Medical need for quality specifications--a NORDKEM project for selecting the appropriate quality in clinical...

The Nordic Clinical Chemistry Project (NORDKEM) has during its existence run several projects dealing with analytical quality requirements and the specifications of such requirements. The latest project-"Medical Need for Quality Specifications in Laboratory Medicine"-started three years ago and is now to be reported. The project consists of three main subprojects and a large number of associated projects. The main subprojects deal with: *External quality assurance for proteins (Per Hyltoft Petersen et al.) *Transferability of clinical laboratory data (Torgny Groth & C-H de Verdier) *Terminology (René Dybkaer) "Clinical goals" are assessed using different kinds of procedures. Comparison with the characteristics of "the analytical procedures" and "the quality assurance programs" gives the Management of the clinical laboratory a background for determining the "analytical quality specifications" of the laboratory. Procedures for setting up clinical goals and analytical quality specifications are given and they are further exemplified in the associated projects. Clinical goals and the analytical quality specifications are expressed and calculated in similar ways as total allowable error (TEa), as a coefficient of variation or an absolute error within defined concentration intervals.