开展品管圈活动降低生物等效性试验血液样本采集超窗率  

Quality control circle activity in reducing incidence of over time window rate of blood sample collection in drug bioequivalence trials

作　　者：张悦翎 朱瑞芳 曾琼[1] 侯晓璇 郑俊红 顾琴 孙叶 江翊国 ZHANG Yue-ling;ZHU Rui-fang;ZENG Qiong;HOU Xiao-xuan;ZHENG Jun-hong;GU Qin;SUN Ye;JIANG Yi-guo(Suzhou Science and Technology Town Hospital,Affiliated to Nanjing Medical University,Suzhou Jiangsu 215153)

机构地区：[1]南京医科大学附属苏州科技城医院,江苏苏州215153

出　　处：《中南药学》2020年第11期1910-1914,共5页Central South Pharmacy

摘　　要：目的探讨品管圈活动对降低血液样本采集超窗率的作用。方法成立品管圈,确立"降低生物等效性试验血液样本采集超窗率"的主题,进行现状调查;收集8个生物等效性试验的血液样本采集数据,分析发生超窗的原因并进行要因分析,制订相应的对策并组织实施,进行效果评价,评估有形成果和无形成果。结果血液样本采集超窗次数由品管圈活动前的13次减少到活动后的4次,进步率为72%,目标达标率为137.5%;品管圈活动前后血液样本采集超窗率分别为0.46%(13/2796)和0.13%(4/2988);同时,圈员能力由活动前的1.0~2.5升高到3.0~4.5。结论品管圈活动可有效降低血液样本采集超窗率,有助于增强科内临床研究护理人员质量管理意识和工作能力,提高试验质量。Objective To determine the effect of quality control circle (QCC) activity on reducing the over time window rate of blood sample collection.Methods The QCC was established,the theme of reducing the over time window rate in blood sample collection was the subject.Status survey was conducted.The blood sample collection data of 8 bioequivalence trials were collected,and the causes of over time window were analyzed.Targeted counter measures and corrective measures were formulated and implemented.The tangible and intangible results were evaluated respectively.Results The number of blood samples of over time window decreased from 13 before the QCC activity to 4 after the QCC activity,with a progress rate of 72% and a target rate of 137.5%.The over time window rates were 0.46% (13/2796) and 0.13% (4/2988) before and after the QCC activity.After the QCC activity,the scores of circling ability increased from 1.0~2.5 to 3.0~4.5.Conclusion The QCC activities play a significant role in reducing the rate of over time window of blood sample collection,help to enhance the quality management and work ability of clinical research nurses,and improve the quality of clinical trials.

关 键 词：品管圈 生物等效性试验 血液样本采集 超窗率 

分 类 号：R95[医药卫生—药学]