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基于FMEA模式及SHEL分析法在静脉用药调配中心药品调配差错风险管理中的应用 被引量:2

Application of FMEA model and SHEL analysis in the risk management of drug dispensing errors in the PIVAS
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摘要 目的:探讨静脉用药调配中心(pharmacy intravenous admixture service,PIVAS)在药品调配流程中易导致差错的潜在风险,落实防范措施,降低差错发生率。方法:采用失效模式和效应分析(failure mode and effect analysis,FMEA)法对PIVAS药品调配全流程各环节进行风险识别与评估,量化评分,筛选需要优先优化的中高风险点的关键失效模式,再应用SHEL[软件(software,S)、硬件(hardware,H)、环境(environment,E)、人(liveware,L)]分析法制定改进措施并评价干预后的效果。结果:根据风险优先值(risk priority number,RPN)筛选出药品溶解后未能按规范量加入输液中、未按规范操作流程进行配置、调配后未进行认真核对等10个需要优先改善的中高风险点,经过干预措施实施后,10个中高风险点的RPN值均下降,RPN总值由2 674降至980,RPN降幅达63.35%。干预后差错率更低,差异有统计学意义(P<0.05)。结论:应用FMEA模式及SHEL分析法对PIVAS药品调配全流进行管理,可以有效防范各项风险,减少差错的发生,保障用药安全。 OBJECTIVE CTo explore potential risks of drug dispensing errors in pharmacy intravenous admixture services(PIVAS),and to implement preventive measures,thus reducing error rates.METHODS The risk of dispensing procedures in PIVAS was identified and evaluated by applying the failure mode and effect analysis(FMEA)model.The risks of potential failure modes were quantitatively scored,and their risk priority number was calculated to screen failure modes that needed to be improved in priority.The corresponding improvement measures were developed by the SHEL(software[S],hardware[H],environment[E]and liveware[L]) analysis.The effect of intervention before and after rectification was evaluated.RESULTS Based on the risk priority number(RPN),10 medium-to-high risk points were identified,such as failure to add dissolved drugs into the infusion according to the standard dosage,non-compliance with standardized operation procedures during preparation,and lack of thorough verification after compounding and dispensing.After interventions of preventive measures,the RPN scores of the 10 critical risk points decreased from 2674 to 980,and the RPN reduction reached 63.35%.After implementations,the error rate was significantly reduced(P<0.05).CONCLUSION The use of FMEA and SHEL analysis to the whole-process management of drug dispensing in the PIVAS can effectively prevent various risks,reduce the incidence of errors,and ensure medication safety.
作者 黄捷 张先洲 HUANG Jie;ZHANG Xianzhou(Department of Pharmacy,Renmin Hospital of Wuhan University,Hubei Wuhan 430060,China)
出处 《中国医院药学杂志》 北大核心 2025年第19期2254-2259,共6页 Chinese Journal of Hospital Pharmacy
关键词 静脉用药调配中心 调配差错 风险评估 FMEA模式分析 SHEL分析 pharmacy intravenous admixture service dispensing errors risk evaluation failure mode and effect analysis SHEL mode analysis
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