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