42 CFR § 493.1283 - Standard: Test records.
(a) The laboratory must maintain an information or record system that includes the following:
(1) The positive identification of the specimen.
(2) The date and time of specimen receipt into the laboratory.
(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s).
(b) Records of patient testing including, if applicable, instrument printouts, must be retained.