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

Abstract

Abstract: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.

Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories

“…Therefore, while the Milan Consensus condensed the hierarchy, it specifically granted laboratories the freedom to select the most practical goals when necessary. This of course means the potential for chaos in performance specifications will continue ( 35 ). However, as new tests emerge, as new clinical uses for existing tests change and evolve, so too will our TEa goals.…”

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

“…Talking about the analytical performance of hs-cTn assays poses the vital question as to the requisite degree of quality needed and to what extent measurement uncertainty is tolerable without jeopardizing patient safety [40]. The basic concept underlying this issue arose from the EFLM Strategic Conference held in Milan in 2014, which defined analytical performance specifications (APSs) according to different models [41,42]. Notably, cTn should be considered as an analyte for which the model based on the effect of analytical performance on clinical outcomes should be applied in order to define APS [43].…”

Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters

“…Defining analytical performance specifications (APSs) for each CBC component is essential to ensure that the measurement error will not distort the clinical interpretation of the result [1][2][3][4]. According to the consensus statement delivered by the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), the recommended approaches for deriving APS should preferably rely on (1) the effect of measurement performance on clinical outcome (model 1) or on (2) the biological variation (BV) of the measurand (model 2) [5,6]. If APS based on these models cannot be made, state-of-the-art, defined as the highest level of performance technically achievable, could be used (model 3).…”