Title 42 Part 493 → Subpart K → §493.1263

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1263

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1263

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

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1263

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

§493.1263   Standard: Mycology.

(a) The laboratory must check each batch (prepared in-house), lot number (commercially prepared), and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s).

(b) For antifungal susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s).

(1) The laboratory must establish limits for acceptable control results.

(2) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure.

(3) The results for the control organism(s) must be within established limits before reporting patient results.

(c) The laboratory must document all control procedures performed, as specified in this section.