Source plasma donation.

Assembly Member Solache's California Source Plasma Donation Centers Act establishes a regulatory framework authorizing and overseeing facilities that collect source plasma through plasmapheresis. The legislation permits these centers to compensate donors while implementing comprehensive safety and oversight requirements.

The bill creates a distinct licensing category for source plasma donation centers under the State Department of Public Health, separate from existing blood bank regulations. Centers must obtain department licenses, employ medical directors, and follow specific protocols for donor screening, informed consent, and HIV testing. The legislation allows qualified personnel, including registered nurses and specially trained phlebotomists, to conduct donations under a physician's supervision, though the physician need not be physically present.

To protect donor privacy and public health, the act requires centers to maintain records of HIV test results and notify local health officers of reactive results if donors cannot be located directly. Health officers must then expunge these records after completing notification attempts. The department holds inspection and enforcement authority, with violations constituting misdemeanors punishable by fines up to $1,000 and/or 30 days imprisonment. Licensing fees will support oversight through the Clinical Laboratory Improvement Fund.

The measure exempts source plasma donation centers from certain blood bank requirements while maintaining their classification as service providers rather than sellers of plasma products. This creates a dedicated regulatory structure for the source plasma industry while preserving existing public health protections.