Objective 2: Improve risk management and blood sector performance

In 2013-14, the NBA achieved a range of objectives to improve blood sector performance and risk management, particularly in the areas of immunoglobulin (Ig) governance, evaluation of new products, ICT developments, data availability and analysis and risk and knowledge management.

Immunoglobulin (Ig) Governance

The NBA made significant progress to implement new Ig authorisation and clinical governance arrangements. These arrangements will address a range of deficiencies identified in the 2012-13 review of the management of Ig, including:

  • significant variations and inefficiencies in Ig management processes nationally
  • variation in dosing
  • high prescription rates in some conditions compared to international rates of use
  • limited transparency of price implications
  • no accountability for cost with the prescriber.

Key 2013-14 achievements included:

  • development and governments’ approval of the business cases describing the high level functional model for new authorisation and clinical governance arrangements and the associated supporting national database
  • development and implementation of new management processes for NIg and SCIg
  • establishment of the National Ig Governance Advisory Committee.

New products to meet patient needs

In 2013-14, for the first time since 2003, two new product types that significantly enhance clinical treatment options were added to the national blood arrangements. The approval to add new types of blood products provided under the National Blood Arrangements requires a structured process of evaluations. A range of criteria are applied, including clinical need and clinic/patient utility, potential health benefits and risks, cost and budget implications, cost effectiveness, supply security and national self-sufficiency, feasibility of implementation, and international practice.

Generally, submissions for new products are received from relevant suppliers. The NBA manages the process of framing an initial evaluation, working together with expert advisers and relevant stakeholders. Recommendations are taken to the Jurisdictional Blood Committee (JBC) for consideration. Where a proposal is material or complex, it may be referred for evaluation by the Medical Services Advisory Committee (MSAC).

The two new products added to the National Supply List were as follows.

Subcutaneous immunoglobulin (SCIg)

Fibrinogen concentrate for congenital fibrinogen deficiency

Immunoglobulin products, produced from blood plasma, are important for a range of acute and potentially debilitating diseases, including a number of chronic immunodeficiency and neurological conditions. To date, patients have mainly been treated with intravenous immunoglobulin products, requiring a hospital based infusion every two to four weeks. In March 2013, JBC approved the addition of SCIg, which allows a suitable subgroup of patients to be treated through smaller, more frequent infusions into subcutaneous tissue. This treatment can then potentially be undertaken at home with appropriate patient training and ongoing monitoring and support from a suitable hospital.

Availability of SCIg commenced through a structured hospital based implementation model from September 2013. As at 30 June 2014, up to 33 hospitals across Australia have established SCIg programmes.

Fibrinogen is an essential protein in the bloodstream which is critical to the formation of blood clots to prevent bleeding. Congenital fibrinogen deficiency is a rare disorder where fibrinogen is not produced normally. Patients may suffer debilitating bleeding symptoms similar to haemophilia, including life threatening critical organ bleeding.

In December 2013, JBC approved the addition of fibrinogen concentrate, for patients requiring treatment for congenital fibrinogen deficiency. Supply of the product commenced from 1 July 2014, with product generally being made available through 18 haemophilia treatment centres and clinics around Australia.

Subcutaneous immunoglobulin (SCIg) strand Patient collecting subcutaneous immunoglobulin product
from a hospital dispenser

Patient collecting subcutaneous immunoglobulin product from a hospital dispenser

Evaluation of new products

The working group established by the JBC, including NBA and jurisdictional representatives, progressed work on the requirements and processes for evaluations to be undertaken under Schedule 4 of the National Blood Agreement.

Following an NBA evaluation, the JBC endorsed a Schedule 4 proposal for inclusion of Fibrinogen Concentrate for congenital fibrinogen deficiency on the National Supply List. Supply of Fibrinogen Concentrate for congenital fibrinogen deficiency will commence on 1 July 2014.

Data developments

In 2013–14, the NBA continued its drive to improve data capture and analysis across all aspects of the supply chain. This area of activity is a key strategy to improve the overall efficiency and sustainability of the sector by providing a measurement for improvement.

A significant amount of data and information exists within the blood sector, however, the extent to which this data is currently available to the parties that need it, the quality of the data, and the capacity of the systems that hold it, varies widely. The adoption of a new data visualisation and analysis tool has significantly enhanced the NBA’s ability to harness data across all data domains managed by the NBA.

During 2013-14, the NBA progressed the following activities identified in the National Blood Sector Data and Information Strategy and Scorecard 2013-2016:

  • Discard Data
    • Collected, analysed and distributed discard data from the BloodNet Fate Module to support the establishment of targets for discard rates in 2014-15 under the National Blood and Blood Product Wastage Reduction Strategy 2013-2017.
    • Specified BloodNet discard reports were launched to jurisdictions and health providers.
  • Haemovigilance
    • Published the National Haemovigilance Report 2013 based on data for 2009-10 and 2010-11 collected by states and territories.
    • Developed and progressed a national haemovigilance programme options paper.
    • Developed a Consensus Guideline for the Recognition and Treatment of Acute Transfusion Events which is expected to be published in early 2014-15.
  • Australian Bleeding Disorders Registry (ABDR)
    • Published the ABDR Annual Report for 2012-13.
    • Produced the Australian Haemophilia Centre Directors’ Organisation (AHCDO) draft Benchmarking Report.
    • Developed a data extract for HTC staff to review as part of the data integrity process of the ABDR which will be implemented in early 2014-15.
  • Red Cell Data Linkage: the NBA progressed agreements for data linkage arrangements with South Australia and Queensland. It is expected these agreements will form the prototype for the remaining jurisdictions.
  • National Blood Sector Data and Information Governance Framework: the NBA developed a National Blood Sector Data and Information Governance Framework. The JBC will formally consider the framework for endorsement in late 2014.

Risk Management

The management of blood sector risk remains a core element of ensuring the security and availability of the blood supply. 2013-14 saw the NBA complete two major activities to further strengthen risk management arrangements relating to:

  • the National Blood Supply Contingency Plan
  • blood sector risks, particularly as they relate to liability provisions under the Deed with the Red Cross.

National Blood Supply Contingency Plan (NBSCP)

The NBSCP is a cornerstone measure to manage risks to the blood supply. In 2013-14 a range of measures were implemented to further strengthen contingency management arrangements, including the following:

  • The development and approval of a new annex dealing with the management of a shortage of supply of platelets. The new annex includes a range of contingency management enhancements which will form the basis of a complete revision of the parent NBSCP document.
  • A formal strengthening of the interface with national horizon scanning and communicable disease management arrangements with the Commonwealth Department of Health Office of Health Protection (OHP), including:
    • NBA participation as an observer in future Communicable Disease Network Australia (CDNA) meetings.
    • Joint NBA and OHP sponsorship of a joint paper to the Australian Health Protection Principal Committee (AHPPC) meeting in the second half of 2014 as a basis for discussion of a strengthened contingency management interface.
    • Cross representation between the NBA and OHP in contingency exercises.

Review of Risk Management in the Blood Sector

In preparation for the development of a new Deed of Agreement with the Red Cross, the NBA completed an independent comprehensive Review of Risk Management in the Blood Sector, previously known as the National Managed Fund Action Plan Review. The Review identified changes in risks since 2000 and whether there were potential liabilities that would not be adequately met by current risk mitigations. The Review recommendations have resulted in the programming of a range of operational improvements being implemented in consultation with the Blood Service. Governments are currently considering some further strategic recommendations and, subject to endorsement, these will be reflected in the new Deed of Agreement with the Red Cross.

Information Communication Technology (ICT) developments

ICT systems development and operations continue as a key enabler of both data collection/analysis and business process reform across the sector.

The NBA continued to pursue outcomes identified in the JBC-approved National Blood Sector ICT Strategy 2013-16 designed to:

  • deliver ICT capabilities to drive performance improvement
  • deliver ICT capabilities to enhance collaboration and training across the sector
  • increase the resilience of existing ICT capabilities
  • improve ICT governance and management.

A significant 2013-14 outcome affecting all NBA ICT systems was the implementation of improved disaster recovery ICT arrangements. Further infrastructure enhancements, including improved redundancy will be commissioned in late 2014.

Australian Bleeding Disorders Registry

The Australian Bleeding Disorders Registry (ABDR) is a clinical tool in use on a daily basis by clinicians in all Australian haemophilia treatment centres to assist in the management and treatment of people with bleeding disorders. The NBA delivered a number of updates and improvements to the Registry in 2013-14, most notably including an enhanced self-service data extract capability that facilitates more detailed analysis.

A significant enhancement of the ABDR was the release of the MyABDR smartphone application for Android and iPhone on 28 February 2014. This app works as a patient interface into ABDR and exchanges a rich set of information including treatment and bleeds, inventory stock on hand and discards, weight and height, treatment plans, memos, contact, photographs, documents and delivery address information and includes a reporting module. The full deployment, including face to face HTC staff and patient/carer training sessions across Australia has concluded with sessions receiving positive feedback from both the patients and HTC staff. The MyABDR app was officially launched by Senator The Hon Fiona Nash, Assistant Minister for Health on 21 March 2014.

As highlighted, the NBA won three ACT iAwards presented by the ACT Chief Minister on 17 June 2014 for the MyABDR App development topping each of the categories of:

  • Government
  • Health
  • Community

The iAwards State Presentations are where iAwards host organisations, local branches, sponsors and members of the local ICT industry announce the State and Territory winners and national finalists for the prestigious 2014 iAwards. These awards honour the best and most innovative solutions in each State or Territory. Winners and merit recipients of these State and Territory awards go on to represent their State or Territory at the national phase of judging which will be held in Melbourne on 29 August 2014 at the Melbourne Convention and Exhibition Centre.

BloodNet

The implementation of BloodNet across health providers continued throughout 2013-14, with 98 per cent of volume issued by the Blood Service nationally processed through BloodNet as at 30 June 2014. Significant BloodNet enhancements delivered in 2013-14 included:

  • a refresh of the BloodNet Graphic User Interface (GUI) and website
  • the development and release of a range of BloodNet reports that improve the management utility of the system for users, including for example, fate reports for health providers that summarise issues, transfers and discards
  • development and implementation of BloodNet-Laboratory Information System (LIS) interfaces at an individual health provider level. Over 20 per cent of volume issued by the Blood Service nationally is now processed through an automated LIS interface, improving efficiency and accuracy.
Senator The Hon Fiona Nash, Assistant Minister for Health at the official launch of the MyABDR app on 21 March 2014

Senator The Hon Fiona Nash, Assistant Minister for Health at the official launch of the MyABDR app on 21 March 2014

MyABDR-a global first-intergrated patient recording for people with bleeding disorders

2014 iAwards Logo

MyABDR App Advert

The MyABDR patient interface into the Australian Bleeding Disorders Registry (ABDR) was launched by Senator The Hon Fiona Nash, Assistant Minister for Health on 21 March 2014.

MyABDR enables people with bleeding disorders and their carers to record their bleeds, infusions and product inventory in real-time, enabling them to assume greater control of their own health.

All data entered into MyABDR is stored in the ABDR in real-time, which enables patients and the health professionals caring for them to have access to the latest information in a single system.

Since its launch, over 300 patients have already registered and commenced using the app, with additional patients joining the system every day.

In addition to receiving high praise from users and health professionals across Australia, MyABDR was also recognised by the ICT industry. MyABDR was awarded three different awards in the ACT division of the iAwards for the categories of government, community and health.

Peter O’Halloran and Michael Linegar from the NBA receive the iAward from ACT Chief Minister Katy Gallagher Peter O’Halloran and Michael Linegar from the NBA receive the iAward from ACT Chief Minister Katy Gallagher

Sector monitoring

In 2013-14, the NBA further strengthened its horizon scanning of international developments that may influence the management of blood and blood products in Australia. This monitoring activity informs the provision of current, proactive and informed analysis to governments to enable the NBA to fulfil its functions under the National Blood Agreement.

Our focus in 2013-14 was:

  • new product developments and applications
  • global regulatory and blood practice trends, including donor safety
  • scientific and clinical research with implications for future supply or demand in the sector
  • business events that may have an impact on global supply, demand and pricing, such as changes in company structure, financial outlook, production capacity, organisation, ownership, and marketing and contractual arrangements
  • diseases or pandemics that may have an impact on supply or risks to the safety of products
  • developments in testing methods, vaccines and disease control strategies that could potentially mitigate risks to supply
  • any other emerging risks that could potentially put financial or other pressures of any kind on the Australian sector.

The NBA regularly posts to its website a selection of items from this horizon scanning process, illustrating the wide range of factors which may influence industry operations and patient outcomes. This information is available from www.blood.gov.au/monitoring-international-trends-blood-sector. It includes a June 2014 paper on trends in infectious diseases of potential interest to the blood sector.

During 2013-14 NBA closely monitored a number of key developments, including:

  • discussion of fresh blood and its constituents included increasing acceptance of a restrictive transfusion policy
  • issues debated in patient blood management emphasised transfusion protocols in specific contexts such as major trauma (including brain injury) and various surgical specialties
  • suppliers continued to develop and trial longer acting clotting factors for patient convenience; some of these products received their first regulatory approval somewhere in the world
  • researchers continued to seek treatments for haemophilia other than the administration of clotting factors. These included gene therapy and the administration of RNAi therapeutics
  • stem cell research continues to have relevance to the blood sector in its potential to lead to transfusible product and to lead to changes in the surgical contexts in which transfusion may be considered
  • CSL opened the CSL Behring (Australia) Pty Ltd biotechnology manufacturing facility in Melbourne, and Grifols opened its major new plasma fractionation facility in North Carolina.