Application research of risk management software based on ISO 22367 in the laboratory information field
10.3760/cma.j.cn114452-20240510-00238
- VernacularTitle:基于ISO 22367的风险管理软件在实验室信息领域的应用研究
- Author:
Chang′ai HU
1
;
Xin HUANG
;
Zaizhen HU
;
Dagan YANG
Author Information
1. 浙江大学医学院附属第一医院检验科，杭州 310003
- Publication Type:Journal Article
- Keywords:
Quality management;
Risk management;
Laboratory information system;
Digital intelligent
- From:
Chinese Journal of Laboratory Medicine
2024;47(12):1470-1476
- CountryChina
- Language:Chinese
-
Abstract:
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.
