基于ISO 22367的风险管理软件在实验室信息领域的应用研究  

Application research of risk management software based on ISO 22367 in the laboratory information field

作　　者：胡长爱[1] 黄鑫[1] 胡再振 杨大干[1] Hu Chang'ai;Huang Xin;Hu Zaizhen;Yang Dagan(Department of Laboratory Medicine,the First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou 310003,China;Hangzhou Lingyun Technology Co.,Ltd,Hangzhou 311121,China)

机构地区：[1]浙江大学医学院附属第一医院检验科,杭州310003 [2]杭州羚云科技有限公司,杭州311121

出　　处：《中华检验医学杂志》2024年第12期1470-1476,共7页Chinese Journal of Laboratory Medicine

摘　　要：目的探讨风险管理软件用于降低实验室信息领域的相关风险的可行性。方法组建风险控制小组实施风险管理的应用研究。通过头脑风暴、失效模式和效应分析等方法, 使用借助风险管理软件对2024年浙江大学医学院附属第一医院ISO 15189条款7.6数据控制和信息管理进行风险评估, 并实施风险控制、风险监控和风险管理评审。结果在数据控制和信息管理领域识别出42项风险点。经过风险控制小组评估, 确定其中1项高风险, 风险系数为51.56, 3项中风险, 风险系数分别为35.45、31.27、30.75。采取相应的风险控制措施后, 4项风险点的风险系数均降低到25以下可接受范围, 并纳入风险监测列表。结论应用风险管理软件有助于实验室信息领域风险管理的实施。Objective:To reduce associated risks in the field of laboratory information through risk management software.Method:A risk control team was established to conduct an application research on risk management.Based on ISO 15189 Clause 7.6 control of data and information management,the risk control team used the software to conduct risk assessments on the First Affiliated Hospital,Zhejiang University School of Medicine in 2024 through methods such as brainstorming,Failure Mode and Effects Analysis(FMEA).Risk control,risk monitoring,and risk management review were implemented.Result:42 risk points were identified in the fields of data control and information management.After evaluation by the risk control team,it was determined that one item is high-risk with a risk number of 51.56 and three items are medium risk with risk numbers of 35.45,31.27,and 30.75 The risk priority numbers of the 4 risk points were reduced to acceptable levels below 25 after taking appropriate risk control measures,then the 4 risk points were monitored.Conclusion:The application of risk management software is helpful for the implementation of risk management in the laboratory information field.

关 键 词：质量管理 风险管理 实验室信息系统 数智化 

分 类 号：TP311.5[自动化与计算机技术—计算机软件与理论] R197.32[自动化与计算机技术—计算机科学与技术]