Abstract: 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-I was 1.36‰ (194/142 616). 1 726 cases of blood donation adverse reactions were reporteddetected in stage-Ⅱ, including 1 673 cases of onset DRVR, 10 cases of delayed DRVR, 38 cases of hematoma and five cases of citrate reaction. The reported incidence of stage-II was 7.87‰ (1 726/219 419). In stage-Ⅲ, 3 456 cases of blood donation adverse reactions were reported, including 3 348 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‰ (3 456/267 740) in stage-III. The reported incidence of the three stages increased gradually, and the difference was statistically significant (P<0.01, χ²=1 484.10). Conclusion A basic hemovigilance process has been established through 3 stages of development. The management of adverse reactions of blood donation by using electronic record form, clarifying the reporting scope, path and responsibilities of adverse reactions, and incorporating the reporting of adverse reactions into monthly quality Objectives benefits implementation of hemovigilance.

Key words: Adverse reaction of blood donation, Process management, Effect analysis, Hemovigilance