Attachment B - Mandatory Guidelines

Tuesday,
April 13, 2004

Part III

Department of
Health and Human
Services
Substance Abuse and Mental Health
Services Administration
Mandatory Guidelines and Proposed
Revisions to Mandatory Guidelines for
Federal Workplace Drug Testing
Programs; Notices

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Federal Register / Vol. 69, No. 71 / Tuesday, April 13, 2004 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Revised mandatory guidelines.
AGENCY:

SUMMARY: The Department of Health and
Human Services (‘‘HHS’’ or
‘‘Department’’) is establishing standards
for determining the validity of urine
specimens collected under the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs.
These standards ensure that specimen
validity testing (SVT) and reporting
procedures are uniformly applied to all
Federal agency urine specimens when a
validity test is conducted.
DATES: Effective Date: November 1,
2004.
Comment Date: Submit comments on
or before June 14, 2004.
ADDRESSES: You may submit comments,
identified by (insert docket number and/
or RIN number), by any of the following
methods:
• E-mail: [email protected]. Include
docket number and/or RIN number in
the subject line of the message.
• Fax: 301–443–3031.
• Mail: 5600 Fishers Lane, Rockwall
II, Suite 815, Rockville, Maryland
20857.
• Hand Delivery/Courier: 5515
Security Lane, Suite 815, Rockville,
Maryland 20852.
Instructions: All submissions received
must include the agency name and
docket number or Regulatory
Information Number (RIN) for this
rulemaking. All comments will be
available for public review at 5515
Security Lane, Suite 815, Rockville,
Maryland 20852.
FOR FURTHER INFORMATION CONTACT:
Walter F. Vogl, Ph.D., Division of
Workplace Programs, CSAP, 5600
Fishers Lane, Rockwall II, Suite 815,
Rockville, Maryland 20857, telephone
(301) 443–6014, fax (301) 443–3031, or
e-mail: [email protected].
SUPPLEMENTARY INFORMATION:

I. Background
The Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Mandatory Guidelines) establish the
scientific and technical guidelines for
Federal workplace drug testing
programs and standards for certification
of laboratories engaged in urine drug
testing for Federal agencies, under

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authority of section 503 of Pub. L. 100–
71, 5 U.S.C. 7301 note, and E. O. No.
12564. The Mandatory Guidelines were
first published in the Federal Register
on April 11, 1988 (53 FR 11979), and
revised on June 9, 1994 (59 FR 29908),
and on November 13, 1998 (63 FR
63483).
The Department is revising the
Mandatory Guidelines here concerning
the determination of the validity of
urine specimens. In another document
published along with this revision, the
Department is proposing to revise the
Mandatory Guidelines again to add
alternative specimens, instrumented
initial test facilities, and point of
collection testing.
The alternative specimen proposal
will be subject to a 90-day comment
period after which the Department will
consider the comments received and
issue a final revision. Until the final
revision on alternative specimens is
issued, the Mandatory Guidelines as
contained in this revision govern.
This revision becomes effective 180
days after the date of publication so that
laboratories have an opportunity to
purchase and become familiar with
testing equipment to be used in
assessing the validity of a urine
specimen.
The revision of the Guidelines is
subject to further comment only on the
creatinine criterion that is part of the
requirement to report a urine specimen
as substituted because the Department
has based this criterion on information
received after the comment period
closed on October 22, 2001.
II. Summary of the Proposed Revised
Mandatory Guidelines
On August 21, 2001, HHS published
a notice in the Federal Register (66 FR
43876), proposing that the Mandatory
Guidelines be revised to include
standards for determining the validity of
urine specimens collected by Federal
agencies under the Federal Workplace
Drug Testing Program. These proposed
revisions to the Mandatory Guidelines
establish the analytical standards for
determining the validity of urine
specimens in order to ensure that SVT
and reporting procedures are uniformly
applied to all Federal agency urine
specimens. Set forth below is a
description of the major provisions of
the proposed revision of the Mandatory
Guidelines, including, among other
things, definitions for certain terms
associated with SVT, a discussion of the
specific SVT requirements and how
validity testing results should be
reported, clarification of the
qualifications and responsibilities of a
Medical Review Officer (MRO), how a

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donor may challenge the accuracy of a
validity testing result, and an expansion
of the existing performance testing
program and laboratory inspection
program.
Provisions of the Proposed Revisions to
the Mandatory Guidelines
1. Definitions
The proposed revisions added
definitions specifically associated with
specimen validity testing. These include
the definitions for adulterated
specimen, confirmatory validity test,
dilute specimen, initial validity test,
invalid result, non-negative specimen,
oxidizing adulterant, and substituted
specimen.
2. SVT Requirement
The proposed revisions require each
Federal agency to have specimen
validity tests conducted on all urine
specimens collected under the
Mandatory Guidelines.
3. Split Specimen Testing
The proposed revisions grant the
donor the right to request that a split
(Bottle B) specimen be tested to confirm
an adulteration or substitution result
that was reported by the primary
laboratory on the primary (Bottle A)
specimen.
4. SVT Reporting Criteria
The proposed revisions add a new
section, entitled ‘‘Validity Testing,’’ to
the Mandatory Guidelines. The new
section requires a laboratory to conduct
validity testing and establishes the
criteria that must be used by a
laboratory to report a specimen as
adulterated, substituted, invalid, or
dilute.
5. Cutoff Levels
The proposed revisions establish a pH
cutoff for reporting a specimen as
adulterated and establish a creatinine
cutoff and a specific gravity cutoff for
reporting a specimen as substituted. The
creatinine concentration cutoff is
proposed to be less than 5 mg/dL. The
specific gravity cutoff is proposed to be
less than 1.002. The pH cutoff is
proposed to be less than 3.
6. Retesting
The proposed revisions require a
second laboratory to conduct validity
tests when it is unable to reconfirm the
drug or drug metabolite that was
originally reported positive in a single
specimen or primary (Bottle A)
specimen. The proposed revisions also
add criteria for retesting a specimen for
adulterants and substitution.

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Federal Register / Vol. 69, No. 71 / Tuesday, April 13, 2004 / Notices
7. Quality Control
The proposed revisions establish
specific quality control criteria and
other procedural and test requirements
for performing each individual validity
test.
8. MRO Qualifications and Duties
The proposed revisions clarify the
qualifications and responsibilities of the
MRO and expand the MRO’s duties to
review adulteration, substitution, and
invalid test results reported by a
laboratory.
9. Donor’s Right To Challenge Results
The proposed revisions provide that a
donor has the same right to challenge
the accuracy of a positive, adulterated,
or substituted result reported for a
single specimen collection as for a split
specimen collection.
10. HHS Notification of Results
The proposed revisions state that an
MRO will notify the designated
regulatory office that is responsible for
the laboratory certification program
when a second laboratory fails to
reconfirm a positive, adulterated, or
substituted result reported by a first
laboratory.
11. Performance Testing and Laboratory
Inspection Programs
The proposed revisions expand the
performance testing program and the
laboratory inspection program. The
performance testing program will
include performance testing samples to
challenge each certified laboratory’s
ability to correctly perform validity
tests. The inspection program will
include inspecting and evaluating the
SVT procedures used by the laboratories
in a manner similar to that for all other
laboratory operations.
III. Summary of Public Comments and
HHS’s Response
The August 21, 2001, Federal Register
notice proposing revisions to the
Mandatory Guidelines set forth a 60-day
public comment period, ending on
October 22, 2001. During the public
comment period, the terrorist strikes of
September 11 occurred, which have
demanded a new focus and resolve from
our government and citizens, that
continue undiminished to date.
Initially, there was concern that the
public comment period would need to
be extended, or that some comments
might be delayed due to temporary
disruptions in the delivery of
documents. In light of the national
emergency, the Department determined
that public comments would be
considered, even if they were received

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a few days after the formal ending date.
That proved to be unnecessary. The
Department received 23 public
comments by October 22nd on the
proposed changes from Federal
agencies, individuals, organizations,
laboratories, and companies that were
then made available for public view on
our Internet Web site
(www.drugfreeworkplace.gov). All
written comments were reviewed and
taken into consideration in the
preparation of the revised Mandatory
Guidelines. Set forth below is an
overview of the various comments and
recommendations received and the
Department’s responses to those
concerns. Similar comments are
considered together.
Over the past several years, there has
been an increasing number of chemical
adulterants marketed on the Internet
and in counter-culture, pro-drug use
magazines. These adulterants are
advertised as able to prevent
laboratories from detecting drugs or
metabolites in physiological specimens
(e.g., urine, hair, oral fluid) that are
collected as part of a drug testing
program. These products are often toxic
or corrosive and are sold to be added to
a specimen in order to mask the
presence of any drugs or metabolites.
Examples of adulterants include various
nitrites (Klear, Whizzies), pyridinium
chlorochromate (Urine Luck, LL481,
Sweet Pee’s Spoiler), surfactant (Mary
Jane SuperClean 13), and acid (Amber13, THC–Free). As of this time,
approximately 400 different products
(although many contain the same
adulterant) are available for adulterating
urine specimens.
Even more blatant are recent increases
in openly marketed promises to conceal
current illicit drug use by substituting a
‘‘clean’’ urine specimen for the druguser’s ‘‘dirty’’ one. Some products
actually advertise a prosthetic device in
a range of skin tones complete with
waistband, fluid reservoir,
thermocouple heating device, and
externally formulated and color-dyed
solution marketed as synthetic urine.
These devices and systems are targeted
for use by individuals who want to
conceal their illicit drug use by using
such a system to suborn a drug test.
The final requirements that make up
the revisions to the Mandatory
Guidelines are based on seven years of
experience with SVT. These revisions
are the collective product of a broad
community of medical, forensic,
research, and production laboratory
testing experts who have contributed
their knowledge, determination, and
problem-solving skills to address those
who would cheat on a drug test.

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In reviewing different specimen
validity test procedures and methods,
the Department learned from mistakes
made by participants. The Department
corrected these mistakes as they
occurred, including making corrections
or canceling test results in cases where
laboratory inspectors, contractor staff,
and Federal program staff were not
certain about the ability of a laboratory
forensically to defend a test result in
court. This approach is a practice the
Department will continue.
The Department has established these
final requirements for SVT to produce
the most accurate, reliable, and correctly
interpreted test results. In a national
system that has reduced the number of
detected adulterated and substituted
specimens to the current levels of about
three one-hundredths of one percent of
all federally mandated workplace tests
performed in the past year, some may
ask if it is worth the effort to prevent
this very small number of individuals
from masking their personal use of
illicit drugs. The answer is yes. The
purpose of the entire program has been
to prevent and deter the use of illicit
drugs in the Federal workplace. It has
been vitally important to always project
a sure and certain standard that Federal
employees will be held personally
accountable regarding employment
selection or even job retention should
they choose to use illicit drugs.
The Department intends to decrease
or remove opportunities to subvert a
workplace drug test through these
revisions to the Mandatory Guidelines
and will seek to hold all individuals
accountable for their choices.
1. Mandatory SVT (Paragraph 2.1(a)(4))
The Department specifically
requested comments from Federal
agencies and employees covered by E.O.
12564 and Pub. L. 100–71 regarding the
proposal to require SVT as part of their
drug testing programs. Only one Federal
agency submitted a comment on this
issue. The comment submitted
concurred with the proposal to make
SVT mandatory on urine specimens
collected by all Federal agencies.
Because there were no comments
submitted by Federal agencies or
Federal employees opposed to the
proposal, the Department believes it is
appropriate to require each Federal
agency to make SVT a required part of
its workplace drug testing program.
2. Donor Right To Request a Retest of an
Adulterated or Substituted Specimen
(Sections 2.2(h) and 2.6(e))
One commenter suggested that the
proposed requirement for the donor to
request a retest on a single specimen or

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a test of a split specimen within 72
hours after being notified by the MRO
that his or her specimen was reported
positive, adulterated, or substituted was
insufficient. The 72-hour rule has been
in the Guidelines since 1994 and the
Department is not aware of any occasion
in which the donor was unable to
request a test of a split specimen within
this time frame. Additionally, MROs
have the discretion to extend the 72hour time frame when necessary. The
proposed revision to this section of the
Mandatory Guidelines simply expands
the donor’s ability to request a retest
when a specimen is identified as
adulterated or substituted. The donor
shall be allowed the same ability to
request through the MRO a retest of a
single specimen that is reported either
drug positive, adulterated, or
substituted. In cases where a split
specimen was collected consistent with
agency policy, the donor shall be
allowed the same ability to request
through the MRO a retest of the split
(Bottle B) specimen when the primary
specimen is reported either drug
positive, adulterated, or substituted.
Based on our experience, the
Department continues to believe that 72
hours is a sufficient period of time for
a donor to request a retest on a single
specimen or a test of the split specimen
after being notified by the MRO that his
or her specimen was reported positive,
adulterated, or substituted.
The same commenter also suggested
that a Federal agency should have the
authority to direct a retest of a single
specimen or the test of a split specimen
at any time. The Department believes
that limiting the ability to request a
retest to the donor ensures that each
donor is offered the same chance to
dispute the reported test results.
However, the Guidelines do not
preclude a judge from issuing a court
order to retest a specimen, an
administrative law judge from ordering
a retest of a specimen, or a Federal
agency from retesting a specimen as part
of a legal or administrative proceeding
to defend a test result when the donor
elected not to request a retest of a
specimen reported positive, adulterated,
or substituted. A new paragraph
2.6(e)(4) has been included to ensure
that a Federal agency may conduct a
retest under this limited situation.
3. SVT (Section 2.4(g))
One commenter suggested that it is
unnecessary for all laboratories to have
the capability to identify and quantitate
oxidizing adulterants and recommended
establishing a list of laboratories that
would specialize in adulteration testing.
The Department does not agree with this

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recommendation. The Department
believes that all laboratories must have
the capability and actually test all
specimens for one or more oxidizing
adulterants. This is especially critical
for those specimens where a drug test
result or other evidence indicates that a
specimen may be adulterated.
Otherwise, many specimens adulterated
with oxidants may simply be reported
as negative. This action is consistent
with the Federal Workplace Drug
Testing Program goal of ensuring an
accurate and reliable result on every
specimen tested, whether the result is
positive or negative for drugs,
adulterated, substituted, or invalid.
One commenter suggested there is no
value in determining the pH for every
specimen because the number of
specimens reported with a pH that is too
low or too high is extremely low. The
Department believes that the
elimination of this requirement would
allow the use of adulterants that alter
the pH causing it to be out of the normal
physiological range, and hence interfere
with obtaining a valid drug test or
adulterant result. Therefore, as was
proposed, the revisions to the
Mandatory Guidelines shall require that
a laboratory determine the pH for every
specimen tested.
One commenter suggested the
requirement that a laboratory must test
a specimen for oxidizing adulterants did
not clearly state that the test(s) was to
be performed on each specimen. The
Department agrees that the statement of
the requirement in the proposed
revisions was unclear. As a result,
paragraph 2.4(g)(4) has been revised to
indicate that one or more validity tests
for oxidizing adulterants must be
performed on each specimen.
One commenter recommended either
to define abnormal color or odor or to
delete any reference to abnormal
physical characteristics as a condition to
perform additional validity tests. The
Department believes there are physical
characteristics that can be used to
identify specimens that may require
some additional validity tests. However,
definitions cannot be developed to
specifically describe all the possible
abnormal characteristics that may be
observed by laboratory personnel. In
response to this comment, the
parenthetical reference to color, odor, or
excessive foaming has been deleted in
the Mandatory Guidelines to avoid
limiting the possible characteristics that
may be used to trigger additional
validity tests. Because of the large
number of adulterants being marketed to
mask the presence of or remove drugs or
metabolites from a specimen, the
Department fully intends for color, odor,

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and excessive foaming, among others, to
remain as abnormal physical
characteristics that can be evaluated at
a laboratory and prompt additional
testing as specified in paragraph
2.4(g)(5). However, a laboratory may
choose not to test the specimen if the
laboratory believes that testing the
specimen may damage its instruments.
For example, a specimen that is
gelatinous may possibly clog the tubing
used in an immunoassay analyzer,
thereby shutting down the instrument
and requiring extensive maintenance. In
such a case, the laboratory may assume
that the urine specimen is not a valid
urine specimen and must report an
invalid result to the MRO. This invalid
result is then used by the MRO to direct
the agency to have the donor
immediately submit another urine
specimen using a direct observed
collection. See section 2.6(c).
One commenter stated that
insufficient data exists to support the
proposed requirement that a specimen
be reported as an ‘‘invalid result’’ if
validity testing performed on the
specimen shows creatinine
concentration and specific gravity
results that are considered to be
inconsistent with normal human
physiology. The Department believes
that the conditions given for creatinine
concentration and specific gravity
results that are inconsistent with normal
range values indicate possible
tampering with the specimen. The
requirement to report these inconsistent
values as ‘‘invalid results’’ ensures the
collection of another specimen to
determine if the donor did provide a
valid specimen or, in fact, did tamper
with the first specimen collected.
With regard to the proposal to
establish the lower specific gravity
cutoff as less than 1.002 for the
substitution criteria, the Department has
reconsidered this proposal and is
establishing the specific gravity cutoff as
less than or equal to 1.0010. Note that
this cutoff is stated to four decimal
places. This will retain the specific
gravity cutoff that the laboratories have
been using since HHS issued guidance
for all laboratories in determining the
validity of a specimen (Division of
Workplace Programs Memorandum
dated September 28, 1998, Subject:
Guidance for Reporting Specimen
Validity Test Results, Program
Document #35). At the time the Program
Guidance was issued and the proposed
changes to the Mandatory Guidelines
were published in August 2001, the
refractometers that were in use read the
values to three decimal places (i.e.,
1.001). Since the time that the
Department published the proposed

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cutoff of less than 1.002, a new series of
electronic refractometers have been
made available that measure specific
gravity to four decimal places. The use
of a refractometer that measures specific
gravity to four decimal places allows a
laboratory to report and display specific
gravity values that are within one tenthousandth from the cutoff rather than
being essentially a ‘‘yes’’ or ‘‘no’’ answer
(that is, 1.000 or 1.001 for a ‘‘yes’’
answer, 1.002 for a ‘‘no’’ answer when
using a three decimal place
refractometer). Therefore, the
Department directs that all laboratories
must use refractometers that report and
display specific gravity to four decimal
places. These instruments also have
electronic and hard copy reporting
peripheral device capability and thus
allow machine generated
documentation, which recent
administrative and legal proceedings
have advocated.
After the close of the public comment
period, and prior to the publication of
a final notice in the Federal Register
that would have established the criteria
used to report a specimen as
substituted, the Department became
aware of supplemental information from
a Congressionally-mandated study by
the Department of Transportation (DOT)
Federal Aviation Administration (FAA)
indicating that the Department’s
treatment of substitution should be
reconsidered. The information was
presented at a conference sponsored by
the FAA in Tampa, Florida, on February
4–6, 2003, that brought together
toxicologists, nephrologists and other
physicians, MROs, technical experts in
various fields, and HHS and DOT
officials. Attendees at the conference
generally agreed that it would be
appropriate to lower the creatinine
criterion that is part of the requirement
to report a urine specimen as
substituted. This information lead DOT
to publish an interim final rule in the
Federal Register (68 FR 31624) on May
28, 2003, that changed the way MROs
were expected to interpret substitution
results reported by the laboratories.
This supplemental information
strongly suggested that if the
Department adopted the proposed
cutoffs as written, in rare, but very real
circumstances, it might be possible to
misidentify an individual as providing a
substituted specimen, when in fact the
specimen was actually produced by the
individual. To date, to the best of our
knowledge, there have not been any
Federal employees who have raised a
challenge to the specific creatinine
decision point of less than or equal to
5 mg/dL and specific gravity less than
or equal to 1.001 or greater than or equal

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to 1.020 as defining a ‘‘substituted
specimen.’’ After careful consideration
of the supplemental information, the
Department believes that it is
appropriate to propose lowering the
creatinine decision point to identify a
substituted specimen to less than 2 mg/
dL and specific gravity to less than or
equal to 1.0010 or greater than or equal
to 1.0200. With regard to the proposal
in August 2001 to establish the lower
specific gravity cutoff as less than 1.002
for the substitution criteria, the
Department has reconsidered this
proposal and is requiring to establish
the specific gravity cutoff as less than or
equal to 1.0010. Note that this cutoff is
now stated to four decimal places. This
will retain the specific gravity cutoff
that the laboratories have been using
since HHS issued guidance for all
laboratories in determining the validity
of a specimen (Division of Workplace
Programs memorandum dated
September 28, 1998, Subject: Guidance
for Reporting Specimen Validity Test
Results, Program Document #35). At the
time the Program Guidance was issued
and the proposed changes to the
Mandatory Guidelines were published
in August 2001, the refractometers that
were in use read the values to three
decimal places (i.e., 1.001). Since the
time that the Department published the
proposed cutoff of less than 1.002, a
new series of electronic refractometers
have been made available that measure
specific gravity to four decimal places.
Therefore, the Department is requiring
that all laboratories must use
refractometers that report and display
specific gravity to four decimal places.
These instruments also have electronic
and hard copy reporting peripheral
device capability and thus allow
machine generated documentation,
which recent administrative and legal
proceedings have advocated.
4. Reporting Results (Section 2.4(h))
Three commenters expressed concern
that the same test could be used for both
the initial and confirmatory validity
tests. The commenters believe that the
initial validity test should use a
different analytical methodology than
the confirmatory validity test before a
specimen can be reported adulterated or
substituted. The Department agrees with
the commenters’ recommendation that
initial and confirmatory validity tests
use a different analytical methodology
and has revised the reporting policy for
adulterants to require that two different
methods are used before a specimen can
be reported as adulterated. If a
laboratory uses the same test (e.g., the
same colorimetric test) for both the
initial test and the confirmatory test, the

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laboratory may only report an ‘‘invalid
result’’ for a specimen rather than an
adulterated result. Paragraph 2.4(h)(4)
clearly describes the combination of
methods that a laboratory must use to
report a specimen as adulterated for a
specific adulterant. The only exceptions
to this requirement pertain to the tests
used to measure the creatinine
concentration, specific gravity, and pH.
To report a specimen as adulterated
because the pH is too low or too high,
a pH meter may be used for both the
initial and confirmatory pH tests
because it is considered a reference
method by the scientific community, is
a highly reliable instrument, and gives
extremely accurate results when
properly calibrated. Further, pH values
represent a logarithmic scale and
therefore represent very large
differences between each pH unit. Based
on this assessment, using a pH meter for
both the initial and confirmatory pH
tests is scientifically and forensically
valid.
The Department believes it is
scientifically acceptable to use the same
creatinine test for both the initial and
confirmatory creatinine tests and to use
refractometry to measure specific
gravity for both the initial and
confirmatory specific gravity tests. For
creatinine, the most accepted method to
determine the creatinine concentration
is the Jaffe’ or modified Jaffe’
colorimetric procedure. In addition, any
endogenous substance that may
interfere with the creatinine
colorimetric test is going to produce a
reading such that the creatinine
concentration will appear to be higher
rather than lower than the true
creatinine concentration. In other
words, interfering compounds will
increase the creatinine concentration,
raising it above 2 mg/dL, and therefore
the specimen will not meet the criteria
to report it as substituted. As of this
time, the Department does not know of
any endogenous interfering substance
that will lower the apparent reading on
the colorimetric creatinine test.
Therefore, the Department believes it is
acceptable to use the same colorimetric
creatinine test for both the initial and
confirmatory tests.
With regard to using refractometry for
both specific gravity tests, a
refractometer, like a pH meter, is
considered a reference instrument and
its results are scientifically acceptable.
Therefore, the Department believes it is
acceptable to use refractometry for both
specific gravity tests. Moreover, the
combination of specific gravity and
creatinine serves as two tests employing
different scientific principles.

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A valid scientific identification is
based on the use of two methods used
on two separate aliquots obtained from
the original urine specimen. The nature
of the analytical method is based on the
chemical composition of the substance
to be tested. Further, the combination of
techniques is a function of both the
expected prevalence of the substance to
be tested and the nature of the analytical
technique. This may be illustrated by
the following examples:
(1) For drugs, drugs are tested by
immunoassay on the first aliquot. Each
immunoassay test has variable
specificity for a particular drug class.
The gas chromatography/mass
spectrometry (GC/MS) confirmatory
drug test is specific for a particular drug
or metabolite. The presence of drugs is
not expected in a urine specimen. While
the number of drugs to be identified in
a urine specimen is limited to those
specified by these Guidelines, the
number of drugs to be excluded
comprises a long list.
(2) For creatinine, creatinine is tested
by colorimetric assays using the same
assay in each of two aliquots. The
presence of creatinine in urine is
expected. Its concentration is normally
expected to be relatively high and it is
among a very small number of waste
products found in urine.
(3) For alcohol, although not part of
the Federal workplace drug testing
program, a breath sample is initially
tested on an approved device and, if
positive, a confirmatory test is
conducted using the same approved
device on a second breath sample. The
most common of the breath devices
utilizes a fuel cell in which the alcohol
is consumed resulting in a proportional
electronic response. Alcohol is a volatile
substance and although not expected to
be present in the breath, is among a very
short list of possible substances. The
concentration of alcohol, when present
in the body, is relatively very high.
The three examples constitute valid
scientific and forensic identification
although there is variation in the
analytical parameters and expected
prevalence of the substances in
biological specimens. Program
Documents 35 and 37 issued by HHS in
1998 and 1999 established the
framework for reporting a specimen as
substituted and adulterated. This
framework included an analysis on two
aliquots with various qualitative and
quantitative procedures. Each laboratory
had the flexibility to develop the
specific testing requirements, to validate
the methods used, and to establish
quality control procedures using good
laboratory practices. This generally
stated scientific approach has been

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recommended since the inception of
this program.
Our on-going review of specimen
validity test results and inspection of
laboratories has shown analysis to date
to be competent and reasonable and to
have met satisfactory scientific criteria.
Results of these specimen validity tests
have also been introduced and
effectively been supported in legal
proceedings. The Department conducted
a special review of SVT in all certified
laboratories. This included analysis for
adulterants where the same test was
used on two different aliquots of the
donor’s specimen. Based on program
experience and availability and
development of refined analytical
procedures, the Department is
establishing specific requirements for
analytical procedures to identify the
common adulterants. See section 2.4(h).
One commenter recommended
reporting any specimen with a nitrite
concentration between 200 mcg/mL and
500 mcg/mL as an ‘‘invalid result.’’ The
Department agrees with this
recommendation and has changed the
Guidelines at paragraph 2.4(h)(7)(iii) to
include a nitrite range as one of the
conditions upon which a specimen
must be reported as an ‘‘invalid result.’’
Although a 500 mcg/mL nitrite
concentration is established as the
concentration at or above which a
specimen is reported adulterated for
nitrite, clinical evidence (see Urry, F.M.
et al., Nitrite Adulteration of Workplace
Urine Drug Testing Specimens. 1.
Sources and Associated Concentrations
of Nitrite in Urine and Distinction
Between Natural Sources and
Adulteration, ‘‘Journal of Analytical
Toxicology’’ 22: 89–95 (1998)) indicates
that any nitrite concentration above 129
mcg/mL is not physiologically possible
and is, therefore, an abnormal
concentration. The Department also
notes that since Program Documents 35
and 37 were issued in 1998 and 1999
and the proposed Changes to the
Mandatory Guidelines were published
in August 2001, some adulterant
products now contain lower amounts of
nitrite mixed with other oxidant
compounds in an effort to avoid
detection.
5. Retesting a Specimen for Adulterants
(Section 2.4(k))
One commenter suggested deleting
any reference to limit of quantitation
(LOQ) when a second laboratory is
retesting a specimen for any adulterant
other than when retesting for pH or to
reconfirm the presence of nitrite. The
commenter suggested that the retesting
should use the limit of detection (LOD)
as is used when retesting a specimen for

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a drug positive to ensure consistency
between the retesting policy for drugs
and the policy for retesting adulterants.
The Department agrees with the
recommendation and has specified
using the LOD to reconfirm the presence
of an adulterant except when retesting
for pH and nitrite. However, the
retesting for an adulterant requires the
second laboratory to use its
confirmatory test for the adulterant that
was reported present in the single or
Bottle A specimen by the first
laboratory. For example, reconfirming a
pH that was too low or too high requires
the second laboratory to test an aliquot
of a single specimen or the split (Bottle
B) specimen using its confirmatory pH
meter test. Another example,
reconfirming the presence of chromium
(VI) requires the second laboratory to
test an aliquot of a single specimen or
the split (Bottle B) specimen using its
confirmatory test to determine the
presence of chromium (VI) above the
LOD. The second laboratory cannot use
its initial colorimetric test to reconfirm
the presence of chromium (VI).
6. Quality Control Requirements for
Validity Tests (Section 2.5(d))
One commenter suggested that the
Mandatory Guidelines should specify
what the reference method is for each
type of validity test. The Department
believes that the methods being used for
the various validity tests, with the
exception of the pH meter, do not meet
the classical definition of a reference
method (i.e., a method to which other
tests are compared). The Department
views it as more important that the
performance characteristics of the
method used for each type of validity
test can be documented by the
laboratory prior to using the method, as
is the case for the drug tests used by the
laboratories. Establishing the
performance characteristics of a method
prior to its use ensures that the method
can provide accurate measurements on
donor specimens which are verified by
simultaneously obtaining results for
quality control samples. If the quality
control samples results indicate a
possible error, then all specimens
associated with those quality control
samples must be retested until the
quality control sample results satisfy the
acceptance criteria established by the
laboratory.
One commenter suggested that the
proposed number of calibrators and
controls is excessive for some of the
validity tests. The Department believes
that the proposed quality control
requirements for the validity tests are
appropriate and are similar to those
required for the initial and confirmatory

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drug tests. Since the results of validity
tests can lead to the same personnel
actions that may occur as if the
specimen was reported positive for a
drug, it is essential that every effort is
made to ensure the accuracy and
reliability of every validity test result.

point (i.e., greater than or equal to
1.0200). Therefore, the Department has
combined the controls that are required
when conducting either the initial or
confirmatory specific gravity tests
regardless of which decision point is
applicable.

7. Requirements for Measuring
Creatinine Concentration (Section
2.5(e))
One commenter suggested that
requiring calibrators at 5 mg/dL and 20
mg/dL for a creatinine test requires an
unnecessary re-validation of the test and
that a control in the normal range
(greater than 20 mg/dL) is useful. The
Department proposed using calibrators
at 5 mg/dL and 20 mg/dL because most
creatinine tests are calibrated at 100 mg/
dL. Since the decision points for our
workplace drug testing program are so
much lower than used for most clinical
laboratory testing, it is essential that the
method be validated and calibrated at 2
mg/dL to ensure the highest degree of
accuracy and confidence around the
decision point used to determine a
substituted specimen. With regard to
including a control in the normal range,
the commenter overlooked the fact that
a control in the normal range was
included in the requirements for the
initial creatinine test. Given an initial
creatinine test result at less than the 2
mg/dL cutoff concentration, there is no
need to run another control in the
normal range for the confirmatory test.
However, controls are needed above and
below 2 mg/dL to ensure the highest
degree of accuracy and confidence
around the cutoff.

9. Requirements for Measuring pH
(Section 2.5(g))

8. Requirements for Measuring Specific
Gravity (Section 2.5(f))
One commenter stated that the
requirement for four quality control
samples when determining specific
gravity is excessive. The commenter
suggested simply including one
calibrator at each decision point and
one control in the normal range. The
Department believes that a decision
point must be bracketed whenever
possible to ensure the accuracy of a test
result rather than using the approach
recommended by the commenter. Since
the time the proposed policy was
published, the Department has reevaluated the control requirements for
measuring specific gravity. The
Department believes that each initial
and confirmatory specific gravity test
should have a calibrator and controls
covering the entire range rather than
selecting controls based on whether the
specimen is being evaluated against the
lower decision point (i.e., less than or
equal to 1.0010) or the higher decision

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One commenter suggested that, when
determining pH levels, a control in the
normal range should also be included.
The Department agrees with this
suggestion and is requiring that either a
calibrator or control in the normal range
be included in each test batch when
conducting either the initial or
confirmatory pH test.
One commenter noted that the
controls proposed for a colorimetric pH
test are inconsistent with the controls
required for a pH meter test. The
Department believes that this
inconsistency cannot be eliminated due
to the differences in the way
colorimetric pH tests and pH meters are
calibrated.
Section 2.5(g) has been revised to
require the use of three controls when
using a pH screening test (i.e., pH paper,
dipsticks, or colorimetric tests that have
a narrow dynamic range and do not
support the pH cutoffs) to determine if
the pH of a specimen is too low or too
high. This section also specifies the
calibrators and controls that must be
used if an initial colorimetric pH test or
initial pH meter test is conducted
without having used a screening test to
determine if the pH of a specimen may
be too low or too high. Additionally, the
Department believes that when a pH
screening test is used and the pH of the
specimen is possibly too low or too
high, the initial and confirmatory pH
meter tests may use calibrators and
controls that are focused on either the
lower or upper decision point, as
appropriate. This is a reasonable
approach because pH meter tests are
manual rather than automated.
However, an exception exists when a
colorimetric pH test is used as the initial
pH test whether a screening pH test was
or was not conducted. The Department
believes that most laboratories will use
an initial colorimetric pH test to test all
specimens received, rather than using
screening tests, because it is an
automated procedure and would be
efficient and cost effective compared to
using pH screening tests or a ‘‘manual’’
pH meter test. To avoid having to repeat
the colorimetric pH test with focused
calibrators and controls only for those
specimens that may have a pH that is
too low or too high, the entire pH range

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should be covered with appropriate
calibrators and controls.
10. Requirements for Performing
Oxidizing Adulterant Tests (Section
2.5(h))
Several commenters expressed
concern with the proposed requirements
for performing oxidizing adulterant
tests. There was a general request for
more specific information and a concern
that these oxidizing tests fail to meet
appropriate scientific standards. The
Department agrees that the proposed
requirement for performing oxidizing
adulterants was unclear. Therefore, the
Department has revised the
requirements described in section
2.5(h). The Department expects each
laboratory to test each specimen for one
or more oxidizing adulterants. This can
be accomplished by either using a single
test that responds to several oxidizing
adulterants (e.g., a general oxidant
colorimetric test for the initial test for
oxidizing adulterants) or one or more
initial tests that identify specific
oxidizing adulterants (e.g., an initial
nitrite colorimetric test, an initial
chromium (VI) colorimetric test).
Additionally, the Department is
permitting the general oxidant
colorimetric test to be used with
different calibrators or controls to
possibly detect different adulterants. For
example, the general oxidant
colorimetric test can be used to detect
nitrite using a calibrator or control with
a greater than or equal to 200 mcg/mL
nitrite-equivalent cutoff or to detect
chromium (VI) using a greater than or
equal to 50 mcg/mL chromium (VI)equivalent cutoff. Since individuals
attempting to subvert the drug testing
program may use a number of different
oxidizing adulterants, the testing
requirement for oxidizing adulterants is
intentionally drafted broadly to permit
the flexibility needed to combat such
tampering with the testing process.
Although these oxidizing adulterant
tests are new, the Department expects
the laboratories to validate each
oxidizing adulterant test before it is
used to test donor specimens and to
apply the specified quality control
requirements to ensure the proper
performance of each test on donor
specimens.
11. Requirements for Performing
‘‘Other’’ Adulterant Tests (Section 2.5(j))
One commenter suggested that the
proposed requirement for the
performance of ‘‘other’’ validity tests for
adulterants did not permit the flexibility
necessary to ensure that as new
adulterants are identified, the
Mandatory Guidelines would permit

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laboratories to test for these new
adulterants. The Department agrees with
that comment and has revised paragraph
2.5(j)(3) to ensure that newly identified
adulterants not included in paragraphs
2.5(j)(1) or (2) or in any other section of
the Mandatory Guidelines can be tested
for by a laboratory.
One commenter asked if a specimen
containing glutaraldehyde could be
reported as adulterated based on using
the confirmatory test procedure on two
separate aliquots. The revision to the
Mandatory Guidelines requires that a
specimen can only be reported
adulterated for glutaraldehyde if the
initial and confirmatory glutaraldehyde
tests use different methodologies. For
glutaraldehyde, the characteristic
response on immunoassay drug tests is
very well established and may serve as
the initial test for determining the
presence of glutaraldehyde or by
performing a separate initial aldehyde
test. The confirmatory test for
glutaraldehyde traditionally has been
gas chromatography/mass spectrometry.
12. MRO Qualifications and Review of
Results (Section 2.6)
One commenter recommended that
the Mandatory Guidelines be revised to
require an MRO to complete formal
training and pass an examination, as
required in the DOT Procedures for
Transportation Workplace Drug and
Alcohol Testing Program (49 CFR Part
40). The Department recognizes that
other changes to the Mandatory
Guidelines may be needed; however,
our intent in the solicitation of comment
was to focus only on proposing changes
associated with mandating validity
testing on specimens collected under
the Mandatory Guidelines.
One commenter expressed concern
that an MRO may direct a laboratory to
send a specimen to another laboratory
before determining that the second
laboratory has the capability to perform
any additional tests. The Department
agrees that an MRO should always
contact a laboratory to determine its
capability before having a specimen
transferred for additional validity
testing. This policy applies especially to
paragraph 2.6(c)(2) when Laboratory A
reports an invalid result and the
laboratory and MRO agree that further
testing may be useful in an attempt to
be able to report a positive, adulterated,
or substituted result.
13. Laboratory Result Not Reconfirmed
by a Second Laboratory (Section 2.6(g))
One commenter interpreted the
proposed requirement that the MRO
notify the designated HHS regulatory
office when a second laboratory was

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unable to reconfirm the result reported
by the original laboratory testing the
specimen as meaning that the MRO is
not receiving the same notification. The
agency’s designated representative
always receives all results reported by
an MRO. This requirement is intended
to ensure that the HHS regulatory office
is notified of such reports to permit the
initiation of an investigation to
determine if an error was made by either
laboratory.
14. Additional Changes Related to the
New SVT Requirements
In addition to the changes discussed
above, the Department is revising other
sections of the Mandatory Guidelines
that are directly affected by the new
SVT requirements.
In section 1.2, the original definitions
for an ‘‘initial test’’ and a ‘‘confirmatory
test’’ are being changed to read ‘‘initial
drug test’’ and ‘‘confirmatory drug test,’’
respectively, to prevent any confusion
with the new definitions for ‘‘initial
validity test’’ and ‘‘confirmatory validity
test.’’ The Department is adding the
word ‘‘drug’’ throughout the Mandatory
Guidelines when referring to initial drug
tests and confirmatory drug tests.
Under section 2.2(f)(4), the collector
must direct the donor to empty his or
her pockets and display the items to
ensure that no items are present that
could be used to adulterate the
specimen. If nothing is there that can be
used to adulterate a specimen, the donor
places the items back into his or her
pockets and the collection procedure
continues. If the donor refuses to show
the collector the items in his or her
pockets, this is considered a refusal to
cooperate in the testing process. The
Department believes this requirement is
necessary because of the ease with
which a donor can conceal a small
amount of an adulterant and the
availability of numerous adulterants on
the Internet and in drug culture
magazines. This change also ensures
consistency with the collection
procedure specified in the DOT drug
testing regulations (49 CFR Part 40). The
Department believes that every effort
must be made to prevent a donor from
bringing something to the collection site
that could be used to adulterate a
specimen and, thereby, preventing it
from being properly tested for drugs.
Section 2.4(h)(2) was revised to
ensure that each specimen is subject to
validity testing to determine that it is a
valid urine specimen before a negative
result is reported.
Section 2.2(h)(8) was deleted because
it only deals with the testing of a split
(Bottle B) specimen that failed to

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reconfirm a positive drug result reported
for Bottle A.
In section 2.4(h), the Department
included all the reporting requirements
to report a specimen adulterated,
substituted, diluted, or as an invalid
result in paragraphs (4), (5), (6), and (7).
A new section 2.4(h)(12) was
included to require a laboratory to
report on the Federal CCF and/or
computer-generated electronic report
the actual numerical value (e.g.,
concentration) associated with an
adulterated specimen (when applicable)
and the confirmatory creatinine
concentration and the confirmatory
specific gravity for a substituted
specimen. The Department believes that
this requirement will eliminate the need
for an MRO to generate a separate
written request, thereby reducing the
paperwork associated with each
adulterated and substituted specimen.
Section 2.4(h)(15) was revised to
require each laboratory to provide a
statistical summary report every six
months rather than monthly to a Federal
agency. The format for the report was
also changed to include the provision
for information on adulterated,
substituted, and invalid specimens. The
Department believes reducing the
frequency of the report to a semi-annual
basis is cost effective and avoids
requiring laboratories to report a
summary for several specimens as
opposed to a more reasonable number
that would be tested over a six-month
period of time. Both of these changes are
consistent with the requirements in the
DOT drug testing regulations (49 CFR
Part 40).
In sections 2.4(i) and 3.9, the
requirement to retain positive
specimens in long-term storage is
expanded to include specimens
reported as adulterated, substituted, and
invalid. Because administrative and/or
legal actions may be taken that relate to
specimens with these results, it is
imperative that they be retained frozen
and available for possible future
retesting.
In section 2.4(j), the retesting policy
for drugs has been expanded. If a second
laboratory fails to reconfirm the
presence of a drug when retesting a
single specimen or testing a split (Bottle
B) specimen, the second laboratory is
required to conduct validity tests in an
attempt to determine a reason for failing
to reconfirm the presence of the drug or
metabolite.
Sections 2.5(k)(1) and (3) have been
revised to require that an agency blind
sample program includes samples that
are adulterated or substituted along with
negative samples and drug positive
samples. This requirement ensures that

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a laboratory’s procedures are challenged
with samples that are adulterated or
substituted.
Section 2.6, where appropriate, has
been revised to describe how an MRO
is expected to review adulterated,
substituted, and invalid results as well
as drug positive results.
Sections 2.6(g)(1) through (16) give
specific requirements on how an MRO
reports a result to a Federal agency
when Laboratory B fails to reconfirm the
test result reported by Laboratory A. The
Department believes these requirements
are necessary to ensure uniformity
among MROs when a failed to reconfirm
occurs.
Section 2.6(h) has been revised to
describe how an MRO shall report a
final test result to a Federal agency.
Section 3.4 has been revised to ensure
that each laboratory has the capability to
test for the five required classes of drugs
as well as to conduct validity tests as
specified in these Mandatory
Guidelines.
Section 3.5 has been revised to clarify
that all drug and validity tests are to be
conducted by a certified laboratory at
the same facility.
Sections 3.17, 3.18, and 3.19 have
been revised to clearly distinguish
between performance testing (PT)
samples that contain drugs and PT
samples that will challenge a
laboratory’s specimen validity tests. In
the proposed changes to the Mandatory
Guidelines, a revision was proposed to
section 3.2 to indicate that laboratories
would be challenged with specimen
validity samples in the PT program and
inspections would include reviewing
validity testing procedures. The
Department believes the specific
performance requirements for the
samples challenging a laboratory’s
specimen validity tests are comparable
to the requirements for the performance
testing with samples containing drugs or
metabolites.
15. Other Changes
The Department is making several
technical changes and/or clarifications
to other sections of the Mandatory
Guidelines. Several of these changes
reflect policies or procedures that have
been previously implemented. The
Department believes it is appropriate to
include these changes in this revision of
the Guidelines.
The term ‘‘collection site person’’ is
being replaced with the term ‘‘collector’’
throughout the Mandatory Guidelines.
The Department is making this change
because the use of the term ‘‘collector’’
has become the most common way to
refer to the individual involved with
collecting a specimen from a donor.

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The term ‘‘specimen chain of custody
form’’ is being replaced with the term
‘‘Federal drug testing custody and
control form’’ (or ‘‘Federal CCF’’)
throughout the Mandatory Guidelines.
This is the official name given to the
form approved by the Office of
Management and Budget (OMB) to
collect a urine specimen from a Federal
employee.
The definition for ‘‘chain of custody’’
has been revised to clarify that it refers
to a ‘‘process’’ that is used to track the
handling and storage of specimens
rather than ‘‘procedures’’ and deleted
the sentences that reference the OMB
form because the Federal CCF is defined
separately.
Section 2.2(g) was revised because the
current Federal CCF does not allow a
collector to transfer the custody of a
specimen to another individual prior to
releasing the specimen to an express
carrier or courier for shipment to a
laboratory. In addition, the first
sentence requiring the collector to
maintain the specimen bottle within
sight is redundant with the requirement
in paragraph 2.2(f)(17) as revised and
was deleted.
Section 2.4(b)(2) was revised to
clearly describe the types of errors that
may occasionally occur on a Federal
CCF and/or specimen bottle label/seal
that are considered to be fatal flaws.
These errors require a laboratory to stop
the testing process and to report the
result as rejected for testing. Paragraph
2.4(b)(3) was added to describe two
types of correctable flaws that, if not
corrected, would also require the
laboratory to report a specimen as
rejected for testing. Provisions similar to
these were originally implemented by
Program Document #9 (October 10,
1991). The Department believes
including these provisions in the
Guidelines will ensure uniform
treatment by laboratories when these
types of errors occur. The provisions are
also consistent with those contained in
the DOT drug testing regulations (49
CFR Part 40).
Section 2.4(f)(1) was revised to allow
a laboratory to report a quantitative drug
test result three different ways. The
Department believes that a laboratory
should have the option to report a
quantitative result as either ‘‘exceeds the
linear range of the test,’’ ‘‘greater than or
equal to (specify the upper limit of
linearity),’’ or as an accurate
quantitative result obtained by diluting
an aliquot of the specimen before
conducting the confirmatory drug test.
Section 2.4(h)(13) and (14) were
revised to describe the different ways
results can be transmitted from a
laboratory to an MRO. A laboratory

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always completes the test result section
on the Federal CCF; however, a copy of
the Federal CCF may or may not be sent
to the MRO depending on whether the
test result is negative or non-negative.
For a negative result, an electronic
report is sufficient. The Department
believes the reporting requirements in
these two sections will reduce the
paperwork burden and is consistent
with the intended use of the five-part
Federal CCF.
A new section 2.4(h)(11) was
included to require a laboratory to
report to an MRO a quantitative value
for morphine or codeine that is greater
than or equal to 15,000 ng/mL. Section
2.6(d) was also revised regarding the
policy that an MRO must follow when
verifying a donor specimen as positive
for morphine or codeine when the
concentration is at or above 15,000 ng/
mL. The Department believes that a
morphine or codeine concentration at or
above 15,000 ng/mL is high enough to
prevent falsely accusing an individual
of opiate abuse who may have only
eaten poppy seeds or falsely accusing an
individual who does not exhibit any
clinical evidence of opiate abuse and
does not provide a legitimate medical
explanation. These revisions are also
consistent with the laboratory reporting
and MRO verification policies in DOT
49 CFR Part 40.
Section 2.4(h)(14) was revised to
clarify that a laboratory may report all
test results by faxing a completed copy
of the Federal CCF, sending a completed
copy of the Federal CCF by courier or
mail, electronically transmitting a
legible image or copy of the completed
Federal CCF, and/or may forward a
computer-generated electronic report.
The Department believes that revising
this paragraph clarifies the point that
sending a computer-generated electronic
report does not prohibit a laboratory
from also sending a completed Federal
CCF by one of the other ways described.
The section also requires that a copy of
the completed Federal CCF must be
transmitted by one of the ways
described for a non-negative result (i.e.,
a computer-generated electronic report
is not sufficient, by itself, when a
laboratory reports a non-negative result
to the MRO).
Sections 2.5(b) and (c) were revised to
modify the general quality control
requirements for the initial drug and
confirmatory drug tests. The current
Guidelines require including ‘‘positive
control(s) fortified with drug or
metabolite’’ and ‘‘at least one positive
control with the drug or metabolite at or
near the threshold (cutoff).’’ These two
requirements can actually be satisfied
using a single control, which was not

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the intent of the requirements. The use
of the original phrase ‘‘at or near the
threshold (cutoff)’’ is too vague and
allows different interpretations. The
Department believes the revised
requirements will ensure consistency by
stating that each initial drug test batch
shall include a control targeted at 25
percent above the cutoff and a control
targeted at 75 percent of the cutoff. The
revised requirements in these two
sections have been described in other
NLCP program documents for several
years and placing them in the
Mandatory Guidelines eliminates
possible misinterpretation.
A new section 2.5(c)(4) was added to
require a laboratory to include in each
confirmatory drug test batch at least one
calibrator or control at or below 40
percent of the cutoff. Prior Department
policy required a laboratory to include
such a calibrator or control only when
the confirmatory drug test batch
contained an aliquot of a single
specimen or a split (Bottle B) specimen
received from a different laboratory for
confirmatory drug testing. The
Department believes including a
calibrator or control at or below 40
percent of the cutoff in each
confirmatory drug test batch is
appropriate to ensure that the laboratory
documents the accuracy of the
confirmatory drug test below the cutoff
for each confirmatory drug test whether
it contains or does not contain such a
specimen received from a different
laboratory. This has been clarified in
other program documents and ensures
that a uniform policy exists in all
laboratories.
Section 3.20 has been revised to
provide that the number of inspectors
on an inspection team can be two or
more rather than the three previously
specified for any inspection. In practice,
the number of inspectors on an
inspection team has varied depending
on the size of the laboratory. This
change was implemented several years
ago because the consolidation and
growth of several laboratories caused a
significant increase in their workloads,
and these increases made it difficult for
inspectors to review a sufficient number
of non-negative test results in the time
allotted. By changing the number of
inspectors for different sized
laboratories, the percentage of nonnegative test results reviewed by the
inspection teams remains somewhat
comparable between the different sized
laboratories. Currently, there are several
very small laboratories, and using two
inspectors is clearly sufficient to
conduct a thorough review of the
laboratory’s procedures and test results.
Conversely, several very large

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laboratories have workloads that require
more inspectors to conduct a thorough
review of both their procedures and test
results. The Department believes this
change is fair, equitable, and cost
effective for all the laboratories.
Other appropriate minor editorial
changes are being made for clarity and
consistency.
16. List of Adulterants
In accordance with the Federal
Register notice (66 FR 43876) dated
August 21, 2001, the Department will
begin including a list of known
adulterants in the monthly Federal
Register notice that lists the laboratories
that meet minimum standards to engage
in urine drug testing for Federal
agencies. The list will be revised as new
adulterants are identified.
Executive Order 12866: Economic
Impact
In accordance with Executive Order
12866, the agency has submitted the
Guidelines for review by the Office of
Management and Budget. However,
because the Mandatory Guidelines will
not have an annual impact of $100
million or more, and will not have a
material adverse effect on the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local or tribal governments, they
are not subject to the detailed analysis
requirements of Section 6(a)(3)(C) of
Executive Order 12866.
Paperwork Reduction Act of 1995
These guidelines contain information
collection provisions which are subject
to review by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA)(44
U.S.C. 3507(d)). The title, description
and respondent description of the
information collections are shown in the
following paragraphs with an estimate
of the annual reporting 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: Mandatory Guidelines for
Federal Workplace Drug Testing
Programs.
Description: The Mandatory
Guidelines for Federal Workplace Drug
Testing Programs establish the scientific
and technical guidelines for Federal
Workplace drug testing programs and
standards for certification of laboratories
engaged in urine drug testing for Federal
agencies under authority of section 503
of Public Law 100–71, 5 U.S.C. 7301
and Executive Order 12564. These

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revisions to the Mandatory Guidelines
do not change the information
collection requirements in them.
The Mandatory Guidelines establish
the standards for a National Laboratory
Certification Program (NLCP), which
include requirements for a laboratory to
become certified and to maintain
certification. Prior to the initial
certification process, each interested
laboratory is required to submit an
application to the NLCP contractor for
review and evaluation.
Certified laboratories are inspected
every six months. Prior to each
maintenance inspection, the laboratory
receives and completes a copy of
Sections B and C of the NLCP
inspection checklist. The information
submitted by the laboratory allows the
members of the inspection team to
become familiar with a laboratory’s
procedures before arriving at the
laboratory to conduct the inspection,
thereby facilitating the completion of
the inspection.
The Mandatory Guidelines require
certified laboratories to maintain
information concerning quality
assurance and quality control, security
and chain of custody, documentation, to
report test results in accordance with
the specifications, and to participate in
a performance testing and inspection
program. In addition, there are
procedures that are used to review the
suspension or proposed revocation of a
certified laboratory.
The Mandatory Guidelines also
require using an OMB-approved Federal
custody and control form (CCF) to
document the integrity and security of
a urine specimen from the time it is
collected until received by the
laboratory.
Description of Respondents:
Individuals or Households; Business or
other for-profit; Not-for profit
institutions.
Response burden estimate: We
estimate the total annual response
burden imposed by the Mandatory
Guidelines to be 1,786,839 hours. This
is comprised as follows: (1) A laboratory
is estimated to require an average of 3
hours to complete the NLCP
Application form. An average of 3
laboratories apply each year, resulting
in an annual estimate of 9 hours of
response burden. (2) Sections B and C
of the NLCP Inspection Checklist, which
average 3 hours to complete, must be
completed in advance of each of the 2
annual inspections. Based on 50
certified laboratories undergoing 2
maintenance inspections each year, the
annual estimated response burden for
the NLCP Inspection Checklist is 300
hours. (3) Recordkeeping, reporting and

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disclosure burden for each laboratory is
estimated at 250 hours per laboratory
per year, for an annual total of 12,500

19653

hours for 50 laboratories. This estimate
includes the following:

Section

Topic
Recordkeeping

2.3(a)(4)* .............................................................
2.3(a)(5)* and 2.4(q)(1)* .....................................
2.3(a)(6)* and 2.5(a)* ..........................................
2.3(f)* ..................................................................
2.4(a)(1)* .............................................................
2.4(a)(2)* and (b)(4)* ..........................................
2.4(h)(17)* ...........................................................
2.4(p)* .................................................................
2.5(k)(6) ..............................................................

Responsible person at laboratory documents in-service training of personnel.
Maintain manual of all procedures used and dates they were in effect.
Documentation of quality assurance program.
Specifies contents of laboratory personnel files.
Requires documentation of laboratory visitor access.
Requires use of laboratory chain of custody form by personnel conducting tests.
Requires specimen records to be maintained for two years.
Requires two year retention of documentation of all aspects of testing process.
Requires documenting retesting when false positive error occurs on blind performance testing
sample.
Reporting

2.2(c), 2.2(f)(8) and 2.2(f)(14) .............................
2.4(h); 3.17(f) ......................................................
2.4(h)(15) ............................................................
2.6(h)(1) ..............................................................
3.17(f) ..................................................................
4.4 and 4.5(a) .....................................................
4.6 .......................................................................
4.7(a) ...................................................................
4.9(a) and (c) ......................................................

Require use of Federal CCF by collector and specify things to note on it.
Specifies reporting of test results from laboratory to Medical Review Officer (MRO); specifies
same reporting method for performance testing samples.
Specifies contents of periodic laboratory summary statistical report to Federal agency.
Specifies MRO reporting of final test results to Federal agency using Federal CCF.
Specifies laboratory reporting of performance test samples.
Specify contents of laboratory request for official review of suspension/proposed revocation of
certification.
Requires appellant notification to reviewing official at end of abeyance period.
Specifies contents of appellant review submission.
Specify contents of appellant expedited review file.
Disclosure

3.4 .......................................................................

Note: Activities designated by an * are
considered to be usual and customary
business practices for such laboratories and
no additional burden is considered to be
imposed by these requirements.

(4) There are an estimated 7,096,000
Federal CCFs completed each year, with
an average response burden of 5
minutes for the donor, 4 minutes for the
collector, 3 minutes for the laboratory,
and 3 minutes for the Medical Review
Officer. This results in 1,419,200 hours
of burden.
Individuals and organizations may
submit comments on these burden
estimates or any other aspect of these
information collection provisions,
including suggestions for reducing the
burden, and should direct them to:
SAMHSA Reports Clearance Officer,
Room 16–105, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
The information collection provisions
in the Mandatory Guidelines have been
approved under OMB control number
0930–0158. This approval expires July
31, 2006. An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information

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Requires laboratories to notify non-regulated private-sector employers/clients when testing
specimens not under Guidelines.

unless it displays a currently valid OMB
control number.
Charles G. Curie,
Administrator, SAMHSA.
Dated: April 2, 2004.
Tommy G. Thompson,
Secretary.

Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Subpart A—General
Sec.
1.1 Applicability.
1.2 Definitions.
1.3 Future Revisions.
Subpart B—Scientific and Technical
Requirements
2.1 The Drugs.
2.2 Specimen Collection Procedures.
2.3 Laboratory Personnel.
2.4 Laboratory Analysis Procedures.

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Quality Assurance and Quality Control.
Reporting and Review of Results.
Protection of Employee Records.
Individual Access to Test and
Laboratory Certification Results.

Subpart C—Certification of Laboratories
Engaged in Urine Drug Testing for Federal
Agencies

The Mandatory Guidelines as revised
are hereby adopted in accordance with
section 503 of Public Law 100–71 and
Executive Order 12564. For the public’s
convenience, the full version of the
Mandatory Guidelines as revised is
provided. It includes the new validity
testing requirements as well as the
changes to the opiate cutoff
concentrations that became effective on
December 1, 1998 (63 FR 63483).

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2.5
2.6
2.7
2.8

3.1
3.2
3.3
3.4

Introduction.
Goals and Objectives of Certification.
General Certification Requirements.
Capability to Test for Five Classes of
Drugs and to Conduct Validity Tests
3.5 Initial and Confirmatory Capability at
Same Site.
3.6 Personnel.
3.7 Quality Assurance and Quality Control.
3.8 Security and Chain of Custody.
3.9 One-Year Storage for Positive,
Adulterated, Substituted, and Invalid
Specimens.
3.10 Documentation.
3.11 Reports.
3.12 Certification.
3.13 Revocation.
3.14 Suspension.
3.15 Notice.
3.16 Recertification.
3.17 Performance Testing (PT) Requirement
for Certification.
3.18 PT Program Samples.
3.19 Evaluation of PT Sample Results.
3.20 Inspections.
3.21 Results of Inadequate Performance.
3.22 Listing of Certified Laboratories

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Subpart D—Procedures for Review of
Suspension or Proposed Revocation of a
Certified Laboratory
4.1 Applicability.
4.2 Definitions.
4.3 Limitation on Issues Subject to Review.
4.4 Specifying Who Represents the Parties.
4.5 The Request for Informal Review and
the Reviewing Official’s Response.
4.6 Abeyance Agreement.
4.7 Preparation of the Review File and
Written Argument.
4.8 Opportunity for Oral Presentation.
4.9 Expedited Procedures for Review of
Immediate Suspension.
4.10 Ex parte Communications.
4.11 Transmission of Written
Communications by Reviewing Official
and Calculation of Deadlines.
4.12 Authority and Responsibilities of
Reviewing Official.
4.13 Administrative Record.
4.14 Written Decision.
4.15 Court Review of Final Administrative
Action; Exhaustion of Administrative
Remedies.
Authority: E.O. 12564 and sec. 503 of Pub.
L. 100–71.

Subpart A—General
Section 1.1—Applicability
(a) These mandatory 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) And 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.
(b) Subpart C of these Guidelines
(which establishes laboratory
certification standards) applies to any
laboratory which has or seeks
certification to perform urine drug
testing for Federal agencies under a drug
testing program conducted under E.O.
12564. Only laboratories certified under
these standards are authorized to
perform urine drug testing for Federal
agencies.
(c) The Intelligence Community, as
defined by Executive Order No. 12333,
shall be subject to these Guidelines only
to the extent agreed to by the head of the
affected agency.
(d) These Guidelines do not apply to
drug testing conducted under legal
authority other than Executive Order
12564, including testing of persons in
the criminal justice system, such as
arrestees, detainees, probationers,
incarcerated persons, or parolees.1 (e)
1 Although HHS has no authority to regulate the
transportatiion industry, the Department of

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Agencies may not deviate from the
provisions of these Guidelines without
the written approval of the Secretary. In
requesting approval for a deviation, an
agency must petition the Secretary in
writing and describe the specific
provision or provisions for which a
deviation is sought and the rationale
therefor. The Secretary may approve the
request upon a finding of good cause as
determined by the Secretary.
(f) Agencies shall purchase drug
testing services only from laboratories
certified by HHS or an HHS-recognized
certification program in accordance
with these Guidelines.
Section 1.2

Definitions

For purposes of these Guidelines, the
following definitions are adopted:
Aliquot. A fractional part of a
specimen used for testing. It is taken as
a sample representing the whole
specimen.
Adulterated Specimen. A urine
specimen containing a substance that is
not a normal constituent or containing
an endogenous substance at a
concentration that is not a normal
physiological concentration.
Calibrator. A solution of known
concentration used to calibrate a
measurement procedure or to compare
the response obtained with the response
of a test specimen/sample. The
concentration of the analyte of interest
in the calibrator is known within limits
ascertained during its preparation.
Calibrators may be used to establish a
calibration curve over a range of
interest.
Certifying Scientist. An individual
with at least a bachelor’s degree in the
chemical or biological sciences or
medical technology or equivalent who
reviews all pertinent data and quality
control results. The individual shall
have training and experience in the
theory and practice of all methods and
procedures used in the laboratory,
including a thorough understanding of
chain of custody procedures, quality
control practices, and analytical
procedures relevant to the results that
the individual certifies. Relevant
training and experience shall also
Transportation (DOT) does have such authority.
DOT is required by law to develop requirements for
its regualted industry that ‘‘incorporate the
Department of Health and Human Services
scientific and technical guidelines dated April 11,
1988, and any amendments to those guidelines
* * *’’ See, e.g., 49 U.S.C. 20140(c)(2). In carrying
out its mandate, DOT requires by regulation that its
federally regulated employers use only HHS
certified laboratories in the testing of employees, 49
CFR 40.39, and incorporates the scientific and
technical aspects of the guidelines in its
regulations. The DOT-regulated industry should
refer to the DOT regulations at 49 CFR Part 40.

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include the review, interpretation, and
reporting of test results; maintenance of
chain of custody; and proper remedial
action to be taken in response to test
systems being out of control-limits or
detecting aberrant test or quality control
results.
Chain of Custody. Refers to the
process used to document the handling
and storage of a specimen.
Collection Site. A place designated by
the agency where individuals present
themselves for the purpose of providing
a specimen of their urine to be analyzed
for the presence of drugs.
Collector. A person who instructs and
assists individuals at a collection site
and who receives and makes an initial
examination of the urine specimen
provided by those individuals. A
collector shall have successfully
completed training to carry out this
function.
Confirmatory Drug Test. A second
analytical procedure to identify the
presence of a specific drug or metabolite
which is independent of the initial test
and which uses a different technique
and chemical principle from that of the
initial test in order to ensure reliability
and accuracy. (At this time, gas
chromatography/mass spectrometry
(GC/MS) is the only authorized
confirmation method for cocaine,
marijuana, opiates, amphetamines, and
phencyclidine.)
Confirmatory Validity Test. A second
test performed on a different aliquot of
the original urine specimen to further
support a validity test result.
Control. A sample used to monitor the
status of an analysis to maintain its
performance within desired limits.
Dilute Specimen. A urine specimen
with creatinine and specific gravity
values that are lower than expected for
human urine.
Donor. The individual from whom a
urine specimen is collected.
Federal Drug Testing Custody and
Control Form (Federal CCF). The OMBapproved form used to document the
handling and transfer of a specimen
from the time of collection until receipt
by the laboratory and used by the
certifying scientist to certify the
laboratory results.
Initial Drug Test (also known as
Screening Test). An immunoassay test
to eliminate ‘‘negative’’ urine specimens
from further consideration and to
identify the presumptively positive
specimens that require confirmation or
further testing.
Initial Validity Test. The first test
used to determine if a urine specimen
is adulterated, dilute, or substituted.
Invalid Result. Refers to the result
reported by a laboratory for a urine

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specimen that contains an unidentified
adulterant, contains an unidentified
interfering substance, has an abnormal
physical characteristic, or has an
endogenous substance at an abnormal
concentration that prevents the
laboratory from completing testing or
obtaining a valid drug test result.
Laboratory Chain of Custody Form.
The form(s) used by the testing
laboratory to document the handling
and security of the specimen and all
aliquots of the specimens during testing
and storage by the laboratory. The form,
which may account for an entire
laboratory test batch, shall include the
names and signatures of all individuals
who handled the specimens or aliquots
and the date and purpose of the access.
Limit of Detection. The lowest
concentration at which an analyte can
be reliably shown to be present under
defined conditions.
Limit of Quantitation. The lowest
concentration at which an analyte can
be reliably shown to be present and
quantified under defined conditions.
Medical Review Officer (MRO). A
licensed physician responsible for
receiving laboratory results generated by
an agency’s drug testing program who
has knowledge of substance abuse
disorders and has appropriate medical
training to interpret and evaluate an
individual’s test result together with his
or her medical history and any other
relevant biomedical information.
Non-Negative Specimen. A urine
specimen that is reported as adulterated,
substituted, positive (for a drug or drug
metabolite), or invalid.
Oxidizing Adulterant. A substance
that acts alone or in combination with
other substances to oxidize drugs 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. Examples of these agents include,
but are not limited to, nitrites,
pyridinium chlorochromate, chromium
(VI), bleach, iodine, halogens,
peroxidase, and peroxide.
Quality Control Sample. A sample
used to evaluate whether or not the
analytical procedure is operating within
predefined tolerance limits. Calibrators,
controls, negative urine samples, and
blind samples are collectively referred
to as ‘‘quality control samples’’ and each
as a ‘‘sample.’’
Reason to Believe. Reason to believe
that a particular individual may alter or
substitute the urine specimen as
provided in section 4(c) of Executive
Order 12564.
Sample. A representative portion of a
urine specimen or quality control
sample used for testing.

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Secretary. The Secretary of Health and
Human Services or the Secretary’s
designee. The Secretary’s designee may
be a contractor or other recognized
organization which acts on behalf of the
Secretary in implementing these
Guidelines.
Specimen. The portion of urine that is
collected from a donor.
Standard. A reference material of
known purity or a solution containing a
reference material at a known
concentration.
Substituted Specimen. A urine
specimen with creatinine and specific
gravity values that are so diminished or
so divergent that they are not consistent
with normal human urine.
Section 1.3

Future Revisions

In order to ensure the full reliability
and accuracy of drug assays, 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. These changes
will be published in final as a notice in
the Federal Register.
Subpart B—Scientific and Technical
Requirements
Section 2.1

The Drugs

(a) The President’s Executive Order
12564 defines ‘‘illegal drugs’’ as those
included in Schedule I or II of the
Controlled Substances Act (CSA), but
not when used pursuant to a valid
prescription or when used as otherwise
authorized by law. Hundreds of drugs
are covered under Schedule I and II and
while it is not feasible to test routinely
for all of them, Federal drug testing
programs shall test for drugs as follows:
(1) Federal agency applicant and
random drug testing programs shall, at
a minimum, test urine specimens for
marijuana and cocaine;
(2) Federal agency applicant and
random drug testing programs may also
test urine specimens for opiates,
amphetamines, and phencyclidine;
(3) When conducting reasonable
suspicion, post accident, or unsafe
practice testing, a Federal agency may
have a urine specimen tested for any
drug listed in Schedule I or II of the
CSA; and
(4) Federal agency drug testing
programs shall have validity tests
performed on urine specimens, as
provided under section 2.4(g).
(b) Any agency covered by these
guidelines shall petition the Secretary in
writing for approval to include in its
testing protocols any drugs (or classes of
drugs) not listed for Federal agency

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19655

testing in paragraph (a) of this section.
Such approval shall be limited to the
use of the appropriate science and
technology and shall not otherwise limit
agency discretion to test for any drugs
covered under Schedule I or II of the
CSA.
(c) Urine specimens collected
pursuant to Executive Order 12564,
Public Law 100–71, and these
Guidelines shall not be used for any
other analysis or test unless authorized
by an agency’s drug-free workplace
program.
(d) These Guidelines are not intended
to limit any agency which is specifically
authorized by law to include additional
categories of drugs in the drug testing of
its own employees or employees in its
regulated industries.
Section 2.2 Specimen Collection
Procedures
(a) Designation of Collection Site. An
agency drug testing program shall have
one or more designated collection sites
which have all necessary personnel,
materials, equipment, facilities, and
supervision to provide for the
collection, security, temporary storage,
and shipping or transportation of urine
specimens to a certified drug testing
laboratory.
(b) Security. A collection site must be
secure. If a collection site facility is
dedicated solely to urine collection, it
shall be secure at all times. If a facility
cannot be dedicated solely to drug
testing, the portion of the facility used
for collecting specimens shall be
secured during the time a specimen is
collected.
(c) Chain of Custody. A Federal CCF
shall be properly completed by a
collector for each urine specimen
collected for a Federal agency to
document the collection of the
specimen and the transfer of the
specimen to the laboratory for testing.
(d) Access to Authorized Personnel
Only. No unauthorized personnel shall
be permitted in any part of the
designated collection site when urine
specimens are collected or stored.
(e) Privacy. The procedure for
collecting a urine specimen shall allow
individual privacy unless there is
reason to believe that a particular donor
may alter or substitute the specimen to
be provided.
(f) Integrity and Identity of Specimen.
The collector shall take the following
minimum precautions to ensure that a
urine specimen is correctly documented
as being provided by a specific donor
and that the donor has not adulterated,
substituted, or diluted the specimen:
(1) To deter the dilution of a specimen
at the collection site, a toilet bluing

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agent shall be placed in a toilet tank
wherever possible, so the reservoir of
water in the toilet bowl always remains
blue. There shall be no other source of
water (e.g., no shower or sink) in the
enclosure where urination occurs.
(2) When a donor arrives at the
collection site, the collector shall
request the donor to present photo
identification. If the donor does not
have proper photo identification, the
collector shall contact the supervisor of
the donor, the coordinator of the drug
testing program, or any other agency
official who can positively identify the
donor. If the donor’s identity cannot be
established, the collector shall not
proceed with the collection.
(3) If the donor fails to arrive at the
assigned time or if the donor fails to
remain present through the completion
of the collection, the collector shall
contact the appropriate authority to
obtain guidance on the action to be
taken.
(4) The collector shall ask the donor
to remove any unnecessary outer
garments such as a coat or jacket that
might conceal items or substances that
could be used to tamper with or
adulterate the donor’s urine specimen.
The collector shall ensure that all
personal belongings such as a purse or
briefcase remain with the outer
garments. The donor may retain his or
her wallet. The collector directs the
donor to empty his or her pockets and
display the items to ensure that no items
are present that could be used to
adulterate the specimen. If nothing is
there that can be used to adulterate a
specimen, the donor places the items
back into the pockets and the collection
procedure continues. If the donor
refuses to show the collector the items
in his or her pockets, this is considered
a ‘‘refusal to test.’’ If an item is found
that appears to have been brought to the
collection site with the intent to
adulterate the specimen, a direct
observation collection procedure is
used. If the item appears to be
inadvertently brought to the collection
site, the collector shall secure the item
and continue with the normal collection
procedure.
(5) The donor shall be instructed to
wash and dry his or her hands prior to
urination.
(6) After washing hands, the donor
shall remain in the presence of the
collector and shall not have access to
any water fountain, faucet, soap
dispenser, cleaning agent, or any other
materials which could be used to
adulterate the specimen.
(7) The collector shall give the donor
a clean specimen bottle or specimen
collection container. The donor may

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provide his/her specimen in the privacy
of a stall or otherwise partitioned area
that allows for individual privacy.
(8) The collector shall note any
unusual behavior or appearance on the
Federal CCF.
(9) In the exceptional event that an
agency-designated collection site is not
accessible and there is an immediate
requirement for specimen collection
(e.g., an accident investigation), a public
rest room may be used according to the
following procedures: A person of the
same gender as the donor shall
accompany the donor into the public
rest room which shall be made secure
during the collection procedure. If
possible, a toilet bluing agent shall be
placed in the bowl and any accessible
toilet tank. The collector shall remain in
the rest room, but outside the stall, until
the specimen is collected. If no bluing
agent is available to deter specimen
dilution, the collector shall instruct the
donor not to flush the toilet until the
specimen is delivered to the collector.
After the collector has possession of the
specimen, the donor will be instructed
to flush the toilet and to participate with
the collector in completing the chain of
custody procedures.
(10) Upon receiving the specimen
from the donor, the collector shall
determine the volume of urine in the
specimen bottle/container.
(i) If the volume is at least 30
milliliters (mL), the collector will
proceed with step (11) below.
(ii) If the volume is less than 30 mL
and the temperature is within the
acceptable range specified in step (13)
below, the specimen is discarded and a
second specimen shall be collected. The
donor may be given 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 24 ounces). If the donor
fails for any reason to provide 30 mL of
urine for the second specimen collected,
the collector shall contact the
appropriate authority to obtain guidance
on the action to be taken.
(iii) If the volume is less than 30 mL
and the temperature is outside the
acceptable range specified in step (13)
below, a second specimen shall be
collected using the procedure specified
in step (13) below.
(11) After the specimen has been
provided and submitted to the collector,
the donor shall be allowed to wash his
or her hands.
(12) Immediately after the specimen is
collected, the collector shall measure
the temperature of the specimen. The
temperature measuring device used
must accurately reflect the temperature
of the specimen and not contaminate

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the specimen. The time from urination
to temperature measurement is critical
and in no case shall exceed 4 minutes.
(13) If the temperature of the
specimen is outside the range of 32°–
38°C/90°–100°F, that is a reason to
believe that the donor may have altered
or substituted the specimen, and
another specimen shall be collected
under direct observation of a person of
the same gender and both specimens
shall be forwarded to the laboratory for
testing. The agency shall select the
observer if there is no collector of the
same gender available. A donor may
volunteer to have his or her oral
temperature taken to provide evidence
to counter the reason to believe the
donor may have altered or substituted
the specimen caused by the specimen’s
temperature falling outside the
prescribed range.
(14) Immediately after the specimen is
collected, the collector shall also inspect
the specimen to determine if this is any
sign indicating that the specimen may
not be a valid urine specimen. Any
unusual finding shall be noted on the
Federal CCF.
(15) A specimen suspected of not
being a valid urine specimen shall be
forwarded to the laboratory for testing.
(16) When there is any reason to
believe that a donor may have altered or
substituted the specimen, another
specimen shall be obtained as soon as
possible under the direct observation of
a person of the same gender and both
specimens shall be forwarded to the
laboratory for testing. The agency shall
select the observer if there is no
collector of the same gender available.
(17) Both the donor and the collector
shall keep the specimen bottle/container
in view at all times prior to its being
sealed and labeled. If the specimen is
transferred from a specimen collection
container to a specimen bottle, the
collector shall request the donor to
observe the transfer of the specimen and
the placement of the tamper-evident
label/seal on the bottle.
(18) The collector and the donor shall
be present at the same time during
procedures outlined in paragraphs (19)
to (22) of this section.
(19) The collector shall place the
tamper-evident label/seal on the
specimen bottle. The collector shall
record the date of the collection on the
tamper-evident label/seal.
(20) The donor shall initial the
tamper-evident label/seal on the
specimen bottle for the purpose of
certifying that it is the specimen
collected from him or her.
(21) The collector shall ensure that all
the information required on the Federal
CCF is provided.

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(22) The donor shall be asked to read
and sign a statement on the Federal CCF
certifying that the specimen identified
as having been collected from him or
her is in fact the specimen he or she
provided.
(23) Based on a reason to believe that
the donor may alter or substitute the
specimen to be provided, a higher level
supervisor shall review and concur in
advance with any decision by a
collector to obtain a specimen under
direct observation. The person directly
observing the specimen collection shall
be of the same gender. The agency shall
select the observer if there is no
collector of the same gender available.
(24) The collector shall sign the
Federal CCF.
(25) The urine specimen and Federal
CCF are now ready for shipment. If the
specimen is not immediately prepared
for shipment, it shall be appropriately
safeguarded during temporary storage.
(26) While any part of the above chain
of custody procedures is being
performed, it is essential that the urine
specimen and Federal CCF be under the
control of the collector. If the collector
leaves the collection site momentarily,
the urine specimen and Federal CCF
shall be taken with him or her or shall
be secured. After the collector returns to
the collection site, the custody process
will continue. If the collector is leaving
for an extended period of time, the
specimen and Federal CCF shall be
packaged for shipment to the laboratory
before he or she leaves the collection
site.
(g) Collection Control. If the specimen
and Federal CCF are not immediately
prepared for transfer to the laboratory,
they shall be appropriately safeguarded
until the specimen and Federal CCF are
prepared for transfer to the laboratory.
(h) Split Specimens. An agency may,
but is not required to, use a split
specimen method of collection. If the
urine specimen is split into two
specimen bottles (hereinafter referred to
as Bottle A and Bottle B) the following
procedure shall be used:
(1) The donor shall urinate into either
a specimen bottle or specimen
collection container. The collector, in
the presence of the donor, after
determining specimen temperature,
pours the urine into two specimen
bottles that are labeled Bottle A and
Bottle B or, if Bottle A was used to
collect the specimen, pours an
appropriate amount into Bottle B. A
minimum of 45 mL of urine is required
when using a split specimen procedure,
i.e., 30 mL for Bottle A and 15 mL for
Bottle B.
(2) The Bottle A specimen, containing
a minimum of 30 mL of urine, is to be

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used for the drug test. If there is no
additional urine available for the second
specimen bottle (Bottle B), the first
specimen bottle (Bottle A) shall
nevertheless be processed for testing.
(3) A minimum of 15 mL of urine
shall be poured into the second
specimen bottle (Bottle B).
(4) All requirements of this part shall
be followed with respect to Bottle A and
Bottle B, including the requirements
that a copy of the Federal CCF
accompany the two bottles processed
under split sample procedures.
(5) The collector shall send the split
specimens (Bottle A and Bottle B) at the
same time to the laboratory that will be
testing the Bottle A specimen.
(6) If the test of the primary (Bottle A)
specimen is verified positive,
adulterated, or substituted by the MRO,
the MRO shall report the result to the
agency. Only the donor may request
through the MRO that the split (Bottle
B) specimen be tested by a second
certified laboratory to reconfirm the
positive, adulterated, or substituted
result reported by the primary
laboratory. The MRO shall honor the
request if it is made within 72 hours
after informing the donor that a positive,
adulterated, or substituted result was
being reported to the agency. The
second laboratory shall test the split
specimen in accordance with the
requirements in section 2.4 pertaining to
retesting for drugs, adulterants, or
substitution.
(7) Any action taken by a Federal
agency as a result of an MRO verified
positive, adulterated, or substituted test
result (e.g., removing a donor from
performing a safety-sensitive function)
may proceed whether Bottle B is or is
not tested.
(i) Transportation to Laboratory. A
collector shall arrange to ship the
collected specimens to the certified
laboratory. The specimens shall be
placed in containers designed to
minimize the possibility of damage
during shipment, for example, specimen
boxes or padded mailers; and those
containers shall be securely sealed to
eliminate the possibility of undetected
tampering. The collector shall ensure
that the Federal CCF is enclosed within
the container sealed for shipment to the
drug testing laboratory. Since specimens
are sealed in packages that would
indicate any tampering during transit to
the laboratory and couriers, express
carriers, and postal service personnel do
not have access to the Federal CCFs,
there is no requirement that such
personnel document chain of custody
for the package during transit.

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Section 2.3

19657

Laboratory Personnel

(a) Day-to-Day Management.
(1) The laboratory shall have a
responsible person (RP) to assume
professional, organizational,
educational, and administrative
responsibility for the laboratory’s urine
drug testing facility.
(2) This individual shall have
documented scientific qualifications in
analytical forensic toxicology. Minimum
qualifications are:
(i) Certification as a laboratory
director by the State in forensic or
clinical laboratory toxicology; or
(ii) A Ph.D. in one of the natural
sciences with an adequate
undergraduate and graduate education
in biology, chemistry, and
pharmacology or toxicology; or
(iii) Training and experience
comparable to a Ph.D. in one of the
natural sciences, such as a medical or
scientific degree with additional
training and laboratory/research
experience in biology, chemistry, and
pharmacology or toxicology; and
(iv) In addition to the requirements in
(i), (ii), and (iii) above, minimum
qualifications also require:
(A) Appropriate experience in
analytical forensic toxicology including
experience with the analysis of
biological material for drugs of abuse,
and
(B) Appropriate training and/or
experience in forensic applications of
analytical toxicology, e.g., publications,
court testimony, research concerning
analytical toxicology of drugs of abuse,
or other factors which qualify the
individual as an expert witness in
forensic toxicology.
(3) This individual shall be engaged
in and responsible for the day-to-day
management of the drug testing
laboratory even where another
individual has overall responsibility for
an entire multi-speciality laboratory.
(4) This individual shall be
responsible for ensuring that there are
enough personnel with adequate
training and experience to supervise
and conduct the work of the drug testing
laboratory. He or she shall assure the
continued competency of laboratory
personnel by documenting their inservice training, reviewing their work
performance, and verifying their skills.
(5) This individual shall be
responsible for the laboratory‘s having a
procedure manual which is complete,
up-to-date, available for laboratory
personnel, and followed by those
personnel. The procedure manual shall
be reviewed, signed, and dated by this
responsible person whenever
procedures are first placed into use or

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changed or when a new individual
assumes responsibility for management
of the drug testing laboratory. Copies of
all procedures and dates on which they
are in effect shall be maintained.
(Specific contents of the procedure
manual are described in paragraph
2.4(q)(1).)
(6) This individual shall be
responsible for maintaining a quality
assurance program to assure the proper
performance and reporting of all test
results; for maintaining acceptable
analytical performance for all controls
and standards; for maintaining quality
control testing; and for assuring and
documenting the validity, reliability,
accuracy, precision, and performance
characteristics of each test and test
system.
(7) This individual shall be
responsible for taking all remedial
actions necessary to maintain
satisfactory operation and performance
of the laboratory in response to quality
control systems not being within
performance specifications, errors in
result reporting or in analysis of
performance testing results. This
individual shall ensure that specimen
results are not reported until all
corrective actions have been taken and
he or she can assure that the results
provided are accurate and reliable.
(b) Certifying Test Results. The
certified laboratory shall have one or
more certifying scientists, as defined in
section 1.2, who review all pertinent
data and quality control results to attest
to the validity of the laboratory’s test
results. A laboratory may designate
certifying scientists that only certify
results that are reported negative and
certifying scientists that certify results
that are reported both negative and nonnegative.
(c) Day-to-Day Operations and
Supervision of Analysts. The
laboratory’s urine drug testing facility
shall have an individual(s) to be
responsible for day-to-day operations
and to supervise the technical analysts.
This individual(s) shall have at least a
bachelor’s degree in the chemical or
biological sciences or medical
technology or equivalent. He or she
shall have training and experience in
the theory and practice of the
procedures used in the laboratory,
resulting in his or her thorough
understanding of quality control
practices and procedures; the review,
interpretation, and reporting of test
results; maintenance of chain of
custody; and proper remedial actions to
be taken in response to test systems
being out of control limits or detecting
aberrant test or quality control results.

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(d) Other Personnel. Other technical
and nontechnical staff shall have the
necessary training and skills for the
tasks assigned.
(e) Training. The laboratory shall
make available continuing education
programs to meet the needs of
laboratory personnel.
(f) Files. Each laboratory personnel
file shall include, at a minimum, a
resume, any professional certification or
license, a job description, and
documentation to show that the
individual has been properly trained to
perform his or her job.
Section 2.4 Laboratory Analysis
Procedures
(a) Security and Chain of Custody.
(1) Drug testing laboratories shall be
secure at all times. They shall have in
place sufficient security measures to
control access to the premises and to
ensure that no unauthorized personnel
handle specimens or gain access to the
laboratory processes or to areas where
records are stored. Access to these
secured areas shall be limited to
specifically authorized individuals
whose authorization is documented.
With the exception of personnel
authorized to conduct inspections on
behalf of Federal agencies for which the
laboratory is engaged in urine testing or
on behalf of the Secretary or emergency
personnel (e.g., firefighters and medical
rescue teams), all authorized visitors
and maintenance and service personnel
shall be escorted at all times. The
laboratory shall maintain a record that
documents the dates, time of entry and
exit, escort and purpose of entry of
authorized visitors, maintenance
personnel, and service personnel
accessing secured areas.
(2) Laboratories shall use chain of
custody procedures to maintain control
and accountability of specimens from
receipt through completion of testing,
reporting of results, during storage, and
continuing until final disposition of
specimens. The date and purpose shall
be documented on a laboratory chain of
custody form each time a specimen is
handled or transferred, and every
individual in the chain shall be
identified. Accordingly, authorized
technicians shall be responsible for each
urine specimen or aliquot in their
possession and shall sign and complete
appropriate entries on the laboratory
chain of custody forms for those
specimens or aliquots as they are
received.
(b) Receiving.
(1) After opening a shipping package
and gaining access to a specimen and its
accompanying Federal CCF, an
accessioner shall compare the

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information on the specimen bottle
label/seal to the information on the
accompanying Federal CCF.
(2) The following discrepancies are
considered to be fatal flaws and the
laboratory must stop the testing process
and reject the specimen for testing and
indicate the reason for rejecting the
specimen on the Federal CCF:
(i) The specimen ID number on the
specimen bottle 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 the specimen
bottle label/seal;
(ii) The specimen bottle label/seal is
broken or shows evidence of tampering
on the specimen bottle from a single
specimen collection or on the primary
(Bottle A) specimen from a split
specimen collection (and the split
specimen cannot be designated as the
primary (Bottle A) specimen);
(iii) The collector’s printed name and
signature are omitted on the Federal
CCF; or
(iv) There is an insufficient amount of
urine for analysis in the specimen bottle
from a single specimen collection or in
the primary (Bottle A) specimen from a
split specimen collection (unless the
split specimen can be designated as the
primary (Bottle A) specimen).
(3) The following discrepancies are
considered to be correctable flaws:
(i) If a collector failed to sign the
Federal CCF, the laboratory must
attempt to recover the collector’s
signature before reporting the test result.
If the collector can provide a
memorandum for record recovering the
signature, the laboratory may report the
test result for the specimen. If the
laboratory cannot recover the collector’s
signature, the laboratory must report a
rejected for testing result and indicate
the reason for the rejected for testing
result on the Federal CCF.
(ii) If a specimen is submitted using
a non-Federal form or an expired
Federal CCF, the laboratory must test
the specimen and also attempt to obtain
a memorandum for record explaining
why a non-Federal form or an expired
Federal CCF was used and ensure that
the form used contains all the required
information. If the laboratory cannot
obtain a memorandum for record from
the collector, the laboratory must report
a rejected for testing result and indicate
the reason for the rejected for testing
result on the report to the MRO.
(4) Specimen bottles will normally be
retained within the laboratory’s
accession area until all analyses have
been completed. Aliquots and
laboratory chain of custody forms shall
be used by laboratory personnel
conducting initial and confirmatory

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tests while the original specimen bottles
and Federal CCFs remain in secure
storage.
(c) Short-Term Refrigerated Storage.
Specimens that do not receive an initial
test within 7 days of arrival at the
laboratory shall be placed in secure
refrigeration units. Temperatures shall
not exceed 6°C. A certified laboratory
must have the capability to ensure
proper storage conditions in the event of
a prolonged power failure.
(d) Specimen Processing. A laboratory
will normally process specimens by
grouping them into batches. The
number of specimens in each batch may
vary significantly. Every batch shall
satisfy the quality control requirements
in section 2.5.
(e) Initial Drug Test. (1) The initial
drug test shall use an immunoassay
which meets the requirements of the
Food and Drug Administration for
commercial distribution. The following
initial cutoff levels shall be used when
screening specimens to determine
whether they are negative for these five
drugs or classes of drugs:

presumptive positives due to structural
analogues; a valid analytical result
cannot be obtained using immunoassay
technique ‘‘A’’ and immunoassay
technique ‘‘B’’ is used in an attempt to
obtain a valid analytical result.
(f) Confirmatory Drug Test.
(1) A specimen identified as positive
on an initial drug test shall be
confirmed for the class(es) of drugs
screened positive on the initial drug test
using gas chromatography/mass
spectrometry (GC/MS) at the cutoff
values listed in this paragraph. Each
confirmatory drug test shall provide a
quantitative result. When the
concentration of a drug or metabolite
exceeds the linear range of the standard
curve, the certified laboratory may
record the result as ‘‘exceeds the linear
range of the test’’ or as ‘‘greater than or
equal to (insert the value for the upper
limit of the linear range),’’ or may dilute
an aliquot of the specimen to obtain an
accurate quantitative result when the
concentration is above the upper limit
of the linear range.

CONFIRMATORY DRUG TEST LEVEL

INITIAL DRUG TEST LEVEL

(ng/mL)
(ng/mL)
Marijuana metabolites ....................
Cocaine metabolites .......................
Opiate metabolites ..........................
Phencyclidine ..................................
Amphetamines ................................

50
300
2,000
25
1,000

(2) These test levels are subject to
change by the Department of Health and
Human Services as advances in
technology or other considerations
warrant identification of these
substances at other concentrations. The
agency requesting the authorization to
include other drugs shall submit to the
Secretary in writing the agency’s
proposed initial drug test methods,
testing levels, and proposed
performance test program.
(3) A negative specimen shall be
discarded or may be pooled for use in
the laboratory’s internal quality control
program unless validity test results
indicate that the specimen may not be
a valid specimen.
(4) Multiple initial drug tests (also
known as rescreening) for the same drug
or drug class may be performed
provided that all tests meet all
Guideline cutoffs and quality control
requirements (see section 2.5(b)).
Examples: a test is performed by
immunoassay technique ‘‘A’’ for all
drugs using the HHS cutoff levels, but
presumptive positive amphetamines are
forwarded for immunoassay technique
‘‘B’’ to eliminate any possible

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Marijuana metabolite 1 ....................
Cocaine metabolite 2 .......................
Opiates
Morphine .........................................
Codeine ..........................................
6-Acetylmorphine 3 ..........................
Phencyclidine ..................................
Amphetamines
Amphetamine ..................................
Methamphetamine 4 ........................

15
150
2,000
2,000
10
25
500
500

1 Delta-9-tetrahydrocannabinol-9-carboxylic
acid.
2 Benzoylecgonine.
3 Test for 6-AM when the morphine concentration is greater than or equal to 2,000 ng/
mL.
4 Specimen must also contain amphetamine
at a concentration greater than or equal to 200
ng/mL.

(2) These test levels are subject to
change by the Department of Health and
Human Services as advances in
technology or other considerations
warrant identification of these
substances at other concentrations. The
agency requesting the authorization to
include other drugs shall submit to the
Secretary in writing the agency’s
proposed confirmatory test methods,
testing levels, and proposed
performance test program.
(3) A specimen that tests negative on
confirmatory drug tests shall be
discarded or may be pooled for use in
the laboratory’s internal quality control
program unless validity test results
indicate that the specimen may not be
a valid specimen.

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19659

(g) Validity Testing. A certified
laboratory shall:
(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;
(4) Perform one or more validity tests
for oxidizing adulterants on every
specimen; and
(5) Perform additional validity tests
when the following conditions are
observed:
(i) Abnormal physical characteristics;
(ii) Reactions or responses
characteristic of an adulterant obtained
during initial or confirmatory drug tests
(e.g., non-recovery of internal standards,
unusual response); or
(iii) Possible unidentified interfering
substance or adulterant.
The choice of additional validity tests
is dependent on the observed indicators
or characteristics as described in (i), (ii),
and (iii) of this section.
(h) Reporting Results.
(1) The laboratory shall report a test
result directly to the agency’s MRO
within an average of 5 working days
after receipt of the specimen by the
laboratory using the Federal CCF and/or
an electronic report. Before any test
result is reported, it must be certified as
correct by a certifying scientist.
(2) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported negative
when each initial drug test is negative
or it is negative on a confirmatory drug
test and each specimen validity test
result indicates that the specimen is a
valid urine specimen.
(3) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported positive
for a specific drug when the initial drug
test is positive and the confirmatory
drug test is positive.
(4) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported
adulterated when:
(i) The pH is less than 3 or greater
than or equal to 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;
(ii) The nitrite concentration is greater
than or equal to 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-

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wavelength spectrophotometry, ion
chromatography, capillary
electrophoresis) on the second aliquot;
(iii) The presence of chromium (VI) is
verified using either a general oxidant
colorimetric test (with a greater than or
equal to 50 mcg/mL chromium (VI)equivalent cutoff) or a chromium (VI)
colorimetric test (chromium (VI)
concentration greater than or equal to 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 greater
than or equal to the LOD of the
confirmatory test on the second aliquot;
(iv) The presence of halogen (e.g.,
bleach, iodine, fluoride) is verified
using either a general oxidant
colorimetric test (with a greater than or
equal to 200 mcg/mL nitrite-equivalent
cutoff or a greater than or equal to 50
mcg/mL chromium (VI)-equivalent
cutoff) or halogen colorimetric test
(halogen concentration greater than or
equal to the LOD) 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 greater
than or equal to the LOD of the
confirmatory test on the second aliquot;
(v) 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 GC/MS for
the confirmatory test with the
glutaraldehyde concentration greater
than or equal to the LOD of the analysis
on the second aliquot;
(vi) The presence of pyridine
(pyridinium chlorochromate) is verified
using either a general oxidant
colorimetric test (with a greater than or
equal to 200 mcg/mL nitrite-equivalent
cutoff or a greater than or equal to 50
mcg/mL chromium (VI)-equivalent
cutoff) or a chromium (VI) colorimetric
test (chromium (VI) concentration
greater than or equal to 50 mcg/mL) for
the initial test on the first aliquot and
GC/MS for the confirmatory test with
the pyridine concentration greater than
or equal to the LOD of the analysis on
the second aliquot;
(vii) The presence of a surfactant is
verified by using a surfactant
colorimetric test with a greater than or
equal to 100 mcg/mL dodecylbenzene
sulfonate-equivalent cutoff for the initial

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test on the first aliquot and a different
confirmatory test (e.g., multi-wavelength
spectrophotometry) with a greater than
or equal to 100 mcg/mL dodecylbenzene
sulfonate-equivalent cutoff on the
second aliquot; or
(viii) The presence of any other
adulterant not specified in 4(iii) through
4(vii) of this section is verified using an
initial test on the first aliquot and a
different confirmatory test on the
second aliquot.
(5) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported
substituted when the creatinine
concentration is less than 2 mg/dL and
the specific gravity is less than or equal
to 1.0010 or greater than or equal to
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.
(6) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported dilute
when the creatinine concentration is
greater than or equal to 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.
(7) A urine specimen from a single
specimen collection or the primary
(Bottle A) specimen from a split
specimen collection is reported as an
invalid result when:
(i) 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 greater
than or equal to 2 mg/dL on either or
both the initial or confirmatory
creatinine tests);
(ii) The pH is greater than or equal to
3 and less than 4.5 or greater than or
equal to 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;
(iii) The nitrite concentration is
greater than or equal to 200 mcg/mL
using a nitrite colorimetric test or
greater than or equal to the equivalent
of 200 mcg/mL nitrite using a general

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oxidant colorimetric test for both the
initial test and the confirmatory test or
using either initial test and the nitrite
concentration is greater than or equal to
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;
(iv) The possible presence of
chromium (VI) is determined using the
same chromium (VI) colorimetric test
with a cutoff greater than or equal to 50
mcg/mL chromium (VI) for both the
initial test and the confirmatory test on
two separate aliquots;
(v) The possible presence of a halogen
(e.g., bleach, iodine, fluoride) is
determined using the same halogen
colorimetric test with a cutoff greater
than or equal to the LOD for both the
initial test and the confirmatory test on
two separate aliquots or relying on the
odor of the specimen as the initial test;
(vi) 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
test and the confirmatory test on two
separate aliquots;
(vii) The possible presence of an
oxidizing adulterant is determined by
using the same general oxidant
colorimetric test (with a greater than or
equal to 200 mcg/mL nitrite-equivalent
cutoff, a greater than or equal to 50 mcg/
mL chromium (VI)-equivalent cutoff, or
a halogen concentration is greater than
or equal to the LOD) for both the initial
test and the confirmatory test on two
separate aliquots;
(viii) The possible presence of a
surfactant is determined by using the
same surfactant colorimetric test with a
greater than or equal to 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff for both the initial test and the
confirmatory test on two separate
aliquots or a foam/shake test for the
initial test;
(ix) Interference occurs on the
immunoassay drug tests on two separate
aliquots (i.e., valid immunoassay drug
test results cannot be obtained);
(x) Interference with the GC/MS drug
confirmation assay occurs on at least
two separate aliquots of the specimen
and the laboratory is unable to identify
the interfering substance;
(xi) The physical appearance of the
specimen is such that testing the system
may damage the laboratory’s
instruments; or
(xii) If the physical appearances of
Bottles A and B (when a split specimen
collection is used) are clearly different,

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the test result for Bottle A is one of the
reasons stated in (i) through (xi) of this
section and/or was screened negative for
drugs.
(8) The laboratory shall reject a
specimen for testing when a fatal flaw
occurs as described in paragraph
2.4(b)(2) or when a correctable flaw as
described in paragraph 2.4(b)(3) is not
recovered. The 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.
(9) The laboratory must report all nonnegative test results for a specimen. For
example, a specimen can be positive for
a specific drug and adulterated.
(10) For a specimen that is tested
positive for a drug, the laboratory shall
report the specimen as positive and
specify the drug for which the specimen
is positive. The concentration of the
drug shall be provided to the MRO only
when the MRO requests such
information. The MRO’s request may
either be a general request covering all
such results or be on a case by case
basis. When the concentration of an
analyte exceeds the linear range of the
standard curve, the laboratory may
report to the MRO that the quantitative
value ‘‘exceeds the linear range of the
test,’’ that the quantitative value is
‘‘greater than or equal to (insert the
value for the upper limit of the linear
range),’’ or may report an accurate
quantitative value above the upper limit
of the linear range that was obtained by
diluting an aliquot of the specimen. The
MRO shall not disclose the
concentration of the drug to the agency.
(11) The laboratory shall provide
quantitative values for confirmed opiate
results for morphine or codeine that are
greater than or equal to 15,000 ng/mL,
even if the MRO has not requested
quantitative values for the test result.
(12) For a specimen that is found to
be adulterated or substituted, the
laboratory shall report the specimen as
adulterated or substituted and shall
provide the numerical values that
support the adulterated (when
applicable) or substituted result. For a
specimen that has an invalid result for
one of the reasons stated in paragraphs
2.4(h)(7)(iv) to (xii), the laboratory shall
contact the MRO and both will decide
if testing by another certified laboratory
would be useful in being able to report
a positive or adulterated result. If no
further testing is necessary, the
laboratory then reports the invalid result
to the MRO.
(13) The laboratory may transmit
results to the MRO by various electronic
means (for example, teleprinters,
facsimile, or computer) in a manner

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designed to ensure confidentiality of the
information. Results may not be
provided verbally by telephone. The
laboratory must ensure the security of
the data transmission and limit access to
any data transmission, storage, and
retrieval system.
(14) For all test results, a laboratory
may fax, courier, mail, or electronically
transmit a legible image or copy of the
completed Federal CCF, and/or forward
a computer-generated electronic report.
However, for non-negative results, the
laboratory must fax, courier, mail, or
electronically transmit a legible image
or copy of the completed Federal CCF.
(15) The laboratory shall provide to
the agency official responsible for
coordination of the drug-free workplace
program a semi-annual statistical
summary report of urinalysis testing of
Federal employees and shall not include
in the summary any personal
identifying information. In order to
avoid sending data from which it is
likely that information about a donor’s
test result can be readily inferred, the
laboratory must not send a summary
report if the agency has fewer than five
specimen test results in a six-month
period. When that situation occurs, the
laboratory must send the agency a report
indicating that not enough specimens
were tested to permit providing a
summary report. The summary report
shall include test results that are
reported within the six-month period.
Normally, the summary report is sent
within 14 calendar days after the end of
the six-month period covered by the
report. The summary report shall
contain the following information:
Reporting Period: (inclusive dates)
Laboratory Name and Address
Federal Agency Name
(i) Specimen Results Reported (total
number)
By Type of Test
(a) Pre-employment (number)
(b) Post-Accident (number)
(c) Random (number)
(d) Reasonable Suspicion/Cause
(number)
(e) Return-to-Duty (number)
(f) Follow-up (number)
(g) Type of Test Not Noted on CCF
(number)
(ii) Specimens Reported
(a) Negative (number)
(b) Negative and Dilute (number)
(iii) Specimens Reported as Rejected for
Testing (total number)
By Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
(iv) Specimens Reported as Positive
(total number)
By Drug

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19661

(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opiates (number)
(1) Codeine (number)
(2) Morphine (number)
(3) 6-AM (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(v) Adulterated (number)
(vi) Substituted (number)
(vii) Invalid Result (number)
(16) The laboratory shall make
available copies of all analytical results
for Federal drug testing programs when
requested by HHS or any Federal agency
for which the laboratory is performing
drug testing services.
(17) Unless otherwise instructed by
the agency in writing, all records
pertaining to a given urine specimen
shall be retained by the drug testing
laboratory for a minimum of 2 years.
(i) Long-Term Storage. Long-term
frozen storage (¥20°C or less) ensures
that positive, adulterated, substituted,
and invalid urine specimens will be
available for any necessary retest.
Unless otherwise authorized in writing
by the agency, drug testing laboratories
shall retain and place in properly
secured long-term frozen storage for a
minimum of 1 year all specimens
reported positive, adulterated,
substituted, or invalid. Within this 1year period, an agency may request the
laboratory to retain the specimen for an
additional period of time. If no such
request is received from the agency, the
laboratory may discard the specimen at
the end of this 1-year period.
(j) Retesting a Specimen for Drugs.
(1) A second laboratory shall use its
confirmatory drug test when retesting an
aliquot of a single specimen or testing
a split (Bottle B) specimen for the drug
or drug metabolite that was reported
positive in the single specimen or the
primary (Bottle A) specimen by the first
laboratory.
(2) Because some drugs or drug
metabolites may deteriorate during
storage, the retest of an aliquot of a
single specimen or the test of a split
(Bottle B) specimen is not subject to a
specific drug cutoff requirement, but
must provide data sufficient to confirm
the presence of the drug or metabolite.
(3) If the second laboratory fails to
reconfirm the presence of the drug or
drug metabolite that was reported by the
first laboratory, the second laboratory
shall attempt to determine the reason for
not reconfirming the presence of the
drug or drug metabolite by conducting
specimen validity tests. The second
laboratory shall conduct the same

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specimen validity tests it would
conduct on a single specimen or a
primary (Bottle A) specimen. The
second laboratory reports all test results
to the MRO.
(k) Retesting a Specimen for
Adulterants.
(1) A second laboratory shall use the
required confirmatory validity test
specified in paragraph 2.4(h)(4) and the
same confirmatory criterion specified in
paragraph 2.4(h)(4) to reconfirm an
adulterant result when retesting an
aliquot from a single specimen
collection or when testing a split (Bottle
B) specimen.
(2) The second laboratory may only
retest an aliquot from a single specimen
collection or test a split (Bottle B)
specimen for the adulterant reported by
the first laboratory.
(l) Retesting a Specimen for
Substitution.
(1) A second laboratory shall use its
confirmatory creatinine test and
confirmatory specific gravity test, when
retesting an aliquot of a single specimen
or testing a split (Bottle B) specimen, to
reconfirm that the creatinine
concentration was less than 2 mg/dL
and the specific gravity was less than or
equal to 1.0010 or greater than or equal
to 1.0200.
(2) The second laboratory may only
retest an aliquot from a single specimen
collection or test a split (Bottle B)
specimen to reconfirm the substituted
result reported by the first laboratory.
(m) Subcontracting. Drug testing
laboratories shall not subcontract and
shall perform all work with their own
personnel and equipment unless
otherwise authorized by the Secretary.
(n) Laboratory Facilities.
(1) Laboratory facilities shall comply
with applicable provisions of any State
licensor requirements.
(2) Laboratories certified in
accordance with Subpart C of these
Guidelines shall have the capability, at
the same laboratory premises, of
performing initial and confirmatory
tests for the five classes of drugs
(marijuana, cocaine, opiates,
phencyclidine, and amphetamines) and
performing the validity tests specified in
these Guidelines.
(o) Inspections. The Secretary, a
Federal agency, or any organization
performing laboratory certification on
behalf of the Secretary may inspect the
laboratory at any time. Federal agency
contracts with laboratories for drug
testing, as well as contracts for
collection site services, shall permit the
agency to conduct unannounced
inspections. In addition, prior to the
award of a contract the agency may
carry out pre-award inspections and

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evaluation of the procedural aspects of
the laboratory’s drug testing operation.
(p) Documentation. The drug testing
laboratories shall maintain and make
documents of all aspects of the testing
process available for at least 2 years.
This 2-year period may be extended
upon written notification by HHS or by
any Federal agency for which laboratory
services are being provided. The
required documentation shall include
personnel files on all individuals
authorized to have access to specimens;
Federal CCFs and laboratory chain of
custody forms; quality assurance/quality
control records; procedure manuals; all
test data (including calibration curves
and any calculations used in
determining test results); reports;
performance records on performance
testing; performance on certification
inspections; and hard copies of
computer-generated data. The laboratory
shall be required to maintain method
validation data and any documents for
any specimen under legal challenge for
an indefinite period.
(q) Additional Requirements for
Certified Laboratories.
(1) Each laboratory shall have a
procedure manual which includes the
principles of each test, preparation of
reagents, standards and controls,
calibration procedures, derivation of
results, linearity of methods, sensitivity
of the methods, cutoff values,
mechanisms for reporting results,
controls, criteria for unacceptable
specimens and results, corrective
actions to be taken when the test
systems are outside of acceptable limits,
reagents and expiration dates, and
references. Copies of all procedures and
dates on which they are in effect shall
be maintained as part of the manual.
(2) Laboratory calibrators and controls
shall be prepared using pure drug
reference materials, stock standard
solutions obtained from other
laboratories, or standard solutions
obtained from commercial
manufacturers. The calibrators and
controls shall be properly labeled as to
content and concentration. The
standards (e.g., pure reference materials,
stock standard solutions, purchased
standards) shall be labeled with the
following dates: when received (if
applicable); when prepared or opened;
when placed in service; and expiration
date.
(3) Volumetric pipettes and measuring
devices shall be certified for accuracy or
be checked by gravimetric, colorimetric,
or other verification procedure.
Automatic pipettes and dilutors shall be
checked for accuracy and
reproducibility before being placed in
service and checked periodically

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thereafter. There shall be written
procedures for instrument set-up and
normal operation, a schedule for
checking critical operating
characteristics for all instruments,
tolerance limits for acceptable function
checks, and instructions for major
troubleshooting and repair. Records
shall be available on preventive
maintenance.
(4) There shall be written procedures
for the actions to be taken when systems
are out of acceptable limits or errors are
detected. There shall be documentation
that these procedures are followed and
that all necessary corrective actions are
taken. There shall also be in place
systems to verify all stages of testing and
reporting and documentation that these
procedures are followed.
(5) A laboratory shall make available
a qualified individual to testify in an
administrative or disciplinary
proceeding against a Federal employee
when that proceeding is based on a nonnegative result reported by the
laboratory.
(6) The laboratory shall not enter into
any relationship with an agency’s MRO
that may be construed as a potential
conflict of interest or derive any
financial benefit by having an agency
use a specific MRO.
Section 2.5 Quality Assurance and
Quality Control
(a) General. Drug testing laboratories
shall have a quality assurance program
which encompasses all aspects of the
testing process including but not limited
to specimen accessioning, chain of
custody, security and reporting of
results, initial and confirmatory testing,
certification of calibrators and controls,
and validation of analytical procedures.
The performance characteristics (e.g.,
accuracy, precision, limit of detection
(LOD), limit of quantitation (LOQ),
specificity) shall be documented for
each test as appropriate. Validation of
procedures shall document that
carryover does not affect the donor’s
specimen results. Periodic reverification of analytical procedures is
required. Quality assurance procedures
shall be designed, implemented, and
reviewed to monitor the conduct of each
step of the testing process.
(b) Laboratory Quality Control
Requirements for Initial Drug Tests.
Each analytical run of specimens to be
screened shall include:
(1) Sample(s) certified to contain no
drug (i.e., negative urine samples);
(2) At least one control fortified with
drug or metabolite targeted at 25 percent
above the cutoff;

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(3) At least one control fortified with
drug or metabolite targeted at 75 percent
of the cutoff;
(4) A sufficient number of calibrators
to ensure and document the linearity of
the assay method over time in the
concentration area of the cutoff. After
acceptable values are obtained for the
known calibrators, those values will be
used to calculate sample data;
(5) A minimum of 10 percent of the
total specimens and quality control
samples in each analytical run shall be
quality control samples; and
(6) One percent of each run, with a
minimum of at least one sample, shall
be the laboratory’s blind quality control
samples to appear as routine specimens
to the laboratory analysts.
(c) Laboratory Quality Control
Requirements for Confirmatory Drug
Tests.
Each analytical run of specimens to be
confirmed shall include:
(1) Sample(s) certified to contain no
drug (i.e., negative urine samples);
(2) Positive calibrator(s) and control(s)
fortified with drug or metabolite;
(3) At least one control with drug or
metabolite targeted at 25 percent above
the cutoff; and
(4) At least one calibrator or control
that is targeted at or below 40 percent
of the cutoff.
(d) Laboratory Quality Control
Requirements for Specimen Validity
Tests.
(1) Each validity test result shall be
based on performing an initial validity
test on one aliquot and a confirmatory
validity test on a second aliquot; and
(2) Each analytical run of specimens
for which an initial or confirmatory
validity test is being performed shall
include the appropriate calibrators and
controls.
(e) Requirements for performing
creatinine tests.
(1) The creatinine concentration shall
be measured to one decimal place on
both the initial creatinine test and the
confirmatory creatinine test.
(2) The initial creatinine test shall
have a calibrator at 2 mg/dL.
(3) The initial creatinine test shall
have a control in the range of 1.0 mg/
dL to 1.5 mg/dL, a control in the range
of 3 mg/dL to 20 mg/dL, and a control
in the range of 21 mg/dL to 25 mg/dL.
(4) The confirmatory creatinine test
(performed on those specimens with a
creatinine concentration less than 2 mg/
dL on the initial test) shall have a
calibrator at 2 mg/dL, a control in the
range of 1.0 mg/dL to 1.5 mg/dL, and a
control in the range of 3 mg/dL to 4 mg/
dL.
(f) Requirements for performing
specific gravity tests.

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(1) The refractometer shall report and
display the specific gravity to four
decimal places. The refractometer shall
be interfaced with a laboratory
information management system
(LIMS), computer, and/or generate a
hard copy of the digital electronic
display to document the numerical
result.
(2) The initial and confirmatory
specific gravity tests shall have a
calibrator or control at 1.0000.
(3) The initial and confirmatory
specific gravity tests shall have the
following controls:
(i) One control targeted at 1.0020;
(ii) One control in the range of 1.0040
to 1.0180; and
(iii) One control greater than or equal
to 1.0200 but not greater than 1.0250.
(g) Requirements for performing pH
tests.
(1) Colorimetric pH tests that have the
dynamic range of 2 to 12 to support the
3 and 11 pH cutoffs and pH meters must
be capable of measuring pH to one
decimal place. Colorimetric pH tests,
dipsticks, and pH paper that have a
narrow dynamic range and do not
support the cutoffs may be used only to
determine if an initial pH validity test
must be performed.
(2) pH screening tests shall 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.
(3) An initial colorimetric pH test
shall have the following calibrators and
controls:
(i) One calibrator at 3;
(ii) One calibrator at 11;
(iii) One control in the range of 2 to
2.8;
(iv) One control in the range 3.2 to 4;
(v) One control in the range of 4.5 to
9;
(vi) One control in the range of 10 to
10.8;
(vii) One control in the range of 11.2
to 12.
(4) An initial pH meter test, if a pH
screening test is not used, shall have the
following calibrators and controls:
(i) One calibrator at 4;
(ii) One calibrator at 7;
(iii) One calibrator at 10;
(iv) One control in the range of 2 to
2.8;
(v) One control in the range 3.2 to 4;
(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 or confirmatory pH
meter test, if a pH screening test is used,

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shall have the following calibrators and
controls when the screening result
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 2 to
2.8; and
(iv) One control in the range 3.2 to 4.
(6) An initial or confirmatory pH
meter test, if a pH screening test is used,
shall have the following calibrators and
controls when the screening result
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.
(h) Requirements for performing
oxidizing adulterant tests.
(1) The initial test shall include an
appropriate calibrator at a cutoff
specified in sections 2.4(h)(4) and (7) 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.
(2) A confirmatory test for a specific
oxidizing adulterant shall use a different
analytical method than that used for the
initial test. Each confirmatory test batch
shall 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.
(i) Requirements for performing nitrite
tests. The initial and confirmatory
nitrite tests shall have a calibrator at the
cutoff concentration, a control without
nitrite (i.e., certified negative urine), one
control in the range of 200 mcg/mL to
400 mcg/mL, and one control in the
range of 500 mcg/mL to 625 mcg/mL.
(j) Requirements for performing
‘‘other’’ adulterant tests.
(1) The initial and confirmatory tests
for any ‘‘other’’ adulterant that may be
identified in the future shall satisfy the
requirements in section 2.5(d).
(2) The confirmatory test for ‘‘other’’
adulterants shall use a different
analytical principle or chemical reaction
than that used for the initial test.
(3) The initial and confirmatory tests
for adulterants in this section shall
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.
(k) Agency Blind Sample Program.

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(1) Agencies shall only use blind
quality control samples that have been
certified by the supplier to be negative
(i.e., certified by immunoassay and GC/
MS to contain no drug), drug positive
(i.e., certified by immunoassay and GC/
MS to contain a drug(s)/metabolite(s)
between 1.5 and 2 times the initial drug
test cutoff concentration), adulterated
(i.e., certified to be adulterated with a
specific adulterant using an appropriate
confirmatory validity test(s)), or
substituted (i.e., the creatinine
concentration and specific gravity
satisfy the criteria for a substituted
specimen using confirmatory creatinine
and specific gravity tests, respectively).
The supplier shall also provide the
expiration date for each quality control
sample to ensure that each quality
control sample will give the expected
result when it is submitted and correctly
tested by a laboratory before the
expiration date.
(2) During the initial 90-day period of
any new drug testing program, each
agency shall submit blind performance
test samples to each laboratory it
contracts with in the amount of at least
20 percent of the total number of
specimens submitted (up to a maximum
of 200 blind samples) and thereafter a
minimum of 3 percent blind samples
(up to a maximum of 100 blind samples)
submitted per quarter.
(3) Approximately 75 percent of the
blind quality control samples shall be
negative (i.e., certified to contain no
drug), approximately 15 percent shall be
positive for one or more drugs, and
approximately 10 percent shall be either
adulterated or substituted. The positive
samples shall be spiked only with those
drugs for which the agency is testing.
(4) The agency shall investigate any
unsatisfactory blind performance test
sample results and submit its findings to
the Secretary. The Secretary shall
continue the investigation to ensure that
the laboratory has corrected the cause of
the unsatisfactory performance test
result. A report of the Secretary’s
investigative findings and the corrective
action taken by the laboratory shall be
sent to the agency contracting officer.
The Secretary shall ensure notification
of the finding to all other Federal
agencies for which the laboratory is
engaged in urine drug testing and
coordinate any necessary action.
(5) Should a false positive error occur
on a blind performance test sample and
the error is determined to be an
administrative error (clerical, sample
mixup, etc.), the Secretary shall require
the laboratory to take corrective action
to minimize the occurrence of the
particular error in the future; and, if
there is reason to believe the error could

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have been systematic, the Secretary may
also require review and reanalysis of
previously run specimens.
(6) Should a false positive error occur
on a blind performance test sample and
the error is determined to be a technical
or methodological error, the laboratory
shall submit all data from the batch of
specimens which included the false
positive specimen. In addition, the
laboratory shall retest all specimens
analyzed positive for that drug or
metabolite from the time of final
resolution of the error back to the time
of the last satisfactory performance test
cycle. This retesting shall be
documented by a statement signed by
the Responsible Person. The Secretary
may require an on-site review of the
laboratory which may be conducted
unannounced during any hours of
operation of the laboratory. The
Secretary has the option of revoking
(section 3.13) or suspending (section
3.14) the laboratory’s certification or
recommending that no further action be
taken if the case is one of less serious
error in which corrective action has
already been taken, thus reasonably
assuring that the error will not occur
again.
Section 2.6 Reporting and Review of
Results
(a) MRO Qualifications.
(1) An MRO shall be a licensed
physician (Doctor of Medicine or
Osteopathy).
(2) An MRO shall have knowledge
about and clinical experience in
controlled substance abuse disorders,
detailed knowledge of alternative
medical explanations for laboratory
positive drug test results, knowledge
about issues relating to adulterated and
substituted specimens, and knowledge
about possible medical causes for
specimens that may be reported as
having an invalid result.
(3) 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 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 drug
testing laboratory or have any agreement
with the laboratory that may be
construed as a potential conflict of
interest.
(b) MRO Review of Results. An
essential part of the drug testing
program is the final review of each test
result reported by a laboratory. A
positive drug test result does not
automatically identify a donor as an
illegal drug user nor does an

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adulterated, substituted, or invalid test
result automatically indicate that a
donor has tampered with a specimen.
The review of a non-negative test result
shall be performed by the MRO before
the result is transmitted to the agency’s
designated representative. Staff under
the direct, personal supervision of the
MRO may review and report a negative
test result to the agency’s designated
representative.
(c) MRO Review of Positive,
Adulterated, Substituted, or Invalid Test
Results.
(1) Prior to making a final decision on
a specimen that was reported positive,
adulterated, substituted, or an invalid
test result by the laboratory, the MRO
shall interview the donor to determine
if the donor has a valid medical
explanation for the test result. This
action could include a review of the
donor’s medical history and a review of
any other biomedical factors. The MRO
shall review medical records made
available by the donor when a result
could have resulted from taking a
legally prescribed medication. After
making a determination, the MRO
reports the verified result to the
agency’s designated representative.
(2) When a laboratory reports an
invalid result because of one of the
reasons specified in paragraphs
2.4(h)(7)(iv) to (xii), the MRO and the
laboratory shall determine if additional
testing by another HHS-certified
laboratory may be useful in resolving
the reason for the invalid result and
possibly being able to report a positive
or adulterated result. If the MRO and the
laboratory agree that no further testing
would be useful, the MRO shall report
the invalid result as ‘‘Test Cancelled—
Invalid Result (specify reason for the
invalid result)’’ to the agency and
indicate one of the following actions:
(i) An immediate direct observed
collection is not required because the
explanation provided by the donor for
the invalid result is acceptable with no
further action required unless a negative
test result is required (i.e, preemployment, return-to-duty, or followup test); or
(ii) An immediate direct observed
collection is required because the
explanation provided by the donor for
the invalid result is not acceptable.
(d) Verification for Opiates; Review
for Prescription Medication. Before the
MRO verifies a confirmed positive result
for opiates, he or she shall determine
that there is clinical evidence—in
addition to the urine test result—of
illegal use of any opium, opiate, or
opium derivative (e.g., morphine/
codeine) listed in Schedule I or II of the
Controlled Substances Act. This

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requirement does not apply if the
laboratory confirms the presence of 6acetylmorphine (i.e., the presence of
this metabolite is proof of heroin use) or
the morphine or codeine concentration
is greater than or equal to 15,000 ng/mL
and the donor does not present a
legitimate medical explanation for the
presence of morphine or codeine at or
above this concentration. Consumption
of food products must not be considered
a legitimate medical explanation for the
donor having morphine or codeine at or
above this concentration.
(e) Donor Request to MRO for Retest.
(1) For a positive, adulterated, or
substituted result reported on a single
specimen or a primary (Bottle A)
specimen, a donor may request through
the MRO that an aliquot from the single
specimen or the split (Bottle B)
specimen be tested by a second HHScertified laboratory to verify the result
reported by the first laboratory. For a
single specimen or primary (Bottle A)
specimen reported as an invalid result,
a donor may not request that an aliquot
from the single specimen or the split
(Bottle B) specimen be tested by a
second HHS-certified laboratory.
(2) The donor has 72 hours (from the
time the MRO notified the donor that
his or her specimen was reported
positive, adulterated, or substituted) to
request a retest of an aliquot from the
single specimen or to test the split
(Bottle B) specimen.
(3) If the single specimen or split
(Bottle B) specimen cannot be tested by
a second laboratory (e.g., insufficient
volume, lost in transit, split (Bottle B)
not available), the MRO shall direct the
agency to immediately collect another
specimen under direct observation.
(4) If a donor chooses not have an
aliquot from the single specimen or the
split (Bottle B) specimen tested by a
second HHS-certified laboratory, a
Federal agency may have a single or
split specimen retested as part of a legal
or administrative proceeding to defend
an original positive, adulterated, or
substituted result.
(f) Result Consistent with Legal Drug
Use. If the MRO determines there is a
legitimate medical explanation for the
positive drug test result, he or she shall
normally take no further action and
report the test result as negative.
(g) Laboratory Result Not Reconfirmed
by a Second Laboratory. After a second
laboratory tests an aliquot of the single
specimen or the split (Bottle B)
specimen, the MRO shall take the
following actions when the second
laboratory reports the following results:
(1) Failed to reconfirm a single or all
drug positive results and adulterated. If
the donor provides a legitimate medical

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explanation for the adulteration result,
the MRO reports a failed to reconfirm
(specify drug(s)) and cancels both tests.
If there is no legitimate medical
explanation, the MRO reports a failed to
reconfirm (specify drug(s)) and a refusal
to test to the agency and indicates the
adulterant that is present in the urine
specimen. The MRO gives the donor 72
hours to request that Laboratory A
retests the single or Bottle 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.
(2) Failed to reconfirm a single or all
drug positive results and substituted. If
the donor provides a legitimate medical
explanation for the substituted result,
the MRO reports a failed to reconfirm
(specify drug(s)) and cancels both tests.
If there is no legitimate medical
explanation, the MRO reports a failed to
reconfirm (specify drug(s)) and a refusal
to test (substituted) to the agency. The
MRO gives the donor 72 hours to
request Laboratory A to review the
creatinine and specific gravity results
for the single or Bottle A specimen. If
the original creatinine and specific
gravity results confirm that the
specimen was substituted, the MRO
reports a refusal to test (substituted) to
the agency. If the original creatinine and
specific gravity results from Laboratory
A 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 appropriate
regulatory office about the failed to
reconfirm and cancelled test.
(3) Failed to reconfirm a single or all
drug positive results and not
adulterated or substituted. The MRO
reports to the agency a failed to
reconfirm result (specify drug(s)),
cancels both tests, and notifies the
appropriate regulatory office.
(4) Failed to reconfirm a single or all
drug positive results and invalid result.
The MRO reports to the agency a failed
to reconfirm result (specify drug(s) and
gives 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 appropriate
regulatory office.

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(5) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and adulterated. The MRO reports to the
agency a reconfirmed result (specify
drug(s)) and a failed to reconfirm result
(specify 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 appropriate regulatory office
regarding the test results for the
specimen.
(6) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and substituted. The MRO reports to the
agency a reconfirmed result (specify
drug(s)) and a failed to reconfirm result
(specify 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 appropriate regulatory office
regarding the test results for the
specimen.
(7) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and not adulterated or substituted. The
MRO reports a reconfirmed result
(specify drug(s)) and a failed to
reconfirm result (specify 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 appropriate regulatory
office regarding the test results for the
specimen.
(8) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and invalid result. The MRO reports to
the agency a reconfirmed result (specify
drug(s)) and a failed to reconfirm result
(specify 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
appropriate regulatory office regarding
the test results for the specimen.
(9) Failed to reconfirm substitution or
adulteration. The MRO reports to the
agency a failed to reconfirm result
(specify adulterant or not substituted)
and cancels both tests. The MRO shall
notify the appropriate regulatory office
regarding the test results for the
specimen.
(10) 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 (specify drug(s)). The MRO tells

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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.
(11) 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 (specify
drug(s) and specify adulterant or
substituted) and cancels both tests. The
MRO shall notify the appropriate
regulatory office regarding the test
results for the specimen.
(12) Failed to reconfirm at least one
drug and reconfirmed the adulterated
result. The MRO reports to the agency
a reconfirmed result (specify drug(s) and
adulterated) and a failed to reconfirm
result (specify 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.
(13) Failed to reconfirm at least one
drug and failed to reconfirm the
adulterated result. The MRO reports to
the agency a reconfirmed result (specify
drug(s)) and a failed to reconfirm result
(specify drug(s) and specify adulterant).
The MRO tells the agency that it may
take action based on the reconfirmed
drug(s) although Laboratory B failed to
reconfirm one or more drugs and failed
to reconfirm the adulterated result.
(14) Failed to reconfirm an
adulterated result and failed to
reconfirm a substituted result. The MRO
reports to the agency a failed to
reconfirm result ((specify adulterant)
and not substituted) and cancels both
tests. The MRO shall notify the
appropriate regulatory office regarding
the test results for the specimen.
(15) 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 (specify adulterant). The MRO
tells the agency that it may take action
based on the substituted result although
Laboratory B failed to reconfirm the
adulterated result.
(16) 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.
(h) Reporting Final Results. The MRO
shall report the final results of the tests
in writing and in a manner designed to
ensure confidentiality of the
information. When reporting the result

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for a single specimen or primary (Bottle
A) specimen to the agency, the MRO
shall report whether the specimen was
negative, dilute, positive (specify drug),
refusal to test (adulterated or
substituted), or test cancelled (state
reason). When reporting the result for a
retest of an aliquot of a single specimen
or the test of a split (Bottle B) specimen
to the agency, the MRO shall report
reconfirmed, failed to reconfirm (state
reason), refusal to test (adulterated or
substituted), or cancel both test results
as described in section 2.6(g). The MRO
shall not disclose any numerical values
to the agency.
Section 2.7
Records

Protection of Employee

Consistent with 5 U.S.C. 522a(m) and
48 CFR 24.101–24.104, all laboratory
contracts shall require that the
contractor comply with the Privacy Act,
5 U.S.C. 522a. In addition, laboratory
contracts shall require compliance with
patient access and confidentiality
provisions of sec. 503 of Public Law
100–71. The agency shall establish a
Privacy Act System of Records or
modify an existing system, or use any
applicable Government-wide system of
records to cover the agency’s records of
employee urinalysis results. The
contract and the Privacy Act System of
Records shall specifically require that
employee records be maintained and
used with the highest regard for
employee privacy.
Section 2.8 Individual Access to Test
and Laboratory Certification Results
In accordance with sec. 503 of Public
Law 100–71, any Federal employee who
is the subject of a drug test shall, upon
written request, have access to any
records relating to his or her drug test
and any records relating to the results of
any relevant certification, review, or
revocation-of-certification proceedings.
Subpart C—Certification of
Laboratories Engaged in Urine Drug
Testing for Federal Agencies
Section 3.1

Introduction

Urine drug testing is a critical
component of efforts to combat drug
abuse in our society. Many laboratories
are familiar with good laboratory
practices but may be unfamiliar with the
special procedures required when drug
test results are used in the employment
context. Accordingly, the following are
minimum standards to certify
laboratories engaged in urine drug
testing for Federal agencies.
Certification, even at the highest level,
does not guarantee accuracy of each
result reported by a laboratory

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conducting urine drug testing for
Federal agencies. Therefore, results from
laboratories certified under these
Guidelines must be interpreted with a
complete understanding of the total
collection, analysis, and reporting
process before a final conclusion is
made.
Section 3.2 Goals and Objectives of
Certification
(a) Uses of Urine Drug Testing. Urine
drug testing is an important tool to
identify drug users in a variety of
settings. In the proper context, urine
drug testing can be used to deter drug
abuse in general. To be a useful tool, the
testing procedure must be capable of
detecting drugs, drug metabolites,
adulterants, or substituted specimens
according to sections 2.4(e), 2.4(f), and
2.4(g) to protect the rights of the Federal
employees being tested.
(b) Need to Set Standards;
Inspections. The ability to accurately
determine the presence or absence of
specific drugs/metabolites or to
accurately determine the validity of a
urine specimen is critical to achieving
the goals of the testing program and to
protect the rights of the Federal
employees being tested. Standards have
been set which laboratories engaged in
Federal employee urine drug testing
shall meet to achieve the required
accuracy of test results. These
laboratories will be evaluated by the
Secretary or the Secretary’s designee as
defined in section 1.2 in accordance
with these Guidelines. Applicant
laboratories shall test three cycles of
performance testing samples that
challenge the laboratory’s ability to
correctly test for drugs and to correctly
perform specimen validity tests.
Applicant laboratories shall undergo an
initial inspection and upon certification
are also required to undergo a second
inspection within 3 months after being
certified. Certified laboratories are
required to analyze quarterly
performance testing samples that
challenge the laboratories to correctly
test for drugs and to correctly perform
validity tests and are required to
undergo periodic inspections.
(c) Urine Drug Testing Applies
Analytical Forensic Toxicology. The
possible impact of a non-negative test
result on an individual’s livelihood or
rights, together with the possibility of a
legal challenge of the result, sets this
type of test apart from most clinical
laboratory testing. In fact, urine drug
testing should be considered a special
application of analytical forensic
toxicology. That is, in addition to the
application of appropriate analytical
methodology, the specimen must be

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treated as evidence, and all aspects of
the testing procedure must be
documented and available for possible
court testimony. Laboratories engaged in
urine drug testing for Federal agencies
will require the services and advice of
a qualified forensic toxicologist, or
individual with equivalent
qualifications (both training and
experience) to address the specific
needs of the Federal drug testing
program, including the demands of
chain of custody of specimens, security,
proper documentation of all records,
storage of non-negative specimens for
later or independent testing,
presentation of evidence in court, and
expert witness testimony.
Section 3.3 General Certification
Requirements
A laboratory must meet all the
pertinent provisions of these Guidelines
in order to qualify for and maintain
certification under these standards.
Section 3.4 Capability to Test for Five
Classes of Drugs and to Conduct
Validity Tests
To be certified, a laboratory must be
capable of testing for marijuana,
cocaine, opiates, amphetamines, and
phencyclidine using the initial
immunoassay and confirmatory GC/MS
methods and conducting the specimen
validity tests as specified in these
Guidelines. The certification program
will be limited to these five classes of
drugs and specimen validity tests in
accordance with the methods specified
in these Guidelines (sections 2.4(e), (f),
and (g)). The laboratory will be
inspected and performance tested for
these drugs and validity tests. Certified
laboratories must clearly inform all nonregulated, private-sector employers/
clients when their specimens are being
tested using procedures that are
different from those for which the
laboratory is certified (i.e., testing
specimens not under the Guidelines).
Section 3.5 Initial and Confirmatory
Capability at Same Site
Certified laboratories shall have the
capability to perform initial and
confirmatory drug tests and initial and
confirmatory validity tests at the same
laboratory site.
Section 3.6 Personnel
Laboratory personnel shall meet the
requirements specified in section 2.3 of
these Guidelines. These Guidelines
establish the exclusive standards for
qualifying or certifying those laboratory
personnel involved in urinalysis testing
whose functions are prescribed by these
Guidelines. A certification of a

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laboratory under these Guidelines shall
be a determination that these
qualification requirements have been
met.
Section 3.7 Quality Assurance and
Quality Control
Certified laboratories shall have a
quality assurance program which
encompasses all aspects of the testing
process, including but not limited to
specimen accessioning, chain of
custody, security and reporting of
results, initial and confirmatory testing,
and validation of analytical procedures.
As specified in these Guidelines, quality
control procedures shall be designed,
implemented, and reviewed to monitor
testing.
Section 3.8
Custody

Security and Chain of

Laboratories shall meet the security
and chain of custody requirements
provided in section 2.4(a).
Section 3.9 One-Year Storage for
Positive, Adulterated, Substituted, and
Invalid Specimens
All positive, adulterated, substituted,
and invalid specimens shall be retained
in accordance with the provisions of
section 2.4(i) of these Guidelines.
Section 3.10

Documentation

The laboratory shall maintain and
make available for at least 2 years
documentation in accordance with the
specifications in section 2.4(p).
Section 3.11

Reports

The laboratory shall report test results
in accordance with the specifications in
section 2.4(h).
Section 3.12

Certification

(a) General. The Secretary may certify
any laboratory that meets the standards
in these Guidelines to conduct urine
drug testing. In addition, the Secretary
may consider to be certified any
laboratory that is certified by an HHSrecognized certification program in
accordance with these Guidelines.
(b) Criteria. In determining whether to
certify a laboratory or to accept the
certification of an HHS-recognized
certification program in accordance
with these Guidelines, the Secretary
shall consider the following criteria:
(1) The adequacy of the laboratory
facilities;
(2) The expertise and experience of
the laboratory personnel;
(3) The excellence of the laboratory’s
quality assurance/quality control
program;
(4) The performance of the laboratory
on any performance tests;

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(5) The laboratory’s compliance with
standards as reflected in any laboratory
inspections; and
(6) Any other factors affecting the
reliability and accuracy of drug or
validity tests and reporting done by the
laboratory.
(c) Corrective Action by Certified
Laboratories. A laboratory must meet all
the pertinent provisions of these
Guidelines in order to qualify for and
maintain certification. The Secretary has
broad discretion to take appropriate
action to ensure the full reliability and
accuracy of drug and validity testing
and reporting, to resolve problems
related to drug and validity testing, and
to enforce all standards set forth in these
Guidelines. The Secretary shall have the
authority to issue directives to any
laboratory suspending the use of certain
analytical procedures when necessary to
protect the integrity of the testing
process; order any laboratory to
undertake corrective actions to respond
to material deficiencies identified by an
inspection or through proficiency
testing; order any laboratory to send
aliquots of urine specimens to another
laboratory for retesting when necessary
to ensure the accuracy of testing under
these Guidelines; order the review of
results for specimens tested under the
Guidelines for private-sector employers/
clients to the extent necessary to ensure
the full reliability of drug and validity
testing for Federal agencies; and order
any other action necessary to address
deficiencies in drug or validity testing,
analysis, specimen collection, chain of
custody, reporting of results, or any
other aspect of the certification program.
Section 3.13 Revocation
(a) General. The Secretary shall
revoke certification of any laboratory
certified under these provisions or
accept revocation by an HHS-recognized
certification program in accordance
with these Guidelines if the Secretary
determines that revocation is necessary
to ensure the full reliability and
accuracy of drug and validity tests and
the accurate reporting of test results.
(b) Factors to Consider. 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 validity tests; for example, a
false positive error in reporting the
results of an employee’s drug test;
(2) Unsatisfactory participation in
performance evaluations or laboratory
inspections;
(3) A material violation of a
certification standard or a contract term
or other condition imposed on the

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laboratory by a Federal agency using the
laboratory’s services;
(4) Conviction for any criminal
offense committed as an incident to
operation of the laboratory; or
(5) Any other cause which materially
affects the ability of the laboratory to
ensure the full reliability and accuracy
of drug and validity tests and the
accurate reporting of results.
(c) Period and Terms. 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 and validity
testing of Federal employees.
Section 3.14 Suspension
(a) Criteria. Whenever the Secretary
has reason to believe that revocation
may be required and that immediate
action is necessary in order to protect
the interests of the United States and its
employees, the Secretary may
immediately suspend a laboratory’s
certification to conduct urine drug and
validity testing for Federal agencies. The
Secretary may also accept suspension of
certification by an HHS-recognized
certification program in accordance
with these Guidelines.
(b) Period and Terms. The period and
terms of suspension shall be determined
by the Secretary and shall depend upon
the facts and circumstances of the
suspension and the need to ensure
accurate and reliable drug and validity
testing of Federal employees.
Section 3.15 Notice
(a) Written Notice. When a laboratory
is suspended or the Secretary seeks to
revoke certification, the Secretary shall
immediately serve the laboratory with
written notice of the suspension or
proposed revocation by facsimile 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) Opportunity for Informal Review.
The written notice shall state that the
laboratory will be afforded an
opportunity for an informal review of
the suspension or proposed revocation
if it so requests in writing within 30
days of the date the laboratory received
the notice, or if expedited review is
requested, within 3 days of the date the
laboratory received the notice. Subpart
D contains detailed procedures to be
followed for an informal review of the
suspension or proposed revocation.

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(c) Effective Date. A suspension shall
be effective immediately. A proposed
revocation shall 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 shall terminate immediately
and any proposed revocation shall not
take effect.
(d) HHS-Recognized Certification
Program. The Secretary’s responsibility
under this section may be carried out by
an HHS-recognized certification
program in accordance with these
Guidelines.
(e) Public Notice. The Secretary will
publish in the Federal Register the
name, address, and telephone number of
any laboratory that has its certification
suspended or revoked under section
3.13 or section 3.14, respectively, and
the name of any laboratory which has its
suspension lifted. The Secretary shall
provide to any member of the public
upon request the written notice
provided to a laboratory that has its
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 D.
Section 3.16 Recertification
Following revocation, a laboratory
may apply for recertification. Unless
otherwise provided by the Secretary in
the notice of revocation under section
3.13(a) or the reviewing official’s
decision under section 4.9(e) or 4.14(a),
a laboratory which has had its
certification revoked may reapply for
certification as an applicant laboratory.
Section 3.17 Performance Testing (PT)
Requirement for Certification
(a) An Initial and Continuing
Requirement. The PT program is a part
of the initial evaluation of a laboratory
seeking certification (both PT and
laboratory inspection are required) and
of the continuing assessment of
laboratory performance necessary to
maintain this certification.
(b) Three Initial Cycles Required.
Successful participation in three PT
cycles of testing shall be required before
a laboratory is eligible to be considered
for certification.
(c) Four Cycles Per Year. After
certification, laboratories shall be
challenged with at least 10 PT samples
on a quarterly cycle.
(d) Laboratory Procedures Identical
for PT Samples and Routine Specimens.
All procedures associated with the
handling and testing of the PT samples

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by the laboratory shall to the greatest
extent possible be carried out in a
manner identical to that applied to
routine specimens, unless otherwise
specified.
(e) Agency PT Samples. Any certified
laboratory shall be subject to receiving
and testing PT samples (see section
2.5(k)) submitted by a Federal agency. A
certified laboratory is expected to
correctly test and report each agency
submitted PT sample (that is, report a
negative sample as negative, a drug
positive sample as positive, an
adulterated sample as adulterated, or a
substituted sample as substituted).
(f) Reporting PT Sample Results. The
laboratory shall report results of PT
program samples to the certifying
organization in the same manner as
specified in section 2.4(h) for routine
specimens.
Section 3.18 PT Program Samples
(a) Drug PT Samples. Each PT cycle
shall have samples that contain the
drugs and drug metabolites listed in
sections 2.4(e) and (f). For some
samples, the composition will consist of
the parent drug as well as metabolites.
Also, more than one drug class may be
included in one sample, but generally
no more than two drugs will be present
in any one sample. For any particular
PT cycle, the samples in each set of
samples going to the laboratories may
vary but, within any annual period, all
laboratories participating in the PT
program will have analyzed the same
total set of samples.
(b) Composition of the Drug PT
Samples. PT program samples shall
satisfy, but are not limited to, one of the
following criteria:
(1) A drug or drug metabolite
concentration will be at least 20 percent
above the cutoff for either the initial
drug test or the confirmatory drug test
depending on which is to be evaluated;
(2) For retest samples, the drug or
drug metabolite concentration may be as
low as 40 percent of the cutoff;
(3) For routine samples, the drug or
drug metabolite concentration may be
below the cutoff for special purposes;
(4) A negative sample shall contain no
target drug analyte at a concentration
greater than 10 percent of the
confirmatory cutoff;
(5) Samples may be fortified with
interfering substances.
(c) Specimen Validity Testing PT
Samples. Each PT cycle shall contain
samples that challenge a laboratory’s
ability to identify substituted and
adulterated specimens. For any
particular PT cycle, the samples in each
set of samples going to the laboratories
may vary but, within any annual period,

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all laboratories participating in the PT
program will have analyzed the same
total set of specimen validity testing PT
samples.
(d) Composition of the Specimen
Validity Testing PT Samples. Specimen
validity testing PT samples 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 less than 2.75 or
greater than 11.25;
(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;
(5) The specific gravity will be less
than or equal to 1.0050 or between
1.0170 and 1.0230.
Section 3.19 Evaluation of PT Sample
Results
(a) Initial Certification of Applicant
Laboratories.
(1) An applicant laboratory shall not
report any false positive drug test result
on any PT sample during the initial
certification process. A false positive
drug result will automatically disqualify
a laboratory from further consideration.
(2) An applicant laboratory shall
maintain an overall grade of 90 percent
for the three cycles of PT samples that
challenge the laboratory’s ability to
conduct drug tests (i.e., it must correctly
identify and confirm 90 percent of the
total drug challenges). A laboratory
which achieves a score on any one cycle
of the initial certification process such
that it can no longer achieve a grade of
90 percent over three consecutive PT
cycles will be immediately disqualified
from further consideration.
(3) An applicant laboratory shall
obtain quantitative values over the three
initial PT cycles that are within ±20
percent or ±2 standard deviations of the
calculated reference group mean
(whichever range is larger) for at least 80
percent of the total drug challenges.
Failure to satisfy this requirement for
the total drug challenges will result in
disqualification.
(4) An applicant laboratory shall not
obtain any quantitative value on a drug
challenge sample that differs by more
than 50 percent from the calculated
reference group mean. An applicant
laboratory that obtains a quantitative
value that differs by more than 50
percent on any drug challenge sample
will result in disqualification.
(5) An applicant laboratory shall
successfully detect and quantitate in
accordance with paragraphs (a)(2),
(a)(3), and (a)(4) of this section at least

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50 percent of the challenges for each
drug. An applicant laboratory that fails
to successfully quantitate at least 50
percent of the challenges for each drug
will result in disqualification.
(6) An applicant laboratory shall
maintain an overall grade of 80 percent
for the three cycles of PT samples that
challenge the laboratory’s ability to
conduct specimen validity tests (i.e., to
correctly identify and confirm 80
percent of the total specimen validity
testing challenges). An applicant
laboratory that achieves a score on any
one of the initial PT cycles such that it
can no longer achieve a total grade of 80
percent over the three consecutive PT
cycles for the specimen validity testing
samples will result in disqualification.
(7) For quantitative specimen validity
tests, an applicant laboratory shall
obtain quantitative values for at least 80
percent of the total challenges that
satisfy the following criteria:
(i) Nitrite and creatinine
concentrations are within ±20 percent or
±2 standard deviations of the calculated
reference group mean;
(ii) pH values are within ±0.3 pH
units of the calculated reference group
mean; and
(iii) Specific gravity values are within
±0.0003 specific gravity units of the
calculated reference group mean.
An applicant laboratory that achieves
a score on any one initial PT cycle such
that it cannot achieve a total grade of 80
percent over three consecutive PT
cycles for the specimen validity testing
samples will be disqualified.
(8) An applicant laboratory shall not
obtain any quantitative value on a
specimen validity testing sample that
differs by more than ±50 percent for
nitrite and creatinine concentrations,
±0.8 units for pH measurements, or
±0.0006 units for specific gravity from
the calculated reference group means.
An applicant laboratory that reports
such an error for an initial certification
PT sample will be disqualified.
(9) For qualitative specimen validity
tests, an applicant laboratory shall
correctly report at least 80 percent of the
challenges for each qualitative specimen
validity test over the three initial PT
cycles. Failure to correctly report at
least 80 percent for each qualitative
specimen validity test will result in
disqualification.
(10) An applicant laboratory shall not
report any sample as adulterated with a
compound that is not present in the
sample, adulterated based on pH when
the calculated group reference mean is
within the acceptable pH range, or
substituted when the calculated group
means for both creatinine and specific
gravity are within the acceptable range.

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An applicant laboratory reporting any
such error will be disqualified.
(b) Evaluation of Certified
Laboratories.
(1) Requirement for No False
Positives. A certified laboratory that
reports a false positive drug result for a
PT sample may be subject to suspension
or revocation of its certification. The
most serious false positive is by drug
class, such as reporting THCA in a
negative PT sample or reporting cocaine
metabolite in a PT sample containing
only opiates. An identification or
reporting error within a class (e.g.,
reporting codeine for morphine) is
unacceptable, but is less serious than a
misidentification of a class.
(2) Requirement to Identify and
Confirm 90 Percent of Total Drug
Challenges. Failure of a certified
laboratory to maintain a grade of 90
percent over two consecutive PT cycles
(i.e., to identify 90 percent of the total
drug challenges and to correctly confirm
90 percent of the total drug challenges)
may result in suspension or revocation
of the laboratory’s certification.
(3) Requirement to Quantitate 80
Percent of Total Drug Challenges Within
±20 Percent or ±2 Standard Deviations.
Quantitative values reported by a
certified laboratory over two
consecutive PT cycles must be within
±20 percent or ±2 standard deviations of
the calculated reference group mean
(whichever is larger) for at least 80
percent of the total drug challenges. A
certified laboratory that fails to achieve
the 80 percent requirement may have its
certification suspended or revoked.
(4) Requirement to Quantitate within
50 Percent of Calculated Reference
Group Mean. A certified laboratory shall
not obtain any quantitative value on a
drug challenge that differs by more than
±50 percent from the calculated
reference group mean. More than one
error of this type for the same drug class
over two consecutive PT cycles may
result in suspension or revocation of the
laboratory’s certification.
(5) Requirement to Successfully Detect
and Quantitate 50 Percent of the Total
Drug Challenges for Any Individual
Drug. For each drug, a certified
laboratory must successfully detect and
quantitate in accordance with
paragraphs (b)(3) and (b)(4) of this
section at least 50 percent of the total
drug challenges.
(6) No False Adulterated or
Substituted Specimen Validity Testing
Sample Result. A certified laboratory
shall not report any sample as
adulterated with a compound that is not
present in the sample, adulterated based
on pH when the calculated group
reference mean is within the acceptable

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pH range, or substituted when the
calculated group means for both
creatinine and specific gravity are
within the acceptable range. A certified
laboratory that reports this type of error
may have its certification suspended or
revoked.
(7) Requirement to Identify and
Confirm 80 Percent of the Total
Specimen Validity Testing Challenges.
A certified laboratory shall maintain an
overall grade of 80 percent over two
consecutive PT cycles that challenge the
laboratory’s ability to conduct specimen
validity tests (i.e., to correctly identify
and confirm 80 percent of the total
specimen validity testing challenges). A
certified laboratory that fails to maintain
a grade of 80 percent over two
consecutive PT cycles may have its
certification suspended or revoked.
(8) Requirement to Correctly
Quantitate 80 Percent of the Total
Challenges for Quantitative Specimen
Validity Tests. For quantitative
specimen validity tests, a certified
laboratory shall obtain quantitative
values for at least 80 percent of the total
challenges that satisfy the following
criteria:
(i) Nitrite and creatinine
concentrations are within ±20 percent or
±2 standard deviations of the calculated
reference group mean;
(ii) pH values are within ±0.3 pH
units of the calculated reference group
mean; and
(iii) Specific gravity values are within
±0.0003 specific gravity units of the
calculated reference group mean.
A certified laboratory that fails to
achieve 80 percent over two consecutive
PT cycles may have its certification
suspended or revoked.
(9) Requirement to Report No More
than One Quantitative Error for a
Quantitative Specimen Validity Test. A
certified laboratory shall not obtain any
quantitative value on a specimen
validity testing sample that differs by
more than ±50 percent for nitrite and
creatinine concentrations, ±0.8 unit for
pH measurements, or ±0.0006 units for
specific gravity from the calculated
reference group means. More than one
error of this type for the same
adulterant, for creatinine, for pH, or for
specific gravity over two consecutive PT
cycles may result in suspension or
revocation of a laboratory’s certification.
(10) Requirement for Each Qualitative
Specimen Validity Test. For each
qualitative specimen validity test, a
certified laboratory shall correctly report
at least 80 percent of the challenges for
each qualitative specimen validity test
over two consecutive PT cycles. A
certified laboratory that fails to correctly
report at least 80 percent of the

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challenges may have its certification
suspended or revoked.
(11) Procedures When Requirements
in Paragraphs (b)(1)—(b)(10) of this
Section Are Not Met. The laboratory
shall be allowed 5 working days in
which to provide any explanation for its
unsuccessful performance, including
administrative error or methodological
error, and to develop and submit a plan
for implementing corrective actions to
address the source of the error within 30
days. The Secretary may revoke or
suspend the laboratory’s certification or
take no further action, depending on the
seriousness of the errors and whether
there is evidence that the source of the
poor performance has been corrected
and that current performance meets the
requirements for a certified laboratory
under these Guidelines. The Secretary
may require that additional performance
tests be carried out to determine
whether the source of the poor
performance has been removed. If the
Secretary determines to suspend or
revoke the laboratory’s certification, the
laboratory’s official status will become
‘‘Suspended’’ or ‘‘Revoked’’ until the
suspension or revocation is lifted or
until any recertification process is
complete.
(c) Eighty Percent of Participating
Laboratories Must Detect Drug or
Specimen Validity Testing Challenge. A
laboratory’s performance shall be
evaluated for all drug and specimen
validity testing challenges unless the
overall response from participating
laboratories indicates that less than 80
percent of them were able to correctly
report the drug or specimen validity
testing challenge.
(d) Participation Required. Failure to
participate in a PT cycle or to
participate satisfactorily may result in
the suspension or revocation of a
laboratory’s certification.
Section 3.20 Inspections
(a) Frequency. Prior to laboratory
certification under these Guidelines and
at least twice a year after certification,
a team of two or more qualified and
trained inspectors shall conduct an onsite inspection of laboratory premises.
Inspections shall document the overall
ability of the laboratory to satisfy the
certification requirements specified in
these Guidelines.
(b) Inspectors. The Secretary shall
establish criteria for the selection of
inspectors to ensure high quality,
unbiased, and thorough inspections.
The inspectors shall perform
inspections consistent with the
guidance in section 3.12(b).
(c) Inspection Performance. Inspectors
shall assess the overall compliance of

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the certified or applicant laboratory to
these Guidelines. The laboratory’s
operation shall be consistent with good
forensic laboratory practice and shall be
in compliance with these Guidelines. It
is the laboratory’s responsibility to
correct deficiencies identified during
the inspection consistent with these
Guidelines and with good forensic
laboratory practice. In accordance with
sections 3.13 and 3.14, deficiencies
identified at inspections may be the
basis for suspending or revoking a
laboratory’s certification.
Section 3.21 Results of Inadequate
Performance
Failure of a laboratory to comply with
any aspect of these Guidelines may lead
to revocation or suspension of
certification as provided in sections 3.13
and 3.14 of these Guidelines.
Section 3.22 Listing of Certified
Laboratories
A Federal Register listing of
laboratories certified by HHS will be
updated and published periodically.
Laboratories which are in the applicant
stage of HHS certification are not to be
considered as meeting the minimum
requirements in these Guidelines. A
laboratory is not certified until HHS has
sent the laboratory an HHS letter of
certification.
Subpart D—Procedures for Review of
Suspension or Proposed Revocation of
a Certified Laboratory
Section 4.1 Applicability
These procedures apply when:
(a) The Secretary has notified a
laboratory in writing that its
certification to perform urine drug
testing under these Mandatory
Guidelines for Federal Workplace Drug
Testing Programs has been suspended or
that the Secretary proposes to revoke
such certification.
(b) The laboratory has, within 30 days
of the date of such notification or within
3 days of the date of such notification
when seeking an expedited review of a
suspension, requested in writing an
opportunity for an informal review of
the suspension or proposed revocation.
Section 4.2 Definitions
Appellant. Means the laboratory
which has been notified of its
suspension or proposed revocation of its
certification to perform urine drug and/
or validity testing and has requested an
informal review thereof.
Respondent. Means the person or
persons designated by the Secretary in
implementing these Guidelines
(currently the National Laboratory
Certification Program is located in the

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Division of Workplace Programs,
Substance Abuse and Mental Health
Services Administration).
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 his or her 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 4.3 Limitation 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
Mandatory Guidelines for Federal
Workplace Drug Testing Programs, and
other relevant law. The legal validity of
the Mandatory Guidelines shall not be
subject to review under these
procedures.
Section 4.4 Specifying Who Represents
the Parties
The appellant’s request for review
shall specify the name, address, and
phone number of the appellant’s
representative. In its first written
submission to the reviewing official, the
respondent shall specify the name,
address, and phone number of the
respondent’s representative.
Section 4.5 The Request for Informal
Review and the Reviewing Official’s
Response
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.
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 4.6 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

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the laboratory attempts to regain
compliance with the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs 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.

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

(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 his or her
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 Oral
Presentation. The presiding official will
attempt to schedule the oral
presentation within 30 days of the date
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

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Section 4.8 Opportunity for Oral
Presentation

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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 his or her
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 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

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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 his or
her 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 4.9 Expedited Procedures for
Review of Immediate Suspension
(a) Applicability. When the Secretary
notifies a laboratory in writing that its
certification to perform urine drug and/
or validity 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 laboratory
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, tabbed, indexed, and organized
chronologically, and (2) a written
statement, not to exceed 20 doublespaced pages, explaining the party’s
position concerning the suspension and
any proposed revocation. No reply brief
is permitted.
(d) Oral Presentation. If an oral
presentation is requested by the
appellant or otherwise granted by the
reviewing official, the presiding official
will attempt to schedule the oral
presentation within 7–10 days of the
date of appellant’s request for review at
a time and place determined by the
presiding official following consultation
with the parties. The presiding official
may hold a pre-hearing conference in
accordance with section 4.8(c) and will
conduct the oral presentation in
accordance with the procedures of
sections 4.8(e), (f), and (g).
(e) Written Decision. The reviewing
official shall issue a written decision
upholding or denying the suspension or

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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 4.14 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 facsimile
or overnight mail.
Section 4.10

Ex Parte Communications

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 4.11 Transmission of Written
Communications by Reviewing Official
and Calculation of Deadlines
Because of the importance of a timely
review, the reviewing official should
normally transmit written
communications to either party by
facsimile 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. In
counting days, include Saturdays,
Sundays, and 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 4.12 Authority and
Responsibilities of 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

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Federal Register / Vol. 69, No. 71 / Tuesday, April 13, 2004 / Notices

19673

accordance with the objectives of these
procedures.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

SUPPLEMENTARY INFORMATION:

Section 4.13

Substance Abuse and Mental Health
Services Administration

The Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Guidelines) were first published in the
Federal Register on April 11, 1988 (53
FR 11970), and have since been revised
in the Federal Register on June 9, 1994
(59 FR 29908), and on September 30,
1997 (62 FR 51118). The Guidelines
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 Pub. L. 100–
71, 5 U.S.C. section 7301 note, and E.O.
12564.
In developing and organizing the
proposed revisions to the Guidelines,
there are a number of issues presented
in this preamble, that include the
rationale for the order and manner of
presentation of what is proposed and
why. These issues are first presented by
general topic area, and later presented
in summary, as they appear in the text
of the proposed Guidelines.

Administrative Record

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 4.14

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
therefor 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 his or her
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 Notice. If the suspension
and proposed revocation are upheld, the
revocation will become effective
immediately and the public will be
notified by publication of a notice 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 notice will be given by
publication in the Federal Register.
Section 4.15 Court Review of Final
Administrative Action; Exhaustion of
Administrative Remedies
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 4.9(e) or 4.14(a), constitutes final
agency action and is ripe for judicial
review as of the date of the decision.
[FR Doc. 04–7985 Filed 4–6–04; 12:39 pm]
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Proposed Revisions to Mandatory
Guidelines for Federal Workplace Drug
Testing Programs
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice of proposed revisions to
mandatory guidelines.
AGENCY:

SUMMARY: The Department of Health and
Human Services (‘‘HHS’’ or
‘‘Department’’) is proposing to establish
scientific and technical guidelines for
the testing of hair, sweat, and oral fluid
specimens in addition to urine
specimens; scientific and technical
guidelines for using on-site tests to test
urine and oral fluid at the collection
site; requirements for the certification of
instrumented initial test facilities; and
added standards for collectors, on-site
testers, and medical review officers.
DATES: Submit comments on or before
July 12, 2004.
ADDRESSES: You may submit comments,
identified by (insert docket number and/
or RIN number), by any of the following
methods:
• E-mail: [email protected]. Include
docket number and/or RIN number in
the subject line of the message.
• Fax: 301–443–3031
• Mail: 5600 Fishers Lane, Rockwall
II, Suite 815, Rockville, Maryland
20857.
• Hand Delivery/Courier: 5515
Security Lane, Suite 815, Rockville,
Maryland 20852.
• Information Collection
Requirements: Submit comments 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).
Instructions: All submissions received
must include the agency name and
docket number or Regulatory
Information Number (RIN) for this
rulemaking. All comments will be
available for public review at 5515
Security Lane, Suite 815, Rockville,
Maryland 20852.
FOR FURTHER INFORMATION CONTACT:
Walter F. Vogl, Ph.D., Drug Testing
Section, Division of Workplace
Programs, CSAP, 5600 Fishers Lane,
Rockwall II, Suite 815, Rockville,
Maryland 20857, 301–443–6014 (voice),
301–443–3031 (fax), [email protected]
(e-mail).

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Background

History of the HHS Certification
Program for Federal Employee Drug
Testing Programs, and Related
Knowledge
Since the beginning of the program in
1988, many challenges have been
overcome and lessons learned from the
specific and rigorous HHS certification
of laboratories to perform forensic
workplace testing for job applicants and
Executive Branch Federal employees.
The initial Guidelines were published
for a 60-day public comment period,
and were first published as a final
notice in the Federal Register in April
of 1988. Originally, it was believed that
fewer than 10 laboratories would apply
for HHS certification under the
Guidelines to conduct Federal employee
drug testing, and that the Department
would not require even that many to test
the urine specimens from all Federal
agencies.
This situation changed very quickly
when the Department of Transportation
(DOT) published a final drug testing
rule (54 FR 49854) in December 1989 for
its regulated transportation industries.
DOT required its regulated industries to
use drug testing laboratories that were
certified by HHS. This requirement
began a close relationship between HHS
and DOT. Additionally, the Nuclear
Regulatory Commission (NRC) in its
Fitness for Duty program contained in
10 CFR Part 26 requires its licensees to
use drug testing laboratories certified by
HHS.

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