Adverse events

The Blood Management Standard(Opens in a new tab/window) defines adverse events in the following ways:

  • 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.

Reporting a transfusion-related adverse event

Health service organisations (HSOs) should ensure that transfusion-related adverse events are:

  1. reported in an incident management and investigation system
  2. reported to the pathology service provider if required
  3. reported to the supplier if required:
    • for fresh blood products, report to Lifeblood (for transfusion-related acute lung injury, transfusion-transmitted infection, or reactions or incidents suspected to be related to the blood component quality, Lifeblood manufacturing, or labelling errors only)
    • for blood-related products, report to the manufacturer.

The supplier is responsible for checking if the event needs to be reported to the Therapeutic Goods Administration(Opens in a new tab/window) (TGA).

HSOs also submit the event to the state or territory health department.

The manufacturer makes most adverse event reports to the TGA(Opens in a new tab/window). Reports can also be made by:

  • state and territory health departments
  • HSOs
  • health professionals
  • patients.

Sentinel events

A sentinel event is a particular type of serious incident that is wholly preventable and has caused serious harm to, or the death of, a patient.

Sentinel events are:

ABO incompatibility is a sentinel event.

Our role in haemovigilance

Haemovigilance refers to the surveillance of the entire blood transfusion chain, from blood donation to following up with patients after transfusion. It is a set of processes and procedures to:

  • improve blood and blood product management
  • monitor and improve safety for people donating or receiving blood.

Under the National Blood Agreement, the NBA is required to promote optimal safety and quality in the supply, management and use of products, including through uniform national standards. This includes through the Strategic Framework for the National Haemovigilance Program(Opens in a new tab/window) (national framework).

 

National framework and the standard

The national framework outlines the roles and responsibilities for haemovigilance in Australia.

The Blood Management Standard(Opens in a new tab/window) includes 2 actions for HSOs. These actions relate to reporting transfusion-related adverse events:

Data collection

Haemovigilance data submitted to the NBA is currently collated by states and territories using the blood-related adverse event definitions in either the 2010 or 2015 Australian Haemovigilance Minimum Data Set(Opens in a new tab/window) (AHMDS).

States and territories are responsible for validating, aggregating, and de-identifying the data before submission to the NBA for inclusion in the Australian haemovigilance reports.

It is anticipated that implementation of the new 2024 Australian Haemovigilance Minimum Data Set will begin on 1 July 2025 for the 2025-26 reporting period. The NBA will liaise with the jurisdictions to develop updated reporting forms (if required) to report against the new AHMDS. 

 

State and territory haemovigilance programs

Haemovigilance advisory committee

Our Haemovigilance Advisory Committee gives advice to the NBA on:

  • adverse event reporting from HSOs
  • national transfusion safety priorities
  • the annual haemovigilance report
  • the national framework development and delivery.

Webinars and seminars

This series of webinars(Opens in a new tab/window) has experts talking about their experiences with haemovigilance.

Australia is also a member of the International Haemovigilance Network (IHN)(Opens in a new tab/window). IHN holds a haemovigilance seminar each year for member countries and researchers.

IHN brings together people and organisations from around the world with an interest in haemovigilance for education and support. IHN holds international scientific seminars and provides a forum for:

  • developing definitions
  • sharing and analysing data for benchmarking and practice improvement.
     

Get in touch

Email: haemovigilance@blood.gov.au

Last updated: 27 Mar 2024

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