Bill > AB481

This bill modifies California law regarding unlicensed personnel working in clinical laboratories by clarifying and expanding the definition of permissible activities and supervision requirements. The bill defines "assist" or "assisting" as specific tasks performed by trained personnel under direct supervision, such as loading and unloading specimens, cleaning equipment, moving assays between instruments, and transferring samples using calibrated equipment. It requires that unlicensed laboratory personnel have a high school diploma or equivalent and meet specific training requirements, including understanding laboratory procedures, receiving verbal instructions, and directly observing tasks performed by licensed personnel. Additionally, the bill mandates that before performing any tasks, personnel must demonstrate their skills under direct and constant supervision, and must meet federal Clinical Laboratory Improvement Amendments (CLIA) requirements for moderate or high complexity testing. The bill also explicitly defines "supervision and control" to mean that a licensed professional must be physically present in the laboratory and readily available for consultation during the entire time unlicensed personnel are working. The laboratory director is responsible for designating supervisors and maintaining overall responsibility for personnel performance. By expanding the scope of activities and clarifying supervision standards, the bill aims to ensure proper training and oversight of unlicensed laboratory workers.

Budget and Finance, Business and Industry

https://leginfo.legislature.ca.gov/faces/billStatusClient.xhtml?bill_id=202520260AB481