California Business and Professions Code
Section 1241 (a) This chapter applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination, and to all persons performing clinical laboratory tests or examinations or engaging in clinical laboratory practice in California or on biological specimens originating in California, except as provided in subdivision (b).
Section 1300 (p) In addition to the payment of registration or licensure fees, a clinical laboratory located outside of the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
California Code of Regulations 17 CCR Ā§ 1039.2. Clinical Laboratory Personnel Requirements
(a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examination in California shall meet the requirements for performing, supervising, consulting on, or directing laboratory tests or examinations as set forth in Chapter 3 for the type and complexity of tests performed and irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration.
(b) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations outside California on biological specimens originating in California and irrespective of whether the clinical laboratory where the tests or examinations are performed is operated under a CLIA certificate or under a state license or registration, shall meet all personnel requirements set forth in Chapter 3 for the type and complexity of testing performed, or shall provide evidence to the department that they substantially meet those requirements by documenting inclusion, Licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards.ā