EXECUTIVE SUMMARY

This is the third national Australian Haemovigilance Report. It provides an overview of blood transfusion and donation-related adverse events in Australia, and recent data and information on fresh blood product issues and usage. The report also delivers 10 key recommendations in the areas of:

• National blood quality and safety initiatives
• Reducing human errors
• Data standards
• Reporting capacity.

Donor vigilance data for 2011-12

Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors. This report includes a new section to present the donor vigilance data contributed by the Australian Red Cross Blood Service (Blood Service).

During 2011-12, there was a total of 1.3 million donations, including 0.9 million whole blood donations, 0.36 million plasma donations and 0.04 million platelet donations. There were 29,525 event reports in 2011-12, with only 704 of these classified as serious adverse events. The overall reported ratio of donation-related adverse events was 1:45 in 2011-12. The frequency of adverse events was found to be higher in younger and female blood donors, especially those under the age of 20 years.

Fresh blood product issue and usage data

There were 2.3 million components of fresh blood products issued in Australia in 2009-10 and 2010-11. Red blood cells (RBC) accounted for about two-thirds of all issues. The demand for RBC over the last few years has been slowing due to improvements in appropriate use; the issues of RBC per 1000 population decreased from 36.31 in 2007-08 to 36.09 in 2010-11. The demand for fresh frozen plasma (FFP) also decreased during the same period. In contrast, the demand for platelets and cryoprecipitate units rose steadily over the past four years to 2010-11.

The Australian and international data shows, despite an ageing population, the demand for RBC may not increase as much as predicted in other studies and further deceases in surgical RBC use may be achievable. However, the ageing population is likely to increase demand for medical (as opposed to surgical) use of fresh blood components.

Haemovigilance data for 2009-10 and 2010-11

The NBA National Haemovigilance Program and Haemovigilance Advisory Committee (HAC) continue to support the development and alignment of state level reporting systems with the recommended national haemovigilance dataset and Australian National Haemovigilance Data Dictionary (ANHDD).

This report includes validated adverse event data from state level systems, including the BloodSafe program in South Australia (SA), Queensland's (QLD) Incidents in Transfusion program (QiiT was decommissioned in 2013 due to the restructure of Queensland's public health system) and Victoria's (VIC) Blood Matters Serious Transfusion Incident Reporting (STIR) program. STIR also supports haemovigilance in Tasmania (TAS), the Australian Capital Territory (ACT) and the Northern Territory (NT). New South Wales (NSW) also provided limited non-validated haemovigilance data for 2009-11. Western Australia (WA) is the only jurisdiction not contributing to the national dataset for the reporting period of this report from July 2009 to June 2011.

There were 1,207 adverse events reported to the National Haemovigilance Program from 2008-09 to 2010-11. The number of reports increased significantly from 294 in 2008-09 to 582 in 2010-11 likely due to the improved adverse event reporting from NSW and other states and territories. The most frequently reported adverse events are febrile non-haemolytic transfusion reactions (FNHTR) and severe allergic reactions, representing 52% and 26% of all reports respectively. The first three confirmed cases of post-transfusion purpura (PTP) were reported in 2009-10 and 2010-11. The data for transfusion-associated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), and delayed haemolytic transfusion reaction (DHTR) indicates that these adverse events remain largely under-reported. Despite the large increase in the number of reports, there were no deaths caused by transfusion-related adverse events in 2009-10 and 2010-11; there were 2 such deaths in 2008-09. The number of life-threatening cases also dropped significantly for most adverse event types during the same period.

Adverse event summary

Adverse event	2008-09	2009-10	2010-11	All reports
				Number	Per cent
FNHTR	154	158	321	633	52.4%
Severe allergic reaction	87	84	142	313	25.9%
IBCT	22	23	30	75	6.2%
Anaphylactoid or anaphylactic reaction	8	12	33	53	4.4%
TACO	6	12	24	42	3.5%
DHTR	4	8	10	22	1.8%
TTI	3	18	11	32	2.7%
AHTR	7	6	2	15	1.2%
TRALI	3	8	8	19	1.6%
PTP	-	2	1	3	0.2%
Total number of reports	294	331	582	1,207	100%

Source: NBA

Recommendations

The NBA, in conjunction with the HAC, makes 10 recommendations in this report in the following areas:

1. Promote the recognition and management of transfusion-related adverse events
2. Implement programs at the national, state and local hospital levels to improve reporting of serious adverse events

3. Clinical staff should comply with national guidelines on sample collection and administration of blood and blood products
4. Promote the application of technological adjuncts such as portable barcode readers and/or radio-frequency identification scanners to reduce the scope for error
5. Develop tools to encourage alignment of prescribing practice with clinical guidelines

6. Review and re-develop the Australian National Haemovigilance Data Dictionary
7. Provide tools for hospitals on the application of Australian National Haemovigilance Data Dictionary and reporting of haemovigilance data
8. Continue to include donor vigilance data in national haemovigilance reporting

9. Conduct a scoping exercise for a national haemovigilance system
10. Maintain and improve existing capacities for haemovigilance data reporting.