42 C.F.R. § 493.1290   Condition: Postanalytic systems.


Title 42 - Public Health


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

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§ 493.1290   Condition: Postanalytic systems.

Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in §493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in §493.1299 for each specialty and subspecialty of testing performed.

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