42 CFR 493.1283: Standard: Test records.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER G—STANDARDS AND CERTIFICATION
- PART 493—LABORATORY REQUIREMENTS
- Subpart K—Quality System for Nonwaived Testing
(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.
Collected 2026-08-27T02:26:11Z. Source file · JSON