Title 42 Part 493 → Subpart K → §493.1283

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1283

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1283

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1283

Title 42: Public Health
Subpart K—Quality System for Nonwaived Testing

§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.

(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.