(a) For the purposes of this chapter whenever the department determines that a new category of license is necessary, either to direct a laboratory, or to perform clinical laboratory tests or examinations in specific specialties or subspecialties, or that the specialties or subspecialties authorized under an existing license category should be modified, it shall adopt regulations identifying the license category or modification, the education, training, and examination necessary to obtain the license, and the specialty or subspecialty, or both, included within the new license category, or within the existing category as modified.
(b) Any CLIA regulation adopted by HCFA as a final rule after January 1, 1994, shall be evaluated by the department in consultation with the multidisciplinary committee appointed pursuant to Section 1228. Any new federal regulation that is deemed by the department to be equivalent to or more stringent than California laws or regulations, shall become effective by operation of law as a regulation adopted under this chapter, 90 days after adoption by HCFA and the department publishes the notice required by subdivision (c), or on January 1, 1996, whichever is later. After publishing the notice required by subdivision (c), any new federal regulation deemed by the department to be less stringent than current California law or regulation shall be noticed by the department as a comparable state regulation for a rulemaking proceeding in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, which shall result in the adoption, amendment, or rejection of that noticed state regulation.
(c) The department shall publish a notice in the California Regulatory Notice Register indicating that a CLIA regulation has been adopted by HCFA as a final rule. The notice shall include the citation to the Federal Register or the Code of Federal Regulations for the CLIA regulation. The notice shall also include the department’s determination regarding whether the regulation is more stringent, equivalent to, or less stringent than current California law or regulation.
(Amended by Stats. 1995, Ch. 510, Sec. 8. Effective January 1, 1996.)
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