Clinical laboratories.

Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines "laboratory director," for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA. This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity. Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensee's specialty. This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances. Existing law requires an applicant for a clinical laboratory bioanalyst's license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years' experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health. This bill would revise the application requirements to provide that an applicant's minimum of 4 years' experience be in a clinical laboratory certified under CLIA. Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for those licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided. This bill would rename the license for clinical molecular biologist as the license for clinical genetic molecular biologist. The bill would apply existing license renewal fees to persons renewing a clinical cytogeneticist's license or clinical genetic molecular biologist's license.