[Federal Register Volume 59, Number 110 (Thursday, June 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13940]
[[Page Unknown]]
[Federal Register: June 9, 1994]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Substance Abuse and Mental Health Services Administration
_______________________________________________________________________
Mandatory Guidelines for Federal Workplace Drug Testing Programs;
Notice
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, PHS,
HHS.
ACTION: Revised mandatory guidelines.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) revises some
of the scientific and technical guidelines for Federal drug testing
programs and revises certain standards for certification of
laboratories engaged in urine drug testing for Federal agencies.
EFFECTIVE DATE: September 1, 1994.
FOR FURTHER INFORMATION CONTACT: Dr. Donna M. Bush, Chief, Drug Testing
Section, Division of Workplace Programs, Substance Abuse and Mental
Health Services Administration (SAMHSA), room 9A-53, 5600 Fishers Lane,
Rockville, Maryland 20857, tel. (301) 443-6014.
SUPPLEMENTARY INFORMATION: The Department is revising the guidelines
entitled ``Mandatory Guidelines for Federal Workplace Drug Testing
Programs,'' (Mandatory Guidelines) which were initially published in
the Federal Register on April 11, 1988 (53 FR 11979). These Mandatory
Guidelines and the revisions are developed in accordance with Executive
Order No. 12564 dated September 15, 1986, and section 503 of Public Law
100-71, 5 U.S.C. section 7301 note, the Supplemental Appropriations Act
for fiscal year 1987 dated July 11, 1987. The revisions to the
Mandatory Guidelines incorporate changes based on the comments
submitted and the Department's first 5 years of experience in
implementing and administering these Guidelines.
BACKGROUND AND SUMMARY OF PUBLIC COMMENTS AND POLICIES OF THE REVISED
GUIDELINES
A. Proposed Revised Mandatory Guidelines
The basic purpose of the Mandatory Guidelines is to establish
scientific and technical guidelines for Federal agencies' workplace
drug testing programs and to establish a certification program for
laboratories engaged in urine drug testing for Federal agencies. The
proposed revisions published in the Federal Register on January 25,
1993 (58 FR 6062), retained the basic requirements in the Mandatory
Guidelines published in the Federal Register on April 11, 1988, but as
indicated above refined some requirements in order to incorporate
changes based on the Department's first 5 years of experience in
implementing and administering these Guidelines.
The major changes proposed in the notice published in the Federal
Register on January 25, 1993, are summarized here to facilitate the
discussion of the comments received during the public comment period.
The Department proposed reducing the requirement to collect 60 mL
of urine at the collection site to 30 mL. This change was proposed
because many times donors have difficulty in providing the 60 mL of
urine. In addition, 30 mL is adequate to complete the required testing
and satisfy other program requirements.
The Department proposed to revise the specimen collection procedure
to allow Federal agencies to use an optional ``split specimen''
collection procedure. Several Federal agencies have been granted
waivers to use split specimen collection procedures during the past 5
years. Establishing a ``split specimen'' procedure will ensure that
each Federal agency will be using the same procedure. The Department
believes that appropriate guidance must be provided regarding the
minimum acceptable volumes for the split specimens, measuring
temperature before a single donor specimen is transferred into two
separate specimen bottles, sending both split specimen bottles to the
laboratory at the same time to ensure that they are subject to the same
shipping and storage conditions, and specifying the procedures for
testing Bottle B when the Bottle A specimen is reported positive.
The Department proposed to revise the collection procedure to allow
Federal agencies to use an individual of the same gender, other than a
collection site employee, to observe the collection of a specimen
whenever there is reason to believe the individual may have altered or
substituted the specimen. This change is based on the understanding
that it is not always possible to have a collection site employee of
the same gender observe the collection.
The Department proposed a change to allow a laboratory to use a
certifying scientist who is only certified to review initial drug tests
which are negative. This could assist in reducing the cost of testing
without compromising the reliability of drug testing.
The Department proposed that the initial test level for marijuana
metabolites be reduced from 100 ng/mL to 50 ng/mL. This change reflects
advances in technology of immunoassay tests for marijuana metabolites.
The Department proposed to allow laboratories to use multiple
immunoassay tests for the same drug or drug class. This would allow
laboratories to use an initial test and then forward all presumptive
positives for a second test by a different immunoassay technique to
minimize possible presumptive positives due to the presence of
structural analogues in the specimen. In addition, this policy would
allow a laboratory to use a different immunoassay for specimens that
may be untestable with one immunoassay.
The Department proposed that in order to report a specimen positive
for only methamphetamine, the specimen must also contain the metabolite
amphetamine at a concentration equal to or greater than 200 ng/mL by
the confirmatory test. This proposed requirement would ensure that high
concentrations of sympathomimetic amines available in over-the-counter
and prescription medications will not be misidentified as
methamphetamine.
The Department proposed reducing the number of blind samples a
Federal agency must submit each quarter to its contracting laboratory
from 10% of all samples to a minimum of 3% (with a maximum of 100 blind
samples). This proposed change may significantly reduce the costs
associated with maintaining a blind sample program without affecting
the Federal agency's ability to monitor a laboratory's performance.
The performance testing sample portion of the laboratory
certification program was proposed to be changed by reducing the
performance testing (PT) challenges for certified laboratories from 6
cycles per year to 4 cycles per year. Experience in this and other
performance testing programs indicates that 4 cycles per year is
sufficient to assess a laboratory's ability to test and report results
for performance testing samples.
The Department proposed restricting the types of arrangements that
can exist between the Medical Review Officer (MRO) and the laboratory
to ensure that a conflict of interest does not exist. The restrictions
would require that the agency's MRO not be an employee or an agent of,
or have any financial interest in, the laboratory for which the MRO is
reviewing drug testing results. Similarly, the laboratory would be
prohibited from entering into any agreement with an MRO that could be
construed as a conflict of interest.
A new subpart D was proposed which provides detailed procedures for
the internal review of a suspension or proposed revocation of a
laboratory's certification to perform drug testing. These procedures
will ensure and provide a timely and fair review of all suspensions or
proposed revocations.
The Department proposed that the written notice of the suspension
which is sent to the laboratory, as well as the reviewing official's
written decision upholding or denying suspension or proposed revocation
under the review procedures in subpart D, would be made available to
the public upon request. This provision ensures that the public has
access to the documents containing the basis for HHS's actions.
B. Public Comments and the Department's Responses
The Department received 73 public comments on the proposed changes
from Federal agencies, individuals, organizations, and companies. About
50% of these supported all or some of the proposed changes. All written
comments were reviewed and taken into consideration in the preparation
of the revised Mandatory Guidelines. The substantive concerns raised in
the public comments and the Department's responses to the comments are
set out below. Similar comments are considered together.
1. Definitions
A number of commenters expressed concerns with the definitions in
section 1.2. It was suggested that the definition for chain of custody
indicate that couriers do not need to document chain of custody while
the specimens are in transit to the laboratory. The Department agrees
that the Mandatory Guidelines should be clarified to address that
issue. Specimens are sealed in packages and any tampering with a sealed
specimen would be noticed by the laboratory and documented on the
specimen chain of custody. In addition, as a practical matter,
couriers, express couriers, and postal service personnel do not have
access to the specimen chain of custody form since the form is inside
the sealed package. Section 2.2(i) of the Mandatory Guidelines that
discusses the transportation of a specimen to a laboratory has been
revised to clarify this point.
One commenter recommended that the definitions in the Guidelines
conform to the definitions established by the National Committee for
Clinical Laboratory Standards (NCCLS) since the proposed definitions
may be in conflict with the efforts of that nonprofit, educational
organization. The Department fully supports the efforts of this
committee to develop standard definitions since a common understanding
of definitions is essential for maintaining a high level of performance
within laboratory testing programs. The Department has revised the
definitions in section 1.2 to ensure that they are consistent with
those proposed currently by NCCLS. The Department has changed the
proposed definitions for calibrator, control, and standard as well as
included new definitions for donor, specimen, sample, and quality
control sample. The Department also made appropriate changes in other
sections of the Guidelines to ensure that the terms used were
consistent with these new definitions. The Department notes, however,
that these changes are not substantive, but rather are technical in
nature to clarify the definitions. The Department believes these
changes will eliminate the confusion expressed by several other
commenters regarding the use of these terms in other sections of the
Guidelines.
One commenter believes the proposed definition for the certifying
scientist should specifically state that the individual understands
chain of custody. The Department intended that the definition of
certifying scientist include that the individual have a thorough
understanding of chain of custody, since it was proposed that such
individual have ``training and experience in the theory and practice of
all methods and procedures used in the laboratory.'' See section 1.2.
However, in order to prevent any confusion, the definition has been
changed to clarify this issue.
One commenter suggested that the Secretary require a certifying
scientist to possess at least a masters degree, so they would be equal
to experts presented by an employee who is contesting the result in
court or in an administrative proceeding. Based on the Department's
experience, there are numerous highly qualified individuals serving as
certifying scientists who possess bachelors' degrees, and who have the
expertise to testify as to the records they have certified. These
certifying scientists do not need to be qualified as experts in
litigation, as the defense may qualify someone else in the laboratory
or outside the laboratory to perform this function, if necessary.
Further, the Department believes that requiring higher educational
requirements would place an unnecessary burden on the laboratories, as
well as eliminate many qualified individuals from serving as certifying
scientists.
One commenter believes the requirement to use an Office of
Management and Budget (OMB) approved specimen chain of custody form
requires the laboratories to use OMB approved laboratory chain of
custody forms. This interpretation is incorrect. The Department
proposed that such forms be used only for specimen chain of custody
forms, not laboratory chain of custody forms. The Department believes
that standard specimen chain of custody forms are important to ensure
that collection sites have a consistent form so as to reduce any errors
or incomplete documentation when filling out the forms.
One commenter noted that the Department's proposed definition of an
immunoassay test is ambiguous and does not support the policy that
allows using a second immunoassay test for specimens that are
presumptively positive for amphetamines. Specifically, the term
``initial test'' was proposed to be defined as ``[a]n immunoassay test
to eliminate ``negative'' urine specimens from further consideration
and to identify the class of drugs that requires confirmation.'' The
Department agrees with the commenter that the definition is ambiguous.
The Department supports allowing laboratories to perform multiple
immunoassay tests for the same drug or drug class. Therefore, the
Department has clarified the definition to ensure that further testing
is consistent with section 2.4(e)(4) which permits conducting multiple
initial tests.
2. Dilution/Adulteration Tests
Several commenters concurred with section 2.1(c) which clarifies
that laboratories may conduct dilution/adulteration testing to
determine the validity of the specimen while some commenters sought to
have the Secretary define the specific tests to be conducted and
require that such tests be performed. The issue regarding the types of
dilution/adulteration testing to be performed has been highly
controversial among forensic laboratory professionals since there is a
lack of data to suggest that dilution/adulteration testing can clearly
identify a donor who has intentionally taken a substance to affect the
outcome of a drug test or has otherwise diluted or adulterated the
specimen. At this time, the Department believes that such testing
should remain optional and the selection of tests to be conducted for
possible dilution/adulteration and the cutoff levels for such tests, if
conducted, should be determined by the laboratories based on their best
judgment.
Two commenters requested that the Department allow dilution/
adulteration testing to be conducted at the collection site. The
Department believes that it is better able to monitor the performance
of such testing when it is conducted by laboratory personnel, rather
than require agencies to monitor such testing at the collection sites.
During the laboratory inspection process, the Department is able to
evaluate the laboratories' performance of such testing to ensure that
tests are performed properly, chain of custody is not broken, and
cross-contamination does not occur from one donor specimen to another
which could impact the integrity of a specimen. The MRO can review the
results of the dilution/adulteration tests and make a decision on the
basis of the test and on his or her interview of the donor to determine
whether a medical factor may have contributed to the results of such
testing. In addition, disallowing the use of dilution/adulteration
testing at the collection site ensures that agency employees are not
unnecessarily subject to observed collection and thus protects the
privacy of individuals to the maximum extent possible.
3. Specimen Collection Procedure
With regard to the specimen collection procedure, a number of
commenters were highly supportive of reducing the required volume of a
urine specimen from 60 mL to 30 mL as stated in section 2.2(f)(10). One
commenter, however, expressed concern that 30 mL is insufficient when
dealing with a specimen that is positive for more than one drug. That
may be the case in some cases. Nevertheless, the number of specimens
that are positive for more than one drug is very small and most volumes
collected generally exceed 30 mL. The Department believes this reduced
volume requirement will make it easier for an individual to provide a
urine specimen with sufficient volume on the first attempt rather than
requiring the collection of a second specimen after drinking a
reasonable quantity of liquid. It is noted that the policy of combining
additional urine, after drinking a reasonable amount of liquid, with a
partial specimen (i.e., an insufficient volume of urine on the first
void) has been eliminated. The Department believes the reduced volume
requirements will ensure that a sufficient volume is collected on the
first void and combining partial specimens will not be necessary.
One commenter expressed concern over the fact that the Mandatory
Guidelines did not specify limitations or guidance as to the amount of
liquid to be given a donor who could not provide a 30 mL urine
specimen. The commenter expressed concerns regarding the possible risk
of water intoxication if there is no limit established for the amount
of liquid that can be provided. The Department concurs and has changed
the example given in section 2.2(f)(10) to read ``(e.g., an 8 oz glass
of water every 30 minutes, but not to exceed a maximum of 24 oz).'' The
example provided describes a reasonable amount of liquid to be provided
and the Department would expect collection sites to use reasonable care
in its determination of the amount of liquid to provide donors.
Several commenters noted that the temperature range stated in the
proposed revisions did not agree with the range stated in the
introductory discussion of the proposed changes. A notice correcting
the error was published in the Federal Register on March 1, 1993. The
correct temperature range is ``32 deg.-38 deg./90 deg.-100 deg.F.''
There was general agreement that the marginally wider temperature
range will not adversely affect the ability to detect a donor who may
possibly tamper with the specimen. Two commenters, however, believe
that the lower limit of the temperature range should be increased. The
Department does not agree with this recommendation. A urine specimen
provided in a collection cup that is at room temperature will cool
quickly; therefore, a narrow temperature range will significantly
increase the number of specimens that will not satisfy the temperature
range requirements. This would cause numerous unnecessary collections
of second specimens and falsely raise suspicions that many donors have
tampered with their specimens.
With regard to the collection of a urine specimen when using direct
observation, one commenter suggested that the employee's agency choose
the observer if there is no collection site person of the same gender
available. The Department agrees and sections 2.2(f)(13), 2.2(f)(16),
and 2.2(f)(23) have been revised to include this requirement. The
Department believes that the agency will select an individual who will
act responsibly and reliably so as not to substantiate any allegation
to the contrary by an employee.
One commenter believes that only trained collectors should be
involved in the collection procedure, especially when direct
observation is required. The Department acknowledges that trained
personnel should be involved in the collection of urine specimens;
however, it is not always possible to ensure that a trained collection
site person of the same gender will be available when a direct
observation is required. Allowing the agency to select an individual to
act as the observer, when there are unusual circumstances, ensures that
the collection will occur promptly and as scheduled rather than
delaying the collection unnecessarily.
One commenter believed that observed collection should never be
used in any circumstances. The Department disagrees. The Department
continues to believe that observed collection is justified and
necessary when there exists reasonable suspicion to believe that the
donor altered or substituted the specimen. Observed collections do not
occur frequently. However, the Department believes that any invasion of
a donor's privacy is greatly outweighed by public health and safety
concerns in such cases.
One commenter recommended that we refer to the individual providing
the urine specimen as the ``donor.'' The Department concurs with the
recommendation and has replaced the word ``individual,'' when it refers
to the person providing a urine specimen, with the word ``donor''
throughout the Guidelines. A definition for donor has been included in
section 1.2. In addition, the use of the word ``donor'' is consistent
with its use on the specimen chain of custody form.
One commenter suggested that the entire collection procedure be
revised substantially to provide more specific guidance to agencies on
the collection process. The Department believes the procedure, as
described, provides sufficient guidance to the agencies on the
collection process, including factors to ensure that urine specimens
are collected properly and satisfy chain of custody requirements. The
changes made in the Mandatory Guidelines with regard to the single
specimen collection procedure and the optional split specimen procedure
should clarify the procedures and, thereby, address many of the
concerns raised by this commenter without completely revising and
expanding the descriptions of the collection procedures.
Many commenters concurred with including an optional split specimen
collection procedure. They believed it was important to include split
specimens since the Omnibus Transportation Employee Testing Act of
1991, Title V of Public Law 102-143, requires using a split specimen
collection procedure for industries regulated by the Department of
Transportation (DOT). This is particularly important since Federal
employees from a number of Departments will be subject to both the
requirements of DOT (49 CFR Part 40) and the requirements of the
Mandatory Guidelines and Executive Order 12564 (September 15, 1986).
Two commenters suggested allowing the use of two or three
containers to collect split specimens. The Department agrees with this
recommendation and has revised the collection procedure to indicate
clearly that either a specimen bottle or a specimen container may be
used when collecting urine specimens. However, when using a split
specimen collection procedure, it is not acceptable for a donor to
provide the split specimens by urinating directly into both Bottle A
and Bottle B. The specimen must be provided by urinating into only one
container or into Bottle A. After the temperature is measured, if the
specimen was provided directly into Bottle A, an appropriate amount is
poured into Bottle B. If a specimen container was used, appropriate
amounts are poured from the specimen container into both Bottle A and
Bottle B. For split specimen collections, this procedure ensures that
the specimens in Bottle A and Bottle B are identical, it is easier to
measure the temperature of a single specimen rather than to measure the
temperature of two specimens that were collected in separate
containers, and it is easier for a donor to provide one specimen in a
single container/bottle rather than into two separate bottles.
It was suggested by several commenters that we specify the amount
of urine to be poured into Bottle B. We concur with that recommendation
and have changed section 2.2(h)(3) of the split specimen procedure to
specify that a minimum of 15 mL of urine shall be poured into Bottle B.
Since Bottle B will only be tested for a specific substance(s), 15 mL
is sufficient to conduct the testing and to allow a sufficient quantity
to be retained frozen if Bottle A is reported positive. Additionally,
section 2.2(h)(1) has been changed to specify that a minimum of 45 mL
of urine is required when using a split specimen collection procedure
rather than the 30 mL minimum when using the single specimen collection
procedure.
One commenter was concerned with the handling and storage of the
split specimen (Bottle B) after the Bottle A specimen is shipped to the
laboratory. We agree that the wording in section 2.2(h)(5) of the split
specimen collection procedure regarding refrigerating the specimens was
confusing and it has been revised. The Department believes that the
most efficient and cost effective way to handle split specimens is to
send both the Bottle A and Bottle B specimens to the laboratory at the
same time including the appropriate specimen chain of custody forms.
This procedure will ensure the integrity of both Bottle A and Bottle B.
This procedure is also simpler and more cost effective than one which
would require the collection site to retain Bottle B specimens until
the results for the Bottle A specimens are reported by the MRO to the
agency and the agency notifies the collection site to either discard
the Bottle B specimens or to ship a specific Bottle B specimen to
another certified laboratory. When both specimens are received by the
laboratory, Bottle A is normally tested within one day and, if
positive, both Bottle A and Bottle B can be placed in secure,
refrigerated storage until the confirmatory test is completed. This
procedure will ensure that both specimens are treated essentially the
same and subject to similar storage conditions until the testing is
completed.
Several commenters were concerned with the impact that a failed to
reconfirm result on the Bottle B specimen would have on a donor since
personnel action may have been taken based on an MRO verified positive
result for Bottle A. Although a failed to reconfirm result for Bottle B
requires the MRO to void the test result for Bottle A and an agency may
be required to reverse any personnel action that may have been taken,
we believe failed to reconfirm reports will occur infrequently and this
possibility should not be the basis for an agency to delay any
personnel action. The Department believes that removing an employee,
for example, from a safety-sensitive position which may impact public
health and safety outweighs the minimal possibility that the testing of
Bottle B will not reconfirm the presence of a drug or metabolite.
In view of the comments, section 2.2(h)(6) has also been clarified
to indicate the MRO's responsibility to report a positive result for
Bottle A. When an MRO has verified the test of the first specimen
bottle (Bottle A) as a positive result, the MRO must report the result
to the agency without waiting for the donor to request that the Bottle
B specimen be tested.
Several commenters expressed concern regarding the actions taken
when a second laboratory fails to reconfirm the presence of a drug or
metabolite in the second specimen bottle (Bottle B) in a split specimen
collection. Since the Bottle B specimen is tested without regard to the
cutoff levels, the result reported by the second laboratory is not
reported as a negative or positive result, but reported as either
reconfirmed or failed to reconfirm the presence of a drug or
metabolite. The Department agrees that if this situation occurs, an
investigation must be conducted. The Department has added this
requirement in section 2.2(h)(8) of the Mandatory Guidelines and has
required the MRO to notify the donor's agency. In addition, the Federal
agency must contact the Secretary and the Secretary will investigate
the failed to reconfirm result and attempt to determine the reason for
the inconsistent results between Bottle A and Bottle B. HHS will report
its findings to the Federal agency and ensure that appropriate action
is taken to prevent the recurrence of the failed to reconfirm result.
Some commenters simply did not like permitting Federal agencies to
have the option of a split specimen procedure, believing, for example,
that the use of a split specimen procedure gives the perception of a
lack of confidence in the results when using a single specimen
collection, that the additional administrative and collection costs are
not justified, and that there is an increased risk of administrative
errors.
It should be noted that certain Federal employees are subject to
both the Mandatory Guidelines and the Omnibus Transportation Employee
Act of 1991, Title V of Public Law 102-431, (Omnibus Act) which
requires split specimens. Therefore, the agencies must have the
flexibility to collect split specimens as required by the Omnibus Act.
Since Federal agencies may also request a waiver under section 1.1(e)
of the Mandatory Guidelines and the Department has provided a number of
agencies with a waiver to permit split specimens during the past 5
years, the Department believes including an optional split specimen
collection procedure in the Mandatory Guidelines will ensure
consistency among all agencies currently using split specimens and
those wanting to implement split specimen collections. In addition,
each agency should have the option of treating its employees equally
rather than treating its employees under the Omnibus Act differently
from the employees only subject to the Mandatory Guidelines.
With regard to the perception that the results from a single
specimen collection are unreliable and not adequate to protect employee
rights when compared to a split specimen collection, the Department is
confident that the results from a single specimen collection are
scientifically and legally supportable. This belief is based on the
stringent requirements that have been established by the Mandatory
Guidelines--that is, requiring the use of rigorous chain of custody
procedures when handling and testing specimens; requiring laboratories
to use qualified and trained personnel, validated analytical testing
procedures, and extensive internal quality control and quality
assurance procedures; requiring laboratories to participate in a
comprehensive certification program that includes performance testing
samples and semi-annual inspections; and using MROs to ensure that
procedures have been followed as required.
Although the split specimen procedures are designed to minimize
administrative errors, the Department acknowledges that any time
procedures are modified the risk of administrative errors increases.
However, the use of a standard specimen chain of custody form should
minimize such errors and the Department, through the inspection
process, will monitor the laboratories' procedures in processing split
specimens.
The procedures for split specimens are also designed to keep the
administrative burden at a minimum. The Department believes that the
paperwork for collection sites or laboratories will not increase much
since the collection sites will be using a seven-part chain of custody
form instead of a six-part form and sending both split specimens to the
laboratory at the same time and in the same shipping container. This
should minimize the additional cost and administrative burden on both
collection sites and laboratories.
One commenter believed that split specimen collections create a
potential to reverse results especially if there is a significant
variation in the analytical sensitivities of the confirmatory tests
used by each of the HHS-certified laboratories. The Department is aware
of this potential and has provided guidance to the laboratories with
regard to their capability to accurately quantitate and identify drugs
at concentrations that are 40 percent of the confirmatory test levels.
The Department believes this guidance and challenging laboratories with
performance testing samples at these low concentrations will ensure
that all laboratories have essentially the same sensitivity for each of
the confirmatory tests.
Finally, one commenter requested guidance on whether the donor or
agency would be responsible for paying the costs associated with
analyzing the split specimen. The Department believes that the decision
regarding financial responsibility for testing Bottle B is one the
agencies must decide.
4. Certifying Test Results
One commenter stated that the proposed revision to section 2.3(b)
that discusses ``test validation'' did not make it clear that a
laboratory may use a certifying scientist who is only certified to
review initial drug tests which are negative. Although this is the
intent of this section and to ensure that no confusion exists, the
title of section 2.3(b) has been changed to read ``Certifying Test
Results'' and that section has been revised to state clearly that a
laboratory may designate a certifying scientist(s) that is only
qualified to certify results that are negative on the initial test. We
note, however, that if a certifying scientist certifies confirmatory
test results, the individual must have training and experience in all
``procedures relevant to the results that the individual certifies.''
This includes both initial test and confirmatory test procedures.
Changing the title of this section to read ``Certifying Test Results''
should also ensure that we are referring to the review and
certification of specimen test results rather than the results
associated with ``validating'' an analytical procedure before it is
used to test specimens. The Department believes there was some
confusion associated with the former title of this section.
5. Security and Chain of Custody
One commenter requested that the security requirements in section
2.4(a)(1), as proposed, be revised to allow emergency personnel access
to all sections of the laboratory without escorts. The requirements for
security pertain to limiting and documenting access under normal
situations and providing escorts for authorized visitors, maintenance,
and service personnel. For real emergencies, such as fires, it would be
inappropriate to require the laboratory to provide an escort. This
section has been changed to ensure that emergency personnel (such as
firefighters) can have unescorted access similar to that authorized for
inspectors. As suggested by the commenter, it would be acceptable for
the laboratory to document the emergency and include, to the extent
practicable, dates, time of entry and exit, and purpose of entry for
all emergency response personnel. It must be noted that this exception
does not apply to emergency ``service'' personnel, such as
manufacturers' technical representatives who are called to repair an
instrument or to conduct routine service.
6. Specimen Processing
One commenter noted that the word ``standards'' had been used
incorrectly in section 2.4(d), as proposed, when stating the
requirements for each initial and confirmatory batch. The Department
concurs and has changed this section to state that each initial and
confirmatory batch must satisfy the quality control requirements in
sections 2.5(b) and 2.5(c), respectively, rather than using terms such
as ``standards'' and ``controls.'' Additionally, the last sentence of
this section has been deleted because it is not entirely correct.
Quality control samples must be known to laboratory technicians
conducting the testing while only blind performance testing samples are
unknown (i.e., the location in the batch, drug or metabolite present,
and concentration). The requirements for laboratory blind performance
testing samples and agency blind samples are discussed in section 2.5.
7. Marijuana Initial Test Level
Many respondents concurred with lowering the initial test level for
marijuana metabolites from 100 to 50 ng/mL as proposed in section
2.4(e). However, one commenter claimed that the lowered cutoff
concentration would identify the occasional user. The intent of Federal
workplace drug testing programs is to identify individuals who use
illegal substances regardless of whether they are regular or occasional
users. Lowering the initial test level should increase the ability to
detect any use of marijuana.
Another commenter questioned the impact that might result by the
lowered cutoff concentration for those individuals who are exposed to
passive inhalation (i.e., breathing the smoke exhaled by another
individual smoking marijuana cigarettes). The Department does not
believe that passive inhalation is a reasonable defense or that
significant exposure can occur through passive inhalation to cause a
urine specimen to be reported positive. A comprehensive study of
passive inhalation conducted at the National Institute on Drug Abuse's
Addiction Research Center in Baltimore (see Cone, E.J., et al., Passive
Inhalation of Marijuana Smoke: Urinalysis and Room Air Levels of Delta-
9-Tetrahydrocannabinol, Journal of Analytical Toxicology, 11: 89-96,
1987) indicates that it takes extensive exposure to extremely high
concentrations under unrealistic conditions to cause a positive result;
therefore, passive inhalation is not a reasonable explanation for a
positive result.
8. Initial and Confirmatory Tests
One commenter believed that the wording in section 2.4(e)(3), as
proposed, conflicted with the authority to conduct dilution/
adulteration tests as stated in section 2.1(c). The Department agrees
that this section needs to be clarified. A laboratory may conduct
dilution/adulteration tests on all specimens, whether they are positive
or negative, and either before or after conducting the initial test.
Section 2.4(e)(3) has been changed to clarify this policy.
Several commenters questioned the use of specimens that test
negative on either the initial test or the confirmatory test for the
laboratory's internal quality control program as proposed in sections
2.4(e)(3) and 2.4(f)(3). These commenters were concerned that the
results may have been affected by such factors as medications that may
have been taken, the health of the donors, and possible unknown
problems with confirmation, thereby, making these specimens unsuitable
as quality control samples. Several of these commenters recommended the
use of certified negative urine or, at a minimum, confirming the
negative pool by GC/MS prior to its use in a quality control program.
In response to these concerns, the Department notes that the
laboratory's operation must be consistent with good forensic laboratory
practice (see section 3.20(c)) and such practice requires a laboratory
to always certify a urine pool as negative before it is used to prepare
negative samples or to prepare other quality control samples. If pooled
urine does not satisfy the criteria for acceptability, it is discarded.
Such certification of the urine will ensure the quality of a
laboratory's internal quality control program.
9. Multiple Initial Tests
Two commenters supported the use of multiple initial tests as
stated in section 2.4(e)(4), as proposed, while several commenters
expressed concern with permitting the use of multiple testing. The
Department believes that the use of multiple initial tests may reduce
the number of presumptive positives that are forwarded to confirmatory
testing that will not be confirmed and may allow obtaining a valid
analytical result if a specimen is untestable on one immunoassay test.
The use of multiple initial tests has been widely used with regard to
testing for amphetamines and this policy should apply to all drugs.
In addition, there are reports that various substances, including
prescription medications, can prevent obtaining a valid initial test
result when using one immunoassay test. We believe it is appropriate to
use a different immunoassay test in order to obtain a valid initial
test result before reporting the specimen as ``test not performed'' and
including an appropriate comment on the specimen chain of custody form.
To clarify this issue, the example given in section 2.4(e)(4) has been
changed to include the use of a second immunoassay test for untestable
specimens.
It is noted that the last sentence of section 2.4(e)(4), as
proposed, has been deleted since it is redundant with the requirements
as stated in the first sentence of the section.
10. 200 ng/mL Amphetamine Reporting Rule
Six commenters concurred with the proposal in sections 2.4(f)(1)
and 2.4(g)(2) that require a methamphetamine positive to contain at
least 200 ng/mL of amphetamine before reporting the result as positive.
Two commenters recommended that the 200 ng/mL rule be dropped entirely
because they believed it is no longer relevant and the emphasis should
be on improving the quality of the GC/MS confirmatory procedure. Seven
commenters held similar views that the 200 ng/mL rule is too
conservative and produces too many false negatives and recommended that
it be lowered to either 100 or 50 ng/mL or at least equal to or greater
than the limit of detection for amphetamine.
The Department believes that the 200 ng/mL requirement implemented
as a temporary policy since December 22, 1990, is a necessary one to
prevent false positive test results. On a special set of performance
testing samples provided to the laboratories by the program, the
Department found that the requirement adequately controlled all of the
possible technical problems based on observations of results reported
by the laboratories on that set of performance testing samples. The
results indicated that a significant number of laboratories experienced
chromatographic resolution problems when methamphetamine was present
with ephedrine and 2% of the performance testing results evidenced a
methamphetamine response when challenged with high concentrations of
over-the-counter medications (e.g., ephedrine, pseudoephedrine, or
phenylpropanolamine). These results indicated that the 200 ng/mL rule
was effective in preventing any false positive results and should be
continued. In addition, recent information provided by laboratories
regarding their limits of quantitation and their results on performance
testing samples that contained very low concentrations of amphetamine
and methamphetamine indicate that 200 ng/mL continues to be the lowest
concentration that most of the laboratories can reliably identify and
quantitate for either methamphetamine or amphetamine. For these
reasons, the Department believes using a lower concentration or
eliminating the 200 ng/mL rule would increase the possibility for
reporting a false positive methamphetamine result.
11. Reporting Results
One commenter was concerned that substituting ``certifying
scientist'' in section 2.4(g)(5), as proposed, for the responsible
person was making the certifying scientist responsible for the overall
laboratory operations. We believe the commenter did not understand the
purpose for changing the wording in this section. The use of
``certifying scientist'' in this section ensures that the requirement
is consistent with current program practice. The responsible person
continues to be responsible for the overall operation of the laboratory
(see section 2.3(a)); however, section 2.4(g)(5) allows a certifying
scientist to sign the external chain of custody form that is sent to
the MRO.
12. Calibrators and Controls
One commenter raised concern with the materials used to prepare
calibrators and controls which as described in section 2.4(n)(2) only
allowed calibrators and controls to be prepared from pure drug
standards. The commenter correctly indicated that calibrators and
controls were available from other sources. The Department concurs and
has revised the sentence to allow calibrators and controls to be
prepared not only from pure drug reference materials, but from stock
standard solutions obtained from other laboratories, or from commercial
manufacturers. This change clarifies that laboratories have the
flexibility to obtain ``standards'' used to prepare the calibrators and
controls from different sources.
13. Potential Conflicts of Interest
Several commenters supported the policies in sections 2.4(n)(6) and
2.6(b), as proposed, that restricts the types of relationships between
laboratories and Medical Review Officers to ensure there were no
conflicts of interest. There were several comments submitted, however,
stating that these requirements were not necessary since there is no
evidence that MROs have not acted in the interest of the donor or that
current arrangements have adversely affected the ability of an MRO to
monitor laboratories. The Department does not question the dedication
and integrity of its certified laboratories and the MROs in carrying
out their responsibilities and protecting the interests of the Federal
agencies and donors. Nevertheless, the Department believes the issue
must be addressed.
The MRO plays an essential role in the Federal drug testing
program. See generally section 2.6 of the Mandatory Guidelines. The MRO
is a licensed physician with a knowledge of substance abuse disorders
who verifies whether the tests are positive or negative. In the case of
a positive result reported by the laboratory, the Mandatory Guidelines
require that the MRO contact the employee and personally interview the
employee, i.e., in-person or by telephone, to determine whether
alternate medical explanations would explain a positive result. See
section 2.6(c). During the course of such interview and possibly
through having the specimen retested, the MRO may identify false
positive test results. In such a case, the MRO is required to contact
the Secretary so that the Department can conduct an investigation into
the matter and take whatever action is necessary to prevent such a
result from occurring in the future. See section 2.6(g).
Because the MRO plays such an essential role, the Department
believes any relationship that may be construed as a potential conflict
of interest may be sufficient to undermine the integrity of the
program. Every Federal agency, employee, and job applicant must have
complete assurance that test results will be thoroughly reviewed and,
if errors are discovered, that the MRO will report the error and an
appropriate investigation and corrective action will be taken.
14. Laboratory Quality Control Requirements for Initial Tests
There were several comments submitted regarding the requirements in
section 2.5(b), as proposed, for quality control samples when
conducting the initial test. The commenters believed the proposed
requirements were confusing and suggested using different terms to
describe the types of quality controls that must be included in each
initial test batch. The Department concurs that the quality control
requirements in this section were confusing and they have been revised
based on the definitions in section 1.2. It should be noted the changes
to this section only clarify the requirements for quality control
samples; the actual policy has not changed from the original Mandatory
Guidelines. See section 2.5(b) of 53 FR 11979, 11984 (April 11, 1988).
We have also revised the quality control requirements for each
confirmatory test batch in section 2.5(c) using the new definitions in
section 1.2 without changing the policy as compared to the original
Mandatory Guidelines. See section 2.5(c) of 53 FR 11979, 11985 (April
11, 1988).
In addition, it was noted that there was an error in the
requirement that each initial test batch must contain a minimum of 20%
quality control samples. A correction stating that 10% was the minimum
amount was published in the Federal Register on March 1, 1993.
15. Agency Blind Sample Program
A number of commenters supported reducing the requirements for
agency blind samples from 10% to 3% as indicated in section 2.5(d)(2).
One commenter suggested retaining the 10% minimum and one commenter
suggested establishing a minimum number of blind samples per quarter
for organizations with a small test population. The Department believes
the reduced requirement will not have a significant impact on the
ability of an agency to evaluate its entire drug testing program;
however, there is no prohibition for an agency to use a higher
percentage or a higher number of blind samples to be submitted with
donor specimens.
The Department has also changed the requirements for the number of
blind samples to be submitted with donor specimens during the initial
90-day period of any new contract to conform with reducing the
requirements of blind samples as provided by section 2.5(d)(2). Our
experience during the past 5 years suggests that it is not necessary to
submit large numbers of blind samples to verify the testing conducted
by the certified laboratories.
16. Reanalysis Authorized
Two commenters expressed concern with the retesting policy proposed
in section 2.6(e) which provided that only the MRO was authorized to
order a reanalysis of the original specimen or Bottle B from a split
specimen collection. One commenter believes the donor was authorized to
request a retest of the original specimen. It is the Department's
position that if an MRO cannot verify a positive result for whatever
reason, only the MRO is authorized to request the retest of the
original specimen since the MRO is the only individual who has all the
information necessary to identify a particular specimen in a
laboratory.
Another commenter pointed out an inconsistency between the retest
policy proposed in this section and the policy proposed for testing
Bottle B from a split specimen collection as described in section
2.2(h)(6) which states that only the donor may request through the MRO
that the second specimen bottle (Bottle B) be tested. The Department
agrees that there is an inconsistency in the proposed policies because
we inadvertently referred to the Bottle B specimen in section 2.6(e)
rather than the Bottle A specimen. Section 2.6(e) has been changed to
clarify that only the MRO may request the retest of either a single
specimen or a Bottle A specimen when using a split specimen collection.
The procedures for the testing of Bottle B remain as proposed in
section 2.2(h)(6)--that is, only the donor may request through the MRO
that Bottle B be tested.
17. Reporting Final Results to the Agency
One commenter suggested that section 2.6(h), as proposed, which
clarifies the requirement that the MRO provide written reports to the
agency on positive and negative drug test results would significantly
increase the administrative costs associated with the program and
recommended that the MRO be required to provide written reports to the
agency for positive results only. The Department disagrees. Written
reports from the MRO to the agency on all specimens tested ensures that
all specimens have been tested and the results of all specimens have
been reviewed by the MRO. In addition, the Department believes that
this requirement for written reports to the agency does not prevent the
MRO from reporting several results on the same correspondence sent to
the agency and, therefore, should not significantly affect the cost
associated with the MRO review of drug testing results.
18. Certified Laboratories Notifying Private Sector Clients
Two commenters were concerned that the policy in section 3.4 did
not adequately ensure that a laboratory would inform clients if and
when the laboratory did not satisfy the certification requirements. The
Department concurs that a laboratory must inform its clients when its
certification has been suspended. Since the program began, this
notification has been required and is set out in the suspension letter
that is sent to the laboratory.
However, the intent of the requirement in section 3.4 that
certified laboratories clearly inform clients when procedures followed
do not conform to the Mandatory Guidelines is not related to suspension
and/or proposed revocation actions. The purpose is to ensure that
unregulated, private sector clients are aware that the laboratory may
be using procedures that are not subject to or in accordance with the
Mandatory Guidelines. The Department believes that a certified
laboratory must not use its certification to promote itself as such if,
in fact, it uses procedures that do not comply with the Mandatory
Guidelines for such clients. This section has been revised to clarify
this requirement.
19. Performance Testing Program
There were several comments submitted regarding changing the
performance testing (PT) program from a bimonthly program to a
quarterly program as stated in various sections of subpart C. One
commenter disagreed with changing the performance testing program to a
quarterly program because this would prolong the recertification
process and suggested that a monthly PT program would be more
appropriate. The Department has no intention of changing the initial
certification procedures or to change the procedures when a laboratory
has been suspended and must successfully analyze performance testing
samples prior to having the suspension lifted. In addition, the
Department believes a monthly PT program does not allow sufficient time
for a laboratory to receive its results on a set of PT samples, analyze
its performance, and initiate appropriate corrective action before the
next cycle of PT samples.
One commenter was concerned that adopting a quarterly PT program
without changing the criteria for determining acceptable performance,
as set out in section 3.19, would increase the period for evaluating a
laboratory's performance to 9 months. The Department concurs that the
criteria for determining acceptable performance, that is, performance
on 3 consecutive quarterly PT cycles, would unduly lengthen the time
before corrective action may be taken. Since the total number of PT
samples in 2 cycles of the quarterly PT program will be essentially the
same as those for 3 cycles of the bimonthly PT program, it is
appropriate to establish acceptable performance criteria based on
performance over 2 consecutive cycles of quarterly PT samples. All
criteria in section 3.19 that pertain to evaluating the performance of
certified laboratories have been changed to evaluate acceptable
performance over 2 consecutive cycles rather than over 3 consecutive
cycles, which retains the 6-month evaluation period.
One commenter agreed with the change in section 3.19(b)(4), as
proposed, that would allow a certified laboratory to have one
quantitative result greater than 50% from the target value without
requiring program action against the laboratory. However, the commenter
is concerned that the cause for the error may not be investigated since
program action is not taken against the laboratory. The Department did
not intend that this change would prevent any investigation into the
cause for the error or that the laboratory would not be required by the
Department to make a concerted effort to determine the cause for the
error and to take appropriate corrective action.
One commenter believes that the overall costs for the certification
program may be decreased without compromising the high quality of the
program by increasing the PT challenges to a monthly program and
decreasing the maintenance inspections to once a year. The Department
disagrees with this proposal because it is important to inspect
laboratories at least every six months to ensure that the laboratory
has continued to satisfy the requirements of the Mandatory Guidelines
and for the inspectors to review the results reported for the PT
samples. If corrective action is necessary, it will be more timely than
if inspections were on a yearly basis. In addition, the existence of a
significant problem over a long period of time would possibly
jeopardize the results of many more personnel specimens.
20. Corrective Action by Certified Laboratories
Several commenters expressed concern that section 3.12(c), as
proposed, would give the Secretary the authority to review all results
and activities associated with a laboratory's testing of specimens for
private sector, unregulated clients. This was not the intent and the
section has been changed to indicate that the Secretary has authority
to review results for specimens collected for private sector clients
that were tested by the certified laboratory under the Mandatory
Guidelines to the extent necessary to ensure the full reliability of
drug testing for Federal agencies.
21. Recertification
One commenter was concerned with the policy contained in section
3.16, as proposed, because the commenter believed the procedure to
regain certification after the laboratory's certification has been
revoked would be prolonged given that the maintenance PT program has
been reduced to a quarterly program. The commenter misunderstood that
provision. The Department has not changed the initial certification
procedure (section 3.16) under which a laboratory that had its
certification revoked must proceed to regain certification. Thus, such
a laboratory will proceed as in the past and must satisfactorily
perform in each phase of the initial certification process. However,
the first sentence of section 3.16 has been changed to indicate that
the recertification policy applies only when a laboratory has its
certification revoked.
22. Inspection Performance
One commenter was concerned that the meaning of the phrase
``consistent with good forensic laboratory practice'' in section
3.20(c), as proposed, was too subjective. The commenter believes that
each inspection team interprets laboratory's procedures differently,
thereby, what is acceptable during one inspection may be unacceptable
during the next inspection. We do not concur with this assessment of
the inspection process. Although there is some inherent subjectivity in
the inspection process when applying certain criteria under the
Mandatory Guidelines, the inspectors are provided clear guidance on
what is to be inspected and what is acceptable and unacceptable. The
Department requires trained, qualified inspectors to use a
comprehensive checklist consisting of some 300 questions to evaluate a
laboratory's procedures. They are asked to respond ``yes'' or ``no'' to
the questions and then provide comments if the answer is unacceptable.
This checklist ensures that each inspector is reviewing essentially all
of the same laboratory documents and results. The inspection reports
are reviewed by the Department to ensure that program requirements and
policies are applied consistently among all laboratories. In addition,
it is the responsibility of each laboratory to review the Mandatory
Guidelines, to be aware of what is to be inspected by reviewing the
checklist and other program documents, to correct deficiencies, and to
use good forensic laboratory practice in its testing program.
One commenter suggested that the word ``all'' be deleted from the
second sentence in section 3.20(c), as proposed, because a laboratory
is not required to correct ``all'' deficiencies identified by the
inspectors. We concur with the comment and have deleted the word
``all.'' The Department's policy has always been to include minor
deficiencies or concerns in the critique developed from the inspection
reports and give the laboratory the option to take whatever additional
corrective action it deems appropriate for these minor deficiencies or
concerns.
23. Procedures for Review of Suspension or Proposed Revocation of a
Certified Laboratory
One commenter suggests that the definition of appellant in section
4.2, as proposed, is unclear and believes that the review procedures
only apply when there is a proposed revocation. The Department
disagrees with this position. The Department believes that principles
of fairness necessitate allowing laboratories to seek internal reviews
not only of proposed revocations but also internal reviews of immediate
suspensions.
24. Other Minor Changes
In addition to the changes discussed above, there were several
minor changes made in other sections. The acronym ``MRO'' has been
added to the definition for Medical Review Officer in section 1.2.
Since the original Guidelines were published, the ``MRO'' acronym has
become a common and accepted way to refer to a physician performing
this function. We have replaced ``Medical Review Officer'' with ``MRO''
throughout the Guidelines.
Section 2.5(d)(4) was changed to clarify that an agency shall
investigate any unsatisfactory blind performance testing results and
submit its findings to HHS rather than HHS conducting the initial
investigation. The Department believes the agency must gather all
pertinent information and investigate the reason before HHS is
contacted to continue the investigation and to ensure that the
laboratory has taken corrective action.
Section 2.6(c) has been simplified to require the MRO to send
results only to the designated person in the agency rather than to both
agency's Employee Assistance Program and to the agency's management
official. The Department believes that the agency should have the
discretion to determine who should receive results.
Section 3.3 was clarified to read that a laboratory must satisfy
all pertinent provisions of the Guidelines in order to maintain
certification while the original requirement only addressed satisfying
the provisions in order to qualify for certification.
Section 3.15(b) was revised to conform with the review procedure in
new subpart D which allows laboratories the opportunity for an informal
review of a program action within 30 days of the date the laboratory
received the notice, or if seeking an expedited review, within 3 days
of the date the laboratory received the notice.
Two commenters noted that section 3.18(b) referred to a subset of
PT samples as ``directed specimens'' rather than as ``retest samples''
which is current program terminology. We concur with the comment
submitted and have revised the section to refer to these PT samples as
``retest samples.''
Other appropriate minor editorial changes have been made for
clarity and consistency.
Information Collection Requirements
Any comments related to the Paperwork Reduction Act of 1980 may be
sent to the HHS Desk Officer, Office of Information and Regulatory
Affairs, Office of Management and Budget, room 3001, New Executive
Office Building, Washington, DC 20503.
Information collection and recordkeeping requirements which would
be imposed on laboratories engaged in urine drug testing for Federal
agencies concern quality assurance and quality control; security and
chain of custody; documentation; reports; performance testing; and
inspections as set out in sections 3.7, 3.8, 3.10, 3.11, 3.17, and
3.20. To facilitate ease of use and uniform reporting, a specimen chain
of custody form has been developed as referenced in sections 1.2,
2.2(c), and 2.2(f).
The information collection and recordkeeping requirements contained
in these Mandatory Guidelines have been submitted to the Office of
Management and Budget for review under section 3504(h) of the Paperwork
Reduction Act of 1980.
Dated: February 7, 1994.
Philip R. Lee,
Assistant Secretary for Health.
Dated: March 16, 1994.
Donna E. Shalala,
Secretary.
The Mandatory Guidelines as revised are hereby adopted in
accordance with Executive Order 12564 and section 503 of Pub. L. 100-
71. For the public's convenience the Mandatory Guidelines as revised
are set out in full as follows:
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Subpart A--General
1.1 Applicability.
1.2 Definitions.
1.3 Future Revisions.
Subpart B--Scientific and Technical Requirements
2.1 The Drugs.
2.2 Specimen Collection Procedures.
2.3 Laboratory Personnel.
2.4 Laboratory Analysis Procedures.
2.5 Quality Assurance and Quality Control.
2.6 Reporting and Review of Results.
2.7 Protection of Employee Records.
2.8 Individual Access to Test and Laboratory Certification Results.
Subpart C--Certification of Laboratories Engaged in Urine Drug Testing
for Federal Agencies
3.1 Introduction.
3.2 Goals and Objectives of Certification.
3.3 General Certification Requirements.
3.4 Capability to Test for Five Classes of Drugs.
3.5 Initial and Confirmatory Capability at Same Site.
3.6 Personnel.
3.7 Quality Assurance and Quality Control.
3.8 Security and Chain of Custody.
3.9 One-Year Storage for Confirmed Positives.
3.10 Documentation.
3.11 Reports.
3.12 Certification.
3.13 Revocation.
3.14 Suspension.
3.15 Notice.
3.16 Recertification.
3.17 Performance Testing (PT) Requirement for Certification.
3.18 Performance Test Samples Composition.
3.19 Evaluation of Performance Testing.
3.20 Inspections.
3.21 Results of Inadequate Performance.
3.22 Listing of Certified Laboratories.
Subpart D--Procedures for Review of Suspension or Proposed Revocation
of a Certified Laboratory
4.1 Applicability.
4.2 Definitions.
4.3 Limitations on Issues Subject to Review.
4.4 Specifying Who Represents the Parties.
4.5 The Request for Informal Review and the Reviewing Official's
Response.
4.6 Abeyance Agreement.
4.7 Preparation of the Review File and Written Argument.
4.8 Opportunity for Oral Presentation.
4.9 Expedited Procedures for Review of Immediate Suspension.
4.10 Ex Parte Communications.
4.11 Transmission of Written Communications by Reviewing Official
and Calculation of Deadlines.
4.12 Authority and Responsibilities of Reviewing Official.
4.13 Administrative Record.
4.14 Written Decision.
4.15 Court Review of Final Administrative Action; Exhaustion of
Administrative Remedies.
Authority: E.O. 12564 and Sec. 503 of Pub. L. 100-71.
Subpart A--General
Section 1.1 Applicability.
(a) These mandatory guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but
excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(3) And any other employing unit or authority of the Federal
Government except the United States Postal Service, the Postal Rate
Commission, and employing units or authorities in the Judicial and
Legislative Branches.
(b) Subpart C of these Guidelines (which establishes laboratory
certification standards) applies to any laboratory which has or seeks
certification to perform urine drug testing for Federal agencies under
a drug testing program conducted under E.O. 12564. Only laboratories
certified under these standards are authorized to perform urine drug
testing for Federal agencies.
(c) The Intelligence Community, as defined by Executive Order No.
12333, shall be subject to these Guidelines only to the extent agreed
to by the head of the affected agency.
(d) These Guidelines do not apply to drug testing conducted under
legal authority other than E.O. 12564, including testing of persons in
the criminal justice system, such as arrestees, detainees,
probationers, incarcerated persons, or parolees.
(e) Agencies may not deviate from the provisions of these
Guidelines without the written approval of the Secretary. In requesting
approval for a deviation, an agency must petition the Secretary in
writing and describe the specific provision or provisions for which a
deviation is sought and the rationale therefor. The Secretary may
approve the request upon a finding of good cause as determined by the
Secretary.
(f) Agencies shall purchase drug testing services only from
laboratories certified by HHS or an HHS-recognized certification
program in accordance with these Guidelines.
Section 1.2 Definitions
For purposes of these Guidelines the following definitions are
adopted:
Aliquot. A fractional part of a specimen used for testing. It is
taken as a sample representing the whole specimen.
Calibrator. A solution of known concentration used to calibrate a
measurement procedure or to compare the response obtained with the
response of a test specimen/sample. The concentration of the analyte of
interest in the calibrator is known within limits ascertained during
its preparation. Calibrators may be used to establish a calibration
curve over a range of interest.
Certifying Scientist. An individual with at least a bachelor's
degree in the chemical or biological sciences or medical technology or
equivalent who reviews all pertinent data and quality control results.
The individual shall have training and experience in the theory and
practice of all methods and procedures used in the laboratory,
including a thorough understanding of chain of custody procedures,
quality control practices, and analytical procedures relevant to the
results that the individual certifies. Relevant training and experience
shall also include the review, interpretation, and reporting of test
results; maintenance of chain of custody; and proper remedial action to
be taken in response to test systems being out of control-limits or
detecting aberrant test or quality control results.
Chain of Custody. Procedures to account for the integrity of each
urine specimen by tracking its handling and storage from point of
specimen collection to final disposition of the specimen. These
procedures shall require that an Office of Management and Budget (OMB)
approved specimen chain of custody form be used from time of collection
to receipt by the laboratory and that upon receipt by the laboratory an
appropriate laboratory chain of custody form(s) account for the
specimens and samples within the laboratory. Chain of custody forms
shall, at a minimum, include an entry documenting date and purpose each
time a specimen or sample is handled or transferred and identifying
every individual in the chain of custody.
Collection Site. A place designated by the agency where individuals
present themselves for the purpose of providing a specimen of their
urine to be analyzed for the presence of drugs.
Collection Site Person. A person who instructs and assists
individuals at a collection site and who receives and makes an initial
examination of the urine specimen provided by those individuals. A
collection site person shall have successfully completed training to
carry out this function.
Confirmatory Test. A second analytical procedure to identify the
presence of a specific drug or metabolite which is independent of the
initial test and which uses a different technique and chemical
principle from that of the initial test in order to ensure reliability
and accuracy. (At this time gas chromatography/mass spectrometry (GC/
MS) is the only authorized confirmation method for cocaine, marijuana,
opiates, amphetamines, and phencyclidine.)
Control. A sample used to monitor the status of an analysis to
maintain its performance within desired limits.
Donor. The individual from whom a urine specimen is collected.
Initial Test (also known as Screening Test). An immunoassay test to
eliminate ``negative'' urine specimens from further consideration and
to identify the presumptively positive specimens that require
confirmation or further testing.
Laboratory Chain of Custody Form. The form(s) used by the testing
laboratory to document the security of the specimen and all aliquots of
the specimens during testing and storage by the laboratory. The form,
which may account for an entire laboratory test batch, shall include
the names and signatures of all individuals who accessed the specimens
or aliquots and the date and purpose of the access.
Medical Review Officer (MRO). A licensed physician responsible for
receiving laboratory results generated by an agency's drug testing
program who has knowledge of substance abuse disorders and has
appropriate medical training to interpret and evaluate an individual's
positive test result together with his or her medical history and any
other relevant biomedical information.
Quality Control Sample. A sample used to evaluate whether or not
the analytical procedure is operating within predefined tolerance
limits. Calibrators, controls, negative urine samples, and blind
samples are collectively referred to as ``quality control samples'' and
each as a ``sample.''
Reason to Believe. Reason to believe that a particular individual
may alter or substitute the urine specimen as provided in section 4(c)
of E.O. 12564.
Sample. A representative portion of a urine specimen or quality
control sample used for testing.
Secretary. The Secretary of Health and Human Services or the
Secretary's designee. The Secretary's designee may be a contractor or
other recognized organization which acts on behalf of the Secretary in
implementing these Guidelines.
Specimen. The portion of urine that is collected from a donor.
Specimen Chain of Custody Form. An OMB approved form used to
document the security of the specimen from time of collection until
receipt by the laboratory. This form, at a minimum, shall include
specimen identifying information, date and location of collection, name
and signature of collector, name of testing laboratory, and the names
and signatures of all individuals who had custody of the specimen from
time of collection until the specimen was prepared for shipment to the
laboratory.
Standard. A reference material of known purity or a solution
containing a reference material at a known concentration.
Section 1.3 Future Revisions
In order to ensure the full reliability and accuracy of drug
assays, the accurate reporting of test results, and the integrity and
efficacy of Federal drug testing programs, the Secretary may make
changes to these Guidelines to reflect improvements in the available
science and technology. These changes will be published in final as a
notice in the Federal Register.
Subpart B--Scientific and Technical Requirements
Section 2.1 The Drugs
(a) The President's Executive Order 12564 defines ``illegal drugs''
as those included in Schedule I or II of the Controlled Substances Act
(CSA), but not when used pursuant to a valid prescription or when used
as otherwise authorized by law. Hundreds of drugs are covered under
Schedule I and II and while it is not feasible to test routinely for
all of them, Federal drug testing programs shall test for drugs as
follows:
(1) Federal agency applicant and random drug testing programs shall
at a minimum test for marijuana and cocaine;
(2) Federal agency applicant and random drug testing programs are
also authorized to test for opiates, amphetamines, and phencyclidine;
and
(3) When conducting reasonable suspicion, accident, or unsafe
practice testing, a Federal agency may test for any drug listed in
Schedule I or II of the CSA.
(b) Any agency covered by these guidelines shall petition the
Secretary in writing for approval to include in its testing protocols
any drugs (or classes of drugs) not listed for Federal agency testing
in paragraph (a) of this section. Such approval shall be limited to the
use of the appropriate science and technology and shall not otherwise
limit agency discretion to test for any drugs covered under Schedule I
or II of the CSA.
(c) Urine specimens collected pursuant to Executive Order 12564,
Public Law 100-71, and these Guidelines shall be used only to test for
those drugs included in agency drug-free workplace plans and may not be
used to conduct any other analysis or test unless otherwise authorized
by law except if additional testing is required to determine the
validity of the specimen. Urine that tests negative by initial or
confirmatory testing may, however, be pooled for use in the
laboratory's internal quality control program.
(d) These Guidelines are not intended to limit any agency which is
specifically authorized by law to include additional categories of
drugs in the drug testing of its own employees or employees in its
regulated industries.
Section 2.2 Specimen Collection Procedures
(a) Designation of Collection Site. Each agency drug testing
program shall have one or more designated collection sites which have
all necessary personnel, materials, equipment, facilities, and
supervision to provide for the collection, security, temporary storage,
and shipping or transportation of urine specimens to a certified drug
testing laboratory.
(b) Security. Procedures shall provide for the designated
collection site to be secure. If a collection site facility is
dedicated solely to urine collection, it shall be secure at all times.
If a facility cannot be dedicated solely to drug testing, the portion
of the facility used for testing shall be secured during drug testing.
(c) Chain of Custody. Chain of custody standardized forms shall be
properly executed by authorized collection site personnel upon receipt
of specimens. Handling and transportation of urine specimens from one
authorized individual or place to another shall always be accomplished
through chain of custody procedures. Every effort shall be made to
minimize the number of persons handling specimens.
(d) Access to Authorized Personnel Only. No unauthorized personnel
shall be permitted in any part of the designated collection site when
urine specimens are collected or stored.
(e) Privacy. Procedures for collecting urine specimens shall allow
individual privacy unless there is reason to believe that a particular
donor may alter or substitute the specimen to be provided.
(f) Integrity and Identity of Specimen. Agencies shall take
precautions to ensure that a urine specimen not be adulterated or
diluted during the collection procedure and that information on the
urine bottle and on the specimen chain of custody form can identify the
donor from whom the specimen was collected. The following minimum
precautions shall be taken to ensure that unadulterated specimens are
obtained and correctly identified:
(1) To deter the dilution of specimens at the collection site,
toilet bluing agents shall be placed in toilet tanks wherever possible,
so the reservoir of water in the toilet bowl always remains blue. There
shall be no other source of water (e.g., no shower or sink) in the
enclosure where urination occurs.
(2) When a donor arrives at the collection site, the collection
site person shall request the donor to present photo identification. If
the donor does not have proper photo identification, the collection
site person shall contact the supervisor of the donor, the coordinator
of the drug testing program, or any other agency official who can
positively identify the donor. If the donor's identity cannot be
established, the collection site person shall not proceed with the
collection.
(3) If the donor fails to arrive at the assigned time, the
collection site person shall contact the appropriate authority to
obtain guidance on the action to be taken.
(4) The collection site person shall ask the donor to remove any
unnecessary outer garments such as a coat or jacket that might conceal
items or substances that could be used to tamper with or adulterate the
donor's urine specimen. The collection site person shall ensure that
all personal belongings such as a purse or briefcase remain with the
outer garments. The donor may retain his or her wallet.
(5) The donor shall be instructed to wash and dry his or her hands
prior to urination.
(6) After washing hands, the donor shall remain in the presence of
the collection site person and shall not have access to any water
fountain, faucet, soap dispenser, cleaning agent, or any other
materials which could be used to adulterate the specimen.
(7) The collection site person shall give the donor a clean
specimen bottle or specimen container. The donor may provide his/her
specimen in the privacy of a stall or otherwise partitioned area that
allows for individual privacy.
(8) The collection site person shall note any unusual behavior or
appearance on the specimen chain of custody form.
(9) In the exceptional event that an agency-designated collection
site is not accessible and there is an immediate requirement for
specimen collection (e.g., an accident investigation), a public rest
room may be used according to the following procedures: A person of the
same gender as the donor shall accompany the donor into the public rest
room which shall be made secure during the collection procedure. If
possible, a toilet bluing agent shall be placed in the bowl and any
accessible toilet tank. The collection site person shall remain in the
rest room, but outside the stall, until the specimen is collected. If
no bluing agent is available to deter specimen dilution, the collection
site person shall instruct the donor not to flush the toilet until the
specimen is delivered to the collection site person. After the
collection site person has possession of the specimen, the donor will
be instructed to flush the toilet and to participate with the
collection site person in completing the chain of custody procedures.
(10) Upon receiving the specimen from the donor, the collection
site person shall determine the volume of urine in the specimen bottle/
container.
(i) If the volume is greater than 30 milliliters (mL), the
collection site person will proceed with step (11) below.
(ii) If the volume is less than 30 mL and the temperature is within
the acceptable range specified in step (13) below, the specimen is
discarded and a second specimen shall be collected. The donor may be
given a reasonable amount of liquid to drink for this purpose (e.g., an
8 oz glass of water every 30 min, but not to exceed a maximum of 24
oz). If the donor fails for any reason to provide 30 mL of urine for
the second specimen collected, the collection site person shall contact
the appropriate authority to obtain guidance on the action to be taken.
(iii) If the volume is less than 30 mL and the temperature is
outside the acceptable range specified in step (13) below, a second
specimen shall be collected using the procedure specified in step (13)
below.
(11) After the specimen has been provided and submitted to the
collection site person, the donor shall be allowed to wash his or her
hands.
(12) Immediately after the specimen is collected, the collection
site person shall measure only the temperature of the specimen. The
temperature measuring device used must accurately reflect the
temperature of the specimen and not contaminate the specimen. The time
from urination to temperature measurement is critical and in no case
shall exceed 4 minutes.
(13) If the temperature of the specimen is outside the range of
32 deg.-38 deg.C/90 deg.-100 deg.F, that is a reason to believe that
the donor may have altered or substituted the specimen, and another
specimen shall be collected under direct observation of a person of the
same gender and both specimens shall be forwarded to the laboratory for
testing. The agency shall select the observer if there is no collection
site person of the same gender available. A donor may volunteer to have
his or her oral temperature taken to provide evidence to counter the
reason to believe the donor may have altered or substituted the
specimen caused by the specimen's temperature falling outside the
prescribed range.
(14) Immediately after the specimen is collected, the collection
site person shall also inspect the specimen to determine its color and
look for any signs of contaminants. Any unusual findings shall be noted
on the specimen chain of custody form.
(15) All specimens suspected of being adulterated or diluted shall
be forwarded to the laboratory for testing.
(16) When there is any reason to believe that a donor may have
altered or substituted the specimen to be provided, another specimen
shall be obtained as soon as possible under the direct observation of a
person of the same gender and both specimens shall be forwarded to the
laboratory for testing. The agency shall select the observer if there
is no collection site person of the same gender available.
(17) Both the donor and the collection site person shall keep the
specimen bottle/container in view at all times prior to its being
sealed and labeled. If the specimen is transferred from a specimen
container to a specimen bottle, the collection site person shall
request the donor to observe the transfer of the specimen and the
placement of the tamper-evident seal/tape on the bottle. The tamper-
evident seal may be in the form of evidence tape, a self-sealing bottle
cap with both a tamper-evident seal and unique coding, cap and bottle
systems that can only be sealed one time, or any other system that
ensures any tampering with the specimen will be evident to laboratory
personnel during the accessioning process.
(18) The collection site person and the donor shall be present at
the same time during procedures outlined in paragraphs (f)(19)-(f)(22)
of this section.
(19) The collection site person shall place securely on the
specimen bottle an identification label which contains the date, the
donor's specimen number, and any other identifying information provided
or required by the agency.
(20) The donor shall initial the identification label on the
specimen bottle for the purpose of certifying that it is the specimen
collected from him or her.
(21) The collection site person shall enter on the specimen chain
of custody form all information identifying the specimen.
(22) The donor shall be asked to read and sign a statement on the
specimen chain of custody form certifying that the specimen identified
as having been collected from him or her is in fact that specimen he or
she provided.
(23) Based on a reason to believe that the donor may alter or
substitute the specimen to be provided, a higher level supervisor shall
review and concur in advance with any decision by a collection site
person to obtain a specimen under direct observation. The person
directly observing the specimen collection shall be of the same gender.
The agency shall select the observer if there is no collection site
person of the same gender available.
(24) The collection site person shall complete the specimen chain
of custody form.
(25) The urine specimen and specimen chain of custody form are now
ready for shipment. If the specimen is not immediately prepared for
shipment, it shall be appropriately safeguarded during temporary
storage.
(26) While any part of the above chain of custody procedures is
being performed, it is essential that the urine specimen and custody
documents be under the control of the involved collection site person.
If the involved collection site person leaves his or her work station
momentarily, the urine specimen and specimen chain of custody form
shall be taken with him or her or shall be secured. After the
collection site person returns to the work station, the custody process
will continue. If the collection site person is leaving for an extended
period of time, the specimen shall be packaged for mailing before he or
she leaves the site.
(g) Collection Control. To the maximum extent possible, collection
site personnel shall keep the donor's specimen bottle within sight both
before and after the donor has urinated. After the specimen is
collected, it shall be properly sealed and labeled. A specimen chain of
custody form shall be used for maintaining control and accountability
of each specimen. The date and purpose shall be documented on a
specimen chain of custody form each time a specimen is handled or
transferred and every individual in the chain shall be identified.
Every effort shall be made to minimize the number of persons handling
specimens.
(h) Split Specimens. An agency may, but is not required to, use a
split specimen method of collection. If the urine specimen is split
into two specimen bottles (hereinafter referred to as Bottle A and
Bottle B) the following procedure shall be used:
(1) The donor shall urinate into either a specimen bottle or
specimen container. The collection site person, in the presence of the
donor, after determining specimen temperature, pours the urine into two
specimen bottles that are labeled Bottle A and Bottle B or, if Bottle A
was used to collect the specimen, pours an appropriate amount into
Bottle B. A minimum of 45 mL of urine is required when using a split
specimen procedure, i.e., 30 mL for Bottle A and 15 mL for Bottle B.
(2) The Bottle A specimen, containing a minimum of 30 mL of urine,
is to be used for the drug test. If there is no additional urine
available for the second specimen bottle (Bottle B), the first specimen
bottle (Bottle A) shall nevertheless be processed for testing.
(3) A minimum of 15 mL of urine shall be poured into the second
specimen bottle (Bottle B).
(4) All requirements of this part shall be followed with respect to
Bottle A and Bottle B, including the requirements that a copy of the
chain of custody form accompany each bottle processed under split
sample procedures.
(5) The collection site shall send the split specimens (Bottle A
and Bottle B) at the same time to the laboratory that will be testing
the Bottle A specimen.
(6) If the test of the first specimen bottle (Bottle A) is verified
positive by the MRO, the MRO shall report the result to the agency.
Only the donor may request through the MRO that the second specimen
bottle (Bottle B) be tested in an HHS-certified laboratory for presence
of the drug(s) for which a positive result was obtained in the test of
the first specimen bottle (Bottle A). The MRO shall honor such a
request if it is made within 72 hours of the donor's having received
notice that he or she tested positive. The result of this test is
transmitted to the MRO without regard to the cutoff levels used to test
the first specimen bottle (Bottle A).
(7) Any action taken by a Federal agency as a result of an MRO
verified positive drug test (e.g., removal from performing a safety-
sensitive function) may proceed whether Bottle B is or is not tested.
(8) If the result of the test on the second specimen bottle (Bottle
B) fails to reconfirm the result reported for Bottle A, the MRO shall
void the test result for Bottle A and the donor shall re-enter the
group subject to random testing as if the test had not been conducted.
The MRO shall notify the Federal agency when a failed to reconfirm has
occurred and the agency shall contact the Secretary. The Secretary will
investigate the failed to reconfirm result and attempt to determine the
reason for the inconsistent results between Bottle A and Bottle B. HHS
will report its findings to the agency including recommendations and/or
actions taken to prevent the recurrence of the failed to reconfirm
result.
(i) Transportation to Laboratory. Collection site personnel shall
arrange to ship the collected specimens to the drug testing laboratory.
The specimens shall be placed in containers designed to minimize the
possibility of damage during shipment, for example, specimen boxes or
padded mailers; and those containers shall be securely sealed to
eliminate the possibility of undetected tampering. The collection site
personnel shall ensure that the specimen chain of custody form is
enclosed within each container sealed for shipment to the drug testing
laboratory. Since specimens are sealed in packages that would indicate
any tampering during transit to the laboratory and couriers, express
carriers, and postal service personnel do not have access to the chain
of custody forms, there is no requirement that such personnel document
chain of custody for the package during transit.
Section 2.3 Laboratory Personnel
(a) Day-to-Day Management. (1) The laboratory shall have a
responsible person (RP) to assume professional, organizational,
educational, and administrative responsibility for the laboratory's
urine drug testing facility.
(2) This individual shall have documented scientific qualifications
in analytical forensic toxicology. Minimum qualifications are:
(i) Certification as a laboratory director by the State in forensic
or clinical laboratory toxicology; or
(ii) A Ph.D. in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or
(iii) Training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with
additional training and laboratory/research experience in biology,
chemistry, and pharmacology or toxicology; and
(iv) In addition to the requirements in (i), (ii), and (iii) above,
minimum qualifications also require:
(A) Appropriate experience in analytical forensic toxicology
including experience with the analysis of biological material for drugs
of abuse, and
(B) Appropriate training and/or experience in forensic applications
of analytical toxicology, e.g., publications, court testimony, research
concerning analytical toxicology of drugs of abuse, or other factors
which qualify the individual as an expert witness in forensic
toxicology.
(3) This individual shall be engaged in and responsible for the
day-to-day management of the drug testing laboratory even where another
individual has overall responsibility for an entire multispeciality
laboratory.
(4) This individual shall be responsible for ensuring that there
are enough personnel with adequate training and experience to supervise
and conduct the work of the drug testing laboratory. He or she shall
assure the continued competency of laboratory personnel by documenting
their inservice training, reviewing their work performance, and
verifying their skills.
(5) This individual shall be responsible for the laboratory's
having a procedure manual which is complete, up-to-date, available for
personnel performing tests, and followed by those personnel. The
procedure manual shall be reviewed, signed, and dated by this
responsible person whenever procedures are first placed into use or
changed or when a new individual assumes responsibility for management
of the drug testing laboratory. Copies of all procedures and dates on
which they are in effect shall be maintained. (Specific contents of the
procedure manual are described in section 2.4(n)(1))
(6) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; for maintaining acceptable analytical performance for all
controls and standards; for maintaining quality control testing; and
for assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test
system.
(7) This individual shall be responsible for taking all remedial
actions necessary to maintain satisfactory operation and performance of
the laboratory in response to quality control systems not being within
performance specifications, errors in result reporting or in analysis
of performance testing results. This individual shall ensure that
sample results are not reported until all corrective actions have been
taken and he or she can assure that the results provided are accurate
and reliable.
(b) Certifying Test Results. The laboratory's urine drug testing
facility shall have a certifying scientist(s), as defined in section
1.2, who reviews all pertinent data and quality control results in
order to attest to the validity of the laboratory's test reports. A
laboratory may designate certifying scientists that are qualified to
certify only results that are negative on the initial test and
certifying scientists that are qualified to certify both initial and
confirmatory tests.
(c) Day-to-Day Operations and Supervision of Analysts. The
laboratory's urine drug testing facility shall have an individual(s) to
be responsible for day-to-day operations and to supervise the technical
analysts. This individual(s) shall have at least a bachelor's degree in
the chemical or biological sciences or medical technology or
equivalent. He or she shall have training and experience in the theory
and practice of the procedures used in the laboratory, resulting in his
or her thorough understanding of quality control practices and
procedures; the review, interpretation, and reporting of test results;
maintenance of chain of custody; and proper remedial actions to be
taken in response to test systems being out of control limits or
detecting aberrant test or quality control results.
(d) Other Personnel. Other technicians or nontechnical staff shall
have the necessary training and skills for the tasks assigned.
(e) Training. The laboratory's urine drug testing program shall
make available continuing education programs to meet the needs of
laboratory personnel.
(f) Files. Laboratory personnel files shall include: resume of
training and experience; certification or license, if any; references;
job descriptions; records of performance evaluation and advancement;
incident reports; and results of tests which establish employee
competency for the position he or she holds, such as a test for color
blindness, if appropriate.
Section 2.4 Laboratory Analysis Procedures
(a) Security and Chain of Custody. (1) Drug testing laboratories
shall be secure at all times. They shall have in place sufficient
security measures to control access to the premises and to ensure that
no unauthorized personnel handle specimens or gain access to the
laboratory processes or to areas where records are stored. Access to
these secured areas shall be limited to specifically authorized
individuals whose authorization is documented. With the exception of
personnel authorized to conduct inspections on behalf of Federal
agencies for which the laboratory is engaged in urine testing or on
behalf of the Secretary or emergency personnel (e.g., firefighters and
medical rescue teams), all authorized visitors and maintenance and
service personnel shall be escorted at all times. The laboratory shall
maintain a record that documents the dates, time of entry and exit, and
purpose of entry of authorized visitors, maintenance, and service
personnel accessing secured areas.
(2) Laboratories shall use chain of custody procedures to maintain
control and accountability of specimens from receipt through completion
of testing, reporting of results, during storage, and continuing until
final disposition of specimens. The date and purpose shall be
documented on an appropriate chain of custody form each time a specimen
is handled or transferred, and every individual in the chain shall be
identified. Accordingly, authorized technicians shall be responsible
for each urine specimen or aliquot in their possession and shall sign
and complete chain of custody forms for those specimens or aliquots as
they are received.
(b) Receiving. (1) When a shipment of specimens is received,
laboratory personnel shall inspect each package for evidence of
possible tampering and compare information on specimen bottles within
each package to the information on the accompanying chain of custody
forms. Any direct evidence of tampering or discrepancies in the
information on specimen bottles and the specimen chain of custody forms
attached to the shipment shall be immediately reported to the agency
and shall be noted on the specimen chain of custody forms which shall
accompany the specimens while they are in the laboratory's possession.
(2) Specimen bottles will normally be retained within the
laboratory's accession area until all analyses have been completed.
Aliquots and laboratory chain of custody forms shall be used by
laboratory personnel for conducting initial and confirmatory tests
while the original specimen and specimen chain of custody form remain
in secure storage.
(c) Short-Term Refrigerated Storage. Specimens that do not receive
an initial test within 7 days of arrival at the laboratory shall be
placed in secure refrigeration units. Temperatures shall not exceed
6 deg.C. Emergency power equipment shall be available in case of
prolonged power failure.
(d) Specimen Processing. Laboratory facilities for urine drug
testing will normally process specimens by grouping them into batches.
The number of specimens in each batch may vary significantly depending
on the size of the laboratory and its workload. When conducting either
initial or confirmatory tests, every batch shall satisfy the quality
control requirements in sections 2.5 (b) and (c), respectively.
(e) Initial Test. (1) The initial test shall use an immunoassay
which meets the requirements of the Food and Drug Administration for
commercial distribution. The following initial cutoff levels shall be
used when screening specimens to determine whether they are negative
for these five drugs or classes of drugs:
------------------------------------------------------------------------
Initial
test
level (ng/
mL)
------------------------------------------------------------------------
Marijuana metabolites........................................ 50
Cocaine metabolites.......................................... 300
Opiate metabolites........................................... \1\300
Phencyclidine................................................ 25
Amphetamines................................................. 1,000
------------------------------------------------------------------------
\1\25 ng/mL if immunoassay specific for free morphine.
(2) These test levels are subject to change by the Department of
Health and Human Services as advances in technology or other
considerations warrant identification of these substances at other
concentrations. The agency requesting the authorization to include
other drugs shall submit to the Secretary in writing the agency's
proposed initial test methods, testing levels, and proposed performance
test program.
(3) Specimens that test negative on all initial immunoassay tests
will be reported negative. No further testing of these negative
specimens for drugs is permitted and the specimens shall either be
discarded or pooled for use in the laboratory's internal quality
control program.
(4) Multiple initial tests (also known as rescreening) for the same
drug or drug class may be performed provided that all tests meet all
Guideline cutoffs and quality control requirements (see section
2.5(b)). Examples: a test is performed by immunoassay technique ``A''
for all drugs using the HHS cutoff levels, but presumptive positive
amphetamines are forwarded for immunoassay technique ``B'' to eliminate
any possible presumptive positives due to structural analogues; a valid
analytical result cannot be obtained using immunoassay technique ``A''
and immunoassay technique ``B'' is used in an attempt to obtain a valid
analytical result.
(f) Confirmatory Test. (1) All specimens identified as positive on
the initial test shall be confirmed for the class(es) of drugs screened
positive on the initial test using gas chromatography/mass spectrometry
(GC/MS) at the cutoff values listed in this paragraph. All
confirmations shall be by quantitative analysis. Concentrations which
exceed the linear region of the standard curve shall be documented in
the laboratory record as ``exceeds the linear range of the test.''
------------------------------------------------------------------------
Confirmatory
test level
(ng/mL)
------------------------------------------------------------------------
Marijuana metabolite\1\................................... 15
Cocaine metabolite\2\..................................... 150
Opiates:
Morphine................................................ 300
Codeine................................................. 300
Phencyclidine............................................. 25
Amphetamines:
Amphetamine............................................. 500
Methamphetamine\3\...................................... 500
------------------------------------------------------------------------
\1\Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\Benzoylecgonine.
\3\Specimen must also contain amphetamine at a concentration
200 ng/mL.
(2) These test levels are subject to change by the Department of
Health and Human Services as advances in technology or other
considerations warrant identification of these substances at other
concentrations. The agency requesting the authorization to include
other drugs shall submit to the Secretary in writing the agency's
proposed confirmatory test methods, testing levels, and proposed
performance test program.
(3) Specimens that test negative on confirmatory tests shall be
reported negative. No further testing of these specimens for drugs is
permitted and the specimens shall either be discarded or pooled for use
in the laboratory's internal quality control program.
(g) Reporting Results. (1) The laboratory shall report test results
to the agency's MRO within an average of 5 working days after receipt
of the specimen by the laboratory. Before any test result is reported
(the results of initial tests, confirmatory tests, or quality control
data), it shall be reviewed and the test certified as an accurate
report by a certifying scientist who satisfies the requirements
described by the definition in section 1.2. The report shall identify
the drugs/metabolites tested for, whether positive or negative, and the
cutoff for each, the specimen number assigned by the agency, and the
drug testing laboratory specimen identification number.
(2) Except as otherwise provided by this subsection, the laboratory
shall report as negative all specimens which are negative on the
initial test or negative on the confirmatory test. Only specimens
confirmed positive shall be reported positive for a specific drug. For
amphetamines, to report a specimen positive for methamphetamine only,
the specimen must also contain amphetamine at a concentration equal to
or greater than 200 ng/mL by the confirmatory test. If this criterion
is not met, the specimen must be reported as negative for
methamphetamine.
(3) The MRO may request from the laboratory and the laboratory
shall provide quantitation of test results. The MRO may not disclose
quantitation of test results to the agency but shall report only
whether the test was positive or negative.
(4) The laboratory may transmit results to the MRO by various
electronic means (for example, teleprinters, facsimile, or computer) in
a manner designed to ensure confidentiality of the information. Results
may not be provided verbally by telephone. The laboratory must ensure
the security of the data transmission and limit access to any data
transmission, storage, and retrieval system.
(5) The laboratory shall send only to the MRO a certified copy of
the original chain of custody form signed by a certifying scientist.
(6) The laboratory shall provide to the agency official responsible
for coordination of the drug-free workplace program a monthly
statistical summary of urinalysis testing of Federal employees and
shall not include in the summary any personal identifying information.
Initial and confirmation data shall be included from test results
reported within that month. Normally this summary shall be forwarded by
registered or certified mail not more than 14 calendar days after the
end of the month covered by the summary. The summary shall contain the
following information:
Initial Testing:
(i) Number of specimens received;
(ii) Number of specimens reported out; and
(iii) Number of specimens screened positive for: Marijuana
metabolites, Cocaine metabolites, Opiate metabolites, Phencyclidine,
and Amphetamines.
Confirmatory Testing:
(i) Number of specimens received for confirmation;
(ii) Number of specimens confirmed positive for: Marijuana
metabolite, Cocaine metabolite, Morphine, codeine, Phencyclidine,
Amphetamine, and Methamphetamine. (7) The laboratory shall make
available copies of all analytical results for Federal drug testing
programs when requested by HHS or any Federal agency for which the
laboratory is performing drug testing services.
(8) Unless otherwise instructed by the agency in writing, all
records pertaining to a given urine specimen shall be retained by the
drug testing laboratory for a minimum of 2 years.
(h) Long-Term Storage. Long-term frozen storage (-20 deg.C or
less) ensures that positive urine specimens will be available for any
necessary retest. Unless otherwise authorized in writing by the agency,
drug testing laboratories shall retain and place in properly secured
long-term frozen storage for a minimum of 1 year all specimens
confirmed positive. Within this 1-year period an agency may request the
laboratory to retain the specimen for an additional period of time. If
no such request is received, the laboratory may discard the specimen
after the end of 1 year, except that the laboratory shall be required
to maintain any specimens under legal challenge for an indefinite
period.
(i) Retesting of a Specimen (i.e., the reanalysis by gas
chromatography/mass spectrometry of a specimen previously reported
positive or the testing of Bottle B of a split specimen collection).
Because some analytes deteriorate or are lost during freezing and/or
storage, quantitation for a retest is not subject to a specific cutoff
requirement but must provide data sufficient to confirm the presence of
the drug or metabolite.
(j) Subcontracting. Drug testing laboratories shall not subcontract
and shall perform all work with their own personnel and equipment
unless otherwise authorized by the agency. The laboratory must be
capable of performing testing for the five classes of drugs (marijuana,
cocaine, opiates, phencyclidine, and amphetamines) using the initial
immunoassay and confirmatory GC/MS methods specified in these
Guidelines.
(k) Laboratory Facilities. (1) Laboratory facilities shall comply
with applicable provisions of any State licensure requirements.
(2) Laboratories certified in accordance with Subpart C of these
Guidelines shall have the capability, at the same laboratory premises,
of performing initial and confirmatory tests for each drug or
metabolite for which service is offered.
(l) Inspections. The Secretary, any Federal agency utilizing the
laboratory, or any organization performing laboratory certification on
behalf of the Secretary may reserve the right to inspect the laboratory
at any time. Agency contracts with laboratories for drug testing, as
well as contracts for collection site services, shall permit the agency
to conduct unannounced inspections. In addition, prior to the award of
a contract the agency may carry out preaward inspections and evaluation
of the procedural aspects of the laboratory's drug testing operation.
(m) Documentation. The drug testing laboratories shall maintain and
make available for at least 2 years documentation of all aspects of the
testing process. This 2-year period may be extended upon written
notification by HHS or by any Federal agency for which laboratory
services are being provided. The required documentation shall include
personnel files on all individuals authorized to have access to
specimens; chain of custody forms; quality assurance/quality control
records; procedure manuals; all test data (including calibration curves
and any calculations used in determining test results); reports;
performance records on performance testing; performance on
certification inspections; and hard copies of computer-generated data.
The laboratory shall be required to maintain documents for any specimen
under legal challenge for an indefinite period.
(n) Additional Requirements for Certified Laboratories.
(1) Procedure Manual. Each laboratory shall have a procedure manual
which includes the principles of each test, preparation of reagents,
standards and controls, calibration procedures, derivation of results,
linearity of methods, sensitivity of the methods, cutoff values,
mechanisms for reporting results, controls, criteria for unacceptable
specimens and results, remedial actions to be taken when the test
systems are outside of acceptable limits, reagents and expiration
dates, and references. Copies of all procedures and dates on which they
are in effect shall be maintained as part of the manual.
(2) Calibrators and Controls. Laboratory calibrators and controls
shall be prepared using pure drug reference materials, stock standard
solutions obtained from other laboratories, or standard solutions
obtained from commercial manufacturers. The calibrators and controls
shall be properly labeled as to content and concentration. The
standards (e.g., pure reference materials, stock standard solutions,
purchased standards) shall be labeled with the following dates: When
received (if applicable); When prepared or opened; when placed in
service; and expiration date.
(3) Instruments and Equipment. (i) Volumetric pipettes and
measuring devices shall be certified for accuracy or be checked by
gravimetric, colorimetric, or other verification procedure. Automatic
pipettes and dilutors shall be checked for accuracy and reproducibility
before being placed in service and checked periodically thereafter.
(ii) There shall be written procedures for instrument set-up and
normal operation, a schedule for checking critical operating
characteristics for all instruments, tolerance limits for acceptable
function checks, and instructions for major troubleshooting and repair.
Records shall be available on preventive maintenance.
(4) Remedial Actions. There shall be written procedures for the
actions to be taken when systems are out of acceptable limits or errors
are detected. There shall be documentation that these procedures are
followed and that all necessary corrective actions are taken. There
shall also be in place systems to verify all stages of testing and
reporting and documentation that these procedures are followed.
(5) Personnel Available to Testify at Proceedings. A laboratory
shall have qualified personnel available to testify in an
administrative or disciplinary proceeding against a Federal employee
when that proceeding is based on positive urinalysis results reported
by the laboratory.
(6) Restrictions. The laboratory shall not enter into any
relationship with an agency's MRO that may be construed as a potential
conflict of interest or derive any financial benefit by having an
agency use a specific MRO.
Section 2.5 Quality Assurance and Quality Control
(a) General. Drug testing laboratories shall have a quality
assurance program which encompasses all aspects of the testing process
including but not limited to specimen acquisition, chain of custody,
security and reporting of results, initial and confirmatory testing,
certification of calibrators and controls, and validation of analytical
procedures. Quality assurance procedures shall be designed,
implemented, and reviewed to monitor the conduct of each step of the
testing process.
(b) Laboratory Quality Control Requirements for Initial Tests. Each
analytical run of specimens to be screened shall include:
(1) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(2) Positive control(s) fortified with drug or metabolite;
(3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff);
(4) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of
the cutoff. After acceptable values are obtained for the known
calibrators, those values will be used to calculate sample data;
(5) A minimum of 10 percent of the total specimens and quality
control samples in each analytical run shall be quality control
samples; and
(6) One percent of each run, with a minimum of at least one sample,
shall be the laboratory's blind quality control samples to appear as
normal samples to the laboratory analysts.
Implementation of procedures to ensure that carryover does not
contaminate the testing of an donor's specimen shall be documented.
(c) Laboratory Quality Control Requirements for Confirmation Tests.
Each analytical run of specimens to be confirmed shall include:
(1) Sample(s) certified to contain no drug (i.e., negative urine
samples);
(2) Positive calibrator(s) and control(s) fortified with drug or
metabolite; and
(3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff).
The linearity and precision of the method shall be periodically
documented. Implementation of procedures to ensure that carryover does
not contaminate the testing of a donor's specimen shall also be
documented.
(d) Agency Blind Sample Program.
(1) Agencies shall only purchase blind quality control materials
that: (a) have been certified by immunoassay and GC/MS and (b) have
stability data which verifies those materials' performance over time.
(2) During the initial 90-day period of any new drug testing
program, each agency shall submit blind performance test samples to
each laboratory it contracts with in the amount of at least 20 percent
of the total number of specimens submitted (up to a maximum of 200
blind samples) and thereafter a minimum of 3 percent blind samples (up
to a maximum of 100 blind samples) submitted per quarter.
(3) Approximately 80 percent of the blind quality control samples
shall be negative (i.e., certified to contain no drug) and the
remaining samples shall be positive for one or more drugs per sample in
a distribution such that all the drugs to be tested are included in
approximately equal frequencies of challenge. The positive samples
shall be spiked only with those drugs for which the agency is testing.
(4) The agency shall investigate any unsatisfactory blind
performance test sample results and submit its findings to the
Secretary. The Secretary shall continue the investigation to ensure
that the laboratory has corrected the cause of the unsatisfactory
performance test result. A report of the Secretary's investigative
findings and the corrective action taken by the laboratory shall be
sent to the agency contracting officer. The Secretary shall ensure
notification of the finding to all other Federal agencies for which the
laboratory is engaged in urine drug testing and coordinate any
necessary action.
(5) Should a false positive error occur on a blind performance test
sample and the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary shall require the
laboratory to take corrective action to minimize the occurrence of the
particular error in the future; and, if there is reason to believe the
error could have been systematic, the Secretary may also require review
and reanalysis of previously run specimens.
(6) Should a false positive error occur on a blind performance test
sample and the error is determined to be a technical or methodological
error, the laboratory shall submit all quality control data from the
batch of specimens which included the false positive specimen. In
addition, the laboratory shall retest all specimens analyzed positive
for that drug or metabolite from the time of final resolution of the
error back to the time of the last satisfactory performance test cycle.
This retesting shall be documented by a statement signed by the
Responsible Person. The Secretary may require an on-site review of the
laboratory which may be conducted unannounced during any hours of
operation of the laboratory. The Secretary has the option of revoking
(section 3.13) or suspending (section 3.14) the laboratory's
certification or recommending that no further action be taken if the
case is one of less serious error in which corrective action has
already been taken, thus reasonably assuring that the error will not
occur again.
Section 2.6 Reporting and Review of Results
(a) Medical Review Officer Shall Review Results. An essential part
of the drug testing program is the final review of results. A positive
test result does not automatically identify an employee/applicant as an
illegal drug user. An individual with a detailed knowledge of possible
alternate medical explanations is essential to the review of results.
This review shall be performed by the MRO prior to the transmission of
results to agency administrative officials.
(b) Medical Review Officer--Qualifications and Responsibilities.
The MRO shall be a licensed physician with knowledge of substance abuse
disorders. The MRO may be an employee of the agency or a contractor for
the agency; however, the 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, the 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. The role of the MRO is
to review and interpret positive test results obtained through the
agency's testing program. In carrying out this responsibility, the MRO
shall examine alternate medical explanations for any positive test
result. This action could include conducting a medical interview with
the donor, review of the donor's medical history, or review of any
other relevant biomedical factors. The MRO shall review all medical
records made available by the donor when a confirmed positive test
could have resulted from legally prescribed medication. The MRO shall
not, however, consider the results of urine specimens that are not
obtained or processed in accordance with these Guidelines.
(c) Positive Test Result. Prior to making a final decision to
verify a positive test result, the MRO shall give the donor an
opportunity to discuss the test result with him or her. Following
verification of a positive test result, the MRO shall report the result
to the agency's official designated to receive results.
(d) Verification for Opiates; Review for Prescription Medication.
Before the MRO verifies a confirmed positive result for opiates, he or
she shall determine that there is clinical evidence--in addition to the
urine test--of illegal use of any opium, opiate, or opium derivative
(e.g., morphine/codeine) listed in Schedule I or II of the Controlled
Substances Act. This requirement does not apply if the confirmatory
procedure for opiates confirms the presence of 6-monoacetylmorphine
since the presence of this metabolite is proof of heroin use.
(e) Reanalysis Authorized. Should any question arise as to the
accuracy or validity of a positive test result, only the MRO is
authorized to order a retest of a single specimen or the Bottle A
specimen from a split specimen collection. Such retests are authorized
only at laboratories certified under these Guidelines.
(f) Result Consistent With Legal Drug Use. If the MRO determines
there is a legitimate medical explanation for the positive test result,
he or she shall take no further action and report the test result as
negative.
(g) Result Scientifically Insufficient. Additionally, the MRO,
based on review of inspection reports, quality control data, and other
pertinent results, may determine that the result is scientifically
insufficient for further action and declare the test specimen negative.
In this situation the MRO may request a retest of the original specimen
before making this decision. (The MRO may request that the retest be
performed by the same laboratory or, as provided in section 2.6(e),
that an aliquot of the original specimen be sent for a retest to an
alternate laboratory which is certified in accordance with these
Guidelines.) The laboratory shall assist in this review process as
requested by the MRO by making available the individual responsible for
day-to-day management of the urine drug testing laboratory or other
employee who is a forensic toxicologist or who has equivalent forensic
experience in urine drug testing, to provide specific consultation as
required by the agency. The MRO shall report to the Secretary all
negative findings based on scientific insufficiency but shall not
include any personal identifying information in such reports.
(h) Reporting Final Results. The MRO shall report the final results
of the drug tests in writing and in a manner designed to ensure
confidentiality of the information.
Section 2.7 Protection of Employee Records
Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all
laboratory contracts shall require that the contractor comply with the
Privacy Act, 5 U.S.C. 522a. In addition, laboratory contracts shall
require compliance with patient access and confidentiality provisions
of section 503 of Public Law 100-71. The agency shall establish a
Privacy Act System of Records or modify an existing system, or use any
applicable Government-wide system of records to cover both the agency's
and the laboratory's records of employee urinalysis results. The
contract and the Privacy Act System of Records shall specifically
require that employee records be maintained and used with the highest
regard for employee privacy.
Section 2.8 Individual Access to Test and Laboratory Certification
Results
In accordance with section 503 of Public Law 100-71, any Federal
employee who is the subject of a drug test shall, upon written request,
have access to any records relating to his or her drug test and any
records relating to the results of any relevant certification, review,
or revocation-of-certification proceedings.
Subpart C--Certification of Laboratories Engaged in Urine Drug Testing
for Federal Agencies
Section 3.1 Introduction
Urine drug testing is a critical component of efforts to combat
drug abuse in our society. Many laboratories are familiar with good
laboratory practices but may be unfamiliar with the special procedures
required when drug test results are used in the employment context.
Accordingly, the following are minimum standards to certify
laboratories engaged in urine drug testing for Federal agencies.
Certification, even at the highest level, does not guarantee accuracy
of each result reported by a laboratory conducting urine drug testing
for Federal agencies. Therefore, results from laboratories certified
under these Guidelines must be interpreted with a complete
understanding of the total collection, analysis, and reporting process
before a final conclusion is made.
Section 3.2 Goals and Objectives of Certification
(a) Uses of Urine Drug Testing. Urine drug testing is an important
tool to identify drug users in a variety of settings. In the proper
context, urine drug testing can be used to deter drug abuse in general.
To be a useful tool, the testing procedure must be capable of detecting
drugs or their metabolites at concentrations indicated in sections
2.4(e) and 2.4(f).
(b) Need to Set Standards; Inspections. Reliable discrimination
between the presence, or absence, of specific drugs or their
metabolites is critical, not only to achieve the goals of the testing
program but to protect the rights of the Federal employees being
tested. Thus, standards have been set which laboratories engaged in
Federal employee urine drug testing must meet in order to achieve
maximum accuracy of test results. These laboratories will be evaluated
by the Secretary or the Secretary's designee as defined in section 1.2
in accordance with these Guidelines. The qualifying evaluation will
involve three rounds of performance testing plus an on-site inspection.
Maintenance of certification requires participation in a quarterly
performance testing program plus periodic, on-site inspections. One
inspection following successful completion of a performance testing
regimen is required for initial certification. This must be followed by
a second inspection within 3 months, after which biannual inspections
will be required to maintain certification.
(c) Urine Drug Testing Applies Analytical Forensic Toxicology. The
possible impact of a positive test result on an individual's livelihood
or rights, together with the possibility of a legal challenge of the
result, sets this type of test apart from most clinical laboratory
testing. In fact, urine drug testing should be considered a special
application of analytical forensic toxicology. That is, in addition to
the application of appropriate analytical methodology, the specimen
must be treated as evidence, and all aspects of the testing procedure
must be documented and available for possible court testimony.
Laboratories engaged in urine drug testing for Federal agencies will
require the services and advice of a qualified forensic toxicologist,
or individual with equivalent qualifications (both training and
experience) to address the specific needs of the Federal drug testing
program, including the demands of chain of custody of specimens,
security, proper documentation of all records, storage of positive
specimens for later or independent testing, presentation of evidence in
court, and expert witness testimony.
Section 3.3 General Certification Requirements
A laboratory must meet all the pertinent provisions of these
Guidelines in order to qualify for and maintain certification under
these standards.
Section 3.4 Capability to Test for Five Classes of Drugs
To be certified, a laboratory must be capable of testing for at
least the following five classes of drugs: marijuana, cocaine, opiates,
amphetamines, and phencyclidine using the initial immunoassay and
quantitative confirmatory GC/MS methods specified in these Guidelines.
The certification program will be limited to the five classes of drugs
(sections 2.1(a) (1) and (2)) and the methods (sections 2.4 (e) and
(f)) specified in these Guidelines. The laboratory will be surveyed and
performance tested only for these methods and drugs. Certification of a
laboratory indicates that any test result reported by the laboratory
for the Federal Government meets the standards in these Guidelines for
the five classes of drugs using the methods specified. Certified
laboratories must clearly inform all unregulated, private clients when
their specimens are being tested using procedures that are different
from those for which the laboratory is certified (i.e., testing
specimens not under the Guidelines).
Section 3.5 Initial and Confirmatory Capability at Same Site
Certified laboratories shall have the capability, at the same
laboratory site, of performing both initial immunoassays and
confirmatory GC/MS tests (sections 2.4 (e) and (f)) for marijuana,
cocaine, opiates, amphetamines, and phencyclidine and for any other
drug or metabolite for which agency drug testing is authorized
(sections 2.1(a) (1) and (2)). All positive initial test results shall
be confirmed prior to reporting them.
Section 3.6 Personnel
Laboratory personnel shall meet the requirements specified in
section 2.3 of these Guidelines. These Guidelines establish the
exclusive standards for qualifying or certifying those laboratory
personnel involved in urinalysis testing whose functions are prescribed
by these Guidelines. A certification of a laboratory under these
Guidelines shall be a determination that these qualification
requirements have been met.
Section 3.7 Quality Assurance and Quality Control
Drug testing laboratories shall have a quality assurance program
which encompasses all aspects of the testing process, including but not
limited to specimen acquisition, chain of custody, security and
reporting of results, initial and confirmatory testing, and validation
of analytical procedures. Quality control procedures shall be designed,
implemented, and reviewed to monitor the conduct of each step of the
process of testing for drugs as specified in section 2.5 of these
Guidelines.
Section 3.8 Security and Chain of Custody
Laboratories shall meet the security and chain of custody
requirements provided in section 2.4(a).
Section 3.9 One-Year Storage for Confirmed Positives
All confirmed positive specimens shall be retained in accordance
with the provisions of section 2.4(h) of these Guidelines.
Section 3.10 Documentation
The laboratory shall maintain and make available for at least 2
years documentation in accordance with the specifications in section
2.4(m).
Section 3.11 Reports
The laboratory shall report test results in accordance with the
specifications in section 2.4(g).
Section 3.12 Certification
(a) General. The Secretary may certify any laboratory that meets
the standards in these Guidelines to conduct urine drug testing. In
addition, the Secretary may consider to be certified any laboratory
that is certified by an HHS-recognized certification program in
accordance with these Guidelines.
(b) Criteria. In determining whether to certify a laboratory or to
accept the certification of an HHS-recognized certification program in
accordance with these Guidelines, the Secretary shall consider the
following criteria:
(1) The adequacy of the laboratory facilities;
(2) The expertise and experience of the laboratory personnel;
(3) The excellence of the laboratory's quality assurance/ quality
control program;
(4) The performance of the laboratory on any performance tests;
(5) The laboratory's compliance with standards as reflected in any
laboratory inspections; and
(6) Any other factors affecting the reliability and accuracy of
drug tests and reporting done by the laboratory.
(c) Corrective Action by Certified Laboratories. A laboratory must
meet all the pertinent provisions of these Guidelines in order to
qualify for and maintain certification. The Secretary has broad
discretion to take appropriate action to ensure the full reliability
and accuracy of drug testing and reporting, to resolve problems related
to drug testing, and to enforce all standards set forth in these
Guidelines. The Secretary shall have the authority to issue directives
to any laboratory suspending the use of certain analytical procedures
when necessary to protect the integrity of the testing process;
ordering any laboratory to undertake corrective actions to respond to
material deficiencies identified by an inspection or through
proficiency testing; ordering any laboratory to send aliquots of urine
specimens 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.
Section 3.13 Revocation
(a) General. The Secretary shall revoke certification of any
laboratory certified under these provisions or accept revocation by an
HHS-recognized certification program in accordance with these
Guidelines if the Secretary determines that revocation is necessary to
ensure the full reliability and accuracy of drug tests and the accurate
reporting of test results.
(b) Factors to Consider. The Secretary shall consider the following
factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the
results of drug tests; for example, a false positive error in reporting
the results of an employee's drug test;
(2) Unsatisfactory participation in performance evaluations or
laboratory inspections;
(3) A material violation of a certification standard or a contract
term or other condition imposed on the laboratory by a Federal agency
using the laboratory's services;
(4) Conviction for any criminal offense committed as an incident to
operation of the laboratory; or
(5) Any other cause which materially affects the ability of the
laboratory to ensure the full reliability and accuracy of drug tests
and the accurate reporting of results.
(c) Period and Terms. The period and terms of revocation shall be
determined by the Secretary and shall depend upon the facts and
circumstances of the revocation and the need to ensure accurate and
reliable drug testing of Federal employees.
Section 3.14 Suspension
(a) Criteria. Whenever the Secretary has reason to believe that
revocation may be required and that immediate action is necessary in
order to protect the interests of the United States and its employees,
the Secretary may immediately suspend a laboratory's certification to
conduct urine drug testing for Federal agencies. The Secretary may also
accept suspension of certification by an HHS-recognized certification
program in accordance with these Guidelines.
(b) Period and Terms. The period and terms of suspension shall be
determined by the Secretary and shall depend upon the facts and
circumstances of the suspension and the need to ensure accurate and
reliable drug testing of Federal employees.
Section 3.15 Notice
(a) Written Notice. When a laboratory is suspended or the Secretary
seeks to revoke certification, the Secretary shall immediately serve
the laboratory with written notice of the suspension or proposed
revocation by facsimile mail, personal service, or registered or
certified mail, return receipt requested. This notice shall state the
following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) Opportunity for Informal Review. The written notice shall state
that the laboratory will be afforded an opportunity for an informal
review of the suspension or proposed revocation if it so requests in
writing within 30 days of the date the laboratory received the notice,
or if expedited review is requested, within 3 days of the date the
laboratory received the notice. Subpart D contains detailed procedures
to be followed for an informal review of the suspension or proposed
revocation.
(c) Effective Date. A suspension shall be effective immediately. A
proposed revocation shall be effective 30 days after written notice is
given or, if review is requested, upon the reviewing official's
decision to uphold the proposed revocation. If the reviewing official
decides not to uphold the suspension or proposed revocation, the
suspension shall terminate immediately and any proposed revocation
shall not take effect.
(d) HHS-Recognized Certification Program. The Secretary's
responsibility under this section may be carried out by an HHS-
recognized certification program in accordance with these Guidelines.
(e) Public Notice. The Secretary will publish in the Federal
Register the name, address, and telephone number of any laboratory that
has its certification suspended or revoked under section 3.13 or
section 3.14, respectively, and the name of any laboratory which has
its suspension lifted. The Secretary shall provide to any member of the
public upon request the written notice provided to a laboratory that
has its certification suspended or revoked, as well as the reviewing
official's written decision which upholds or denies the suspension or
proposed revocation under the procedures of subpart D.
Section 3.16 Recertification
Following revocation, a laboratory may apply for recertification.
Unless otherwise provided by the Secretary in the notice of revocation
under section 3.13(a) or the reviewing official's decision under
section 4.9(e) or 4.14(a), a laboratory which has had its certification
revoked may apply for certification in accordance with this section. In
order to be certified, the laboratory shall meet the criteria of
section 3.12(b), as well as all other requirements of these Guidelines,
including the successful participation in three cycles of performance
testing (sections 3.17(b) and 3.19(a)) and a laboratory inspection
(sections 3.2(b) and 3.20). Once certified, the laboratory must undergo
a second inspection within three months, after which biannual
inspections will be required to maintain certification (section
3.2(b)), as well as participation in the quarterly performance testing
program (sections 3.1(b) and 3.17(c)).
Section 3.17 Performance Testing (PT) Requirement for Certification
(a) An Initial and Continuing Requirement. The PT program is a part
of the initial evaluation of a laboratory seeking certification (both
PT and laboratory inspection are required) and of the continuing
assessment of laboratory performance necessary to maintain this
certification.
(b) Three Initial Cycles Required. Successful participation in
three cycles of testing shall be required before a laboratory is
eligible to be considered for certification.
(c) Four Challenges Per Year. After certification, laboratories
shall be challenged with at least 10 PT samples on a quarterly cycle.
(d) Laboratory Procedures Identical for Performance Test and
Routine Employee Specimens. All procedures associated with the handling
and testing of the PT samples by the laboratory shall to the greatest
extent possible be carried out in a manner identical to that applied to
routine laboratory specimens, unless otherwise specified.
(e) Blind Performance Test. Any certified laboratory shall be
subject to blind PT samples (see section 2.5(d)). Performance on blind
PT samples shall be at the same level as for the open or non-blind PT
samples.
(f) Reporting--Open Performance Test. The laboratory shall report
results of open PT samples to the certifying organization in the same
manner as specified in section 2.4(g)(2) for routine specimens.
Section 3.18 Performance Test Samples Composition
(a) Description of the Drugs. PT samples shall contain those drugs
and metabolites which each certified laboratory must be prepared to
assay in concentration ranges that allow detection of the analytes by
commonly used immunoassay screening techniques. These levels are
generally in the range of concentrations which might be expected in the
urine of recent drug users. For some drug analytes, the sample
composition will consist of the parent drug as well as major
metabolites. In some cases, more than one drug class may be included in
one sample, but generally no more than two drugs will be present in any
one sample in order to imitate the type of specimen which a laboratory
normally encounters. For any particular PT cycle, the actual
composition of kits going to different laboratories will vary but,
within any annual period, all laboratories participating will have
analyzed the same total set of samples.
(b) Concentrations. PT samples (as differentiated from blind
quality control samples) shall be spiked with the drug classes and
their metabolites that are required for certification (marijuana,
cocaine, opiates, amphetamines, and phencyclidine) with concentration
levels set by, but not limited to, one of the following schema: (1) At
least 20 percent above the cutoff limit for either the initial assay or
the confirmatory test, depending on which is to be evaluated; (2) below
the cutoff limit as retest samples (for GC/MS quantitation); and, (3)
below the cutoff limit for special purposes. Some PT samples may be
identified for GC/MS assay only (retest samples). Blanks shall contain
less than 2 ng/mL of any of the target drugs. These concentration and
drug types may be changed periodically in response to factors such as
changes in detection technology and patterns of drug use. Finally, PT
samples may be constituted with interfering substances.
Section 3.19 Evaluation of Performance Testing
(a) Initial Certification. (1) An applicant laboratory shall not
report any false positive result during PT for initial certification.
Any false positive will automatically disqualify a laboratory from
further consideration.
(2) An applicant laboratory shall maintain an overall grade level
of 90 percent for the three cycles of PT required for initial
certification, i.e., it must correctly identify and confirm 90 percent
of the total drug challenges. Any laboratory which achieves a score on
any one cycle of the initial certification such that it can no longer
achieve a total grade of 90 percent over the three consecutive PT
cycles will be immediately disqualified from further consideration.
(3) An applicant laboratory shall obtain quantitative values for at
least 80 percent of the total drug challenges which are 20
percent or 2 standard deviations (whichever range is
larger) of the calculated reference group mean. Failure to achieve 80
percent will result in disqualification.
(4) An applicant laboratory shall not obtain any quantitative
values that differ by more than 50 percent from the calculated
reference group mean. Any quantitative values that differ by more than
50 percent will result in disqualification.
(5) For any individual drug, an applicant laboratory shall
successfully detect and quantitate in accordance with paragraphs
(a)(2), (a)(3), and (a)(4) of this section at least 50 percent of the
total drug challenges. Failure to successfully quantitate at least 50
percent of the challenges for any individual drug will result in
disqualification.
(b) Ongoing Testing of Certified Laboratories. (1) False Positives
and Procedures for Dealing with Them. No false drug identifications are
acceptable for any drugs for which a laboratory offers service. Under
some circumstances a false positive test may result in suspension or
revocation of certification. The most serious false positives are by
drug class, such as reporting THC in a blank specimen or reporting
cocaine in a specimen known to contain only opiates. Misidentifications
within a class (e.g., codeine for morphine) are also false positives
which are unacceptable in an appropriately controlled laboratory, but
they are clearly less serious errors than misidentification of a class.
The following procedures shall be followed when dealing with a false
positive:
(i) The agency detecting a false positive error shall immediately
notify the laboratory and the Secretary of any such error.
(ii) The laboratory shall provide the Secretary with a written
explanation of the reasons for the error within 5 working days. If
required by paragraph (b)(1)(v) below, this explanation shall include
the submission of all quality control data from the batch of specimens
that included the false positive specimen.
(iii) The Secretary shall review the laboratory's explanation
within 5 working days and decide what further action, if any, to take.
(iv) If the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary may direct the laboratory
to take corrective action to minimize the occurrence of the particular
error in the future and, if there is reason to believe the error could
have been systematic, may require the laboratory to review and
reanalyze previously run specimens.
(v) If the error is determined to be a technical or methodological
error, the laboratory shall submit to the Secretary all quality control
data from the batch of specimens which included the false positive
specimen. In addition, the laboratory shall retest all specimens
analyzed positive by the laboratory from the time of final resolution
of the error back to the time of the last satisfactory performance test
cycle. This retesting shall be documented by a statement signed by the
laboratory's responsible person. Depending on the type of error which
caused the false positive, this retesting may be limited to one analyte
or may include any drugs a laboratory certified under these Guidelines
must be prepared to assay. The laboratory shall immediately notify the
agency if any result on a specimen that has been retested must be
corrected because the criteria for a positive are not satisfied. The
Secretary may suspend or revoke the laboratory's certification for all
drugs or for only the drug or drug class in which the error occurred.
However, if the case is one of a less serious error for which effective
corrections have already been made, thus reasonably assuring that the
error will not occur again, the Secretary may decide to take no further
action.
(vi) During the time required to resolve the error, the laboratory
shall remain certified but shall have a designation indicating that a
false positive result is pending resolution. If the Secretary
determines that the laboratory's certification must be suspended or
revoked, the laboratory's official status will become ``Suspended'' or
``Revoked'' until the suspension or revocation is lifted or any
recertification process is complete.
(2) Requirement to Identify and Confirm 90 Percent of Total Drug
Challenges. In order to remain certified, laboratories must
successfully complete four cycles of PT per year. Failure of a
certified laboratory to maintain a grade of 90 percent over the span of
two consecutive PT cycles, i.e., to identify 90 percent of the total
drug challenges and to correctly confirm 90 percent of the total drug
challenges, may result in suspension or revocation of certification.
(3) Requirement to Quantitate 80 Percent of Total Drug Challenges
at 20 Percent or 2 Standard Deviations.
Quantitative values obtained by a certified laboratory for at least 80
percent of the total drug challenges must be 20 percent or
2 standard deviations (whichever range is larger) of the
appropriate reference or peer group mean as measured over two
consecutive PT cycles.
(4) Requirement to Quantitate Within 50 Percent of Calculated
Reference Group Mean. After achieving certification a laboratory is
permitted one quantitative result differing by more than 50% from the
target value within two consecutive cycles of PT. More than one error
of this type within two consecutive PT cycles may result in a
suspension or proposed revocation.
(5) Requirement to Successfully Detect and Quantitate 50 Percent of
the Total Drug Challenges for Any Individual Drug. For any individual
drug, a certified laboratory must successfully detect and quantitate in
accordance with paragraphs (b)(2),(b)(3), and (b)(4) of this section at
least 50 percent of the total drug challenges.
(6) Procedures When Requirements in Paragraphs (b)(2)--(b)(5) of
this Section Are Not Met. If a certified laboratory fails to maintain a
grade of 90 percent over the span of two consecutive PT cycles after
initial certification as required by paragraph (b)(2) of this section
or if it fails to successfully quantitate results as required by
paragraphs (b)(3),(b)(4), or (b)(5) of this section, the laboratory
shall be immediately informed that its performance fell under the 90
percent level or that it failed to quantitate test results successfully
and how it failed to quantitate successfully. The laboratory shall be
allowed 5 working days in which to provide any explanation for its
unsuccessful performance, including administrative error or
methodological error, and evidence that the source of the poor
performance has been corrected. The Secretary may revoke or suspend the
laboratory's certification or take no further action, depending on the
seriousness of the errors and whether there is evidence that the source
of the poor performance has been corrected and that current performance
meets the requirements for a certified laboratory under these
Guidelines. The Secretary may require that additional performance tests
be carried out to determine whether the source of the poor performance
has been removed. If the Secretary determines to suspend or revoke the
laboratory's certification, the laboratory's official status will
become ``Suspended'' or ``Revoked'' until the suspension or revocation
is lifted or until any recertification process is complete.
(c) 80 Percent of Participating Laboratories Must Detect Drug. A
laboratory's performance shall be evaluated for all samples for which
drugs were spiked at concentrations above the specified performance
test level unless the overall response from participating laboratories
indicates that less than 80 percent of them were able to detect a drug.
(d) Participation Required. Failure to participate in a PT cycle or
to participate satisfactorily may result in suspension or revocation of
certification.
Section 3.20 Inspections
(a) Frequency. Prior to laboratory certification under these
Guidelines and at least twice a year after certification, a team of
three qualified inspectors, at least two of whom have been trained as
laboratory inspectors, shall conduct an on-site inspection of
laboratory premises. Inspections shall document the overall quality of
the laboratory setting for the purposes of certification to conduct
urine drug testing. Inspection reports may also contain recommendations
to the laboratory to correct deficiencies noted during the inspection.
(b) Inspectors. The Secretary shall establish criteria for the
selection of inspectors to ensure high quality, unbiased, and thorough
inspections. The inspectors shall perform inspections consistent with
the guidance provided by the Secretary. Inspectors shall document the
overall quality of the laboratory's drug testing operation.
(c) Inspection Performance. The laboratory's operation shall be
consistent with good forensic laboratory practice and shall be in
compliance with these Guidelines. It is the laboratory's responsibility
to correct deficiencies identified during the inspection and to have
the knowledge, skill, and expertise to correct deficiencies consistent
with good forensic laboratory practice. Consistent with sections 3.13
and 3.14, deficiencies identified at inspections may be the basis for
suspending or revoking a laboratory's certification.
Section 3.21 Results of Inadequate Performance
Failure of a laboratory to comply with any aspect of these
Guidelines may lead to revocation or suspension of certification as
provided in sections 3.13 and 3.14 of these Guidelines.
Section 3.22 Listing of Certified Laboratories
A Federal Register listing of laboratories certified by HHS will be
updated and published periodically. Laboratories which are in the
applicant stage of HHS certification are not to be considered as
meeting the minimum requirements in these Guidelines. A laboratory is
not certified until HHS has sent the laboratory an HHS letter of
certification.
Subpart D--Procedures for Review of Suspension or Proposed Revocation
of a Certified Laboratory
Section 4.1 Applicability
These procedures apply when:
(a) The Secretary has notified a laboratory in writing that its
certification to perform urine drug testing under these Mandatory
Guidelines for Federal Workplace Drug Testing Programs has been
suspended or that the Secretary proposes to revoke such certification.
(b) The laboratory has, within 30 days of the date of such
notification or within 3 days of the date of such notification when
seeking an expedited review of a suspension, requested in writing an
opportunity for an informal review of the suspension or proposed
revocation.
Section 4.2 Definitions
Appellant: Means the laboratory which has been notified of its
suspension or proposed revocation of its certification to perform urine
drug testing and has requested an informal review thereof.
Respondent: Means the person or persons designated by the Secretary
in implementing these Guidelines (currently the National Laboratory
Certification Program is located in the Division of Workplace Programs,
Substance Abuse and Mental Health Services Administration).
Reviewing Official: Means the person or persons designated by the
Secretary who will review the suspension or proposed revocation. The
reviewing official may be assisted by one or more of his or her
employees or consultants in assessing and weighing the scientific and
technical evidence and other information submitted by the appellant and
respondent on the reasons for the suspension and proposed revocation.
Section 4.3 Limitation on Issues Subject to Review
The scope of review shall be limited to the facts relevant to any
suspension or proposed revocation, the necessary interpretations of
those facts, the Mandatory Guidelines for Federal Workplace Drug
Testing Programs, and other relevant law. The legal validity of the
Mandatory Guidelines shall not be subject to review under these
procedures.
Section 4.4 Specifying Who Represents the Parties
The appellant's request for review shall specify the name, address,
and phone number of the appellant's representative. In its first
written submission to the reviewing official, the respondent shall
specify the name, address, and phone number of the respondent's
representative.
Section 4.5 The Request for Informal Review and the Reviewing
Official's Response
(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 4.6 Abeyance Agreement
Upon mutual agreement of the parties to hold these procedures in
abeyance, the reviewing official will stay these procedures for a
reasonable time while the laboratory attempts to regain compliance with
the Mandatory Guidelines for Federal Workplace Drug Testing Programs or
the parties otherwise attempt to settle the dispute. As part of an
abeyance agreement, the parties can agree to extend the time period for
requesting review of the suspension or proposed revocation. If abeyance
begins after a request for review has been filed, the appellant shall
notify the reviewing official at the end of the abeyance period
advising whether the dispute has been resolved. If the dispute has been
resolved, the request for review will be dismissed. If the dispute has
not been resolved, the review procedures will begin at the point at
which they were interrupted by the abeyance agreement with such
modifications to the procedures as the reviewing official deems
appropriate.
Section 4.7 Preparation of the Review File and Written Argument
The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments.
The procedures for development of the review file and submission of
written argument are:
(a) Appellant's Documents and Brief. Within 15 days after receiving
the acknowledgment of the request for review, the appellant shall
submit to the reviewing official the following (with a copy to the
respondent):
(1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages,
explaining why respondent's decision to suspend or propose revocation
of appellant's certification is wrong (appellant's brief).
(b) Respondent's Documents and Brief. Within 15 days after
receiving a copy of the acknowledgment of the request for review, the
respondent shall submit to the reviewing official the following (with a
copy to the appellant):
(1) A review file containing documents supporting respondent's
decision to suspend or revoke appellant's certification to perform
urine drug 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 submission, or 20 days after receiving acknowledgment of the
request for review, whichever is later, each party may submit a short
reply not to exceed 10 double-spaced pages.
(d) Cooperative Efforts. Whenever feasible, the parties should
attempt to develop a joint review file.
(e) Excessive Documentation. The reviewing official may take any
appropriate step to reduce excessive documentation, including the
return of or refusal to consider documentation found to be irrelevant,
redundant, or unnecessary.
Section 4.8 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 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 4.9 Expedited Procedures for Review of Immediate Suspension
(a) Applicability. When the Secretary notifies a laboratory in
writing that its certification to perform urine drug testing has been
immediately suspended, the appellant may request an expedited review of
the suspension and any proposed revocation. The appellant must submit
this request in writing to the reviewing official within 3 days of the
date the laboratory received notice of the suspension. The request for
review must include a copy of the suspension and any proposed
revocation, a brief statement of why the decision to suspend and
propose revocation is wrong, and the appellant's request for an oral
presentation, if desired. A copy of the request for review must also be
sent to the respondent.
(b) Reviewing Official's Response. As soon as practicable after the
request for review is received, the reviewing official will send an
acknowledgment with a copy to the respondent.
(c) Review File and Briefs. Within 7 days of the date the request
for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
following: (1) a review file containing essential documents relevant to
the review, tabbed, indexed, and organized chronologically, and (2) a
written statement, not to exceed 20 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 pre-hearing conference in
accordance with section 4.8(c) and will conduct the oral presentation
in accordance with the procedures of sections 4.8 (e), (f), and (g).
(e) Written Decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation and
will attempt to issue the decision within 7-10 days of the date of the
oral presentation or within 3 days of the date on which the transcript
is received or the date of the last submission by either party,
whichever is later. All other provisions set forth in section 4.14 will
apply.
(f) Transmission of Written Communications. Because of the
importance of timeliness for these expedited procedures, all written
communications between the parties and between either party and the
reviewing official shall be by facsimile or overnight mail.
Section 4.10 Ex parte Communications
Except for routine administrative and procedural matters, a party
shall not communicate with the reviewing or presiding official without
notice to the other party.
Section 4.11 Transmission of Written Communications by Reviewing
Official and Calculation of Deadlines
(a) Because of the importance of a timely review, the reviewing
official should normally transmit written communications to either
party by facsimile or overnight mail in which case the date of
transmission or day following mailing will be considered the date of
receipt. In the case of communications sent by regular mail, the date
of receipt will be considered 3 days after the date of mailing.
(b) In counting days, include Saturdays, Sundays, and holidays.
However, if a due date falls on a Saturday, Sunday, or Federal holiday,
then the due date is the next Federal working day.
Section 4.12 Authority and Responsibilities of Reviewing Official
In addition to any other authority specified in these procedures,
the reviewing official and the presiding official, with respect to
those authorities involving the oral presentation, shall have the
authority to issue orders; examine witnesses; take all steps necessary
for the conduct of an orderly hearing; rule on requests and motions;
grant extensions of time for good reasons; dismiss for failure to meet
deadlines or other requirements; order the parties to submit relevant
information or witnesses; remand a case for further action by the
respondent; waive or modify these procedures in a specific case,
usually with notice to the parties; reconsider a decision of the
reviewing official where a party promptly alleges a clear error of fact
or law; and to take any other action necessary to resolve disputes in
accordance with the objectives of these procedures.
Section 4.13 Administrative Record
The administrative record of review consists of the review file;
other submissions by the parties; transcripts or other records of any
meetings, conference calls, or oral presentation; evidence submitted at
the oral presentation; and orders and other documents issued by the
reviewing and presiding officials.
Section 4.14 Written Decision
(a) Issuance of Decision. The reviewing official shall issue a
written decision upholding or denying the suspension or proposed
revocation. The decision will set forth the reasons for the decision
and describe the basis therefor in the record. Furthermore, the
reviewing official may remand the matter to the respondent for such
further action as the reviewing official deems appropriate.
(b) Date of Decision. The reviewing official will attempt to issue
his or her decision within 15 days of the date of the oral
presentation, the date on which the transcript is received, or the date
of the last submission by either party, whichever is later. If there is
no oral presentation, the decision will normally be issued within 15
days of the date of receipt of the last reply brief. Once issued, the
reviewing official will immediately communicate the decision to each
party.
(c) Public Notice. If the suspension and proposed revocation are
upheld, the revocation will become effective immediately and the public
will be notified by publication of a notice in the Federal Register. If
the suspension and proposed revocation are denied, the revocation will
not take effect and the suspension will be lifted immediately. Public
notice will be given by publication in the Federal Register.
Section 4.15 Court Review of Final Administrative Action; Exhaustion
of Administrative Remedies
Before any legal action is filed in court challenging the
suspension or proposed revocation, respondent shall exhaust
administrative remedies provided under this subpart, unless otherwise
provided by Federal Law. The reviewing official's decision, under
section 4.9(e) or 4.14(a), constitutes final agency action and is ripe
for judicial review as of the date of the decision.
[FR Doc. 94-13940 Filed 6-8-94; 8:45 am]
BILLING CODE 4160-20-P