Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in §§ 493.1251 through 493.1283 , 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 analytic systems and correct identified problems as specified in § 493.1289 for each specialty and subspecialty of testing performed.
42 C.F.R. §493.1250