Clinical Laboratories Regulation

VII. Key Issues: Regulation & Reform >> B. Health Care Regulation >> Health Facilities Regulation >> Clinical Laboratories Regulation


Because clinical laboratories often serve numerous states, it made sense for the federal government to take the lead in ensuring and regulating their quality. The Clinical Laboratory Improvement Act (CLIA) and subsequent amendments establish quality control standards for all clinical laboratories throughout the U.S. Major amendments were enacted in 1988 (CLIA 88), although final regulations were not published until February 1992. The Duke Center for Health Policy and Inequalities Research has developed a draft working paper assessing the costs and benefits of clinical laboratory regulation (pdf)

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