Adding Value to Proficiency Testing Programs

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) (1) have caused great changes not only in US laboratories but in clinical laboratories throughout the world. CLIA’s requirements for pre- and postanalytical control were harbingers of more complete approaches to the implementation of quality systems in clinical laboratories, such as the quality model just introduced by the National Committee for Clinical Laboratory Standards (2). CLIA’s maximum allowable error specifications for proficiency testing (the so-called CLIA limits) are being used by manufacturers to help set analytical performance goals for new laboratory analyzers. These specifications have ignited a transatlantic debate (3) regarding the formulation of analytical goals based strictly on patient variation vs the CLIA goals, which were based on a host of variables, including physician surveys, patient variation, analytical performance, and even prior proficiency testing (PT) performance.The enactment of CLIA 88 unraveled the comfortable existence of a few large PT providers who primarily served hospital laboratories. In the early 1990s, thousands of previously unregulated physician office laboratories were added to the PT pool. Many of these laboratories eventually subscribed to newly established PT providers whose missions were more closely aligned to the participants’ medical organizations, e.g., the American Academy of Family Physicians and the American Society of Internal Medicine. As of 1998, there were 20 different CLIA-certified PT programs (4). The presumably decreased profitability of the PT business has led to a commoditization of PT products and less effort expended in the design and manufacture of PT specimens for analytes that are not directly regulated by CLIA.Another result, coincident with the enactment of CLIA 88, was the development of PT programs that serve a narrow spectrum of users, such as those using instruments of a specific manufacturer. Finally, the requirement to subscribe to CLIA-approved PT programs has eroded the …