative results reported 
over two consecutive PT cycles. An HHS-certified test facility must not 
obtain a quantitative value outside the specified range for a drug or 
specimen validity test result, based on the appropriate reference or 
peer group mean.
    The Department also revised Section 9.6(a)(11) for an applicant 
laboratory and Section 9.7(a)(10) for an HHS-certified laboratory to 
address requirements for PT samples reported as substituted based on 
biomarker test results, in addition to those reported as substituted 
based on creatinine and specific gravity test results.

Subpart K--Laboratory

    Section 11.19 describes the requirements for an HHS-certified 
laboratory to report primary (A) specimen test results to an MRO. The 
Department proposes to revise the requirements for reporting a specimen 
as substituted in item 11.19(e) to include specimens with a biomarker 
concentration inconsistent with that established for human urine, in 
addition to those reported as substituted based on creatinine and 
specific gravity test results (see also Sections 1.5, 3.7, and 3.9).
    Section 11.19(g) addresses laboratory and MRO discussions to 
determine whether additional testing may be useful for specimens with 
certain invalid results. Because biomarker testing could be used to 
identify substitution, the Department has revised this section to 
indicate that additional testing may be useful in being able to report 
a substituted result, as well as positive or adulterated results.
    Section 11.19(g) describes the requirements for a laboratory to 
report a specimen as invalid. The Department has added an item 13 
addressing tests used to determine specimen validity, other than those 
specifically listed in this section.
    The Department also proposes to add a new item 11.19(m) stating 
that the laboratory must use the HHS-specified nomenclature published 
with the drug and biomarker testing panels on reports. This change is 
to ensure consistency in reporting and interpretation of test results, 
by requiring the results of each test performed to be reported using 
clear and correct nomenclature for test analytes, with the same 
terminology and units of measurement. See also Section 3.4.

Subpart L--Instrumented Initial Test Facility (IITF)

    Section 12.15 describes the requirements for an HHS-certified IITF 
to report primary (A) specimen test results to an MRO. The Department 
proposes to add a new item 12.15(e) stating that the IITF must use the 
HHS-specified nomenclature published with the drug and biomarker 
testing panels on reports. See also Section 3.4.

Subpart M--Medical Review Officer (MRO)

    Section 13.4(f) describes when an MRO must conduct a medical 
examination or review an examining physician's findings when the 
collector reported that the donor was unable to provide a specimen. The 
Department has clarified that a medical examination is not required 
when an alternate specimen was collected.
    Section 13.5(c)(2) describes MRO actions when a laboratory reports 
an invalid result in conjunction with a positive, adulterated, or 
substituted result. The Department has added an item to this section to 
clarify that the MRO takes the required action for the invalid result 
(specified in item f of this section) only when the MRO has verified 
the other result(s) for the specimen (i.e., positive, adulterated, or 
substituted) as negative or when the split (B) specimen was tested and 
reported as a failure to reconfirm.
    Section 13.5(d) describes MRO actions to determine whether the 
donor has a legitimate medical explanation for a positive specimen test 
result. The Department added a new item Section 13.5(d)(1) to clarify 
that the MRO reports a positive result when the donor admits 
unauthorized use of the drug(s) that caused the positive test result, 
and documents the admission of unauthorized use in the MRO records and 
in the MRO's report to the Federal agency. A donor's admission of 
unauthorized use corroborates the positive test.
    Currently, Section 13.5(d)(2) includes the policies of the 
Department that passive exposure to marijuana smoke and ingestion of 
food products containing marijuana are not acceptable medical 
explanations for a positive marijuana test result. The Department 
proposes to reword this section to clarify that these policies apply to 
any positive urine drug test results, not only positive marijuana 
results. Item i of this section now states that passive exposure to any 
drug is not an acceptable medical explanation for a positive drug test, 
with ``exposure to secondhand marijuana smoke'' as an example of 
passive exposure. Item ii of this section now states that ingestion of 
food products containing a drug is not an acceptable medical 
explanation for a positive drug test, with ``products containing 
marijuana'' and ``poppy seeds containing codeine and/or morphine'' as 
examples. The Department also proposes to add a new item iii to this 
section stating that a physician's authorization or medical 
recommendation for a Schedule I

[[Page 20565]]

substance is not an acceptable medical explanation for a positive drug 
test. Under the CSA, a Schedule I substance is defined as a drug, 
chemical, or other substance with no currently accepted medical use in 
the United States, a lack of accepted safety for use under medical 
supervision, and a high potential for abuse. (Ref. 13) The DEA 
maintains the current listing of controlled substances on their 
website.
    Section 13.5(d)(3) describes MRO actions when the donor has no 
legitimate medical explanation for a positive drug test result. The 
Department has revised this section to remove the exceptions for 
codeine and morphine. As described above under MRO verification of 
codeine and morphine test results, the Department has removed the 
additional 15,000 ng/mL decision point for codeine and morphine, as 
well as the requirement for the MRO to report such specimens as 
positive based on clinical evidence of illicit drug use (in addition to 
the drug test results). The MRO will follow the same verification 
procedures for all specimens with positive test results.
    Section 13.9 describes how an MRO reports primary (A) drug test 
results to an agency. The Department proposes to add a new item 13.9(e) 
stating that the MRO must use the HHS-specified nomenclature published 
with the drug and biomarker testing panels on reports. See also Section 
3.4.
    The Department has included a new Section 13.11 describing the 
proposed requirement for an MRO to send semiannual reports to the 
Secretary or designated HHS representative for Federal agency specimens 
that were reported as positive by a laboratory and verified as negative 
by the MRO. As described under Medical Review Officer (MRO) semiannual 
reports above, this change will enable Department oversight of MRO 
practices and will enhance the Department's ability to verify the 
accuracy of MRO reports and address areas of confusion about Guidelines 
requirements. In addition, the information in the MRO reports will be 
matched to information submitted to the NLCP by HHS-certified 
laboratories for the same specimens, thereby improving statistical 
analyses and providing a clearer picture of illicit drug use by Federal 
job applicants and employees. The reports must not include any 
personally identifiable information for the donor, and must be 
submitted within 14 working days after the end of the semiannual period 
(i.e., in July and January). Section 13.11 lists the information that 
must be included on the reports. To facilitate report preparation and 
review, the Department will include a template for these MRO reports in 
the MRO Guidance Manual and will arrange a secure method for MROs to 
submit reports electronically.
    The Department has included a new Section 13.12 describing the 
Federal agency's responsibilities for designating an MRO. These 
responsibilities include verifying and documenting that individuals 
meet the MRO requirements in these Guidelines before allowing them to 
serve as an MRO for the agency's drug testing program and on an ongoing 
basis, and ensuring that each MRO reports drug test results in 
accordance with the Guidelines. Further, the Federal agency must obtain 
documentation from the MRO to confirm that the MRO and any external 
service provider ensures the confidentiality integrity and availability 
of the data and limits the access to any data transmission, storage, 
and retrieval system.

Subpart N--Split Specimen Tests

    Section 14.4 describes how an HHS-certified laboratory reports a 
split (B) urine specimen when the primary (A) specimen was reported 
substituted. The Department proposes to revise this section to address 
primary (A) specimens reported as substituted based on biomarker test 
results, in addition to those reported as substituted based on 
creatinine and specific gravity test results. See also Section 1.5.
    Section 14.5 states that the HHS-certified laboratory that tested a 
split (B) specimen must report the results to the MRO. The Department 
proposes to reword this section to require the laboratory to use the 
HHS-specified nomenclature published with the drug and biomarker 
testing panels on reports for split (B) specimens. See also Section 
3.4.
    Section 14.6 describes the actions an MRO takes after receiving a 
split (B) urine specimen result from an HHS-certified laboratory. 
Section 14.6(c) specifies MRO actions when the laboratory failed to 
reconfirm one or more positive results and reported the split specimen 
as substituted. The Department proposes to revise this item to address 
actions when the B specimen was reported as substituted based on 
biomarker test results, in addition to those reported as substituted 
based on creatinine and specific gravity test results. See also Section 
1.5. The Department also proposes to add a new item 14.6(k) to address 
MRO verification of split (B) specimen results when the B specimen 
fails to reconfirm adulteration or substitution and is invalid.
    Section 14.7 describes how an MRO reports split (B) specimen test 
results to an agency. The Department proposes to add a new item 14.7(e) 
stating that the MRO must use the HHS-specified nomenclature published 
with the drug and biomarker testing panels on reports. See also Section 
3.4.

General Revisions

    In addition to the proposed changes described by subpart and 
section above, the Department has edited the UrMG to address proposed 
changes (e.g., removing ``for urine'' when referring to substituted 
specimens; referencing the proposed annual FRN with drug and biomarker 
testing panels) and has reworded some items for clarity and/or for 
consistency with the OFMG.

Impact of These Guidelines on Government Regulated Industries

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

Costs and Benefits

Costs

    The proposed UrMG revision to publish the drug testing panel in a 
separate FRN each year (e.g., Section 3.4) may result in a cost 
increase for HHS-certified test facilities and MROs (e.g., costs for 
test supplies, assay validation, administrative changes) when a new 
drug is added to the panel or when analytes or cutoffs are changed for 
current drugs. The added costs will depend on the change. For example, 
implementation costs would be lower for laboratories that already offer 
the drug test or use the different analyte or cutoff for their non-
regulated clients. MROs may experience increased costs when an agency 
chooses to test their Federal job applicants and employees for a new 
authorized drug with a high positivity rate or a Schedule II drug 
requiring the MRO to review medical explanations. Additional costs for 
testing and MRO review will be incorporated into the overall cost for 
the Federal agency submitting the specimen to the laboratory. Added 
costs to MROs would be expected to shift to Federal agencies over time, 
as existing contracts expire and new contract terms are negotiated. As 
noted earlier in this preamble, the Department will consider costs when 
deciding whether to make a change to the authorized drug tests. At this 
time, the Department will not

[[Page 20566]]

require HHS-certified test facilities to implement authorized biomarker 
tests. Each laboratory and IITF should conduct their own cost analysis 
when deciding whether to offer biomarker testing to federally regulated 
clients. The Department will consider costs when deciding whether to 
require all certified test facilities to test for a specific biomarker.
    The proposed change to the morphine confirmatory test cutoff from 
2,000 ng/mL to 4,000 ng/mL will result in some initial costs for HHS-
certified laboratories (e.g., to revalidate their opiate confirmatory 
assays, revise opiate calibrators and controls, and revise review and 
reporting procedures). However, there should also be some cost savings 
as described below under Benefits.
    There will be some administrative costs for MROs associated with 
the generation and submission of the semiannual reports of verified-
negative results (see Section 13.11). The Department encourages the use 
of electronic recordkeeping to facilitate information retrieval and 
report generation, and will enable secure submission of electronic 
information to reduce MRO costs to provide these reports.

Benefits

    The potential benefits of more timely changes to the drug testing 
panel will result in a healthier and more productive workforce, as well 
as avoid the issues associated with addiction and rehabilitation. Since 
the personnel tested under this program are in positions that are 
safety sensitive, potential benefits include decreased risk of 
transportation and workplace accidents, decreased risk of low-
probability high consequence events, a more responsible workforce in 
positions of public trust, and potentially reducing individuals' 
dependence or addiction and the personal benefits associated with those 
conditions. Considering the potential health and performance costs of 
drug misuse, the benefits to the Federal workplace and the individuals 
within that workplace justify the more agile method of changing the 
drug testing panel for the Federal workplace drug testing programs.
    The number of commercial substitution and adulteration products 
aimed at defeating a drug test continues to proliferate for both urine 
and oral fluid. Manufacturers alter their existing products or develop 
new products to subvert drug and specimen validity tests in federally 
regulated workplace programs. (Ref. 15 and 16) When the Department 
added provisions for biomarker testing in the current UrMG, the intent 
was to identify non-human urine samples that were submitted for testing 
in place of the donor's urine. The proposed revision to report a 
specimen as substituted (not invalid) based on biomarker testing is 
consistent with this intention. This revision, as well as the 
Department review and approval of biomarker tests and the added 
flexibility for making changes to the drug and biomarker testing 
panels, will strengthen the Federal Government's ability to identify 
illicit drug use and donor attempts to subvert drug tests.
    The proposed requirement for semiannual MRO reports on laboratory-
positive/MRO-negative results will enable the Department to ensure 
accurate reports and MRO compliance with Guidelines requirements. The 
information in the MRO reports will be matched to information for the 
same specimens that was submitted to the NLCP by the HHS-certified 
laboratory, thereby improving statistical analyses and providing a 
clearer picture of illicit drug use by Federal job applicants and 
employees.
    As noted above under Costs, HHS-certified laboratories will incur 
some initial costs for changing the morphine confirmatory test cutoff; 
however, laboratories will also experience some benefits in that the 
removal of the 15,000 ng/mL decision points for codeine and morphine 
will simplify codeine and morphine review and reporting procedures. 
MROs may also experience some savings, as the removal of the decision 
points and clinical evaluation requirement for some codeine and 
morphine positive results will simplify the MRO verification process. 
That is, codeine and morphine positive results will be reviewed and 
verified using the same procedures as positive results for other drugs.

Information Collection/Record Keeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines, which establish the 
scientific and technical guidelines for Federal workplace drug testing 
programs and establish standards for certification of laboratories 
engaged in urine drug testing for Federal agencies under authority of 5 
U.S.C. 7301 and Executive Order 12564, are approved by the Office of 
Management and Budget (OMB) under control number 0930-0158. The Federal 
Drug Testing Custody and Control Form (Federal CCF) used to document 
the collection and chain of custody of urine and oral fluid specimens 
at the collection site, for laboratories to report results, and for 
Medical Review Officers to make a determination; the National 
Laboratory Certification Program (NLCP) application; the NLCP 
Laboratory Information Checklist; and recordkeeping requirements in the 
current Guidelines, as approved under control number 0930-0158, will 
remain in effect.
    In support of the Government Paperwork Reduction Act (PRA), the 
Department revised the Federal CCF to enable its use as an electronic 
form (78 FR 42091, July 15, 2013) and developed requirements and 
oversight procedures to ensure that HHS-certified test facilities and 
other service providers (e.g., collection sites, MROs) using an 
electronic version of the Federal CCF (ECCF) maintain the accuracy, 
security, and confidentiality of electronic drug test information. 
Before a Federal ECCF can be used for Federal agency specimens, HHS-
certified test facilities must submit detailed information and proposed 
standard operating procedures (SOPs) to the NLCP for SAMHSA review and 
approval, and undergo an NLCP inspection focused on the proposed ECCF.
    Since 2013, SAMHSA has encouraged the use of Federal ECCFs and 
other electronic processes in HHS-certified test facilities, when 
practicable, for federally regulated testing operations. In accordance 
with Section 8108(a) of the SUPPORT for Patients and Communities Act, 
SAMHSA has set a deadline of August 31, 2023, for all HHS-certified 
laboratories to submit a request for approval of an electronic 
(paperless) Federal CCF.
    The title and description of the information collected and 
respondent description are shown in the following paragraphs with an 
estimate of the annual reporting, disclosure, and recordkeeping burden. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information.
    Title: The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs Using Urine.
    Description: The Mandatory Guidelines establish the scientific and 
technical guidelines for Federal drug testing programs and establish 
standards for certification of laboratories engaged in drug testing for 
Federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301 
note, and Executive Order 12564. Federal drug testing programs test 
applicants to sensitive positions, individuals involved in accidents,

[[Page 20567]]

individuals for cause, and random testing of persons in sensitive 
positions.
    Description of Respondents: Individuals or households, businesses, 
or other-for-profit and not-for-profit institutions.
    The burden estimates in the tables below are based on the following 
number of respondents: 38,000 donors who apply for employment or are 
employed in testing designated positions, 100 collectors, 25 urine 
specimen testing laboratories, 1 IITF, and 100 MROs.

                                                           Estimate of Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
9.2(a)(1)......................................  Laboratory or IITF required to submit                10               1               3              30
                                                  application for certification.
9.12(a)(3).....................................  Materials to submit to become an HHS                 10               1               2              20
                                                  inspector.
11.3...........................................  Laboratory submits qualifications of                 10               1               2              20
                                                  responsible person (RP) to HHS.
11.4(c)........................................  Laboratory submits information to HHS                10               1               2              20
                                                  on new RP or alternate RP.
11.22..........................................  Specifications for laboratory                        10               5             0.5              25
                                                  semiannual statistical report of test
                                                  results to each Federal agency.
12.3(a)........................................  IITF \1\ submits qualifications of RT                 1               1               1               1
                                                  to HHS.
12.4(c)........................................  IITF \1\ submits information to HHS on                1               1               1               1
                                                  new RT or alternate RT.
12.19..........................................  Specifications for IITF \1\ semiannual                1               1               1               1
                                                  statistical report of test results to
                                                  each Federal agency.
13.9 and 14.7..................................  Specifies that MRO must report all                  100              14    0.05 (3 min)              70
                                                  verified primary and split specimen
                                                  test results to the Federal agency.
13.11..........................................  Specifications for MRO semiannual                   100               2             0.5             100
                                                  report to the Secretary or designated
                                                  representative for Federal agency
                                                  specimen results that were laboratory-
                                                  positive and MRO-verified negative.
16.1(b) & 16.5(a)..............................  Specifies content of request for                      1               1               3               3
                                                  informal review of suspension/proposed
                                                  revocation of certification.
16.4...........................................  Specifies information appellant                       1               1             0.5             0.5
                                                  provides in first written submission
                                                  when laboratory suspension/revocation
                                                  is proposed.
16.6...........................................  Requires appellant to notify reviewing                1               1             0.5             0.5
                                                  official of resolution status at end
                                                  of abeyance period.
16.7(a)........................................  Specifies contents of appellant                       1               1              50              50
                                                  submission for review.
16.9(a)........................................  Specifies content of appellant request                1               1               3               3
                                                  for expedited review of suspension or
                                                  proposed revocation.
16.9(c)........................................  Specifies contents of review file and                 1               1              50              50
                                                  briefs.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             259  ..............  ..............             395
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application for certification to test federally regulated specimens.
  IITF numbers are provided in this analysis as placeholders for administrative purposes.

    The following reporting requirements are also in the proposed 
Guidelines, but have not been addressed in the above reporting burden 
table: Collector must report any unusual donor behavior or refusal to 
participate in the collection process on the Federal CCF (Sections 1.8, 
8.9); collector annotates the Federal CCF when a sample is a blind 
sample (Section 10.3(a)); MRO notifies the Federal agency and HHS when 
an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6 
and 13.7 describe the actions an MRO takes for the medical evaluation 
of a donor who cannot provide a urine specimen. SAMHSA has not 
calculated a separate reporting burden for these requirements because 
they are included in the burden hours estimated for collectors to 
complete Federal CCFs and for MROs to report results to Federal 
agencies.

                                                          Estimate of Annual Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a), 8.5(f)(2)(iii), 8.6(b)(2)..............  Collector must contact Federal agency               100               1    0.05 (3 min)               5
                                                  point of contact.
11.23, 11.24...................................  Information on drug test that                        25              10               3             750
                                                  laboratory must provide to Federal
                                                  agency upon request or to donor
                                                  through MRO.

[[Page 20568]]

 
12.20, 12.21...................................  Information on drug test that IITF must               1               1               1               1
                                                  provide to Federal agency upon request
                                                  or to donor through MRO.
13.8(b)........................................  MRO must inform donor of right to                   100              14               3           4,200
                                                  request split specimen test when a
                                                  positive, adulterated, or substituted
                                                  result is reported.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             226  ..............  ..............            4956
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The following disclosure requirements are also included in the 
proposed Guidelines, but have not been addressed in the above 
disclosure burden table: The collector must explain the basic 
collection procedure to the donor and answer any questions (Section 
8.3(e) and (g)). SAMHSA believes having the collector explain the 
collection procedure to the donor and answer any questions is a 
standard business practice and not a disclosure burden.

                                                         Estimate of Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.5, 8.8..................................  Collector completes Federal CCF for                 100             380    0.07 (4 min)           2,660
                                                  specimen collected.
8.8(d) & (f)...................................  Donor initials specimen labels/seals             38,000               1    0.08 (5 min)           3,040
                                                  and signs statement on the Federal CCF.
11.8(a) & 11.19................................  Laboratory completes Federal CCF upon                25           1,520    0.05 (3 min)           1,900
                                                  receipt of specimen and before
                                                  reporting result.
12.8(a) & 12.15................................  IITF completes Federal CCF upon receipt               1               1               1               1
                                                  of specimen and before reporting
                                                  result.
13.4(d)(4),13.9(c),14.7(c).....................  MRO completes Federal CCF before                    100             380    0.05 (3 min)           1,900
                                                  reporting the primary or split
                                                  specimen result.
14.1(b)........................................  MRO documents donor's request to have               100               2    0.05 (3 min)              10
                                                  split specimen tested.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................          38,326  ..............  ..............           9,511
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The proposed Guidelines contain several recordkeeping requirements 
that SAMHSA considers not to be an additional recordkeeping burden. In 
subpart D, a trainer is required to document the training of an 
individual to be a collector (Section 4.3(a)(3)) and the documentation 
must be maintained in the collector's training file (Section 4.3(c)). 
SAMHSA believes this training documentation is common practice and is 
not considered an additional burden. In subpart F, if a collector uses 
an incorrect form to collect a Federal agency specimen, the collector 
is required to provide a statement (Section 6.2(b)) explaining why an 
incorrect form was used to document collecting the specimen. SAMHSA 
believes this is an extremely infrequent occurrence and does not create 
a significant additional recordkeeping burden. Subpart H (Sections 
8.4(c), 8.5(d)(2), 8.5(e)(1) and (2)) requires collectors to enter any 
information on the Federal CCF of any unusual findings during the urine 
specimen collection procedure. These recordkeeping requirements are an 
integral part of the collection procedure and are essential to 
documenting the chain of custody for the specimens collected. The 
burden for these entries is included in the recordkeeping burden 
estimated to complete the Federal CCF and is, therefore, not considered 
an additional recordkeeping burden. Subpart K describes a number of 
recordkeeping requirements for laboratories associated with their 
testing procedures, maintaining chain of custody, and keeping records 
(i.e., Sections 11.1(a) and (d); 11.2(b), (c), and (d); 11.6(b); 
11.7(c); 11.8; 11.11(a); 11.14(a); 11.17; 11.21(a), (b), and (c); 
11.22; 11.23(a); and 11.24). These recordkeeping requirements are 
necessary for any laboratory to conduct forensic drug testing and to 
ensure the scientific supportability of the test results. Therefore, 
they are considered to be standard business practice and are not 
considered a burden for this analysis.
    Thus, the total annual response burden associated with the testing 
of urine specimens by the laboratories and IITFs is estimated to be 
14,862 hours (that is, the sum of the total hours from the above 
tables). This is in addition to the 1,788,809 hours currently approved 
by OMB under control number 0930-0158 for urine testing under the 
current Guidelines.
    As required by section 3507(d) of the PRA, the Secretary has 
submitted a copy of these proposed Guidelines to OMB for its review. 
Comments on the information collection requirements are specifically 
solicited in order to: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of HHS's functions, 
including whether the information will have practical utility; (2) 
evaluate the accuracy of HHS's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and (4) minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other

[[Page 20569]]

technological collection techniques or other forms of information 
technology.
    OMB is required to make a decision concerning the collection of 
information contained in these proposed Guidelines between 30 and 60 
days after publication of this document in the Federal Register. 
Therefore, a comment to OMB is best assured of having its full effect 
if OMB receives it within 30 days of publication. This does not affect 
the deadline for the public to comment to HHS on the proposed 
Guidelines.
    Organizations and individuals desiring to submit comments on the 
information collection requirements should direct them to the Office of 
Information and Regulatory Affairs, OMB, New Executive Office Building, 
725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for 
SAMHSA. Because of delays in receipt of mail, comments may also be sent 
to 202-395-6974 (fax).

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2019. DEA/DC/DO/DOE, DEA PRB 11-15-19-44.
13. U.S. Department of Justice (DOJ), Drug Enforcement Agency (DEA), 
Diversion Control Division. Controlled Substance Schedules. https://www.deadiversion.usdoj.gov. Accessed June 9, 2021.
14. U.S. Department of Defense (DoD). Instruction 1010.16, Technical 
procedures for the military drug abuse testing program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf. 
Accessed June 9, 2021.
15. Kim, V.J., Okano, C.K., Osborne, C.R., Frank, D.M., Meana, C.T., 
Castaneto, M.S, 2018. Can synthetic urine replace authentic urine to 
``beat'' workplace drug testing? Drug Test. Anal., 11(2), 331-335.
16. Quest Diagnostics, 2018. Workforce drug positivity at highest 
rate in a decade, finds analysis of more than 10 million drug test 
results. https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf. Accessed October 
19, 2018.

Summary

    These proposed revisions are intended to simplify changes to the 
authorized drug testing panel for Federal workplace drug testing 
programs, facilitate the identification of substituted specimens using 
biomarker testing, improve detection of illicit codeine and/or morphine 
use, and provide the Department with information on Federal agency drug 
test specimens that were reported as positive for a drug or drug 
metabolite by a laboratory and verified negative by the Medical Review 
Officer (MRO). The Department believes that the proposed revisions to 
the Mandatory Guidelines save costs and improve the effectiveness of 
Federal workplace drug testing programs.

    Dated: March 22, 2022.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Substance 
Abuse and Mental Health Services Administration.
    Approved: March 22, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using 
Urine Specimens

Subpart A--Applicability
1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these 
Guidelines?
1.3 How does a federal agency request a change from these 
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect employee records?
1.7 What is a refusal to take a federally regulated drug test?
1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?
Subpart B--Urine Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may a urine specimen be collected?
2.3 How is each urine specimen collected?
2.4 What volume of urine is collected?
2.5 How does the collector split the urine specimen?
2.6 When may an entity or individual release a urine specimen?
Subpart C--Urine Specimen Tests
3.1 Which tests are conducted on a urine specimen?
3.2 May a specimen be tested for drugs other than those in the drug 
testing panel?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug and biomarker test analytes and cutoffs for 
urine?
3.5 May an HHS-certified laboratory perform additional drug and/or 
specimen validity tests on a specimen at the request of the Medical 
Review Officer (MRO)?
3.6 What criteria are used to report a urine specimen as 
adulterated?
3.7 What criteria are used to report a urine specimen as 
substituted?
3.8 What criteria are used to report a urine specimen as dilute?
3.9 What criteria are used to report an invalid result for a urine 
specimen?
Subpart D--Collectors
4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?

[[Page 20570]]

4.3 What are the requirements to be a collector?
4.4 What are the requirements to be an observer for a direct 
observed collection?
4.5 What are the requirements to be a trainer for collectors?
4.6 What must a federal agency do before a collector is permitted to 
collect a specimen?
Subpart E--Collection Sites
5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a 
specimen at the collection site?
5.6 What are the privacy requirements when collecting a urine 
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?
Subpart G--Urine Specimen Collection Containers and Bottles
7.1 What is used to collect a urine specimen?
7.2 What are the requirements for a urine collection container and 
specimen bottles?
7.3 What are the minimum performance requirements for a urine 
collection container and specimen bottles?
Subpart H--Urine Specimen Collection Procedure
8.1 What privacy must the donor be given when providing a urine 
specimen?
8.2 What must the collector ensure at the collection site before 
starting a urine specimen collection?
8.3 What are the preliminary steps in the urine specimen collection 
procedure?
8.4 What steps does the collector take in the collection procedure 
before the donor provides a urine specimen?
8.5 What steps does the collector take during and after the urine 
specimen collection procedure?
8.6 What procedure is used when the donor states that they are 
unable to provide a urine specimen?
8.7 If the donor is unable to provide a urine specimen, may another 
specimen type be collected for testing?
8.8 How does the collector prepare the urine specimens?
8.9 When is a direct observed collection conducted?
8.10 How is a direct observed collection conducted?
8.11 When is a monitored collection conducted?
8.12 How is a monitored collection conducted?
8.13 How does the collector report a donor's refusal to test?
8.14 What are a federal agency's responsibilities for a collection 
site?
Subpart I--HHS Certification of Laboratories and IITFs
9.1 Who has the authority to certify laboratories and IITFs to test 
urine specimens for federal agencies?
9.2 What is the process for a laboratory or IITF to become HHS-
certified?
9.3 What is the process for a laboratory or IITF to maintain HHS 
certification?
9.4 What is the process when a laboratory or IITF does not maintain 
its HHS certification?
9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory?
9.7 What are the PT requirements for an HHS-certified urine 
laboratory?
9.8 What are the PT requirements for an applicant IITF?
9.9 What are the PT requirements for an HHS-certified IITF?
9.10 What are the inspection requirements for an applicant 
laboratory or IITF?
9.11 What are the maintenance inspection requirements for an HHS-
certified laboratory or IITF?
9.12 Who can inspect an HHS-certified laboratory or IITF and when 
may the inspection be conducted?
9.13 What happens if an applicant laboratory or IITF does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?
9.14 What happens if an HHS-certified laboratory or IITF does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?
9.15 What factors are considered in determining whether revocation 
of a laboratory's or IITF's HHS certification is necessary?
9.16 What factors are considered in determining whether to suspend a 
laboratory's or an IITF's HHS certification?
9.17 How does the Secretary notify an HHS-certified laboratory or 
IITF that action is being taken against the laboratory or IITF?
9.18 May a laboratory or IITF that had its HHS certification revoked 
be recertified to test federal agency specimens?
9.19 Where is the list of HHS-certified laboratories and IITFs 
published?
Subpart J--Blind Samples Submitted by an Agency
10.1 What are the requirements for federal agencies to submit blind 
samples to HHS-certified laboratories or IITFs?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory 
or IITF?
10.4 What happens if an inconsistent result is reported for a blind 
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications must the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified 
laboratory?
11.5 What qualifications must an individual have to certify a result 
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other personnel of an 
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory 
maintain?
11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?
11.9 What test(s) does an HHS-certified laboratory conduct on a 
urine specimen received from an IITF?
11.10 What are the requirements for an initial drug test?
11.11 What must an HHS-certified laboratory do to validate an 
initial drug test?
11.12 What are the batch quality control requirements when 
conducting an initial drug test?
11.13 What are the requirements for a confirmatory drug test?
11.14 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
11.15 What are the batch quality control requirements when 
conducting a confirmatory drug test?
11.16 What are the analytical and quality control requirements for 
conducting specimen validity tests?
11.17 What must an HHS-certified laboratory do to validate a 
specimen validity test?
11.18 What are the requirements for conducting each specimen 
validity test?
11.19 What are the requirements for an HHS-certified laboratory to 
report a test result?
11.20 How long must an HHS-certified laboratory retain specimens?
11.21 How long must an HHS-certified laboratory retain records?
11.22 What statistical summary reports must an HHS-certified 
laboratory provide for urine testing?
11.23 What HHS-certified laboratory information is available to a 
federal agency?
11.24 What HHS-certified laboratory information is available to a 
federal employee?
11.25 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
11.26 What type of relationship can exist between an HHS-certified 
laboratory and an HHS-certified IITF?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 What must be included in the HHS-certified IITF's standard 
operating procedure manual?
12.2 What are the responsibilities of the responsible technician 
(RT)?
12.3 What qualifications must the RT have?
12.4 What happens when the RT is absent or leaves an HHS-certified 
IITF?

[[Page 20571]]

12.5 What qualifications must an individual have to certify a result 
reported by an HHS-certified IITF?
12.6 What qualifications and training must other personnel of an 
HHS-certified IITF have?
12.7 What security measures must an HHS-certified IITF maintain?
12.8 What are the IITF chain of custody requirements for specimens 
and aliquots?
12.9 What are the requirements for an initial drug test?
12.10 What must an HHS-certified IITF do to validate an initial drug 
test?
12.11 What are the batch quality control requirements when 
conducting an initial drug test?
12.12 What are the analytical and quality control requirements for 
conducting specimen validity tests?
12.13 What must an HHS-certified IITF do to validate a specimen 
validity test?
12.14 What are the requirements for conducting each specimen 
validity test?
12.15 What are the requirements for an HHS-certified IITF to report 
a test result?
12.16 How does an HHS-certified IITF handle a specimen that tested 
positive, adulterated, substituted, or invalid at the IITF?
12.17 How long must an HHS-certified IITF retain a specimen?
12.18 How long must an HHS-certified IITF retain records?
12.19 What statistical summary reports must an HHS-certified IITF 
provide?
12.20 What HHS-certified IITF information is available to a federal 
agency?
12.21 What HHS-certified IITF information is available to a federal 
employee?
12.22 What types of relationships are prohibited between an HHS-
certified IITF and an MRO?
12.23 What type of relationship can exist between an HHS-certified 
IITF and an HHS-certified laboratory?
Subpart M--Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards 
that certify MROs approved?
13.3 What training is required before a physician may serve as an 
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing a urine specimen's test 
results?
13.6 What action does the MRO take when the collector reports that 
the donor did not provide a sufficient amount of urine for a drug 
test?
13.7 What happens when an individual is unable to provide a 
sufficient amount of urine for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because 
of a permanent or long-term medical condition?
13.8 Who may request a test of a split (B) specimen?
13.9 How does an MRO report a primary (A) specimen test result to an 
agency?
13.10 What types of relationships are prohibited between an MRO and 
an HHS-certified laboratory or an HHS-certified IITF?
13.11 What reports must an MRO provide to the Secretary for urine 
testing?
13.12 What are a federal agency's responsibilities for designating 
an MRO?
Subpart N--Split Specimen Tests
14.1 When may a split (B) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen 
when the primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) urine 
specimen when the primary (A) specimen was reported adulterated?
14.4 How does an HHS-certified laboratory test a split (B) urine 
specimen when the primary (A) specimen was reported substituted?
14.5 Who receives the split (B) specimen result?
14.6 What action(s) does an MRO take after receiving the split (B) 
urine specimen result from the second HHS-certified laboratory?
14.7 How does an MRO report a split (B) specimen test result to an 
agency?
14.8 How long must an HHS-certified laboratory retain a split (B) 
specimen?
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory or an 
HHS-certified IITF to report a urine specimen as rejected for 
testing?
15.2 What discrepancies require an HHS-certified laboratory or an 
HHS-certified IITF to report a specimen as rejected for testing 
unless the discrepancy is corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory or an HHS-certified IITF to reject a urine 
specimen for testing or an MRO to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?
Subpart P--Laboratory or IITF Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory or IITF be 
suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written 
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate 
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing 
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?

Subpart A--Applicability

Section 1.1 To whom do these Guidelines apply?

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

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

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

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

    (a) Each federal agency must ensure that its workplace drug testing 
program complies with the provisions of these Guidelines unless a 
waiver has been obtained from the Secretary.
    (b) To obtain a waiver, a federal agency must submit a written 
request to

[[Page 20572]]

the Secretary that describes the specific change for which a waiver is 
sought and a detailed justification for the change.

Section 1.4 How are these Guidelines revised?

    (a) To ensure the full reliability and accuracy of specimen tests, 
the accurate reporting of test results, and the integrity and efficacy 
of federal drug testing programs, the Secretary may make changes to 
these Guidelines to reflect improvements in the available science and 
technology.
    (b) Revisions to these Guidelines will be published in final as a 
notice in the Federal Register.

Section 1.5 What do the terms used in these Guidelines mean?

    The following definitions are adopted:
    Accessioner. The individual who signs the Federal Drug Testing 
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.
    Adulterated Specimen. A specimen that has been altered, as 
evidenced by test results showing either a substance that is not a 
normal constituent for that type of specimen or showing an abnormal 
concentration of a normal constituent (e.g., nitrite in urine).
    Aliquot. A portion of a specimen used for testing.
    Alternate Responsible Person. The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified laboratory when the 
responsible person is unable to fulfill these obligations.
    Alternate Responsible Technician. The person who assumes 
professional, organizational, educational, and administrative 
responsibility for the day-to-day management of the HHS-certified IITF 
when the responsible technician is unable to fulfill these obligations.
    Alternate Technology Initial Drug Test. An initial drug test using 
technology other than immunoassay to differentiate negative specimens 
from those requiring further testing.
    Batch. A number of specimens or aliquots handled concurrently as a 
group.
    Biomarker. An endogenous substance used to validate a biological 
specimen.
    Biomarker Testing Panel. The panel published in the Federal 
Register that includes the biomarkers authorized for testing, with 
analytes and cutoffs for initial and confirmatory biomarker tests, as 
described under Section 3.4.
    Blind Sample. A sample submitted to an HHS-certified test facility 
for quality assurance purposes, with a fictitious identifier, so that 
the test facility cannot distinguish it from a donor specimen.
    Calibrator. A sample of known content and analyte concentration 
prepared in the appropriate matrix used to define expected outcomes of 
a testing procedure. The test result of the calibrator is verified to 
be within established limits prior to use.
    Cancelled Test. The result reported by the MRO to the federal 
agency when a specimen has been reported to the MRO as an invalid 
result (and the donor has no legitimate explanation) or rejected for 
testing, when a split specimen fails to reconfirm, or when the MRO 
determines that a fatal flaw or unrecovered correctable flaw exists in 
the forensic records (as described in Sections 15.1 and 15.2).
    Carryover. The effect that occurs when a sample result (e.g., drug 
concentration) is affected by a preceding sample during the preparation 
or analysis of a sample.
    Certifying Scientist (CS). The individual responsible for verifying 
the chain of custody and scientific reliability of a test result 
reported by an HHS-certified laboratory.
    Certifying Technician (CT). The individual responsible for 
verifying the chain of custody and scientific reliability of negative, 
rejected for testing, and (for urine) negative/dilute results reported 
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
    Chain of Custody (COC) Procedures. Procedures that document the 
integrity of each specimen or aliquot from the point of collection to 
final disposition.
    Chain of Custody Documents. Forms used to document the control and 
security of the specimen and all aliquots. The document may account for 
an individual specimen, aliquot, or batch of specimens/aliquots and 
must include the name and signature of each individual who handled the 
specimen(s) or aliquot(s) and the date and purpose of the handling.
    Collection Container. A receptacle used to collect a donor's drug 
test specimen.
    Collection Site. The location where specimens are collected.
    Collector. A person trained to instruct and assist a donor in 
providing a specimen.
    Confirmatory Drug Test. A second analytical procedure performed on 
a separate aliquot of a specimen to identify and quantify a specific 
drug or drug metabolite.
    Confirmatory Specimen Validity Test. A second test performed on a 
separate aliquot of a specimen to further support a specimen validity 
test result.
    Control. A sample used to evaluate whether an analytical procedure 
or test is operating within predefined tolerance limits.
    Cutoff. The analytical value (e.g., drug, drug metabolite, or 
biomarker concentration) used as the decision point to determine a 
result (e.g., negative, positive, adulterated, invalid, or substituted) 
or the need for further testing.
    Dilute Specimen. A urine specimen with creatinine and specific 
gravity values that are lower than expected but are still within the 
physiologically producible ranges of human urine.
    Donor. The individual from whom a specimen is collected.
    Drug Testing Panel. The panel published in the Federal Register 
that includes the drugs authorized for testing, with analytes and 
cutoffs for initial and confirmatory drug tests, as described under 
Section 3.4.
    External Service Provider. An independent entity that performs 
services related to federal workplace drug testing on behalf of a 
federal agency, a collector/collection site, an HHS[hyphen]certified 
laboratory, a Medical Review Officer (MRO), or (for urine) an 
HHS[hyphen]certified Instrumented Initial Test Facility (IITF).
    Failed to Reconfirm. The result reported for a split (B) specimen 
when a second HHS-certified laboratory is unable to corroborate the 
result reported for the primary (A) specimen.
    Federal Drug Testing Custody and Control Form (Federal CCF). The 
Office of Management and Budget (OMB) approved form that is used to 
document the collection and chain of custody of a specimen from the 
time the specimen is collected until it is received by the test 
facility (i.e., HHS-certified laboratory or, for urine, HHS-certified 
IITF). It may be a paper (hardcopy), electronic, or combination 
electronic and paper format (hybrid). The form may also be used to 
report the test result to the Medical Review Officer.
    Gender Identity. Gender identity means an individual's internal 
sense of being male or female, which may be different from an 
individual's sex assigned at birth.
    HHS. The Department of Health and Human Services.
    Initial Drug Test. An analysis used to differentiate negative 
specimens from those requiring further testing.
    Initial Specimen Validity Test. The first analysis used to 
determine if a specimen is adulterated, invalid, substituted, or (for 
urine) dilute.

[[Page 20573]]

    Instrumented Initial Test Facility (IITF). A permanent location 
where (for urine) initial testing, reporting of results, and 
recordkeeping are performed under the supervision of a responsible 
technician.
    Invalid Result. The result reported by an HHS-certified laboratory 
in accordance with the criteria established in Section 3.9 when a 
positive, negative, adulterated, or substituted result cannot be 
established for a specific drug or specimen validity test.
    Laboratory. A permanent location where initial and confirmatory 
drug testing, reporting of results, and recordkeeping are performed 
under the supervision of a responsible person.
    Limit of Detection. The lowest concentration at which the analyte 
(e.g., drug or drug metabolite) can be identified.
    Limit of Quantification (LOQ). For quantitative assays, the lowest 
concentration at which the identity and concentration of the analyte 
(e.g., drug or drug metabolite) can be accurately established.
    Lot. A number of units of an item (e.g., reagents, quality control 
material) manufactured from the same starting materials within a 
specified period of time for which the manufacturer ensures that the 
items have essentially the same performance characteristics and 
expiration date.
    Medical Review Officer (MRO). A licensed physician who reviews, 
verifies, and reports a specimen test result to the federal agency.
    Negative Result. The result reported by an HHS-certified laboratory 
or (for urine) an HHS-certified IITF to an MRO when a specimen contains 
no drug and/or drug metabolite; or the concentration of the drug or 
drug metabolite is less than the cutoff for that drug or drug class.
    Oral Fluid Specimen. An oral fluid specimen is collected from the 
donor's oral cavity and is a combination of physiological fluids 
produced primarily by the salivary glands.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drug or drug metabolites to prevent 
the detection of the drugs or drug metabolites, or affects the reagents 
in either the initial or confirmatory drug test.
    Performance Testing (PT) Sample. A program-generated sample sent to 
a laboratory or (for urine) to an IITF to evaluate performance.
    Positive Result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the confirmatory test cutoff.
    Reconfirmed. The result reported for a split (B) specimen when the 
second HHS-certified laboratory corroborates the original result 
reported for the primary (A) specimen.
    Rejected for Testing. The result reported by an HHS-certified 
laboratory or (for urine) HHS-certified IITF when no tests are 
performed on a specimen because of a fatal flaw or an unrecovered 
correctable error (see Sections 15.1 and 15.2).
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of an HHS-certified laboratory.
    Responsible Technician (RT). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of an HHS-certified IITF.
    Sample. A performance testing sample, calibrator or control used 
during testing, or a representative portion of a donor's specimen.
    Secretary. The Secretary of the U.S. Department of Health and Human 
Services.
    Specimen. Fluid or material collected from a donor at the 
collection site for the purpose of a drug test.
    Split Specimen Collection (for Urine). A collection in which the 
specimen collected is divided into a primary (A) specimen and a split 
(B) specimen, which are independently sealed in the presence of the 
donor.
    Standard. Reference material of known purity or a solution 
containing a reference material at a known concentration.
    Substituted Specimen. A specimen that has been submitted in place 
of the donor's specimen, as evidenced by the absence of a biomarker or 
a biomarker concentration inconsistent with that established for a 
human specimen, as indicated in the biomarker testing panel, or (for 
urine) creatinine and specific gravity values that are outside the 
physiologically producible ranges of human urine, in accordance with 
the criteria to report a specimen as substituted in UrMG Section 3.7.

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

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

Section 1.7 What is a refusal to take a federally regulated drug test?

    (a) As a donor for a federally regulated drug test, you have 
refused to take a federally regulated drug test if you:
    (1) Fail to appear for any test within a reasonable time, as 
determined by the federal agency, consistent with applicable agency 
regulations, after being directed to do so by the federal agency;
    (2) Fail to remain at the collection site until the collection 
process is complete;
    (3) Fail to provide a specimen (e.g., urine or another authorized 
specimen type) for any drug test required by these Guidelines or 
federal agency regulations;
    (4) In the case of a direct observed or monitored collection, fail 
to permit the observation or monitoring of your provision of a specimen 
when required as described in Sections 8.9 and 8.10;
    (5) Fail to provide a sufficient amount of urine when directed, and 
it has been determined, through a required medical evaluation, that 
there was no legitimate medical explanation for the failure as 
determined by the process described in Section 13.6;
    (6) Fail or decline to participate in an alternate specimen 
collection (e.g., oral fluid) as directed by the federal agency or 
collector (i.e., as described in Section 8.6);
    (7) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification

[[Page 20574]]

process (i.e., Section 13.6) or as directed by the federal agency. In 
the case of a federal agency applicant/pre-employment drug test, the 
donor is deemed to have refused to test on this basis only if the 
federal agency applicant/pre-employment test is conducted following a 
contingent offer of employment. If there was no contingent offer of 
employment, the MRO will cancel the test;
    (8) Fail to cooperate with any part of the testing process (e.g., 
refuse to empty pockets when directed by the collector, disrupt the 
collection process, fail to wash hands after being directed to do so by 
the collector);
    (9) For an observed collection, fail to follow the observer's 
instructions related to the collection process;
    (10) Bring materials to the collection site for the purpose of 
adulterating, substituting, or diluting the specimen;
    (11) Attempt to adulterate, substitute, or dilute the specimen;
    (12) Possess or wear a prosthetic or other device that could be 
used to interfere with the collection process; or
    (13) Admit to the collector or MRO that you have adulterated or 
substituted the specimen.

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

    (a) A refusal to take a test may result in the initiation of 
disciplinary or adverse action for a federal employee, up to and 
including removal from federal employment. An applicant's refusal to 
take a pre-employment test may result in non-selection for federal 
employment.
    (b) When a donor has refused to participate in a part of the 
collection process, including failing to appear in a reasonable time 
for any test, the collector must terminate the collection process and 
take action as described in Section 8.13. Required action includes 
immediately notifying the federal agency's designated representative by 
any means (e.g., telephone or secure facsimile [fax] machine) that 
ensures that the refusal notification is immediately received and, if a 
Federal CCF has been initiated, documenting the refusal on the Federal 
CCF, signing and dating the Federal CCF, and sending all copies of the 
Federal CCF to the federal agency's designated representative.
    (c) When documenting a refusal to test during the verification 
process as described in Sections 13.4, 13.5, and 13.6, the MRO must 
complete the MRO copy of the Federal CCF to include:
    (1) Checking the refusal to test box;
    (2) Providing a reason for the refusal in the remarks line; and
    (3) Signing and dating the MRO copy of the Federal CCF.

Subpart B--Urine Specimens

Section 2.1 What type of specimen may be collected?

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

Section 2.2 Under what circumstances may a urine specimen be collected?

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

Section 2.3 How is each urine specimen collected?

    Each urine specimen is collected as a split specimen as described 
in Section 2.5.

Section 2.4 What volume of urine is collected?

    A donor is expected to provide at least 45 mL of urine for a 
specimen.

Section 2.5 How does the collector split the urine specimen?

    The collector pours at least 30 mL into a specimen bottle that is 
designated as A (primary) and then pours at least 15 mL into a specimen 
bottle that is designated as B (split).

Section 2.6 When may an entity or individual release a urine specimen?

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

Subpart C--Urine Specimen Tests

Section 3.1 Which tests are conducted on a urine specimen?

    A federal agency:
    (a) Must ensure that each specimen is tested for marijuana and 
cocaine metabolites as provided in the drug testing panel described 
under Section 3.4;
    (b) Is authorized to test each specimen for other Schedule I or II 
drugs as provided in the drug testing panel;
    (c) Must ensure that the following specimen validity tests are 
conducted on each urine specimen:
    (1) Determine the creatinine concentration on every specimen;
    (2) Determine the specific gravity on every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (3) Determine the pH on every specimen; and
    (4) Perform one or more specimen validity tests for oxidizing 
adulterants on every specimen.
    (d) Is authorized to test each specimen for one or more biomarkers 
as provided in the biomarker testing panel; and
    (e) If a specimen exhibits abnormal characteristics (e.g., unusual 
odor or color, semi-solid characteristics), causes reactions or 
responses characteristic of an adulterant during initial or 
confirmatory drug tests (e.g., non-recovery of internal standard, 
unusual response), or contains an unidentified substance that 
interferes with the confirmatory analysis, then additional testing may 
be performed.

Section 3.2 May a specimen be tested for drugs other than those in the 
drug testing panel?

    (a) On a case-by-case basis, a specimen may be tested for 
additional drugs, if a federal agency is conducting the collection for 
reasonable suspicion or post accident testing. A specimen collected 
from a federal agency employee may be tested by the federal agency for 
any drugs listed in Schedule I or II of the Controlled Substances Act. 
The federal agency must request the HHS-certified laboratory to test 
for the additional drug, include a justification to test a specific 
specimen for the drug, and ensure that the HHS-certified laboratory has 
the capability to test for the drug and has established properly 
validated initial and confirmatory analytical methods. If an initial 
test procedure is not available upon request for a suspected Schedule I 
or Schedule II drug, the federal agency can request an HHS-certified 
laboratory to test for the drug by analyzing two separate aliquots of 
the specimen in two separate testing batches using the confirmatory 
analytical method. Additionally, the split (B) specimen will be 
available for testing if the donor requests a retest at another HHS-
certified laboratory.

[[Page 20575]]

    (b) A federal agency covered by these Guidelines must petition the 
Secretary in writing for approval to routinely test for any drug class 
not listed in the drug testing panel described under Section 3.4. Such 
approval must be limited to the use of the appropriate science and 
technology and must not otherwise limit agency discretion to test for 
any drug tested under paragraph (a) of this section.

Section 3.3 May any of the specimens be used for other purposes?

    (a) Specimens collected pursuant to Executive Order 12564, Public 
Law 100-71, and these Guidelines must only be tested for drugs and to 
determine their validity in accordance with Subpart C of these 
Guidelines. Use of specimens by donors, their designees, or any other 
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing) 
is prohibited unless authorized in accordance with applicable federal 
law.
    (b) These Guidelines are not intended to prohibit federal agencies 
specifically authorized by law to test a specimen for additional 
classes of drugs in its workplace drug testing program.

Section 3.4 What are the drug and biomarker test analytes and cutoffs 
for urine?

    The Secretary will publish the drug and biomarker test analytes and 
cutoffs (i.e., the ``drug testing panel'' and ``biomarker testing 
panel'') for initial and confirmatory drug and biomarker tests in the 
Federal Register each year. The drug and biomarker testing panels will 
also be available on the internet at http://www.samhsa.gov/workplace/drug-testing.
    This drug testing panel will remain in effect until the effective 
date of a new drug testing panel published in the Federal Register:

----------------------------------------------------------------------------------------------------------------
                                                                   Confirmatory test        Confirmatory test
         Initial test analyte          Initial test cutoff \1\          analyte            cutoff concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolite (THCA) \2\......  50 ng/mL \3\...........  THCA...................  15 ng/mL
Cocaine metabolite (Benzoylecgonine).  150 ng/mL \3\..........  Benzoylecgonine........  100 ng/mL
Codeine/Morphine.....................  2,000 ng/mL............  Codeine................  2,000 ng/mL
                                                                Morphine...............  4,000 ng/mL
Hydrocodone/Hydromorphone............  300 ng/mL..............  Hydrocodone............  100 ng/mL
                                                                Hydromorphone..........  100 ng/mL
Oxycodone/Oxymorphone................  100 ng/mL..............  Oxycodone..............  100 ng/mL
                                                                Oxymorphone............  100 ng/mL
6-Acetylmorphine.....................  10 ng/mL...............  6-Acetylmorphine.......  10 ng/mL
Phencyclidine........................  25 ng/mL...............  Phencyclidine..........  25 ng/mL
Amphetamine/Methamphetamine..........  500 ng/mL..............  Amphetamine............  250 ng/mL
                                                                Methamphetamine........  250 ng/mL
MDMA \4\/MDA \5\.....................  500 ng/mL..............  MDMA...................  250 ng/mL
                                                                MDA....................  250 ng/mL
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
  cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
  not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending
  on the technology. At least one analyte within the group must have a concentration equal to or greater than
  the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the
  laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, [Delta]-9-tetrahydrocannabinol-9-carboxylic acid
  (THCA).
\3\ Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for an alternate
  technology initial test that is specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL for
  benzoylecgonine).
\4\ Methylenedioxymethamphetamine (MDMA).
\5\ Methylenedioxyamphetamine (MDA).

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

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

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

Section 3.6 What criteria are used to report a urine specimen as 
adulterated?

    An HHS-certified laboratory reports a primary (A) specimen as 
adulterated when:
    (a) The pH is less than 4 or equal to or greater than 11 using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (b) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion

[[Page 20576]]

chromatography, capillary electrophoresis) on the second aliquot;
    (c) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with an equal to or greater than 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration equal to or greater than 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration equal to or greater than the LOQ of the confirmatory test 
on the second aliquot;
    (d) The presence of a halogen (e.g., chlorine from bleach, iodine, 
fluoride) is verified using either a general oxidant colorimetric test 
(with an equal to or great than 200 mcg/mL nitrite-equivalent cutoff or 
an equal to or great than 50 mcg/mL chromium (VI)-equivalent cutoff) or 
halogen colorimetric test (halogen concentration equal to or greater 
than the LOQ) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration equal to or greater than the LOQ of the 
confirmatory test on the second aliquot;
    (e) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and a different confirmatory test (e.g., GC/MS) for 
the confirmatory test with the glutaraldehyde concentration equal to or 
greater than the LOQ of the analysis on the second aliquot;
    (f) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with an 
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an 
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration equal to 
or greater than 50 mcg/mL) for the initial test on the first aliquot 
and a different confirmatory test (e.g., GC/MS) for the confirmatory 
test with the pyridine concentration equal to or greater than the LOQ 
of the analysis on the second aliquot;
    (g) The presence of a surfactant is verified by using a surfactant 
colorimetric test with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (h) The presence of any other adulterant not specified in 
paragraphs (b) through (g) of this section is verified using an initial 
test on the first aliquot and a different confirmatory test on the 
second aliquot.

Section 3.7 What criteria are used to report a urine specimen as 
substituted?

    An HHS-certified laboratory reports a primary (A) specimen as 
substituted when:
    (a) The creatinine concentration is less than 2 mg/dL on both the 
initial and confirmatory creatinine tests on two separate aliquots 
(i.e., the same colorimetric test may be used to test both aliquots) 
and the specific gravity is less than or equal to 1.0010 or equal to or 
greater than 1.0200 on both the initial and confirmatory specific 
gravity tests on two separate aliquots (i.e., a refractometer is used 
to test both aliquots), or
    (b) A biomarker is not detected or is present at a concentration 
inconsistent with that established for human urine for both the initial 
(first) test and the confirmatory (second) test on two separate 
aliquots (i.e., using the test analytes and cutoffs in the biomarker 
testing panel).

Section 3.8 What criteria are used to report a urine specimen as 
dilute?

    A dilute result may be reported only in conjunction with the 
positive or negative drug test results for a specimen.
    (a) An HHS-certified laboratory or an HHS-certified IITF reports a 
primary (A) specimen as dilute when the creatinine concentration is 
greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is 
equal to or greater than 1.002 but less than 1.003 on a single aliquot.
    (b) In addition, an HHS-certified laboratory reports a primary (A) 
specimen as dilute when the creatinine concentration is equal to or 
greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is 
greater than 1.0010 but less than 1.0030.

Section 3.9 What criteria are used to report an invalid result for a 
urine specimen?

    An HHS-certified laboratory reports a primary (A) specimen as an 
invalid result when:
    (a) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is equal to or 
greater than 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (b) The pH is equal to or greater than 4 and less than 4.5 or equal 
to or greater than 9 and less than 11 using either a colorimetric pH 
test or pH meter for the initial test and a pH meter for the 
confirmatory test on two separate aliquots;
    (c) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test or equal to or greater than the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial (first) test and the second test or using 
either initial test and the nitrite concentration is equal to or 
greater than 200 mcg/mL but less than 500 mcg/mL for a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, capillary electrophoresis) on two separate aliquots;
    (d) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI) for both the initial (first) test and the 
second test on two separate aliquots;
    (e) The possible presence of a halogen (e.g., chlorine from bleach, 
iodine, fluoride) is determined using the same halogen colorimetric 
test with a cutoff equal to or greater than the LOQ for both the 
initial (first) test and the second test on two separate aliquots or 
relying on the odor of the specimen as the initial test;
    (f) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde present) or characteristic immunoassay 
response on one or more drug immunoassay tests for both the initial 
(first) test and the second test on two separate aliquots;
    (g) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with an equal to 
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or 
greater than 50 mcg/mL chromium (VI)-

[[Page 20577]]

equivalent cutoff, or a halogen concentration is equal to or greater 
than the LOQ) for both the initial (first) test and the second test on 
two separate aliquots;
    (h) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with an equal to greater than 100 
mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial 
(first) test and the second test on two separate aliquots or a foam/
shake test for the initial test;
    (i) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid immunoassay or alternate technology initial drug 
test results cannot be obtained);
    (j) Interference with the drug confirmatory assay occurs on two 
separate aliquots of the specimen and the laboratory is unable to 
identify the interfering substance;
    (k) The physical appearance of the specimen (e.g., viscosity) is 
such that testing the specimen may damage the laboratory's instruments;
    (l) The specimen has been tested and the appearances of the primary 
(A) and the split (B) specimens (e.g., color) are clearly different; or
    (m) A specimen validity test (i.e., other than the tests listed 
above) on two separate aliquots of the specimen indicates that the 
specimen is not valid for testing.

Subpart D--Collectors

Section 4.1 Who may collect a specimen?

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

Section 4.2 Who may not collect a specimen?

    (a) A federal agency employee who is in a testing designated 
position and subject to the federal agency drug testing rules must not 
be a collector for co-workers in the same testing pool or who work with 
that employee on a daily basis.
    (b) A federal agency applicant or employee must not collect their 
own drug testing specimen.
    (c) An employee working for an HHS-certified laboratory or IITF 
must not act as a collector if the employee could link the identity of 
the donor to the donor's drug test result.
    (d) To avoid a potential conflict of interest, a collector must not 
be related to the employee (e.g., spouse, ex-spouse, relative) or 
personal friend (e.g., fianc[eacute]e).

Section 4.3 What are the requirements to be a collector?

    (a) An individual may serve as a collector if they fulfill the 
following conditions:
    (1) Is knowledgeable about the collection procedure described in 
these Guidelines;
    (2) Is knowledgeable about any guidance provided by the federal 
agency's Drug-Free Workplace Program and additional information 
provided by the Secretary relating to the collection procedure 
described in these Guidelines;
    (3) Is trained and qualified to collect a urine specimen. Training 
must include the following:
    (i) All steps necessary to complete a urine collection;
    (ii) Completion and distribution of the Federal CCF;
    (iii) Problem collections;
    (iv) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (v) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of the donor, ensuring the 
security of the specimen, and avoiding conduct or statements that could 
be viewed as offensive or inappropriate.
    (4) Has demonstrated proficiency in collections by completing five 
consecutive error-free mock collections.
    (i) The five mock collections must include one uneventful 
collection scenario, one insufficient specimen quantity scenario, one 
temperature out of range scenario, one scenario in which the donor 
refuses to sign the Federal CCF, and one scenario in which the donor 
refuses to initial the specimen bottle tamper-evident seal.
    (ii) A qualified trainer for collectors must monitor and evaluate 
the individual being trained, in person or by a means that provides 
real-time observation and interaction between the trainer and the 
trainee, and the trainer must attest in writing that the mock 
collections are error-free.
    (b) A trained collector must complete refresher training at least 
every five years that includes the requirements in paragraph (a) of 
this section.
    (c) The collector must maintain the documentation of their training 
and provide that documentation to a federal agency when requested.
    (d) An individual may not collect specimens for a federal agency 
until the individual's training as a collector has been properly 
documented.

Section 4.4 What are the requirements to be an observer for a direct 
observed collection?

    (a) An individual may serve as an observer for a direct observed 
collection when the individual has satisfied the requirements:
    (1) Is knowledgeable about the direct observed collection procedure 
described in Section 8.9 of these Guidelines;
    (2) Is knowledgeable about any guidance provided by the federal 
agency's Drug-Free Workplace Program or additional information provided 
by the Secretary relating to the direct observed collection procedure 
described in these Guidelines;
    (3) Has received training on the following subjects:
    (i) All steps necessary to perform a direct observed collection; 
and
    (ii) The observer's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of individuals being 
tested, ensuring that the observation is done in a professional manner 
that minimizes the discomfort to the employee so observed, ensuring the 
security of the specimen by maintaining visual contact with the 
collection container until it is delivered to the collector, and 
avoiding conduct or statements that could be viewed as offensive or 
inappropriate.
    (b) The gender of the observer must be the same as the donor's 
gender, which is determined by the donor's gender identity. The 
observer selection process is described in Section 8.10(b).
    (c) The observer is not required to be a trained collector.

Section 4.5 What are the requirements to be a trainer for collectors?

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

[[Page 20578]]

documentation to a federal agency when requested.

Section 4.6 What must a federal agency do before a collector is 
permitted to collect a specimen?

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

Subpart E--Collection Sites

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

    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) In the event that an agency-designated collection site is not 
accessible and there is an immediate requirement to collect a urine 
specimen (e.g., an accident investigation), a public restroom may be 
used for the collection, using the procedures for a monitored 
collection described in Section 8.12.

Section 5.2 What are the requirements for a collection site?

    The facility used as a collection site must have the following:
    (a) Provisions to ensure donor privacy during the collection (as 
described in Section 8.1);
    (b) A suitable and clean surface area that is not accessible to the 
donor for handling the specimens and completing the required paperwork;
    (c) A secure temporary storage area to maintain specimens until the 
specimen is transferred to an HHS-certified laboratory or IITF;
    (d) A restricted access area where only authorized personnel may be 
present during the collection;
    (e) A restricted access area for the storage of collection 
supplies;
    (f) The ability to store records securely; and
    (g) The ability to restrict the donor access to potential diluents 
in accordance with Section 8.2.

Section 5.3 Where must collection site records be stored?

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

Section 5.4 How long must collection site records be stored?

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

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

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

Section 5.6 What are the privacy requirements when collecting a urine 
specimen?

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

Subpart F--Federal Drug Testing Custody and Control Form

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

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

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

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

Subpart G--Urine Specimen Collection Containers and Bottles

Section 7.1 What is used to collect a urine specimen?

    A single-use collection container with a means (i.e., thermometer) 
to measure urine temperature and two specimen bottles must be used.

Section 7.2 What are the requirements for a urine collection container 
and specimen bottles?

    (a) The collection container, the thermometer, and the specimen 
bottles must not substantially affect the composition of drugs and/or 
metabolites in the urine specimen.
    (b) The two specimen bottles must be sealable and non-leaking, and 
must maintain the integrity of the specimen during storage and 
transport so that the specimen contained therein can be tested in an 
HHS-certified laboratory or IITF for the presence of drugs or their 
metabolites.
    (c) The two specimen bottles must be sufficiently transparent to 
enable an objective assessment of specimen appearance and 
identification of abnormal physical characteristics without opening the 
bottle.

[[Page 20579]]

Section 7.3 What are the minimum performance requirements for a urine 
collection container and specimen bottles?

    (a) The collection container must be capable of holding at least 55 
mL and have a volume marking clearly noting a level of 45 mL.
    (b) One of the two specimen bottles must be capable of holding at 
least 35 mL and the other at least 20 mL, and each must have a volume 
marking clearly noting the appropriate level (30 mL for the primary 
specimen and 15 mL for the split specimen).
    (c) The thermometer may be affixed to or built into the collection 
container and must provide graduated temperature readings from 32-38 
[deg]C/90-100 [deg]F. Alternatively, the collector may use another 
technology to measure specimen temperature (e.g., thermal radiation 
scanning), providing the thermometer does not come into contact with 
the specimen.

Subpart H--Urine Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing a urine 
specimen?

    The following privacy requirements apply when a donor is providing 
a urine specimen:
    (a) Only authorized personnel and the donor may be present in the 
restricted access area where the collection takes place.
    (b) The collector is not required to be the same gender as the 
donor. The gender of the observer for purposes of a direct observed 
collection (i.e., as described in Section 8.10) must be the same as the 
donor's gender, which is determined by the donor's gender identity. The 
gender of the monitor for a monitored collection (i.e., as described in 
Section 8.12) must be the same as the donor's gender, unless the 
monitor is a medical professional (e.g., nurse, doctor, physician's 
assistant, technologist, or technician licensed or certified to 
practice in the jurisdiction in which the collection takes place).
    (c) The collector must give the donor visual privacy while 
providing the specimen. The donor is allowed to provide a urine 
specimen in an enclosed stall within a multi-stall restroom or in a 
single person restroom during a monitored collection.

Section 8.2 What must the collector ensure at the collection site 
before starting a urine specimen collection?

    The collector must deter the dilution or substitution of a specimen 
at the collection site by:
    (a) Placing a toilet bluing agent in a toilet bowl or toilet tank, 
so the reservoir of water in the toilet bowl always remains blue. If no 
bluing agent is available or if the toilet has an automatic flushing 
system, the collector shall turn the water supply off to the toilet and 
flush the toilet to remove the water in the toilet when possible.
    (b) Secure other sources of water (e.g., shower or sink) in the 
enclosure where urination occurs. If the enclosure has a source of 
water that cannot be disabled or secured, a monitored collection must 
be conducted in accordance with Section 8.11.

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

    The collector must take the following steps before beginning a 
urine specimen collection:
    (a) If a donor fails to arrive at the collection site at the 
assigned time, the collector must follow the federal agency policy or 
contact the federal agency representative to obtain guidance on action 
to be taken.
    (b) When the donor arrives at the collection site, the collector 
should begin the collection procedure without undue delay. For example, 
the collection should not be delayed because the donor states that they 
are unable to urinate or an authorized employer or employer 
representative is late in arriving.
    (c) The collector requests the donor to present photo 
identification (e.g., driver's license; employee badge issued by the 
employer; an alternative photo identification issued by a federal, 
state, or local government agency). If the donor does not have proper 
photo identification, the collector shall contact the supervisor of the 
donor or the federal agency representative who can positively identify 
the donor. If the donor's identity cannot be established, the collector 
must not proceed with the collection.
    (d) The collector must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (e) The collector explains the basic collection procedure to the 
donor.
    (f) The collector provides the instructions for completing the 
Federal CCF for the donor's review, and informs the donor that the 
instructions are available upon request.
    (g) The collector answers any reasonable and appropriate questions 
the donor may have regarding the collection procedure.
    (h) The collector asks the donor to remove any unnecessary outer 
garments (e.g., coat, jacket) that might conceal items or substances 
that could be used to adulterate or substitute the urine specimen. The 
collector must ensure that all personal belongings (e.g., purse or 
briefcase) remain with the outer garments. The donor may retain the 
donor's wallet.
    (i) The collector asks the donor to empty the donor's pockets and 
display the contents to ensure no items are present that could be used 
to adulterate or substitute the specimen.
    (1) If no items are present that can be used to adulterate, 
substitute, or dilute the specimen, the collector instructs the donor 
to return the items to their pockets and continues the collection 
procedure.
    (2) If an item is present whose purpose is to adulterate, 
substitute, or dilute the specimen (e.g., a commercial drug culture 
product or other substance for which the donor has no reasonable 
explanation), this is considered a refusal to test. The collector must 
stop the collection and report the refusal to test as described in 
Section 8.13.
    (3) If an item that could be used to adulterate, substitute, or 
dilute the specimen (e.g., common personal care products such as 
eyedrops, mouthwash, or hand sanitizer) appears to have been 
inadvertently brought to the collection site, the collector must secure 
the item and continue with the normal collection procedure.
    (4) If the donor refuses to show the collector the items in their 
pockets, this is considered a refusal to test. The collector must stop 
the collection and report the refusal to test as described in Section 
8.13.
    (j) The collector shall instruct the donor to wash and dry the 
donor's hands prior to urination. After washing the donor's hands, the 
donor must remain in the presence of the collector and must not have 
access to any water fountain, faucet, soap dispenser, cleaning agent, 
or any other materials which could be used to adulterate or substitute 
the specimen.
    (k) If the donor refuses to wash their hands when instructed by the 
collector, this is considered a ``refusal to test.'' The collector must 
stop the collection and report the refusal to test as described in 
Section 8.13.

Section 8.4 What steps does the collector take in the collection 
procedure before the donor provides a urine specimen?

    (a) The collector will provide or the donor may select a specimen 
collection container that is clean, unused, wrapped/sealed in original 
packaging and compliant with Subpart G. The

[[Page 20580]]

specimen collection container package will be opened in view of the 
donor.
    (b) The collector instructs the donor to provide the specimen in 
the privacy of a stall or otherwise partitioned area that allows for 
individual privacy. The collector directs the donor to provide a 
specimen of at least 45 mL, to not flush the toilet, and to return with 
the specimen as soon as the donor has completed the void.
    (1) Except in the case of a direct observed collection (i.e., as 
described in Section 8.10) or a monitored collection (i.e., as 
described in Section 8.12), neither the collector nor anyone else may 
go into the room with the donor.
    (2) The collector may set a reasonable time limit for specimen 
collection.
    (c) The collector notes any unusual behavior or appearance of the 
donor on the Federal CCF. If the collector detects any conduct that 
clearly indicates an attempt to tamper with a specimen (e.g., 
substitute urine in plain view or an attempt to bring into the 
collection site an adulterant or urine substitute), the collector must 
report a refusal to test in accordance with Section 8.13.

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

    Integrity and Identity of the Specimen. The collector must take the 
following steps during and after the donor provides the urine specimen:
    (a) The collector must inform the donor that, once the collection 
procedure has begun, the donor must remain at the collection site 
(i.e., in an area designated by the collector) until the collection is 
complete and that failure to follow these instructions will be reported 
as a refusal to test. This includes the wait period (i.e., up to 3 
hours) if needed to provide a sufficient specimen as described in step 
(f)(2) below and in Section 8.6.
    (b) After providing the specimen, the donor gives the specimen 
collection container to the collector. Both the donor and the collector 
must keep the specimen container in view at all times until the 
collector seals the specimen bottles as described in Section 8.8.
    (c) After the donor has given the specimen to the collector, 
whenever practical, the donor shall be allowed to wash the donor's 
hands and the donor may flush the toilet.
    (d) The collector must measure the temperature of the specimen 
within 4 minutes of receiving the specimen from the donor. The 
collector records on the Federal CCF whether or not the temperature is 
in the acceptable range of 32[deg]-38 [deg]C/90[deg]-100 [deg]F.
    (1) The temperature measuring device must accurately reflect the 
temperature of the specimen and not contaminate the specimen.
    (2) If the temperature of the specimen is outside the range of 
32[deg]-38 [deg]C/90[deg]-100 [deg]F, that is a reason to believe that 
the donor may have adulterated or substituted the specimen. Another 
specimen must be collected under direct observation in accordance with 
Section 8.9. The collector must forward both specimens (i.e., from the 
first and second collections) to an HHS-certified laboratory for 
testing and record a comment on the Federal CCF for each specimen.
    (e) The collector must inspect the specimen to determine if there 
is any sign indicating that the specimen may not be a valid urine 
specimen (e.g., unusual color, presence of foreign objects or material, 
unusual odor).
    (1) The collector notes any unusual finding on the Federal CCF. A 
specimen suspected of not being a valid urine specimen must be 
forwarded to an HHS-certified laboratory for testing.
    (2) When there is any reason to believe that a donor may have 
adulterated or substituted the specimen, another specimen must be 
obtained as soon as possible under direct observation in accordance 
with Section 8.10. The collector must forward both specimens (i.e., 
from the first and second collections) to an HHS-certified laboratory 
for testing and record a comment on the Federal CCF for each specimen.
    (f) The collector must determine the volume of urine in the 
specimen container. The collector must never combine urine collected 
from separate voids to create a specimen.
    (1) If the volume is at least 45 mL, the collector will proceed 
with steps described in Section 8.8.
    (2) If the volume is less than 45 mL, the collector discards the 
specimen and immediately collects a second specimen using the same 
procedures as for the first specimen (including steps in paragraphs c 
and d of this section).
    (i) The collector may give the donor a reasonable amount of liquid 
to drink for this purpose (e.g., an 8 ounce glass of water every 30 
minutes, but not to exceed a maximum of 40 ounces over a period of 3 
hours or until the donor has provided a sufficient urine specimen). 
However, the donor is not required to drink any fluids during this 
waiting time.
    (ii) If the donor provides a sufficient urine specimen (i.e., at 
least 45 mL), the collector proceeds with steps described in Section 
8.8.
    (iii) If the employee has not provided a sufficient specimen (i.e., 
at least 45 mL) within three hours of the first unsuccessful attempt to 
provide the specimen, the collector records the reason for not 
collecting a urine specimen on the Federal CCF, notifies the federal 
agency's designated representative for authorization of an alternate 
specimen to be collected, and sends the appropriate copies of the 
Federal CCF to the MRO and to the federal agency's designated 
representative. The federal agency may choose to provide the collection 
site with a standard protocol to follow in lieu of requiring the 
collector to notify the agency's designated representative for 
authorization in each case. If an alternate specimen is authorized, the 
collector may begin the collection procedure for the alternate specimen 
(see Section 8.7) in accordance with the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using the alternative specimen.
    (g) If the donor fails to remain present through the completion of 
the collection, declines to have a direct observed collection as 
required in steps (d)(2) or (e)(2) above, refuses to provide a second 
specimen as required in step (f)(2) above, or refuses to provide an 
alternate specimen as authorized in step (f)(2)(iii) above, the 
collector stops the collection and reports the refusal to test in 
accordance with Section 8.13.

Section 8.6 What procedure is used when the donor states that they are 
unable to provide a urine specimen?

    (a) If the donor states that they are unable to provide a urine 
specimen during the collection process, the collector requests that the 
donor enter the restroom (stall) and attempt to provide a urine 
specimen.
    (b) The donor demonstrates their inability to provide a specimen 
when he or she comes out of the stall with an empty collection 
container.
    (1) If the donor states that they could provide a specimen after 
drinking some fluids, the collector gives the donor a reasonable amount 
of liquid to drink for this purpose (e.g., an 8 ounce glass of water 
every 30 minutes, but not to exceed a maximum of 40 ounces over a 
period of 3 hours or until the donor has provided a sufficient urine 
specimen). If the donor simply needs more time before attempting to 
provide a urine specimen, the donor may choose not to drink any fluids 
during the 3 hour wait time.
    (2) If the donor states that they are unable to provide a urine 
specimen, the collector records the reason for not collecting a urine 
specimen on the

[[Page 20581]]

Federal CCF, notifies the federal agency's designated representative 
for authorization of an alternate specimen to be collected, and sends 
the appropriate copies of the Federal CCF to the MRO and to the federal 
agency's designated representative. The federal agency may choose to 
provide the collection site with a standard protocol to follow in lieu 
of requiring the collector to notify the agency's designated 
representative for authorization in each case. If an alternate specimen 
is authorized, the collector may begin the collection procedure for the 
alternate specimen (see Section 8.7) in accordance with the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using the 
alternative specimen.

Section 8.7 If the donor is unable to provide a urine specimen, may 
another specimen type be collected for testing?

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

Section 8.8 How does the collector prepare the urine specimens?

    (a) All federal agency collections are to be split specimen 
collections.
    (b) The collector, in the presence of the donor, pours the urine 
from the collection container into two specimen bottles to be labeled 
``A'' and ``B''. The collector pours at least 30 mL of urine into 
Bottle A and at least 15 mL into Bottle B, and caps each bottle.
    (c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over each specimen bottle cap. 
The collector records the date of the collection on the tamper-evident 
labels/seals.
    (d) The collector instructs the donor to initial the tamper-evident 
labels/seals on each specimen bottle. If the donor refuses to initial 
the labels/seals, the collector notes the refusal on the Federal CCF 
and continues with the collection process.
    (e) The collector must ensure that all the information required on 
the Federal CCF is provided.
    (f) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the specimens identified were collected 
from the donor. If the donor refuses to sign the certification 
statement, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (g) The collector signs and prints their name on the Federal CCF, 
completes the Federal CCF, and distributes the copies of the Federal 
CCF as required.
    (h) The collector seals the specimens (Bottle A and Bottle B) in a 
package and, within 24 hours or during the next business day, sends 
them to the HHS-certified laboratory or IITF that will be testing the 
Bottle A urine specimen.
    (i) If the specimen and Federal CCF are not immediately transported 
to an HHS-certified laboratory or IITF, they must remain under direct 
control of the collector or be appropriately secured under proper 
specimen storage conditions until transported.
    (j) The collector must discard any urine left over in the 
collection container after both specimen bottles have been 
appropriately filled and sealed. There is one exception to this 
requirement: The collector may use excess urine to conduct clinical 
tests (e.g., protein, glucose) if the collection was conducted in 
conjunction with a physical examination required by federal agency 
regulation. Neither the collector nor anyone else may conduct further 
testing (such as specimen validity testing) on the excess urine.

Section 8.9 When is a direct observed collection conducted?

    A direct observed collection procedure must be conducted when:
    (a) The agency has authorized a direct observed collection because:
    (1) The donor's previous drug test result was reported by an MRO as 
positive, adulterated, or substituted; or
    (2) The HHS-certified laboratory reports to the MRO that a specimen 
is invalid, and the MRO reported to the agency that there was not a 
legitimate medical explanation for the result; or
    (3) The MRO reported to the agency that the primary (A) specimen 
was positive, adulterated, or substituted but the test was cancelled 
because the split (B) specimen could not be tested or the split 
specimen failed to reconfirm the primary specimen result; or
    (b) At the collection site, an immediate collection of a second 
urine specimen is required because:
    (1) The temperature of the specimen collected during a routine 
collection is outside the acceptable temperature range; or
    (2) The collector suspects that the donor has tampered with the 
specimen during a routine collection (e.g., abnormal physical 
characteristic such as unusual color and/or odor, and/or excessive 
foaming when shaken).
    (c) The collector must contact a collection site supervisor to 
review and concur in advance with any decision by the collector to 
obtain a specimen under direct observation.
    (d) If the donor declines to have a direct observed collection, the 
collector reports a refusal to test (i.e., as described in Section 
8.13).

Section 8.10 How is a direct observed collection conducted?

    (a) A direct observed collection procedure is the same as that for 
a routine collection, except an observer watches the donor urinate into 
the collection container. The observer's gender must be the same as the 
donor's gender, which is determined by the donor's gender identity, 
with no exception to this requirement.
    (b) Before an observer is selected, the collector informs the donor 
that the gender of the observer will match the donor's gender, which is 
determined by the donor's gender identity (as defined in Section 1.5). 
The collector then selects the observer to conduct the observation:
    (i) The collector asks the donor to identify the donor's gender on 
the Federal CCF and initial it.
    (ii) The donor will then be provided an observer whose gender 
matches the donor's gender.
    (iii) The collector documents the observer's name and gender on the 
Federal CCF.
    (c) If there is no collector available of the same gender as the 
donor's gender, the collector or collection site supervisor shall 
select an observer trained in direct observed specimen collection as 
described in Section 4.4. The observer may be an individual that is not 
a trained collector.
    (d) At the point in a routine collection where the donor enters the 
restroom with the collection container, a direct observed collection 
includes the following additional steps:
    (1) The observer enters the restroom with the donor;
    (2) The observer must directly watch the urine go from the donor's 
body into the collection container (the use of mirrors or video cameras 
is not permitted);
    (3) The observer must not touch or handle the collection container 
unless the observer is also serving as the collector;
    (4) After the donor has completed urinating into the collection 
container:
    (i) If the same person serves as the observer and collector, that 
person may receive the collection container from the donor while they 
are both in the restroom;
    (ii) If the observer is not serving as the collector, the donor and 
observer leave the restroom and the donor hands the collection 
container directly to the collector. The observer must maintain visual 
contact of the collection

[[Page 20582]]

container until the donor hands the container to the collector.
    (5) The collector checks the box for an observed collection on the 
Federal CCF and writes the name of the observer and the reason for an 
observed collection on the Federal CCF; and
    (6) The collector then continues with the routine collection 
procedure in Section 8.3.

Section 8.11 When is a monitored collection conducted?

    (a) In the event that an agency-designated collection site is not 
available and there is an immediate requirement to collect a specimen 
(e.g., an accident investigation), a public restroom may be used for 
the collection, using the procedures for a monitored collection 
described in Section 8.12.
    (b) If the enclosure used by the donor to provide a specimen has a 
source of water that cannot be disabled or secured, a monitored 
collection must be conducted.
    (c) If the donor declines to permit a collection to be monitored 
when required, the collector reports a refusal to test (i.e., as 
described in Section 8.13).

Section 8.12 How is a monitored collection conducted?

    A monitored collection is the same as that for a routine 
collection, except that a monitor accompanies the donor into the 
restroom to check for signs that the donor may be tampering with the 
specimen. The monitor remains in the restroom, but outside the stall, 
while the donor is providing the specimen. A person of the same gender 
as the donor shall serve as the monitor, unless the monitor is a 
medical professional (e.g., nurse, doctor, physician's assistant, 
technologist, or technician licensed or certified to practice in the 
jurisdiction in which the collection takes place). The same procedures 
used for selecting an observer of the appropriate gender in Section 
8.10(b) must be used to select the monitor for the purposes of Section 
8.12, unless the monitor is a medical professional as described above. 
The monitor may be an individual other than the collector and need not 
be a qualified collector.
    (a) The collector secures the restroom being used for the monitored 
collection so that no one except the employee and the monitor can enter 
the restroom until after the collection has been completed.
    (b) The monitor enters the restroom with the donor.
    (c) The monitor must not watch the employee urinate into the 
collection container. If the monitor hears sounds or makes other 
observations indicating an attempt by the donor to tamper with a 
specimen, there must be an additional collection under direct 
observation in accordance with Section 8.9.
    (d) The monitor must not touch or handle the collection container 
unless the monitor is also the collector.
    (e) After the donor has completed urinating into the collection 
container:
    (1) If the same person serves as the monitor and collector, that 
person may receive the collection container from the donor while they 
are both in the restroom;
    (2) If the monitor is not serving as the collector, the donor and 
monitor leave the restroom and the donor hands the collection container 
directly to the collector. The monitor must ensure that the employee 
takes the collection container directly to the collector as soon as the 
employee has exited the enclosure.
    (f) If the monitor is not serving as the collector, the collector 
writes the name of the monitor on the Federal CCF.
    (g) The collector then continues with the routine collection 
procedure in Section 8.3.

Section 8.13 How does the collector report a donor's refusal to test?

    If there is a refusal to test as defined in Section 1.7, the 
collector stops the collection, discards any urine collected and 
reports the refusal to test by:
    (a) Notifying the federal agency by means (e.g., telephone, email, 
or secure fax) that ensures that the notification is immediately 
received,
    (b) Documenting the refusal to test on the Federal CCF, and
    (c) Sending all copies of the Federal CCF to the federal agency's 
designated representative.

Section 8.14 What are a federal agency's responsibilities for a 
collection site?

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

Subpart I--HHS Certification of Laboratories and IITFs

Section 9.1 Who has the authority to certify laboratories and IITFs to 
test urine specimens for federal agencies?

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

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

    (a) A laboratory or IITF seeking HHS certification must:
    (1) Submit a completed OMB-approved application form (i.e., the 
applicant laboratory or IITF provides detailed information on both the 
administrative and analytical procedures to be used for federally 
regulated specimens);
    (2) Have its application reviewed as complete and accepted by HHS;

[[Page 20583]]

    (3) Successfully complete the PT challenges in 3 consecutive sets 
of initial PT samples;
    (4) Satisfy all the requirements for an initial inspection; and
    (5) Receive notification of certification from the Secretary before 
testing specimens for federal agencies.

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

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

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

    (a) A laboratory or IITF that does not maintain its HHS 
certification must:
    (1) Stop testing federally regulated specimens;
    (2) Ensure the security of federally regulated specimens and 
records throughout the required storage period described in Sections 
11.20, 11.21, 12.18, and 14.8;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.23, 11.24, 12.20, 12.21, and Subpart P; and
    (4) Follow the HHS suspension and revocation procedures when 
imposed by the Secretary, follow the HHS procedures in Subpart P that 
will be used for all actions associated with the suspension and/or 
revocation of HHS-certification.

Section 9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?

    (a) PT samples used to evaluate drug tests will be prepared using 
the following specifications:
    (1) PT samples may contain one or more of the drugs and drug 
metabolites in the drug classes listed in the drug testing panel and 
must satisfy one of the following parameters:
    (i) The concentration of a drug or metabolite will be at least 20 
percent above the initial test cutoff for the drug or drug metabolite;
    (ii) The concentration of a drug or metabolite may be as low as 40 
percent of the confirmatory test cutoff when the PT sample is 
designated as a retest sample; or
    (iii) The concentration of drug or metabolite may differ from 
9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
    (2) A PT sample may contain an interfering substance, an 
adulterant, or other substances for special purposes, or may satisfy 
the criteria for a substituted specimen, dilute specimen, or invalid 
result.
    (3) A negative PT sample will not contain a measurable amount of a 
target analyte.
    (b) PT samples used to evaluate specimen validity tests shall 
satisfy, but are not limited to, one of the following criteria:
    (1) The nitrite concentration will be at least 20 percent above the 
cutoff;
    (2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5;
    (3) The concentration of an oxidant will be at a level sufficient 
to challenge a laboratory's ability to identify and confirm the 
oxidant;
    (4) The creatinine concentration will be between 0 and 20 mg/dL; or
    (5) The specific gravity will be less than or equal to 1.0050 or 
between 1.0170 and 1.0230.
    (c) For each PT cycle, the set of PT samples going to each HHS-
certified laboratory or IITF will vary but, within each calendar year, 
each HHS-certified laboratory or IITF will analyze essentially the same 
total set of samples.
    (d) The laboratory or IITF must (to the greatest extent possible) 
handle, test, and report a PT sample in a manner identical to that used 
for a donor specimen, unless otherwise specified.

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

    (a) An applicant laboratory that seeks certification under these 
Guidelines must satisfy the following criteria on three consecutive 
sets of PT samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over the three sets of PT samples;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over the three sets of PT samples;
    (4) For the confirmatory drug tests, correctly determine the 
concentrations (i.e., no more than 20 percent or 2 standard deviations [whichever is larger] from the appropriate 
reference or peer group means) for at least 80 percent of the total 
drug challenges over the three sets of PT samples;
    (5) For the confirmatory drug tests, do not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group mean;
    (6) For each confirmatory drug test, correctly identify and 
determine the concentrations (i.e., no more than 20 percent 
or 2 standard deviations [whichever is larger] from the 
appropriate reference or peer group means) for at least 50 percent of 
the drug challenges for an individual drug over the three sets of PT 
samples;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over the three sets of PT samples;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over the three sets of PT 
samples;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over the three 
sets of PT samples that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are no more than 20 percent or 2 standard deviations from the 
appropriate reference or peer group mean; and
    (ii) pH values are no more than 0.3 pH units from the 
appropriate reference or peer group mean using a pH meter; and
    (iii) Specific gravity values are no more than 0.0003 
specific gravity units from the appropriate reference or peer group 
mean when the mean is less than 1.0100 and specific gravity values are 
no more than 0.0004 specific gravity units from the 
appropriate reference or peer group mean when the mean is equal to or 
greater than 1.0100;
    (10) Do not obtain any quantitative value on a specimen validity 
test PT sample that differs from the appropriate reference or peer 
group mean by more than 50 percent for nitrite and 
creatinine concentrations, 0.8 pH units using a pH meter, 
0.0006 specific gravity units when the mean is less than 
1.0100, or 0.0007 specific gravity units when the mean is 
equal to or greater than 1.0100; and
    (11) Do not report any sample as adulterated with a compound that 
is not present in the sample, adulterated based on pH when the 
appropriate reference or peer group mean is within the acceptable pH 
range, substituted when the appropriate reference or peer group

[[Page 20584]]

means for both creatinine and specific gravity are within the 
acceptable range, or substituted when the appropriate reference or peer 
group mean for a biomarker is within the acceptable range.
    (b) Failure to satisfy these requirements will result in 
disqualification.

Section 9.7 What are the PT requirements for an HHS-certified urine 
laboratory?

    (a) A laboratory certified under these Guidelines must satisfy the 
following criteria on the maintenance PT samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over two consecutive PT cycles;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over two consecutive PT cycles;
    (4) For the confirmatory drug tests, correctly determine that the 
concentrations for at least 80 percent of the total drug challenges are 
no more than 20 percent or 2 standard 
deviations (whichever is larger) from the appropriate reference or peer 
group means over two consecutive PT cycles;
    (5) For the confirmatory drug tests, do not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group mean;
    (6) For each confirmatory drug test, correctly identify and 
determine that the concentrations for at least 50 percent of the drug 
challenges for an individual drug are no more than 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group means over two consecutive PT 
cycles;
    (7) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over two consecutive PT cycles;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over two consecutive PT cycles;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over two 
consecutive PT cycles that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are no more than 20 percent or 2 standard deviations from the 
appropriate reference or peer group mean;
    (ii) pH values are no more than 0.3 pH units from the 
appropriate reference or peer group mean using a pH meter; and
    (iii) Specific gravity values are no more than 0.0003 
specific gravity units from the appropriate reference or peer group 
mean when the mean is less than 1.0100 and specific gravity values are 
no more than 0.0004 specific gravity units from the 
appropriate reference or peer group mean when the mean is equal to or 
greater than 1.0100;
    (10) Do not obtain any quantitative value on a specimen validity 
test PT sample that differs from the appropriate reference or peer 
group mean by more than 50 percent for nitrite and 
creatinine concentrations, 0.8 pH units using a pH meter, 
0.0006 specific gravity units when the mean is less than 
1.0100, or 0.0007 specific gravity units when the mean is 
equal to or greater than 1.0100; and
    (11) Do not report any PT sample as adulterated with a compound 
that is not present in the sample, adulterated based on pH when the 
appropriate reference or peer group mean is within the acceptable pH 
range, substituted when the appropriate reference or peer group means 
for both creatinine and specific gravity are within the acceptable 
range, or substituted when the appropriate reference or peer group mean 
for a biomarker is within the acceptable range.
    (b) Failure to participate in all PT cycles or to satisfy these 
requirements may result in suspension or revocation of an HHS-certified 
laboratory's certification.

Section 9.8 What are the PT requirements for an applicant IITF?

    (a) An applicant IITF that seeks certification under these 
Guidelines must satisfy the following criteria on three consecutive 
sets of PT samples:
    (1) Correctly identify at least 90 percent of the total drug 
challenges over the three sets of PT samples;
    (2) Correctly identify at least 80 percent of the drug challenges 
for each individual drug test over the three sets of PT samples;
    (3) Correctly identify at least 80 percent of the total specimen 
validity test challenges over the three sets of PT samples;
    (4) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over the three sets of PT 
samples;
    (5) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total specimen validity test 
challenges over the three sets of PT samples that satisfy the following 
criteria:
    (i) Creatinine concentrations are no more than 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group mean; and
    (ii) Specific gravity values are no more than 0.001 
specific gravity units from the appropriate reference or peer group 
mean; and
    (6) Must not obtain any quantitative value on a specimen validity 
test PT sample that differs from the appropriate reference or peer 
group mean by more than 50 percent for creatinine 
concentration or 0.002 specific gravity units for specific 
gravity.
    (b) Failure to satisfy these requirements will result in 
disqualification.

Section 9.9 What are the PT requirements for an HHS-certified IITF?

    (a) An IITF certified under these Guidelines must satisfy the 
following criteria on the maintenance PT samples to maintain its 
certification:
    (1) Correctly identify at least 90 percent of the total drug 
challenges over two consecutive PT cycles;
    (2) Correctly identify at least 80 percent of the drug challenges 
for each individual drug test over two consecutive PT cycles;
    (3) Correctly identify at least 80 percent of the total specimen 
validity test challenges over two consecutive PT cycles;
    (4) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over two consecutive PT cycles;
    (5) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total specimen validity test 
challenges over two consecutive PT cycles that satisfy the following 
criteria:
    (i) Creatinine concentrations are no more than 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group mean; and
    (ii) Specific gravity values are no more than 0.001 
specific gravity units from the appropriate reference or peer group 
mean; and
    (6) Must not obtain any quantitative value on a specimen validity 
test PT sample that differs from the appropriate reference or peer 
group mean by more than 50 percent for creatinine 
concentration, or 0.002 specific gravity units for specific 
gravity.
    (b) Failure to participate in all PT cycles or to satisfy these 
requirements may result in suspension or revocation of an HHS-certified 
IITF's certification.

Section 9.10 What are the inspection requirements for an applicant 
laboratory or IITF?

    (a) An applicant laboratory or IITF is inspected by a team of two 
inspectors.

[[Page 20585]]

    (b) Each inspector conducts an independent review and evaluation of 
all aspects of the laboratory's or IITF's testing procedures and 
facilities using an inspection checklist.

Section 9.11 What are the maintenance inspection requirements for an 
HHS-certified laboratory or IITF?

    (a) An HHS-certified laboratory or IITF must undergo an inspection 
3 months after becoming certified and at least every 6 months 
thereafter.
    (b) An HHS-certified laboratory or IITF is inspected by one or more 
inspectors. The number of inspectors is determined according to the 
number of specimens reviewed. Additional information regarding 
inspections is available from SAMHSA.
    (c) Each inspector conducts an independent evaluation and review of 
the HHS-certified laboratory's or IITF's procedures, records, and 
facilities using guidance provided by the Secretary.
    (d) To remain certified, an HHS-certified laboratory or IITF must 
continue to satisfy the minimum requirements as stated in these 
Guidelines.

Section 9.12 Who can inspect an HHS-certified laboratory or IITF and 
when may the inspection be conducted?

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

Section 9.13 What happens if an applicant laboratory or IITF does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?

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

Section 9.14 What happens if an HHS-certified laboratory or IITF does 
not satisfy the minimum requirements for either the PT program or the 
inspection program?

    (a) If an HHS-certified laboratory or IITF fails to satisfy the 
minimum requirements for certification, the laboratory or IITF is given 
a period of time (e.g., 5 or 30 working days depending on the nature of 
the deficiency) to provide any explanation for its performance and 
evidence that all deficiencies have been corrected.
    (b) A laboratory's or IITF's HHS certification may be revoked, 
suspended, or no further action taken depending on the seriousness of 
the deficiencies and whether there is evidence that the deficiencies 
have been corrected and that current performance meets the requirements 
for certification.
    (c) An HHS-certified laboratory or IITF may be required to undergo 
a special inspection or to test additional PT samples to address 
deficiencies.
    (d) If an HHS-certified laboratory's or IITF's certification is 
revoked or suspended in accordance with the process described in 
Subpart P, the laboratory or IITF is not permitted to test federally 
regulated specimens until the suspension is lifted or the laboratory or 
IITF has successfully completed the certification requirements as a new 
applicant laboratory or IITF.

Section 9.15 What factors are considered in determining whether 
revocation of a laboratory's or IITF's HHS certification is necessary?

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

Section 9.16 What factors are considered in determining whether to 
suspend a laboratory's or IITF's HHS certification?

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

Section 9.17 How does the Secretary notify an HHS-certified laboratory 
or IITF that action is being taken against the laboratory or IITF?

    (a) When laboratory's or IITF's HHS certification is suspended or 
the Secretary seeks to revoke HHS certification, the Secretary shall 
immediately serve the HHS-certified laboratory or IITF with written 
notice of the suspension or proposed revocation by fax, mail, personal 
service, or registered or certified mail, return receipt requested. 
This notice shall state the following:
    (1) The reasons for the suspension or proposed revocation;
    (2) The terms of the suspension or proposed revocation; and
    (3) The period of suspension or proposed revocation.
    (b) The written notice shall state that the laboratory or IITF will 
be afforded an opportunity for an informal review of the suspension or 
proposed revocation if it so requests in writing within 30 days of the 
date the laboratory or IITF received the notice, or if expedited review 
is requested, within 3 days of the date the laboratory or IITF received 
the notice. Subpart P contains detailed procedures to be followed for 
an informal review of the suspension or proposed revocation.
    (c) A suspension must be effective immediately. A proposed 
revocation

[[Page 20586]]

must be effective 30 days after written notice is given or, if review 
is requested, upon the reviewing official's decision to uphold the 
proposed revocation. If the reviewing official decides not to uphold 
the suspension or proposed revocation, the suspension must terminate 
immediately and any proposed revocation shall not take effect.
    (d) The Secretary will publish in the Federal Register the name, 
address, and telephone number of any HHS-certified laboratory or IITF 
that has its certification revoked or suspended under Section 9.13 or 
Section 9.14, respectively, and the name of any HHS-certified 
laboratory or IITF that has its suspension lifted. The Secretary shall 
provide to any member of the public upon request the written notice 
provided to a laboratory or IITF that has its HHS certification 
suspended or revoked, as well as the reviewing official's written 
decision which upholds or denies the suspension or proposed revocation 
under the procedures of Subpart P.

Section 9.18 May a laboratory or IITF that had its HHS certification 
revoked be recertified to test federal agency specimens?

    Following revocation, a laboratory or IITF may apply for 
recertification. Unless otherwise provided by the Secretary in the 
notice of revocation under Section 9.17 or the reviewing official's 
decision under Section 16.9(e) or 16.14(a), a laboratory or IITF which 
has had its certification revoked may reapply for HHS certification as 
an applicant laboratory or IITF.

Section 9.19 Where is the list of HHS-certified laboratories and IITFs 
published?

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

Subpart J--Blind Samples Submitted by an Agency

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

    (a) Each federal agency is required to submit blind samples for its 
workplace drug testing program. The collector must send the blind 
samples to the HHS-certified laboratory or IITF that the collector 
sends employee specimens.
    (b) Each federal agency must submit at least 3 percent blind 
samples along with its donor specimens based on the projected total 
number of donor specimens collected per year (up to a maximum of 400 
blind samples). Every effort should be made to ensure that blind 
samples are submitted quarterly.
    (c) Approximately 75 percent of the blind samples submitted each 
year by an agency must be negative, 15 percent must be positive for one 
or more drugs, and 10 percent must either be adulterated or 
substituted.

Section 10.2 What are the requirements for blind samples?

    (a) Drug positive blind samples must be validated by the supplier 
as to their content using appropriate initial and confirmatory tests.
    (1) Drug positive blind samples must be fortified with one or more 
of the drugs or metabolites listed in the drug testing panel.
    (2) Drug positive blind samples must contain concentrations of 
drugs between 1.5 and 2 times the initial drug test cutoff.
    (b) Drug negative blind samples (i.e., certified to contain no 
drugs) must be validated by the supplier as negative using appropriate 
initial and confirmatory tests.
    (c) A blind sample that is adulterated must be validated using 
appropriate initial and confirmatory specimen validity tests, and have 
the characteristics to clearly show that it is an adulterated sample at 
the time of validation.
    (d) A blind sample that is substituted must be validated using 
appropriate initial and confirmatory specimen validity tests, and have 
the characteristics to clearly show that it is a substituted sample at 
the time of validation.
    (e) The supplier must provide information on the blind samples' 
content, validation, expected results, and stability to the collection 
site/collector sending the blind samples to the laboratory or IITF, and 
must provide the information upon request to the MRO, the federal 
agency for which the blind sample was submitted, or the Secretary.

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

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

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

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

Subpart K--Laboratory

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

    (a) An HHS-certified laboratory must have a standard operating 
procedure (SOP) manual that describes, in detail, all HHS-certified 
laboratory operations. When followed, the SOP manual ensures that all 
specimens are tested using the same procedures.

[[Page 20587]]

    (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 under the direction of 
an alternate RP for a period of up to 180 days while seeking to hire 
and receive the Secretary's approval of the RP's replacement.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all federally regulated 
specimens if the laboratory does not have a permanent RP within 180 
days. The suspension will be lifted upon the Secretary's approval of 
the new permanent RP.
    (c) To nominate an individual as an RP or alternate RP, the HHS-
certified laboratory must submit the following documents to the 
Secretary: The candidate's current resume or curriculum vitae, copies 
of diplomas and licensures, a training plan (not to exceed 90 days) to 
transition the candidate into the position, an itemized comparison of 
the candidate's qualifications to the minimum RP qualifications 
described in the Guidelines, and have official academic transcript(s) 
submitted from the candidate's institution(s) of higher learning. The 
candidate must be found qualified during an on-site inspection of the 
HHS-certified laboratory.
    (d) The HHS-certified laboratory must fulfill additional inspection 
and PT criteria as required prior to conducting federally regulated 
testing under a new RP.

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

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

[[Page 20588]]

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 test(s) does an HHS-certified laboratory conduct on a 
urine specimen received from an IITF?

    An HHS-certified laboratory must test the specimen in the same 
manner as a specimen that had not been previously tested.

Section 11.10 What are the requirements for an initial drug test?

    (a) An initial drug test may be:
    (1) An immunoassay; or
    (2) An alternate technology (e.g., spectrometry, spectroscopy).
    (b) An HHS-certified laboratory must validate an initial drug test 
before testing specimens.
    (c) Initial drug tests must be accurate and reliable for the 
testing of specimens when identifying drugs or their metabolites.
    (d) An HHS-certified laboratory may conduct a second initial drug 
test using a method with different specificity, to rule out cross-
reacting compounds. This second initial drug test must satisfy the 
batch quality control requirements specified in Section 11.12.

Section 11.11 What must an HHS-certified laboratory do to validate an 
initial drug test?

    (a) An HHS-certified laboratory must demonstrate and document the 
following for each initial drug test:
    (1) The ability to differentiate negative specimens from those 
requiring further testing;
    (2) The performance of the test around the cutoff, using samples at 
several concentrations between 0 and 150 percent of the cutoff;
    (3) The effective concentration range of the test (linearity);
    (4) The potential for carryover;
    (5) The potential for interfering substances; and
    (6) The potential matrix effects if using an alternate technology.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) Each initial drug test using an alternate technology must be 
re-verified periodically or at least annually.

Section 11.12 What are the batch quality control requirements when 
conducting an initial drug test?

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

Section 11.13 What are the requirements for a confirmatory drug test?

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

Section 11.14 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?

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

[[Page 20589]]

Section 11.15 What are the batch quality control requirements when 
conducting a confirmatory drug test?

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

Section 11.16 What are the analytical and quality control requirements 
for conducting specimen validity tests?

    (a) Each invalid, adulterated, or substituted specimen validity 
test result must be based on an initial specimen validity test on one 
aliquot and a confirmatory specimen validity test on a second aliquot;
    (b) The HHS-certified laboratory must establish acceptance criteria 
and analyze calibrators and controls as appropriate to verify and 
document the validity of the test results (required specimen validity 
tests are addressed in Section 11.18); and
    (c) Controls must be analyzed concurrently with specimens.

Section 11.17 What must an HHS-certified laboratory do to validate a 
specimen validity test?

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

Section 11.18 What are the requirements for conducting each specimen 
validity test?

    (a) The requirements for measuring creatinine concentration are as 
follows:
    (1) The creatinine concentration must be measured to one decimal 
place on both the initial creatinine test and the confirmatory 
creatinine test;
    (2) The initial creatinine test must have the following calibrators 
and controls:
    (i) A calibrator at 2 mg/dL;
    (ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
    (iii) A control in the range of 3 mg/dL to 20 mg/dL; and
    (iv) A control in the range of 21 mg/dL to 25 mg/dL.
    (3) The confirmatory creatinine test (performed on those specimens 
with a creatinine concentration less than 2 mg/dL on the initial test) 
must have the following calibrators and controls:
    (i) A calibrator at 2 mg/dL;
    (ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL; and
    (iii) A control in the range of 3 mg/dL to 4 mg/dL.
    (b) The requirements for measuring specific gravity are as follows:
    (1) For specimens with initial creatinine test results greater than 
5 mg/dL and less than 20 mg/dL, laboratories may perform a screening 
test using a refractometer that measures urine specific gravity to at 
least three decimal places to identify specific gravity values that are 
acceptable (equal to or greater than 1.003) or dilute (equal to or 
greater than 1.002 and less than 1.003). Specimens must be subjected to 
an initial specific gravity test using a four decimal place 
refractometer when the initial creatinine test result is less than or 
equal to 5 mg/dL or when the screening specific gravity test result 
using a three decimal place refractometer is less than 1.002.
    (2) The screening specific gravity test must have the following 
calibrators and controls:
    (i) A calibrator or control at 1.000;
    (ii) One control targeted at 1.002;
    (iii) One control in the range of 1.004 to 1.018.
    (3) For the initial and confirmatory specific gravity tests, the 
refractometer must report and display specific gravity to four decimal 
places. The refractometer must be interfaced with a laboratory 
information management system (LIMS), computer, and/or generate a paper 
copy of the digital electronic display to document the numerical values 
of the specific gravity test results;
    (4) The initial and confirmatory specific gravity tests must have 
the following calibrators and controls:
    (i) A calibrator or control at 1.0000;
    (ii) One control targeted at 1.0020;
    (iii) One control in the range of 1.0040 to 1.0180; and
    (iv) One control equal to or greater than 1.0200 but not greater 
than 1.0250.
    (c) Requirements for measuring pH are as follows:
    (1) Colorimetric pH tests that have the dynamic range of 3 to 12 to 
support the 4 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to one decimal place. Colorimetric pH tests, dipsticks, 
and pH paper (i.e., screening tests) that have a narrow dynamic range 
and do not support the cutoffs may be used only to determine if an 
initial pH specimen validity test must be performed;
    (2) For the initial and confirmatory pH tests, the pH meter must 
report and display pH to at least one decimal place. The pH meter must 
be interfaced with a LIMS, computer, and/or generate a paper copy of 
the digital electronic display to document the numerical values of the 
pH test results;
    (3) pH screening tests must have, at a minimum, the following 
controls:
    (i) One control below the lower decision point in use;
    (ii) One control between the decision points in use; and
    (iii) One control above the upper decision point in use;
    (4) An initial colorimetric pH test must have the following 
calibrators and controls:
    (i) One calibrator at 4;
    (ii) One calibrator at 11;
    (iii) One control in the range of 3 to 3.8;
    (iv) One control in the range 4.2 to 5;
    (v) One control in the range of 5 to 9;
    (vi) One control in the range of 10 to 10.8; and
    (vii) One control in the range of 11.2 to 12;
    (5) An initial pH meter test, if a pH screening test is not used, 
must have the following calibrators and controls:
    (i) One calibrator at 3;
    (ii) One calibrator at 7;
    (iii) One calibrator at 10;
    (iv) One control in the range of 3 to 3.8;
    (v) One control in the range 4.2 to 5;
    (vi) One control in the range of 10 to 10.8; and
    (vii) One control in the range of 11.2 to 12;
    (6) An initial pH meter test (if a pH screening test is used) or 
confirmatory pH meter test must have the following calibrators and 
controls when the result of the preceding pH test indicates that the pH 
is below the lower decision point in use:
    (i) One calibrator at 4;
    (ii) One calibrator at 7;
    (iii) One control in the range of 3 to 3.8; and
    (iv) One control in the range 4.2 to 5; and
    (7) An initial pH meter test (if a pH screening test is used) or 
confirmatory pH meter test must have the following calibrators and 
controls when the result of the preceding pH test indicates that the pH 
is above the upper decision point in use:
    (i) One calibrator at 7;
    (ii) One calibrator at 10;
    (iii) One control in the range of 10 to 10.8; and
    (iv) One control in the range of 11.2 to 12.
    (d) Requirements for performing oxidizing adulterant tests are as 
follows:
    (1) The initial test must include an appropriate calibrator at the 
cutoff

[[Page 20590]]

specified in Sections 11.19(d)(2), (3), or (4) for the compound of 
interest, a control without the compound of interest (i.e., a certified 
negative control), and at least one control with one of the compounds 
of interest at a measurable concentration; and
    (2) A confirmatory test for a specific oxidizing adulterant must 
use a different analytical method than that used for the initial test. 
Each confirmatory test batch must include an appropriate calibrator, a 
control without the compound of interest (i.e., a certified negative 
control), and a control with the compound of interest at a measurable 
concentration.
    (e) The requirements for measuring the nitrite concentration are 
that the initial and confirmatory nitrite tests must have a calibrator 
at the cutoff, a control without nitrite (i.e., certified negative 
urine), one control in the range of 200 mcg/mL to 250 mcg/mL, and one 
control in the range of 500 mcg/mL to 625 mcg/mL.

Section 11.19 What are the requirements for an HHS-certified laboratory 
to report a test result?

    (a) Laboratories must report a test result to the agency's MRO 
within an average of 5 working days after receipt of the specimen. 
Reports must use the Federal CCF and/or an electronic report. Before 
any test result can be reported, it must be certified by a certifying 
scientist or a certifying technician (as appropriate).
    (b) A primary (A) specimen is reported negative when each initial 
drug test is negative or if the specimen is negative upon confirmatory 
drug testing, and the specimen does not meet invalid criteria as 
described in items (h)(1) through (h)(12) below.
    (c) A primary (A) specimen is reported positive for a specific drug 
or drug metabolite when both the initial drug test is positive and the 
confirmatory drug test is positive in accordance with the cutoffs 
listed in the drug testing panel.
    (d) A primary (A) urine specimen is reported adulterated when:
    (1) The pH is less than 4 or equal to or greater than 11 using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (2) The nitrite concentration is equal to or greater than 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (3) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with an equal to or greater than 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration equal to or greater than 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration equal to or greater than the LOQ of the confirmatory test 
on the second aliquot;
    (4) The presence of halogen (e.g., chlorine from bleach, iodine, 
fluoride) is verified using either a general oxidant colorimetric test 
(with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff 
or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent 
cutoff) or halogen colorimetric test (halogen concentration equal to or 
greater than the LOQ) for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, inductively coupled plasma-mass spectrometry) with 
a specific halogen concentration equal to or greater than the LOQ of 
the confirmatory test on the second aliquot;
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and a different confirmatory method (e.g., GC/MS) for 
the confirmatory test with the glutaraldehyde concentration equal to or 
greater than the LOQ of the analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with an 
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an 
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration equal to 
or greater than 50 mcg/mL) for the initial test on the first aliquot 
and a different confirmatory method (e.g., GC/MS) for the confirmatory 
test with the pyridine concentration equal to or greater than the LOQ 
of the analysis on the second aliquot;
    (7) The presence of a surfactant is verified by using a surfactant 
colorimetric test with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (8) The presence of any other adulterant not specified in 
paragraphs (d)(2) through (d)(7) of this section is verified using an 
initial test on the first aliquot and a different confirmatory test on 
the second aliquot.
    (e) A primary (A) urine specimen is reported substituted when:
    (1) The creatinine concentration is less than 2 mg/dL and the 
specific gravity is less than or equal to 1.0010 or equal to or greater 
than 1.0200 on both the initial and confirmatory creatinine tests 
(i.e., the same colorimetric test may be used to test both aliquots) 
and on both the initial and confirmatory specific gravity tests (i.e., 
a refractometer is used to test both aliquots) on two separate 
aliquots; or
    (2) A biomarker is not present or is present at a concentration 
inconsistent with that established for human urine.
    (f) A primary (A) urine specimen is reported dilute when the 
creatinine concentration is equal to or greater than 2 mg/dL but less 
than 20 mg/dL and the specific gravity is greater than 1.0010 but less 
than 1.0030 on a single aliquot.
    (g) For a specimen that has an invalid result for one of the 
reasons stated in items (h)(4) through (h)(13) below, the HHS-certified 
laboratory shall contact the MRO and both will decide if testing by 
another HHS-certified laboratory would be useful in being able to 
report a positive, adulterated, or substituted result. If no further 
testing is necessary, the HHS-certified laboratory then reports the 
invalid result to the MRO.
    (h) A primary (A) urine specimen is reported as an invalid result 
when:
    (1) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is equal to or 
greater than 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (2) The pH is equal to or greater than 4 and less than 4.5 or equal 
to or greater than 9 and less than 11 using either a

[[Page 20591]]

colorimetric pH test or pH meter for the initial test and a pH meter 
for the confirmatory test on two separate aliquots;
    (3) The nitrite concentration is equal to or greater than 200 mcg/
mL using a nitrite colorimetric test or equal to or greater than the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial (first) test and the second test or using 
either initial test and the nitrite concentration is equal to or 
greater than 200 mcg/mL but less than 500 mcg/mL for a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, capillary electrophoresis) on two separate aliquots;
    (4) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff equal to or greater 
than 50 mcg/mL chromium (VI) for both the initial (first) test and the 
second test on two separate aliquots;
    (5) The possible presence of a halogen (e.g., chlorine from bleach, 
iodine, fluoride) is determined using the same halogen colorimetric 
test with a cutoff equal to or greater than the LOQ for both the 
initial (first) test and the second test on two separate aliquots or 
relying on the odor of the specimen as the initial test;
    (6) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde present) or characteristic immunoassay 
response on one or more drug immunoassay tests for both the initial 
(first) test and the second test on two separate aliquots;
    (7) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with an equal to 
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or 
greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen 
concentration is equal to or greater than the LOQ) for both the initial 
(first) test and the second test on two separate aliquots;
    (8) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with an equal to or greater than 
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the 
initial (first) test and the second test on two separate aliquots or a 
foam/shake test for the initial test;
    (9) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (10) 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;
    (11) The physical appearance of the specimen is such that testing 
the specimen may damage the laboratory's instruments;
    (12) The physical appearances of the A and B specimens are clearly 
different (note: A is tested); or
    (13) A specimen validity test (i.e., other than the tests listed 
above) on two separate aliquots of the specimen indicates that the 
specimen is not valid for testing.
    (i) 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.
    (j) An HHS-certified laboratory must report all positive, 
adulterated, substituted, and invalid test results for a urine 
specimen. For example, a specimen can be positive for a specific drug 
and adulterated.
    (k) An HHS-certified laboratory must report the confirmatory 
concentration of each drug or drug metabolite reported for a positive 
result.
    (l) An HHS-certified laboratory must report numerical values of the 
specimen validity test results that support a specimen that is reported 
adulterated, substituted, or invalid (as appropriate).
    (m) An HHS-certified laboratory must report results using the HHS-
specified nomenclature published with the drug and biomarker testing 
panels.
    (n) When the concentration of a drug or drug metabolite exceeds the 
validated linear range of the confirmatory test, HHS-certified 
laboratories may report to the MRO that the quantitative value exceeds 
the linear range of the test or that the quantitative value is greater 
than ``insert the actual value for the upper limit of the linear 
range,'' or laboratories may report a quantitative value above the 
upper limit of the linear range that was obtained by diluting an 
aliquot of the specimen to achieve a result within the method's linear 
range and multiplying the result by the appropriate dilution factor.
    (o) HHS-certified laboratories may transmit test results to the MRO 
by various electronic means (e.g., teleprinter, fax, or computer). 
Transmissions of the reports must ensure confidentiality and the 
results may not be reported verbally by telephone. Laboratories and 
external service providers must ensure the confidentiality, integrity, 
and availability of the data and limit access to any data transmission, 
storage, and retrieval system.
    (p) 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.
    (q) 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 11.20 How long must an HHS-certified laboratory retain 
specimens?

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

Section 11.21 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 11.23) 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.

[[Page 20592]]

Section 11.22 What statistical summary reports must an HHS-certified 
laboratory provide for urine 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 and the number reported 
negative/dilute;
    (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 11.23 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 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 11.24 What HHS-certified laboratory information is available to 
a federal employee?

    A federal employee who is the subject of a workplace drug test may 
submit a written request through the MRO and/or the federal agency 
requesting copies of any records relating to the employee's drug test 
results or a documentation package as described in Section 11.23(b) and 
any relevant certification, review, or revocation of certification 
records. Federal employees, or their designees, are not permitted 
access to their specimens collected pursuant to Executive Order 12564, 
Public Law 100-71, and these Guidelines.

Section 11.25 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.

Section 11.26 What type of relationship can exist between an HHS-
certified laboratory and an HHS-certified IITF?

    An HHS-certified laboratory can enter into any relationship with an 
HHS-certified IITF.

Subpart L--Instrumented Initial Test Facility (IITF)

Section 12.1 What must be included in the HHS-certified IITF's standard 
operating procedure manual?

    (a) An HHS-certified IITF must have a standard operating procedure 
(SOP) manual that describes, in detail, all HHS-certified IITF 
operations. When followed, the SOP manual ensures that all specimens 
are tested consistently 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 
two years.

Section 12.2 What are the responsibilities of the responsible 
technician (RT)?

    (a) Manage the day-to-day operations of the HHS-certified IITF even 
if another

[[Page 20593]]

individual has overall responsibility for alternate areas of a multi-
specialty facility.
    (b) Ensure that there are sufficient personnel with adequate 
training and experience to supervise and conduct the work of the HHS-
certified IITF. The RT must ensure the continued competency of IITF 
personnel 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 IITF, and ensure that it is 
followed. The SOP manual must be reviewed, signed, and dated by the RT 
when procedures are first placed into use or changed or when a new 
individual assumes responsibility for the management of the HHS-
certified IITF. The SOP must be reviewed and documented by the RT 
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 
IITF 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 RT 
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 12.3 What qualifications must the RT have?

    An RT must:
    (a) Have at least a bachelor's degree in the chemical or biological 
sciences or medical technology, or equivalent;
    (b) Have training and experience in the analytical methods and 
forensic procedures used by the HHS-certified IITF;
    (c) Have 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;
    (d) Be found to fulfill RT responsibilities and qualifications, as 
demonstrated by the HHS-certified IITF's performance and verified upon 
interview by HHS-trained inspectors during each on-site inspection; and
    (e) Qualify as a certifying technician.

Section 12.4 What happens when the RT is absent or leaves an HHS-
certified IITF?

    (a) HHS-certified IITFs must have an RT and an alternate RT. When 
an RT is absent, an alternate RT must be present and qualified to 
fulfill the responsibilities of the RT.
    (1) If an HHS-certified IITF is without the RT and alternate RT for 
14 calendar days or less (e.g., temporary absence due to vacation, 
illness, business trip), the HHS-certified IITF may continue operations 
and testing of federal agency specimens under the direction of a 
certifying technician.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend an IITF's HHS certification for all specimens if the IITF does 
not have an RT or alternate RT for a period of more than 14 calendar 
days. The suspension will be lifted upon the Secretary's approval of a 
new permanent RT or alternate RT.
    (b) If the RT leaves an HHS-certified IITF:
    (1) The HHS-certified IITF may maintain certification and continue 
testing federally regulated specimens under the direction of an 
alternate RT for a period of up to 180 days while seeking to hire and 
receive the Secretary's approval of the RT's replacement.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend an IITF's HHS certification for all federally regulated 
specimens if the IITF does not have a permanent RT within 180 days. The 
suspension will be lifted upon the Secretary's approval of the new 
permanent RT.
    (c) To nominate an individual as the RT or alternate RT, the HHS-
certified IITF 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 RT 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 IITF.
    (d) The HHS-certified IITF must fulfill additional inspection and 
PT criteria as required prior to conducting federally regulated testing 
under a new RT.

Section 12.5 What qualifications must an individual have to certify a 
result reported by an HHS-certified IITF?

    A certifying technician must have:
    (a) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified IITF relevant to the results that 
the individual certifies; and
    (b) 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 12.6 What qualifications and training must other personnel of 
an HHS-certified IITF have?

    (a) All HHS-certified IITF 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 IITF 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 12.7 What security measures must an HHS-certified IITF 
maintain?

    (a) An HHS-certified IITF 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 IITF must maintain records documenting the 
identity of the visitor and escort, date, time of entry and exit, and 
purpose for the access to the secured area.

Section 12.8 What are the IITF chain of custody requirements for 
specimens and aliquots?

    (a) HHS-certified IITFs must use chain of custody procedures 
(internal and external) to maintain control and accountability of 
specimens from the time of receipt at the IITF through completion of 
testing, reporting of results, during storage, and continuing until 
final disposition of the specimens.
    (b) HHS-certified IITFs 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.

[[Page 20594]]

    (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 12.9 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 IITF must validate an initial drug test before 
testing specimens;
    (c) Initial drug tests must be accurate and reliable for the 
testing of urine specimens when identifying drugs or their metabolites.
    (d) An HHS-certified IITF 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 12.11.

Section 12.10 What must an HHS-certified IITF do to validate an initial 
drug test?

    (a) An HHS-certified IITF must demonstrate and document the 
following for each initial drug test:
    (1) The ability to differentiate negative specimens from those 
requiring further testing;
    (2) The performance of the test around the cutoff, using samples at 
several concentrations between 0 and 150 percent of the cutoff;
    (3) The effective concentration range of the test (linearity);
    (4) The potential for carryover;
    (5) The potential for interfering substances; and
    (6) The potential matrix effects if using an alternate technology.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) Each initial drug test using an alternate technology must be 
re-verified periodically or at least annually.

Section 12.11 What are the batch quality control requirements when 
conducting an initial drug test?

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

Section 12.12 What are the analytical and quality control requirements 
for conducting specimen validity tests?

    (a) Each specimen validity test result must be based on performing 
a single test on one aliquot;
    (b) The HHS-certified IITF must establish acceptance criteria and 
analyze calibrators and controls as appropriate to verify and document 
the validity of the test results in accordance with Section 12.14; and
    (c) Controls must be analyzed concurrently with specimens.

Section 12.13 What must an HHS-certified IITF do to validate a specimen 
validity test?

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

Section 12.14 What are the requirements for conducting each specimen 
validity test?

    (a) The requirements for measuring creatinine concentration are as 
follows:
    (1) The creatinine concentration must be measured to one decimal 
place on the test;
    (2) The creatinine test must have the following calibrators and 
controls:
    (i) A calibrator at 2 mg/dL;
    (ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
    (iii) A control in the range of 3 mg/dL to 20 mg/dL; and
    (iv) A control in the range of 21 mg/dL to 25 mg/dL.
    (b) The requirements for measuring specific gravity are as follows:
    (1) For specimens with creatinine test results greater than 5 mg/dL 
and less than 20 mg/dL, an IITF must perform a screening test using a 
refractometer to identify specific gravity values that are acceptable 
(equal to or greater than 1.003) or dilute (equal to or greater than 
1.002 and less than 1.003). Specimens must be forwarded to an HHS-
certified laboratory when the creatinine test result is less than or 
equal to 5 mg/dL or when the screening specific gravity test result is 
less than 1.002.
    (2) The screening specific gravity test must have the following 
calibrators and controls:
    (i) A calibrator or control at 1.000;
    (ii) One control targeted at 1.002; and
    (iii) One control in the range of 1.004 to 1.018.
    (c) The requirements for measuring pH are as follows:
    (1) The IITF may perform the pH test using a pH meter, colorimetric 
pH test, dipsticks, or pH paper. Specimens must be forwarded to an HHS-
certified laboratory when the pH is less than 4.5 or equal to or 
greater than 9.0.
    (2) The pH test must have, at a minimum, the following calibrators 
and controls:
    (i) One control below 4.5;
    (ii) One control between 4.5 and 9.0;
    (iii) One control above 9.0; and
    (iv) One or more calibrators as appropriate for the test. For a pH 
meter: Calibrators at 4, 7, and 10.
    (d) The requirements for measuring the nitrite concentration are 
that the nitrite test must have a calibrator at 200 mcg/mL nitrite, a 
control without nitrite (i.e., certified negative urine), one control 
in the range of 200 mcg/mL to 250 mcg/mL, and one control in the range 
of 500 mcg/mL to 625 mcg/mL. Specimens with a nitrite concentration 
equal to or greater than 200 mcg/mL must be forwarded to an HHS-
certified laboratory; and,
    (e) Requirements for performing oxidizing adulterant tests are that 
the test must include an appropriate calibrator at the cutoff specified 
in Sections 11.19(d)(3), (4), or (6) for the compound of interest, a 
control without the compound of interest (i.e., a certified negative 
control), and at least one control with one of the compounds of 
interest at a measurable concentration. Specimens with an oxidizing 
adulterant result equal to or greater than the cutoff must be forwarded 
to an HHS-certified laboratory.

Section 12.15 What are the requirements for an HHS-certified IITF to 
report a test result?

    (a) An HHS-certified IITF must report a test result to the agency's 
MRO within an average of 3 working days after receipt of the specimen. 
Reports must use the Federal CCF and/or an electronic report. Before 
any test result can be reported, it must be certified by a certifying 
technician.
    (b) A primary (A) specimen is reported negative when each drug test 
is negative and each specimen validity test result indicates that the 
specimen is a valid urine specimen.

[[Page 20595]]

    (c) A primary (A) urine specimen is reported dilute when the 
creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL 
and the specific gravity is equal to or greater than 1.002 but less 
than 1.003.
    (d) An HHS-certified IITF shall reject a urine 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 IITF will indicate on the Federal CCF that the specimen 
was rejected for testing and provide the reason for reporting the 
rejected for testing result.
    (e) An HHS-certified IITF must report results using the HHS-
specified nomenclature published with the drug and biomarker testing 
panels.
    (f) HHS-certified IITFs may transmit test results to the MRO by 
various electronic means (e.g., teleprinter, fax, or computer). 
Transmissions of the reports must ensure confidentiality and the 
results may not be reported verbally by telephone. IITFs 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.
    (g) HHS-certified IITFs 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.
    (h) For rejected specimens, IITFs must fax, courier, mail, or 
electronically transmit a legible image or copy of the completed 
Federal CCF.

Section 12.16 How does an HHS-certified IITF handle a specimen that 
tested positive, adulterated, substituted, or invalid at the IITF?

    (a) The remaining specimen is resealed using a tamper-evident 
label/seal;
    (b) The individual resealing the remaining specimen initials and 
dates the tamper-evident label/seal; and
    (c) The resealed specimen and split specimen and the Federal CCF 
are sealed in a leak-proof plastic bag, and are sent to an HHS-
certified laboratory under chain of custody within one day after 
completing the drug and specimen validity tests.

Section 12.17 How long must an HHS-certified IITF retain a specimen?

    A specimen that is negative, negative/dilute, or rejected for 
testing is discarded.

Section 12.18 How long must an HHS-certified IITF retain records?

    (a) An HHS-certified IITF must retain all records generated to 
support test results for at least 2 years. The IITF may convert 
hardcopy records to electronic records for storage and then discard the 
hardcopy records after six months.
    (b) A federal agency may request the HHS-certified IITF to maintain 
a documentation package (as described in Section 12.20) 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 IITF must be in writing and must specify the period of time to 
maintain the documentation package.
    (c) An HHS-certified IITF may retain records other than those 
included in the documentation package beyond the normal two-year period 
of time.

Section 12.19 What statistical summary reports must an HHS-certified 
IITF provide?

    (a) HHS-certified IITFs 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 IITF name and address;
    (3) Federal agency name;
    (4) Total number of specimens tested;
    (5) Number of specimens collected by reason for test;
    (6) Number of specimens reported negative and the number reported 
negative/dilute;
    (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; 
and
    (10) Number of specimens forwarded to an HHS-certified laboratory 
for testing.
    (b) An HHS-certified IITF 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 IITF is performing drug-testing services.
    (c) An HHS-certified IITF 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 IITF.

Section 12.20 What HHS-certified IITF information is available to a 
federal agency?

    (a) Following a federal agency's receipt of a positive, 
adulterated, or substituted drug test report from a laboratory, the 
federal agency may submit a written request for copies of the IITF 
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 
IITF 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 IITF, and a copy of the electronic report (if any) 
generated by the HHS-certified IITF;
    (4) A brief description of the HHS-certified IITF's drug and 
specimen validity testing procedures, instrumentation, and batch 
quality control requirements;
    (5) Copies of all test data for the donor's specimen with all 
calibrators and controls and copies of all internal chain of custody 
documents related to the tests; and
    (6) Copies of the r[eacute]sum[eacute] or curriculum vitae for the 
RT and for the certifying technician of record.

Section 12.21 What HHS-certified IITF information is available to a 
federal employee?

    A federal employee who is the subject of a drug test may provide a 
written request through the MRO and/or the federal agency requesting 
access to any records relating to the employee's drug test results or a 
documentation package (as described in Section 12.20) and any relevant 
certification, review, or revocation of certification records.

[[Page 20596]]

Section 12.22 What types of relationships are prohibited between an 
HHS-certified IITF and an MRO?

    An HHS-certified IITF 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 IITF 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 IITF or have any agreement with an HHS-certified IITF that 
may be construed as a potential conflict of interest.

Section 12.23 What type of relationship can exist between an HHS-
certified IITF and an HHS-certified laboratory?

    An HHS-certified IITF can enter into any relationship with an HHS-
certified laboratory.

Subpart M--Medical Review Officer (MRO)

Section 13.1 Who may serve as an MRO?

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

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

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

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

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

Section 13.4 What are the responsibilities of an MRO?

    (a) The MRO must review all positive, adulterated, rejected for 
testing, invalid, and substituted test results.
    (b) Staff under the direct, personal supervision of the MRO may 
review and report negative and (for urine) negative/dilute test results 
to the agency's designated representative. The MRO must review at least 
5 percent of all negative results reported by the MRO staff to ensure 
that the MRO staff are properly performing the review process.
    (c) The MRO must discuss potential invalid results with the HHS-
certified laboratory, as addressed in Section 11.19(g) 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 a urine specimen's test 
results?

    (a) When the HHS-certified laboratory or HHS-certified IITF reports 
a negative result for the primary (A) specimen, the MRO reports a 
negative result to the agency.
    (b) When the HHS-certified laboratory or HHS-certified IITF reports 
a negative/dilute result for the primary (A) urine specimen, the MRO 
reports a negative/dilute result to the agency and directs the agency 
to immediately collect another specimen from the donor.
    (1) If the recollected specimen provides a negative or negative/
dilute result, the MRO reports a negative result to the agency, with no 
further action required.
    (2) If the recollected specimen provides a result other than 
negative or negative/dilute, the MRO follows the procedures in 13.5(c) 
through (f) for the recollected specimen.
    (c) When the HHS-certified laboratory reports multiple results for 
the primary

[[Page 20597]]

(A) urine specimen, as the MRO, you must follow the verification 
procedures described in 13.5(d) through (f) and:
    (1) Report all verified positive and/or refusal to test results to 
the federal agency.
    (2) If an invalid result was reported in conjunction with a 
positive, adulterated, or substituted result, do not report the 
verified invalid result to the federal agency at this time. The MRO 
takes the action described in 13.5(f) for the verified invalid 
result(s) for the primary (A) specimen only when:
    (i) The MRO verifies the laboratory-reported positive, adulterated, 
or substituted result as negative based on a legitimate medical 
explanation as described in 13.5(d)(2) and 13.5(e)(1); or
    (ii) The split (B) specimen is tested and reported as a failure to 
reconfirm as described in Section 14.6(m).
    (d) 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 report to the agency.
    (2) If the donor provides documentation (e.g., a valid 
prescription) to support a legitimate medical explanation for the 
positive result, the MRO reports the test result as negative to the 
agency. If the laboratory also reports that the urine specimen is 
dilute, the MRO reports a negative/dilute result to the agency and 
directs the agency to immediately collect another specimen from the 
donor. The MRO follows the procedures in 13.5(b)(1) or (2) for the 
recollected specimen.
    (i) Passive exposure to a drug (e.g., exposure to secondhand 
marijuana smoke) is not a legitimate medical explanation for a positive 
drug test result.
    (ii) Ingestion of food products containing a drug (e.g., products 
containing marijuana, poppy seeds containing codeine and/or morphine) 
is not a legitimate medical explanation for a positive urine drug test 
result.
    (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. If the laboratory also reports that the urine 
specimen is dilute, the MRO may choose not to report the dilute result.
    (e) When the HHS-certified laboratory reports an adulterated or 
substituted result for the primary (A) urine 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 explanation, the 
MRO reports a refusal to test to the federal agency because the urine 
specimen was adulterated or substituted.
    (f) When the HHS-certified laboratory reports an invalid result for 
the primary (A) urine specimen, the MRO must contact the donor to 
determine if there is a legitimate explanation for the invalid result. 
In the case of an invalid result based on pH of 9.0 to 9.5, when an 
employee has no other medical explanation for the pH in this range, the 
MRO must consider whether there is evidence of elapsed time and high 
temperature that could account for the pH value. The MRO may contact 
the collection site, HHS-certified IITF, and/or HHS-certified 
laboratory to discuss time and temperature issues (e.g., time elapsed 
from collection to receipt at the testing facility, likely temperature 
conditions between the time of the collection and transportation to the 
testing facility, specimen storage conditions).
    (1) If the donor provides a legitimate explanation (e.g., a 
prescription medication) or if the MRO determines that time and 
temperature account for the pH in the 9.0 to 9.5 range, the MRO reports 
a test cancelled result with the reason for the invalid result and 
informs the federal agency that a recollection is not required because 
there is a legitimate explanation for the invalid result.
    (2) If the donor is unable to provide a legitimate explanation or 
if the MRO determines that time and temperature fail to account for the 
pH in the 9.0-9.5 range, the MRO reports a test cancelled result with 
the reason for the invalid result and directs the federal agency to 
immediately collect another urine specimen from the donor using a 
direct observed collection.
    (i) If the specimen collected under direct observation provides a 
valid result, the MRO follows the procedures in 13.5(a) through (e).
    (ii) If the specimen collected under direct observation provides an 
invalid result, the MRO reports this specimen as test cancelled and 
recommends that the agency collect another authorized specimen type 
(e.g., oral fluid).
    (g) When two separate specimens collected during the same testing 
event were sent to the HHS-certified laboratory for testing (e.g., the 
collector sent a urine specimen out of temperature range and the 
subsequently collected specimen--urine or another authorized specimen 
type), as the MRO, you must follow the verification procedures 
described in Sections 13.4, 13.5, and 13.6, and:
    (1) If both specimens were verified negative, report the result as 
negative.
    (2) If one specimen was verified negative and the other was not 
(i.e., the specimen was verified as negative/dilute or as positive, 
adulterated, substituted, and/or invalid), report only the verified 
result(s) other than negative. For example, if you verified one 
specimen as negative and the other as a refusal to test because the 
specimen was substituted, report only the refusal to the federal 
agency.
    (3) If both specimens were verified as positive, adulterated, and/
or substituted, report all results. For example, if you verified one 
specimen as positive and the other as a refusal to test because the 
specimen was adulterated, report the positive and the refusal results 
to the federal agency.
    (4) If one specimen has been verified and the HHS-certified 
laboratory has not reported the result(s) of the other specimen,
    (i) Report verified result(s) of positive, adulterated, or 
substituted immediately and do not wait to receive the result(s) of the 
other specimen.
    (ii) Do not report a verified result of negative, negative/dilute, 
or invalid for the first specimen to the federal agency. Hold the 
report until results of both specimens have been received and verified.
    (5) When the HHS-certified laboratory reports an invalid result for 
one or both specimens, follow the procedures in paragraph (c) above.
    (h) When the HHS-certified laboratory or HHS-certified IITF 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. The recollected 
specimen must be the same type (i.e., urine).

[[Page 20598]]

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

    (a) When another specimen type (e.g., oral fluid) was collected as 
authorized by the federal agency, the MRO reviews and reports the test 
result in accordance with the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using the alternative specimen.
    (b) When the federal agency did not authorize the collection of an 
alternative specimen, the MRO consults with the federal agency. The 
federal agency immediately directs the donor to obtain, within five 
days, an evaluation from a licensed physician, acceptable to the MRO, 
who has expertise in the medical issues raised by the donor's failure 
to provide a specimen. The MRO may perform this evaluation if the MRO 
has appropriate expertise.
    (1) For purposes of this section, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a medically documented pre-existing psychological 
disorder, but does not include unsupported assertions of ``situational 
anxiety'' or dehydration. 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. Examples would include destruction (any cause) of the glomerular 
filtration system leading to renal failure; unrepaired traumatic 
disruption of the urinary tract; or a severe psychiatric disorder 
focused on genitourinary matters. Acute or temporary medical 
conditions, such as cystitis, urethritis, or prostatitis, though they 
might interfere with collection for a limited period of time, cannot 
receive the same exceptional consideration as the permanent or long-
term conditions discussed in the previous sentence.
    (2) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the donor was required to take a federally regulated drug 
test, but was unable to provide a sufficient amount of urine 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 paragraph 
(b)(3) of this section and the basis for the recommendation. The 
statement must not include detailed information on the employee's 
medical condition beyond what is necessary to explain the referral 
physician's conclusion.
    (3) As the MRO, if another physician performed the evaluation, you 
must consider and assess the referral physician's recommendations in 
making your determination. You must make one of the following 
determinations and report it to the federal agency in writing:
    (i) A medical condition as defined in paragraph (b)(1) of this 
section has, or with a high degree of probability could have, precluded 
the employee from providing a sufficient amount of urine, but is not a 
permanent or long-term disability. As the MRO, you must report a test 
cancelled result to the federal agency.
    (ii) A permanent or long-term medical condition as defined in 
paragraph (b)(1) of this section has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of urine and is highly likely to prevent the employee 
from providing a sufficient amount of urine for a very long or 
indefinite period of time. As the MRO, you must follow the requirements 
of Section 13.7, as appropriate. If Section 13.7 is not applicable, you 
report a test cancelled result to the federal agency and recommend that 
the agency authorize collection of an alternative specimen type (e.g., 
oral fluid) for any subsequent drug tests for the donor.
    (iii) There is not an adequate basis for determining that a medical 
condition has, or with a high degree of probability could have, 
precluded the employee from providing a sufficient amount of urine. As 
the MRO, you must report a refusal to test to the federal agency.
    (4) When a federal agency receives a report from the MRO indicating 
that a test is cancelled as provided in paragraph (b)(3)(i) of this 
section, the agency takes no further action with respect to the donor. 
When a test is canceled as provided in paragraph (b)(3)(ii) of this 
section, the agency takes no further action with respect to the donor 
other than designating collection of an alternate specimen type (i.e., 
authorized by the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs) for any subsequent collections, in accordance with 
the federal agency plan. The donor remains in the random testing pool.

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

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

[[Page 20599]]

the donor to begin or resume performing official functions, because a 
negative test is needed for that purpose).

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

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

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

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

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

    An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory or an HHS-certified IITF 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 HHS-certified 
IITF, or have any agreement with the HHS-certified laboratory or the 
HHS-certified IITF that may be construed as a potential conflict of 
interest.

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

    (a) An MRO must send to the Secretary or designated HHS 
representative a semiannual report of federal agency specimens that 
were reported as positive for a drug or drug metabolite by a laboratory 
and verified as negative by the MRO. The report must not include any 
personally identifiable information for the donor and must be submitted 
by mail, fax, or other secure electronic transmission method within 14 
working days after the end of the semiannual period (i.e., in January 
and July). The semiannual report must contain the following 
information:
    (1) Reporting period (inclusive dates);
    (2) MRO name, company name, and address;
    (3) Federal agency name; and
    (4) For each laboratory-reported positive drug test result that was 
verified as negative by the MRO:
    (i) Specimen identification number;
    (ii) Laboratory name and address;
    (iii) Positive drug(s) or drug metabolite(s) the MRO 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 have any 
financial interest in an HHS-certified laboratory or an HHS-certified 
IITF that tests the agency's specimens, as described in Section 13.10.
    (b) The federal agency must verify and document that each MRO 
reviewing and reporting results for the agency:
    (1) Completes training on any revisions to these Guidelines prior 
to their effective date;
    (2) at least every five years, maintains their certification by 
completing requalification training and passing a requalification 
examination; and
    (3) provides biannual reports to the Secretary or designated HHS 
representative as required in Section 13.11;
    (c) The federal agency must ensure that each MRO reports drug test 
results to the agency in accordance with Sections 13.9 and 14.7.
    (1) Before allowing an MRO to report results electronically, the 
agency must obtain documentation from the MRO to confirm that the MRO 
and any external service providers ensure the confidentiality, 
integrity, and availability of the data and limit access to any data 
transmission, storage, and retrieval system.

Subpart N--Split Specimen Tests

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

    (a) The donor may request, verbally or in writing, through the MRO 
that the split (B) specimen be tested at a different (i.e., second) 
HHS-certified 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) urine specimen cannot be tested by a second HHS-
certified laboratory (e.g., insufficient specimen, lost in transit, 
split not available, no second HHS-certified laboratory available to 
perform the test), the MRO reports to the federal agency that the test 
must be cancelled and the reason for the cancellation. The MRO directs 
the federal agency to ensure the immediate recollection of another 
urine specimen from the donor under direct observation, with no notice 
given to the

[[Page 20600]]

donor of this collection requirement until immediately before the 
collection.
    (d) If a donor chooses not to have the split (B) specimen tested by 
a second HHS-certified laboratory, a federal agency may have a split 
(B) specimen retested as part of a legal or administrative proceeding 
to defend an original positive, adulterated, or substituted result.

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

    (a) The testing of a split (B) specimen for a drug or metabolite is 
not subject to the testing cutoffs established.
    (b) The HHS-certified laboratory is only required to confirm the 
presence of the drug or metabolite that was reported positive in the 
primary (A) specimen.
    (c) For a split (B) urine specimen, if the second HHS-certified 
laboratory fails to reconfirm the presence of the drug or drug 
metabolite that was reported by the first HHS-certified laboratory, the 
second laboratory must conduct specimen validity tests in an attempt to 
determine the reason for being unable to reconfirm the presence of the 
drug or drug metabolite. The second laboratory should conduct the same 
specimen validity tests as it would conduct on a primary (A) urine 
specimen and reports those results to the MRO.

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

    (a) An HHS-certified laboratory must use one of the following 
criteria to reconfirm an adulterated result when testing a split (B) 
urine specimen:
    (1) pH must be measured using the laboratory's confirmatory pH test 
with the appropriate cutoff (i.e., either less than 4 or equal to or 
greater than 11);
    (2) Nitrite must be measured using the laboratory's confirmatory 
nitrite test with a cutoff of equal to or greater than 500 mcg/mL;
    (3) Surfactant must be measured using the laboratory's confirmatory 
surfactant test with a cutoff of equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff; or
    (4) For adulterants without a specified cutoff (e.g., 
glutaraldehyde, chromium (VI), pyridine, halogens (such as, chlorine 
from bleach, iodine), peroxidase, peroxide, other oxidizing agents), 
the laboratory must use its confirmatory specimen validity test at an 
established LOQ to reconfirm the presence of the adulterant.
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
adulterated result reported by the first HHS-certified laboratory.

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

    (a) An HHS-certified laboratory must use the following criteria to 
reconfirm a substituted result when testing a split (B) urine specimen:
    (1) For substitution based on creatinine and specific gravity 
testing: The creatinine must be measured using the laboratory's 
confirmatory creatinine test with a cutoff of less than 2 mg/dL, and 
the specific gravity must be measured using the laboratory's 
confirmatory specific gravity test with the specified cutoffs of less 
than or equal to 1.0010 or equal to or greater than 1.0200.
    (2) For substitution based on biomarker testing: The laboratory 
must test for the biomarker using its confirmatory test (i.e., using 
the confirmatory test analytes and cutoffs in the biomarker testing 
panel).
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
substituted result reported by the first HHS-certified laboratory.

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

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

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

    The MRO takes the following actions when the second HHS-certified 
laboratory reports the result for the split (B) urine specimen as:
    (a) Reconfirmed the drug(s), adulteration, and/or substitution 
result. The MRO reports reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
the specimen was adulterated. If the donor provides a legitimate 
medical explanation for the adulteration result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and a refusal to 
test to the agency and indicates the adulterant that is present in the 
specimen. The MRO gives the donor 72 hours to request that Laboratory A 
retest the primary (A) specimen for the adulterant. If Laboratory A 
reconfirms the adulterant, the MRO reports refusal to test and 
indicates the adulterant present. If Laboratory A fails to reconfirm 
the adulterant, the MRO cancels both tests and directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure. The MRO shall notify the appropriate regulatory office about 
the failed to reconfirm and cancelled test.
    (c) Failed to reconfirm a single or all drug positive results and 
the specimen was substituted. If the donor provides a legitimate 
medical explanation for the substituted result, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and cancels both 
tests. If there is no legitimate medical explanation, the MRO reports a 
failed to reconfirm result (specifying the drug[s]) and a refusal to 
test (substituted) to the agency. The MRO gives the donor 72 hours to 
request additional review or testing as follows:
    (1) For substitution based on creatinine and specific gravity: 
Request that Laboratory A review the creatinine and specific gravity 
results for the primary (A) specimen.
    (2) For substitution based on biomarker testing: Request that 
Laboratory A test the primary (A) specimen using its confirmatory test 
for the biomarker.
    (i) 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.
    (ii) If the primary (A) specimen's results fail to confirm that the 
specimen was substituted, the MRO cancels both tests and directs the 
agency to immediately collect another specimen using a direct observed 
collection procedure. The MRO shall notify the HHS office responsible 
for coordination of the drug-free workplace program about the failed to 
reconfirm and cancelled test.
    (d) Failed to reconfirm a single or all drug positive results and 
the specimen was not adulterated or substituted. The MRO reports to the 
agency a failed to reconfirm result (specifying the drug[s]), cancels 
both tests, and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (e) Failed to reconfirm a single or all drug positive results and 
the specimen had an invalid result. The MRO reports to the agency a 
failed to reconfirm result (specifying the drug[s] and the reason

[[Page 20601]]

for the invalid result), cancels both tests, directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure, and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was adulterated. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and found that the specimen was 
adulterated. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was substituted. The MRO reports to the agency 
a reconfirmed result (specifying the drug[s]) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and found that the specimen was 
substituted. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (h) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen was not adulterated or substituted. The MRO 
reports to the agency a reconfirmed result (specifying the drug[s]) and 
a failed to reconfirm result (specifying the drug[s]). The MRO tells 
the agency that it may take action based on the reconfirmed drug(s) 
although Laboratory B failed to reconfirm one or more drugs. The MRO 
shall notify the HHS office responsible for coordination of the drug-
free workplace program regarding the test results for the specimen.
    (i) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and the specimen had an invalid result. The MRO reports to the 
agency a reconfirmed result (specifying the drug[s]) and a failed to 
reconfirm result (specifying the drug[s]). The MRO tells the agency 
that it may take action based on the reconfirmed drug(s) although 
Laboratory B failed to reconfirm one or more drugs and reported an 
invalid result. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (j) Failed to reconfirm substitution or adulteration. The MRO 
reports to the agency a failed to reconfirm result (not adulterated: 
Specifying the adulterant/pH or not substituted) and cancels both 
tests. The MRO shall notify the HHS office responsible for coordination 
of the drug-free workplace program regarding the test results for the 
specimen.
    (k) Failed to reconfirm substitution or adulteration and the 
specimen had an invalid result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: Specifying the adulterant/pH or 
not substituted, and the reason for the invalid result), cancels both 
tests, directs the agency to immediately collect another specimen using 
a direct observed collection procedure and notifies the HHS office 
responsible for coordination of the drug-free workplace program.
    (l) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterated or substituted result. The MRO reports to 
the agency a reconfirmed result (adulterated or substituted) and a 
failed to reconfirm result (specifying the drug[s]). The MRO tells the 
agency that it may take action based on the reconfirmed result 
(adulterated or substituted) although Laboratory B failed to reconfirm 
the drug(s) result.
    (m) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterated or substituted result. The MRO 
reports to the agency a failed to reconfirm result (specifying the 
drug[s] and not adulterated: Specifying the adulterant/pH or not 
substituted) and cancels both tests. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (n) Failed to reconfirm at least one drug and reconfirmed the 
adulterated result. The MRO reports to the agency a reconfirmed result 
(specifying the drug[s] and adulterated) and a failed to reconfirm 
result (specifying the drug[s]). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) and the adulterated result 
although Laboratory B failed to reconfirm one or more drugs.
    (o) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterated result. The MRO reports to the agency a reconfirmed 
result (specifying the drug[s]) and a failed to reconfirm result 
(specifying the drug[s] and not adulterated: Specifying the adulterant/
pH). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and failed to reconfirm the adulterated result.
    (p) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result (not adulterated: Specifying the adulterant/pH, and 
not substituted) and cancels both tests. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (q) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (not adulterated: 
Specifying the adulterant/pH). The MRO tells the agency that it may 
take action based on the substituted result although Laboratory B 
failed to reconfirm the adulterated result.
    (r) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.

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

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

[[Page 20602]]

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

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

Subpart O--Criteria for Rejecting a Specimen for Testing

Section 15.1 What discrepancies require an HHS-certified laboratory or 
an HHS-certified IITF to report a urine specimen as rejected for 
testing?

    The following discrepancies are considered to be fatal flaws. The 
HHS-certified laboratory or IITF 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 collector's printed name and signature are omitted on the 
Federal CCF;
    (d) There is an insufficient amount of specimen for analysis in the 
primary (A) specimen unless the split (B) specimen can be re-designated 
as the primary (A) specimen;
    (e) 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;
    (f) The specimen was received at the HHS-certified laboratory or 
IITF without a CCF;
    (g) The CCF was received at the HHS-certified laboratory or IITF 
without a specimen;
    (h) The collector performed two separate collections using one CCF; 
or
    (i) The HHS-certified laboratory or IITF 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 or 
an HHS-certified IITF to report a specimen as rejected for testing 
unless the discrepancy is corrected?

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

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

    (a) The following omissions and discrepancies on the Federal CCF 
that are received by the HHS-certified laboratory or IITF should not 
cause an HHS-certified laboratory or IITF to reject a urine specimen or 
cause an MRO to cancel a test:
    (1) An incorrect laboratory name and address appearing at the top 
of the form;
    (2) Incomplete/incorrect/unreadable employer name or address;
    (3) MRO name is missing;
    (4) Incomplete/incorrect MRO address;
    (5) A transposition of numbers in the donor's Social Security 
Number or employee identification number;
    (6) A telephone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``reason for test'' box is not marked;
    (9) A ``drug tests to be performed'' box is not marked;
    (10) A ``collection'' box is not marked;
    (11) The ``observed'' box is not marked (if applicable);
    (12) The collection site address is missing;
    (13) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (14) The time of collection is not indicated;
    (15) The date of collection is not indicated;
    (16) Incorrect name of delivery service;
    (17) The collector has changed or corrected information by crossing 
out the original information on either the Federal CCF or specimen 
label/seal without dating and initialing the change; or
    (18) The donor's name inadvertently appears on the HHS-certified 
laboratory or IITF copy of the Federal CCF or on the tamper-evident 
labels used to seal the specimens.
    (19) The collector failed to check the specimen temperature box and 
the ``Remarks'' line did not have a comment regarding the temperature 
being out of range. If, after at least 5 business days, the collector 
cannot provide a memorandum for record to attest to the fact that the 
collector did measure the specimen temperature, the HHS-certified 
laboratory or IITF may report the test result for the specimen but 
indicates that the collector could not provide a memorandum to recover 
the omission.
    (b) The following omissions and discrepancies on the Federal CCF 
that are made at the HHS-certified laboratory or IITF should not cause 
an MRO to cancel a test:
    (1) The testing laboratory or IITF fails to indicate the correct 
name and address in the results section when a different laboratory or 
IITF name and address is printed at the top of the Federal CCF;
    (2) The accessioner fails to print their name;
    (3) The certifying scientist or certifying technician fails to 
print their name;
    (4) The certifying scientist or certifying technician accidentally 
initials the Federal CCF rather than signing for a specimen reported as 
rejected for testing;
    (c) The above omissions and discrepancies should occur no more than 
once a month. The expectation is that each trained collector and HHS-
certified laboratory or IITF will make every effort to ensure that the 
Federal CCF is properly completed and that all the information is 
correct. When an

[[Page 20603]]

error occurs more than once a month, the MRO must direct the collector, 
HHS-certified laboratory, or HHS-certified IITF (whichever is 
responsible for the error) to immediately take corrective action to 
prevent the recurrence of the error.

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

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

Subpart P--Laboratory or IITF Suspension/Revocation Procedures

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

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

Section 16.2 What definitions are used for this subpart?

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

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

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

Section 16.4 Who represents the parties?

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

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

    (a) Within 30 days of the date of the notice of the suspension or 
proposed revocation, the appellant must submit a written request to the 
reviewing official seeking review, unless some other time period is 
agreed to by the parties. A copy must also be sent to the respondent. 
The request for review must include a copy of the notice of suspension 
or proposed revocation, a brief statement of why the decision to 
suspend or propose revocation is wrong, and the appellant's request for 
an oral presentation, if desired.
    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.

Section 16.6 What is an abeyance agreement?

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

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

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's Documents and Brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is wrong (appellant's brief).
    (b) Respondent's Documents and Brief. Within 15 days after 
receiving a copy of the acknowledgment of the

[[Page 20604]]

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

Section 16.8 When is there an opportunity for oral presentation?

    (a) Electing Oral Presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding Official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary Conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues, stipulations 
and admissions, limitations on evidence and witnesses that will be 
presented at the hearing, time allotted for each witness and the 
hearing altogether, scheduling the hearing, and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at their discretion, produce a written document 
summarizing the conference or transcribe the conference, either of 
which will be made a part of the record.
    (d) Time and Place of the Oral Presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date the appellant's request for review is received or within 10 days 
of submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the Oral Presentation.
    (1) General. The presiding official is responsible for conducting 
the oral presentation. The presiding official may be assisted by one or 
more of the official's employees or consultants in conducting the oral 
presentation and reviewing the evidence. While the oral presentation 
will be kept as informal as possible, the presiding official may take 
all necessary steps to ensure an orderly proceeding.
    (2) Burden of Proof/Standard of Proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
wrong.
    (3) Admission of Evidence. The Federal Rules of Evidence do not 
apply and the presiding official will generally admit all testimonial 
evidence unless it is clearly irrelevant, immaterial, or unduly 
repetitious. Each party may make an opening and closing statement, may 
present witnesses as agreed upon in the prehearing conference or 
otherwise, and may question the opposing party's witnesses. Since the 
parties have ample opportunity to prepare the review file, a party may 
introduce additional documentation during the oral presentation only 
with the permission of the presiding official. The presiding official 
may question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At their discretion, the presiding 
official may require or permit the parties to submit post-hearing 
briefs or proposed findings and conclusions. Each party may submit 
comments on any major prejudicial errors in the transcript.

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

    (a) Applicability. When the Secretary notifies an HHS-certified 
laboratory or IITF in writing that its certification to perform drug 
testing has been immediately suspended, the appellant may request an 
expedited review of the suspension and any proposed revocation. The 
appellant must submit this request in writing to the reviewing official 
within 3 days of the date the HHS-certified laboratory or IITF received 
notice of the suspension. The request for review must include a copy of 
the suspension and any proposed revocation, a brief statement of why 
the decision to suspend and propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing Official's Response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review File and Briefs. Within 7 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, which is tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the

[[Page 20605]]

suspension and any proposed revocation. No reply brief is permitted.
    (d) Oral Presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official, the presiding 
official will attempt to schedule the oral presentation within 7-10 
days of the date of appellant's request for review at a time and place 
determined by the presiding official following consultation with the 
parties. The presiding official may hold a prehearing conference in 
accordance with Section 16.8(c) and will conduct the oral presentation 
in accordance with the procedures of Sections 16.8(e), (f), and (g).
    (e) Written Decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7-10 days of the date of the 
oral presentation or within 3 days of the date on which the transcript 
is received or the date of the last submission by either party, 
whichever is later. All other provisions set forth in Section 16.14 
will apply.
    (f) Transmission of Written Communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be by fax, secured electronic transmissions, 
or overnight mail.

Section 16.10 Are any types of communications prohibited?

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

Section 16.11 How are communications transmitted by the reviewing 
official?

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

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

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

Section 16.13 What administrative records are maintained?

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

Section 16.14 What are the requirements for a written decision?

    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefore in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
their decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of 
the date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public Notification. If the suspension and proposed revocation 
are upheld, the revocation will become effective immediately and the 
public will be notified by publication of a notification in the Federal 
Register. If the suspension and proposed revocation are denied, the 
revocation will not take effect and the suspension will be lifted 
immediately. Public notification will be given by publication in the 
Federal Register.

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

    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal Law. The reviewing official's decision, under 
Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe 
for judicial review as of the date of the decision.
[FR Doc. 2022-06886 Filed 4-6-22; 8:45 am]
BILLING CODE 4162-20-P