Interpretation Response #PI-95-029
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
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Office of Drug Enforcement and Program Compliance
49 CFR Part 40 Interpretation
Question: Describe the proper handling and processing of a split specimen. Response: Section 40.29(b)(1)(ii) states, "Where the employer has used the split sample method, and the laboratory observes that the split sample 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."
Section 40.29(b)(2) states, in part "...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."
Section 40.29(b)(3) states, in part "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."
Section 40.33(f) states, in part: "If the employee requests an analysis of the split specimen within 72 hours of having been informed of a verified positive test, the MRO shall direct, in writing, the laboratory to provide the split specimen to another DHHS-certified laboratory for analysis. If the analysis of the split specimen fails to reconfirm the presence of the drug(s) or drug metabolite(s) found in the specimen, or if the split specimen is unavailable, inadequate for testing or untestable, the MRO shall cancel the test and report cancellation and the reasons for it to the DOT, the employer, and the employee."
There are several points to be made in the reference of the above paragraphs, or parts of paragraphs, pertaining to split specimens:
1. If the primary laboratory does not receive a split specimen with the primary, or the split specimen is leaking, or the split specimen's seal is broken, or has any other problem that would make it unavailable for testing, the primary laboratory should still process the primary specimen as if there were no problems with the split specimen. The laboratory should not bring any split specimen deficiency to the attention of the MRO at this time. (40.29(b)(1)(ii))
2. The seal on the split specimen must remain intact--just as the split specimen was sealed at the collection site. (40.29(b)(2))
3. The MRO will direct the primary laboratory to forward the split specimen to a second DHHS-certified laboratory. At the second DHHS-certified laboratory, the split specimen shall only be used to reconfirm the presence of the drug(s) or drug metabolite(s) found in the primary specimen. (40.29(b)(2))
4. Only a request from the employee can authorize the MRO to initiate the forwarding of the split specimen to the second DHHS-certified laboratory for analysis.