基于外部审核模式的血站质量管理体系评价与持续改进  

Evaluation and improvement of blood station quality management system:based on external audit

作　　者：李雪梅 付海忠 董菲 徐丽华 王胜 LI Xuemei;FU Haizhong;DONG Fei;XU Lihua;WANG Sheng(Weifang Central Blood Station,Weifang 261043,China)

机构地区：[1]潍坊市中心血站,山东潍坊261043

出　　处：《中国输血杂志》2023年第11期1040-1045,共6页Chinese Journal of Blood Transfusion

摘　　要：目的识别血站质量管理体系外部审核(简称外审)中主要不合格项及其性质,以采取相应的必要纠正和预防措施来持续改进质量体系。方法收集2017—2019年本站在国家、山东省血液安全技术核查(分别简称国审、省审)及4个血站血液安全技术联审(简称站际互审)中发现的与《血站质量管理规范》不符的不合格项(数据),采用Excel表和帕累托曲线(图)做统计分析并据此制定并实施相应的纠正和预防不合格(项)再发生的措施,外审3个月后本站质量管理部门对纠正预防措施做跟踪、识别和评价,验证这些举措的充分性、有效性以便实时修订或采取新的纠正预防措施。结果本血站在这3年里所参加的共7次血站质量管理体系外部审核中(含国审、省审各2次及站际互审3次),不合格项主要质量条款为“12监控和持续改进”11.90%(15/126)、“13献血服务”11.90%(15/126)、“06设备”10.32%(13/126)、“11记录”10.32%(13/126)、“03组织与人员”8.73%(11/126)、“15血液制备”7.94%(10/126)、“08安全与卫生”7.14%(9/126)、“14血液检测”7.14%(9/126),其中2次国审和2次省审不合格项排第1的均为“监控和持续改进”分别为16.67%(5/30)、14.71%(5/34)、站际互审占比8.06%(5/62)(P>0.05);站际互审占第1位的是“记录”19.35%(12/62),国审和省审中的“记录”分别为0和2.94%(1/34)(P<0.05)。结论外部监督审核,产生的不合格项是质量改进的重要依据。分析本血站质量管理体系外部审核的不合格项,采取纠正预防措施改进薄弱环节,并对纠正预防措施效果进行跟踪评价,能够切实保证血站质量管理体系的持续有效运行。Objective To identify the main unqualified items in the external audit of blood station quality management system(referred to as external audit),in order to take necessary measures to continuously improve the quality system.Methods Unqualified items(data)in the national and Shandong provincial blood safety technical audits(referred to as national and provincial audits)and four blood station blood safety technical joint audits(referred to as inter station mutual audits)from 2017 to 2019 were collected and analyzed by Excel and Pareto curves(graphs).Corresponding corrective and preventive measures were developed and implemented,and then tracked and evaluated by the quality management department three months after the external audit to verify their effectiveness.Results In a total of 7 external audits of blood station quality management system that our blood station has participated in over the past 3 years(including 2 national audits,2 provincial audits,and 3 inter station mutual audits),the main unqualified terms were“12 monitoring and continuous improvement”11.90%(15/126),“13 blood donation services”11.90%(15/126),“06 equipment”10.32%(13/126),“11 records”10.32%(13/126),“03 organization and personnel”8.73%(11/126),“15 blood preparation”7.94%(10/126),“08 safety and health”7.14%(9/126),and“14 blood testing”7.14%(9/126).Among them,“monitoring and continuous im-provement”ranked first in two national audits and two provincial audits,with 16.67%(5/30)and 14.71%(5/34),respectively,and was 8.06%(5/62)in inter station mutual audit,and the difference between the three kinds of audits was not statistically significant(P>0.05).“Records”accounted the highest proportion in inter station mutual review of 19.35%(12/62),while was respectively 0 and 2.94%(1/34)in national and provincial audits,with statistically significant difference between the three kinds of audits(P<0.05).Conclusion External audit against unqualified items is important for quality improvement.By analyzing the unqualified

关 键 词：血站管理 质量管理体系 外部审核 质量评价 质量改进 

分 类 号：R457.12[医药卫生—治疗学] U472.32[医药卫生—临床医学]