Chief Executive Review

John Cahill commenced as Chief Executive of the National Blood Authority on 4 October 2016.

He has come to this role from a position as First Assistant Secretary in the Commonwealth Department of Health. He brings wide ranging policy, program, operations, service delivery and corporate management knowledge and experience, including more than 23 years' experience as a senior executive with various federal government departments and agencies.

His most recent roles have involved the leadership and management of major projects and the delivery of challenging and complex services across Australia and in Australia's partner countries in relation to highly sensitive and contested policy development and implementation. This has included the management and delivery of significant health services, infrastructure services, major procurement and the management of contracts with a value in excess of A$10 billion. It has also included difficult security and logistics operations.

John was inaugural Chief Executive of Biosecurity Australia, responsible for successfully establishing and leading that Agency to undertake independent science-based risk assessments of animal and plant health risks to Australia and provide policy advice to government on these issues. He had previously worked in senior executive roles involving large and complex operations delivering Australia's quarantine border controls relating to animal, plant and human health issues. He has also been responsible for delivering substantial corporate management, governance and related services including HR, finance and ICT. He has extensive leadership and management experience in a commercially operating regulatory authority with budgets exceeding $300 million annually and more than 3,000 geographically dispersed staff.

It was clear to me on my commencement as Chief Executive of the NBA that the NBA is a high performing, well regarded organisation doing important work in the blood sector.

The year just concluded has seen the delivery of significant projects and outcomes by the NBA in relation to the provision of a secure and affordable supply of blood products, improving immunoglobulin governance, developing and implementing guidance and programs for the appropriate management, use and reduced wastage of blood products, and ICT and data collection and development.

A snapshot of some key highlights for the year are as follows:

• The Australian Red Cross Blood Service (Blood Service) is the sole supplier of fresh blood products. The provision of fresh blood products under the Deed of Agreement is an essential clinical service that saves lives every day. The NBA has an ongoing program with the Blood Service to improve contract performance and accountability under the Deed. The NBA implemented a new nine year Deed of Agreement with the Blood Service on 1 July 2016 and included a three year funding and service agreement. This represented the culmination of a number of years of collaborative work between Blood Service and NBA teams to work through all aspects of the service and funding arrangements
• The CSL Australian Fractionation Agreement (CAFA) is the NBA's contract with CSL Behring (Australia) Pty Ltd for the manufacture of plasma derived products for Australian use. The CAFA expires on 31 December 2017. In March 2017, senior representatives of the NBA met with CSL Behring (Australia) Pty Ltd to commence substantive negotiations on a new National Fractionation Agreement for Australia that is due to commence on 1 January 2018
• Under the National Immunoglobulin Governance Program, the NBA continued to work with the National Immunoglobulin Governance Advisory Committee throughout the year to strengthen the governance and management of government-funded immunoglobulin products and deliver positive changes to benefit the thousands of Australians reliant on this product. The NBA also worked with our Clinical Specialist Working Groups to continue evolving the Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria). This is to ensure government-funded immunoglobulin products are directed to the patients who are most likely to benefit from using these products based on reliable evidence and where alternative therapies were limited. Following on from last year's completion of revisions to conditions where immunoglobulin can be categorised as having either an 'established therapeutic role' or an 'emerging therapeutic role', a public consultation was conducted. This public consultation invited feedback on the changes proposed to conditions categorised as for use in 'exceptional circumstances only'. The NBA is grateful to the members of the public and others who took the time to review the consultation documents and provide submissions
• Complementing this portfolio of work, the NBA successfully launched BloodSTAR. This is a national immunoglobulin ordering and outcomes database which has been designed to enable the generation of whole of system performance data to support continuous improvement and drive the accuracy and efficiency of access and authorisation processes well into the future. Following its launch, a total of 6,868 existing patients in most states and territories have so far been transitioned to the new system in a staged but seamless process that achieved continuity of health care for affected patients. The new electronic authorisation system replaces paper-based and phone processes for immunoglobulin products and standardises access and supply arrangements. BloodSTAR is the result of years of planning, development and testing not only within the NBA but across all Australian governments, and in collaboration with patients, clinicians and health service providers. As the NBA prepares for BloodSTAR implementation in New South Wales, we wish to express our gratitude to everyone who has contributed to the success of this important project
• On 11 November 2016 the PathWest laboratory at Fiona Stanley Hospital in Perth, Western Australia, placed the 1,000,000 order in BloodNet. This was a significant milestone for the BloodNet system which was introduced in 2011 as a national system that allows staff in health facilities across Australia to order blood and blood products in a standardised, quick, easy and secure way from the Blood Service. The milestone was marked with the presentation of a commemorative award from NBA Chief Executive Mr John Cahill to PathWest Laboratory Senior Scientist Ms Annette Le-Viellez
• Ms Gayle Ginnane was re-appointed Chair of the NBA Advisory Board this year, along with the reappointments of Adjunct Professor Chris Brook PSM and Deputy Secretary Mark Cormack from the Commonwealth Department of Health. There were also two new eminent appointments to the Board: Professor Lyn Beazley AO and Associate Professor Alison Street AO. Continuing members are Ms Patti Warn and Mr Paul Bedbrook. We would like to thank Professor George Rubin, whose Board term has expired, for his contribution to the work of the Board and the NBA over a number of years
• The NBA successfully concluded the second funding round under the National Blood Sector Research and Development Pilot. This is an exciting initiative which initially focussed on key areas of potential research to support the patient blood management and immunoglobulin governance programs
• In late 2016, a breach of data security occurred in relation to some donor information held by the Blood Service. The breach arose from unauthorised access being obtained to donor information held in an insecure environment by a third party provider that develops and maintains the Blood Service's website. The Blood Service took immediate steps to notify all donors and governments and to enhance security of systems. A Taskforce was established and the NBA worked closely with the Blood Service over many months to ensure all risks were addressed. A number of internal and external reviews were conducted, including by the Australian Information and Privacy Commissioner. The Commissioner commended the Blood Service's handling of the incident and the Blood Service has entered into an enforceable undertaking to address the Commissioner's findings. The NBA also reviewed and improved its own data and ICT security in light of the incident
• Governments funded a pilot project for two plasma only donor centres. New technologies and processes will be trialled by the Blood Service with the aims of improving the efficiency of plasma and reducing costs. Two pilot plasma only centres are being developed, to be located in Townsville and Canberra. The Townsville centre is due to open in September 2017, and the Canberra centre in March 2018
• Following a successful tender process, in October 2016 the NBA entered into a contractual arrangement with CSL Behring (Australia) Pty Ltd to supply C1 Esterase Inhibitor Concentrate (Berinert) for the following indications for hereditary angioedema: treatment of acute attacks; pre-procedural (short term) prophylaxis for high risk procedures such as dental work, head or neck surgery, or surgery requiring intubation; and as a routine (long term) prophylaxis for patients who experience the equivalent of eight or more acute attacks per month
• The NBA commenced the redevelopment of BloodNet (BloodNet 5) in August 2016 with a series of visits to hospital/laboratory sites to understand usability and enhancement requirements. The implementation of BloodNet 5 is expected in 2017-18
• The NBA successfully passed the Digital Transformation Agency (DTA) digital service standard alpha assessment of the BloodNet 5 application in March 2017. In doing so, the NBA was the first Commonwealth agency to pass this assessment unassisted by the DTA
• During 2016-17 the NBA continued its work with key stakeholders to implement BloodNet-Laboratory Information System (LIS) interfaces under a new set of specifications. NSW Pathology North went live in October 2016 as the first BloodNet-LIS site certified and QLD Pathology Queensland went live in June 2017. All BloodNet-LIS interfaces currently in place account for processing 35 per cent of national issues of fresh blood products
• The NBA has continued to use flexible staffing arrangements to ensure it can employ adequate staff to deliver against the demands and expectations reflected in the work program and funding determined by jurisdictional governments. As a small agency, the approved staffing level continues to challenge the organisation and how it can ensure it has the best and most stable workforce to most appropriately manage functions and funding in excess of $1 billion. This will continue to be a challenge in 2017-18
• The NBA has reframed its internal governance arrangements to ensure there is a more orderly, resilient and transparent process of decision-making, governance, accountability and risk management.

Ensuring the supply of blood products

The NBA's primary responsibility is to ensure Australia has a safe, secure, adequate and affordable supply of blood and blood related products to meet clinical demand. The clinical demand for blood and blood related products in Australia was met without interruption. A saving of $49.1 million was achieved against the annual budget approved and funded by all jurisdictional governments. This saving brings the total amount of funding returned to governments over the last five years to $495.6 million.

The year saw further improvement in the appropriate use of fresh blood. The 2016-17 demand for red cells decreased by 1.4 per cent. This result builds on the progress already made in this strategic planning cycle to bring the total reduction in red cell demand over the last five years to 22 per cent, realising significant improvements in patient outcomes and financial savings of $103 million. Demand for platelets remained steady with no increase in demand in 2016-17 over 2015-16.

Improvements in supply performance and efficiency under the new Deed of Agreement with the Australian Red Cross Society (Red Cross) once again saw the Blood Service achieve a surplus of approximately $27.3 million. This will return a 2016-17 saving of approximately $22.3 million to governments after funding of $5.0 million is retained by the Blood Service for investment in further improvements by the Blood Service under the Deed.

In mid-January 2017, the NBA released a Request for Information and Stakeholder Consultation Paper directed at potential suppliers and clinical and patient stakeholders to inform consideration of future procurement arrangements for clotting factor products, specifically recombinant factors VIIa, VIII and IX products. Final formal submissions were received on 12 April 2017. A period of further engagement followed with industry and stakeholders to clarify information around some of the issues raised and more generally to assist with understanding those issues. A summary overview of the outcomes of the stakeholder consultation is to be made available in early 2017-18 on the NBA website.

The NBA completed its annual Supply Risk and Mitigation Project to review supply security arrangements for all plasma and recombinant products. This included the validation of existing stock and contractual supply reserves.

Improving the management and use of blood products

Throughout the year the NBA maintained a focus on governments' priorities for the blood sector through activities under the key sector policies and strategies agreed by all governments, particularly the National Blood and Blood Product Wastage Reduction Strategy 2013-17 and the National Patient Blood Management (PBM) Guidelines Implementation Strategy 2013-17. An ongoing program of activities also supports the implementation of the Health Ministers' Statement on national stewardship expectations for the supply of blood and blood products. These programs contribute to the sustainability of the blood supply by improving the management and use of blood products. In 2016-17, the NBA:

• worked with jurisdictional and clinical committees to develop the new PBM Implementation Strategy for 2017-21
• commenced a review of the 2003 Guidelines on the Prophylactic Use of Rh D Immunoglobulin (Anti-D) in Obstetrics to ensure they continue to reflect current evidence and best clinical practice
• worked with jurisdictional and clinical representatives to oversee the process for the review and update of the PBM Guidelines and to identify a more sustainable methodology for updating clinical practice guidelines in the future
• promoted the work of the NBA and engaged with stakeholders by participating in multiple national conferences and events
• continued collaborative work with the Australian Commission on Safety and Quality in Health Care (ACSQHC) on a review of the National Safety and Quality Health Service (NSQHS) Standards, Standard 7: Blood and Blood Products, and the completion of the National Patient Blood Management Collaborative, focussing on identification and management of pre-operative anaemia and iron deficiency.

As I noted at the outset, 2016-17 has been another year of significant achievements for the NBA and its staff. I would like to acknowledge the contribution made by my Deputy, Michael Stone, for the extended period he acted as General Manager of the NBA following the departure of my predecessor in February 2016 until my arrival in October 2016.

I close this report by again recognising the contribution of the many stakeholders across the sector who gave generously of their time, professionalism and passion in working on some very important issues with the NBA during the year. We look forward to working with you again in 2017-18. I would also like to thank the staff of the NBA who work tirelessly and are so committed to saving and improving Australian lives through a world class blood supply.

John Cahill
Chief Executive