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CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER G—STANDARDS AND CERTIFICATION (parts 482 to 498) > PART 493—LABORATORY REQUIREMENTS > SUBPART K—Quality System for Nonwaived Testing (§493.1200 to §493.1299) > 493.1262—Standard: Mycobacteriology.

CFR

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.
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