Chapter 3 : Regulatory Compliance

Abstract:

Clinical laboratories have come a long way since the 1900s when concerns were raised that they were too expensive and testing was too time consuming to be of practical use (1). In spite of those objections, laboratories have become the cornerstone of medical decision making. The beginning of laboratory regulation can be traced to the 1940s when Sunderman and Belk published findings from a voluntary survey of proficiency testing of regional laboratories that showed significant variation in laboratory performance (2). At around the same time, the College of American Pathology (CAP) was established, and one of its first functions was the initiation of national proficiency surveys in 1947 and 1948. The results further confirmed the need for standardization and regulation of clinical laboratories (3). In subsequent years, participation in proficiency surveys became standard practice among large hospital and reference laboratories (4). In 1967, Congress passed the Clinical Laboratory Improvement Amendment of 1967 (CLIA 67), which mandated certain minimum performance standards for reference laboratories involved in interstate commerce (4, 5). Similar regulation for hospital laboratories that were funded by Medicare followed in 1968 (6). The CLIA 67 regulations mandated that laboratories participate in “state approved or state operated proficiency testing programs” (5).