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性室间质量评估（EQA）的兴趣有所增加。室间质量保证计划为提高各个实验室的临床试验质量提供了反馈。参与的实验室应按照其处理病人样本的惯常做法处理调查样本。然而，在临床微生物学的室间质评中，仍存在许多问题。道德风险（答复中的不诚实，调查样本的处理方式会改善评估结果），由于时间和成本的限制，调查依赖于志愿者，这些都是最初的问题。此外，人们对评估结果所用的标准知之甚少，因此，无论是审查员还是参与者都不清楚评估是如何进行的。全国性的EQA程序只能检测到粗差，并使用无效的方法来评估常规性能。我们发现，在几乎所有的区域公共实验室的区域EQA的承诺是不够的。主要问题是地方政府的重组导致预算减少，因此缺乏人力资源。在实用科学方面，我们一直落后于美国、加拿大和英国等其他国家。在第51届日本实验医学会（JSLM）年会上，JSLM和日本临床微生物学学会就临床微生物学的EQA计划举行了联合研讨会。我们提出了一些实用的策略，为解决问题和整合全国和区域的环境质量评价计划。

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.