Elective Course:Evaluating and monitoring analytical quality in laboratory medicine 1730-A-ZF-EVALUATING

Clinicians and patients expect laboratory results to be equivalent, independent of the laboratory producing them and of employed measuring systems. To reach this goal, it is essential to implement a measurement standardization process based on metrological traceability of patient results to higher order references. To this regard, the main requirements are: a) the identification of an unbroken metrological traceability chain to implement the appropriate transfer of the measurement trueness to commercial calibrators and patient results, b) the estimate of measurement uncertainty budget, with definition of permissible limits for clinical application of measurements, and c) a postmarket surveillance surveying the suitability of in vitro diagnostics

(IVD) for clinical use and of laboratory performances in using them The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. Estimating and checking MU in medical laboratories is essential to understand its influence on measurement results and, ultimately, their clinical suitability.