采供血机构血液成分制备质量监测指标的构建和初步评价

Construction and preliminary evaluation of monitoring index of blood component preparation quality in blood banks

目的提升血液成分制备的质量水平和持续改进能力。方法采用问卷调查辅以微信核实的方式,收集28家血站2019年12月—2020年2月期间在血液成分制备过程中的质量监测数据,通过同比和环比开展差异分析。结果血液成分制备血袋破损率血液中心和中心血站3种血液(血浆、原料浆和全血)的血袋破损率:血液中心分别为0.04%、0.09%和0.03%;中心血站分别为0.09%、0.04%和0.03%,无统计学差异。华东地区15家血站的血浆和全血血袋破损率(分别为0.11%、0.05%)较其它地区高,P<0.05。开展脂血筛查血站和未开展或部分开展脂血筛查血站的临床退回脂肪/乳糜血浆报废率比较有显著性差异(开展脂血筛查血站2.04%、未开展或部分开展脂血筛查血站7.69%)。血液中心的溶血血浆报废率均值为0.28%,中心血站的溶血血浆报废率均值为0.05%,P>0.05。贴签错误率(0.22%)比较血站规模、地理位置、血液成分制备场所规模P>0.05。病毒灭活血浆穿刺/接驳渗漏率比较血站规模和地理位置P>0.05。项目组发放问卷28份,回收问卷率100%。8项质量监测指标试行率84.46%、适用率93.81%、可行率94.18%、有效率94.59%。结论血液成分制备质量监测指标已建立,并经初步评价指标适用、有效和可行。建立和运行血液成分制备质量监测指标,有利于血站有效监测血液制备过程,持续改进质量管理体系,并为建立血站评价体系打好基础。

Objective To continuously improve the quality and capability of blood component preparation in blood banks. Methods The quality monitoring data regarding the blood production process from December 2019 to February 2020, reported by 28 blood stations(11 provincial blood centers and 17 regional central blood stations), was collected by questionnaires, paralleled by WeChat App for further verification. The data we collected was compared and analyzed on the year-on-year and month-on-month basis.Results The damage rate of bags involved in plasma, raw plasma and whole blood manufacturing in blood centers and blood stations were 0.04%, 0.09%, 0.03% and 0.09%,0.04%,0.03%, respectively, and no significant difference was noticed between each other. The damage rate of bags involved in plasma and whole blood manufacturing were 0.11% and 0.05% in 15 blood stations in east China, which was significantly higher than those in other areas(P<0.05). The discarding rate of fatty/lipemic blood from blood stations that had carried out lipemia screening and those had not carried out/partially carried out lipemia screening were 2.04% and 7.69%, showing significant differences(P<0.05). The average discarding rate due to hemolysis in blood centers and blood stations were 0.28% and 0.05%,with no significant difference(P>0.05). The error incidence of labeling was 0.22%, with no significant correlation with blood station scale, location and size of blood production site(P>0.05). And the leakage rate at puncturing and connecting steps of virus inactivated plasma manufacturing had, no significant correlation with the scale and location of blood stations(P>0.05). 28 questionnaires were distributed by the project team, and 100% were returned. The trial rate, applicable rate, feasible rate and effective rate of 8 quality monitoring indicators were 84.46%, 93.81%, 94.18% and 94.59%, respectively.Conclusion The quality monitoring index of blood production process has been established and proved to be applicable, effective and feasible after the preliminary evaluation. It contributes to the dynamic monitoring of production process and ongoing improvement of quality management system, paving the way for the establishment of blood bank evaluation system.