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CLIA & Your Laboratory

ACP 2014 CLIA & Your Laboratory A Guide for Physicians and Their Staff November 2014 ACP 2014 2 Introduction The American College of Physicians (ACP) welcomes your interest in this guide to the clinical Laboratory Improvement Amendments of 1988 (CLIA 88). We hope that you will find it helpful in answering many of your questions regarding regulations for clinical Laboratory testing. These CLIA regulations are far-reaching, and now regulate physician-office Laboratory (POL) testing on a national scale. ACP originally published this guide in 1988. It has been revised periodically to reflect the changes made to the regulations as a result of its implementation and ongoing modifications to CLIA. Among these changes are: The creation of a second moderate testing category A revised waived category Compliance measures for states that are CLIA-exempt Requirements for lab director certification for high-complexity labs An updated fee schedule for CLIA certificates This guide has been divided into nine chapters: The first chapter, The Origin of CLIA 88: An Overview, traces the legislative and regulatory history of CLIA 88 and details some of its key components.

Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). We hope that you ... An updated fee schedule for CLIA certificates ... has seriously affected patients in rural areas who travel an average of 15 miles to laboratory testing sites. Furthermore, the survey found that some patients were obtaining ...

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