| FTA Drug and Alcohol
Regulation Updates Issue 29, page 2 |
INTERIM FINAL FULE |
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Where To Find?.....
The information presented on this
page should be used to update Chapter 7 of the revised Implementation
Guidelines. |
Specimen Validity Testing On November 9, 2004, the Department of Transportation (DOT) issued an interim final rule (IFR) amending its drug testing procedures to change instructions to laboratories and Medical Review Officers (MROs) with respect to adulterated, substituted, and diluted specimen results. The IFR was published in the Federal Register Vol. 69, No. 216, pages 64865-64868. This change to 49 CFR Part 40 makes the rule consistent with the new specimen validity testing requirements established by the U.S. Department of Health and Human Services (HHS) that went into effect on November 1, 2004 (see Updates, Issue 27, page 2) and are referred to as the HHS Mandatory Guidelines. The new IFR replaces the previously issued IFR published in the Federal Register on May 28, 2003 (see Updates, Issue 25, page 2) that established validity testing procedures for DOT mandated drug testing in the absence of the HHS standards. Previously, the rule recognized two tiers of substitute specimens. Specimens having creatinine levels less than 2 mg/dL were considered to be substituted requiring medical review by an MRO, while specimens with creatinine levels between 2 and 5 mg/dL were also considered to be substituted, but required MROs to have employers send employees for a retest under direct observation. Under the new IFR, specimens are determined to be substitute only if the creatinine levels are below 2mg/dL. The higher tier, creatinine levels between 2 and 5 mg/dL, no longer exist as substitute and all references to such have been removed from Part 40. MRO medical reviews and verification are required for substituted specimen results. Specimens are 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. MRO medical reviews and verification are not required for dilute specimens. The IFR also adopts HHS instructions that direct laboratories to perform validity tests for oxidizing adulterants and additional validity test when certain conditions (e.g., abnormal physical characteristics) are observed. The IFR also makes specimen validity testing instructions for the laboratories consistent with the HHS Mandatory Guidelines as well as the laboratory results reporting requirements. The DOT differs from the HHS Mandatory Guidelines in three major areas. First, the DOT authorizes, but does not require laboratories to perform specimen validity testing. Laboratories that conduct specimen validity testing of DOT specimens, however, must do so in accordance with the testing requirements established in the HHS Mandatory Guidelines. Second, even though specimens with creatinine levels greater than or equal to 2 mg/dL but equal to or less than 5mg/dL are considered negative dilute rather than substitute, the MRO is still required to have the employer send the employee immediately for a recollection under direct observation. And, finally, under the DOT rule, laboratories are required to provide creatinine and specific gravity numerical values for all specimens they report to the MRO as being negative dilute. For additional information regarding this IFR, contact Jim L. Swart, Deputy Director, ODAPC at (202) 366-3784 or jim.swart@ost.dot.gov.
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