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克罗地亚的外部质量评估:问题、挑战及特殊情况。

External Quality Assessment in Croatia: problems, challenges, and specific circumstances.

作者信息

Krleza Jasna Lenicek, Celap Ivana, Tanaskovic Jelena Vlasic

机构信息

Croatian Centre for Quality Assessment in Laboratory Medicine, Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia; Department of Laboratory Diagnostics, Children's Hospital Zagreb, Zagreb, Croatia.

Croatian Centre for Quality Assessment in Laboratory Medicine, Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia; Clinical Institute of Chemistry, University Hospital Centre Sestre milosrdnice, Zagreb, Croatia.

出版信息

Biochem Med (Zagreb). 2017 Feb 15;27(1):86-92. doi: 10.11613/BM.2017.011.

Abstract

In Croatian medical laboratories (ML), external quality assessment (EQA) has a long tradition of almost half of a century. At national level, EQA is provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) which is a part of Croatian Society of Medical Biochemistry and Laboratory Medicine.
This case study aimed to summarize the main challenges, which are set to CROQALM and their possible solutions.
CROQALM has 10 schemes, covering majority of analysis for which medical biochemistry laboratories in Croatia are authorized for, including pre-analytical and post-analytical phase of laboratory work. Assessment scheme has three exercises year. One sample scheme and exercise is distributed to participants depending on their application. All data transfer and evaluation of the results are done using web interface and statistical software for evaluation of quality in laboratory medicine.
Since CROQALM has relatively small number of participating laboratories (N = 197) with lot of different manufacturers of instruments used for analysis in all schemes, constant challenges are present in the evaluation of the results (commutability problems, statistical analysis ). Further, number of participating medical laboratories is even lower for highly specific parameters, which are in the scope of clinical laboratories only.
Despite the obstacles we are faced to, EQA at national level is useful tool regarding standardization and harmonization aspects in total testing process within the country. Furthermore, it gives participating laboratories recognition and proof for meeting expected quality criteria in the community they serve.

摘要

在克罗地亚的医学实验室(ML)中,外部质量评估(EQA)有着近半个世纪的悠久传统。在国家层面,EQA由克罗地亚医学检验质量评估中心(CROQALM)提供,该中心是克罗地亚医学生物化学与检验医学学会的一部分。

本案例研究旨在总结CROQALM面临的主要挑战及其可能的解决方案。

CROQALM有10个方案,涵盖了克罗地亚医学生物化学实验室被授权进行的大部分分析项目,包括实验室工作的分析前和分析后阶段。评估方案每年有三次练习。根据参与者的申请,向他们分发一个样本方案和练习。所有数据传输和结果评估均通过网络界面和用于评估检验医学质量的统计软件进行。

由于CROQALM参与的实验室数量相对较少(N = 197),且在所有方案中使用了许多不同制造商的分析仪器,因此在结果评估中(互换性问题、统计分析)一直存在挑战。此外,对于仅在临床实验室范围内的高度特定参数,参与的医学实验室数量甚至更低。

尽管我们面临诸多障碍,但国家层面的EQA在该国整个检测过程的标准化和协调方面是一个有用的工具。此外,它为参与的实验室提供了认可,并证明它们在其服务的社区中达到了预期的质量标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63f0/5382851/f548b9d99d7d/bm-27-86-f1.jpg

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