1. Definitions
The proposal would modify some existing definitions and add new definitions specifically associated with specimen validity testing. These include the definitions for adulterated specimen, confirmatory validity test, dilute specimen, initial validity test, invalid result, non-negative specimen, oxidizing adulterant, and substituted specimen.
2. SVT Requirement
The proposal would make SVT mandatory by removing the option to conduct SVT and add text requiring SVT.
3. Adulterant and Invalid Testing
Two tables would be added to Part 40 that would help inform MROs and others about the cutoffs and procedures laboratories are directed by HHS to use in reporting adulterants and invalid results. DOT specifically seeks comment on whether these tables (shown in the Federal Register notice) add value to the testing process.
4. Primary Specimen Lab Results
Categories are proposed to be added to section 40.97 to help MROs and labs understand how to deal with reporting and reviewing multiple test results from the same testing event. The three categories are:
- Negative Results, which includes negative, negative-dilute
- Non-negative Results, which includes positive, positive-dilute, adulterated, substituted, and invalid
- Rejected for Testing
5. Reporting Invalid Results with No Employee Interview
The proposal includes guidance to MROs on closing results when the MRO and the employer were not able to reach the employee to complete the interview process. These results would be handled similar to part 40's regulations on positive, adulterated, and substituted specimens.
6. Closing the Invalid Loops
The proposal addresses problems faced by MROs when an employee produces a second invalid result after providing a recollection under direct observation because of an initial invalid result. This proposed change also addresses what an MRO should do when an invalid test is cancelled for a legitimate reason but a negative result is required (return to duty, follow up etc.).
- A second invalid result for the same reason would require the MRO to report the test as cancelled after confirming that the collection was properly observed.
- A second invalid result for a different reason would require the MRO to report the test result as a refusal after confirming with the collector that the collection was properly observed.
- When a test is cancelled for a legitimate reason but a negative test is required, DOT proposes to require the MRO to determine if there is clinical evidence that the individual is an illicit drug user. The requirements would mirror 40.195. DOT specifically seeks comments on whether the finding of illicit drug use during this medical evaluation causes the test to be cancelled. Should these tests be cancelled or treated as positives?
7. Split Specimen Testing
The proposal would make a variety of changes for split specimens. In this proposal, DOT attempts to categorize split results into five categories in order to help MROs understand the responsibilities associated with each result. DOT specifically seeks comment from MROs on these categories:
- Split specimens that reconfirm all or some of the primary results
- Split specimens that fail to reconfirm all the primary results because drugs were not detected and/or validity criteria were not met
- Split specimens that fail to reconfirm all the primary results and the split is reported as invalid, adulterated and/or substituted
- Split specimens that fail to reconfirm some but not all of the primary results and the split is also reported as invalid, adulterated and/or substituted
- Split specimens that are not available for testing or there is no split lab available to test the split
In addition to the changes proposed above, DOT asked for comment on additional issues, including:
1. The relative worth of continuing to have the collector send in two specimens (i.e., a temperature out of range specimen or one that showed signs of tampering and the subsequent observed specimen) instead of sending only the specimen collected under direct observation. Do the complications caused by linking (or failure to link) the two collections outweigh the possibility that the initial specimen will be non-negative while the observed specimen will be negative or cancelled? What are some of the complications employers and MROs have experienced by having two different results on the two specimens for the same testing event? Can MROs report the verified results for two specimens for the same testing event on the same report? Do we simply need to make it clearer in part 40 that a non-negative result(s) for one specimen takes precedence over a negative or cancelled result for the other specimen?
2. The benefits of requiring all laboratories conducting DOT testing to utilize two methodologies for SVT (except pH) or for directing employers to use only laboratories that employ two methodologies. What will be the associated costs to laboratories and employers for requiring laboratories to utilize two methodologies? For invalid results, are required recollections under direct observation timely enough to identify drug use? Before laboratories report invalid results, are they contacting MROs (as required by the DOT and HHS) to discuss if sending the specimen to another HHS-certified laboratory will be useful?
3. Are the negative-dilute recollections under direct observation yielding results that show employee drug use? Given the threat to public safety, what percentage of positive results on these recollections would be considered too low to justify conducting them?
4. Should MROs have the same reporting responsibilities for downgraded negative-dilute results as they have for any other negative-dilute result? Should employers have the same responsibilities to recollect under direct observation when the creatinine concentration is in the 2-5 mg/dL range or the same recollection options if creatinine is above 5 mg/dL?
5. Realistic-looking prosthetic devices which hold and heat urine (or water mixed with powdered urine) are available for purchase and are known to have been used during observed collections. They are available in a variety of colors making them difficult to detect. We are interested in your comments as to the appropriateness of having a collector make sure that the employee is not using a prosthetic device during an observed collection. For example, would it be appropriate to require that collectors and observers, as appropriate, check for these devices by having male employees lower their pants and underwear just before observed collections take place? What should be the consequence if a device is found?
You may read the Notice of Proposed Rulemaking in its entirety by clicking here, or download it in pdf format by clicking here.
The notice contains instructions for submitting comments to DOT, which are due by December 30, 2005.
