Clinical laboratories: total protein test: authorization.

Existing law generally requires the State Department of Public Health to license and regulate clinical laboratories and various clinical laboratory personnel, and makes a violation of the provisions relating to clinical laboratories and personnel a crime. Existing law, until January 1, 2023, authorizes a person to perform a total protein test using a digital refractometer in a licensed plasma collection center if the department determines that specified conditions are met, including that the person performs the test in accordance with standardized procedures developed and approved by the center's supervising physician and surgeon or licensed clinical laboratory director and verifies the test results in a specified manner. This bill would instead require the department to determine that the person performs the test in accordance with standardized procedures approved by the center's supervising physician and surgeon or licensed clinical laboratory director, and to additionally determine that job descriptions for individuals responsible for process supervision of the total protein test include specified responsibilities. The bill would require the center to perform control procedures as specified by the manufacturer and consistent with federal regulations. The bill would delete the requirement that results be verified in a specified manner as a condition of a person being authorized to conduct a total protein test. The bill would also indefinitely extend the above-described authorization to perform a total protein test. By expanding the crime applicable to this extended authority, the bill would impose 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.