临床输血质量管理体系的建立

Establishment of quality management system in clinical blood transfusion

为确保血液和血液成分的安全和合理使用,必须加强临床输血的质量管理。根据ISO9001:2000标准,文中建立了有效的临床输血质量管理体系,其关键控制点涵盖了人员、设备、试剂、环境、血液储存、运输与发放、输血不良反应和计算机管理系统等。编写的质量管理体系文件包括质量手册、程序文件、标准操作规程和质量记录,所有有效文件必须经授权和受控。

In order to ensure the safe and appropriate use of blood and its components, the quality management in clinical blood transfusion should be strengthened. An effective quality management system （QMS） in clinical blood transfusion was established according to ISO 9001：2000 standards in our department. The key control points of the system included personnel, equipment, reagent, environment, storage, transport and blood distribution, adverse reactions and computer management. QMS documentations on quality manual, documented procedures, standard operating procedures （SOP） and quality records were individually developed. All effective documentations were authorized and monitored.