Laboratory Policy and Regulations

Abstract

Like medical devices and pharmaceuticals, laboratory tests are subject to oversight and policies to assure safety and efficacy. Appropriate use of laboratory methods requires an understanding of the basic regulatory methods regarding laboratory testing. The Centers for Medicare and Medicaid Services began regulation of laboratory testing in 1988 through the Clinical Laboratory Improvement Amendments (<abbrev>CLIA</abbrev>). The purpose of <abbrev>CLIA</abbrev> is to ensure high quality laboratory results and testing practices. Laboratories must follow <abbrev>CLIA</abbrev> regulations to achieve certification and accreditation. When manufacturers initially submit laboratory tests for Food and Drug Administration (<abbrev>FDA</abbrev>) approval, the <abbrev>FDA</abbrev> will review submitted data to categorize the test into one of three complexity categories defined by <abbrev>CLIA</abbrev>: waived, moderate, and high complexity. Tests that are in the waived category are tests that have low complexity and can be completed outside of a traditional laboratory, often as a point-of-care test (<abbrev>POCT</abbrev>).