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

被引:58
作者
Panteghini, Mauro [1 ]
Ceriotti, Ferruccio [2 ]
Jones, Graham [3 ]
Oosterhuis, Wytze [4 ]
Plebani, Mario [5 ]
Sandberg, Sverre [6 ,7 ,8 ]
机构
[1] Univ Milan, Res Ctr Metrol Traceabil Lab Med CIRME, Via GB Grassi 74, I-20157 Milan, Italy
[2] Osped Maggiore Policlin, Fdn IRCCS Ca Granda, Cent Lab, Milan, Italy
[3] St Vincents Hosp, SydPath, Sydney, NSW, Australia
[4] Zuyderland Med Ctr, Dept Clin Chem & Haematol, Heerlen, Netherlands
[5] Univ Hosp Padova, Dept Lab Med, Padua, Italy
[6] Haraldsplass Deaconess Hosp, Norwegian Qual Improvement Lab Examinat Noklus, Bergen, Norway
[7] Univ Bergen, Dept Global Publ Hlth & Primary Hlth Care, Bergen, Norway
[8] Haukeland Hosp, Norwegian Porphyria Ctr, Lab Clin Biochem, Bergen, Norway
关键词
biological variation; outcome; performance specifications; ANALYTICAL QUALITY SPECIFICATIONS; STOCKHOLM CONSENSUS CONFERENCE; SUBJECT BIOLOGICAL VARIATION; ANALYTICAL GOALS; METROLOGICAL TRACEABILITY; EUROPEAN FEDERATION; GLYCATED HEMOGLOBIN; CLINICAL-CHEMISTRY; PLASMA-GLUCOSE; TOTAL ERROR;
D O I
10.1515/cclm-2017-0772
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:1849 / 1856
页数:8
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