§ 40.96 What criteria do laboratories use to establish that a specimen is invalid?
Wording first on file in the 2008 annual edition, superseded May 2, 2023.
(a) As a laboratory, you must use the invalid test result criteria for the initial and confirmation 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, for a specimen having an invalid result for one of the reasons outlined in the HHS Mandatory Guidelines, you must contact the MRO to discuss whether sending the specimen to another HHS certified laboratory for testing would be useful in being able to report a positive or adulterated result.
(c) As a laboratory, you must report invalid results in accordance with the invalid test result criteria as required by the HHS Guidelines and provide the numerical value that supports the invalid result, where appropriate, such as pH.
(d) As a laboratory, you must report the reason a test result is invalid.
[73 FR 35970, June 25, 2008]
Amendment history
2 distinct wordings on file since Oct. 1, 2008- [73 FR 35970, June 25, 2008]
- [73 FR 35970, June 25, 2008]
A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section.