北京市地方标准《静脉用药集中调配规范》解读
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篇名: 北京市地方标准《静脉用药集中调配规范》解读
TITLE: Interpretation of Local Standard Specification for Pharmacy Intravenous Centralized Admixture in Beijing
摘要: 目的:解读北京市地方标准《静脉用药集中调配规范》(DB11/T1701-2019)(简称“《北京市地标》”)的要点,为医疗机构管理者及静脉用药集中调配中心(PIVAS)工作人员深入理解该标准并进一步提升医疗机构PIVAS工作质量提供指导和参考。方法:从《北京市地标》的制定背景和主要内容进行详细解读,并与原国家卫生部组织颁布的《静脉用药集中调配质量管理规范》(简称“《国家规范》”)和广东省药学会发布的《广东省医疗机构静脉药物配置中心质量管理规范(试行)》(简称“《广东省规范》”)进行比较。结果与结论:《北京市地标》经北京市市场监督管理局批准发布并于2020年4月1日正式实施;其正文共分为7个部分,主要包括适用范围、规范性引用文件、术语和定义、基本要求、环境要求(设计、选址、布局)、设备设施(通风系统及操作台、运行维护)、调配要求。《北京市地标》在遵循《国家规范》要求的基础上进一步细化了相关内容,与《广东省规范》一样,分别结合各自地方特色和实践现状,增强了标准的适用性和可操作性。该地方标准是我国第一个以标准形式固定下来的静脉用药调配规范,有望推动北京市PIVAS工作质量的提升,使拟建、在建和运行维护中的PIVAS都能符合统一的标准,减少建成后无法通过验收或再进行改建的现象。
ABSTRACT: OBJECTIVE:To interpret the key points in local standard Specification for Pharmacy Intravenous Centralized Admixture(DB11/T 1701-2019)(Beijing Local Standard for short )in Beijing ,and to provide guidance and reference for managers of medical institutions and staff of PIVAS to deeply understand the standard and further improve the quality of PIVAS in medical institutions. METHODS :The background and main content of Beijing Local Standard were interpreted in detail ,and then compared with Quality Specification of Pharmacy Intravenous Admixture (National Specification for short )promulgated by Chinese National Ministry of Public Health and Quality Specification of Pharmacy Intravenous Admixture Services of Guangdong Provincial (Trial)(Specification of Guangdong Province for short )promulgated by Guangdong Pharmaceutical Association. RESULTS & CONCLUSIONS:Beijing Local Standard had been promulgated and implemented by Beijing Municipal Administration for Market Regulation on April 1st,2020. The text of Beijing Local Standard is divided into 7 parts,mainly including the scope of application,normative references ,terms and definitions ,basic requirement ,environmental requirements (design,location, layout),equipment and facilities (ventilation system and console ,operation and maintenance ),and admixture requirements. Beijing Local Standard further refines the relevant contents on the basis of following the requirements of National Specification . Like Specification of Guangdong Province ,the applicability and operability of the standard are enhanced by combining their local characteristics and practice status. As the first local standard in this domain ,the local standard is expected to promote the improvement of the working quality of PIVAS in Beijing ,enable the PIVAS of proposed construction ,under construction and operation maintenance to meet uniform standards and reduce the failure of acceptance or reconstruction after completion.
期刊: 2021年第32卷第01期
作者: 杜雅薇,庞宁,毕玉,赵荣生
AUTHORS: DU Yawei ,PANG Ning,BI Yu,ZHAO Rongsheng
关键字: 静脉用药集中调配规范;静脉用药集中调配中心;地方标准;解读
KEYWORDS: Specification for Pharmacy Intravenous Centralized Admixture ;Pharmacy intravenous admixture service ;Local
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