[Federal Register: April 13, 2004 (Volume 69, Number
71)]
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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Section
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Topic
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Recordkeeping
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2.3(a)(4)*................Responsible
person at laboratory documents in-service training of personnel. 2.3(a)(5)*…………Maintain manual of all procedures used and dates they were in effect. and 2.4(q)(1)* 2.3(a)(6)*…………Documentation of quality assurance program. and 2.5(a)* 2.3(f)*.....................Specifies contents of laboratory personnel files. 2.4(a)(1)*................Requires documentation of laboratory visitor access. 2.4(a)(2)*…………Requires use of laboratory chain of custody form by personnel conducting and (b)(4)* tests. 2.4(h)(17)*..............Requires specimen records to be maintained for two years. 2.4(p)*....................Requires two year retention of documentation of all aspects of testing process. 2.5(k)(6).................Requires documenting retesting when false positive error occurs on blind performance testing sample. |
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Reporting
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2.2(c), 2.2(f)(8)…..Require use of
Federal CCF by collector and specify things to note on it. and 2.2(f)(14) 2.4(h); 3.17(f).........Specifies reporting of test results from laboratory to Medical Review Officer (MRO); specifies same reporting method for performance testing samples. 2.4(h)(15)...............Specifies contents of periodic laboratory summary statistical report to Federal agency. 2.6(h)(1).................Specifies MRO reporting of final test results to Federal agency using Federal CCF. 3.17(f)....................Specifies laboratory reporting of performance test samples. 4.4 and 4.5(a)..……Specify contents of laboratory request for official review of suspension/proposed revocation of certification. 4.6.........................Requires appellant notification to reviewing official at end of abeyance period. 4.7(a).....................Specifies contents of appellant review submission. 4.9(a) and (c).........Specify contents of appellant expedited review file. |
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Disclosure
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3.4..........................Requires laboratories to notify non-regulated private-sector employers/clients when testing specimens not under Guidelines. |
Note: Activities designated by an * are considered to be usual and customary business practices for such laboratories and no additional burden is considered to be imposed by these requirements.
(4) There are an estimated 7,096,000 Federal CCFs
completed each year, with an average response burden of 5 minutes for the
donor, 4 minutes for the collector, 3 minutes for the laboratory, and 3 minutes
for the Medical Review Officer. This results in 1,419,200 hours of burden.
Individuals and organizations may submit comments on
these burden estimates or any other aspect of these information collection
provisions, including suggestions for reducing the burden, and should direct
them to: SAMHSA Reports Clearance Officer, Room 16-105, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
The information collection provisions in the Mandatory Guidelines have been approved under OMB control number 0930-0158. This approval expires July 31, 2006. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Charles G. Curie,
Administrator, SAMHSA.
Dated: April 2, 2004.
Tommy G. Thompson,
Secretary.
The Mandatory Guidelines as revised are hereby adopted in accordance with section 503 of Public Law 100-71 and Executive Order 12564. For the public's convenience, the full version of the Mandatory Guidelines as revised is provided. It includes the new validity testing requirements as well as the changes to the opiate cutoff concentrations that became effective on December 1, 1998 (63 FR 63483).
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Subpart A--General
Sec.
1.1 Applicability.
1.2 Definitions.
1.3 Future Revisions.
Subpart B--Scientific and Technical Requirements
2.1 The Drugs.
2.2 Specimen Collection Procedures.
2.3 Laboratory Personnel.
2.4 Laboratory Analysis Procedures.
2.5 Quality Assurance and Quality Control.
2.6 Reporting and Review of Results.
2.7 Protection of Employee Records.
2.8 Individual Access to Test and Laboratory Certification Results.
Subpart C--Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies
3.1 Introduction.
3.2 Goals and Objectives of Certification.
3.3 General Certification Requirements.
3.4 Capability to Test for Five Classes of Drugs and to Conduct Validity Tests
3.5 Initial and Confirmatory Capability at Same Site.
3.6 Personnel.
3.7 Quality Assurance and Quality Control.
3.8 Security and Chain of Custody.
3.9 One-Year Storage for Positive, Adulterated, Substituted, and Invalid
Specimens.
3.10 Documentation.
3.11 Reports.
3.12 Certification.
3.13 Revocation.
3.14 Suspension.
3.15 Notice.
3.16 Recertification.
3.17 Performance Testing (PT) Requirement for Certification.
3.18 PT Program Samples.
3.19 Evaluation of PT Sample Results.
3.20 Inspections.
3.21 Results of Inadequate Performance.
3.22 Listing of Certified Laboratories
[[Page 19654]]
Subpart D--Procedures for Review of Suspension or Proposed Revocation of a Certified Laboratory
4.1 Applicability.
4.2 Definitions.
4.3 Limitation on Issues Subject to Review.
4.4 Specifying Who Represents the Parties.
4.5 The Request for Informal Review and the Reviewing Official's Response.
4.6 Abeyance Agreement.
4.7 Preparation of the Review File and Written Argument.
4.8 Opportunity for Oral Presentation.
4.9 Expedited Procedures for Review of Immediate Suspension.
4.10 Ex parte Communications.
4.11 Transmission of Written Communications by Reviewing Official and
Calculation of Deadlines.
4.12 Authority and Responsibilities of Reviewing Official.
4.13 Administrative Record.
4.14 Written Decision.
4.15 Court Review of Final Administrative Action; Exhaustion of Administrative
Remedies.
Authority: E.O. 12564 and sec. 503 of Pub. L. 100-71.
Subpart A--General
Section 1.1--Applicability
(a) These mandatory guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the
Armed Forces as defined in 5 U.S.C. 2101(2));
(3) And any other employing unit or authority of the Federal Government except
the United States Postal Service, the Postal Rate Commission, and employing
units or authorities in the Judicial and Legislative Branches.
(b) Subpart C of these Guidelines (which establishes laboratory certification
standards) applies to any laboratory which has or seeks certification to
perform urine drug testing for Federal agencies under a drug testing program
conducted under E.O. 12564. Only laboratories certified under these standards
are authorized to perform urine drug testing for Federal agencies.
(c) The Intelligence Community, as defined by Executive Order No. 12333, shall
be subject to these Guidelines only to the extent agreed to by the head of the
affected agency.
(d) These Guidelines do not apply to drug testing conducted under legal
authority other than Executive Order 12564, including testing of persons in the
criminal justice system, such as arrestees, detainees, probationers,
incarcerated persons, or parolees.\1\
(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.
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\1\ Although HHS has no authority to regulate the transportatiion industry, the
Department of Transportation (DOT) does have such authority. DOT is required by
law to develop requirements for its regualted industry that "incorporate the
Department of Health and Human Services scientific and technical guidelines
dated April 11, 1988, and any amendments to those guidelines * * *" See, e.g.,
49 U.S.C. 20140(c)(2). In carrying out its mandate, DOT requires by regulation
that its federally regulated employers use only HHS certified laboratories in
the testing of employees, 49 CFR 40.39, and incorporates the scientific and
technical aspects of the guidelines in its regulations. The DOT-regulated
industry should refer to the DOT regulations at 49 CFR Part 40.
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(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.
Adulterated Specimen. A urine specimen
containing a substance that is not a normal constituent or containing an
endogenous substance at a concentration that is not a normal physiological
concentration.
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. Refers to the process used to
document the handling and storage of a specimen.
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.
Collector. 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 collector
shall have successfully completed training to carry out this function.
Confirmatory Drug 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.)
Confirmatory Validity Test. A second test
performed on a different aliquot of the original urine specimen to further
support a validity test result.
Control. A sample used to monitor the status of
an analysis to maintain its performance within desired limits.
Dilute Specimen. A urine specimen with
creatinine and specific gravity values that are lower than expected for human
urine.
Donor. The individual from whom a urine
specimen is collected.
Federal Drug Testing Custody and Control Form (Federal
CCF). The OMB-approved form used to document the handling and transfer
of a specimen from the time of collection until receipt by the laboratory and
used by the certifying scientist to certify the laboratory results.
Initial Drug Test (also known as Screening Test). An immunoassay test to eliminate "negative" urine specimens from
further consideration and to identify the
presumptively positive specimens that require confirmation or further testing.
Initial Validity Test. The first test used to determine if a urine
specimen is adulterated, dilute, or substituted.
Invalid Result. Refers to the result reported by a laboratory for a urine
[[Page 19655]]
specimen that contains an unidentified adulterant,
contains an unidentified interfering substance, has an abnormal physical
characteristic, or has an endogenous substance at an abnormal concentration
that prevents the laboratory from completing testing or obtaining a valid drug
test result.
Laboratory Chain of Custody Form. The form(s)
used by the testing laboratory to document the handling and 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 handled the
specimens or aliquots and the date and purpose of the access.
Limit of Detection. The lowest concentration at
which an analyte can be reliably shown to be present under defined conditions.
Limit of Quantitation. The lowest concentration
at which an analyte can be reliably shown to be present and quantified under
defined conditions.
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 test
result together with his or her medical history and any other relevant
biomedical information.
Non-Negative Specimen. A urine specimen that is
reported as adulterated, substituted, positive (for a drug or drug metabolite),
or invalid.
Oxidizing Adulterant. A substance that acts
alone or in combination with other substances to oxidize drugs or drug
metabolites to prevent the detection of the drugs or drug metabolites, or
affects the reagents in either the initial or confirmatory drug test. Examples
of these agents include, but are not limited to, nitrites, pyridinium
chlorochromate, chromium (VI), bleach, iodine, halogens, peroxidase, and
peroxide.
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 Executive Order 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.
Standard. A reference material of known purity
or a solution containing a reference material at a known concentration.
Substituted Specimen. A urine specimen with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human urine.
Section 1.3 Future Revisions
In order to ensure the full reliability and accuracy of drug assays, the accurate reporting of test results, and the integrity and efficacy of Federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology. These changes will be published in final as a notice in the Federal Register.
Subpart B--Scientific and Technical Requirements
Section 2.1 The Drugs
(a) The President's Executive Order 12564 defines
"illegal drugs" as those included in Schedule I or II of the Controlled
Substances Act (CSA), but not when used pursuant to a valid prescription or
when used as otherwise authorized by law. Hundreds of drugs are covered under
Schedule I and II and while it is not feasible to test routinely for all of
them, Federal drug testing programs shall test for drugs as follows:
(1) Federal agency applicant and random drug testing
programs shall, at a minimum, test urine specimens for marijuana and cocaine;
(2) Federal agency applicant and random drug testing
programs may also test urine specimens for opiates, amphetamines, and
phencyclidine;
(3) When conducting reasonable suspicion, post
accident, or unsafe practice testing, a Federal agency may have a urine
specimen tested for any drug listed in Schedule I or II of the CSA; and
(4) Federal agency drug testing programs shall have
validity tests performed on urine specimens, as provided under section 2.4(g).
(b) Any agency covered by these guidelines shall petition the Secretary in
writing for approval to include in its testing protocols any drugs (or classes
of drugs) not listed for Federal agency testing in paragraph (a) of this
section. Such approval shall be limited to the use of the appropriate science
and technology and shall not otherwise limit agency discretion to test for any
drugs covered under Schedule I or II of the CSA.
(c) Urine specimens collected pursuant to Executive
Order 12564, Public Law 100-71, and these Guidelines shall not be used for any
other analysis or test unless authorized by an agency's drug-free workplace
program.
(d) These Guidelines are not intended to limit any agency which is specifically authorized by law to include additional categories of drugs in the drug testing of its own employees or employees in its regulated industries.
Section 2.2 Specimen Collection Procedures
(a) Designation of Collection Site. An agency drug
testing program shall have one or more designated collection sites which have
all necessary personnel, materials, equipment, facilities, and supervision to
provide for the collection, security, temporary storage, and shipping or
transportation of urine specimens to a certified drug testing laboratory.
(b) Security. A collection site must 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 collecting specimens shall be secured
during the time a specimen is collected.
(c) Chain of Custody. A Federal CCF shall be properly
completed by a collector for each urine specimen collected for a Federal agency
to document the collection of the specimen and the transfer of the specimen to
the laboratory for testing.
(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. The procedure for collecting a urine
specimen 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. The collector
shall take the following minimum precautions to ensure that a urine specimen is
correctly documented as being provided by a specific donor and that the donor
has not adulterated, substituted, or diluted the specimen:
(1) To deter the dilution of a specimen at the collection site, a toilet bluing
[[Page 19656]]
agent shall be placed in a toilet tank 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
collector shall request the donor to present photo identification. If the donor
does not have proper photo identification, the collector 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 collector shall not proceed with the
collection.
(3) If the donor fails to arrive at the assigned time
or if the donor fails to remain present through the completion of the
collection, the collector shall contact the appropriate authority to obtain
guidance on the action to be taken.
(4) The collector 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 collector 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. The collector directs the donor to empty his or her pockets and
display the items to ensure that no items are present that could be used to
adulterate the specimen. If nothing is there that can be used to adulterate a
specimen, the donor places the items back into the pockets and the collection
procedure continues. If the donor refuses to show the collector the items in
his or her pockets, this is considered a "refusal to test." If an item is found
that appears to have been brought to the collection site with the intent to
adulterate the specimen, a direct observation collection procedure is used. If
the item appears to be inadvertently brought to the collection site, the
collector shall secure the item and continue with the normal collection
procedure.
(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 collector 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 collector shall give the donor a clean
specimen bottle or specimen collection container. The donor may provide his/her
specimen in the privacy of a stall or otherwise partitioned area that allows
for individual privacy.
(8) The collector shall note any unusual behavior or
appearance on the Federal CCF.
(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 collector 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
collector shall instruct the donor not to flush the toilet until the specimen
is delivered to the collector. After the collector has possession of the
specimen, the donor will be instructed to flush the toilet and to participate
with the collector in completing the chain of custody procedures.
(10) Upon receiving the specimen from the donor, the
collector shall determine the volume of urine in the specimen bottle/container.
(i) If the volume is at least 30 milliliters (mL), the
collector 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
ounce glass of water every 30 minutes, but not to exceed a maximum of 24
ounces). If the donor fails for any reason to provide 30 mL of urine for the
second specimen collected, the collector 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 collector, the donor shall be allowed to wash his or her
hands.
(12) Immediately after the specimen is collected, the
collector shall measure the temperature of the specimen. The temperature
measuring device used must accurately reflect the temperature of the specimen
and not contaminate the specimen. The time from urination to temperature
measurement is critical and in no case shall exceed 4 minutes.
(13) If the temperature of the specimen is outside the
range of 32[deg]-38[deg]C/90[deg]-100[deg]F, that is a reason to believe that
the donor may have altered or substituted the specimen, and another specimen
shall be collected under direct observation of a person of the same gender and
both specimens shall be forwarded to the laboratory for testing. The agency
shall select the observer if there is no collector 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
collector shall also inspect the specimen to determine if this is any sign
indicating that the specimen may not be a valid urine specimen. Any unusual
finding shall be noted on the Federal CCF.
(15) A specimen suspected of not being a valid urine
specimen 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, 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 collector of the
same gender available.
(17) Both the donor and the collector 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 collection container to
a specimen bottle, the collector shall request the donor to observe the
transfer of the specimen and the placement of the tamper-evident label/seal on
the bottle.
(18) The collector and the donor shall be present at
the same time during procedures outlined in paragraphs (19) to (22) of this
section.
(19) The collector shall place the tamper-evident
label/seal on the specimen bottle. The collector shall record the date of the
collection on the tamper-evident label/seal.
(20) The donor shall initial the tamper-evident
label/seal on the specimen bottle for the purpose of certifying that it is the
specimen collected from him or her.
(21) The collector shall ensure that all the information required on the Federal CCF is provided.
[[Page 19657]]
(22) The donor shall be asked to read and sign a
statement on the Federal CCF certifying that the specimen identified as having
been collected from him or her is in fact the specimen he or she provided.
(23) Based on a reason to believe that the donor may
alter or substitute the specimen to be provided, a higher level supervisor
shall review and concur in advance with any decision by a collector 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 collector of the same gender available.
(24) The collector shall sign the Federal CCF.
(25) The urine specimen and Federal CCF are now ready
for shipment. If the specimen is not immediately prepared for shipment, it
shall be appropriately safeguarded during temporary storage.
(26) While any part of the above chain of custody
procedures is being performed, it is essential that the urine specimen and
Federal CCF be under the control of the collector. If the collector leaves the
collection site momentarily, the urine specimen and Federal CCF shall be taken
with him or her or shall be secured. After the collector returns to the
collection site, the custody process will continue. If the collector is leaving
for an extended period of time, the specimen and Federal CCF shall be packaged
for shipment to the laboratory before he or she leaves the collection site.
(g) Collection Control. If the specimen and Federal
CCF are not immediately prepared for transfer to the laboratory, they shall be
appropriately safeguarded until the specimen and Federal CCF are prepared for
transfer to the laboratory.
(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 collection container. The collector, 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 Federal CCF accompany the two bottles processed under split sample
procedures.
(5) The collector 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 primary (Bottle A) specimen is
verified positive, adulterated, or substituted by the MRO, the MRO shall report
the result to the agency. Only the donor may request through the MRO that the
split (Bottle B) specimen be tested by a second certified laboratory to
reconfirm the positive, adulterated, or substituted result reported by the
primary laboratory. The MRO shall honor the request if it is made within 72
hours after informing the donor that a positive, adulterated, or substituted
result was being reported to the agency. The second laboratory shall test the
split specimen in accordance with the requirements in section 2.4 pertaining to
retesting for drugs, adulterants, or substitution.
(7) Any action taken by a Federal agency as a result
of an MRO verified positive, adulterated, or substituted test result (e.g.,
removing a donor from performing a safety-sensitive function) may proceed
whether Bottle B is or is not tested.
(i) Transportation to Laboratory. A collector shall arrange to ship the collected specimens to the certified 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 collector shall ensure that the Federal CCF is enclosed within the 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 Federal CCFs, there is no requirement that such personnel document chain of custody for the package during transit.
Section 2.3 Laboratory Personnel
(a) Day-to-Day Management.
(1) The laboratory shall have a responsible person
(RP) to assume professional, organizational, educational, and administrative
responsibility for the laboratory's urine drug testing facility.
(2) This individual shall have documented scientific
qualifications in analytical forensic toxicology. Minimum qualifications are:
(i) Certification as a laboratory director by the
State in forensic or clinical laboratory toxicology; or
(ii) A Ph.D. in one of the natural sciences with an
adequate undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or
(iii) Training and experience comparable to a Ph.D. in
one of the natural sciences, such as a medical or scientific degree with
additional training and laboratory/research experience in biology, chemistry,
and pharmacology or toxicology; and
(iv) In addition to the requirements in (i), (ii), and
(iii) above, minimum qualifications also require:
(A) Appropriate experience in analytical forensic
toxicology including experience with the analysis of biological material for
drugs of abuse, and
(B) Appropriate training and/or experience in forensic
applications of analytical toxicology, e.g., publications, court testimony,
research concerning analytical toxicology of drugs of abuse, or other factors
which qualify the individual as an expert witness in forensic toxicology.
(3) This individual shall be engaged in and
responsible for the day-to-day management of the drug testing laboratory even
where another individual has overall responsibility for an entire
multi-specialty laboratory.
(4) This individual shall be responsible for ensuring
that there are enough personnel with adequate training and experience to
supervise and conduct the work of the drug testing laboratory. He or she shall
assure the continued competency of laboratory personnel by documenting their
in-service training, reviewing their work performance, and verifying their
skills.
(5) This individual shall be responsible for the laboratory's having a procedure manual which is complete, up-to-date, available for laboratory personnel, 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
[[Page 19658]]
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 paragraph 2.4(q)(1).)
(6) This individual shall be responsible for
maintaining a quality assurance program to assure the proper performance and
reporting of all test results; for maintaining acceptable analytical
performance for all controls and standards; for maintaining quality control
testing; and for assuring and documenting the validity, reliability, accuracy,
precision, and performance characteristics of each test and test system.
(7) This individual shall be responsible for taking
all remedial actions necessary to maintain satisfactory operation and
performance of the laboratory in response to quality control systems not being
within performance specifications, errors in result reporting or in analysis of
performance testing results. This individual shall ensure that specimen results
are not reported until all corrective actions have been taken and he or she can
assure that the results provided are accurate and reliable.
(b) Certifying Test Results. The certified laboratory
shall have one or more certifying scientists, as defined in section 1.2, who
review all pertinent data and quality control results to attest to the validity
of the laboratory's test results. A laboratory may designate certifying
scientists that only certify results that are reported negative and certifying
scientists that certify results that are reported both negative and
non-negative.
(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 technical and nontechnical
staff shall have the necessary training and skills for the tasks assigned.
(e) Training. The laboratory shall make available
continuing education programs to meet the needs of laboratory personnel.
(f) Files. Each laboratory personnel file shall include, at a minimum, a resume, any professional certification or license, a job description, and documentation to show that the individual has been properly trained to perform his or her job.
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, escort and purpose of entry of authorized visitors,
maintenance personnel, 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 a laboratory 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 appropriate
entries on the laboratory chain of custody forms for those specimens or
aliquots as they are received.
(b) Receiving.
(1) After opening a shipping package and gaining
access to a specimen and its accompanying Federal CCF, an accessioner shall
compare the information on the specimen bottle label/seal to the information on
the accompanying Federal CCF.
(2) The following discrepancies are considered to be
fatal flaws and the laboratory must stop the testing process and reject the
specimen for testing and indicate the reason for rejecting the specimen on the
Federal CCF:
(i) The specimen ID number on the specimen bottle
label/seal does not match the ID number on the Federal CCF or the ID number is
missing either on the Federal CCF or on the specimen bottle label/seal;
(ii) The specimen bottle label/seal is broken or shows
evidence of tampering on the specimen bottle from a single specimen collection
or on the primary (Bottle A) specimen from a split specimen collection (and the
split specimen cannot be designated as the primary (Bottle A) specimen);
(iii) The collector's printed name and signature are
omitted on the Federal CCF; or
(iv) There is an insufficient amount of urine for
analysis in the specimen bottle from a single specimen collection or in the
primary (Bottle A) specimen from a split specimen collection (unless the split
specimen can be designated as the primary (Bottle A) specimen).
(3) The following discrepancies are considered to be
correctable flaws:
(i) If a collector failed to sign the Federal CCF, the
laboratory must attempt to recover the collector's signature before reporting
the test result. If the collector can provide a memorandum for record
recovering the signature, the laboratory may report the test result for the
specimen. If the laboratory cannot recover the collector's signature, the
laboratory must report a rejected for testing result and indicate the reason
for the rejected for testing result on the Federal CCF.
(ii) If a specimen is submitted using a non-Federal
form or an expired Federal CCF, the laboratory must test the specimen and also
attempt to obtain a memorandum for record explaining why a non-Federal form or
an expired Federal CCF was used and ensure that the form used contains all the
required information. If the laboratory cannot obtain a memorandum for record
from the collector, the laboratory must report a rejected for testing result
and indicate the reason for the rejected for testing result on the report to
the MRO.
(4) 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 conducting initial and confirmatory
[[Page 19659]]
tests while the original specimen bottles and Federal
CCFs remain in secure storage.
(c) Short-Term Refrigerated Storage. Specimens
that do not receive an initial test within 7 days of arrival at the laboratory
shall be placed in secure refrigeration units. Temperatures shall not exceed
6[deg]C. A certified laboratory must have the capability to ensure proper
storage conditions in the event of a prolonged power failure.
(d) Specimen Processing. A laboratory will
normally process specimens by grouping them into batches. The number of
specimens in each batch may vary significantly. Every batch shall satisfy the
quality control requirements in section 2.5.
(e) Initial Drug Test. (1) The initial drug 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 Drug Test Level
|
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|
(ng/mL)
|
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Marijuana
metabolites....................................... 50 Cocaine metabolites.......................................... 300 Opiate metabolites............................................2,000 Phencyclidine..............................................….. 25 Amphetamines..................................................1,000 |
---------------------------------------------------------------------------------------- |
(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 drug
test methods, testing levels, and proposed performance test program.
(3) A negative specimen shall be discarded or may be
pooled for use in the laboratory's internal quality control program unless
validity test results indicate that the specimen may not be a valid specimen.
(4) Multiple initial drug tests (also known as
rescreening) for the same drug or drug class may be performed provided that all
tests meet all Guideline cutoffs and quality control requirements (see section
2.5(b)). Examples: a test is performed by immunoassay technique "A" for all
drugs using the HHS cutoff levels, but presumptive positive amphetamines are
forwarded for immunoassay technique "B" to eliminate any possible presumptive
positives due to structural analogues; a valid analytical result cannot be
obtained using immunoassay technique "A" and immunoassay technique "B" is used
in an attempt to obtain a valid analytical result.
(f) Confirmatory Drug Test.
(1) A specimen identified as positive on an initial drug test shall be confirmed for the class(es) of drugs screened positive on the initial drug test using gas chromatography/mass spectrometry (GC/MS) at the cutoff values listed in this paragraph. Each confirmatory drug test shall provide a quantitative result. When the concentration of a drug or metabolite exceeds the linear range of the standard curve, the certified laboratory may record the result as "exceeds the linear range of the test" or as "greater than or equal to (insert the value for the upper limit of the linear range)," or may dilute an aliquot of the specimen to obtain an accurate quantitative result when the concentration is above the upper limit of the linear range.
Confirmatory Drug Test Level
|
--------------------------------------------------------------------------------------- |
(ng/mL)
|
--------------------------------------------------------------------------------------- |
Marijuana metabolite
\1\............................... 15 Cocaine metabolite \2\.................................. 150 Opiates Morphine..................................................... 2,000 Codeine....................................................... 2,000 6-Acetylmorphine \3\................................... 10 Phencyclidine............................................... 25 Amphetamines Amphetamine............................................... 500 Methamphetamine \4\................................... 500 |
--------------------------------------------------------------------------------------- |
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Benzoylecgonine.
\3\ Test for 6-AM when the morphine concentration is greater than or equal to
2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration greater than or
equal to 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) A specimen that tests negative on confirmatory
drug tests shall be discarded or may be pooled for use in the laboratory's
internal quality control program unless validity test results indicate that the
specimen may not be a valid specimen.
(g) Validity Testing. A certified laboratory shall:
(1) Determine the creatinine concentration on every
specimen;
(2) Determine the specific gravity on every specimen
for which the creatinine concentration is less than 20 mg/dL;
(3) Determine the pH on every specimen;
(4) Perform one or more validity tests for oxidizing
adulterants on every specimen; and
(5) Perform additional validity tests when the
following conditions are observed:
(i) Abnormal physical characteristics;
(ii) Reactions or responses characteristic of an
adulterant obtained during initial or confirmatory drug tests (e.g.,
non-recovery of internal standards, unusual response); or
(iii) Possible unidentified interfering substance or
adulterant.
The choice of additional validity tests is dependent on the observed indicators
or characteristics as described in (i), (ii), and (iii) of this section.
(h) Reporting Results.
(1) The laboratory shall report a test result directly
to the agency's MRO within an average of 5 working days after receipt of the
specimen by the laboratory using the Federal CCF and/or an electronic report.
Before any test result is reported, it must be certified as correct by a
certifying scientist.
(2) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
negative when each initial drug test is negative or it is negative on a
confirmatory drug test and each specimen validity test result indicates that
the specimen is a valid urine specimen.
(3) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
positive for a specific drug when the initial drug test is positive and the
confirmatory drug test is positive.
(4) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
adulterated when:
(i) The pH is less than 3 or greater than or equal to
11 using either a pH meter or a colorimetric pH test for the initial test on
the first aliquot and a pH meter for the confirmatory test on the second
aliquot;
(ii) The nitrite concentration is greater than or equal to 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (e.g., multi-
[[Page 19660]]
wavelength spectrophotometry, ion chromatography,
capillary electrophoresis) on the second aliquot;
(iii) The presence of chromium (VI) is verified using
either a general oxidant colorimetric test (with a greater than or equal to 50
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test
(chromium (VI) concentration greater than or equal to 50 mcg/mL) for the
initial test on the first aliquot and a different confirmatory test (e.g.,
multi-wavelength spectrophotometry, ion chromatography, atomic absorption
spectrophotometry, capillary electrophoresis, inductively coupled plasma-mass
spectrometry) with the chromium (VI) concentration greater than or equal to the
LOD of the confirmatory test on the second aliquot;
(iv) The presence of halogen (e.g., bleach, iodine, fluoride) is verified using either a general oxidant colorimetric test (with a greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a greater than or equal to 50 mcg/mL chromium
(VI)-equivalent cutoff) or halogen colorimetric test
(halogen concentration greater than or equal to the LOD) for the initial test
on the first aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry, ion chromatography, inductively coupled plasma-mass
spectrometry) with a specific halogen concentration greater than or equal to
the LOD of the confirmatory test on the second aliquot;
(v) The presence of glutaraldehyde is verified using
either an aldehyde test (aldehyde present) or the characteristic immunoassay
response on one or more drug immunoassay tests for the initial test on the
first aliquot and GC/MS for the confirmatory test with the glutaraldehyde
concentration greater than or equal to the LOD of the analysis on the second
aliquot;
(vi) The presence of pyridine (pyridinium
chlorochromate) is verified using either a general oxidant colorimetric test
(with a greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or a
chromium (VI) colorimetric test (chromium (VI) concentration greater than or
equal to 50 mcg/mL) for the initial test on the first aliquot and GC/MS for the
confirmatory test with the pyridine concentration greater than or equal to the
LOD of the analysis on the second aliquot;
(vii) The presence of a surfactant is verified by
using a surfactant colorimetric test with a greater than or equal to 100 mcg/mL
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first
aliquot and a different confirmatory test (e.g., multi-wavelength
spectrophotometry) with a greater than or equal to 100 mcg/mL dodecylbenzene
sulfonate-equivalent cutoff on the second aliquot; or
(viii) The presence of any other adulterant not
specified in 4(iii) through 4(vii) of this section is verified using an initial
test on the first aliquot and a different confirmatory test on the second
aliquot.
(5) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
substituted when the creatinine concentration is less than 2 mg/dL and the
specific gravity is less than or equal to 1.0010 or greater than or equal to
1.0200 on both the initial and confirmatory creatinine tests (i.e., the same
colorimetric test may be used to test both aliquots) and on both the initial
and confirmatory specific gravity tests (i.e., a refractometer is used to test
both aliquots) on two separate aliquots.
(6) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
dilute when the creatinine concentration is greater than or equal to 2 mg/dL
but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less
than 1.0030 on a single aliquot.
(7) A urine specimen from a single specimen collection
or the primary (Bottle A) specimen from a split specimen collection is reported
as an invalid result when:
(i) Inconsistent creatinine concentration and specific
gravity results are obtained (i.e., the creatinine concentration is less than 2
mg/dL on both the initial and confirmatory creatinine tests and the specific
gravity is greater than 1.0010 but less than 1.0200 on the initial and/or
confirmatory specific gravity test, the specific gravity is less than or equal
to 1.0010 on both the initial and confirmatory specific gravity tests and the
creatinine concentration is greater than or equal to 2 mg/dL on either or both
the initial or confirmatory creatinine tests);
(ii) The pH is greater than or equal to 3 and less
than 4.5 or greater than or equal to 9 and less than 11 using either a
colorimetric pH test or pH meter for the initial test and a pH meter for the
confirmatory test on two separate aliquots;
(iii) The nitrite concentration is greater than or
equal to 200 mcg/mL using a nitrite colorimetric test or greater than or equal
to the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric
test for both the initial test and the confirmatory test or using either
initial test and the nitrite concentration is greater than or equal to 200
mcg/mL but less than 500 mcg/mL for a different confirmatory test (e.g.,
multi-wavelength spectrophotometry, ion chromatography, capillary
electrophoresis) on two separate aliquots;
(iv) The possible presence of chromium (VI) is
determined using the same chromium (VI) colorimetric test with a cutoff greater
than or equal to 50 mcg/mL chromium (VI) for both the initial test and the
confirmatory test on two separate aliquots;
(v) The possible presence of a halogen (e.g., bleach,
iodine, fluoride) is determined using the same halogen colorimetric test with a
cutoff greater than or equal to the LOD for both the initial test and the
confirmatory test on two separate aliquots or relying on the odor of the
specimen as the initial test;
(vi) The possible presence of glutaraldehyde is
determined by using the same aldehyde test (aldehyde present) or characteristic
immunoassay response on one or more drug immunoassay tests for both the initial
test and the confirmatory test on two separate aliquots;
(vii) The possible presence of an oxidizing adulterant
is determined by using the same general oxidant colorimetric test (with a
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff, a greater than
or equal to 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen
concentration is greater than or equal to the LOD) for both the initial test
and the confirmatory test on two separate aliquots;
(viii) The possible presence of a surfactant is
determined by using the same surfactant colorimetric test with a greater than
or equal to 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the
initial test and the confirmatory test on two separate aliquots or a foam/shake
test for the initial test;
(ix) Interference occurs on the immunoassay drug tests
on two separate aliquots (i.e., valid immunoassay drug test results cannot be
obtained);
(x) Interference with the GC/MS drug confirmation
assay occurs on at least two separate aliquots of the specimen and the
laboratory is unable to identify the interfering substance;
(xi) The physical appearance of the specimen is such
that testing the system may damage the laboratory's instruments; or
(xii) If the physical appearances of Bottles A and B (when a split specimen collection is used) are clearly different,
[[Page 19661]]
the test result for Bottle A is one of the reasons
stated in (i) through (xi) of this section and/or was screened negative for
drugs.
(8) The laboratory shall reject a specimen for testing
when a fatal flaw occurs as described in paragraph 2.4(b)(2) or when a
correctable flaw as described in paragraph 2.4(b)(3) is not recovered. The
laboratory will indicate on the Federal CCF that the specimen was rejected for
testing and provide the reason for reporting the rejected for testing result.
(9) The laboratory must report all non-negative test
results for a specimen. For example, a specimen can be positive for a specific
drug and adulterated.
(10) For a specimen that is tested positive for a
drug, the laboratory shall report the specimen as positive and specify the drug
for which the specimen is positive. The concentration of the drug shall be
provided to the MRO only when the MRO requests such information. The MRO's
request may either be a general request covering all such results or be on a
case by case basis. When the concentration of an analyte exceeds the linear
range of the standard curve, the laboratory may report to the MRO that the
quantitative value "exceeds the linear range of the test," that the
quantitative value is "greater than or equal to (insert the value for the upper
limit of the linear range)," or may report an accurate quantitative value above
the upper limit of the linear range that was obtained by diluting an aliquot of
the specimen. The MRO shall not disclose the concentration of the drug to the
agency.
(11) The laboratory shall provide quantitative values
for confirmed opiate results for morphine or codeine that are greater than or
equal to 15,000 ng/mL, even if the MRO has not requested quantitative values
for the test result.
(12) For a specimen that is found to be adulterated or
substituted, the laboratory shall report the specimen as adulterated or
substituted and shall provide the numerical values that support the adulterated
(when applicable) or substituted result. For a specimen that has an invalid
result for one of the reasons stated in paragraphs 2.4(h)(7)(iv) to (xii), the
laboratory shall contact the MRO and both will decide if testing by another
certified laboratory would be useful in being able to report a positive or
adulterated result. If no further testing is necessary, the laboratory then
reports the invalid result to the MRO.
(13) 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.
(14) For all test results, a laboratory may fax,
courier, mail, or electronically transmit a legible image or copy of the
completed Federal CCF, and/or forward a computer-generated electronic report.
However, for non-negative results, the laboratory must fax, courier, mail, or
electronically transmit a legible image or copy of the completed Federal CCF.
(15) The laboratory shall provide to the agency official responsible for coordination of the drug-free workplace program a semi-annual statistical summary report of urinalysis testing of Federal employees and shall not include in the summary any personal identifying information. In order to avoid sending data from which it is likely that information about a donor's test result can be readily inferred, the laboratory must not send a summary report if the agency has fewer than five specimen test results in a six-month period. When that situation occurs, the laboratory must send the agency a report indicating that not enough specimens were tested to permit providing a summary report. The summary report shall include test results that are reported within the six-month period. Normally, the summary report is sent within 14 calendar days after the end of the six-month period covered by the report. The summary report shall contain the following information:
Reporting Period: (inclusive dates)
Laboratory Name and Address
Federal Agency Name
(i) Specimen Results Reported (total number)
By Type of Test
(16) The laboratory shall make available copies of all
analytical results for Federal drug testing programs when requested by HHS or
any Federal agency for which the laboratory is performing drug testing
services.
(17) 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.
(i) Long-Term Storage. Long-term frozen storage
(-20[deg]C or less) ensures that positive, adulterated, substituted, and
invalid urine specimens will be available for any necessary retest. Unless
otherwise authorized in writing by the agency, drug testing laboratories shall
retain and place in properly secured long-term frozen storage for a minimum of
1 year all specimens reported positive, adulterated, substituted, or invalid.
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 from
the agency, the laboratory may discard the specimen at the end of this 1-year
period.
(j) Retesting a Specimen for Drugs.
(1) A second laboratory shall use its confirmatory
drug test when retesting an aliquot of a single specimen or testing a split
(Bottle B) specimen for the drug or drug metabolite that was reported positive
in the single specimen or the primary (Bottle A) specimen by the first
laboratory.
(2) Because some drugs or drug metabolites may
deteriorate during storage, the retest of an aliquot of a single specimen or
the test of a split (Bottle B) specimen is not subject to a specific drug
cutoff requirement, but must provide data sufficient to confirm the presence of
the drug or metabolite.
(3) If the second laboratory fails to reconfirm the presence of the drug or drug metabolite that was reported by the first laboratory, the second laboratory shall attempt to determine the reason for not reconfirming the presence of the drug or drug metabolite by conducting specimen validity tests. The second laboratory shall conduct the same
[[Page 19662]]
specimen validity tests it would conduct on a single
specimen or a primary (Bottle A) specimen. The second laboratory reports all
test results to the MRO.
(k) Retesting a Specimen for Adulterants.
(1) A second laboratory shall use the required
confirmatory validity test specified in paragraph 2.4(h)(4) and the same
confirmatory criterion specified in paragraph 2.4(h)(4) to reconfirm an
adulterant result when retesting an aliquot from a single specimen collection
or when testing a split (Bottle B) specimen.
(2) The second laboratory may only retest an aliquot
from a single specimen collection or test a split (Bottle B) specimen for the
adulterant reported by the first laboratory.
(l) Retesting a Specimen for Substitution.
(1) A second laboratory shall use its confirmatory
creatinine test and confirmatory specific gravity test, when retesting an
aliquot of a single specimen or testing a split (Bottle B) specimen, to
reconfirm that the creatinine concentration was less than 2 mg/dL and the
specific gravity was less than or equal to 1.0010 or greater than or equal to
1.0200.
(2) The second laboratory may only retest an aliquot
from a single specimen collection or test a split (Bottle B) specimen to
reconfirm the substituted result reported by the first laboratory.
(m) Subcontracting. Drug testing laboratories
shall not subcontract and shall perform all work with their own personnel and
equipment unless otherwise authorized by the Secretary.
(n) Laboratory Facilities.
(1) Laboratory facilities shall comply with applicable
provisions of any State licensor 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 the five classes of
drugs (marijuana, cocaine, opiates, phencyclidine, and amphetamines) and
performing the validity tests specified in these Guidelines.
(o) Inspections. The Secretary, a Federal
agency, or any organization performing laboratory certification on behalf of
the Secretary may inspect the laboratory at any time. Federal 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 pre-award
inspections and evaluation of the procedural aspects of the laboratory's drug
testing operation.
(p) Documentation. The drug testing
laboratories shall maintain and make documents of all aspects of the testing
process available for at least 2 years. 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; Federal CCFs
and laboratory 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 method
validation data and any documents for any specimen under legal challenge for an
indefinite period.
(q) Additional Requirements for Certified Laboratories.
(1) 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, corrective
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) 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) 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. 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) 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) A laboratory shall make available a qualified
individual to testify in an administrative or disciplinary proceeding against a
Federal employee when that proceeding is based on a non-negative result
reported by the laboratory.
(6) The laboratory shall not enter into any relationship with an agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having an agency use a specific MRO.
Section 2.5 Quality Assurance and Quality Control
(a) General. Drug testing laboratories shall
have a quality assurance program which encompasses all aspects of the testing
process including but not limited to specimen accessioning, chain of custody,
security and reporting of results, initial and confirmatory testing,
certification of calibrators and controls, and validation of analytical
procedures. The performance characteristics (e.g., accuracy, precision, limit
of detection (LOD), limit of quantitation (LOQ), specificity) shall be
documented for each test as appropriate. Validation of procedures shall
document that carryover does not affect the donor's specimen results. Periodic
re-verification of analytical procedures is required. 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 Drug Tests.
Each analytical run of specimens to be screened shall include:
(1) Sample(s) certified to contain no drug (i.e., negative urine samples);
(2) At least one control fortified with drug or metabolite targeted at 25
percent above the cutoff;
[[Page 19663]]
(3) At least one control fortified with drug or
metabolite targeted at 75 percent of the 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 routine specimens to the laboratory analysts.
(c) Laboratory Quality Control Requirements for
Confirmatory Drug Tests.
Each analytical run of specimens to be confirmed shall include:
(1) Sample(s) certified to contain no drug (i.e.,
negative urine samples);
(2) Positive calibrator(s) and control(s) fortified
with drug or metabolite;
(3) At least one control with drug or metabolite
targeted at 25 percent above the cutoff; and
(4) At least one calibrator or control that is
targeted at or below 40 percent of the cutoff.
(d) Laboratory Quality Control Requirements for
Specimen Validity Tests.
(1) Each validity test result shall be based on
performing an initial validity test on one aliquot and a confirmatory validity
test on a second aliquot; and
(2) Each analytical run of specimens for which an
initial or confirmatory validity test is being performed shall include the
appropriate calibrators and controls.
(e) Requirements for performing creatinine tests.
(1) The creatinine concentration shall be measured to
one decimal place on both the initial creatinine test and the confirmatory
creatinine test.
(2) The initial creatinine test shall have a
calibrator at 2 mg/dL.
(3) The initial creatinine test shall have a control
in the range of 1.0 mg/dL to 1.5 mg/dL, a control in the range of 3 mg/dL to 20
mg/dL, and a control in the range of 21 mg/dL to 25 mg/dL.
(4) The confirmatory creatinine test (performed on
those specimens with a creatinine concentration less than 2 mg/dL on the
initial test) shall have a calibrator at 2 mg/dL, a control in the range of 1.0
mg/dL to 1.5 mg/dL, and a control in the range of 3 mg/dL to 4 mg/dL.
(f) Requirements for performing specific gravity tests.
(1) The refractometer shall report and display the
specific gravity to four decimal places. The refractometer shall be interfaced
with a laboratory information management system (LIMS), computer, and/or
generate a hard copy of the digital electronic display to document the
numerical result.
(2) The initial and confirmatory specific gravity
tests shall have a calibrator or control at 1.0000.
(3) The initial and confirmatory specific gravity
tests shall have the following controls:
(i) One control targeted at 1.0020;
(ii) One control in the range of 1.0040 to 1.0180; and
(iii) One control greater than or equal to 1.0200 but
not greater than 1.0250.
(g) Requirements for performing pH tests.
(1) Colorimetric pH tests that have the dynamic range
of 2 to 12 to support the 3 and 11 pH cutoffs and pH meters must be capable of
measuring pH to one decimal place. Colorimetric pH tests, dipsticks, and pH
paper that have a narrow dynamic range and do not support the cutoffs may be
used only to determine if an initial pH validity test must be performed.
(2) pH screening tests shall have, at a minimum, the
following controls:
(i) One control below the lower decision point in use;
(ii) One control between the decision points in use; and
(iii) One control above the upper decision point in use.
(3) An initial colorimetric pH test shall have the
following calibrators and controls:
(i) One calibrator at 3;
(ii) One calibrator at 11;
(iii) One control in the range of 2 to 2.8;
(iv) One control in the range 3.2 to 4;
(v) One control in the range of 4.5 to 9;
(vi) One control in the range of 10 to 10.8;
(vii) One control in the range of 11.2 to 12.
(4) An initial pH meter test, if a pH screening test
is not used, shall have the following calibrators and controls:
(i) One calibrator at 4;
(ii) One calibrator at 7;
(iii) One calibrator at 10;
(iv) One control in the range of 2 to 2.8;
(v) One control in the range 3.2 to 4;
(vi) One control in the range of 10 to 10.8; and
(vii) One control in the range of 11.2 to 12.
(5) An initial or confirmatory pH meter test, if a pH
screening test is used, shall have the following calibrators and controls when
the screening result indicates that the pH is below the lower decision point in
use:
(i) One calibrator at 4;
(ii) One calibrator at 7;
(iii) One control in the range of 2 to 2.8; and
(iv) One control in the range 3.2 to 4.
(6) An initial or confirmatory pH meter test, if a pH
screening test is used, shall have the following calibrators and controls when
the screening result indicates that the pH is above the upper decision point in
use:
(i) One calibrator at 7;
(ii) One calibrator at 10;
(iii) One control in the range of 10 to 10.8; and
(iv) One control in the range of 11.2 to 12.
(h) Requirements for performing oxidizing adulterant tests.
(1) The initial test shall include an appropriate
calibrator at a cutoff specified in sections 2.4(h)(4) and (7) for the compound
of interest, a control without the compound of interest (i.e., a certified
negative control), and at least one control with one of the compounds of
interest at a measurable concentration.
(2) A confirmatory test for a specific oxidizing
adulterant shall use a different analytical method than that used for the
initial test. Each confirmatory test batch shall include an appropriate
calibrator, a control without the compound of interest (i.e., a certified
negative control), and a control with the compound of interest at a measurable
concentration.
(i) Requirements for performing nitrite tests. The
initial and confirmatory nitrite tests shall have a calibrator at the cutoff
concentration, a control without nitrite (i.e., certified negative urine), one
control in the range of 200 mcg/mL to 400 mcg/mL, and one control in the range
of 500 mcg/mL to 625 mcg/mL.
(j) Requirements for performing "other" adulterant
tests.
(1) The initial and confirmatory tests for any "other"
adulterant that may be identified in the future shall satisfy the requirements
in section 2.5(d).
(2) The confirmatory test for "other" adulterants
shall use a different analytical principle or chemical reaction than that used
for the initial test.
(3) The initial and confirmatory tests for adulterants
in this section shall include an appropriate calibrator, a control without the
compound of interest (i.e., a certified negative control), and a control with
the compound of interest at a measurable concentration.
(k) Agency Blind Sample Program.
[[Page 19664]]
(1) Agencies shall only use blind quality control
samples that have been certified by the supplier to be negative (i.e.,
certified by immunoassay and GC/MS to contain no drug), drug positive (i.e.,
certified by immunoassay and GC/MS to contain a drug(s)/metabolite(s) between
1.5 and 2 times the initial drug test cutoff concentration), adulterated (i.e.,
certified to be adulterated with a specific adulterant using an appropriate
confirmatory validity test(s)), or substituted (i.e., the creatinine
concentration and specific gravity satisfy the criteria for a substituted
specimen using confirmatory creatinine and specific gravity tests,
respectively). The supplier shall also provide the expiration date for each
quality control sample to ensure that each quality control sample will give the
expected result when it is submitted and correctly tested by a laboratory
before the expiration date.
(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 75 percent of the blind quality
control samples shall be negative (i.e., certified to contain no drug),
approximately 15 percent shall be positive for one or more drugs, and
approximately 10 percent shall be either adulterated or substituted. 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 data from the batch of specimens which included the false positive specimen. In addition, the laboratory shall retest all specimens analyzed positive for that drug or metabolite from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting shall be documented by a statement signed by the Responsible Person. The Secretary may require an on-site review of the laboratory which may be conducted unannounced during any hours of operation of the laboratory. The Secretary has the option of revoking (section 3.13) or suspending (section 3.14) the laboratory's certification or recommending that no further action be taken if the case is one of less serious error in which corrective action has already been taken, thus reasonably assuring that the error will not occur again.
Section 2.6 Reporting and Review of Results
(a) MRO Qualifications.
(1) An MRO shall be a licensed physician (Doctor of
Medicine or Osteopathy).
(2) An MRO shall have knowledge about and clinical
experience in controlled substance abuse disorders, detailed knowledge of
alternative medical explanations for laboratory positive drug test results,
knowledge about issues relating to adulterated and substituted specimens, and
knowledge about possible medical causes for specimens that may be reported as
having an invalid result.
(3) An MRO may be an employee of the agency or a
contractor for the agency; however, an 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, an 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.
(b) MRO Review of Results. An essential part of
the drug testing program is the final review of each test result reported by a
laboratory. A positive drug test result does not automatically identify a donor
as an illegal drug user nor does an adulterated, substituted, or invalid test
result automatically indicate that a donor has tampered with a specimen. The
review of a non-negative test result shall be performed by the MRO before the
result is transmitted to the agency's designated representative. Staff under
the direct, personal supervision of the MRO may review and report a negative
test result to the agency's designated representative.
(c) MRO Review of Positive, Adulterated, Substituted,
or Invalid Test Results.
(1) Prior to making a final decision on a specimen
that was reported positive, adulterated, substituted, or an invalid test result
by the laboratory, the MRO shall interview the donor to determine if the donor
has a valid medical explanation for the test result. This action could include
a review of the donor's medical history and a review of any other biomedical
factors. The MRO shall review medical records made available by the donor when
a result could have resulted from taking a legally prescribed medication. After
making a determination, the MRO reports the verified result to the agency's
designated representative.
(2) When a laboratory reports an invalid result
because of one of the reasons specified in paragraphs 2.4(h)(7)(iv) to (xii),
the MRO and the laboratory shall determine if additional testing by another
HHS-certified laboratory may be useful in resolving the reason for the invalid
result and possibly being able to report a positive or adulterated result. If
the MRO and the laboratory agree that no further testing would be useful, the
MRO shall report the invalid result as "Test Cancelled--Invalid Result (specify
reason for the invalid result)" to the agency and indicate one of the following
actions:
(i) An immediate direct observed collection is not
required because the explanation provided by the donor for the invalid result
is acceptable with no further action required unless a negative test result is
required (i.e., pre-employment, return-to-duty, or follow-up test); or
(ii) An immediate direct observed collection is
required because the explanation provided by the donor for the invalid result
is not acceptable.
(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 result--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
[[Page 19665]]
requirement does not apply if the laboratory confirms
the presence of 6-acetylmorphine (i.e., the presence of this metabolite is
proof of heroin use) or the morphine or codeine concentration is greater than
or equal to 15,000 ng/mL and the donor does not present a legitimate medical
explanation for the presence of morphine or codeine at or above this
concentration. Consumption of food products must not be considered a legitimate
medical explanation for the donor having morphine or codeine at or above this
concentration.
(e) Donor Request to MRO for Retest.
(1) For a positive, adulterated, or substituted result
reported on a single specimen or a primary (Bottle A) specimen, a donor may
request through the MRO that an aliquot from the single specimen or the split
(Bottle B) specimen be tested by a second HHS-certified laboratory to verify
the result reported by the first laboratory. For a single specimen or primary
(Bottle A) specimen reported as an invalid result, a donor may not request that
an aliquot from the single specimen or the split (Bottle B) specimen be tested
by a second HHS-certified laboratory.
(2) The donor has 72 hours (from the time the MRO
notified the donor that his or her specimen was reported positive, adulterated,
or substituted) to request a retest of an aliquot from the single specimen or
to test the split (Bottle B) specimen.
(3) If the single specimen or split (Bottle B)
specimen cannot be tested by a second laboratory (e.g., insufficient volume,
lost in transit, split (Bottle B) not available), the MRO shall direct the
agency to immediately collect another specimen under direct observation.
(4) If a donor chooses not have an aliquot from the
single specimen or the split (Bottle B) specimen tested by a second
HHS-certified laboratory, a Federal agency may have a single or split specimen
retested as part of a legal or administrative proceeding to defend an original
positive, adulterated, or substituted result.
(f) Result Consistent with Legal Drug Use. If
the MRO determines there is a legitimate medical explanation for the positive
drug test result, he or she shall normally take no further action and report
the test result as negative.
(g) Laboratory Result Not Reconfirmed by a Second
Laboratory. After a second laboratory tests an aliquot of the single
specimen or the split (Bottle B) specimen, the MRO shall take the following
actions when the second laboratory reports the following results:
(1) Failed to reconfirm a single or all drug positive
results and adulterated. If the donor provides a legitimate medical explanation
for the adulteration result, the MRO reports a failed to reconfirm (specify
drug(s)) and cancels both tests. If there is no legitimate medical explanation,
the MRO reports a failed to reconfirm (specify drug(s)) and a refusal to test
to the agency and indicates the adulterant that is present in the urine
specimen. The MRO gives the donor 72 hours to request that Laboratory A retests
the single or Bottle A specimen for the adulterant. If Laboratory A reconfirms
the adulterant, the MRO reports refusal to test and indicates the adulterant
present. If Laboratory A fails to reconfirm the adulterant, the MRO cancels
both tests and directs the agency to immediately collect another specimen using
a direct observed collection procedure. The MRO shall notify the appropriate
regulatory office about the failed to reconfirm and cancelled test.
(2) Failed to reconfirm a single or all drug positive
results and substituted. If the donor provides a legitimate medical explanation
for the substituted result, the MRO reports a failed to reconfirm (specify
drug(s)) and cancels both tests. If there is no legitimate medical explanation,
the MRO reports a failed to reconfirm (specify drug(s)) and a refusal to test
(substituted) to the agency. The MRO gives the donor 72 hours to request
Laboratory A to review the creatinine and specific gravity results for the
single or Bottle A specimen. If the original creatinine and specific gravity
results confirm that the specimen was substituted, the MRO reports a refusal to
test (substituted) to the agency. If the original creatinine and specific
gravity results from Laboratory A fail to confirm that the specimen was
substituted, the MRO cancels both tests and directs the agency to immediately
collect another specimen using a direct observed collection procedure. The MRO
shall notify the appropriate regulatory office about the failed to reconfirm
and cancelled test.
(3) Failed to reconfirm a single or all drug positive
results and not adulterated or substituted. The MRO reports to the agency a
failed to reconfirm result (specify drug(s)), cancels both tests, and notifies
the appropriate regulatory office.
(4) Failed to reconfirm a single or all drug positive
results and invalid result. The MRO reports to the agency a failed to reconfirm
result (specify drug(s) and gives the reason for the invalid result), cancels
both tests, directs the agency to immediately collect another specimen using a
direct observed collection procedure, and notifies the appropriate regulatory
office.
(5) Failed to reconfirm one or more drugs, reconfirmed
one or more drugs, and adulterated. The MRO reports to the agency a reconfirmed
result (specify drug(s)) and a failed to reconfirm result (specify drug(s)).
The MRO tells the agency that it may take action based on the reconfirmed
drug(s) although Laboratory B failed to reconfirm one or more drugs and found
that the specimen was adulterated. The MRO shall notify the appropriate
regulatory office regarding the test results for the specimen.
(6) Failed to reconfirm one or more drugs, reconfirmed
one or more drugs, and substituted. The MRO reports to the agency a reconfirmed
result (specify drug(s)) and a failed to reconfirm result (specify drug(s)).
The MRO tells the agency that it may take action based on the reconfirmed
drug(s) although Laboratory B failed to reconfirm one or more drugs and found
that the specimen was substituted. The MRO shall notify the appropriate
regulatory office regarding the test results for the specimen.
(7) Failed to reconfirm one or more drugs, reconfirmed
one or more drugs, and not adulterated or substituted. The MRO reports a
reconfirmed result (specify drug(s)) and a failed to reconfirm result (specify
drug(s)). The MRO tells the agency that it may take action based on the
reconfirmed drug(s) although Laboratory B failed to reconfirm one or more
drugs. The MRO shall notify the appropriate regulatory office regarding the
test results for the specimen.
(8) Failed to reconfirm one or more drugs, reconfirmed
one or more drugs, and invalid result. The MRO reports to the agency a
reconfirmed result (specify drug(s)) and a failed to reconfirm result (specify
drug(s)). The MRO tells the agency that it may take action based on the
reconfirmed drug(s) although Laboratory B failed to reconfirm one or more drugs
and reported an invalid result. The MRO shall notify the appropriate regulatory
office regarding the test results for the specimen.
(9) Failed to reconfirm substitution or adulteration.
The MRO reports to the agency a failed to reconfirm result (specify adulterant
or not substituted) and cancels both tests. The MRO shall notify the
appropriate regulatory office regarding the test results for the specimen.
(10) Failed to reconfirm a single or all drug positive results and reconfirmed an adulterated or substituted result. The MRO reports to the agency a reconfirmed result (adulterated or substituted) and a failed to reconfirm result (specify drug(s)). The MRO tells
[[Page 19666]]
the agency that it may take action based on the
reconfirmed result (adulterated or substituted) although Laboratory B failed to
reconfirm the drug(s) result.
(11) Failed to reconfirm a single or all drug positive
results and failed to reconfirm the adulterated or substituted result. The MRO
reports to the agency a failed to reconfirm result (specify drug(s) and specify
adulterant or substituted) and cancels both tests. The MRO shall notify the
appropriate regulatory office regarding the test results for the specimen.
(12) Failed to reconfirm at least one drug and
reconfirmed the adulterated result. The MRO reports to the agency a reconfirmed
result (specify drug(s) and adulterated) and a failed to reconfirm result
(specify drug(s)). The MRO tells the agency that it may take action based on
the reconfirmed drug(s) and the adulterated result although Laboratory B failed
to reconfirm one or more drugs.
(13) Failed to reconfirm at least one drug and failed
to reconfirm the adulterated result. The MRO reports to the agency a
reconfirmed result (specify drug(s)) and a failed to reconfirm result (specify
drug(s) and specify adulterant). The MRO tells the agency that it may take
action based on the reconfirmed drug(s) although Laboratory B failed to
reconfirm one or more drugs and failed to reconfirm the adulterated result.
(14) Failed to reconfirm an adulterated result and
failed to reconfirm a substituted result. The MRO reports to the agency a
failed to reconfirm result ((specify adulterant) and not substituted) and
cancels both tests. The MRO shall notify the appropriate regulatory office
regarding the test results for the specimen.
(15) Failed to reconfirm an adulterated result and
reconfirmed a substituted result. The MRO reports to the agency a reconfirmed
result (substituted) and a failed to reconfirm result (specify adulterant). The
MRO tells the agency that it may take action based on the substituted result
although Laboratory B failed to reconfirm the adulterated result.
(16) Failed to reconfirm a substituted result and
reconfirmed an adulterated result. The MRO reports to the agency a reconfirmed
result (adulterated) and a failed to reconfirm result (not substituted). The
MRO tells the agency that it may take action based on the adulterated result
although Laboratory B failed to reconfirm the substituted result.
(h) Reporting Final Results. The MRO shall report the final results of the tests in writing and in a manner designed to ensure confidentiality of the information. When reporting the result for a single specimen or primary (Bottle A) specimen to the agency, the MRO shall report whether the specimen was negative, dilute, positive (specify drug), refusal to test (adulterated or substituted), or test cancelled (state reason). When reporting the result for a retest of an aliquot of a single specimen or the test of a split (Bottle B) specimen to the agency, the MRO shall report reconfirmed, failed to reconfirm (state reason), refusal to test (adulterated or substituted), or cancel both test results as described in section 2.6(g). The MRO shall not disclose any numerical values to the agency.
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 sec. 503 of Public Law 100-71. The agency shall establish a Privacy Act System of Records or modify an existing system, or use any applicable Government-wide system of records to cover the agency'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 sec. 503 of Public Law 100-71, any Federal employee who is the subject of a drug test shall, upon written request, have access to any records relating to his or her drug test and any records relating to the results of any relevant certification, review, or revocation-of-certification proceedings.
Subpart C--Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies
Section 3.1 Introduction
Urine drug testing is a critical component of efforts to combat drug abuse in our society. Many laboratories are familiar with good laboratory practices but may be unfamiliar with the special procedures required when drug test results are used in the employment context. Accordingly, the following are minimum standards to certify laboratories engaged in urine drug testing for Federal agencies. Certification, even at the highest level, does not guarantee accuracy of each result reported by a laboratory conducting urine drug testing for Federal agencies. Therefore, results from laboratories certified under these Guidelines must be interpreted with a complete understanding of the total collection, analysis, and reporting process before a final conclusion is made.
Section 3.2 Goals and Objectives of Certification
(a) Uses of Urine Drug Testing. Urine drug
testing is an important tool to identify drug users in a variety of settings.
In the proper context, urine drug testing can be used to deter drug abuse in
general. To be a useful tool, the testing procedure must be capable of
detecting drugs, drug metabolites, adulterants, or substituted specimens
according to sections 2.4(e), 2.4(f), and 2.4(g) to protect the rights of the
Federal employees being tested.
(b) Need to Set Standards; Inspections. The
ability to accurately determine the presence or absence of specific
drugs/metabolites or to accurately determine the validity of a urine specimen
is critical to achieving the goals of the testing program and to protect the
rights of the Federal employees being tested. Standards have been set which
laboratories engaged in Federal employee urine drug testing shall meet to
achieve the required 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. Applicant laboratories shall test
three cycles of performance testing samples that challenge the laboratory's
ability to correctly test for drugs and to correctly perform specimen validity
tests. Applicant laboratories shall undergo an initial inspection and upon
certification are also required to undergo a second inspection within 3 months
after being certified. Certified laboratories are required to analyze quarterly
performance testing samples that challenge the laboratories to correctly test
for drugs and to correctly perform validity tests and are required to undergo
periodic inspections.
(c) Urine Drug Testing Applies Analytical Forensic Toxicology. The possible impact of a non-negative 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
[[Page 19667]]
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 non-negative specimens for later or independent testing, presentation of evidence in court, and expert witness testimony.
Section 3.3 General Certification Requirements
A laboratory must meet all the pertinent provisions of these Guidelines in order to qualify for and maintain certification under these standards.
Section 3.4 Capability to Test for Five Classes of Drugs and to Conduct Validity Tests
To be certified, a laboratory must be capable of testing for marijuana, cocaine, opiates, amphetamines, and phencyclidine using the initial immunoassay and confirmatory GC/MS methods and conducting the specimen validity tests as specified in these Guidelines. The certification program will be limited to these five classes of drugs and specimen validity tests in accordance with the methods specified in these Guidelines (sections 2.4(e), (f), and (g)). The laboratory will be inspected and performance tested for these drugs and validity tests. Certified laboratories must clearly inform all non-regulated, private-sector employers/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 to perform initial and confirmatory drug tests and initial and confirmatory validity tests at the same laboratory site.
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
Certified laboratories shall have a quality assurance program which encompasses all aspects of the testing process, including but not limited to specimen accessioning, chain of custody, security and reporting of results, initial and confirmatory testing, and validation of analytical procedures. As specified in these Guidelines, quality control procedures shall be designed, implemented, and reviewed to monitor testing.
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 Positive, Adulterated, Substituted, and Invalid Specimens
All positive, adulterated, substituted, and invalid specimens shall be retained in accordance with the provisions of section 2.4(i) 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(p).
Section 3.11 Reports
The laboratory shall report test results in accordance with the specifications in section 2.4(h).
Section 3.12 Certification
(a) General. The Secretary may certify any
laboratory that meets the standards in these Guidelines to conduct urine drug
testing. In addition, the Secretary may consider to be certified any laboratory
that is certified by an HHS-recognized certification program in accordance with
these Guidelines.
(b) Criteria. In determining whether to certify
a laboratory or to accept the certification of an HHS-recognized certification
program in accordance with these Guidelines, the Secretary shall consider the
following criteria:
(1) The adequacy of the laboratory facilities;
(2) The expertise and experience of the laboratory personnel;
(3) The excellence of the laboratory's quality assurance/quality control
program;
(4) The performance of the laboratory on any performance tests;
(5) The laboratory's compliance with standards as reflected in any laboratory
inspections; and
(6) Any other factors affecting the reliability and accuracy of drug or
validity 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 and validity testing and reporting, to resolve problems related to drug and validity 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; order any laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through proficiency testing; order any laboratory to send aliquots of urine specimens to another laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; order the review of results for specimens tested under the Guidelines for private-sector employers/clients to the extent necessary to ensure the full reliability of drug and validity testing for Federal agencies; and order any other action necessary to address deficiencies in drug or validity testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
Section 3.13 Revocation
(a) General. The Secretary shall revoke
certification of any laboratory certified under these provisions or accept
revocation by an HHS-recognized certification program in accordance with these
Guidelines if the Secretary determines that revocation is necessary to ensure
the full reliability and accuracy of drug and validity 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
and validity tests; for example, a false positive error in reporting the
results of an employee's drug test;
(2) Unsatisfactory participation in performance evaluations or laboratory
inspections;
(3) A material violation of a certification standard or a contract term or
other condition imposed on the
[[Page 19668]]
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 and validity 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 and validity
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 and validity 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 and validity 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 reapply for certification as an applicant laboratory.
Section 3.17 Performance Testing (PT) Requirement for Certification
(a) An Initial and Continuing Requirement. The
PT program is a part of the initial evaluation of a laboratory seeking
certification (both PT and laboratory inspection are required) and of the
continuing assessment of laboratory performance necessary to maintain this
certification.
(b) Three Initial Cycles Required. Successful
participation in three PT cycles of testing shall be required before a
laboratory is eligible to be considered for certification.
(c) Four Cycles Per Year. After certification, laboratories shall be challenged with at least 10 PT samples on a quarterly cycle.
(d) Laboratory Procedures Identical for PT Samples and
Routine 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
specimens, unless otherwise specified.
(e) Agency PT Samples. Any certified laboratory
shall be subject to receiving and testing PT samples (see section 2.5(k))
submitted by a Federal agency. A certified laboratory is expected to correctly
test and report each agency submitted PT sample (that is, report a negative
sample as negative, a drug positive sample as positive, an adulterated sample
as adulterated, or a substituted sample as substituted).
(f) Reporting PT Sample Results. The laboratory shall report results of PT program samples to the certifying organization in the same manner as specified in section 2.4(h) for routine specimens.
Section 3.18 PT Program Samples
(a) Drug PT Samples. Each PT cycle shall have
samples that contain the drugs and drug metabolites listed in sections 2.4(e)
and (f). For some samples, the composition will consist of the parent drug as
well as metabolites. Also, 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.
For any particular PT cycle, the samples in each set of samples going to the
laboratories may vary but, within any annual period, all laboratories
participating in the PT program will have analyzed the same total set of
samples.
(b) Composition of the Drug PT Samples. PT
program samples shall satisfy, but are not limited to, one of the following
criteria:
(1) A drug or drug metabolite concentration will be at least 20 percent above
the cutoff for either the initial drug test or the confirmatory drug test
depending on which is to be evaluated;
(2) For retest samples, the drug or drug metabolite concentration may be as low
as 40 percent of the cutoff;
(3) For routine samples, the drug or drug metabolite concentration may be below
the cutoff for special purposes;
(4) A negative sample shall contain no target drug analyte at a concentration
greater than 10 percent of the confirmatory cutoff;
(5) Samples may be fortified with interfering substances.
(c) Specimen Validity Testing PT Samples. Each PT cycle shall contain samples that challenge a laboratory's ability to identify substituted and adulterated specimens. For any particular PT cycle, the samples in each set of samples going to the laboratories may vary but, within any annual period,
[[Page 19669]]
all laboratories participating in the PT program will
have analyzed the same total set of specimen validity testing PT samples.
(d) Composition of the Specimen Validity Testing PT
Samples. Specimen validity testing PT samples shall satisfy, but are
not limited to, one of the following criteria:
(1) The nitrite concentration will be at least 20 percent above the cutoff;
(2) The pH will be less than 2.75 or greater than 11.25;
(3) The concentration of an oxidant will be at a level sufficient to challenge
a laboratory's ability to identify and confirm the oxidant;
(4) The creatinine concentration will be between 0 and 20 mg/dL;
(5) The specific gravity will be less than or equal to 1.0050 or between 1.0170
and 1.0230.
Section 3.19 Evaluation of PT Sample Results
(a) Initial Certification of Applicant Laboratories.
(1) An applicant laboratory shall not report any false
positive drug test result on any PT sample during the initial certification
process. A false positive drug result will automatically disqualify a
laboratory from further consideration.
(2) An applicant laboratory shall maintain an overall
grade of 90 percent for the three cycles of PT samples that challenge the
laboratory's ability to conduct drug tests (i.e., it must correctly identify
and confirm 90 percent of the total drug challenges). A laboratory which
achieves a score on any one cycle of the initial certification process such
that it can no longer achieve a grade of 90 percent over three consecutive PT
cycles will be immediately disqualified from further consideration.
(3) An applicant laboratory shall obtain quantitative
values over the three initial PT cycles that are within +/-20 percent or +/-2
standard deviations of the calculated reference group mean (whichever range is
larger) for at least 80 percent of the total drug challenges. Failure to
satisfy this requirement for the total drug challenges will result in
disqualification.
(4) An applicant laboratory shall not obtain any
quantitative value on a drug challenge sample that differs by more than 50
percent from the calculated reference group mean. An applicant laboratory that
obtains a quantitative value that differs by more than 50 percent on any drug
challenge sample will result in disqualification.
(5) 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 challenges for each drug. An applicant
laboratory that fails to successfully quantitate at least 50 percent of the
challenges for each drug will result in disqualification.
(6) An applicant laboratory shall maintain an overall
grade of 80 percent for the three cycles of PT samples that challenge the
laboratory's ability to conduct specimen validity tests (i.e., to correctly
identify and confirm 80 percent of the total specimen validity testing
challenges). An applicant laboratory that achieves a score on any one of the
initial PT cycles such that it can no longer achieve a total grade of 80
percent over the three consecutive PT cycles for the specimen validity testing
samples will result in disqualification.
(7) For quantitative specimen validity tests, an
applicant laboratory shall obtain quantitative values for at least 80 percent
of the total challenges that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are within +/-20 percent or +/-2
standard deviations of the calculated reference group mean;
(ii) pH values are within +/-0.3 pH units of the calculated reference group
mean; and
(iii) Specific gravity values are within +/-0.0003 specific gravity units of
the calculated reference group mean.
An applicant laboratory that achieves a score on any one initial PT cycle such
that it cannot achieve a total grade of 80 percent over three consecutive PT
cycles for the specimen validity testing samples will be disqualified.
(8) An applicant laboratory shall not obtain any
quantitative value on a specimen validity testing sample that differs by more
than +/-50 percent for nitrite and creatinine concentrations, +/-0.8 units for
pH measurements, or +/-0.0006 units for specific gravity from the calculated
reference group means. An applicant laboratory that reports such an error for
an initial certification PT sample will be disqualified.
(9) For qualitative specimen validity tests, an
applicant laboratory shall correctly report at least 80 percent of the
challenges for each qualitative specimen validity test over the three initial
PT cycles. Failure to correctly report at least 80 percent for each qualitative
specimen validity test will result in disqualification.
(10) An applicant laboratory shall not report any
sample as adulterated with a compound that is not present in the sample,
adulterated based on pH when the calculated group reference mean is within the
acceptable pH range, or substituted when the calculated group means for both
creatinine and specific gravity are within the acceptable range. An applicant
laboratory reporting any such error will be disqualified.
(b) Evaluation of Certified Laboratories.
(1) Requirement for No False Positives. A certified
laboratory that reports a false positive drug result for a PT sample may be
subject to suspension or revocation of its certification. The most serious
false positive is by drug class, such as reporting THCA in a negative PT sample
or reporting cocaine metabolite in a PT sample containing only opiates. An
identification or reporting error within a class (e.g., reporting codeine for
morphine) is unacceptable, but is less serious than a misidentification of a
class.
(2) Requirement to Identify and Confirm 90 Percent of
Total Drug Challenges. Failure of a certified laboratory to maintain a grade of
90 percent over 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 the laboratory's
certification.
(3) Requirement to Quantitate 80 Percent of Total Drug
Challenges Within +/-20 Percent or +/-2
Standard Deviations. Quantitative values reported by a certified laboratory
over two consecutive PT cycles must be within +/-20 percent or +/-2 standard
deviations of the calculated reference group mean (whichever is larger) for at
least 80 percent of the total drug challenges. A certified laboratory that
fails to achieve the 80 percent requirement may have its certification
suspended or revoked.
(4) Requirement to Quantitate within 50 Percent of
Calculated Reference Group Mean. A certified laboratory shall not obtain any
quantitative value on a drug challenge that differs by more than +/-50 percent
from the calculated reference group mean. More than one error of this type for
the same drug class over two consecutive PT cycles may result in suspension or
revocation of the laboratory's certification.
(5) Requirement to Successfully Detect and Quantitate
50 Percent of the Total Drug Challenges for Any Individual Drug. For each drug,
a certified laboratory must successfully detect and quantitate in accordance
with paragraphs (b)(3) and (b)(4) of this section at least 50 percent of the
total drug challenges.
(6) No False Adulterated or Substituted Specimen Validity Testing Sample Result. A certified laboratory shall not report any sample as adulterated with a compound that is not present in the sample, adulterated based on pH when the calculated group reference mean is within the acceptable
[[Page 19670]]
pH range, or substituted when the calculated group
means for both creatinine and specific gravity are within the acceptable range.
A certified laboratory that reports this type of error may have its
certification suspended or revoked.
(7) Requirement to Identify and Confirm 80 Percent of
the Total Specimen Validity Testing Challenges. A certified laboratory shall
maintain an overall grade of 80 percent over two consecutive PT cycles that
challenge the laboratory's ability to conduct specimen validity tests (i.e., to
correctly identify and confirm 80 percent of the total specimen validity
testing challenges). A certified laboratory that fails to maintain a grade of
80 percent over two consecutive PT cycles may have its certification suspended
or revoked.
(8) Requirement to Correctly Quantitate 80 Percent of
the Total Challenges for Quantitative Specimen Validity Tests. For quantitative
specimen validity tests, a certified laboratory shall obtain quantitative
values for at least 80 percent of the total challenges that satisfy the
following criteria:
(i) Nitrite and creatinine concentrations are within +/-20 percent or +/-2
standard deviations of the calculated reference group mean;
(ii) pH values are within +/-0.3 pH units of the calculated reference group
mean; and
(iii) Specific gravity values are within +/-0.0003 specific gravity units of
the calculated reference group mean.
A certified laboratory that fails to achieve 80 percent over two consecutive PT
cycles may have its certification suspended or revoked.
(9) Requirement to Report No More than One
Quantitative Error for a Quantitative Specimen Validity Test. A certified
laboratory shall not obtain any quantitative value on a specimen validity
testing sample that differs by more than +/-50 percent for nitrite and
creatinine concentrations, +/-0.8 unit for pH measurements, or +/-0.0006 units
for specific gravity from the calculated reference group means. More than one
error of this type for the same adulterant, for creatinine, for pH, or for
specific gravity over two consecutive PT cycles may result in suspension or
revocation of a laboratory's certification.
(10) Requirement for Each Qualitative Specimen
Validity Test. For each qualitative specimen validity test, a certified
laboratory shall correctly report at least 80 percent of the challenges for
each qualitative specimen validity test over two consecutive PT cycles. A
certified laboratory that fails to correctly report at least 80 percent of the
challenges may have its certification suspended or revoked.
(11) Procedures When Requirements in Paragraphs
(b)(1)--(b)(10) of this Section Are Not Met. 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 to
develop and submit a plan for implementing corrective actions to address the
source of the error within 30 days. 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) Eighty Percent of Participating Laboratories Must
Detect Drug or Specimen Validity Testing Challenge. A laboratory's
performance shall be evaluated for all drug and specimen validity testing
challenges unless the overall response from participating laboratories
indicates that less than 80 percent of them were able to correctly report the
drug or specimen validity testing challenge.
(d) Participation Required. Failure to participate in a PT cycle or to participate satisfactorily may result in the suspension or revocation of a laboratory's certification.
Section 3.20 Inspections
(a) Frequency. Prior to laboratory
certification under these Guidelines and at least twice a year after
certification, a team of two or more qualified and trained inspectors shall
conduct an on-site inspection of laboratory premises. Inspections shall
document the overall ability of the laboratory to satisfy the certification
requirements specified in these Guidelines.
(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 in section 3.12(b).
(c) Inspection Performance. Inspectors shall assess the overall compliance of the certified or applicant laboratory to these Guidelines. 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 consistent with these Guidelines and with good forensic laboratory practice. In accordance with sections 3.13 and 3.14, deficiencies identified at inspections may be the basis for suspending or revoking a laboratory's certification.
Section 3.21 Results of Inadequate Performance
Failure of a laboratory to comply with any aspect of these Guidelines may lead to revocation or suspension of certification as provided in sections 3.13 and 3.14 of these Guidelines.
Section 3.22 Listing of Certified Laboratories
A Federal Register listing of laboratories certified by HHS will be updated and published periodically. Laboratories which are in the applicant stage of HHS certification are not to be considered as meeting the minimum requirements in these Guidelines. A laboratory is not certified until HHS has sent the laboratory an HHS letter of certification.
Subpart D--Procedures for Review of Suspension or Proposed Revocation of a Certified Laboratory
Section 4.1 Applicability
These procedures apply when:
(a) The Secretary has notified a laboratory in writing
that its certification to perform urine drug testing under these Mandatory
Guidelines for Federal Workplace Drug Testing Programs has been suspended or
that the Secretary proposes to revoke such certification.
(b) The laboratory has, within 30 days of the date of such notification or within 3 days of the date of such notification when seeking an expedited review of a suspension, requested in writing an opportunity for an informal review of the suspension or proposed revocation.
Section 4.2 Definitions
Appellant. Means the laboratory which has been
notified of its suspension or proposed revocation of its certification to
perform urine drug and/or validity 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
[[Page 19671]]
Division of Workplace Programs, Substance Abuse and
Mental Health Services Administration).
Reviewing Official. Means the person or persons designated by the Secretary who
will review the suspension or proposed revocation. The reviewing official may
be assisted by one or more of his or her employees or consultants in assessing
and weighing the scientific and technical evidence and other information
submitted by the appellant and respondent on the reasons for the suspension and
proposed revocation.
Section 4.3 Limitation on Issues Subject to Review
The scope of review shall be limited to the facts relevant to any suspension or proposed revocation, the necessary interpretations of those facts, the Mandatory Guidelines for Federal Workplace Drug Testing Programs, and other relevant law. The legal validity of the Mandatory Guidelines shall not be subject to review under these procedures.
Section 4.4 Specifying Who Represents the Parties
The appellant's request for review shall specify the name, address, and phone number of the appellant's representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and phone number of the respondent's representative.
Section 4.5 The Request for Informal Review and the Reviewing Official's Response
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.
Within 5 days after receiving the request for review, the reviewing official
will send an acknowledgment and advise the appellant of the next steps. The
reviewing official will also send a copy of the acknowledgment to the
respondent.
Section 4.6 Abeyance Agreement
Upon mutual agreement of the parties to hold these procedures in abeyance, the reviewing official will stay these procedures for a reasonable time while the laboratory attempts to regain compliance with the Mandatory Guidelines for Federal Workplace Drug Testing Programs or the parties otherwise attempt to settle the dispute. As part of an abeyance agreement, the parties can agree to extend the time period for requesting review of the suspension or proposed revocation. If abeyance begins after a request for review has been filed, the appellant shall notify the reviewing official at the end of the abeyance period advising whether the dispute has been resolved. If the dispute has been resolved, the request for review will be dismissed. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate.
Section 4.7 Preparation of the Review File and Written Argument
The appellant and the respondent each participate in
developing the file for the reviewing official and in submitting written
arguments. The procedures for development of the review file and submission of
written argument are:
(a) Appellant's Documents and Brief. Within 15
days after receiving the acknowledgment of the request for review, the
appellant shall submit to the reviewing official the following (with a copy to
the respondent):
(1) A review file containing the documents supporting
appellant's argument, tabbed and organized chronologically, and accompanied by
an index identifying each document. Only essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed 20
double-spaced pages, explaining why respondent's decision to suspend or propose
revocation of appellant's certification is wrong (appellant's brief).
(b) Respondent's Documents and Brief. Within 15
days after receiving a copy of the acknowledgment of the request for review,
the respondent shall submit to the reviewing official the following (with a
copy to the appellant):
(1) A review file containing documents supporting
respondent's decision to suspend or revoke appellant's certification to perform
urine drug and/or validity testing, tabbed and organized chronologically, and
accompanied by an index identifying each document. Only essential documents
should be submitted to the reviewing official.
(2) A written statement, not exceeding 20
double-spaced pages in length, explaining the basis for suspension or proposed
revocation (respondent's brief).
(c) Reply Briefs. Within 5 days after receiving
the opposing party's submission, or 20 days after receiving acknowledgment of
the request for review, whichever is later, each party may submit a short reply
not to exceed 10 double-spaced pages.
(d) Cooperative Efforts. Whenever feasible, the
parties should attempt to develop a joint review file.
(e) Excessive Documentation. The reviewing official may take any appropriate step to reduce excessive documentation, including the return of or refusal to consider documentation found to be irrelevant, redundant, or unnecessary.
Section 4.8 Opportunity for Oral Presentation
(a) Electing Oral Presentation. If an
opportunity for an oral presentation is desired, the appellant shall request it
at the time it submits its written request for review to the reviewing
official. The reviewing official will grant the request if the official
determines that the decision-making process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide for an
oral presentation at the official's own initiative or at the request of the
respondent.
(b) Presiding Official. The reviewing official
or designee will be the presiding official responsible for conducting the oral
presentation.
(c) Preliminary Conference. The presiding official may hold a prehearing
conference (usually a telephone conference call) to consider any of the
following: simplifying and clarifying issues; stipulations and admissions;
limitations on evidence and witnesses that will be presented at the hearing;
time allotted for each witness and the hearing altogether; scheduling the
hearing; and any other matter that will assist in the review process. Normally,
this conference will be conducted informally and off the record; however, the
presiding official may, at his or her discretion, produce a written document
summarizing the conference or transcribe the conference, either of which will
be made a part of the record.
(d) Time and Place of Oral Presentation. The presiding official will attempt to schedule the oral presentation within 30 days of the date appellant's request for review is received or within 10 days of submission of the last reply brief, whichever is later. The oral presentation will be held at a time and place
[[Page 19672]]
determined by the presiding official following
consultation with the parties.
(e) Conduct of the Oral Presentation.
(1) General. The presiding official is responsible for
conducting the oral presentation. The presiding official may be assisted by one
or more of his or her employees or consultants in conducting the oral
presentation and reviewing the evidence. While the oral presentation will be
kept as informal as possible, the presiding official may take all necessary
steps to ensure an orderly proceeding.
(2) Burden of Proof/Standard of Proof. In all cases,
the respondent bears the burden of proving by a preponderance of the evidence
that its decision to suspend or propose revocation is appropriate. The
appellant, however, has a responsibility to respond to the respondent's
allegations with evidence and argument to show that the respondent is wrong.
(3) Admission of Evidence. The rules of evidence do
not apply and the presiding official will generally admit all testimonial
evidence unless it is clearly irrelevant, immaterial, or unduly repetitious.
Each party may make an opening and closing statement, may present witnesses as
agreed upon in the prehearing conference or otherwise, and may question the
opposing party's witnesses. Since the parties have ample opportunity to prepare
the review file, a party may introduce additional documentation during the oral
presentation only with the permission of the presiding official. The presiding
official may question witnesses directly and take such other steps necessary to
ensure an effective and efficient consideration of the evidence, including
setting time limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on
motions including, for example, motions to exclude or strike redundant or
immaterial evidence, motions to dismiss the case for insufficient evidence, or
motions for summary judgment. Except for those made during the hearing, all
motions and opposition to motions, including argument, must be in writing and
be no more than 10 double-spaced pages in length. The presiding official will
set a reasonable time for the party opposing the motion to reply.
(5) Transcripts. The presiding official shall have the
oral presentation transcribed and the transcript shall be made a part of the
record. Either party may request a copy of the transcript and the requesting
party shall be responsible for paying for its copy of the transcript.
(f) Obstruction of Justice or Making of False
Statements. Obstruction of justice or the making of false statements by
a witness or any other person may be the basis for a criminal prosecution under
18 U.S.C. 1505 or 1001.
(g) Post-hearing Procedures. At his or her discretion, the presiding official may require or permit the parties to submit post-hearing briefs or proposed findings and conclusions. Each party may submit comments on any major prejudicial errors in the transcript.
Section 4.9 Expedited Procedures for Review of Immediate Suspension
(a) Applicability. When the Secretary notifies
a laboratory in writing that its certification to perform urine drug and/or
validity testing has been immediately suspended, the appellant may request an
expedited review of the suspension and any proposed revocation. The appellant
must submit this request in writing to the reviewing official within 3 days of
the date the laboratory received notice of the suspension. The request for
review must include a copy of the suspension and any proposed revocation, a
brief statement of why the decision to suspend and propose revocation is wrong,
and the appellant's request for an oral presentation, if desired. A copy of the
request for review must also be sent to the respondent.
(b) Reviewing Official's Response. As soon as
practicable after the request for review is received, the reviewing official
will send an acknowledgment with a copy to the respondent.
(c) Review File and Briefs. Within 7 days of
the date the request for review is received, but no later than 2 days before an
oral presentation, each party shall submit to the reviewing official the
following: (1) A review file containing essential documents relevant to the
review, tabbed, indexed, and organized chronologically, and (2) a written
statement, not to exceed 20 double-spaced pages, explaining the party's
position concerning the suspension and any proposed revocation. No reply brief
is permitted.
(d) Oral Presentation. If an oral presentation
is requested by the appellant or otherwise granted by the reviewing official,
the presiding official will attempt to schedule the oral presentation within
7-10 days of the date of appellant's request for review at a time and place
determined by the presiding official following consultation with the parties.
The presiding official may hold a pre-hearing conference in accordance with
section 4.8(c) and will conduct the oral presentation in accordance with the
procedures of sections 4.8(e), (f), and (g).
(e) Written Decision. The reviewing official
shall issue a written decision upholding or denying the suspension or proposed
revocation and will attempt to issue the decision within 7-10 days of the date
of the oral presentation or within 3 days of the date on which the transcript
is received or the date of the last submission by either party, whichever is
later. All other provisions set forth in section 4.14 will apply.
(f) Transmission of Written Communications. Because of the importance of timeliness for these expedited procedures, all written communications between the parties and between either party and the reviewing official shall be by facsimile or overnight mail.
Section 4.10 Ex Parte Communications
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
Section 4.11 Transmission of Written Communications by Reviewing Official and Calculation of Deadlines
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. 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
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accordance with the objectives of these procedures.
Section 4.13 Administrative Record
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
Section 4.14 Written Decision
(a) Issuance of Decision. The reviewing
official shall issue a written decision upholding or denying the suspension or
proposed revocation. The decision will set forth the reasons for the decision
and describe the basis therefor in the record. Furthermore, the reviewing
official may remand the matter to the respondent for such further action as the
reviewing official deems appropriate.
(b) Date of Decision. The reviewing official
will attempt to issue his or her decision within 15 days of the date of the
oral presentation, the date on which the transcript is received, or the date of
the last submission by either party, whichever is later. If there is no oral
presentation, the decision will normally be issued within 15 days of the date
of receipt of the last reply brief. Once issued, the reviewing official will
immediately communicate the decision to each party.
(c) Public Notice. If the suspension and proposed revocation are upheld, the revocation will become effective immediately and the public will be notified by publication of a notice in the Federal Register. If the suspension and proposed revocation are denied, the revocation will not take effect and the suspension will be lifted immediately. Public notice will be given by publication in the Federal Register.
Section 4.15 Court Review of Final Administrative Action; Exhaustion of Administrative Remedies
Before any legal action is filed in court challenging the suspension or proposed revocation, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal Law. The reviewing official's decision, under section 4.9(e) or 4.14(a), constitutes final agency action and is ripe for judicial review as of the date of the decision.
[FR Doc. 04-7985 Filed 4-6-04; 12:39 pm]
BILLING CODE 4162-20-P