Adverse reactions to blood donations: the READ project

Area of Science:

• Transfusion Medicine
• Public Health
• Patient Safety

Background:

• Italy recorded over 2.4 million blood component donations in 2006.
• Donations are collected by Transfusion Structures (TS) and Donor Association Centres.
• The READ project aimed to establish a network for monitoring adverse events (AE) in blood donations.

Purpose of the Study:

• To test a standardized system for monitoring adverse events (AE) in blood donations.
• To create a network of Transfusion Structures (TS) for AE data collection.
• To analyze the incidence and characteristics of AE in blood donation.

Main Methods:

• Developed standardized data collection forms (READ 1 and READ 2) compatible with ISBT-EHN.
• Collected data from six TS between February and August 2008.
• Monitored 89,332 blood donations for adverse events.

Main Results:

• Recorded 523 AE, occurring in 0.59% of donations.
• Mean symptom duration was 17 minutes; 77% were vasovagal AE.
• 47 AE were severe; 59% required no treatment, and three donors required brief hospital monitoring.

Conclusions:

• Standardized forms facilitated data collection and analysis.
• Identified challenges in haemovigilance: organizational issues, limited sensitivity, inadequate training, and unclear responsibilities.
• Recommended addressing identified problems at local, regional, and national levels for improved haemovigilance.