What is an adverse event?
An adverse event is an incident in which harm resulted to a person receiving health care. In the case of blood and blood products the resulting harm was from the transfusion of blood and blood products.
An incident is an event or circumstance that resulted, or could have resulted, in unintended and/or unnecessary harm to a person and/or a complaint, loss or damage, and a near miss is an incident that did not cause harm, but had the potential to do so.
The Australian Haemovigilance Report 2015 (2.02 MB) notes that haemovigilance has become a more routine part of clinical practice in Australia. Human errors continue to contribute significantly to transfusion-related adverse events however the introduction of mandatory reporting of adverse events under the National Standard for Blood and Blood Products Safety and Quality (NSQHS Standard 7) contributes to the understanding of transfusion related errors, and allows for identification of safety and quality measures to deliver better transfusion outcomes.
Reporting of adverse events
Monitoring of adverse events, and analysing patterns of adverse events, allows for identification of areas of risk and for addressing improvement opportunities. Health professionals must report adverse events that occur as a result of administration of blood and blood products.
The NSQHS Standard 7 on Blood and Blood Products requires health service organisations to ensure that adverse events are included in their incident management and investigation systems, and that they participate in haemovigilance activities conducted by the organisation or at state or national level.
The Therapeutic Goods Administration (TGA) maintains a reporting service for adverse events or defects in medicines in Australia. Information on TGA reporting can be found on the Reporting medicine and vaccine adverse events page and reports can be submitted in various ways which are summarised on the Reporting problems page on the TGA website.
Information for health providers about the individual product requirements for reporting of adverse events can be found at Where do I Report Adverse Events.
Management of adverse events
One of the likely reasons adverse events are under reported is the recognition and elucidation of the cause of the event is often difficult to determine. The NBA in collaboration with the Haemovigilance Advisory Committee (HAC) and other stakeholders is developing a guidance document for the recognition and management of acute transfusion reactions such as TACO and TRALI. The NBA sought input from stakeholders as part of a public consultation process and received a number of comments. The key message was that the guidance (including a chart) was too complex. The guidance is being reworked and will be published on the NBA website in due course.