省域血站主要血液质量指标监测值框量区间的建立与应用成效

Establishment and application of measurement range of main blood quality indicators in provincial blood stations

目的获得河北省域血站提供临床使用的红细胞类、血浆及衍生物类及去白细胞单采血小板等主要血液成分的几项质量指标监测值框量区间,了解监测值分布状态及监测水平变化,进一步加强全省血站质控实验室同质化建设。方法2023年收集河北省12家血站2015—2022年常供血液成分抽检数据,制作散点图并设置框量标记,以均值±SD线作为框量区间上限和下限,2024年补充2023年监测数值后对比前后两个框量区间变化,进行稳定性、整体水平分析。结果2015—2022年框量区间与2015—2023年框量区间标准差对比:去白细胞悬浮红细胞-血红蛋白含量由8.132减小为7.993;洗涤红细胞-血红蛋白含量由6.252减小为6.104;洗涤红细胞-上清蛋白质含量由0.273减小为0.267;冷沉淀凝血因子-FⅧ含量由57.506减小为56.276;新鲜冰冻血浆-FⅧ含量由0.920减小为0.892;去白细胞单采血小板-白细胞残留量由0.653减小为0.644、去白细胞单采血小板-红细胞混入量由2.653减小为2.603,以上项目标准差范围缩小,监测值更为集中,离散度降低;2015—2022年框量区间与2015—2023年框量区间均值对比:去白细胞悬浮红细胞的白细胞残留量均值由0.362增长为0.476、洗涤红细胞的血红蛋白含量均值由44.915减小为44.861、上清蛋白质含量均值由0.280增长为0.283、溶血率均值由0.137增长为0.142、冷沉淀凝血因子的FⅧ含量均值由133.989减小为133.271、新鲜冰冻血浆的血浆蛋白含量均值由60.262减小为60.208、FⅧ含量均值由1.301减小为1.277、去白细胞单采血小板-血小板含量均值由3.036减小为3.033,均值距离国标线更近,反映出2023年监测数值不合格值或接近国标线值增多。各项目分类观察:凝血类项目长期合格率较低,未见好转;生化类均稳定性增强但发生整体偏移,平均值近国标线,后续检测不合格可能性增强;计数类涉及项目较多,未表现明显共同性特征。结论探索采用“mean±SD”形式在各项汇总数据分析中的应用,能够较为直观地展现全省监测值在不同项目中呈现的分布状态,形成了既往9年的指标区间框架,表现了各项目类型特征,为后续各单位的质控实验室数据分析提供思路,以采取积极措施提升监测水平。

Objective To obtain the monitoring measurement range of quality indicators of red blood cells,plasma and derivatives and leukocyte-reduced apheresis platelets provided by blood stations in Hebei province,explore the distribution of monitoring values and the change of monitoring level,so as to further strengthen the homogenization construction of quality control laboratories in blood stations in Hebei.Methods In 2023,the sampling data of 12 blood stations in Hebei from 2015 to 2022 were collected,scatter plots were made and the range markers were set,and the“mean±SD”line was taken as the upper limit and lower limit of the measurement range.In 2024,the monitoring values in 2023 were added,and the changes of two measurement ranges were compared to analyze the stability and overall level.Results Comparison of the measurement range from 2015 to 2022 and the measurement range from 2015 to 2023 showed that the standard deviation of the content of deleukocyte suspension of red blood cells-hemoglobin,washed erythrocyte-hemoglobin,washed erythrocyte-supernatant protein,cryoprecipitate coagulation factor-FⅧ,fresh frozen plasma-FⅧ,leukocyte-reduced apheresis platelets-leukocyte residue and leukocyte-reduced apheresis platelet-red blood cell concentration decreased from 8.132 to 7.993,6.252 to 6.104,0.273 to 0.267,57.506 to 56.276,0.920 to 0.892,0.653 to 0.644 and 2.653 to 2.603,respectively.The narrowing of the standard deviation range of the above items led to more concentrated monitoring values and reduced dispersion.Comparison of the measurement range from 2015 to 2022 and the measurement range from 2015 to 2023 showed that the mean value of leukocyte residue of the deleukocyte suspension of red blood cells,hemoglobin content of the wash erythrocyte,protein content of supernatant of the wash erythrocyte,hemolysis rate of the wash erythrocyte,FⅧcontent of the cryoprecipitate coagulation factor,plasma protein content of the fresh frozen plasma,FⅧcontent of the fresh frozen plasma,platelet content of the leukocyte-reduced apheresis platelets changed from 0.362 to 0.476,44.915 to 44.861,0.280 to 0.283,0.137 to 0.142,133.989 to 133.271,60.262 to 60.208,1.301 to 1.277 and 3.036 to 3.033,respectively,and was closer to the national standard line,which reflects an increase in the number of unqualified monitoring values or values close to the national standard line in 2023.The long-term qualified rate of coagulation items was low,and no improvement has been observed.The stability of biochemical items has been enhanced but overall deviation has occurred,with the average value close to the national standard line.The possibility of subsequent testing failure has increased.The counting items showed no obvious common characteristics.Conclusion The use of“mean±SD”in the analysis can visually display the distribution of monitoring values of different items in Hebei,forming an indicator measurement range covering the past nine years.It shows the characteristics of each item,and provides reference for subsequent quality control laboratory data analysis of each blood stations to takes active measures to improve the monitoring level.