VALIDITY TESTING

August 9, 2001
Federal Register Vol. 66
Pages 41996 - 42036

December 31, 2003
Federal Register Vol. 68
Pages 75455-75466
Primary Topic: One Page MIS Form

Notice of Interpretation:
April 22, 2002
Federal Register Vol. 67,
Pages 19615-19616
Primary Topic: FTA/USCG regulation applicability to ferry boats.

   On October 31, 2005, the Department of Transportation (DOT) published a Notice of Proposed Rulemaking (NPRM) proposing to amend certain provisions of its drug and alcohol testing procedures to change instructions to laboratories, medical review officers, and employers with respect to validity testing. The NPRM was printed in the Federal Register, Volume 70, No. 209, pages 62276-62288. The proposed changes are intended to create consistency with respect to adulterated, substituted, diluted, and invalid specimen results. This NPRM also proposes to make specimen validity testing mandatory for all DOT tests.
   Comments to the NPRM were accepted through December 31, 2005. However, late filed comments will be considered to the extent practicable. Those interested in commenting should consult the NPRM for submission procedures.
   The NPRM seeks to “harmonize” the DOT’s specimen validity testing requirements with the requirements contained in the Department of Health and Human Services (HHS) Mandatory Guidelines and the HHS Medical Review Officer Manual. Specifically, the NPRM proposes:

• Specimen validity testing will be mandatory for all DOT covered testing;
• DOT will utilize HHS instructions to laboratories for establishing and directing laboratory procedures for specimen validity testing, and will accept HHS criteria for cutoff levels, laboratory testing equipment and specimen validity testing parameters;
• DOT will modify term definitions to make them consistent with HHS Mandatory Guidelines definitions;
• DOT will continue to require laboratories to contact Medical Review Officers (MROs) when specific invalid results are found;
• DOT will generally adopt HHS procedures for laboratories and MRO action and reporting of primary and split specimens;
• Consistent with the MRO Manual, split testing if not offered for an invalid test result;
• A second invalid result collected under direct observation that occurs for a reason other than the reason determined for the first invalid result will be verified as a test refusal;
• HHS’ blind specimen certification criteria will be adopted and HHS’ semi-annual laboratory report items will also be adopted by the DOT.

   As part of the NPRM (§40.97, §40.187), the DOT has also established a method of categorizing test results to avoid confusion, promote understanding and facilitate correct MRO verification and reporting responses to the varying test results.
   The DOT continues to differ from the HHS Mandatory Guidelines by maintaining its requirement that MROs treat laboratory reported negative-dilute results with creatinine levels within the 2-5mg/dL range as negative-dilutes that require immediate recollections under direct observation. Similarly, the DOT continues to allow employers the policy option to require recollection for other negative dilutes above the range specified above (see article in Updates, Issue 30, Page 6.).
   The NPRM also proposes that in the instance where an individual has a series of invalid test results for the same reason, the tests will be cancelled. In the event of a pre-employment, return-to-duty, or follow-up test where a negative result is required, the DOT proposes to allow the MRO to label the test as negative if he or she determines there is no clinical evidence that the employee is an illicit drug user using the procedures defined in §40.195. The same process is to be used when an individual has a long-term medical condition that causes an invalid result. If in addition to an invalid result, the specimen is also determined to be adulterated, substituted, positive, or a test refusal, the non-negative test result holds and the MRO need not report the invalid result.
   The proposed rule also solicited input on the method of direct observation in relation to realistic-looking prosthetic devices.