中国药业2025，Vol.34Issue(23)：20-25,6.DOI:10.3969/j.issn.1006-4931.2025.23.005
血液制品批签发检验过程风险分析与应对措施初探
Risk Analysis and Countermeasures in the Inspection Process of Blood Products Batch Issuance
摘要
Abstract
Objective To analyze the risks in the batch issuance inspection process of blood products,and to improve the accuracy and reliability of the batch issuance of blood products.Methods Through the three-dimensional risk matrix method,the risks in the links of the blood product risk points such as sample circulation,sample inspection,data review,and quality management system were identified and evaluated based on the relevant provisions of the Laboratory Risk Management Guidelines,and targeted response measures were put forward.Results The main risk links in the batch issuance and inspection process of blood products included sample circulation,inspection standard,instrument and equipment,standard substances and reagents,sample processing,personnel authorization training,inspection records and reports,data review,quality management system,etc.There were risks of different degrees in different links.The highest risk level was level Ⅱ,which is acceptable.Corresponding countermeasures were proposed for the risks in different links,and level Ⅱ risks should be closely monitored and appropriate intervention measures should be taken when necessary.Conclusion By analyzing and evaluating the risks in the batch issuance and inspection process of blood products,and taking corresponding intervention measures,the risk level of batch issuance can be reduced to ensure the safety of public medication,and provide a reference for risk management of other batch issuance laboratories of biological products.关键词
血液制品/批签发/实验室风险管理/风险矩阵法/应对措施Key words
blood products/batch issuance/laboratory risk management/risk matrix method/countermeasures分类
医药卫生引用本文复制引用
刘荷英,洪燕,刘小英,刘宁..血液制品批签发检验过程风险分析与应对措施初探[J].中国药业,2025,34(23):20-25,6.基金项目
江西省药品监督管理局科研项目[2023GL05]. （）
