Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

• Published in: Clinical chemistry and laboratory medicine Vol. 55; no. 12; pp. 1849 - 1856
• Main Authors: Panteghini, Mauro, Ceriotti, Ferruccio, Jones, Graham, Oosterhuis, Wytze, Plebani, Mario, Sandberg, Sverre
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 26.10.2017; Walter De Gruyter & Company
• Subjects: biological variation; Clinical Laboratory Techniques - standards; Clinical Medicine - standards; Humans; Laboratories; Laboratories - standards; Medicine; outcome; performance specifications; Quality Control; Specifications; biological variation; outcome; performance specifications
• ISSN: 1434-6621; 1437-4331; 1437-4331
• DOI: 10.1515/cclm-2017-0772

Measurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be “fit for purpose” and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.