The Initial Australian Haemovigilance Report 2008 presented a selection of the available information on transfusion-related adverse events reported in Australia over a period of three to five years before the report. It did not include haemovigilance data from individual hospitals or hospital networks, only information reported to and held at the state or territory level.
Data sources at that time included state and territory healthcare reporting systems, such as AIMS (used in the public health care sector of SA and WA), IIMS (used by all eight NSW area health services), STIR (used by the VIC Department of Human Services Quality Improvement Unit), RiskMan (used by ACT Health and a number of private healthcare organisations), and PRIME (Acclaim Safety Systems Ltd), which was the healthcare reporting facility for QLD Health. The 2008 report also made use of data from AIHW National Hospital Morbidity Database (NHMD).
A number of caveats applied to the adverse events data presented in the 2008 report, including:
The reporting period and caveats associated with the 2008 report mean that the data is not directly comparable with the data of the current report. Any apparent differences in reporting rates of adverse events should be considered in the context of the significant improvements that have been made in Australian haemovigilance since the 2008 report, which aim to increase reporting and the quality of data reported.
The Initial Australian Haemovigilance Report 2008 made four broad recommendations:
The first three recommendations were pursued through the establishment of an ongoing National Haemovigilance Program and the HAC to provide governance to haemovigilance at a national level in Australia. As an aid to procedural training and process improvements BloodSafe eLearning Australia was approved for funding by the Jurisdictional Blood Committee (JBC) as a suitable vehicle to deliver broad based education on appropriate and safe blood transfusion practices to a wide range of ancillary and professional health provider audiences over a three year period beginning in December 2009. To ensure that patients are not unnecessarily exposed to the risks associated with transfusion the NBA also embarked on a program to revise the NHMRC transfusion guidelines, and replace them with the publication of six modular PBM Guidelines. The fourth recommendation was addressed through the development of a National Patient Blood Management Program.
The 2010 report improved upon the standards of the Initial Australian Haemovigilance Report 2008 in a number of significant ways. The Australian Haemovigilance Report 2010 included validated data from state level haemovigilance programs including BloodSafe in SA, the QLD Incidents in Transfusion program and the VIC Blood Matters and STIR programs. The STIR program also provided data from the haemovigilance activities in TAS, the ACT and the NT. Limited data was included from the NSW Blood Watch program.
The 2010 report detailed serious adverse events reported (n=294) to the Australian National Haemovigilance Program for the 2008-09 period. The relative incidence of the adverse events was comparable to the data of many other developed countries, with a majority of FNHTR (n=154) and allergic reactions (n=87), some serious anaphylactic and anaphylactoid reactions (n=8), haemolytic transfusion reactions (AHTR n=7; DHTR n=4), TACO (n=6), TRALI (n=3) and TTI (n=3). There were 22 IBCT events reported.
Across all reported adverse events, there were 92 reports (31% of reports) that cited one or more contributory factors that could have been avoided. These included prescribing/ordering, specimen collection/labelling, laboratory (testing/dispensing), transport, storage, handling, administration of product, or adverse events where the clinical indications for transfusion did not meet the facilities' transfusion guidelines or where the transfusion procedures undertaken did not adhere to the facilities' transfusion procedures.
Data from the 2010 report is compatible with the new data presented in this report. Relevant observations and discussions have been included in the analyses presented in PART 04 HAEMOVIGILANCE DATA FOR 2009-10 AND 2010-11.
The 2010 report delivered 12 key recommendations in the areas of data quality, jurisdictional capacity to report haemovigilance data, prescribing practice, human errors, and national blood quality and safety initiatives. The following sections and tables summarise the progress made against the recommendations of the 2010 report.
The 2010 report made four recommendations on the subject of data (Table 6). Progress against these recommendations has been as follows:
|
Recommendation from 2010 Report |
Who is Responsible? |
Proposed strategy from 2010 report |
Outcomes |
1 |
Jurisdictions to continue to develop their haemovigilance data capture and validation systems (which should include donor vigilance) to enhance the quality and completeness of data reported to the national dataset |
NBA/JBC; State and territory Departments of Health; Blood Service; Private sector hospitals and private pathology providers |
JBC to consider strategies for further development of haemovigilance systems State and territory Departments of Health to consider establishing ongoing funding for maintenance of haemovigilance systems if funding not already in place |
The number of state and territories reporting validated data remains unchanged The completeness of data remains an issue for some states Donor vigilance data included in this report |
2 |
Programs should be implemented at the national, state and local hospital levels to improve recognition and reporting of under reported serious adverse events such as TACO and TRALI |
JBC; NBA; State and territory Departments of Health; Hospital educators; Relevant professional Colleges and Societies |
Incorporate TACO and TRALI into:
Include advice on risks of TACO and TRALI in PBM Guidelines |
BloodSafe eLearning Australia NBA Patient Blood Management Guidelines Guidance on Recognition and Management of Acute Transfusion Reactions and Events is under development TACO is still largely under-reported |
3 |
Develop the systems and capability to enable the total number of products and patients transfused to be known |
JBC; NBA; State and territory Departments of Health; Blood Service; AIHW; Clinicians; Clinical Coders |
States and territories to consider initiatives to:
|
NSW, SA, WA and QLD have advanced their health data linkage capabilities and the resulting data and analysis on red cell use have been used to inform clinical practice at a state level The NBA is currently coordinating a Red Cell Data Linkage national minimum dataset to inform policy and decision making at a national level |
4 |
HAC to discuss the definition and inclusion of near misses into the dataset |
HAC; NBA; JBC; State and territory Departments of Health |
HAC to discuss near miss definition in data dictionary Promote inclusion of near miss information in jurisdictional data systems |
STIR has captured and reported near miss data at the state level since 2007 The HAC will re-evaluate the national haemovigilance dataset as part of the scoping exercise for a national haemovigilance system |
The 2010 report made two recommendations on the subject of capacity to report haemovigilance data (Table 7). Progress against these recommendations has been as follows:
|
Recommendation from 2010 Report |
Who is Responsible? |
Proposed strategy from 2010 report |
Outcomes |
5 |
Jurisdictions to consider strategies to improve the timeliness and completeness of reporting |
JBC; State and territory Departments of Health; State and territory Quality and Safety Units |
JBC to investigate strategies to support further development of haemovigilance systems State and territory Departments of Health to consider establishing ongoing funding for maintenance of haemovigilance systems |
NBA is scoping the requirements for a national haemovigilance system |
6 |
All transfusing hospitals should have transfusion governance arrangements in place |
State and territory Departments of Health; State and territory Quality and Safety Units; Hospital Administrators |
Jurisdictions to consider providing a directive to administrators responsible for transfusion institutions to establish haemovigilance governance arrangements |
The 2010 report made two recommendations on the subject of prescribing blood and blood products (Table 8). Progress against these recommendations has been as follows:
|
Recommendation from 2010 Report |
Who is Responsible? |
Proposed strategy from 2010 report |
Outcomes |
7 |
Continue to develop, publish and promulgate Patient Blood Management Guidelines |
NBA; ANZSBT; NHMRC; Relevant professional Colleges and Societies |
NBA to continue to work with professional Colleges and Societies and the NHMRC to publish PBM guidelines |
Four PBM Guideline Modules published:
Two further modules are currently under development |
8 |
Research and publish the specific elements that should be included on a blood order/prescription form to encourage alignment of prescribing with clinical guidelines |
NBA; Relevant professional Colleges and Societies |
NBA to consider engaging relevant bodies to work with to develop a national blood order/prescription form |
The current report expands this recommendation to develop tools to encourage alignment of prescribing practice with clinical guidelines |
The 2010 report made two recommendations on the subject of procedural errors during transfusions (Table 9). Progress against these recommendations has been as follows:
|
Recommendation from 2010 Report |
Who is Responsible? |
Proposed strategy from 2010 report |
Outcomes |
9 |
Reduce the potential for procedural errors through training, stringent application of standards, proficiency testing and accreditation |
State and territory Departments of Health; Administration staff; Quality and Safety personnel; Hospital educators; Clinical staff |
Standardised training and development Periodic proficiency testing Compliance with specimen labelling standards and patient identification, as prescribed by the NPAAC and the ANZSBT, and the ACHS accreditation standards required under EQuIP |
BloodSafe eLearning Australia As of June 2013, there are over 186,000 users from 1,000 Australian hospitals registered with BloodSafe eLearning Australia BloodSafe eLearning Australia will develop modules for the PBM guidelines and assist with the implementation of NSQHS Standard 7 |
10 |
Research possible application of technological adjuncts such as portable barcode readers and/or radio-frequency identification scanners to reduce the scope for error |
HAC; Quality and Safety organisations; Research Bodies |
Jurisdictions and the NBA to encourage this research |
A recent pilot study demonstrates that 2D barcode technology and patient safety-software significantly improves the bedside check of patient, blood and blood product identifications in an Australian setting |
The 2010 report made two recommendations on the subject of national blood quality and safety initiatives (Table 10). Progress against these recommendations has been as follows:
|
Recommendation from 2010 Report |
Who is Responsible? |
Proposed strategy from 2010 report |
Outcomes |
11 |
Include Haemovigilance in Accreditation requirements |
NBA; HAC; ACHS; NATA; RCPA; ACSQHC |
NBA and HAC to continue to work with ACHS to monitor and improve accreditation requirements for haemovigilance |
NSQHS Standard 7 developed and published Safety and Quality Improvement Guide for NSQHS Standard 7 developed and published |
12 |
NBA, JBC and HAC to continue to engage with ACSQHC in the judicious development of indicators and standards relevant to the blood sector |
NBA; JBC; HAC; ACSQHC |
Provision of timely input as required by ACSQHC into the development of a Standard for Blood and Blood Products |
NSQHS Standard 7 developed and published Safety and Quality Improvement Guide for NSQHS Standard 7 developed and published |