Haemovigilance is a set of surveillance procedures covering the entire blood transfusion chain, from the donation and processing of blood and its components, to their provision and transfusion to patients, to their follow-up. It includes monitoring, reporting, investigating and analysing adverse events related to the donation, processing and transfusion of blood, as well as development and implementation of recommendations to prevent the occurrence or recurrence of adverse events.1
The National Blood Authority (NBA) has developed a reporting and governance framework for the National Haemovigilance Program for Australia. It reports on serious transfusion related adverse events occurring in participating public and private hospitals.
National Safety and Quality Health Service (NSQHS) Standard 7 on Blood and Blood Products requires health service organisations to report adverse events as follows:
• Action 7.7: The health service organisation uses processes for reporting transfusion-related adverse events, in accordance with national guidelines and criteria
• Action 7.8: The health service organisation participates in haemovigilance activities, in accordance with the national framework (486.35 KB).
A recommendation in the Australian Haemovigilance Report 2013 was to “Conduct a scoping exercise for a national haemovigilance system”. In response to the recommendation, the NBA developed an options paper for consideration by the Haemovigilance Advisory Committee (HAC) and the Jurisdictional Blood Committee (JBC). The outcome from that consultation is the Strategic Framework for the National Haemovigilance Program (Strategic Framework), endorsed by the JBC in September 2014.
The Strategic Framework redefines the scope of national haemovigilance arrangements to emphasise activities that contribute to national standardisation, but suspends further work to develop a national IT system solution at this time. Although the NBA will not host a National Haemovigilance reporting IT system, the NBA will continue to collect, analyse and report haemovigilance data received from state and territories at the level defined in the Australian Haemovigilance Minimum Data Set.
The Strategic Framework is currently under review by HAC. Once it is reviewed it will be provided to JBC for endorsement.
The Australian Haemovigilance Minimum Data Set (AHMDS) enables consistent data collection and analysis of transfusion related adverse events to improve the quality of national haemovigilance reporting. The AHMDS was developed based on the Australian Institute of Health and Welfare (AIHW) Metadata Online Registry (METeOR) format and the International Society of Blood Transfusion (ISBT) standard haemovigilance definitions where possible. Any definitions not covered by these were determined by the Haemovigilance Advisory Committee.
The first edition of the AHMDS (known as the 2010 National Haemovigilance Data Dictionary) is superseded by the 2015 AHMDS.
Haemovigilance Advisory Committee
The NBA’s national haemovigilance program is informed by the Haemovigilance Advisory Committee (HAC). This group provides advice to the NBA on adverse event reporting originating from health service organisations and on national transfusion safety priorities.
In 2018-19, membership of the HAC was refreshed and the new committee was established by the NBA Chief Executive under section 38 of the National Blood Authority Act 2003 to provide advice and guidance in relation to the development and implementation of the Strategic Framework. The new membership is comprised of individuals with expertise and knowledge in the health sector, blood management, quality and safety, and consumer issues.
The HAC Terms of Reference (TOR) (194.85 KB) and Section 38 Instrument (71.89 KB) detail the governance arrangements for HAC. The membership is included in the ToR document. The HAC ToR is approved by the NBA’s Chief Executive.
For more information
Australian Haemovigilance Information and Programs
- NSW Clinical Excellence Commission - The key role of the Clinical Excellence Commission is building capacity for quality and safety improvements in Health Services, including promoting and supporting improvement in clinical quality and safety in public and private health services.
- NSW Health Blood Watch - A program initiated by the NSW Clinical Excellence Commission as a state-wide transfusion medicine improvement program. The web site contains information and resources for consumers and hospitals.
- Queensland Blood Management Program - A program established to ensure the Queensland Government meets its obligations under the National Blood Agreement. It provides links to fact sheets, guidelines and business initiatives related to the management of blood and blood products.
- Queensland Health Patient Safety and Quality Improvement Service - A service designed to maximise best-practice outcomes and minimise patient harm by providing support to Queensland Health.
- South Australian Department of Health BloodSafe Program - BloodSafe is a blood transfusion safety and quality improvement collaboration between the South Australian Department of Health, Transfusion Medicine Services of the Australian Red Cross Lifeblood and South Australian public and private hospitals and their transfusion service providers. The web site includes a set of tools, resources and links for clinicians and consumers.
- Victorian Blood Matters Serious Transfusion Incident Reporting (STIR) system - A Victorian state government program aims to support and enhance best practice in patient blood management (PBM), and the stewardship of blood and blood products, for improved patient outcomes in Victorian health services.. The web site provides consumer information, tools, audits and reports on transfusion incidents.
- Western Australia Haemovigilance Program - The WA Haemovigilance Program was established in 2015 and is managed by the WA Department of Health. All public and private hospitals, including the Royal Flying Doctor Service, have committed to the collection and submission of haemovigilance data on a six monthly basis. The website includes a set of tools, guidelines and information to assist reporting.
International Haemovigilance Information and Programs
- International Haemovigilance Network - The International Haemovigilance Network (IHN) provides a forum for sharing best practice and benchmarking of data, as well as providing a resource for existing and new haemovigilance systems. This IHN web site provides access to documents, news, links and contact details for the network. IHN holds an annual haemovigilance seminar for member countries and researchers. The latest program and presentations can be found at http://ihs-seminar.org/programme.
- International Society of Blood Transfusion (ISBT) - The International Society of Blood Transfusion (ISBT) is the premier international professional society for the field encompassing transfusion and transplantation science and medicine. The ISBT web site provides access to ISBT events and congresses, publications, working parties, news, membership and history information.
- WHO Haemovigilance Program - This web site provides access to haemovigilance definitions, guidelines, global consultations, global databases on blood safety and contact information for the program.
- New Zealand Blood Service. Haemovigilance Program - This link enables users to read and download the Haemovigilance newsletter, notification form and user guide as well as the Haemovigilance Program annual reports. These reports provide information on the adverse events associated with transfusion in New Zealand. They assist health professionals to better understand the risks associated with transfusion and to communicate these to potential recipients.
- Serious Hazards of Transfusion (SHOT) (UK) - This site provides an overview of the UK Serious Hazards of Transfusion (SHOT) program. Annual Haemovigilance reports can be found under the 'SHOT Reports and Summaries' tab located on the left hand side of the screen.
- Transfusion Transmitted Injuries Surveillance System (TTISS) (Canada) - This site provides an overview of the Canadian Transfusion Transmitted Injuries Section. Annual Haemovigilance reports can be found under 'National TTI Surveillance System (TTISS) - Program Reports'.
- Transfusion Quality Management (TRaQ) Program (Canada) - The TRaQ program promotes quality improvement among transfusion medicine professionals through timely sharing of education and quality management information related to current practices and guidelines in transfusion medicine. This web site includes access to TRaQ manuals, education tools and a resource library.
- U.S Biovigilance Network - This site provides information on the U.S haemovigilance system, including background on the network, a list of organizations currently contributing data, related news coverage, and contact information for those interested in learning more about the network or haemovigilance.
1 National Safety and Quality Health Service (NSQHS) Standards and World Health Organization. WHO aide-memoire for ministries of health 2015: National Haemovigilance System. Geneva: WHO; 2015.