CLIA regulations updated.

Abstract

1. Kathy Hansen 2. Don Lavanty On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published revisions to the Final Rule that regulates clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The revisions to the regulations address substantive changes in quality control practices and in the qualifications for non-physician laboratory directors. They also include reorganization of the previous regulations into a format that should be more logical to follow, and removal of some duplicative provisions. The revisions to the CLIA regulations have been expected for years, and CMS officials, in presentations at conferences and in written communication, had promised them “soon” for a long time. To recap history, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were passed overwhelmingly by Congress in 1988, in response to public and media concerns about the quality of laboratory testing. There were media stories about misread PAP smears, inaccurate cholesterol testing, and concerns about unregulated laboratories' performance. The original legislation was generally worded and declared the intent that testing would be reliable and accurate regardless of where it was performed. CMS (then the Health Care Financing Agency – HCFA) was authorized to write regulations to administer the law. Because of many concerns and comments about provisions of the first draft of proposed regulations, the first final rule, containing most of the provisions that we still practice under today, was published on February 28, 1992. Additional changes and extensions to deadlines or phase-in periods were published in final rules on December 6, 1994; May 12,…