目的 建立藥學(xué)服務(wù)轉(zhuǎn)型模式下醫(yī)療機(jī)構(gòu)個(gè)體化藥物治療實(shí)驗(yàn)室（PDTL）質(zhì)量管理制度，規(guī)范和標(biāo)準(zhǔn)化使用PDTL，強(qiáng)化運(yùn)行與效能，提高藥學(xué)檢驗(yàn)臨床工作實(shí)效。方法 以目標(biāo)管理為核心，采用實(shí)證研究與調(diào)查相結(jié)合，綜合評(píng)價(jià)管理體系的合理性、可及性、適宜性、推廣性，以工作實(shí)效和便宜執(zhí)行并重的原則，制定管理制度與相關(guān)評(píng)價(jià)量表供決策與管理。結(jié)果 結(jié)合PDTL實(shí)際管理執(zhí)行情況，制定了4級(jí)管理要求，涵蓋管理制度及質(zhì)量控制2大體系，包括實(shí)驗(yàn)室計(jì)劃（規(guī)劃）、總則、實(shí)驗(yàn)人員、實(shí)驗(yàn)室財(cái)務(wù)、實(shí)驗(yàn)室設(shè)備與器材、實(shí)驗(yàn)室環(huán)境監(jiān)測(cè)、設(shè)備器材運(yùn)行使用檢測(cè)、樣本登記接收、標(biāo)準(zhǔn)操作規(guī)程（SOP）及評(píng)估與認(rèn)證等10大模塊為具體執(zhí)行內(nèi)容，實(shí)施效果評(píng)價(jià)為可操作性強(qiáng)。結(jié)論 建立的PDTL質(zhì)量管理體系客觀可行，可達(dá)到醫(yī)療機(jī)構(gòu)PDTL規(guī)范和標(biāo)準(zhǔn)化運(yùn)行管理的目的，對(duì)提高醫(yī)療機(jī)構(gòu)個(gè)體化藥物治療技術(shù)與平臺(tái)建設(shè)、轉(zhuǎn)型藥學(xué)服務(wù)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(diǎn)科技計(jì)劃應(yīng)用技術(shù)研究與開(kāi)發(fā)面上項(xiàng)目（22KJJH0039）；北京醫(yī)學(xué)獎(jiǎng)勵(lì)基金會(huì)“睿影科研基金（五期）”科研項(xiàng)目（YXJL-2023-0866-0316）