生物保全管理系統（BSL-3）之建置：以臨床病理科實驗室為例

Implementation of Biosecurity Management System (Biosafety Level 3): A Case Study of Clinical Pathology Laboratory

柯亞先(Ya-Hsien Ko) ； 洪文進(Wen-Jin Huang) ； 張家菱(Chia-Ling Chang) ； 湯惠斐(Hui-Fei Tang)

《元培學報》 25期 (2020/12) Pp. 1-15

摘要

本研究是以新北市F醫學中心臨床病理科為例，探討生物保全管理系統之建置。採個案研究法，為Yin（1994）所定義的「型I－整體性的單一個案設計」。自2006年起該臨床病理科實驗室已為ISO-15189所認可，2016年又成功導入「CWA-15793實驗室生物風險管理系統」並獲頒楷模獎。在通過「ISO-15189」與「CWA-15793」之認證基礎上，以生物安全第三級（biosafety level 3; BSL-3）實驗室為目標來建置生物保全管理系統，包括規範、行政與實務三方面。研究結果顯示：在規範面必須納入生物保全攸關之標準作業程序，在行政面必須完善生物保全之組織與權責，在實務面則必須進行生物保全之演習。F醫學中心在上述三面向完成後，已符合疾病管制署於2013年訂定的「實驗室生物保全管理規範」，並符合「全球衛生安全綱領」（Global Health Security Agenda; GHSA）的精神，繼續成為業界的標竿。除此之外，目前全世界正面臨新型冠狀病毒的衝擊，本研究可對檢體保存提供依循，且對臨床單位的傳染防護具有實質幫助。

關鍵字

生物保全管理系統 ； 生物安全第三級（BSL-3） ； 實驗室生物保全管理規範 ； 全球衛生安全綱領

並列摘要

This study investigated the planning and implementation of a Biosecurity Management System for a clinical pathology laboratory at F Medical Center in New Taipei City. The case study method of ＂Type I - Holistic & Single Case Design,＂ as defined by Yin (1994) is applied as our research approach. The Clinical Pathology Department of F Medical Center, ISO-15189 certified in 2006, was selected as the subject. This laboratory further implemented the CWA 15793 guideline in 2016 and received a Model Award on December 9, 2016. Based on achieving ISO-15189 and CWA-15793 certification, the Clinical Pathology Laboratory of F Medical Center set up a goal to implement a Biosecurity Management System of Biosafety Level 3 (BSL-3), which including the following three phases: guidelines, administration, and execution. Study results indicated that guidelines should include biosecurity management system standards and operating procedures; administration section should include a thorough list of biosecurity organizational structures, roles and responsibilities; execution plan should include running drills regularly for simulated catastrophes. After F Medical Center finished the above three phases, it conforms to the Regulations Governing the Laboratory Biosecurity issued by Taiwan Centers for Disease Control in 2013, also conforms to the spirit of Global Health Security Agenda (GHSA) guidelines, and continues to be the benchmark in healthcare industry. In addition, the world now is facing the impact of COVID-19, this paper can provide a basis for the preservation of specimens, and has a substantial help for the infection prevention of clinical pathology laboratory.

並列關鍵字

Biosecurity Management System ； Biosafety Level 3 (BSL-3) ； Regulations Governing the Laboratory Biosecurity ； Global Health Security Agenda (GHSA)