失效模式效应分析在基层医院新生儿首剂疫苗接种管理中的应用

目的 探讨失效模式与效应分析（failure mode and effects analysis，FMEA）在基层医院产科新生儿疫苗（乙肝疫苗首针和卡介苗）接种管理中的应用效果。方法 梳理新生儿疫苗接种过程中的管理流程，运用FMEA管理工具找出潜在失效模式，计算风险指数（risk priority number，RPN）值，并制定改进措施。比较FMEA实施前（2018年出生新生儿）和实施后（2019年出生新生儿）新生儿疫苗接种管理风险系数变化情况、新生儿首针乙肝疫苗、卡介苗接种及时率和接种后疫苗接种信息的准确率。结果 明确新生儿疫苗接种管理5项主要的潜在失效模式，经FMEA改善实施后风险系数RPN值大幅度下降，新生儿首针乙肝疫苗接种及时率由97.61%上升至99.16% （P<0.001），卡介苗接种及时率由84.86%上升至94.94% （P<0.001）；接种后疫苗接种信息单的错误率由5%下降至0.1% （P<0.001）。结论 基层医院产科应用FMEA对新生儿预防接种流程进行风险管理，可有效规范预防接种流程，显著提升新生儿疫苗接种及时率及接种信息管理的准确率，为新生儿疫苗接种安全体系的构建提供实施参考和借鉴。

Application of Failure Mode and Effects Analysis in Management of First Dose of Neonatal Vaccination in Primary Hospital

OBJECTIVE To explore the application effect in neonatal vaccination(first dose hepatitis B vaccine and BCG vaccine) management in primary hospitals by the application of failure mode and effects analysis(FMEA). METHODS Following the protocol of FMEA, the management process of neonatal vaccination was sorted out to explore the potential failure mode. The risk priority number(RPN) was calculated and the failure mode of priority improvement was determined, then improvement measures were formulated and implemented. The implementation effect was evaluated by comparing the risk coefficients of neonatal vaccination management before(newborns in 2018) and after (newborns in 2019) the implementation of FMEA, as well as the timelines and accuracy of vaccination about the first dose of neonatal hepatitis B vaccine and BCG vaccine. RESULTS Five main potential failure modes of neonatal vaccination management were clarified. After the implementation of FMEA, the RPN value of risk coefficient decreased significantly. The timely rate of first dose hepatitis B vaccination increased from 97.61% to 99.16%(P<0.001), and the timely rate of BCG vaccination increased from 84.86% to 94.94%(P<0.001). The inaccuracy of vaccination on information sheet decreased from 5% to 0.1%(P<0.001). CONCLUSION FMEA applies in primary hospital can effectively standardized the neonatal vaccination process, significantly improve the timely rate of neonatal vaccination and the accuracy of vaccination information management, and it can provide practical reference for the construction of neonatal vaccination safety system.