Tissue bank licensing.

Existing law requires the State Department of Public Health to establish regulations, as specified, governing the operation and maintenance of tissue banks licensed in California. Existing law allows for the revocation or suspension of a tissue bank's license for specified reasons. Violation of these provisions is a misdemeanor. This bill would require the collection, processing, storage, or distribution of human tissue for use in California to comply with the edition of Standards for Tissue Banking in effect on January 1, 2011, as published by the American Association of Tissue Banks, and would require the department to evaluate future amendments of these standards to determine which changes to adopt as regulations. This bill would also allow the department to impose on licensed tissue banks, as an alternative to suspension or revocation of a tissue bank's license, a civil administrative penalty of $100 per day of noncompliance per violation not to exceed an aggregate of $3,000. Existing law defines "tissue" as any human cell, group of cells, tissue, or organ, giving specific examples. This bill would delete organ from this definition. Because the bill would make changes to the definition of a crime, it 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.