Application of the healthcare failure mode and effect analysis in the security management of neonatal BCG vaccination

Abstract

Objective To explore the effect of the Healthcare Failure Mode and Effect Analysis (HFMEA) in the security management of newborn Bacillus Calmette-Guerin (BCG) vaccination.Methods One thousand neonates born in 2010 were selected as the experiment group who received the BCG vaccination under the management with the HFMEA.One thousand neonates born in 2009 were served as the control group who received routine BCG vaccination after birth.We performed the hazard analysis and decision making tree by making the effort to find the potential failure mode,reason and effect during the vaccination procedure and formulate and take the steps for top priority issue.Results After the application of the HFMEA into the management,the index of the risk priority number (RPN) ≥8 points in the high risk process could decrease to the average≤6 points by means of controlled measures in the procedure of BCG vaccination.The incidence rate of adverse reaction for the BCG vaccination could decrease to 0.0％ from 0.6％ ( x2 =4.2,P ＜ 0.05 ).Conclusions We can reduce the risk of adverse reaction and promote the rate of safety in BCG vaccination by mean of the management of BCG vaccination procedure with the HFMEA. Key words: BCG vaccine; Vaccination; Healthcare failure mode and effect analysis(HFMEA)