PART IV DEPARTMENT OF HEALTH AND HUMAN SERVICES ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG TESTING PROGRAMS; FINAL GUIDELINES; NOTICE

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• Publication Date: April 11, 1988
• Content Type: MISC

STAT
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Monday
April 11, 1988
Part IV
Department of
Health and Human
Services
Alcohol, Drug Abuse, and Mental Health
Administration
Mandatory Guidelines for Federal
Workplace Drug Testing Programs; Final
Guidelines; Notice
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11970 Federal Register / Vol. 53, No. 69 / Monday, April 11, 1988 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Alcohol, Drug Abuse, and Mental
Health Administration
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
AGENCY: National Institute on Drug
Abuse, HHS.
ACTION: Final Guidelines.
SUMMARY: The Department of Health
and Human Services (DHHS) adopts
scientific and technical guidelines for
Federal drug testing programs and
establishes standards for certification of
laboratories engaged in urine drug
testing for Federal agencies.
EFFECTIVE DATE: April 11, 1988.
FOR FURTHER INFORMATION CONTACT:
Maureen Sullivan [phone].
SUPPLEMENTARY INFORMATION: These
Final Guidelines, titled "Mandatory
Guidelines for Federal Workplace Drug
Testing Programs" were developed in
accordance with Executive Order No.
12564 dated September 15, 1986, and
section 503 of Pub. L.100-71, the
Supplemental Appropriations Act for
fiscal year 1987 dated July 11, 1987. The
statute specifically requires that notice
of proposed mandatory guidelines be
published in the Federal Register; that
interested persons be given not less than
60 days to submit written comments;
and that after review and consideration
of written comments, final guidelines be
published which:
I. Establish comprehensive standards
for all aspects of laboratory drug testing
and laboratory procedures to be applied
in carrying out Executive Order No.
12564, including standards which require
the use of the best available technology
for ensuring the full reliability and
accuracy of drug tests and strict
procedures governing the chain of
custody of specimens collected for drug
'testing;
II. Specify the drugs for which Federal
employees may be tested; and
III. Establish appropriate standards
and procedures for periodic review of
laboratories and criteria for certification
and revocation of certification of
laboratories to perform drug testing in
carrying out Executive Order No. 12564.
Subpart A of this document contains
general provisions. Subpart B, titled
"Scientific and Technical
Requirements," responds to the
mandates in items I and II above.
Subpart C, titled "Certification of
Laboratories Engaged in Urine Drug
Testing for Federal Agencies," responds
to Hein III.
In substance, these Final Guidelines
are very similar to those in the Notice of
Proposed Guidelines published on
August 14, 1987 (52 FR 30638). However,
significant editorial and format changes
have been made. The Guidelines have
been edited as a single, integrated
document organized in a more
traditional format with subparts,
numbered sections, and consistent
paragraph designators. Definitions have
been grouped together in Subpart A.
Rather than repeat identical material,
the document contains internal cross-
references, particularly from Subpart C
to Subpart B. This new organizational
approach should add clarity to
presentation of the material and aid the
cross-referencing and citation of
individual sections and paragraphs.
Prior to addressing comments on the
specifics of the scientific and technical
requirements and the certification
program, it is worth noting that a
number of commentors perceived the
laboratory standards in these
Guidelines as redundant, viewing
existing regulations, guidelines, and
certification/licensure mechanisms of
the Medicare and Clinical Laboratory
Improvement Act of 1967 (CLIA)
interstate licensure program?also
administered by DHHS?as sufficient to
provide quality assurance for urine drug
testing laboratories.
The Medicare and CLIA certification
requirements apply to laboratories
conducting a wide range of medical ,
tests, having been designed for any
medical testing laboratory receiving
Medicare/Medicaid reimbursement or
performing testing on specimens in
interstate commerce, respectively.
The laboratory portion of the
President's Drug-Free Federal
Workplace Program can be
distinguished from the Medicare/CLIA
programs by important differences in
policies, procedures, and personnel
arising from standards appropriate to
the application of analytical forensic
toxicology for this program. Unique
distinguishing features include:
? Rigorous chain of custody
procedures for collection of specimens
and for handling specimens during
testing and storage.
? Stringent standards for making the
drug testing site secure, for restricting
access to all but authorized personnel,
and providing an escort for any others
who are authorized to be on the
premises;
? Precise requirements for quality
assurance and performance testing
specific to urine assays for the presence
of illegal drugs; and
? Specific educational and experience
requirements for laboratory personnel to
ensure their competence and credibility
as experts on forensic urine drug testing,
particularly to qualify them as witnesses
in legal proceedings which challenge the
finding of the laboratory.
Medicare and CLIA laboratory
certification procedures do not provide
for quality assurance and performance
testing specific to urine drug testing
laboratories. With few exceptions, the
Medicare and CLIA certification
programs do not have employees
specifically trained in toxicology to
perform the on-site surveys and
evaluations of the laboratories and the
technologies employed in the
laboratories. The Medicare and CLIA
standards do not address issues such as
cutoff limits for drug detection, grading
criteria for the performance testing
programs, blind performance testing
requirements, specifications for the
analytical techniques to be employed,
types of drugs to be detected (including
metabolites), and detailed outcome
measures of performance such as
requiring assays of quality control
samples and a large number of
performance test samples as an initial
and ongoing requirement for
certification.
The need to assure the protection of
individual rights within the context of a
drug testing program?linked to both
employee assistance programs and the
management potential for taking
adverse action against an employee?
makes essential the development of a
separate laboratory certification
program to respond to the unique
requirements of the program mandated
by the President and the Congress.
These Guidelines set standards for such
a certification program.
The Final Guidelines make clear that
they do not apply to drug testing under
any legal authority other than E.O.
12564, including testing of persons under
the jurisdiction of the criminal justice
system, such as arrestees, detainees,
probationers, incarcerated persons, or
parolees (see ? 1.1(e)). The testing of
persons in the criminal justice system is
different than testing under E.O. 12564
for several reasons: (1) The overriding
purpose of the criminal justice system is
to protect community safety through the
apprehension, adjudication, and
punishment of law violators; (2) the
incidence of drug use among those under
the jurisdiction of the criminal justice
system is high; and (3) the legal interests
at issue in the criminal justice system,
including liberty, privacy, and property
interests, are different and, therefore,
are subject to established practices,
constitutional protections, and
evidentiary rules specific to the criminal
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Federal Register / Vol. 53, No. 69 / Monday, April 11, 1988 / Notices
11971
justice system. The Guidelines also do
not apply to military testing of service
personnel or applicants to the military.
Response to Comments
Written comments to the Notice of
Proposed Guidelines published August
14, 1987, were received from
approximately 150 individuals,
organizations, and Federal agencies. All
written comments were reviewed and
taken into consideration in the
preparation of the Final Guidelines. This
section summarizes major comments
and the Department's response to them.
Similar comments are considered
together.
1. Several commenters requested that
the Guidelines require a split sample
technique in which a second sample or a
portion of a sample could be saved for
further testing. Although this possibility
was considered, it is viewed as a
cumbersome-and expensive process
involving the collection of two separate
sets of samples and the retention of one
for an indefinite period of time in some
type of secured long term refrigerated
storage. The use of a split sample was
suggested as a mechanism to overcome
perceived problems arising out of
situations such as sample mixups,
erroneous identification of samples, and
lost samples. The Department does not
agree that split or additional sample
proposal would have any scientific
advantage over the current system nor,
would they increase reliability. In fact,
such a system could increase the risk of
administrative error by doubling the
labeling, initialing, storage, and
accountability requirements.
Furthermore, the Guidelines already
include sufficient safeguards to
eliminate the problems the use of split or
additional samples are thought to
address; e.g., detailed safeguards for ,
labeling and chain of custody of the
urine sample. Accordingly, we do not
project any real scientific, chain of
custody, or reliability benefits sufficient
to justify placing the added requirement
of collection and storage of split
samples of Federal agencies and have
rejected the split sample requirement.
Furthermore, these Guidelines
specifically reject allowing the tested
employee or anyone else from
presenting to the Medical Review
Officer a split sample or private sample
that does not fully comply with these
Guidelines.
2. A number of commentors said that
specific educational and experience
requirements for laboratory directors
and supervisors were too restrictive and
that specific board certifications,
experience, and degree requirements
were also too restrictive and did not
provide any additional quality
assurance. In many cases these
individuals recommended that the
current Medicare and CLIA personnel
standards be used in place of the
standards proposed in the Guidelines.
Other individuals and organizations
stated that the proposed personnel
standards in the Guidelines were not
stringent enough. Some recommended
that specific standards also be adopted
for the personnel performing the tests.
The Department carefully considered
the comments about the personnel
standards proposed in the Guidelines?
most of which came from employees of
clinical laboratories or organizations
representing those employees?from the
perspective of the intent of the
Guidelines. It is not possible to reconcile
the divergent viewpoint represented in
the comments. In this connection it
should be noted that credentialing
standards for laboratory personnel have
been an issue for a number of years in
other laboratory programs administered
by DHHS, as well as among those who
commented on the Notice proposing
these Guidelines.
The laboratory personnel
requirements in the Guidelines are
designated to assure that any individual
responsible for test-review and result-
reporting is qualified to perform the
function and could appear as an expert
witness in a court challenge of the
results. This requires familiarity with a
wide range of material related to test
selection, quality assurance,
interferences with various tests,
maintenance of chain of custody,
documentation of findings,
interpretation of test results, validation
and verfication of test results, and the
ability to testify as an expert in legal
proceedings. The Guidelines set
personnel requirements for the
individuals responsible for day-to-day
management and operation of
laboratories engaged in urine drug
testing for Federal agencies aimed at
ensuring those competencies.
While a consultant may be able to
carry out some of these specialized
functions, it is essential that
comprehensive oversight and control of
the responsibilities cited above be
exercised by those who are directly
responsible on a day-to-day basis for
the laboratory, who are accountable for
the test results, and who may be called
on to consult with the agency for which
testing is performed as well as to appear
at any legal proceeding to defend the
quality of testing in the laboratory.
Therefore, the Guidelines set functional
employee qualification standards which
are essential to the mission of a drug
testing laboratory and require that
laboratory employees meet those
standards. For the purpose of meeting
laboratory personnel requirements, no
provision is made for the use of
consultants who are not involved in the
day-to-day management or operation of
the laboratory.
The Final Guidelines set functional
requirements for individuals engaged in
the day-to-day management and
operation of laboratories engaged in
urine drug testing for Federal agencies.
They do not specify requirements for
other personnel, including employees
who perform the assays, but rather
depend on the ability of those
responsible individuals to select and
oversee properly qualified employees in
each specific laboratory, and they
depend on outcome measures of
laboratory performance such as
performance testing. The individual
responsible for day-to-day laboratory
management is responsible for
determining staffing needs and types of
? personnel required to perform particular
functions in a specific facility. The
individual responsible for day-to-day
laboratory operations is responsible for
supervision of analysts performing drug
tests and related duties. Outcome
measures will provide the responsible
individual with feedback on the
performance of laboratory employees.
Within this framework, the Guidelines
do not establish qualifications for
additional laboratory positions.
The individuals who perform the tests
are a vital part of any laboratory
operation, and there is no intent to
minimize their importance by omitting
qualifications for them. However, by
holding the appropriate laboratory
officials responsible for review and
certification of all test results before
they are sent forward and by relying on
various quality control and quality
assurance measures, performance
testing and on-site evaluations to
provide direct measures of the quality of
testing- the Department expects to
ensure a standard of excellence in drug
testing without setting additional
personnel requirements. This reliance on
the qualifications of the individuals
responsible for the day-to-day
management and operation of urine drug
testing laboratories does not prohibit the
laboratories themselves from setting
additional employees standards which
may include specific credentials,
certifications, licenses, registries, etc.,
for specific functions. -
However, once a laboratory is
certified in accordance with these
Guidelines, laboratory employees whose
functions are prescribed by these
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11972 Federal Register / Vol. 53, No. 69 / Monday, April 11, 1988 / Notices
Guidelines are deemed qualified. These
Guidelines establish the exclusive
standards for qualifying or certifying
these employees involved in urainalysis
testing. Certification of a laboratory
under these Guidelines shall be a
determination that all appropriate
qualification requirements have been
met. Agencies may not establish or
negotiate additional requirements for
these laboratory personnel.
Some commentors felt that references
to director, supervisor of analysts,
certifying officials, and other analysts
did not clearly distinguish between
those positions. Other commentors
criticized the establishment of specific
position titles. We have clarified
laboratory employee functions and
dropped the use of specific position
titles in 2.3 Laboratory Personnel. A
laboratory engaged in urine drug testing
for Federal agencies must have
personnel to perform the following
functions:
? Be responsible for the day-to-day
management and for the scientific and
technical performance of the drug
testing laboratory (even where another
individual has overall responsibility for
an entire multispeciality laboratory).
? Attest to the validity of the
laboratory's test reports. This individual
may be any employee who is qualified
to be responsible for the day-to-day
management or operation of the drug
testing laboratory.
.? Be responsible for the day-to-day
operation of the drug testing laboratory
and for the direct supervision of
analysts performing drug tests and
related duties.
In response to those commentors who
were concerned about the proposed
requirement for a Ph.D. to qualify as a
laboratory director, the Final Guidelines
provide that the individual responsible
for the day-to-day drug testing
laboratory management may have
education and experience in lieu of a
Ph.D. to demonstrate an individual's
scientific qualifications in analytical
forensic toxicology (see 2.3(a)(2)(iii)).
Together with the specific analytical
forensic toxicology experience required
in 2.3(a)(2)(iv), scientific qualifications
may be demonstrated by showing
"training and experience comparable to
a Ph.D. in one of the natural sciences,
such as a medical or scientific degree
and in addition have training and
laboratory or research experience in
biology, chemistry, and pharmacology or
toxicology." This Ph.D. comparability
provision eliminates the utility of the
"grandfather" clause in the proposed
guidelines, a clause which would have
qualified incumbent laboratory directors
who have a graduate degee in the
natural sciences followed by extensive
experience (6 years postgraduate), in
analytical forensic toxicology. Thus, the
Final Guidelines omit the "Grandfather"
clause.
The Ph.D comparability provision,
while not requiring specific research
experience, recognizes research as one
mechanism for demonstrating scientific
competency to be responsible for day-
to-day laboratory management. Lack of
research experience does not disqualify
an individual for that function if he or
she kas other appropriate training or
experience. The Ph.D. comparability
provision also makes explicit that a
medical degree is an acceptable
alternative to the Ph.D. for this purpose,
provided, of course, that the M.D. has
the other requisite training and
experience.
The Final Guidelines do not require
specific board certification for any
laboratory employees. Some
commentors were concerned
particularly that individuals who
supervise analysts would have to be on
the registry of the American Society for
Clinical Pathologists (ASCP). The
proposed guidelines cited the ASCP
registry, but only as an example of the
type of experience and education that
would qualify an individual to oversee
the day-to-day operations of a urine
drug testing laboratory, including the
supervision of analysts.' The important
factors associated with day-to-day
operation and supervision of analysts in
a forensic toxicology laboratory are
captured in 2.3(c). Therefore, the Final
, Guidelines omit any reference to a
registry as a factor in qualifying an
individual for this function. Likewise,
the Guidelines do not refer to a registry'
for the individual responsible for day-to-
day laboratory management or the
individual responsible for attesting to
the validity of the laboratory's test
reports, but rely instead on education
and experience qualifications set out in
2.3 (a) and (b), respectively.
Consistent with editorial revisions
throughout the Final Guidelines,
editorial changes in the personnel
provisions are intended to clarify
specific education, training, and
experience requirements for individuals
to carrying out vital laboratory
functions, to siinplify by adopting
consistent terminology, and to eliminate
the need to compare similar provisions
by using identical provisions when
appropriate. In this regard, the personnel
provisions in Subpart B, which sets out
the scientific and technical
requirements, and in Subpart C, which
sets out the standards for certification of
laboratories, are identical: Subpart C
simply cross-references the personnel
provisions in Subpart B.
3. A number of commentors said that
it was unnecessarily restrictive to
require that the screening and
confirmation tests be performed at the
same site. They believed that the
majority of tests would be negative and
that would reduce the number of
samples that must,be shipped to another
site and would, in turn, prevent sample
mixup and loss.
After having carefully reviewed this
issue, the Department has determined
that both screening and confirmatory
testing must be performed at the same
time (3.5). Although use of separate
screening and confirmation laboratories
may produce adequate results, Pub. L.
100-71 mandates that the Secretary set
standards which "require " * * strict
procedures governing the chain of
custody of specimens collected for drug
testing." Same-site screening and
confirmation is the best method for
maintaining such strict control in the
chain of custody.
Requiring the two tests to be
performed in the same laboratory will
reduce problems inherent in having two
test sites, such as problems maintaining
chain of custody forms at two test sites;
need for having two separate laboratory
forms; possible mix-ups and loss of
samples in transit between sites;
potential delays in reporting results; and
potential for having results reported
only on the basis of an initial screening
test.
Several commentors indicated that if
screening were done on-site this would
reduce the number of subsequent
requirements for rescreening and result '
in fewer samples being sent to another
site.-The Federal work force testing
program does not envision performing
initial tests at the Collection site.
Therefore, considerations concerning
on-site initial screening tests are not
relevant to the current Federal testing
program.
4. Several commenters indicated that
a number of terms were not defined or
that there was no single section defining
terms used in the Notice of Proposed
Guidelines. The Final Guidelines include
a section to centralize the definitions
that appeared in the proposed document
and add definitions to several
previously undefined terms (1.2). The
term "proficiency testing" has been
edited throughout to read "performance
testing" as a more precise reflection of
the nature of the testing with which
these Guidelines are concerned.
5. A number of commenters said that
the cutoff limits for the reporting of
positive results should be higher or
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11973
lower than those proposed (see 52 FR
30641). There also were commentors
who believed that the cutoff limits for
the screening and confirmation tests
should be set at the same level.
The initial immunoassay test cutoff is
established at levels generally similar to
those used by the Department of
Defense and available with commercial
immunoassays. These levels are
consistent with detection of recent drug
use.
The second set of cutoff levels is for
-the gas chromatography/mass
spectrometry (GC/MS) confirmatory
test, chosen so that the specimens
determined to be positive by the first
technique (screening technique) could
be confirmed at a reasonable level of
analytical accuracy.
The Final Guidelines retain all the
proposed initial test cutoff values
(2.4(e)). Confirmation for marijuana is
changed by 5 ng/ml in accordance with
DOD experience. Likewise, confirmation
for amphetamines reflects the cutoff
intended for the notice of proposed
guidelines consistent with DOD levels.
Cutoffs for specific opiates (morphine
and codeine) and amphetamines
(amphetamine and methamphetamine)
are delineated for clarity (2.4(f)).
In finalizing both screening and
confirmation cutoffs, among the matters
considered were prevalence rate; cross-
reactivity; state of the art in drug
detection; and the experience of the
Department of Defense and other groups
in large-volume drug testing programs.
6. Several commentors indicated that
alcohol should be included among the
substances to be tested. The Department
acknowledges the significance of
alcohol and its use as well as its
potential impact on performance in the
workplace. In any event, alcohol is not
an illegal substance, and Executive
Order 12564, which these Guidelines
implement, only authorizes testing for
illicit drugs listed in Schdule I and
Schedule II of the Controlled Substances
Act. However, nothing in these
Guidelines restricts the authority of
agencies to test for alcohol under
authorities other than E.O. 12564.
7. Several commentors indicated that
photo identifications should be required
at the testing site to ensure that the
tested individual is properly identified.
We concur that proper identification
should be provided by the individuals at
the test site to assure that the correct
individual will be tested. Since most
Federal agencies already issue photo
identification cards to their employees
and most employees have a driver's
license with photo identification, it is
not unreasonable to require this form of
identification for individuals presenting
themselves for testing. In cases where
the individual does not have a proper
photo identification, the collection site
person must get the employee's
supervisor, coordinator of the drug
testing program, or any other agency
official who knows the employee to
provide a positive identification
(2.2(f)(2)).
8. Several commentors suggested that
toilets, water faucets, and other sources
of water which could be used as
adulterants should be taped shut or _
sealed to prevent adulteration of the
sample at the collection site. The
Department acknowledges that sources
of water should not be available which
would enable an individual to adulterate
the sample. However, there are also
needs, such as hand washing, for a
relatively convenient source of water.
These Guidelines cannot anticipate the
needs at each collection site and the
hardship which would be imposed by
sealing all sources of water at the site.
However, the proposed and Final
Guidelines do include in 2.2 precautions
in specimen collection procedures to
ensure the integrity and identity of the
specimen. Because we have taken
reasonable steps to ensure that
specimens are not adulterated at the
collection site and because there are
practical reasons for having a
convenient source of water, the Final
Guidelines do not require that all
sources of water be taped or sealed shut
but rather require that precautions be
taken to ensure that unadulterated
specimens are obtained. Among the
precautions included in 2.2(f) to ensure
unadulterated specimens is a
requirement to use a bluing agent so that
the water in the toilet tank and bowl are
colored blue and that there be no other
source of water in the enclosure where
the sampe is given.
9. Several commentors requested
more specific guidelines to define
"unusual behavior" at the urine
collection site which would give reason
to believe a particular individual may
alter or substitute the specimen to be
provided which, in turn, would trigger
the requirement to obtain a second
specimen under direct observation of a
same gender collection site person (see
2.2(f)(16)). The guidelines focus on
whether there is "reason to believe" (see
1.2 for definition) that a sample is
adulterated. Observations of unusual
behavior may bear on whether there is a
"reason to believe" and for that reason
the Guidelines require such
observations to be documented in the
permanent record book. While it may be
desirable to provide specific
descriptions of or guidelines to identify'
"unusual behavior," the Department
cannot foresee or define every
contingency which might occur. Thus,
"unusual behavior" is not further
defined in the Guidelines.
It should be noted, however, that
other indicia of "reason to believe" are
set out in 2.2(f). For example, 2.2(f)(12)
and (13) require a temperature reading
upon collection of the specimen and
indicate those temperatures which
would give rise to a reason to believe
that a specimen may be altered or
substituted. Elsewhere the Guidelines
require the collection site person to
inspect the sample for unusual color or
other signs of contaminants (2.2(f)(14)).
Likewise, if a collection site person sees
unusual behavior which causes him or
her to question the integrity of the
sample such that it leads to a reason to
believe that a particular individual may
alter or substitute the specimen to be
provided, the Guidelines require that
such an observation be noted in writing
in the permanent record book (2.2(f)(8)).
The Final Guidelines also add a
requirement that any "reason to
believe" observation be concurred in by
a higher level supervisor of the
collection site person (2.2(f)(23).
With regard to reason to believe that
a particular individual may alter or
substitute the specimen based on the
specimen's temperature falling outside
the acceptable range, the Final
Guidelines permit an individual to
volunteer to have an oral temperature
reading to provide evidence that the
temperature of the specimen was
consistent with the individual's body
temperature, i.e., an individual's fever
could cause an elevation in the
temperature of the specimen (2.2(f)(13)).
10. Several commentors said that if
the first specimen is subject to a reason
to believe that the particular individual
may alter or substitute the specimen
which would require a second specimen
to be collected, the second specimen
should be collected immediately. The
Department concurs that the second
specimen should be collected as soon as
the need for it is established. Therefore,
the Guidelines provide that the second
specimen shall be collected as soon as
possible whenever there is reason to
believe that the particular individual
may alter or substitute the specimen.
(2.2(f)(16)).
11. Several commentors wanted to
know the basis for the choice of cocaine
and marijuana as the drugs required to
be screened by all agencies. The
requirement that all agencies screen for
cocaine and marijuana was based on
the incidence and prevalence of their
abuse in the general population and the
experiences of the Department of
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Defense and the Department of
Transportation in screening their work
forces. The choice of cocaine and
marijuana as the only substances for
which all agencies must test takes into
account that the predictive value of any
positive diagnostic test is a function of
prevalence in the tested population.
Agencies have also been authorized to
test for phencyclidine, amphetamines,
and opiates because their high incidence
and prevalence in the general
population may warrant testing of
-
particular agency work forces for these
illegal substances (2.1(a)).
Federal agency requests for screening
drugs other than the five authorized in
these Guidelines must be made in
writing to the Secretary. The Secretary
will review the requests on a case-by-
case basis and make a determination of
the acceptability of the plans, cutoff
limits, and testing protocols. The
Secretary's determination shall be
limited to the use of appropriate science
and technology and shall not otherwise
restrict agency authority to test for drugs
included in schedules I and II of the
Controlled Substances Act (2.1(b)).
12. Several commentors wanted
clarification of the procedures for the
Medical Review Officer's (MRO's)
protocols for performing the review
function. They also wanted to know if
individual employees would have an
opportunity to discuss the Medical
Review Officer's findings with him or
her. Procedures for the conduct of the
medical review function, including a
handbook to cover the activities of the
MRO, will be disseminated to all
Federal agencies. While there is
agreement that there should be an
opportunity for some type of medical
interview between the medical review
officer and the employee prior to the
MRO's final decision concerning a
positive test result, a face-to-face
interview may not always be feasible or
possible. For example, they may be in
widely distant geographic areas, and it
may be more practical to arrange a
telephone or teleconference interview
than a direct meeting. Therefore, we
have provided for flexibility in the
mechanism for this communication and
have stated at 2.7(c) that prior to making
a final decision to verify a positive
result, the MRO shall give the individual
employee an opportunity to discuss the
test result with him or her. The Medical
Review Officer shall not, however,
consider the results of urine samples
that are not obtained or processed in
accordance with these Guidelines.
13. Several commentors indicated that
color blindness measurements for
laboratory workers were not necessary
since none of the currently approved
methodologies involved the use of visual
color measurements. The requirement
that laboratories maintain files which
include information on employee color
vision was originally proposed because
some immunoassay systems have color-
coded components and the reliable
manipulation of such systems requires
good color vision. In view of the
methodologies currently approved in the
Guidelines, we agree that an across-the-
board requirement to maintain files on
color blindness is not warranted.
However, the Department has a more
general concern that laboratories
employ individuals who have the ability
to perform any necessary test
procedures. Therefore, the Guidelines
generally provide at 2.3(1) that
laboratory personnel files shall include
results of any tests which establish
employee competency for the position
he or she holds and provide, as a
specific example, a test for color
blindness if the employee will be using
color coded analytical systems.
Similarly, the final Guidelines do not
require that laboratories maintain any
other medical data about employees
unless that data would be necessary to
show the employee's competency to
perform a specific job function.
While these Guidelines do not require
laboratories to maintain general health
or medical information in employee
files, they do not preclude a laboratory
from maintaining such files. What 2.3(f)
is intended to do is require laboratories
to maintain sufficient files to show
employee competency for the position
he or she holds.
14. One commentor requested that the
laboratory notify agency management
officials of a positive result at the same
time the Medical Review Officer is
notified, so that individuals in sensitive
positions or in positions where they
could pose a hazard to other individuals
or the public could be temporarily
removed from these positions, with no
punitive action, until after the Medical
Review Officer had completed the
review process. After considering both
the safety implications and the
employee rights in this type of
notification, the Department has
determined that it would be
inappropriate to report a result before
the Medical Review Officer has the
opportunity to review the facts and
circumstances and make a decision on
the meaning of the test results. In
instances where an agency determines
that it has a need for immediate action
or might have such a need based on its
mission, the agency should develop a
mechanism to expedite the review
process or allow the Medical Review
Officer to require review of the
individual's general fitness to continue
performing a specific function.
Circumventing the review system would
abridge necessary protections for
employees and could result in
prejudging an individual employee's
case (2.7).
15. Several commentors called for a
medical review board instead of a single
Medical Review Officer. A primary
purpose of the Medical Review Officer
position is to provide for the privacy and
confidentiality of the employee's
personal medical history during the
course of reviewing positive test results.
To call together a board which would be
privy to that private information would
increase the exposure of the employee's
medical history to several other
individuals. Furthermore, the
Department views the physician in the
Medical Review Officer's role in
retaining overall responsibility for
reviewing and interpreting positive test
results. There is no restriction on the
Medical Review Officer's seeking advice
on an ad hoc or a continuous basis from
an individual or group if he or she does
not breach employee confidentiality
during the course of the review and
interpretation of the employee's test
results. Because the Department is
vitally concerned with maintaining
confidentiality and privacy and because
the Medical Review Officer is not now
limited in seeking advice from persons
who might have served on the proposed
medical review board (e.g., the drug
program coordinator, employee
assistance program officials, or any
other agency employee), the Guidelines
will continue to call for review by a
single medical officer rather than a
board (2.7).
16. Several commentors requested
that the term "inexpensive
immunoassay" to describe the initial
test be eliminated since cost should be
left to the agency and the laboratory and
techniques other than immunoassay
should be used to test for certain drugs.
The term "inexpensive" was not
intended to set specifications for price;
that is a matter for negotiation between
the laboratory and the contracting
Federal agency. It was meant to serve as
-part of a generic description of the
procedure and purpose of a screening
assay. The term "initial test" has been
revised in 1.2 and does not use the word
"inexpensive".
17. Several commentors indicated that
more specific guidelines should be
issued to assure the security of test
results whether sent by mail or by
electronic means. The Guidelines clarify
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11975
that the laboratory must ensure the
security of data transmission and limit
access to any data transmission,
storage, and retrieval system (2.4(g)(4)).
18. Several commentors stated that
individuals should have access to all
records, data, and documents relating to
their test results and the certification of
the laboratory which performed the
urine drug test. Section 503 of Pub. L.
100-71 provides that 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. In response to this
comment the provisions of the statute
have been set out in a new paragraph at
2.9. The Department anticipate.s that
individuals will be able to obtain-
information about their own test results
from the agency's Medical Review
Officer, employee assistance program,
or other staff person designated by the
agency. Any other relevant information
will be made available in accordance
with the statute.
19. Several laboratories indicated that
the monthly statistical summary
required of the testing laboratories
would be costly and an excessive
burden. The Department views the?
monthly data as necessary for several
purposes including evaluating the
laboratory testing program, gathering
statistical data to evaluate the drug
testing program's effectiveness, and
providing demographic data on drug use
by the Federal work force. The ,
information will assist in making
decisions concerning changes in policy
or program implementation and
identifying specific programs for
attention. The Department anticipates
that the cost of providing the data will -
be built into the contract the laboratory
signs with each agency. Therefore,
provision of the data will be a function
for which the laboratory is duly
compensated, not an undue cost or
burden (2.4(g)(6)).
20. One commentor indicated that
samples for which the initials on the
specimen bottle and in the permanent
record book do not match should not be
rejected automatically, since that would
provide an opportunity for individuals to
attempt to have their specimens rejected
when they knew the specimens would
test positive. We have considered the
fact that individuals might deliberately
alter their initials in an attempt to have
their samples rejected. However, we do
not anticipate that samples should be-
thrown out solely on the basis of
unmatched initials on the specimen
bottle and in the permanent record
book. If unmatched initials provide
reason to believe that a particular
individual may have altered or
substituted the specimen, both the-
proposed and the Final Guidelines
provide that the specimen be forwarded
for testing along with a second sample
obtained as soon as possible after
reason to believe the individual may
have altered or substituted the specimen
is established (2.2(f) (15) and (16)). The
Final Guidelines ensure the
identification of the person from whom-
the specimen is collected through the
requirement for photo identification (see
2.2(f)(2)). In addition, a principal
responsibility of the collection site-
person is to gather and verify
information on site and to detect any-
problems with the identification of the
specimen. Until experience in the
program indicates that misidentified
samples arising out of unmatched
initials is a significant problem, the
Guidelines will require that the
individual initial the specimen bottle
and sign the permanent record book to-
certify that the identified sample is the
one collected from the individual.
21. One commentor asked if the
Guidelines apply to Federal contract
employees. The Guidelines do not apply
to Federal contract employees; however,
any agency may require a contractor to
test its own employees following the
procedures in the Guidelines by making
the requirement a term or condition of
the contract.
22. One commentor indicated that the
proposed requirement for signing a
procedure manual on an annual basis-
was in conflict with current DHHS
efforts in the Medicare and CLIA
programs to delete the annual signing
requirement and replace it with a
requirement that the manual be signed
initially and whenever changes are
made. We concur with the comment that
the important factor is that the manual
be signed by the responsible individual
whenever a procedure is instituted or
changed or whenever a new individual
becomes responsible for the day-to-day
management of the drug testing
laboratory. The Guidelines do not
require annual signing of the procedure
manual.
The on-site review of the laboratory
together with the assignment to an
individual of the overall responsibility
for the testing will assure that the-
procedures in the manual are current
and followed. If the procedures in the
manual are not current or followed, it is-
an indication that the responsible-
individual is not performing the
oversight function appropriate to the
management of the laboratory.
We have also clarified, that the
individual responsible. for the day-to-
day management of the drug testing-
laboratory is the individual responsible
for signing the manual. (2.3(a)(5)). It is
not appropriate for the individual who is
responsible for day-to-day operations
and: supervision of analysts or for any
other individual to be delegated this
responsibility since the manual is the.
vehicle for selection of methodologies,
and the approval of methodologies is a
principal reason for requiring the
individual responsible for day-to-day
management of the drug testing
laboratory to possess detailed -
knowledge-in the area of toxicology.
23. One commentor indicated that
laboratories should be notified when
they may discard samples. We have
reviewed the comment and concur that
the agency should be able to notify the
laboratOry in writing if it determines
that samples no- longer need to be
retained because no further-action is
pending which will require the.samples.
Both 2.4(g)(8) and 2.4(h) permit the
agency to instruct or authorize storage
for less. than the period for which there
is a storage requirement.
24. Several commentors indicated a
discrepancy in the periods for
maintenance of frozen samples in
storage-1 year in the proposed
guidelines and 6 months in Appendix 13-
to. the proposed guidelines. The time
interval in the, appendix was in error.
The Final Guidelines consistently call
for frozen storage of confirmed positive-
samples for 1 year (2.4(h)). Note-that the
Appendix has been omitted, although
pertinent provisions from it are .
integrated in the Final Guidelines..
25. In response to concern that
specimens may be misused to test for
physiological states other than drug-
abuse (e.g., pregnancy), a provision has
been added to the Final Guidelines to
prohibit the specimens collected for
urine drug testing from.being:used for
any other types of analyses unless
otherwise. authorized by law. It is-
important to the integrity and goals of
the President's program to achieve a
drug-free work place that any specimens
collected for that purpose not be
analyzed or used for inappropriate
purposes. To ensure that outcome, a
paragraph has been added at 2.1(c)
stating that specimens may be used only
to test for those. drugs included in the
agency drug-free-workplace plan and
may not be used to conduct any other
analysis or test unless the agency is-
authorized by law to perform other
analyses.
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MMINIENIMINIMMI NIP
26. One commentor indicated that the
individuals permitted in the "secure test
area" should include routine service and
maintenance personnel and that these
individuals should not require escorts.
While providing escorts for all
employees, including service and
maintenance personnel, may cause
considerable inconvenience, unless the
facilities are secured at night and all
materials locked away with no possible
access, there is always the potential for
tampering with the specimens or test
results. The Guidelines make no
provision for routine service and
maintenance personnel to enter the
secure test area without an escort
(2.4(a)).
27. One commentor suggested that
collection personnel be provided with
gloves or other protective garments to
prevent contamination of the personnel
from the urine. The Department
encourages a protected work
environment for collection site
personnel, including any necessary
protective garments. Various State and
Federal guidelines provide for the health
and safety of employees. Collection
agents are expected to be aware of and
to comply with such provisions to
safeguard their own health and the
health and safety of employees.
However, no requirement was added to
the Guidelines to require provision of
protective garments to collection
personnel.
28. One commentor recommended that
DHHS use its own personnel to
investigate any quality assurance
problems which arise with a particular
laboratory instead of requiring each
agency to have its own investigative
staff. Other commentors viewed
agencies as lacking the in-house
expertise to perform this analysis, and it
was not clear to them who in each
agency should carry out such an
investigation. The Final Guidelines
reflect a decision that the Secretary
(which might include a DHHS contractor
or DHHS recognized certification
program) shall assume this investigative
responsibility and carry out the related
coordinating activities. A coordinating
mechanism within the National Institute
on Drug Abuse (NIDA) will ensure that
all agencies are aware of problems with
any given laboratory. Conducting
investigations and coordinating findings
through DHHS will eliminate the need to
provide a more complex mechanism for
agencies to notify each other about
laboratory performance (2.5(d)(4)).
29. Several commentors Laid that the
format for reporting employee drug test
results was not sufficiently clear and
that while there was a discussion of the
mechanism for reporting performance
test results, there was no comparable
discussion on reporting employee test
results. 2.4(g), Reporting Results,
clarifies that laboratories will not report
quantitation on test results but will
report whether a result is positive or
negative and that this is indicative of a
result being above or below a particular
cutoff limit. A negative report does not
signify the absence of a particular drug
or metabolite but only that the particular
*drugs or metabolites screened for were
not detected at a specified concentration
(i.e., cutoff level).
Quantitation will not be reported to
the agency for confirmed positive
reports, in order to provide for identical
reporting by the laboratory of
performance test specimens and
employee specimens. However,
quantitation may be obtained by the
Medical Review Officer on request from
the laboratory. In the case of the
opiates, we have indicated that the
particular opiate to be reported will
depend on the amounts of morphine and
codeine detected by the confirmation
test. We have included the reporting
scheme in the scientific and technical
requirements as well as in the revision
of the requirements for reporting
performance test results (2.4(g), 3.11
which cross-references 2.4(g), and
3.17(f)).
30. The Final Guidelines attempt to
clarify the purpose of the certification
program, since the comments reflect
uncertainty as to what certification
implies and what would be surveyed in
the process of certifying a laboratory.
Subpart C permits DHHS to recognize
certification programs run by other
organizations. These programs may be
private accrediting organizations that
are recognized by the Secretary to
determine whether laboratories meet the
Guideline requirements. Any laboratory
accredited by these organizations in
accordance with these Guidelines is
deemed to be a certified laboratory, thus
making it eligible to perform urine drug
testing for Federal agencies. DHHS is
contemplating publishing standards for
recognition of private accrediting
organizations in the near future.
The provisions of Subpart C apply to
any laboratory which has or seeks a
contract to perform, or otherwise
performs urine drug testing for Federal
agencies under a drug testing program
conducted under E.O. 12564. Only
certified laboratories will be authorized
to perform urine drug testing for Federal
agencies. However, in order to create a
pool of qualified laboratories to bid on
agency contracts to perform such
testing, the Secretary may certify
laboratories as contract eligible that
meet the requirements of Subpart C.
This pool of qualified laboratories will
lead to competitive pricing and better
services for Federal agencies.
The certification process will be
limited to the five classes of drugs
(2.1)(a) (1) and (2)) and the methods (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 herein. The Guidelines require
that a certified laboratory must inform
its non-Federal clientele when testing
procedures are to be those specified by
these Guidelines. Non-Federal
purchasers are free to bargain with a
certified laboratory for any standards
they may deem appropriate.
31. The Guidelines delete the checklist
in Appendix B of the proposed
certification standards. The checklist
was initially intended to provide a tool
for the inspectors of laboratories to use
in conducting their on-site inspections
and to enumerate the standards
contained in the section on the
certification program published in the
Federal Register. However, there was
confusion regarding whether the
checklist represented an additional or
different set of requirements. Relevant
portions of the checklist have been
integrated in the Guidelines: The
checklist itself will be revised to
correspond to the requirements in the
Guidelines and will be made available
to laboratories by the DHHS-recognized
certification program(s).
32. Several commentors asked that the
specific criteria used by the group(s)
who will perform the certification
function for the Department be detailed
in these Guidelines. In response, the
Guidelines include a new section
explaining how performance testing will
be evaluated for initial certification as
well as for previously certified
laboratories (3.19 (a) and (b)). All major
aspects of the certification program,
including personnel and quality
assurance and quality control
requirements, are included in Subpart C
of these Guidelines. With the addition of
3.19 (a) and (b), we believe the
Guidelines are appropriately specific
and there is no need to include
additional detail in the Guidelines
concerning the certification process.
33. Some commentors indicated that
the number of blind performance test
samples required to be run by the
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11977
laboratories (i.e., 1,000) for initial
certification and (i.e., 250 per quarter)
for continuing certification was
excessive and would be too costly. The
commentors also indicated that it was
not clear whether the laboratory or the
submitting organization would bear the
cost of the samples and if it were
necessary for each submitting
organization to submit this number of
samples to each laboratory. In response
to the comments, we have revised this
section to indicate that each agency
shall submit blind performance test
specimens to each laboratory it
contracts with in the amount of at least
50 percent of the total number of
samples submitted (up to a maximum of
500 samples) during the initial 90-day
period of program implementation and a
minimum of 10 percent of all samples (to
a maximum of 250) submitted per
quarter thereafter. The Final Guidelines
also clarify that approximately 80
percent of the blind performance test
samples are to be blank (i.e., certified to
be drug free) and the remaining samples
are to be positives (2.52(cfl(3) and 3.7).
The cost of the blind performance test
samples will be borne by the submitting
agency.
34. Several commentors requested
corrective action and reanalysis of
previously run specimens in the case of
discovered laboratory administrative
error. They also requested that the union
and all employees who tested positive
be notified of the error in writing. The
recommendation was to notify all
employees with positive results who
were tested between the time of
resolution of the error and the preceding
cycle of correct results. In the case of an
administrative error, there are no plans
to automatically have all specimens
retested. The decision on whether to
retest will be dependent on the type and
extent of the error. For example, if a
single employee's test results were
transcribed incorrectly, nothing would
be gained from rerunning all the
specimens in a given timeframe since it
would not change the values, attributed
to the specimens. If an error occurred
such that it was not clear whose
specimen was being tested and which
results belonged to which specimen, this
would require retesting of the group for
which the values where uncertain and
for those analytes for which the values
were uncertain. However, it would be
unproductive to require the automatic
retesting of all specimens for any error.
Agency policy under which
individuals are notified of errors will
depend on the circumstances: If the
error is corrected before the results are
reported to any employee, it is
unnecessary to notify each employee-
that an error was discovered and
subsequently corrected. If a discovered-
error affects an employee after results
have been reported, the Medical Review
Officer will be notified and the affected
employee will also be notified through
the appropriate mechanisms established
by each agency.
35. Several commentors indicated that
the laboratory contract should be
suspended if the laboratory committed
the same administrative error twice and
that the designated reviewing official's
discretion to continue a laboratory in-
the program should be more limited or
more clearly defined. The Department
has reviewed the comments concerning
-the point at which a contract should be
suspended because of an administrative
error and submits that the current policy
allows sufficient flexibility and
-protection to the employee and the
laboratory and that it should not be
changed. There are no circumstances
under which administrative or human
error can be entirely eliminated. The
major assurance of accuracy in the-
overall program is the series of checks-
to assure that such errors are detected
and corrected. The reviewing official
has been given the necessary flexibility
and definition of authority to make the
appropriate technical and program-
judgments concerning the status of each
facility and to assure that reasonable-
and responsible decisions are made.
Nevertheless, the Final Guidelines add
several features to put greater
responsibility on the individual
responsible for the day-to-day
management of the drug testing
laboratory for the quality assurance
program and ensuring that quality
assurance procedures are followed.
These Guidelines also more clearly
describe what constitutes a quality
assurance and quality control program
to detect and correct errors (2.5) and a
program of performance testing (3.17-
3.19).
We have chosen not to include a
formal definition of administrative or
clerical error in the Guidelines as was
suggested. Among the errors to which
either term refers are incorrect
transcription of test results or errors in
recording specimen identities, i.e., errors
that are not due to the analysis of the
specimens with regard to analytical
accuracy, precision, interpretation of
test results, or calibration of equipment.
Clearly analytical errors are not
considered "administrative." While it is
not possible to write guidelines that
cover every possibility, at no place in
these Guidelines are incorrect analyses
considered administrative error but
- rather are consistently treated as a basis
for prompt action against the laboratory
by the responsible officials.
36. Several commentors indicated that
laboratory inspections should be
conducted unannounced and that union
representatives should be permitted to
accompany the inspection teams. The
Guidelines neither require nor prohibit
unannounced inspections. They
contemplate that agencies will, through
their contract with a certified
laboratory, specify the terms and
conditions of inspections in accordance
with the requirements in the Guidelines.
If individuals other than members of the
inspection team were entitled to
accompany the inspectors, it would
significantly complicate coordination
and conduct of the inspections. More
importantly, we see additional
participants in the inspection as
inhibiting the laboratory's freedom to
provide complete cooperation out of
concern for protecting proprietary
information. While some laboratories
may be willing to provide escorted tours
to union officials to illustrate the quality
of their processes, the Guidelines do not
establith a right for union officials to
participate in inspections incident to
certification of laboratories under these
Guidelines 12.4(11 and 3.20).
37. One cornmentor indicated that any
of the five general factors indicated in
3.13(b) as a possible basis for revocation
in the certification requirements should
inevitably lead to revocation without
any further determination that the _
revocation is "necessary." The issue of
how many potential grounds for
revocation are necessary to determine
that revocation of a laboratory is
necessary was considered when the list
of grounds was developed. The
Department views the nature and
seriousness of the facts concerning the
grounds for revocation as factors to be
weighed in deciding to revoke a
certification. It is difficult and would not
contribute to the maintenance of high
quality testing standards to develop a
priori statements about the magnitude of
an offense or a combination of
violations and to formulate necessary
actions in response to each possible
violation of the provisions of 3.13. All
five factors listed are considered serious
violations of these certification criteria,
and it is not necessary for more than
one factor to be violated to take action
against a laboratory. However, the-
Guidelines retain the flexibility for the
? Secretary to determine that revocation
is necessary to ensure the full reliability
and accuracy of drug tests and the
accurate reporting of test results
(3.13(b)).
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38. Several commentors indicated that
when a laboratory fails a performance
test it would be inordinately expensive
(especially in high volume laboratories)
to retest all samples since the last
performance test the laboratory passed
and to test for all analytes rather than
for the one analyte for which the
laboratory had failed performance
testing. The reason for retesting all
positive samples since the last
successful performance test is that the
quality of the test results has been
called into question. In order to verify
test results for the period between a
successful performance testing and the
failed testing, it will be necessary to
retest all specimens tested positive for
which an incorrect analysis may have
been performed. It is not routinely
necessary to retest for all analytes but
only for those on which the laboratory
failed its performance testing. However,
the laboratory may be required to test
for other analytes if the performance
test failure reflects broader problems
(3.19(b)(1)(v)).
39. Several commentors indicated that
performance testing every other month
is excessive and that quarterly testing
would be sufficient to assure the quality
of the testing. Others indicated that
fewer challenges per shipment would be
adequate to determine the quality of the
laboratory. Still other individuals stated
that the limits for acceptable
performance on performance tests were
too high in terms of the concentrations
used. Others said that the grading
criterion of failure based on one false
positive was too strict. We have
reviewed the concerns that bimonthly
performance testing is excessive and
maintain that the use of performance
tests is a valid outcome measure of
performance and will assist in the
evaluation of quality of the laboratory
performance. If future experience with
the program indicates that a lesser
frequency will assure the quality of the
testing, we will revise the frequency and
the number of specimens accordingly.
Relatively frequent performance testing
reduces the time period for which
samples may have to be rerun in case of
performance test failure (3.17).
To the extent that the Guidelines
amended the cutoff limits for drugs for
which employees may be tested for
consistency with those currently used
by the Department of Defense, it was
necessary to modify the values of the
various performance test samples
correspondingly. We have clarified that
a laboratory must achieve an overall
grade of 90 percent on the first three
cumulative shipments of performance
tests and that if such a poor grade is
obtained on the first or second challenge
that a laboratory cannot achieve an
overall grade of 90 percent on the three
successive performance test challenges,
then the laboratory will fail at that
point. Laboratories already in the
program must achieve a grade of 90
percent on each shipment of
performance testing. It was unclear in
the proposed notice whether the grade
of 90 percent referred only to the
positive samples. We intend that the 90
percent refer only to positive samples,
since any negative sample giving rise to
a false positive would be the basis for
automatic disqualification for initial
certification. It also was unclear
whether the 90 percent referred to
performance on all drugs in the
shipment, not on each drug tested. We
have clarified the Guidelines in both
these areas. We adopted a strategy
requiring 90 percent for all drugs
because it is not always feasible to have
a sufficient number of challenges for
each drug in each shipment to avoid a
single failure on a drug leading to a
failing grade of less than 90 percent
(3.19(b)(2)).
40. Some commentors thought
laboratories should be required to notify
all users if their certification was
revoked. Since the requirements in these
Guidelines only apply to certification for
Federal drug testing programs, it would
be inappropriate to require laboratories
to notify non-Federal users of revocation
or suspension.
41. We have not adopted the
recommendations that any changes in
the Guidelines be accomplished by
publication of a notice, review of
comments, and then publication of final
changes. (Section 503 of Pub. L. 100-71
required such steps for initial
development of these Guidelines.) The
time required for this process would not
permit rapid adjustment to changes in
technology. Accordingly, the Guidelines
retain the provision permitting final
revision of these Guidelines by
publication of a notice in the Federal
Register (1.3).
42. One commentor suggested that
only positive tests be certified as to
accuracy and validity before reporting.
Although this practice would reduce
paperwork, it does not reflect the
potential impact on public safety of false
negative results. The Guidelines
continue to require that negative results
be reviewed carefully and attested to by
the proper officials in the same way as
positive results (2.4(g)).
43. One commentor wanted us to
specify the time the individual
responsible for day-to-day management
must spend in the laboratory. No change
has been made in the Guidelines. The
critical factor here is the quality of the
work and not the absolute number of
hours spent. The Department views the
use of outcome measures of
performance for the laboratory as more
effective in assuring accurate and
reliable test results than attempting to
set hours for the responsible individual
particularly in view of the qualifications
which the Guidelines set for the
individual responsible for day-to-day
management of the drug testing
laboratory.
44. The criterion for retesting
specimens (i.e., those being challenged)
was clarified to indicate that in
performing a retest the laboratory must
confirm the presence of the substance
but does not have to confirm that it is
present above the cutoff level. Since the
drug levels may deteriorate with time, it
is only necessary to show that the drug
(or its metabolite) is present to
reconfirm its presence during retesting
(2.4(i)).
45. A provision has been added to the
Guidelines requiring that laboratories be
capable of testing for at least the five
classes of drugs specified in the
Guidelines. The laboratories are being
required to possess the flexibility to test
for all the specified classes of drugs in
order to assure that they have a
sufficient range of capabilities to
respond to the agencies' testing
protocols, including testing for
reasonable suspicion (3.4).
46. Several Federal agencies
commenting on the proposed guidelines
sought waivers of particular provisions
in reliance on the original Scientific and
Technical Guidelines issued February
13, 1987, which provided that, "Agencies
may not deviate from the provisions of
these Guidelines without the written
approval of the Secretary, Health and
Human Services or his designee." This
waiver statement, which was not
explicit in the proposed guidelines, is
included at 1.1(f). Absent such a waiver,
these Guidelines represent the exclusive
standard for urinalysis testing and
agencies may not deviate from these
established procedures.
In order to clarify that the laboratory
certification standards apply to
laboratories which have or seek
certification to perform urine drug
testing for Federal agencies, a paragraph
was added to the applicability section,
1.1(c), stating that Subpart C of the
Guidelines applies to any laboratory
which has or seeks such certification
and that certification is required to
perform urine drug testing for Federal
agencies.
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11979
Section 4(d) of E.O. 12564 states that
"agencies shall conduct their drug
testing programs in accordance with
* " * (scientific and technical]
guidelines" promulgated by the
Secretary of Health and Human
Services. Since the Guidelines impose
mandatory requirements on a
Government-wide basis, they are
exempt from the duty to bargain under
section 7117(a)(1) of the Federal Service
Labor-Management Relations Statute.
Information Collection Requirements
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 3.7, 3.8, 3.10, 3.11, 3.17, and
3.20. To facilitate ease of use and
uniform reporting, standard forms have
been developed for chain of custody
records and the permanent record books
as referenced in 2.2(c) and (f).
The information collection and
recordkeeping requirements contained
in these Final Guidelines have been
approved by the Office of Management
and Budget under section 3504(h) of the
Paperwork Reduction Act of 1980 and
have been assigned control number
09300130, approved through April 30,
1989.
Date: April 1, 1988.
Robert E. Windom,
Assistant Secretary for Health.
Date: April 1, 1988.
Otis R. Bowen,
Secretary.
These Final Mandatory Guidelines are
hereby adopted in accordance with
Executive Order 12564 and section 503
of Pub. L. 100-71 as set forth below:
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 Interim Certification Procedures.
2.7 Reporting and Review of Results.
2.8 Protection of Employee Records.
2.9 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: Opportunity for Review.
3.16 Recertification.
3.17 Performance Test Requirement for
Certification.
3.18 Performance Test Specimen
Composition.
3.19 Evaluation of Performance Testing.
3.20 Inspections.
3.21 Results of Inadequate Performance.
Authority: E.O. 12564 and sec. 503 of Pub. L.
100-71.
Subpart A-General
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) Any agency or component of an
agency with a drug testing program in
existence as of September 15, 1986, and
the Departments of Transportation and
Energy shall take such action as may be
necessary to ensure that the agency is
brought into compliance with these
Guidelines no later than 90 days after
they take effect, except that any judicial
challenge that affects these Guidelines
shall not affect drug testing programs
subject to this paragraph.
(c) Except as provided in 2.6, 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.
(d) 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.
(e) 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.
(f) 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.
1.2 Definitions.
For purposes of these Guidelines the
following definitions are adapted:
Aliquot A portion of a specimen used
for testing.
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 approved agency chain
of custody form be used from time of
collection to receipt by the laboratory
and that upon receipt of the laboratory
an appropriate laboratory chain of
custody form(s) account for the sample
or sample aliquots within the laboratory.
Chain of custody forms shall, at a
minimum, include an entry documenting
date and purpose each time a specimen
or aliquot 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
intitial test in order to ensure reliability
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and accuracy. (At this time gas
chromatography/mass spectrometry
(GC/MS) is the only authorized
confirmation method for cocaine,
marijuana, opiates, amphetamines, and
phencyclidine.)
Initial Test (also known as Screening
Test) An immunossay screen to
eliminate "negative" urine specimens
from further consideration.
Medical Review Officer 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.
Permanent Record Book A
permanently bound book in which
identifying data on each specimen
collected at a collection site are
permanently recorded in the sequence of
collection.
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.
Secretary The Secretary of Health and
Human Services or the Secretary's
designee. The Secretary's designee may
be contractor or other recognized
organization which acts on behalf of the
Secretary in implementing these
Guidelines.
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
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, Pub.
L. 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.
(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.
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 individual 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 in
the record book can identify the
individual 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 an individual arrives at the
collection site, the collection site person
shall request the individual to present
photo identification. If the individual
does not have proper photo
identification, the collection site person
shall contact the supervisor of the
individual, the coordinator of the drug
testing program, or any other agency
official who can positively identify the
individual. If the individual's identity
cannot be established, the collection site
person shall not proceed with the
collection.
(3) If. the individual 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 individual 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
individual'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 individual may retain his
or her wallet.
(5) The individual shall be instructed
to wash and dry his or her hands prior
to urination.
(6) After washing hands, the
individual 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
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any other materials which could be used
to adulterate the specimen.
(7) The individual 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 in the permanent record
book.
(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 collection site
person of the same gender as the
individual shall accompany the
individual 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 individual 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 individual 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 individual, the collection site person
shall determine that it contains at least
60 milliliters of urine. If there is less than
60 milliliters of urine in the container,
additional urine shall be collected in a
separate container to reach a total of 60
milliliters. (The temperature of the
partial specimen in each separate
container shall be measured in
accordance with paragraph (f)(12) of this
section, and the partial specimens shall
be combined in one container.) The
individual may be given a reasonable
amount of liquid to drink for this
purpose (e.g., a glass of water). If the
individual fails for any reason to
provide 60 milliliters of urine, the
collection site person shall contact the
appropriate authority to obtain guidance
on the action to be taken.
(11) After the specimen has been
provided and submitted to the collection
site person, the individual shall be
allowed to wash his or her hands.
(12) Immediately after the specimen is
collected, the collection site person shall
measure 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 a specimen
is outside the range of 32.5*-37.7?C/
90.5*-99.8T, that is a reason to believe
that the individual may have altered or
substituted the specimen, and another
specimen shall be collected under direct
observation of a same gender collection
site person and both specimens shall be
forwarded to the laboratory for testing.
An individual may volunteer to have his
or her oral temperature taken to provide
evidence to counter the reason to
believe the individual 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 in the permanent record
book.
(15) All specimens suspected of being
adulterated shall be forwarded to the
laboratory for testing.
(16) Whenever there is reason to
believe that a particular individual may
alter or substitute the specimen to be
provided, a second specimen shall be
obtained as soon as possible under the
direct observation of a same gender
collection site person.
(17) Both the individual being tested
and the collection site person shall keep
the specimen in view at all times prior to
its being sealed and labeled. If the
specimen is transferred to a second
bottle, the collection site person shall
request the individual to observe the
transfer of the specimen and the
placement of the tamperproof seal over
the bottle cap and down the sides of the
bottle.
(18) The collection site person and the
individual 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 bottle an
identification label which contains the
date, the individual's specimen number,
and any other identifying information
provided or required by the agency.
(20) The individual 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 in the permanent record book all
information identifying the specimen.
The collection site person shall sign the
permanent record book next to the
identifying information.
(22) The individual shall be asked to
read and sign a statement in the
permanent record book certifying that
the specimen identified as having been
collected from him or her is in fact that
specimen he or she provided.
(23) A higher level supervisor shall
review and concur in advance with any
decision by a collection site person to
obtain a specimen under the direct
observation of a same gender collection
site person based on a reason to believe
that the individual may alter or
substitute the specimen to be provided.
(24) The collection site person shall
complete the chain of custody form.
(25) The urine specimen and chain of
custody form are now ready for
shipment. lithe 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 specimen
and 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. Lithe 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 individual's
specimen bottle within sight both before
and after the individual has urinated.
After the specimen is collected, it shall
be properly sealed and labeled. An
approved chain of custody form shall be
used for maintaining control and
accountability of each specimen from
the point of collection to final
disposition of the specimen. The date
and purpose shall be documented on an
approved 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) 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. On the tape sealing the
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container, the collection site supervisor
shall sign and enter the date specimens
were sealed in the containers for
shipment. The collection site personnel
shall ensure that the chain of custody
documentation is attached to each
container sealed for shipment to the
drug testing laboratory.
2.3 Laboratory Personnel.
(a) Day-to-Day Management.
(1) The laboratory shall have a
qualified individual 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 multispecialty 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 individual 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 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 analysisf
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 tests
results provided are accurateand
reliable.
(b) Test Validation. The laboratory's
urine drug testing facility shall have a
qualified individual(s) 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 more than one
person to perform this function. This
individual(s) may be any employee who
is qualified to be responsible for day-to-
day management or operation of the
drug testing laboratory.
(c) Day-to-Day Operations and
Supervision of Analysts. The
laboratory's urine drug testing facility
shall have an individual 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.
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, all authorized
visitors and maintenance and service
personnel shall be escorted at all times.
Documentation of individuals accessing
these areas, dates, and time of entry and
purpose of entry must be maintained.
(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.
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(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
agency's chain of custody forms
attached to the shipment shall be
immediately reported to the agency and
shall be noted on the laboratory's chain
of custody form 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 the
laboratory's chain of custody forms
shall be used by laboratory personnel
for conducting initial and confirmatory
tests.
(c) Short-Term Refrigerated Storage.
Specimens that do not receive an initial
test within 7 days of arrival at the
laboratory shall be placed in secure
refrigeration units. Temperatures shall
not exceed 6?C. 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 contain an
appropriate number of standards for
calibrating the instrumentation and a
minimum of 10 percent controls. Both
quality control and blind performance
test samples shall appear as ordinary
samples to laboratory analysts.
(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
100
Cocaine metabolites
300
Opiate metabolites
1 300
Phencyclidine
25
Amphetamines
1,000
' 25ng/m1 if immunoassay specific for free
mor-
phine.
(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.
Initial test methods and testing levels for
other drugs shall be submitted in writing
by the agency for the written approval
of the Secretary.
(f) Confirmatory Test. (1) All
specimens identified as positive on the
initial test shall be confirmed using gas
chromatography/mass spectrometry
(GC/MS) techniques at the cutoff values
listed in this paragraph for each drug.
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 "greater than
highest standard curve value."
Marijuana metabolite 1
Cocaine metabolite 2
Opiates:
Confirma-
tory test
level (ng/
ml)
15
150
Morphine
*
300
Codeine
*
300
Phencyclidine
25
Amphetamines:
Amphetamine
500
Methamphetamine
500
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid.
2 Benzoylecgonine.
(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.
Confirmatory test methods and testing
levels for other drugs shall be submitted
in writing by the agency for the written
approval of the Secretary.
(g) Reporting Results. (1) The
laboratory shall report test results to the
agency's Medical Review Officer 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 the
responsible individual. 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. The results
(positive and negative) for all specimens
submitted at the same time to the
laboratory shall be reported back to the
Medical Review Officer at the same
time.
(2) 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.
(3) The Medical Review Officer may
request from the laboratory and the
laboratory shall provide quantitation of
test results. The Medical Review Officer
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 Medical Review Officer 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 Medical Review Officer a certified
copy of the original chain of custody
form signed by the individual
responsible for day-to-day management
of the drug testing laboratory or the
individual responsible for attesting to
the validity of the test reports.
(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:
(i) Initial Testing:
(A) Number of specimens received;
(B) Number of specimens reported out;
and
(C) Number of specimens screened
positive for:
Marijuana metabolites
Cocaine metabolites
Opiate metabolites
Phencyclidine
Amphetamines
(ii) ConfirmatoryTesting:
(A) Number of specimens feceived for
confirmation;
(B) Number of specimens confirmed
positive for:
Marijuana metabolite
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Cocaine metabolite
Morphine, codeine
Phencliclidine
Amphetamine
Methamphetamine
(7) The laboratory shall make
available copies of all analytical results
for Federal drug testing programs when
requested by DHHS 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 ?C or less) ensures
that positive urine specimens will be
available for any necessary retest
during administrative or disciplinary
proceedings. 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, but 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 Specimens. 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.
(I) Inspections. The Secretary, any
Federal agency utilizing the laboratory,
or any organization performing
laboratory certification on behalf of the
Secretary shall 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 shall
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 DHHS 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 documents;
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) Standards and Controls.
Laboratory standards shall be prepared
with pure drug standards which are
properly labeled as to content and
concentration. The standards shall be
labeled with the following dates: when
received; when prepared or opened;
when placed in services; 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 trouble shooting
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
accceptable 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.
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,
and validation of analytical procedures.
Quality assurance procedures shall be
designed, implemented, and reviewed to
monitor the conduct of each step of the
process of testing for drugs.
(b) Laboratory Quality Control
Requirements for Initial Tests. Each
analytical run of specimens to be
screened shall include:
(1) Urine specimens certified to
contain no drug;
(2) Urine specimens fortified with
known standards; and
(3) Positive controls with the drug or
metabolite at or near the threshold
(cutoff).
In addition, with each batch of samples
a sufficient number of standards shall
be included 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 standards, those values will
be used to calculate sample data.
Implementation of procedures to ensure
that carryover does not contaminate the
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11985
testing of an individual's specimen shall
be documented. A minimum of 10
percent of all test samples shall be
quality control specimens. Laboratory
quality control samples, prepared from
spiked urine samples of determined
concentration shall be included in the
run and should appear as normal
samples to laboratory analysts. One
percent of each run, with a minimum of
at least one sample, shall be the
laboratory's own quality control
samples.
(c) Laboratory Quality Control
Requirements for Confirmation Tests.
Each analytical run of specimens to be
confirmed shall include:
- (1) Urine specimens certified to
contain no drug;
(2) Urine specimens fortified with
known standards; and
(3) Positive controls 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 an
individual's specimen shall also be
documented.
(d) Agency Blind Performance Test
Procedures. (1) Agencies shall purchase
drug testing services only from
laboratories certified by DHHS or a
DHHS-Recognized certification program
in accordance with these Guidelines.
Laboratory participation is encouraged
in other performance testing surveys by
which the laboratory's performance is
compared with peers and reference
laboratories.
(2) During the initial 90-day period of
any new drug testing program, each
agency shall submit blind performance
test specimens to each laboratory it
contracts with in the amount of at least
50 percent of the total number of
samples submitted (up to a maximum of
500 samples) and thereafter a minimum
of 10 percent of all samples (to a
maximum of 250) submitted per quarter.
(3) Approximately 80 percent of the
blind performance test samples shall be
blank (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 Secretary shall investigate any
unsatisfactory performance testing
result and, based on this investigation,
the laboratory shall take action to
correct the cause of the unsatisfactory
performance test result. A record shall
be make of the Secretary's investigative
findings and the corrective action taken
by the laboratory, and that record shall
be dated and signed by the individuals
responsible for the day-to-day
management and operation of the drug
testing laboratory. Then the Secretary
shall send the document to the agency
contracting officer as a report of the
unsatisfactory performance testing
incident. 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 specimen
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 specimen
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 individual responsible for day-to-
day management of the laboratory's
urine drug testing. The Secretary may
require an on-site review of the
laboratory which may be conducted
unannounced during any hours of
operations of the laboratory. The
Secretary has the option of revoking
(3.13) or suspending (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.
2.6 Interim Certification Procedures.
During the interim certification period
as determined under paragraph (c),
agencies shall ensure laboratory
competence by one of the following
methods:
(a) Agencies may use agency or
contract laboratories that have been
certified for urinalysis testing by the
Department of Defense; or
(b) Agencies may develop interim self-
certification procedures by establishing
preaward inspections and performance
testing plans approved by DHHS.
(c) The period during which these
interim certification procedures will
apply shall be determined by the
Secretary. Upon noticed by the
Secretary that these interim certification
procedures are no longer available, all
Federal agencies subject to these
Guidelines shall only use laboratories
that have been certified in accordance
with Subpart C of these Guidelines and
all laboratories approved for interim
certification under paragraphs (a) and
(b) of this section shall become certified
in accordance with Subpart C within 120
days of the date of this notice.
2.7 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
Medical Review Officer prior to the
transmission of results to agency
administrative officials.
(b) Medical Review Officer?
Qualifications and Responsibilities. The
Medical Review Officer shall be a
licensed physician with knowledge of
substance abuse disorders and may be
an agency or contract employee. The
role of the Medical Review Officer is to
review and interpret positive test results
obtained through the agency's testing
program. In carrying out this
responsibility, the Medical Review
Officer shall examine alternate medical
explanations for any positive test result.
This action could include conducting a
medical interview with the individual,
review of the individual's medical
history, or review of any other relevant
biomedical factors. The Medical Review
Officer shall review all medical records
made available by the tested individual
when a confirmed positive test could
have resulted from legally prescribed
medication. The Medical Review Officer
shall not, however, consider the results
of urine samples 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 Medical Review
Officer shall give the individual an
opportunity to discuss the test result
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with him or her. Following verification
of a positive test result, the Medical
Review Officer shall refer the case to
the agency Employee Assistance
Program and to the management official
empowered to recommend or take
administrative action.
(d) Verification for opiates; review for
prescription mediation. Before the
Medical Review Officer 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
agency's GC/MS confirmation testing
for opiates confirms the presence of 6-
monoacetylmorphine.)
(e) Reanalysis Authorized. Should
any question arise as to the accuracy or
validity of a positive test result, only the
Medical Review Officer is authorized to
order a reanalysis of the original sample
and such retests are authorized only at
laboratories certified under these
Guidelines.
(f) Result Consistent with Legal Drug
Use. If the Medical Review Officer
determines there is a legitimate medical
explanation for the positive test result,
he or she shall determine that the result
is consistent with legal drug use and
take no further action.
(g) Result Scientifically Insufficient.
Additionally, the Medical Review
Officer, based on review of inspection
reports, quality control data, multiple
samples, 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 Medical
Review Officer may request reanalysis
of the original sample before making this
decision. (The Medical Review Officer
may request that reanalysis be
performed by the same laboratory or, as
provided in 2.7(e), that an aliquot of the -
original specimen be sent for reanalysis
to an alternate laboratory which is
certified in accordance with these
Guidelines.) The laboratory shall assist
in this review process as requested by
the Medical Review Officer 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 Medical Review
Officer shall report to the Secretary all
negative findings based on scientific
insufficiency but shall not include any
personal identifying information in such
renorts.
2.8 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. 552a. In addition, laboratory
contracts shall require compliance with
the patient access and confidentiality
provisions of section 503 of Pub. L. 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 shall specifically
require that employee records be
maintained and used with the highest
regard for employee privacy.
2.9 Individual Access to Test and
Laboratory Certification Results.
In accordance with section 503 of Pub.
L. 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
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.
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 2.4 (e) and
(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 1.2 in
accordance with these Guidelines. The
qualifying evaluation will involve three
rounds of performance testing plus on-
site inspection. Maintenance of
certification requires participation in an
every-other-month 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,
property documentation of all records,
storage of positive specimens for later or
independent testing, presentation of
evidence in court, and expert witness
testimony.
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11987
3.3 General Certification
Requirements.
A laboratory must meet all the
pertinent provisions of these Guidelines
in order to qualify for certification under
these standards.
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 (2.1(a) (1)
and (2)) and the methods (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 Guideline ?- for the
five classes of using the methods
specified. Certified laboratories must
clearly inform non-Federal clients when
procedures followed for those clients
conform to the standards specified in
these Guidelines.
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 (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
(2.1(a) (1)and (2)). All positive initial
test results shall be confirmed prior to
reporting them.
3.6 Personnel.
Laboratory personnel shall meet the
requirements specified in 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.
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 2.5 of
these Guidelines.
3.8 Security and Chain of Custody.
Laboratories shall meet the security
and chain of custody requirements
provided in 2.4(a).
3.9 One-Year Storage for Confirmed
Positives.
All confirmed positive specimens
shall be retained in accordance with the
provisions of 2.4(h) of these Guidelines.
3.10 Documentation.
The laboratory shall maintain and
make available for at least 2 years
documentation in accordance with the
specifications in 2.4(m).
3.11 Reports.
The laboratory shall report test results
in accordance with the specifications in
2.4(g).
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 and
laboratory that is certified by a DHHS-
recognized certification program in
accordance with these Guidelines.
(b) Criteria. In determining whether to
certify a laboratory or to accept the
certification of-a DHHS-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.
3.13 Revocation.
(a) General. The Secretary shall
revoke certification of any laboratory
certified under these provisions or
accept revocation by a DHHS-
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.
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 a DHHS-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.
3.15 Notice; Opportunity for Review.
(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 personal service
or registered or certified mail, return
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11988 Federal Register / Vol. 53, No. 69 / Monday, April 11, 1988 / Notices
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 of mailing or service of the
notice. The review shall be by a person
or persons designated by the Secretary
and shall be based on written
submissions by the laboratory and the
Department of Health and Human
Services and, at the Secretary's
discretion, may include an opportunity
for an oral presentation. Formal rules of
evidence and procedures applicable to
proceedings in a court of law shall not
apply. The decision of the reviewing
official shall be final.
(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) DHHS -Recognized Certification
Program. The Secretary's responsibility
under this section may be carried out by
a DHHS-recognized certification
program in accordance with these
Guidelines. -
3.16 Recertification.
Following the termination or
expiration of any suspension or
revocation, a laboratory may apply for
recertification. Upon the submission of
evidence satisfactory to the Secretary
that the laboratory is in compliance with
these Guidelines or any DHHS-
recognized certification program in
accordance with these Guidelines, and
any other conditions imposed as part of
the suspension or revocation, the
Secretary may recertify the laboratory ?
or accept the recertification of the
laboratory by a DHHS-recognized
certification program.
3.17 Performance Test Requirement for
Certification.
(a) An Initial and Continuing
Requirement. The performance testing
program is a part of the initial
evaluation of a laboratory seeking
certification (both performance testing
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 inspection and certification. These
initial three cycles (and any required for
recertification) can be compressed into a
3-month period (one per month).
(c) Six Challenges Per Year. After
certification, laboratories shall be
challenged every other month with one
set of at least 10 specimens a total of six
cycles per year.
(d) Laboratory Procedures Identical
for Performance Test and Routine
Employee Specimens. All procedures
associated with the handling and testing
of the performance test specimens 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 performance testing (see 2.5(d)).
Performance on blind test specimens
shall be at the same level as for the
open or non-blind performance testing.
(f) Reporting?Open Performance
Test. The laboratory shall report results
of open performance tests to the
certifying organization in the same
manner as specified in 2.4(g)(2) for
routine laboratory specimens.
3.18 Performance Test Specimen
Composition.
(a) Description of the Drugs.
Performance test specimens shall
contain those drugs and metabolites
which each certified laboratory must be
prepared to assay in concentration
ranges that allow detection of the
analyte 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
specimen 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
specimen container, but generally no
more than two drugs will be present in
any one specimen in order to imitate the
type of specimen which a laboratory
normally encounters. For any particular
performance testing 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 specimens.
(b) Concentrations. Performance test
specimens shall be spiked with the drug
classes and their metabolites which are
required for certifications: marijuana,
cocaine, opiates, amphetamines, and
phencyclidine, with concentration levels
set at least 20 percent above the cutoff
limit for either the initial assay or the
confirmatory test, depending on which is
to be evaluated. Some performance test
specimens may be identified for GC/MS
assay only. 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.
3.19 Evaluation of Peformance Testing.
(a) Initial Certification. (1) An
applicant laboratory shall not report any
false positive result during performance
testing 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
performance testing required for initial
certification, i.e., it must correctly
identify and confirm 90 percent of the
total drug challenges for each shipment.
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 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 -1-2 standard
deviations of the calculated reference
group mean (whichever is larger).
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
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Federal Register / Vol. 53, No. 69 / Monday, April 11, 1988 / Notices
11989
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 occurence 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
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 fo 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 individual responsible for
the day-to-day management of the
laboratory's urine drug testing.
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 retest sample must be
corrected because the critieria 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 successfu4 complete
six cycles of performance testing per
year. Failure of a certified laboratory to
maintain a grade of 90 percent on any
required performance test cycle, 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 sv.spension or revocation of
certificatthn.
(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 of the calculated reference
group mean (whichever is larger).
(4) Requirement to Quantitate within
50 Percent of Calculated Reference
Group Mean. No quantitative values
obtained by a certified laboratory may
differ by more than 50 percent from the
calculated reference group mean.
(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
per test cycle 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 successfully
quantitate test results and how it failed
to successfully quantitate. 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 performance test or to
participate satisfactorily may result in
suspension or revocation of
certification.
3.20 Inspections.
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.
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 3.13 and 3.14
of these Guidelines.
[FR Doc. 88-7864 Filed 4-8-88; 8:45 am]
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