Evaluating and monitoring analytical quality in the traceability era
Poor analytical quality may be the bane of medical use of laboratory tests and the fight against the analytical variability presents a daily struggle. Laboratories should prioritize the perspectives and needs of their customers (the patients and healthcare personnel). Among them, comparability of results from the same patient sample when measured by different laboratories using different IVD medical devices is a logical priority to avoid result misinterpretation and potential patient harm.
Harmonization (standardization) of laboratory measurements can be achieved by establishing metrological traceability of the results on clinical samples to stated higher-order references and providing an estimate of the uncertainty of measurement based on an uncertainty budget including all known contributions generated by the employed calibration hierarchy, which in turn should be validated against fit-for-purpose maximum allowable uncertainty derived according to internationally recommended models.
In this meeting, internationally recognized speakers will review the available strategies for establishing, evaluating, and monitoring analytical quality in terms of laboratory result harmonization. They will discuss the most important aspects that may influence the obtaining and maintaining of analytical standardization in laboratory medicine, offering practical solutions aimed at educating all stakeholders—i.e., reference providers, IVD manufacturers, medical laboratories, and External Quality Assessment organizers—for the achievement of harmonized laboratory results.