California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 3 — Clinical Laboratory TechnologyArticle 3 — Application of the ChapterSection 1246.5

Notwithstanding any other provision of law, any person may request, and any licensed clinical laboratory or public health laboratory may perform, the laboratory tests specified in this section. A registered clinical laboratory may perform the laboratory tests specified in this section if the test is subject to a certificate of waiver under CLIA and the laboratory has registered with the department under paragraph (2) of subdivision (a) of Section 1265. A program for nondiagnostic general health assessment that includes a laboratory test specified in this section shall comply with the provisions of Section 1244. The results from any test may be provided directly to the person requesting the test if the test is on or for his or her own body. These test results shall be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician and surgeon.

The tests that may be conducted pursuant to this section are: pregnancy, glucose level, cholesterol, occult blood, and any other test for which there is a test for a particular analyte approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit. A test approved only as an over-the-counter collection device may not be conducted pursuant to this section.

Notes

Allows any person to request, and licensed clinical or public-health laboratories to perform, listed direct-access tests, including pregnancy, glucose, cholesterol, occult blood, and qualifying over-the-counter analyte tests. Allows registered laboratories to perform waived tests if properly registered, requires clear results and referral indicators, and excludes tests approved only as over-the-counter collection devices.

Use as reference

Lexinter.net | California Code, Business and Professions Code - BPC § 1246.5 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-3/article-3/section-1246-5

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