标题：基于RCA法的环节质控措施在成分血制备过程中的应用

      作者：钟泰玉，黄正英，谢淑琳    梅州市中心血站成分科，广东 梅州 514021

      卷次： 2024年35卷14期

      【摘要】 目的 研究基于根本原因分析法(RCA)的环节质控措施在成分血制备过程中的应用效果。方法 选择梅州市中心血站 2019年 1月至 2021年 12月质量控制前血液离心总袋数 283 227袋作为对照组，2022年 1月至2023年6月质量控制后血液离心总袋数123 394袋作为观察组，比较两组各环节血袋破损发生情况。从两组中各随机抽取200袋，比较两组的白细胞残留量、储存期末溶血率和新鲜冰冻血浆Ⅷ因子含量。结果 观察组热合、离心、无菌接合、病毒灭活和速冻环节的血袋破损情况分别为4袋、54袋、2袋、0袋和2袋，总破损率为0.050% (62/123 394)，对照组相应环节的血袋破损情况分别为 20袋、280袋、6袋、0袋和 12袋，总破损率为 0.112% (318/283 277)，观察组总破损率明显低于对照组，差异有统计学意义(P<0.05)；观察组的白细胞残留量、储存期末溶血率分别为(0.53±0.42)×104个U、(0.12±0.09)%，明显低于对照组的(0.69±0.45)×104个U、(0.15±0.08)%，差异均有统计学意义(P<0.05)；观察组的新鲜冰冻血浆Ⅷ因子含量为(0.92±0.15) IU/mL，明显高于对照组的(0.82±0.13) IU/mL，差异有统计学意义(P<0.05)。结论 基于RCA法的环节质控措施在成分血制备过程中的应用效果良好，可显著降低成分血制备过程中的血袋破损率，避免血液浪费，提高血液资源的有效利用率和血液质量，有利于保障临床治疗的顺利进行，提高患者的治疗效果。
      【关键词】 成分血；根本原因分析法；血袋破损；质量控制
      【中图分类号】 R457 【文献标识码】 A 【文章编号】 1003—6350（2024）14—2046—04

Application of link quality control measures based on root cause analysis method in the preparation process ofblood components.
ZHONG Tai-yu, HUANG Zheng-ying, XIE Shu-lin. Department of Composition, Meizhou CentralBlood Station, Meizhou 514021, Guangdong, CHINA
【Abstract】 Objective To study the application effect of quality control measures based on root cause analysis(RCA) method in the preparation process of blood components. Methods A total of 283 227 blood centrifugation bagswere collected before quality control at Meizhou Central Blood Station from January 2019 to December 2021 as the con-trol group, and 123 394 blood centrifugation bags after quality control from January 2022 to June 2023 were collected asthe observation group. The occurrence of blood bag damage in each stage of the two groups were compared. Two hun-dred bags were randomly selected from each group, and the residual amount of white blood cells, hemolysis rate at theend of storage, and factor Ⅷ content in fresh frozen plasma were compared between the two groups. Results The oc-currences of blood bag damage in the heat sealing, centrifugation, aseptic bonding, virus inactivation, and rapid freezingstages of the observation group were 4 bags, 54 bags, 2 bags, 0, and 2 bags, with a total rate of 0.050% (62/123 394), ver-sus 20 bags, 280 bags, 6 bags, 0, and 12 bags in the corresponding stages of the control group, with a total rate of 0.112%(318/283 277); the total damage rate of the observation group was significantly lower than that of the control group (P<0.05). The residual amount of white blood cells and the hemolysis rate at the end of storage in the observation group were(0.53±0.42)×104 U and (0.12±0.09)%, which were significantly lower than (0.69±0.45)×104 U and (0.15±0.08)% in the controlgroup (P<0.05). The content of factor Ⅷ in fresh frozen plasma of the observation group was (0.92±0.15) IU/mL, which wassignificantly higher than (0.82±0.13) IU/mL of the control group (P<0.05). Conclusion The application of quality controlmeasures based on RCA method in the preparation of blood components has shown favorable effects. It can significantlyreduce the rate of blood bag damage during the preparation process, avoide blood waste, improve the effective utilizationrate of blood resources and blood quality, and is conducive to ensuring the smooth progress of clinical treatment and im-proving the treatment effect of patients.
      【Key words】 Blood components; Root cause analysis; Blood bag damage; Quality control