Caballero Andrea, Gómez-Rioja Rubén, Ventura Montserrat, Llopis María Antonia, Bauça Josep Miquel, Gómez-Gómez Carolina, Marzana Itziar, Ibarz Mercedes
Extra-analytical Quality Commission of the Spanish Society of Laboratory Medicine (SEQCML). Department of Clinical Biochemistry, Echevarne Laboratory, Sant Cugat del Vallés, Spain.
Extra-analytical Quality Commission of the Spanish Society of Laboratory Medicine (SEQCML). Servicio de Análisis Clínicos. Hospital La Paz-Cantoblanco-Carlos III, Madrid, Spain.
Adv Lab Med. 2022 May 18;3(2):175-200. doi: 10.1515/almed-2021-0097. eCollection 2022 Jun.
Most errors in laboratory medicine occur in the pre- and post-analytical phases of the total testing process (TTP). In 2014, the Spanish Society of Laboratory Medicine (SEQC) started the current Preanalytical Phase EQA Programme, with the objective of providing a tool for the improvement of the preanalytical phase. The aim of this study was to review the evolution of quality indicators (QI) and the comparability of established performance specifications (PS) with other EQA programmes.
In the SEQC programme, participants were asked to register rejections of the main specimens and the causes for rejections. Data collected from 2014 to 2017, and then reviewed biennially (2018-2019), was used to calculate the percentiles; p25, p50, p75, and p90 for every round, and their means were set as PS. These PS were compared with the results of other programmes.
The evolution of QI results for 2018-2019 period showed general maintenance or improvement, e.g., a significant decrease in the number of serum samples with a haemolytic index ≥0.5 g/L, except for EDTA and citrate samples handle, maybe for an improvement in detection. The comparison with PS for the QI of the IFCC Working Group "Laboratory Errors and Patient Safety" and the Key Incident Management and Monitoring System (KIMMS) programme of the RCPA showed comparable results, supporting the validity of the established specifications.
The PS obtained are a helpful tool for benchmarking and to identify processes of the preanalytical phase whose improvement should be set as a priority.
检验医学中的大多数错误发生在总检验流程（TTP）的分析前和分析后阶段。2014年，西班牙检验医学学会（SEQC）启动了当前的分析前阶段室间质量评价计划，目的是提供一个改善分析前阶段的工具。本研究的目的是回顾质量指标（QI）的演变以及既定性能规范（PS）与其他室间质量评价计划的可比性。
在SEQC计划中，要求参与者记录主要标本的拒收情况及拒收原因。收集2014年至2017年的数据，然后每两年（2018 - 2019年）进行一次回顾，用于计算各轮的第25百分位数、第50百分位数、第75百分位数和第90百分位数，并将其平均值设为PS。将这些PS与其他计划的结果进行比较。
2018 - 2019年期间QI结果的演变显示总体保持或有所改善，例如，溶血指数≥0.5 g/L的血清样本数量显著减少，但乙二胺四乙酸（EDTA）和枸橼酸盐样本处理情况除外，这可能是检测方面有所改善的结果。与国际临床化学和检验医学联合会（IFCC）“实验室错误与患者安全”工作组的QI的PS以及皇家澳大利亚病理学家学院（RCPA）的关键事件管理与监测系统（KIMMS）计划进行比较，结果具有可比性，支持了既定规范的有效性。
获得的PS是一个有助于进行基准比较和识别分析前阶段应优先改进流程的工具。
