台灣地區某醫學中心BSL-3實驗室整修期間的緊急應變措施與風險評估之經驗分享

Experience Sharing of Emergency Response Measures and Risk Assessment During the Refurbishment of BSL-3 Laboratory in A Medical Center in Taiwan

鄭雁方(Yen-Fang Cheng) ； 程雲詳(Yun-Hsiang Cheng) ； 于靜梅(Ching-Mei Yu) ； 張錦標(Jin-Biou Chang)

《中華職業醫學雜誌》 25卷3期 (2018/07) Pp. 211-218

摘要

背景：BSL-3實驗室適用於處理第三級危險群微生物及大量或高濃度、具有高度氣膠擴散危險之第二級危險群微生物之工作。在台灣地區的醫療院所大多用於結核菌檢驗，是24小時運轉之高生物風險的實驗室。CDC「105年度高防護實驗室生物安全查核」，本院BSL-3因進排氣風管系統有部分為軟管建置，現場查核認為有破損之風險，建議更換為不銹鋼硬管，以提升BSL-3實驗室安全之保證。因BSL-3整修期間無法執行臨床結核菌檢驗作業，影響病人安全及醫療品質。本文主要探討BSL-3實驗室無法作業之緊急應變措施及風險評估，提供國內其他BSL-3實驗室之參考。事件分析：因BSL-3整修期約2個月，實驗室無法執行檢驗作業。以RCA手法，進行事件原因分析包括：無備用的BSL-3實驗室、本科每月檢體量約1400-1500件，委外代檢實驗室因空間與人力因素無法代檢、CDC未整合國內合約與認可實驗室，無相互支援的可行性等因素。為了病人安全及醫療品質，本科的緊急應變措施如下：停止檢驗、委外代檢、保存檢體至工程完成後自行檢驗、異地檢驗、行動式實驗室檢驗等。異地檢驗為此事件緊急應變的處理方式。風險評估：異地檢驗之風險評估為：檢體運送過程之生物保全與人員安全的風險；人員對於異地檢驗的環境與設備熟悉度的風險；報告之正確性和及時性的風險。結論：BSL-3為24小時運轉之高生物風險的實驗室。依CWA-15793之要求：需定期保養或故障檢修，必須停止檢驗作業。又因國內其他BSL-3實驗室，空間、設備、人力等因素無法代檢，因此建議中央主管機關：制定BSL-3停止作業的緊急應變計畫、建立國內BSL-3實驗室相互支援網、建議設置國內BSL-3實驗室代檢中心，以提升檢驗品質及病人安全。

關鍵字

BSL-3 ； 緊急應變 ； CWA-15793 ； RCA手法 ； 風險評估

並列摘要

Background: The BSL-3 laboratory is suitable for the processing of the third risk group microorganisms and the second risk group ones with high concentration or high risk of aerosol manipulation. It is used for the culture of Mycobacterium tuberculosis operating 24 hours a day for most hospitals in Taiwan. In the inspection of Annual High Protection Laboratory Biosafety Check by Taiwan CDC, some of the BSL-3's intake and exhaust air duct systems were built by soft hoses which might have a risk of damage considered by the inspectors. It is recommended that the soft hoses are replaced with stainless steel rigid tubes to enhance the safety of the BSL-3 laboratory. Due to the inability to perform the clinical M. tuberculosis cultures during the refurbishment of BSL-3, and the patient's safety and medical quality were affected. This article mainly discusses emergency responses and risk assessments when BSL-3 laboratory was not workable and shared our experiences to the other domestic BSL-3 laboratories. Case Analysis: Due to the BSL-3 refurbishment period of approximately 2 months, the laboratory was unable to perform M. tuberculosis cultures. Using RCA method to analyze the causes of this incident which includes: (1) There are no backup BSL-3 laboratories. (2) The monthly sample volume is approximately 1,400-1,500. (3) The outsourced laboratories cannot be supported due to space and labor issues. (4)The Taiwan CDC does not integrate domestic accredited BSL-3 laboratories and there are no mutual supporting strategies. For the patient safety and medical quality, the emergency responses are as follows: Stop inspections, referral inspections, preservation of specimens and self-testing until the completion of the repair project, off-site inspections, and mobile laboratory tests. Finally, the off-site inspections were chosen for emergency response of this incident. Risk assessment: The risk assessments for off-site inspections are: (1) risks of biological preservation and personnel safety in the process of transport of samples; (2) risks of personnel familiarity with the environment and equipment for remote inspections; (3) risks of correctness and timeliness of reports. Conclusion: The BSL-3 is a high biological risk laboratory that operates 24 hours every day. According to the requirements of CWA-15793, routine operations must be stopped when regular maintenance or troubleshooting is performed. Because other domestic BSL-3 laboratories cannot be referral duo to space, equipment, manpower reasons, we suggested that the Central Competent Authority is advised to establish an emergency response plan for stopping BSL-3 operations and establish a domestic BSL-3 laboratory mutual support network. It is recommended to set up a domestic BSL-3 Laboratory Inspection Center to improve medical quality and patient safety.

並列關鍵字

BSL-3 ； Emergency response ； CWA-15793 ； RCA method ； Risk Assessment