Major and Minor Changes to Testing Sites
California Business and Professions Code (BPC) section 1265 (e) and (g) require clinical laboratories to notify Laboratory Field Services within five days of the appointment of an interim director and within 30 days of any change of ownership, name, location, or permanent laboratory director. Pursuant to BPC 1265 (e), a clinical laboratory registration will be automatically revoked 30 days after a major change of directorship or ownership.
Definitions:
āA major change in laboratory directorshipā means a change in laboratory director or directors resulting in a situation where less than 50 percent of the laboratory directors to whom the current laboratory registration is issued remain after the change (see BPC 1211 (j)). The laboratory must submit a completed application for a new clinical laboratory registration within 30 days of a major change of directorship or cease engaging in clinical laboratory practice.
āA major change in ownershipā means a change in ownership where 50 percent or more of the ownership interest is owned by persons other than the owners to whom the current clinical laboratory registration is issued. See BPC 1211 (f). The laboratory must submit a completed application for a new clinical laboratory registration within 30 days of a major change of ownership or cease engaging in clinical laboratory practice.ā