What is an adverse event?
The following definitions are taken from the Australian Commission on Safety and Quality in Health Care (ACSQHC), National Safety and Quality Health Service (NSQHS) Standards, Second Edition.
- An adverse event is an incident that results, or could have resulted, in harm to a patient or consumer. A near miss is a type of adverse event.
- An incident (clinical) is an event or circumstance that resulted, or could have resulted, in unintended or unnecessary harm to a patient or consumer; or a complaint, loss or damage. An incident may also be a near miss.
- A near miss is an incident or potential incident that was averted and did not cause harm, but had the potential to do so.
The Australian Haemovigilance Report 2015 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. The introduction of mandatory reporting of adverse events under the National Safety and Quality Health Service Standard for Blood Management (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 use processes for reporting transfusion-related adverse events, in accordance with national guidelines and criteria, ensuring that adverse events are included in incident management and investigation systems.
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.
Management of adverse events
Adverse events may be under reported where the cause of the event is 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 received a number of comments from stakeholders through a public consultation process. 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.
Information for health providers about the individual product requirements for reporting of adverse events can be found at Where do I Report Adverse Events.