持续质量改进管理方法在抗肿瘤药物临床试验血标本采集中的应用

Application of continuous quality improvement managernent on blood specimen collection in the clinical trials of anticancer drugs

目的 探讨持续质量改进（CQI）理论在抗肿瘤药物临床试验血标本采集的应用及效果.方法 对2011年3-12月送往中心实验室的1896份临床试验血标本中94份不合格血样原因进行分析,针对血标本采集存在的问题,于2012年2月开始运用持续质量改进的方法,对采血者、患者依从性及采血流程从管理上进行改进,评价持续质量改进后的效果.结果 实施CQI后,血标本不合格率由4.92％下降至1.42％,患者对护士采血技术满意度由85.6％上升至97.2％,服务态度满意度由90.5％上升至99.5％,实施前后比较差异均有统计学意义（x2值分别为42.93,15.57,14.97;P ＜0.01）.结论 实施持续质量改进提高了临床试验血标本合格率及患者满意度.

Objective To investigate the application and effect of continuous quality improvement（CQI） on blood specimen collection in the clinical trials of anticancer drugs.Methods To analyze the causes of 94 unqualified blood specimens in total of 1896 blood specimens in clinical trial which were sent to central laboratory between March and December 2011.In view of the existing problem of blood specimen collection,the CQI was used in February 2012 for improvement of the management of nurse,patient compliance and blood collection process and evaluate the effect after CQI.Results After application of CQI,unqualified rate of blood specimens reduced from 4.92％ to 1.42％,patients＇ satisfaction with blood collection technique of nurses increased from 85.6％ to 97.2％,patients＇ satisfaction with service attitude increased from 90.5％ to 99.5％,and the differences were statistically significant between before and after application of CQI （x2 ＝ 42.93,15.57,14.97,respectively; P ＜0.01）.Conclusions The application of CQI can improve the qualified rate of blood specimens and raise patients＇ satisfaction.