A study to assess and grade the donor adverse events using the severity grading tool of hemovigilance program of...

Donor vigilance is the monitoring of donor adverse events (DAEs) to improve donor safety and the quality of the blood donation process. This study aimed to grade and assess DAEs using a new severity grading tool (SGT) by the Hemovigilance Programme of India and to identify factors influencing it.

A single-center prospective observational study was conducted over 14 months among whole blood and apheresis donors with DAEs. Data was recorded in the Adverse Blood Donor Reaction Reporting Form-2 and supplemented with Blood Centre records. Data were compiled in Microsoft Excel and analyzed using DATAtab 2023.

Out of 11,171 registered blood donors, 7188 were eligible for donation. The overall incidence of DAEs was 288 (4.0%), out of them 0.3% occurred in predonation, 20.5% during donation, and 79.2% in postdonation. Among the DAEs, 95.8% were Grade 1, and 4.2% were Grade 2. DAEs were significantly higher in females, first-time, and apheresis donors, with increased incidence during noon time, summer season, and outdoor camps. Generalized vasovagal reactions were the most common.

Four out of 100 donors were experiencing DAE, and the majority was of Grade 1 severity. Strategies may be adopted to mitigate DAEs among those who are predisposed to DAEs. In addition, unreported delayed DAEs are of further concern for the blood center. Our study found that SGT effectively improves the objective severity grading of DAEs. Terminologies like outside medical care are less relevant in India, where most blood donors with DAEs are managed by the medical team at the blood centre.