(a)You Securitycan andfind chainother ofinformation custody.on (1)the Drugresponsibilities testingof laboratoriesemployers shall be secure at all times. They shall have in place sufficient security measures to control access to the premisesfollowing andsections toof ensurethis thatpart:
§ no unauthorized personnel handle specimens or gain access to the laboratory process or to areas where records are stored40. Access to these secured areas shall be limited to specifically authorized individuals whose authorization is documented3—Definition. 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 DHHS, all authorized visitors and maintenance and service personnel shall be escorted at all times40.35—Information Documentationabout ofDERs individualsthat accessingemployers these areas, dates, and time of entry and purpose of entry must beprovide maintainedcollectors.
(2) Laboratories§ shall40.45—Modifying use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testingCCFs, reportingUse of resultsforeign-language during storage, and continuing until final disposition of specimensCCFs
.
The
§
date and purpose shall be documented on an appropriate chain of custody form each time a specimen is handled or transferred and every individual in the chain shall be identified
40
.
47—Use
Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete chain
of
custody
non-Federal
forms for
those
DOT
specimens
tests
or
aliquots
Federal
as
CCFs
they
for
are
non-DOT
received
tests
.
(b)
Receiving
§ 40
.
67—Requirements
(1)(i) When a shipment of specimens is received, laboratory personnel shall inspect each package
for
evidence of possible tampering and compare information on specimen bottles within each package to the information on the accompanying chain of custody forms. Any
direct
evidence of tampering or discrepancies in the information on specimen bottles and the employer's chain of custody forms attached to the shipment shall be immediately reported to the employer and shall be noted on the laboratory's chain of custody form which shall accompany the specimens while they are in the laboratory's possession
observation
.
(ii)
Where
§
the employer has used the split sample method, and the laboratory observes that the split specimen is untestable, inadequate, or unavailable for testing, the laboratory shall nevertheless test the primary specimen
40
.
173—Responsibility
The
to
laboratory
ensure
does not inform the MRO or the employer of the untestability, inadequacy, or unavailability of the split specimen until and unless the primary specimen is a verified positive
test
and the MRO has informed the laboratory that the employee has requested a test
of
the
split specimen.
(2)
In
§
situations
40.193—Action
where the employer uses the split sample collection method, the laboratory shall log
in
the
“shy
split
bladder”
specimen, with the split specimen bottle seal remaining intact
situations
.
The
§
laboratory shall store this sample securely (see paragraph (c) of this section)
40
.
197—Actions
If
following
the
report
result
of
the
a
test
dilute
of the primary
specimen
is negative, the laboratory may discard the split specimen
.
If
§
the result of the test of the primary specimen is positive, the laboratory shall retain the split specimen in frozen storage for 60 days from the date on which the laboratory acquires it (see paragraph (h) of this section)
40
.
207—Actions
Following
following
the
a
end
report
of
the 60-day period, if not informed by the MRO that the employee has requested
a
test
cancelled
of the split specimen, the laboratory may discard the split specimen.
(3) When directed in writing by the MRO to forward the split specimen to another DHHS-certified laboratory for analysis, the second laboratory shall analyze the split specimen by GC/MS to reconfirm the presence of the
drug
(s)
or drug metabolite(s) found in the primary specimen
test
.
Such GC/MS confirmation shall be conducted without regard to the cutoff levels of
§ 40.
29(f).
209—Actions
The
following
split
and
specimen
consequences
shall be retained in long-term storage for one year by the laboratory conducting the analysis
of
the split specimen (or longer if litigation concerning the test is pending).
(c) Short
non
-
term
fatal
refrigerated
flaws
storage. Specimens that do not receive an initial test within 7 days of arrival at the laboratory shall be placed
in
secure refrigeration units. Temperatures shall not exceed 6°C. Emergency power equipment shall be available in case of prolonged power failure.
(d) Specimen processing. Laboratory facilities for urine
drug
testing will normally process specimens by grouping them into batches
tests
.
The
§
number of specimens in each batch may vary significantly depending on the size of the laboratory and its workload
40
.
215—Information
When
about
conducting
DERs
either
that
initial
employers
or
must
confirmatory
provide
tests,
BATs
every batch shall contain an appropriate number of standards for calibrating the instrumentation
and
a minimum of 10 percent controls
STTs
.
Both
§
quality control and blind performance test samples shall appear as ordinary samples to laboratory analysts
40
.
(e)
225—Modifying
Initial
ATFs;
test. (1) The initial test shall
use
an immunoassay which meets the requirements
of
the
foreign-language
Food
ATFs.
and
§
Drug Administration for commercial distribution
40
.
227—Use
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
non-DOT
test
forms
cutoff levels (ng/ml) Marijuana metabolites 50 Cocaine metabolites 300 Opiate metabolites * 300 Phencyclidine 25 Amphetamines 1,000 *−25 ng/ml if immunoassay specific
for
free
DOT
morphine.
(2)
tests
These cutoff levels are subject to change by the Department of Health and Human Services as advances in technology
or
other
DOT
considerations
ATFs
warrant identification of these substances at other concentrations.
(f) Confirmatory test. (1) All specimens identified as positive on the initial test shall be confirmed using gas chromatography/mass spectrometry (GC/MS) techniques at the cutoff levels listed in this paragraph
for
each drug. All confirmations shall be by quantitative analysis. Concentrations that exceed the linear region of the standard curve shall be documented in the laboratory record as “greater than highest standard curve value.”
Confirmatory test cutoff levels (ng/ml) Marijuana metabolite 1 15 Cocaine metabolite 2 150 Opiates Morphine 300 Codeine 300 Phencyclidine 25 Amphetamines: Amphetamine 500 Methamphetamine 3 500 1 Delta
non
-
9-tetrahydrocannabinol-9-carboxylic
DOT
acid
tests
.
2
§
Benzoylecgonine
40
.
235
3 Specimen must also contain amphetamine at a concentration greater than or equal to 200 ng/ml.
(
2
c
)
These cutoff 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.
(
g
d
)
—responsibility
Reporting results. (1) The laboratory shall report test results
to
the
follow
employer's
instructions
Medical Review Officer within an average of 5 working days after receipt of the specimen by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual. The report shall identify the drugs/metabolites tested
for
,
whether positive or negative, the specimen number assigned by the employer, and the drug testing laboratory specimen identification number (accession number)
ASDs
.
(2)
The
§
laboratory shall report as negative all specimens that are negative on the initial test or negative on the confirmatory test
40
.
255
Only specimens confirmed positive shall be reported positive for a specific drug.
(
3
b
)
—receipt
The Medical Review Officer may request from the laboratory
and
the
storage
laboratory shall provide quantitation
of
test
alcohol
results. The MRO shall report whether the
test
is positive or negative, and may report the drug(s) for which there was a positive test, but shall not disclose the quantitation of test results to the employer. Provided, that the MRO may reveal the quantitation of a positive test result to the employer, the employee, or the decisionmaker in a lawsuit, grievance, or other proceeding initiated by or on behalf of the employee and arising from a verified positive drug test.
(4) The laboratory may transmit results to the Medical Review Officer by various electronic means (for example, teleprinters, facsimile, or computer) in a manner designed to ensure confidentiality of the
information.
Results
§
may not be provided verbally by telephone
40
.
265
The laboratory and employer must ensure the security of the data transmission and limit access to any data transmission, storage, and retrieval system.
(
5
c
)
The laboratory shall send only to the Medical Review Officer the original or a certified true copy of the drug testing custody and control form
-
(
part 2
e
)
,
—actions
which,
in
the
“shy
case
lung”
of
situations.
a
§
report positive for drug use, shall be signed (after the required certification block) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports, and attached to which shall be a copy of the test report
40
.
(6)
267—Cancellation
The laboratory shall provide the employer an aggregate quarterly statistical summary
of
urinalysis
alcohol
testing of the employer's employees
tests
.
Laboratories
§
may provide the report to a consortium provided that the laboratory provides employer-specific data and the consortium forwards the employer-
specific data to the respective employers within 14 days of receipt of the laboratory report
40
.
271—Actions
The
in
laboratory
“correctable
shall
flaw”
provide
situations
the
in
report
alcohol
to the employer or consortium not more than 14 calendar days after the end of the quarter covered by the summary
tests
.
Laboratory
§
confirmation data only shall be included from test results reported within that quarter
40
.
273—Actions
The summary shall contain only the
following
information:
(i)
cancelled
Number of specimens received for testing;
(ii) Number of specimens confirmed positive for—
(A) Marijuana metabolite
(B) Cocaine metabolite
(C) Opiates;
(D) Phencyclidine;
(E) Amphetamines;
(iii) Number of specimens for which a test was not performed.
Quarterly reports shall not contain personal identifying information or other data from which it is reasonably likely that information about individuals’
tests
can
in
be
alcohol
readily inferred
tests
.
If
§
necessary, in order to prevent disclosure of such data, the laboratory shall not send such a report until data are sufficiently aggregated to make such an inference unlikely
40
.
275—Actions
In any quarter
in
which
“non-fatal
a
flaw”
report
situations
is withheld for this reason, or because no testing was conducted, the laboratory shall so inform the consortium/employer
in
writing.
(7)
alcohol
The laboratory shall make available copies of all analytical results for employer drug testing programs when requested by DOT or any DOT agency with regulatory authority over the employer
tests
.
(8)
Unless
§§
otherwise instructed by the employer in writing, all records pertaining to a given urine specimen shall be retained by the drug testing laboratory for a minimum of 2 years
40
.
(h) Long
287
-
term storage
40
.
289—Responsibilities
Long-term
concerning
frozen
SAP
storage (−20°C or less) ensures that positive urine specimens will be available for any necessary retest during administrative or disciplinary proceedings
services
.
Drug
§§
testing laboratories shall retain and place in properly secured long
40.295
-
term frozen storage for a minimum of 1 year all specimens confirmed positive, in their original labeled specimen bottles
40
.
297—Prohibition
Within
on
this
seeking
1-year
second
period,
SAP
an
evaluation
employer (
or
other
changing
person
SAP
designated in a DOT agency regulation) may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year, except that the laboratory shall be required to maintain any specimens known to be under legal challenge for an indefinite period
recommendation
.
(i)
Retesting
§
specimens
40
.
303—Responsibilities
Because
concerning
some
aftercare
analytes deteriorate or are lost during freezing and/or storage, quantitation for a retest is not subject to a specific cutoff requirement but must provide data sufficient to confirm the presence of the drug or metabolite
recommendations
.
(j)
Subcontracting.
§
Drug testing laboratories shall not subcontract and shall perform all work with their own personnel and equipment
40
.
305—Responsibilities
The
concerning
laboratory must be capable of performing testing for the five classes of drugs (marijuana, cocaine, opiates, phencyclidine and amphetamines) using the initial immunoassay and confirmatory GC/MS methods specified in this part. This paragraph does not prohibit subcontracting of laboratory analysis if specimens are sent directly from the collection site
return-
to
-duty
the subcontractor, the subcontractor is a laboratory certified by DHHS as required in this part, the subcontractor performs all analysis and provides storage required under this part, and the subcontractor is responsible to the employer for compliance with this part and applicable DOT agency regulations as if it were the prime contractor
decision
.
(k)
Laboratory
§
facilities
40
.
309—Responsibilities
(1)
concerning
Laboratory
follow-up
facilities shall comply with applicable provisions of any State licensing requirements.
(2) Laboratories certified in accordance with DHHS Guidelines shall have the capability, at the same laboratory premises, of performing initial and confirmatory
tests
for each drug or metabolite for which service is offered
.
(l)
Inspections.
§
The Secretary, a DOT agency, any employer utilizing the laboratory, DHHS or any organization performing laboratory certification on behalf of DHHS reserves the right to inspect the laboratory at any time
40
.
321—General
Employer
confidentiality
contracts with laboratories for drug testing, as well as contracts for collection site services, shall permit the employer and the DOT agency of jurisdiction (directly or through an agent) to conduct unannounced inspections
requirement
.
(m)
Documentation.
§
The drug testing laboratories shall maintain and make available for at least 2 years documentation of all aspects of the testing process
40
.
323—Release
This 2 year period may be extended upon written notification by a DOT agency or by any employer for which laboratory services are being provided. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain
of
custody
confidential
documents;
information
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
litigation
.
The
§
laboratory shall maintain documents for any specimen known to be under legal challenge for an indefinite period
40
.
(n) Additional requirements for certified laboratories.
331
—
(1)
Other
Procedure
circumstances
manual. Each laboratory shall have a procedure manual which includes the principles of each test preparation of reagents, standards and controls, calibration procedures, derivation of results, linearity of methods, sensitivity of methods, cutoff values, mechanisms
for
reporting results, controls criteria for unacceptable specimens and results, remedial actions to be taken when
the
test
release
systems are outside
of
acceptable
confidential
limits,
information.
reagents
§
and expiration dates, and references
40
.
333—Record
Copies
retention
of all procedures and dates on which they are in effect shall be maintained as part of the manual
requirements
.
(2)
Standards
§
and controls
40
.
345—Choice
Laboratory
of
standards
who
shall
reports
be prepared with pure
drug
standards
testing
which
information
are properly labeled as
to
content and concentration
employers
.
The standards shall be labeled with the following dates: when received; when prepared or opened; when placed in service; and expiration date.
(3)
[65
Instruments
FR
and equipment. (i) Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric
79526
,
colorimetric, or other verification procedure
Dec
.
Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and checked periodically thereafter.
(ii) There shall be written procedures for instrument set-up and normal operation
19
,
a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks and instructions for major trouble shooting and repair
2000
.
Records
Redesignated
shall be available on preventive maintenance.
(4) Remedial actions. There shall be written procedures for the actions to be taken when systems are out of acceptable limits or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.
(5) Personnel available to testify
at
proceedings.
66
A laboratory shall have qualified personnel available to testify in an administrative or disciplinary proceeding against an employee when that proceeding is based on positive urinalysis results reported by the laboratory.
(6) The laboratory shall not enter into any relationship with an employer's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having an employer use a specific MRO.
[54
FR
49866
41950
,
Dec
Aug
.
1
9
,
1989
2001
, as amended at
59
82
FR
7356
52244
,
Feb
Nov
.
15
13
,
1994; 59 FR 43001, Aug. 19, 1994
2017
]
RegulusPipeline research