US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1283: Maintain a test record system that captures positive specimen identification, the date and time of receipt, the condition and disposition of unacceptable specimens, and the records and dates of all testing including who performed each test, and retain patient testing records including instrument printouts

What does 1283 require?

The laboratory must maintain an information or record system that includes the positive identification of the specimen, the date and time the specimen was received into the laboratory, the condition and disposition of specimens that did not meet the acceptability criteria, and the records and dates of all specimen testing including the identity of the personnel who performed each test. Records of patient testing, including instrument printouts where applicable, must be retained for the periods in section 493.1105.