國內生醫實驗室之安全衛生管理現況探討

A Study of Occupational Safety and Health Management of Biomedical Laboratories in Taiwan

李瑞真(Jui-Chen Lee)

指導教授 ： 洪慶宜

長榮大學/健康科學學院/職業安全與衛生研究所/碩士(2009年)

https://doi.org/10.6833/CJCU.2009.00039

摘要

本研究之目的在探討國內生醫實驗室對「感染性生物材料管理及傳染病病人檢體採檢辦法」的遵循情形，並藉以暸解目前國內各生醫實驗室之管理現況，且尋求改善方式，以強化生醫實驗室的安全衛生管理工作。本研究針對生物安全等級2級以上實驗室，以量化問卷調查全國之政府所屬檢驗單位、學校研究機構、醫療院所、民間代檢單位及產業研發團隊的檢驗生醫實驗室，並以質化的「生醫實驗室工作人員訪談」輔助資料收集，作為本論文分析之依據。
問卷調查結果發現：(1)國內生醫實驗室對配合調查的意願偏低(問卷回覆率僅9%)；(2)生物安全委員會僅半數是依照「感染性生物材料管理及傳染病病人檢體採檢辦法」規定運作(達51%)，且部分實驗室之安全衛生未依照危害風險程度進行管理(達21%)；(3)對於勞工安全衛生組織管理及自動檢查辦法中的生物安全管理規定，符合比例沒有因實驗室生物安全等級愈高有愈佳之趨勢(Kruskal-Wallis ANOVA顯示6項均為P＞0.05)；(4)在管理項目中的「病原體操作人員血清保存」及「緊急應變計劃的建立」符合程度最低（兩者均僅38%）；設置單位屬性對該法規的符合比例亦沒有顯著影響(Kruskal-Wallis ANOVA顯示6項均為P＞0.05)。生醫實驗室工作人員訪談顯示：(1)個人工作職務上普遍與病原體的接觸機會高，且有操作危害群3級的病原體的可能；(2)個人工作場所的危害自覺，通常以實驗室的生物性危害暴露最為擔憂，危害源主要為檢體中感染性生物的暴露，其原因為實驗室的非獨立性空調設計、檢體外漏傾倒與針扎；(3)受訪實驗室工作人員以生物安全委員會是否運作認知不一，認為生物安全委員會有正常運作的實驗室主管認為，委員會的執行偏重病原體的監控，對於生物性意外應變處理訓練是不足的；(4)實驗室人員對於實驗室安全衛生相關法令規定之熟悉程度不足；(5)普遍認為「感染性生物材料管理與傳染病病人檢體採檢辦法」的頒布與實施，對於實驗室安全衛生的改善有幫助；該辦法規定之「病原體操作人員血清檢體保存」項目不易達成原因，主要與實驗室當初設置的成本考量在空間與實驗室設備有很大的關係；(6)「緊急應變計畫建立」該項則因執行規範尚未明訂，導致執行困難度高且難以取得設置單位的支持；(7)自護制度的推動有助於國內生醫實驗室落實安全衛生之工作，且目前實驗室有足夠的能力去執行。
國內各生醫實驗室對安全衛生管理的重視程度普遍不高，尤其是生物安全管理方面明顯不足。政府應依據實驗室功能與性質，針對該辦法規定項目中不易達成的原因進行整合與調整，特別是針對「病原體操作人員血清檢體保存」與「緊急應變計畫建立」這兩個部分。另為了改善與推動生醫實驗室的安全衛生管理工作，建議可以參考工廠以自護制度來進行管理，以有效達到避免實驗室感染發生事件的發生。

關鍵字

生物性危害 ； 安全衛生管理 ； 生醫實驗室

並列摘要

The study aimed to investigate how a CDC bio-safety regulation, ‘Regulations Governing Management of Infectious Biological Materials and Collection of Specimens from Patients of Communicable Diseases’, was complied and how the occupational safety and health was managed in the biomedical laboratories in Taiwan. The performance of bio-safety management in the laboratories classifying as Biosafety Level 2 and above was investigated by both quantitative questionnaire survey and qualitative interview. Improvement measures were then suggested.
The results of quantitative questionnaire survey on five different types of laboratories (government-own testing lab, academic research lab, hospital testing lab, private-own testing lab, and industrial R&D lab) suggested: (1) most of the laboratories resisted to reveal their management routine (indicated by the 9% response rate); (2) only 51% of the respondents implemented Biosafety Committee according to the regulation and only 21% managed their occupational safety and health issues with risk-based priority; (3) the degree of compliance with the biosafety regulations in ‘Labor Safety and Health Act’ was neither significantly different among different biosafey levels of biomedical laboratories (P>0.05 by Kruskal-Wallis ANOVA), nor among different laboratory types (P>0.05 by Kruskal-Wallis ANOVA); (4) the poorest compliance items were ‘long-term preservation of workers’ yearly serum samples’ as well as ‘the establishment of emergency response plan’ (both only 38% of respondents complied).
The results of qualitative interview of the workers in biomedical laboratories indicated: (1) the workers’ daily routine was highly associated with pathogens, including Risk Group 3 ones; (2) the concern about ‘potential infections, resulting from specimen spill and needle-stick injury in a central air conditioning environment’was the most intense among all types of hazards; (3) there was disagreement between laboratory manager and technician toward the operation of Biosafey Committee. Laboratory managers stated that the committee is routinely operated, but the focal issues of the committee was on the pathogen inventory, instead of the regular training and preparedness for emergency response of bioincident; (4) laboratory workers were unfamiliar with the occupational safety and health regulations; (5) workers generally agreed that the ‘Regulations Governing Management of Infectious Biological Materials and Collection of Specimens from Patients of Communicable Diseases’ can have a positive impact on occupational safety and health; (6) the space limitation, cost consideration, and insufficient facility resulted in a poor compliance with the regulation of ‘long-term preservation of workers’ yearly serum samples’, while lack of general guideline in regulatory level was the reason that the laboratories were unenthusiastic to establish their emergency response plan; (7) volunteer protection program was readily adopt by the biomedical laboratories.
The importance of occupational safety and health, especially biohazard, in
biomedical laboratory was generally negligent by the installation units in Taiwan. Government shall consider set up different levels of management guideline according to different types of laboratories, especially serum preservation and emergency plan. In order to improve the occupational safety and health management, volunteer protection program, which has been widely adopted by factories, is suggested to implement in the biomedical laboratories.

並列關鍵字

biohazard ； occupation safety and health management ； biomedical laboratory

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