生物風險管理CWA 15793之導入：以臨床病理科實驗室為例

Introducing Biorisk Management CWA 15793 in a Clinical Pathology Laboratory

本研究是以新北市F醫學中心臨床病理科為例，探討其負壓（高防護）實驗室導入CWA 15793的過程。採個案研究法，為Yin（1994）所定義的「型I-整體性&單一個案設計」。此生物風險管理須訂定系列的標準作業程序 （Standard Operating Procedures; SOPs，以下簡稱：SOPs）包括目的、範圍、權責、定義、內容等。由F中心生物風險管理SOPs之「內容」可知：其政策與目標明訂於「臨床病理科品質手冊」中，其他如「組織管理、風險管理、內部稽核、人員訓練及考核、保密、門禁卡管理、設施環境、員工健康管理、不符合事件處理、檢體允收品管、設備儀器維護管制、環境安全衛生管理系統變更管制、緊急應變、採購驗收、文件管制、諮詢服務、管理審查、檢驗結果品保」等各項SOP均已訂定。2016年F中心臨床病理科成功導入「CWA 15793實驗室生物風險管理系統」並取得認證，且於2016.12.09獲頒楷模獎。本個案研究結果，可成為國內欲取得CWA 15793認證之生物實驗室的重要參考。 This study investigated the process of implementing Biorisk Management CWA 15793 in a clinical pathology laboratory under negative pressure (high-level safety protection), at the F Medical Center in New Taipei City. The research method was case study of “Type I - Holistic & Single Case Design,” as defined by Yin (1994). CWA 15793 requires the formulation of a set of standard operating procedures (SOPs), including objectives, scope, rights and responsibilities, definitions, content, etc. According to the “content” of the Biorisk Management SOPs of the F Medical Center, the policies and objectives had been stated in the Quality Handbook of Clinical Pathology. Other SOPs had all been formulated with regard to organization management, risk management, internal auditing, personnel training & evaluation, confidentiality, access card management, environment & facilities, personnel health management, noncompliance incident management, quality control of sample acceptance, equipment & instrument maintenance and control, alteration control of environment safety & healthy management system, emergency response, purchasing & acceptance, document control, consultation service, management review, quality assurance of inspection results, etc. The successful introduction of Laboratory Biorisk Management CWA 15793 resulted in the Clinical Pathology Department of F Medical Center achieving the CWA 15793 certification in 2016 and the Model Award on December 9 of the same year. This case study provides important references for domestic biological laboratories that want to obtain the CWA 15793 certification.

This study investigated the process of implementing Biorisk Management CWA 15793 in a clinical pathology laboratory under negative pressure (high-level safety protection), at the F Medical Center in New Taipei City. The research method was case study of “Type I - Holistic & Single Case Design,” as defined by Yin (1994). CWA 15793 requires the formulation of a set of standard operating procedures (SOPs), including objectives, scope, rights and responsibilities, definitions, content, etc. According to the “content” of the Biorisk Management SOPs of the F Medical Center, the policies and objectives had been stated in the Quality Handbook of Clinical Pathology. Other SOPs had all been formulated with regard to organization management, risk management, internal auditing, personnel training & evaluation, confidentiality, access card management, environment & facilities, personnel health management, noncompliance incident management, quality control of sample acceptance, equipment & instrument maintenance and control, alteration control of environment safety & healthy management system, emergency response, purchasing & acceptance, document control, consultation service, management review, quality assurance of inspection results, etc. The successful introduction of Laboratory Biorisk Management CWA 15793 resulted in the Clinical Pathology Department of F Medical Center achieving the CWA 15793 certification in 2016 and the Model Award on December 9 of the same year. This case study provides important references for domestic biological laboratories that want to obtain the CWA 15793 certification.