Fr Mg 2008

Tuesday,
November 25, 2008

Part V

Department of
Health and Human
Services
Substance Abuse and Mental Health
Services Administration

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Mandatory Guidelines for Federal
Workplace Drug Testing Programs; Notice

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Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / 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:

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SUMMARY: This Final Notice of Revisions
to the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
(Revisions to Mandatory Guidelines)
addresses collection and testing of urine
specimens, the requirements for the
certification of Instrumented Initial Test
Facilities (IITFs), and the role of and
standards for collectors and Medical
Review Officers (MROs). Additional
notices of Proposed Revisions to the
Mandatory Guidelines addressing the
use of point of collection testing
(POCT), oral fluid testing, sweat patch
testing, hair testing, and associated
issues will be published at a later date.
With regard to the use of alternative
specimens including hair, oral fluid,
and sweat patch specimens in Federal
Workplace Drug Testing Programs,
significant issues have been raised by
Federal agencies during the review
process which require further
examination, and may require
additional study and analysis. As part of
the review process for these alternative
tests, the Department of Health and
Human Services (‘‘HHS’’ or
‘‘Department’’) plans to issue a notice in
the Federal Register requesting
information and assistance from the
general public to provide or identify
data and research findings that address
specific areas of interest.
DATES: Effective Date: March 25, 2008.
FOR FURTHER INFORMATION CONTACT:
Donna M. Bush, Ph.D., Division of
Workplace Programs, CSAP, SAMHSA,
1 Choke Cherry Road, Room 2–1033,
Rockville, Maryland 20857, (240) 276–
2600 (phone), (240) 276–2610 (Fax), or
e-mail at donna.bush@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:

Background
The 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), on
September 30, 1997, (62 FR 51118), on
November 13, 1998 (63 FR 63483), and
on April 13, 2004, (69 FR 19644). The
Guidelines establish the scientific and
technical guidelines for Federal
workplace drug testing programs and

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establish standards for certification of
laboratories engaged in drug testing for
Federal agencies under authority of
section 503 of Public Law 100–71, 5
U.S.C. Section 7301 note, and Executive
Order (E.O.) 12564.
The Department also published
Proposed Revisions to Mandatory
Guidelines in the Federal Register on
April 13, 2004, (69 FR 19673). These
Proposed Revisions to Mandatory
Guidelines described changing the
Guidelines into a plain language format,
expanding the Federal drug testing
program to include use of alternative
specimens including testing hair, oral
fluid, and sweat patch specimens,
allowing the use of ‘‘point of collection
testing’’ (POCTs) for urine and oral fluid
specimens, establishing the
requirements for certifying
‘‘instrumented initial test facilities’’
(IITFs) to test specimens, and providing
specific standards for collectors, POCT
testers, and MROs. There was a 90-day
public comment period during which
285 commenters submitted comments
on the proposed changes to the
Guidelines. These commenters were
individuals and public and private
entities. The comments are available for
public view on the Department’s
Internet Web site (http://
workplace.samhsa.gov).
Section 503 of Public Law 100–71, 5
U.S.C. Section 7301 note, required the
Department to establish scientific and
technical guidelines and amendments in
accordance with Executive Order 12564,
and to publish Mandatory Guidelines
which establish comprehensive
standards for all aspects of laboratory
drug testing and procedures, including
standards that require the use of the best
available technology for ensuring the
full reliability and accuracy of drug tests
and strict procedures governing the
chain of custody of specimens collected
for drug testing. These revisions to the
Mandatory Guidelines promote and
establish standards that use the best
available technology for ensuring the
full reliability and accuracy of urine
drug tests, while reflecting the ongoing
process of review and evaluation of
legal, scientific, and societal concerns.
The submitted public comments and
additional comments raised by Federal
Agencies during subsequent internal
review of the proposed changes to the
Guidelines raised significant scientific,
legal, and public policy concerns about
the use of alternative specimens and
POCT devices in Federal agency
workplace drug testing programs. Since
each alternative specimen and drug
testing using POCT devices poses
different concerns, the Department
established a staggered timeline for

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issuing final guidance that allows for
further study and research. In assessing
the complexity of the task, the
Department has decided to publish
these final Guidelines with regard to
collection and testing urine specimens,
establishing the requirements for the
certification of IITFs, and establishing
specific standards for collectors and
MROs. The Department considered
several options for issuing one or more
Final Notices in the Federal Register
that may require additional public
comment periods, concerning the use of
alternative specimens and drug testing
technologies such as POCT devices.
Since the scientific, legal, and public
policy information for drug testing oral
fluid, hair, and sweat patch specimens,
and using POCT devices is not as
complete as it is for the laboratory-based
urine drug testing program, developing
Final Notices concerning the use of
these is more challenging. As described
in the notice of Proposed Revisions to
Mandatory Guidelines issued April 13,
2004, the performance of alternative
specimens in pilot performance testing
(PT) programs has been encouraging,
with individual laboratory and group
performance improving over time.
However, there are still three areas of
concern. First, the data from the pilot
PT programs to date show that not all
participants have developed the
capability to test for all required drug
classes, nor to perform such tests with
acceptable accuracy. Second, some drug
classes are more difficult to detect than
others, for any given type of specimen.
Third, the specific drug classes that are
difficult to detect vary by type of
specimen. As a result, it will require
additional study to assist agencies in
determining how to select the
appropriate type of specimen to be
collected from a specific donor, when
the use of a specific drug is suspected.
Nevertheless, HHS believes that the
addition of alternative specimens to the
Federal Workplace Drug Testing
Program would complement urine drug
testing and aid in combating the risks
posed from available methods of
suborning urine drug testing through
adulteration, substitution, and dilution.
Thus, HHS will continue to pursue
testing using alternative specimens.
HHS anticipates issuing further
revisions to the Mandatory Guidelines
addressing the use of oral fluid, sweat
patch, and hair, and the use of POCT
devices for urine and oral fluid. These
revisions will be published in the
Federal Register, with opportunity for
public comment.
All written comments were reviewed
and taken into consideration in the

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preparation of these revised Guidelines.
The preamble only addresses sections of
the draft Guidelines regarding urine
testing that were commented on during
the public comment period or that the
Department is changing. Most section
numbers for the Guidelines issued in
April 2004 were changed in these
Guidelines due to the removal of those
sections concerning alternative
specimens and POCT as well as for
clarity. To make it easier for the public,
the preamble refers to the new section
number and, where appropriate, the
corresponding section number in the
Proposed Revisions to Mandatory
Guidelines issued in April 2004. Similar
comments are considered together in the
discussion.
Reason for the Effective Date
An effective date of 18 months from
the date of publication of these revised
Mandatory Guidelines was chosen to
permit the following activities:
(1) It will take at least 12 months for
manufacturers of immunoassay test kits
to modify or manufacture immunoassay
test kits and ensure compliance with
any applicable statutory and regulatory
requirements before commercialization
of the modified kits.
(2) It will take the HHS-certified
laboratories at least one month to
validate and implement the new test
kits.
(3) It will take 2 to 3 months for the
National Laboratory Certification
Program (NLCP) to challenge the HHScertified laboratories with performance
testing (PT) samples to ensure that the
test kits and test results satisfy the
required performance criteria.
The effective time frame of 18 months
will encompass many activities that will
overlap or occur at the same time within
different industries and Federal
agencies.

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Summary of Public Comments and the
HHS Response
The following comments were
directed to the information and
questions in the preamble.
Initial Test Kit Issues
In the proposed Guidelines, the
Department requested comments on
issues regarding the testing for
amphetamine analogs using one or two
immunoassay test kits because the
laboratory or IITF would be required to
test specimens for the target analytes
listed under amphetamines. Two
commenters believed that two separate
initial test kits would be needed to
appropriately screen specimens for
amphetamines as specified in Section
3.4. One commenter believed three

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separate initial test kits may be required.
Six commenters believed that one initial
test kit could be used to screen for
amphetamine, methamphetamine, and
their analogs. For the most part, the
commenters provided justifications for
their comments. The Department has
evaluated the comments and has
concluded that using either a single
initial test kit or multiple initial test kits
is acceptable depending on the
specificity and sensitivity that the single
initial test kit has with amphetamine
and methamphetamine and its crossreactivity with
methylenedioxymethamphetamine
(MDMA).
Subpart A—Applicability
The Department has revised Section
1.1 to state that the requirements in
these Guidelines also apply to collectors
and MROs. This revision ensures that
collectors and MROs are notified of the
applicable requirements under these
Guidelines.
In Section 1.5, where terms are
defined, the Department has added
several new definitions for terms that
appear in the Guidelines, and revised
several definitions that needed
clarification even though no comments
were received from the public.
The Department has changed the term
to be defined from ‘‘adulterated’’ to
‘‘adulterated specimen.’’ The meaning
of the term has not changed. Only the
wording has been changed to make the
definition clearer.
Definitions were added for ‘‘alternate
responsible person’’ and ‘‘alternate
responsible technician,’’ the individuals
who are pre-approved by HHS to
assume responsibility for the HHScertified drug testing laboratory or IITF,
respectively, when the responsible
person or responsible technician is
absent for an extended period.
The definition for ‘‘cancelled test’’
was reworded for clarification. The
definition is the same.
The term ‘‘carryover’’ was defined.
Carryover, as used in these Guidelines,
refers to the condition that results when
the test result for one sample has been
affected by a preceding sample during
analysis. For example, if the
concentration of a drug in one sample
is very high and cannot be completely
eliminated from the analytical
instrument before the next sample is
tested, the residual drug in the
analytical instrument contributes to the
concentration of that drug in the next
sample.
The definition for ‘‘certifying
scientist’’ was revised to indicate that a
certifying scientist can report any test
result reported from an HHS-certified

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laboratory. The proposed definition
referred to ‘‘non-negative or invalid
result.’’ Since the term ‘‘non-negative’’
was deleted from these Guidelines, the
definition for certifying scientist needed
to be revised.
The definition for ‘‘certifying
technician’’ was revised to state that a
certifying technician can report on the
chain of custody and scientific
reliability of negative, negative/dilute,
and rejected for testing results. This
revised definition clarifies which types
of results a certifying technician can
report. The proposed definition
incorrectly permitted the certifying
technician to report on the chain of
custody and scientific reliability of only
negative test results.
The term ‘‘confirmatory validity test’’
was changed to ‘‘confirmatory specimen
validity test.’’ The term ‘‘validity test’’
was changed to ‘‘specimen validity test’’
throughout the Guidelines, to be
consistent with current terminology
used by the Department.
The definition for a ‘‘cutoff’’ was
revised to apply to specimen validity
tests, as well as drug tests. The term is
used in both contexts.
The definition for ‘‘dilute specimen’’
was revised to state that the term
applies to a urine specimen with
creatinine and specific gravity values
that are lower than expected but still
physiologically possible. This change
shows that a dilute specimen is different
from a substituted specimen.
The definition for ‘‘failed to
reconfirm’’ was revised to clarify that
the term applies when a second
laboratory tests a split (Bottle B)
specimen and is unable to corroborate
the original test result reported by the
primary laboratory.
The definition for ‘‘follow-up test’’
was removed. The definition for
‘‘follow-up test’’ is provided in Federal
agency drug testing plans and does not
need to be repeated in the Guidelines.
The definition for an ‘‘initial validity
test’’ was changed to ‘‘initial specimen
validity test’’ throughout the Guidelines
to be consistent with current
terminology used by the Department.
The term was also revised to include an
‘‘invalid result’’ because an ‘‘invalid
result’’ requires using an initial
specimen validity test as would an
adulterated, diluted, or substituted test
result.
To avoid confusion, the definitions
for an ‘‘instrumented initial test facility’’
and for a ‘‘laboratory’’ were revised to
show that these are permanent
locations.
The definition for ‘‘invalid result’’
was revised to clarify that this type of
result is reported when the test results

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satisfy the criteria established in Section
3.8. The definition in the draft issuance
did not include all of the criteria
described in Section 3.8.
A definition for ‘‘limit of detection’’
(LOD) has been added to these
Guidelines because the Guidelines
require the laboratory to determine the
LOD for each confirmatory drug test
during assay validation. In addition, to
validate specimen validity tests,
laboratories and IITFs are required to
demonstrate and document appropriate
assay characteristics, which may
include the LOD.
A definition for ‘‘limit of
quantitation’’ (LOQ) has been added to
these Guidelines because the Guidelines
require the laboratory to determine the
LOQ for each confirmatory drug test
during assay validation. In addition, to
validate tests used to determine
specimen validity, laboratories and
IITFs are required to demonstrate and
document appropriate assay
characteristics, which may include the
LOQ. Lastly, laboratories and IITFs are
required to use the established LOQ as
the decision point for adulterants
without a program-specified cutoff.
A definition for a ‘‘lot’’ has been
added to these Guidelines because
throughout the Guidelines there are
requirements to validate or verify the
performance characteristics of various
items (e.g., drug test kits, reagents,
quality control material) and to establish
an expiration date. The term ‘‘lot’’ refers
to the item(s) manufactured from the
same starting materials within a
specified period of time which have
essentially the same performance
characteristics and the same expiration
date.
The definition for a ‘‘negative result’’
was revised to clarify that the specimen
must not only be negative for drugs but
must also be a valid urine specimen.
Since these Guidelines require that
specimen validity tests be conducted on
each specimen, this definition states
that a ‘‘negative result’’ indicates that a
specimen is not only negative for drugs
but also that the specimen validity tests
conducted on the specimen indicate
that the specimen is a valid specimen.
The definition for a ‘‘non-negative’’
result was removed from the list of
definitions and replaced with more
specific reporting terms as follows:
Positive result, substituted specimen,
adulterated specimen, or invalid
specimen result.
The definition for a ‘‘performance
testing (PT) sample’’ was revised to
show that it refers to samples that are
program-generated and sent to a testing
facility. The proposed definition did not
indicate the source of the samples.

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The definition for a ‘‘post-accident
test’’ was removed. The definition for
‘‘post-accident test’’ is provided in
Federal agency drug testing plans and
does not need to be repeated in the
Guidelines.
The definition for a ‘‘pre-employment
test’’ was removed. The definition for
‘‘pre-employment test’’ is provided in
Federal agency drug testing plans and
does not need to be repeated in the
Guidelines.
The definition for a ‘‘quality control
(QC) sample’’ was revised to clarify that
the term refers to calibrators or controls.
The definition for a ‘‘random test’’
was removed. The definition for
‘‘random test’’ is provided in Federal
agency drug testing plans and does not
need to be repeated in the Guidelines.
The definition for a ‘‘reasonable
suspicion/cause test’’ was removed. The
definition for ‘‘reasonable suspicion/
cause test’’ is provided in Federal
agency drug testing plans and does not
need to be repeated in the Guidelines.
The definition for ‘‘reconfirmed’’ was
revised to clarify that the definition
applies to a split specimen (Bottle B)
tested by a second laboratory.
The definition for ‘‘return to duty
test’’ was removed. The definition for
‘‘return to duty test’’ is provided in
Federal agency drug testing plans and
does not need to be repeated in the
Guidelines.
The definition for ‘‘rejected for
testing’’ was revised to clarify that this
result may be reported by an IITF, as
well as a laboratory.
Three commenters noted the terms
‘‘sample’’ and ‘‘specimen’’ were used
interchangeably throughout the
Guidelines and suggested that the
definitions be defined and the text
updated accordingly. The Department
agrees and has revised the definitions
for these terms and has revised the
Guidelines text to consistently use the
terms as they are defined in this section.
‘‘Sample’’ refers to a performance
testing (PT) sample, a quality control
sample, or a representative portion of a
donor specimen. ‘‘Specimen’’ refers to
the donor specimen (i.e., urine provided
by the donor for the drug test).
The term ‘‘split specimen’’ was
replaced by ‘‘split specimen collection.’’
The definition of a ‘‘split specimen
collection’’ states that one urine
specimen of sufficient volume is
collected and then divided into two
separate specimen bottles. A ‘‘split
specimen collection’’ does not permit
collecting two different urine specimens
at two different times that are,
respectively, transferred to a Bottle A
and a Bottle B.

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The definition for ‘‘substituted’’ was
changed to ‘‘substituted specimen’’ and
revised to define this as a specimen
submitted in place of the donor’s urine,
as evidenced by creatinine and specific
gravity values outside physiologically
producible ranges of human urine.
Section 1.6 describes what an agency
is required to do to protect employee
records. The policy in this section is the
same as the policy in the Proposed
Revisions to Mandatory Guidelines. The
Department has included a discussion
on the Health Insurance Portability and
Accountability Act of 1996 (HIPAA).
The Department has included a new
Section 1.7, to clarify refusals to test and
who ultimately determines if the
conditions for verifying them are met
(i.e., the collector, the MRO, the Federal
agency).
Subpart B—Specimens
Section 2.1 states that urine is the
only specimen that can be collected by
a Federal agency under the Guidelines
for its workplace drug testing program
to clarify that Federal agencies are
prohibited from collecting any other
type of specimen.
Section 2.2 describes the
circumstances under which a Federal
agency may collect a specimen. The
Department has included this section to
ensure that the circumstances described
are consistent with the reasons for
collecting a specimen as listed on the
Federal CCF.
Section 2.3 requires each urine
specimen to be collected as a split
specimen. This policy is the same as the
policy described in the Proposed
Revisions to Mandatory Guidelines.
Five commenters opposed the part that
the single urine specimen collection
procedure was being eliminated. The
Department disagrees with the
commenters and has eliminated the
single urine specimen collection
procedure, not because the procedure is
forensically or scientifically
unsupportable, but because the split
specimen procedure ensures that the
donor will have access to a split
specimen that was not opened by the
laboratory testing the primary specimen.
Additionally, there are a number of
Federal employees working for agencies
that have employees subject to both
Federal drug testing guidelines and
Department of Transportation
workplace drug testing regulations.
Requiring the use of a split specimen
collection procedure will ensure that
employees working in these dual
regulation situations are treated the
same.

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Subpart C—Drug and Specimen
Validity Tests
Section 3.1 describes the tests that are
performed on each urine specimen. The
policy in this section applies to each
specimen collected by a Federal agency
regardless of the circumstance for which
it was collected as described in Section
2.2. The Department believes that the
wording of the policy in the current and
Proposed Revisions to Mandatory
Guidelines may be incorrectly
interpreted such that the required tests
only apply to specimens collected from
Federal agency applicants and
specimens collected at random.
However, this is not the case. The
wording in this section has been revised
to state that each specimen collected
will be tested for the same drugs and
specimen validity tests. This section
was also revised to describe the
specimen validity tests that must be
performed on each urine specimen. The
requirements and explanations
described for the specimen validity tests
are the same as those described in the
current and Proposed Revisions to
Mandatory Guidelines.
Section 3.2 provides guidance on how
a Federal agency may test a specimen
for additional drugs. Three commenters
requested additional guidance on how a
Federal agency would request
permission to test for an additional drug
on a case-by-case basis. The Department
believes the policy in Section 3.2(a)
adequately describes how a Federal
agency would request to test a donor’s
specimen for a suspected Schedule I or
Schedule II drug that is not part of the
Federal program.
After further review of Section 3.2(a),
however, the Department recognized
that the Guidelines do not address how
to proceed if the Federal agency is
requesting to test for a Schedule I or II
drug for which an immunoassay test is
not available. The Department thus has
added that when the need to test for an
additional drug occurs and there is no
immunoassay test available, an HHScertified laboratory should be permitted
to test for the drug by testing two
separate aliquots of the specimen using
the same confirmatory drug test. The
confirmatory drug test used by the
laboratory must satisfy the requirements
in Section 11.13, the laboratory must
validate the confirmatory drug test in
accordance with the requirements in
Section 11.14, and must satisfy the
quality control requirements as stated in
Section 11.15. The Department believes
that testing the specimen twice using a
validated confirmatory drug test is
scientifically and forensically
acceptable. Additionally, when a

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specimen is reported as positive,
adulterated, or substituted, the
Department allows the donor to request
that Bottle B be tested at another HHScertified laboratory by the confirmatory
method. The testing of the split
specimen by a second HHS-certified
laboratory to reconfirm the drug
reported positive by the first laboratory
is sufficient to protect the donor’s
interests.
Section 3.3 states that urine
specimens collected for Federal agency
workplace drug testing programs may
only be tested for the purpose of
detecting drug use and to determine the
validity of the specimen unless
otherwise authorized by law. Several
commenters expressed concern over the
possibility that DNA testing could be
conducted on a specimen. The
Department states in Section 3.3(a) that
‘‘Federal agency specimens * * * must
only be tested for drugs and to
determine their validity unless
otherwise authorized by law.’’ The
Department is satisfied that the policy,
as stated, prohibits DNA testing on a
specimen but has removed the phrase
‘‘unless otherwise authorized by law’’
from this section to clarify that Federal
agency specimens must only be tested
for drugs and to determine their
validity.
Section 3.4 lists the drugs and drug
metabolites and the initial and
confirmatory cutoff concentrations used
to test and report urine specimens as
negative or positive for a drug. The
initial and confirmatory cutoff
concentrations are the same as in the
Proposed Revisions to Mandatory
Guidelines, but the tables have been
combined to make it easier for the
readers.
Several commenters suggested
including the scientific rationale used to
support the proposed changes to the
cocaine metabolite (benzoylecgonine)
and amphetamine cutoff concentrations.
Three commenters disagreed with the
proposal to lower the amphetamines
initial test cutoff concentration. Two of
the three commenters were concerned
that the lower cutoff will result in
higher costs and more false initial test
positives due to medications available
over the counter. The third commenter
stated that their laboratory currently has
customers who use the lower
amphetamine cutoff concentration and
have no more confirmed positives than
compared to a 1000 ng/mL initial test
cutoff, but who do have more
unconfirmed specimens.
The Department believes the revised
cutoff concentrations will increase the
window of detection for these drugs,
i.e., the number of hours after a drug is

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ingested by an individual that the
concentration of the drug or drug
metabolite in urine will likely remain
above the cutoff concentration. Lower
cutoff concentrations will increase the
number of urine specimens that are
identified as containing cocaine
metabolites and amphetamines and,
thereby, will increase the deterrent
effect of the program and improve
identification of employees using illicit
substances. Based on results reported by
laboratories in the current urine PT
program, the Department believes that
certified laboratories (and IITFs after
they are certified) will have the ability
to report accurate test results using
these revised cutoff concentrations.
There is no evidence available to the
Department to indicate that lowering
these cutoff concentrations will increase
the possibility that a donor who has not
actually used cocaine or amphetamines
will be identified as a drug user. The
Department also points out that the
individual can always challenge the
result with the MRO.
Several commenters raised questions
regarding the proposed options for HHScertified laboratories and IITFs to
perform an initial test for 6–AM. The
commenters stated that the policy
options were unclear as presented in
Section 3.4, and recommended that
HHS provide additional guidance to
prevent inconsistent treatment of
specimens. The Department has revised
the table and footnotes in Section 3.4 to
clarify that all specimens tested for
opiates must be tested for 6–AM. This
policy allows a laboratory to confirm
and report 6–AM by itself, in contrast to
the current Guidelines policy which
requires 6–AM to be tested and reported
in conjunction with a positive morphine
result. Data from laboratories indicate
that 6–AM is present in specimens even
when the morphine concentration is
below 2000 ng/mL.
Sections 3.5, 3.6, 3.7, and 3.8 describe
the criteria for reporting a urine
specimen as adulterated, substituted,
dilute, and invalid, respectively. Each
section was revised to clarify that only
a certified laboratory may report a
specimen as adulterated, substituted, or
invalid; that only a certified laboratory
may report a specimen as dilute when
creatinine is equal to or less than 5 mg/
dL; and that a laboratory or an IITF may
report a specimen as dilute when
creatinine is greater than 5 mg/dL. For
an adulterated or invalid urine
specimen, one commenter requested the
rationale for changing from the 20 mcg/
mL chromium (VI) [Cr (VI)] initial
validity test cutoff in a previous draft
(several preliminary versions of the
Guidelines were posted on the

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SAMHSA workplace Web site before the
Proposed Revisions to Mandatory
Guidelines were published in the
Federal Register to 50 mcg/mL in these
Guidelines. One commenter
recommended using the 20 mcg/mL Cr
(VI) cutoff instead of 50 mcg/mL and
provided supporting data. Although the
Department agrees with the data
provided, the 50 mcg/mL cutoff is
consistent with the capabilities of
current assays’ sensitivity and
specificity. Additionally, most, but not
all, oxidants are quantified at
concentrations greater than 50 mcg/mL
when they are used as urine adulterants.
Unpublished evaluations of samples
spiked with Cr (VI) have shown that for
Cr (VI) to be effective as an adulterant,
the urine concentration is usually much
greater than 100 mcg/mL. For these
reasons, the Department believes that
the 50 mcg/mL Cr (VI) cutoff is
sufficient to identify adulteration with
Cr (VI) and is appropriate. One
commenter recommended using the
limit of quantitation (LOQ) instead of
the limit of detection (LOD) as the
decision point for adulterant tests
without a program specified cutoff. The
commenter stated that an LOQ ensures
that the adulterant has been both
appropriately identified and quantified.
The Department agrees and has revised
the testing requirements in Sections 3.5
and 3.8 to require that the adulterant’s
concentration be equal to or greater than
the LOQ that was determined by the
HHS-certified laboratory.
The Department has revised Section
3.7 to clarify that a dilute result may
only be reported in conjunction with
either a positive test result or a negative
test result. When a urine specimen is
determined to be adulterated or when
an invalid result is being reported, the
Department does not consider finding a
dilute result for such a specimen as
being correct. It is assumed that an
adulterated or invalid urine specimen
has been tampered with and, if it also
happens to satisfy the dilute criteria, the
dilute result would actually be
meaningless. Additionally, by
definition, when a urine specimen is
reported as substituted it cannot be a
dilute specimen. Therefore, a dilute
result cannot be reported in conjunction
with a substituted result.
Subpart D—Collectors
Section 4.1 describes who may collect
a specimen for a Federal agency. Three
commenters recommended allowing
direct supervisors to routinely collect
specimens for federal agency applicant
tests. The Department disagrees and has
always prohibited an immediate
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routinely acting as a collector, unless no
other collector is available and only
when the supervisor or hiring official is
a trained collector.
Section 4.2 describes who may not
collect a specimen. Seven commenters
were opposed to the policy which
prohibits testing facility employees from
collecting specimens if they could link
the donor’s identity to the test results.
The Department has always prohibited
testing facility (HHS-certified
laboratory) employees from collecting
specimens if they could link the donor’s
identity to the test results and believes
that this policy is appropriate. The
Department revised this section to
prohibit an employee who is in a testing
designated position and subject to the
Federal agency drug testing rules from
serving as a collector for co-workers
who are in the same testing pool or who
work together with that employee on a
daily basis, and to prohibit an
individual from collecting his or her
own urine for a federally regulated drug
test.
Section 4.3 describes the
requirements for an individual to be a
collector for a Federal agency. Seven
commenters disagreed with requiring
collectors to read and understand the
Guidelines and felt this should be
limited to the sections pertaining to the
collection of specimens. The
Department agrees and has revised the
policy in Section 4.3(a) to reflect that a
collector must be knowledgeable of the
collection procedure described in the
Guidelines. Four commenters suggested
that there should be standardized
collector training requirements and
documentation requirements for all
collectors. The Department has revised
Section 4.3 to provide more details on
the requirements for collector training
and the documentation requirements.
The Department believes the
requirements as described in this
section are sufficient and appropriate to
ensure that the collector can properly
collect a specimen and correctly
complete the Federal Drug Testing
Custody and Control Form (Federal
CCF).
Several commenters believe it is not
sufficient to allow the agency to select
the observer if there is no collector of
the same gender available, as stated in
the Proposed Revisions to Mandatory
Guidelines. To address this concern, the
Department has included a new Section
4.4 that specifies training requirements
for an individual to serve as an observer
for a direct observed collection (as
described in Section 8.9). The training
requirements are designed to ensure that
any individual serving as an observer
has been trained in procedures for a

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direct observed collection, although he
or she may not be a trained collector.
Other training elements are included to
ensure that the observer interacts with
the donor in a professional manner,
respecting the donor’s modesty and
privacy, and that he or she maintains
the confidentiality of collection
information. The Department also
revised this section to allow the
collector or collection site supervisor to
select the observer.
Section 4.5 describes the
requirements for an individual to be a
trainer for collectors. Three commenters
noted that the Guidelines did not
address approval and monitoring of the
‘‘train the trainer’’ courses. Currently
there are organizations (e.g.,
manufacturers, private entities,
contractors, Federal agencies) that offer
‘‘train the trainer’’ courses. The
Department does not believe that it is
necessary or appropriate to approve the
content of the ‘‘train the trainer’’
courses. If a trainer does not properly
train individuals to be collectors,
collector errors will result as the
Guidelines are enforced and will
demonstrate the need to retrain those
trainers.
Section 4.6 describes what a Federal
agency must do before an individual is
permitted to collect specimens. Five
commenters disagreed with the
requirement for an organization that
manages/employs collectors to retain
the collector training documents, saying
this would be burdensome. The
commenters recommend that collectors
be responsible for their own
documentation. The Department agrees
that many collectors currently retain
their training records and has revised
the policy to indicate that a collector
(who may be self-employed) or
organization (e.g., collector training
company, third party administrator,
Federal agency that employs its own
collectors) must maintain a copy of the
record that documents his or her
training. The Department has also
revised the question to require the
Federal agency to ensure that the
requirements of this section are satisfied
before a collector is permitted to collect
specimens rather than placing the
burden on an organization to satisfy the
requirements. The Federal agency is
always responsible for ensuring that a
collector is properly trained.
Subpart E—Collection Sites
Section 5.1 describes a collection site
as a permanent or temporary facility.
The requirement for a collection site to
have provisions for donor privacy
during the collection procedure has
been moved from Section 5.1 to Section

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5.2, which describes the specific
requirements for a facility that is being
used as a collection site.
Two commenters recommended
including additional criteria in Section
5.2 for a collection site to have a secure
working area and donor privacy. The
Department agrees and is requiring the
collection site in Section 5.2(a) to have
provisions to ensure donor privacy.
Privacy requirements are set forth in
Section 8.1. In addition, Section 5.2(b)
has been revised to reflect the need for
a suitable clean working area that is not
accessible to the donor. The Department
believes the clean working area must
not be accessible to the donor because,
if given an opportunity, a donor may
attempt to tamper with records,
documents, or supplies. The
Department also added Section 5.2(g) to
require facilities to have the ability to
limit donor access to potential
contaminants, adulterants, or diluents.
Section 5.3 describes how long
records must be stored by collection
sites. The record storage requirements in
this section are the same as those
described in the Proposed Revisions to
Mandatory Guidelines. The Department
revised the section to specify the
records that must be retained.
Subpart F—Federal Drug Testing
Custody and Control Forms
Section 6.1 states that an OMBapproved Federal CCF must be used to
document the collection of a urine
specimen. The requirement in this
section is the same as the requirement
described in the Proposed Revisions to
Mandatory Guidelines.
Section 6.2 describes what happens if
the correct Federal CCF is not available
or is not used. The Department
recognizes that occasionally a current
Federal CCF will not be available or a
non-Federal form or expired Federal
CCF will be used by mistake. The
Department does not want this
discrepancy to cause a laboratory or
IITF to automatically reject the
specimen for testing, or cause an MRO
to automatically cancel the test. If the
collector discovers the error before the
specimen is packaged for shipment to a
laboratory or IITF, the collector must
note on the form that the specimen is a
Federal agency specimen and give the
reason for using the incorrect form.
When this information is provided on
the form, the laboratory or IITF simply
proceeds with testing the specimen as a
Federal agency specimen. If the
laboratory, IITF, or MRO discovers that
an incorrect form was used and there is
no explanation given, the laboratory,
IITF, or MRO must attempt to obtain a
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the collector explaining why an
incorrect form was used. If a MFR
cannot be obtained from the collector,
the laboratory or IITF must report a
rejected for testing result (i.e., when
they discovered the error) and the MRO
reports a cancelled test result.
Subpart G—Specimen Collection
Containers
Section 7.1 describes the items to be
used to collect a urine specimen. The
Department added volume requirements
for specimen containers to this section
to ensure that the containers used
would be of a sufficient size to hold the
required amount of urine for primary
and split specimens.
Section 7.2 describes the requirement
that the collection items used must not
affect the specimen collected. The
requirement in this section is the same
as the requirement described in the
Proposed Revisions to Mandatory
Guidelines. However, the proposed
statements regarding FDA clearance for
these collection items has been
removed. FDA has regulatory oversight
of a collection item as a ‘‘device’’ within
the meaning of Section 201(h) of the
Federal Food, Drug, and Cosmetic Act
(the FFDCA) (21 U.S.C. 321(h)), and a
manufacturer must comply with all
statutory and regulatory requirements
for these devices.
Subpart H—Specimen Collection
Procedure
Section 8 establishes the procedures
for collection of a urine specimen. The
Department revised and reorganized the
urine collection procedures in the
Proposed Revisions to Mandatory
Guidelines for clarity and to address
issues raised as described below.
Section 8.1 states the privacy
requirements for specimen collections.
The procedure used to collect a urine
specimen must ensure that a donor is
given a sufficient amount of privacy
under normal circumstances. That is, a
donor is allowed to provide a urine
specimen in the privacy of a restroom or
an enclosed stall. Four commenters
raised concerns with the privacy
requirements that should be given a
donor. The Department evaluated these
comments and believes that it is more
appropriate to address the privacy
requirements in subpart H (which
addresses the collection procedure)
rather than discussing the privacy
requirements in subpart E (which
specifies the requirements for a
collection site). Section 8.1(a) addresses
the comments submitted by stating who
may be present during a collection
procedure. Section 8.1(b) states that the
collector may be a different gender than

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the donor, but the observer of a direct
observed collection procedure must be
the same gender, and a monitor for a
monitored collection must be the same
gender unless the monitor is a medical
professional. Section 8.1(c) clarifies that
the privacy given to a donor is visual
privacy because there may be situations
where it is not possible to prevent the
collector from hearing sounds in the
enclosure where the donor is providing
the specimen.
Section 8.2 describes what a collector
must do before starting a specimen
collection procedure. One commenter
noted that the proposed requirement to
have ‘‘no other source of water (e.g., no
shower or sink) in the enclosure where
urination occurs’’ may not address
temporary collection sites. The
commenter recommended that the
procedure be revised to state that the
collector must disable or secure other
sources of water in the restroom before
starting the collection procedure. One
commenter noted that many public
restrooms are equipped with toilets that
have sensors for automatic flushing. The
Department agrees and has revised this
section to read ‘‘There must be no other
source of water (e.g., no shower or sink)
in the enclosure where urination occurs
that is not secured during the
collection.’’ If the enclosure used by the
donor to provide a specimen has a sink
or other source of water besides the
toilet that cannot be disabled or secured,
the collector must perform a monitored
collection in accordance with Section
8.11. The monitor will listen for any
sounds that may suggest possible
attempts by the donor to tamper with
the specimen.
Section 8.3 describes the preliminary
steps in the collection process. Four
commenters recommended that the
Guidelines describe the type of
identification the collector provides to
the donor. The Department has revised
Section 8.3(c) and included some
examples of the type of identification
that may be provided (e.g., driver’s
license, employee badge issued by the
employer, any other picture
identification issued by a Federal, State,
or local government agency). Two
commenters suggested that the collector
must point out to the donor, but not
require the donor to read, the collection
procedure instructions on the back of
the Federal CCF. The Department agrees
with the comment and has revised
Section 8.3(f) to direct the collector only
to inform the donor where the donor
can find the instructions for the
collection on the back of the Federal
CCF. The collector will allow the donor
to read the procedure if the donor
prefers. One commenter suggested that

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the donor be given the collector’s full
name, name of the collector’s
supervisor, name of the company
conducting the test, and the MRO’s
name, telephone, and address. The
Department agrees with this comment.
With the exception of the name of the
collector’s supervisor, the rest of the
commenter’s request for information is
recorded on the donor’s copy of the
Federal CCF. If some of the information
is missing on the Federal CCF, it is the
responsibility of the collector to obtain
the information and to complete the
Federal CCF in accordance with the
instructions for the use of the Federal
CCF for Federal agency workplace drug
testing programs.
Section 8.4 describes the steps that
the collector takes in the collection
process before the donor provides a
urine specimen. The steps are the same
as in the Proposed Revisions to
Mandatory Guidelines, but include
additional detail.
Section 8.5 specifically addresses the
situation where a donor states that he or
she is unable to provide a urine
specimen. Over 50 commenters
expressed concern with the
Department’s urine collection policy.
They stated that some individuals have
what the commenters refer to as a ‘‘shy
bladder.’’ The commenters noted that
these individuals may be physically
unable to provide a urine specimen
upon demand, and forcing them to
drink fluids creates a great deal of stress
and may not change their ability to
provide a specimen. The commenters
were concerned with how a collector
interacts with a donor who is unable to
provide a sufficient amount of urine to
perform a drug test. The Department’s
urine collection policy was designed to
prevent an individual from intentionally
circumventing the requirement to
provide a urine specimen during a
required collection. The policy is not
intended to cause harm to anyone who
has a condition that prevents them from
providing a urine specimen when
requested. The Department has always
expected a collector to treat the donor
with respect when the donor is unable
to provide a specimen within a
reasonable period of time (3 hours is
considered reasonable). To address the
concern, however, the Department has
revised the urine specimen collection
procedure. If the donor states that he or
she cannot provide a specimen, the
collector requests the donor to go into
the restroom (stall) and attempt to
provide a specimen. This attempt
demonstrates the donor’s inability to
provide a specimen when the donor
comes out of the stall with an empty
collection container. At that time, if the

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donor states that he or she could
provide a specimen after drinking some
fluids, the collector allows the donor to
drink some liquid (as stated in Section
8.5(b)(1)) and continues with the
collection procedure. If the donor states
that he or she simply needs more time,
without a need to drink fluids, before
attempting to provide a urine specimen,
the collector gives the donor up to 3
hours to provide a urine specimen. If
the donor states that he or she is unable
to provide a urine specimen even after
3 hours, the collector records the reason
for not collecting a urine specimen on
the Federal CCF, notifies the Federal
agency’s designated representative, and
sends the Federal CCF to the MRO and
the Federal agency for further
evaluation of the donor. The
requirement for the further evaluation of
the donor by an MRO will prevent
individuals from being falsely accused
of a refusal to test.
Sections 8.5(b)(1) and 8.6(e)(2)
describe the amount of fluid that a
donor may be given at the collection site
in order to collect a sufficient amount of
urine. The reason why a limit is
imposed at all is the concern for the
welfare of the donor, as well as the
concern that the urine specimen may
become diluted. Several commenters
expressed concern with the amount of
fluids given to a donor at the collection
site. The Proposed Revisions to
Mandatory Guidelines instruction to the
collector to give the donor a reasonable
amount of liquid to drink is flexible in
the amount given (note that the
parenthetical in the Guidelines is stated
as an example, not as a requirement).
However, in response to the comment,
the Department has changed the
example in the Proposed Revisions to
Mandatory Guidelines (‘‘an 8 ounce
glass of water every 30 minutes, but not
to exceed a maximum of 24 ounces’’) to
read ‘‘an 8 ounce glass of water every 30
minutes, but not to exceed a maximum
of 40 ounces over a period of 3 hours
or until the donor has provided a
sufficient urine specimen.’’ This change
retains the flexibility that has always
existed in the Federal program and sets
a reasonable time limit within which
most donors would be able to provide
an acceptable amount of urine.
Although the Department has changed
the guidance on the amount of fluid
given the donor, the Department does
not require anyone to drink more fluid
than he or she could comfortably drink.
A statement has also been added to
these sections to clearly state that the
donor is not required to drink any fluids
during this waiting time. The
Department believes that most

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individuals who are unable to provide
a sufficient specimen simply need some
additional time to provide the required
specimen without having a need to
drink fluids.
Section 8.6 describes the steps that
the collector takes in the collection
process after the donor provides a urine
specimen. One commenter
recommended that the collector be
instructed to inspect the stall for signs
of tampering before the donor is
permitted to flush the toilet. While this
practice is acceptable, the Department
has not included this detail in the
Guidelines. Sections 8.2 and 8.3 include
pre-collection procedures to prevent or
detect specimen tampering.
Furthermore, Section 8.4(b) instructs the
collector to perform a recollection under
direct observation if the donor’s conduct
indicates a possible attempt to
adulterate or substitute the specimen.
Section 8.6 also includes procedures
for the collector to measure the
specimen temperature, visually inspect
the specimen, and determine the
specimen volume. Three commenters
recommended deleting the proposed
requirements for a collector to send a
Bottle A specimen to the testing facility
when there is an insufficient volume of
urine collected for the split (Bottle B)
specimen as required because this
contradicted the proposed policy that a
failure to provide 30 mL of urine for the
second specimen collection prompts the
collector to obtain guidance on the
action to be taken. The Department
agrees and has revised the collection
procedures to stop the collection when
the donor does not provide at least 45
mL, the amount required for a split
specimen collection, after two attempts.
When this occurs, the collector notifies
the Federal agency’s designated
representative immediately, and notes
on the Federal CCF the donor’s failure
to provide sufficient urine. The Federal
CCF is sent to the Federal agency and
the MRO. Subsequent actions by the
MRO are described in Sections 13.5 and
13.6.
Section 8.8 is a new section that
combines the reasons that appear in
different sections of the current
Guidelines regarding when a direct
observed collection is used. The reasons
are the same; they have simply been
combined in one section. Section 8.8(c)
requires the collector to notify a
collection site supervisor to review and
concur with the collector’s decision to
perform a direct observed collection
procedure. Three commenters disagreed
with this policy. One commenter
recommended requiring an agency
representative in addition to the
supervisor to review and concur with

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the decision. The Department believes
obtaining permission from a supervisor
is necessary when a decision is needed
to conduct a direct observed collection.
The concurrence from a supervisor will
ensure that the collector is justified in
using a direct observed collection
procedure. The Department also
included in this section the actions a
collector must take when the donor
refuses to provide a specimen under
direct observation.
Section 8.9 is a new section that
describes how a direct observed
collection procedure is conducted. The
Proposed Revisions to Mandatory
Guidelines discussed when a direct
observed collection procedure is
permitted, but did not provide guidance
on how it is to be conducted. The
Department has included additional
information regarding direct observed
collections. This information has been
available from the Department and has
been used since the beginning of the
Federal drug testing program. The
Department believes that the procedure
will ensure that all direct observed
collection procedures are conducted the
same way regardless of the reason for
using the direct observed procedure. In
response to submitted comments, in
addition to requiring the observer to be
the same gender as the donor, the
Department has specified in Section 8.9
that individuals must be trained in
direct observed collection procedures in
order to serve as an observer. Training
requirements are included in a new
Section 4.4. The Department included
two new sections, Sections 8.9 and 8.10,
to address when and how monitored
collections are performed.
Section 8.12 establishes how the
collector reports a donor’s refusal to
test. The Proposed Revisions to
Mandatory Guidelines discussed what
constituted a refusal to test during the
collection process, but did not provide
guidance to the collector on how to
report a refusal to test. Additional
information regarding urine collection is
available from the Department. In
addition, the Department included an
instruction for the collector to discard
any urine collected when a refusal to
test occurred during the collection
process.
Section 8.13 establishes the
responsibilities for Federal agencies
regarding collection sites. Many
commenters disagreed with requiring
Federal agencies to inspect all of their
collection sites. The commenters believe
this requirement to inspect the
hundreds of collection sites would be
cost-prohibitive and logistically
impossible, and there does not seem to
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common enough to justify such an
inspection program. Other commenters
suggested that, in lieu of annual
inspections of all collection sites, HHS
require agencies to inspect only
collection sites which have generated
‘‘fatal flaws.’’ The Department agrees
that requiring Federal agencies to
investigate and possibly inspect
collection sites with ‘‘rejected for
testing’’ errors ensures that collectors
will receive appropriate training to
prevent the recurrence of such errors.
However, the Department maintains that
random inspections are important to
identify any collection procedure
problems that may exist, but are not
readily evident from the Federal CCF
because the forms appear to be properly
completed by the collector. The
Department has revised the inspection
requirements in this section
accordingly. Federal agencies must
inspect only 5 percent of the current
number of collection sites, or up to a
maximum of 50, selected randomly, of
their collection sites each year.
Additionally, Federal agencies are
required to investigate reported
collection site deficiencies (e.g.,
‘‘rejected for testing’’ by either an HHScertified laboratory or HHS-certified
IITF) and take appropriate action which
may include inspecting the collection
site. The number of collection sites
inspected because they have had
‘‘rejected for testing’’ results are not
included in the 5 percent or maximum
of 50 requirement.
Subpart I—HHS Certification of
Laboratories and IITFs
The proposed section describing the
goals and objectives of certifying
laboratories and IITFs was removed
from the Guidelines. Four commenters
suggested that the discussion should be
in the preamble rather than in the
Guidelines. The Department agrees that
the discussion in this section does not
establish any specific analytical
requirements and was removed from
these Guidelines.
Section 9.1 (Section 9.2 in the
Proposed Revisions to Mandatory
Guidelines) states that the Secretary has
the authority to certify laboratories.
Four commenters disagreed with the
right of the Secretary to review private
sector specimen results tested under the
Guidelines. The Department
understands the concerns expressed by
the commenters; however, the review of
private sector specimen or nonregulated specimen results, only occurs
for those private sector specimens that
are tested in batches that contain
federally-regulated specimens. This
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batches because laboratories assemble
these batches by taking the initial test
positive specimens from different initial
test batches to make the confirmatory
test cost effective and efficient.
Therefore, the policy described in this
section is the same policy as described
in the Proposed Revisions to Mandatory
Guidelines.
Section 9.2 (Section 9.3 of the
Proposed Revisions to Mandatory
Guidelines) describes the application
process for a laboratory or IITF,
procedures for maintaining certification,
and what a laboratory or IITF must do
when its certification is not maintained.
In the Proposed Revisions to Mandatory
Guidelines, the term ‘‘imminent harm’’
is used as a reason to require a
laboratory to immediately stop testing
Federal agency specimens. Three
commenters objected to using the term
‘‘imminent harm’’ because they believe
the term limits the Department’s ability
to suspend a laboratory or IITF.
Although the Department has
successfully suspended a number of
laboratories using ‘‘imminent harm’’ as
the basis for an immediate suspension,
the term has been removed from these
Guidelines. The reasons for taking
action against a laboratory or IITF are
more appropriately discussed in
Sections 9.12, 9.13, and 9.14. The
Department has revised Section 9.2(c) to
clarify the requirements when a
laboratory or IITF does not maintain its
HHS certification.
Section 9.3 (Section 9.5 of the
Proposed Revisions to Mandatory
Guidelines) describes the composition
requirements for the PT samples that are
used to challenge a laboratory or IITF’s
drug and specimen validity tests. The
requirements in this section are the
same as those contained in the current
Guidelines, except for the pH
specifications in Section 9.3(b)(2). These
specifications were revised to challenge
the pH tests used by IITFs, as described
in Section 12.14(c)(1), as well as
laboratory pH screening tests with a
narrow dynamic range, as described in
Section 11.18(c)(1).
Section 9.4 (Section 9.9 of the
Proposed Revisions to Mandatory
Guidelines) describes the requirements
that an applicant laboratory must satisfy
when testing the 3 consecutive sets of
PT samples sent to the laboratory during
the initial certification process. Section
9.5 (Section 9.13 of the Proposed
Revisions to Mandatory Guidelines)
describes the requirements that a
certified laboratory must satisfy when
testing the quarterly sets of PT samples
sent to the laboratory as part of the
maintenance PT program. In both
sections, the requirements are the same

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as in the current Guidelines with two
exceptions concerning the evaluation of
specific gravity results. The Department
has retained the acceptable range of no
more than ±0.0003 specific gravity units
from the mean for PT samples with a
mean less than 1.0100, but has
increased the acceptable range to
±0.0004 specific gravity units when a PT
sample’s mean is equal to or greater
than 1.0100. The Department has
retained the limit of ±0.0006 specific
gravity units from the mean for
assessing errors for PT samples with a
mean less than 1.0100, but has
increased the limit to ±0.0007 specific
gravity units when the PT sample’s
mean is equal to or greater than 1.0100.
The Department has been evaluating the
performance of the instruments used to
measure specific gravity to 4 decimal
places and believes increasing the
precision limits for high specific gravity
readings is reasonable and appropriate
due to the nature of the refractive index
and calibration methods using oil to
calibrate the instruments.
Section 9.6 (Section 9.17 of the
Proposed Revisions to Mandatory
Guidelines) describes the PT
requirements an applicant IITF must
satisfy to conduct urine testing and
Section 9.7 (Section 9.21 of the
Proposed Revisions to Mandatory
Guidelines) describes the PT
requirements that an HHS-certified IITF
must satisfy to conduct urine testing.
Both sections were revised to be
consistent with PT challenges for the
initial testing part of a laboratory (i.e.,
requirements addressing confirmatory
test challenges were deleted). One
commenter noted the requirement to
correctly identify and report the total
drug challenges over 3 sets of PT
samples was 80 percent for applicant
and certified IITFs, while it is 90
percent for applicant and certified
laboratories. The commenter
recommended that the requirement be
the same for IITFs and laboratories. The
Department agrees and has revised the
requirement in Section 9.6(a)(1) to be 90
percent for applicant IITFs for initial
testing.
Section 9.8 (Section 9.22 of the
Proposed Revisions to Mandatory
Guidelines) describes the inspection
requirements for an applicant laboratory
or IITF and Section 9.9 (Section 9.23 of
the Proposed Revisions to Mandatory
Guidelines) describes the inspection
requirements for an HHS-certified
laboratory or IITF. The Proposed
Revisions to Mandatory Guidelines
required using at least two inspectors to
inspect an applicant laboratory or IITF.
Three commenters expressed concern
with requiring at least two inspectors to

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inspect an applicant laboratory or IITF,
while the Proposed Revisions to
Mandatory Guidelines permit only one
inspector to potentially be used to
inspect an HHS-certified laboratory or
IITF. The Department has revised
Section 9.8 to require two inspectors
rather than the proposed ‘‘at least two
inspectors.’’ The Department believes
that the inspection of an applicant
laboratory or IITF must be conducted
using two inspectors because this
minimizes the possibility of a laboratory
or IITF disputing the findings of one
inspector as opposed to the findings
from two inspectors. With regard to
HHS-certified laboratories and IITFs, the
Department retained the Proposed
Revisions to Mandatory Guidelines
requirement which states that an HHScertified laboratory or IITF ‘‘is inspected
by one or more inspectors.’’ The
Department believes that one inspector
is appropriate to inspect an HHScertified laboratory or IITF when the
facility is very small, has an extremely
small workload, and has a history of
acceptable performance on testing the
PT samples and on previous
inspections. The Department believes
that using one inspector is sufficient to
conduct a thorough inspection and
makes it cost-effective for very small
HHS-certified laboratories and IITFs to
remain in the certification program.
Section 9.10 specifies the criteria an
individual must satisfy to be eligible for
selection as an inspector for the
Secretary under these Guidelines. This
section also states that the Secretary of
a Federal Agency may inspect an HHScertified laboratory or IITF at any time.
The requirements in this section are the
same as in Section 9.24 of the Proposed
Revisions to Mandatory Guidelines, but
the section has been reworded for
clarity.
Section 9.11 describes what happens
when an applicant laboratory or IITF
fails to satisfy the minimum
requirements for either the PT program
or the inspection program. The
Department believes that an applicant
laboratory or IITF must successfully
satisfy all of the initial certification
process requirements or be required to
begin the process from the very
beginning. That is, submit a new
application with corrective actions
indicated and then successfully satisfy
the requirements for the 3 sets of PT
samples. These requirements are the
same as in the Proposed Revisions to
Mandatory Guidelines, Section 9.25.
Section 9.12 describes what happens
when a certified laboratory or IITF does
not satisfy the minimum requirements
for either the PT program or the
inspection program. The policy in this

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section is the same as that contained in
the current and Proposed Revisions to
Mandatory Guidelines in Section 9.26.
Section 9.13 describes the factors that
are considered when determining
whether to revoke a laboratory’s or
IITF’s certification. The factors
described are the same as those
contained in the current and Proposed
Revisions to Mandatory Guidelines in
Section 9.27.
Section 9.14 states that the Secretary
may suspend a laboratory’s or IITF’s
certification to protect the interests of
the United States. This policy is the
same as that contained in the current
and Proposed Revisions to Mandatory
Guidelines in Section 9.28.
Section 9.15 describes how the
Secretary notifies a laboratory or IITF
that action is being taken against the
laboratory or IITF. The policy in this
section is the same as the policy
described in the current and Proposed
Revisions to Mandatory Guidelines in
Section 9.29.
Section 9.16 describes how a
laboratory that has had its certification
revoked can apply for recertification.
The policy is the same policy as
described in the current and Proposed
Revisions to Mandatory Guidelines in
Section 9.30.
Section 9.17 states that the list of
HHS-certified laboratories and IITFs
will be published monthly in the
Federal Register. This policy is the
same policy as described in the current
and Proposed Revisions to Mandatory
Guidelines in Section 9.31.
Subpart J—Blind Samples Submitted by
an Agency
Section 10.1 describes the
requirements for Federal agencies to
submit blind samples to certified
laboratories or IITFs. Four commenters
expressed concern that the proposed
requirement to submit only 1 percent
blind samples was too low. The
Department agrees and has revised
Section 10.1(b) to require each agency to
submit 3 percent blind samples each
year rather than having one requirement
for the first 90 days (3 percent) and a
different requirement after 90 days (1
percent). The Department also notes that
the HHS-certified laboratories and IITFs
will also be evaluated using quarterly
PT samples and will be receiving the 3
percent blind samples from several
agencies to ensure that they are properly
handling and testing donor specimens.
The policy in Section 10.1(c) describing
the percentage of negative, positive, and
adulterated or substituted blind samples
to be submitted was revised. The
proposed 80 percent negative blind
samples was changed to 75 percent

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negative blind samples, and 20 percent
non-negative was changed to 15 percent
positive and 10 percent adulterated or
substituted.
Section 10.2 describes the specific
requirements for each blind sample and
the requirements are the same as those
contained in the current and Proposed
Revisions to Mandatory Guidelines.
Section 10.3 describes how a collector
submits a blind sample to be tested. The
requirements in this section are the
same as those in the Proposed Revisions
to Mandatory Guidelines. Section 10.4
describes what happens when an
inconsistent result is reported on a blind
sample. The requirements in this
section are the same as those in the
Proposed Revisions to Mandatory
Guidelines.

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Subpart K—Laboratory
Section 11.1 requires each certified
laboratory to have a standard operating
procedure manual and describes what
information must be contained in the
manual. The requirements in this
section are the same as those in the
current and Proposed Revisions to
Mandatory Guidelines.
Section 11.2 describes the
responsibilities of the individual who
has responsibility for the day-to-day
management of the urine drug testing
laboratory. This individual is called the
responsible person (RP). The
responsibilities described in this section
are the same as those described in the
current and Proposed Revisions to
Mandatory Guidelines, except the
requirement that the RP qualify as a
certifying scientist was moved to
Section 11.3(e). The Department
believes the requirement that the RP
qualify as a certifying scientist is more
appropriately included as a
qualification rather than a
responsibility.
Section 11.3 describes the scientific
qualifications that an individual must
have to serve as an RP. Three
commenters believe the requirement for
an RP to have experience with the
collection and analysis of biological
specimens is too general. The
Department believes the qualification as
stated in Section 11.3(b) is appropriate
and does not need to specifically focus
on collecting urine specimens. The
primary purpose for this qualification is
that the RP has experience and
knowledge of the general procedures
and issues that may arise with the
collection and analysis of biological
specimens (e.g., chain of custody,
storage, handling, troubleshooting
problems). The qualifications described
in this section are the same as those

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described in the current and Proposed
Revisions to Mandatory Guidelines.
Section 11.4 describes what happens
when an RP is absent or leaves a
certified laboratory. This section has
been revised to require a laboratory to
have multiple RPs or one RP and an
alternate RP. The requirement in the
Proposed Revisions to Mandatory
Guidelines did not make it clear that the
laboratory must have an alternate RP
when there is only one RP. The
Department believes this requirement
and establishing time limits for the
alternate RP to assume RP duties when
an RP is absent from a laboratory will
minimize the impact on the laboratory,
and enable the laboratory’s continued
compliance with the Guidelines when
the RP is absent. The Department has
revised Section 11.4(c) to state that an
alternate RP must be found acceptable
during an on-site inspection of the
laboratory. This requirement ensures
that the alternate RP is pre-approved.
The Department believes an individual
must be pre-approved as an alternate RP
to ensure that someone with the
appropriate knowledge and
qualifications can assume RP
responsibilities when the RP is absent
from the laboratory.
Section 11.5 describes the
qualifications an individual must have
to certify a result reported by an HHScertified laboratory. An individual who
certifies results may be either a
certifying scientist (CS) or a certifying
technician (CT) depending on the type
of test result he or she is certifying. The
Department has decided to retain the
bachelor’s degree or equivalent
requirement for the certifying scientist
qualifications as described in the
current Guidelines. The Department
believes the training and experience
specified in the Proposed Revisions to
Mandatory Guidelines for a CT are
sufficient to ensure that the CT can
properly certify a negative, negative/
dilute, or rejected for testing result. One
commenter stated that the qualifications
for a CT in an HHS-certified laboratory
were not consistent with the
qualifications for a CT in an HHScertified IITF as described in the
Proposed Revisions to Mandatory
Guidelines. The same requirements are
specified for a CT in the laboratory and
IITF sections (i.e., Sections 11.5(b) and
12.5, respectively). The Department has
further clarified that qualifications for a
CT are the same in a laboratory and in
an IITF by revising the definition for a
certifying technician in Section 1.5. The
revised definition states that a CT can
verify negative, negative/dilute, and
rejected for testing results reported by a
laboratory or IITF.

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Section 11.6 describes the
qualifications and training other
laboratory personnel must have. The
policy in this section is the same as the
policy described in the current and
Proposed Revisions to Mandatory
Guidelines, except that the current and
Proposed Revisions to Mandatory
Guidelines do not specifically state that
the training must be documented.
Section 11.7 describes the security
measures that a certified laboratory
must maintain. This section has been
revised to require the authorized escort
to enter his or her name in the record
used to document the entry of
authorized visitors. The current and
Proposed Revisions to Mandatory
Guidelines did not require such
documentation.
Section 11.8 describes internal
laboratory chain of custody
requirements. The policy in this section
is the same as the policy in the
Proposed Revisions to Mandatory
Guidelines.
Section 11.9 describes the tests an
HHS-certified laboratory must conduct
on a specimen received from an IITF.
Three commenters expressed concern
with requiring an HHS-certified
laboratory to conduct only the
confirmatory test(s) on specimens
received from an HHS-certified IITF.
The commenters recommended that an
HHS-certified laboratory test all
specimens received from an HHScertified IITF as if the specimens had
not been previously tested. The
commenters believe it is important that
all analytical results supporting a
positive, adulterated, substituted, or
invalid result should be generated
within the same facility. The
Department agrees and has revised this
section to require an HHS-certified
laboratory to test each specimen
received from an HHS-certified IITF in
the same manner as if it had not been
previously tested. This revision ensures
that the final analytical results (both the
initial and confirmatory data) and
internal chain of custody documents are
generated by one HHS-certified
laboratory and can be properly reviewed
and certified before the test result is
released.
Section 11.10 describes the
requirements for an initial drug test.
One commenter stated that paragraph
(c) of the Proposed Revisions to
Mandatory Guidelines did not clearly
state that the initial drug test kits must
be ‘‘FDA-cleared.’’ The Department
agrees and clarified that drug tests must
be approved, cleared, or otherwise
recognized by FDA as accurate and
reliable for the testing of a specimen for
identifying drugs of abuse or their

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metabolites. Therefore, it is more
appropriate to refer to ‘‘FDA
requirements’’ rather than limit the
language to ‘‘FDA-cleared.’’ We note
that only those test kits subject to FDA
premarket notification requirements
must be ‘‘FDA-cleared.’’ One commenter
believes that the purpose for conducting
a second initial test was not clearly
stated in paragraph (d). The Department
agrees and has revised this paragraph to
indicate that a second initial drug test
may be used when the second initial
drug test has a different specificity than
the first initial drug test. The second
initial test must satisfy the batch quality
control requirements for an initial drug
test.
Section 11.11 describes what a
laboratory must do to validate an initial
drug test before using it to test donor
specimens. One commenter
recommended that the requirements to
validate an initial drug test should be
more stringent. The Department believes
these requirements are appropriate and
that they give an HHS-certified
laboratory the flexibility it needs to
validate the initial drug tests based on
the instruments they are using. The
Department also moved the requirement
from Section 11.13 to document the
effect of carryover to this section,
because it is more appropriate to
evaluate the possibility of carryover
when the initial drug test is validated.
Knowing when and if carryover can
affect donor specimen results allows a
laboratory to determine when corrective
action must be taken to control for
carryover.
Section 11.12 describes the batch
quality control requirements when
conducting initial drug tests. The
requirements in this section are the
same as those described in the current
and Proposed Revisions to Mandatory
Guidelines.
Section 11.13 describes the
requirements for a confirmatory drug
test. Four commenters disagreed with
allowing the use of other
chromatographic separation and mass
spectrometry techniques for the
confirmatory drug tests. They believe
that gas chromatography/mass
spectrometry (GC/MS) has been the gold
standard since the Federal Workplace
Drug Testing Program began and should
be the only accepted confirmatory
method until other methods are proven
to be reliable and scientifically
supportable. The Department disagrees
and believes that other methods, such as
liquid chromatography/mass
spectrometry (LC/MS), LC/MS/MS, and
GC/MS/MS, have been proven to be
reliable to test specimens. While GC/MS
remains the most common confirmatory

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testing technology used in forensic drug
testing laboratories, the Department
does not want to prohibit laboratories
from using technologies that provide
forensically and scientifically
supportable results. The Department
proposed that these additional
technologies be allowed in Federal
workplace drug testing programs only
after a thorough review of extensive
information obtained through technical
working groups consisting of drug
testing and analytical chemistry experts.
No comments were submitted that
justified removal of these technologies
from the proposed Guidelines. Since the
proposed revisions to the Guidelines
were published in April 2004, the use
of these technologies has become even
more widespread and there have been
numerous studies employing these
methods, providing additional data to
demonstrate their forensic and scientific
acceptability. These methods may offer
some benefits over traditional GC/MS
methods. For example, GC and LC
provide a means to separate drugs of
abuse from other compounds found in
urine. The advantage of LC methods is
that they may require less specimen
preparation prior to analysis, thereby
saving time and costs. Likewise MS and
MS/MS methods are highly selective,
reducing the chance that other
substances present in the urine might
interfere with the analysis and prevent
the laboratory from obtaining a valid
result. MS/MS technology provides an
advantage in that it is also more
sensitive than GC/MS. A properly
validated and controlled GC/MS method
is sensitive enough to meet the
requirements of these Guidelines for
forensic urine drug testing. However,
the increased sensitivity provided by
MS/MS can enable laboratories to use
less specimen volume, which may have
implications in some cases (e.g., when
there are multiple drugs present in a
specimen). Furthermore, many
laboratories have implemented
instruments and test methods using
these different chromatographic and/or
mass spectrometric technologies for
forensic applications other than
federally regulated workplace testing.
Therefore, laboratories that are currently
certified or plan to seek certification
under these Guidelines may already
have the experience and capability to
employ these methods in Federal
workplace testing programs or they may
want to add these newer technologies to
their testing protocols.
Section 11.14 describes what a
laboratory must do to validate a
confirmatory drug test before using it to
test donor specimens. The Department

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moved the requirement from Section
11.16 to document the effect of any
carryover to this section, because it is
more appropriate to evaluate the
possibility of carryover when the
confirmatory drug test method is
validated. Knowing when and if
carryover can affect donor specimen
results allows a laboratory to determine
when corrective action must be taken to
control for carryover.
Section 11.15 describes the batch
quality control requirements when
conducting confirmatory drug tests.
Three commenters recommended that
this section be revised to allow using a
multi-point calibration as well as a
single-point calibration for each batch of
specimens when conducting a
confirmatory test. The Department
agrees and has revised Section
11.15(a)(1) to read ‘‘A calibrator with its
drug concentration at the cutoff.’’ This
revision allows multi-point calibration,
while still requiring a cutoff calibrator.
Section 11.16 describes the analytical
and quality control requirements for
conducting specimen validity tests. The
requirements are the same as those
described in the current Guidelines,
except that Section 11.16(b) specifically
refers to the requirements specified in
Section 11.18 rather than simply stating
that appropriate calibrators and controls
must be included. The Department
believes this revision will ensure that
each laboratory will use the same
calibrators and controls when
conducting specimen validity tests.
Section 11.17 is a new section that
describes what a certified laboratory
must do to validate a specimen validity
test. The Department is establishing
these requirements to ensure that
specimen validity tests, like drug tests,
are validated before they are used for
donor specimens. The policy has been
intentionally written as a general
requirement because each type of
specimen validity test has different
performance characteristics.
Section 11.18 describes the
requirements for conducting each type
of specimen validity test on a urine
specimen. One commenter
recommended allowing an HHScertified laboratory to use a three
decimal place refractometer as a
preliminary specific gravity test to
determine if the initial specific gravity
test must be conducted. The Department
agrees and has revised Section
11.18(b)(1) to allow a laboratory to use
a refractometer measuring to at least
three decimal places as a specific
gravity screening test when the
creatinine is greater than 5.0 mg/dL and
less than 20 mg/dL. However,
laboratories must use a four decimal

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place refractometer to measure specific
gravity for specimens when the initial
creatinine test result is equal to or less
than 5.0 mg/dL or when the screening
specific gravity test result using a three
decimal place refractometer is less than
1.002. These criteria were selected for
deciding whether a three or four
decimal refractometer must be used
because the test results are approaching
the criteria for reporting a substituted
specimen which may lead to adverse
personnel action. The Department also
added the quality control requirements
for conducting the specific gravity
screening test. One commenter
recommended that colorimetric specific
gravity assays be permitted for use as
the initial specific gravity test. The
Department disagrees because these
assays lack the required accuracy and
precision to serve as an initial specific
gravity test. One commenter
recommended that pH meters used for
the initial and confirmatory pH tests
should print a paper copy report or be
interfaced with a Laboratory
Information Management System (LIMS)
or computer. The commenter noted that
the Guidelines include this requirement
for refractometers used to conduct the
initial and confirmatory specific gravity
tests, and the same forensic
considerations apply for pH tests. The
Department agrees and has added
Section 11.18(c)(2) specifying that a pH
meter used for the initial and
confirmatory pH tests must report and
display pH to at least one decimal place,
and must be interfaced with a LIMS or
computer, and/or generate a paper copy
of the digital electronic display to
document the numerical values of the
pH test results.
Section 11.19 describes the
requirements for a certified laboratory to
report results to an MRO. One
commenter was opposed to requiring an
HHS-certified laboratory to provide the
concentration of a drug in a specimen at
the time the test result is reported to the
MRO. The Department disagrees and
believes this policy is appropriate
because, in keeping with the paperwork
reduction and elimination acts, it
eliminates the need for the MRO to
generate a request in writing to obtain
the concentrations for positive
specimens. One commenter stated that
reporting a positive and invalid result
on the same specimen is confusing and
recommended that the positive result
and ‘‘the reason for the invalid result’’
be reported, rather than using the term
‘‘invalid result’’ along with the reason
for the invalid result. The Department
recognizes that requiring the laboratory
to report both results to the MRO may

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be confusing; however, the MRO must
discuss both results with the donor. The
invalid result may only have an impact
on the testing of the split specimen if
requested by the donor. One commenter
recommended that specific guidance be
included on the content of any
computer-generated report. The
Department does not believe detailed
guidance is needed, but has revised the
appropriate Section 11.19(o) to state that
the computer-generated report must
contain sufficient information to ensure
that the test result is properly associated
with the Federal CCF that the MRO
received from the collector. The
Department added Section 11.19(g) to
maintain the policy in the current
Guidelines which requires the
laboratory to contact the MRO prior to
reporting specimens meeting certain
‘‘invalid result’’ criteria. This policy is
important to ensure that the laboratory
and the MRO discuss those specimens
for which a positive or adulterated
result could be determined, using
different or additional tests at another
certified laboratory. If additional testing
does not appear to be feasible, the
laboratory reports the invalid result. The
MRO can initiate action immediately
upon receipt of the report, in
accordance with Section 13.4.
Section 11.20 describes how long a
certified laboratory must retain a
specimen. Section 11.20(c) was revised
to require a Federal agency to specify a
period of time rather than ‘‘an
additional period of time’’ when
requesting a laboratory to retain a
specimen beyond the normal one year
specimen storage period. Also, the
statement that a laboratory must
maintain any specimen under legal
challenge for an indefinite period of
time has been deleted. The laboratory
must be instructed by the agency as to
the period of time the specimen under
legal challenge will need to be retained
beyond the normal one year storage
period.
Section 11.21 describes how long a
certified laboratory must retain records.
This section has been revised to specify
the records that the HHS-certified
laboratory must maintain when there is
a legal challenge to the test result for a
particular specimen. The revision
allows a Federal agency to request a
laboratory to maintain a copy of the
documentation package for the
specimen result being challenged for a
specified period of time. The revision
also permits the HHS-certified
laboratory to retain records other than
those included in the documentation
package beyond the 2 year period of
time that records are normally
maintained.

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Section 11.22 describes the statistical
summary report that a certified
laboratory must provide to an agency.
The summary report is the same as the
report described in the current and
Proposed Revisions to Mandatory
Guidelines. Four commenters expressed
concern with requiring an HHS-certified
laboratory to make qualified personnel
available to testify in a proceeding
against a Federal employee. They were
concerned that several individuals may
be required to testify, thereby disrupting
the laboratory’s ability to continue
testing specimens. The Department
agrees and has revised Section 11.22(d)
to require an HHS-certified laboratory to
make only one qualified individual
available to testify. This change is
consistent with what normally happens
in proceedings where laboratory results
are being challenged by a donor.
Section 11.23 describes the
information a laboratory must make
available to a Federal employee. The
Department has revised this section to
require that the curriculum vitae for the
responsible person(s) be included along
with the curriculum vitae for the
certifying scientist that certified the test
result.
Section 11.24 describes the type of
relationship that is prohibited between
a certified laboratory and an MRO.
Three commenters recommended that
this section be revised to include
additional restrictions or requirements
that can be found in other regulated
programs. The Department believes the
requirements are sufficient to ensure
that an MRO would report a potential
problem with an HHS-certified
laboratory to a Federal agency or to the
appropriate regulatory office within
HHS. In addition, the requirements in
this section have been used successfully
by HHS in previous versions of the
Guidelines. The section has been
reworded to clarify the requirements.
Section 11.25 was added, addressing
the type of relationship allowed
between an HHS-certified laboratory
and an IITF. This section was added for
clarity, and is consistent with the
requirements specified in the IITF
sections of the Proposed Revisions to
Mandatory Guidelines.
The Department removed the
requirement that a certified laboratory
must inform its private sector clients
when it uses testing procedures
different from those used for Federal
agency specimens. Although this
requirement has been a program policy
for many years, the Department is
confident that HHS-certified
laboratories would not intentionally
mislead their private sector clients into
believing that regulated procedures

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would be used to test their specimens
when, in fact, less stringent procedures
are being used.
Subpart L—Instrumented Initial Test
Facility (IITF)
Section 12.1 describes what an HHScertified IITF must include in its
standard operating procedure manual.
The requirements in this section are the
same as the requirements described in
the Proposed Revisions to Mandatory
Guidelines, except a 2 year period was
specified for retaining archived SOPs,
consistent with the requirement for
laboratories in Section 11.1.
Section 12.2 describes the
responsibilities of the responsible
technician (RT). The Department moved
the requirement that the RT qualify as
a certifying technician to Section
12.3(e), because this is a qualification
rather than a responsibility. All other
requirements in this section are the
same as the requirements described in
the Proposed Revisions to Mandatory
Guidelines.
Section 12.3 describes the
qualifications that the RT must have.
One commenter recommended that the
qualifications for the RT be the same as
those for an alternate RP working in an
HHS-certified laboratory. The
Department disagrees with the
recommendation because the
qualifications for an alternate RP
include responsibilities and expertise in
technical areas (i.e., confirmatory
testing) that the RT does not need to
know to fulfill the responsibilities as an
RT. However, the requirements are
similar to those of a CS at an HHScertified laboratory in Section 11.5. The
requirement that the RT qualify as a
certifying technician ensures that the RT
can properly review the same results
that a certifying technician reviews and
reports at an HHS-certified laboratory or
IITF.
Section 12.4 describes what happens
when the RT is absent or leaves an HHScertified IITF. The Department has
revised Section 12.4(c) to state that an
alternate RT must be found acceptable
during an on-site inspection of the IITF.
This requirement ensures that the
alternate RT is pre-approved. The
Department believes an individual must
be pre-approved as an alternate RT to
ensure that someone with the
appropriate knowledge and
qualifications can assume RT
responsibilities when the RT is absent
from the IITF.
Section 12.5 describes the
qualifications an individual must have
to certify a result reported by an HHScertified IITF. The requirements in this
section are the same as the requirements

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described in the Proposed Revisions to
Mandatory Guidelines, and are the same
as those for a CT in a laboratory,
specified in Section 11.5(b).
Section 12.6 describes the
qualifications and training other
personnel must have who work in an
IITF. The requirements in this section
are the same as the requirements
described in the Proposed Revisions to
Mandatory Guidelines, except that the
Proposed Revisions to Mandatory
Guidelines did not specifically state that
the training must be documented.
Section 12.7 describes the security
measures that an HHS-certified IITF
must maintain. The Department has
revised this section to require the
authorized escort to enter his or her
name in the record used to document
the entry of authorized visitors. These
requirements are the same as for an
HHS-certified laboratory, as specified in
Section 11.7. The change in this
requirement clarifies that the record
must always indicate all of the
individuals who may have had access to
specimens maintained in secure areas. It
is not any different than requiring any
employee (whether serving as an escort
or not) to document every time he or she
enters or leaves a secured area.
Section 12.8 describes internal IITF
chain of custody requirements. The
requirements in this section are the
same as the requirements described in
the Proposed Revisions to Mandatory
Guidelines.
Section 12.9 describes the
requirements for an initial drug test
used by an HHS-certified IITF. The
Department has added this section to
ensure that the drug tests used by an
HHS-certified IITF satisfy the same
initial drug test requirements as
required for HHS-certified laboratories.
Section 12.10 was added to describe
validation requirements for initial drug
tests in an HHS-certified IITF. The
requirements are the same as for initial
drug tests in an HHS-certified
laboratory.
Section 12.11 describes the batch
quality control requirements for initial
drug tests in an IITF. These are the same
as the requirements in the Proposed
Revisions to Mandatory Guidelines, in
that the requirements are the same as for
an HHS-certified laboratory. For clarity,
this section has been revised to list the
required quality control samples, rather
than referring to the relevant laboratory
section.
A single section, Section 13.14, was
included in the Proposed Revisions to
Mandatory Guidelines to address
specimen validity testing in IITFs,
referring to the relevant laboratory
sections. The Department has expanded

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the information into three sections to
address the requirements in a manner
consistent with the format of Subpart K
for HHS-certified laboratories.
Section 12.12 addresses the IITF
analytical and quality control
requirements for specimen validity
tests, specifying that testing is
performed on a single aliquot. Since
IITFs do not report adulterated,
substituted, or invalid specimens, there
is no need to perform two tests on
separate aliquots, as required in a
laboratory.
Section 12.13 describes the validation
requirements for specimen validity
tests. The requirements in this section
are the same as for an HHS-certified
laboratory.
Section 12.14 describes the
requirements for an HHS-certified IITF
to conduct each specimen validity test.
One commenter recommended that an
HHS-certified IITF be permitted to use
a pH screening test to determine the pH
rather than requiring the use of a pH
meter. The Department agrees and has
specified in this section that an HHScertified IITF may use a pH screening
test to determine if an initial pH validity
test must be performed. The HHScertified IITF will forward specimens
with pH test results outside the
acceptable range to an HHS-certified
laboratory where the laboratory will
conduct the initial pH validity test and,
if needed, the confirmatory pH validity
test. This policy permits an HHScertified IITF to determine pH without
a requirement to have a pH meter
available for conducting the initial pH
test.
Section 12.15 describes the
requirements for an HHS-certified IITF
to report a negative or rejected for
testing result to an MRO. One
commenter recommended that this
section be revised to allow an HHScertified IITF to report a urine specimen
that is negative/dilute to the MRO. The
Proposed Revisions to Mandatory
Guidelines stated that only a negative
result could be reported by an HHScertified IITF to an MRO. The
Department agrees and has revised the
section to permit an HHS-certified IITF
to report negative, negative/dilute
(when creatinine is greater than 5 mg/
dL), and rejected for testing results
directly to the MRO. All other
requirements in this section are the
same as the requirements described in
the Proposed Revisions to Mandatory
Guidelines.
Section 12.16 describes how an HHScertified IITF handles a specimen that
tested as positive, adulterated,
substituted, or invalid at the IITF. The
Department has revised this section by

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removing the proposed requirement for
the HHS-certified IITF to record these
types of results on the OMB-approved
chain of custody form. The Department
revised the Guidelines (Section 11.10) to
require an HHS-certified laboratory to
perform both initial and confirmatory
testing for specimens received for
testing from an IITF.
Section 12.17 describes how long an
HHS-certified IITF must retain a
specimen. The Department added this
section to specifically state that an HHScertified IITF is permitted to discard
specimens that are reported negative,
negative/dilute, or rejected for testing.
This policy is the same as those for an
HHS-certified laboratory.
Section 12.18 describes how long an
HHS-certified IITF must retain records.
The Department has revised Section
12.18(b) to specify the records that the
HHS-certified IITF must maintain when
there is a legal challenge to the test
result for a particular specimen. The
revision requires a Federal agency to
specify the period of time that an IITF
must maintain a copy of the
documentation package (as described in
Section 12.20) for the specimen result
being challenged rather than requiring
an indefinite period of time as stated in
the Proposed Revisions to Mandatory
Guidelines. Section 12.18(c) was added
to permit an HHS-certified IITF to retain
records other than those included in the
documentation package beyond the 2
year period of time that records are
normally maintained.
Section 12.19 describes the statistical
summary report that an HHS-certified
IITF must provide semiannually to an
agency. One commenter noted that this
section must be revised because an
HHS-certified IITF cannot report an
invalid result. The Department agrees
and has revised this section to clarify
that an IITF indicates the number of
specimens that were reported negative,
negative/dilute, and rejected for testing
on the statistical summary report. The
Department also revised the section to
clarify that an IITF indicates the number
of specimens forwarded to an HHScertified laboratory for additional drug
and/or specimen validity testing. Three
commenters raised concern with the
proposed requirement that an HHScertified IITF must make available
qualified personnel to testify in a
proceeding against a Federal employee
when that proceeding is based on a test
result reported by the HHS-certified
IITF. The Department agrees and has
revised the policy to specifically
indicate that one qualified individual
must be made available to testify. This
change is consistent with what normally
occurs in legal proceedings and is

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consistent with the policy that applies
to an HHS-certified laboratory.
Section 12.20 describes the
information an IITF must make
available to a Federal employee. The
Department has revised this section to
require that the curriculum vitae for the
responsible technician be included
along with the curriculum vitae for the
certifying technician that certified the
test result.
Section 12.21 describes the type of
relationship that is prohibited between
an HHS-certified IITF and an MRO. The
policy in this section is the same policy
as described in the Proposed Revisions
to Mandatory Guidelines. This section
was reworded to clarify the
requirements.
Section 12.22 describes the type of
relationship that can exist between an
HHS-certified IITF and an HHS-certified
laboratory. Three commenters raised
concern over allowing any type of
relationship to exist between an HHScertified IITF and an HHS-certified
laboratory. The Department believes any
relationship is acceptable because HHScertified laboratories and IITFs are
certified independently. Therefore, the
Department has no objection if an HHScertified laboratory wants to establish
and own one or more HHS-certified
IITFs.
Subpart M—Medical Review Officer
(MRO)
Section 13.1 describes who may serve
as an MRO. Several commenters
disagreed with the proposed policy in
Section 13.1(b) to require MRO
organizations to submit their training
programs for review and approval by
HHS before their trained MROs would
be permitted to serve as MROs for
Federal agencies. Other commenters
stated that the Guidelines should
include objective criteria that will be
used to assess and approve the MRO
organization’s training programs. The
Department believes that approving
these MRO training courses is necessary
to ensure that MROs receive all the
information needed to properly evaluate
drug test results and that they
demonstrate and document their
knowledge of the drug testing program
by passing an examination. With regard
to the criteria used by HHS to assess
these training courses, the training
requirements in Section 13.2 will serve
as the basis for approving each MRO
organization’s training course.
Section 13.2 describes the training
requirements before a physician can
serve as an MRO. The training
requirements in this section will serve
as the basis for approving an MRO
organization’s training course. HHS

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approval will focus on how well the
course presents the materials for each
requirement listed in this section and
how well the organization documents
each MRO’s understanding of the
material by examination.
Section 13.3 describes the
responsibilities of an MRO. The
Department revised this section to
address the requirement for the MRO to
medically evaluate donors who were
unable to provide a sufficient amount of
urine for a drug test, as described in
Section 13.5 and to address the
requirement for the MRO and laboratory
to discuss specimens meeting certain
‘‘invalid result’’ criteria, as described in
Section 11.19(g). One commenter
pointed out that the preamble for the
Proposed Revisions to Mandatory
Guidelines required the MRO to review
5 percent of the negative results
reported by staff to ensure that the staff
is properly performing the review
process, but the text did not specify the
5 percent requirement. The Department
has revised Section 13.3(a) to include
this requirement. Three commenters
recommended deleting the sentence
which stated that ‘‘The MRO must
cancel the result for any agency’s
specimen that is not collected or tested
in accordance with these Guidelines.’’
The commenters believed it places a
burden on MROs to be finders of fact
concerning alleged irregularities at the
collection site. The Department agrees
and has deleted the sentence.
Section 13.4 describes what an MRO
must do when reviewing a drug test
result. Three commenters stated that the
proposed section referring to invalid
results reported by an HHS-certified
IITF should be revised, because IITFs
will not report such results. The
Department agrees and has deleted any
reference to an HHS-certified IITF
reporting an invalid result in Section
13.4. If an HHS-certified IITF finds a
presumptive invalid result for a
specimen, the IITF must forward the
specimen to an HHS-certified laboratory
for testing. Recent research supports
that high temperature for an extended
time may increase urine pH up to 9.5.
This means that conditions during
specimen transport and/or storage may
cause pH to fall within the invalid range
(i.e., greater than or equal to 9.0, but less
than 11.0). The Department has added
guidance to MROs in paragraph f of this
section on interpreting an invalid result
based on pH in the range of 9.0 to 9.5.
This allows the MRO to consider time
and temperature as an alternative, nonmedical explanation for this invalid
result. The Department has removed the
sections addressing MRO actions in
response to a second specimen collected

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after an invalid result for which there is
no valid medical explanation. The
Department will provide detailed
guidance for MROs outside of these
Guidelines.
The Department added new Sections
13.5 and 13.6 to describe action the
MRO must take when a collector reports
that a donor was unable to provide a
sufficient urine specimen. Sections
8.5(b)(2) and 8.6(e)(2)(ii) require the
collector to document when a donor did
not provide a urine specimen or when
a donor provided an insufficient amount
(i.e., less than 45 mL). Section 13.5
provides a detailed description of what
the MRO and the Federal agency must
do to determine the reason for the
donor’s inability to provide a urine
specimen. Section 13.6 describes what
the MRO and the Federal agency must
do when a donor has a permanent or
long-term medical condition that
precludes him or her from providing a
sufficient specimen when a negative
result is required (i.e., for a Federal
agency applicant/pre-employment test,
a follow-up test, or a return-to-duty
test).
Section 13.7 describes when the
donor has the opportunity to request the
testing of a split (Bottle B) specimen.
The policy in this section is the same
policy as described in the Proposed
Revisions to Mandatory Guidelines.
Section 13.8 describes how an MRO
reports a primary (Bottle A) specimen
test result to an agency. The
requirements in this section are the
same as those described in the Proposed
Revisions to Mandatory Guidelines.
Section 13.9 describes the type of
relationship that is prohibited between
an MRO and an HHS-certified
laboratory or an HHS-certified IITF. The
Department has revised the question
and policy in this section to delete
references to a POCT.
Subpart N—Split Specimen Tests
Section 14.1 describes when a split
specimen may be tested. Several
commenters disagreed with the
requirement that the donor must request
the testing of his or her split specimen
in writing. The commenters believe the
requirement places an unreasonable
burden on the donor and may cause
unnecessary delays in testing and
reporting split specimen results. The
Department agrees that requiring a
written request may be an obstacle to
getting the split specimen tested in a
timely manner and, therefore, has
revised Section 14.1(b) to allow the
MRO to have a split specimen tested
based on a verbal request from the
donor. However, the MRO is required to
document in his or her records (e.g., a

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donor interview sheet) that the donor
made a verbal request. The Department
believes this documentation is
acceptable to ensure that the donor
properly initiated the request within 72
hours after being informed of the result
by the MRO. The Department has
revised the proposed policy for MRO
action when the split (Bottle B)
specimen cannot be tested by a second
laboratory (e.g., insufficient specimen,
lost in transit, split not available, no
second laboratory available to perform
the test), The Proposed Revisions to
Mandatory Guidelines (Section 15.1)
had required the MRO to direct the
agency to immediately collect another
specimen in these cases. In response to
comments received, the Department has
revised this section, now Section
14.1(c), to require an immediate
recollection under direct observation.
This is consistent with the current
Guidelines.
Sections 14.2, 14.3, and 14.4 describe
the requirements to test split specimens
when the primary specimens are tested
positive, adulterated, or substituted,
respectively. The requirements in these
sections are the same as the
requirements described in the current
and Proposed Revisions to Mandatory
Guidelines.
Section 14.5 requires the second
certified laboratory to report the split
specimen result directly to the MRO.
The policy in this section is the same as
the policy described in the Proposed
Revisions to Mandatory Guidelines.
Section 14.6 describes the specific
action(s) that an MRO must take after
receiving the split specimen result from
the second certified laboratory. The
actions described in this section are the
same as the actions described in the
current and Proposed Revisions to
Mandatory Guidelines.
Section 14.7 describes the different
ways that an MRO can report split
specimen results to an agency. The
policies in this section are the same as
those described in the Proposed
Revisions to Mandatory Guidelines.
Section 14.8 describes how long a
certified laboratory must retain a split
(Bottle B) specimen. The policy in this
section is the same as the policy
described in the Proposed Revisions to
Mandatory Guidelines.
Subpart O—Criteria for Rejecting a
Specimen or Cancelling a Test
Section 15.1 describes those
discrepancies (i.e., ‘‘fatal flaws’’) that
require an HHS-certified laboratory or
an HHS-certified IITF to report a urine
specimen as rejected for testing. The
fatal flaws described in this section are
the same as those described in the

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Proposed Revisions to Mandatory
Guidelines. Section 15.2 describes the
discrepancies that require an HHScertified laboratory or an HHS-certified
IITF to report a urine specimen as
rejected for testing unless the
discrepancy is corrected. The
discrepancies described in this section
are the same as those described in the
Proposed Revisions to Mandatory
Guidelines.
Section 15.3 describes the
deficiencies that are not sufficient to
require an HHS-certified laboratory or
an HHS-certified IITF to reject a urine
specimen for testing or for an MRO to
cancel a test. Several commenters stated
the requirement in this section directing
an MRO to track the frequency of
omissions and discrepancies to
determine when a collector, laboratory,
or IITF should take immediate
corrective action to prevent the
recurrence of an error was unduly
burdensome. The Department believes
this requirement is necessary because
the MRO is the only individual who
reviews all of the information before
making a final determination and
reporting a test result to an agency. If a
collector, laboratory, or IITF continues
to make the same error even though the
error may be insignificant, eliminating
the error on future Federal CCFs is
preferable than having it appear on
every Federal CCF.
Section 15.4 describes the
discrepancies that may require an MRO
to cancel a test. Three commenters
stated that this section contains
correctable discrepancies that should be
included in Section 15.2. The
Department believes that the correctable
discrepancies in this section cannot be
included in Section 15.2 because they
can only be identified as discrepancies
by the MRO. The discrepancies in
Section 15.2 are those that should be
identified by the HHS-certified
laboratory or HHS-certified IITF when
the Federal CCFs and specimens are
received for testing. Four commenters
requested clarification in Section 15.4(c)
and Section 15.4(d), respectively, on the
consequences if the MRO does not
obtain a statement from the certifying
scientist that he or she inadvertently
forgot to sign the Federal CCF and the
HHS-certified laboratory or IITF did not
retransmit a modified electronic report.
The Department agrees and revised
Sections 15.4(c) and (d) to require the
MRO to cancel the test when the
required corrective action was not
taken.

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Subpart P—Laboratory or IITF
Suspension/Revocation Procedures
The requirements in this entire
subpart are the same as the
requirements described in the Proposed
Revisions to Mandatory Guidelines.
Executive Order 12866: Economic
Impact
In accordance with Executive Order
12866, the Department submitted the
Guidelines for review by the Office of
Management and Budget (OMB).
However, because the 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.
The Department asked the
Department of Transportation (DOT) for
its estimate of the annual economic
impact of the revised Guidelines on
their regulated entities. Specifically,
DOT requires that certain industries
(e.g., Federal Motor Carrier Safety
Administration) use the drug testing
standards for HHS-certified laboratories
and HHS-certified IITFs under these
Guidelines. The Department notes that
lowering testing cutoffs for existing
drugs and establishing capability to test
for new drugs, such as MDMA, will not
impose additional costs or burdens on
DOT-regulated entities, since most

Description: The Mandatory
Guidelines establish the scientific and
technical guidelines for Federal
workplace drug testing programs and
establish standards for certification of
laboratories engaged in drug testing for
Federal agencies under authority of
section 503 of Public Law 100–71, 5
U.S.C. 7301 note, and Executive Order
12564. Federal agencies test applicants
to sensitive positions, individuals
involved in accidents, individuals for
cause, and random testing of persons in
sensitive positions. The program has
depended on urine testing since 1988;
the reporting, recordkeeping, and
disclosure requirements associated with
urine testing are approved under OMB
control number 0930–0158.
In an effort to shorten the time for
negative results to be reported to the
Federal agency, the changes also
establish criteria for an IITF that will
only perform initial tests.
Description of Respondents:
Individuals or households; Businesses
or other for-profit institutions; Not-forprofit institutions.
The burden estimates in the tables
below are based on the following
number of respondents: 38,000 Federal
agency applicants who apply for
employment in testing designated
positions, 100 collectors, 50 urine
testing laboratories, 25 IITFs, and 100
MROs.

laboratories currently use similar testing
standards on many non-regulated client
specimens. It is estimated that there
may be 10 percent more users of
amphetamines and cocaine identified
using the lowered cutoffs and testing for
new drugs. The incidence and
prevalence of amphetamines and
cocaine use are very low (approximately
19,000 amphetamines positive and
approximately 40,000 cocaine positive
specimens in more than 6,500,000 tests
conducted in 2007) in the DOTregulated industries, and identification
of 10 percent more positives should not
impose a significant economic impact or
burden for either the testing or the MRO
review of the results.
Paperwork Reduction Act of 1995
These revised Guidelines contain
information collections which are
subject to review by 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 sections with an
estimate of the annual reporting,
disclosure, and recordkeeping burden.
Included in the estimate is the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information.
Title: Mandatory Guidelines for
Federal Workplace Drug Testing
Programs.

ESTIMATE OF ANNUAL REPORTING BURDEN
Purpose

9.2(a)(1) ............................................

Lab or IITF required to submit application for certification.
Materials to submit to become an
HHS inspector.
Lab submits qualifications of new
RPs and alternate RPs to HHS.
Specifications for lab semi-annual
statistical report of test results to
each Federal agency.
IITF submits qualifications of new
RTs and alternate RTs to HHS.
Specifies contents of IITF semi-annual statistical report to Federal
agencies served.
Specifies that MRO must report
verified split specimen test results
to the Federal agency.
Specifies content of request for informal review of suspension/proposed revocation of certification.
Specifies information appellant provides in first written submission
when lab or IITF suspension/revocation is proposed.

9.10(a)(3) ..........................................
11.4(c) ...............................................
11.22(a) .............................................

12.4(c) ...............................................
12.19(a) .............................................

14.7 ...................................................

16.1(b); 16.5(a) .................................
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Number of
respondents

Section

16.4 ...................................................

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Responses/
respondent

Hours/
response

Total hours

28

1

3

84

25

1

2

50

75

1

2

150

75

2

0.5

75

50

1

2

100

25

5

0.5

63

100

5

0.05 (3 min)

25

1

1

3

3

1

1

0.5

0.5

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ESTIMATE OF ANNUAL REPORTING BURDEN—Continued
Number of
respondents

Responses/
respondent

Hours/
response

Section

Purpose

16.6 ...................................................

Requires appellant to notify reviewing official of resolution status at
end of abeyance period.
Specifies contents of appellant submission for review.
Specifies content of appellant request for expedited review of suspension or proposed revocation.
Specifies contents of review file and
briefs.

1

1

0.5

0.5

1

1

50

50

1

1

3

3

1

1

50

50

...........................................................

384

........................

........................

654

16.7(a) ...............................................
16.9(a) ...............................................
16.9(c) ...............................................
TOTAL .......................................

specimen on the Federal CCF (Sections
8.4(3) and 8.6(d)(1)); collector annotates
the Federal CCF when a specimen is a
blind sample (Section 10.3(a)); and
MRO notifies the Federal agency and
HHS when an error occurs on a blind
sample (Section 10.4(c)). SAMHSA has

The following reporting requirements
are also in the Proposed Revisions to
Mandatory Guidelines, but have not
been addressed in the above reporting
burden table: Collector must report any
unusual donor behavior or unusual
physical appearance of the urine

Total hours

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

ESTIMATE OF ANNUAL DISCLOSURE BURDEN
Number of
respondents

Responses/
respondent

Hours/
response

Section

Purpose

4.5(c) .............................

Collector is given name and phone of Federal
agency point of contact.
Information on drug test that lab must provide to
donor through MRO.
Drug test information that IITF must provide to
donor through MRO.
MRO must inform donor of right to request split
specimen test when a positive, adulterated, or
substituted result is reported.

100

1

0.05 (3 min)

5

50

10

3

1,500

25

10

2

500

100

5

3

1,500

..............................................................................

275

........................

........................

3,505

11.23(b) .........................
12.20(b) .........................
13.7(b) ...........................

Total .......................

The following disclosure
requirements are also included in the
Proposed Revisions to Mandatory
Guidelines, but have not been addressed
in the above disclosure burden table:

The collector must explain the basic
collection procedure to the donor and
answer any questions (Sections 8.3(e)
and (g)). SAMHSA believes having the
collector explain the collection

Total hours

procedure to the donor and to answer
any questions is a standard business
practice and not a disclosure burden.

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN
Responses/
respondent

Hours/
response

Purpose

8.3, 8.4, 8.5, 8.6, and 8.7 .................

Collector completes Federal CCF
for specimen collected.
Lab completes Federal CCF upon
receipt of specimen and before
reporting result.
IITF completes Federal CCF upon
receipt of specimen and before
reporting result.
MRO completes the Federal CCF
before reporting result.
MRO documents donor’s request to
have split specimen tested.

100

380

0.07 (4 min)

2,660

50

760

0.05 (3 min)

1,900

25

1520

0.05 (3 min)

1,900

100

380

0.05 (3 min)

1,900

300

1

0.05 (3 min)

15

...........................................................

575

........................

........................

8,375

11.8 and 11.19(a) and (o) .................
12.8(a) and 12.15(f) ..........................
13.3(c)(4) ...........................................
14.1(b) ...............................................
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Number of
respondents

Section

Total ...........................................

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Total hours

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Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / Notices
The revised Mandatory Guidelines
contain a number of recordkeeping
requirements that SAMHSA considers
not to be an additional recordkeeping
burden. In subpart D, a trainer is
required to document the training of an
individual to be a collector (Section
4.3(a)(4)(ii)) and the documentation
must be maintained in the collector’s
training file (Section 4.3(c)). SAMHSA
believes this training documentation is
common practice and is not considered
an additional burden. In subpart F, if a
collector uses an incorrect form to
collect a Federal agency specimen, the
collector is required to provide a
statement (Section 6.2(b)) explaining
why an incorrect form was used to
document collecting the specimen.
SAMHSA believes this is an extremely
infrequent occurrence and does not
create a significant additional
recordkeeping burden. Subpart H
(Section 8.6(d)(1)) requires collectors to
enter any information on the Federal
CCF of any unusual findings during the
urine specimen collection procedure.
These recordkeeping requirements are
an integral part of the collection
procedure and are essential to
documenting the chain of custody for
the specimens collected. The burden for
these entries is included in the
recordkeeping burden estimated to
complete the Federal CCF and is,
therefore, not considered an additional
recordkeeping burden. Subparts K and L
describe a number of recordkeeping
requirements for laboratories and IITFs
associated with their testing procedures,
maintaining chain of custody, and
keeping records (i.e., Sections 11.1(a),
11.1(d), 11.2(b), 11.2(c), 11.2(d), 11.6(a),
11.7(c), 11.8(b), 11.8(c), 11.8(e), 11.11,
11.14, 11.17, 11.21, 12.1(a), 12.1(d),
12.2(b), 12.2(c), 12.2(d), 12.6(b), 12.7(c),
12.8(b), 12.10, 12.13, and 12.18). These
recordkeeping requirements are
necessary for any laboratory or IITF to
conduct forensic drug testing and to
ensure the scientific supportability of
the test results. Therefore, they are
considered to be standard business
practice and are not considered a
burden for this analysis. This same
opinion applies to the recordkeeping
requirements for MROs in Section
13.3(c)(5).
Thus the total annual response
burden associated with the testing of
urine specimens by the laboratories and
IITFs is estimated to be 13,768 hours
(that is, the sum of the total hours from
the above tables). This is in addition to
the 1,786,809 hours currently approved
by OMB under control number 0930–
0158 for urine testing under the current
Mandatory Guidelines.

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As required by section 3507(d) of the
PRA, the Secretary has submitted a copy
of these revised Mandatory Guidelines
to OMB for its review. Comments on the
information collection requirements are
specifically solicited in order to: (1)
Evaluate whether the proposed
collection of information is necessary
for the proper performance of HHS’s
functions, including whether the
information will have practical utility;
(2) evaluate the accuracy of HHS’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) enhance the
quality, utility, and clarity of the
information to be collected; and (4)
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
OMB is required to make a decision
concerning the collection of information
contained in these Guidelines between
30 and 60 days after publication of this
document in the Federal Register.
Therefore, a comment to OMB is best
assured of having its full effect if OMB
receives it within 30 days of
publication.
Organizations and individuals
desiring to submit comments on the
information collection requirements
should direct them to the Office of
Information and Regulatory Affairs,
OMB, New Executive Office Building,
725 17th Street, NW., Washington, DC
20502, Attn: Desk Officer for SAMHSA.
Because of delays in receipt of mail,
comments may also be sent to 202–395–
6974 (fax).

1.6

Dated: July 23, 2008.
Terry L. Cline,
Administrator, SAMHSA.
Dated: July 29, 2008.
Michael O. Leavitt,
Secretary.

Subpart E—Collection Sites

Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Subpart A—Applicability
To whom do these Guidelines apply?
Who is responsible for developing and
implementing these Guidelines?
1.3 How does a Federal agency request a
change from these Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these
Guidelines mean?

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What is an agency required to do to
protect employee records?
1.7 What is a refusal to take a federally
regulated drug test, and what are the
consequences?

Subpart B—Specimens
2.1
2.2
2.3
2.4
2.5

What type of specimen may be
collected?
Under what circumstances may
specimens be collected?
How is each specimen collected?
What volume of urine is collected?
How does the collector split the urine
collected?

Subpart C—Urine Drug and Specimen
Validity Tests
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8

Which drug and specimen validity tests
are conducted on a urine specimen?
May a specimen be tested for additional
drugs?
May any of the specimens be used for
other purposes?
What are the cutoff concentrations for
drug tests?
What criteria are used to report a
specimen as adulterated?
What criteria are used to report a
specimen as substituted?
What criteria are used to report a
specimen as dilute?
What criteria are used to report an
invalid result for a specimen?

Subpart D—Collectors
4.1
4.2
4.3

Who may collect a specimen?
Who may not collect a specimen?
What are the requirements to be a
collector?
4.4 What are the requirements to be an
observer for a direct observed collection?
4.5 What are the requirements to be a
trainer for collectors?
4.6 What must a Federal agency do before
an individual is permitted to collect a
specimen?

5.1

The Mandatory Guidelines as revised
are hereby adopted in accordance with
Section 503 of Public Law 100–71 and
Executive Order 12564.

1.1
1.2

71875

Where can a collection for a drug test
take place?
5.2 What are the requirements for a
collection site?
5.3 How long must collection site records
be stored?
5.4 How does the collector ensure the
security and integrity of a specimen at
the collection site?

Subpart F—Federal Drug Testing
Custody and Control Form
6.1

What form is used for collecting a
specimen?
6.2 What happens if the correct Federal
CCF is not available or is not used?

Subpart G—Specimen Collection
Containers
7.1

What is used to collect a urine
specimen?
7.2 Are there any restrictions on the

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containers and bottles used to collect
urine specimens?

Subpart H—Specimen Collection
Procedure
8.1

What privacy must the donor be given
when providing a specimen?
8.2 What must the collector do at the
collection site before starting a specimen
collection procedure?
8.3 What are the preliminary steps in the
collection process?
8.4 What steps does the collector take in the
collection process before the donor
provides a urine specimen?
8.5 What procedure is used when the donor
states that he or she is unable to provide
a specimen?
8.6 What steps does the collector take in the
collection process after the donor
provides a urine specimen?
8.7 How does the collector prepare the
specimens?
8.8 When is a direct observed collection
conducted?
8.9 How is a direct observed collection
conducted?
8.10 When is a monitored collection
conducted?
8.11 How is a monitored collection
conducted?
8.12 How does the collector report a
donor’s refusal to test?
8.13 What are a Federal agency’s
responsibilities for a collection site?

Subpart I—HHS Certification of
Laboratories and IITFs

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9.1

Who has the authority to certify
laboratories and IITFs to test specimens
for Federal agencies?
9.2 What is the process for a laboratory or
IITF to become certified and maintain
HHS certification and the process when
certification is not maintained?
9.3 What are the qualitative and
quantitative specifications of a
performance test (PT) sample?
9.4 What are the PT requirements for an
applicant laboratory?
9.5 What are the PT requirements for an
HHS-certified laboratory?
9.6 What are the PT requirements for an
applicant IITF?
9.7 What are the PT requirements for an
HHS-certified IITF?
9.8 What are the inspection requirements
for an applicant laboratory or IITF?
9.9 What are the maintenance inspection
requirements for an HHS-certified
laboratory or IITF?
9.10 Who can inspect an HHS-certified
laboratory or IITF and when may the
inspection be conducted?
9.11 What happens if an applicant
laboratory or IITF does not satisfy the
minimum requirements for either the PT
program or the inspection program?
9.12 What happens if an HHS-certified
laboratory or IITF does not satisfy the
minimum requirements for either the PT
program or the inspection program?
9.13 What factors are considered in
determining whether revocation of a

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laboratory’s or IITF’s certification is
necessary?
9.14 What factors are considered in
determining whether to suspend a
laboratory or IITF?
9.15 How does the Secretary notify a
laboratory or IITF that action is being
taken against the laboratory or IITF?
9.16 May a laboratory or IITF that had its
certification revoked be recertified to test
Federal agency specimens?
9.17 Where is the list of HHS-certified
laboratories and IITFs published?

Subpart J—Blind Samples Submitted
by an Agency
10.1

What are the requirements for Federal
agencies to submit blind samples to
HHS-certified laboratories or IITFs?
10.2 What are the requirements for a blind
sample?
10.3 How is a blind sample submitted to an
HHS-certified laboratory or IITF?
10.4 What happens if an inconsistent result
is reported on a blind sample?

Subpart K—Laboratory
11.1

What must be included in the HHScertified laboratory’s standard operating
procedure manual?
11.2 What are the responsibilities of the
responsible person (RP)?
11.3 What scientific qualifications in
analytical toxicology must the RP have?
11.4 What happens when the RP is absent
or leaves an HHS-certified laboratory?
11.5 What qualifications must an individual
have to certify a result reported by an
HHS-certified laboratory?
11.6 What qualifications and training must
other laboratory personnel have?
11.7 What security measures must an HHScertified laboratory maintain?
11.8 What are the internal laboratory chain
of custody requirements for a specimen
or an aliquot?
11.9 What test(s) does an HHS-certified
laboratory conduct on a specimen
received from an IITF?
11.10 What are the requirements for an
initial drug test?
11.11 What must an HHS-certified
laboratory do to validate an initial drug
test?
11.12 What are the batch quality control
requirements when conducting an initial
drug test?
11.13 What are the requirements for a
confirmatory drug test?
11.14 What must an HHS-certified
laboratory do to validate a confirmatory
drug test?
11.15 What are the quality control
requirements when conducting a
confirmatory drug test?
11.16 What are the analytical and quality
control requirements for conducting
specimen validity tests?
11.17 What must an HHS-certified
laboratory do to validate a specimen
validity test?
11.18 What are the requirements for
conducting each specimen validity test?
11.19 What are the requirements for an
HHS-certified laboratory to report a test

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result?
11.20 How long must an HHS-certified
laboratory retain a specimen?
11.21 How long must an HHS-certified
laboratory retain records?
11.22 What statistical summary report must
an HHS-certified laboratory provide?
11.23 What laboratory information is
available to a Federal employee?
11.24 What type of relationship is
prohibited between an HHS-certified
laboratory and an MRO?
11.25 What type of relationship can exist
between an HHS-certified laboratory and
an HHS-certified IITF?

Subpart L—Instrumented Initial Test
Facility (IITF)
12.1

What must be included in the HHScertified IITF’s standard operating
procedure manual?
12.2 What are the responsibilities of the
responsible technician (RT)?
12.3 What qualifications must the RT have?
12.4 What happens when the RT is absent
or leaves an HHS-certified IITF?
12.5 What qualifications must an individual
have to certify a result reported by an
HHS-certified IITF?
12.6 What qualifications and training must
other IITF personel have?
12.7 What security measures must an HHScertified IITF maintain?
12.8 What are the internal IITF chain of
custody requirements for a specimen or
an aliquot?
12.9 What are the requirements for an
initial drug test?
12.10 What must an HHS-certified IITF do
to validate an initial drug test?
12.11 What are the batch quality control
(QC) requirements when conducting an
initial drug test?
12.12 What are the analytical and quality
control requirements for conducting
specimen validity tests?
12.13 What must an HHS-certified IITF do
to validate a specimen validity test?
12.14 What are the requirements for
conducting each specimen validity test?
12.15 What are the requirements for an
HHS-certified IITF to report a test result?
12.16 How does an HHS-certified IITF
handle a specimen that tested positive,
adulterated, substituted, or invalid at the
IITF?
12.17 How long must an HHS-certified IITF
retain a specimen?
12.18 How long must an HHS-certified IITF
retain records?
12.19 What statistical summary report must
an HHS-certified IITF provide?
12.20 What IITF information is available to
a Federal employee?
12.21 What type of relationship is
prohibited between an HHS-certified
IITF and an MRO?
12.22 What type of relationship can exist
between an HHS-certified IITF and an
HHS-certified laboratory?
Subpart M—Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 What are the training requirements
before a physician can serve as an MRO?

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13.3

What are the responsibilities of an
MRO?
13.4 What must an MRO do when
reviewing a test result?
13.5 What action does the MRO take when
the collector reports that the donor did
not provide a sufficient amount of urine
for a drug test?
13.6 What happens when an individual is
unable to provide a sufficient amount of
urine for a Federal agency applicant/preemployment test, a follow-up test, or a
return-to-duty test because of a
permanent or long-term medical
condition?
13.7 Who may request a test of a split
specimen?
13.8 How does an MRO report a primary
(Bottle A) specimen test result to an
agency?
13.9 What type of relationship is prohibited
between an MRO and an HHS-certified
laboratory or an HHS-certified IITF?
Subpart N—Split Specimen Tests 14.1 When
may a split specimen be tested?
14.2 How does an HHS-certified laboratory
test a split (Bottle B) specimen when the
primary (Bottle A) specimen was
reported positive?
14.3 How does an HHS-certified laboratory
test a split (Bottle B) specimen when the
primary (Bottle A) specimen was
reported adulterated?
14.4 How does an HHS-certified laboratory
test a split (Bottle B) specimen when the
primary (Bottle A) specimen was
reported substituted?
14.5 Who receives the split specimen
result?
14.6 What action(s) does an MRO take after
receiving the split (Bottle B) specimen
result from the second HHS-certified
laboratory?
14.7 How does an MRO report a split
(Bottle B) specimen test result to an
agency?
14.8 How long must an HHS-certified
laboratory retain a split (Bottle B)
specimen?

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Subpart O—Criteria for Rejecting a
Specimen for Testing
15.1 What discrepancies require an HHScertified laboratory or an HHS-certified
IITF to report a specimen as rejected for
testing?
15.2 What discrepancies require an HHScertified laboratory or an HHS-certified
IITF to report a specimen as rejected for
testing unless the discrepancy is
corrected?
15.3 What discrepancies are not sufficient
to require an HHS-certified laboratory or
an HHS-certified IITF to reject a
specimen for testing or an MRO to cancel
a test?
15.4 What discrepancies may require an
MRO to cancel a test?
Subpart P—Laboratory or IITF Suspension/
Revocation Procedures
16.1 When may an HHS-certified laboratory
or IITF be suspended?
16.2 What definitions are used for this
subpart?
16.3 Are there any limitations on issues

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subject to review?
Who represents the parties?
When must a request for informal
review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedure is used to prepare the
review file and written argument?
16.8 When is there an opportunity for oral
presentation?
16.9 Are there expedited procedures for
review of immediate suspension?
16.10 Are any types of communications
prohibited?
16.11 How are communications transmitted
by the reviewing official?
16.12 What are the authority and
responsibilities of the reviewing official?
16.13 What administrative records are
maintained?
16.14 What are the requirements for a
written decision?
16.15 Is there a review of the final
administrative action?
16.4
16.5

Subpart A—Applicability
Section 1.1 To whom do these
Guidelines apply?
(a) These Guidelines apply to:
(1) Executive Agencies as defined in
5 U.S.C. 105;
(2) The Uniformed Services, as
defined in 5 U.S.C. 2101(3) (but
excluding the Armed Forces as defined
in 5 U.S.C. 2101(2));
(3) Any other employing unit or
authority of the Federal Government
except the United States Postal Service,
the Postal Rate Commission, and
employing units or authorities in the
Judicial and Legislative Branches; and
(4) The Intelligence Community, as
defined by Executive Order 12333, is
subject to these Guidelines only to the
extent agreed to by the head of the
affected agency;
(5) Laboratories and instrumented
initial test facilities (IITFs) that provide
drug testing services to the Federal
agencies;
(6) Collectors that provide specimen
collection services to the Federal
agencies; and
(7) Medical Review Officers (MROs)
that provide drug testing review and
interpretation of results services to the
Federal agencies.
(b) The Guidelines do not apply to
drug testing under authority other than
Executive Order 12564, including
testing of persons in the criminal justice
system, such as, arrestees, detainees,
probationers, incarcerated persons, or
parolees.1
1 Although

HHS has no authority to regulate the
transportation industry, the Department of
Transportation (DOT) does have such authority.
DOT is required by law to develop requirements for
its regulated industry that ‘‘incorporate the
Department of Health and Human Services
scientific and technical guidelines dated April 11,

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Section 1.2 Who is responsible for
developing and implementing these
Guidelines?
(a) Executive Order 12564 and Public
Law 100–71 require the Department of
Health and Human Services (HHS) to
establish scientific and technical
guidelines for Federal workplace drug
testing programs.
(b) The Secretary has the
responsibility to implement these
Guidelines.
Section 1.3 How does a Federal
agency request a change from these
Guidelines?
(a) Each Federal agency must ensure
that its workplace drug testing program
complies with the provisions of these
Guidelines unless a waiver has been
obtained from the Secretary.
(b) To obtain a waiver, a Federal
agency must submit a written request to
the Secretary that describes the specific
change for which a waiver is sought and
a detailed justification for the change.
Section 1.4
revised?

How are these Guidelines

(a) In order to ensure the full
reliability and accuracy of drug and
specimen validity tests, the accurate
reporting of test results, and the
integrity and efficacy of Federal drug
testing programs, the Secretary may
make changes to these Guidelines to
reflect improvements in the available
science and technology.
(b) The changes will be published in
final as a notice in the Federal Register.
Section 1.5 What do the terms used in
these Guidelines mean?
The following definitions are adopted:
Accessioner. The individual who
receives the specimens at the laboratory
or IITF and signs the Federal drug
testing custody and control form.
Adulterated Specimen. A specimen
that has been altered, as evidenced by
test results showing either a substance
that is not a normal constituent for that
type of specimen or showing an
abnormal concentration of an
endogenous substance.
Aliquot. A fractional part of a
specimen used for testing, representing
the whole specimen.
Alternate Responsible Person. The
person who assumes professional,
organizational, educational, and
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 at 49
CFR Part 40 that its federally-regulated employers
use only HHS-certified laboratories in the testing of
employees, 49 CFR 40.81, and incorporates the
scientific and technical aspects of the HHS
Mandatory Guidelines.

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administrative responsibility for the
day-to-day management of the HHScertified laboratory when the
responsible person is unable to fill these
obligations.
Alternate Responsible Technician.
The person who assumes professional,
organizational, educational, and
administrative responsibility for the
day-to-day management of the HHScertified IITF when the responsible
technician is unable to fill these
obligations.
Batch. A number of specimens that
are being handled and tested as a group.
Calibrator. A solution of known
concentration in the appropriate matrix
that is used to define expected outcomes
of a measurement procedure or to
compare the response obtained with the
response of a test specimen aliquot/
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
concentration range.
Cancelled Test. The result reported by
the MRO to the Federal agency when a
specimen has been reported to the MRO
as invalid result (and the donor has no
legitimate explanation) or rejected for
testing, when a split specimen fails to
reconfirm, or when the MRO determines
that a fatal flaw or unrecovered
correctable error exists in the forensic
records (as described in Sections 15.1
and 15.2).
Carryover. The effect that occurs
when a sample’s result (e.g., drug
concentration) has been affected by a
preceding sample during analysis.
Certifying Scientist (CS). The
individual responsible for verifying the
chain of custody and scientific
reliability of any test result reported by
an HHS-certified laboratory.
Certifying Technician (CT). The
individual responsible for verifying the
chain of custody and scientific
reliability of negative, negative/dilute,
and rejected for testing results reported
by a laboratory or IITF.
Chain of Custody (COC). Procedures
to account for the integrity of each
specimen or aliquot by tracking its
handling and storage from point of
specimen collection to final disposition
of the specimen and its aliquots.
Chain of Custody Document. A form
used to document the security of the
specimen and all aliquots of a specimen.
The document, which may account for
an individual specimen, aliquot, or
batch, must include the names and
signatures of all individuals who
handled the specimen or aliquots and
the date and purpose of the access.

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Collection Site. A place where donors
present themselves for the purpose of
providing a specimen.
Collector. A person who instructs and
assists donors at a collection site and
receives the specimen provided by the
donor.
Confirmatory Drug Test. A second
analytical procedure performed on a
different aliquot of the original
specimen to identify and quantify the
presence of a specific drug or drug
metabolite.
Confirmatory Specimen Validity Test.
A second test performed on a different
aliquot of the original specimen to
further support a specimen validity test
result.
Control. A sample used to evaluate
whether an analytical procedure or test
is operating within predefined tolerance
limits.
Cutoff. The decision point or value
used to establish and report a specimen
as negative, positive, adulterated,
substituted, or invalid.
Dilute Specimen. A urine specimen
with creatinine and specific gravity
values that are lower than expected but
are still within the physiologically
producible ranges of human urine.
Donor. The individual from whom a
specimen is collected.
Failed to Reconfirm. The result
reported for a split specimen when the
second laboratory is unable to
corroborate the original result reported
for the primary specimen.
Federal Drug Testing Custody and
Control Form (Federal CCF). The Office
of Management and Budget (OMB)
approved form that is used to document
the collection, custody, and transport of
a specimen from the time the specimen
is collected until it is received by the
testing site (i.e., certified laboratory,
instrumented initial test facility). The
form may also be used to report the test
result to the Medical Review Officer.
HHS. The Department of Health and
Human Services.
Initial Drug Test. The test used to
differentiate a negative specimen from
one that requires further testing for
drugs or drug metabolites.
Initial Specimen Validity Test. The
first test used to determine if a specimen
is adulterated, diluted, substituted, or
invalid.
Instrumented Initial Test Facility
(IITF). A permanent location where
initial testing, reporting of results, and
recordkeeping are performed under the
supervision of a responsible technician.
Invalid Result. The result reported by
an HHS-certified laboratory in
accordance with the criteria established
in Section 3.8 when a positive, negative,
adulterated, or substituted result cannot

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be established for a specific drug or
specimen validity test.
Laboratory. A permanent location
where initial and confirmatory testing,
reporting of results, and recordkeeping
is performed under the supervision of a
responsible person.
Limit of Detection. The lowest
concentration at which a measurand can
be identified, but (for quantitative
assays) the concentration cannot be
accurately calculated.
Limit of Quantitation. For quantitative
assays, the lowest concentration at
which the identity and concentration of
the measurand can be accurately
established.
Lot. A number of units of an item
(e.g., drug test kits, reagents, quality
control material) manufactured from the
same starting materials within a
specified period of time for which the
manufacturer states that the items have
essentially the same performance
characteristics and the same expiration
date.
Medical Review Officer (MRO). A
licensed physician who reviews,
verifies, and reports a specimen test
result to the agency.
Negative Result. The result reported
by an HHS-certified laboratory or an
HHS-certified IITF to an MRO when a
specimen contains no drug or the
concentration of the drug is less than
the cutoff concentration for that drug or
drug class and the specimen is a valid
specimen.
Oxidizing Adulterant. A substance
that acts alone or in combination with
other substances to oxidize drug or drug
metabolites to prevent the detection of
the drugs or drug metabolites, or affects
the reagents in either the initial or
confirmatory drug test.
Performance Testing (PT) Sample. A
program-generated sample sent to
laboratory or IITF that is used to
evaluate performance.
Positive Result. The result reported by
an HHS-certified laboratory when a
specimen contains a drug or drug
metabolite equal to or greater than the
cutoff concentration.
Quality Control (QC) Sample. A
calibrator or control used to verify that
an analytical test is providing accurate
test results.
Reconfirmed. The result reported for
a split specimen when the second
laboratory is able to corroborate the
original result reported for the primary
specimen.
Rejected for Testing. The result
reported by an HHS-certified laboratory
or HHS-certified IITF when no tests are
performed for a specimen because of a
fatal flaw or an unrecovered correctable

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error (as described in Sections 15.1 and
15.2).
Responsible Person (RP). The person
who assumes professional,
organizational, educational, and
administrative responsibility for the
day-to-day management of the HHScertified laboratory.
Responsible Technician (RT). The
person who assumes professional,
organizational, educational, and
administrative responsibility for the
day-to-day management of the HHScertified IITF.
Sample. A performance testing
sample, quality control material used for
testing, or a representative portion of a
donor specimen.
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. Fluid or material collected
from a donor at the collection site for
the purpose of a drug test. Urine is the
only specimen allowed for Federal
workplace drug testing programs.
Split Specimen Collection. A
collection in which the urine collected
is divided into two separate specimen
bottles, the primary specimen (Bottle A)
and the split specimen (Bottle B).
Standard. Reference material of
known purity or a solution containing a
reference material at a known
concentration.
Substituted Specimen. A specimen
that has been submitted in place of the
donor’s urine, as evidenced by
creatinine and specific gravity values
that are outside the physiologically
producible ranges of human urine.

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Section 1.6 What is an agency
required to do to protect employee
records?
Consistent with 5 U.S.C. 552(a) and
48 CFR 24.101–24.104, all agency
contracts with laboratories, IITFs,
collectors, and MROs must require that
they comply with the Privacy Act, 5
U.S.C. 552(a). In addition, the contracts
must require compliance with employee
access and confidentiality provisions of
Section 503 of Public Law 100–71. Each
Federal agency must establish a Privacy
Act System of Records or modify an
existing system, or use any applicable
Government-wide system of records to
cover the records of employee drug test
results. All contracts and the Privacy
Act System of Records must specifically
require that employee records be
maintained and used with the highest
regard for employee privacy.

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In addition, the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) Privacy Rule, 45 CFR
Parts 160 and 164, Subparts A and E, is
applicable to certain health care
providers with whom a Federal agency
may contract. If a health care provider
is a HIPAA covered entity, the provider
must protect the individually
identifiable health information it
maintains in accordance with the
requirements of the Privacy Rule, which
includes not using or disclosing the
information except as permitted by the
Rule and ensuring there are reasonable
safeguards in place to protect the
privacy of the information. For more
information regarding HIPAA Privacy
Rule, please visit http://www.hhs.gov/
ocr/hipaa.
Section 1.7 What is a refusal to take
a federally regulated drug test, and
what are the consequences?
(a) As a donor for a federally regulated
drug test, you have refused to take a
drug test if you:
(1) Fail to appear for any test (except
a pre-employment test) within a
reasonable time, as determined by the
Federal agency, consistent with
applicable agency regulations, after
being directed to do so by the Federal
agency;
(2) Fail to remain at the collection site
until the collection process is complete
(with the exception of a donor who
leaves the collection site before the
collection process begins for a preemployment test);
(3) Fail to provide a urine specimen
for any drug test required by these
Guidelines or Federal agency
regulations (with the exception of a
donor who leaves the collection site
before the collection process begins for
a pre-employment test);
(4) In the case of a direct observed or
monitored collection, fail to permit the
observation or monitoring of your
provision of a specimen when required
as described in sections 8.8 and 8.10;
(5) Fail to provide a sufficient amount
of urine when directed, and it has been
determined, through a required medical
evaluation, that there was no adequate
medical explanation for the failure as
determined by the process described in
section 13.5;
(6) Fail or decline to take an
additional drug test or collection as
directed by the Federal agency or
collector (i.e., as described in section
8.6);
(7) Fail to undergo a medical
examination or evaluation, as directed
by the MRO as part of the verification
process (i.e., section 13.5) or as directed
by the Federal agency. In the case of a

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Federal agency applicant/preemployment drug test, the donor is
deemed to have refused to test on this
basis only if the Federal agency
applicant/pre-employment test is
conducted following a contingent offer
of employment. If there was no
contingent offer of employment, the
MRO will cancel the test; or
(8) Fail to cooperate with any part of
the testing process (e.g., refuse to empty
pockets when directed by the collector,
disrupt the collection process, fail to
wash hands after being directed to do so
by the collector).
(9) For an observed collection, fail to
follow the observer’s instructions
related to the collection process;
(10) Possess or wear a prosthetic or
other device that could be used to
interfere with the collection process; or
(11) Admit to the collector or MRO
that you have adulterated or substituted
the specimen.
(b) As a Federal agency applicant or
employee, if the MRO reports that you
have a verified adulterated or
substituted test result, you have refused
to take a drug test.
(c) As a Federal agency applicant or
employee, refusal to submit to testing
will result in initiation of disciplinary
action, up to and including dismissal.
(d) As a collector or an MRO, when
a donor refuses to participate in the part
of the testing process in which you are
involved, you must terminate the
portion of the testing process in which
you are involved, document the refusal
on the Federal CCF, and immediately
notify the Federal agency’s designated
representative by any means (e.g.,
telephone or secure fax machine) that
ensures that the refusal notification is
immediately received. As a referral
physician (e.g., physician evaluating
whether medical condition preventing
the donor from providing a sufficient
amount of urine for a drug test or
evaluating a claim of a legitimate
medical explanation in a specimen
validity testing situation), you must
notify the MRO, who in turn will notify
the Federal agency.
(1) As the collector, you must note the
refusal on the Federal CCF and sign and
date the CCF in accordance with section
8.12.
(2) As the MRO, you must note the
refusal and the reason on the MRO copy
of the Federal CCF and sign and date the
CCF.
Subpart B—Specimens
Section 2.1 What type of specimen
may be collected?
Urine is the only specimen a Federal
agency may collect under the

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Guidelines for its workplace drug
testing program.
Section 2.2 Under what circumstances
may specimens be collected?
A Federal agency may collect a
specimen for the following reasons:
(a) Federal agency applicant/Preemployment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post-accident test;
(e) Return to duty test; or
(f) Follow-up test.
Section 2.3
collected?

How is each specimen

Each specimen is collected as a split
specimen as described in Section 2.5.
Section 2.4
collected?

What volume of urine is

A donor is expected to provide at
least 45 mL of urine for a specimen to
be tested at an HHS-certified laboratory
or IITF.
Section 2.5 How does the collector
split the urine collected?
The collector pours at least 30 mL
into a specimen bottle that is labeled
Bottle A (primary) and then pours at
least 15 mL into a specimen bottle that
is labeled Bottle B (split).
Subpart C—Urine Drug and Specimen
Validity Tests
Section 3.1 Which drug and specimen
validity tests are conducted on a urine
specimen?
A Federal agency:
(a) Must ensure that each specimen is
tested for marijuana and cocaine
metabolites as provided under Section
3.4;

(b) Is authorized to test each specimen
for opiates, amphetamines, and
phencyclidine, as provided under
Section 3.4; and
(c) Must ensure that the following
specimen validity tests are conducted
on each specimen:
(1) Determine the creatinine
concentration on every specimen;
(2) Determine the specific gravity on
every specimen for which the creatinine
concentration is less than 20 mg/dL;
(3) Determine the pH on every
specimen; and
(4) Perform one or more specimen
validity tests for oxidizing adulterants
on every specimen.
(d) If a specimen exhibits abnormal
physical characteristics (e.g., unusual
odor or color, semi-solid
characteristics), causes reactions or
responses characteristic of an adulterant
during initial or confirmatory drug tests
(e.g., non-recovery of standards, unusual
response), or contains an unidentified
substance that interferes with the
confirmatory analysis, then additional
testing may be performed.
Section 3.2 May a specimen be tested
for additional drugs?
(a) A specimen may be tested for
additional drugs, on a case-by-case
basis, when a Federal agency is
conducting a specimen collection for
reasonable suspicion, post accident, or
unsafe practice testing. A specimen
collected from a Federal agency
employee may be tested by the Federal
agency for any drugs listed in Schedule
I or II of the Controlled Substances Act
(other than the drugs listed in Section
3.1, or when used pursuant to a valid
prescription or when used as otherwise
authorized by law). The Federal agency
must request the HHS-certified

laboratory to test for the additional drug,
include a justification to test a specific
specimen for the drug, and ensure that
the HHS-certified laboratory has the
capability to test for the drug and has
established properly validated initial
and confirmatory analytical methods. If
an initial test procedure is not available
upon request for a suspected Schedule
I or Schedule II drug, the Federal agency
can request an HHS-certified laboratory
to test for the drug by directing two
separate aliquots of the specimen for the
confirmatory analytical method.
Additionally, the split (Bottle B)
specimen will be available for testing if
the donor requests a retest at another
HHS-certified laboratory.
(b) A Federal agency covered by these
Guidelines must petition the Secretary
in writing for approval to routinely test
for any drug class not listed in Section
3.1. Such approval must be limited to
the use of the appropriate science and
technology and must not otherwise limit
agency discretion to test for any drug
tested under paragraph (a) of this
section.
Section 3.3 May any of the specimens
be used for other purposes?
(a) Federal agency specimens
collected pursuant to Executive Order
12564, Public Law 100–71, and these
Guidelines must only be tested for drugs
and to determine their validity unless
otherwise authorized by law.
(b) These Guidelines are not intended
to prohibit any Federal agency
specifically authorized by law to test a
specimen for additional classes of drugs
in its workplace drug testing program.
Section 3.4 What are the cutoff
concentrations for drug tests?

Initial test analyte

Initial test cutoff
concentration

Confirmatory test analyte

Marijuana metabolites ..............................................
Cocaine metabolites ................................................
Opiate metabolites.
Codeine/Morphine 2 ..........................................

50 ng/mL .......................
150 ng/mL .....................

THCA1 ...............................................
Benzoylecgonine ...............................

15 ng/mL
100 ng/mL

2000 ng/mL ...................

Codeine .............................................
Morphine ............................................
6-Acetylmorphine ...............................
Phencyclidine ....................................

2000 ng/mL
2000 ng/mL
10 ng/mL
25 ng/mL

Amphetamine ....................................
Methamphetamine 5 ...........................
MDMA ................................................
MDA7 .................................................
MDEA8 ...............................................

250
250
250
250
250

6-Acetylmorphine .....................................................
Phencyclidine ...........................................................
Amphetamines 3.
AMP/MAMP 4 ...........................................................

10 ng/mL .......................
25 ng/mL .......................
500 ng/mL .....................

MDMA6 ....................................................................

500 ng/mL .....................

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1 Delta-9-tetrahydrocannabinol-9-carboxylic

Confirmatory test cutoff
concentration

ng/mL
ng/mL
ng/mL
ng/mL
ng/mL

acid (THCA).
is the target analyte for codeine/morphine testing.
3 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at
the specified cutoff.
4 Methamphetamine is the target analyte for amphetamine/methamphetamine testing.
5 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100
ng/mL.
6 Methylenedioxymethamphetamine (MDMA).
7 Methylenedioxyamphetamine (MDA).
2 Morphine

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8 Methylenedioxyethylamphetamine

(MDEA).

Section 3.5 What criteria are used to
report a specimen as adulterated?
An HHS-certified laboratory reports a
primary (Bottle A) specimen as
adulterated when:
(a) The pH is less than 3 or equal to
or greater than 11 using either a pH
meter or a colorimetric pH test for the
initial test on the first aliquot and a pH
meter for the confirmatory test on the
second aliquot;
(b) The nitrite concentration is equal
to or greater than 500 mcg/mL using
either a nitrite colorimetric test or a
general oxidant colorimetric test for the
initial test on the first aliquot and a
different confirmatory test (e.g., multiwavelength spectrophotometry, ion
chromatography, capillary
electrophoresis) on the second aliquot;
(c) The presence of chromium (VI) is
verified using either a general oxidant
colorimetric test (with an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or a chromium (VI)
colorimetric test (chromium (VI)
concentration equal to or greater than 50
mcg/mL) for the initial test on the first
aliquot and a different confirmatory test
(e.g., multi-wavelength
spectrophotometry, ion
chromatography, atomic absorption
spectrophotometry, capillary
electrophoresis, inductively coupled
plasma-mass spectrometry) with the
chromium (VI) concentration equal to or
greater than the limit of quantitation
(LOQ) of the confirmatory test on the
second aliquot;
(d) The presence of halogen (e.g.,
bleach, iodine, fluoride) is verified
using either a general oxidant
colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or halogen
colorimetric test (halogen concentration
equal to or greater than the LOQ) for the
initial test on the first aliquot and a
different confirmatory test (e.g., multiwavelength spectrophotometry, ion
chromatography, inductively coupled
plasma-mass spectrometry) with a
specific halogen concentration equal to
or greater than the LOQ of the
confirmatory test on the second aliquot;
(e) The presence of glutaraldehyde is
verified using either an aldehyde test
(aldehyde present) or the characteristic
immunoassay response on one or more
drug immunoassay tests for the initial
test on the first aliquot and a different
confirmatory test (e.g., GC/MS) for the
confirmatory test with the
glutaraldehyde concentration equal to or

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greater than the LOQ of the analysis on
the second aliquot;
(f) The presence of pyridine
(pyridinium chlorochromate) is verified
using either a general oxidant
colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or a chromium (VI)
colorimetric test (chromium (VI)
concentration equal to or greater than 50
mcg/mL) for the initial test on the first
aliquot and a different confirmatory test
(e.g., GC/MS) for the confirmatory test
with the pyridine concentration equal to
or greater than the LOQ of the analysis
on the second aliquot;
(g) The presence of a surfactant is
verified by using a surfactant
colorimetric test with an equal to or
greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff for the initial test on the first
aliquot and a different confirmatory test
(e.g., multi-wavelength
spectrophotometry) with an equal to or
greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff on the second aliquot; or
(h) The presence of any other
adulterant not specified in paragraphs
(b) through (g) of this section is verified
using an initial test on the first aliquot
and a different confirmatory test on the
second aliquot.
Section 3.6 What criteria are used to
report a specimen as substituted?
An HHS-certified laboratory reports a
primary (Bottle A) specimen as
substituted when the creatinine
concentration is less than 2 mg/dL on
both the initial and confirmatory
creatinine tests on two separate aliquots
(i.e., the same colorimetric test may be
used to test both aliquots) and the
specific gravity is less than or equal to
1.0010 or equal to or greater than 1.0200
on both the initial and confirmatory
specific gravity tests on two separate
aliquots (i.e., a refractometer is used to
test both aliquots).
Section 3.7 What criteria are used to
report a specimen as dilute?
A dilute result may be reported only
in conjunction with the positive or
negative drug test results for a
specimen.
(a) An HHS-certified laboratory or an
HHS-certified IITF reports a primary
(Bottle A) specimen as dilute when the
creatinine concentration is greater than
5 mg/dL but less than 20 mg/dL and the
specific gravity is equal to or greater

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than 1.002 but less than 1.003 on a
single aliquot.
(b) In addition, an HHS-certified
laboratory reports a primary (Bottle A)
specimen as dilute when the creatinine
concentration is equal to or greater than
2 mg/dL but less than or equal to 5 mg/
dL and the specific gravity is greater
than 1.0010 but less than 1.0030.
Section 3.8 What criteria are used to
report an invalid result for a specimen?
An HHS-certified laboratory reports a
primary (Bottle A) specimen as an
invalid result when:
(a) Inconsistent creatinine
concentration and specific gravity
results are obtained (i.e., the creatinine
concentration is less than 2 mg/dL on
both the initial and confirmatory
creatinine tests and the specific gravity
is greater than 1.0010 but less than
1.0200 on the initial and/or
confirmatory specific gravity test, the
specific gravity is less than or equal to
1.0010 on both the initial and
confirmatory specific gravity tests and
the creatinine concentration is equal to
or greater than 2 mg/dL on either or
both the initial or confirmatory
creatinine tests);
(b) The pH is equal to or greater than
3 and less than 4.5 or equal to or greater
than 9 and less than 11 using either a
colorimetric pH test or pH meter for the
initial test and a pH meter for the
confirmatory test on two separate
aliquots;
(c) The nitrite concentration is equal
to or greater than 200 mcg/mL using a
nitrite colorimetric test or equal to or
greater than the equivalent of 200 mcg/
mL nitrite using a general oxidant
colorimetric test for both the initial
(first) test and the second test or using
either initial test and the nitrite
concentration is equal to or greater than
200 mcg/mL but less than 500 mcg/mL
for a different confirmatory test (e.g.,
multi-wavelength spectrophotometry,
ion chromatography, capillary
electrophoresis) on two separate
aliquots;
(d) The possible presence of
chromium (VI) is determined using the
same chromium (VI) colorimetric test
with a cutoff equal to or greater than 50
mcg/mL chromium (VI) for both the
initial (first) test and the second test on
two separate aliquots;
(e) The possible presence of a halogen
(e.g., bleach, iodine, fluoride) is
determined using the same halogen
colorimetric test with a cutoff equal to
or greater than the LOQ for both the
initial (first) test and the second test on

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two separate aliquots or relying on the
odor of the specimen as the initial test;
(f) The possible presence of
glutaraldehyde is determined by using
the same aldehyde test (aldehyde
present) or characteristic immunoassay
response on one or more drug
immunoassay tests for both the initial
(first) test and the second test on two
separate aliquots;
(g) The possible presence of an
oxidizing adulterant is determined by
using the same general oxidant
colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff, an equal to or greater
than 50 mcg/mL chromium (VI)equivalent cutoff, or a halogen
concentration is equal to or greater than
the LOQ) for both the initial (first) test
and the second test on two separate
aliquots;
(h) The possible presence of a
surfactant is determined by using the
same surfactant colorimetric test with
an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff for both the initial (first) test and
the second test on two separate aliquots
or a foam/shake test for the initial test;
(i) Interference occurs on the
immunoassay drug tests on two separate
aliquots (i.e., valid immunoassay drug
test results cannot be obtained);
(j) Interference with the drug
confirmatory assay occurs on two
separate aliquots of the specimen and
the laboratory is unable to identify the
interfering substance;
(k) The physical appearance of the
specimen (e.g., viscosity) is such that
testing the specimen may damage the
laboratory’s instruments; or
(l) The specimen has been tested and
the physical appearances of Bottles A
and B (e.g., color) are clearly different.
Subpart D—Collectors

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Section 4.1
specimen?

Who may collect a

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

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Section 4.2
specimen?

Who may not collect a

(a) A Federal agency employee who is
in a testing designated position and
subject to the Federal agency drug
testing rules must not be a collector for
co-workers who are in the same testing
pool or who work together with that
employee on a daily basis.
(b) A Federal agency applicant or
employee must not collect his or her
own urine.
(c) An employee working for an HHScertified laboratory or IITF must not act
as a collector if the employee could link
the identity of the donor to the donor’s
drug test result.
(d) To avoid a potential conflict of
interest, a collector should not be
someone that is related to the employee
(e.g., spouse, ex-spouse, relative) or a
close personal friend (e.g., fiance´).
Section 4.3 What are the requirements
to be a collector?
(a) An individual may serve as a
collector when the individual:
(1) Is knowledgeable about the
collection procedure described in these
Guidelines;
(2) Is knowledgeable about any
guidance provided by the Federal
agency’s Drug-Free Workplace Program
or additional information provided by
the Secretary relating to these
Guidelines;
(3) Has received training from a
qualified trainer for collectors on the
following subjects:
(i) All steps necessary to complete a
collection correctly and the proper
completion and transmission of the
Federal CCF;
(ii) Problem collections;
(iii) Fatal flaws, correctable flaws, and
how to correct problems in collections;
and
(iv) The collector’s responsibility for
maintaining the integrity of the
collection process, ensuring the privacy
of individuals being tested, ensuring the
security of the specimen, and avoiding
conduct or statements that could be
viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in
collections by completing five
consecutive error-free mock collections.
(i) The five mock collections must
include two uneventful collection
scenarios, one insufficient quantity of
urine scenario, one temperature out of
range scenario, and one scenario in
which the donor refuses to sign the
Federal CCF and initial the specimen
bottle tamper-evident seal.
(ii) A qualified trainer for collectors
must monitor and evaluate the
individual being trained, in person or by

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a means that provides real-time
observation and interaction between the
trainer and the individual being trained,
and attest in writing that the mock
collections are ‘‘error-free.’’
(b) A trained collector must complete
refresher training on the requirements in
paragraph a of this section no less
frequently than every five years from the
date on which he or she was first
trained.
(c) The collector must maintain the
documentation of his or her training and
provide it to a Federal agency when
requested.
(d) An individual may not collect
specimens for a Federal agency until his
or her training as a collector has been
properly documented.
Section 4.4 What are the requirements
to be an observer for a direct observed
collection?
(a) An individual may serve as an
observer for a direct observed collection
when the individual has satisfied the
requirements:
(1) Is knowledgeable about the direct
observed collection procedure described
in Section 8.9 of these Guidelines;
(2) Is knowledgeable about any
guidance provided by the Federal
agency’s Drug-Free Workplace Program
or additional information provided by
the Secretary relating to the direct
observed collection procedure described
in these Guidelines;
(3) Has received training on the
following subjects:
(i) All steps necessary to perform a
direct observed collection correctly; and
(ii) The observer’s responsibility for
maintaining the integrity of the
collection process, ensuring the privacy
of individuals being tested, ensuring
that the observation is done in a
professional manner that minimizes the
discomfort to the employee so observed,
ensuring the security of the specimen by
maintaining visual contact with the
collection container until it is delivered
to the collector, and avoiding conduct or
statements that could be viewed as
offensive or inappropriate.
(b) The observer must be the same
gender as the donor.
(c) The observer is not required to be
a trained collector.
Section 4.5 What are the requirements
to be a trainer for collectors?
(a) An individual is considered to be
a qualified trainer for collectors and
may train others to collect specimens
when the individual has:
(1) Qualified as a trained collector and
regularly conducted drug test
collections for a period of at least one
year; or

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(2) Successfully completed a ‘‘train
the trainer’’ course given by an
organization (e.g., manufacturer, private
entity, contractor, Federal agency).
(b) A qualified trainer for collectors
must complete refresher training in
accordance with the collector
requirements in Section 4.3(a) no less
frequently than every five years from the
date on which he or she was first
trained.
(c) A qualified trainer for collectors
must maintain the documentation of his
or her training and provide it to a
Federal agency when requested.
Section 4.6 What must a Federal
agency do before an individual is
permitted to collect a specimen?
A Federal agency must:
(a) Ensure that the individual that
serves as a collector has satisfied the
requirements described in Section 4.3;
(b) Ensure that the collector (who may
be self-employed) or an organization
(e.g., third party administrator that
provides a collection service, collector
training company, Federal agency that
employs its own collectors) maintains a
copy of the record(s) that document the
individual’s training as a collector; and
(c) Provide to the collector the name
and telephone number of the Federal
agency representative to contact about
problems or issues that may arise during
a specimen collection procedure.
Subpart E—Collection Sites

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Section 5.1 Where can a collection for
a drug test take place?
(a) A collection site may be a
permanent or temporary facility located
either at the work site or at a remote
site.
(b) In the event that an agencydesignated collection site is not
accessible and there is an immediate
requirement to collect a specimen (e.g.,
an accident investigation), a public
restroom may be used for the collection,
using the procedures for a monitored
collection described in Section 8.11.
Section 5.2 What are the requirements
for a collection site?
A facility that is used as a collection
site must have the following:
(a) Provisions to ensure donor privacy
during the specimen collection
procedure in accordance with Section
8.1;
(b) A suitable clean surface area not
accessible to the donor, for handling the
specimens and completing the required
paperwork;
(c) A secure temporary storage
capability to maintain a specimen until
it is transferred to an HHS-certified
laboratory or IITF;

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(d) The ability to restrict access to
only authorized personnel during the
collection;
(e) The ability to restrict access to
collection supplies;
(f) The ability to store records
securely; and
(g) The ability to restrict the donor
access to potential diluents in
accordance with Section 8.2.
Section 5.3 How long must collection
site records be stored?
Collection site records (e.g., collector
copies of the OMB-approved Federal
CCF) must be stored for a minimum of
2 years by the collector or the collector’s
employer.
Section 5.4 How does the collector
ensure the security and integrity of a
specimen at the collection site?
(a) A collector must do the following
to maintain the security and integrity of
a specimen:
(1) Not allow unauthorized personnel
to enter the collection site during the
collection procedure;
(2) Perform only one specimen
collection at a time;
(3) Restrict access to collection
supplies before and during the
collection;
(4) Ensure only the collector and the
donor are allowed to handle the
unsealed specimen;
(5) Ensure the chain of custody is
maintained and documented throughout
the entire collection procedure;
(6) Ensure that the Federal CCF is
enclosed with the specimens and sealed
for shipment to an HHS-certified
laboratory or IITF; and
(7) Ensure that specimens transported
to an HHS-certified laboratory or IITF
are placed in containers designed to
minimize the possibility of damage
during shipment (e.g., specimen boxes,
padded mailers, or other suitable
shipping container), and those
containers are securely sealed to
eliminate the possibility of undetected
tampering;
(b) Since specimens are sealed in
packages that would indicate any
tampering during transit to the HHScertified laboratory or IITF and couriers,
express carriers, and postal service
personnel do not have access to the
Federal CCF or split specimens, there is
no requirement that such personnel
document chain of custody for the
package during transit.

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Subpart F—Federal Drug Testing
Custody and Control Form
Section 6.1 What form is used for
collecting a specimen?
An OMB-approved Federal CCF must
be used to document the collection of
each urine specimen at the collection
site.
Section 6.2 What happens if the
correct Federal CCF is not available or
is not used?
(a) When the collector either by
mistake or as the only means to
document a collection under difficult
circumstances (e.g., post-accident test
with insufficient time to obtain the
correct CCF) uses a non-Federal form or
an expired Federal CCF for a Federal
agency specimen collection, the use of
the incorrect form is not, by itself, a
reason for the laboratory or IITF to
automatically reject the specimen for
testing or for the MRO to cancel the test.
(b) If the collector realizes that an
incorrect form was used before the
specimen bottles are packaged for
transit to the laboratory or IITF, the
collector must show on the form that it
is a Federal agency specimen collection
and give the reason why an incorrect
form was used. Based on the
information provided by the collector,
the laboratory or IITF must handle and
test the specimen as a Federal agency
specimen.
(c) If the laboratory, IITF, or MRO
discovers that an incorrect form was
used by the collector, the laboratory,
IITF, or MRO must obtain a
memorandum for the record from the
collector stating the reason why the
correct Federal CCF was not used to
collect the Federal agency specimen. If
after 5 business days a memorandum for
the record cannot be obtained, the
laboratory or IITF reports a rejected for
testing result and the MRO cancels the
test.
Subpart G—Specimen Collection
Containers
Section 7.1 What is used to collect a
urine specimen?
(a) A single-use collection container/
cup that is capable of holding at least 55
mL; and
(b) Two specimen bottles which can
be sealed for transport; one of which can
hold at least 35 mL and the other at least
20 mL.

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Section 7.2 Are there any restrictions
on the containers and bottles used to
collect urine specimens?
Collection containers/cups and
specimen bottles must not substantially
affect the specimen collected.
Subpart H—Specimen Collection
Procedure

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Section 8.1 What privacy must the
donor be given when providing a
specimen?
The following privacy requirements
apply when a donor is providing a
specimen:
(a) Only authorized personnel and the
donor may be present at the collection
site while the collector is collecting a
specimen.
(b) The collector does not need to be
the same gender as the donor. The
observer for a direct observed collection
(i.e., as described in Section 8.9) must
be the same gender as the donor. The
monitor for a monitored collection (i.e.,
as described in Section 8.11) must be
the same gender as the donor, unless the
monitor is a medical professional (e.g.,
nurse, doctor, physician’s assistant,
technologist, or technician licensed or
certified to practice in the jurisdiction
in which the collection takes place).
(c) The collector must give the donor
visual privacy while providing the
specimen. The donor is allowed to
provide a urine specimen in an enclosed
stall within a multi-stall restroom or in
a single person restroom.
Section 8.2 What must the collector do
at the collection site before starting a
specimen collection procedure?
The collector must deter the dilution
or substitution of a specimen at the
collection site by:
(a) Placing a toilet bluing agent in a
toilet bowl or toilet tank, so the
reservoir of water in the toilet bowl
always remains blue. If no bluing agent
is available or if the toilet has an
automatic flushing system, the collector
shall turn off the water supply to the
toilet and flush the toilet to remove the
water in the toilet when possible.
(b) Securing any other source of water
(e.g., no shower or sink) in the enclosure
where urination occurs that is not
secured during the collection. If the
enclosure used by the donor to provide
a specimen has a source of water that
cannot be disabled or secured, a
monitored collection must be conducted
in accordance with Section 8.10.
Section 8.3 What are the preliminary
steps in the collection process?
The collector must take the following
steps before beginning a collection:

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(a) If a donor fails to arrive at the
collection site at the assigned time, the
collector must contact the Federal
agency representative to obtain
guidance on action to be taken.
(b) When the donor arrives at the
collection site, the collector begins the
testing process without undue delay.
For example, the collection is not
delayed because the donor says he or
she is not ready or is unable to urinate
or because an authorized employer or
employer representative is late in
arriving.
(c) The collector requests the donor to
present photo identification (e.g.,
driver’s license, employee badge issued
by the employer, any other picture
identification issued by a Federal, state,
or local government agency). If the
donor does not have proper photo
identification, the collector shall contact
the supervisor of the donor or the
Federal agency representative who can
positively identify the donor. If the
donor’s identity cannot be established,
the collector shall not proceed with the
collection.
(d) The collector must provide
identification (e.g., employee badge,
employee list) to the donor if the donor
asks.
(e) The collector explains the basic
collection procedure to the donor.
(f) The collector informs the donor
that he or she may read the instructions
for completing the custody and control
form which are located on the back of
the Federal CCF.
(g) The collector answers any
reasonable and appropriate questions
the donor may have regarding the
collection procedure.
(h) The collector asks the donor to
remove any unnecessary outer garments
such as a coat or jacket that might
conceal items or substances that could
be used to adulterate or substitute the
urine specimen:
(1) The collector must ensure that all
personal belongings such as a purse or
briefcase remain with the outer
garments; the donor may retain his or
her wallet.
(2) The collector asks 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
or substitute the specimen;
(3) If nothing is present that can be
used to adulterate or substitute a
specimen, the donor places the items
back into the pockets and the collection
procedure continues;
(4) If an item is found that appears to
have been brought to the collection site
with the intent to adulterate or
substitute the specimen, a direct
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accordance with Section 8.9. If the item
appears to be inadvertently brought to
the collection site, the collector must
secure the item and continue with the
normal collection procedure.
(5) If the donor refuses to show the
collector the items in his or her pockets,
this is considered a ‘‘refusal to test.’’
The collector must stop the collection
and report the refusal to test as
described in Section 8.12.
(i) The collector shall instruct the
donor to wash and dry his or her hands
prior to urination. After washing hands,
the donor must remain in the presence
of the collector and must not have
access to any water fountain, faucet,
soap dispenser, cleaning agent, or any
other materials which could be used to
adulterate or substitute the specimen.
Section 8.4 What steps does the
collector take in the collection process
before the donor provides a urine
specimen?
(a) The collector gives the donor or
allows the donor to select a specimen
collection container. The collector
instructs the donor to provide his or her
specimen in the privacy of a stall or
otherwise partitioned area that allows
for individual privacy. The collector
directs the donor to provide a specimen
of at least 45 mL, to not flush the toilet,
and to return with the specimen as soon
as the donor has completed the void.
(1) Except in the case of a direct
observed collection (i.e., as described in
Section 8.9) or a monitored collection
(i.e., as described in Section 8.11),
neither the collector nor anyone else
may go into the room with the donor.
(2) The collector may set a reasonable
time limit for voiding.
(b) The collector notes any unusual
behavior or appearance of the donor on
the Federal CCF. If the collector detects
any conduct that clearly indicates an
attempt to tamper with a specimen (e.g.,
substitute urine in plain view or an
attempt to bring into the collection site
an adulterant or urine substitute), the
collector must conduct an immediate
collection under direct observation in
accordance with Section 8.8. The
collector must note the conduct and the
fact that the collection was observed on
the CCF.
Section 8.5 What procedure is used
when the donor states that he or she is
unable to provide a specimen?
(a) If the donor states that he or she
is unable to provide a specimen during
the collection process, the collector
requests that the donor enter the
restroom (stall) and attempt to provide
a specimen.

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(b) The donor demonstrates his or her
inability to provide a specimen when he
or she comes out of the stall with an
empty collection container.
(1) If the donor states that he or she
could provide a specimen after drinking
some fluids, the collector gives the
donor a reasonable amount of liquid to
drink for this purpose (e.g., an 8 ounce
glass of water every 30 minutes, but not
to exceed a maximum of 40 ounces over
a period of 3 hours or until the donor
has provided a sufficient urine
specimen). If the donor simply needs
more time before attempting to provide
a urine specimen, the donor is not
required to drink any fluids during this
waiting time.
(2) If the donor states that he or she
is unable to provide a urine specimen,
the collector records the reason for not
collecting a urine specimen on the
Federal CCF, notifies the Federal
agency’s designated representative, and
sends the appropriate copies of the
Federal CCF to the MRO and to the
Federal agency’s designated
representative. The collector stops the
collection procedure and requests that
the donor leave the collection site.
Section 8.6 What steps does the
collector take in the collection process
after the donor provides a urine
specimen?
The collector must take the following
steps after the donor provides the urine
specimen:
(a) After providing the specimen, the
donor gives the specimen collection
container to the collector. Both the
donor and the collector must keep the
specimen container in view at all times
until the collector seals the specimen
bottles as described in Section 8.7.
(b) After the donor has given the
specimen to the collector, whenever
practical, the donor shall be allowed to
wash his or her hands and the donor
may flush the toilet.
(c) The collector must measure the
temperature of the specimen within 4
minutes of receiving the specimen from
the donor. The collector records on the
Federal CCF whether or not the
temperature is in the acceptable range of
32°–38 °C/90°–100 °F.
(1) The temperature measuring device
must accurately reflect the temperature
of the specimen and not contaminate
the specimen.
(2) If the temperature of the specimen
is outside the range of 32°–38° C/90°–
100° F, that is a reason to believe that
the donor may have adulterated or
substituted the specimen. Another
specimen must be collected under direct
observation in accordance with Section
8.8. The collector will forward both

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specimens (i.e., from the first and
second collections) to an HHS-certified
laboratory for testing and records a
comment on the Federal CCF.
(d) The collector must inspect the
specimen to determine if there is any
sign indicating that the specimen may
not be a valid urine specimen (e.g.,
unusual color, presence of foreign
objects or material, unusual odor).
(1) The collector notes any unusual
finding on the Federal CCF. A specimen
suspected of not being a valid urine
specimen must be forwarded to an HHScertified laboratory for testing.
(2) When there is any reason to
believe that a donor may have
adulterated or substituted the specimen,
another specimen must be obtained as
soon as possible under direct
observation in accordance with Section
8.8. The collector will forward both
specimens (i.e., from the first and
second collections) to an HHS-certified
laboratory for testing and records a
comment on the Federal CCF.
(e) The collector must determine the
volume of urine in the specimen
container. The collector must never
combine urine collected from separate
voids to create a specimen.
(1) If the volume is at least 45 mL, the
collector will proceed with steps
described in Section 8.7.
(2) If the volume is less than 45 mL,
the collector discards the specimen and
immediately collects a second specimen
using the same procedures as for the
first specimen (including steps in
paragraphs c and d of this section).
(i) The collector may give the donor
a reasonable amount of liquid to drink
for this purpose (e.g., an 8 ounce glass
of water every 30 minutes, but not to
exceed a maximum of 40 ounces over a
period of 3 hours or until the donor has
provided a sufficient urine specimen).
However, the donor is not required to
drink any fluids during this waiting
time.
(ii) If the donor provides a sufficient
urine specimen (i.e., at least 45 mL), the
collector proceeds with steps described
in Section 8.7.
(iii) If the employee has not provided
a sufficient specimen (i.e., at least 45
mL) within three hours of the first
unsuccessful attempt to provide the
specimen, the collector stops the
collection procedure and:
(A) Notes on the Federal CCF that the
donor has not provided a sufficient
volume of urine for the drug test;
(B) Notifies the Federal agency’s
designated representative;
(C) Discards the insufficient
specimen;
(D) Requests that the donor leave the
collection site;

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(E) Sends the appropriate copies of
the Federal CCF to the MRO and to the
Federal agency.
(f) If the donor fails to remain present
through the completion of the
collection, declines to have a direct
observed collection as required in steps
(c)(2) or (d)(2) above, or refuses to
provide a second specimen as required
in step (e)(2) above, the collector stops
the collection and reports the refusal to
test in accordance with Section 8.12.
Section 8.7 How does the collector
prepare the specimens?
(a) All Federal agency collections are
to be split specimen collections.
(b) The collector, in the presence of
the donor, pours the urine from the
collection container into two specimen
bottles to be labeled Bottle A and Bottle
B. The collector pours at least 30 mL of
urine into Bottle A and at least 15 mL
into Bottle B, and caps each bottle.
(c) In the presence of the donor, the
collector places a tamper-evident label/
seal from the Federal CCF over each
specimen bottle cap. The collector
records the date of the collection on the
tamper-evident labels/seals.
(d) The donor initials the tamperevident labels/seals on each specimen
bottle. If the donor refuses to initial the
labels/seals, the collector notes the
refusal on the Federal CCF and
continues with the collection process.
(e) The collector asks the donor to
read and sign a statement on the Federal
CCF certifying that the specimens
identified were collected from him or
her. If the donor refuses to sign the
certification statement, the collector
notes the refusal on the Federal CCF and
continues with the collection process.
(f) The collector signs and prints his
or her name on the Federal CCF,
completes the Federal CCF, and
distributes the copies of the CCF as
required.
(g) The collector seals the specimens
(Bottle A and Bottle B) and Federal CCF
in a package in accordance with
instructions on the back of the Federal
CCF for transfer to an HHS-certified
laboratory or IITF.
(h) If the specimen bottles and Federal
CCF are not immediately prepared for
transfer to an HHS-certified laboratory
or IITF, they must be appropriately
safeguarded until the transfer occurs.
(i) The collector must discard any
urine left over in the collection
container after both specimen bottles
have been appropriately filled and
sealed. There is one exception to this
requirement: The collector may use
excess urine to conduct clinical tests
(e.g., protein, glucose) if the collection
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physical examination required by a
Federal agency regulation. Neither the
collector nor anyone else may conduct
further testing (such as specimen
validity testing) on the excess urine.
Section 8.8 When is a direct observed
collection conducted?
A direct observed collection
procedure must be conducted when:
(a) The agency has authorized a direct
observed collection because:
(1) The donor’s previous drug test
result was reported by an MRO as
positive, adulterated, or substituted; or
(2) The certified laboratory reports to
the MRO that a specimen is invalid, and
the MRO reported to the agency that
there was not an adequate medical
explanation for the result; or
(3) The MRO reported to the agency
that the primary bottle (A) specimen
was positive, adulterated, or substituted
result had to be cancelled because the
test of the split specimen could not be
tested and/or the split specimen bottle
(B) failed to reconfirm; or
(b) At the collection site, an
immediate collection of a second urine
specimen is required because:
(1) The temperature of the specimen
collected during a routine collection is
outside the acceptable temperature
range;
(2) The collector suspects that the
donor has tampered with the specimen
during a routine collection (e.g.,
abnormal physical characteristic such as
unusual color and/or odor, and/or
excessive foaming when shaken);
(3) The collector observes conduct by
the donor that indicates a possible
attempt to adulterate or substitute the
specimen; or
(4) The collector observed materials
brought by the donor to the collection
site for the purpose of adulterating,
substituting, or diluting the specimen.
(c) The collector must contact a
collection site supervisor to review and
concur in advance with any decision by
the collector to obtain a specimen under
direct observation.
(d) If the donor declines to have a
direct observed collection, the collector
reports a refusal to test (i.e., as described
in Section 8.12).

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Section 8.9 How is a direct observed
collection conducted?
A direct observed collection
procedure is the same as that for a
routine collection, except an observer
watches the donor urinate into the
collection container. The observer must
be the same gender as the donor with no
exception to this requirement. If there is
no collector available of the same
gender as the donor, the collector or

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collection site supervisor shall select an
observer trained in direct observed
specimen collection as described in
Section 4.4. The observer may be an
individual that is not a trained collector.
At the point in a routine collection
where the donor enters the restroom
with the collection container, a direct
observed collection includes the
following additional steps:
(a) The observer enters the restroom
with the donor;
(b) The observer must directly watch
the urine go from the donor’s body into
the collection container (the use of
mirrors or video cameras is not
permitted);
(c) The observer must not touch or
handle the collection container unless
the observer is also serving as the
collector;
(d) After the donor has completed
urinating into the collection container:
(1) If the same person serves as the
observer and collector, he or she may
receive the collection container from the
donor while they are both in the
restroom;
(2) If the observer is not serving as the
collector, the donor and observer leave
the restroom and the donor hands the
collection container directly to the
collector. The observer must maintain
visual contact of the collection
container until the donor hands the
container to the collector.
(e) The collector checks the box for an
observed collection on the Federal CCF
and writes the name of the observer and
the reason for an observed collection on
the Federal CCF; and
(f) The collector then continues with
the routine collection procedure in
Section 8.7.
Section 8.10 When is a monitored
collection conducted?
(a) In the event that an agencydesignated collection site is not
available and there is an immediate
requirement to collect a specimen (e.g.,
an accident investigation), a public
restroom may be used for the collection,
using the procedures for a monitored
collection described in Section 8.11.
(b) If the enclosure used by the donor
to provide a specimen has a source of
water that cannot be disabled or
secured, a monitored collection must be
conducted.
(c) If the donor declines to permit a
collection to be monitored when
required, the collector reports a refusal
to test (i.e., as described in Section
8.12).
Section 8.11 How is a monitored
collection conducted?
A monitored collection is the same as
that for a routine collection, except that

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a monitor accompanies the donor into
the restroom to check for signs that the
donor may be tampering with the
specimen. The monitor remains in the
restroom, but outside the stall, while the
donor is providing the specimen. A
person of the same gender as the donor
shall serve as the monitor, unless the
monitor is a medical professional (e.g.,
nurse, doctor, physician’s assistant,
technologist, or technician licensed or
certified to practice in the jurisdiction
in which the collection takes place). The
monitor may be an individual other
than the collector and need not be a
qualified collector.
(a) The collector secures the restroom
being used for the monitored collection
so that no one except the employee and
the monitor can enter the restroom until
after the collection has been completed.
(b) The monitor enters the restroom
with the donor.
(c) The monitor must not watch the
employee urinate into the collection
container. If the monitor hears sounds
or makes other observations indicating
an attempt by the donor to tamper with
a specimen, there must be an additional
collection under direct observation in
accordance with Section 8.8.
(d) The monitor must not touch or
handle the collection container unless
the monitor is also the collector.
(e) After the donor has completed
urinating into the collection container:
(1) If the same person serves as the
monitor and collector, he or she may
receive the collection container from the
donor while they are both in the
restroom;
(2) If the monitor is not serving as the
collector, the donor and monitor leave
the restroom and the donor hands the
collection container directly to the
collector. The monitor must ensure that
the employee takes the collection
container directly to the collector as
soon as the employee has exited the
enclosure.
(f) If the monitor is not serving as the
collector, the collector writes the name
of the monitor on the Federal CCF.
(g) The collector then continues with
the routine collection procedure in
Section 8.7.
Section 8.12 How does the collector
report a donor’s refusal to test?
The collector stops the collection,
discards any urine collected, and
reports the refusal to test by:
(a) Notifying the Federal agency by
means (e.g., telephone, e-mail, or secure
fax) that ensures that the notification is
immediately received,
(b) Documenting the refusal to test on
the Federal CCF, and

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(c) Sending all copies of the Federal
CCF to the Federal agency’s designated
representative.

certified by HHS under these Guidelines
to test specimens for Federal agencies
unless it holds such certification.

Section 8.13 What are a Federal
agency’s responsibilities for a collection
site?
(a) A Federal agency must ensure that
collectors and collection sites satisfy all
requirements in subparts D, E, F, G, and
H.
(b) A Federal agency (or only one
Federal agency when several agencies
are using the same collection site) must
inspect 5 percent or up to a maximum
of 50 collection sites each year, selected
randomly from those sites used to
collect agency specimens.
(c) A Federal agency must investigate
reported collection site deficiencies
(e.g., specimens reported ‘‘rejected for
testing’’ by an HHS-certified IITF or
HHS-certified laboratory) and take
appropriate action which may include
inspecting the collection site. The
inspections of these additional
collection sites may not be included in
the 5 percent or maximum of 50
collection sites inspected annually.

Section 9.2 What is the process for a
laboratory or IITF to become certified
and maintain HHS certification and the
process when certification is not
maintained?
(a) A laboratory or IITF seeking HHS
certification must:
(1) Submit a completed OMBapproved application form (i.e., the
applicant laboratory or IITF provides
detailed information on both the
administrative and analytical
procedures to be used for Federal
agency specimens after it is certified);
(2) Have its application reviewed as
complete and accepted by HHS;
(3) Successfully complete the PT
challenges in 3 consecutive sets of
initial PT samples;
(4) Satisfy all the requirements for an
initial inspection; and
(5) Receive a letter of certification
from the Secretary before being able to
test specimens for Federal agencies.
(b) To maintain HHS certification, a
laboratory or IITF must:
(1) Successfully participate in both
the maintenance PT and inspection
programs (i.e., successfully test the
required quarterly sets of maintenance
PT samples, undergo an inspection 3
months after being certified, and
undergo maintenance inspections every
6 months thereafter);
(2) Respond in an appropriate, timely,
and complete manner to required
corrective action in the event of
problems identified in either the
maintenance PT or inspection program
or in operations and reporting; and
(3) Satisfactorily complete corrective
remedial action and undergo a special
inspection and, as necessary, special PT
sets to maintain or restore certification
when material deficiencies occur in
either the PT program, inspection
program, or in operations and reporting.
(c) A laboratory or IITF that does not
maintain its HHS certification must:
(1) Stop testing Federal agency
specimens;
(2) Ensure the security of Federal
agency specimens and records
throughout the required storage period
described in Sections 11.20, 11.21,
12.18, and 14.8;
(3) Ensure access to Federal agency
specimens and records in accordance
with Sections 11.23, 12.20, and subpart
N; and
(3) When suspension and revocation
procedures are imposed by the
Secretary, follow the HHS procedures in
subpart P that will be used for all
actions associated with the suspension
and/or revocation of HHS-certification.

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Subpart I—HHS Certification of
Laboratories and IITFs
Section 9.1 Who has the authority to
certify laboratories and IITFs to test
specimens for Federal agencies?
(a) The Secretary has broad discretion
to take appropriate action to ensure the
full reliability and accuracy of drug
testing and reporting, to resolve
problems related to drug testing, and to
enforce all standards set forth in these
Guidelines. The Secretary has the
authority to issue directives to any
laboratory or IITF suspending the use of
certain analytical procedures when
necessary to protect the integrity of the
testing process; ordering any laboratory
or IITF to undertake corrective actions
to respond to material deficiencies
identified by an inspection or through
performance testing; ordering any
laboratory or IITF to send specimens or
specimen aliquots to another laboratory
for retesting when necessary to ensure
the accuracy of testing under these
Guidelines; ordering the review of
results for specimens tested under the
Guidelines for private sector clients to
the extent necessary to ensure the full
reliability of drug testing for Federal
agencies; and ordering any other action
necessary to address deficiencies in
drug testing, analysis, specimen
collection, chain of custody, reporting of
results, or any other aspect of the
certification program.
(b) A laboratory or IITF is prohibited
from stating or implying that it is

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Section 9.3 What are the qualitative
and quantitative specifications of a
performance test (PT) sample?
(a) PT samples used to evaluate drug
tests will be formulated as follows:
(1) A PT sample may contain one or
more of the drugs and metabolites in the
drug classes listed in Section 3.4 and
satisfy one of the following parameters:
(i) The concentration of a drug or
metabolite will be at least 20 percent
above the initial test cutoff
concentration for the drug;
(ii) The concentration of a drug or
metabolite may be as low as 40 percent
of the confirmatory test cutoff
concentration when the PT sample is
designated as a retest sample; or
(iii) The concentration of drug or
metabolite may be at another
concentration for a special purpose.
(2) A PT sample may contain an
interfering substance, an adulterant, or
satisfy the criteria for a substituted
specimen, dilute specimen, or invalid
result.
(3) A negative PT sample will not
contain a measurable amount of a target
analyte.
(b) PT samples used to evaluate
specimen validity tests shall satisfy, but
are not limited to, one of the following
criteria:
(1) The nitrite concentration will be at
least 20 percent above the cutoff;
(2) The pH will be between 1.5 and
5.0 or between 8.5 and 12.5;
(3) The concentration of an oxidant
will be at a level sufficient to challenge
a laboratory’s ability to identify and
confirm the oxidant;
(4) The creatinine concentration will
be between 0 and 20 mg/dL; or
(5) The specific gravity will be less
than or equal to 1.0050 or between
1.0170 and 1.0230.
(c) For each PT cycle, the set of PT
samples going to each laboratory or IITF
will vary but, within each calendar year,
each laboratory or IITF will analyze
essentially the same total set of samples.
(d) The laboratory or IITF must, to the
greatest extent possible, handle, test,
and report a PT sample in a manner
identical to that used for a donor
specimen, unless otherwise specified.
Section 9.4 What are the PT
requirements for an applicant
laboratory?
(a) An applicant laboratory that seeks
certification under these Guidelines
must satisfy the following criteria on 3
consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and
report at least 90 percent of the total
drug challenges over the 3 sets of PT
samples;

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(3) Correctly identify at least 80
percent of the drug challenges for each
initial drug test over the 3 sets of PT
samples;
(4) For the confirmatory drug tests,
correctly determine that the
concentrations for at least 80 percent of
the total drug challenges are no more
than ±20 percent or ±2 standard
deviations (whichever is larger) from the
appropriate reference or peer group
means over the 3 sets of PT samples;
(5) For the confirmatory drug tests,
must not obtain any drug concentration
on a PT sample that differs by more than
±50 percent from the appropriate
reference or peer group mean;
(6) For each confirmatory drug test,
correctly identify and determine that the
concentrations for at least 50 percent of
the drug challenges are no more than
±20 percent or ±2 standard deviations
(whichever is larger) from the
appropriate reference or peer group
means over the 3 sets of PT samples;
(7) Correctly identify at least 80
percent of the total specimen validity
testing challenges over the 3 sets of PT
samples;
(8) Correctly identify at least 80
percent of the challenges for each
individual specimen validity test over
the 3 sets of PT samples;
(9) For quantitative specimen validity
tests, obtain quantitative values for at
least 80 percent of the total challenges
over the 3 sets of PT samples that satisfy
the following criteria:
(i) Nitrite and creatinine
concentrations are no more than ±20
percent or ±2 standard deviations from
the appropriate reference or peer group
mean; and
(ii) pH values are no more than ±0.3
pH units from the appropriate reference
or peer group mean using a pH meter;
and
(iii) Specific gravity values are no
more than ±0.0003 specific gravity units
from the appropriate reference or peer
group mean when the mean is less than
1.0100 and specific gravity values are no
more than ±0.0004 specific gravity units
from the appropriate reference or peer
group mean when the mean is equal to
or greater than 1.0100;
(10) Must not obtain any quantitative
value on a specimen validity test PT
sample that differs from the appropriate
reference or peer group mean by more
than ±50 percent for nitrite and
creatinine concentrations, ±0.8 pH units
using a pH meter, ±0.0006 specific
gravity units when the mean is less than
1.0100, or ±0.0007 specific gravity units
when the mean is equal to or greater
than 1.0100; and
(11) Must not report any sample as
adulterated with a compound that is not

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present in the sample, adulterated based
on pH when the appropriate reference
or peer group mean is within the
acceptable pH range, or substituted
when the appropriate reference or peer
group means for both creatinine and
specific gravity are within the
acceptable range.
(b) Failure to satisfy these
requirements will result in
disqualification.
Section 9.5 What are the PT
requirements for an HHS-certified
laboratory?
(a) A laboratory certified under these
Guidelines must satisfy the following
criteria on the maintenance PT samples
to maintain its certification:
(1) Have no false positive results;
(2) Correctly identify, confirm, and
report at least 90 percent of the total
drug challenges over 2 consecutive PT
cycles;
(3) Correctly identify at least 80
percent of the drug challenges for each
initial drug test over 2 consecutive PT
cycles;
(4) For the confirmatory drug tests,
correctly determine that the
concentrations for at least 80 percent of
the total drug challenges are no more
than ±20 percent or ±2 standard
deviations (whichever is larger) from the
appropriate reference or peer group
means over 2 consecutive PT cycles;
(5) For the confirmatory drug tests,
obtain no more than one drug
concentration on a PT sample that
differs by more than ±50 percent from
the appropriate reference or peer group
mean over 2 consecutive PT cycles;
(6) For each confirmatory drug test,
correctly identify and determine that the
concentrations for at least 50 percent of
the drug challenges for an individual
drug are no more than ±20 percent or ±2
standard deviations (whichever is
larger) from the appropriate reference or
peer group means over 2 consecutive PT
cycles;
(7) Correctly identify at least 80
percent of the total specimen validity
test challenges over 2 consecutive PT
cycles;
(8) Correctly identify at least 80
percent of the challenges for each
individual specimen validity test over 2
consecutive PT cycles;
(9) For quantitative specimen validity
tests, obtain quantitative values for at
least 80 percent of the total challenges
over 2 consecutive PT cycles that satisfy
the following criteria:
(i) Nitrite and creatinine
concentrations are no more than ±20
percent or ±2 standard deviations from
the appropriate reference or peer group
mean;

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(ii) pH values are no more than ±0.3
pH units from the appropriate reference
or peer group mean using a pH meter;
and
(iii) Specific gravity values are no
more than ±0.0003 specific gravity units
from the appropriate reference or peer
group mean when the mean is less than
1.0100 and specific gravity values are no
more than ±0.0004 specific gravity units
from the appropriate reference or peer
group mean when the mean is equal to
or greater than 1.0100;
(10) Obtain no more than one
quantitative value over 2 consecutive PT
cycles on a specimen validity test PT
sample that differs from the appropriate
reference or peer group mean by more
than ±50 percent for nitrite and
creatinine concentrations, ±0.8 pH units
using a pH meter, ±0.0006 specific
gravity units when the mean is less than
1.0100, or ±0.0007 specific gravity units
when the mean is equal to or greater
than 1.0100; and
(11) Do not report any PT sample as
adulterated with a compound that is not
present in the sample, adulterated based
on pH when the appropriate reference
or peer group mean is within the
acceptable pH range, or substituted
when the appropriate reference or peer
group means for both creatinine and
specific gravity are within the
acceptable range.
(b) Failure to participate in a PT cycle
or to satisfy these requirements may
result in suspension or revocation of an
HHS-certified laboratory’s certification.
Section 9.6 What are the PT
requirements for an applicant IITF?
(a) An applicant IITF that seeks
certification under these Guidelines
must satisfy the following criteria on 3
consecutive sets of PT samples:
(1) Correctly identify at least 90
percent of the total drug challenges over
the 3 sets of PT samples;
(2) Correctly identify at least 80
percent of the drug challenges for each
individual drug test over the 3 sets of PT
samples;
(3) Correctly identify at least 80
percent of the total specimen validity
test challenges over the 3 sets of PT
samples;
(4) Correctly identify at least 80
percent of the challenges for each
individual specimen validity test over
the 3 sets of PT samples;
(5) For quantitative specimen validity
tests, obtain quantitative values for at
least 80 percent of the total specimen
validity test challenges over the 3 sets
of PT samples that satisfy the following
criteria:
(i) Creatinine concentrations are no
more than ±20 percent or ±2 standard

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deviations (whichever is larger) from the
appropriate reference or peer group
mean; and
(ii) Specific gravity values are no
more than ±0.001 specific gravity units
from the appropriate reference or peer
group mean; and
(6) Must not obtain any quantitative
value on a specimen validity test PT
sample that differs from the appropriate
reference or peer group mean by more
than ±50 percent for creatinine
concentration, or ±0.002 specific gravity
units for specific gravity.
(b) Failure to satisfy these
requirements will result in
disqualification.

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

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

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

(a) An IITF certified under these
Guidelines must satisfy the following
criteria on the maintenance PT samples
to maintain its certification:
(1) Correctly identify at least 90
percent of the total drug challenges over
2 consecutive PT cycles;
(2) Correctly identify at least 80
percent of the drug challenges for each
individual drug test over 2 consecutive
PT cycles;
(3) Correctly identify at least 80
percent of the total specimen validity
test challenges over 2 consecutive PT
cycles;
(4) Correctly identify at least 80
percent of the challenges for each
individual specimen validity test over 2
consecutive PT cycles;
(5) For quantitative specimen validity
tests, obtain quantitative values for at
least 80 percent of the total specimen
validity test challenges over 2
consecutive PT cycles that satisfy the
following criteria:
(i) Creatinine concentrations are no
more than ±20 percent or ±2 standard
deviations (whichever is larger) from the
appropriate reference or peer group
mean; and
(ii) Specific gravity values are no
more than ±0.001 specific gravity units
from the appropriate reference or peer
group mean; and
(6) Obtain no more than one
quantitative value over 2 consecutive PT
cycles on a specimen validity test PT
sample that differs from the appropriate
reference or peer group mean by more
than ±50 percent for creatinine
concentration, or ±0.002 specific gravity
units for specific gravity.
(b) Failure to participate in a PT cycle
or to satisfy these requirements may
result in suspension or revocation of an
HHS-certified IITF’s certification.

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(a) An applicant laboratory or IITF is
inspected by a team of two inspectors.
(b) Each inspector conducts an
independent review and evaluation of
all aspects of the laboratory’s or IITF’s
testing procedures and facilities using
an inspection checklist.
(c) To become certified, an applicant
laboratory or IITF must satisfy the
minimum requirements as stated in
these Guidelines.
Section 9.9 What are the maintenance
inspection requirements for an HHScertified laboratory or IITF?

Section 9.10 Who can inspect an HHScertified laboratory or IITF and when
may the inspection be conducted?
(a) An individual may be selected as
an inspector for the Secretary if he or
she satisfies the following criteria:
(1) Has experience and an educational
background similar to that required for
either the responsible person or the
certifying scientist as described in
subpart K for a laboratory or as a
responsible technician as described in
subpart L;
(2) Has read and thoroughly
understands the policies and
requirements contained in these
Guidelines and in other guidance
consistent with these Guidelines
provided by the Secretary;
(3) Submits a resume and
documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an
inspector on an inspection of an HHScertified laboratory or IITF under these
Guidelines.
(b) The Secretary or a Federal agency
may conduct an inspection at any time.

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Section 9.11 What happens if an
applicant laboratory or IITF does not
satisfy the minimum requirements for
either the PT program or the inspection
program?
If an applicant laboratory or IITF fails
to satisfy the requirements established
for the initial certification process, the
applicant laboratory or IITF must start
the initial certification process from the
beginning.
Section 9.12 What happens if an HHScertified laboratory or IITF does not
satisfy the minimum requirements for
either the PT program or the inspection
program?
(a) If an HHS-certified laboratory or
IITF fails to satisfy the minimum
requirements for certification, the
laboratory or IITF is given a period of
time (e.g., 5 or 30 working days
depending on the nature of the issue) to
provide any explanation for its
performance and evidence that any
deficiency has been corrected.
(b) A laboratory’s or IITF’s
certification may be revoked,
suspended, or no further action taken
depending on the seriousness of the
errors and whether there is evidence
that any deficiency has been corrected
and that current performance meets the
requirements for a certified laboratory or
IITF.
(c) An HHS-certified laboratory or
IITF may be required to undergo a
special inspection or to test additional
PT samples, depending on the nature of
the performance, to verify that any
deficiency has been corrected.
(d) If an HHS-certified laboratory’s or
IITF’s certification is revoked or
suspended in accordance with the
process described in subpart P, the
laboratory or IITF is not permitted to
test specimens for Federal agencies until
the suspension is lifted or the laboratory
or IITF has successfully completed the
certification requirements as a new
applicant laboratory or IITF.
Section 9.13 What factors are
considered in determining whether
revocation of a laboratory’s or IITF’s
certification is necessary?
(a) The Secretary shall revoke
certification of any laboratory or IITF
certified in accordance with these
Guidelines if the Secretary determines
that revocation is necessary to ensure
the full reliability and accuracy of drug
and specimen validity tests and the
accurate reporting of test results.
(b) The Secretary shall consider the
following factors in determining
whether revocation is necessary:
(1) Unsatisfactory performance in
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drug and specimen validity tests; for
example, a laboratory reporting a false
positive result for an employee’s drug
test;
(2) Unsatisfactory participation in
performance testing evaluations or
inspections;
(3) A material violation of a
certification standard or a contract term
or other condition imposed on the
laboratory or IITF by a Federal agency
using the laboratory’s or IITF’s services;
(4) Conviction for any criminal
offense committed incident to operation
of the laboratory or IITF; or
(5) Any other cause that materially
affects the ability of the laboratory or
IITF to ensure the full reliability and
accuracy of drug and specimen validity
tests and the accurate reporting of
results.
(c) The period and terms of revocation
shall be determined by the Secretary
and shall depend upon the facts and
circumstances of the revocation and the
need to ensure accurate and reliable
drug and validity testing of Federal
employee specimens.

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Section 9.14 What factors are
considered in determining whether to
suspend a laboratory or IITF?
(a) 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 (either partially or
fully) a laboratory’s or IITF’s
certification to conduct drug and
specimen validity testing for Federal
agencies.
(b) 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 specimen
validity testing of Federal employee
specimens.
Section 9.15 How does the Secretary
notify a laboratory or IITF that action
is being taken against the laboratory or
IITF?
(a) When a laboratory or IITF is
suspended or the Secretary seeks to
revoke certification, the Secretary shall
immediately serve the laboratory or IITF
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

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(3) The period of suspension or
proposed revocation.
(b) The written notice shall state that
the laboratory or IITF will be afforded
an opportunity for an informal review of
the suspension or proposed revocation
if it so requests in writing within 30
days of the date the laboratory or IITF
received the notice, or if expedited
review is requested, within 3 days of the
date the laboratory or IITF received the
notice. Subpart P contains detailed
procedures to be followed for an
informal review of the suspension or
proposed revocation.
(c) A suspension must be effective
immediately. A proposed revocation
must be effective 30 days after written
notice is given or, if review is requested,
upon the reviewing official’s decision to
uphold the proposed revocation. If the
reviewing official decides not to uphold
the suspension or proposed revocation,
the suspension must terminate
immediately and any proposed
revocation shall not take effect.
(d) The Secretary will publish in the
Federal Register the name, address, and
telephone number of any laboratory or
IITF that has its certification revoked or
suspended under Section 9.13 or
Section 9.14, respectively, and the name
of any laboratory or IITF that has its
suspension lifted. The Secretary shall
provide to any member of the public
upon request the written notice
provided to a laboratory or IITF that has
its certification suspended or revoked,
as well as the reviewing official’s
written decision which upholds or
denies the suspension or proposed
revocation under the procedures of
subpart P.
Section 9.16 May a laboratory or IITF
that had its certification revoked be
recertified to test Federal agency
specimens?
Following revocation, a laboratory or
IITF may apply for recertification.
Unless otherwise provided by the
Secretary in the notice of revocation
under Section 9.13(a) or the reviewing
official’s decision under Section 16.9(e)
or 16.14(a), a laboratory or IITF which
has had its certification revoked may
reapply for certification as an applicant
laboratory or IITF.
Section 9.17 Where is the list of HHScertified laboratories and IITFs
published?
(a) The list of HHS-certified
laboratories and IITFs is published
monthly in the Federal Register.
(b) An applicant laboratory or IITF is
not included on the list.

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Subpart J—Blind Samples Submitted
by an Agency
Section 10.1 What are the
requirements for Federal agencies to
submit blind samples to HHS-certified
laboratories or IITFs?
(a) Each Federal agency is required to
submit blind samples for its workplace
drug testing program. The blind samples
are to be sent to the HHS-certified
laboratory or HHS-certified IITF to
which the collector sends employee
specimens for the Federal agency.
(b) Each Federal agency must submit
at least 3 percent blind samples along
with its donor specimens based on the
projected total number of donor
specimens collected per year. Every
effort should be made to ensure that
some of the blind samples are submitted
quarterly.
(c) Of the blind samples submitted
each year by an agency, approximately
75 percent of the blind samples must be
negative, 15 percent must be positive for
one or more drugs, and 10 percent must
either be adulterated or substituted.
Section 10.2 What are the
requirements for a blind sample?
(a) A blind sample that is drug
positive must be validated by the
supplier as to its content using
appropriate initial and confirmatory
tests.
(b) A blind sample that is negative
(i.e., certified to contain no drug) must
be validated by the supplier as negative
using appropriate initial and
confirmatory tests.
(c) The supplier must provide
information regarding the shelf life of
the blind sample.
(d) For a blind sample that is drug
positive, the concentration of the drug it
contains should be between 1.5 and 2
times the initial drug test cutoff
concentration and must be spiked or
contain one or more of the drugs or
metabolites listed in Section 3.4.
(e) A blind sample that is adulterated
must have the characteristics to clearly
show that it is an adulterated sample at
the time it is validated by the supplier.
(f) A blind sample that is substituted
must have the characteristics to clearly
show that it is a substituted sample at
the time it is validated by the supplier.
Section 10.3 How is a blind sample
submitted to an HHS-certified
laboratory or IITF?
(a) A blind sample is submitted using
the same Federal CCF as used for a
donor specimen. The collector provides
the required information to ensure that
the Federal CCF has been properly
completed as well as providing

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fictitious initials on the specimen label/
seal. The collector must indicate that
the specimen is a blind sample on the
MRO copy where a donor would
normally provide a signature.
(b) A collector should attempt to
distribute the required number of blind
samples throughout the total number of
donor specimens rather than submitting
all of the blind samples as a single
group.
Section 10.4 What happens if an
inconsistent result is reported on a
blind sample?
If an HHS-certified laboratory or IITF
reports a result for a blind sample that
is inconsistent with the expected result
(e.g., a laboratory or IITF reports a
negative result for a blind sample that
was supposed to be positive, a
laboratory reports a positive result for a
blind sample that was supposed to be
negative):
(a) The MRO must contact the
supplier of the blind sample and
attempt to determine if the supplier
made a mistake when preparing the
blind sample;
(b) The MRO must contact the
collector and determine if the collector
made an error when preparing the blind
sample for transfer to the laboratory or
IITF;
(c) If there is no obvious reason for the
inconsistent result, the MRO must
notify both the Federal agency for which
the blind sample was submitted and the
Secretary; and
(d) The Secretary shall investigate the
blind sample error. A report of the
Secretary’s investigative findings and
the corrective action taken by the HHScertified laboratory or IITF must be sent
to the Federal agency. The Secretary
shall ensure notification of the finding
to all other Federal agencies for which
the laboratory or IITF is engaged in drug
testing and coordinate any necessary
action to prevent the recurrence of the
error.

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Subpart K—Laboratory
Section 11.1 What must be included in
the HHS-certified laboratory’s standard
operating procedure manual?
(a) An HHS-certified laboratory must
have a standard operating procedure
(SOP) manual that describes, in detail,
all laboratory operations. When
followed, it ensures that all specimens
are tested using the same procedures
and in a consistent manner.
(b) The SOP manual must include, but
is not limited to, a detailed description
of the following:
(1) Chain of custody procedures;
(2) Accessioning;

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(3) Security;
(4) Quality control/quality assurance
programs;
(5) Analytical methods and
procedures;
(6) Equipment and maintenance
programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, laboratory
information management systems.
(c) All procedures in the SOP manual
must be in compliance with these
Guidelines and other guidance provided
by the Secretary.
(d) A copy of all procedures that have
been replaced or revised and the dates
on which they were in effect must be
maintained for 2 years to allow the
laboratory to retrieve the procedures
that were used to test a specimen.
Section 11.2 What are the
responsibilities of the responsible
person (RP)?
(a) Manage the day-to-day operations
of the drug testing laboratory even
where another individual has overall
responsibility for an entire multispecialty laboratory.
(b) Ensure that there are enough
personnel with adequate training and
experience to supervise and conduct the
work of the drug testing laboratory. The
RP must ensure the continued
competency of laboratory personnel by
documenting their in-service training,
reviewing their work performance, and
verifying their skills.
(c) Maintain a complete, current SOP
manual that is available for personnel in
the drug testing laboratory, and
followed by those personnel. The SOP
manual must be reviewed, signed, and
dated by the RP(s) whenever procedures
are first placed into use or changed or
when a new individual assumes
responsibility for management of the
drug testing laboratory.
(d) Maintain a quality assurance
program to assure the proper
performance and reporting of all test
results; verify and monitor acceptable
analytical performance for all controls
and standards; monitor quality control
testing; document the validity,
reliability, accuracy, precision, and
performance characteristics of each test
and test system.
(e) Implement 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
samples, and deficiencies identified
during inspections. This individual
must ensure that specimen results are

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not reported until all corrective actions
have been taken and he or she can
assure that the results provided are
accurate and reliable.
Section 11.3 What scientific
qualifications in analytical toxicology
must the RP have?
The RP must have documented
scientific qualifications in analytical
toxicology. Minimum qualifications are:
(a) Be certified as a laboratory director
by the State in forensic or clinical
laboratory toxicology, have a Ph.D. in
one of the natural sciences, or have
training and experience comparable to a
Ph.D. in one of the natural sciences with
training and laboratory/research
experience in biology, chemistry, and
pharmacology or toxicology;
(b) Have experience in forensic
toxicology with emphasis on the
collection and analysis of biological
specimens for drugs of abuse;
(c) Have experience in forensic
applications of analytical toxicology
(e.g., publications, court testimony,
conducting research on the toxicology of
drugs of abuse) or qualify as an expert
witness in forensic toxicology;
(d) Be found to fulfill RP
responsibilities and qualifications upon
interview by HHS-trained inspectors
during each on-site inspection of the
laboratory; and
(e) Qualify as a certifying scientist.
Section 11.4 What happens when the
RP is absent or leaves an HHS-certified
laboratory?
(a) All HHS-certified laboratories
must have multiple RPs or one RP and
an alternate RP. When an RP or multiple
RPs are absent at the same time, an
alternate RP must be present and able to
maintain the responsibilities of the RP.
(1) When an HHS-certified laboratory
is without the RP and alternate RP for
14 calendar days or less (e.g., vacation,
illness, business trip), the certified
laboratory may continue testing Federal
agency specimens under the direction of
a certifying scientist.
(2) The Secretary, in accordance with
these Guidelines, will suspend a
laboratory’s certification for all
specimens if the laboratory does not
have an RP or alternate RP for a period
of more than 14 calendar days. The
suspension will be lifted upon the
Secretary’s approval of a new
permanent RP or alternate RP.
(b) When an RP permanently leaves
an HHS-certified laboratory:
(1) An HHS-certified laboratory may
maintain its certification and continue
testing Federal agency specimens under
the direction of an alternate RP for a
period of up to 180 days while seeking

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to hire and receive the Secretary’s
approval of the new permanent RP.
(2) The Secretary, in accordance with
these Guidelines, will suspend a
laboratory’s certification for all
specimens if the laboratory does not
have a permanent RP within 180 days.
The suspension will be lifted upon the
Secretary’s approval of the new
permanent RP.
(c) To nominate an individual as an
RP or alternate RP, the laboratory must
submit to the Secretary the candidate’s
current resume or curriculum vitae,
copies of diplomas and any licensures,
a training plan (not to exceed 90 days)
to transition into the RP position, an
itemized defense of the candidate’s
qualifications compared to the
minimum RP qualifications described in
the Guidelines, and arrange to have
official academic transcript(s) submitted
by the candidate’s institution(s) of
higher learning. The candidate must be
found acceptable during an on-site
inspection of the laboratory.
(d) The laboratory must fulfill other
inspection and PT criteria as required
prior to conducting Federal agency
testing under a new RP.

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Section 11.5 What qualifications must
an individual have to certify a result
reported by an HHS-certified
laboratory?
(a) The certifying scientist must have:
(1) At least a bachelor’s degree in the
chemical or biological sciences or
medical technology, or equivalent;
(2) Training and experience in the
analytical methods and forensic
procedures used by the laboratory that
are relevant to the results that the
individual certifies; and
(3) Training and experience in
reviewing and reporting forensic test
results, maintenance of chain of
custody, and understanding proper
remedial action in response to problems
that may arise.
(b) The certifying technician must
have:
(1) Training and experience in the
analytical methods and forensic
procedures used by the laboratory that
are relevant to the results that the
individual certifies; and
(2) Training and experience in
reviewing and reporting forensic test
results, maintenance of chain of
custody, and understanding proper
remedial action in response to problems
that may arise.
Section 11.6 What qualifications and
training must other laboratory
personnel have?
(a) All laboratory staff (e.g.,
technicians, administrative staff) must

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have the appropriate training and skills
for the tasks assigned.
(b) Each individual working in an
HHS-certified laboratory must be
properly trained (i.e., receive training in
each area of work that the individual
will be performing, including training in
forensic procedures related to their job
duties) before he or she is permitted to
work independently with regulated
specimens and the training must be
documented.
Section 11.7 What security measures
must an HHS-certified laboratory
maintain?
(a) An HHS-certified laboratory must
control access to the drug testing
facility, specimens, aliquots, and
records.
(b) Authorized visitors must be
escorted at all times, except for
individuals conducting inspections (i.e.,
for the Department, a Federal agency, a
state, or other accrediting agency) or
emergency personnel (such as,
firefighters and medical rescue teams).
(c) A laboratory must maintain a
record that documents the dates, time of
entry and exit, and purpose of entry of
authorized escorted visitors accessing
secured areas, and their authorized
escorts.
Section 11.8 What are the internal
laboratory chain of custody
requirements for a specimen or an
aliquot?
(a) An HHS-certified laboratory must
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 the specimens.
(b) An HHS-certified laboratory must
use chain of custody procedures to
document the handling and transfer of
aliquots throughout the testing process
and until final disposal.
(c) The date and purpose must be
documented on an appropriate chain of
custody document each time a specimen
or aliquot is handled or transferred, and
every individual in the chain must be
identified.
(d) Chain of custody must be
maintained and documented by using
either paper copy or electronic
procedures.
(e) Each individual that handles a
specimen or aliquot must sign and
complete the appropriate entries on the
chain of custody document when the
specimen or aliquot is received.

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Section 11.9 What test(s) does an
HHS-certified laboratory conduct on a
specimen received from an IITF?
An HHS-certified laboratory must test
the specimen in the same manner as a
specimen that had not been previously
tested.
Section 11.10 What are the
requirements for an initial drug test?
(a) An initial drug test must be an
immunoassay test.
(b) A laboratory must validate an
initial drug test before using it to test
specimens.
(c) Initial drug test kits must be
approved, cleared, or otherwise
recognized by FDA as accurate and
reliable for the testing of a specimen for
identifying drugs of abuse or their
metabolites.
(d) A laboratory may conduct a
second initial drug test using a method
with different specificity, to rule out
cross-reacting compounds. This second
initial drug test must satisfy the batch
quality control requirements specified
in Section 11.12.
Section 11.11 What must an HHScertified laboratory do to validate an
initial drug test?
(a) An HHS-certified laboratory must
demonstrate and document for each
initial test:
(1) The ability to differentiate positive
and negative specimens;
(2) The performance of the test around
the cutoff concentration, using samples
at several concentrations between 0 and
150 percent of the cutoff concentration;
(3) The effective concentration range
of the test; and
(4) The effect of carryover that may
occur between aliquots.
(b) Each new lot of an initial drug test
reagent must be verified prior to being
placed into service.
Section 11.12 What are the batch
quality control requirements when
conducting an initial drug test?
(a) Each batch of specimens must
contain the following QC samples:
(1) At least one control certified to
contain no drug or drug metabolite;
(2) At least one positive control with
the drug or drug metabolite targeted at
25 percent above the cutoff;
(3) At least one control with the drug
or drug metabolite targeted at 75 percent
of the cutoff; and
(4) At least one control that appears
as a donor specimen to the laboratory
analysts.
(b) A minimum of 10 percent of the
total specimens and quality control
samples in each batch must be quality

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control samples (i.e., calibrators or
controls).

(c) Controls must be analyzed
concurrently with specimens.

Section 11.13 What are the
requirements for a confirmatory drug
test?
(a) The analytical method used must
combine chromatographic separation
and mass spectrometric identification
(e.g., GC/MS, liquid chromatography/
mass spectrometry (LC/MS), GC/MS/
MS, LC/MS/MS).
(b) A confirmatory drug test must be
validated before the laboratory can use
it to test specimens.

Section 11.17 What must an HHScertified laboratory do to validate a
specimen validity test?
An HHS-certified laboratory must
demonstrate and document for each
specimen validity test the appropriate
performance characteristics of the test;
and must re-verify the test periodically,
or at least annually.

Section 11.14 What must an HHScertified laboratory do to validate a
confirmatory drug test?
(a) An HHS-certified laboratory must
demonstrate and document for each
confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantitation;
(4) The accuracy and precision at the
cutoff concentration;
(5) The accuracy and precision at 40
percent of the cutoff concentration; and
(6) The potential for interfering
substances.
(7) The effect of carryover that may
occur between aliquots.
(b) An HHS-certified laboratory must
re-verify its confirmatory drug test
methods periodically or at least
annually.

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Section 11.15 What are the quality
control requirements when conducting
a confirmatory drug test?
(a) Each batch of specimens must
contain, at a minimum, the following
QC specimens:
(1) A calibrator with its drug
concentration at the cutoff;
(2) At least one control certified to
contain no drug or drug metabolite;
(3) At least one positive control with
the drug or drug metabolite targeted at
25 percent above the cutoff; and
(4) At least one control targeted at or
below 40 percent of the cutoff.
(b) A minimum of 10 percent of the
total specimens and quality control
samples in each batch must be quality
control samples (i.e., calibrators or
controls).
Section 11.16 What are the analytical
and quality control requirements for
conducting specimen validity tests?
(a) Each specimen validity test result
must be based on performing an initial
specimen validity test on one aliquot
and a second or confirmatory test on a
second aliquot;
(b) Each specimen validity test must
satisfy the QC requirements in Section
11.18; and

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Section 11.18 What are the
requirements for conducting each
specimen validity test?
(a) The requirements for measuring
creatinine concentration are as follows:
(1) The creatinine concentration must
be measured to one decimal place on
both the initial creatinine test and the
confirmatory creatinine test;
(2) The initial creatinine test must
have a calibrator at 2 mg/dL;
(3) The initial creatinine test must
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;
and
(4) The confirmatory creatinine test
(performed on those specimens with a
creatinine concentration less than 2 mg/
dL on the initial test) must 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.
(b) The requirements for measuring
specific gravity are as follows:
(1) For specimens with initial
creatinine test results greater than 5 mg/
dL and less than 20 mg/dL, laboratories
may perform a screening test using a
refractometer that measures urine
specific gravity to at least three decimal
places to identify specific gravity values
that are acceptable (equal to or greater
than 1.003) or dilute (equal to or greater
than 1.002 and less than 1.003).
Specimens must be subjected to an
initial specific gravity test using a four
decimal place refractometer when the
initial creatinine test result is less than
or equal to 5 mg/dL or when the
screening specific gravity test result
using a three decimal place
refractometer is less than 1.002. The
screening specific gravity test must have
the following controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002;
(iii) One control in the range of 1.004
to 1.018.
(2) For the initial and confirmatory
specific gravity tests, the refractometer
must report and display specific gravity
to four decimal places. The
refractometer must be interfaced with a

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laboratory information management
system (LIMS), computer, and/or
generate a paper copy of the digital
electronic display to document the
numerical values of the specific gravity
test results;
(3) The initial and confirmatory
specific gravity tests must have a
calibrator or control at 1.0000; and
(4) The initial and confirmatory
specific gravity tests must 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 equal to or greater
than 1.0200 but not greater than 1.0250.
(c) Requirements for measuring pH
are as follows:
(1) Colorimetric pH tests that have the
dynamic range of 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 (i.e., screening
tests) that have a narrow dynamic range
and do not support the cutoffs may be
used only to determine if an initial pH
specimen validity test must be
performed;
(2) For the initial and confirmatory
pH tests, the pH meter must report and
display pH to at least one decimal place.
The pH meter must be interfaced with
a LIMS, computer, and/or generate a
paper copy of the digital electronic
display to document the numerical
values of the pH test results;
(3) pH screening tests must have, at a
minimum, the following controls:
(i) One control below the lower
decision point in use;
(ii) One control between the decision
points in use; and
(iii) One control above the upper
decision point in use;
(4) An initial colorimetric pH test
must have the following calibrators and
controls:
(i) One calibrator at 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; and
(vii) One control in the range of 11.2
to 12;
(5) An initial pH meter test, if a pH
screening test is not used, must have the
following calibrators and controls:
(i) One calibrator at 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;

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(vi) One control in the range of 10 to
10.8; and
(vii) One control in the range of 11.2
to 12;
(6) An initial or confirmatory pH
meter test, if a pH screening test is used,
must 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;
and
(7) An initial or confirmatory pH
meter test, if a pH screening test is used,
must 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.
(d) Requirements for performing
oxidizing adulterant tests are as follows:
(1) The initial test must include an
appropriate calibrator at the cutoff
specified in Sections 11.19(d)(2), (3), or
(4) for the compound of interest, a
control without the compound of
interest (i.e., a certified negative
control), and at least one control with
one of the compounds of interest at a
measurable concentration; and
(2) A confirmatory test for a specific
oxidizing adulterant must use a
different analytical method than that
used for the initial test. Each
confirmatory test batch must include an
appropriate calibrator, a control without
the compound of interest (i.e., a
certified negative control), and a control
with the compound of interest at a
measurable concentration.
(e) The requirements for measuring
the nitrite concentration are that the
initial and confirmatory nitrite tests
must have a calibrator at the cutoff
concentration, a control without nitrite
(i.e., certified negative urine), one
control in the range of 200 mcg/mL to
250 mcg/mL, and one control in the
range of 500 mcg/mL to 625 mcg/mL.

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Section 11.19 What are the
requirements for an HHS-certified
laboratory to report a test result?
(a) An HHS-certified laboratory must
report a test result directly to the
agency’s MRO within an average of 5
working days after receipt of the
specimen using the Federal CCF and/or
an electronic report. Before any test
result is reported, it must be certified by

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a certifying scientist or a certifying
technician, as appropriate.
(b) A primary (Bottle A) specimen 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.
(c) A primary (Bottle A) specimen is
reported positive for a specific drug
when the initial drug test is positive and
the confirmatory drug test is positive in
accordance with Section 3.4.
(d) A primary (Bottle A) specimen is
reported adulterated when:
(1) The pH is less than 3 or equal to
or greater than 11 using either a pH
meter or a colorimetric pH test for the
initial test on the first aliquot and a pH
meter for the confirmatory test on the
second aliquot;
(2) The nitrite concentration is equal
to or greater than 500 mcg/mL using
either a nitrite colorimetric test or a
general oxidant colorimetric test for the
initial test on the first aliquot and a
different confirmatory test (e.g., multiwavelength spectrophotometry, ion
chromatography, capillary
electrophoresis) on the second aliquot;
(3) The presence of chromium (VI) is
verified using either a general oxidant
colorimetric test (with an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or a chromium (VI)
colorimetric test (chromium (VI)
concentration equal to or greater than 50
mcg/mL) for the initial test on the first
aliquot and a different confirmatory
test (e.g., multi-wavelength
spectrophotometry, ion
chromatography, atomic absorption
spectrophotometry, capillary
electrophoresis, inductively coupled
plasma-mass spectrometry) with the
chromium (VI) concentration equal to or
greater than the LOQ of the
confirmatory test on the second aliquot;
(4) The presence of halogen (e.g.,
bleach, iodine, fluoride) is verified
using either a general oxidant
colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or halogen
colorimetric test (halogen concentration
equal to or greater than the LOQ) for the
initial test on the first aliquot and a
different confirmatory test (e.g., multiwavelength spectrophotometry, ion
chromatography, inductively coupled
plasma-mass spectrometry) with a
specific halogen concentration equal to
or greater than the LOQ of the
confirmatory test on the second aliquot;
(5) The presence of glutaraldehyde is
verified using either an aldehyde test

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(aldehyde present) or the characteristic
immunoassay response on one or more
drug immunoassay tests for the initial
test on the first aliquot and a different
confirmatory method (e.g., GC/MS) for
the confirmatory test with the
glutaraldehyde concentration equal to or
greater than the LOQ of the analysis on
the second aliquot;
(6) The presence of pyridine
(pyridinium chlorochromate) is verified
using either a general oxidant
colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or
greater than 50 mcg/mL chromium (VI)equivalent cutoff) or a chromium (VI)
colorimetric test (chromium (VI)
concentration equal to or greater than 50
mcg/mL) for the initial test on the first
aliquot and a different confirmatory
method (e.g., GC/MS) for the
confirmatory test with the pyridine
concentration equal to or greater than
the LOQ of the analysis on the second
aliquot;
(7) The presence of a surfactant is
verified by using a surfactant
colorimetric test with an equal to or
greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff for the initial test on the first
aliquot and a different confirmatory test
(e.g., multi-wavelength
spectrophotometry) with an equal to or
greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff on the second aliquot; or
(8) The presence of any other
adulterant not specified in paragraphs
d(2) through d(7) of this section is
verified using an initial test on the first
aliquot and a different confirmatory test
on the second aliquot.
(e) A primary (Bottle A) specimen 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 equal to or
greater than 1.0200 on both the initial
and confirmatory creatinine tests (i.e.,
the same colorimetric test may be used
to test both aliquots) and on both the
initial and confirmatory specific gravity
tests (i.e., a refractometer is used to test
both aliquots) on two separate aliquots.
(f) A primary (Bottle A) specimen is
reported dilute when the creatinine
concentration is equal to or greater than
2 mg/dL but less than 20 mg/dL and the
specific gravity is greater than 1.0010
but less than 1.0030 on a single aliquot.
(g) For a specimen that has an invalid
result for one of the reasons stated in
items (h)4 through (h)12 below, 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

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Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / Notices
adulterated result. If no further testing is
necessary, the laboratory then reports
the invalid result to the MRO.
(h) A primary (Bottle A) specimen is
reported as an invalid result when:
(1) Inconsistent creatinine
concentration and specific gravity
results are obtained (i.e., the creatinine
concentration is less than 2 mg/dL on
both the initial and confirmatory
creatinine tests and the specific gravity
is greater than 1.0010 but less than
1.0200 on the initial and/or
confirmatory specific gravity test, the
specific gravity is less than or equal to
1.0010 on both the initial and
confirmatory specific gravity tests and
the creatinine concentration is equal to
or greater than 2 mg/dL on either or
both the initial or confirmatory
creatinine tests);
(2) The pH is equal to or greater than
3 and less than 4.5 or equal to or greater
than 9 and less than 11 using either a
colorimetric pH test or pH meter for the
initial test and a pH meter for the
confirmatory test on two separate
aliquots;
(3) The nitrite concentration is equal
to or greater than 200 mcg/mL using a
nitrite colorimetric test or equal to or
greater than the equivalent of 200 mcg/
mL nitrite using a general oxidant
colorimetric test for both the initial
(first) test and the second test or using
either initial test and the nitrite
concentration is equal to or greater than
200 mcg/mL but less than 500 mcg/mL
for a different confirmatory test (e.g.,
multi-wavelength spectrophotometry,
ion chromatography, capillary
electrophoresis) on two separate
aliquots;
(4) The possible presence of
chromium (VI) is determined using the
same chromium (VI) colorimetric test
with a cutoff equal to or greater than 50
mcg/mL chromium (VI) for both the
initial (first) test and the second test on
two separate aliquots;
(5) The possible presence of a halogen
(e.g., bleach, iodine, fluoride) is
determined using the same halogen
colorimetric test with a cutoff equal to
or greater than the LOQ for both the
initial (first) test and the second test on
two separate aliquots or relying on the
odor of the specimen as the initial test;
(6) The possible presence of
glutaraldehyde is determined by using
the same aldehyde test (aldehyde
present) or characteristic immunoassay
response on one or more drug
immunoassay tests for both the initial
(first) test and the second test on two
separate aliquots;
(7) The possible presence of an
oxidizing adulterant is determined by
using the same general oxidant

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colorimetric test (with an equal to or
greater than 200 mcg/mL nitriteequivalent cutoff, an equal to or greater
than 50 mcg/mL chromium (VI)equivalent cutoff, or a halogen
concentration is equal to or greater than
the LOQ) for both the initial (first) test
and the second test on two separate
aliquots;
(8) The possible presence of a
surfactant is determined by using the
same surfactant colorimetric test with
an equal to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff for both the initial (first) test and
the second test on two separate aliquots
or a foam/shake test for the initial test;
(9) Interference occurs on the
immunoassay drug tests on two separate
aliquots (i.e., valid immunoassay drug
test results cannot be obtained);
(10) Interference with the
confirmatory drug test occurs on at least
two separate aliquots of the specimen
and the laboratory is unable to identify
the interfering substance;
(11) The physical appearance of the
specimen is such that testing the
specimen may damage the laboratory’s
instruments; or
(12) The physical appearance of
Bottles A and B are clearly different and
Bottle A tested negative for drugs.
(i) An HHS-certified laboratory shall
reject a primary (Bottle A) urine
specimen for testing when a fatal flaw
occurs as described in Section 15.1 or
when a correctable flaw as described in
Section 15.2 is not recovered. The
laboratory will indicate on the Federal
CCF that the specimen was rejected for
testing and provide the reason for
reporting the rejected for testing result.
(j) An HHS-certified laboratory must
report all positive, adulterated,
substituted, and invalid test results for
a specimen. For example, a specimen
can be positive for a specific drug and
adulterated.
(k) An HHS-certified laboratory must
report the concentration of the drug or
drug metabolite for a positive result.
(l) An HHS-certified laboratory must
report numerical values of the specimen
validity test results that support a
specimen that is reported adulterated,
substituted, or invalid (as appropriate).
(m) When the concentration of an
analyte exceeds the linear range of the
standard curve, an HHS-certified
laboratory may report to the MRO that
the quantitative value exceeds the linear
range of the test, that the quantitative
value is greater than ‘‘insert the actual
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.

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(n) An HHS-certified laboratory may
transmit a result to the MRO by various
electronic means (e.g., teleprinter,
facsimile, or computer) in a manner
designed to ensure confidentiality of the
information. A result may not be
reported verbally by telephone. A
laboratory must ensure the security of
the data transmission and limit access to
any data transmission, storage, and
retrieval system.
(o) For all test results, an HHScertified laboratory may fax, courier,
mail, or electronically transmit a legible
image or copy of the completed Federal
CCF, and/or forward a computergenerated electronic report. The
computer-generated report must contain
sufficient information to ensure that the
test result is properly associated with
the custody and control form that the
MRO received from the collector. For
positive, adulterated, substituted, and
invalid results, the laboratory must fax,
courier, mail, or electronically transmit
a legible image or copy of the completed
Federal CCF.
Section 11.20 How long must an HHScertified laboratory retain a specimen?
(a) An HHS-certified laboratory must
retain a specimen that was reported
either drug positive, adulterated,
substituted, or as an invalid result for a
minimum of 1 year.
(b) A retained specimen must be kept
in a secured frozen storage (¥20 °C or
less) to ensure its availability for any
necessary retesting during an
administrative or judicial proceeding.
(c) Within the 1-year storage period, a
Federal agency may request a laboratory
to retain a specimen for an additional
specified period of time.
Section 11.21 How long must an HHScertified laboratory retain records?
(a) An HHS-certified laboratory must
retain all records generated to support
test results for at least 2 years.
(b) A Federal agency may request an
HHS-certified laboratory to maintain a
copy of the documentation package (as
described in Section 11.23 that supports
the chain of custody, testing, and
reporting of a donor’s specimen that is
under legal challenge by a donor. The
Federal agency’s request to the
laboratory must be in writing and must
specify the period of time to maintain
the documentation package.
(c) The laboratory may retain records
other than those included in the
documentation package beyond the
normal 2 year period of time to ensure
that it can fully support the reported test
result.

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Section 11.22 What statistical
summary report must an HHS-certified
laboratory provide?
(a) An HHS-certified laboratory must
provide to each Federal agency for
which testing is conducted a
semiannual statistical summary report
that contains the following information:
(1) Reporting period (inclusive dates);
(2) Laboratory name and address;
(3) Federal agency name;
(4) Total number of specimen results
reported;
(5) Number of specimens collected by
reason for test;
(6) Number of specimens reported
negative and the number reported
negative/dilute;
(7) Number of specimens rejected for
testing because of a fatal flaw and the
number rejected for testing because of
an uncorrected flaw;
(8) Number of specimens reported
positive;
(9) Number of specimens reported
positive for each drug;
(10) Number of specimens reported
adulterated;
(11) Number of specimens reported
substituted; and
(12) Number of specimens reported as
invalid result.
(b) The report must be submitted by
mail, fax, or e-mail within 14 working
days after the end of the semiannual
period. The summary report must not
include any personal identifying
information.
(c) The HHS-certified laboratory must
make available copies of an agency’s test
results when requested by the Secretary
or by the Federal agency for which the
laboratory is performing drug-testing
services.
(d) The HHS-certified laboratory must
make available a qualified individual to
testify in a proceeding against a Federal
employee when that proceeding is based
on a test result reported by the HHScertified laboratory.
Section 11.23 What laboratory
information is available to a Federal
employee?
(a) A Federal employee who is the
subject of a drug test may, upon written
request through the MRO and the
Federal agency, have access to any
records relating to his or her drug test,
any records relating to the results of any
relevant certification, review, or
revocation of certification proceedings,
and access to a documentation package.
(b) A standard documentation
package provided by an HHS-certified
laboratory must consist of the following
items:
(1) A cover sheet that provides a brief
description of the drug testing

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procedures and specimen validity tests
performed on the donor’s specimen;
(2) A table of contents page that lists
by page number all documents and
materials in the package;
(3) A copy of the Federal CCF with
any attachments, internal chain of
custody records for the specimen,
memoranda (if any) generated by the
laboratory, and a copy of the electronic
report (if any) generated by the
laboratory;
(4) A brief description of the
laboratory’s initial drug and specimen
validity test procedures,
instrumentation, batch quality control
requirements, and copies of the initial
test data for the donor’s specimen with
all calibrators and controls identified
and copies of all internal chain of
custody documents related to the initial
tests;
(5) A brief description of the
laboratory’s confirmatory drug and
specimen validity test procedures,
instrumentation, batch quality control
requirements, and copies of the
confirmatory test data for the donor’s
specimen with all calibrators and
controls identified and copies of all
internal chain of custody documents
related to the confirmatory tests; and
(6) A copy of the resume or
curriculum vitae for the RP(s) and the
certifying scientist that certified the test
result.
Section 11.24 What type of
relationship is prohibited between an
HHS-certified laboratory and an MRO?
A certified laboratory must not enter
into any relationship with a Federal
agency’s MRO that may be construed as
a potential conflict of interest or derive
any financial benefit by having a
Federal agency use a specific MRO.
This means an MRO may be an
employee of the agency or a contractor
for the agency; however, an MRO shall
not be an employee or agent of or have
any financial interest in the 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.
Section 11.25 What type of
relationship can exist between an HHScertified laboratory and an HHScertified IITF?
An HHS-certified laboratory can enter
into any relationship with an HHScertified IITF.

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Subpart L—Instrumented Initial Test
Facility (IITF)
Section 12.1 What must be included in
the HHS-certified IITF’s standard
operating procedure manual?
(a) An HHS-certified IITF must have
a standard operating procedure (SOP)
manual that describes, in detail, all IITF
operations.
(b) The SOP manual must include, but
is not limited to, a detailed description
of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance
programs;
(5) Analytical methods and
procedures;
(6) Equipment and maintenance
programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and
laboratory information management
systems.
(c) All procedures in the SOP manual
must be in compliance with these
Guidelines and other guidance
documents.
(d) A copy of all procedures that have
been replaced or revised and the dates
on which they were in effect must be
maintained by the HHS-certified IITF
for two years to allow the IITF to
retrieve the procedures that were used
to test a specimen.
Section 12.2 What are the
responsibilities of the responsible
technician (RT)?
(a) Manage the day-to-day operations
of the IITF even where another
individual has overall responsibility for
an entire multi-specialty facility.
(b) Ensure that there are enough
personnel with adequate training and
experience to supervise and conduct the
work of the IITF. The RT must ensure
the continued competency of IITF
personnel by documenting their inservice training, reviewing their work
performance, and verifying their skills.
(c) Maintain a complete, current SOP
manual that is available for personnel at
the IITF, and followed by those
personnel. The SOP manual must be
reviewed, signed, and dated by the RT
whenever procedures are first placed
into use or changed or when a new
individual assumes responsibility for
management of the IITF.
(d) Maintain a quality assurance
program to assure the proper
performance and reporting of all test
results; verify and monitor acceptable
analytical performance for all controls
and standards; monitor quality control

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testing; document the validity,
reliability, accuracy, precision, and
performance characteristics of each test
and test system.
(e) Implement all remedial actions
necessary to maintain satisfactory
operation and performance of the IITF
in response to quality control systems
not being within performance
specifications, errors in result reporting
or in analysis of performance testing
samples, and deficiencies identified
during inspections. This individual
must 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.

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Section 12.3 What qualifications must
the RT have?
An RT must:
(a) Have at least a bachelor’s degree in
the chemical or biological sciences or
medical technology, or equivalent;
(b) Have training and experience in
the analytical methods and forensic
procedures used by the IITF that are
relevant to the results;
(c) Have training and experience in
reviewing and reporting forensic test
results, maintenance of chain of
custody, recordkeeping, and
understanding proper remedial action in
response to problems that may arise;
(d) Be found to fulfill RT
responsibilities and qualifications upon
interview by HHS-trained inspectors
during each on-site inspection of the
HHS-certified IITF; and
(e) Qualify as a certifying technician.
Section 12.4 What happens when the
RT is absent or leaves an HHS-certified
IITF?
(a) All HHS-certified IITFs must have
an RT and an alternate RT. When an RT
is absent, an alternate RT must be
present and able to maintain the
responsibilities of the RT.
(1) When an HHS-certified IITF is
without the RT and alternate RT for 14
calendar days or less (e.g., vacation,
illness, business trip), the HHS-certified
IITF may continue testing Federal
agency specimens under the direction of
a certifying technician.
(2) The Secretary, in accordance with
these Guidelines, will suspend an IITF’s
certification for all specimens if the IITF
does not have an RT or alternate RT for
a period of more than 14 calendar days.
The suspension will be lifted upon the
Secretary’s approval of a new
permanent RT or alternate RT.
(b) When an RT permanently leaves
an HHS-certified IITF:
(1) The HHS-certified IITF may
maintain its certification and continue

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testing Federal agency specimens under
the direction of an alternate RT for a
period of up to 180 days while seeking
to hire and receive the Secretary’s
approval of the new permanent RT.
(2) The Secretary, in accordance with
these Guidelines, will suspend an IITF’s
certification for all specimens if the IITF
does not have a permanent replacement
RT within 180 days. The suspension
will be lifted upon the Secretary’s
approval of the new permanent RT.
(c) To nominate an individual as RT
or alternate RT, the IITF must submit to
the Secretary the candidate’s current
resume or curriculum vitae, copies of
diplomas and any licensures, a training
plan (not to exceed 90 days) to
transition into the RT position, an
itemized defense of the candidate’s
qualifications compared to the
minimum RT qualifications described in
the Guidelines, and arrange to have
official academic transcript(s) submitted
by the candidate’s institution(s) of
higher learning. The candidate must be
found acceptable during an on-site
inspection of the IITF.
(d) The HHS-certified IITF must fulfill
other inspection and PT criteria as
required prior to conducting Federal
agency testing under a new RT.
Section 12.5 What qualifications must
an individual have to certify a result
reported by an HHS-certified IITF?
The certifying technician must have:
(a) Training and experience in the
analytical methods and forensic
procedures used by the IITF that are
relevant to the results that the
individual certifies; and
(b) Training and experience in
reviewing and reporting forensic test
results, maintenance of chain of
custody, and understanding proper
remedial action in response to problems
that may arise.
Section 12.6 What qualifications and
training must other IITF personnel
have?
(a) All IITF staff (e.g., technicians,
administrative staff) must have the
appropriate training and skills for the
tasks assigned.
(b) Each individual working in an
HHS-certified IITF must be properly
trained (i.e., receive training in each
area of work that the individual will be
performing, including training in
forensic procedures related to their job
duties) before he or she is permitted to
work independently in any area of the
facility with Federal agency specimens
and the training must be documented.

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Section 12.7 What security measures
must an HHS-certified IITF maintain?
(a) An HHS-certified IITF must
control access to the facility and ensure
that no unauthorized individual can
gain access to specimens, aliquots, or
records.
(b) Authorized visitors must be
escorted at all times except for
individuals authorized to conduct
inspections on behalf of Federal, state,
or other accrediting agencies or
emergency personnel (e.g., firefighters
and medical rescue teams).
(c) An HHS-certified IITF must
maintain a record that documents the
dates, time of entry and exit, and
purpose of entry of authorized escorted
visitors accessing secured areas, and
their authorized escorts.
Section 12.8 What are the internal
IITF chain of custody requirements for
a specimen or an aliquot?
(a) An HHS-certified IITF must 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 the specimens.
(b) An HHS-certified IITF must use
chain of custody procedures to
document the handling and transfer of
aliquots throughout the testing process
and until final disposal.
(c) The date and purpose must be
documented on an appropriate chain of
custody document each time a specimen
or aliquot is handled or transferred, and
every individual in the chain must be
identified.
(d) Chain of custody must be
maintained and documented by using
either paper copy or electronic
procedures.
(e) Each individual that handles a
specimen or aliquot must sign and
complete the appropriate entries on the
chain of custody document when the
specimen or aliquot is received.
Section 12.9 What are the
requirements for an initial drug test?
(a) An initial drug test must be an
immunoassay test.
(b) An IITF must validate an initial
drug test before using it to test
specimens;
(c) Initial drug test kits must be
approved, cleared, or otherwise
recognized by FDA as accurate and
reliable for the testing of a specimen for
identifying drugs of abuse or their
metabolites.
(d) An IITF may conduct a second
initial drug test using a method with
different specificity, to rule out cross-

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reacting compounds. This second initial
drug test must satisfy the batch quality
control requirements specified in
Section 12.11.
Section 12.10 What must an HHScertified IITF do to validate an initial
drug test?
(a) An HHS-certified IITF must
demonstrate and document for each
initial drug test:
(1) The ability to differentiate positive
and negative specimens;
(2) The performance of the test around
the cutoff concentration, using samples
at several concentrations between 0 and
150 percent of the cutoff concentration;
(3) The effective concentration range
of the test; and
(4) The effect of carryover that may
occur between aliquots.
(b) Each new lot of a drug test reagent
must be verified prior to being placed
into service.
Section 12.11 What are the batch
quality control (QC) requirements when
conducting an initial drug test?
(a) Each batch of specimens must
contain the following QC samples:
(1) At least one control certified to
contain no drug or drug metabolite;
(2) At least one positive control with
the drug or drug metabolite targeted at
25 percent above the cutoff;
(3) At least one control with the drug
or drug metabolite targeted at 75 percent
of the cutoff; and
(4) At least one control that appears
as a donor specimen to the IITF
analysts.
(b) A minimum of 10 percent of the
total specimens and QC samples in each
batch must be QC samples (i.e.,
calibrators or controls).
Section 12.12 What are the analytical
and quality control requirements for
conducting specimen validity tests?
(a) Each specimen validity test result
must be based on a single test on one
aliquot;
(b) Each specimen validity test must
satisfy the QC requirements in Section
12.14; and
(c) Controls must be analyzed
concurrently with specimens.

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Section 12.13 What must an HHScertified IITF do to validate a specimen
validity test?
An HHS-certified IITF must
demonstrate and document for each
specimen validity test the appropriate
performance characteristics of the test;
and must re-verify the test periodically,
or at least annually.

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Section 12.14 What are the
requirements for conducting each
specimen validity test?
(a) The requirements for measuring
creatinine concentration are as follows:
(1) The creatinine concentration must
be measured to one decimal place on
the test;
(2) The creatinine test must have a
calibrator at 2 mg/dL; and
(3) The creatinine test must 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.
(b) The requirements for measuring
specific gravity are as follows:
(1) For specimens with creatinine test
results less than 20 mg/dL and greater
than 5.0 mg/dL, an IITF must perform
a screening test using a refractometer to
identify specific gravity values that are
acceptable (equal to or greater than
1.003) or dilute (equal to or greater than
1.002 and less than 1.003). Specimens
must be forwarded to an HHS-certified
laboratory when the creatinine test
result is equal to or less than 5.0 mg/dL
or when the screening specific gravity
test result is less than 1.002.
(2) The screening specific gravity test
must have the following QC samples:
(i) A calibrator or control at 1.000; and
(ii) One control targeted at 1.002; and
(iii) One control in the range of 1.004
to 1.018.
(c) The requirements for measuring
pH are as follows:
(1) The IITF may perform the pH test
using a pH meter, colorimetric pH test,
dipsticks, or pH paper. Specimens must
be forwarded to an HHS-certified
laboratory when the pH is less than 4.5
or equal to or greater than 9.0.
(2) The pH test must have, at a
minimum, the following QC samples:
(i) One control below 4.5;
(ii) One control between 4.5 and 9.0;
(iii) One control above 9.0; and
(iv) One or more calibrators as
appropriate for the test. For a pH meter:
Calibrators at 4, 7, and 10.
(d) The requirements for measuring
the nitrite concentration are that the
nitrite test must have a calibrator at 200
mcg/mL nitrite, a control without nitrite
(i.e., certified negative urine), one
control in the range of 200 mcg/mL to
250 mcg/mL, and one control in the
range of 500 mcg/mL to 625 mcg/mL.
Specimens with a nitrite concentration
equal to or greater than 200 mcg/mL
must be forwarded to an HHS-certified
laboratory; and,
(e) Requirements for performing
oxidizing adulterant tests are that the
test must include an appropriate
calibrator at the cutoff specified in

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Sections 11.19(d)(3), (4), or (6) for the
compound of interest, a control without
the compound of interest (i.e., a
certified negative control), and at least
one control with one of the compounds
of interest at a measurable
concentration. Specimens with an
oxidizing adulterant result equal to or
greater than the cutoff must be
forwarded to an HHS-certified
laboratory.
Section 12.15 What are the
requirements for an HHS-certified IITF
to report a test result?
(a) An HHS-certified IITF must report
a test result directly to the agency’s
MRO within an average of 3 working
days after receipt of the specimen using
the Federal CCF and/or electronic
report. Before any test result is reported,
it must be certified by a certifying
technician.
(b) A primary (Bottle A) specimen is
reported negative when each drug test is
negative and each specimen validity test
result indicates that the specimen is a
valid urine specimen.
(c) A primary (Bottle A) urine
specimen is reported dilute when the
creatinine concentration is greater than
5 mg/dL but less than 20 mg/dL and the
specific gravity is equal to or greater
than 1.002 but less than 1.003.
(d) An HHS-certified IITF shall reject
a urine specimen for testing when a fatal
flaw occurs as described in Section 15.1
or when a correctable flaw as described
in Section 15.2 is not recovered. The
IITF will indicate on the Federal CCF
that the specimen was rejected for
testing and provide the reason for
reporting the rejected for testing result.
(e) An HHS-certified IITF may
transmit a result to the MRO by various
electronic means (e.g., teleprinter,
facsimile, or computer) in a manner
designed to ensure confidentiality of the
information. A result may not be
reported verbally by telephone. An IITF
must ensure the security of the data
transmission and limit access to any
data transmission, storage, and retrieval
system.
(f) For all test results, an HHScertified IITF 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. The computergenerated report must contain sufficient
information to ensure that the test result
is properly associated with the custody
and control form that the MRO received
from the collector.

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Section 12.16 How does an HHScertified IITF handle a specimen that
tested positive, adulterated, substituted,
or invalid at the IITF?
(a) The remaining specimen is
resealed using a tamper-evident label/
seal;
(b) The individual resealing the
remaining specimen initials and dates
the tamper-evident label/seal; and
(c) The resealed specimen and split
specimen and the Federal CCF are
sealed in a leak-proof plastic bag, and
are sent to an HHS-certified laboratory
under chain of custody within one day
after completing the drug and specimen
validity tests.
Section 12.17 How long must an HHScertified IITF retain a specimen?
A specimen that is negative, negative/
dilute, or rejected for testing is
discarded.
Section 12.18 How long must an HHScertified IITF retain records?
(a) An HHS-certified IITF must retain
all records generated to support test
results for at least 2 years.
(b) A Federal agency may request an
HHS-certified IITF to maintain a copy of
the documentation package (as
described in Section 12.20(b)) that
supports the chain of custody, testing,
and reporting of a donor’s specimen that
is under legal challenge by a donor. The
Federal agency’s request to the IITF
must be in writing and must specify the
period of time to maintain the
documentation package.
(c) The IITF may retain records other
than those included in the
documentation package beyond the
normal 2 year period of time to ensure
that it can fully support the reported test
result.

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Section 12.19 What statistical
summary report must an HHS-certified
IITF provide?
(a) An HHS-certified IITF must
provide to each Federal agency for
which testing is conducted a
semiannual statistical summary report
that contains the following information:
(1) Reporting period (inclusive dates);
(2) IITF name and address;
(3) Federal agency name;
(4) Total number of specimens tested;
(5) Number of specimens collected by
reason for test;
(6) Number of specimens reported
negative and the number reported
negative/dilute;
(7) Number of specimens rejected for
testing because of a fatal flaw and the
number rejected for testing because of
an uncorrected flaw;

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(8) Number of specimens forwarded to
an HHS-certified laboratory for
additional drug testing and/or specimen
validity testing.
(b) The report must be submitted by
mail, fax, or e-mail within 14 working
days after the end of the semiannual
period.
(c) The HHS-certified IITF must make
available copies of an agency’s test
results when requested by the Secretary
or by the Federal agency for which the
IITF is performing drug-testing services.
(d) The HHS-certified IITF must make
available a qualified individual to testify
in a proceeding against a Federal
employee when that proceeding is based
on a test result reported by the HHScertified IITF.
Section 12.20 What IITF information
is available to a Federal employee?
(a) A Federal employee who is the
subject of a drug test may, upon written
request through the MRO and the
Federal agency, have access to any
records relating to his or her drug test,
any records relating to the results of any
relevant certification, review, or
revocation of certification proceedings,
and access to a documentation package.
(b) A standard documentation
package provided by an HHS-certified
IITF must contain the following items:
(1) A cover sheet that provides a brief
description of the drug testing
procedures and specimen validity tests
performed on the donor’s specimen;
(2) A table of contents page that lists
by page number all documents and
materials in the package;
(3) A copy of the Federal CCF with
any attachments, copies of all internal
chain of custody records for the
specimen, memoranda (if any) generated
by the IITF, and a copy of the electronic
report (if any) generated by the IITF;
(4) A brief description of the IITF’s
drug and specimen validity test
procedures, instrumentation, batch QC
requirements;
(5) Copies of all test data for the
donor’s specimen with all calibrators
and controls identified and copies of all
internal chain of custody documents
related to the tests; and
(6) Copies of the resume or
curriculum vitae for the responsible
technician and for the certifying
technician that certified the test result.
Section 12.21 What type of
relationship is prohibited between an
HHS-certified IITF and an MRO?
An HHS-certified IITF must not enter
into any relationship with a Federal
agency’s MRO that may be construed as
a potential conflict of interest or derive

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any financial benefit by having a
Federal agency use a specific MRO.
This means an MRO may be an
employee of the agency or a contractor
for the agency; however, an MRO shall
not be an employee or agent of or have
any financial interest in an HHScertified IITF for which the MRO is
reviewing drug testing results.
Additionally, an MRO shall not derive
any financial benefit by having an
agency use a specific HHS-certified IITF
or have any agreement with an HHScertified IITF that may be construed as
a potential conflict of interest.
Section 12.22 What type of
relationship can exist between an HHScertified IITF and an HHS-certified
laboratory?
An HHS-certified IITF can freely enter
into any relationship with an HHScertified laboratory.
Subpart M—Medical Review Officer
(MRO)
Section 13.1 Who may serve as an
MRO?
(a) A licensed physician who has:
(1) Either a Doctor of Medicine (M.D.)
or Doctor of Osteopathy (D.O.) degree;
(2) Knowledge regarding the
pharmacology and toxicology of illicit
drugs;
(3) The training necessary to serve as
an MRO as set out in Section 13.2; and
(4) Satisfactorily passed an
examination administered by a
nationally recognized entity that
certifies MROs or subspecialty board for
physicians performing a review of
Federal employee drug test results,
which has been approved by the
Secretary.
(b) Nationally recognized entities that
certify MROs or subspecialty boards for
physicians performing a review of
Federal employee drug test results that
seek approval by the Secretary must
submit their qualifications and a sample
examination. Based on an annual
objective review of the qualifications
and content of the examination, the
Secretary shall annually publish a list in
the Federal Register of those entities
and boards that have been approved.
Section 13.2 What are the training
requirements before a physician can
serve as an MRO?
A physician must receive training that
includes a thorough review of:
(a) The collection procedures used to
collect Federal agency specimens;
(b) How to interpret test results
reported by laboratories;
(c) Chain of custody, reporting, and
recordkeeping requirements for Federal
agency specimens;

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(d) The HHS Mandatory Guidelines
for Federal Workplace Drug Testing
Programs; and
(e) Procedures for interpretation,
review, and reporting of results
specified by any Federal agency for
which the individual may serve as
MRO.
Section 13.3 What are the
responsibilities of an MRO?
(a) The MRO must review all positive,
adulterated, substituted, rejected for
testing, and invalid test results. Staff
under the direct, personal supervision
of the MRO may review and report
negative and negative/dilute test results
to the agency’s designated
representative. The MRO must review at
least 5 percent of all negative results
reported by the MRO staff to ensure that
the MRO staff are properly performing
the review process
(b) The MRO must discuss potential
invalid results with the laboratory as
addressed in Section 11.19(g), to
determine whether testing at another
certified laboratory may be warranted.
(c) After receiving a report from an
HHS-certified laboratory or HHScertified IITF, the MRO must:
(1) Review the information on the
MRO copy of the Federal CCF that was
received from the collector and the
report received from the HHS-certified
laboratory or HHS-certified IITF;
(2) Interview the donor when
required;
(3) Make a determination regarding
the test result;
(4) Report the verified result to the
Federal agency;
(5) Maintain the records (for a
minimum of 2 years) and the
confidentiality of the information;
(6) Review all positive, adulterated,
substituted, and invalid test results
before the result is transmitted to the
agency’s designated representative; and
(d) The MRO must conduct a medical
evaluation when a collector reports that
the donor was unable to provide a urine
specimen, as addressed in Section 13.5.

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Section 13.4 What must an MRO do
when reviewing a test result?
(a) When an HHS-certified laboratory
or HHS-certified IITF reports a negative
result on the primary (Bottle A)
specimen, the MRO reports a negative
result to the agency.
(b) When an HHS-certified laboratory
or HHS-certified IITF reports a negative/
dilute result on the primary (Bottle A)
urine specimen, the MRO reports a
negative/dilute result to the agency and
directs the agency to immediately
collect another specimen from the
donor.

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(c) When an HHS-certified laboratory
reports a positive result on the primary
(Bottle A) urine specimen, the MRO
contacts the donor to determine if there
is any legitimate medical explanation
for the positive result.
(1) If the donor provides a legitimate
medical explanation for the positive
result, the MRO reports the test result as
negative to the agency. If a laboratory
also reports that the specimen is dilute,
the MRO reports a negative/dilute result
to the agency and directs the agency to
immediately collect another specimen
from the donor.
(2) If the donor is unable to provide
a legitimate medical explanation, the
MRO reports a positive result to the
agency. If a laboratory also reports that
the specimen is dilute, the MRO may
choose not to report the dilute result.
(d) When an HHS-certified laboratory
reports a positive result for opiates on
the primary (Bottle A) urine specimen,
the MRO must 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.
However, this requirement does not
apply if the laboratory confirms the
presence of 6-acetylmorphine (i.e., the
presence of this metabolite is proof of
heroin use) or the morphine or codeine
concentration is equal to or greater than
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) When an HHS-certified laboratory
reports an adulterated or substituted
result on the primary (Bottle A) urine
specimen, the MRO contacts the donor
to determine if the donor has a
legitimate medical explanation for the
adulterated or substituted result.
(1) If the donor provides a medical
explanation that is legitimate, the MRO
reports a negative result to the Federal
agency.
(2) If the donor is unable to provide
a legitimate medical explanation, the
MRO reports a refusal to test to the
Federal agency because the specimen
was adulterated or substituted.
(f) When an HHS-certified laboratory
reports an invalid result on the primary
(Bottle A) urine specimen, the MRO
contacts the donor to determine if there
is a legitimate medical explanation for
the invalid result. In the case of an
invalid result based on pH of 9.0 to 9.5,
when an employee has no other medical

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explanation for the pH in this range, the
MRO must consider whether there is
evidence of elapsed time and high
temperature that could account for the
pH value. The MRO may contact the
collection site, IITF, and/or laboratory to
discuss time and temperature issues
(e.g., time elapsed from collection to
receipt at the testing facility, likely
temperature conditions between the
time of the collection and transportation
to the testing facility, specimen storage
conditions).
(i) If the donor provides a medical
explanation that appears to be legitimate
(e.g., a valid prescription medication) or
if the MRO determines that time and
temperature account for the pH in the
9.0–9.5 range, the MRO reports a test
cancelled result with the reason for the
invalid result and informs the Federal
agency that a recollection is not
required because there is an acceptable
explanation for the invalid result.
(ii) If the donor is unable to provide
an acceptable medical explanation or if
the MRO determines that time and
temperature fail to account for the pH in
the 9.0–9.5 range, the MRO reports a test
cancelled result with the reason for the
invalid result and directs the Federal
agency to immediately collect another
specimen from the donor using a direct
observed collection.
(g) When an HHS-certified laboratory
or HHS-certified IITF reports a rejected
for testing result on the primary (Bottle
A) urine specimen, the MRO reports a
test cancelled result to the agency and
directs the agency to immediately
collect another specimen from the
donor.
Section 13.5 What action does the
MRO take when the collector reports
that the donor did not provide a
sufficient amount of urine for a drug
test?
(a) For purposes of this section, a
medical condition includes an
ascertainable physiological condition
(e.g., a urinary system dysfunction) or a
medically documented pre-existing
psychological disorder, but does not
include unsupported assertions of
‘‘situational anxiety’’ or dehydration.
Permanent or long-term medical
conditions are those physiological,
anatomic, or psychological
abnormalities documented as being
present prior to the attempted
collection, and considered not amenable
to correction or cure for an extended
period of time, if ever. Examples would
include destruction (any cause) of the
glomerular filtration system leading to
renal failure; unrepaired traumatic
disruption of the urinary tract; or a
severe psychiatric disorder focused on

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Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / Notices
genitor-urinary matters. Acute or
temporary medical conditions, such as
cystitis, urethritis or prostatitis, though
they might interfere with collection for
a limited period of time, cannot receive
the same exceptional consideration as
the permanent or long-term conditions
discussed in the previous sentence.
(b) When the collector reports that the
donor did not provide a sufficient
amount of urine, the MRO consults with
the Federal agency. The Federal agency
immediately directs the donor to obtain,
within five days, an evaluation from a
licensed physician, acceptable to the
MRO, who has expertise in the medical
issues raised by the donor’s failure to
provide a specimen. (The MRO may
perform this evaluation if the MRO has
appropriate expertise.)
(1) As the MRO, if another physician
will perform the evaluation, you must
provide the other physician with the
following information and instructions:
(i) That the donor was required to take
a federally regulated drug test, but was
unable to provide a sufficient amount of
urine to complete the test;
(ii) The consequences of the
appropriate Federal agency regulation
for refusing to take the required drug
test;
(iii) That the referral physician must
agree to follow the requirements of
paragraphs (c) through (e) of this
section.
(c) As the referral physician
conducting this evaluation, you must
recommend that the MRO make one of
the following determinations:
(1) A medical condition as defined in
paragraph (a) of this section has, or with
a high degree of probability could have,
precluded the employee from providing
a sufficient amount of urine. As the
MRO, if you accept this
recommendation, you must report a test
cancelled result to the Federal agency.
(2) There is not an adequate basis for
determining that a medical condition
has, or with a high degree of probability
could have, precluded the employee
from providing a sufficient amount of
urine. As the MRO, if you accept this
recommendation, you must report a
refusal to test to the Federal agency.
(d) As the referral physician making
the evaluation, after completing your
evaluation, you must provide a written
statement of your recommendations and
the basis for them to the MRO. You
must not include in this statement
detailed information on the employee’s
medical condition beyond what is
necessary to explain your conclusion.
(e) If, as the referral physician making
this evaluation, you determine that the
employee’s medical condition is a
serious and permanent or long-term

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disability (as defined in paragraph a of
this section) that is highly likely to
prevent the employee from providing a
sufficient amount of urine for a very
long or indefinite period of time, you
must set forth your determination and
the reasons for it in your written
statement to the MRO. As the MRO,
upon receiving such a report, you must
follow the requirements of Section 13.6,
where applicable.
(f) As the MRO, you must seriously
consider and assess the referral
physician’s recommendations in making
your determination about whether the
employee has a medical condition that
has, or with a high degree of probability
could have, precluded the employee
from providing a sufficient amount of
urine. You must report your
determination to the Federal agency in
writing as soon as you make it.
(g) When a Federal agency receives a
report from the MRO indicating that a
test is cancelled as provided in
paragraph (c)(1) of this section, the
agency takes no further action with
respect to the donor. The donor remains
in the random testing pool.
Section 13.6 What happens when an
individual is unable to provide a
sufficient amount of urine for a Federal
agency applicant/pre-employment test,
a follow-up test, or a return-to-duty test
because of a permanent or long-term
medical condition?
(a) This section concerns a situation
in which the donor has a medical
condition that precludes him or her
from providing a sufficient specimen for
a Federal agency applicant/preemployment test, a follow-up test, or a
return-to-duty test; and the condition
involves a permanent or long-term
disability (as defined in paragraph (a) of
Section 13.5). As the MRO in this
situation, you must do the following:
(1) You must determine if there is
clinical evidence that the individual is
an illicit drug user. You must make this
determination by personally
conducting, or causing to be conducted,
a medical evaluation and through
consultation with the donor’s physician
and/or the physician who conducted the
evaluation under Section 13.5.
(2) If you do not personally conduct
the medical evaluation, you must ensure
that one is conducted by a licensed
physician acceptable to you.
(b) If the medical evaluation reveals
no clinical evidence of drug use, as the
MRO, you must report the result to the
Federal agency as a negative test with
written notations regarding results of
both the evaluation conducted under
Section 13.5 and any further medical
examination. This report must state the

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basis for the determination that a
permanent or long-term medical
condition exists, making provision of a
sufficient urine specimen impossible,
and for the determination that no signs
and symptoms of drug use exist.
(c) If the medical evaluation reveals
clinical evidence of drug use, as the
MRO, you must report the result to the
Federal agency as a cancelled test with
written notations regarding results of
both the evaluation conducted under
Section 13.5 and any further medical
examination. This report must state that
a permanent or long-term medical
condition (as defined in Section 13.5(a)
exists, making provision of a sufficient
urine specimen impossible, and state
the reason for the determination that
signs and symptoms of drug use exist.
Because this is a cancelled test, it does
not serve the purposes of a negative test
(e.g., the Federal agency is not
authorized to allow the donor to begin
or resume performing official functions,
because a negative test is needed for that
purpose).
Section 13.7 Who may request a test of
a split specimen?
(a) For a positive, adulterated, or
substituted result reported on a primary
(Bottle A) specimen, a donor may
request through the MRO that the split
(Bottle B) specimen be tested by a
second HHS-certified laboratory to
verify the result reported by the first
laboratory.
(b) 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 test of the split (Bottle B)
specimen. The MRO must inform the
donor that he or she has the opportunity
to request a test of the split (Bottle B)
specimen when the MRO informs the
donor that a positive, adulterated, or
substituted result is being reported to
the Federal agency on the primary
(Bottle A) specimen.
Section 13.8 How does an MRO report
a primary (Bottle A) specimen test
result to an agency?
(a) The MRO must report all verified
results to an agency by faxing a
completed MRO copy of the Federal
CCF, transmitting a scanned image of
the completed MRO copy of the Federal
CCF, or faxing a separate report using a
letter/memorandum format.
(b) A verified result may not be
reported to the agency until the MRO
has completed the review process.
(c) The MRO must send a paper copy
of either the completed MRO copy of
the Federal CCF or the separate letter/

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memorandum report for all positive,
adulterated, and substituted results.
(d) The MRO must not disclose
numerical values of drug test results to
the agency.
Section 13.9 What type of relationship
is prohibited between an MRO and an
HHS-certified laboratory or an HHScertified IITF?
An MRO must not be an employee,
agent of, or have any financial interest
in an HHS-certified laboratory or an
HHS-certified IITF for which the MRO
is reviewing drug test results.
This means an MRO must not derive
any financial benefit by having an
agency use a specific HHS-certified
laboratory or HHS-certified IITF, or have
any agreement with the HHS-certified
laboratory or the HHS-certified IITF that
may be construed as a potential conflict
of interest.
Subpart N—Split Specimen Tests

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Section 14.1 When may a split
specimen be tested?
(a) A donor has the opportunity to
request through the MRO that the split
(Bottle B) specimen be tested at a
different (i.e., second) HHS-certified
laboratory when the primary (Bottle A)
specimen was determined by the MRO
to be positive, adulterated, or
substituted.
(b) A donor has 72 hours to initiate
the request after being informed of the
result by the MRO. The MRO must
document in his or her records the
verbal request from the donor to have
the split (Bottle B) specimen tested.
(c) If the split (Bottle B) specimen
cannot be tested by a second laboratory
(e.g., insufficient specimen, lost in
transit, split not available, no second
laboratory available to perform the test),
the MRO reports to the Federal agency
and the donor that the test must be
cancelled and the reason for the
cancellation. The MRO directs the
Federal agency to ensure the immediate
recollection of another specimen from
the donor under direct observation, with
no notice given to the donor of this
collection requirement until
immediately before the collection.
(d) If a donor chooses not to have the
split (Bottle B) specimen tested by a
second laboratory, a Federal agency may
have a split (Bottle B) specimen retested
as part of a legal or administrative
proceeding to defend an original
positive, adulterated, or substituted
result.

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Section 14.2 How does an HHScertified laboratory test a split (Bottle
B) specimen when the primary (Bottle
A) specimen was reported positive?
(a) The testing of a split (Bottle B)
specimen for a drug or metabolite is not
subject to the testing cutoff
concentrations established.
(b) The laboratory is only required to
confirm the presence of the drug or
metabolite that was reported positive in
the primary (Bottle A) specimen.
(c) 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
must conduct specimen validity tests in
an attempt to determine the reason for
being unable to reconfirm the presence
of the drug or drug metabolite. The
second laboratory should conduct the
same specimen validity tests as it would
conduct on a primary (Bottle A)
specimen and reports those results to
the MRO.
Section 14.3 How does an HHScertified laboratory test a split (Bottle
B) specimen when the primary (Bottle
A) specimen was reported adulterated?
(a) A laboratory must use one of the
following criteria to reconfirm an
adulterated result when testing a split
(Bottle B) specimen:
(1) pH must be measured using the
laboratory’s confirmatory pH test with
the appropriate cutoff (i.e., either less
than 3 or equal to or greater than 11);
(2) Nitrite must be measured using the
laboratory’s confirmatory nitrite test
with a cutoff concentration of equal to
or greater than 500 mcg/mL;
(3) Surfactant must be measured using
the laboratory’s confirmatory surfactant
test with a cutoff concentration of equal
to or greater than 100 mcg/mL
dodecylbenzene sulfonate-equivalent
cutoff; or
(4) For adulterants without a specified
cutoff (e.g., glutaraldehyde, chromium
(VI), pyridine, halogens (such as, bleach,
iodine), peroxidase, peroxide, other
oxidizing agents), the laboratory must
use its confirmatory specimen validity
test at an established limit of
quantitation (LOQ) to reconfirm the
presence of the adulterant.
(b) The second laboratory may only
conduct the confirmatory specimen
validity test(s) needed to reconfirm the
adulterated result reported by the first
laboratory.
Section 14.4 How does an HHScertified laboratory test a split (Bottle
B) specimen when the primary (Bottle
A) specimen was reported substituted?
(a) A laboratory must use the
following criteria to reconfirm a

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substituted result when testing a split
(Bottle B) specimen:
(1) The creatinine must be measured
using the laboratory’s confirmatory
creatinine test with a cutoff
concentration of less than 2 mg/dL; and
(2) The specific gravity must be
measured using the laboratory’s
confirmatory specific gravity test with
the specified cutoffs of less than or
equal to 1.0010 or equal to or greater
than 1.0200.
(b) The second laboratory may only
conduct the confirmatory specimen
validity test(s) needed to reconfirm the
substituted result reported by the first
laboratory.
Section 14.5 Who receives the split
specimen result?
The second HHS-certified laboratory
must transmit the result directly to the
MRO.
Section 14.6 What action(s) does an
MRO take after receiving the split
(Bottle B) specimen result from the
second HHS-certified laboratory?
The MRO takes the following actions
when the second laboratory reports the
result for the split urine specimen as:
(a) Reconfirmed the drug(s),
adulteration, and/or substitution result.
The MRO reports reconfirmed to the
agency.
(b) Failed to reconfirm a single or all
drug positive results and adulterated. If
the donor provides a legitimate medical
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 retest
the primary (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.
(c) 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

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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 primary (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 HHS office
responsible for coordination of the drugfree workplace program about the failed
to reconfirm and cancelled test.
(d) 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 HHS
office responsible for coordination of
the drug-free workplace program.
(e) 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 HHS office
responsible for coordination of the drugfree workplace program.
(f) 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 HHS office official responsible for
coordination of the drug-free workplace
program regarding the test results for the
specimen.
(g) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and 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 HHS office responsible for
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program regarding the test results for the
specimen.
(h) 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 HHS office responsible
for coordination of the drug-free
workplace program regarding the test
results for the specimen.
(i) Failed to reconfirm one or more
drugs, reconfirmed one or more drugs,
and 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 HHS
office responsible for coordination of
the drug-free workplace program
regarding the test results for the
specimen.
(j) Failed to reconfirm substitution or
adulteration. The MRO reports to the
agency a failed to reconfirm result
(specify adulterant or not substituted)
and cancels both tests. The MRO shall
notify the HHS office responsible for
coordination of the drug-free workplace
program regarding the test results for the
specimen.
(k) Failed to reconfirm 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
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.
(l) 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 HHS office
responsible for coordination of the drugfree workplace program regarding the
test results for the specimen.
(m) 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

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on the reconfirmed drug(s) and the
adulterated result although Laboratory B
failed to reconfirm one or more drugs.
(n) 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.
(o) 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 HHS office
responsible for coordination of the drugfree workplace program regarding the
test results for the specimen.
(p) 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.
(q) Failed to reconfirm a substituted
result and reconfirmed an adulterated
result. The MRO reports to the agency
a reconfirmed result (adulterated) and a
failed to reconfirm result (not
substituted). The MRO tells the agency
that it may take action based on the
adulterated result although Laboratory B
failed to reconfirm the substituted
result.
Section 14.7 How does an MRO report
a split (Bottle B) specimen test result to
an agency?
(a) The MRO must report all verified
results to an agency by faxing a
completed MRO copy of the Federal
CCF, transmitting a scanned image of
the completed MRO copy of the Federal
CCF, or faxing a separate report using a
letter/memorandum format.
(b) A verified result may not be
reported to the agency until the MRO
has completed the review process.
(c) The MRO must send a paper copy
of either the completed MRO copy of
the Federal CCF or the separate letter/
memorandum report for all positive,
adulterated, and substituted results.
(d) The MRO must not disclose the
numerical values of the drug test results
to the agency.

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Section 14.8 How long must an HHScertified laboratory retain a split (Bottle
B) specimen?
A split (Bottle B) specimen is retained
for the same period of time that a
primary (Bottle A) specimen is retained
and under the same storage conditions.
This applies even for those cases when
the split (Bottle B) specimen is tested by
a second laboratory and the second
laboratory does not confirm the original
result reported by the first laboratory on
the primary (Bottle A) specimen.
Subpart O—Criteria for Rejecting a
Specimen for Testing
Section 15.1 What discrepancies
require an HHS-certified laboratory or
an HHS-certified IITF to report a
specimen as rejected for testing?
The following discrepancies are
considered to be fatal flaws. The
laboratory or IITF must stop the testing
process, reject the specimen for testing,
and indicate the reason for rejecting the
specimen on the Federal CCF when:
(a) The specimen ID number on the
specimen label/seal does not match the
ID number on the Federal CCF, or the
ID number is missing either on the
Federal CCF or on the specimen label/
seal;
(b) The specimen label/seal is broken
or shows evidence of tampering on the
primary (Bottle A) specimen and the
split (Bottle B) specimen cannot be redesignated as the primary (Bottle A)
specimen;
(c) The collector’s printed name and
signature are omitted on the Federal
CCF; or
(d) There is an insufficient amount of
specimen for analysis in the primary
(Bottle A) specimen unless the split
(Bottle B) specimen can be re-designated
as the primary (Bottle A) specimen.

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Section 15.2 What discrepancies
require an HHS-certified laboratory or
an HHS-certified IITF to report a
specimen as rejected for testing unless
the discrepancy is corrected?
The following discrepancies are
considered to be correctable:
(a) If a collector failed to sign the
Federal CCF, the HHS-certified
laboratory or IITF must attempt to
recover the collector’s signature before
reporting the test result. If the collector
can provide a memorandum for record
recovering the signature, the laboratory
or IITF may report the test result for the
specimen. If after 5 business days the
laboratory or IITF cannot recover the
collector’s signature, the laboratory or
IITF must report a rejected for testing
result and indicate the reason for the

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rejected for testing result on the Federal
CCF.
(b) If a specimen is submitted using a
non-Federal form or an expired Federal
CCF, the laboratory or IITF must test the
specimen and also attempt to obtain a
memorandum for record explaining why
a non-Federal form or an expired
Federal CCF was used and ensure that
the form used contains all the required
information. If after 5 business days the
laboratory or IITF cannot obtain a
memorandum for record from the
collector, the laboratory or IITF must
report a rejected for testing result and
indicate the reason for the rejected for
testing result on the report to the MRO.
Section 15.3 What discrepancies are
not sufficient to require an HHScertified laboratory or an HHS-certified
IITF to reject a specimen for testing or
an MRO to cancel a test?
(a) The following omissions and
discrepancies on the Federal CCF that
are received by the laboratory or IITF
are considered insignificant and should
not cause a laboratory or IITF to reject
a specimen or cause an MRO to cancel
a test:
(1) An incorrect laboratory name and
address appears at the top of the form;
(2) Incomplete/incorrect/unreadable
employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO
address;
(5) A transposition of numbers in the
donor’s SSN;
(6) A phone number is missing/
incorrect;
(7) A fax number is missing/incorrect;
(8) A ‘‘reason for test’’ box is not
marked;
(9) A ‘‘drug tests to be performed’’ box
is not marked;
(10) A ‘‘specimen collection’’ box is
not marked;
(11) The ‘‘observed’’ box is not
marked (if applicable);
(12) The collection site address is
missing;
(13) The collector’s printed name is
missing but the collector’s signature is
properly recorded;
(14) The time of collection is not
indicated;
(15) The date of collection is not
indicated;
(16) Incorrect name of delivery
service;
(17) The collector has changed or
corrected information by crossing out
the original information on either the
Federal CCF or specimen label/seal
without dating and initialing the
change; or
(18) The donor’s name inadvertently
appears on the laboratory copy of the

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Federal CCF or on the tamper-evident
labels used to seal the specimens.
(19) The collector failed to check the
specimen temperature box and the
‘‘Remarks’’ line did not have a comment
regarding the temperature being out of
range. If after 5 business days the
collector cannot provide a
memorandum for record to attest to the
fact that he or she did measure the
specimen temperature, the laboratory or
IITF may report the test result for the
specimen but indicates that the collector
could not provide a memorandum to
recover the omission.
(b) The following omissions and
discrepancies on the Federal CCF that
are made at the laboratory or IITF are
considered insignificant and should not
cause an MRO to cancel a test:
(1) The testing laboratory or IITF fails
to indicate the correct name and address
in the results section when a different
laboratory or IITF name and address is
printed at the top of the Federal CCF;
(2) The accessioner fails to print his
or her name;
(3) The certifying scientist or
certifying technician fails to print his or
her name;
(4) The certifying scientist or
certifying technician accidentally
initials the Federal CCF rather than
signing for a specimen reported as
rejected for testing;
(5) The accessioner fails to mark one
of the ‘‘primary (Bottle A) specimen
bottle seal intact’’ boxes, but the
laboratory or IITF reported a ‘‘rejected
for testing’’ result with an appropriate
comment on the ‘‘Remarks’’ line.
(c) The above omissions and
discrepancies are considered
insignificant only when they occur no
more than once a month. The
expectation is that each trained collector
and HHS-certified laboratory or IITF
will make every effort to ensure that the
Federal CCF is properly completed and
that all the information is correct. When
an error occurs more than once a month,
the MRO must direct the collector,
laboratory, or IITF (whichever is
responsible for the error) to immediately
take corrective action to prevent the
recurrence of the error.
Section 15.4 What discrepancies may
require an MRO to cancel a test?
(a) An MRO must attempt to correct
the following errors:
(1) The donor’s signature is missing
on the MRO copy of the Federal CCF
and the collector failed to provide a
comment that the donor refused to sign
the form;
(2) The certifying scientist failed to
sign the paper copy (Copy 1) of the
Federal CCF for a specimen being

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reported drug positive, adulterated,
substituted, or invalid result; or
(3) The electronic report provided by
the HHS-certified laboratory or HHScertified IITF does not contain all the
data elements required for the HHS
standard electronic laboratory or IITF
report for a specimen being reported
drug positive, adulterated, substituted,
invalid result, or rejected for testing test
result.
(b) If error (a)(1) occurs, the MRO
must contact the collector to obtain a
statement to verify that the donor
refused to sign the MRO copy. If after 5
business days the collector cannot
provide such a statement, the MRO
must cancel the test.
(c) If error (a)(2) occurs, the MRO
must obtain a statement from the
certifying scientist that he or she
inadvertently forgot to sign the Federal
CCF, but did, in fact, properly conduct
the certification review. If after 5
business days the MRO cannot get a
statement from the certifying scientist,
the MRO must cancel the test.
(d) If error (a)(3) occurs, the MRO
must contact the HHS-certified
laboratory or HHS-certified IITF. If after
5 business days the laboratory or IITF
does not retransmit a corrected
electronic report, the MRO must cancel
the test.

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.

Subpart P—Laboratory or IITF
Suspension/Revocation Procedures

Section 16.5 When must a request for
informal review be submitted?
(a) Within 30 days of the date of the
notice of the suspension or proposed
revocation, the appellant must submit a
written request to the reviewing official
seeking review, unless some other time
period is agreed to by the parties. A
copy must also be sent to the
respondent. The request for review must
include a copy of the notice of
suspension or proposed revocation, a
brief statement of why the decision to
suspend or propose revocation is wrong,
and the appellant’s request for an oral
presentation, if desired.
(b) Within 5 days after receiving the
request for review, the reviewing official
will send an acknowledgment and
advise the appellant of the next steps.
The reviewing official will also send a
copy of the acknowledgment to the
respondent.

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Section 16.1 When may an HHScertified laboratory or IITF be
suspended?
These procedures apply when:
(a) The Secretary has notified an HHScertified laboratory or IITF in writing
that its certification to perform drug
testing under these Guidelines has been
suspended or that the Secretary
proposes to revoke such certification.
(b) The HHS-certified laboratory or
IITF has, within 30 days of the date of
such notification or within 3 days of the
date of such notification when seeking
an expedited review of a suspension,
requested in writing an opportunity for
an informal review of the suspension or
proposed revocation.
Section 16.2 What definitions are used
for this subpart?
Appellant. Means the HHS-certified
laboratory or IITF which has been
notified of its suspension or proposed
revocation of its certification to perform
drug and/or specimen validity testing
and has requested an informal review
thereof.
Respondent. Means the person or
persons designated by the Secretary in
implementing these Guidelines.

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Section 16.3 Are there any limitations
on issues subject to review?
The scope of review shall be limited
to the facts relevant to any suspension
or proposed revocation, the necessary
interpretations of those facts, the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs, and
other relevant law. The legal validity of
these Guidelines shall not be subject to
review under these procedures.
Section 16.4 Who represents the
parties?
The appellant’s request for review
shall specify the name, address, and
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 16.6 What is an abeyance
agreement?
Upon mutual agreement of the parties
to hold these procedures in abeyance,
the reviewing official will stay these
procedures for a reasonable time while
the laboratory or IITF attempts to regain
compliance with the Guidelines or the
parties otherwise attempt to settle the
dispute. As part of an abeyance

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agreement, the parties can agree to
extend the time period for requesting
review of the suspension or proposed
revocation. If abeyance begins after a
request for review has been filed, the
appellant shall notify the reviewing
official at the end of the abeyance
period advising whether the dispute has
been resolved. If the dispute has been
resolved, the request for review will be
dismissed. If the dispute has not been
resolved, the review procedures will
begin at the point at which they were
interrupted by the abeyance agreement
with such modifications to the
procedures as the reviewing official
deems appropriate.
Section 16.7 What procedure is used
to prepare the review file and written
argument?
The appellant and the respondent
each participate in developing the file
for the reviewing official and in
submitting written arguments. The
procedures for development of the
review file and submission of written
argument are:
(a) Appellant’s Documents and Brief.
Within 15 days after receiving the
acknowledgment of the request for
review, the appellant shall submit to the
reviewing official the following (with a
copy to the respondent):
(1) A review file containing the
documents supporting appellant’s
argument, tabbed and organized
chronologically, and accompanied by an
index identifying each document. Only
essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed
20 double-spaced pages, explaining why
respondent’s decision to suspend or
propose revocation of appellant’s
certification is wrong (appellant’s brief).
(b) Respondent’s Documents and
Brief. Within 15 days after receiving a
copy of the acknowledgment of the
request for review, the respondent shall
submit to the reviewing official the
following (with a copy to the appellant):
(1) A review file containing
documents supporting respondent’s
decision to suspend or revoke
appellant’s certification to perform drug
and/or specimen 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
proposed revocation (respondent’s
brief).
(c) Reply Briefs. Within 5 days after
receiving the opposing party’s

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submission, or 20 days after receiving
acknowledgment of the request for
review, whichever is later, each party
may submit a short reply not to exceed
10 double-spaced pages.
(d) Cooperative Efforts. Whenever
feasible, the parties should attempt to
develop a joint review file.
(e) Excessive Documentation. The
reviewing official may take any
appropriate step to reduce excessive
documentation, including the return of
or refusal to consider documentation
found to be irrelevant, redundant, or
unnecessary.
Section 16.8 When is there an
opportunity for oral presentation?
(a) Electing Oral Presentation. If an
opportunity for an oral presentation is
desired, the appellant shall request it at
the time it submits its written request
for review to the reviewing official. The
reviewing official will grant the request
if the official determines that the
decision-making process will be
substantially aided by oral presentations
and arguments. The reviewing official
may also provide for an oral
presentation at the official’s own
initiative or at the request of the
respondent.
(b) Presiding Official. The reviewing
official or designee will be the presiding
official responsible for conducting the
oral presentation.
(c) Preliminary Conference. The
presiding official may hold a prehearing
conference (usually a telephone
conference call) to consider any of the
following: simplifying and clarifying
issues; stipulations and admissions;
limitations on evidence and witnesses
that will be presented at the hearing;
time allotted for each witness and the
hearing altogether; scheduling the
hearing; and any other matter that will
assist in the review process. Normally,
this conference will be conducted
informally and off the record; however,
the presiding official may, at 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
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

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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
Federal Rules of Evidence do not apply
and the presiding official will generally
admit all testimonial evidence unless it
is clearly irrelevant, immaterial, or
unduly repetitious. Each party may
make an opening and closing statement,
may present witnesses as agreed upon
in the prehearing conference or
otherwise, and may question the
opposing party’s witnesses. Since the
parties have ample opportunity to
prepare the review file, a party may
introduce additional documentation
during the oral presentation only with
the permission of the presiding official.
The presiding official may question
witnesses directly and take such other
steps necessary to ensure an effective
and efficient consideration of the
evidence, including setting time
limitations on direct and crossexaminations.
(4) Motions. The presiding official
may rule on motions including, for
example, motions to exclude or strike
redundant or immaterial evidence,
motions to dismiss the case for
insufficient evidence, or motions for
summary judgment. Except for those
made during the hearing, all motions
and opposition to motions, including
argument, must be in writing and be no
more than 10 double-spaced pages in
length. The presiding official will set a
reasonable time for the party opposing
the motion to reply.
(5) Transcripts. The presiding official
shall have the oral presentation
transcribed and the transcript shall be
made a part of the record. Either party
may request a copy of the transcript and
the requesting party shall be responsible
for paying for its copy of the transcript.
(f) Obstruction of Justice or Making of
False Statements. Obstruction of justice
or the making of false statements by a
witness or any other person may be the
basis for a criminal prosecution under
18 U.S.C. 1505 or 1001.

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(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 16.9 Are there expedited
procedures for review of immediate
suspension?
(a) Applicability. When the Secretary
notifies a laboratory or IITF in writing
that its certification to perform drug and
specimen 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 or IITF received notice of the
suspension. The request for review must
include a copy of the suspension and
any proposed revocation, a brief
statement of why the decision to
suspend and propose revocation is
wrong, and the appellant’s request for
an oral presentation, if desired. A copy
of the request for review must also be
sent to the respondent.
(b) Reviewing Official’s Response. As
soon as practicable after the request for
review is received, the reviewing official
will send an acknowledgment with a
copy to the respondent.
(c) Review File and Briefs. Within 7
days of the date the request for review
is received, but no later than 2 days
before an oral presentation, each party
shall submit to the reviewing official the
following:
(1) A review file containing essential
documents relevant to the review,
tabbed, indexed, and organized
chronologically; and
(2) A written statement, not to exceed
20 double-spaced pages, explaining the
party’s position concerning the
suspension and any proposed
revocation. No reply brief is permitted.
(d) Oral Presentation. If an oral
presentation is requested by the
appellant or otherwise granted by the
reviewing official, the presiding official
will attempt to schedule the oral
presentation within 7–10 days of the
date of appellant’s request for review at
a time and place determined by the
presiding official following consultation
with the parties. The presiding official
may hold a prehearing conference in
accordance with Section 16.8(c) and
will conduct the oral presentation in
accordance with the procedures of
Sections 16.8(e), (f), and (g).
(e) Written Decision. The reviewing
official shall issue a written decision
upholding or denying the suspension or

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Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / Notices
proposed revocation and will attempt to
issue the decision within 7–10 days of
the date of the oral presentation or
within 3 days of the date on which the
transcript is received or the date of the
last submission by either party,
whichever is later. All other provisions
set forth in Section 16.14 will apply.
(f) Transmission of Written
Communications. Because of the
importance of timeliness for these
expedited procedures, all written
communications between the parties
and between either party and the
reviewing official shall be by facsimile,
secured electronic transmissions, or
overnight mail.
Section 16.10 Are any types of
communications prohibited?
Except for routine administrative and
procedural matters, a party shall not
communicate with the reviewing or
presiding official without notice to the
other party.

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Section 16.11 How are
communications transmitted by the
reviewing official?
(a) Because of the importance of a
timely review, the reviewing official
should normally transmit written
communications to either party by
facsimile, secured electronic
transmissions, or overnight mail in
which case the date of transmission or
day following mailing will be
considered the date of receipt. In the
case of communications sent by regular
mail, the date of receipt will be
considered 3 days after the date of
mailing.
(b) In counting days, include
Saturdays, Sundays, and Federal
holidays. However, if a due date falls on
a Saturday, Sunday, or Federal holiday,
then the due date is the next Federal
working day.

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Section 16.12 What are the authority
and responsibilities of the reviewing
official?
In addition to any other authority
specified in these procedures, the
reviewing official and the presiding
official, with respect to those authorities
involving the oral presentation, shall
have the authority to issue orders;
examine witnesses; take all steps
necessary for the conduct of an orderly
hearing; rule on requests and motions;
grant extensions of time for good
reasons; dismiss for failure to meet
deadlines or other requirements; order
the parties to submit relevant
information or witnesses; remand a case
for further action by the respondent;
waive or modify these procedures in a
specific case, usually with notice to the
parties; reconsider a decision of the
reviewing official where a party
promptly alleges a clear error of fact or
law; and to take any other action
necessary to resolve disputes in
accordance with the objectives of these
procedures.
Section 16.13 What administrative
records are maintained?
The administrative record of review
consists of the review file; other
submissions by the parties; transcripts
or other records of any meetings,
conference calls, or oral presentation;
evidence submitted at the oral
presentation; and orders and other
documents issued by the reviewing and
presiding officials.
Section 16.14 What are the
requirements for a written decision?
(a) Issuance of Decision. The
reviewing official shall issue a written
decision upholding or denying the
suspension or proposed revocation. The
decision will set forth the reasons for

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the decision and describe the basis
therefore in the record. Furthermore, the
reviewing official may remand the
matter to the respondent for such
further action as the reviewing official
deems appropriate.
(b) Date of Decision. The reviewing
official will attempt to issue 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 16.15 Is there a review of the
final administrative action?
Before any legal action is filed in
court challenging the suspension or
proposed revocation, respondent shall
exhaust administrative remedies
provided under this subpart, unless
otherwise provided by Federal law. The
reviewing official’s decision, under
Section 16.9(e) or 16.14(a), constitutes
final agency action and is ripe for
judicial review as of the date of the
decision.
[FR Doc. E8–26726 Filed 11–24–08; 8:45 am]
BILLING CODE 4162–20–P

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