[Biorisk Management for Clinical Diagnostic Laboratories].

Mika Shigematsu
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Abstract

The mission of the clinical diagnostic laboratory is to continuously provide high-quality diagnostic services. For this purpose, quality management, continuous technical improvement, work place safety assurance, and biosecurity are their objectives. Biorisks arise from handling clinical samples categorized at the highest risk level due to their unknown nature. The "undetermined risk" was not able to risk assess by predetermined risk management approach explained in many existing biosafety references, such as the Biosafety in Microbi- ological and Biomedical Laboratories. By reviewing books, documents, article, and standard guidelines on biorisk management or biosafety, this report provides a comprehensive summary of how biorisk is defined, the existing approach to biorisk assessment, how human factors play roles in biorisk assessment, how vital communication and incident reporting are in biorisk management, and how the biorisk management system support the clinical diagnostic laboratories to fulfil their mission. Given that laboratories are already imple- menting the Quality Management System from the International Standard Organization and starting to report its positive impact on daily activity, it is logical to consider how to integrate the biorisk management system together. A biorisk management system will allow a laboratory to continue business at a high standard not just by preventing laboratory accidents, but proactively reducing near misses and incidents and improving diagnostic process efficiency through risk-assessment-based biosafety and biosecurity. [Review].

临床诊断实验室的生物风险管理。
临床诊断实验室的使命是不断提供高质量的诊断服务。为此,质量管理、持续技术改进、工作场所安全保证和生物安全是他们的目标。生物风险来自于处理因其未知性质而被分类为最高风险级别的临床样本。在许多现有的生物安全文献中,如微生物学和生物医学实验室的生物安全,无法通过预先确定的风险管理方法来评估“未确定风险”。通过回顾有关生物风险管理或生物安全的书籍、文件、文章和标准指南,本报告全面总结了生物风险是如何定义的,现有的生物风险评估方法,人为因素在生物风险评估中如何发挥作用,沟通和事件报告在生物风险管理中的重要性,以及生物风险管理系统如何支持临床诊断实验室履行其使命。鉴于实验室已经在实施国际标准组织的质量管理体系,并开始报告其对日常活动的积极影响,考虑如何将生物风险管理体系整合在一起是合乎逻辑的。生物风险管理系统不仅可以防止实验室事故,还可以通过基于风险评估的生物安全和生物保障主动减少未遂事故和事件,并提高诊断过程效率,从而使实验室能够以高标准继续开展业务。(审查)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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