医疗机构个体化药物治疗实验室质量管理体系的构建与效果评价  

Construction and effect evaluation of quality management system of personalized drug therapy laboratory in medical institutions

作　　者：谢星星 刘学 胡珊珊 刘易陇 张杰[4] 余彬 苟惠 范小冬 李晓璇 彭铭瑶 范玲 余志刚[1] 郑洋 XIE Xingxing;LIU Xue;HU Shanshan;LIU Yilong;ZHANG Jie;YU Bin;GOU Hui;FAN Xiaodong;LIXiaoxuan;PENG Mingyao;FAN Ling;YU Zhigang;ZHENG Yang(Department of Pharmacy,Ya'an People's Hospital,Ya'an 625000,China;Drug Clinical Trial Institute,Affiliated Hospital of Zunyi Medical University,Zunyi 563000,China;Department of Pharmacy,Leshan People's Hospital,Leshan 614000,China;Department of Pharmacy,Nanbu People's Hospital,Nanchong 637000,China;Department of Pharmacy,Mianyang Central Hospital,Mianyang 621000,China;Department of Pharmacy,Affiliated Hospital of Southwest Medical University,Luzhou 646000,China;Department of Pharmacy,Xichong People's Hospital,Nanchong 637000,China;Department of Pharmacy,The Second People's Hospital of Yibin,Yibin 644000,China;Drug Clinical Trial Institution,Ya'an People's Hospital,Ya'an 625000,China;Drug Clinical Trial Institution,Affiliated Hospital of Southwest Medical University,Luzhou 646000,China)

机构地区：[1]雅安市人民医院药剂科,四川雅安625000 [2]遵义医科大学附属医院药物临床试验机构,贵州遵义563000 [3]乐山市人民医院药学部,四川乐山614000 [4]南部县人民医院药学部,四川南充637000 [5]绵阳市中心医院药学部,四川绵阳621000 [6]西南医科大学附属医院药学部,四川泸州646000 [7]西充县人民医院药学部,四川南充637000 [8]宜宾市第二人民医院药剂科,四川宜宾644000 [9]雅安市人民医院药物临床试验机构,四川雅安625000 [10]西南医科大学附属医院药物临床试验机构,四川泸州646000

出　　处：《药物评价研究》2024年第3期581-587,共7页Drug Evaluation Research

基　　金：雅安市重点科技计划应用技术研究与开发面上项目(22KJJH0039);北京医学奖励基金会“睿影科研基金(五期)”科研项目(YXJL-2023-0866-0316)。

摘　　要：目的建立药学服务转型模式下医疗机构个体化药物治疗实验室(PDTL)质量管理制度,规范和标准化使用PDTL,强化运行与效能,提高药学检验临床工作实效。方法以目标管理为核心,采用实证研究与调查相结合,综合评价管理体系的合理性、可及性、适宜性、推广性,以工作实效和便宜执行并重的原则,制定管理制度与相关评价量表供决策与管理。结果结合PDTL实际管理执行情况,制定了4级管理要求,涵盖管理制度及质量控制2大体系,包括实验室计划(规划)、总则、实验人员、实验室财务、实验室设备与器材、实验室环境监测、设备器材运行使用检测、样本登记接收、标准操作规程(SOP)及评估与认证等10大模块为具体执行内容,实施效果评价为可操作性强。结论建立的PDTL质量管理体系客观可行,可达到医疗机构PDTL规范和标准化运行管理的目的,对提高医疗机构个体化药物治疗技术与平台建设、转型药学服务模式均具有重要意义。Objective To establish the quality management system of personalized drug therapy laboratory(PDTL)in medical institutions under the mode of pharmaceutical care transformation,standardize and standardize the construction of personalized drug therapy laboratory,strengthen the operation and efficiency,and improve the effectiveness of clinical work in pharmaceutical testing.Methods With management by objectives as the core,the rationality,accessibility,suitability and promotion of the management system were evaluated comprehensively by combining empirical research and investigation,and the management system and related evaluation scales were developed for decision-making and management based on the principle of paying equal attention to work effectiveness and cheap implementation.Results Combined with the actual management implementation of PDTL,four levels of management requirements have been formulated,covering two systems of management system and quality control.Ten modules,including laboratory plan(planning),general principles,laboratory personnel,laboratory finance,laboratory equipment and equipment,laboratory environment monitoring,equipment operation and use testing,sample registration and receipt,standard operating procedures(SOP)and evaluation and certification,are specific implementation contents,the implementation effect evaluation is operable.Conclusion The quality management system of personalized drug therapy laboratory established is objective and feasible,which can achieve the purpose of standardized and standardized operation management of personalized drug therapy laboratory in medical institutions,and is of great significance for improving the construction of personalized drug therapy technology and platform in medical institutions and transforming the mode of pharmaceutical care.

关 键 词：个体化药物治疗 实验室 管理制度 质量控制体系 效果评价 

分 类 号：R95[医药卫生—药学]