The budget trailer bill adopted as part of the state’s final 2015-16 budget amends Section 1220 of the Business and Professions Code pertaining to clinical laboratories. Specifically, the budget trailer bill allows clinical laboratories to establish an alternative quality control program that meets federal regulations under the Clinical Laboratory Improvement Act and that may include the use of alternative quality control testing procedures already recognized by the Centers for Medicare & Medicaid Services (CMS). Until now, the California Department of Public Health has interpreted regulations in a way that did not recognize federally approved alternative quality control methods, requiring labs to perform frequent quality control tests, which are substantially more expensive than the current federally recognized equivalent quality control (EQC) procedures and the impending individualized quality control plans (IQCPs).
Alternative quality control procedures now in state statute under the budget trailer bill include those recognized by CMS, which are EQC procedures until Dec. 31 and, beginning Jan. 1, 2016, an IQCP as incorporated in Appendix C of the State Operations Manual adopted by CMS.
Hospitals interested in implementing an IQCP may want to refer to the guide released by CMS in May in conjunction with the Centers for Disease Control and Prevention.