Olson John D, Jennings Ian, Meijer Piet, Bon Chantal, Bonar Roslyn, Favaloro Emmanuel J, Higgins Russell A, Keeney Michael, Mammen Joy, Marlar Richard A, Meley Roland, Nair Sukesh C, Nichols William L, Raby Anne, Reverter Joan C, Srivastava Alok, Walker Isobel
Department of Pathology, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
United Kingdom National External Quality Assurance Service - Blood Coagulation (UK-NEQAS-BC), Sheffield, UK.
Blood Coagul Fibrinolysis. 2018 Jan;29(1):111-119. doi: 10.1097/MBC.0000000000000690.
: Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of 'pass' or 'fail' is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance.
实验室质量计划依赖于内部质量控制和外部质量评估（EQA）。EQA计划为实验室提供未知样本进行检测。实验室的结果会与其他进行相同检测的（同行）实验室进行比较。EQA计划使用多种方法和统计工具来确定目标值，并对“通过”或“失败”进行性能评估。国际血栓与止血外部质量保证组织的EQA提供者参与了一项研究，以比较使用同一实验室结果数据集进行性能分析的结果。11个采用8种不同分析方法的EQA组织参与其中。来自218个实验室的正常和延长活化部分凝血活酶时间（aPTT）以及正常和降低的因子VIII（FVIII）的数据被发送给EQA提供者，他们使用各自的aPTT和FVIII评估方法分析该数据集，确定数据集中每个实验室记录的性能。提供者还总结了他们确定目标值和实验室性能的统计方法。数据集中的每个实验室记录针对四种分析物中的每一种都由所有EQA提供者评定为通过/失败。EQA计划之间在通过/失败分级方面缺乏一致性。正常和延长aPTT结果的分级不一致率分别为17.9%和11%，正常和降低FVIII结果的分级不一致率分别为20.2%和17.4%。本研究中的所有EQA计划都采用了符合国际标准化组织（ISO）ISO 13528的统计方法，但对所有四种分析物的实验室结果评估显示出显著的分级不一致。
