Implementation Guidelines - Federal Transit Administration - U.S. ...
Implementation Guidelines - Federal Transit Administration - U.S. ... Implementation Guidelines - Federal Transit Administration - U.S. ...
Initial Confirmation Type of Drug or Test Test Metabolite Cutoff Levels Cutoff Levels (1) Marijuana Metabolites (i) Delta-9- 50 tetrahydrocanna-binal-9carboxylic acid (THC) 15 (2) Cocaine Metabolites (Benzoylecgonine) 300 150 (3) Phencyclidine (PCP) 25 25 (4) Amphetamines 1000 (i) Amphetamine 500 (ii) Methamphetamine 500 a (5) Opiate Metabolites 2000 (i) Codeine 2000 (ii) Morphine 2000 (iii) 6acetylmorphine 10 b (6 AM) Opiate levels above 15,000 ng/mL will be automatically reported because the responsibilities of the MRO and employee change with opiate levels this high. In this case the burden of proof shifts to the employee to provide a verifiable medical explanation for such high levels. Split Specimen Testing. The primary laboratory must provide secure storage for the split sample for 1 year if the primary specimen is positive, adulterated, or substituted. If directed by the MRO, the primary laboratory shall forward the split specimen bottle, with seal intact, a copy of the MRO request, and a copy of the custody and control form to a different DHHSapproved laboratory. If the split specimen is unavailable for testing, the lab must provide as much information as possible to the MRO regarding the cause of the unavailability. In the case of a positive test result, the second lab must test the specimen for the presence of the drug(s)or drug metabolite a Specimen must also contain amphetamine at a concentration of greater than or equal to 200 ng/mL. b Test for 6-AM in the specimen. Conduct this test only when specimen contains morphine at a concentration greater than or equal to 2000 ng/mL. independent of the cutoff levels. If the presence of the substance(s) is found, the primary test will be confirmed positive. If the test fails to reconfirm the presence of the drug/metabolites that were reported positive by the primary lab, the second lab must conduct validity testing on the split to determine if the specimen was adulterated or substituted. If the split does not reconfirm the presence of the drug/metabolite and there is no evidence of adulteration or substitution, the result will be reported to the MRO, the test will be cancelled, and the failure to reconfirm will be reported to the DOT Office of Drug and Alcohol Policy and Compliance (ODAPC). Where a primary test result shows the specimen was adulterated or substituted, the second lab must test the split specimen in the same manner as the primary to determine if the specimen was adulterated or substituted. If the adulteration or substitution is found, the primary test result will be confirmed. If not, the result will be reported to the MRO, the test cancelled, and the failure to reconfirm will be reported to the ODAPC. If the split is unavailable for testing and, therefore, cannot be used to reconfirm the primary test result, the primary test will be cancelled and the MRO will direct the employer to have the employee retested under direct observation. Split specimen test results can only be reported to the MRO. Specimen Storage and Record Keeping. All confirmed non-negative specimens must be retained by the laboratory in long-term frozen storage for a minimum of 1 year. The laboratory must provide semi-annual summation reports consistent with 49 CFR Part 40, Appendix B reporting requirements to each covered employer for whom they conduct testing. The summaries must be sent by January 20 Chapter 7. Drug Testing Procedures 7-16 August 2002
for the preceding 6 months ending on December 31 and July 20 for the preceding 6 months ending on June 30. Employers or C/TPAs that have fewer than 2000 DOT-covered employees are not required to perform blind specimen testing. Section 4. MEDICAL REVIEW OFFICER The FTA regulation requires that all drug testing laboratory results must be reviewed by a qualified MRO. The purpose of this review is to verify and validate test results. An MRO is defined in the regulation as a licensed physician responsible for receiving and reviewing laboratory results generated by an employer’s drug testing program and evaluating medical explanations for certain drug test results. The MRO must be knowledgeable about and have clinical experience in controlled substance abuse disorders. The MRO must have the appropriate medical training to interpret and evaluate laboratory confirmed positive test results and be knowledgeable about alternative medical explanations for laboratory confirmed test results. The MRO must be aware of issues relating to adulterated and substituted specimens and possible medical causes for invalid test results. As discussed in Chapter 5, MROs must know the DOT MRO Guidelines, Part 40 and applicable DOT agency rules (i.e., FTA Part 655). MROs must receive qualification training and complete at least 12 hours of professional development hours of continuing education that is relevant to MRO functions during each subsequent 3year period. The MRO is to serve as an independent, impartial gatekeeper responsible for the accuracy and integrity of the drug testing process. As such, the MRO is required to perform the following functions (§40.123): • Receive the results of drug tests from the laboratory. • Conduct administrative review of the CCF to ensure it is legible, accurate, and signed by the laboratory’s certifying scientist. Check for fatal and correctable flaws. Take action to immediately correct correctable flaws. If appropriate, the MRO may request the laboratory to analyze the original specimen again to verify the accuracy of the reported test result. • Provide feedback as appropriate to the DER and service agents regarding performance issues. Report major problems to the ODAPC and FTA as appropriate. • The MRO or his/her staff must make at least three attempts to contact the employee spaced reasonably over a 24-hour period, including the day and evening using the telephone numbers listed on the CCF. All Chapter 7. Drug Testing Procedures 7-17 August 2002
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Initial Confirmation<br />
Type of Drug or Test Test<br />
Metabolite Cutoff<br />
Levels<br />
Cutoff Levels<br />
(1) Marijuana Metabolites<br />
(i) Delta-9-<br />
50<br />
tetrahydrocanna-binal-9carboxylic<br />
acid (THC)<br />
15<br />
(2) Cocaine Metabolites<br />
(Benzoylecgonine)<br />
300 150<br />
(3) Phencyclidine (PCP) 25 25<br />
(4) Amphetamines 1000<br />
(i) Amphetamine 500<br />
(ii) Methamphetamine 500 a<br />
(5) Opiate Metabolites 2000<br />
(i) Codeine 2000<br />
(ii) Morphine<br />
2000<br />
(iii) 6acetylmorphine<br />
10 b<br />
(6 AM)<br />
Opiate levels above 15,000 ng/mL will be<br />
automatically reported because the<br />
responsibilities of the MRO and employee<br />
change with opiate levels this high. In this<br />
case the burden of proof shifts to the<br />
employee to provide a verifiable medical<br />
explanation for such high levels.<br />
Split Specimen Testing. The primary<br />
laboratory must provide secure storage for<br />
the split sample for 1 year if the primary<br />
specimen is positive, adulterated, or<br />
substituted. If directed by the MRO, the<br />
primary laboratory shall forward the split<br />
specimen bottle, with seal intact, a copy of<br />
the MRO request, and a copy of the custody<br />
and control form to a different DHHSapproved<br />
laboratory. If the split specimen is<br />
unavailable for testing, the lab must provide<br />
as much information as possible to the MRO<br />
regarding the cause of the unavailability.<br />
In the case of a positive test result, the<br />
second lab must test the specimen for the<br />
presence of the drug(s)or drug metabolite<br />
a Specimen must also contain amphetamine at a<br />
concentration of greater than or equal to 200 ng/mL.<br />
b Test for 6-AM in the specimen. Conduct this test<br />
only when specimen contains morphine at a<br />
concentration greater than or equal to 2000 ng/mL.<br />
independent of the cutoff levels. If the<br />
presence of the substance(s) is found, the<br />
primary test will be confirmed positive. If<br />
the test fails to reconfirm the presence of the<br />
drug/metabolites that were reported positive<br />
by the primary lab, the second lab must<br />
conduct validity testing on the split to<br />
determine if the specimen was adulterated or<br />
substituted. If the split does not reconfirm<br />
the presence of the drug/metabolite and<br />
there is no evidence of adulteration or<br />
substitution, the result will be reported to the<br />
MRO, the test will be cancelled, and the<br />
failure to reconfirm will be reported to the<br />
DOT Office of Drug and Alcohol Policy and<br />
Compliance (ODAPC).<br />
Where a primary test result shows the<br />
specimen was adulterated or substituted, the<br />
second lab must test the split specimen in<br />
the same manner as the primary to<br />
determine if the specimen was adulterated or<br />
substituted. If the adulteration or<br />
substitution is found, the primary test result<br />
will be confirmed. If not, the result will be<br />
reported to the MRO, the test cancelled, and<br />
the failure to reconfirm will be reported to<br />
the ODAPC.<br />
If the split is unavailable for testing and,<br />
therefore, cannot be used to reconfirm the<br />
primary test result, the primary test will be<br />
cancelled and the MRO will direct the<br />
employer to have the employee retested<br />
under direct observation. Split specimen<br />
test results can only be reported to the MRO.<br />
Specimen Storage and Record<br />
Keeping. All confirmed non-negative<br />
specimens must be retained by the<br />
laboratory in long-term frozen storage for a<br />
minimum of 1 year. The laboratory must<br />
provide semi-annual summation reports<br />
consistent with 49 CFR Part 40, Appendix B<br />
reporting requirements to each covered<br />
employer for whom they conduct testing.<br />
The summaries must be sent by January 20<br />
Chapter 7. Drug Testing Procedures 7-16 August 2002