Regional hemovigilance system for adverse reactions to blood donation / 中国输血杂志

ABSTRACT

【Objective】 To establish a regional hemovigilance system of adverse reactions to blood donation(ARBD) and to evaluate its operation effect. 【Methods】 A regional monitoring working group was established to improve the ARBD monitoring system in two phases [phase-ⅠJanuary-June, 2019 and phase-Ⅱ July-December, 2019). The suitability of monitoring standards and reporting approaches, as well as the running effect of this system were evaluated by comparing the accuracy of ARBD classification and severity grading, timely report processing and the contents of reports submitted in two phases. The incidence of ARBD and the number of different types of ARBD cases in the two phases were analyzed to compare the monitoring effect. 【Results】 7 and 17 blood banks joined the regional working groups in phase-Ⅰand phase-Ⅱ, respectively. In phase-Ⅰ, 565 cases of ARBD were reported, 72.04%(407/565)of them was accurately sorted and 80.95%(34/42)were timely reported. Over 99% of reports covered such monitoring items as blood donors′ gender, type of blood donation, place of blood donation, organization mode of blood donation, symptom of ARBD, type, severity grading and other related factors, and less than 20% of reports recorded the details concerning the treatment following ARBD. In phase-Ⅱ, 1098 cases of ARBD were reported, 94.54%(1 038/1 098)of them was accurately sorted and 96.08%(98/102)were timely reported. Over 97% of reports covered the monitoring items mentioned above, still less than 30%, though elevated in comparison with phase-Ⅰ, of reports recorded the details concerning the treatment following ARBD, and less than 20% tracked the ARBD. The overall incidence of ARBD reported was 0.87%, while 0.93%(1 098/118 565)in phase-Ⅱ and 0.77%(565/73 267)in phase-Ⅰ, with statistically significant differences (P<0.01). 【Conclusion】 The regional monitoring system for ARBD in Chongqing, with Blood Safety Hemovigilance Guidelines(T/CSBT 001-2019)as the standard and the Blood Safety Monitoring Management Information System as the reporting approach, has been basically established through two phases of development, and the reporting contents need to be further managed at specific levels.