California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 3 — Clinical Laboratory TechnologyArticle 3 — Application of the ChapterSection 1241.1
(a) A primary care clinic, licensed pursuant to subdivision (a) of Section 1204 of the Health and Safety Code, that is operating within a network of primary care clinics, may be issued a license to operate a clinical laboratory pursuant to Section 1265, which authorizes the conduct of clinical laboratory tests and examinations from its network of primary care clinics, if all of the following conditions are met:
(1) The central laboratory’s sole purpose is performing moderate or high complexity clinical laboratory tests and examinations, or both, for the patients of the clinics in the network.
(2) Prior to performing any tests or examinations, the central laboratory obtains a certificate under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) (CLIA) and a state laboratory license for the appropriate complexity level of clinical laboratory testing pursuant to Section 1265.
(b) For purposes of this section, “network of primary care clinics” means two or more primary care clinics operated by the same nonprofit corporation with the same board of directors and the same corporate officers, and operating under the same procedures and protocols.
Notes
Allows a licensed primary care clinic in a qualifying nonprofit network to receive a clinical-laboratory license covering testing for network patients when the central laboratory performs only moderate- or high-complexity testing and first obtains CLIA certification and a state laboratory license. Defines a qualifying network as at least two clinics sharing the same nonprofit corporation, board, officers, procedures, and protocols.
Use as reference
Lexinter.net | California Code, Business and Professions Code - BPC § 1241.1 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-3/article-3/section-1241-1