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.

R95

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）