摘要
目的:探讨体外诊断试剂规范化管理体系。方法:对体外诊断试剂在供应和使用过程中存在的安全和质量风险因素进行分析,并介绍运用"一体化冷链运输射频识别周转箱"对体外诊断试剂进行整个流程规范化可溯源管理。结果:建立了体外诊断试剂从采购、冷链物流运输、入库验收到使用一整套规范的动态跟踪管理体系。结论:射频识别技术对体外诊断试剂各环节可进行实时监控与记录,确保试剂的质量安全与可溯源。
Objective: To explore the standardized management system of in vitro diagnostic reagents.Methods: The safety and quality risks were investigated in the process of provision and application of in vitro diagnostic reagents, and it was introduced how our hospital applied multi-function RFID circulating boxes to the standardized traceable management of in vitro diagnostic reagents. Results: Our hospital established the dynamic tracking management system in purchase, cold-chain transportation, warehouse entry inspection and use of in vitro diagnostic reagents. Conclusions: The RFID technology can simultaneously monitor and record all steps to ensure the quality, safety and traceablity of the reagents.
出处
《药学与临床研究》
2016年第2期182-184,共3页
Pharmaceutical and Clinical Research
基金
江苏省"六大高峰人才"项目资助(2014-YY-001)
江苏省卫生厅医学重点人才项目(RC201170
H201108)
奥赛康临床药学基金(201412-1)
江苏高校优势学科建设工程资助项目(JX10231801)
关键词
体外诊断试剂
一体化冷链运输RFID周转箱
冷链运输
溯源
In vitro diagnostic reagent
Multi-function RFID circulating box
Cold-chain transportation
Traceability
