Notice of Specimen Validity Testing Interim Final Rule

The Department of Transportation (DOT) issued an interim final rule (IFR) in the Federal Register today (Tuesday, November 9, 2004) amending certain provisions of its drug and alcohol testing procedures to change instructions to laboratories and medical review officers with respect to adulterated, substituted, and diluted specimen results. This change is intended to avoid inconsistency with new specimen validity testing (SVT) requirements established by the U.S. Department of Health and Human Services (HHS) that went into effect on November 1, 2004.

1. The DOT will remove from part 40 the requirement that MROs deal with substituted results in a two-tiered fashion (i.e., medical review for some and recollection under direct observation for others). MROs will provide medical review and verification for all laboratory-reported substituted specimen results.

2. The DOT will remove Part 40 references to substituted specimens having creatinine levels greater than or equal to 2 mg/dL. These simply no longer exist under HHS Mandatory Guidelines.

3. Laboratory testing criteria for specific gravity and creatinine concentration of substituted specimens and diluted specimens will be made consistent with the HHS Mandatory Guidelines. A urine specimen will be considered dilute when the creatinine concentration is greater than or equal to 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030.

4. The DOT will make SVT laboratory instructions consistent with the HHS Mandatory Guidelines. We will also adopt HHS instructions that direct laboratories to perform validity tests for oxidizing adulterants and additional validity tests when certain conditions (e.g., abnormal physical characteristics) are observed.

5. In addition, the DOT will make laboratory results reporting requirements parallel to those in the HHS Mandatory Guidelines (with the exception of negative-dilute specimen results).

6. While DOT will change a number of items in part 40 to bring consistency between part 40 and the HHS Mandatory Guidelines regarding SVT, there are several important items that will be different:

   1. The DOT will maintain its current position that SVT is authorized but not required. However, laboratories conducting SVT of DOT specimens must do so in accordance with the testing requirements established in the HHS Mandatory Guidelines.

   2. The DOT will require MROs to treat laboratory reported negative-dilute results with creatinine levels greater than or equal to 2 mg/dL but equal to or less than 5 mg/dL as negative-dilutes that require immediate recollections under direct observation.

   3. To assist MROs with their negative-dilute results responsibilities, DOT will require laboratories to provide creatinine and specific gravity numerical values for all specimens they report to the MRO as being negative-dilute.