台灣醫院醫療不良事件根本原因分析現況與相關因素探討

Status of root cause analysis in medical adverse events and related factors among hospitals in Taiwan

10.6288/TJPH.202110_40(5).110052

洪聖惠(Sheng-Hui Hung)；鍾國彪(Kuo-Piao Chung)；王拔群(Pa-Chun Wang)

根本原因分析 ； 醫療不良事件 ； 人為因素 ； 病人安全 ； root cause analysis ； medical adverse event ； human factor ； patient safety

台灣公共衛生雜誌

40卷5期（2021 / 10 / 29）

508 - 524

繁體中文

目標：本研究欲瞭解台灣醫院內部進行醫療不良事件根因調查分析之現況，進一步探討調查員個人經驗與醫院特性等對調查時人為因素掌握之相關性。方法：採橫斷性調查，以自擬問卷匿名普查全國負責醫療不良事件通報窗口及根因分析調查員，以雙變量分析探討醫院對於醫療不良事件之根因調查分析現況及影響因素間之相關性。結果：共調查122家醫院、590名調查員，平均回收率91.6%。醫院97.5%設有專責單位，89.3%採自主通報。91%設有根因分析小組。調查員18.6%未接受過訓練，35.8%自覺訓練不足，49.1%僅一半甚至更少的信心以現行調查工具能有效掌握根因，94.2%表示調查有障礙，前三位為「事後回溯困難，記憶偏差」、「受訪人員排斥」及「調查員經驗不足」。調查員之個人經驗，不論專業背景、調查年資、件數、是否接受調查訓練及時數、自覺訓練是否足夠等皆會顯著影響調查時對人為因素掌握度。結論：台灣醫院內部通報制度普遍已建立，調查員個人經驗為影響調查結果的重要因素，應更加重視與培訓。

Objectives: This study explored the status of root cause analysis (RCA) of adverse events in Taiwan's hospitals. This study also examined the associations between investigator's personal experience, hospital characteristics with human factors consideration when conducting RCA. Methods: This study adopted a large-scale cross-sectional survey featuring a self-developed questionnaire to investigate the status of the RCA of adverse events and RCA investigators in Taiwanese hospitals. Participants were recruited from institutions responsible for medical adverse event and root cause investigation. Bivariate analysis was applied to analyze the RCA for adverse events and its associated factors. Results: A total of 122 units for hospital patient safety and 590 RCA investigators were surveyed. The questionnaire response rate was 91.6%. Of the hospitals from which participants were recruited, 97.5% had dedicated units to handle reports, 89.3% adopted voluntary reporting system, and 91% established RCA teams. Of the investigators surveyed, 18.6% had not been trained in RCA and 35.8% of the trained investigators still felt insufficiently equipped to engage in RCA. Furthermore, 49.1% of the investigators reported having less confidence to obtain root causes by current investigation tools, and 94.2% of the investigators noted obstacles in adverse event analysis and investigation. The experience of the RCA investigators, including years of participation in the analysis, the number of analysis participated in, whether they received RCA training, total hours of RCA training, and the adequacy of conscious training affected investigators' consideration of human factors when investigating adverse events. Conclusions: The internal reporting system in Taiwan's hospitals is well established, and the personal experience of investigators is a key factor affecting the results of RCA investigations. RCA investigators should, therefore, receive attention and high-quality training.

1. Benn, J,Koutantji, M,Wallace, L(2009).Feedback from incident reporting: information and action to improve patient safety.Qual Saf Health Care,18,11-21.
2. Bowie, P,Skinner, J,Wet, C(2013).Training health care professionals in root cause analysis: a crosssectional study of post-training experience, benefits and attitudes.BMC Health Serv Res,13,50.
3. Diller, T,Helmrich, G,Dunning, S,Cox, S,Buchanan, A,Shappell, S(2014).The Human Factors Analysis Classification System (HFACS) applied to health care.Am J Med Qual,29,181-190.
4. Farley, DO,Haviland, A,Champagne, S(2008).Adverseevent-reporting practices by US hospitals: results of a national survey.Qual Saf Health Care,17,416-423.
5. Gurses, AP,Ozok, AA,Pronovost, PJ(2012).Time to accelerate integration of human factors and ergonomics in patient safety.BMJ Qual Saf,21,347-351.
6. Hanskamp-Sebregts, M,Zegers, M,Vincent, C,van Gurp, PJ,de Vet, HCW,Wollersheim, H(2016).Measurement of patient safety: a systemic review of the reliability and validity of adverse event detection with record review.BMJ Open,6,e011078.
7. Human Factors Analysis Classification System. Human factors definition. Available at: https://www.hfacs.com/. Accessed April 1, 2018.
8. Hutchinson, A,Young, TA,Cooper, KL(2009).Trends in healthcare incident reporting and relationship to safety and quality data in acute hospitals: results from the National Reporting and Learning System.Qual Saf Health Care,18,5-10.
9. Kellogg, KM,Hettinger, Z,Shah, M(2017).Our current approach to root cause analysis: is it contributing to our failure to improve patient safety?.BMJ Qual Saf,26,381-387.
10. Khorsandi, M,Skouras, C,Beatson, K,Alijani, A(2012).Quality review of an adverse incident reporting system and root cause analysis of serious adverse surgical incidents in a teaching hospital of Scotland.Patient Saf Surg,6,21.
11. Kim, J,Kim, S,Jung, Y,Kim, EK(2010).Status and problems of adverse event reporting systems in Korean hospitals.Healthc Inform Res,16,166-176.
12. Kohn, LT(ed.),Corrigan, JM(ed.),Donaldson, MS(ed.),Institute of Medicine (US) Committee on Quality of Health Care in America(ed.)(2000).To Err Is Human: Building a Safer Health System.Washington DC:National Academies Press (US).
13. Mire, JJ,Lorenzo, S,Carrillo, I(2017).Lessons learned for reducing the negative impact of adverse events on patients, health professionals and healthcare organizations.Int J Qual Health Care,29,450-460.
14. Mitchell, RJ,Williamson, AM,Molesworth, B,Chung, AZO(2014).A review of the use of human factors classification frameworks that identify causal factors for adverse events in the hospital setting.Ergonomics,57,1443-1472.
15. Peerally, MF,Carr, S,Waring, J,Dixon-Woods, M(2017).The problem with root cause analysis.BMJ Qual Saf,26,417-422.
16. Rabøl, LI,Andersen, ML,Østergaard, D,Bjørn, B,Lilja, B,Mogensen, T(2011).Descriptions of verbal communication errors between staff. An analysis of 84 root cause analysis-reports from Danish hospitals.BMJ Qual Saf,20,268-274.
17. Reason, J(1995).Understanding adverse events: human factors.Qual Health Care,4,80-89.
18. Taylor-Adams, S,Vincent, C(2004).Systems analysis of clinical incidents: the London protocol.Clin Risk,10,211-220.
19. Wang, CH,Shin, CL,Chen, WJ(2016).Epidemiology of medical adverse events: perspectives from a single institute in Taiwan.J Formos Med Assoc,115,434-439.
20. Wiegmann DA, Shappell SA. Human Factors Analysis and Classification System, HFACS in Healthcare. RCA 2.0 Handbook, 2016. Available at: https://www.hfacs.com/hfacs-framwork.html. Accessed May 26, 2021.
21. 石崇良, CL,侯勝茂, SM,薛亞聖, YS,鍾國彪, KP,蘇喜, S,廖熏香, HH(2005)。異常事件通報系統與通報障礙。台灣醫學，9，63-70。
22. 洪蘭（譯）, DL(Trans.)(2020).快思慢想.台北=Taipei:天下文化=Commonwealth Publishing.
23. 財團法人醫療品質暨醫院評鑑策進會=Joint Commission of Taiwan(2006).根本原因分析法教師版手冊.台北=Taipei:行政院衛生署=Department of Health, Executive Yuan, R.O.C. (Taiwan).
24. 財團法人醫療品質暨醫院評鑑策進會：台灣病人安全通報系統2019年年報。https://www.patientsafety.mohw.gov.tw/Content/Downloads/List01.aspx?SiteID=1&MmmID=621273303702500244。引用2020/10/15。 Joint Commission of Taiwan. 2019 Annual report on the Taiwan patient-safety reporting system, 2019. Available at: https://www.patientsafety.mohw.gov.tw/Content/Downloads/List01.aspx?SiteID=1&MmmID=621273303702500244. Accessed October 15, 2020. [In Chinese]
25. 衛生福利部：109-110年度【醫院版】醫療品質及病人安全工作目標。https://www.mmh.org.tw/QAPS/goal109.pdf。引用2021/07/21。 Ministry of Health and Welfare, R.O.C. (Taiwan). 2020-2011 medical quality and patient safety work targets (hospital version). Available at: https://www.mmh.org.tw/QAPS/goal109.pdf. Accessed July 21. [In Chinese]

1. 蘇慧真,莊樹義(2023)。某醫院中藥局導入飲片藥材異常大量耗用監控機制成效分析。北台灣中醫醫學雜誌，15(1)，25-32。