The transfusion of blood and blood components is a core part of healthcare service delivery to patients. While the use of blood and blood components can be lifesaving, there are also risks associated with transfusion. In Australia, the risk of transmission of infectious disease (such as HIV, hepatitis B and C) through blood transfusions has reduced significantly in recent years through improved manufacturing and laboratory processes. However, in common with other developed countries, the non-infectious risks of transfusion, especially those related to human errors, continue to occur and affect patients' safety and health.
The mechanisms to ensure the safety of transfusions in Australia include:
- clinical transfusion guidelines to direct transfusion practices
- state and territory audit systems to monitor guideline compliance
- jurisdictional and national transfusion education initiatives to train and update clinical staff on best transfusion practices
- development of a national patient blood management program to create leadership for the appropriate use of blood and blood products
- a National Haemovigilance Program which monitors, through state and territory haemovigilance systems, the occurrence of transfusion-related serious adverse events in patients.
Surveillance of adverse transfusion events is the cornerstone of haemovigilance systems. The World Health Organization (WHO) states that:
'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.'
However, there are many ways in which haemovigilance is defined. A founding definition of haemovigilance was set out in Directive 2002/98/EC of the European Parliament, setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components:
'A set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow‑up of donors'.
The International Haemovigilance Network (IHN)definition is the most widely used:
'A set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence.'
Haemovigilance is now universally recognised as an integral part of safety in blood transfusion, and increasing attention is being paid to haemovigilance in many countries. The WHO Global Database on Blood Safety Summary Report 2011 indicates that a national haemovigilance system was present in 13% of low-income countries, 30% of middle-income countries and 78% of high‑income countries (data based on 106 responding countries). National haemovigilance systems provide an evidence base for the improvement of transfusion practice that displays the real risks and hazards of transfusion in a given community/country and allows for the dissemination of these findings and the instigation of appropriate actions, including educational processes to prevent recurrence.