[Domestic and international trends concerning allowable limits of error in external quality assessment scheme]

Abstract

Many external quality assessment schemes (EQAS) are performed to support quality improvement of the services provided by participating laboratories for the benefits of patients. The EQAS organizer shall be responsible for ensuring that the method of evaluation is appropriate for maintenance of the credibility of the schemes. Procedures to evaluate each participating laboratory are gradually being standardized. In most cases of EQAS, the peer group mean is used as a target of accuracy, and the peer group standard deviation is used as a criterion for inter-laboratory variation. On the other hand, Fraser CG, et al. proposed desirable quality specifications for any imprecision and inaccuracies, which were derived from inter- and intra-biologic variations. We also proposed allowable limits of analytical error, being less than one-half of the average intra-individual variation for evaluation of imprecision, and less than one-quarter of the inter- plus intra-individual variation for evaluation of inaccuracy. When expressed in coefficient of variation terms, these allowable limits may be applied at a wide range of levels of quantity.