转化医学中心规范化质量管理

The standardized quality management of translational medical center

为避免转化医学的研究产生偏倚,应建立转化医学标准化质量管理和质量控制体系,加强实验技术队伍建设和实验质量的监控,重視医学实验室的国际资格认证(ISO15189),执行良好实验室规范和安全保护措施,落实转化医学动物模型的科学管理,遵循赫尔辛基宣言的精神,实行临床试验注册和报告规范,优化临床研究的质量,掌握卫生技术评估标准,实施围手术期的临床路径管理,建立人的组织库,促进分子标志物的研究,建立并加强大数据时代临床资料数据库的质量管理,实现医院管理标准的现代化,改进医疗护理质量,增强医院竞争力。转化医学中心规范化的质量管理是提高外科实验室和临床研究质量的重要手段。

In order to prevent introduction of bias at the translational medicine,it is urgent to establish a standardized quality management and quality control system for the translational medicine, strengthen the construction of the experimental and technical team and supervision of experiment quality, pay attention to medical laboratory accreditation according to IS015189, carry out standard operation procedure,clinical laboratory biosafety administration, translational animal model science and administration, to realize registered and good publication practice in randomized clinical trials of surgical intervention according to Declaration of Helsinki, improve clinical research, health technology assessment,perioperative clinical pathway management, to build human tissue bank and expedite molecular marker research, quality management ofclinical database in big data time, to realize modernization in standardization management of hospital so that it can update the hospital management, improve the medical quality and enhance the hospital＇s competition. The standardized quality management of translational medical center is an important means to improve the quality of laboratory and clinical study in surgery.