Regulatory compliance for point-of-care testing: 2009 United States perspective

All clinical laboratory testing in the United States is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88 or CLIA) and overseen by the Centers for Medicare and Medicaid Services. CLIA profoundly changed the prevailing United States regulatory philosophy by imposing uniform requirements for all clinical laboratory testing regardless of where tests are performed. In the hospital, regulatory compliance is usually ensured by regular inspections of the laboratory by either the Joint Commission or by the College of American Pathologists. These organizations may include requirements beyond the minimum standard mandated by CLIA. This article reviews the status of regulatory compliance of point-of-care testing from a perspective of the current regulations in effect in the United States in 2009.