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目的建立成分血制备过程、制备环境信息化系统,确保在安全有效的环境下,制备的成分血符合国家质量要求,同时实现成分血制备过程记录的可追溯性。方法采用物联网方式,通过数据采集软件监控8个区域制备环境及10类关键设备,同时记录环境温湿度及设备运行过程数据,生成的数据文件与血站标准化管理系统进行数据交互,形成成分血制备过程及环境温湿度的数据信息链。结果 8个区域制备环境温湿度均在18-25℃和35%-80%;10类关键设备运行数据包括献血码、操作者、设备资产编号、物料信息、制备方法、制备环境、产品重量(容量)、目视检查等至少11项数据信息链;整合展示电子报表包含12个明细表、19个按类别汇总表、10个质量受控表格、1个血液制备过程查询记录;结论建立和实施成分血制备过程信息化系统,既符合行业法律法规的要求,也实现人、机、料、法、环、信的可追溯,更是实现创新型管理模式的转变。
Objective To establish the process of preparation of blood components and prepare the environmental information system to ensure that the prepared blood meets the national quality requirements in a safe and effective environment and at the same time achieves the traceability of the blood preparation process records. Methods IOT was used to monitor the preparation environment and 10 kinds of key equipment in 8 regions through data acquisition software. At the same time, the data of environmental temperature and humidity and equipment operation were recorded. The generated data files interacted with the blood stasis standardized management system to form the blood components Preparation and environmental temperature and humidity data and information chain. Results The temperature and humidity of the preparation area in the eight regions were both 18-25 ℃ and 35% -80%. The operation data of 10 types of key equipment included blood donation code, operator, equipment asset number, material information, preparation method, preparation environment, product weight Capacity), visual inspection of at least 11 data information chain; integrated display electronic report contains 12 schedules, 19 by type summary table, 10 quality controlled forms, a blood preparation process query records; Conclusion The establishment and implementation The information system of blood component preparation process not only meets the requirements of industry laws and regulations, but also realizes the traceability of people, machines, materials, laws, circles and letters, and realizes the transformation of innovative management mode.