42 C.F.R. § 493.1283 Standard: Test records.
Title 42 - Public Health
(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. (3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (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.
Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing
Analytic Systems
§ 493.1283 Standard: Test records.
