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Title 42 Part 493 → Subpart K → §493.1262

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1262

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1262

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

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1262


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart K—Quality System for Nonwaived Testing


§493.1262   Standard: Mycobacteriology.

(a) Each day of use, the laboratory must check all reagents or test procedures used for mycobacteria identification with at least one acid-fast organism that produces a positive reaction and an acid-fast organism that produces a negative reaction.

(b) For antimycobacterial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimycobacterial 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 week 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.