Healing arts: clinical laboratories: personnel.

Existing law prohibits, except as specified, a person from performing a clinical laboratory test or examination classified as of moderate or high complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of the laboratory director, as specified. A violation of these provisions is a crime. 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 under the supervision and control of a physician and surgeon or licensed person. This bill would authorize a person to assist, as defined, in the performance of moderate or high complexity testing in a clinical laboratory if the person, in addition to the above requirements, meets the requirements under CLIA for moderate or high complexity testing. Prior to assisting in the performance of the specified activities, the bill would require the person, under direct and constant supervision, to demonstrate the skills and ability to satisfactorily perform the task. The bill would require the laboratory director to designate the supervisor and to maintain overall responsibility for the supervision and performance of the unlicensed laboratory personnel. By expanding the application of an existing crime, this bill would create a state-mandated local program. This bill would define supervision and control, as used above, to mean direction, management, and awareness of the activity of unlicensed laboratory personnel by a physician and surgeon or licensed person, who must be physically present in the laboratory and readily available for consultation during the entire time that the unlicensed laboratory personnel are engaged in the duties. 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.