Zhang Lichao, Jiang Kefeng, Chen Jialing, Zhang Zhixiong, Zhang Liyan, Xu Meiyining, Li Jiaqi, Gu Bing
Guangdong Center for Clinical Laboratory, 89346 Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University , Guangzhou, China.
Department of Parasitology, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, China.
Clin Chem Lab Med. 2025 Mar 10;63(8):1573-1581. doi: 10.1515/cclm-2024-1457. Print 2025 Jul 28.
The identification of reliable quality indicators (QIs) in the total testing process (TTP) is a pivotal step in quantifying laboratory service quality. This study comprehensively evaluated the performance quality and explored the factors affecting laboratory quality in Guangdong Province, China, by analyzing the results of QIs.
The Guangdong Clinical Laboratory Center organized an external quality assessment program for QIs, and the Clinet-EQA system was used to distribute questionnaires and collect data. The results of the QIs are expressed as percentages, sigma, or minutes. The optimum, desirable, and minimum quality specifications (QSs) were defined based on the percentiles of the QIs. Furthermore, the QIs were evaluated in different disciplines and hospital grades.
A total of 335 laboratories in Guangdong Province reported complete data from 2020 to 2023, and QI performance progressively improved over the years. The performance of 11 QIs attained the minimum acceptable standard (sigma value ≥3), and most QIs across the diverse disciplines and hospital grades exhibited statistically significant differences. Compared to the QSs published by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety (WG-LEPS), the QSs for the 15 QIs in Guangdong Province in 2023 were stricter or roughly equivalent, except for the percentage of intra-laboratory turnaround time for emergency potassium tests.
From 2020 to 2023, the QIs in the post-analytical phase achieved the best performance. It is essential for laboratories to reinforce the construction of their information infrastructure, thereby guaranteeing the accurate collection of reliable data and enabling effective long-term monitoring.
识别总检测过程（TTP）中可靠的质量指标（QIs）是量化实验室服务质量的关键步骤。本研究通过分析质量指标的结果，全面评估了中国广东省实验室的性能质量，并探讨了影响实验室质量的因素。
广东省临床检验中心组织了质量指标的外部质量评估计划，并使用Clinet-EQA系统分发问卷和收集数据。质量指标的结果以百分比、西格玛或分钟表示。根据质量指标的百分位数定义了最佳、理想和最低质量规范（QSs）。此外，还对不同学科和医院等级的质量指标进行了评估。
广东省共有335家实验室报告了2020年至2023年的完整数据，多年来质量指标的性能逐步提高。11个质量指标的性能达到了最低可接受标准（西格玛值≥3），不同学科和医院等级的大多数质量指标存在统计学显著差异。与国际临床化学和检验医学联合会（IFCC）实验室误差与患者安全工作组（WG-LEPS）发布的质量规范相比，2023年广东省15个质量指标的质量规范除急诊钾检测的实验室内部周转时间百分比外，更为严格或大致相当。
2020年至2023年，分析后阶段的质量指标表现最佳。实验室必须加强其信息基础设施建设，从而确保准确收集可靠数据并实现有效的长期监测。
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