目的 建立藥學服務轉型模式下醫(yī)療機構個體化藥物治療實驗室（PDTL）質量管理制度，規(guī)范和標準化使用PDTL，強化運行與效能，提高藥學檢驗臨床工作實效。方法 以目標管理為核心，采用實證研究與調(diào)查相結合，綜合評價管理體系的合理性、可及性、適宜性、推廣性，以工作實效和便宜執(zhí)行并重的原則，制定管理制度與相關評價量表供決策與管理。結果 結合PDTL實際管理執(zhí)行情況，制定了4級管理要求，涵蓋管理制度及質量控制2大體系，包括實驗室計劃（規(guī)劃）、總則、實驗人員、實驗室財務、實驗室設備與器材、實驗室環(huán)境監(jiān)測、設備器材運行使用檢測、樣本登記接收、標準操作規(guī)程（SOP）及評估與認證等10大模塊為具體執(zhí)行內(nèi)容，實施效果評價為可操作性強。結論 建立的PDTL質量管理體系客觀可行，可達到醫(yī)療機構PDTL規(guī)范和標準化運行管理的目的，對提高醫(yī)療機構個體化藥物治療技術與平臺建設、轉型藥學服務模式均具有重要意義。

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

雅安市重點科技計劃應用技術研究與開發(fā)面上項目（22KJJH0039）；北京醫(yī)學獎勵基金會“睿影科研基金（五期）”科研項目（YXJL-2023-0866-0316）