(P-TS-59) Implementation of an institutional hemovigilance program in Argentina

Background/Case Studies: Hemovigilance is a set of surveillance procedures covering the vein-to-vein transfusion process which encompasses the reporting, monitoring and analyzing of adverse events with the overarching goal of improving donor and patient safety.
Hemovigilance schemes make it possible to obtain objective, precise, complete and rigorous information regarding the profile of adverse reactions to transfusion that occur in patient care and constitute key source to assessment of transfusion reactions, detection of vulnerabilities and implementation of strategies to improve transfusion safety.
In Argentina, as well as in most Latin American countries, there is not an official and mandatory hemovigilance reporting system.In our institution there was no hemovigilance program that actively searches for, investigates and analyzes transfusion reactions.Since October 2022 we have started to implement an institutional active hemovigilance program.
The objective of this work is to know the frequency and profile of adverse transfusion reactions in patients transfused in the hospital and to assess the results of achievement a Hemovigilance program to implement and guide actions aimed at improving transfusion safety.

Study

Design/Methods: We conducted an observational, analytic, longitudinal, prospective cohort study. All transfused patients were monitored to actively investigate the occurrence of adverse transfusion reactions through a new hemovigilance protocol implemented by transfusion medicine service's staff. All patients who received transfusions of blood components during 2023 were included in the analysis. The study has been approved by the ethics committee, and participating patients signed an informed consent form.
We followed the definitions and classification of adverse reactions, severity and imputability stated developed by the International Hemovigilance Network (INH) and the International Society of Blood Transfusion (ISBT). All transfusion reactions detected were reported and analyzed.

Results/Findings: A total of 8773 blood products were transfused during 2023.For all blood products, a total of 71 transfusion reactions were reported (0.8%), of which were imputed “possible-probable” 59 (0.7%): 29 (49%) allergic reactions, 28 (47%) febrile non hemolytic transfusion reactions, 1 (1.7%) transfusion-related acute lung injury and 1 (1.7%) transfusion associated circulatory overload.The general rate by type of blood component was 0.85% for RBC, 0.52% for PC, 0.54% for FFP and 7.6% for granulocytes. Compared with the number of reports from previous stage (0.39%  in 2021),  the new hemovigilance program increased the report number in a 100%. 

Conclusions: The implementation of an institutional hemovigilance program managed to increase the percentage of notifications of adverse transfusion reactions and, through their analysis, implement actions to mitigate them and thus improve transfusion safety.