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 an individual who, among others, is a duly licensed naturopathic doctor. Existing law defines "laboratory scientist" and authorizes a person licensed as a clinical laboratory scientist and qualified under CLIA to perform the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in certain specialties. This bill would expand the definition of "laboratory director" for purposes of a clinical laboratory test or examination classified as waived to include a duly licensed clinical laboratory scientist and a duly licensed limited clinical laboratory scientist. The bill would authorize a person licensed as a clinical laboratory scientist and qualified under CLIA to additionally perform the duties and responsibilities of a waived laboratory director, as specified under CLIA.