[Federal Register Volume 73, Number 228 (Tuesday, November 25, 2008)]
[Notices]
[Pages 71857-71907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26726]



[[Page 71857]]

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Part V





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration



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Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Notice

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Revised Mandatory Guidelines.

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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 
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 
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

[[Page 71859]]

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 HHS-certified 
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.

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 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 cross-reactivity 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 HHS-certified 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 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

[[Page 71860]]

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.
    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.
    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 HHS-certified 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 specimen is reported as 
positive, adulterated, or substituted, the Department allows the donor 
to request that Bottle B be tested at another HHS-certified 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 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 HHS-certified 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

[[Page 71862]]

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 supervisor 
or hiring official from 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 
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

[[Page 71863]]

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 OMB-approved 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 Memorandum For Record (MFR) from 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 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

[[Page 71864]]

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 
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 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

[[Page 71865]]

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 be evidence that errors by collectors are 
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 HHS-certified 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 non-regulated 
specimen results, only occurs for those private sector specimens that 
are tested in batches that contain federally-regulated specimens. This 
usually occurs with confirmatory test 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

[[Page 71866]]

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 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 HHS-certified laboratory or IITF ``is 
inspected by one or more inspectors.'' The Department believes that one 
inspector is appropriate to inspect an HHS-certified 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 HHS-certified 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 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

[[Page 71867]]

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.

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 
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 HHS-certified 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 HHS-certified 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.
    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 HHS-certified 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

[[Page 71868]]

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 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 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 HHS-certified 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

[[Page 71869]]

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 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.
    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

[[Page 71870]]

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 HHS-certified 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 HHS-
certified 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 HHS-certified 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 HHS-certified IITF. The requirements 
in this section are the same as the requirements 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 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 HHS-
certified IITF may use a pH screening test to determine if an initial 
pH validity test must be performed. The HHS-certified 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 HHS-certified 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 HHS-
certified 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 HHS-certified 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 HHS-certified IITF handles a 
specimen that tested as positive, adulterated, substituted, or invalid 
at the IITF. The Department has revised this section by

[[Page 71871]]

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 HHS-certified 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 HHS-certified laboratory for additional drug and/or 
specimen validity testing. Three commenters raised concern with the 
proposed requirement that an HHS-certified 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 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 HHS-certified IITF and an HHS-certified laboratory. 
The Department believes any relationship is acceptable because HHS-
certified laboratories and IITFs are certified independently. 
Therefore, the Department has no objection if an HHS-certified 
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 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, non-medical 
explanation for this invalid result. The Department has removed the 
sections addressing MRO actions in response to a second specimen 
collected

[[Page 71872]]

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 
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 
Proposed Revisions to Mandatory Guidelines. Section 15.2 describes the 
discrepancies that require an HHS-certified 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.

[[Page 71873]]

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 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 DOT-regulated 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.
    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-for-profit 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.

                                       Estimate of Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of      Responses/        Hours/
            Section                  Purpose        respondents     respondent       response       Total hours
----------------------------------------------------------------------------------------------------------------
9.2(a)(1).....................  Lab or IITF                   28               1               3              84
                                 required to
                                 submit
                                 application for
                                 certification.
9.10(a)(3)....................  Materials to                  25               1               2              50
                                 submit to
                                 become an HHS
                                 inspector.
11.4(c).......................  Lab submits                   75               1               2             150
                                 qualifications
                                 of new RPs and
                                 alternate RPs
                                 to HHS.
11.22(a)......................  Specifications                75               2             0.5              75
                                 for lab semi-
                                 annual
                                 statistical
                                 report of test
                                 results to each
                                 Federal agency.
12.4(c).......................  IITF submits                  50               1               2             100
                                 qualifications
                                 of new RTs and
                                 alternate RTs
                                 to HHS.
12.19(a)......................  Specifies                     25               5             0.5              63
                                 contents of
                                 IITF semi-
                                 annual
                                 statistical
                                 report to
                                 Federal
                                 agencies served.
14.7..........................  Specifies that               100               5    0.05 (3 min)              25
                                 MRO must report
                                 verified split
                                 specimen test
                                 results to the
                                 Federal agency.
16.1(b); 16.5(a)..............  Specifies                      1               1               3               3
                                 content of
                                 request for
                                 informal review
                                 of suspension/
                                 proposed
                                 revocation of
                                 certification.
16.4..........................  Specifies                      1               1             0.5             0.5
                                 information
                                 appellant
                                 provides in
                                 first written
                                 submission when
                                 lab or IITF
                                 suspension/
                                 revocation is
                                 proposed.

[[Page 71874]]

 
16.6..........................  Requires                       1               1             0.5             0.5
                                 appellant to
                                 notify
                                 reviewing
                                 official of
                                 resolution
                                 status at end
                                 of abeyance
                                 period.
16.7(a).......................  Specifies                      1               1              50              50
                                 contents of
                                 appellant
                                 submission for
                                 review.
16.9(a).......................  Specifies                      1               1               3               3
                                 content of
                                 appellant
                                 request for
                                 expedited
                                 review of
                                 suspension or
                                 proposed
                                 revocation.
16.9(c).......................  Specifies                      1               1              50              50
                                 contents of
                                 review file and
                                 briefs.
                                                 ---------------------------------------------------------------
    TOTAL.....................  ................             384  ..............  ..............             654
----------------------------------------------------------------------------------------------------------------

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

                                      Estimate of Annual Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of      Responses/        Hours/
            Section                  Purpose        respondents     respondent       response       Total hours
----------------------------------------------------------------------------------------------------------------
4.5(c)........................  Collector is                 100               1    0.05 (3 min)               5
                                 given name and
                                 phone of
                                 Federal agency
                                 point of
                                 contact.
11.23(b)......................  Information on                50              10               3           1,500
                                 drug test that
                                 lab must
                                 provide to
                                 donor through
                                 MRO.
12.20(b)......................  Drug test                     25              10               2             500
                                 information
                                 that IITF must
                                 provide to
                                 donor through
                                 MRO.
13.7(b).......................  MRO must inform              100               5               3           1,500
                                 donor of right
                                 to request
                                 split specimen
                                 test when a
                                 positive,
                                 adulterated, or
                                 substituted
                                 result is
                                 reported.
                                                 ---------------------------------------------------------------
    Total.....................  ................             275  ..............  ..............           3,505
----------------------------------------------------------------------------------------------------------------

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

                                     Estimate of Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of      Responses/        Hours/
            Section                  Purpose        respondents     respondent       response       Total hours
----------------------------------------------------------------------------------------------------------------
8.3, 8.4, 8.5, 8.6, and 8.7...  Collector                    100             380    0.07 (4 min)           2,660
                                 completes
                                 Federal CCF for
                                 specimen
                                 collected.
11.8 and 11.19(a) and (o).....  Lab completes                 50             760    0.05 (3 min)           1,900
                                 Federal CCF
                                 upon receipt of
                                 specimen and
                                 before
                                 reporting
                                 result.
12.8(a) and 12.15(f)..........  IITF completes                25            1520    0.05 (3 min)           1,900
                                 Federal CCF
                                 upon receipt of
                                 specimen and
                                 before
                                 reporting
                                 result.
13.3(c)(4)....................  MRO completes                100             380    0.05 (3 min)           1,900
                                 the Federal CCF
                                 before
                                 reporting
                                 result.
14.1(b).......................  MRO documents                300               1    0.05 (3 min)              15
                                 donor's request
                                 to have split
                                 specimen tested.
                                                 ---------------------------------------------------------------
    Total.....................  ................             575  ..............  ..............           8,375
----------------------------------------------------------------------------------------------------------------


[[Page 71875]]

    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.
    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).

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

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

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A--Applicability

1.1 To whom do these Guidelines apply?
1.2 Who is responsible for developing and implementing these 
Guidelines?
1.3 How does a Federal agency request a change from these 
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect employee records?
1.7 What is a refusal to take a federally regulated drug test, and 
what are the consequences?

Subpart B--Specimens

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

Subpart C--Urine Drug and Specimen Validity Tests

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

Subpart D--Collectors

4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be 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?

Subpart E--Collection Sites

5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 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

[[Page 71876]]

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

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 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 HHS-certified 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 HHS-certified 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 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 HHS-certified IITF's standard 
operating procedure manual?
12.2 What are the responsibilities of the responsible technician 
(RT)?
12.3 What qualifications must the RT have?
12.4 What happens when the RT is absent or leaves an HHS-certified 
IITF?
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 HHS-certified 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?

[[Page 71877]]

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/pre-
employment 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?

Subpart O--Criteria for Rejecting a Specimen for Testing

15.1 What discrepancies require an HHS-certified laboratory or an 
HHS-certified IITF to report a specimen as rejected for testing?
15.2 What discrepancies require an HHS-certified laboratory or an 
HHS-certified IITF to report a specimen as rejected for testing 
unless the discrepancy is corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory or an HHS-certified IITF to reject a 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 subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What 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?

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, 
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.
---------------------------------------------------------------------------

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

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

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

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

Section 1.4 How are these Guidelines revised?

    (a) 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

[[Page 71878]]

administrative responsibility for the day-to-day management of the HHS-
certified 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 HHS-certified 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.
    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 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

[[Page 71879]]

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 HHS-certified laboratory.
    Responsible Technician (RT). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified 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.

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.
    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 pre-
employment 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 Federal 
agency applicant/pre-employment drug test, the donor is deemed to have 
refused to test on this basis only if the Federal agency applicant/pre-
employment test is conducted following a contingent offer of 
employment. If there was no contingent offer of employment, the MRO 
will cancel the test; 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

[[Page 71880]]

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/Pre-employment test;
    (b) Random test;
    (c) Reasonable suspicion/cause test;
    (d) Post-accident test;
    (e) Return to duty test; or
    (f) Follow-up test.

Section 2.3 How is each specimen collected?

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

Section 2.4 What volume of urine is collected?

    A donor is expected to provide at least 45 mL of urine for a 
specimen 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 cutoff       Confirmatory test        Confirmatory test
         Initial test analyte               concentration               analyte           cutoff  concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolites................  50 ng/mL...............  THCA\1\................  15 ng/mL
Cocaine metabolites..................  150 ng/mL..............  Benzoylecgonine........  100 ng/mL
Opiate metabolites...................
    Codeine/Morphine \2\.............  2000 ng/mL.............  Codeine................  2000 ng/mL
                                                                Morphine...............  2000 ng/mL
6-Acetylmorphine.....................  10 ng/mL...............  6-Acetylmorphine.......  10 ng/mL
Phencyclidine........................  25 ng/mL...............  Phencyclidine..........  25 ng/mL
Amphetamines \3\.....................
AMP/MAMP \4\.........................  500 ng/mL..............  Amphetamine............  250 ng/mL
                                                                Methamphetamine \5\....  250 ng/mL
MDMA\6\..............................  500 ng/mL..............  MDMA...................  250 ng/mL
                                                                MDA\7\.................  250 ng/mL
                                                                MDEA\8\................  250 ng/mL
----------------------------------------------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
\2\ Morphine 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).

[[Page 71881]]

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

Section 3.6 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 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

[[Page 71882]]

two separate aliquots or relying on the odor of the specimen as the 
initial test;
    (f) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde present) or characteristic immunoassay 
response on one or more drug immunoassay tests for both the initial 
(first) test and the second test on two separate aliquots;
    (g) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with an equal to 
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or 
greater than 50 mcg/mL chromium (VI)-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

Section 4.1 Who may collect a specimen?

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

Section 4.2 Who may not collect a specimen?

    (a) A Federal agency employee who is in a testing designated 
position and subject to the Federal agency drug testing rules must not 
be a collector for co-workers 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 HHS-certified laboratory or IITF 
must not act as a collector if the employee could link the identity of 
the donor to the donor's drug test result.
    (d) To avoid a potential conflict of interest, a collector should 
not be someone that is related to the employee (e.g., spouse, ex-
spouse, relative) or a close personal friend (e.g., fianc[eacute]).

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 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

[[Page 71883]]

    (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

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

    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) In the event that an agency-designated collection site is not 
accessible and there is an immediate requirement to collect a 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;
    (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 HHS-certified 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.

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.

[[Page 71884]]

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

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:
    (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 observed collection procedure is used in 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.

[[Page 71885]]

    (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[deg]-38 [deg]C/90[deg]-100 [deg]F.
    (1) The temperature measuring device must accurately reflect the 
temperature of the specimen and not contaminate the specimen.
    (2) If the temperature of the specimen is outside the range of 
32[deg]-38[deg] C/90[deg]-100[deg] F, that is a reason to believe that 
the donor may have adulterated or substituted the specimen. Another 
specimen must be collected under direct observation in accordance with 
Section 8.8. 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.
    (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 HHS-certified laboratory for testing.
    (2) When there is any reason to believe that a donor may have 
adulterated or substituted the specimen, another specimen must be 
obtained as soon as possible under direct observation in accordance 
with Section 8.8. 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;
    (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 tamper-evident labels/seals on each 
specimen bottle. If the donor refuses to initial the labels/seals, the 
collector notes the refusal on the Federal CCF and continues with the 
collection process.
    (e) The collector 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 was conducted in 
conjunction with a

[[Page 71886]]

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).

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 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 agency-designated collection site is not 
available and there is an immediate requirement to collect a specimen 
(e.g., an accident investigation), a public restroom may be used for 
the collection, using the procedures for a monitored collection 
described in Section 8.11.
    (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 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

[[Page 71887]]

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

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.

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

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 OMB-approved application form (i.e., the 
applicant laboratory or IITF provides detailed information on both the 
administrative and analytical procedures to be used for 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.

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;

[[Page 71888]]

    (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 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;
    (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

[[Page 71889]]

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

    (a) An IITF certified under these Guidelines must satisfy the 
following criteria on the maintenance PT samples to maintain its 
certification:
    (1) Correctly identify at least 90 percent of the total drug 
challenges over 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.

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

    (a) An applicant laboratory or IITF is inspected by a team of two 
inspectors.
    (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 
HHS-certified laboratory or 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 HHS-certified laboratory or IITF must 
continue to satisfy the minimum requirements as stated in these 
Guidelines.

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

    (a) An individual may be selected as an inspector for the Secretary 
if 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 HHS-
certified laboratory or IITF under these Guidelines.
    (b) The Secretary or a Federal agency may conduct an inspection at 
any time.

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 HHS-certified laboratory or IITF does 
not satisfy the minimum requirements for either the PT program or the 
inspection program?

    (a) If an HHS-certified laboratory or IITF fails to satisfy the 
minimum requirements for certification, the laboratory or IITF is given 
a period of time (e.g., 5 or 30 working days depending on the nature of 
the 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 analyzing and reporting the 
results of

[[Page 71890]]

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.

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
    (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 HHS-certified 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.

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

[[Page 71891]]

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 HHS-certified 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.

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;
    (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 
multi-specialty 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 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

[[Page 71892]]

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.

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 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.

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 HHS-certified 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

[[Page 71893]]

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

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 11.14 What must an HHS-certified 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.

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
    (c) Controls must be analyzed concurrently with specimens.

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

    An HHS-certified laboratory must demonstrate and document for each 
specimen validity test the appropriate performance characteristics of 
the test; and must re-verify the test periodically, or at least 
annually.

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 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;

[[Page 71894]]

    (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.

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 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., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (3) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with an equal to or greater than 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration equal to or greater than 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration equal to or greater than the LOQ of the confirmatory test 
on the second aliquot;
    (4) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with an 
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an 
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or 
halogen colorimetric test (halogen concentration equal to or greater 
than the LOQ) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration equal to or greater than the LOQ of the 
confirmatory test on the second aliquot;
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and a different confirmatory method (e.g., GC/MS) for 
the confirmatory test with the glutaraldehyde concentration equal to or 
greater than the LOQ of the analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with an 
equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an 
equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration equal to 
or greater than 50 mcg/mL) for the initial test on the first aliquot 
and a different confirmatory method (e.g., GC/MS) for the confirmatory 
test with the pyridine concentration equal to or greater than the LOQ 
of the analysis on the second aliquot;
    (7) The presence of a surfactant is verified by using a surfactant 
colorimetric test with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with an equal to or greater than 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (8) The presence of any other adulterant not specified in 
paragraphs d(2) through d(7) of this section is verified using an 
initial test on the first aliquot and a different confirmatory test on 
the second aliquot.
    (e) A primary (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

[[Page 71895]]

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 colorimetric test (with an equal to 
or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or 
greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen 
concentration is equal to or greater than the LOQ) for both the initial 
(first) test and the second test on two separate aliquots;
    (8) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with an equal to or greater than 
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the 
initial (first) test and the second test on two separate aliquots or a 
foam/shake test for the initial test;
    (9) Interference occurs on the 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.
    (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 HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a legible image or copy of 
the completed Federal CCF, and/or forward a computer-generated 
electronic report. 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 HHS-certified 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 [deg]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 HHS-certified 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.

[[Page 71896]]

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 HHS-certified 
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 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 HHS-
certified laboratory and an HHS-certified IITF?

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

Subpart L--Instrumented Initial Test Facility (IITF)

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

    (a) An HHS-certified IITF must have a standard operating procedure 
(SOP) manual that describes, in detail, all 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 in-service 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

[[Page 71897]]

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.

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 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.

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-

[[Page 71898]]

reacting compounds. This second initial drug test must satisfy the 
batch quality control requirements specified in Section 12.11.

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

    (a) An HHS-certified IITF must demonstrate and document 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.

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

    An HHS-certified IITF must demonstrate and document for each 
specimen validity test the appropriate performance characteristics of 
the test; and must re-verify the test periodically, or at least 
annually.

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 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 HHS-certified 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 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.

[[Page 71899]]

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

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

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

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

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

    (a) An HHS-certified IITF must retain all records generated to 
support test results for at least 2 years.
    (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.

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;
    (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 HHS-certified 
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 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 HHS-certified IITF for which the MRO 
is reviewing drug testing results. Additionally, an MRO shall not 
derive any financial benefit by having an agency use a specific HHS-
certified IITF or have any agreement with an HHS-certified IITF that 
may be construed as a potential conflict of interest.

Section 12.22 What type of relationship can exist between an HHS-
certified IITF and an HHS-certified laboratory?

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

Subpart M--Medical Review Officer (MRO)

Section 13.1 Who may serve as an MRO?

    (a) A 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;

[[Page 71900]]

    (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 
HHS-certified IITF, the MRO must:
    (1) Review the information on the MRO copy of the Federal CCF that 
was received from the collector and the report received from the HHS-
certified laboratory or HHS-certified IITF;
    (2) Interview the donor when required;
    (3) Make a determination regarding the test result;
    (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.

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.
    (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 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

[[Page 71901]]

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 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/pre-employment 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 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/

[[Page 71902]]

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 HHS-certified IITF?

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

Subpart N--Split Specimen Tests

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.

Section 14.2 How does an HHS-certified 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 HHS-certified 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 HHS-certified 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 
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

[[Page 71903]]

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 drug-free 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 drug-free 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 coordination of the drug-free 
workplace program regarding the test results for the specimen.
    (h) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and 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 drug-
free 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 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 drug-free 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.

[[Page 71904]]

Section 14.8 How long must an HHS-certified 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 re-designated 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.

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 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 HHS-
certified 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 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

[[Page 71905]]

reported drug positive, adulterated, substituted, or invalid result; or
    (3) The electronic report provided by the HHS-certified laboratory 
or HHS-certified IITF does not contain all the data elements required 
for the HHS standard 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.

Subpart P--Laboratory or IITF Suspension/Revocation Procedures

Section 16.1 When may an HHS-certified laboratory or IITF be suspended?

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

Section 16.2 What definitions are used for this subpart?

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

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

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

Section 16.6 What is an abeyance agreement?

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

Section 16.7 What 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

[[Page 71906]]

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 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 cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At 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

[[Page 71907]]

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.

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.

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

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

Section 16.13 What administrative records are maintained?

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

Section 16.14 What are the requirements for a written decision?

    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefore in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
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