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.