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目的通过根因分析发现过氧化氢等离子低温灭菌生物监测不合格的原因，采取有效的规避措施，降低生物监测阳性的发生，减少资源浪费，提高患者的安全。方法查阅2013年~2015年过氧化氢等离子低温灭菌资料，对2013年~2014年发生过氧化氢生物监测不合格事件，运用根因分析方法进行近端原因、根本原因分析，制定改进措施，并在2014年~2015年对改进效果进行追踪。结果采取规范操作流程、质量评价标准，提升操作依从等措施后，过氧化氢生物监测合格率达到100%。结论根因分析法为系统、有效地降低过氧化氢等离子低温灭菌生物监测不合格的发生，提供了的科学途径。“,”Objective Through Root Cause Analysis to avoid hydrogen peroxide low temperature plasma sterilization biological monitoring the occurrence of unqualified, reduce waste of resources, improve the safety of patients. Methods Survey in 2013-2015 hydrogen peroxide low temperature plasma sterilization data, from 2013 to 2014 hydrogen peroxide biological biological monitoring positive events, using the method of returning analysis for proximal cause, root cause analysis, improvement measures, and in 2014~2015 to improve the effect of tracking. Results After continuous quality improvement, the hydrogen peroxide biological monitoring qualified rate reached 100%. Conclusion Root Cause Analysical method can previod a scientific way to reduce hydrogen peroxide low temperature plasma sterilization biological monitoring the occurrence of unqualified.