[Biorisk Management for Clinical Diagnostic Laboratories].

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].