Objective 2: Improve risk management and blood sector performance

A key feature of the 2012-13 Federal Budget was governments’ endorsement of funded measures to improve blood sector performance and risk management. This included objectives to improve data capture and analysis and appropriate and efficient use of blood products. As outlined in this section, the NBA made significant progress against these objectives, particularly in the areas of ICT developments, data availability and analysis, IVIg governance and risk and knowledge management.

Review of IVIg

The NBA, on behalf of all Australian governments, completed a review of the adequacy of the current IVIg authorisation and clinical governance arrangements. The aim of the review was to identify options for improvements in the management of IVIg. The review also analysed the issues, benefits and risks of potentially including NIg and subcutaneous immunoglobulin (SCIg) in the IVIg management framework.

The review identified that there are significant variations in IVIg management processes nationally, with process inefficiencies, under investment in integrated data systems and limited evidence of alternative therapies being considered before prescription. It also found variation in dosing, high prescription rates in some conditions compared to international rates of use, limited transparency of price implications and no accountability for cost with the prescriber.

In March 2013, the JBC considered the final report of the review and endorsed the NBA commencing work to implement five short term improvement projects recommended by the review. The five projects are to:

• describe the functional model for the current authorisation and clinical governance arrangements, and formally allocate responsibility in each jurisdiction
• introduce new management processes to include NIg and SCIg in the IVIg authorisation process
• improve patient information to ensure patients are aware of the Criteria requirements for eligibility and ongoing therapy
• centralise hospital ordering and product management at the blood bank or pharmacy for improved management, and define when and how emergency stock should be managed
• define and deliver a package of information concerning current IVIg products and arrangements, particularly for junior medical and nursing staff.

Key longer term strategic projects recommended by the review will be considered in 2013-14 for establishing an improved framework for strengthening the clinical governance and authorisation of immunoglobulin in Australia.

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.

The NBA undertook an evaluation of two Schedule 4 proposals for inclusion of SCIg as a new product type supplied and funded under the national blood arrangements. The Medical Services Advisory Committee (MSAC) provided advice on the proposals and the NBA evaluation in November 2012.

In March 2013, the JBC approved the introduction of SCIg under the national blood arrangements. The first phase of implementation will be through hospital-based management arrangements, with no additional cost to patients, and further work will be undertaken to support supply of SCIg for other pathways of care. Supply of SCIg will commence in September 2013, including both domestically manufactured and imported SCIg products.

Data developments

In the 2012–13 Federal Budget, the NBA received strong endorsement from governments for 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 ustainability 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.

During 2012-13 JBC endorsed the National Blood Sector Data and Information Strategy and Scorecard 2013 – 2016 which shows the NBA’s direction, in relation to data. The strategy is available for download from www.blood.gov.au/data-research and outlines activities the NBA will undertake to underpin improvement over the next three years. They include:

1. Establish an overall architecture for data collection and information flows and relationships
2. Define governance principles for the collection and management of data and information
3. Promote a standardised approach to data sets and system capabilities
4. Prioritise data collection and system development required for the sector
5. Drive sector improvement with data analyses and publication.

As part of the strategy the NBA developed a set of key performance indicators aligned with the national health performance framework, for use in benchmarking and monitoring the blood sector.

In relation to data developments the NBA also delivered the following activities during 2012-13:

1. Wastage data
• Collected, analysed and distributed wastage data from both the Blood Service Electronic Returns Information Capture (ERIC) system (which ceased on 30 June 2013) and the BloodNet Fate Module that has expanded to 94 per cent of health providers nationally to support the National Blood and Blood Products Wastage Reduction Strategy 2013-17 and to establish targets for wastage rates in 2014-15.
• Specified BloodNet discard reports to be launched to jurisdictions and health providers in August 2013.
2. Haemovigilance
• Revised the terms of reference and membership for the Haemovigilance Advisory Committee (HAC) and appointed a new chair. The HAC met on 27 June 2013, the first time since 2011.
• Drafted the National Haemovigilance Report 2013, which includes data for 2009-10 and 2010-11 collected by states and territories. Publication of this report is expected in September 2013.
• Commenced work to scope a national haemovigilance system and worked with states and territories to understand requirements.
• Developed a project proposal for the publication of a Consensus Guideline for the Recognition and Treatment of Acute Transfusion Events.
3. Publication of the ABDR Annual Report for 2011-12
4. Red Cell Linkage
• NBA met with jurisdictional data personnel for a workshop on 26 March 2013 to agree a final dataset for data submission with episode level de-identified data. The draft dataset and outcomes of the meeting have been sent to the attendees for review and clearance. A follow-up meeting is expected early in 2013-14 to discuss data collection and next steps.
5. National Blood Sector Data and Information Governance Framework
• Commenced development of a National Blood Sector Data and Information Governance Framework, including a set of principles to determine data standards and the framework which can be developed and assessed for endorsement and publication in 2013-14.

Risk Management

The management of blood sector risk remains a core element of ensuring the security and availability of the blood supply. 2012-13 saw the NBA undertake a higher than normal level of activity to review and further strengthen risk management arrangements. There were three areas subject to comprensive review:

• the NBSCP as it relates to fresh blood
• sector risks as they relate to NMF liability provision
• NBA risk management framework.

National Blood Supply Contingency Plan

The NBSCP is a cornerstone measure to manage risks to the blood supply. In 2012-13 it underwent one of its most serious tests since its approval in 2006. The incident occurred in 2012 when the Blood Service National Blood Management System (NBMS) failed on 4 July, resulting in a decline in blood stocks and production across Australia. The NBMS is a national IT system that supports fresh blood collection, processing and distribution. The NBA monitored the situation and activated the NBSCP on 6 July, and in consultation with the Blood Service actively managed the contingency at a national level until deactivation of the plan on 11 July when it was judged that stocks had returned to levels within manageable operational tolerances. The NBMS returned to its normal operating environment on 22 July. This contingency prompted a number of internal and independent reviews of the Blood Service IT and risk and contingency management arrangements, the recommendations of which have been, or are programmed to be, implemented. Notably this includes significant strengthening of the NBSCP in relation to the management of platelets and infectious diseases.

National Managed Fund Action Plan review

The NBA coordinated the independent National Managed Fund Action Plan review to comprehensively determine the current Blood Service risk profile and assess potential liability that would not be adequately met by current risk mitigations. It is expected the review will be completed during 2013-14.

Risk management framework

The NBA reviewed its enterprise wide risk management process and implemented a new risk management framework and supporting process that is aligned to the Australian/New Zealand Standard AS/NZS ISO 31000:2009. These new arrangements strengthen the NBA risk identification and treatment regime. Key aspects of these new arrangements include:

• definition of roles and responsibilities in relation to risk management in the NBA, including a role for the NBA Board in the provision of advice in relation to the identification, evaluation and treatment of strategic risks
• establishment of a bottom-up hierarchical risk review process that culminates in an NBA Board review of key strategic risks
• establishment of a supporting living risk register that captures the results of the identification, analysis, evaluation and treatment of enterprise risks relevant to the responsibilities of the NBA
• incorporation of risk mitigation measures in the NBA Operational Plan 2013-14.

ICT developments

Information communication technology (ICT) systems development and operations continue as a key enabler of both data collection/analysis and business process reform across the sector. A wide range of activities undertaken in 2012-13 have directly contributed to improved performance in the sector.

National Blood Sector ICT Strategy 2013-16

JBC approved the National Blood Sector ICT Strategy 2013-16 in March 2013. The strategy provides a coordinated, strategic approach, informed by the National Health Reforms, to guide the design, development and operation of ICT systems to facilitate the efficient and effective operation of the Australian blood sector. The strategy outlines four priority streams of activities:

1. Deliver ICT capabilities to drive performance improvement
2. Deliver ICT capabilities to enhance collaboration and training across the sector
3. Increase the resilience of existing ICT capabilities
4. Improved ICT governance and management

All new system developments and major enhancements for the 2013-16 period are programmed in the strategy, leading to greater certainty and a common understanding of development priorities across the sector.

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 (HTCs) to assist in the management and treatment of people with bleeding disorders. The NBA uses de-identified data from ABDR to assist in the development and evolution of demand models to better predict clinical demand for clotting factor products.

First developed in 1995, the fourth generation redevelopment of the ABDR was launched in August 2012, completing a project commenced in March 2011. Whilst maintaining a familiar look and feel for users from the previous third generation system, the redeveloped ABDR has resulted in major performance improvements, including the ability to capture and analyse a much greater range of clinical data.

In parallel with these enhancements, the ABDR Steering Committee (consisting of representatives of AHCDO, Haemophilia Foundation Australia (HFA), jurisdictions and the NBA) have been undertaking a comprehensive review of the system governance arrangements. This review will ensure that the governance of the system and its data continues to meet community expectations and our legislative obligations.

The ABDR Annual Report 2011-12 (see www.blood.gov.au/data-analysis-reporting) provides an example of the de-identified data that is available to the wider community through the ABDR.

BloodPortal

Launched in August 2012, BloodPortal provides a central user management and authentication system for users of all NBA ICT systems across the blood sector. BloodPortal enables these users to have a single username and password covering all systems, a single place to update their contact details with the NBA and to subscribe to a range of mailing lists relating to transfusion in Australia. These mailing lists supplement existing communication channels, enabling the NBA to communicate effectively to a target and much greater audience on specific topics than was previously possible.

BloodChat

Launched in October 2012, BloodChat is a group of online discussion forums relating to transfusion matters that enables those involved in transfusion across Australia to collaborate, communicate and share resources and ideas without having to leave their hospitals.

BloodNet

The implementation of BloodNet across health providers continued throughout 2012-13, with 95 per cent of volume issued by the Blood Service nationally processed through BloodNet as of 30 June 2013 (up from 75 per cent at 30 June 2012).

A key area of focus for BloodNet throughout 2012-13 was in the implementation of the fate module (recording discards of units by health providers and transfers of units between health providers) which as of 30 June 2013 was processing 94 per cent of unit discards nationally (up from 45 per cent at 30 June 2012). This implementation involved on-site face to face training at over 200 health providers and a substantial number of online training sessions.

Data obtained from the fate module in BloodNet was key to the development of the National Blood and Blood Product Wastage Reduction Strategy 2013-17 and is currently being used by health providers and jurisdictions to identify and manage the wastage of blood and blood products. A range of reports were developed to assist in this task, with further reports to be produced in 2013-14.

BloodNet – Laboratory Information System (LIS) Interfaces

The proof of concept trial to interface BloodNet to health provider Laboratory Information Systems (LISs) continued in 2012-13, with eleven health providers’ LIS now interfaced into BloodNet. The trial has confirmed the feasibility and desirability of such interfaces. The interfaces provide an increased flow of data enabling more accurate demand modelling to occur. These improvements support key wastage reduction projects such as the National Inventory Management Framework project.

The time-saving in health providers of interfacing is substantial, with one major metropolitan health provider identifying that the interface will decrease data entry time by over 17 hours per week in their pathology laboratory.

Throughout 2013-14, the NBA will continue to work with a range of health providers and LIS vendors to further progress LIS interfaces.

Sector monitoring

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 2012-13 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.

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-trendsblood-sector.

During 2012-13 NBA closely monitored a number of key developments, including:

• discussion of fresh blood and its constituents included a strong emphasis on PBM including appropriate transfusion and perioperative anaemia management
• continued debate on the impact of age of red cells at transfusion
• the considerable activity from suppliers in pre-clinical and clinical trials to develop longer acting clotting factors for patient convenience
• IVIg is losing market share to SCIg, in particular in Europe the subcutaneous product is reported to satisfy over one quarter of the market
• large clinical trial of Baxter International’s liquid immunoglobulin, Gammagard, in Alzheimer’s disease reported in May indicating Gammagard did not meet the primary endpoints of the trial
• dengue fever and its impact on blood collection in Australia’s north
• Chinese-origin bird flu H7N9 and Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) were both on the World Health Organization’s (WHO) watch list for possible pandemic potential
• Chagas disease, West Nile virus and tick-borne infections remained of concern in blood collection overseas.