While we offer refer to labs operating "under CLIA regulations," those regulations are usually very short. (Ensure appropriate controls are performed...). There is somewhat more guidance under state inspection manuals on the CMS website.
See State Operations Manual, Chapter 6, Special Procedures for Laboratories, 256 pages, update 199, January 2020.
See also, "Survey Procedures and Interpretative Guidelines for Laboratories and Laboratory Services," which is "Appendix C" to the above. This weighs in at 418 pages; currently Rev. 166, February 2017.
Much of the quality systems in general seem to be managed at 493.1230ff (manual, p147ff).
There is a comment re standing orders, 493.1240. There is a definition of reflex testing at page 46, and regarding quality controls at 493.801b.
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See my April 2022 blog.
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