February 11, 1998

Is It Time to Turn the Page on CLIA 1988?

Author Affiliations

From the Department of Pathology and Laboratory Medicine, University of Kentucky, Chandler Medical Center, Lexington.

JAMA. 1998;279(6):473-475. doi:10.1001/jama.279.6.473

The passage of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the implementation of the regulations in 1993 constituted a sea change in the regulation of clinical laboratories in the United States. Although conceived predominantly as a response to perceived and documented problems in cytology testing, CLIA was viewed by many in Congress as a needed extension of federal regulatory oversight to large numbers of previously unregulated laboratories, most of which were physicians' office laboratories (POLs). Professionals in hospital and independent laboratories previously regulated under Medicare and federal interstate commerce statutes have experienced portions of the CLIA regulations as overly prescriptive and burdensome. Others, primarily in management positions, welcomed the decreased stringency of personnel requirements as an opportunity for greater flexibility in staffing, whereas many in the professional laboratory community interpreted these changes as a dangerous weakening and dumbing down of personnel standards. From the onset, organized medicine opposed CLIA as an unwarranted intervention by the federal government into the traditional practice of medicine and the patient-physician relationship.

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