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十个国家的外部质量评估表现:国际临床化学联合会全球实验室质量项目。

External quality assessment performance in ten countries: an IFCC global laboratory quality project.

机构信息

Rbaisconsulting, Queensland, Australia.

University Paris City, Paris, France.

出版信息

Clin Chem Lab Med. 2024 Sep 2;62(12):2435-2443. doi: 10.1515/cclm-2024-0859. Print 2024 Nov 26.

Abstract

OBJECTIVES

This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas.

METHODS

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly.

RESULTS

The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard.

CONCLUSIONS

All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality.

摘要

目的

本研究旨在评估不同文化和环境背景下的外部质量评估(EQA)实验室结果的有效性,并确定潜在的改进领域。

方法

国际临床化学和实验室医学联合会(IFCC)全球实验室质量工作组(TF-GLQ)开展了一项为期两年的研究(2022 年和 2023 年),其中由一家商业供应商向 IFCC 十个成员国的 100 家实验室提供 EQA 材料、相关软件和在线培训。TF-GLQ 每月对结果进行分析,展示每个国家的提交数量、每个实验室的检测数量、可接受率、随机失败情况,并评估哪些分析物表现不佳。

结果

EQA 材料每季度发放一次。一些国家的海关在及时放行材料方面存在问题,导致实验室无法按时收到材料,从而无法提交。我们在此报告第二年的调查结果。实验室之间的检查数量有所不同,从七个到 84 个分析物不等。在所调查的十个国家中,有六个国家在整个 12 个月的周期内平均有超过 90%的可接受结果,一个国家有两个月的九个月返回结果不可接受,另外四个国家被认为没有达到可接受的标准。

结论

所有 100 家参与实验室均对 EQA 调查及相关服务表示满意,包括现场培训和报告处理。然而,样本接收问题表明,在整个 12 个月的周期内分发材料可能会带来好处。EQA 性能的显著差异表明,四个国家需要长期的援助、培训和指导。为了确保可靠的患者结果,在某些国家推广 EQA 对于达到所需的质量水平至关重要。

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