ADVOCACY

This bill would authorize the department, upon appropriation by the Legislature, to establish a grant program to provide funding to training programs that both offer training programs for clinical laboratory scientists or medical laboratory technicians, and are approved by the department or accredited by a recognized accrediting program approved by the department. The bill would also authorize the department to award grants to those  training programs in the amount of no more than $600,000, to be used within 3 years of receiving a grant.

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.

Existing law, the California Emergency Services Act, authorizes the Governor to declare a state of emergency during conditions of disaster or extreme peril to persons or property, including epidemics. Pursuant to this authority, on March 4, 2020, the Governor declared a state of emergency relating to the novel coronavirus 2019 (COVID-19) pandemic, and ordered, among other things, that the certification and licensure requirements as specified in statute and regulation be suspended to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments (CLIA) for high complexity testing and who are performing analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any certified public health laboratory or licensed clinical laboratory, and that the California Health and Human Services Agency is required to identify and make available medical facilities and other facilities that are suitable for use as medical facilities as necessary for treating individuals who test positive for COVID-19.

Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.  

This bill would repeal these provisions as of July 1, 2028.

Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.

This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program.

This bill modifies provisions relating to Medicare payment rates for clinical diagnostic laboratory services, including by requiring payment rates for certain widely available clinical diagnostic laboratory tests to be based on a statistical sampling of private sector rates.