Sec.  40.91  What validity tests must laboratories conduct on primary specimens?

     As a laboratory, when you conduct validity testing under Sec.  40.89, you must conduct it in accordance with the requirements of this section.

    (a) You must test each primary specimen for creatinine. You must also determine its specific gravity if you find that the creatinine concentration is less than 20 mg/dL.

    (b) You must measure the pH of each primary specimen.

    (c) You must test each primary specimen to determine if it contains substances that may be used to adulterate the specimen. Your tests must have the capability of determining whether any substance identified in current HHS requirements or specimen validity guidance is present in the specimen.

    (d) If you suspect the presence of an interfering substance/adulterant that could make a test result invalid, but you are unable to identify it (e.g., a new adulterant), you must, as the first laboratory, send the specimen to another HHS certified laboratory that has the capability of doing so.

    (e) If you identify a substance in a specimen that appears to be an adulterant, but which is not listed in current HHS requirements or guidance, you must report the finding in writing to ODAPC and the Division of Workplace Programs, HHS, within three business days. You must also complete testing of the specimen for drugs, to the extent technically feasible.

    (f) You must conserve as much as possible of the specimen for possible future testing.