"Haemovigilance is required to identify and prevent occurrence or recurrence of transfusion related unwanted events, to increase the safety, efficacy and efficiency of blood transfusion, covering all activities of the transfusion chain from donor to recipient."
The system should include monitoring, identification, reporting, investigation and analysis of adverse events near-misses and reactions related to transfusion and manufacturing.
The information gained from the investigations and analyses facilitate corrective and preventive actions to be taken to minimize the potential risks associated with safety and quality in blood processing and transfusion for donors, patients and staff. Such information is also key to introduce required changes in the applicable policies, improve standards, systems and processes, assist in the formulation of guidelines, and increase the safety and quality of the entire process from donation to transfusion.
The haemovigilance system should involve all relevant stakeholders, and should be coordinated between the blood transfusion service, hospital clinical staff and transfusion laboratories, hospital transfusion committees, regulatory agency and national health authorities. Extension of the haemovigilance system to regional and global sharing of information will further enhance the process of learning for improvement.
The WHO draft guidelines on adverse event reporting and learning systems: from information to action emphasize the fundamental role of reporting systems in enhancing patient safety by learning from failures of health care systems. Effectiveness of such systems should be measured not only by data reporting and analysis but by the use of such systems to improve patient safety.