§ 26.131 Cutoff levels for validity screening and initial validity tests.
(a) Each validity test result from the licensee testing facility must be based on performing either a validity screening test or an initial validity test, or both, on one or more aliquots of a urine specimen. The licensee testing facility shall forward any specimen that yields a questionable validity screening or initial validity test result to the HHS-certified laboratory for further testing. Licensee testing facilities need not perform validity screening tests before conducting initial validity tests of a specimen.
(b) At a minimum, the licensee testing facility shall test each urine specimen for creatinine, pH, and one or more oxidizing adulterants. Licensees and other entities may not specify more stringent cutoff levels for validity screening and initial validity tests than those specified in this section. If tests or observations indicate one or more of the following from either a validity screening test or an initial validity test, the licensee testing facility shall forward the specimen to the HHS-certified laboratory for additional testing:
(1) Creatinine is less than 20 milligrams (mg) per deciliter (dL);
(2) The pH of the specimen is either less than 4.5 or equal to or greater than 9, using either a colorimetric pH test with a dynamic range of 2 to 12 or pH meter that is capable of measuring pH to one decimal place (for initial validity tests), or colorimetric pH tests, dipsticks, and pH paper (for pH validity screening tests) that have a narrow dynamic range;
(3) Nitrite or other oxidant concentration is equal to or greater than 200 micrograms (mcg) per mL or equal to or greater than 200 mcg/mL nitrite-equivalents using either a nitrite colorimetric test or a general oxidant colorimetric test;
(4) The possible presence of an oxidizing adulterant (e.g., chromium (VI), pyridine (pyridinium chlorochromate)) is determined using either a general oxidant colorimetric test (with a cutoff equal to or greater than 50 mcg/mL chromium (VI)-equivalents) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL);
(5) The possible presence of halogen (e.g., bleach, iodine, fluoride) is determined using a general oxidant colorimetric test (with a cutoff equal to or greater than 200 mcg/mL nitrite-equivalents or equal to or greater than 50 mcg/mL chromium (VI)-equivalents), a halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOD)), or the odor of the specimen;
(6) The possible presence of glutaraldehyde is determined using either an aldehyde test (aldehyde present) or the characteristic immunoassay response is observed on one or more drug immunoassay tests;
(7) The possible presence of a surfactant is determined by using a surfactant colorimetric test with a cutoff equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent or a foam/shake test; or
(8) The specimen shows evidence of adulterants, including, but not limited to, the following:
(i) Abnormal physical characteristics;
(ii) Reactions or responses characteristic of an adulterant obtained during the validity screening or initial test; or
(iii) A possible unidentified interfering substance or adulterant, demonstrated by interference occurring on the immunoassay drug tests on two separate aliquots (i.e., valid immunoassay drug test results cannot be obtained).
[73 FR 17204 Mar. 31, 2008]