Laboratory

Parent Issue

Budget Trailer Bill Recognizes Alternative Quality Control in Clinical Laboratories

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).