Strategies for Error Reduction: Why More Stringent Premarket Evaluations Do Little to Prevent Laboratory Errors and Traffic Accidents

Abstract

Laboratory testing is a complex process with a significant error rate. Studies of laboratory errors have found that the major causes are preanalytical factors, interferences, and process errors. Efforts by regulatory agencies to improve quality via more stringent premarket evaluations of laboratory tests therefore have poor prospects of reducing laboratory errors and improving test quality. Efforts toward increasing the regulation of laboratory tests are analogous to preventing traffic accidents by increasing the premarket evaluation of automobiles. This analogy illustrates how increased premarket evaluation has limited prospects for quality improvement and, in some cases, actually contributes to errors and lower quality. Tools that are used by laboratories to detect, prevent, and address analytical errors are discussed, and the increased implementation of such tools offers approaches that can be used to improve laboratory quality.