June 3, 2003

Judy Yost, MA, MT, (ASCP)

The final CLIA regulations with comment were published in 1992 and contained phase-ins for Quality Control (QC) and Personnel to allow previously unregulated laboratories the opportunity to understand and comply with CLIA requirements. The QC and Personnel phase-ins have been extended several times with the current extension expiring December 31, 2000. In response to comments to the 1992 regulations, Clinical Laboratory Improvement Advisory Committee (CLIAC) recommendations and the technical advice of nationally recognized QC experts, some new QC concepts have been introduced into a final regulation currently in DHHS clearance. In addition, many of the current QC, Quality Assurance (QA) and Patient Test management (PTM) requirements have been reformatted to follow the flow of a specimen through the laboratory; i.e., the total testing process. This facilitates the laboratories’ ability to identify and prevent laboratory errors as discussed in the recent Institute of Medicine report on Medical Errors and introduces the concepts of Quality Systems into CLIA.