Are regulation-driven performance criteria still acceptable? – The German point of view

摘要: Performance criteria should be a challenge for the laboratories to improve their quality. In countries with mandatory proficiency testing, definition of performance is particular issue. If mandated from regulatory bodies medico-scientific institutions, scientific approaches (i.e., based on biological variation), state-of-the-art approach technical feasibility) as well medical needs can used set up such Richtlinie der Bundesarztekammer (RiliBAK; Guideline German Medical Association Quality Assurance in Laboratory Examinations) Germany. The experiences RiliBAK show that these have revised an ongoing basis.