基于《血液安全监测指南》开展临床输血不良事件监测的探索*

doi:10.3969/j.issn.1671-2587.2023.01.009

临床输血与检验 ›› 2023, Vol. 25 ›› Issue (1): 48-55.DOI: 10.3969/j.issn.1671-2587.2023.01.009

基于《血液安全监测指南》开展临床输血不良事件监测的探索^*

程志祥, 任林, 曹红荣, 张玉, 王珊珊, 张国庆, 黄霞

230012 合肥,安徽医科大学第一附属医院输血科（程志祥,任林,曹红荣,张玉,王珊珊,张国庆）; 安徽省公共卫生临床中心（程志祥,任林,曹红荣,张玉,王珊珊,张国庆）; 重庆市血液中心（黄霞）

收稿日期:2022-10-28 发布日期:2023-02-20
通讯作者: 黄霞,女,主任技师,博士,主要从事血液质量管理和血液安全监测体系建立研究,（E-mail）xiahuangyy@163.com。
作者简介:程志祥（1979-）,男,副主任技师,硕士,主要从事临床输血及血液安全监测工作,（E-mail）chengzhixiang@sina.com。
基金资助:
*本课题受重庆市科卫联合医学科研项目（No.2022ZDXM031）资助

Haemovigilance for Guideline-based Blood Transfusion Adverse Events

CHENG Zhi-xiang, REN Lin, CAO Hong-rong, et al

The First Affiliated Hospital of Anhui Medical University,Hefei 230012

Received:2022-10-28 Published:2023-02-20

摘要/Abstract

摘要： 目的分析我院开展临床输血不良事件监测的数据,探讨哨点单位开展临床输血不良事件监测体系的建立和效果评价。方法 2020~2021年依据《血液安全监测指南（T/CSBT 001-2019）》对输血链中临床输血不良事件开展监测实践,收集两年监测数据并进行回顾性分析。结果分析对比近两年临床输血不良事件在各环节中报告例数及报告率显示,2021年新增输血不良事件9类,减少输血不良事件8类,其中报告率增加以TS-B01（χ²=5.49,P=0.02）、TS-B05（χ²=8.46,P<0.01）及TS-F04（χ²=9.81,P<0.01）差异有统计学意义,报告率减少以TS-D12（χ²=4.80,P=0.03）及TS-I06（χ²=15.07,P<0.01）差异有统计学意义。两年内,不良事件发生环节均主要集中在“输血前评估及输血申请TS-B”环节（152例,46.63%）。而其他发生环节的占比在两年间有所变化,其中“实验室检测”比例从17.42%下降到6.70%（χ²=9.20,P<0.01）,“支持保障”比例从15.91%下降到2.58%（χ²=19.02,P<0.01）,而“血液输注”从0.76%增加到9.79%（χ²=11.14,P<0.01）,“输血后处置与评价”从3.03%增加到11.86%（χ²=8.05,P<0.01）。不良事件发生的主要部门为外科系统（129例,39.57%）,且呈现增长趋势（从25.76%上升到48.97%,χ²=17.70,P<0.01）,其次为输血科（73例,22.39%）,呈现明显下降趋势（从33.33%下降到14.95%,χ²=15.28,P<0.01）。不良事件主要原因是人员问题,其中与医师有关的人员问题占首位（196例,60.12%）,其次为与输血科技师有关的人员问题（49例,15.03%）,但呈现下降趋势（从18.18%下降至7.73%,χ²=8.15,P<0.01）。将两年不良事件以输注的血液成分不同而进行分类发现,发生在输注红细胞成分的不良事件报告率最高,分别为2.35%和3.28%。结论利用《指南》建立临床输血不良事件监测体系并有效开展监测活动,可以提高输血不良事件的识别能力和处理能力,及时发现偏差并进行针对性改进,实现输血质量与安全的持续改进。

关键词: 血液安全监测, 不良事件, 临床输血, 血液安全

Abstract: Objective To analyze the data based on the haemovigilance of transfusion related adverse events(TRAEs) in our hospital,and to investigate the establishment of haemovigilance system and to evaluate its effectiveness regarding TRAEs at sentinel institutions. Methods In accordance with the Guideline for Haemovigilance (T/CSBT 001-2019),surveillance of TRAEs in the transfusion chain was carried out from 2020 to 2021,and data were retrospectively analyzed. Results TRAE data in the past two years showed that 9 types were added and 8 types were not observed in 2021. The most significant increased rates reported were TS-B01 (χ²=5.49,P=0.02),TS-B05 (χ²=8.46,P<0.01) and TS-F04 (χ²=9.81,P<0.01). The decreased rates were TS-D12 (χ²=4.80,P=0.03) and TS-I06 (χ²=15.07,P<0.01). Within the two years,TRAEs were mainly reported in the "pre-transfusion assessment and transfusion application TS-B" (152 cases,46.63%). While,the proportion of other events changed during the two years. Of which,the proportions of laboratory testing decreased from 17.42% to 6.70% (χ²=9.20,P<0.01),support coverage from 15.91% to 2.58% (χ²=19.02,P<0.01). Whereas the rates of blood transfusion increased from 0.76% to 9.79% (χ²=11.14,P<0.01),post-transfusion disposition and evaluation from 3.03% to 11.86% (χ²=8.05,P<0.01). Adverse events were mainly reported in surgical departments (129 cases,39.57%),with an increasing trend (from 25.76% to 48.97%,χ²=17.70,P<0.01),followed by in transfusion department (73 cases,22.39%) with a decreasing trend (from 33.33% to 14.95%,χ²=15.28,P<0.01). The main causes of adverse events were human errors,among which errors related to physician accounting for 60.12%,followed by errors related to technician accounting for 15.03% with a decreasing trend (from 18.18% to 7.73%,χ²=8.15,P<0.01). Based on blood components transfused,red blood cells transfusion had the highest reported rate accounting for 2.35% and 3.28% respectively. Conclusion The establishment and monitor of haemovigilance for guideline-based clinical transfusion adverse events improved the identification and management of transfusion adverse events. It found the deviation in time and made targeted improvement to achieve continuous improvement of blood transfusion quality and safety.

Key words: Haemovigilance, Adverse events, Clinical blood transfusion, Blood safety

中图分类号:

R457

程志祥, 任林, 曹红荣, 张玉, 王珊珊, 张国庆, 黄霞. 基于《血液安全监测指南》开展临床输血不良事件监测的探索^*[J]. 临床输血与检验, 2023, 25(1): 48-55.

CHENG Zhi-xiang, REN Lin, CAO Hong-rong, et al. Haemovigilance for Guideline-based Blood Transfusion Adverse Events[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2023, 25(1): 48-55.

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基于《血液安全监测指南》开展临床输血不良事件监测的探索^*

Haemovigilance for Guideline-based Blood Transfusion Adverse Events

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