Source: Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Subj: Mandatory Guidelines for Federal Workplace Drug Testing Programs
アメリカ連邦政府の職場でのドラッグテストを広げたのはレーガン大統領で、１９８６年に大統領令１２５６４号に署名し、連邦の職員に対して公私にわたって 「ドラッグ・フリー」 であることを強制した。これが契機となって、嫌疑のない職員にまでドラッグテストが行われることが当たり前になった。
Subpart A - General
1.3 Future Revisions
Subpart B - Scientific and Technical Requirements
2.1 The Drugs
2.2 Specimen Collection Procedures
2.3 Laboratory Personnel
2.4 Laboratory Analysis Procedures
2.5 Quality Assurance and Quality Control
2.6 Reporting and Review of Results
2.7 Protection of Employee Records
2.8 Individual Access to Test and Laboratory Certification Results
Subpart C - Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies
3.2 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
3.7 Quality Assurance and Quality Control
3.8 Security and Chain of Custody
3.9 One-Year Storage for Confirmed Positives
3.17 Performance Testing (PT) Requirement for Certification
3.18 Performance Test Samples Composition
3.19 Evaluation of Performance Testing
3.21 Results of Inadequate Performance
3.22 Listing of Certified Laboratories
Subpart D - Procedures for Review of Suspension or Proposed Revocation of a Certified Laboratory
4.3 Limitations on Issues Subject to Review
4.4 Specifying Who Represents the Parties
4.5 The Request for Informal Review and the Reviewing Official's Response
4.6 Abeyance Agreement
4.7 Preparation of the Review File and Written Argument
4.8 Opportunity for Oral Presentation
4.9 Expedited Procedures for Review of Immediate Suspension
4.10 Ex Parte Communications
4.11 Transmission of Written Communications by Reviewing Official and Calculation of Deadlines
4.12 Authority and Responsibilities ofReviewing Official
4.13 Administrative Record
4.14 Written Decision
4.15 Court Review of Final Administrative Action; Exhaustion of Administrative Remedies
Authority: E.O. 12564 and Sec. 503 of Pub. L. 100-71.
Subpart A - General
Section 1.1 Applicability.
- (a) These mandatory guidelines apply to:
- (1) Executive Agencies as defined in 5 U.S.C. 105;
- (2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but
excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
- (3) And any other employing unit or authority of the Federal Government
except the United States Postal Service, the Postal Rate Commission,
and employing units or authorities in the Judicial and Legislative
- (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
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
Laboratory Chain of Custody Form The form(s) used by the testing
laboratory to document the security of the specimen and all aliquots of
the specimens during testing and storage by the laboratory. The form,
which may account for an entire laboratory test batch, shall include
the names and signatures of all individuals who accessed the specimens
or aliquots and the date and purpose of the access.
Medical Review Officer (MRO) A licensed physician responsible for
receiving laboratory results generated by an agency's drug testing
program who has knowledge of substance abuse disorders and has
appropriate medical training to interpret and evaluate an individual's
positive test result together with his or her medical history and any
other relevant biomedical information. Quality Control Sample A sample
used to evaluate whether or not the analytical procedure is operating
within predefined tolerance limits. Calibrators, controls, negative
urine samples, and blind samples are collectively referred to as
"quality control samples" and each as a "sample."
Reason to Believe Reason to believe that a particular individual may
alter or substitute the urine specimen as provided in section 4(c) of
E.O. 12564. Sample A representative portion of a urine specimen or
quality control sample used for testing.
Secretary The Secretary of Health and Human Services or the Secretary's
designee. The Secretary's designee may be a contractor or other
recognized organization which acts on behalf of the Secretary in
implementing these Guidelines.
Specimen The portion of urine that is collected from a donor.
Specimen Chain of Custody Form An OMB approved form used to document the
security of the specimen from time of collection until receipt by the
laboratory. This form, at a minimum, shall include specimen identifying
information, date and location of collection, name and signature of
collector, name of testing laboratory, and the names and signatures of
all individuals who had custody of the specimen from time of collection
until the specimen was prepared for shipment to the laboratory.
Standard A reference material of known purity or a solution containing
a reference material at a known concentration.
Section 1.3 Future Revisions.
In order to ensure the full reliability and accuracy of drug assays,
the accurate reporting of test results, and the integrity and efficacy
of Federal drug testing programs, the Secretary may make changes to
these Guidelines to reflect improvements in the available science and
technology. These changes will be published in final as a notice in the
Subpart B - Scientific and Technical Requirements
Section 2.1 The Drugs.
- (a) The President's Executive Order 12564 defines "illegal drugs" as
those included in Schedule I or II of the Controlled Substances Act
(CSA), but not when used pursuant to a valid prescription or when used
as otherwise authorized by law. Hundreds of drugs are covered under
Schedule I and II and while it is not feasible to test routinely for
all of them, Federal drug testing programs shall test for drugs as
- (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 except if additional testing is required to determine the validity
of the specimen. Urine that tests negative by initial or confirmatory
testing may, however, be pooled for use in the laboratory's internal
quality control program.
- (d) These Guidelines are not intended to limit any agency which is
specifically authorized by law to include additional categories of
drugs in the drug testing of its own employees or employees in its
Section 2.2 Specimen Collection Procedures.
- (a) Designation of Collection Site. Each agency drug testing program
shall have one or more designated collection sites which have all
necessary personnel, materials, equipment, facilities, and supervision
to provide for the collection, security, temporary storage, and
shipping or transportation of urine specimens to a certified drug
- (b) Security. Procedures shall provide for the designated collection
site to be secure. If a collection site facility is dedicated solely to
urine collection, it shall be secure at all times. If a facility cannot
be dedicated solely to drug testing, the portion of the facility used
for testing shall be secured during drug testing.
- (c) Chain of Custody. Chain of custody standardized forms shall be
properly executed by authorized collection site personnel upon receipt
of specimens. Handling and transportation of urine specimens from one
authorized individual or place to another shall always be accomplished
through chain of custody procedures. Every effort shall be made to
minimize the number of persons handling specimens.
- (d) Access to Authorized Personnel Only. No unauthorized personnel
shall be permitted in any part of the designated collection site when
urine specimens are collected or stored.
- (e) Privacy. Procedures for collecting urine specimens shall allow
individual privacy unless there is reason to believe that a particular
donor may alter or substitute the specimen to be provided.
- (f) Integrity and Identity of Specimen. Agencies shall take precautions
to ensure that a urine specimen not be adulterated or diluted during
the collection procedure and that information on the urine bottle and
on the specimen chain of custody form can identify the donor from whom
the specimen was collected. The following minimum precautions shall be
taken to ensure that unadulterated specimens are obtained and correctly
- (1) To deter the dilution of specimens at the collection site, toilet
bluing agents shall be placed in toilet tanks wherever possible, so the
reservoir of water in the toilet bowl always remains blue. There shall
be no other source of water (e.g., no shower or sink) in the enclosure
where urination occurs.
- (2) When a donor arrives at the collection site, the collection site
person shall request the donor to present photo identification. If the
donor does not have proper photo identification, the collection site
person shall contact the supervisor of the donor, the coordinator of
the drug testing program, or any other agency official who can
positively identify the donor. If the donor's identity cannot be
established, the collection site person shall not proceed with the
- (3) If the donor fails to arrive at the assigned time, the collection
site person shall contact the appropriate authority to obtain guidance
on the action to be taken.
- (4) The collection site person shall ask the donor to remove any
unnecessary outer garments such as a coat or jacket that might conceal
items or substances that could be used to tamper with or adulterate the
donor's urine specimen. The collection site person shall ensure that
all personal belongings such as a purse or briefcase remain with the
outer garments. The donor may retain his or her wallet.
- (5) The donor shall be instructed to wash and dry his or her hands
prior to urination.
- (6) After washing hands, the donor shall remain in the presence of the
collection site person and shall not have access to any water fountain,
faucet, soap dispenser, cleaning agent, or any other materials which
could be used to adulterate the specimen.
- (7) The collection site person shall give the donor a clean specimen
bottle or specimen container. The donor may provide his/her specimen in
the privacy of a stall or otherwise partitioned area that allows for
- (8) The collection site person shall note any unusual behavior or
appearance on the specimen chain of custody form.
- (9) In the exceptional event that an agency-designated collection site
is not accessible and there is an immediate requirement for specimen
collection (e.g., an accident investigation), a public rest room may be
used according to the following procedures: A person of the same gender
as the donor shall accompany the donor into the public rest room which
shall be made secure during the collection procedure. If possible, a
toilet bluing agent shall be placed in the bowl and any accessible
toilet tank. The collection site person shall remain in the rest room,
but outside the stall, until the specimen is collected. If no bluing
agent is available to deter specimen dilution, the collection site
person shall instruct the donor not to flush the toilet until the
specimen is delivered to the collection site person. After the
collection site person has possession of the specimen, the donor will
be instructed to flush the toilet and to participate with the
collection site person in completing the chain of custody procedures.
- (10) Upon receiving the specimen from the donor, the collection site
person shall determine the volume of urine in the specimen
- (i) If the volume is greater than 30 milliliters (mL), the collection
site person will proceed with step (11) below.
- (ii) If the volume is less than 30 mL and the temperature is within the
acceptable range specified in step (13) below, the specimen is
discarded and a second specimen shall be collected. The donor may be
given a reasonable amount of liquid to drink for this purpose (e.g., an
8 oz glass of water every 30 min, but not to exceed a maximum of 24
oz). If the donor fails for any reason to provide 30 mL of urine for
the second specimen collected, the collection site person shall contact
the appropriate authority to obtain guidance on the action to be taken.
- (iii) If the volume is less than 30 mL and the temperature is outside
the acceptable range specified in step (13) below, a second specimen
shall be collected using the procedure specified in step (13) below.
- (11) After the specimen has been provided and submitted to the
collection site person, the donor shall be allowed to wash his or her
- (12) Immediately after the specimen is collected, the collection site
person shall measure only the temperature of the specimen. The
temperature measuring device used must accurately reflect the
temperature of the specimen and not contaminate the specimen. The time
from urination to temperature measurement is critical and in no case
shall exceed 4 minutes.
- (13) If the temperature of the specimen is outside the range of 32 -38
C/90 -100 F, that is a reason to believe that the donor may have
altered or substituted the specimen, and another specimen shall be
collected under direct observation of a person of the same gender and
both specimens shall be forwarded to the laboratory for testing. The
agency shall select the observer if there is no collection site person
of the same gender available. A donor may volunteer to have his or her
oral temperature taken to provide evidence to counter the reason to
believe the donor may have altered or substituted the specimen caused by
the specimen's temperature falling outside the prescribed range.
- (14) Immediately after the specimen is collected, the collection site
person shall also inspect the specimen to determine its color and look
for any signs of contaminants. Any unusual findings shall be noted on
the specimen chain of custody form.
- (15) All specimens suspected of being adulterated or diluted shall be
forwarded to the laboratory for testing.
- (16) When there is any reason to believe that a donor may have altered
or substituted the specimen to be provided, another specimen shall be
obtained as soon as possible under the direct observation of a person
of the same gender and both specimens shall be forwarded to the
laboratory for testing. The agency shall select the observer if there
is no collection site person of the same gender available.
- (17) Both the donor and the collection site person shall keep the
specimen bottle/container in view at all times prior to its being
sealed and labeled. If the specimen is transferred from a specimen
container to a specimen bottle, the collection site person shall
request the donor to observe the transfer of the specimen and the
placement of the tamper-evident seal/tape on the bottle. The tamperevident
seal may be in the form of evidence tape, a self- sealing
bottle cap with both a tamper-evident seal and unique coding, cap and
bottle systems that can only be sealed one time, or any other system
that ensures any tampering with the specimen will be evident to
laboratory personnel during the accessioning process.
- (18) The collection site person and the donor shall be present at the
same time during procedures outlined in paragraphs (f)(19)-(f)(22) of
- (19) The collection site person shall place securely on the specimen
bottle an identification label which contains the date, the donor's
specimen number, and any other identifying information provided or
required by the agency.
- (20) The donor shall initial the identification label on the specimen
bottle for the purpose of certifying that it is the specimen collected
from him or her.
- (21) The collection site person shall enter on the specimen chain of
custody form all information identifying the specimen.
- (22) The donor shall be asked to read and sign a statement on the
specimen chain of custody form certifying that the specimen identified
as having been collected from him or her is in fact that specimen he or
- (23) Based on a reason to believe that the donor may alter or substitute
the specimen to be provided, a higher level supervisor shall review and
concur in advance with any decision by a collection site person to
obtain a specimen under direct observation. The person directly
observing the specimen collection shall be of the same gender. The
agency shall select the observer if there is no collection site person
of the same gender available.
- (24) The collection site person shall complete the specimen chain of
- (25) The urine specimen and specimen chain of custody form are now
ready for shipment. If the specimen is not immediately prepared for
shipment, it shall be appropriately safeguarded during temporary
- (26) While any part of the above chain of custody procedures is being
performed, it is essential that the urine specimen and custody
documents be under the control of the involved collection site person.
If the involved collection site person leaves his or her work station
momentarily, the urine specimen and specimen chain of custody form
shall be taken with him or her or shall be secured. After the
collection site person returns to the work station, the custody process
will continue. If the collection site person is leaving for an extended
period of time, the specimen shall be packaged for mailing before he or
she leaves the site.
- (g) Collection Control. To the maximum extent possible, collection site
personnel shall keep the donor's specimen bottle within sight both
before and after the donor has urinated. After the specimen is
collected, it shall be properly sealed and labeled. A specimen chain of
custody form shall be used for maintaining control and accountability
of each specimen. The date and purpose shall be documented on a specimen
chain of custody form each time a specimen is handled or transferred
and every individual in the chain shall be identified. Every effort
shall be made to minimize the number of persons handling specimens.
- (h) Split Specimens. An agency may, but is not required to, use a split
specimen method of collection. If the urine specimen is split into two
specimen bottles (hereinafter referred to as Bottle A and Bottle B) the
following procedure shall be used:
- (1) The donor shall urinate into either a specimen bottle or specimen
container. The collection site person, in the presence of the donor,
after determining specimen temperature, pours the urine into two
specimen bottles that are labeled Bottle A and Bottle B or, if Bottle A
was used to collect the specimen, pours an appropriate amount into
Bottle B. A minimum of 45 mL of urine is required when using a split
specimen procedure, i.e., 30 mL for Bottle A and 15 mL for Bottle B.
- (2) The Bottle A specimen, containing a minimum of 30 mL of urine, is
to be used for the drug test. If there is no additional urine available
for the second specimen bottle (Bottle B), the first specimen bottle
(Bottle A) shall nevertheless be processed for testing.
- (3) A minimum of 15 mL of urine shall be poured into the second specimen
bottle (Bottle B).
- (4) All requirements of this part shall be followed with respect to
Bottle A and Bottle B, including the requirements that a copy of the
chain of custody form accompany each bottle processed under split sample
- (5) The collection site shall send the split specimens (Bottle A and
Bottle B) at the same time to the laboratory that will be testing the
Bottle A specimen.
- (6) If the test of the first specimen bottle (Bottle A) is verified
positive by the MRO, the MRO shall report the result to the agency.
Only the donor may request through the MRO that the second specimen
bottle (Bottle B) be tested in an HHS-certified laboratory for presence
of the drug(s) for which a positive result was obtained in the test of
the first specimen bottle (Bottle A). The MRO shall honor such a
request if it is made within 72 hours of the donor's having received
notice that he or she tested positive. The result of this test is
transmitted to the MRO without regard to the cutoff levels used to test
the first specimen bottle (Bottle A).
- (7) Any action taken by a Federal agency as a result of an MRO verified
positive drug test (e.g., removal from performing a safety-sensitive
function) may proceed whether Bottle B is or is not tested.
- (8) If the result of the test on the second specimen bottle (Bottle B)
fails to reconfirm the result reported for Bottle A, the MRO shall void
the test result for Bottle A and the donor shall re-enter the group
subject to random testing as if the test had not been conducted. The
MRO shall notify the Federal agency when a failed to reconfirm has
occurred and the agency shall contact the Secretary. The Secretary will
investigate the failed to reconfirm result and attempt to determine the
reason for the inconsistent results between Bottle A and Bottle B. HHS
will report its findings to the agency including recommendations and/or
actions taken to prevent the recurrence of the failed to reconfirm
- (i) Transportation to Laboratory. Collection site personnel shall
arrange to ship the collected specimens to the drug testing laboratory.
The specimens shall be placed in containers designed to minimize the
possibility of damage during shipment, for example, specimen boxes or
padded mailers; and those containers shall be securely sealed to
eliminate the possibility of undetected tampering. The collection site
personnel shall ensure that the specimen chain of custody form is
enclosed within each container sealed for shipment to the drug testing
laboratory. Since specimens are sealed in packages that would indicate
any tampering during transit to the laboratory and couriers, express
carriers, and postal service personnel do not have access to the chain
of custody forms, there is no requirement that such personnel document
chain of custody for the package during transit.
Section 2.3 Laboratory Personnel.
- (a) Day-to-Day Management.
- (1) The laboratory shall have a responsible person (RP) to assume
professional, organizational, educational, and administrative
responsibility for the laboratory's urine drug testing facility.
- (2) This individual shall have documented scientific qualifications in
analytical forensic toxicology. Minimum qualifications are:
- (i) Certification as a laboratory director by the State in forensic or
clinical laboratory toxicology; or
- (ii) A Ph.D. in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or
- (iii) Training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with
additional training and laboratory/research experience in biology,
chemistry, and pharmacology or toxicology; and
- (iv) In addition to the requirements in (i),(ii), and (iii) above,
minimum qualifications also require:
- (A) Appropriate experience in analytical forensic toxicology including
experience with the analysis of biological material for drugs of abuse,
- (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
- (3) This individual shall be engaged in and responsible for the day-today
management of the drug testing laboratory even where another
individual has overall responsibility for an entire multispecialty
- (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
- (5) This individual shall be responsible for the laboratory`s having a
procedure manual which is complete, up-to-date, available for personnel
performing tests, and followed by those personnel. The procedure manual
shall be reviewed, signed, and dated by this responsible person
whenever procedures are first placed into use or changed or when a new
individual assumes responsibility for management of the drug testing
laboratory. Copies of all procedures and dates on which they are in
effect shall be maintained. (Specific contents of the procedure manual
are described in section 2.4(n)(1))
- (6) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; for maintaining acceptable analytical performance for all
controls and standards; for maintaining quality control testing; and
for assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test
- (7) This individual shall be responsible for taking all remedial
actions necessary to maintain satisfactory operation and performance of
the laboratory in response to quality control systems not being within
performance specifications, errors in result reporting or in analysis
of performance testing results. This individual shall ensure that
sample results are not reported until all corrective actions have been
taken and he or she can assure that the results provided are accurate
- (b) Certifying Test Results. The laboratory's urine drug testing
facility shall have a certifying scientist(s), as defined in section
1.2, who reviews all pertinent data and quality control results in
order to attest to the validity of the laboratory's test reports. A
laboratory may designate certifying scientists that are qualified to
certify only results that are negative on the initial test and
certifying scientists that are qualified to certify both initial and
- (c) Day-to-Day Operations and Supervision of Analysts. The laboratory's
urine drug testing facility shall have an individual(s) to be
responsible for day-to-day operations and to supervise the technical
analysts. This individual(s) shall have at least a bachelor's degree in
the chemical or biological sciences or medical technology or
equivalent. He or she shall have training and experience in the theory
and practice of the procedures used in the laboratory, resulting in his
or her thorough understanding of quality control practices and
procedures; the review, interpretation, and reporting of test results;
maintenance of chain of custody; and proper remedial actions to be
taken in response to test systems being out of control limits or
detecting aberrant test or quality control results.
- (d) Other Personnel. Other technicians or nontechnical staff shall have
the necessary training and skills for the tasks assigned.
- (e) Training. The laboratory's urine drug testing program shall make
available continuing education programs to meet the needs of laboratory
- (f) Files. Laboratory personnel files shall include: resume of training
and experience; certification or license, if any; references; job
descriptions; records of performance evaluation and advancement;
incident reports; and results of tests which establish employee
competency for the position he or she holds, such as a test for color
blindness, if appropriate.
Section 2.4 Laboratory Analysis Procedures.
- (a) Security and Chain of Custody.
- (1) Drug testing laboratories shall
be secure at all times. They shall have in place sufficient security
measures to control access to the premises and to ensure that no
unauthorized personnel handle specimens or gain access to the
laboratory processes or to areas where records are stored. Access to
these secured areas shall be limited to specifically authorized
individuals whose authorization is documented. With the exception of
personnel authorized to conduct inspections on behalf of Federal
agencies for which the laboratory is engaged in urine testing or on
behalf of the Secretary or emergency personnel (e.g., firefighters and
medical rescue teams), all authorized visitors and maintenance and
service personnel shall be escorted at all times. The laboratory shall
maintain a record that documents the dates, time of entry and exit, and
purpose of entry of authorized visitors, maintenance, and service
personnel accessing secured areas.
- (2) Laboratories shall use chain of custody procedures to maintain
control and accountability of specimens from receipt through completion
of testing, reporting of results, during storage, and continuing until
final disposition of specimens. The date and purpose shall be
documented on an appropriate chain of custody form each time a specimen
is handled or transferred, and every individual in the chain shall be
identified. Accordingly, authorized technicians shall be responsible
for each urine specimen or aliquot in their possession and shall sign
and complete chain of custody forms for those specimens or aliquots as
they are received.
- (b) Receiving.
- (1) When a shipment of specimens is received, laboratory
personnel shall inspect each package for evidence of possible tampering
and compare information on specimen bottles within each package to the
information on the accompanying chain of custody forms. Any direct
evidence of tampering or discrepancies in the information on specimen
bottles and the specimen chain of custody forms attached to the shipment
shall be immediately reported to the agency and shall be noted on the
specimen chain of custody forms which shall accompany the specimens
while they are in the laboratory's possession.
- (2) Specimen bottles will normally be retained within the laboratory's
accession area until all analyses have been completed. Aliquots and
laboratory chain of custody forms shall be used by laboratory personnel
for conducting initial and confirmatory tests while the original
specimen and specimen chain of custody form remain in secure storage.
- (c) Short-Term Refrigerated Storage. Specimens that do not receive an
initial test within 7 days of arrival at the laboratory shall be placed
in secure refrigeration units. Temperatures shall not exceed 6 C.
Emergency power equipment shall be available in case of prolonged power
- (d) Specimen Processing. Laboratory facilities for urine drug testing
will normally process specimens by grouping them into batches. The
number of specimens in each batch may vary significantly depending on
the size of the laboratory and its workload. When conducting either
initial or confirmatory tests, every batch shall satisfy the quality
control requirements in sections 2.5 (b) and (c), respectively.
- (e) Initial Test.
- (1) The initial test shall use an immunoassay which
meets the requirements of the Food and Drug Administration for
commercial distribution. The following initial cutoff levels shall be
used when screening specimens to determine whether they are negative
for these five drugs or classes of drugs:
Initial Test Level (ng/mL)
Marijuana metabolites............ 50
Cocaine metabolites............... 300
Opiate metabolites................. 300*
* 25 ng/mL if immunoassay specific for free morphine.
- (2) These test levels are subject to change by the Department of Health
and Human Services as advances in technology or other considerations
warrant identification of these substances at other concentrations. The
agency requesting the authorization to include other drugs shall submit
to the Secretary in writing the agency's proposed initial test methods,
testing levels, and proposed performance test program.
- (3) Specimens that test negative on all initial immunoassay tests will
be reported negative. No further testing of these negative specimens
for drugs is permitted and the specimens shall either be discarded or
pooled for use in the laboratory's internal quality control program.
- (4) Multiple initial tests (also known as rescreening) for the same
drug or drug class may be performed provided that all tests meet all
Guideline cutoffs and quality control requirements (see section
2.5(b)). Examples: a test is performed by immunoassay technique "A" for
all drugs using the HHS cutoff levels, but presumptive positive
amphetamines are forwarded for immunoassay technique "B" to eliminate
any possible presumptive positives due to structural analogues; a valid
analytical result cannot be obtained using immunoassay technique "A"
and immunoassay technique "B" is used in an attempt to obtain a valid
- (f) Confirmatory Test.
- (1) All specimens identified as positive on the
initial test shall be confirmed for the class(es) of drugs screened
positive on the initial test using gas chromatography/mass spectrometry
(GC/MS) at the cutoff values listed in this paragraph. All
confirmations shall be by quantitative analysis. Concentrations which
exceed the linear region of the standard curve shall be documented in
the laboratory record as "exceeds the linear range of the test."
Confirmatory Test Level (ng/mL)
Marijuana metabolite1 15
Cocaine metabolite2 150
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid
3 Specimen must also contain amphetamine at a concentration > 200 ng/mL
- (2) These test levels are subject to change by the Department of Health
and Human Services as advances in technology or other considerations
warrant identification of these substances at other concentrations. The
agency requesting the authorization to include other drugs shall submit
to the Secretary in writing the agency's proposed confirmatory test
methods, testing levels, and proposed performance test program.
- (3) Specimens that test negative on confirmatory tests shall be reported
negative. No further testing of these specimens for drugs is permitted
and the specimens shall either be discarded or pooled for use in the
laboratory's internal quality control program.
- (g) Reporting Results.
- (1) The laboratory shall report test results to
the agency's MRO within an average of 5 working days after receipt of
the specimen by the laboratory. Before any test result is reported (the
results of initial tests, confirmatory tests, or quality control data),
it shall be reviewed and the test certified as an accurate report by a
certifying scientist who satisfies the requirements described by the
definition in section 1.2. The report shall identify the
drugs/metabolites tested for, whether positive or negative, and the
cutoff for each, the specimen number assigned by the agency, and the
drug testing laboratory specimen identification number.
- (2) Except as otherwise provided by this subsection, the laboratory
shall report as negative all specimens which are negative on the
initial test or negative on the confirmatory test. Only specimens
confirmed positive shall be reported positive for a specific drug. For
amphetamines, to report a specimen positive for methamphetamine only,
the specimen must also contain amphetamine at a concentration equal to
or greater than 200 ng/mL by the confirmatory test. If this criterion
is not met, the specimen must be reported as negative for
- (3) The MRO may request from the laboratory and the laboratory shall
provide quantitation of test results. The MRO may not disclose
quantitation of test results to the agency but shall report only
whether the test was positive or negative.
- (4) The laboratory may transmit results to the MRO by various
electronic means (for example, teleprinters, facsimile, or computer) in
a manner designed to ensure confidentiality of the information. Results
may not be provided verbally by telephone. The laboratory must ensure
the security of the data transmission and limit access to any data
transmission, storage, and retrieval system.
- (5) The laboratory shall send only to the MRO a certified copy of the
original chain of custody form signed by a certifying scientist.
- (6) The laboratory shall provide to the agency official responsible for
coordination of the drug-free workplace program a monthly statistical
summary of urinalysis testing of Federal employees and shall not
include in the summary any personal identifying information. Initial
and confirmation data shall be included from test results reported
within that month. Normally this summary shall be forwarded by
registered or certified mail not more than 14 calendar days after the
end of the month covered by the summary. The summary shall contain the
- (i) Number of specimens received;
- (ii) Number of specimens reported out; and
- (iii) Number of specimens screened positive for:
- (i) Number of specimens received for confirmation;
- (ii) Number of specimens confirmed positive for:
- (7) The laboratory shall make available copies of all analytical
results for Federal drug testing programs when requested by HHS or any
Federal agency for which the laboratory is performing drug testing
- (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. Unless otherwise authorized in writing by the agency, drug
testing laboratories shall retain and place in properly secured longterm
frozen storage for a minimum of 1 year all specimens confirmed
positive. Within this 1- year period an agency may request the
laboratory to retain the specimen for an additional period of time. If
no such request is received, the laboratory may discard the specimen
after the end of 1 year, except that the laboratory shall be required to
maintain any specimens under legal challenge for an indefinite period.
(i) Retesting of a Specimen (i.e., the reanalysis by gas
chromatography/mass spectrometry of a specimen previously reported
positive or the testing of Bottle B of a split specimen collection).
Because some analytes deteriorate or are lost during freezing and/or
storage, quantitation for a retest is not subject to a specific cutoff
requirement but must provide data sufficient to confirm the presence of
the drug or metabolite.
(j) Subcontracting. Drug testing laboratories shall not subcontract and
shall perform all work with their own personnel and equipment unless
otherwise authorized by the agency. The laboratory must be capable of
performing testing for the five classes of drugs (marijuana, cocaine,
opiates, phencyclidine, and amphetamines) using the initial immunoassay
and confirmatory GC/MS methods specified in these Guidelines.
(k) Laboratory Facilities. (1) Laboratory facilities shall comply with
applicable provisions of any State licensure requirements.
(2) Laboratories certified in accordance with Subpart C of these
Guidelines shall have the capability, at the same laboratory premises,
of performing initial and confirmatory tests for each drug or
metabolite for which service is offered.
(l) Inspections. The Secretary, any Federal agency utilizing the
laboratory, or any organization performing laboratory certification on
behalf of the Secretary may reserve the right to inspect the laboratory
at any time. Agency contracts with laboratories for drug testing, as
well as contracts for collection site services, shall permit the agency
to conduct unannounced inspections. In addition, prior to the award of
a contract the agency may carry out preaward inspections and evaluation
of the procedural aspects of the laboratory's drug testing operation.
(m) Documentation. The drug testing laboratories shall maintain and
make available for at least 2 years documentation of all aspects of the
testing process. This 2-year period may be extended upon written
notification by HHS or by any Federal agency for which laboratory
services are being provided. The required documentation shall include
personnel files on all individuals authorized to have access to
specimens; chain of custody forms; quality assurance/quality control
records; procedure manuals; all test data (including calibration curves
and any calculations used in determining test results); reports;
performance records on performance testing; performance on
certification inspections; and hard copies of computer- generated data.
The laboratory shall be required to maintain documents for any specimen
under legal challenge for an indefinite period.
(n) Additional Requirements for Certified Laboratories.
- (1) Procedure Manual. Each laboratory shall have a procedure manual
which includes the principles of each test, preparation of reagents,
standards and controls, calibration procedures, derivation of results,
linearity of methods, sensitivity of the methods, cutoff values,
mechanisms for reporting results, controls, criteria for unacceptable
specimens and results, remedial actions to be taken when the test
systems are outside of acceptable limits, reagents and expiration
dates, and references. Copies of all procedures and dates on which they
are in effect shall be maintained as part of the manual.
- (2) Calibrators and Controls. Laboratory calibrators and controls shall
be prepared using pure drug reference materials, stock standard
solutions obtained from other laboratories, or standard solutions
obtained from commercial manufacturers. The calibrators and controls
shall be properly labeled as to content and concentration. The
standards (e.g., pure reference materials, stock standard solutions,
purchased standards) shall be labeled with the following dates: when
received (if applicable); when prepared or opened; when placed in
service; and expiration date.
- (3) Instruments and Equipment.
- (i) Volumetric pipettes and measuring
devices shall be certified for accuracy or be checked by gravimetric,
colorimetric, or other verification procedure. Automatic pipettes and
dilutors shall be checked for accuracy and reproducibility before being
placed in service and checked periodically thereafter.
- (ii) There shall be written procedures for instrument set-up and normal
operation, a schedule for checking critical operating characteristics
for all instruments, tolerance limits for acceptable function checks,
and instructions for major troubleshooting and repair. Records shall be
available on preventive maintenance.
- (4) Remedial Actions. There shall be written procedures for the actions
to be taken when systems are out of acceptable limits or errors are
detected. There shall be documentation that these procedures are
followed and that all necessary corrective actions are taken. There
shall also be in place systems to verify all stages of testing and
reporting and documentation that these procedures are followed.
- (5) Personnel Available to Testify at Proceedings. A laboratory shall
have qualified personnel available to testify in an administrative or
disciplinary proceeding against a Federal employee when that proceeding
is based on positive urinalysis results reported by the laboratory.
- (6) Restrictions. The laboratory shall not enter into any relationship
with an agency's MRO that may be construed as a potential conflict of
interest or derive any financial benefit by having an agency use a
Section 2.5 Quality Assurance and Quality Control.
- (a) General. Drug testing laboratories shall have a quality assurance
program which encompasses all aspects of the testing process including
but not limited to specimen acquisition, chain of custody, security and
reporting of results, initial and confirmatory testing, certification
of calibrators and controls, and validation of analytical procedures.
Quality assurance procedures shall be designed, implemented, and
reviewed to monitor the conduct of each step of the testing process.
- (b) Laboratory Quality Control Requirements for Initial Tests. Each
analytical run of specimens to be screened shall include:
- (1) Sample(s) certified to contain no drug (i.e., negative urine
- (2) Positive control(s) fortified with drug or metabolite;
- (3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff);
- (4) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of
the cutoff. After acceptable values are obtained for the known
calibrators, those values will be used to calculate sample data;
- (5) A minimum of 10 percent of the total specimens and quality control
samples in each analytical run shall be quality control samples; and
- (6) One percent of each run, with a minimum of at least one sample,
shall be the laboratory's blind quality control samples to appear as
normal samples to the laboratory analysts. Implementation of procedures
to ensure that carryover does not contaminate the testing of an donor's
specimen shall be documented.
- (c) Laboratory Quality Control Requirements for Confirmation Tests.
Each analytical run of specimens to be confirmed shall include:
- (1) Sample(s) certified to contain no drug (i.e., negative urine
- (2) Positive calibrator(s) and control(s) fortified with drug or
- (3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff). The linearity and precision of the method
shall be periodically documented. Implementation of procedures to ensure
that carryover does not contaminate the testing of a donor's specimen
shall also be documented.
- (d) Agency Blind Sample Program.
- (1) Agencies shall only purchase blind quality control materials that:
(a) have been certified by immunoassay and GC/MS and (b) have stability
data which verifies those materials' performance over time.
- (2) During the initial 90-day period of any new drug testing program,
each agency shall submit blind performance test samples to each
laboratory it contracts with in the amount of at least 20 percent of
the total number of specimens submitted (up to a maximum of 200 blind
samples) and thereafter a minimum of 3 percent blind samples (up to a
maximum of 100 blind samples) submitted per quarter.
- (3) Approximately 80 percent of the blind quality control samples shall
be negative (i.e., certified to contain no drug) and the remaining
samples shall be positive for one or more drugs per sample in a
distribution such that all the drugs to be tested are included in
approximately equal frequencies of challenge. The positive samples
shall be spiked only with those drugs for which the agency is testing.
- (4) The agency shall investigate any unsatisfactory blind performance
test sample results and submit its findings to the Secretary. The
Secretary shall continue the investigation to ensure that the
laboratory has corrected the cause of the unsatisfactory performance
test result. A report of the Secretary's investigative findings and the
corrective action taken by the laboratory shall be sent to the agency
contracting officer. The Secretary shall ensure notification of the
finding to all other Federal agencies for which the laboratory is
engaged in urine drug testing and coordinate any necessary action.
- (5) Should a false positive error occur on a blind performance test
sample and the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary shall require the
laboratory to take corrective action to minimize the occurrence of the
particular error in the future; and, if there is reason to believe the
error could have been systematic, the Secretary may also require review
and reanalysis of previously run specimens.
- (6) Should a false positive error occur on a blind performance test
sample and the error is determined to be a technical or methodological
error, the laboratory shall submit all quality control data from the
batch of specimens which included the false positive specimen. In
addition, the laboratory shall retest all specimens analyzed positive
for that drug or metabolite from the time of final resolution of the
error back to the time of the last satisfactory performance test cycle.
This retesting shall be documented by a statement signed by the
Responsible Person. The Secretary may require an on-site review of the
laboratory which may be conducted unannounced during any hours of
operation of the laboratory. The Secretary has the option of revoking
(section 3.13) or suspending (section 3.14) the laboratory's
certification or recommending that no further action be taken if the
case is one of less serious error in which corrective action has
already been taken, thus reasonably assuring that the error will not
Section 2.6 Reporting and Review of Results.
- (a) Medical Review Officer Shall Review Results. An essential part of
the drug testing program is the final review of results. A positive
test result does not automatically identify an employee/applicant as an
illegal drug user. An individual with a detailed knowledge of possible
alternate medical explanations is essential to the review of results.
This review shall be performed by the MRO prior to the transmission of
results to agency administrative officials.
- (b) Medical Review Officer - Qualifications and Responsibilities. The
MRO shall be a licensed physician with knowledge of substance abuse
disorders. The MRO may be an employee of the agency or a contractor for
the agency; however, the MRO shall not be an employee or agent of or
have any financial interest in the laboratory for which the MRO is
reviewing drug testing results. Additionally, the MRO shall not derive
any financial benefit by having an agency use a specific drug testing
laboratory or have any agreement with the laboratory that may be
construed as a potential conflict of interest. The role of the MRO is
to review and interpret positive test results obtained through the
agency's testing program. In carrying out this responsibility, the MRO
shall examine alternate medical explanations for any positive test
result. This action could include conducting a medical interview with
the donor, review of the donor's medical history, or review of any
other relevant biomedical factors. The MRO shall review all medical
records made available by the donor when a confirmed positive test
could have resulted from legally prescribed medication. The MRO shall
not, however, consider the results of urine specimens that are not
obtained or processed in accordance with these Guidelines.
- (c) Positive Test Result. Prior to making a final decision to verify a
positive test result, the MRO shall give the donor an opportunity to
discuss the test result with him or her. Following verification of a
positive test result, the MRO shall report the result to the agency's
official designated to receive results.
- (d) Verification for Opiates; Review for Prescription Medication.
Before the MRO verifies a confirmed positive result for opiates, he or
she shall determine that there is clinical evidence--in addition to the
urine test--of illegal use of any opium, opiate, or opium derivative
(e.g., morphine/codeine) listed in Schedule I or II of the Controlled
Substances Act. This requirement does not apply if the confirmatory
procedure for opiates confirms the presence of 6- monoacetylmorphine
since the presence of this metabolite is proof of heroin use.
- (e) Reanalysis Authorized. Should any question arise as to the accuracy
or validity of a positive test result, only the MRO is authorized to
order a retest of a single specimen or the Bottle A specimen from a
split specimen collection. Such retests are authorized only at
laboratories certified under these Guidelines.
- (f) Result Consistent with Legal Drug Use. If the MRO determines there
is a legitimate medical explanation for the positive test result, he or
she shall take no further action and report the test result as
- (g) Result Scientifically Insufficient. Additionally, the MRO, based on
review of inspection reports, quality control data, and other pertinent
results, may determine that the result is scientifically insufficient
for further action and declare the test specimen negative. In this
situation the MRO may request a retest of the original specimen before
making this decision. (The MRO may request that the retest be performed
by the same laboratory or, as provided in section 2.6(e), that an
aliquot of the original specimen be sent for a retest to an alternate
laboratory which is certified in accordance with these Guidelines.) The
laboratory shall assist in this review process as requested by the MRO
by making available the individual responsible for day-to-day
management of the urine drug testing laboratory or other employee who is
a forensic toxicologist or who has equivalent forensic experience in
urine drug testing, to provide specific consultation as required by the
agency. The MRO shall report to the Secretary all negative findings
based on scientific insufficiency but shall not include any personal
identifying information in such reports.
- (h) Reporting Final Results. The MRO shall report the final results of
the drug tests in writing and in a manner designed to ensure
confidentiality of the information.
Section 2.7 Protection of Employee Records.
Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all
laboratory contracts shall require that the contractor comply with the
Privacy Act, 5 U.S.C. 522a. In addition, laboratory contracts shall
require compliance with patient access and confidentiality provisions
of section 503 of 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 of Records shall specifically
require that employee records be maintained and used with the highest
regard for employee privacy.
Section 2.8 Individual Access to Test and Laboratory Certification Results.
In accordance with section 503 of 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
Subpart C - Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies
Section 3.1 Introduction.
Urine drug testing is a critical component of efforts to combat drug
abuse in our society. Many laboratories are familiar with good
laboratory practices but may be unfamiliar with the special procedures
required when drug test results are used in the employment context.
Accordingly, the following are minimum standards to certify
laboratories engaged in urine drug testing for Federal agencies.
Certification, even at the highest level, does not guarantee accuracy
of each result reported by a laboratory conducting urine drug testing
for Federal agencies. Therefore, results from laboratories certified
under these Guidelines must be interpreted with a complete
understanding of the total collection, analysis, and reporting process
before a final conclusion is made.
Section 3.2 Goals and Objectives of Certification.
- (a) Uses of Urine Drug Testing. Urine drug testing is an important tool
to identify drug users in a variety of settings. In the proper context,
urine drug testing can be used to deter drug abuse in general. To be a
useful tool, the testing procedure must be capable of detecting drugs or
their metabolites at concentrations indicated in sections 2.4(e) and
- (b) Need to Set Standards; Inspections. Reliable discrimination between
the presence, or absence, of specific drugs or their metabolites is
critical, not only to achieve the goals of the testing program but to
protect the rights of the Federal employees being tested. Thus,
standards have been set which laboratories engaged in Federal employee
urine drug testing must meet in order to achieve maximum accuracy of
test results. These laboratories will be evaluated by the Secretary or
the Secretary's designee as defined in section 1.2 in accordance with
these Guidelines. The qualifying evaluation will involve three rounds
of performance testing plus an on-site inspection. Maintenance of
certification requires participation in a quarterly performance testing
program plus periodic, on-site inspections. One inspection following
successful completion of a performance testing regimen is required for
initial certification. This must be followed by a second inspection
within 3 months, after which biannual inspections will be required to
- (c) Urine Drug Testing Applies Analytical Forensic Toxicology. The
possible impact of a positive test result on an individual's livelihood
or rights, together with the possibility of a legal challenge of the
result, sets this type of test apart from most clinical laboratory
testing. In fact, urine drug testing should be considered a special
application of analytical forensic toxicology. That is, in addition to
the application of appropriate analytical methodology, the specimen
must be treated as evidence, and all aspects of the testing procedure
must be documented and available for possible court testimony.
Laboratories engaged in urine drug testing for Federal agencies will
require the services and advice of a qualified forensic toxicologist,
or individual with equivalent qualifications (both training and
experience) to address the specific needs of the Federal drug testing
program, including the demands of chain of custody of specimens,
security, proper documentation of all records, storage of positive
specimens for later or independent testing, presentation of evidence in
court, and expert witness testimony.
Section 3.3 General Certification Requirements.
A laboratory must meet all the pertinent provisions of these Guidelines
in order to qualify for and maintain certification under these
Section 3.4 Capability to Test for Five Classes of Drugs.
To be certified, a laboratory must be capable of testing for at least
the following five classes of drugs: marijuana, cocaine, opiates,
amphetamines, and phencyclidine using the initial immunoassay and
quantitative confirmatory GC/MS methods specified in these Guidelines.
The certification program will be limited to the five classes of drugs
(sections 2.1(a)(1) and (2)) and the methods (sections 2.4(e) and (f))
specified in these Guidelines. The laboratory will be surveyed and
performance tested only for these methods and drugs. Certification of a
laboratory indicates that any test result reported by the laboratory for
the Federal Government meets the standards in these Guidelines for the
five classes of drugs using the methods specified. Certified
laboratories must clearly inform all unregulated, private clients when
their specimens are being tested using procedures that are different
from those for which the laboratory is certified (i.e., testing
specimens not under the Guidelines).
Section 3.5 Initial and Confirmatory Capability at Same Site.
Certified laboratories shall have the capability, at the same
laboratory site, of performing both initial immunoassays and
confirmatory GC/MS tests (sections 2.4(e) and (f)) for marijuana,
cocaine, opiates, amphetamines, and phencyclidine and for any other
drug or metabolite for which agency drug testing is authorized
(sections 2.1(a)(1) and (2)). All positive initial test results shall
be confirmed prior to reporting them.
Section 3.6 Personnel.
Laboratory personnel shall meet the requirements specified in section
2.3 of these Guidelines. These Guidelines establish the exclusive
standards for qualifying or certifying those laboratory personnel
involved in urinalysis testing whose functions are prescribed by these
Guidelines. A certification of a laboratory under these Guidelines
shall be a determination that these qualification requirements have
Section 3.7 Quality Assurance and Quality Control.
Drug testing laboratories shall have a quality assurance program which
encompasses all aspects of the testing process, including but not
limited to specimen acquisition, chain of custody, security and
reporting of results, initial and confirmatory testing, and validation
of analytical procedures. Quality control procedures shall be designed,
implemented, and reviewed to monitor the conduct of each step of the
process of testing for drugs as specified in section 2.5 of these
Section 3.8 Security and Chain of Custody.
Laboratories shall meet the security and chain of custody requirements
provided in section 2.4(a).
Section 3.9 One-Year Storage for Confirmed Positives.
All confirmed positive specimens shall be retained in accordance with
the provisions of section 2.4(h) of these Guidelines.
Section 3.10 Documentation.
The laboratory shall maintain and make available for at least 2 years
documentation in accordance with the specifications in section 2.4(m).
Section 3.11 Reports.
The laboratory shall report test results in accordance with the
specifications in section 2.4(g).
Section 3.12 Certification.
- (a) General. The Secretary may certify any laboratory that meets the
standards in these Guidelines to conduct urine drug testing. In
addition, the Secretary may consider to be certified any laboratory
that is certified by an HHS-recognized certification program in
accordance with these Guidelines.
- (b) Criteria. In determining whether to certify a laboratory or to
accept the certification of an HHS-recognized certification program in
accordance with these Guidelines, the Secretary shall consider the
- (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
- (4) The performance of the laboratory on any performance tests;
- (5) The laboratory's compliance with standards as reflected in any
laboratory inspections; and
- (6) Any other factors affecting the reliability and accuracy of drug
tests and reporting done by the laboratory.
- (c) Corrective Action by Certified Laboratories. A laboratory must meet
all the pertinent provisions of these Guidelines in order to qualify
for and maintain certification. The Secretary has broad discretion to
take appropriate action to ensure the full reliability and accuracy of
drug testing and reporting, to resolve problems related to drug
testing, and to enforce all standards set forth in these Guidelines.
The Secretary shall have the authority to issue directives to any
laboratory suspending the use of certain analytical procedures when
necessary to protect the integrity of the testing process; ordering any
laboratory to undertake corrective actions to respond to material
deficiencies identified by an inspection or through proficiency
testing; ordering any laboratory to send aliquots of urine specimens to
another laboratory for retesting when necessary to ensure the accuracy
of testing under these Guidelines; ordering the review of results for
specimens tested under the Guidelines for private sector clients to the
extent necessary to ensure the full reliability of drug testing for
Federal agencies; and ordering any other action necessary to address
deficiencies in drug testing, analysis, specimen collection, chain of
custody, reporting of results, or any other aspect of the certification
Section 3.13 Revocation.
- (a) General. The Secretary shall revoke certification of any laboratory
certified under these provisions or accept revocation by an HHSrecognized
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
- (3) A material violation of a certification standard or a contract term
or other condition imposed on the laboratory by a Federal agency using
the laboratory's services;
- (4) Conviction for any criminal offense committed as an incident to
operation of the laboratory; or
- (5) Any other cause which materially affects the ability of the
laboratory to ensure the full reliability and accuracy of drug tests
and the accurate reporting of results.
- (c) Period and Terms. The period and terms of revocation shall be
determined by the Secretary and shall depend upon the facts and
circumstances of the revocation and the need to ensure accurate and
reliable drug testing of Federal employees.
Section 3.14 Suspension.
- (a) Criteria. Whenever the Secretary has reason to believe that
revocation may be required and that immediate action is necessary in
order to protect the interests of the United States and its employees,
the Secretary may immediately suspend a laboratory's certification to
conduct urine drug testing for Federal agencies. The Secretary may also
accept suspension of certification by an HHS-recognized certification
program in accordance with these Guidelines.
- (b) Period and Terms. The period and terms of suspension shall be
determined by the Secretary and shall depend upon the facts and
circumstances of the suspension and the need to ensure accurate and
reliable drug testing of Federal employees.
Section 3.15 Notice.
- (a) Written Notice. When a laboratory is suspended or the Secretary
seeks to revoke certification, the Secretary shall immediately serve
the laboratory with written notice of the suspension or proposed
revocation by facsimile mail, personal service, or registered or
certified mail, return receipt requested. This notice shall state the
- (1) The reasons for the suspension or proposed revocation;
- (2) The terms of the suspension or proposed revocation; and
- (3) The period of suspension or proposed revocation.
- (b) Opportunity for Informal Review. The written notice shall state
that the laboratory will be afforded an opportunity for an informal
review of the suspension or proposed revocation if it so requests in
writing within 30 days of the date the laboratory received the notice,
or if expedited review is requested, within 3 days of the date the
laboratory received the notice. Subpart D contains detailed procedures
to be followed for an informal review of the suspension or proposed
- (c) Effective Date. A suspension shall be effective immediately. A
proposed revocation shall be effective 30 days after written notice is
given or, if review is requested, upon the reviewing official's
decision to uphold the proposed revocation. If the reviewing official
decides not to uphold the suspension or proposed revocation, the
suspension shall terminate immediately and any proposed revocation
shall not take effect.
- (d) HHS-Recognized Certification Program. The Secretary's
responsibility under this section may be carried out by an HHSrecognized
certification program in accordance with these Guidelines.
- (e) Public Notice. The Secretary will publish in the Federal Register
the name, address, and telephone number of any laboratory that has its
certification suspended or revoked under section 3.13 or section 3.14,
respectively, and the name of any laboratory which has its suspension
lifted. The Secretary shall provide to any member of the public upon
request the written notice provided to a laboratory that has its
certification suspended or revoked, as well as the reviewing official's
written decision which upholds or denies the suspension or proposed
revocation under the procedures of subpart D.
Section 3.16 Recertification.
Following revocation, a laboratory may apply for recertification.
Unless otherwise provided by the Secretary in the notice of revocation
under section 3.13(a) or the reviewing official's decision under
section 4.9(e) or 4.14(a), a laboratory which has had its certification
revoked may apply for certification in accordance with this section. In
order to be certified, the laboratory shall meet the criteria of
section 3.12(b), as well as all other requirements of these Guidelines,
including the successful participation in three cycles of performance
testing (sections 3.17(b) and 3.19(a)) and a laboratory inspection
(sections 3.2(b) and 3.20). Once certified, the laboratory must undergo
a second inspection within three months, after which biannual
inspections will be required to maintain certification (section
3.2(b)), as well as participation in the quarterly performance testing
program (sections 3.1(b) and 3.17(c)).
Section 3.17 Performance Testing (PT) Requirement for Certification.
- (a) An Initial and Continuing Requirement. The PT program is a part of
the initial evaluation of a laboratory seeking certification (both PT
and laboratory inspection are required) and of the continuing
assessment of laboratory performance necessary to maintain this
- (b) Three Initial Cycles Required. Successful participation in three
cycles of testing shall be required before a laboratory is eligible to
be considered for certification.
- (c) Four Challenges Per Year. After certification, laboratories shall
be challenged with at least 10 PT samples on a quarterly cycle.
- (d) Laboratory Procedures Identical for Performance Test and Routine
Employee Specimens. All procedures associated with the handling and
testing of the PT samples by the laboratory shall to the greatest extent
possible be carried out in a manner identical to that applied to
routine laboratory specimens, unless otherwise specified.
- (e) Blind Performance Test. Any certified laboratory shall be subject to
blind PT samples (see section 2.5(d)). Performance on blind PT samples
shall be at the same level as for the open or non-blind PT samples.
- (f) Reporting - Open Performance Test. The laboratory shall report
results of open PT samples to the certifying organization in the same
manner as specified in section 2.4(g)(2) for routine specimens.
Section 3.18 Performance Test Samples Composition.
- (a) Description of the Drugs. PT samples shall contain those drugs and
metabolites which each certified laboratory must be prepared to assay
in concentration ranges that allow detection of the analytes by
commonly used immunoassay screening techniques. These levels are
generally in the range of concentrations which might be expected in the
urine of recent drug users. For some drug analytes, the sample
composition will consist of the parent drug as well as major
metabolites. In some cases, more than one drug class may be included in
one sample, but generally no more than two drugs will be present in any
one sample in order to imitate the type of specimen which a laboratory
normally encounters. For any particular PT cycle, the actual
composition of kits going to different laboratories will vary but,
within any annual period, all laboratories participating will have
analyzed the same total set of samples.
- (b) Concentrations. PT samples (as differentiated from blind quality
control samples) shall be spiked with the drug classes and their
metabolites that are required for certification (marijuana, cocaine,
opiates, amphetamines, and phencyclidine) with concentration levels set
by, but not limited to, one of the following schema:
- (1) at least 20 percent above the cutoff limit for either the initial assay or the
confirmatory test, depending on which is to be evaluated;
- (2) below the cutoff limit as retest samples (for GC/MS quantitation); and,
- (3) below the cutoff limit for special purposes. Some PT samples may be
identified for GC/MS assay only (retest samples). Blanks shall contain
less than 2 ng/mL of any of the target drugs. These concentration and
drug types may be changed periodically in response to factors such as
changes in detection technology and patterns of drug use. Finally, PT
samples may be constituted with interfering substances.
Section 3.19 Evaluation of Performance Testing.
- (a) Initial Certification.
- (1) An applicant laboratory shall not report
any false positive result during PT for initial certification. Any
false positive will automatically disqualify a laboratory from further
- (2) An applicant laboratory shall maintain an overall grade level of 90
percent for the three cycles of PT required for initial certification,
i.e., it must correctly identify and confirm 90 percent of the total
drug challenges. Any laboratory which achieves a score on any one cycle
of the initial certification such that it can no longer achieve a total
grade of 90 percent over the three consecutive PT cycles will be
immediately disqualified from further consideration.
- (3) An applicant laboratory shall obtain quantitative values for at
least 80 percent of the total drug challenges which are ±20 percent or
±2 standard deviations (whichever range is larger) of the calculated
reference group mean. Failure to achieve 80 percent will result in
- (4) An applicant laboratory shall not obtain any quantitative values
that differ by more than 50 percent from the calculated reference group
mean. Any quantitative values that differ by more than 50 percent will
result in disqualification.
- (5) For any individual drug, an applicant laboratory shall successfully
detect and quantitate in accordance with paragraphs (a)(2),(a)(3), and
(a)(4) of this section at least 50 percent of the total drug
challenges. Failure to successfully quantitate at least 50 percent of
the challenges for any individual drug will result in disqualification.
- (b.) Ongoing Testing of Certified Laboratories.
- (1) False Positives and Procedures for Dealing with Them. No false drug identifications are
acceptable for any drugs for which a laboratory offers service. Under
some circumstances a false positive test may result in suspension or
revocation of certification. The most serious false positives are by
drug class, such as reporting THC in a blank specimen or reporting
cocaine in a specimen known to contain only opiates. Misidentifications
within a class (e.g., codeine for morphine) are also false positives
which are unacceptable in an appropriately controlled laboratory, but
they are clearly less serious errors than misidentification of a class.
The following procedures shall be followed when dealing with a false
- (i) The agency detecting a false positive error shall immediately
notify the laboratory and the Secretary of any such error.
- (ii) The laboratory shall provide the Secretary with a written
explanation of the reasons for the error within 5 working days. If
required by paragraph (b)(1)(v) below, this explanation shall include
the submission of all quality control data from the batch of specimens
that included the false positive specimen.
- (iii) The Secretary shall review the laboratory's explanation within 5
working days and decide what further action, if any, to take.
- (iv) If the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary may direct the laboratory
to take corrective action to minimize the occurrence of the particular
error in the future and, if there is reason to believe the error could
have been systematic, may require the laboratory to review and
reanalyze previously run specimens.
- (v) If the error is determined to be a technical or methodological
error, the laboratory shall submit to the Secretary all quality control
data from the batch of specimens which included the false positive
specimen. In addition, the laboratory shall retest all specimens
analyzed positive by the laboratory from the time of final resolution
of the error back to the time of the last satisfactory performance test
cycle. This retesting shall be documented by a statement signed by the
laboratory's responsible person. Depending on the type of error which
caused the false positive, this retesting may be limited to one analyte
or may include any drugs a laboratory certified under these Guidelines
must be prepared to assay. The laboratory shall immediately notify the
agency if any result on a specimen that has been retested must be
corrected because the criteria for a positive are not satisfied. The
Secretary may suspend or revoke the laboratory's certification for all
drugs or for only the drug or drug class in which the error occurred.
However, if the case is one of a less serious error for which effective
corrections have already been made, thus reasonably assuring that the
error will not occur again, the Secretary may decide to take no further
- (vi) During the time required to resolve the error, the
laboratory shall remain certified but shall have a designation
indicating that a false positive result is pending resolution. If the
Secretary determines that the laboratory's certification must be
suspended or revoked, the laboratory's official status will become
"Suspended" or "Revoked" until the suspension or revocation is lifted
or any recertification process is complete.
- (2) Requirement to Identify and Confirm 90 Percent of Total Drug
Challenges. In order to remain certified, laboratories must
successfully complete four cycles of PT per year. Failure of a
certified laboratory to maintain a grade of 90 percent over the span of
two consecutive PT cycles, i.e., to identify 90 percent of the total
drug challenges and to correctly confirm 90 percent of the total drug
challenges, may result in suspension or revocation of certification.
- (3) Requirement to Quantitate 80 Percent of Total Drug Challenges at
±20 Percent or ±2 Standard Deviations. Quantitative values obtained
by a certified laboratory for at least 80 percent of the total drug
challenges must be ±20 percent or ±2 standard deviations (whichever
range is larger) of the appropriate reference or peer group mean as
measured over two consecutive PT cycles.
- (4) Requirement to Quantitate within 50 Percent of Calculated Reference
Group Mean. After achieving certification a laboratory is permitted one
quantitative result differing by more than 50% from the target value
within two consecutive cycles of PT. More than one error of this type
within two consecutive PT cycles may result in a suspension or proposed
- (5)Requirement to Successfully Detect and Quantitate 50 Percent of the
Total Drug Challenges for Any Individual Drug. For any individual drug,
a certified laboratory must successfully detect and quantitate in
accordance with paragraphs (b)(2),(b)(3), and (b)(4) of this section at
least 50 percent of the total drug challenges.
- (6) Procedures When Requirements in Paragraphs (b)(2) - (b)(5) of this
Section Are Not Met. If a certified laboratory fails to maintain a
grade of 90 percent over the span of two consecutive PT cycles after
initial certification as required by paragraph (b)(2) of this section
or if it fails to successfully quantitate results as required by
paragraphs (b)(3),(b)(4), or (b)(5) of this section, the laboratory
shall be immediately informed that its performance fell under the 90
percent level or that it failed to quantitate test results successfully
and how it failed to quantitate successfully. The laboratory shall be
allowed 5 working days in which to provide any explanation for its
unsuccessful performance, including administrative error or
methodological error, and evidence that the source of the poor
performance has been corrected. The Secretary may revoke or suspend the
laboratory's certification or take no further action, depending on the
seriousness of the errors and whether there is evidence that the source
of the poor performance has been corrected and that current performance
meets the requirements for a certified laboratory under these
Guidelines. The Secretary may require that additional performance tests
be carried out to determine whether the source of the poor performance
has been removed. If the Secretary determines to suspend or revoke the
laboratory's certification, the laboratory's official status will
become "Suspended" or "Revoked" until the suspension or revocation is
lifted or until any recertification process is complete.
- (c) 80 Percent of Participating Laboratories Must Detect Drug. A
laboratory's performance shall be evaluated for all samples for which
drugs were spiked at concentrations above the specified performance
test level unless the overall response from participating laboratories
indicates that less than 80 percent of them were able to detect a drug.
- (d) Participation Required. Failure to participate in a PT cycle or to
participate satisfactorily may result in suspension or revocation of
Section 3.20 Inspections.
- (a) Frequency. Prior to laboratory certification under these Guidelines
and at least twice a year after certification, a team of three
qualified inspectors, at least two of whom have been trained as
laboratory inspectors, shall conduct an on-site inspection of
laboratory premises. Inspections shall document the overall quality of
the laboratory setting for the purposes of certification to conduct
urine drug testing. Inspection reports may also contain recommendations
to the laboratory to correct deficiencies noted during the inspection.
- (b) Inspectors. The Secretary shall establish criteria for the
selection of inspectors to ensure high quality, unbiased, and thorough
inspections. The inspectors shall perform inspections consistent with
the guidance provided by the Secretary. Inspectors shall document the
overall quality of the laboratory's drug testing operation.
- (c) Inspection Performance. The laboratory's operation shall be
consistent with good forensic laboratory practice and shall be in
compliance with these Guidelines. It is the laboratory's responsibility
to correct deficiencies identified during the inspection and to have
the knowledge, skill, and expertise to correct deficiencies consistent
with good forensic laboratory practice. Consistent with sections 3.13
and 3.14, deficiencies identified at inspections may be the basis for
suspending or revoking a laboratory's certification.
Section 3.21 Results of Inadequate Performance.
Failure of a laboratory to comply with any aspect of these Guidelines
may lead to revocation or suspension of certification as provided in
sections 3.13 and 3.14 of these Guidelines.
Section 3.22 Listing of Certified Laboratories.
A Federal Register listing of laboratories certified by HHS will be
updated and published periodically. Laboratories which are in the
applicant stage of HHS certification are not to be considered as
meeting the minimum requirements in these Guidelines. A laboratory is
not certified until HHS has sent the laboratory an HHS letter of
Subpart D - Procedures for Review of Suspension or Proposed Revocation of a Certified Laboratory.
Section 4.1 Applicability.
These procedures apply when:
- (a) The Secretary has notified a laboratory in writing that its
certification to perform urine drug testing under these Mandatory
Guidelines for Federal Workplace Drug Testing Programs has been
suspended or that the Secretary proposes to revoke such certification.
- (b) The laboratory has, within 30 days of the date of such notification
or within 3 days of the date of such notification when seeking an
expedited review of a suspension, requested in writing an opportunity
for an informal review of the suspension or proposed revocation.
Section 4.2 Definitions.
Appellant Means the laboratory which has been notified of its
suspension or proposed revocation of its certification to perform urine
drug testing and has requested an informal review thereof.
Respondent Means the person or persons designated by the Secretary in
implementing these Guidelines (currently the National Laboratory
Certification Program is located in the Division of Workplace Programs,
Substance Abuse and Mental Health Services Administration).
Reviewing Official Means the person or persons designated by the
Secretary who will review the suspension or proposed revocation. The
reviewing official may be assisted by one or more of his or her
employees or consultants in assessing and weighing the scientific and
technical evidence and other information submitted by the appellant and
respondent on the reasons for the suspension and proposed revocation.
Section 4.3 Limitation on Issues Subject to Review.
The scope of review shall be limited to the facts relevant to any
suspension or proposed revocation, the necessary interpretations of
those facts, the Mandatory Guidelines for Federal Workplace Drug
Testing Programs, and other relevant law. The legal validity of the
Mandatory Guidelines shall not be subject to review under these
Section 4.4 Specifying Who Represents the Parties.
The appellant's request for review shall specify the name, address, and
phone number of the appellant's representative. In its first written
submission to the reviewing official, the respondent shall specify the
name, address, and phone number of the respondent's representative.
Section 4.5 The Request for Informal Review and the Reviewing Official's Response.
- (a) Within 30 days of the date of the notice of the suspension or
proposed revocation, the appellant must submit a written request to the
reviewing official seeking review, unless some other time period is
agreed to by the parties. A copy must also be sent to the respondent.
The request for review must include a copy of the notice of suspension
or proposed revocation, a brief statement of why the decision to
suspend or propose revocation is wrong, and the appellant's request for
an oral presentation, if desired.
- (b) Within 5 days after receiving the request for review, the reviewing
official will send an acknowledgment and advise the appellant of the
next steps. The reviewing official will also send a copy of the
acknowledgment to the respondent.
Section 4.6 Abeyance Agreement.
Upon mutual agreement of the parties to hold these procedures in
abeyance, the reviewing official will stay these procedures for a
reasonable time while the laboratory attempts to regain compliance with
the Mandatory Guidelines for Federal Workplace Drug Testing Programs or
the parties otherwise attempt to settle the dispute. As part of an
abeyance agreement, the parties can agree to extend the time period for
requesting review of the suspension or proposed revocation. If abeyance
begins after a request for review has been filed, the appellant shall
notify the reviewing official at the end of the abeyance period
advising whether the dispute has been resolved. If the dispute has been
resolved, the request for review will be dismissed. If the dispute has
not been resolved, the review procedures will begin at the point at
which they were interrupted by the abeyance agreement with such
modifications to the procedures as the reviewing official deems
Section 4.7 Preparation of the Review File and Written Argument.
The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments.
The procedures for development of the review file and submission of
written argument are:
- (a) Appellant's Documents and Brief. Within 15 days after receiving the
acknowledgment of the request for review, the appellant shall submit to
the reviewing official the following (with a copy to the respondent):
- (1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
- (2) A written statement, not to exceed 20 double-spaced pages,
explaining why respon- dent's decision to suspend or propose revocation
of appellant's certification is wrong (appellant's brief).
- (b) Respondent's Documents and Brief. Within 15 days after receiving a
copy of the acknowledgment of the request for review, the respondent
shall submit to the reviewing official the following (with a copy to
- (1) A review file containing documents supporting respondent's decision
to suspend or revoke appellant's certification to perform urine drug
testing, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
- (2) A written statement, not exceeding 20 double-spaced pages in
length, explaining the basis for suspension or proposed revocation
- (c) Reply Briefs. Within 5 days after receiving the opposing party's
submission, or 20 days after receiving acknowledgment of the request
for review, whichever is later, each party may submit a short reply not
to exceed 10 double-spaced pages.
- (d) Cooperative Efforts. Whenever feasible, the parties should attempt
to develop a joint review file.
- (e) Excessive Documentation. The reviewing official may take any
appropriate step to reduce excessive documentation, including the
return of or refusal to consider documentation found to be irrelevant,
redundant, or unnecessary.
Section 4.8 Opportunity for Oral Presentation.
- (a) Electing Oral Presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the time it
submits its written request for review to the reviewing official. The
reviewing official will grant the request if the official determines
that the decision- making process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide
for an oral presentation at the official's own initiative or at the
request of the respondent.
- (b) Presiding Official. The reviewing official or designee will be the
presiding official responsible for conducting the oral presentation.
- (c) Preliminary Conference. The presiding official may hold a
prehearing conference (usually a telephone conference call) to consider
any of the following: simplifying and clarifying issues; stipulations
and admissions; limitations on evidence and witnesses that will be
presented at the hearing; time allotted for each witness and the
hearing altogether; scheduling the hearing; and any other matter that
will assist in the review process. Normally, this conference will be
conducted informally and off the record; however, the presiding
official may, at his or her discre- tion, produce a written document
summarizing the conference or transcribe the conference, either of
which will be made a part of the record.
- (d) Time and Place of Oral Presentation. The presiding official will
attempt to schedule the oral presentation within 30 days of the date
appellant's request for review is received or within 10 days of
submission of the last reply brief, whichever is later. The oral
presentation will be held at a time and place determined by the
presiding official following consultation with the parties.
- (e) Conduct of the Oral Presentation.
- (1) General. The presiding official is responsible for conducting the
oral presentation. The presiding official may be assisted by one or
more of his or her employees or consultants in conducting the oral
presentation and reviewing the evidence. While the oral presentation
will be kept as informal as possible, the presiding official may take
all necessary steps to ensure an orderly proceeding.
- (2) Burden of Proof/Standard of Proof. In all cases, the respondent
bears the burden of proving by a preponderance of the evidence that its
decision to suspend or propose revocation is appropriate. The
appellant, however, has a responsibility to respond to the respondent's
allegations with evidence and argument to show that the respondent is
- (3) Admission of Evidence. The rules of evidence do not apply and the
presiding official will generally admit all testimonial evidence unless
it is clearly irrelevant, immaterial, or unduly repetitious. Each party
may make an opening and closing statement, may present witnesses as
agreed upon in the prehearing conference or otherwise, and may question
the opposing party's witnesses. Since the parties have ample
opportunity to prepare the review file, a party may introduce
additional documentation during the oral presentation only with the
permission of the presiding official. The presiding official may
question witnesses directly and take such other steps necessary to
ensure an effective and efficient consideration of the evidence,
including setting time limitations on direct and cross-examinations.
- (4) Motions. The presiding official may rule on motions including, for
example, motions to exclude or strike redundant or immaterial evidence,
motions to dismiss the case for insufficient evidence, or motions for
summary judgment. Except for those made during the hearing, all motions
and opposition to motions, including argument, must be in writing and
be no more than 10 double-spaced pages in length. The presiding
official will set a reasonable time for the party opposing the motion
- (5) Transcripts. The presiding official shall have the oral
presentation transcribed and the transcript shall be made a part of the
record. Either party may request a copy of the transcript and the
requesting party shall be responsible for paying for its copy of the
- (f) Obstruction of Justice or Making of False Statements. Obstruction
of justice or the making of false statements by a witness or any other
person may be the basis for a criminal prosecution under 18 U.S.C. 1505
- (g) Post-hearing Procedures. At his or her discretion, the presiding
official may require or permit the parties to submit post-hearing
briefs or proposed findings and conclusions. Each party may submit
comments on any major prejudicial errors in the transcript.
Section 4.9 Expedited Procedures for Review of Immediate Suspension.
- (a) Applicability. When the Secretary notifies a laboratory in writing
that its certification to perform urine drug testing has been
immediately suspended, the appellant may request an expedited review of
the suspension and any proposed revocation. The appellant must submit
this request in writing to the reviewing official within 3 days of the
date the laboratory received notice of the suspension. The request for
review must include a copy of the suspension and any proposed
revocation, a brief statement of why the decision to suspend and
propose revocation is wrong, and the appellant's request for an oral
presentation, if desired. A copy of the request for review must also be
sent to the respondent.
- (b) Reviewing Official's Response. As soon as practicable after the
request for review is received, the reviewing official will send an
acknowledgment with a copy to the respondent.
- (c) Review File and Briefs. Within 7 days of the date the request for
review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
- (1) a review file containing essential documents relevant to
the review, tabbed, indexed, and organized chronologically, and
- (2) a written statement, not to exceed 20 double-spaced pages, explaining the
party's position concerning the suspension and any proposed revocation.
No reply brief is permitted.
- (d) Oral Presentation. If an oral presentation is requested by the
appellant or otherwise granted by the reviewing official, the presiding
official will attempt to schedule the oral presentation within 7-10
days of the date of appellant's request for review at a time and place
determined by the presiding official following consultation with the
parties. The presiding official may hold a pre-hearing conference in
accordance with section 4.8(c) and will conduct the oral presentation
in accordance with the procedures of sections 4.8(e),(f),and (g).
- (e) Written Decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation and
will attempt to issue the decision within 7-10 days of the date of the
oral presentation or within 3 days of the date on which the transcript
is received or the date of the last submission by either party,
whichever is later. All other provisions set forth in section 4.14 will
- (f) Transmission of Written Communications. Because of the importance
of timeliness for these expedited procedures, all written
communications between the parties and between either party and the
reviewing official shall be by facsimile or overnight mail.
Section 4.10 Ex parte Communications.
Except for routine administrative and procedural matters, a party shall
not communicate with the reviewing or presiding official without notice
to the other party.
Section 4.11 Transmission of Written Communications by Reviewing Official and Calculation of Deadlines.
- (a) Because of the importance of a timely review, the reviewing
official should normally transmit written communications to either
party by facsimile or overnight mail in which case the date of
transmission or day following mailing will be considered the date of
receipt. In the case of communications sent by regular mail, the date
of receipt will be considered 3 days after the date of mailing.
- (b) In counting days, include Saturdays, Sundays, and holidays.
However, if a due date falls on a Saturday, Sunday, or Federal holiday,
then the due date is the next Federal working day.
Section 4.12 Authority and Responsibilities of Reviewing Official.
In addition to any other authority specified in these procedures, the
reviewing official and the presiding official, with respect to those
authorities involving the oral presentation, shall have the authority
to issue orders; examine witnesses; take all steps necessary for the
conduct of an orderly hearing; rule on requests and motions; grant
extensions of time for good reasons; dismiss for failure to meet
deadlines or other requirements; order the parties to submit relevant
information or witnesses; remand a case for further action by the
respondent; waive or modify these procedures in a specific case,
usually with notice to the parties; reconsider a decision of the
reviewing official where a party promptly alleges a clear error of fact
or law; and to take any other action necessary to resolve disputes in
accordance with the objectives of these procedures.
Section 4.13 Administrative Record.
The administrative record of review consists of the review file; other
submissions by the parties; transcripts or other records of any
meetings, conference calls, or oral presentation; evidence submitted at
the oral presentation; and orders and other documents issued by the
reviewing and presiding officials.
Section 4.14 Written Decision.
- (a) Issuance of Decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation.
The decision will set forth the reasons for the decision and describe
the basis therefor in the record. Furthermore, the reviewing official
may remand the matter to the respondent for such further action as the
reviewing official deems appropriate.
- (b) Date of Decision. The reviewing official will attempt to issue his
or her decision within 15 days of the date of the oral presentation,
the date on which the transcript is received, or the date of the last
submission by either party, whichever is later. If there is no oral
presentation, the decision will normally be issued within 15 days of
the date of receipt of the last reply brief. Once issued, the reviewing
official will immediately communicate the decision to each party.
- (c) Public Notice. If the suspension and proposed revocation are
upheld, the revocation will become effective immediately and the public
will be notified by publication of a notice in the Federal Register.
If the suspension and proposed revocation are denied, the revocation
will not take effect and the suspension will be lifted immediately.
Public notice will be given by publication in the Federal Register.
Section 4.15 Court Review of Final Administrative
Action; Exhaustion of Administrative Remedies.
Before any legal action is filed in court challenging the suspension or
proposed revocation, respondent shall exhaust administrative remedies
provided under this subpart, unless otherwise provided by Federal Law.
The reviewing official's decision, under section 4.9(e) or 4.14(a),
constitutes final agency action and is ripe for judicial review as of
the date of the decision
"This Mandatory Guidelines Federal Workplace is provided as
a SAMPLE only and without any warranty, express or implied,
as to its legal effect. The Mandatory Guidelines Federal
Workplace should be used as a guide and is not a substitute
for obtaining legal advice and may not be suitable for all