Study of external quality assessment programs in clinical microbiology in Japan

在过去的30年里，日本临床实验室对质量保证和全国范围内的外部质量评估（EQA）的兴趣有所增加。EQA项目为提高各个实验室的临床测试质量提供了反馈。参与的实验室应按照其处理病人标本的惯常做法处理调查样本。然而，在临床微生物学的EQA项目中出现了许多问题。道德风险（回答不诚实，调查样本的处理方式改善了评估结果），由于时间和成本限制而依赖志愿者的调查是最初的一些问题。此外，用于评估结果的标准理解得很差，因此审查员和参与者都不清楚评估是如何工作的。全国性的EQA项目只能检测出严重的错误，并使用无效的方法来评估日常表现。我们发现，几乎所有区域公共实验室对区域EQA的承诺都是不够的。主要问题是，地方自治团体的结构调整导致预算减少，人力不足。在实用科学方面，我们一直落后于美国、加拿大和英国等国家。在51街。日本检验医学学会（JSLM）年会、JSLM与日本临床微生物学会（JSLM）联合举办临床微生物学EQA项目研讨会。在此基础上，提出了解决问题和整合全国和地区EQA项目的若干可行策略。

The interest in quality assurance and nationwide external quality assessment(EQA) in clinical laboratories in Japan has increased over the past 30 years. The EQA programs have provided feedback for improving clinical tests quality in individual laboratories. The participating laboratories have been expected to process the survey samples according to their usual practice for patient specimens. However, many problems relating to the EQA programs in clinical microbiology have been raised. Moral hazard (dishonesty in the responses, survey samples being handled in a manner that improves assessment results), surveys depending on volunteers because of time and cost limitations were some of the initial problems. In addition, the criteria used to evaluate the results were poorly understood, so that neither examiners not participants were clear as to how the evaluation worked. The nationwide EQA programs can detect only gross errors and use invalid methods for evaluating routine performances. We found that commitment to regional EQA in almost all of regional public laboratories is insufficient. The main problem is that a restructuring of local governments resulted is lower budgets and so they are short of human resources. We have been lagging behind other countries such as the USA, Canada and the UK in the practical sciences. At the 51st.Annual Meeting of the Japanese Society of Laboratory Medicine(JSLM), a Joint Symposium of JSLM and the Japanese Society of Clinical Microbiology was conducted on EQA programs in clinical microbiology. We proposed several practical strategies for solutions for the problems and integration of nationwide and regional EQA programs.