49 C.F.R. § 40.89
What are the adulterant cutoff concentrations for initial and confirmation urine tests?
(a) As a laboratory, you must use the cutoff concentrations for the initial and confirmation adulterant testing as required by the HHS Mandatory Guidelines and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, you must report results at or above the cutoffs (or for pH, at or above or below the values, as appropriate) as adulterated and provide the numerical value that supports the adulterated result.
Notes of Decisions
Cited in 2
cases (1 in the last 5 years), 2009–2023 · leading case: Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259 (E.D.N.Y 2009).
Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259 (E.D.N.Y 2009). “49 C.F.R. § 40.89 (a). Insofar as relevant to plaintiffs’ cases, HHS indicated in PD 35 that a laboratory should report a specimen as “substituted” if “the creatinine concentration is 5 mg/dL and the specific gravity is 1.”
In the Interest of K.R.K.-L.H. v. the State of Texas (Tex. App. 2023). “3349 C.F.R. §§ 40.89 , .91. 22 trial court would have known that federal law requires an MRO to be a licensed physician and to have training in collection procedures for urine specimens, chain of custody, reporting, recordkeeping, interpretation of drug and validity of test…”
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