Harmonization in the clinical laboratory and the nature of external quality assessment in the near future
2022
Abstract
In vitro device diagnostics requirements (IVDR 746), harmonization of results, realized by metrological traceability of calibration are the main fields of next development in laboratory medicine. Corresponding face of external quality assurance programs (EQA) are here briefly described.
We deal with problems of commutability of control materials and also with analytical performance specification values (APS). The role of biological variation introduced in EuBIVAS database is also briefly mentioned Problems of using the non-commutable control materials should be solved intensively too.
The necessity of stepwise development EQA is clear and leads via commutability control materials and well determined analytical performance values.