CLIA is an acronym for the “Clinical Laboratory Improvement Amendments,” a set of quality regulations that must be followed in every clinical laboratory in the U.S. The regulations cover all administrative aspects of running a clinical lab, and were first published in 1988 (that’s why people still say “CLIA ’88” even though it has been amended three times since then). There are far too many details to mention, but in short, CLIA gives labs guidelines on things like how they must be organized, what personnel can perform what tests, and how proficiency in testing must be assessed (just to name a very few!). The regulations are found in 42 CFR 493.

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