摘要
目的 建立有效的血站血液质量控制监测指标体系,对采供血质量控制指标数据进行分析,客观评价血液质量控制过程的差距,促进血站血液质量控制的持续提升和标准化管理.方法 建立覆盖采供血全过程的献血服务、成分制备、血液检测、血液供应和质量控制的质量监测指标体系,向山东省 17 家血站发放《采供血过程质量监测指标统计表》,明确指标定义和计算公式,收集各血站 2022 年 1-12 月质量监测指标数据,利用SPSS25.0 软件对其中的质量控制(20 个)的质量监测指标数据进行统计学分析,P<0.05 差异具有统计学意义.结果 17 家血站关键设备监测合格率、环境卫生监测合格率、关键物料监测合格率、血液质量检查项目合格率平均值分别为 99.47％、99.51％、99.95％和 98.99％,不同规模血站间环境卫生监测合格率差异具有统计学意义(P<0.05),血液质量检查项目总数与血液制备总量皮尔逊相关系数r=0.645(P<0.05).检验报废率、非检验报废率平均值为 1.14％、3.36％,在不同规模血站间的报废率差异均具有统计学意义(P<0.05).乳糜血报废率平均为 3.07％,乳糜血报废率与非检验报废率成正相关(r=0.9813,P<0.05),实施乳糜血控制措施的血站和未实施控制措施的血站之间的乳糜血报废率差异具有统计学意义(P<0.05).血液色泽异常报废率、非标量血液报废率、血袋破损报废率、溶血报废率、血液蛋白析出报废率、血液凝块报废率平均值为 0.20％、0.14％、0.06％、0.06％、0.02％、0.02％,6 项指标在大、中、小规模血站间进行比较,差异有统计学意义(P均<0.05);血液过期报废率、其他因素报废率、保密性弃血报废率、不合格标本血报废率平均值为 0.02％、0.05％、0.003％、0.004％.气泡血报废率为 0.015％,异物血报废率和标签不合格血报废率均为0.结论 山东省血站质量控制监测指标体系能够监测过程管理中的薄弱环节,具有较好的适用性、可行性和有效性,有利于血站自身和血站之间的比对,取长补短,持续提升全省采供血质量控制水平,推进全省血液质量管理同质化和标准化发展,以及为开展血站综合评价奠定基础.
Abstract
Objective To establish an effective quality monitoring indicator system for blood quality control in blood banks,in order to analyze the quality control indicators for blood collection and supply,and evaluate blood quality control process,thus promoting continuous improvement and standardizing management of blood quality control in blood banks.Methods A quality monitoring indicator system covering the whole process of blood collection and supply,including blood donation services,component preparation,blood testing,blood supply and quality control was established.The Question-naire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shan-dong,which clarified the definition and calculation formula of indicators.The quality monitoring indicator data from January to December 2022 in each blood bank were collected,and 20 quality control indicators data were analyzed by SPSS25.0 soft-ware.Results The average pass rate of key equipment monitoring,environment monitoring,key material monitoring,and blood testing item monitoring of 17 blood banks were 99.47％,99.51％,99.95％and 98.99％,respectively.Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05),and the Pearson correlation coefficient(r)between the total number of blood quality testing items and the total amount of blood com-ponent preparation was 0.645(P<0.05).The average discarding rates of blood testing or non-blood testing were 1.14％and 3.36％respectively,showing significant difference among blood banks of varied scales(P<0.05).The average discarding rate of lipemic blood was 3.07％,which had a positive correlation with the discarding rate of non testing(r=0.981 3,P<0.05).There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without(P<0.05).The average discarding rate of abnormal color,non-standard volume,blood bag damage,hemolysis,blood protein precipitation and blood clotting were 0.20％,0.14％,0.06％,0.06％,0.02％and 0.02％respectively,showing statistically significant differences among large,medium and small blood banks(P<0.05).The average discarding rates of expired blood,other factors,confidential unit exclusion and unqualified samples were 0.02％,0.05％,0.003％and 0.004％,respectively.The discarding rate of blood with air bubbles was 0.015％,while that of blood with foreign body and unqualified label were 0.Conclusion The quality control indicator sys-tem of blood banks in Shandong can monitor weak points in process management,with good applicability,feasibility,and effectiveness.It is conducive to evaluate different blood banks,continuously improve the quality control level of blood collec-tion and supply,promote the homogenization and standardization of blood quality management,and lay the foundation for comprehensive evaluation of blood banks in Shandong.
国家科技期刊平台
NSTL
万方数据