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Subpart A - General
Section 1.1 Applicability.
(a) These mandatory guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but
excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(3) And any other employing unit or authority of the Federal Government
except the United States Postal Service, the Postal Rate Commission,
and employing units or authorities in the Judicial and Legislative
(b) Subpart C of these Guidelines (which establishes laboratory
certification standards) applies to any laboratory which has or
seeks certification to perform urine drug testing for Federal
agencies under a drug testing program conducted under E.O. 12564.
Only laboratories certified under these standards are authorized
to perform urine drug testing for Federal agencies.
(c) The Intelligence Community, as defined by Executive Order
No. 12333, shall be subject to these Guidelines only to the extent
agreed to by the head of the affected agency.
(d) These Guidelines do not apply to drug testing conducted
under legal authority other than E.O. 12564, including testing
of persons in the criminal justice system, such as arrestees,
detainees, probationers, incarcerated persons, or parolees.
(e) Agencies may not deviate from the provisions of these Guidelines
without the written approval of the Secretary. In requesting approval
for a deviation, an agency must petition the Secretary in writing
and describe the specific provision or provisions for which a
deviation is sought and the rationale therefor. The Secretary
may approve the request upon a finding of good cause as determined
by the Secretary.
(f) Agencies shall purchase drug testing services only from
laboratories certified by HHS or an HHS-recognized certification
program in accordance with these Guidelines.
Section 1.2 Definitions.
For purposes of these Guidelines the following definitions are
adopted: Aliquot A fractional part of a specimen used for testing.
It is taken as a sample representing the whole specimen.
Calibrator A solution of known concentration used to calibrate
a measurement procedure or to compare the response obtained with
the response of a test specimen/sample. The concentration of the
analyte of interest in the calibrator is known within limits ascertained
during its preparation. Calibrators may be used to establish a
calibration curve over a range of interest. Certifying Scientist
An individual with at least a bachelor's degree in the chemical
or biological sciences or medical technology or equivalent who
reviews all pertinent data and quality control results. The individual
shall have training and experience in the theory and practice
of all methods and procedures used in the laboratory, including
a thorough understanding of chain of custody procedures, quality
control practices, and analytical procedures relevant to the results
that the individual certifies. Relevant training and experience
shall also include the review, interpretation, and reporting of
test results; maintenance of chain of custody; and proper remedial
action to be taken in response to test systems being out of control-limits
or detecting aberrant test or quality control results.
Chain of Custody Procedures to account for the integrity of
each urine specimen by tracking its handling and storage from
point of specimen collection to final disposition of the specimen.
These procedures shall require that an Office of Management and
Budget (OMB) approved specimen chain of custody form be used from
time of collection to receipt by the laboratory and that upon
receipt by the laboratory an appropriate laboratory chain of custody
form(s) account for the specimens and samples within the laboratory.
Chain of custody forms shall, at a minimum, include an entry documenting
date and purpose each time a specimen or sample is handled or
transferred and identifying every individual in the chain of custody.
Collection Site A place designated by the agency where individuals
present themselves for the purpose of providing a specimen of
their urine to be analyzed for the presence of drugs. Collection
Site Person A person who instructs and assists individuals at
a collection site and who receives and makes an initial examination
of the urine specimen provided by those individuals. A collection
site person shall have successfully completed training to carry
out this function.
Confirmatory Test A second analytical procedure to identify the
presence of a specific drug or metabolite which is independent
of the initial test and which uses a different technique and chemical
principle from that of the initial test in order to ensure reliability
and accuracy. (At this time gas chromatography/mass spectrometry
(GC/MS) is the only authorized confirmation method for cocaine,
marijuana, opiates, amphetamines, and phencyclidine.) Control
A sample used to monitor the status of an analysis to maintain
its performance within desired limits.
Donor The individual from whom a urine specimen is collected.
Initial Test (also known as Screening Test) An immunoassay test
to eliminate "negative" urine specimens from further
consideration and to identify the presumptively positive specimens
that require confirmation or further testing.
Laboratory Chain of Custody Form The form(s) used by the testing
laboratory to document the security of the specimen and all aliquots
of the specimens during testing and storage by the laboratory.
The form, which may account for an entire laboratory test batch,
shall include the names and signatures of all individuals who
accessed the specimens or aliquots and the date and purpose of
Medical Review Officer (MRO) A licensed physician responsible
for receiving laboratory results generated by an agency's drug
testing program who has knowledge of substance abuse disorders
and has appropriate medical training to interpret and evaluate
an individual's positive test result together with his or her
medical history and any other relevant biomedical information.
Quality Control Sample A sample used to evaluate whether or not
the analytical procedure is operating within predefined tolerance
limits. Calibrators, controls, negative urine samples, and blind
samples are collectively referred to as "quality control
samples" and each as a "sample."
Reason to Believe Reason to believe that a particular individual
may alter or substitute the urine specimen as provided in section
4(c) of E.O. 12564. Sample A representative portion of a urine
specimen or quality control sample used for testing.
Secretary The Secretary of Health and Human Services or the Secretary's
designee. The Secretary's designee may be a contractor or other
recognized organization which acts on behalf of the Secretary
in implementing these Guidelines.
Specimen The portion of urine that is collected from a donor.
Specimen Chain of Custody Form An OMB approved form used to
document the security of the specimen from time of collection
until receipt by the laboratory. This form, at a minimum, shall
include specimen identifying information, date and location of
collection, name and signature of collector, name of testing laboratory,
and the names and signatures of all individuals who had custody
of the specimen from time of collection until the specimen was
prepared for shipment to the laboratory.
Standard A reference material of known purity or a solution
containing a reference material at a known concentration.
Section 1.3 Future Revisions.
In order to ensure the full reliability and accuracy of drug assays,
the accurate reporting of test results, and the integrity and
efficacy of Federal drug testing programs, the Secretary may make
changes to these Guidelines to reflect improvements in the available
science and technology. These changes will be published in final
as a notice in the Federal Register.
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