GOVERNMENTAL PERSPECTIVES ON EVALUATING LABORATORY PERFORMANCE

The quality of laboratory analytical performance required to support m edical decision-making has been defined in four major ways: (a) by the analytical variance of the state of the practice; (b) by the total va riance, including analytical and biological variability; (c) by the lo ss of diagnostic efficiency attributable to analytical error; and (d) by medical-usefulness criteria. From the federal government's perspect ive, the answer to the question ''How good must a laboratory test resu lt be to be medically relevant?'' must take into account the clinical context of the test, with accompanying concerns about access, timeline ss, and cost, as well as limits for precision and accuracy in the anal ytical process and the frequency and potential patient-care impact of error in the pre- and postanalytical steps of the total testing proces s. Therefore, medically relevant goals should encompass not only analy tical precision and accuracy but also goals to provide access to clini cally effective tests and to reduce errors in the total testing proces s that can lead to medically misleading information. Development of mo re appropriate regulatory requirements for laboratories, as well as an y needed improvements in instrumentation and methodology, should focus on ensuring that goals for medically relevant results are met by appr opriate design and management of the entire process of laboratory test ing.