Objective: To carry out effective management for the cold-chain temperature of in vitro diagnostic reagent so as to provide safe and credible inspection basis for clinical diagnosis and treatment. Methods: The remote control and alarm platform of cold storage and refrigerator were applied to achieve acceptance for temperature control of in vitro diagnostic reagent, and achieve acceptance for temperature and achieve differentiation management for unqualified product. These methods could ensure controllability of temperature for the reagent with requirements of cold-chain. Results: Through the management of cold-chain of in vitro diagnostic reagents, hospital has achieved effective supervising for them, and hospital has concrete record for these reagents in the entire medical process, and all of them were traceability. Therefore, it provide effective guarantee for clinical safety. Conclusion: The support of informatization technique and implementation of management system of hospital can ensure the cold-chain management of entire process is not out of control, and enhance the stability and accuracy of clinical test results and effective guarantee the safety of diagnosis and treatment for hospital.%目的:对体外诊断试剂冷链温度进行有效的管理,为临床诊疗提供安全可信的检查依据.方法:应用冷库和院内冰箱远程监控及报警平台,对体外诊断试剂入库温控验收、温度验收以及对不合格品种的差异化处理,保证有冷链要求试剂的温度可控性.结果:通过对体外诊断试剂冷链的管理,体外诊断试剂在医院得到了有效的监管,其在使用中全程有记录,可追溯,为临床医疗安全提供了有效的保障.结论:通过信息化技术的支撑和医院管理制度的落实,保证体外诊断试剂全流程冷链管理不失控,提高临床检验结果的稳定性和准确性,有效保障医院诊疗的安全.
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