Chinese Journal of Tissue Engineering Research ›› 2015, Vol. 19 ›› Issue (18): 2947-2852.doi: 10.3969/j.issn.2095-4344.2015.18.028
Zhang Ying, Kang Rui
Received:
2015-02-10
Online:
2015-04-30
Published:
2015-04-30
Contact:
Kang Rui, M.D., Doctoral supervisor, Professor, School of Reliability and Systems Engineering, Beijing University of Aeronautics and Astronautics, Beijing 100191, China
About author:
Zhang Ying, Studying for doctorate, School of Reliability and Systems Engineering, Beijing University of Aeronautics and Astronautics, Beijing 100191, China
CLC Number:
Zhang Ying, Kang Rui . Models and methods of failure analysis and risk assessment during medical treatment[J]. Chinese Journal of Tissue Engineering Research, 2015, 19(18): 2947-2852.
2 急诊心肌梗死抢救MPFARA实施 MPFARA for emergency rescue of myocardial infarction 文章以某医院急诊科的心肌梗死抢救过程为分析对象,实施MPFARA分析过程。以急诊科当前采用的心肌梗死抢救流程,编制心肌梗死抢救步骤表。并根据该急诊科2009年1月至2013年12月共5年内心肌梗死抢救过程相关的统计数据信息,制定风险分析评分标准,在该评分标准基础上,给出风险判断准则。然后对步骤表中每个确定的步骤,根据该步骤的要求,分析其缺陷、原因和影响,依据风险分析判断缺陷和原因是否在可接受范围内。根据风险分析结果,提出相应的建议措施,并对实施建议措施后的风险进行评估。 2.1 制定心肌梗死抢救过程步骤表 某医院急诊科心肌梗死患者的抢救流程如图2所示,根据图2编制表1所示的心肌梗死抢救步骤表。 2.2 风险分析评分标准和判断准则 2.2.1 制定风险分析评分标准 针对急诊心肌梗死抢救过程分析对象,根据临床数据统计和经验,制定严酷度(S)、发生概率(O)和检测度(D)的评分准则如表 2所示。 2.2.2 确定风险判断准则 采用RPN进行风险分析,必须先确定RPN临界值,该值是是否需要改进设计或采取补偿措施的判据。文献[1]中RPN临界值,建议范围为RPN最大值的15%-21.6%之间,文章中RPN的最大值为100(5×5×4),因此RPN临界值范围可定为15-22,文章确定RPN临界值取20,即RPN≥20的"
缺陷和原因必须进行改进。 文章采用严酷度与RPN联合判断的方法,严酷度为5的缺陷必须消除,即严酷度≥5或RPN≥20的缺陷和原因,必须进行进一步分析,提出合理的建议和措施,降低该缺陷和原因对患者的影响。 2.3 MPFARA实施 2.3.1 填写MPFARA表 文章以“10 min内紧急抢救”的“阿司匹林300 mg嚼服”步骤为例,说明MPFARA缺陷、原因和影响分析的详细内容。以2009年1月至2011年12月这段时间内的病例数据为基础,通过填写表3,分析该步骤可能出现的缺陷、原因和影响。根据严酷度、发生概率和检测度的评分,计算RPN,根据S和RPN的结果,判断该缺陷和原因的风险是否可接受,根据上节所述,S≥5和RPN≥20的缺陷和原因,必须进行改进。 2.3.2 建议措施及结果 对表4中不可接受(S≥5或RPN≥20)的缺陷和原因进一步分析,提出相应的建议和改进措施,见表5。 以2012年1月至2013年12月时间内的病例数据为基础,统计根据建议措施改进后的数据,对实施建议和措施后的结果再次给出严酷度、发生概率和检测度的评分,计算RPN,如果改进后风险仍然超过可接受的范围(RPN≥20或者S≥5),则在备注中予以注释、重点说明。 从表中结果可见,改进后严酷度为5的缺陷被消除,其他缺陷和原因也将风险降低到可接受的水平。"
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