Panel discussion: how to monitor and minimize variation and mistakes

Abstract

Panel II of the 1996 Clinical Chemistry Forum was a discussion initiated by brief formal presentations from Rosemary Bakes-Martin of the US Centers for Disease Control and Prevention (CDC), Cornelia Rooks of the US Food and Drug Administration (FDA), William Hamlin of the College of American Pathologists (CAP), Nathan Gochman of Beckman Instruments, and David Witte of this Forum Committee. ### Rosemary Bakes-Martin, CDC. The CDC concept of quality control (QC) in 1996 includes the problematic phrase, “Run two levels of control per day.” The process for analytical QC should both assess the potential for error and monitor the process over time. In assessing the potential for error, laboratorians need to look at the test system, the environment, and the operator. Alternatives need to be considered. Nontraditional ways to assure that the test system is under control, or is producing the correct result, must be considered. The manufacturer builds systems to monitor equipment and environment. A good training program assures that the operator knows what to do with these systems. Competency testing and quality assurance (QA) help ensure that the operator does the correct thing. No matter how training, competency, and QC are accomplished, it is important to monitor all three over time. The laboratory director probably is the best person to determine how often to monitor the test system, environment, and operator. Because we at CDC are in a regulatory environment and there must be minimum standards, we believe there must be something done to monitor an analytical process at least weekly. ### Cornelia Rooks, FDA. The FDA has been involved in the premarket evaluation of in vitro diagnostic devices for >20 years. Review is directed at establishing the safety and effectiveness of products before marketing through independent review of performance data and labeling. FDA’s review of QC is grounded in its unique labeling regulation and is …