[Code of Federal Regulations]
[Title 49, Volume 1, Parts 1 to 99]
[Revised as of October 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 49CFR40.29]
 
[Page 570-574]
 
 TITLE 49--TRANSPORTATION
 
 Subtitle A--Office of the Secretary of Transportation
 
PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG TESTING PROGRAMS--Table of Contents
 
 Subpart B--Drug Testing
 
Sec. 40.29 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 process 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 DHHS, 
all authorized visitors and maintenance and service personnel shall be 
escorted at all times. Documentation of individuals accessing these 
areas, dates, and time of entry and purpose of entry must be maintained.
 (2) Laboratories shall use chain of custody procedures to maintain 
control and accountability of specimens from receipt through completion 
of testing, reporting of results during storage, and continuing until 
final disposition of specimens. The date and purpose shall be documented 
on an appropriate chain of custody form each time a specimen is handled 
or transferred and every individual in the chain shall be identified. 
Accordingly, authorized technicians shall be responsible for each urine 
specimen or aliquot in their possession and shall sign and complete 
chain of custody forms for those specimens or aliquots as they are 
received.
  (b) Receiving. (1)(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.
 (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. The laboratory 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 where the employer uses the split sample 
collection method, the laboratory shall log in the split specimen, with 
the split specimen bottle seal remaining intact. The laboratory shall 
store this sample securely (see paragraph (c) of this section). If the 
result of the test 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
 
[[Page 571]]
 
paragraph (h) of this section). Following the end of the 60-day period, 
if not informed by the MRO that the employee has requested a test 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. Such GC/MS confirmation shall be conducted without regard to 
the cutoff levels of Sec. 40.29(f). The split specimen 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-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. 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. 
The number of specimens in each batch may vary significantly depending 
on the size of the laboratory and its workload. When conducting either 
initial or confirmatory tests, every batch shall contain an appropriate 
number of standards for calibrating the instrumentation and a minimum of 
10 percent controls. Both quality control and blind performance test 
samples shall appear as ordinary samples to laboratory analysts.
 (e) Initial test. (1) The initial test shall use an immunoassay 
which meets the requirements of the Food and Drug Administration for 
commercial distribution. The following initial cutoff levels shall be 
used when screening specimens to determine whether they are negative for 
these five drugs or classes of drugs:
 
------------------------------------------------------------------------
 Initial test
 cutoff levels
  (ng/ml)
------------------------------------------------------------------------
Marijuana metabolites................................... 50
Cocaine metabolites..................................... 300
Opiate metabolites...................................... 2000
Phencyclidine........................................... 25
Amphetamines............................................ 1,000
------------------------------------------------------------------------
 
 
 (2) 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.
 (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..............................................  2000
 Codeine............................................... 2000
 6-Acetylmorphine \4\.................................. 10 ng/ml.
Phencyclidine........................................... 25
Amphetamines:
 Amphetamine........................................... 500
 Methamphetamine \3\................................... 500
------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Benzoylecgonine.
\3\ Specimen must also contain amphetamine at a concentration greater
 than or equal to 200 ng/ml.
\4\ Test for 6-AM when morphine concentration exceeds 2,000 ng/ml.
 
 
 (2) 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) Reporting results. (1) The laboratory shall report test results 
to the employer's 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,
 
[[Page 572]]
 
whether positive or negative, the specimen number assigned by the 
employer, and the drug testing laboratory specimen identification number 
(accession number).
 (2) The laboratory shall report as negative all specimens that are 
negative on the initial test or negative on the confirmatory test. Only 
specimens confirmed positive shall be reported positive for a specific 
drug.
 (3) The Medical Review Officer may request from the laboratory and 
the laboratory shall provide quantitation of test 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. 
The laboratory and employer must ensure the security of the data 
transmission and limit access to any data transmission, storage, and 
retrieval system.
 (5) The laboratory shall send only to the Medical Review Officer the 
original or a certified true copy of the drug testing custody and 
control form (part 2), which, in the case of 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.
 (6) The laboratory shall provide the employer an aggregate quarterly 
statistical summary of urinalysis testing of the employer's employees. 
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. The laboratory shall provide the 
report to the employer or consortium not more than 14 calendar days 
after the end of the quarter covered by the summary. Laboratory 
confirmation data only shall be included from test results reported 
within that quarter. The summary shall contain only the following 
information:
 (i) 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 be readily inferred. 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. In any quarter in which a report is withheld for this reason, 
or because no testing was conducted, the laboratory shall so inform the 
consortium/employer in writing.
 (7) 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.
 (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.
 (h) Long-term storage. Long-term frozen storage (-20 deg.C or less) 
ensures that positive urine specimens will be available for any 
necessary retest during administrative or disciplinary proceedings. Drug 
testing laboratories shall retain and place in properly secured long-
term frozen storage for a minimum of 1 year all specimens confirmed 
positive, in their original labeled specimen bottles. Within this 1-
 
[[Page 573]]
 
year period, an employer (or other person 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.
 (i) Retesting specimens. Because some analytes deteriorate or are 
lost during freezing and/or storage, quantitation for a retest is not 
subject to a specific cutoff requirement but must provide data 
sufficient to confirm the presence of the drug or metabolite.
 (j) Subcontracting. Drug testing laboratories shall not subcontract 
and shall perform all work with their own personnel and equipment. The 
laboratory must be capable of performing testing for the five classes of 
drugs (marijuana, cocaine, opiates, phencyclidine and amphetamines) 
using the initial immunoassay and confirmatory GC/MS methods specified 
in this part. This paragraph does not prohibit subcontracting of 
laboratory analysis if specimens are sent directly from the collection 
site to 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.
 (k) Laboratory facilities. (1) Laboratory 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. Employer 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.
 (m) Documentation. The drug testing laboratories shall maintain and 
make available for at least 2 years documentation of all aspects of the 
testing process. This 2 year period may be extended upon written 
notification by 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 documents; 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 maintain documents for any specimen known to be under legal 
challenge for an indefinite period.
 (n) Additional requirements for certified laboratories.--(1) 
Procedure manual. Each laboratory shall have a procedure manual which 
includes the principles of each test preparation of reagents, standards 
and controls, calibration procedures, derivation of results, linearity 
of methods, sensitivity of methods, cutoff values, mechanisms for 
reporting results, controls criteria for unacceptable specimens and 
results, remedial actions to be taken when the test systems are outside 
of acceptable limits, reagents and expiration dates, and references. 
Copies of all procedures and dates on which they are in effect shall be 
maintained as part of the manual.
 (2) Standards and controls. Laboratory standards shall be prepared 
with pure drug standards which are properly labeled as to content and 
concentration. The standards shall be labeled with the following dates: 
when received; when prepared or opened; when placed in service; and 
expiration date.
 (3) Instruments and equipment. (i) Volumetric pipettes and measuring 
devices shall be certified for accuracy or
 
[[Page 574]]
 
be checked by gravimetric, colorimetric, or other verification 
procedure. Automatic pipettes and dilutors shall be checked for accuracy 
and reproducibility before being placed in service and checked 
periodically thereafter.
 (ii) There shall be written procedures for instrument set-up and 
normal operation, a schedule for checking critical operating 
characteristics for all instruments, tolerance limits for acceptable 
function checks and instructions for major trouble shooting and repair. 
Records shall be available on preventive maintenance.
 (4) Remedial actions. There shall be written procedures for the 
actions to be taken when systems are out of acceptable limits or errors 
are detected. There shall be documentation that these procedures are 
followed and that all necessary corrective actions are taken. There 
shall also be in place systems to verify all stages of testing and 
reporting and documentation that these procedures are followed.
 (5) Personnel available to testify at proceedings. A laboratory 
shall have qualified personnel available to testify in an administrative 
or disciplinary proceeding against 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, Dec. 1, 1989, as amended at 59 FR 7356, Feb. 15, 1994; 59 
FR 43001, Aug. 19, 1994; 63 FR 65129, Nov. 25, 1998]