Healing arts: clinical laboratories: personnel.

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 authorizes unlicensed laboratory personnel who have earned a high school diploma or its equivalent and who meet specified training requirements to perform specified activities in a licensed clinical laboratory under the direct and constant supervision of a physician and surgeon or licensed person, including biological specimen collection, assisting in preventive maintenance, and preparing and storing reagents and culture media. Existing law authorizes unlicensed laboratory personnel who do not meet the specified training requirements only to perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing. A violation of these provisions is a crime. This bill would revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, as defined, and those activities that may not be performed by an unlicensed person. Existing law prohibits unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure, and from performing any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation. This bill would provide an exception to these prohibitions if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. The bill would also prohibit unlicensed laboratory personnel from releasing results of waived, moderate-, or high-complexity testing. The bill would make conforming changes. By expanding the scope of an existing crime, this bill would create a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.