医疗失效模式与效应分析在慢性病管理中应用可行性分析
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摘要
医疗失效模式与效应分析(healthcare failure mode and effect analysis,HFMEA)是在失效模式与效应分析(failure mode and effects analysis,FMEA)基础上,整合了危害分析与关键控制点(hazard analysis and critical point,HACCP)及根本原因分析法(root cause analysis,RCA)等理论,形成的一种基于团队、系统和前瞻性的可靠性分析方法,通过对医疗服务系统中潜在失效问题的严重程度、发生率等进行评估,辨别存在的安全风险,预先建立预防措施,设计或优化医疗服务流程,以预防不良事件的发生。HFMEA在慢性病管理中应用的可行性,为我国社区慢性病管理质量持续提升提供新的思路。采用文献分析法归纳HFMEA的起源、概念及内涵特征,详细分析HFMEA的实施方法和步骤以及新的发展趋势,并聚焦当前我国社区慢性病管理热点问题,阐明应用HFMEA理论进行慢性病管理的具体可行性。HFMEA是国际先进的前瞻性医疗质量管理方法,在我国社区慢性病管理领域应用具有极其必要性和可行性,有利于将"事后纠正"的规范化管理模式转变为"事前预防"的风险控制机制,从而提高慢性病管理水平。
Health care failure mode and effect analysis(HFMEA)is based on failure mode and effect analysis(FMEA),which integrates hazard analysis and critical point(HACCP)and root cause analysis(RCA).A team-based,systematic and prospective reliability analysis method is proposed to identify the safety risks by assessing the severity and incidence of potential failures in the medical service system,to establish preventive measures in advance,and to design or optimize the medical service process in order to prevent the occurrence of adverse events.The feasibility of applying HFMEA in chronic disease management provides a new way to improve the quality of community chronic disease management in China.This paper sums up the origin,concept and connotation of HFMEA by literature analysis,and analyses the implementation methods and steps of HFMEA and its new development trend in detail,focusing on the current hot issues of community chronic disease management in China,we clarify the specific feasibility of applying HFMEA theory to chronic disease management.HFMEA is an advanced and forward-looking medical quality management method in the world.It is extremely necessary and feasible to apply HFMEA in the field of community chronic disease management in China.It is conducive to transforming the standardized management mode of"post-correction"into the risk control mechanism of"pre-prevention",so as to improve the level of chronic disease management.
Health care failure mode and effect analysis(HFMEA)is based on failure mode and effect analysis(FMEA),which integrates hazard analysis and critical point(HACCP)and root cause analysis(RCA).A team-based,systematic and prospective reliability analysis method is proposed to identify the safety risks by assessing the severity and incidence of potential failures in the medical service system,to establish preventive measures in advance,and to design or optimize the medical service process in order to prevent the occurrence of adverse events.The feasibility of applying HFMEA in chronic disease management provides a new way to improve the quality of community chronic disease management in China.This paper sums up the origin,concept and connotation of HFMEA by literature analysis,and analyses the implementation methods and steps of HFMEA and its new development trend in detail,focusing on the current hot issues of community chronic disease management in China,we clarify the specific feasibility of applying HFMEA theory to chronic disease management.HFMEA is an advanced and forward-looking medical quality management method in the world.It is extremely necessary and feasible to apply HFMEA in the field of community chronic disease management in China.It is conducive to transforming the standardized management mode of"post-correction"into the risk control mechanism of"pre-prevention",so as to improve the level of chronic disease management.
引文
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[8]Latino RJ.Optimizing FMEA and RCA efforts in health care[J].J Healthc Risk Manag,2004,24(3):21-28.
[9]Reason J.Education and debate:Human error:Models and management[J].BMJ,2000,320(7237):768-770.
[10]孙慧.基于FMEA理论结直肠术后手术部位感染的风险管理模式初探与临床应用研究[D].南京:东南大学,2017.
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[12]Chadwick L,Fallon EF.Evaluation and critique of healthcare failure mode and effect analysis applied in a radiotherapy case study[J].Hum Factors Ergon Manuf,2013,23(2):116-127.
[13]Habraken MM,Van der Schaaf TW,Leistikow IP.Prospective risk analysis of health care processes:A systematic evaluation of the use of HFMEA in Dutch health care[J].Ergonomics,2009,52(7):809-819.
[14]Faiella G,Parand A,Franklin BD,et al.Expanding healthcare failure mode and effect analysis:A composite proactive risk analysis approach[J].Reliab Eng Syst Saf,2018,169.
[15]Ghasemi M,Khoshakhlagh AH,Mahmudi S.Identification and assessment of medical errors in the triage area of an educational hospital using the SHERPA technique in Iran[J].Int J Occup Saf Ergon,2015,21(3):382-390.
[16]Lyons M,Adams S,Woloshynowych M,et al.Human reliability analysis in healthcare:A review of techniques[J].Int J Risk Saf Med,2004,16(4):223-237.
[17]Leveson N.A new accident model for engineering safer systems[J].Safety Science,2004,42(4):237-270.
[18]Fleming CH,Leveson NG.Improving hazard analysis and certification of integrated modular avionics[J].J Aerosp Inform Syst,2014,11(6):397-411.
[19]Torbjrn Bjerga,Aven T,Zio E.Uncertainty treatment in risk analysis of complex systems:The cases of STAMP and FRAM[J].Reliab Eng Syst Saf,2016,156:203-209.
[20]Stanton NA.Hierarchical task analysis:Developments,applications,and extensions[J].Appl Ergon,2006,37(1):55-79.
[21]Stanton NA,Salmon PM,Walker GH,et al.Human factors methods:A practical guide for engineering and design[M].Second·Lyndon:Ashgate Publishing Limited,2013.
[22]张银华,陈燕,晋溶辰,等.我国社区慢性病管理模式及其评价[J].全科护理,2015,13(24):2351-2354.
[23]《国家基层高血压防治管理指南(2017版)》高血压治疗原则[J].实用心脑肺血管病杂志,2018,26(4):85.
[24]苟雪英.社区门诊高血压患者不合理用药情况调查分析[J].中国卫生产业,2017,14(11):178-180.
[25]中国高血压基层管理指南(2014年修订版)[J].中华高血压杂志,2015,23(1):24-43,15.
[26]吴秋兰,曾广民,王谏珠,等.社区高血压的转诊现状及分析[J].中国医药指南,2012,10(33):686-687.
[27]黄雪玲.高血压患者自我管理现状调查与经验探讨[J].医药前沿,2015,5(9):368-369.
[28]吴声应,夏腊梅,冯惠颜.原发性高血压患者日常自我管理现状调查分析[J].中国现代药物应用,2014,8(6):221-222.
[2]DeRosier J,Stalhandske E,Bagian JP.Using health care failure mode and effect analysis:The VA national center for patient safety’s prospective risk analysis system[J].Jt Comm J Qual Improv,2002,28(5):248-267,209.
[3]Duwe B,Fuchs BD.Failure mode and effects analysis application to critical care medicine[J].Crit Care Clin,2005,21(1):21-30,vii.
[4]Vélez-Díaz-Pallarés M,Delgado-Silveira E,Carretero-Accame ME.U-sing healthcare failure mode and effect analysis to reduce medication errors in the process of drug prescription,validation and dispensing in hospitalised patients[J].BMJ Qual Saf,2013,22(1):42-52.
[5]孙茜,孙春霞,孙晓阳.探讨医疗失效模式与效应分析在危重症患者院内转运流程中的应用研究[J].中国全科医学,2018,21(32):4022-4027.
[6]Ursprung R.Random safety auditing,root cause analysis,failure mode and effects analysis[J].Clin Perinatal,2010,37(1):141-165.
[7]Cronrath P,Lynch TW,Gilson LJ,et al.PCA oversedation:Application of healthcare failure mode effect(HFMEA)analysis[J].Nurs Econ,2011,29(2):79-87.
[8]Latino RJ.Optimizing FMEA and RCA efforts in health care[J].J Healthc Risk Manag,2004,24(3):21-28.
[9]Reason J.Education and debate:Human error:Models and management[J].BMJ,2000,320(7237):768-770.
[10]孙慧.基于FMEA理论结直肠术后手术部位感染的风险管理模式初探与临床应用研究[D].南京:东南大学,2017.
[11]Potts HW,Anderson JE,Colligan L,et al.Assessing the validity of prospective hazard analysis methods:A comparison of two techniques[J].BMC Health Serv Res,2014,14:41.
[12]Chadwick L,Fallon EF.Evaluation and critique of healthcare failure mode and effect analysis applied in a radiotherapy case study[J].Hum Factors Ergon Manuf,2013,23(2):116-127.
[13]Habraken MM,Van der Schaaf TW,Leistikow IP.Prospective risk analysis of health care processes:A systematic evaluation of the use of HFMEA in Dutch health care[J].Ergonomics,2009,52(7):809-819.
[14]Faiella G,Parand A,Franklin BD,et al.Expanding healthcare failure mode and effect analysis:A composite proactive risk analysis approach[J].Reliab Eng Syst Saf,2018,169.
[15]Ghasemi M,Khoshakhlagh AH,Mahmudi S.Identification and assessment of medical errors in the triage area of an educational hospital using the SHERPA technique in Iran[J].Int J Occup Saf Ergon,2015,21(3):382-390.
[16]Lyons M,Adams S,Woloshynowych M,et al.Human reliability analysis in healthcare:A review of techniques[J].Int J Risk Saf Med,2004,16(4):223-237.
[17]Leveson N.A new accident model for engineering safer systems[J].Safety Science,2004,42(4):237-270.
[18]Fleming CH,Leveson NG.Improving hazard analysis and certification of integrated modular avionics[J].J Aerosp Inform Syst,2014,11(6):397-411.
[19]Torbjrn Bjerga,Aven T,Zio E.Uncertainty treatment in risk analysis of complex systems:The cases of STAMP and FRAM[J].Reliab Eng Syst Saf,2016,156:203-209.
[20]Stanton NA.Hierarchical task analysis:Developments,applications,and extensions[J].Appl Ergon,2006,37(1):55-79.
[21]Stanton NA,Salmon PM,Walker GH,et al.Human factors methods:A practical guide for engineering and design[M].Second·Lyndon:Ashgate Publishing Limited,2013.
[22]张银华,陈燕,晋溶辰,等.我国社区慢性病管理模式及其评价[J].全科护理,2015,13(24):2351-2354.
[23]《国家基层高血压防治管理指南(2017版)》高血压治疗原则[J].实用心脑肺血管病杂志,2018,26(4):85.
[24]苟雪英.社区门诊高血压患者不合理用药情况调查分析[J].中国卫生产业,2017,14(11):178-180.
[25]中国高血压基层管理指南(2014年修订版)[J].中华高血压杂志,2015,23(1):24-43,15.
[26]吴秋兰,曾广民,王谏珠,等.社区高血压的转诊现状及分析[J].中国医药指南,2012,10(33):686-687.
[27]黄雪玲.高血压患者自我管理现状调查与经验探讨[J].医药前沿,2015,5(9):368-369.
[28]吴声应,夏腊梅,冯惠颜.原发性高血压患者日常自我管理现状调查分析[J].中国现代药物应用,2014,8(6):221-222.