Clinical laboratory technology and pharmacists.

(1) 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 provides that nothing in those provisions restrict, limit, or prevent any person licensed to provide health care services under the state's laws, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the professions or occupation for which they are licensed. Existing law provides that nothing in those provisions authorize any person to perform or order health care services or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results. This bill would state that nothing in those provisions prevents a licensed pharmacist from practicing the profession or occupation for which they are licensed. The bill would also provide that nothing in those provisions authorizes any person to perform or order health care services or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide or order that care or utilize the results. 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 and the test is performed by specified persons, including a pharmacist if ordering drug therapy-related laboratory tests, as provided, or if performing skin puncture, as provided. Existing law exempts from that prohibition a pharmacist at a community pharmacy who, upon customer request, performs only specified tests that are classified as waived under the CLIA and are approved by the federal Food and Drug Administration (FDA) for specified purposes, and meets specified requirements, including that for purposes of the CLIA that the person identified as responsible for directing and supervising testing oversight and decisionmaking be the pharmacist-in-charge. This bill would revise and expand the types of persons that may perform those tests, including licensed pharmacists, except as provided, if the results of the tests can be lawfully utilized within their practice, and would make conforming changes. The bill would broaden the exemption by providing that the above-described prohibition does not apply to a licensed pharmacist who, upon patient request or hospital authorization, performs tests that are classified as waived under the CLIA or are approved or authorized by the FDA, and meets specified requirements. The bill would remove the requirement that for purposes of the CLIA that person identified as responsible for directing and supervising testing oversight and decisionmaking be the pharmacist-in-charge. The bill would make conforming changes. (2) Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. That law makes it a misdemeanor for any person to knowingly violate any of the provisions of that law when no other penalty is provided. That law authorizes a pharmacist to order and interpret tests, among other things, for the purpose of monitoring and managing the efficacy and toxicity of drug therapies. This bill would authorize a pharmacist to order and interpret tests for the purpose of promoting patient health. The Pharmacy Law also authorizes a pharmacist to perform specified procedures or functions as part of the care provided by certain facilities or persons, as provided, in accordance with the policies, procedures, or protocols of those facilities or persons. Under existing law, those procedures or functions include ordering or performing routine drug therapy-related patient assessment procedures, ordering screening or drug therapy-related tests, and administering drugs and biologicals by injection pursuant to a prescriber's order. Existing law requires the policies, procedures, or protocols to include, among other things, a requirement that those procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician. This bill would expand the procedures or functions that a pharmacist may perform as part of the care provided by certain facilities or persons, as provided, including by authorizing a pharmacist to order or perform patient assessment procedures. The bill would revise the requirements relating to the policies, procedures, or protocols by requiring that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a diagnosing or treating prescriber. Existing law authorizes a pharmacist to perform skin puncture in the course of performing routine patient assessment procedures or other specified procedures. Existing law defines routine patient assessment procedure as a procedure that a patient could, with or without a prescription, perform for themselves, or clinical laboratory tests that are classified as waived pursuant to the CLIA, as provided. This bill would remove from the definition of routine patient assessment procedures a procedure that a patient could, with or without a prescription, perform for themselves. By expanding the scope of a crime, 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.