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Objective 2. Improve risk management and blood sector performance

In 2018-19 the NBA achieved a range of objectives to improve blood sector performance and risk management, particularly in the areas of immunoglobulin governance, evaluation of new products, ICT developments, data availability and analysis and risk and knowledge management.

Ig Governance

Work on the NBA Immunoglobulin (Ig) Governance Program continued throughout 2018-19 to improve the governance and management of publicly funded Ig. This program aims to ensure:

• Ig product use and management reflects appropriate clinical practice and represents efficient, effective and ethical expenditure of government funds, in accordance with relevant national safety and quality standards for health care
• access to Ig products is consistent with the Criteria for access determined by governments
• improved capture of information on the need for, use of, and outcomes of treatment with Ig products (including adverse events) to inform future changes to the Criteria.

During the 2018-19 period the program focused on the six key activities listed below:

1. launching BloodSTAR in New South Wales, completing the nation-wide implementation of BloodSTAR
2. implementation of Version 3 of the Criteria and commencement of a transition strategy
3. development of Version 3 of the National Policy
4. development of a performance improvement strategy focused on enhanced management and use of Ig
5. engagement with the program's network of committees to deliver the activities listed above, and plan for the next three years
6. partnering to develop Ig-specific education and training.

Launch of BloodSTAR in New South Wales

The BloodSTAR system was developed by the NBA on behalf of all Australian governments to support health providers in managing their Ig governance obligations as set out in the National Policy. The system standardises and manages access to the supply of Ig products by enabling authorisation requests to be submitted electronically and work-flowed to an authoriser for assessment and approval.

In preparation for the implementation of BloodSTAR into NSW, the NBA worked closely with the NSW Ministry of Health and the Blood Service to transition legacy patient authorisations into BloodSTAR and create user profiles for clinicians with existing patients. User profiles were also created for nurses and facility administrators based on data available from the Ministry of Health and the network of Local Health Districts.

An extensive training program was undertaken in NSW, which delivered approximately one hundred training sessions through a combination of face to face and online sessions.

The successful implementation of BloodSTAR in NSW from 22 October 2018 completes the national rollout process. BloodSTAR is now the sole channel for clinicians to seek authorisation for access to Ig products under the national blood arrangements, in accordance with the National Policy. National implementation ensures consistency of processes and application of the National Policy, including the Criteria to ensure Ig products are directed to patients who are likely to benefit and for whom there are no safe and effective alternative treatments.

The NBA has continued to enhance BloodSTAR so that functionality supports the Criteria and the Ig Governance Program objectives in general, as well as improving usability for end users.

Version 3 of the National Policy

The National Policy was first published in November 2014 and was revised in July 2016 to include the implementation of BloodSTAR. The National Policy sets out the process that must be followed and describes the rules and requirements that must be complied with to ensure appropriate access to government funded Ig products in Australia.

The National Policy was updated in 2018-19 to reflect the full implementation of BloodSTAR in all jurisdictions and the release of Version 3 of the Criteria in October 2018.

The National Policy comprises the following information:

Performance Improvement Strategy

During 2018-19 the NBA developed the Strategy to strengthen Ig governance, drive improvement in the prescription, use and management of Ig products and support the Ig Governance Program to continue to deliver against agreed objectives.

The Strategy promotes a nationally consistent approach to monitoring performance and identifying obstacles and challenges to performance. As part of the Strategy, specific tools and mechanisms exist to promote continuous improvement amongst all aspects of the program. The centralised governance of Ig at a national level, together with the ability to capture robust data through BloodSTAR, provides a sound foundation to progress activities identified within the Strategy.

The Strategy identifies education, training and support activities to support health professions that are involved in the management and use of Ig. It also identifies communication activities and a strategy to strengthen current relationships and build new relationships with stakeholders both in Australia and abroad. Data collection, analysis and reporting activities also feature and provide assurance that the Ig Governance Program is successfully directing government-funded Ig products to patients that benefit and that the program represents efficient, effective and ethical expenditure of government funds. Knowledge development activities support further policy development in the future, promoting sustainability and enabling the Ig Governance Program to be responsive to change including in response to new advances in research.

Data and reporting activities remain a focus for the Ig Governance Program going forward. An initial tranche of reports was developed during 2018-19 to provide jurisdictions with information to draw out factors from each of the key performance areas and are intended to inform future reporting, promote discussion, and highlight areas for improvement – both for the NBA and external stakeholders.

Implementation of Version 3 of the Criteria

Version 3 of the Criteria was implemented nationally on 22 October 2018 through BloodSTAR. The revised Criteria aimed to more clearly articulate and standardise diagnostic, qualifying and review requirements. More comprehensive justification and evidence is now required to confirm patient eligibility, strengthening the capacity to direct Ig products to those who will genuinely derive a health benefit. The changes to the Criteria impacted a range of stakeholders including patients, clinicians, authorisers, nurses, and dispensers. A range of strategies and materials were developed, under the auspices of an over-arching transition project plan, to aid the implementation of Version 3 of the Criteria and support the transition of patients to the new version.

The revised Criteria will undergo regular review to ensure the qualifying, exclusion and review criteria and indicative dosages for each condition remain appropriate and in keeping with an evidence-based approach.

The Criteria identifies the conditions and circumstances for which the use of Ig is clinically appropriate and accessible to patients under the National Blood Agreement and within the National Policy: Access to Government Funded Immunoglobulin Products in Australia.

Version 1 of the Criteria was published in 2007 and was updated to Version 2 in 2012. The development and implementation of Version 3 of the Criteria in BloodSTAR was a major project spanning four years and involved wide public consultation to allow community consideration of proposed revisions.

The Criteria was developed by Specialist Working Groups including practicing medical specialists and in collaboration with relevant clinical colleges and societies, Version 3 of the Criteria clearly articulates and standardises the diagnostic, qualifying and review criteria, initial and continuing authorisation periods, dosing controls and supporting evidence for access to publicly funded Ig.

Changes to the Criteria include:

• in some conditions, patients must be diagnosed or reviewed by a particular type of specialist (for example an immunologist) to access Ig
• a small number of conditions were merged with other conditions to better align with the predominant clinical features
• following a review of the evidence, and based on expert clinical opinion and public consultation, Ig is no longer funded for a small number of conditions. This is because there has been limited use, alternative therapies have been demonstrated to be more effective, or there is insufficient evidence to support the use of Ig therapy for those conditions
• indications for Ig therapy are now more descriptive to better support the decision to provide access to funded Ig therapy and assist the prescriber to select the appropriate criteria and dosing regimens
• for some conditions more evidence is required to confirm that a patient has trialled first line therapies where they are available, and particularly if they are more cost effective
• in some conditions, it is clearer when Ig therapy is indicated and more direction is provided regarding the types of investigations to be used in the assessment of patients. These assessment methods will provide consistency and allow comparison of results to determine clinical response to Ig therapy for re-authorisation at review
• formal patient review is required to continue receiving funded Ig as ongoing therapy. Minimum levels have been defined for the expected clinical response to Ig therapy in most conditions
• dosing has now been defined for many conditions and recommended dosing levels are now clearly described.

Revision of the Criteria for the Clinical Use of Immunoglobulin in Australia – Version 3

The Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia (the Criteria) changed to Version 3 in BloodSTAR on 22 October 2018. As is usual after a major change, the National Blood Authority has received a variety of feedback from users and is working hard to provide clarification or implement improvements. There are answers to some common questions below.

Transition Historical Review Questions

It is important that Immunoglobulin (Ig) therapy is directed to those patients where it is likely to be effective and who do not have safe alternative therapies. For many continuing authorisation requests for patients transitioning from Version 2 to Version 3 of the Criteria, medical officers will need to provide some additional historical information about the patient's diagnosis and initial response to Ig therapy in the form of Transition Review questions. This is to ensure patients transition appropriately to the right indication, and to ensure they are still eligible to receive Ig product under the new Version 3 of the Criteria.

The transition review questions will appear only once for each patient who was previously approved for Ig therapy in Version 2. Many of the historical questions are non-mandatory or allow for medical officers to provide a response indicating the result is not known or wasn't tested. In most cases a written description can be provided. We ask that medical officers provide information where it is available, although it is recognised that some patients will have been diagnosed under a different specialist or some time ago and this information may not be readily accessible.

Mandatory and Non-mandatory Questions

While most questions in authorisation requests are mandatory, it is important to note that some are not. Mandatory questions are marked using a red asterisk (*) and BloodSTAR will not allow submission of a request to proceed if these are not completed. Where there is no red asterisk, a response is not mandatory and the submission can proceed.

Specialist and Consultation Requirements

It is a requirement, as outlined in the National Policy: Access to Government-Funded Immunoglobulin Products in Australia (National Policy) and the Criteria, that all patients in BloodSTAR must be treated by a medical specialist; this is called the Treating Medical Specialist.

Most conditions in Version 3 of the Criteria require a diagnosis or review by a particular type of specialist to access government-funded Ig. The National Immunoglobulin Policy requires all specialists to have their specialist qualification along with the Specialty Field of Practice registered with the Australian Health Practitioner Regulation Agency (AHPRA).

A consultation for diagnosis or review does not always need to take place face to face. A consultation with the appropriate specialist may occur by telephone, written correspondence or video-consultation. These arrangements can be particularly useful for patients who are not located in a metropolitan area so they can receive access to timely treatment.

It should be noted that it is at the discretion of the consulted medical specialist to accept responsibility for the diagnosis, review or prescription of Ig treatment for a patient. Medical officers completing the authorisation request (Requesting Medical Officer) will receive a warning if they have not selected the required specialist type before submitting. The consulted specialist must be nominated within BloodSTAR on the authorisation request as either:

• Treating Medical Specialist (TMS), i.e. the patient's usual specialist
• Diagnosing Medical Officer, i.e. the consulted specialist who is responsible for ensuring diagnostic criteria are met (this may be the same as the TMS)
• Reviewing Medical Officer, i.e. the consulted specialist who participated in the clinical review of the patient (this may be the same as the TMS).

Changes to Specialist Requirements

There have been changes to the diagnosing or reviewing specialist type for some conditions in Version 3 of the Criteria to access funded Ig. Medical officers completing the authorisation request will receive a warning if they have not selected the required specialist type before submitting.

In some conditions the revised Version 3 of the Criteria allows for the diagnosis to be made by additional specialist medical officers who may already manage patients with these conditions which will improve ease of access.

Why did the Criteria Change?

• To align with new evidence
• To ensure those whose health is most likely to be improved with Ig therapy can get it
• To manage the growth in demand for this precious, human-derived product.

Ig is a precious biological product derived from donated blood plasma, and as such, its use should be consistent with the evidence base and prescribed for the treatment of patients who are likely to benefit from immunoglobulin therapy, and for whom there are no safe and effective alternative treatments.

The significant annual growth in Ig use, the relatively high cost of Ig products and the potential for supply shortages mean that it is important to maintain a focus on ensuring that use remains consistent with an evidence-based approach and that Ig is able to be accessed under the national blood arrangements for those patients with the greatest clinical need.

Version 3 of the Criteria describes the conditions and indications for which the use of Ig is appropriate and government funded under the National Blood Agreement. Requests to access publicly funded immunoglobulin products in Australia must be authorised under Version 3 of the Criteria.

The changes to Version 3 of the Criteria will assist with meeting the National Safety and Quality Service (NSQHS) Standard 7 – Blood Management.

Where can I find more information?

Version 3 of the Criteria and supporting information is now available at www.criteria.blood.gov.au. Health professionals can view or print the Criteria by condition, check patient eligibility, review the assessment scales used for neurological conditions and check dosing with the dose calculator.

1 With effect from 4 June 2018, the NBA contracts with Baxalta Australia Pty Ltd were novated to Shire Australia Pty Limited. Throughout this report references are made to Shire Australia Pty Limited.

2 With effect from 26 April 2018, the NBA contract with Seqirus Pty Ltd was novated to Immulab Pty Ltd. Throughout this report references are made to Immulab Pty Ltd

While some changes meant that many patients could transition seamlessly from Version 2 to Version 3, others required additional information and assessments in order to be able to continue to receive government funded Ig. These transitions occurred throughout 2018 and will continue into 2019-20. The NBA continues to monitor the transition process closely. As at 30 June 2019, over 70 per cent of patients had transitioned to Version 3 of the Criteria. Extensive communication activities were undertaken to ensure patients and clinicians were aware of the changes and to support patients through the transition process.

Network of committees

In 2018-19 the NBA continued to work with the Ig Governance Program's network of committees to deliver program activities including the projects outlined above.

The program's principal committee, National Immunoglobulin Governance Advisory Committee (NIGAC), met four times during the year to provide advice to the NBA on particular aspects of the Ig Governance Program and to oversee the work of Specialist Working Groups (SWGs). Key projects that involved NIGAC and SWGs specifically in 2018-19 included the review of Version 3 of the Criteria, transition planning for patients and the development of the Performance Improvement Strategy.

Throughout the year, the NBA engaged with jurisdictional health departments, Ig interest groups established by State and Territory health departments and the recently established National Ig Interest Group to support Ig governance arrangements. Engagement with these groups ensures transparency between the program and jurisdictions, and creates channels to communicate issues, provide feedback, and facilitate understanding.

Ig Governance education and training

The NBA is committed to promoting the efficient and effective use of Ig under the national arrangements and providing education to health providers on their role in the Program.

In 2018-19 the NBA partnered with BloodSafe e-Learning Australia, an organisation with expertise and experience in health professional education, to develop and deliver innovative educational content.

The NBA has been working with BloodSafe e-Learning Australia to develop and implement educational content aimed at health care staff involved with the prescription, use and management of Ig products in Australia. Development of resources will continue in 2019-20, scheduled to be released in the same year.

Evaluation of new products

A 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 advice from the NBA, the JBC endorsed proposals for the following products to be referred to the Medical Services Advisory Committee (MSAC) for consideration of a health technology assessment and possible inclusion on the National Supply List:

• extended half-life clotting factor concentrates for treatment of haemophilia A and B
• Emicizumab for routine prophylaxis in patients with congenital haemophilia A with Factor VIII inhibitors
• purified human alpha1-proteinase inhibitor for the treatment of alpha1-proteinase inhibitor deficiency, leading to chronic obstructive pulmonary disease.

The above assessments are well underway and the outcomes of the MSAC review process are expected to be considered by the JBC during 2019-20.

Data developments

In 2017-18 the NBA continued to build its data capture and analysis capabilities across all aspects of the supply chain, particularly through the release of BloodNet 5 and BloodSTAR 3, along with Version 3 of the Criteria. This area of activity is a key strategy to improve the overall efficiency and sustainability of the sector by providing a measurement for improvement. All existing system reports were reviewed for accuracy. Some were removed and replaced with other reports which better met the needs of users.

A significant amount of data and information exists within the blood sector. The extent to which this data is currently available to those who need it, the quality of the data, and the capacity of the systems that hold it, varies widely. During 2018-19 the NBA progressed the following activities:

• added new system reports for use by stakeholders
• refined existing and implemented additional monthly and quarterly issue reports for stakeholders
• collected, analysed and distributed discard data from BloodNet to support the establishment of revised targets for discard rates
• refined existing and developed new reports on discards by both public and private health providers
• for haemovigilance:
  • refreshed the Haemovigilance Advisory Committee membership and updated the terms of reference
  • developed the annual National Haemovigilance Report for 2014-15 with data collected by states and territories, donor vigilance data was collected from the Blood Service
  • developed the annual National Haemovigilance Report for 2015-16 with data collected by states and territories, donor vigilance data was collected from the Blood Service
  • undertook activities as part of the work plan to support implementation of the Strategic Framework for the National Haemovigilance Program approved in 2014-15 and drafted a revised work plan and Strategic Framework for 2019-22
  • established working groups to continue to develop haemovigilance tools
  • reviewed the Australian Haemovigilance Minimum Data Set for haemovigilance reporting
• developed and implemented the National Blood Product Management Improvement Strategy 2018-22 (Improvement Strategy)
• for Australian Bleeding Disorders Registry (ABDR):
  • developed the ABDR Annual Report for 2017-18
  • continued to develop the set of data standards as part of the data integrity process for the ABDR for review by AHCDO Executive and the Data Managers
  • provided to AHCDO the 2017-18 ABDR Benchmarking Report
• developed the Ig Annual Report for 2017-18 from BloodSTAR and STARS
• provided BloodSTAR reporting to jurisdictions
• responded to 65 data requests from internal and external stakeholders.

HAEMOVIGILANCE ADVISORY COMMITTEE

The National Blood Authority (NBA) has developed reporting and governance frameworks for the National Haemovigilance Program for Australia. This provides a mechanism for reporting on serious transfusion related adverse events occurring in participating public and private hospitals.

The NBA has established a Haemovigilance Advisory Committee (HAC) to inform the work of this program.

In 2018-19 the HAC was formally re-established by the NBA Chief Executive under section 38 of the National Blood Authority Act 2003 (the NBA Act) to provide advice and guidance in relation to the development and implementation of the Strategic Framework for National Haemovigilance (Strategic Framework). The Committee membership was also refreshed and includes broad expert membership relevant to haemovigilance issues.

Standards

The National Safety and Quality Health Service Standard, Standard 7 – Blood Management requires health service organisations to report adverse events as follows:

Action 7.7 - The health service organisation uses processes for reporting transfusion related adverse events, in accordance with national guidelines and criteria

Action 7.8 - The health service organisation participates in haemovigilance activities, in accordance with the national framework.

Activities

The HAC also contributes to national haemovigilance activities through:

• data analysis
• research
• case studies and audits

This helps to identify opportunities for improvement and contribute to national reporting if required.

New membership

The HAC is now a group comprising members with expertise and knowledge in the health sector, blood management, quality and safety and consumer issues.

New membership also extended to nominees from (but not limited to) the Therapeutic Goods Administration, the Australian Commission on Safety and Quality in Health Care, and the Australian Institute of Health and Welfare.

The Committee Chair is Associate Professor Alison Street AO who has a deep knowledge and understanding of haemovigilance issues. Professor Street is also an NBA Board member.

The first meeting of the new HAC was held in Canberra in April 2019 to discuss future priorities of the committee, including raising awareness of haemovigilance in Australia to improve patient care and patient outcomes.

Working Groups

Working groups have also been established to provide advice to deliver specific programs to the HAC. These working groups consist of HAC members and/or expert advisors.

Risk management

The NBA continues to prioritise risk management across the agency and remains committed to ensuring security of the national blood supply.

The NBA Risk Management Policy and Procedures were reviewed in 2018-19 ensuring processes are in place to inform and support the NBA's strategic risks. Ongoing enhancement to the suite of blood systems and commitment to best practice ensure both operational and strategic risk planning continues to be a key focus across the NBA.

National Blood Supply Contingency Plan (NBSCP)

The NBSCP specifically addresses potential risk issues or interruptions to the supply of blood and blood products within Australia. Significant work on the NBSCP during the year included:

• In 2018-19 an updated version of the NBSCP, as endorsed by JBC, was published on the NBA website
• With the support of JBC, the NBA has engaged an expert consultant to assess the effectiveness of the plan and develop a plan for simulation exercises

In 2019-20 the NBSCP will be updated to reflect changes and improvements identifed as a result of this work.

Business Continuity Plan (BCP)

The BCP is undergoing significant review and in 2018-19 the NBA focused on expanding all recovery plans that support the NBA's critical business processes. This focus is to address a recent business impact analysis of the BCP, taking into account development and expansion to the suite of services provided within the Blood Operations Centre, such as BloodNet and BloodSTAR.

Supply risk mitigation for plasma derived and recombinant products

Specific risk management strategies have been developed and implemented for individual plasma and recombinant products. The plasma and recombinant supply risk assessment is updated annually. The NBA completed the update for 2018-19. The update included the validation of existing stock and contractual supply reserves.

BLOODNET 5 IMPLEMENTATION

BloodNet – System Update

BloodNet is Australia's online blood ordering and inventory management system. It allows health providers to order blood and blood products from the Australian Red Cross Blood Service (Blood Service) in a standardised way. BloodNet version 5 (BloodNet 5) was successfully released to users on Sunday 1 July 2018.

BloodNet 5 has provided an enhanced user experience that is simpler, clearer and faster while capturing important data to benefit the NBA, jurisdictions and health providers.

The update delivered:

• simple and easy to use compared with previous versions
• Quick actions - the 'quick actions' menu on the homepage provides direct links to commonly used functions. Some of these functions include; creating an order, creating a transfer, accessing reports and managing order templates
• Facility favourites - special orders that are likely to be ordered regularly can be added to the 'facilities favourites' list
• Customisable stock order templates - up to 10 stock order templates can be created and there is an option to set a default template. Fresh components and manufactured products can be added to the same template.

The update provided streamlined processes for ordering and receipting blood and blood products:

• Updated user interface - the user interface was updated with streamlined functions and a modern look and feel. The screens and navigation were designed to help provide a more user friendly experience
• Dashboards – four dashboards (ordering, receipting, stock movement and authorisation) were implemented to provide a quick summary of required actions and quick access to key functionality.

BloodNet 5 has been built on the latest technology platform with Government security controls. As part of the implementation approach, the system went through security testing to ensure the platform is reliable and secure.

BloodNet – System Update Key Milestones

• The 1.5 millionth BloodNet order was placed on 17 April 2019 by Western Diagnostic Pathology, Peel Campus in Western Australia.
• The 20 millionth product was processed on 28 June 2019 by Royal Brisbane and Women's Hospital, since the start of BloodNet.

BloodNet User Reference Group (BURG)

The BloodNet User Reference Group (BURG) is made up of users of BloodNet with an interest in providing the NBA ongoing feedback and input in relation to the updates and changes proposed to the system.

The NBA collaborated with BURG throughout the year. Feedback from BURG enabled several functional improvements which were implemented with the release of BloodNet 5.1 and 5.2. The NBA acknowledges the great contribution from the group and values its continuous support and ongoing involvement in ensuring BloodNet is fit for purpose.

Information Communication Technology (ICT)

The National Blood Authority (NBA) operates a range of Information and Communications Technology (ICT) systems, many of them world-leaders in their field. These systems directly enable blood and blood product ordering, the management of product authorisations and the clinical management and treatment of patients with bleeding disorders. They are underpinned by infrastructure that has been designed to minimise service interruptions, and maximise system availability and performance.

ICT systems are also a key enabler of data collection and analysis to inform research, policy development, system reporting and governance controls.

These systems enable us to provide a safe, secure and affordable blood supply for all Australians.

Australian Bleeding Disorders Registry

The ABDR is a clinical tool used 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 associated patient portal (MyABDR) is used by patients to record and manage data relating to their bleeding disorders. The NBA supported and managed both ABDR and MyABDR in 2018-19.

Canadian Bleeding Disorders Registry

In 2015 the NBA entered into a contract with McMaster University acting on behalf of the Association of Hemophilia Clinic Directors of Canada (AHCDC), to provide the Canadian Bleeding Disorder Registry (CBDR) and associated system support services. The CBDR is a modified form of the ABDR and comprises Bleeding Disorders Registry (BDR) functionality and a patient mobile interface (MyCBDR). This contract continues until 2020.

The NBA is currently engaged in consultations with AHCDC and McMaster University, the Australian Haemophilia Centre Directors Organisation (AHCDO), and other stakeholders, in relation to the potential benefits of a continued engagement between the NBA and Australian and Canadian organisations in relation to CBDR, including the possibility of:

• continued NBA support for and further development of BDR-based platforms
• a greater emphasis on more "synergistic" software development between Australian and Canadian requirements
• collaborate to foster research

All Haemophilia Treatment Centres (HTCs) in Australia use ABDR and in Canada 23 of 25 HTCs use CBDR.

BloodNet

BloodNet is Australia's online blood and blood products ordering and inventory management system, providing Australian hospitals and laboratories with the ability to order blood and blood products. BloodNet 5 was implemented on 1 July 2018 and incorporated a complete rebuild of the BloodNet platform and major interface design changes to enhance usability and streamlined functions, while meeting privacy, security and accessibility commitments.

The project was delivered through a user-centric, iterative approach. Co-designing solutions with users enabled the delivery of a fit for purpose and effective product. The platform interfaces with Laboratory Information Systems (LIS) in Australian hospital systems, providing near real-time visibility of the national blood supply for the first time. BloodNet 5 has delivered substantial improvements in the ease, efficiency and accuracy of blood ordering and management, with significantly reduced timeframes for product ordering activities.

BLOODSTAR NSW OCTOBER 2018

The implementation of BloodSTAR and the Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia (the Criteria) Version 3, represent the culmination of a substantial body of work over a number of years.

The roll-out of BloodSTAR in NSW was the final important piece of work to achieve full implementation of this national system, developed by the NBA, to properly manage and inform access to this precious and costly blood product. The accompanying roll-out of Version 3 of the Criteria is a critical piece of the overall clinical management system and process to better govern immunoglobulin (Ig) access.

BloodSTAR helps clinicians and patients by providing a national system interface with the Australian Red Cross Blood Service in relation to the authorisation of products.

NSW go-live

The NBA and the NSW Ministry of Health (NSW MoH) worked closely together to implement BloodSTAR in NSW. State-wide training for both public and private NSW prescribers, nurses and dispensers was delivered both face to face and through online demonstrations.

The NBA uploaded data on NSW facilities, clinicians and patients into BloodSTAR for the 22 October 2018 implementation. This was largely an automated process and as a result the majority of public facilities and clinicians were NOT required to register themselves.

On 22 October 2018, BloodNet was enhanced to support the globally recognised barcoding standard, ISBT 128, which was implemented by the Blood Service in November 2018.

The BloodNet 5 project was also recognised as a finalist in the iTnews Benchmark Awards for 2018-19 in the Federal Government category.

BloodSTAR

The BloodSTAR 3 implementation on 22 October 2018 also concluded the system's successful national rollout to all states and territories. It supports the updated Version 3 of the Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria).

BloodSTAR is now the sole channel for doctors to seek authorisations to prescribe Ig products funded under the National Blood Agreement. It provides full visibility of publicly funded immunoglobulin (Ig) usage across Australia in a sector which costs Australian governments over half a billion dollars annually.

Enhancements to product allocation capabilities in BloodSTAR were implemented in March 2019. This allows the NBA to more effectively manage the allocation of domestic and imported products.

BloodNet-Laboratory Information System (LIS) Interface

During 2018-19 the NBA continued to work with Laboratory Information System (LIS) vendors to deploy capability allowing BloodNet to interface with LIS. Several LIS vendors have completed, or are nearing completion of, BloodNet LIS vendor certification.

The BloodNet LIS interface provides real time savings for pathology services and jurisdictions through the automated exchange of data. The interface also provides benefits in improved product management in real-time and the potential to further improve longer term business processes and product management practices through improved data quality and analysis.

Pathology Queensland and the NBA initially piloted the integration of BloodSTAR through the AUSLAB-BloodNet LIS interface. A full rollout to all 34 Pathology Queensland sites occurred in January 2019. BloodSTAR patient authorisations are now directly updated from their LIS, which means staff no longer need to separately update both BloodNet and AUSLAB when managing orders and dispensing.

2018-19 Sector monitoring

In 2018-19 the NBA continued its horizon scanning of international experience that may influence the management of blood and blood products in Australia. This monitoring activity informs the provision of current and proactive analysis to governments to enable the NBA to fulfil its functions under the National Blood Agreement.

Our focus in 2018-19 was:

• new product developments and applications
• global regulatory and blood practice trends
• scientific and clinical research with implications for 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 affect supply or risk
• 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, clinical practice and patient outcomes. This information is available from www.blood.gov.au/monitoring-international-trends-blood-sector.

During 2018-19, key developments included:

• global demand for immunoglobulin grew, not least because of expanded indications. In some countries, patients found their treatment rationed
• global capacity for plasma collection and processing expanded
• new therapeutic and prophylactic products were developed or approved for haematological conditions
• there was increasing interest in developing gene therapy for inherited blood disorders. Bluebird Bio, Inc. received EU conditional marketing authorisation for its gene therapy for some patients with transfusion-dependent-Thalassemia. A five-year pay-as-you-go model was proposed
• the Japanese government approved a plan for blood transfusions to include platelets created from artificially derived stem cells for patients with intractable diseases
• a US study concluded that universal screening of donated blood for the Zika virus, by individual donation nucleic acid testing (a practice implemented in 2016) "was cost-effective only in the high mosquito season in Puerto Rico"
• some research suggests transfusion threshholds should be age-related
• researchers discovered that microbes in the human gut can facilitate conversion of the common blood type A to a universal donor blood type
• a study of blood donor samples in areas of New South Wales and Queensland found that as many as one in 20 people had been exposed to Q fever
• Ebola continued to spread in the Democratic Republic of Congo.