National Blood Authority
AUSTRALIAN HAEMOVIGILANCE REPORT
A report by the National Blood Authority Haemovigilance Advisory Committee
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PART 02 PREVIOUS AUSTRALIAN HAEMOVIGILANCE DATA AND PERFORMANCE

Initial Australian Haemovigilance Report 2008

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.

Australian Haemovigilance Report 2010

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.

Scorecard - Performance to date

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.

Data

The 2010 report made four recommendations on the subject of data (Table 6). Progress against these recommendations has been as follows:

Table 6: Progress against data recommendations of Australian Haemovigilance Report 2010

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:

  • SA BloodSafe eLearning
  • Post Graduate Certificate in Transfusion Practice
  • Junior Medical Officer (JMO) Education

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:

  • Use data linkage to determine the number of patients transfused in the public hospital system
  • Improve the capture and utilisation of registry data

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

Capacity

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:

Table 7: Progress against capacity recommendations of Australian Haemovigilance Report 2010

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

NSQHS Standard 7 - Blood and Blood Products

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

NSQHS Standard 7 - Blood and Blood Products

Prescribing

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:

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Table 8: Progress against prescribing recommendations of Australian Haemovigilance Report 2010

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:

  • Module 1 - Critical Bleeding/Massive Transfusion
  • Module 2 - Perioperative
  • Module 3 - Medical
  • Module 4 - Critical Care

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

Procedural errors

The 2010 report made two recommendations on the subject of procedural errors during transfusions (Table 9). Progress against these recommendations has been as follows:

Table 9: Progress against recommendations of Australian Haemovigilance Report 2010 on procedural errors

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

National blood quality and safety initiatives

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:

Table 10: Progress against recommendations of Australian Haemovigilance Report 2010 on national blood quality and safety initiatives

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

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