某血液中心开展献血不良反应监测实践及效果评价  

Establishment and Evaluation of Hemovigilance Process for Adverse Reactions to Blood Donationin One Blood Center

作　　者：杨俊鸿[1] 胡文杰 杨培[1] 邓莉[1] 黄霞[1] 徐永柱 YANG Jun-hong;HU Wen-jie;YANG Pei(Chongqing Blood Center,Chongqing 400052)

机构地区：[1]重庆市血液中心,重庆400052

出　　处：《临床输血与检验》2023年第1期21-26,共6页Journal of Clinical Transfusion and Laboratory Medicine

基　　金：重庆市科卫联合医学科研青年项目(No.2022QNXM056);重庆市科卫联合医学科研重点项目(No.2022ZDXM031)资助。

摘　　要：目的建立血站献血不良反应监测流程并评价其运行效果。方法本中心在2018年1月~2021年12月分3个阶段建立献血不良反应监测流程,系统性地开展献血不良反应监测。第1阶段(2018年1~12月)根据卫生行业标准《献血不良反应分类指南》(WS/T551-2017)设计献血不良反应登记表,采用纸质方式记录和每月报告献血不良反应监测情况;第2阶段(2019年1月~2020年6月)采用电子版记录表(1.0版)监测献血不良反应;第3阶段(2020年7月~2021年12月)采用电子版记录表(2.0版)监测献血不良反应,明确报告范围、途径和职责,并纳入每月质量目标进行管理。本文回顾性分析建立献血不良反应监测流程的3个阶段采取的监测和管理措施。通过分析监测标准适用性、报告途径适用性和监测效果,评价血站监测流程运行的有效性。结果第1阶段报告3类献血不良反应194例,其中即发型献血相关血管迷走神经反应(DRVR)187例,血肿1例,枸橼酸盐反应6例;第1阶段报告发生率为1.36‰(194/142616)。第2阶段报告4类献血不良反应1726例,其中即发型DRVR1673例,迟发型DRVR10例,血肿38例,枸橼酸盐反应5例;报告发生率为7.87‰(1726/219419)。第3阶段报告5类献血不良反应3456例,其中即发型DRVR3348例,迟发型DRVR29例,血肿34例,神经刺激8例,枸橼酸盐反应37例;报告发生率为12.91‰(3456/267740)。3个阶段报告发生率逐步提升,差异有统计学意义(P<0.01,χ^(2)=1484.10)。结论通过3个阶段的发展,基本建立了本中心献血不良反应监测流程。采用电子版记录表、明确献血不良反应报告范围、途径和职责,并将不良反应报告情况纳入每月质量目标进行管理有利于献血不良反应监测工作的开展。Objective To establish a hemovigilance process for adverse reactions of blood donation in one blood center and to evaluate its effect.Methods From January 2018 to December 2021,the hemovigilance process of adverse reactions of blood donation was established in three stages.In stage-Ⅰ(January-December 2018),a registration form was designed according to the health standard"Guidelines for Classification of Blood Donation Adverse Reactions"(WS/T 551-2017).The information of adverse reactions was recorded in paper form and reported monthly.In stage-Ⅱ(January 2019-June 2020),the electronic record form(version 1.0)was used to record the information of adverse reactions.In stage-Ⅲ(July 2020-December 2021),the electronic record form was upgraded to version 2.0,and the reporting scope,path and responsibility were clarified.Adverse reaction data was included in the monthly management of quality objectives.This article retrospectively analyzed the management measures adopted in three stages of the established hemovigilance process of adverse reactions.The applicability of the criteria,the feasibility of the reporting path and the monitoring effect were used to evaluate the effectiveness of the hemovigilance process.Results In stage-Ⅰ,194 cases of adverse reactions were detected,including 187 cases of blood donation related vasovagal reaction(DRVR),one case of hematoma and six cases of citrate reaction.The reported incidence of stage-Ⅰwas 1.36‰(194/142616).1726 cases of blood donation adverse reactions were reporteddetected in stage-Ⅱ,including 1673 cases of onset DRVR,10 cases of delayed DRVR,38 cases of hematoma and five cases of citrate reaction.The reported incidence of stage-Ⅱwas 7.87‰(1726/219419).In stage-Ⅲ,3456 cases of blood donation adverse reactions were reported,including 3348 cases of onset DRVR,29 cases of delayed DRVR,34 cases of hematoma,8 cases of nerve irritation and 37 cases of citrate reaction.The reported incidence was 12.91‰(3456/267740)in stage-Ⅲ.The reported incidence of the thr

关 键 词：献血不良反应 流程管理 效果分析 血液安全监测 

分 类 号：R457[医药卫生—治疗学]