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Subpart C - Certification of Laboratories Engaged in
Urine Drug Testing for Federal Agencies
Section 3.1 Introduction.
Urine drug testing is a critical component of efforts to combat
drug abuse in our society. Many laboratories are familiar with
good laboratory practices but may be unfamiliar with the special
procedures required when drug test results are used in the employment
context. Accordingly, the following are minimum standards to certify
laboratories engaged in urine drug testing for Federal agencies.
Certification, even at the highest level, does not guarantee accuracy
of each result reported by a laboratory conducting urine drug
testing for Federal agencies. Therefore, results from laboratories
certified under these Guidelines must be interpreted with a complete
understanding of the total collection, analysis, and reporting
process before a final conclusion is made.
Section 3.2 Goals and Objectives of Certification.
(a) Uses of Urine Drug Testing. Urine drug testing is an important
tool to identify drug users in a variety of settings. In the proper
context, urine drug testing can be used to deter drug abuse in
general. To be a useful tool, the testing procedure must be capable
of detecting drugs or their metabolites at concentrations indicated
in sections 2.4(e) and 2.4(f).
(b) Need to Set Standards; Inspections. Reliable discrimination
between the presence, or absence, of specific drugs or their metabolites
is critical, not only to achieve the goals of the testing program
but to protect the rights of the Federal employees being tested.
Thus, standards have been set which laboratories engaged in Federal
employee urine drug testing must meet in order to achieve maximum
accuracy of test results. These laboratories will be evaluated
by the Secretary or the Secretary's designee as defined in section
1.2 in accordance with these Guidelines. The qualifying evaluation
will involve three rounds of performance testing plus an on-site
inspection. Maintenance of certification requires participation
in a quarterly performance testing program plus periodic, on-site
inspections. One inspection following successful completion of
a performance testing regimen is required for initial certification.
This must be followed by a second inspection within 3 months,
after which biannual inspections will be required to maintain
(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
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
Certified laboratories shall have the capability, at the same
laboratory site, of performing both initial immunoassays and confirmatory
GC/MS tests (sections 2.4(e) and (f)) for marijuana, cocaine,
opiates, amphetamines, and phencyclidine and for any other drug
or metabolite for which agency drug testing is authorized (sections
2.1(a)(1) and (2)). All positive initial test results shall be
confirmed prior to reporting them.
Section 3.6 Personnel.
Laboratory personnel shall meet the requirements specified in
section 2.3 of these Guidelines. These Guidelines establish the
exclusive standards for qualifying or certifying those laboratory
personnel involved in urinalysis testing whose functions are prescribed
by these Guidelines. A certification of a laboratory under these
Guidelines shall be a determination that these qualification requirements
have been met.
Section 3.7 Quality Assurance and Quality Control.
Drug testing laboratories shall have a quality assurance program
which encompasses all aspects of the testing process, including
but not limited to specimen acquisition, chain of custody, security
and reporting of results, initial and confirmatory testing, and
validation of analytical procedures. Quality control procedures
shall be designed, implemented, and reviewed to monitor the conduct
of each step of the process of testing for drugs as specified
in section 2.5 of these Guidelines.
Section 3.8 Security and Chain of Custody.
Laboratories shall meet the security and chain of custody requirements
provided in section 2.4(a).
Section 3.9 One-Year Storage for Confirmed Positives.
All confirmed positive specimens shall be retained in accordance
with the provisions of section 2.4(h) of these Guidelines.
Section 3.10 Documentation.
The laboratory shall maintain and make available for at least
2 years documentation in accordance with the specifications in
Section 3.11 Reports.
The laboratory shall report test results in accordance with the
specifications in section 2.4(g).
Section 3.12 Certification.
(a) General. The Secretary may certify any laboratory that meets
the standards in these Guidelines to conduct urine drug testing.
In addition, the Secretary may consider to be certified any laboratory
that is certified by an HHS-recognized certification program in
accordance with these Guidelines.
(b) Criteria. In determining whether to certify a laboratory
or to accept the certification of an HHS-recognized certification
program in accordance with these Guidelines, the Secretary shall
consider the following criteria:
(1) The adequacy of the laboratory facilities;
(2) The expertise and experience of the laboratory personnel;
(3) The excellence of the laboratory's quality assurance/ quality
(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 HHS-recognized
certification program in accordance with these Guidelines if the
Secretary determines that revocation is necessary to ensure the
full reliability and accuracy of drug tests and the accurate reporting
of test results.
(b) Factors to Consider. The Secretary shall consider the following
factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the
results of drug tests; for example, a false positive error in
reporting the results of an employee's drug test;
(2) Unsatisfactory participation in performance evaluations or
(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
(b) Period and Terms. The period and terms of suspension shall
be determined by the Secretary and shall depend upon the facts
and circumstances of the suspension and the need to ensure accurate
and reliable drug testing of Federal employees.
Section 3.15 Notice.
(a) Written Notice. When a laboratory is suspended or the Secretary
seeks to revoke certification, the Secretary shall immediately
serve the laboratory with written notice of the suspension or
proposed revocation by facsimile mail, personal service, or registered
or certified mail, return receipt requested. This notice shall
state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) Opportunity for Informal Review. The written notice shall
state that the laboratory will be afforded an opportunity for
an informal review of the suspension or proposed revocation if
it so requests in writing within 30 days of the date the laboratory
received the notice, or if expedited review is requested, within
3 days of the date the laboratory received the notice. Subpart
D contains detailed procedures to be followed for an informal
review of the suspension or proposed revocation.
(c) Effective Date. A suspension shall be effective immediately.
A proposed revocation shall be effective 30 days after written
notice is given or, if review is requested, upon the reviewing
official's decision to uphold the proposed revocation. If the
reviewing official decides not to uphold the suspension or proposed
revocation, the suspension shall terminate immediately and any
proposed revocation shall not take effect.
(d) HHS-Recognized Certification Program. The Secretary's responsibility
under this section may be carried out by an HHS-recognized certification
program in accordance with these Guidelines.
(e) Public Notice. The Secretary will publish in the Federal
Register the name, address, and telephone number of any laboratory
that has its certification suspended or revoked under section
3.13 or section 3.14, respectively, and the name of any laboratory
which has its suspension lifted. The Secretary shall provide to
any member of the public upon request the written notice provided
to a laboratory that has its certification suspended or revoked,
as well as the reviewing official's written decision which upholds
or denies the suspension or proposed revocation under the procedures
of subpart D.
Section 3.16 Recertification.
Following revocation, a laboratory may apply for recertification.
Unless otherwise provided by the Secretary in the notice of revocation
under section 3.13(a) or the reviewing official's decision under
section 4.9(e) or 4.14(a), a laboratory which has had its certification
revoked may apply for certification in accordance with this section.
In order to be certified, the laboratory shall meet the criteria
of section 3.12(b), as well as all other requirements of these
Guidelines, including the successful participation in three cycles
of performance testing (sections 3.17(b) and 3.19(a)) and a laboratory
inspection (sections 3.2(b) and 3.20). Once certified, the laboratory
must undergo a second inspection within three months, after which
biannual inspections will be required to maintain certification
(section 3.2(b)), as well as participation in the quarterly performance
testing program (sections 3.1(b) and 3.17(c)).
Section 3.17 Performance Testing (PT) Requirement for
(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
(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
(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
Section 3.18 Performance Test Samples Composition.
(a) Description of the Drugs. PT samples shall contain those drugs
and metabolites which each certified laboratory must be prepared
to assay in concentration ranges that allow detection of the analytes
by commonly used immunoassay screening techniques. These levels
are generally in the range of concentrations which might be expected
in the urine of recent drug users. For some drug analytes, the
sample composition will consist of the parent drug as well as
major metabolites. In some cases, more than one drug class may
be included in one sample, but generally no more than two drugs
will be present in any one sample in order to imitate the type
of specimen which a laboratory normally encounters. For any particular
PT cycle, the actual composition of kits going to different laboratories
will vary but, within any annual period, all laboratories participating
will have analyzed the same total set of samples.
(b) Concentrations. PT samples (as differentiated from blind
quality control samples) shall be spiked with the drug classes
and their metabolites that are required for certification (marijuana,
cocaine, opiates, amphetamines, and phencyclidine) with concentration
levels set by, but not limited to, one of the following schema:
(1) at least 20 percent above the cutoff limit for either the
initial assay or the confirmatory test, depending on which is
to be evaluated; (2) below the cutoff limit as retest samples
(for GC/MS quantitation); and, (3) below the cutoff limit for
special purposes. Some PT samples may be identified for GC/MS
assay only (retest samples). Blanks shall contain less than 2
ng/mL of any of the target drugs. These concentration and drug
types may be changed periodically in response to factors such
as changes in detection technology and patterns of drug use. Finally,
PT samples may be constituted with interfering substances.
Section 3.19 Evaluation of Performance Testing.
(a) Initial Certification.
(1) An applicant laboratory shall not report any false positive
result during PT for initial certification. Any false positive
will automatically disqualify a laboratory from further consideration.
(2) An applicant laboratory shall maintain an overall grade level
of 90 percent for the three cycles of PT required for initial
certification, i.e., it must correctly identify and confirm 90
percent of the total drug challenges. Any laboratory which achieves
a score on any one cycle of the initial certification such that
it can no longer achieve a total grade of 90 percent over the
three consecutive PT cycles will be immediately disqualified from
(3) An applicant laboratory shall obtain quantitative values for
at least 80 percent of the total drug challenges which are ±20
percent or ±2 standard deviations (whichever range is larger)
of the calculated reference group mean. Failure to achieve 80
percent will result in disqualification.
(4) An applicant laboratory shall not obtain any quantitative
values that differ by more than 50 percent from the calculated
reference group mean. Any quantitative values that differ by more
than 50 percent will result in disqualification.
(5) For any individual drug, an applicant laboratory shall successfully
detect and quantitate in accordance with paragraphs (a)(2),(a)(3),
and (a)(4) of this section at least 50 percent of the total drug
challenges. Failure to successfully quantitate at least 50 percent
of the challenges for any individual drug will result in disqualification.
(b.) Ongoing Testing of Certified Laboratories. (1) False Positives
and Procedures for Dealing with Them. No false drug identifications
are acceptable for any drugs for which a laboratory offers service.
Under some circumstances a false positive test may result in suspension
or revocation of certification. The most serious false positives
are by drug class, such as reporting THC in a blank specimen or
reporting cocaine in a specimen known to contain only opiates.
Misidentifications within a class (e.g., codeine for morphine)
are also false positives which are unacceptable in an appropriately
controlled laboratory, but they are clearly less serious errors
than misidentification of a class. The following procedures shall
be followed when dealing with a false positive:
(i) The agency detecting a false positive error shall immediately
notify the laboratory and the Secretary of any such error.
(ii) The laboratory shall provide the Secretary with a written
explanation of the reasons for the error within 5 working days.
If required by paragraph (b)(1)(v) below, this explanation shall
include the submission of all quality control data from the batch
of specimens that included the false positive specimen.
(iii) The Secretary shall review the laboratory's explanation
within 5 working days and decide what further action, if any,
(iv) If the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary may direct the laboratory
to take corrective action to minimize the occurrence of the particular
error in the future and, if there is reason to believe the error
could have been systematic, may require the laboratory to review
and reanalyze previously run specimens.
(v) If the error is determined to be a technical or methodological
error, the laboratory shall submit to the Secretary all quality
control data from the batch of specimens which included the false
positive specimen. In addition, the laboratory shall retest all
specimens analyzed positive by the laboratory from the time of
final resolution of the error back to the time of the last satisfactory
performance test cycle. This retesting shall be documented by
a statement signed by the laboratory's responsible person. Depending
on the type of error which caused the false positive, this retesting
may be limited to one analyte or may include any drugs a laboratory
certified under these Guidelines must be prepared to assay.
The laboratory shall immediately notify the agency if any result
on a specimen that has been retested must be corrected because
the criteria for a positive are not satisfied. The Secretary may
suspend or revoke the laboratory's certification for all drugs
or for only the drug or drug class in which the error occurred.
However, if the case is one of a less serious error for which
effective corrections have already been made, thus reasonably
assuring that the error will not occur again, the Secretary may
decide to take no further action. (vi) During the time required
to resolve the error, the laboratory shall remain certified but
shall have a designation indicating that a false positive result
is pending resolution. If the Secretary determines that the laboratory's
certification must be suspended or revoked, the laboratory's official
status will become "Suspended" or "Revoked"
until the suspension or revocation is lifted or any recertification
process is complete.
(2) Requirement to Identify and Confirm 90 Percent of Total
Drug Challenges. In order to remain certified, laboratories must
successfully complete four cycles of PT per year. Failure of a
certified laboratory to maintain a grade of 90 percent over the
span of two consecutive PT cycles, i.e., to identify 90 percent
of the total drug challenges and to correctly confirm 90 percent
of the total drug challenges, may result in suspension or revocation
(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
(4) Requirement to Quantitate within 50 Percent of Calculated
Reference Group Mean. After achieving certification a laboratory
is permitted one quantitative result differing by more than 50%
from the target value within two consecutive cycles of PT. More
than one error of this type within two consecutive PT cycles may
result in a suspension or proposed revocation.
(5)Requirement to Successfully Detect and Quantitate 50 Percent
of the Total Drug Challenges for Any Individual Drug. For any
individual drug, a certified laboratory must successfully detect
and quantitate in accordance with paragraphs (b)(2),(b)(3), and
(b)(4) of this section at least 50 percent of the total drug challenges.
(6) Procedures When Requirements in Paragraphs (b)(2) - (b)(5)
of this Section Are Not Met. If a certified laboratory fails to
maintain a grade of 90 percent over the span of two consecutive
PT cycles after initial certification as required by paragraph
(b)(2) of this section or if it fails to successfully quantitate
results as required by paragraphs (b)(3),(b)(4), or (b)(5) of
this section, the laboratory shall be immediately informed that
its performance fell under the 90 percent level or that it failed
to quantitate test results successfully and how it failed to quantitate
successfully. The laboratory shall be allowed 5 working days in
which to provide any explanation for its unsuccessful performance,
including administrative error or methodological error, and evidence
that the source of the poor performance has been corrected. The
Secretary may revoke or suspend the laboratory's certification
or take no further action, depending on the seriousness of the
errors and whether there is evidence that the source of the poor
performance has been corrected and that current performance meets
the requirements for a certified laboratory under these Guidelines.
The Secretary may require that additional performance tests be
carried out to determine whether the source of the poor performance
has been removed. If the Secretary determines to suspend or revoke
the laboratory's certification, the laboratory's official status
will become "Suspended" or "Revoked" until
the suspension or revocation is lifted or until any recertification
process is complete.
(c) 80 Percent of Participating Laboratories Must Detect Drug.
A laboratory's performance shall be evaluated for all samples
for which drugs were spiked at concentrations above the specified
performance test level unless the overall response from participating
laboratories indicates that less than 80 percent of them were
able to detect a drug.
(d) Participation Required. Failure to participate in a PT cycle
or to participate satisfactorily may result in suspension or revocation
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
(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
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