First donor haemovigilance system at a national level in China: Establishment and improvement

作者全名："Yang, Junhong; Fan, Dinrong; Xie, Dongfu; Guo, Xiaojie; Zhu, Wenqing; He, Tao; Huang, Xia"

作者地址："[Yang, Junhong; Huang, Xia] Chongqing Blood Ctr, 21 Huafu Rd, Chongqing 400052, Peoples R China; [Yang, Junhong; Xie, Dongfu; Guo, Xiaojie; He, Tao; Huang, Xia] Working Party Hemovigilance Chinese Soc Blood Tran, 1 Guihuayuan Rd, Chongqing 400015, Peoples R China; [Fan, Dinrong] Chongqing Med Univ, Sch Nursing, Chongqing, Peoples R China; [Fan, Dinrong] Chongqing Med Univ, Dept Crit Care Med, Affiliated Hosp 2, Chongqing, Peoples R China; [Xie, Dongfu] Shanghai Red Cross Blood Ctr, Shanghai, Peoples R China; [Guo, Xiaojie] Anhui Blood Ctr, Hefei, Peoples R China; [Zhu, Wenqing] Fujian Blood Ctr, Fuzhou, Peoples R China; [He, Tao] Chongqing Soc Blood Tranfus, Chongqing, Peoples R China"

通信作者："Huang, X (通讯作者)，Chongqing Blood Ctr, 21 Huafu Rd, Chongqing 400052, Peoples R China.; He, T; Huang, X (通讯作者)，Working Party Hemovigilance Chinese Soc Blood Tran, 1 Guihuayuan Rd, Chongqing 400015, Peoples R China."

来源：VOX SANGUINIS

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000946328600001

JCR分区：Q3

影响因子：1.8

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：adverse reactions; blood donation; donor health; haemovigilance

摘要："Background and Objectives: No systematic study has measured the incidence of adverse reactions (ARs) to blood donation at the national level in China before 2019. The objective of this study was to establish an effective reporting system to collect information on ARs to blood donation in China.Materials and Methods: The status of donor haemovigilance (DHV) in blood collection facilities in China was evaluated, and an online DHV system was established to collect data on ARs to blood donation in July 2019. The definitions of ARs were based on the International Society of Blood Transfusion (ISBT) standards. The prevalence and data quality of ARs from 2019 to 2021 were analysed.Results: A standard online reporting system has been established for ARs to blood donation. In total, 61, 62 and 81 participating sites were included in this pilot study in 2019, 2020 and 2021, respectively. From July 2019 to December 2021, 21,502 cases of whole-blood-related ARs and 1114 cases of apheresis platelet-related ARs were reported, with an incidence of 3.8 parts per thousand and 2.2 parts per thousand, respectively. Data completeness for key reporting elements improved from 41.7% (15/36) in 2019 to 74.4% (29/39) in 2020. Data quality analysis for the year 2021 yielded similar results as for 2020.Conclusion: The construction and continuous improvement of the blood donor safety monitoring system prompted the establishment of the DHV system. Improvements have been made to the DHV system in China, with a significant increase in sentinels and higher data quality."

基金机构："Chongqing Science and Health Research Fund [2022ZDXM031, 2022QNXM056]"

基金资助正文："ACKNOWLEDGEMENTS This work was supported by the Chongqing Science and Health Research Fund (2022ZDXM031, 2022QNXM056). The authors thank all participating sites for their input, as well as everyone who has provided feedback data. J.Y. and D.F. performed the study and wrote the first draft of the manuscript; D.X. contributed to the definitions; X.G. and W.Z. performed the statistical analysis; T.H. and X.H. contributed to the study design and manuscript review."