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
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
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:
a. 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.
b. 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.
c. 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