ANNUAL REPOR T2018–19 - Blood · ANNUAL REPOR T 2018–19 . ... 1.1 NBA Organisation as at 30...

NATIONAL BLOOD AUTHORITYAUSTRALIA

NATION

AL BLOOD AUTHORITY AUSTRALIA

ANN

UAL REPORT 2018 –19 ANNUAL REPORT 2018–19

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ISSN 1832–1909

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TABLE 1.1 Aids to access details current report period (2018-19)

Annual report contact officer (title/position held) Director People & Communications

Contact phone number +61 2 6151 5000

Contact email [email protected]

Entity website (URL) www.blood.gov.au

NBA ANNUAL REPORT / 2018–19ii

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LETTER OF TRANSMITTAL

iiiLETTER OF TRANSMITTAL

CONTENTS

Letter of Transmittal iii

PART 1: OVERVIEW 1Organisation at a glance 2Chief Executive review 10NBA Board and report 15

PART 2: ANNUAL PERFORMANCE 21Annual performance reporting statement 22Performance results 25Objective 1. Secure the supply of blood and blood products 33Objective 2. Improve risk management and blood sector performance 52Objective 3. Promote the safe and efficient use of blood and blood products 68

PART 3: MANAGEMENT AND ACCOUNTABILITY 77Structure, governance and authority in the blood sector 78Planning framework 83Service charter 86External scrutiny 87Fraud control 87Human resources and people management 88

PART 4: FINANCIAL MANAGEMENT 103Financial management 104Financial performance 106Assets management 111Purchasing 112Financial statements 114

NBA ANNUAL REPORT / 2018–19iv

PART 5: APPENDICES 157Appendix 1. Committee and Board Member Profiles 158Appendix 2. Fresh blood components supplied under contract by the Blood Service in 2018-19 164Appendix 3. Plasma and recombinant products supplied under contract in 2018-19 166Appendix 4. Mandatory Reporting 170Appendix 5. List of Requirements 178Appendix 6. Acronyms and Abbreviations 186Index 189 TABLES1.1 Aids to access details current report period (2018-19) ii1.2 Details of Accountable Authority during the current report period (2018-19) 31.3 Government funding for the supply of blood and blood products, 2009-10 to 2018-19 42.1 Performance Criteria Qualitative Deliverable - provide a safe, secure and affordable supply of blood and blood related products and services 252.2 Performance Criteria Quantitative Deliverable - provide a safe, secure and affordable supply of blood and blood related products and services 262.3 Performance Criteria Qualitative Deliverable - drive performance improvement in the Australian blood sector 272.4 Performance Criteria Quantitative Deliverable - drive performance improvement in the Australian blood sector 282.5 Performance Criteria Qualitative Deliverable - promote a best practice model of management and use of blood and blood related products and services 292.6 Performance Criteria Qualitative Deliverable - develop policy and provide policy advice on the sustainability of the blood sector 312.7 Performance Criteria Qualitative Deliverable - the National Blood Authority is a high performing organisation 322.8 Performance Criteria Quantitative Deliverable - the National Blood Authority is a high performing organisation 322.9 Blood and blood products purchased, by supplier, 2014-15 to 2018-19 342.10 Fresh blood expenditure: increases over the last 10 years 362.11 Immunoglobulin growth 432.12 Blood Service: selected key performance indicators, 2018-19 452.13 CSL Behring (Australia) Pty Ltd’s performance under the NaFAA, 2018-19 472.14 Imported IVIg: Key performance indicators, by supplier, 2018-19 492.15 Imported plasma and recombinant blood products: key performance indicators, by supplier, 2018-19 503.1 NBA’s performance in achieving business plan objectives, 2014-15 to 2018-19 853.2 APSC comparison current year versus last year 893.3 Australian Public Service Act ongoing employees current report period (2018-19) 903.4 Australian Public Service Act non-ongoing employees current report period (2018-19) 90

CONTENTS v

3.5 Australian Public Service Act ongoing employees previous report period (2017-18) 903.6 Australian Public Service Act non-ongoing employees previous report period (2017-18) 913.7 Australian Public Service Act employees by full time and part time status current report period (2018-19) 913.8 Australian Public Service Act employees by full time and part time status previous report period (2017-18) 923.9 Age demographic of NBA staff as at 30 June 2019 923.10 All ongoing employees current report period (2018-19) 943.11 All non-ongoing employees current report period (2018-19) 943.12 All ongoing employees previous report period (2017-18) 943.13 All non-ongoing employees previous report period (2017-18) 943.14 Australian Public Service Act employment type by location current report period (2018-19) 943.15 Australian Public Service Act employment type by location previous report period (2017-18) 963.16 Australian Public Service Act employment arrangements current report period (2018-19) 963.17 Australian Public Service Act employment salary ranges by classification level (minimum/ maximum) current report period (2018-19) 973.18 Information about remuneration for key management personnel 993.19 Information about remuneration for senior executives 994.1 Departmental and Administered funding and expenditure 2018-19: a summary 1054.2 Key results in financial performance, 2014-15 to 2018-19 1074.3 Administered revenue, 2014-15 to 2018-19 1094.4 Key results of administered expenses, 2014-15 to 2018-19 1094.5 Number and expenditure on consultants current report period (2018-19) 1134.6 Expenditure on consultancy services, 2014–15 to 2018-19 1135.1 Fresh blood components supplied under contract by the Blood Service, 2018-19 1655.2 Plasma and recombinant products supplied under contract 2018-19 1665.3 NBA environmental performance indicators 1725.4 Agency resource statement 1755.5 Agency expenses by outcome 1765.6 Report on financial performance summary 1775.7 List of requirements 178

NBA ANNUAL REPORT / 2018–19vi

FIGURES1.1 NBA Organisation as at 30 June 2019 42.1 Returns to government 2014-15 to 2018-19 372.2 Red cells issued by the Blood Service 2014-15 to 2018-19 per ‘000 population 382.3 Platelets issued by the Blood Service 2014-15 to 2018-19 per ‘000 population 382.4 Whole blood to apheresis plasma for fractionation 2014-15 to 2018-19 392.5 Plasma derived and overseas product expenditure: cumulative increases on 2003-04 base year 402.6 Issues of Factor VIII products 2014-15 to 2018-19 per ‘000 population 402.7 Issues of Factor IX products 2014-15 to 2018-19 per ‘000 population 412.8 Issues of Factor VIIa products 2014-15 to 2018-19 per ‘000 population 422.9 Issues of FEIBA, 2014-15 to 2018-19 per ‘000 population 422.10 Issues of Ig products, 2014-15 to 2018-19 per ‘000 population 433.1 Governance and Authority in the Blood Sector 783.2 Governance and Authority in the NBA 793.3 NBA Planning Framework 843.4 NBA Organisational Chart 88

CONTENTS vii

ORGANISATION AT A GLANCE

CHIEF EXECUTIVE REVIEW

NBA BOARD AND REPORT

OVERVIEW

PART 1

ORGANISATION AT A GLANCE

Our VisionSaving and improving Australian lives through a world-class blood supply.

Our roleThe National Blood Authority (NBA) is a statutory agency within the Australian government health portfolio that manages and coordinates arrangements for the supply of blood and blood products and services on behalf of all Australian governments.The primary objectives under the National Blood Agreement are to:

• provide an adequate, safe, secure and affordable supply of blood products, blood related products and blood related services

• promote safe, high quality management and use of blood products, blood related products and blood related services in Australia.

The NBA • works with all Australian Governments to determine the clinical requirements for blood and blood

products and develop an annual supply plan and budget

• negotiates and manages national contracts with suppliers of blood and blood products to obtain the products needed

• assesses blood supply risk and develops commensurate contingency planning

• supports the work of all Australian governments to improve the way blood products are governed, managed and used – including developing and facilitating strategies and programs that will improve the safety, quality and effectiveness of blood usage, particularly in the areas of national standards, criteria, guidelines and data capture and analysis

• works collaboratively with key stakeholders to provide expert advice to support government policy development, including identification of emerging risks, developments, trends and new opportunities

• manages the evaluation of proposals for blood sector improvements, including proposals for new products, technologies and system changes

• provides secretariat support to the Jurisdictional Blood Committee (JBC).

NBA ANNUAL REPORT / 2018–192

AuthorityThe NBA was established by the National Blood Authority Act 2003 (NBA Act) following the signing of the National Blood Agreement by all state and territory Health Ministers in November 2002. As a material statutory agency, the NBA has a range of corporate and compliance responsibilities under the NBA Act, the Public Governance, Performance and Accountability Act 2013 (PGPA Act), and the Public Service Act 1999, along with a responsibility to meet ministerial, parliamentary and financial reporting requirements.

Accountable AuthorityDetails of the NBA’s Accountable Authority during the current report period (2018-19) appear in Table 1.2 below.

TABLE 1.2 Details of Accountable Authority during the current report period (2018-19)

Name Position title/ position held

Date of commencement Date of cessation

Mr John Cahill Chief Executive October 2016 n/a

Responsible Ministers and PortfolioThe NBA exists within the portfolio responsibilities of the Minister for Health. The NBA General Manager is the Chief Executive of the NBA and is a statutory officer responsible to the Commonwealth Minister for Health and the Council of Australian Governments (COAG) Health Council.

Our Outcome Access to a secure supply of safe and affordable blood products, including through national supply arrangements and coordination of best practice standards within agreed funding policies under the national blood arrangements.

FundingUnder the National Blood Agreement between the Australian Government and the states and territories, 63 per cent of NBA funding is provided by the Australian Government and the remaining 37 per cent is provided by the state and territory governments. The funding covers both the national blood supply and the operations of the NBA.

In the last ten years, governments have provided funding of $10,345.6 million for the supply of blood and blood products as summarised in Table 1.3. In 2018-19, the total amount provided was $1,203.6 million. Governments provided funding of $9.9 million in 2018-19, for the operation of the NBA.

PART 1 OVERVIEW 3

TABLE 1.3 Government funding for the supply of blood and blood products, 2009-10 to 2018-19

Year Amount ($M) Growth (%)

2009-10 878.8 8.9

2010-11 939.2 6.9

2011-12 1,015.6 8.1

2012-13 1,049.3 3.3

2013-14 1,095.9 4.4

2014-15 922.7 -15.8

2015-16 1,040.9 12.8

2016-17 1,046.3 0.5

2017-18 1,153.3 10.2

2018-19 1,203.6 4.4Total 10,345.6 3.9 (average)

Note: Figures balance to the Audited Financial Statements

Our StaffAs at 30 June 2019, the NBA had an average staffing level of 55.62 staff. At this date, it also employed 23 contract staff. The organisational structure at 30 June 2019 is shown at Figure 1.1.

FIGURE 1.1 NBA Organisation as at 30 June 2019

LocationThe NBA is located in Canberra at 243 Northbourne Avenue, Lyneham ACT.

Chief Executive

Deputy Chief ExecutiveCommercial Blood Products

& Business Services

Deputy Chief ExecutiveFresh Blood Products& Business SystemsSenior Advisor

Blood & Data Services

DirectorImmunoglobulin

Governance

DirectorResearch &

Product Review

DirectorPeople &

Communications

Chief Finance Officer

DirectorCommercial Blood

Products

Chief InformationOfficer

DirectorFresh Blood

Products & Services

Executive Office


Key Events in the NBA’s History by Financial Year 2003 • Established by the National Blood Authority Act 2003 following the signing of the

National Blood Agreement by all State and Territory Health Ministers in November 2002

2004 • Commencement of national supply arrangements for imported intravenous immunoglobulin (IVIg) to ensure sufficiency of supply in all jurisdictions

2005 • Commencement of an adequate supply of recombinant Factors VIII and IX to fully meet demand

2006 • NBA executed a Deed of Agreement with the Australian Red Cross Society for the provision of fresh blood products and plasma for fractionation

• NBA won the Prime Minister’s Silver Award for Excellence in Public Sector Management for procurement of recombinant (manufactured) products

2007 • First edition of Criteria for the clinical use of IVIg in Australia was approved

2008 • Launch of the National Blood Supply Contingency Plan (NBSCP) to provide clear governance for managing blood shortages

• Launch of the redeveloped Australian Bleeding Disorders Registry (ABDR) to better support planning and clinical management of people with bleeding disorders

2009 • Establishment of the Australian National Haemovigilance Program to report on serious transfusion related adverse events

• NBA was awarded the Australian Government Comcover Award for Excellence in Risk Management for the NBSCP

2010 • New CSL Australian Fractionation Agreement came into effect

• NBA won a United Nations Public Service Award in the Advancing Knowledge Management in Government category

2011 • National rollout of BloodNet, an online web based blood ordering system

• Release of the first module (Critical Bleeding/Massive Transfusion) of the Patient Blood Management (PBM) Guidelines

2012 • Release of PBM Guidelines Module 2 Perioperative and Module 3 Medical

• Second edition of IVIg Criteria in Australia was published

2013 • Release of PBM Guidelines Module 4 Critical Care

• Inaugural National Blood Symposiums conducted in Sydney, Melbourne and Adelaide

2014 • National rollout of MyABDR

• Inaugural PBM Conference held in Perth

• Immunoglobulin governance program and National Immunoglobulin Governance Advisory Committee (NIGAC) established

PART 1 OVERVIEW 5

2015 • NBA won ACT iAwards in three categories for innovation surrounding the development of BloodNet interfaces with health provider laboratory information systems

• National Blood Symposium held in Brisbane, including the presentation of the inaugural National Blood Awards for Excellence in the Management of Blood

• Release of PBM Guidelines Module 5 Obstetrics and Maternity

2016 • A new Deed of Agreement was finalised with the Australian Red Cross Society for the provision of fresh blood products and plasma for fractionation supplied by the Australian Red Cross Blood Service

• Release of PBM Guidelines Module 6 Neonatal and Paediatrics

• Release of National Haemophilia Guidelines developed with the Australian Haemophilia Centre Directors’ Organisation (AHCDO)

• National Blood Sector Research and Development Pilot commenced

• BloodSTAR launched for registration by hospitals and clinicians

2017 • The new Deed of Agreement with the Australian Red Cross Society for the provision of fresh blood products and plasma for fractionation supplied by the Australian Red Cross Blood Service implemented on 1 July 2016

• BloodSTAR implemented in most states and territories

• Round 2 of the National Blood Sector Research and Development Pilot commenced

• Redevelopment of BloodNet commenced (BloodNet 5)

• Negotiations to replace CSL Australian Fractionation Agreement commence

2018 • National Fractionation Agreement for Australia (NaFAA) commenced on 1 January 2018 and continues until 31 December 2026 subject to a review in 2022

• National Blood Sector Research and Development Program continued with two further funding rounds

• BloodSafe eLearning delivered more than 1 million courses and celebrated its tenth (10th) year anniversary

• Consultation for potential future arrangements for imported plasma and recombinant products completed

• Limited interim arrangements for extended half-life clotting factor products

• Redevelopment of BloodNet completed with go live on 1 July 2018


2019 • Implementation of redeveloped BloodNet on 1 July 2018

• National implementation of BloodSTAR completed in all states and territories with NSW going live in October 2018

• Interim access arrangements for extended half-life clotting factor products continued

• Revised Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria) implemented and available in BloodSTAR for users in all states and territories

• National Blood Sector Research and Development Program continued and round four grant funding commenced

• NBA organisation restructured and additional Deputy Chief Executive position filled

PART 1 OVERVIEW 7

Year at a Glance: Snapshot of the blood sector in 2018-19

KEY ACHIEVEMENTS

DELIVERY OF UNINTERRUPTED SUPPLY TO MEET CLINICAL DEMAND AT A SIGNIFICANT SAVING OF $68.9 MILLION

BLOODNET REDEVELOPMENT RELEASED IN ALL JURISDICTIONS

BLOODSTAR FULLY IMPLEMENTED AS A NATIONAL SYSTEM

VERSION 3 OF THE CRITERIA FOR IMMUNOGLOBULIN RELEASED IN BLOODSTAR IN OCTOBER 2018

Issuing

639,051UNITS OF RED CELLS ISSUED

135,798UNITS OF

PLATELETS ISSUED

3,182,554GRAMS

DOMESTIC Ig ISSUED

3,389,922GRAMS

IMPORTEDIg ISSUED

Donating

500,536TOTALACTIVEDONORS

179,391NUMBER OFPLASMAPHERESIS

DONORS

1,456,337B L O O DDONORS

Ordering

187,284NUMBER OF BLOODNET

ORDERS

513AVERAGE NUMBER

OF ORDERSPER DAY

2,213,308NUMBER OF UNITS

RECEIVED BY BLOODNET FACILITIES

99%NATIONAL UPTAKE

ON BLOODNET FATE MODULE

143LABORATORIES

INTERFACED WITHBLOODNET

Supplying

$667.9MILLION

FRESH BLOODCOMPONENTS

$568.1 MILLION

PLASMA DERIVED

& RECOMBINANTPRODUCTS

$4.7MILLION

DIAGNOSTICREAGENTS

Managing

6,348PATIENTS

REGISTERED IN ABDR

1,755PATIENTS RECIEVING

PRODUCTS FORBLEEDING DISORDERS


lg PRODUCTS

1,277FACILITIES ISSUED

BLOOD IN BLOODNET

UNIQUE VISITORSTO THE NBA

WEBSITE

6.4 DAYSAVERAGE AGE OF RED BLOOD CELLS

AT ISSUE

11,894DISCARDS OF RED

BLOOD CELLS

550,320REGISTERED USERS

OF BLOODSAFE eLEARNING

6,920GUIDELINE &

CRITERIA PUBLICATIONS DISTRIBUTED

Budgeting

$1,203.6MILLIONGOVT FUNDING FOR PRODUCT

SUPPLY

$9.9MILLION

OPERATIONAL FUNDING

$68.9MILLIONSAVING

TOGOVERNMENTS

238,526

Collecting and

Processing

736TONNES OF

PLASMA COLLECTED

76FIXED

COLLECTIONSITES

5MANUFACTURING

AND TESTING

SITES

Transfusing


Year at a Glance: Snapshot of the blood sector in 2018-19

KEY ACHIEVEMENTS

Issuing

639,051UNITS OF RED CELLS ISSUED

135,798UNITS OF

PLATELETS ISSUED

3,182,554GRAMS

DOMESTIC Ig ISSUED

3,389,922GRAMS

IMPORTEDIg ISSUED

Donating

500,536TOTALACTIVEDONORS

179,391NUMBER OFPLASMAPHERESIS

DONORS

1,456,337B L O O DDONORS

Ordering

187,284NUMBER OF BLOODNET

ORDERS

513AVERAGE NUMBER

OF ORDERSPER DAY

2,213,308NUMBER OF UNITS

RECEIVED BY BLOODNET FACILITIES

99%NATIONAL UPTAKE

ON BLOODNET FATE MODULE

143LABORATORIES

INTERFACED WITHBLOODNET

Supplying

$667.9MILLION

FRESH BLOODCOMPONENTS

$568.1 MILLION

PLASMA DERIVED

& RECOMBINANTPRODUCTS

$4.7MILLION

DIAGNOSTICREAGENTS

Managing

6,348PATIENTS

REGISTERED IN ABDR


PRODUCTS FORBLEEDING DISORDERS


lg PRODUCTS

1,277FACILITIES ISSUED

BLOOD IN BLOODNET

UNIQUE VISITORSTO THE NBA

WEBSITE

6.4 DAYSAVERAGE AGE OF RED BLOOD CELLS

AT ISSUE

11,894DISCARDS OF RED

BLOOD CELLS

550,320REGISTERED USERS

OF BLOODSAFE eLEARNING

6,920GUIDELINE &

CRITERIA PUBLICATIONS DISTRIBUTED

Budgeting

$1,203.6MILLIONGOVT FUNDING FOR PRODUCT

SUPPLY

$9.9MILLION

OPERATIONAL FUNDING

$68.9MILLIONSAVING

TOGOVERNMENTS

238,526

Collecting and

Processing

736TONNES OF

PLASMA COLLECTED

76FIXED

COLLECTIONSITES

5MANUFACTURING

AND TESTING

SITES

Transfusing

A REDUCTION IN RED BLOOD CELL WASTAGE FROM 2.2% to 1.9%

NATIONAL BLOOD SECTOR RESEARCH AND DEVELOPMENT PROGRAM FUNDING FOR ROUND FOUR COMMENCED

CONSULTATION FOR POTENTIAL FUTURE ARRANGEMENTS FOR IMPORTED PLASMA AND RECOMBINANT PRODUCTS COMPLETED

CONTINUED LIMITED INTERIM ARRANGEMENTS FOR EXTENDED HALF-LIFE CLOTTING FACTOR PRODUCTS

PART 1 OVERVIEW 9

CHIEF EXECUTIVE REVIEW

I am pleased to report that the National Blood Authority (NBA) has had another good year in managing the continued delivery of a safe, secure and affordable supply of blood, blood products and services for Australia.

This year, we have again worked closely with governments, patients, patient groups, clinicians, suppliers and others to achieve the best outcome possible within available funding for all Australians who require blood and blood products and services. We have developed and rolled-out new and improved national systems to directly assist patients, clinicians and others to help manage and monitor health, supply and performance issues. We have accelerated the consideration of new blood products that have the potential to improve the health and quality of life for Australians with bleeding disorders. We have also continued with our work internally to improve the Agency’s management systems, processes, governance and accountability arrangements.

The clinical demand for blood and blood related products in Australia was met without interruption. A saving of $68.9 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 seven years to $624.7 million.

Improvements in supply performance and efficiency under the long-term Deed of Agreement with the Australian Red Cross Blood Service (Blood Service) once again achieved a surplus of approximately $74.8 million. This will return a saving to governments of approximately $69.8 million in 2018-19, after allowing the Blood Service to retain $5 million to invest in further improvements in accordance with the Deed.


There have been a number of very important projects to highlight during 2018-19. In particular, BloodNet 5 was implemented nationally in all states and territories on 1 July 2018. BloodNet is Australia’s online blood ordering and inventory management system that now supports more than 15,000 users across the country. 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. Further system enhancements to BloodNet during 2018-19, have also supported the implementation of ISBT 128 barcoding methodology by the Blood Service.

The national implementation of BloodSTAR during 2018-19, was also a very significant development. The implementation of this system in NSW in October 2018 completed the last piece of the national jigsaw for the roll-out of a digital system that provides the sole channel for clinicians to seek authorisation for access to Immunoglobulin products.

The national implementation of BloodSTAR coincided with the concurrent release of revised Criteria for the clinical use of intravenous immunoglobulin in Australia (Version 3 of the Criteria).

The countdown in the NBA Blood Operations Centre.

The smooth and very successful implementation of these systems together with the revised Criteria is the culmination of substantial work that has extended over many years. This has involved not just many NBA staff in policy, program, technology development, training and education activities, but also staff in jurisdictions, clinical specialist working groups and many other individuals and groups.

The completion of these projects is a great example of effective national arrangements at work. They have had good ‘buy-in’ from all users and beneficiaries to deliver major improvements to the overall clinical management, processes and governance that inform and manage access to precious and costly blood and blood products. Additionally, for the first time the NBA and jurisdictions will have access to a truly national system of information and data that will better inform decisions in relation to the supply and affordability of products into the future.

I am very pleased to note that these systems and the associated program activities have already been nominated for awards. More importantly, there is also early evidence from this work of a slowing in the growth of demand for Immunoglobulin products during 2018-19. We expect this work will be reinforced as the Performance Improvement Strategy for the Immunoglobulin Governance Program is implemented.

This year saw the implementation of a revised organisational structure for the NBA. An additional senior executive position was added to the senior management structure with consequential adjustments made to improve accountabilities, governance and the management of risks in an increasingly complex and more substantial set of program responsibilities and funding. Ms Elizabeth Quinn was appointed to

PART 1 OVERVIEW 11

the new Deputy Chief Executive role with primary responsibility for Fresh Blood Products and Business Systems, encompassing the contract management of the Australian Red Cross Blood Service and the NBA’s ICT and data management activities. Mr Michael Stone continued in the other Deputy Chief Executive role, with continuing responsibilities for Commercial Blood Products and Business Services, encompassing the management of the national fractionation agreement with CSL Behring as well as commercial supply contracts with CSL Behring and other multi-national companies.

The NBA’s continuing active consideration of domestic and global demand and supply issues for plasma derived products resulted in the NBA attending the International Plasma Protein Congress in the Netherlands in March 2019 the Plasma Protein Forum in the USA in June 2019. During both visits, discussions were also held with government officials, suppliers and others, and plasma collection facilities as well as manufacturing sites were also visited. Relevant first-hand information was also obtained through a visit to Canada which has some comparable challenges to Australia in the supply and management of blood and blood products.

The safe, secure and affordable supply of blood and blood products in Australia is influenced by both the domestic and international context, including global developments and issues. The NBA has therefore maintained active international engagement activities since its inception in 2003 and also maintains active horizon scanning across the blood sector. These activities reflect the importance of understanding and influencing global issues, understanding commercial networks and markets in the blood sector, building and maintaining networks and intelligence across the sector, setting and influencing strategic directions where we can, and obtaining the best possible prices and contracts for products on behalf of governments. The engagement includes participation in both domestic and international bilateral and multi-lateral meetings, discussions, conferences and other forums involving patients, patient groups, clinicians, suppliers, governments and others.

Following initial consideration by the NBA, the Jurisdictional Blood Committee (JBC) approved the inclusion of Extended Half-Life (EHL) recombinant Factor VIII and Factor IX products within the national funding and supply arrangements. This was well received by patients and patient groups and clinicians. The decision was supported by an assessment undertaken by the Medical Services Advisory Committee (MSAC). The NBA has now included EHL Factor VIII and Factor IX products in the national tender for clotting factors and related products that will be finalised in 2019-20.

In March 2019 the NBA welcomed the appointment of Dr Amanda Rischbieth as the new Chair of the NBA Advisory Board. This followed completion of the term of Ms Gayle Ginnane who had chaired the Board for some eight years. Ms Ginnane had provided great leadership to the Board over an extended period and was a great source of advice and guidance to successive NBA Chief Executives. Dr Rischbieth has extensive experience in health and academic positions, including as a CEO and in other roles across health care delivery, clinical responsibilities (including in critical care), public health, research, ethics, and corporate governance. She is a Fellow of the Australian Institute of Company Directors and has continuing responsibilities as a Visiting Scientist at Harvard University in Boston.

L to R: Ms Gayle Ginnane, Past Chair NBA Board, Mr John Cahill Chief Executive NBA and Dr Amanda Rischbieth Chair NBA Board.


The Secretary of the Department of Health, Ms Glenys Beauchamp PSM, visited the NBA in July 2018. Ms Beauchamp spoke with NBA staff and received briefings on many of the NBA’s current activities and challenges. She complimented the NBA on its work and the importance of its contribution to the broader health sector and government priorities.

The long-term contract with CSL Behring continues to be implemented, with significant savings arising from this contract being achieved through progressive implementation of ‘Process Migration’. The NBA is participating in governance arrangements for this process, which represents an alignment of operations by CSL Behring in Australia with its operations in other countries.

This important work has been book-ended nicely with the completion of negotiations at the end of 2018 for the new Output Based Funding Model and associated financial arrangements for the Blood Service. Again, this outcome will result in further savings for governments and efficiencies in the operations of the Blood Service.

There is further specific work to be undertaken in relation to the operations of the Blood Service during 2019-20, with a major review of the efficiency of the Blood Service to be undertaken. This has been commissioned by the JBC and will require substantial work and input from the NBA, as well as from the Blood Service, to complete the review by the end of 2019.

The ‘bread and butter’ work of the NBA is active supply and contract management; and the people, systems and services that support this work. This is where we now spend some $1.2 billion annually. The work can be persistent and, at times, intense and involve challenging discussions, information gathering, negotiation and reporting with suppliers, prospective suppliers, jurisdictions and others. This continues to be done professionally, ethically and consistently well.

The NBA’s research and development grants program continued with Round 3 funding finalised that provided grants in early 2019 to address evidence gaps in patient blood management and funding for research relating to Immunoglobulin issues. The NBA R&D program will continue, with the assessment of Round 4 grant applications being finalised towards the end of 2018-19, and decisions to be made in the first part of 2019-20. New and growing work is also emerging with the NBA’s increased involvement with health technology assessments and processes for new products and reviewing the utilisation of existing products. Again, this will continue into 2019-20.

The Secretary of the Department of Health, Ms Glenys Beauchamp PSM, receives a briefing on the Blood Operations Centre.

PART 1 OVERVIEW 13

In the important area of guidelines and the quality use of blood products, we made significant progress in the review of the national guidelines for the use of Anti-D immunoglobulin, in continuing the complex review and update of the suite of Patient Blood Management (PBM) Guidelines, and in continuing the PBM implementation and wastage reduction programs. Governments approved ongoing funding of $1 million annually for the BloodSAFE eLearning Australia (BEA) program which provides certainty for this clinical education program managed through the Department of Health and Ageing in South Australia. BEA received 56,987 new user registrations in 2018-19, and, by June 2019, it had 550,320 learners registered who had completed 1,214,312 courses. This equates to more than 1.8 million hours of education with courses provided without charge to participants and a suite of short videos being available to participants.

The NBA continued to make critical contributions to the revision of the National Quality and Safety Health Service Standard, including by ensuring the continuation of the Blood Management Standard, and with the development of supporting materials for implementation. There has also been substantial work to refresh the Haemovigilance Advisory Committee and its important work in supporting the national haemovigilance program, including the collection, analysis and publication of national haemovigilance data.

Maintaining effective relationships and communication with all stakeholders and interests is a vital part of the NBA’s work and a key challenge for a small Agency in the time and effort required to achieve proper engagement. We continued to meet regularly and share information with patient and clinical representative groups and individuals, with supplier partners and prospective suppliers, with professional bodies and many others. We also attended and participated in conferences and events and made presentations on issues of interest to relevant groups.

I would like to once again recognise the very substantial contributions that many of our stakeholders across the blood sector make through generously giving their time, expertise, professionalism and passion to work on some very important issues with the NBA during the year. We look forward to working with you again in 2019-20.

I would also like to thank my executive management group for their ongoing support, commitment and dedication, and especially thank all of the staff of the NBA who continue to deliver a national blood system that is second to none. It has been a busy year – and the next year promises to be even busier!

John Cahill Chief Executive


NBA BOARD AND REPORT

The NBA Board was established under Part 3 of the National Blood Authority Act 2003. The Board provides advice to the Chief Executive about the performance of the NBA’s functions. It is not a decision making body and has no formal or direct role in the day-to-day management or governance of the NBA. The Board does, however, consider key strategic issues facing the NBA.

The role and responsibilities of the Board fall into three main categories:

• considering and providing advice on strategic issues and direction

• helping to ensure effective governance, including providing advice on fraud, audit and risk management and the NBA’s financial performance

• liaising and engaging with stakeholders to strengthen relationships, promote the role of the NBA and contribute to the development of the organisation and the performance of the NBA’s functions.

Board MembershipI am pleased to have been appointed as Chair of the NBA Board for a period of four years from 21 March 2019. I would like to take this opportunity to thank the previous NBA Board Chair, Ms Gayle Ginnane, for her significant contributions as the Chair of the NBA Board for the preceding eight years. A number of other Board members have also had their terms extended and the Board now has the following composition:

• Dr Amanda Rischbieth – Chair from March 2019

• Mr Geoffrey Bartle – Community Representative

• Professor Lyn Beazley AO – State and Territory Representative (Small Jurisdiction)

• Mr Paul Bedbrook – Financial Expert

• Professor Chris Brook PSM – State and Territory Representative (Large Jurisdiction)

• Ms Penny Shakespeare – Australian Government Representative

• Associate Professor Alison Street AO – Public Health Expert

Outgoing member

• Ms Gayle Ginnane – Chair until March 2019

PART 1 OVERVIEW 15

Year in ReviewThe NBA Board met four times during 2018-19, and considered a number of significant issues and reports relating to the blood sector and the work of the NBA generally. The Board was able to provide advice to the Chief Executive and NBA across a range of priority business areas including:

• the emerging dynamics of plasma and immunoglobulin demand and supply

• the proposed review of the efficiency of the Australian Red Cross Blood Service

• the work of the Immunoglobulin (Ig) Governance Program, revised Ig access criteria, performance improvement activities and the national implementation of BloodSTAR

• issues relating to expiring contracts for imported Ig

• subcutaneous Ig issues

• haemovigilance activities

• the development, implementation and funding of the NBA ICT Roadmap for blood sector systems 2018-22

• clotting factor procurement

• the continuing implementation of the contract with CSL Behring, including the alignment of manufacturing arrangements by CSL Behring under its ‘process migration’ program

• the consideration of new products under the national blood arrangements

• product utilisation reviews.

The NBA Board received reports from the NBA on progress against strategic and operational plans and provided advice and input to develop future plans, strategies, actions, budgets and organisational arrangements. This work included discussion of:

• the National Supply Plan and Budget for 2019-20

• the development and implementation of a new organisational structure for the NBA that was implemented during the year, and associated improvements to NBA governance, lines of accountability and risk management

• the development of a replacement for the NBA Enterprise Agreement expiring in early 2019

• the NBA Corporate Plan and Business Plan, future priorities and budget issues

• the critical importance of the NBA’s continuing international engagement.

The Board’s engagement with stakeholders during 2018-19, included receiving a valuable presentation from CSL Behring on its activities and operations. The regular joint meeting between the Boards of the NBA and the Blood Service was held in August 2018 in Canberra and discussed the following issues of mutual interest:

• the Blood Service plasma strategy

• reviews of the Blood Service under the Deed of Agreement with the NBA

• the Blood Service research and development program

• clinical risk management and governance.


The Joint meeting of the NBA and Blood Service Boards, 30 August 2018.

The Board was also pleased to have an opportunity to visit the pilot plasma collection centre in Canberra. This is a new centre and is one of two pilot facilities funded by governments, with the other being located in Townsville.

NBA Board Members at the Canberra pilot plasma donor centre August 2018.

2019-20 PrioritiesThe NBA’s core focus is to ensure the safe, secure, adequate and affordable supply of blood and blood products and services in Australia. The NBA has done this extremely well since its inception, and the focus of the Board is to therefore continue to support and advise the NBA in achieving this in the most appropriate and effective way.

There are a number of material ‘headwinds’ emerging in the blood sector during 2019-20 and the Board expects to provide input across a range of important issues relating to the NBA’s work program, including:

• progressing the major review of the Blood Service and the consideration of any issues arising from this

• the consideration of domestic plasma collection arrangements, the evolving global dynamics affecting Ig supply and demand, and issues relating to the NBA’s contracts for imported Ig and associated procurement arrangements

PART 1 OVERVIEW 17

• national supply and funding issues

• national risk assessment and management

• Ig governance performance improvement

• the continuing development and revision of national guidelines

• patient blood management, including the potential for international collaboration

• national supply efficiency and continued efforts to achieve reduced wastage of blood and blood products

• the funding and implementation of systems to support the work of the NBA and performance improvement in the blood sector

• research and development issues

• issues relating to the availability and supply of new products

• corporate governance and management

• NBA management and leadership development.

In closing, I would like to thank my fellow Board members for their valuable contributions on all of the matters considered throughout the year. The Board looks forward to adding value to the important work of the NBA in the year ahead and providing support and expert advice to the Chief Executive and the NBA as required.

NBA Board Members at 30 June 2019 (L to R) Mr Geoffrey Bartle, Ms Penny Shakespeare, Dr Amanda Rischbieth (Chair), Mr Paul Bedbrook, Professor Chris Brook PSM, Professor Lyn Beazley AO and Associate Professor Alison Street AO.

Finally, on behalf of the Board, I wish to acknowledge the extraordinary work of all the NBA staff in successfully delivering the Authority’s program in 2018-19. I commend them for their professionalism, expertise and high level of service.

Amanda Rischbieth Chair National Blood Authority Board


Farewell to Ms Gayle GinnaneThe Chief Executive, on behalf of the NBA, farewelled and thanked Ms Gayle Ginnane for her fantastic contribution to the work of the NBA and its management and performance over the last eight years as Chair of the NBA Advisory Board. Ms Ginnane completed her term as Board Chair in March 2019 when a new Chair was appointed by the government.

Ms Ginnane is held in the highest regard by both NBA staff and within the blood sector more generally. Ms Ginnane’s advice and guidance to the NBA and, more specifically, to successive NBA Chief Executives, reflected her enormous experience and knowledge in relation to the NBA’s work, blood sector and health management issues and in relation to the requirements and practice of good corporate governance and management.

Ms Ginnane was initially appointed as Chair of the NBA Advisory Board in May 2011. Her appointment terms were subsequently extended and enabled her to contribute to and provide advice on a wide range of significant issues. These included:

• new processing sites for the Blood Service in Sydney and Melbourne

• new Agreements with the Blood Service and contracts with CSL Behring and other suppliers of blood and blood products and services

• the acquisition of new products for national supply and the achievement of substantial cost savings and efficiencies from various procurement outcomes and contract management

• the development and implementation of the Patient Blood Management Guidelines

• improvements to arrangements for clinical access and appropriate use of Immunoglobulin in Australia

• the development and implementation of critical national information and management systems to support effective blood sector arrangements and funding

• the successful implementation of a wastage strategy for fresh blood products

• the development and implementation of an Immunoglobulin governance program

• the introduction of an NBA research and development program, which is now into a fourth round

This is by no means an exhaustive list of issues that Gayle has contributed her wisdom and advice to over the years, but provides some indication of the depth and breadth of her contribution. We sincerely thank Gayle for the professionalism, enthusiasm, dedication and wise counsel she has given to the NBA over many years and wish her and her family well for the future.

Welcome to Dr Amanda Rischbieth Dr Rischbieth was appointed as Chair of the NBA Board in March 2019. Dr Rischbieth brings more than 30 years’ experience in health and management roles, including as a CEO, non-executive director and other roles across health care delivery, clinical responsibilities (including critical care), public health, research, ethics and corporate governance.

We welcome Amanda to the NBA and to the challenges of blood sector issues and look forward to working with her and her Board colleagues to address these challenges.

L to R: Ms Ginanne, Past Chair NBA Board, Mr John Cahill Chief Executive NBA, Dr Amanda Rischbieth Chair NBA Board.

CHAIRING THE NBA ADVISORY BOARD

PART 1 OVERVIEW 19

ANNUAL PERFORMANCE REPORTING STATEMENT

PERFORMANCE RESULTS

OBJECTIVE 1. SECURE THE SUPPLY OF BLOOD AND BLOOD PRODUCTS

OBJECTIVE 2. IMPROVE RISK MANAGEMENT AND BLOOD SECTOR PERFORMANCE

OBJECTIVE 3. PROMOTE THE SAFE AND EFFICIENT USE OF BLOOD AND BLOOD PRODUCTS

ANNUAL PERFORMANCE

PART 2

ANNUAL PERFORMANCE REPORTING STATEMENT

In 2018-19, the National Blood Authority performance reporting format reflects the annual performance statement structure (Resource Management Guide No. 135 Annual Reports for non-corporate Commonwealth entities).

Accountable Authority statementI, as the accountable authority of the National Blood Authority, present the 2018-19, Annual Performance Statements of the National Blood Authority, as required under paragraph 39(1)(a) of the Public Governance, Performance and Accountability Act 2013 (PGPA Act). In my opinion, these annual performance statements are based on properly maintained records, accurately reflect the performance of the entity, and comply with subsection 39(2) of the PGPA Act.

John Cahill Chief Executive National Blood Authority


Introductory statementThe enhanced Commonwealth performance framework1, established under the Public Governance, Performance and Accountability Act 2013, requires a Commonwealth entity such as the National Blood Authority (NBA) to include an annual performance statement in its annual report.

The purpose of the annual performance statement, as a key element of the enhanced Commonwealth performance framework, is to explain the extent to which the agency has achieved its objectives in the relevant year, against the measures for assessing performance set out in both the entity’s Corporate Plan and its Portfolio Budget Statement.

In accordance with paragraph 17(2)(b) of the Public Governance, Performance and Accountability Rule 2014 (PGPA Rule), the National Blood Authority Audit and Risk Committee has reviewed the National Blood Authority’s performance reporting as part of its functions and considers the reporting appropriate.

The role of the National Blood Authority is to:

1. provide an adequate, safe, secure and affordable supply of blood products, blood related products and blood related services

2. promote safe, high quality management and use of blood products, blood related products and blood related services in Australia.

The National Blood Authority represents the interests of the Australian and State and Territory governments, and is established within the Australian Government’s Health portfolio.

In 2018-19, the National Blood Authority aligned the performance criteria published in the National Blood Authority’s Corporate Plan and Portfolio Budget Statement. The annual performance statements in this annual report are mapped to the Corporate Plan and the Portfolio Budget Statement by way of a reference at the end of each performance criteria.

1 The enhanced Commonwealth performance framework, as relevant for the NBA, is set out in Part 2-3 of the Public Governance, Performance and Accountability Act 2013 and Part 2-3 of the Public Governance, Performance and Accountability Rule 2014, together with the following Resource Management Guides: RMG No. 130 Enhanced Commonwealth performance framework, RMG No. 131 Developing good performance information, RMG No. 132 Corporate plans for Commonwealth entities, RMG No. 134 Annual Performance Statements for Commonwealth entities , RMG No.135 Annual Reports for non-corporate Commonwealth entities and RMG No. 136 Annual reports for Commonwealth entities (http://www.finance.gov.au/resource-management/performance/).

PART 2 ANNUAL PERFORMANCE 23

http://www.finance.gov.au/resource-management/performance/

A well-functioning independent audit committee is critical to the good governance and effective management of a Commonwealth agency. The independent advice and assurance provided by the NBA Audit and Risk Committee (ARC) is a valuable support for the NBA’s Chief Executive and executive management team in relation to the appropriateness of the NBA’s financial and performance reporting, systems of risk oversight and management, and systems of internal control.

About the CommitteeThe ARC is established by the NBA Chief Executive in accordance with the PGPA Act 2013. It comprises three to four members including an independent Chair (appointed in consultation with the NBA Board Chair), other independent members, and an NBA Board representative. Membership is carefully rotated to ensure an effective range of skills and experiences, and to support succession planning.

The ARC members in 2018-19 were:

Mr Ken Barker (Chair)

Mr Paul Bedbrook (Board representative)

Mrs Roslyn Jackson

Mr Greg Fraser (since 1 May 2019)

The ARC Charter is approved by the NBA Chief Executive and is regularly reviewed in conjunction with the ARC. In 2018-19 the name and Charter of the ARC were updated to better reflect the role of the ARC in the oversight of the NBA risk management framework. The ARC undertakes an annual process of performance self-assessment.

The NBA Chief Executive, Deputy Chief Executives, and Chief Finance Officer maintain an active engagement with the ARC and attend ARC meetings. This provides relevant organisational input and context to assist the deliberations of the Committee and enhances the direct benefit of the advice provided by the ARC.

Representatives from the Australian National Audit Office (ANAO) and the NBA internal auditors (currently RSM (Australia) also attend meetings as observers for most matters.

Induction and briefingOn appointment ARC members receive briefing on NBA governance and operations. Throughout the year the NBA Chief Executive updates the ARC directly on unfolding matters of strategic and operational significance. In 2018-19 these included:

S The Blood Service Review S immunoglobulin demand and management issues S global and domestic market dynamics S NBA organisational structure S NBA Enterprise Agreement S NBA Blood Sector Systems S NBA ICT Roadmap.

Areas of focus for 2018-19The ARC Charter defines four primary areas of focus. In 2018-19 matters considered by the ARC included:

Financial reporting S NBA consideration of the implications of revised

accounting standards. S Engagement with NBA management and ANAO in

relation to the annual financial statements audit, including formal clearance of annual financial statements.

Performance reporting S NBA Corporate Plan, Business Plan and

Operational Scorecard. S NBA annual performance KPIs and reporting.

Systems of risk oversight and management S NBA strategic risk management and business

continuity framework. S NBA fraud control framework. S Comcover benchmark reporting. S NMF investment framework and performance.

Systems of internal control S Annual internal audit work plan, reports, and

implementation of recommendations, including internal audits in relation to:

• contract management

• staff travel arrangements

• financial controls framework

• procurements under $80,000.

AUDIT AND RISK COMMITTEE


Performance results1. Provide a safe, secure and affordable supply of blood and blood related products and servicesThe NBA worked with state and territory governments and suppliers so that requirements for day-to-day product supply and future demand were well managed. Supply of blood and blood products has been uninterrupted with no periods of shortage.

TABLE 2.1 Performance Criteria Qualitative Deliverable - provide a safe, secure and affordable supply of blood and blood related products and services

Qualitative Deliverable

2018-19 Reference Point 2018-19 Results Against Performance Criteria

Providing a safe, secure and affordable supply of blood and blood related products and services to ensure access best meets clinical need in Australia.

Continue implementation of the Immunoglobulin Governance Program.

BloodSTAR fully implemented in all states and territories and version 3 of the Criteria implemented on 22 October 2018, ensuring immunoglobulin (Ig) product use and management reflects appropriate clinical practice and efficient, effective and ethical expenditure of government funds.

Finalise and implement the revised National Blood Supply Contingency Plan.

The revised National Blood Supply Contingency Plan was published on the NBA website. A program of simulation exercises is in development.

Implement the National Blood Product Management Improvement Strategy 2018-22.

Continued implementation of wastage target and performance reporting.

Blood products are available to meet clinical need.

Blood and blood products available to meet clinical demand. There were no contingency events during the reporting period.

Collection and production yield for domestic immunoglobulin maximised.

Collection and production yield for domestic immunoglobulin maximised with 736 tonnes of plasma collected by the Blood Service for product to be fractionated at CSL Behring.


TABLE 2.2 Performance Criteria Quantitative Deliverable - provide a safe, secure and affordable supply of blood and blood related products and services

Quantitative Indicator

2017-18Actual

2018-19BudgetTarget

2019-20 Forward Year 1


2021-22ForwardYear 3

2018-19 Results AgainstPerformance Criteria

Minimise wastage to ensure availability of product to meet clinical demand.

<3% <3% <3% <3% <3% Discards as a percentage of net issues of red blood cells was 1.9 per cent.

Variance between actual and budget is kept to a minimum both in monetary and product volumes.

<5% <5% <5% <5% <5% Variance between actual and budget was less than 3.3 per cent both in monetary and product volumes.

Performance Criteria Source: Portfolio Budget Statements, pp. 351-353 NBA Corporate Plan 2018-19 to 2021-22 p.13.


2. Drive performance improvement in the Australian blood sectorIn 2018-19, the NBA undertook a number of initiatives to improve the efficiency and effectiveness of the blood supply network. The NBA has further consolidated savings from the sixth year of implementing the National Wastage Reduction Strategy, which was approved by Australian governments in 2013. TABLE 2.3 Performance Criteria Qualitative Deliverable - drive performance improvement in the Australian blood sector

Qualitative Deliverable 2018-19 Reference Point 2018-19 Results Against Performance Criteria

Driving performance improvement in the Australian blood sector through a national information management and data analysis capability.

Implement the revised National ICT and Data Strategy.

The Australian Blood Sector Systems and Data Roadmap 2018-22 was approved by Jurisdictional Blood Committee in December 2018.

Finalise the implementation of BloodNet interfaces with hospital laboratory information systems.

The NBA continued to work with key stakeholders to implement the BloodNet/laboratory information system interfaces.

Implement the Immunoglobulin Performance Improvement Strategy.

The JBC approved the National Immunoglobulin Governance Program Performance Improvement Strategy 2019-20 to 2021-22 in March 2019.

Establish immunoglobulin governance performance indicators and reporting.

The NBA worked with jurisdictions, expert groups and stakeholders in 2018-19, to identify and establish performance indicators and reporting.

National Data and ICT strategy and National Patient Blood Management Implementation Strategy 2017-21 are progressed.

Strategies are progressed and results published against the expected outcomes in the strategies.

All strategies have been updated and published where necessary. Reporting against these is completed as part of the NBA Business Plan.

Performance scorecard and comparator benchmark data is published by 31 December each year.

Monthly wastage comparator benchmarks published with jurisdictions. Annual performance scorecards provided as part of annual reporting.

Performance Criteria Source: Portfolio Budget Statements, pp.351-353, NBA Corporate Plan 2018-19 to 2021-22, p.15.


TABLE 2.4 Performance Criteria Quantitative Deliverable - drive performance improvement in the Australian blood sector


2017-18Actual

2018-19BudgetTarget




2018-19 Results AgainstPerformance Criteria

Percentage of national blood supply processed by laboratories interfaced to BloodNet.

37% =>60% =>80% =>85% =>85% 36 per cent of laboratories interfaced with BloodNet.

Performance Criteria Source: Portfolio Budget Statements, pp.351-353, NBA Corporate Plan 2018-19 to 2021-22, p.15.

3. Promote a best practice model of management and use of blood and blood related products and servicesIn 2018-19, the NBA continued to research and investigate different methodologies for updating clinical practice guidelines to identify a more sustainable methodology for reviewing and updating the Patient Blood Management (PBM) Guidelines.

The NBA implemented the National Patient Blood Management Implementation Strategy 2017-21 and is undertaking a review of current tools and resources.

In 2018-19, the NBA continued to develop materials that promote the safe and efficient use of products, informed by close engagement with clinicians. The NBA was unable to finalise the revision and publication of updated editions of the PBM Guidelines Modules. The revised guideline for the use of Anti-D was drafted and will be released for public consultation in 2019-20.

In addition, the NBA continued to work with the Australian Commission on Safety and Quality in Health Care (ACSQHC) to develop resources for the implementation of the second edition of the National Safety and Quality Health Service (NSQHS) Standard for Blood Management.


TABLE 2.5 Performance Criteria Qualitative Deliverable - promote a best practice model of management and use of blood and blood related products and services


Promoting a best practice model of management and use of blood and blood related products and services.

Develop and promote an expanded suite of tools to support health providers to implement the National Safety and Quality Health Service Blood Management Standards.

The NBA engaged a consultant to develop a Training Needs Analysis to inform the next suite of education and training tools.

Continue the review and revision of Criteria for access to immunoglobulin products under the national blood arrangements.

Version 3 of the Criteria implemented nationally on 22 October 2018 through BloodSTAR.

Develop and support health technology assessment and utilisation review processes for immunoglobulin and other existing and proposed new blood products.

Product information and data to inform health technology assessment and utilisation review.

Revise and publish updated modules of the National Patient Blood Management Guidelines.

The enhanced PBM guidelines project outcomes will be tabled with JBC in 2019-20.



Support best practice management and use of blood and blood related products through a robust framework.

Sustain improvements in the management and use of blood products by:

A continued and sustained improvement in the management and use of blood products demonstrated by:

• improving inventory management practices as part of the National Inventory Management Framework rollout

• improved inventory management as part of the redeveloped BloodNet rollout in July 2018 and improved delivery schedule for fresh products that reduces the number of orders and deliveries for health providers

• improving the delivery schedule for fresh products that reduces the number of orders placed by health providers

• demand for red blood cells remained stable

• reducing wastage in comparison to the 2017-18 result

• reduction in discards as a percentage of net issues (DAPI) for red blood cells from 2.2 per cent in 2017-18 to 1.9 per cent in 2018-19

• the number of publications from grant funded research.

• articles published from grant funded research were not reported.

Support clinicians to use best practice models for the management and use of blood and blood products.

Update, develop and promote a number of clinical guidelines, clinical practice tools and resources for use within the sector.

No clinical guidelines published due to the revised scope and extended stakeholder engagement processes.

One guideline in 2018-19. One resource made available in 2018-19.

Performance Criteria Source: Portfolio Budget Statements, pp. 351-353, NBA Corporate Plan 2018-19 to 2021-22, p.17.


4. Develop policy and provide policy advice on the sustainability of the blood sectorThe NBA continued to work with state and territory governments providing advice and guidance in developing strategies to ensure the sustainability of the blood sector so that requirements for blood and blood products for product supply and future demand are well managed.

TABLE 2.6 Performance Criteria Qualitative Deliverable - develop policy and provide policy advice on the sustainability of the blood sector


Output Based Funding Model (OBFM) with the Blood Service in place.

Key parameters that underpin the fourth Blood Service OBFM agreed.

The key parameters were negotiated and agreed for the fourth Blood Service OBFM (2019-22).

The National Blood Authority provided advice to key stakeholders in 2018-19.

Support the development of JBC proposals to integrate blood arrangements into wider health sector reform.

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.

Performance Criteria Source: NBA Corporate Plan 2018-19 to 2021-22 p.18.


5. The National Blood Authority is a high performing organisation The NBA continued to develop capability across a broad range of business programs and activities. In 2018-19, the NBA continued to attract and retain high quality staff for the range of required disciplines across the agency, provided professional and personal development opportunities for staff, maintained strong internal and external relationships and began introducing electronic business processes to enhance performance, governance and compliance.

TABLE 2.7 Performance Criteria Qualitative Deliverable - the National Blood Authority is a high performing organisation


Implement an eLearning system for all NBA staff.

All annual APS mandatory learning and development modules can be completed online by NBA staff.

Implemented in early 2018-19, reporting period to coincide with NBA Annual Performance and Development cycle.

Performance Criteria Source: NBA Corporate Plan 2018-19 to 2021-22, p.20.

Table 2.8 Performance Criteria Quantitative Deliverable - the National Blood Authority is a high performing organisation


2017-18Actual

2018-19BudgetTarget




2018-19 Results Against Performance Criteria

Continue to be an employer of choice with a staff retention rate of >80 per cent.

79.5% >80.0% >80.0% >80.0% >80.0% 88.90%

Maintain a safe and healthy work environment with a reportable incident rate of <2 per cent.

0% <1% <1% <1% <1% 1.66%

Performance Criteria Source: NBA Corporate Plan 2018-19 to 2021-22, p.20


OBJECTIVE 1. SECURE THE SUPPLY OF BLOOD AND BLOOD PRODUCTS

It is the responsibility of the NBA to manage the national blood supply to ensure that healthcare providers have sustainable, reliable and efficient access to blood and blood products needed for patient care. The NBA ensures blood supply security by working with states and territories to determine and manage an annual supply plan and budget, and by negotiating and managing blood supply contracts and arrangements with local and overseas suppliers.

National Supply Plan and BudgetA key element of the NBA’s role in ensuring security of supply is to develop, coordinate and monitor the annual National Supply Plan and Budget (NSP&B), including obtaining annual approval from Health Ministers.

This is achieved by:

• developing a national estimate of product demand

• liaising with states and territories to refine the estimated demand for products

• collecting and distributing data on product issued and reporting variations to jurisdictions on the approved supply plan

• intensively managing products if they are in short supply.

Performance against the 2018-19 NSP&BThroughout 2018-19 products were supplied to meet clinical demand and supply risks were effectively managed. The approved budget for 2018-19 covering the supply and management of blood and blood products and services under contract was $1,259.48 million, comprising $677.23 million for fresh blood products and plasma collection) and $569.2 million for plasma and recombinant products. There is $13.04 million included for items such as support for the publication of PBM Guidelines, maintenance of the Australian Haemophilia Centre Directors’ Organisation (AHCDO), administration of the Australian Bleeding Disorders Registry (ABDR), BloodSafe eLearning and the operations of the NBA. Table 2.9 identifies the NBA’s expenditure for the supply of products in each product category by supplier in 2018-19 and prior years.


TABLE 2.9 Blood and blood products purchased, by supplier, 2014-15 to 2018-19

Supplier Products Purchased 2014-15 ($M)

2015-16 ($M)

2016-17 ($M)

2017-18 ($M)

2018-19 ($M)

CSL Behring (Australia) Pty Ltd

Plasma Products

• Albumin • Immunoglobulin

products (Ig) (including Intravenous Immunoglobulin (IVIg), Subcutaneous Intravenous Immunoglobulin (SCIg) and hyperimmune products)

• Plasma derived clotting factors

Imported Plasma and Recombinant Products

• Rh(D) Ig • Factors XI and XIII • Fibrinogen Concentrate • C1 Esterase Inhibitor

Concentrate

245.19 282.49 351.83 376.61 397.45

Australian Red Cross Blood Service

Fresh Blood Products

• whole blood • red blood cells • platelets • clinical fresh

frozen plasma • cryoprecipitate • plasma for fractionation • cryo-depletion plasma • serum eye drops • therapeutic

venesections

547.10 588.40 582.40 620.69 667.94

Shire Australia Pty Limited1


• Protein C Concentrate • Activated Prothrombin

Complex Concentrate • Recombinant Factor VIII

and IX

Imported IVIg

29.11

40.30

36.62

28.35

31.45

0.00

34.25

0.00

39.11

0.00

Bayer Australia Limited


• Recombinant Factor VIII

9.00 1.07 0.00 0.00 0.00


Supplier Products Purchased 2014-15 ($M)

2015-16 ($M)

2016-17 ($M)

2017-18 ($M)

2018-19 ($M)

Pfizer Australia Pty Ltd


• Recombinant Factor VIII • Recombinant Factor IX

54.66 56.48 56.89 49.43 37.56

Novo Nordisk Pharmaceuticals Pty Ltd


• Recombinant Factor VIIa

• Recombinant Factor XIII

32.81 36.39 24.20 35.28 35.57

Sanofi-aventis Australia Pty Ltd formerly Bioverativ Australia Pty Ltd


• Recombinant Factor Vlll

• Recombinant Factor lX

0.00 0.00 0.00 3.68 19.72

Octapharma Pty Ltd

Imported IVIg 70.02 47.05 0.00 0.00 0.00

Grifols Australia Pty Ltd

Imported IVIg

Diagnostic Reagent Products

• blood grouping sera • reagent red

cell products

0.00

0.41

11.58

0.36

36.30

0.33

44.72

0.37

38.70

0.38

Immulab Pty Ltd2 Diagnostic Reagent Products


cell products

0.00 0.00 0.00 3.44 3.00

Ortho-Clinical Diagnostics Australia Pty Ltd (Johnson & Johnson Medical Pty Ltd)



cell products

0.44 0.43 0.44 0.71 0.79

Bio-Rad Laboratories Pty Ltd



cell products

0.52 0.48 0.54 0.28 0.54

Total Purchases of Blood and Blood Products 1,029.56 1,089.70 1,084.40 1,169.45 1,240.77

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.


Fresh blood productsThe list of fresh blood products supplied in 2018-19 is at Appendix 2 Fresh blood components supplied under contract by the Blood Service in 2018-19. The four main products were:

1. red blood cells

2. platelets

3. clinical fresh frozen plasma

4. plasma for fractionation.

As demonstrated in Table 2.10, the increase in fresh blood expenditure has progressively moderated over the last ten years primarily as a result of improved efficiencies in Blood Service operations, and in the last seven years, a significant reduction in the demand for some fresh blood products due to improved appropriate use and reduced wastage.

TABLE 2.10 Fresh blood expenditure: increases over the last 10 years

Year Amount ($M) Growth (%)

2009-10 456.1 9.3

2010-11 496.6 8.9

2011-12 526.3 6.0

2012-13 549.3 4.4

2013-14 583.1 6.2

2014-15 547.1 -6.2

2015-16 588.4 7.5

2016-17 582.4 -1.0

2017-18 620.7 6.6

2018-19 667.9 7.6Total 5,617.9 4.9 (average)


Fresh blood expenditure in 2018-19 compared to 2017-18 increased by 7.6 per cent. Key factors that have influenced the changes include the following:

• an increase in the quantity of collected plasma for fractionation from 675 tonnes to 736 tonnes

• annual price indexation of 2.95 per cent

• moderation in demand for some fresh products as a result of improved appropriate use and reduced wastage.

During the last five years, the NBA has seen returns to government year on year as highlighted in Figure 2.1. In 2018-19 $72.2 million was returned including $69.8 million for the Blood Service operating surplus and a saving from the decrease in red blood cell demand of 1.3 per cent against the budget. This compared to $48.5 million in 2017-18 (which included $39.7 million operating surplus and 0.9 per cent decrease in red blood cell demand).

10

0

20

30

40

50

60

70

80

2014-15

2015-16

2016-17

2017-18

2018-19

$ M

illio

ns

FIGURE 2.1 Returns to government 2014-15 to 2018-19

Red blood cellsRed blood cells comprise approximately 21.5 per cent of total blood and blood product expenditure and are the second largest item of cost in fresh products behind plasma for fractionation. Figure 2.2 illustrates that there was no change in issues of red blood cells compared to 2017-18, with continuation of the steady decline in issues per 1,000 head of population nationally from 28.3 in 2014-15 to 25.1 in 2018-19. In the last five years, demand for red cells has declined by 6 per cent, realising a saving in excess of $85 million. The decline in red cell demand is the result of the ongoing success of programs to improve appropriate use and reduce wastage. These programs encompass a range of health provider and clinical engagement activities, development of best practice guidelines and tools, improved data collection and analysis and improved education and training arrangements. The publication and implementation of the Patient Blood Management Guidelines underpins much of the success in improving appropriate use of fresh blood products.


22.00

23.00

24.00

25.00

26.00

27.00

29.00

30.00

31.00

28.00

2014-15

2015-16

Quantity (Issued Packs) Left Hand Side (LHS)

Units per ‘000 population Right Hand Side (RHS)

640,000

660,000

680,000

700,000

720,000

620,000

600,000

580,000

560,000

540,000

520,000

2016-17

2017-18

2018-19

UNIT

S

UNITS PER ‘000 POPULATION

FIGURE 2.2 Red Cells issued by the Blood Service 2014-15 to 2018-19 per ‘000 population

PlateletsPlatelets comprise 4.4 per cent of total blood and blood product expenditure. Figure 2.3 illustrates that there was a 2.6 per cent increase in issues of platelets from 2017-18 and an increase in issues per 1,000 head of population. Platelets are either derived from an apheresis collection or a whole blood collection. In 2018-19 platelets issued were 66 per cent whole blood pooled (70 per cent in 2017-18) and 34 per cent apheresis (30 per cent in 2017-18).

2014-15

133,000

134,000

132,000

131,000

130,000

129,000

127,000

128,000

5.10

5.20

5.30

5.40

5.50

5.60

5.70

5.80

UNIT

S

UNITS PER ‘000 POPULATION

2015-16

2016-17

2017-18

2018-19

Quantity (Issued Packs) LHS per ‘000 population RHS

FIGURE 2.3 Platelets issued by the Blood Service 2014-15 to 2018-19 per ‘000 population


Plasma for fractionation

The Blood Service collects plasma for fractionation to supply to CSL Behring (Australia) Pty Ltd for the manufacture of plasma derived products. In 2018-19 the Jurisdictional Blood Committee (JBC) target for the quantity of plasma to be collected by the Blood Service was 695.7 tonnes. The growth in plasma collected by the Blood service in 2018-19 exceeded governments’ target by 40 tonnes. The additional plasma for fractionation included 18.5 tonnes of plasma from the two pilot plasma only donor centres. The growth in apheresis plasma collection by the Blood Service over the last five years is shown in Figure 2.4.

In 2014-15 the ratio of whole blood to apheresis plasma for fractionation was 32:68 and in 2018-19 23:77. This is in part due to the decline in red blood cell demand.

50%

60%

%

70%

80%

90%

100%

40%

30%

20%

10%

0 %

Apheresis Whole Blood

2014-15

2015-16

2016-17

2017-18

2018-19

FIGURE 2.4 Whole blood to apheresis plasma for fractionation 2014-15 to 2018-19

Plasma and recombinant products The cost of plasma derived and recombinant blood products issued under NBA arrangements in 2018-19 totalled $571.3 million, an increase of $23.0 million (4.2 per cent) from 2017-18. Decreases in volume and cost for domestic Immunoglobulin (Ig) ($9.0 million or 4.6 per cent overall volume and cost reduction) and Prothrombinex ($1.2 million or 7.9 per cent volume reduction) offset increases in demand for Factor VIII Anti-Inhibitor, recombinant Factor VIII and imported Ig resulting in an increase of $26.9 million from 2017-18. In addition, C1 Esterase increased by $2.9 million.

In the 15 years to 2018-19, expenditure on plasma and recombinant products issued under the national blood arrangements has increased from $205.2 million to $571.3 million. Key drivers of this increase are:

• $413.0 million from increased demand

• $51.8 million to fund recombinant clotting factor products (rFVIII and rFIX).

The combined effect of demand and price drivers on expenditure can be seen in Figure 2.5. It is of note that significant improvements in price have driven a large increase in savings that offsets the increase in demand.


2003-04

2005-06

2007-08

2009-10

2011-12

2013-14

2015-16

2014-15

2012-13

2010-11

2008-09

2006-07

2004-05

2016-17

2017-18

500

600

700

400

300

200

100

0

-100

-200

$ M

ILLI

ON

BasePrice increaseDemand increaseSafety increase

2018-19

FIGURE 2.5 Plasma derived and overseas product expenditure: cumulative increases on 2003-04 base year

Issues of clotting factorsIn 2018-19 clotting factors comprised 13.9 per cent of total blood and blood product expenditure. Figure 2.6 indicates that the demand for Factor VIII products increased by 6.7 per cent when compared to 2017-18. The demand for recombinant Factor VIII increased by 8.3 per cent in 2017-18. Plasma derived Factor VIII demand decreased by 3.6 per cent.

The implementation of limited interim arrangements to provide temporary access to Extended Half Life recombinant Factor VIII clotting factor products under the national supply arrangements contributed to the variability of year-to-year growth for these products.

180,000,000

200,000,000

160,000,000

140,000,000

120,000,000

100,000,000

80,000,000

60,000,000

40,000,000

20,000,000

7,600

7,800

8,000

7,400

7,200

7,000

6,800

6,600

6,200

6,400

6,000

INTE

RNAT

ION

AL U

NIT

S

IUs PER ‘000 POPULATION

Recombinant Factor VIII LHSPlasma Derived Factor VIII LHS

2014-15

2015-16

2016-17

2017-18

IUs per ‘000 population RHS

2018-19

FIGURE 2.6 Issues of Factor VIII products 2014-15 to 2018-19 per ‘000 population


The demand for Factor IX products in 2018-19 decreased by 12.6 per cent compared to 2017-18 (). Plasma derived Factor IX demand decreased by 1.3 per cent in 2018-19 due to a reduction in specific patient requirements. Demand for recombinant Factor IX decreased by 12.8 per cent in 2018-19.

The implementation of the limited interim arrangements to provide temporary access to Extended Half Life recombinant Factor IX clotting factor products under the national supply arrangements contributed to the variability of year-to-year growth for these products.

30,000,000

25,000,000

20,000,000

15,000,000

10,000,000

5,000,000

0

INTE

RNAT

ION

AL U

NIT

S

1,300

35,000,000 1,400

1,200

1,100

1,000

900

800

IUs PER ‘000 POPULATION

Recombinant Factor IX LHS Plasma Derived Factor IX LHS IUs per ‘000 population RHS

2014-15

2015-16

2016-17

2017-18

2018-19

FIGURE 2.7 Issues of Factor IX products 2014-15 to 2018-19 per ‘000 population

The 2018-19 level of demand for recombinant Factor VIIa decreased by 0.8 per cent and Factor VIII Anti-Inhibitor (FEIBA) decreased by 17.3 percent compared to 2017-18.


Demand for recombinant Factor VIIa and FEIBA can change significantly from year to year as a result of the variable needs of a small number of patients.

These products have also been variable due to ongoing clinical trials in the clotting factor space.

30,000

25,000

20,000

15,000

10,000

5,000

0

MIC

ROGR

AMS

1.2

1.4

1.0

0.8

0.6

0.4

0.2

0

MICROGRAM

S PER ‘000 POPULATION

2014-15

2015-16

2016-17

2017-18

2018-19

Recombinant Factor VIIa LHS Micrograms per ‘000 population RHS

FIGURE 2.8 Issues of Factor VIIa products 2014-15 to 2018-19 per ‘000 population

3,000,000

4,000,000

5,000,000

2,000,000

1,000,000

0 0.0

50.0

100.0

150.0

200.0

250.0

UNIT

S

UNITS PER ’000 POPULATION

2014-15

2015-16

2016-17

2017-18

2018-19

FEIBA Issued Units LHS IUs per ‘000 population RHS

FIGURE 2.9 Issues of FEIBA, 2014-15 to 2018-19 per ‘000 population


Issues of immunoglobulin (Ig)

Demand for Ig was growing at a consistent annual rate of more than 10 per cent up to 2017-18. However, this growth decreased to 7.2 per cent in 2018-19, which is the lowest annual rate of increase since 2004-05 when Australia first secured supply sufficiency through national importation of Ig by the NBA. The National Fractionation Agreement for Australia (NaFAA) with CSL Behring commenced on 1 January 2018, for the continued manufacture and supply of fractionated blood plasma products and delivered savings in 2018-19 of $7.4 million for domestic immunoglobulin.

TABLE 2.11 Immunoglobulin growth

2014-15 2015-16 2016-17 2017-18 2018-1910.2% 12.4% 11.2% 10.6% 7.2%

In 2018-19 a total of 6.57 million grams of Ig was issued nationally representing a cost of $613.0 million (including the cost of plasma for fractionation). Of this amount, 48.4 per cent was Ig produced in Australia and 51.6 per cent was imported. Figure 2.10 shows the total growth of Ig per year and the relative proportion of imported Ig compared to domestic Ig.

Domestic Ig LHSImported Ig LHS Grams per ‘000 population RHS

5,000,000

4,000,000

3,000,000

2,000,000

1,000,000

-

6,000,000

7,000,000

250

300

200

150

100

50

0

GRAM

S

GRAMS PER ‘000 POPULATION

2014-15

2015-16

2016-17

2017-18

2018-19

FIGURE 2.10 Issues of Immunoglobulin products, 2014-15 to 2018-19 per ‘000 population


Contract ManagementThe NBA manages contracts with suppliers of blood and blood products to ensure security of supply. Contracts are developed in accordance with the Commonwealth Procurement Rules, and managed in accordance with Best Practice Guidance for contract management, including the guideline from the Department of Finance on Developing and Managing Contracts.

In 2018-19 the NBA managed 15 blood and blood product supply contracts and arrangements.

The contracts managed by the NBA included:

• fresh blood product procurement - Australia’s fresh blood component requirements through the Deed of Agreement with the Australian Red Cross Society

• plasma and recombinant product procurement - Australia’s plasma product and recombinant product requirements through:

• the National Fractionation Agreement for Australia (NaFAA) with CSL Behring

• contracts for the provision of imported IVIg, imported recombinant factors VIIa, VIII, IX, and XIII, and other imported plasma and recombinant products from commercial suppliers

• red cell diagnostic reagent products.

Deed of Agreement with the Australian Red Cross SocietyThe Deed of Agreement (Deed) with the Australian Red Cross Society for the supply of fresh blood products by the Blood Service is one of the most important contracts managed by the NBA. The Blood Service is the sole supplier of fresh blood products. The provision of fresh blood products under the Deed is an essential clinical service that saves lives every day. The NBA has an ongoing program with the Blood Service to assure contract performance and accountability under the Deed.

The NBA implemented a nine year Deed with the Australian Red Cross Society on 1 July 2016 and included a three year funding and services agreement. A new three year funding and services agreement was negotiated during 2018-19 and commences on 1 July 2019.

Funding provided to the Blood Service is based on an Output Based Funding Model (OBFM) arrangement agreed by governments. Funding in 2018-19 was $667.9 million, an increase of $47.2 million from 2017-18.

PerformanceThe performance of the Blood Service is a key element in meeting blood sector objectives. Governments expect the Blood Service to deliver effective services and value for money. Governments outline their expectations of the Blood Service in relation to performance through the Deed and the Blood Service Statement of Expectations. Blood Service performance against selected indicators is outlined in Table 2.12.


TABLE 2.12 Blood Service: selected key performance indicators, 2018-19

Domain Indicator 2017-18 result

2018-19 Blood Service

target

2018-19 result*

Donor management New donors Whole Blood 82,533 94,000 (refer note1)

100,096 (refer note1)

Apheresis Plasma2

52,333

Supply chain management Number of days within inventory bands

365 365 331

Red cell yield (proportion of collections converted to supply)

91.70% ≥90% 92%

Age of red cells at issue (days)

7.7 <8.0 6.4

Order fulfilment red cells 98.60% ≥90% 98.44%

Quality and level of service

Health provider satisfaction with Blood Service (mean score out of 10)

9.2 9.2 9.0

Finance Main operating program financial result

$45.2M surplus

$60.9M surplus

$74.8M surplus

(refer note3)

* As measured by the Blood Service as at August 2019.

1The 2018-19 Target and Result combined whole blood and apheresis plasma donors. 2First time apheresis plasma donor target includes a combination of donors that converted from previously donating whole blood, and new donors as a result of change in 2017-18 that enables donors to donate plasma as their first donation. 3 Result unlikely to change however subject to audit clearance.

Implementing improvements to current arrangements

A number of initiatives were commenced under the Deed during 2018-19, including:

• commencement of an independent external review of the efficiency of the Blood Service, as requested by the Jurisdictional Blood Committee (JBC)

• development of a new Blood Service Statement of Expectations for 2019-22, including updated key performance indicators (KPIs)

• development of the second Funding and Services Agreement covering the period 2019-22, to commence on 1 July 2019

• development of the fourth cycle of the Output Based Funding Model (OBFM) for the period 2019-22, to commence on 1 July 2019.


The NBA and Blood Service data and ICT systems security arrangements continued to be reinforced in response to the Blood Service’s data breach incident in 2016. The Blood Service has actioned all recommendations arising from various reviews of the incident. The Office of the Australian Information Commissioner (OAIC) has confirmed in writing that it is satisfied the Blood Service has met the terms of the enforceable undertaking given in response to the 2016 DonateBlood privacy incident. The NBA has agreed with the Blood Service that this matter is now closed.

New technologies and processes continued to be trialled by the Blood Service to improve the efficiency of plasma collection and reduce costs through the continued testing of two pilot plasma only donor collection centres in Townsville and Canberra. The refurbished Townsville centre opened in September 2017 and a new Canberra facility opened in April 2018. In 2018-19 the two centres collected a combined total of 18.5 tonnes of plasma against a forecast of 20.5 tonnes.

The performance and learnings from the two pilot centres will be assessed during 2019-20.

Blood Service research and developmentThe Blood Service and the NBA have a current Research and Development Framework that was introduced on 1 July 2016. In 2018-19 the Blood Service received grant funding under the Deed of approximately $9.6 million for its research and development program in the following five strategic research areas:

• donor behaviour • donor health and wellbeing • product development and storage • product safety • product usage.

The Blood Service research and development business outcomes were on track with most of the research projects completed in 2018-19 being translated into changed business practices or learnings.

This year, research and development at the Blood Service remained focused on understanding what motivates current and future donors, the safety and quality of blood components, development of sensitive, specific and cost-effective testing capabilities, enhancement of knowledge of transfusible blood components and their interactions with patients, and improvement of practice. A strong emphasis is placed on translational research through close interaction between the research and development and operational arms of the business through all stages of a research project’s life cycle.

National Fractionation Agreement for Australia (NaFAA)Many of the plasma derived products used in Australia are manufactured under the NaFAA by CSL Behring (Australia) Pty Ltd from plasma collected by the Blood Service. CSL Behring (Australia) Pty Ltd is the sole manufacturer of plasma derived blood products in Australia and the NBA is responsible for negotiating and managing the NaFAA.

The NaFAA came into force on 1 January 2018 and will continue until 31 December 2026, subject to a review in 2022.

In 2018-19, 736.4 tonnes of Australian plasma was pooled for fractionation under the agreements, and expenditure totalled $263.0 million.


Performance The 2018-19 performance by CSL Behring (Australia) Pty Ltd against the NaFAA key performance indicators (KPIs) is shown in Table 2.13. Sufficient supply of all products was maintained at all times. The performance of CSL Behring (Australia) Pty Ltd was within defined tolerances for each of the KPIs.

TABLE 2.13 CSL Behring (Australia) Pty Ltd’s performance under the NaFAA, 2018-19

Description of performance measure

Results 2018-19

Q1 Q2 Q3 Q4 Annual

KPI1 Plasma stewardship

Achieved Achieved Achieved Achieved*# Achieved

KPI2 Production yield IVIg

SCIg

4.780 g/kg

N/A

4.867 g/kg

4.550 g/kg

4.913 g/kg

4.581 g/kg

4.828 g/kg

4.318 g/kg

4.846 g/kg

4.542 g/kg

KPI3 Management of required inventory levels

Minimum starting plasma inventory

Not active in 2018-19

Products in CSL Behring (Australia) Pty Ltd inventory

100% 100% 100% 100% 100%

Products in CSL Behring (Australia) Pty Ltd reserve

100% 100% 100% 100% 100%

KPI4 Fulfilment of orders

Orders by distributor (Blood Service) and non-distributor

100% 100% 100% 99% 100%

KPI5 Shelf life of national reserve products

100% 100% 100% 100% 100%

Note: Values of less than 100 per cent but greater than 90 per cent are considered to be achieved *Departed without material effect #Subject to confirmation

Imported Immunoglobulin (Ig)Ig is imported to meet the shortfall in domestic Ig production against clinical demand in Australia. In addition to supply under the national blood arrangements, the NBA also supports the purchase of small amounts of obtained imported Ig when necessary through direct orders by individual jurisdictions.

Two contracts are in place for the supply of imported Ig under the national blood arrangements. The contracts commenced in September 2015 and the base term expired on 31 December 2018. The NBA exercised the available extension options and the contracts will expire on 31 December 2020. The suppliers are CSL Behring (Australia) Pty Ltd and Grifols Australia Pty Ltd. In 2018-19 the NBA expended $155.61 million for both contracts.


NBA ProcurementThe NBA has developed a robust approach to tendering and contracting for blood products, reflecting both the policy objectives of governments under the National Blood Agreement, and the policies and requirements of the Australian Government procurement framework.

The NBA currently manages 15 contracts with suppliers of blood and blood products. Contracts are developed in accordance with the Commonwealth Procurement Rules, and managed in accordance with best practice guidance for contract management, including Best Practice Guidance for contract management, including the guideline from the Department of Finance on Developing and Managing Contracts.

In 2019 the NBA released a tender to establish new national supply arrangements for imported plasma and recombinant products. This includes Standard Half Life (SHL) and Extended Half Life (EHL) rFVIII and rFIX products.

Successful tenderers will be required to supply rFVIII or rFIX products to meet orders from health providers in Australia, maintain contractually required supply security reserves, and provide a range of product support services.

The release of this Request for Tender followed earlier consultation with clinical stakeholders and potential suppliers. Key points identified from the consultation process and other market intelligence are that:

S in general, there is continued support for access to a secure supply of the safest and most efficacious therapies with a preference for EHL products

S the importance of patient access to products with administration devices suitable to all patients with different degrees of dexterity

S a number of potential new product variants including SHL and EHL products, bypassing therapies to treat patients with inhibitors, monoclonal antibodies and gene therapy.

Limited Interim Arrangements for Extended Half Life Clotting Factor ProductsIn 2018 the NBA implemented limited interim arrangements to provide temporary access to EHL rFVIII and FIX clotting factor products under the national supply arrangements for a limited number of haemophilia A and B patients with high priority needs based on prioritisation criteria.

These arrangements provide rFVIII and FIX products from the supplier companies Shire Australia Pty Limited and Sanofi-aventis Australia Pty Limited (formerly Bioverativ) for approximately two hundred patients, under the coordination and monitoring of the Australian Haemophilia Centre Directors’ Organisation (AHCDO) by arrangement with the NBA.

Patients with high priority needs were nominated for participation in the limited interim arrangements by the Directors of the Haemophilia Treatment Centres (HTCs) providing the care for those patients. Decisions about the prioritisation of patients to receive EHL products under the limited interim arrangements are coordinated by AHCDO through its Clinical Advisory Group sub-committee.

TENDER FOR FVIII AND FIX


Performance The 2018-19 performance of both CSL Behring (Australia) Pty Ltd and Grifols Australia Pty Ltd against the contractual KPIs is shown in Table 2.14. Sufficient supply of products was maintained to meet demand during the year and was not adversely affected by transient or administrative KPI deviations.

TABLE 2.14 Imported IVIg: key performance indicators, by supplier, 2018-19

KPI Performance CSL Behring (Australia) Pty Ltd

Grifols Australia Pty Ltd

KPI1 In-country reserve Achieved Achieved

KPI2 Shelf life on products delivered Achieved Achieved

KPI3 Delivery performance Achieved Achieved

KPI4 Reporting accuracy and timeliness Achieved Achieved

In some instances, performance deviated from contracted requirements at some periods during the year and was managed by the NBA.

Imported plasma derived and recombinant blood productsThe NBA has contracts with suppliers for the importation of selected plasma derived and recombinant blood products to augment domestic supply where these products are not produced in Australia or domestic production cannot meet demand.

In 2018-19, the NBA managed supply contracts for imported plasma and recombinant products with the following five companies:

• CSL Behring (Australia) Pty Ltd

• Novo Nordisk Pharmaceuticals Pty Ltd

• Pfizer Australia Pty Limited

• Sanofi-aventis Australia Pty Ltd formerly Bioverativ Australia Pty Ltd

• Shire Australia Pty Limited

Expenditure on the above contracts in 2018-19 amounted to $149.49 million.

PerformanceThe 2018-19 performance of suppliers of imported plasma and recombinant blood products for each performance measure is shown in Table 2.15. All suppliers satisfactorily met required performance levels.


TABLE 2.15 Imported plasma and recombinant blood products: key performance indicators, by supplier, 2018-19

KPI Performance measure

Sanofi-aventis Australia Pty Ltd (Alprolix, Eloctate)

CSL Behring (Australia) Pty Ltd (Rhophylac, RiaSTAP, Fibrogammin, Berinert)

CSL Behring (Australia) Pty Ltd (Factor XI Concentrate)

Novo Nordisk Pharma-ceuticals Pty Ltd (NovoSeven, NovoThirteen)

Pfizer Australia Pty Ltd (Xyntha, BeneFIX)

Shire Australia Pty Limited(FEIBA,Ceprotin)

Shire Australia Pty Limited(Advate, Rixubis, Adynovate)

KPI1 In-country reserve Product Inventory

Achieved Achieved Achieved Achieved Achieved Achieved Achieved

KPI2 Shelf life on products delivered


KPI3 Delivery performance


KPI4 Reporting accuracy and timeliness

Achieved Not achieved*

Achieved Achieved Achieved Achieved Not achieved*

In some instances, performance deviated from contracted requirements at some periods during the year and was managed by the NBA.

* This contract deviation did not adversely impact overall supply during the year.

Red cell diagnostic reagent productsRed cell diagnostic reagents are used for testing to establish the blood group of human red cells, detect red cell antibodies and to control, standardise and validate routine haematology tests.

The NBA has established a standing offer arrangement with the following four suppliers for the period 1 July 2016 to 30 June 2019. The NBA has exercised available extension options extending the term of the standing offer arrangements to 30 June 2021.

• Bio-RAD Laboratories Pty Ltd

• Grifols Australia

• Immulab Pty Ltd

• Ortho-Clinical Diagnostics (Johnson & Johnson Medical Pty Ltd)

The standing offer lists more than 100 red cell diagnostic products, which are used in laboratory tests known as blood typing and cross matching. These tests ensure that when a person needs a blood transfusion, they receive blood that is compatible with their own.

Expenditure on diagnostic reagent supply is capped at $4.85 million per year. The NBA administers the cap for suppliers on behalf of jurisdictions.


EMERGING GLOBAL DYNAMICSThe National Blood Agreement requires the National Blood Authority (NBA) “to monitor the national and international environment in which the Australian blood sector operates for new technological, clinical, risk or other developments that may impact on the national blood supply” and requires the NBA “to maintain a systematic approach to identifying new developments, and providing a clearinghouse and coordination function for information in relation to new developments”. The framework used to guide this monitoring function is described below.

Our FrameworkThe NBA monitors international developments which may influence the management of blood and blood products in Australia. Our focus is on:

S information that may have an impact on global supply, demand and pricing, such as changes in company structure, capacity, organisation and ownership

S potential new product developments and applications

S global regulatory and blood practice trends

S other emerging risks that could potentially put financial or other pressures on the Australian sector.

Current areas of interest S Fresh Blood: transmissible diseases,

manufacturing, testing, synthetic blood products, adverse reactions and haemovigilance

S Plasma Products: transmissible diseases, manufacturing, new uses and products, international demand, supply and pricing

S Blood Management: techniques (before, during and after surgery), risk identification, overseas programs and demand management during constrained supply

S Recombinant Products: new uses and products, changes to products, supply, demand and price and adverse reactions

S Policy and Regulation: Australia and overseas S Logistics

Horizon Scanning S The NBA maintains constant horizon scanning

and intelligence gathering, including from existing and potential suppliers, relevant industry analysts, and communications with comparable organisations in countries including the United Kingdom, Canada and New Zealand.

S The value of international knowledge gained through NBA’s engagement on the global stage translates to a greater understanding for the local Australian blood sector. In 2018-19 the NBA’s Chief Executive and Deputy Chief Executive attended international conferences with the resultant sharing of knowledge with the Australia blood sector. This places Australia at the forefront of knowledge and understanding.

International engagement

S International Plasma Protein Congress, 19-20 March 2019 – Amsterdam, Netherlands

S Plasma Protein Forum, 18-19 June 2019 – Reston, Virginia, USA

S visits to CSL Behring sites in Switzerland and the USA

S CSL Behring visit, Bern, Switzerland S visits to Grifols sites in Spain, USA and Canada.

L to R: Mr Markus Weber, Director, IgG & Albumin Bulk Manufacturing, CSL Behring, Mr John Cahill Chief Executive NBA, Ms Sandra Ruckstuhl - Head of Europe Manufacturing Sites Communications CSL Behring at the CSL Behring site in Bern, Switzerland, March 2018.


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 GovernanceWork 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 strategy3. development of Version 3 of the National Policy4. 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 WalesThe 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 PolicyThe 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:

Background Captures information relevant to patient access to government-funded Ig products and may assist readers of this document to understand the various policies and processes associated with the National Policy and the Ig Governance Program more broadly

Principles Provides the foundation for the provision of Ig products under the National Blood Agreement and the remaining sections in this document

Access arrangements

Roles and responsibilities

Tools and resources

Glossary

Describes the processes, rules and requirements that must be followed to access Ig products under the National Blood Agreement

Identifies those directly involved in the prescription, use and management of government-funded Ig products throughout the supply chain and within health services and describes the responsibilities, authority and accountability of each of those roles

Provides guidance on where to find useful tools and resources

Identifies and defines terms and acronyms relevant to this policy and associated processes

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 CriteriaVersion 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.


https://www.blood.gov.au/system/files/documents/nba-national-blood-agreement.pdf

https://www.blood.gov.au/national-policy-to-ig

https://www.blood.gov.au/national-policy-to-ig

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 QuestionsWhile 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.

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


Specialist and Consultation RequirementsIt 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:

S Treating Medical Specialist (TMS), i.e. the patient’s usual specialist

S 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)

S 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 RequirementsThere 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?

S To align with new evidence

S To ensure those whose health is most likely to be improved with Ig therapy can get it

S 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 trainingThe 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 productsA 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 developmentsIn 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.

StandardsThe 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.

ActivitiesThe HAC also contributes to national haemovigilance activities through:

S data analysis

S research

S case studies and audits

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

New membershipThe 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 GroupsWorking 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 managementThe 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 – 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:

S simple and easy to use compared with previous versions

S 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

S Facility favourites - special orders that are likely to be ordered regularly can be added to the ‘facilities favourites’ list

S 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:

S 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

S 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

S The 1.5 millionth BloodNet order was placed on 17 April 2019 by Western Diagnostic Pathology, Peel Campus in Western Australia.

S 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.

BLOODNET 5 IMPLEMENTATION


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 RegistryThe 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 RegistryIn 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.

BloodNetBloodNet 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.


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.

NSW go-liveThe 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.

BLOODSTAR NSW OCTOBER 2018

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.


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.

BloodSTARThe 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) InterfaceDuring 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 monitoringIn 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.


https://www.blood.gov.au/monitoring-international-trends-blood-sector

https://www.blood.gov.au/monitoring-international-trends-blood-sector

OBJECTIVE 3. PROMOTE THE SAFE AND EFFICIENT USE OF BLOOD AND BLOOD PRODUCTS

In 2018-19 the NBA continued its program to promote the safe and efficient use of blood and blood products through the identification and synthesis of new clinical evidence, development of draft clinical guidance in collaboration with clinical stakeholders, and research and analysis of methodologies capable of retaining the currency of clinical practice guidelines. This includes the delivery of a range of tools and resources to support implementation activities in relation to reducing wastage and improving fresh blood use based on the NBA-developed Patient Blood Management Guidelines (PBM Guidelines).

PBM GuidelinesAlmost 160,000 hard copies of the PBM modules 1 to 6 have been issued. They have also been downloaded in over 60 countries. They provide evidence-based guidance on optimisation of the patient’s own blood, non-transfusion strategies to minimise blood loss and bleeding and strategies to manage anaemia.

In 2018-19 the research protocol, literature searches and screening of literature for the update of the critical bleeding/massive transfusion module (Module 1) were completed. The synthesis of evidence is currently underway.

In 2018-19, the research protocol, literature searches and screening of literature were completed to underpin the update of the perioperative (Module 2), medical (Module 3), critical care (Module 4), obstetrics and maternity (Module 5) and neonatal and paediatric (Module 6) modules. The findings are being used to:

• identify changes to the evidence since the modules were published

• inform whether the existing themes of the PBM Guidelines should be retained or amended

• inform a research question list.

A review of the PBM Guidelines is underway. The review is considering a broader scope across the suite of modules rather than updating each module in isolation. The review of the PBM Guidelines is also seeking to identify and implement a more sustainable guideline model where clinical guidance can be updated and disseminated as the evidence base and clinical practice evolves. During 2018-19 research and analysis of methodologies was undertaken.

While the review is underway, the original modules remain available to guide practice.

Neonatal and Paediatrics

Patient Blood Management Guidelines: Module 6

Patient Blood Managem

ent Guidelines: Module 6 Neonatal and Paediatrics

PBM Guidelines publication covers


Guideline for the prophylactic use of Rh D Immunoglobulin in maternity careIn 2018-19 the multi-disciplinary Expert Reference Group (ERG) overseeing the development of an evidence-based guideline on the prophylactic use of Rh D Immunoglobulin in maternity care finalised the research protocol, considered the synthesised evidence, and commenced the guideline drafting process.

ImplementationA core element of ensuring reference material influences the safe and efficient use of blood and blood products are activities that support their implementation. In 2018-19 the NBA continued its focus on activities to support implementation of measures to reduce wastage of blood and improve appropriate use through PBM the National Patient Blood Management Implementation Strategy 2017-2021 and the National Blood Product Management Improvement Strategy 2018-22 (Improvement Strategy). The strategies address a significant proportion of requirements identified in the 2010 Australian Health Ministers’ Statement on National Stewardship Expectations on the Supply of Blood and Blood Products.

Promotion and communicationThe NBA promotes improved inventory management and appropriate clinical use of blood and blood products at a range of relevant national and international forums.

In 2018-19 the NBA continued its promotion and communication campaign to increase awareness of the need to improve clinical practice and inventory management in relation to blood products. This included representation, promotion and education activities at a range of clinical and health sector conferences and events, including the following:

• Australian Society of Clinical Immunology and Allergy (ASCIA), September 2018

• Blood 2018 (formally HAA), October 2018

• Rural Medicine Australia (RMA), October 2018

• Perioperative Patient Blood Management Symposium, February 2019

• Royal College of Pathologists of Australia (RCPA) Pathology Update, February 2019

• Australian Private Hospitals Association (AHPA), March 2019

• International Plasma Protein Congress, March 2019

• Australian and New Zealand Association of Neurologists (ANZAN), May 2019

• Plasma Protein Forum, June 2019.


Education and TrainingBloodSafe eLearning AustraliaBloodSafe eLearning Australia provides online education and training resources for health professionals in Australia. The program aims to improve knowledge of patient blood management and clinical transfusion practice in order to improve patient outcomes.

BloodSafe eLearning Australia is funded by the National Blood Authority on behalf of all Australian governments. During 2018-19, the BloodSafe eLearning Australia program:

• delivered 216,148 hours of education

• had 153,618 courses completed by users, with 12,802 courses completed on average each month, approximately one course completed every three minutes

• registered 56,987 new users

• was used by more than 1,500 Australian health care organisations including hospitals, pathology laboratories, staffing agencies to improve staff knowledge and assist them to meet their accreditation requirements

• promoted the courses in professional journals and scientific, medical and nursing conferences, and provided resources for organisations to undertake their own promotions

• developed new courses on viscoelastic haemostasis testing, a clinical transfusion practice refresher course, and patient blood management in neonate and paediatric settings based on the national Patient Blood Management Guideline Module 6

• undertook a major review and update of courses on Patient Blood Management Essentials and iron deficiency anaemia.

National Safety and Quality Health Service StandardsThe National Safety and Quality Health Service (NSQHS) Standards were developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC) with the Australian government, state and territory partners, consumers and the private sector providing input and feedback.

The primary aim of the NSQHS Standards is to protect the public from harm and improve the quality of health care. They describe the level of care that should be provided by health service organisations and the systems that are needed to deliver such care.

The Blood Management Standard - Standard 7 aims to improve outcomes for patients by identifying risks and using strategies that optimise and conserve a patient’s own blood, as well as ensuring that any blood and blood products that patients receive are safe and appropriate. The Blood Management Standard covers all elements in the blood management and clinical transfusion process and includes the principles of patient blood management (PBM).

During 2018-19 the NBA continued to work with the ACSQHC and other stakeholders in the implementation of the second edition of the NSQHS Standards.


EDUCATION AND TRAININGThe first course, Clinical Transfusion Practice, was released in late 2007. The course catalogue has since expanded to 31 courses, one mobile device application (‘app’) and a range of other resources, with further courses in development. All courses are based on published guidelines, evidence-based practice and expert opinion.

New CoursesSome highlights from 2018-19 include the development of new courses:

S viscoelastic haemostasis testing

S clinical transfusion practice refresher

S patient blood management in neonate and paediatric settings based on the national Patient Blood Management Guideline Module 6.

BEA also undertook a major review and update of courses on Patient Blood Management Essentials and iron deficiency anaemia bringing the total number of educational courses available to 31.

The average number of course completions per month is more than 12,000 with the Iron Deficiency Anaemia Essentials course - only released in April 2019, having over 1,000 course completions.

In 2018-19 user feedback was overwhelmingly positive with users expressing appreciation for the courses, and indicating that they have learnt new knowledge that can be applied in their workplace.

‘…the course, carries a lot of detail and encourages further exploration through its links. I followed up with several of these which added to the interest.’ Medical Consultant/Specialist March 2019

ConferencesThe NBA partners with promoting BEA courses at many of the scientific conferences in Australia including:

S Blood 2018

S Rural Medicine Australia (RMA18)

S Pathology Update Melbourne

S Australian Private Hospital Association National conference

S Australian and New Zealand Association of Neurologists Conference.

BloodSafe eLearning Australia


BLOOD 2018 AWARDSBlood 2018 Awards sponsored by the National Blood Authority Blood 2018 is the annual combined scientific meeting of the Haematology Society of Australia and New Zealand (HSANZ), the Australian and New Zealand Society of Blood Transfusion (ANZSBT) and the Thrombosis and Haemostasis Society of Australia and New Zealand (THSANZ). The NBA actively participates in this meeting, and sponsors two key awards. Since 2014, the ANZSBT Council has been awarding a prize sponsored by the NBA for the best poster or oral presentation with a transfusion focus by a young investigator, and since 2017, for the best poster or oral presentation on haemovigilance.

Young Investigator Award In 2018 the recipient of the $500 Young Investigator award was Ms Alexis Perros, a research scientist at the Australian Red Cross Blood Service, Brisbane, Australia. Alexis is in the final stages of her PhD at the University of Queensland, and her main research focus is investigating immunomodulation after transfusion. Alexis presented her research, “Transfusion modulates leucocyte populations in cardiac surgery patients” in the ANZSBT Presidential Symposium, and also had two poster presentations, “Underlying inflammation influences immunoregulatory cell immune responses in a model of platelet concentrate and packed red blood cell transfusion” and “Assessment of transfusion-related immune modulation in cardiac surgery patients”. Coronary artery bypass grafting is a complex surgical procedure which triggers a systemic inflammatory response that may be exacerbated by transfusion. Alexis’ research, a collaboration between the Blood Service and The Prince Charles Hospital, found that multiple leucocyte subsets were modulated following transfusion in coronary artery bypass grafting patients. Modulation of the patient’s immune response may contribute to adverse patient outcomes, including increased rates of infection and mortality. Increasing our understanding of how transfusion and

cardiac surgery modulate a patient’s immune system may help predict adverse patient outcomes.

Alexis is supervised at the Blood Service by A/Prof Melinda Dean, Dr Helen Faddy and Prof Robert Flower and at the University of Queensland by A/Prof Stuart Kellie

Haemovigilance Award In 2018, the recipient of the $500 Best poster/oral presentation on haemovigilance award was Ms Christine Akers, a Transfusion Nurse within the Victorian Blood Matters program. The program is a collaboration between the Victorian Department of Health and Human Services and the Australian Red Cross Blood Service. Her award winning presentation was titled ‘Transfusion associated circulatory overload: promoting awareness and reporting’. Chris showcased the education campaign aimed at raising the awareness of transfusion associated circulatory overload (TACO) within 79 health services in Victoria for a single month in 2017. The team used a number of educational tools (available on the Blood Matters website) to raise awareness with clinical staff. The campaign resulted in an increased number of TACO notifications through the Serious Transfusion Incident Reporting (STIR) program.

Best Poster/Oral Presentation

Award on Haemovigilance

The National Blood Authority is sponsoring an award of $500 at the

ANZSBT Annual Scientific Meeting as judged by

ANZSBT Council.The NBA has published

the Australian Haemovigilance Minimum Data Set and the Strategic

Framework for the National Haemovigilance Program to support and enhance haemovigilance

activities in Australia.

To view the National Haemovigilance Reports and

the Australian Haemovigilance Minimum Data Set

visit www.blood.gov.au For further information email: [email protected]


Research and DevelopmentNational blood sector research and development prioritiesUnder the National Blood Agreement the NBA is required ‘...to facilitate and fund appropriate research, policy development or other action in relation to new developments by relevant government or non-government persons or bodies’. The National Blood Research and Development Strategic Priorities 2013-16 is under review. This is intended to provide a useful resource to guide priority setting for research. It may be used by researchers to support funding requests, including from the National Health and Medical Research Council, by identifying that their research aligns with priorities communicated by governments.

National blood sector research and development programIn September 2015 the NBA received approval from funding governments to implement a pilot program to directly fund some research and development activities in the blood sector.

The program targets the following topics, where the priority for research has been identified through pre-existing strategic programs of the NBA and governments in the blood sector:

• patient blood management evidence gaps, as identified in each module of the PBM Guidelines

• efficient and effective use of immunoglobulin products, as highlighted through the Ig Governance Program.

The overarching objectives are to identify and fund research that will:

• enhance the sustainability and affordability of the national supply of blood products, including through increased efficiency and reduced blood product usage and wastage

• identify appropriate use and reduce inappropriate use of blood products

• maintain or enhance clinical outcomes for patients by providing evidence or new knowledge to:

• understand the biological action of blood products

• identify optimum treatment, dosing or indications for use for blood products

• compare the use of blood products with alternative strategies and treatments.

In 2016-17, the NBA commenced funding nine successful research grant applications from Round 1 of the Pilot. Seven from twenty three high quality applications were funded in Round 2 under the pilot. Grants for these projects commenced early 2017-18. Six from seventeen high quality applications were funded under the grant program. Grants for these projects commenced in 2018-19. Round 4 attracted twenty two high quality applications which were under consideration at the end of the 2018-19 financial year.

In 2018, an evaluation of the pilot confirmed the viability and value of research and development funding to support a National Blood Sector Research and Development Program.

The NBA has received a substantial level of high quality input from clinical, academic, research and government experts who participated in the review process and assisted the NBA in determining the mix of research projects to be funded within the Program’s limited budget. The NBA is confident that the funded research will be a valuable contribution towards achievement of the blood sector’s research outcomes. The outcomes of each grant funding round are reported on the NBA’s website.

Several projects have completed successfully to date with publications being accepted in peer reviewed journals. Funded research has been presented at multiple conferences within Australia and overseas. Outcomes from the R&D Program support the evolution of the Criteria and the PBM Guidelines.

Best Poster/Oral Presentation

Award on Haemovigilance

The National Blood Authority is sponsoring an award of $500 at the

ANZSBT Annual Scientific Meeting as judged by

ANZSBT Council.The NBA has published

the Australian Haemovigilance Minimum Data Set and the Strategic

Framework for the National Haemovigilance Program to support and enhance haemovigilance

activities in Australia.

To view the National Haemovigilance Reports and

the Australian Haemovigilance Minimum Data Set

visit www.blood.gov.au For further information email: [email protected]


National Blood Sector Research and Development 3rd and 4th RoundNational Blood Sector Research and Development ProgramThe National Blood Sector Research and Development Program has continued with two further funding rounds (Round 3 in 2018 and Round 4 in 2019). Funding may be available for up to three years in each round. Projects of various types and durations have been considered in the process.

Applications for grant funding fall into one of the following categories:

S project grants (up to 3 years)

S seed grants (up to 1 year)

S scholarship grants (up to 1 year).

Round 4 has closed and applications are currently under consideration. Round 4 attracted a large number of applications across the immunoglobulin and patient blood management streams.

The NBA assembled a high quality expert review panel comprising:

S clinical experts

S academics

S researchers

S senior government personnel.

The expert review panel will consider the applications against the R&D Program’s key criteria which focus on:

S research focus

S scope and potential value

S quality

S governance and ethics

S efficient and effective use of funds.

Strict management of conflicts, or potential conflicts of interest was adopted. The round 4 process is expected to be completed in time for newly funded projects to commence in early 2020.


THANK YOU FROM THE NATIONAL BLOOD AUTHORITYThe NBA could not fulfil its role in the blood sector without the extraordinary help and support of the clinical, scientific and consumer community.

All external stakeholders in the blood sector provide the NBA with advice that allows the NBA to produce quality outputs and meet the objectives of the national blood arrangements.

Thank you to our clinical, scientific, and consumer advisors.

These include the members of the: S Patient Blood Management Guidelines

Clinical Consumer Reference Group

S Rh D Immunoglobulin (Anti-D) Guideline Expert Reference

S National Immunoglobulin Governance Advisory Committee and the Specialist Working Groups for Immunology, Haematology, Neurology and Transplantation Medicine

S Australian Bleeding Disorders Registry Steering Committee

S Australian Bleeding Disorders Registry User Reference Group

S Australian Haemophilia Centre Directors’ Organisation

S National Patient Blood Management Steering Committee

S Haemovigilance Advisory Committee

S BloodNet User Reference Group

S Immunoglobulin User Acceptance Testing Group

S MyABDR User Reference Group

S National Blood Authority Audit and Risk Committee

S National Ig Interest Group (supports Ig governance arrangements)

S National Blood Sector R&D Program Expert Review Panel.

The NBA would also like to acknowledge the support it receives from the many colleges, societies and individuals who contribute to our publications, resources and tools.


STRUCTURE, GOVERNANCE AND AUTHORITY IN THE BLOOD SECTOR

PLANNING FRAMEWORK

SERVICE CHARTER

EXTERNAL SCRUTINY

FRAUD CONTROL

HUMAN RESOURCES AND PEOPLE MANAGEMENT

MANAGEMENT AND ACCOUNTABILITY

PART 3

STRUCTURE, GOVERNANCE AND AUTHORITY IN THE BLOOD SECTORGovernance ArrangementsThe key governing bodies in the Australian blood sector and their roles and relationships with each other are set out in the National Blood Agreement and National Blood Authority Act 2003 and are depicted in Figure 3.1.

National BloodAuthority (NBA)

National Blood Authority (NBA)Advisory Board

Australian HealthMinisters’ Advisory

Council (AHMAC)

Commonwealth State & Territory

Governments

Clinical Principal Committee (CPC)

Jurisdictional BloodCommitee (JBC)

Minister for Health

The Council ofAustralian Governments

(COAG) Health Council

Suppliers of plasma products

Suppliers of freshblood products

Suppliers of recombinant products

Suppliers of diagnostic products

Regulator:Therapeutic Goods

Administration (TGA)

FIGURE 3.1 Governance and Authority in the Blood Sector


Establishment of the National Blood AuthorityThe National Blood Agreement between all governments outlines the policy framework for the current national blood arrangements. The Agreement outlines the:

• nationally agreed objectives of governments for the blood sector (primary and secondary)

• governance arrangements for the sector

• administrative arrangements for the management of the national blood supply

• financial arrangements for the national blood supply.

The NBA emerged from the 2001 Review of the Australian Blood Banking and Plasma Product Sector undertaken by Sir Ninian Stephen. The Stephen Review noted the need for changes to the inconsistent and fragmented arrangements that applied to the blood sector at that time. More specifically, there were 30 agreements in existence between the governments, the Blood Service and CSL. In addition, supply costs had tripled between 1991 and 1999.

The Stephen Review recommended the strengthening of the arrangements for the coordination and oversight of Australia’s blood supply, including the establishment of a National Blood Authority to manage Australia’s blood supply at a national level.

Negotiations to develop a national management framework commenced in June 2001 in consultation with the states, territories and other key interest groups.

Commonwealth legislation allowing for the establishment of the NBA passed through both Houses of Parliament and the new Authority came into existence on 1 July 2003.

NBA Governance CommitteesAn overview of the NBA Governance structure is shown in Figure 3.2.

NBA BusinessCommittee

NBA Chief Executive/General Manager

NBA Audit and RiskCommittee

Staff ParticipationForum

FIGURE 3.2 Governance and Authority in the NBA

PART 3 MANAGEMENT AND ACCOUNTABILITY 79

Three committees assist the NBA Chief Executive to plan and manage corporate governance, outcome delivery, strategic projects and stakeholder interests:

• The NBA Business Committee is the primary governance committee for the NBA. It provides strategic oversight and direction for the management of the NBA and its business and finance activities.

The role of the NBA Business Committee is to:

• support and advise the Chief Executive

• provide strategic leadership, guidance and direction in relation to all business activities and processes and also in relation to people management, financial management and ICT issues

• review NBA business plans and activities, and monitor progress regularly against key milestones and deliverables

• consider NBA investment priorities and review these priorities on a regular basis

• oversee relevant sub-committees and project boards.

The Committee comprises the Chief Executive, Deputy Chief Executives, Chief Finance Officer, Chief Information Officer and Director, People and Communications. The Committee is chaired by the Chief Executive and supported by the Executive Support Office. Other staff may be required to attend meetings for relevant agenda items.

• The NBA Audit and Risk Committee (ARC) provides independent advice and assurance to the Chief Executive on strategies to enhance the organisation’s governance control and risk management framework assist with planning and conducting the NBA internal audit program and support financial and legislative compliance. The Committee met five times in 2018-19.

Its membership in 2018-19 was as follows:

• Mr Ken Barker (Chair)

• Mr Paul Bedbrook (Board representative)

• Mrs Roslyn Jackson

• Mr Greg Fraser (since 1 May 2019)

• Representatives from the Australian National Audit Office (ANAO) and the NBA internal auditors (currently RSM (Australia) also attend meetings as observers for most matters.

• The Staff Participation Forum (SPF) - the NBA has an established SPF to consult directly with its employees and representatives about significant decisions that affect their working lives. The SPF is a group comprised of NBA staff representatives, NBA management representatives and a Work Health and Safety representative.


NBA ManagementAs at 30 June 2019, the NBA Executive Management team comprised the following

• Chief Executive – Mr John Cahill

• Deputy Chief Executive Commercial Blood Products and Business Services – Mr Michael Stone

• Deputy Chief Executive Fresh Blood Products and Business Systems – Ms Elizabeth Quinn.

As at 30 June 2019, the NBA comprised two business streams, Commercial Blood Products and Business Services and the Fresh Blood Products and Business Systems. The two streams comprise teams as below:

Commercial Blood Products and Business Services

• Commercial Blood Products

• Immunoglobulin Governance

• Research and Product Review

• Finance and Business Services

• People and Communications

• Legal Services

Fresh Blood Products and Business Systems

• Blood and Data Services

• Blood Operations Centre

• Fresh Blood Products and Services

• Information Technology Services

• Risk Management.

Internal Audit and Risk The NBA’s internal audit and risk program, guided by the Audit and Risk Committee, plays a key part in risk mitigation. The Audit and Risk Committee reviews the risk register on an annual basis as a key input in developing the internal audit and risk program.

RSM (Australia) conducted a range of audits and reviews in line with the work program developed in conjunction with the Audit and Risk Committee. The 2018-19 work program encompassed reviews of the NBA’s:

• contract management performance

• travel arrangements

• financial controls framework

• updated fraud and corruption control plan

• procurement under $80K.

The Audit and Risk Committee continued to monitor the implementation of internal audit report recommendations through status reports.


Our PeopleAs a small independent agency, the NBA provides an environment that empowers staff to take direct responsibility for delivering significant outcomes in a challenging and ever changing industry. We espouse an environment of diversity, enthusiasm and leadership, with a strong work ethic.

Revised Organisation StructureThis year saw the implementation of a revised organisational structure for the NBA as shown in the above organisational chart. An additional senior executive position was added to the senior management structure with consequential adjustments made to improve accountabilities, governance and the management of risks.

The Deputy Chief Executives, reporting directly to the Chief Executive are:

Commercial Blood Products and Business Services – Mr Michael Stone

S Michael is responsible for commercial strategy, tendering and contracting for national supply of immunoglobulin, albumin, clotting factor concentrate, and other plasma derived products, recombinant and other alternative products, and diagnostic reagent products. This includes national supply planning processes, and the coordination of the assessment of proposals for public funding of new products.

Fresh Blood Products and Business Systems – Ms Elizabeth Quinn

S Elizabeth’s responsibilities encompass fresh blood products and services and related issues, including the coordination of national supply planning processes across Australia. She has principal NBA executive responsibility for the contract with the Australian Red Cross Blood Service. She also has executive responsibility for the CIO group and the NBA’s ICT and data management activities, as well as the coordination of the NBA’s corporate risk management work.

ORGANISATION RESTRUCTURE

Chief Executive


& Business Services




Governance

DirectorResearch &

Product Review

DirectorPeople &

Communications



Products


DirectorFresh Blood

Products & Services

Executive Office


PLANNING FRAMEWORKThe NBA has an established comprehensive planning framework as depicted in Figure 3.3.

Current programs include:

• National Supply and Funding

• National Risk Assessment and Management

• Immunoglobulin Governance

• National Guidelines Development and Implementation

• National Supply Efficiency and Wastage Reduction

• Information Management and Technology

• Blood Sector Knowledge Development

• Research and Development

• Corporate Governance and Management.


Legislative and Policy

Environment

National Blood Authority ActPublic Governance, Performance and

Accountability (PGPA) ActPublic Service Act

Auditor General Act

National Blood Agreement (for the Australian blood sector)

Ministers Stewardship Statement

(for health providers)

Ministers Statement of Expectations (for the ARCBS)

Domestic Supply PolicyOnshore Fractionation Policy

Overseas Supply Policy

NBA Corporate Plan

JBC Strategic Plan

Objectives

Horizon Scanning

Strategies Programs Operations

NBA

Ann

ual R

epor

t / P

BS

Secure the supply of blood and blood

products

Improve risk management and

blood sector performance

NBA

Indi

vidu

al P

erfo

rman

ce P

lans

NBA

Ris

k M

anag

emen

t Pla

n

NBA

Ope

ratio

nal P

lan

Provide a safe and affordable supply of

blood and blood related products and services to

ensure access best meets clinical need in

Australia

Drive performance improvement in the

Australian blood sector through a national

information and data analysis capability

Promote a best practice model of management and use of blood and

blood related products and services in Australia

Ensure the National Blood Authority is a high performing organisation

National Supply and Funding

Immunoglobulin Governance

National Guidelines Development and Implementation

National Supply Efficiency and Wastage Reduction

Research and Development

Corporate Governance and Management

Promote the safe and efficient use of blood and blood products Develop policy and

provide policy advice on the sustainability of the

blood sector in Australia, including

financial sustainability

National Risk Assessment and Management

Immunoglobulin Governance

National Guidelines Development and Implementation

National Supply Efficiency and Wastage Reduction

Information Management and Technology

Blood Sector Knowledge Development

FIGURE 3.3 NBA Planning Framework


Progress against the Business Plan is monitored and reviewed by the NBA Business Committee quarterly. A quarterly report on progress against key actions is also provided to the NBA Board and Audit and Risk Committee.

In 2018-19 the NBA delivered 81 per cent of activities against the planned outcomes. Table 3.1 demonstrates the overall trend in the NBA’s delivery against the business plan over the past five years. Some activities have been delayed due to revision of timelines and changing priorities as agreed by the Executive.

TABLE 3.1 NBA’s performance in achieving business plan objectives, 2014-15 to 2018-19

Year 2014-15 2015–16 2016–17 2017-18 2018-19

Performance (%) 91% 97% 98% 70% 81%

Key operational achievements for 2018-19 included the following:

• the uninterrupted supply of blood and blood products to meet all clinical demand in accordance with the approved NSP&B

• the NSP&B approved by COAG Health Council in accordance with Schedule 3 of the National Blood Agreement

• Version 3 of the Criteria for access to immunoglobulin products under the national blood arrangements implemented

• implementation of BloodSTAR in NSW to complete the national rollout

• development and implementation of the revised National ICT and Data Strategy

• transition of Research and Development pilot to ‘business as usual’ Research and Development program focussing on strategic priorities

• making a Determination under Section 24(1) of the Public Service Act 1999 to continue the current terms and conditions of employment for staff under the EA and increase salaries by two per cent per annum for each of the next three years

• introducing an e-Learning system and other learning and development opportunities for NBA staff.

National Blood Authority Service CharterThe NBA developed a new and simplified service charter in 2018-19. The NBA service charter is available on the NBA website at www.blood.gov.au/charter.

The revised NBA service charter forms an integral part of our business improvement process and enhances the way we conduct our day-to-day business. In essence, our service charter outlines:

• our ongoing commitment to the high standard of service that our stakeholders have come to expect from us

• the expectations that we have of our stakeholders so that they can help us deliver the highest standards of service.

Further complementing our business process is our streamlined feedback mechanism. We are committed to providing a high level of service to all our stakeholders and we welcome feedback on our level of service on an ongoing basis. Stakeholders can provide feedback directly to us via our website on www.blood.gov.au/feedback. Feedback is recorded, monitored and acted upon as appropriate, with a view to improving our performance and, ultimately, our level of service.

The NBA received three complaints and three compliments in 2018-19.


National Blood Authority Service Charter

The NBA developed a new and simplified service charter in 2018-19. The NBA service charter is available on the NBA website at www.blood.gov.au/charter.

The revised NBA service charter forms an integral part of our business improvement process and enhances the way we conduct our day-to-day business. In essence, our service charter outlines:

S our ongoing commitment to the high standard of service that our stakeholders have come to expect from us

S the expectations that we have of our stakeholders so that they can help us deliver the highest standards of service.

Further complementing our business process is our streamlined feedback mechanism. We are committed to providing a high level of service to all our stakeholders and we welcome feedback on our level of service on an ongoing basis. Stakeholders can provide feedback directly to us via our website on www.blood.gov.au/feedback. Feedback is recorded, monitored and acted upon as appropriate, with a view to improving our performance and, ultimately, our level of service.

The NBA received the 3 complaints and 3 compliments in 2018-19.


EXTERNAL SCRUTINYThere have been no judicial decisions, decisions of administrative tribunals or decisions of the Australian Information Commissioner in 2018-19 that have had, or may have, a significant impact on the operations of the NBA. There were no legal actions lodged against the NBA in 2018-19.

There have been no reports on the operations of the NBA by the Auditor-General (other than the reports on financial statements), or a Parliamentary committee or the Commonwealth Ombudsman in 2018-19. There were no capability reviews released during 2018-19.

FRAUD CONTROLConsistent with the Public Governance, Performance and Accountability Rule 2014 (section 10), the NBA conducts fraud risk assessments regularly and when there is a substantial change in the structure, functions or activities of the organisation.

Under the current fraud control plan, the NBA continually monitors accountability and control frameworks to meet the specific needs of the agency, and ensures that it complies with the Public Governance, Performance and Accountability Rule 2014.

No instances of fraud were detected during the reporting year.

Certification of fraud control arrangements

I, John Cahill, certify that I am satisfied that for 2018-19, the National Blood Authority has:

• prepared fraud risk assessments and a fraud control plan;

• in place appropriate fraud prevention, detection, investigation and reporting mechanisms that meet the specific needs of the NBA; and

• taken all reasonable measures to appropriately deal with fraud relating to the NBA.

John Cahill Chief Executive National Blood Authority


HUMAN RESOURCES AND PEOPLE MANAGEMENTNBA organisational structure

The structure of the NBA as at 30 June 2019, can be seen in Figure 3.4 below. There are two business streams, namely Fresh Blood Products and Business Systems and Commercial Blood Products and Business Services.

Chief Executive


& Business Services




Governance

DirectorResearch &

Product Review

DirectorPeople &

Communications



Products


DirectorFresh Blood

Products & Services

Executive Office

FIGURE 3.4 NBA Organisational Chart

During 2018-19 the NBA continued its commitment to managing and developing its employees to meet organisational objectives. The results of the 2019, Australian Public Service (APS) Employee Census indicates the success of the NBA in continuing to be an organisation with a strong and happy team culture focussed on outcome delivery.

The APS Commission set a target rate of 70 per cent of APS employee participation for the Employee Census and the NBA exceeded this with a 81 per cent return, 4 per cent higher than the APS participation rate of 77 per cent.

The overall employee census outcomes for the NBA were very pleasing, indicating the organisation has a stable, happy and motivated workforce. Areas for improvement relate to dealing more effectively with underperformance, increasing opportunities for mobility, talent management/career progression and internal communication and change management.

The key points from the Australian Public Service Census (APSC) 2018-19 are shown in Table 3.2 with a comparison against last year (2017-18).


TABLE 3.2 APSC comparison current year versus last year

APSC Measure 2017-18 % 2018-19 %

understand how their role contributed to achieving an outcome for the Australian public

Question not asked

in 2017-18

93

considered that their supervisor acted in accordance with the APS Values in their everyday work

90 95

felt their supervisor encouraged them to contribute ideas 81 98

believed strongly in the purpose and objectives of the NBA 94 95

stated that they considered their SES manager was of a high quality

64 63

considered that their SES manager was sufficiently visible i.e. seen in action

57 60

were satisfied with the work-life balance in their current job

73 67

felt that their workgroup were committed to workplace safety

90 88

felt they were valued for their contribution to the NBA 55 51

stated that they were satisfied with their current job 78 74

felt a strong personal attachment to the NBA 69 77

were satisfied with the non-monetary employment conditions at the NBA e.g. leave and flexible work arrangements

88 77

considered that the NBA provided access to effective learning and development opportunities

71 81

would recommend the NBA as a good place to work 81 81

were proud to work at the NBA 86 91

Our valuesThe NBA strongly endorses the APS Values, Employment Principles and Code of Conduct.This underpins expectations for the behaviour and conduct from all of our staff. Employees at the NBA understand their responsibilities associated with being a member of the APS and being a representative of the NBA and of the Australian government.

WorkforceThe total number of APS staff employed in the NBA was 60 employees (55.62 full time equivalent) at the end of June 2019. The following tables provide a breakdown of NBA staff numbers by classification, gender and employment type for the current report period 2018-19 and the previous report period 2017-18.


TABLE 3.3 Australian Public Service Act ongoing employees current report period (2018-19)

Male Female

Full- Time Part-Time Total Full- Time Part-Time Total Total

SES 1 1 - 1 1 - 1 2

EL 2 4 - 4 4 - 4 8

EL 1 6 - 6 9 3 12 18

APS6 - - - 9 3 12 12

APS5 2 - 2 6 2 8 10

APS4 - - - 1 - 1 1

Other 1 1 2 - - - 2

Total 14 1 15 30 8 38 53

Other includes Chief Executive and Legal 1

TABLE 3.4 Australian Public Service Act non-ongoing employees current report period (2018-19)

Male Female


EL 1 1 - 1 - 1 1 2

APS 6 - - - 2 - 2 2

APS 4 1 - 1 2 - 2 3

Total 2 - 2 4 1 5 7

TABLE 3.5 Australian Public Service Act ongoing employees previous report period (2017-18)

Male Female


SES 1 1 - 1 - - - 1

EL 2 3 - 3 4 - 4 7

EL 1 7 - 7 10 4 14 21

APS 6 - - - 7 2 9 9

APS 5 2 - 2 7 2 9 11

APS 4 - - - 1 - 1 1

Other 2 - 2 - - - 2

Total 15 - 15 29 8 37 52


TABLE 3.6 Australian Public Service Act non-ongoing employees previous report period (2017-18)

Male Female


EL 1 - - - - 1 1 1

APS 5 1 - 1 - - - 1

APS 4 1 - 1 2 - 2 3

Total 2 - 2 2 1 3 5

TABLE 3.7 Australian Public Service Act employees by full time and part time status current report period (2018-19)

Ongoing Non-Ongoing

Full- Time Part-Time Total Ongoing

Full- Time Part-Time Total Non-

Ongoing

Total

SES 1 2 - 2 - - - 2

EL 2 8 - 8 - - - 8

EL 1 15 3 18 1 1 2 20

APS 6 9 3 12 2 - 2 14

APS 5 8 2 10 - - - 10

APS 4 1 - 1 3 - 3 4

Other 1 1 2 - - - 2

Total 44 9 53 6 1 7 60



TABLE 3.8 Australian Public Service Act Employees by full time and part time status previous report period (2017-18)

Ongiong Non-Ongoing

Full- Time Part-Time Total Ongoing

Full- Time Part-Time Total Non-

Ongoing

Total

SES 1 1 - 1 - - - 1

EL 2 7 - 7 - - - 7

EL 1 17 4 21 - 1 1 22

APS 6 7 2 9 - - - 9

APS 5 9 2 11 1 - 1 12

APS 4 1 - 1 3 - 3 4

Other 2 - 2 - - - 2

Total 44 8 52 4 1 5 57


The average age of NBA staff is 44.96 years. Table 3.8 provides a breakdown of the age demographic of NBA employees.

TABLE 3.9 Age demographic of NBA staff as at 30 June 2019

Age profile Number of employees

20-25 Nil

26-30 6

31-35 7

36-40 9

41-45 9

46-50 12

51-55 8

56-60 5

61-65 3

66+ 1

Total 60

We have 58 staff located in the Australian Capital Territory, one in New South Wales and one in Queensland. Both New South Wales and Queensland employees are part-time.


LEARNHUB – ONLINE TRAINING FOR ALL NBA STAFF

In August 2018 the NBA launched Learnhub, an e-learning management system designed to provide NBA staff easy access to training courses and other development resources. Learnhub is an intuitive, user friendly system that allows staff to access a range of content including APS annual mandatory awareness training modules, Skillsoft, Lynda.com and GoodPractice. Of importance, Learnhub allows staff to shape and drive their learning journey at their own pace, anywhere, anytime.

Learnhub has become a pivotal tool for capturing and extracting learning and development data for internal and external reporting purposes.

The Chief Executive is personally committed to providing continuing learning and development opportunities for all NBA staff. These opportunities contribute to and empower staff to be part of a productive, progressive, innovative and engaged workforce, and develop their skills to support the role of government in delivering services to the Australian community at the highest standard.

The introduction of Learnhub is the latest in the NBA’s ongoing commitment to investing in the development of its staff, as this is crucial for engaging people and creating a high performing workplace.


TABLE 3.10 All ongoing employees current report period (2018-19)

Male Female


NSW - - - - 1 1 1

QLD - - - - 1 1 1

ACT 15 - 15 30 6 36 51

Total 15 - 15 30 8 38 53

TABLE 3.11 All non-ongoing employees current report period (2018-19)

Male Female


ACT 2 - 2 4 1 5 7

Total 2 - 2 4 1 5 7

TABLE 3.12 All ongoing employees previous report period (2017-18)

Male Female


NSW - - - - 1 1 1

QLD - - - - 1 1 1

ACT 15 - 15 28 7 35 50

Total 15 - 15 28 9 37 52

TABLE 3.13 All non-ongoing employees previous report period (2017-18)

Male Female


ACT 2 - 2 3 - 3 5

Total 2 - 2 3 - 3 5

TABLE 3.14 Australian Public Service Act employment type by location current report period (2018-19)

Ongoing Non-Ongoing Total

NSW 1 - 1

QLD 1 - 1

ACT 51 7 58

Total 53 7 60


Australian Public Service Employee CensusDuring 2018-19, the NBA continued its commitment to managing and developing its employees to meet organisational objectives. The results of the 2019 Australian Public Service (APS) Employee Census indicates the success of the NBA in continuing to be an organisation with a strong and happy team culture focussed on outcome delivery.

The APS Commission set a target rate of 70 per cent of APS employee participation for the Employee Census and the NBA exceeded this with an 81 per cent return, 4 per cent higher than the APS participation rate of 77 per cent.

The overall employee census outcomes for the NBA were very pleasing, indicating the organisation has a stable, happy and motivated workforce. Areas for improvement relate to addressing underperformance, increasing opportunities for mobility, talent management/career progression and internal communication and change management.

Maintaining a safe and healthy work environmentWorkplace health and safety matters are standing agenda items that are routinely discussed at a variety of organisational reporting meetings such as HR reporting to the senior executive group, the Business Committee and the Staff Participation Forum.

Initiatives that were undertaken by the NBA during the year to maintain its ongoing commitment to a safe and secure workplace included:

S the continued availability of workstation assessments for all new starters as well as assessments for existing staff who felt it necessary for their wellbeing

S access to the EAP

S expansion of ICT remote working capabilities to cover all staff, enabling staff to work from outside the office on an ad hoc basis

S sit-to-stand desks

S implementation and ongoing management of the WHS governance framework.

OUR APPROACH TO PEOPLEThe NBA has established a Staff Participation Forum to consult directly with its employees and their representatives about significant decisions that affect their working lives. The SPF is a group comprised of NBA staff representatives, NBA Management representatives and a Work Health and Safety representative.

Enterprise AgreementOn 24 December 2018 the Chief Executive signed a Determination under Section 24(1) of the Public Service Act 1999. The effect of this Determination was to continue the current terms and conditions of employment for staff under the NBA Enterprise Agreement 2015-2018 and increase salaries by 2 per cent per annum for each of the next three years.

The NBA has in place an active and proper process of performance management and review. These are obligations that staff have under Part E of the NBA Enterprise Agreement 2015-2018, including obligations relating to salary advancement. To the right is the annual performance cycle.


TABLE 3.15 Australian Public Service Act employment type by location previous report period (2017-18)

Ongoing Non-Ongoing Total

NSW 1 - 1

QLD 1 - 1

ACT 50 5 55

Total 52 5 57

We have a diverse workforce with 14 per cent of NBA employees identifying as being from non-English speaking backgrounds and 27 per cent were born outside of Australia. In 2018-19 the NBA did not have any employees who reported as identifying themselves as Indigenous.

In 2018-19 the NBA made efforts to attract indigenous employees through open/non- targeted recruitment and retention processes that included exploring alternate pathways such as the Australian Government Indigenous Program. In addition, previously established relationships with indigenous recruitment organisations have been strengthened.

Staff turnover and retentionStaff turnover reduced from 12.3 per cent in 2017-18 to 11.1 per cent in 2018-19. Nine people departed the NBA during 2018-19.

The average length of service for staff at the NBA is 5.3 years, which is consistent with the previous year and 46.66 per cent of staff average length of service at the NBA is more than five years.

NBA Enterprise AgreementThe current enterprise agreement (EA) was approved on 12 January 2016. On 24 December 2018, a Determination was made under Section 24(1) of the Public Service Act 1999 to continue the current terms and conditions of employment for staff under the EA and increase salaries by 2 per cent per annum for each of the next three years. The first salary increase was effective on 19 January 2019.

The table below details salary ranges by classification level (reflecting the full span of salaries available under the Determination and in any Individual Flexibility Agreements).

TABLE 3.16 Australian Public Service Act employment arrangements current report period (2018-19)

SES Non-SES Total

Common Law or Section 24 Agreement 2 - 2

Individual Flexibility Arrangements - 13 13

Enterprise Agreement/Section 24 (1) Determination - 44 44

Total 2 57 59

Chief Executive NOT included in above figures


TABLE 3.17 Australian Public Service Act employment salary ranges by classification level (minimum/maximum) current report period (2018-19)

Classification Minimum Salary Maximum Salary

SES 1 190,585 218,273

EL 2 120,883 164,719

EL 1 101,721 116,916

APS 6 82,415 104,291

APS 5 74,709 78,851

APS 4 68,687 72,578

APS 3 60,625 67,201

APS 2 52,462 57,248

APS 1 44,871 50,410

Other 101,281 122,625

Other - Legal 1

Non–salary benefitsThe EA and other employment arrangements provide a range of non-salary benefits in addition to those consistent with national employment standards and the Fair Work Act 2009. The benefits provided are very similar to those provided by many other agencies and are detailed in the EA and available on the NBA website at https://www.blood.gov.au/employment-benefits.


https://www.blood.gov.au/employment-benefits

Non-SES employees may have access to the following non-salary benefits

• annual Christmas close-down

• Australian Defence Force Reserve leave

• breastfeeding facilities

• Employee Assistance Program (EAP)

• family and domestic violence leave

• financial and/or paid leave to support professional development

• flexible working arrangements with time off in lieu (TOIL) where appropriate (for EL employees)

• flex-time (for APS classified employees)

• home-based work, laptop computers, internet access, and mobile phones

• individual flexibility arrangements

• influenza vaccinations for staff and their immediate family members

• leave for compassionate purposes

• maternity and adoption leave

• NBA’s health and wellbeing program

• parental leave

• provision of eyesight testing and reimbursement of prescribed eyewear costs specifically for use with screen-based equipment

• purchase up to an additional four weeks annual leave per year

• recreation and personal leave at half pay

• salary packaging arrangements.

SES non-salary benefits include all of the above (except flex-time and TOIL) plus

• airport lounge membership

• executive vehicle allowance

• onsite car parking.


Productivity gainsDuring the year, the NBA continued to adjust staffing levels to meet program and resourcing demands and contribute to the government’s efficiency dividend strategy.

The NBA has commenced a review of all governance processes, procedures and guidance materials to streamline practices, aimed at improving the utilisation of corporate and executive resources. The review includes HR, financial and reporting policies and practices ensuring they align with the NBA’s appetite for risk and support the Agency’s corporate strategy and business plan.

The NBA continued services through the Department of Health Shared Services Centre. The NBA also continued to use Commonwealth panel arrangements for the external provision of services such as recruitment, training, annual influenza vaccinations and the Employee Assistance Program (EAP).

Remuneration and performance payTotal remuneration for senior executive officers is determined through negotiation between individual officers and the Chief Executive, taking into account the broader economic environment as well as APS and Remuneration Tribunal benchmark data. Performance pay is not available to NBA staff.

TABLE 3.18 Information about remuneration for key management personnel

Short-term benefits Post employment

benefits

Other long term benefits

Total remuneration

Name Position title Base salary

Other benefits

Super contributions

Long service

leave

John Cahill Chief Executive $344,250 $6,629 $33,170 $7,457 $391,506

Michael Stone Deputy Chief Executive

$192,671 $8,164 $34,085 $6,576 $241,496

Elizabeth Quinn Deputy Chief Executive

$156,975 -$6,695 $30,978 $5,649 $186,906

1 Amounts are reported on an accrual basis.2 Ms Quinn joined the NBA in October 2018 so the amounts reported are for part year.

TABLE 3.19 Information about remuneration for senior executives

Short-term benefits Post employment

benefits

Other long term benefits

Total remuneration

Total remuneration bands

Number of senior executives

Average base salary

Average other

benefits and allowances

Average superannuation

contributions

Average long service

leave

Average total remuneration

$0- $220,000 1 $156,975 -$6,695 $30,978 $5,649 $186,906

$220,001- $245,000

1 $192,671 $8,164 $34,085 $6,576 $241,496

$370,001- $395,000

1 $344,250 $6,629 $33,170 $7,457 $391,506


Professional and personal developmentEmployee development in the APS is an important contributor to a productive, progressive, innovative and engaged workforce. The NBA recognises the importance of ensuring that staff members continue to develop their skills and this is facilitated through sourced internal training, in-house training programs and external training and development opportunities such as stakeholder engagement and conferences.

NBA explored options for implementing an eLearning management system in support of ongoing professional and personal development for staff. The NBA considered the Learnhub eLearning management system to be the most appropriate system which will strengthen and build upon existing staff skills as well as satisfy annual mandatory training requirements. In August 2018, the NBA implemented Learnhub.

Following on from a recent restructure, analysis of the 2018-19 APS employee census results and as part of the broader People Strategy, the NBA has identified the need to build and develop the existing people capability within the agency, in particular at the executive level (EL). The EL cohort comprises a significant proportion of NBA staff numbers and is a key dependency in the delivery of the NBA’s strategic and operational objectives. An EL development training program is currently under development.

Work health and safety (WHS) Workplace health and safety matters are standing agenda items that are routinely discussed at a variety of organisational reporting meetings such as HR reporting to the senior executive management group, the Business Committee and the SPF.

There was one reportable incident lodged with Comcare during the reporting year. No investigations were conducted by Comcare during the reporting year.

Initiatives that were undertaken by the NBA during the year to maintain its ongoing commitment to a safe and secure workplace included:

• the continued availability of workstation assessments for all new starters as well as assessments for existing staff who felt it necessary for their wellbeing

• access to the EAP

• expansion of ICT remote working capabilities to cover all staff, enabling staff to work from outside the office on an ad hoc basis

• sit-to-stand desks

• implementation and ongoing management of the WHS governance framework.

Health and wellbeingThe NBA recognises the value of encouraging a work environment that supports the health and wellbeing of its employees. Some of the eligible activities which are open to staff members include:

• health memberships

• specialist advice/programs

• annual influenza vaccinations for staff and their immediate families.


Page Intentionally Blank


FINANCIAL MANAGEMENT

FINANCIAL PERFORMANCE

ASSETS MANAGEMENT

PURCHASING

FINANCIAL STATEMENTS


PART 4


FundingThe functions of the NBA are outlined in the National Blood Authority Act 2003 and the National Blood Agreement. As a material statutory agency, the NBA has a range of corporate and compliance responsibilities under the National Blood Authority Act 2003, the Public Governance, Performance and Accountability Act 2013, and the Australian Public Service Act 1999, along with a responsibility to meet ministerial, parliamentary and financial reporting requirements.

Under the National Blood Agreement between the Australian government and the states and territories, 63 per cent of NBA funding is provided by the Australian government and the remaining 37 per cent is provided by the State and Territory governments. The funding covers both the national blood supply and the operations of the NBA.

For budgeting and accounting purposes, the NBA’s financial transactions are classified as either departmental or administered revenues or expenses:

• assets, liabilities, revenues and expenses controlled by the NBA for its operations are classified as departmental revenues and expenses

• activities and expenses controlled or incurred by the NBA on behalf of governments, mainly for the procurement of the requested products and services, are classified as administered revenues and expenses.

Transactions in the National Blood Account are separated into departmental and administered components. All balances in the National Managed Fund (Blood and Blood Products) Special Account are administered funds.

The NBA’s agency resource statement and total resources for outcome tables are given in Appendix 4. Table 4.1 summarises the NBA’s high level funding and expenditure for 2018–19.


TABLE 4.1 Departmental and Administered funding and expenditure 2018-19: a summary

Funding ($M) Expenditure ($M)

Departmental - NBA Operations 10.151 10.828

Administered - national blood and blood product supply

1,207.921 1,196.072

Special accountsThe NBA operates through two special accounts, the National Blood Account and the National Managed Fund (NMF) Blood and Blood Products Special Account 2017.

Special accounts are held in the Consolidated Revenue Fund and are used for setting aside and recording amounts to be used for specified purposes. Funding received from the Australian government and the states and territories is held within the special accounts and expended as required.

Funding for the supply of blood and blood products and the operation of the NBA is included in the National Blood Account, established under section 40 of the National Blood Authority Act 2003.

The NMF Blood and Blood Products Special Account 2017 was established under section 78 of the Public Governance, Performance and Accountability Act 2013 to accumulate funds required to meet potential product liability claims against the Blood Service. Contributions to the account have been made by all governments and the Blood Service. In addition, interest is received on special account balances.

PART 4 FINANCIAL MANAGEMENT 105

FINANCIAL PERFORMANCE

This section provides a summary of the NBA’s financial performance for 2018-19. Details of departmental and administered results are shown in the audited financial statements, and this summary should be read in conjunction with those statements.

Audit reportThe NBA received an unqualified audit report for 2018–19.

Departmental financesThe NBA’s departmental finances cover the NBA’s operations.

Operating resultThe NBA’s income statement reports a 2018-19 operating loss of $0.677 million, compared with an operating loss of $2.052 million in 2017-18.


TABLE 4.2 Key results in financial performance, 2014-15 to 2018-19

Revenue & expenses 2014–15 ($’000)

2015–16 ($’000)

2016–17 ($’000)

2017–18 ($’000)

2018–19 ($’000)

Contributions from the Australian government

6.266 5.719 5.636 5.590 5.682

Contributions from states and territories and other revenue

4.590 3.877 4.376 4.087 4.469

Total revenue 10.856 9.596 10.012 9.677 10.151

Employee expenses 6.695 6.469 6.744 6.637 7.438

Supplier expenses 3.753 3.002 2.350 4.698 2.909

Other expenses 0.439 0.380 0.521 0.394 0.481

Total expenses 10.887 9.851 9.615 11.729 10.828

Operating result (0.031) (0.255) 0.397 (2.052) (0.677)

RevenueTotal departmental revenue received in 2018-19 amounted to $10.151 million: $5.682 million in funding from the Australian government; $4.469 million in contributions received from the states and territories and other revenue; and $0.066 million for resources received free of charge. This represents an increase of $0.474 million (4.90 per cent) on revenue received in 2017-18. Other revenue refers to contributions arising from officers transferring from other agencies.

ExpensesThe NBA’s expenses for 2018-19 amounted to $10.828 million. This represents a decrease of $0.901 million (7.70 per cent) on total expenses from 2017-18.

Balance sheetDetails of the NBA’s assets and liabilities are presented in the audited financial statements in this report.

Financial assetsThe NBA held cash and cash equivalents of $8.678 million at 30 June 2019. This included funds received from all jurisdictions and transferred to the Official Public Account held by the Department of Finance until required for expenditure. Trade and other receivables increased by $0.434 to $1.353 million.

Non-financial assetsThere was no significant change in the carrying amount of non-financial assets during the financial year.


PayablesThere was no significant change in the carrying amount of payables during the financial year.

ProvisionsEmployee provisions, which cover annual and long service leave entitlements, increased by $0.369 million to $2.414 million.


Administered financesThe NBA’s administered finances include contributions from all states and territories and the Australian government for the supply of blood and blood products. Each year the Council of Australian Governments (COAG) Health Council approves an annual National Supply Plan and Budget, which is formulated by the NBA from demand estimates provided by the states and territories.

RevenueTotal revenue for 2018-19 is presented in Table 4.3. Total revenue increased by $49.173 million (a 4.2 per cent increase, down from the 10.35 per cent increase the prior year) for the current financial year. In 2018-19, the NBA returned $52.00 million (2017-18 $39.38 million) to the Commonwealth, state and territory governments for the 2017-18 end of year reconciliation as part of the National Blood Agreement.

TABLE 4.3 Administered revenue, 2014-15 to 2018-19

Administered revenue 2014-15 ($’000)

2015-16 ($’000)

2016-17 ($’000)

2017-18 ($’000)

2018-19 ($’000)

Funding for supply of blood and blood products

922.718 1,040.865 1,046.325 1,153.302 1,203.591

Total administered revenues 927.522 1,045.279 1,050.159 1,158.748 1,207.921

ExpensesTotal administered expenses for 2018-19 including grants and rendering of goods and services are presented in Table 4.4. Administered expenses for 2018-19 increased by 2.67 per cent over those for 2017-18. The Blood Service as part of the Output Based Funding Model returned $39.70 million in 2018 19 (2017-18 $22.273 million).

TABLE 4.4 Key results of administered expenses, 2014-15 to 2018-19

Administered expense 2014-15 ($’000)

2015-16 ($’000)

2016-17 ($’000)

2017-18 ($’000)

2018-19 ($’000)

Grants to the private sector - non-profit organisation

8.577 8.830 0.401 0.599 0.738

Rendering of goods and services - external entities

960.818 1,056.815 1,061.265 1,163.196 1,193.734

Other 0.803 0.716 1.169 1.275 1.600

Total administered expenses 970.198 1,066.361 1,062.835 1,165.070 1,196.072


Administered assets and liabilitiesAdministered assets comprise the following:

• funds held in the Official Public Account • investments made in relation to the NMF • Goods and Services Tax (GST) receipts from the Australian Taxation Office and payments to

suppliers for products • blood and blood product inventory held for distribution, including the national reserve of blood products

• a prepayment to the Blood Service as part of the OBFM.

Administered liabilities comprise payables to suppliers.

During 2018-19 net administered assets increased by $15.253 million.


ASSETS MANAGEMENT

The NBA has developed an asset replacement strategy to ensure that it has adequate funding for the replacement of assets as these come to the end of their useful life.


PURCHASING

The NBA adheres to the Commonwealth Procurement Rules and best practice guidance when undertaking procurements. The guidelines are applied to the NBA’s activities through the accountable authority’s management instructions and key business processes.

The NBA has developed business processes to ensure that the knowledge and best practices developed within the agency for key purchasing activities are captured and made available to new staff and that relevant procedures and processes are documented and followed.

Over recent years several internal audit programs have tested these processes to ensure that they meet government policy and better practice. The audit findings have been consistently favourable in relation to complying with mandatory processes. The NBA has implemented recommended opportunities.

The key business processes are constantly reviewed and refined as part of the NBA’s own requirement for continual improvement in the management of its core business functions.

Exempt contractsThe Chief Executive did not issue any exemptions from the required publication of any contract or standing offer in the purchasing and disposal gazette.

Competitive tendering and contractingThere were no contracts of $100,000 or more (inclusive of GST) let in 2018-19 that did not provide for the Auditor-General’s access to the contractor’s premises.

ConsultantsThe selection and engagement of consultants was treated in the same way as the procurement of other property and services and was conducted in accordance with the Public Governance, Performance and Accountability Act 2013, Commonwealth Procurement Rules and internal policies and procedures. During 2018–19, five new consultancy contracts were entered into involving total actual expenditure of $461,127 (GST inclusive). In addition, three ongoing consultancy contracts were active during the 2018-19 year, involving actual expenditure of $192,299 (GST inclusive). Total expenditure on consultancies in 2018–19 was $653,426 (GST inclusive).

Annual reports contain information about actual expenditure on contracts for consultancies. Information on the value of contracts and consultancies is available on the AusTender website, www.tenders.gov.au. No contracts were entered into that were exempt from reporting on the AusTender website - www.tenders.gov.au. Table 4.5 shows total expenditure on all consultancy services in 2018-19.


http://www.tenders.gov.au

http://www.tenders.gov.au

TABLE 4.5 Number and expenditure on consultants current report period (2018-19)

Total

Number of new contracts entered into during the period 5

Total actual expenditure during the period on new contracts (including GST) $461,127

Number of ongoing contracts engaging consultants that were entered into during a previous period

3

Total actual expenditure during the period on ongoing contracts (including GST) $653,426

Procurement Initiatives to Support Small BusinessThe NBA supports small business participation in the Commonwealth government procurement market. Small and Medium Enterprises (SME) and Small Enterprise participation statistics are available on the Department of Finance’s website: www.finance.gov.au/procurement/statistics-on-commonwealth-purchasing-contracts

The NBA recognises the importance of ensuring that small businesses are paid on time. The results of the Survey of Australian Government Payments to Small Business are available on the Treasury’s website - www.treasury.gov.au.

The NBA has in place procurement practices which support SMEs. This includes but is not limited to electronic systems or other processes used to facilitate on-time payment performance, including the use of payment cards.

Table 4.6 shows total expenditure on all consultancy services from 2014-15 to 2018-19 covering both new contracts let in the applicable year and ongoing contracts let in previous years.

TABLE 4.6 Expenditure on consultancy services, 2014–15 to 2018-19

Year Number let Total expenditure on new and existing consultancies ($)

2014-15 17 $1,193,693

2015-16 11 $424,193

2016-17 4 $69,922

2017-18 7 $392,766

2018-19 8 $653,426


http://www.finance.gov.au/procurement/statistics-on-commonwealth-purchasing-contracts

http://www.treasury.gov.au

GPO Box 707 CANBERRA ACT 2601 19 National Circuit BARTON ACT Phone (02) 6203 7300 Fax (02) 6203 7777

INDEPENDENT AUDITOR’S REPORT

To the Minister for Health

Opinion In my opinion, the financial statements of the National Blood Authority (‘the Entity’) for the year ended 30 June 2019:

(a) comply with Australian Accounting Standards – Reduced Disclosure Requirements and the Public Governance, Performance and Accountability (Financial Reporting) Rule 2015; and

(b) present fairly the financial position of the Entity as at 30 June 2019 and its financial performance and cash flows for the year then ended.

The financial statements of the Entity, which I have audited, comprise the following statements as at 30 June 2019 and for the year then ended:

Statement by the Accountable Authority and Chief Financial Officer; Statement of Comprehensive Income; Statement of Financial Position; Statement of Changes in Equity; Cash Flow Statement; Administered Schedule of Comprehensive Income; Administered Schedule of Assets and Liabilities; Administered Reconciliation Schedule; Administered Cash Flow Statement; and Notes to the financial statements, comprising a Summary of Significant Accounting Policies and other

explanatory information.

Basis for opinion I conducted my audit in accordance with the Australian National Audit Office Auditing Standards, which incorporate the Australian Auditing Standards. My responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Statements section of my report. I am independent of the Entity in accordance with the relevant ethical requirements for financial statement audits conducted by the Auditor‐General and his delegates. These include the relevant independence requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (the Code) to the extent that they are not in conflict with the Auditor‐General Act 1997. I have also fulfilled my other responsibilities in accordance with the Code. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinion.

FINANCIAL STATEMENTS


Accountable Authority’s responsibility for the financial statements As the Accountable Authority of the National Blood Authority, the Chief Executive Officer (CEO) is responsible under the Public Governance, Performance and Accountability Act 2013 (the Act) for the preparation and fair presentation of annual financial statements that comply with Australian Accounting Standards – Reduced Disclosure Requirements and the rules made under the Act. The CEO is also responsible for such internal control as the CEO determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, the CEO is responsible for assessing the ability of the Entity to continue as a going concern, taking into account whether the Entity’s operations will cease as a result of an administrative restructure or for any other reason. The CEO is also responsible for disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the assessment indicates that it is not appropriate.

Auditor’s responsibilities for the audit of the financial statements My objective is to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes my opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian National Audit Office Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements.

As part of an audit in accordance with the Australian National Audit Office Auditing Standards, I exercise professional judgement and maintain professional skepticism throughout the audit. I also:

identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for my opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control;

obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Entity’s internal control;

evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the Accountable Authority;

conclude on the appropriateness of the Accountable Authority’s use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Entity’s ability to continue as a going concern. If I conclude that a material uncertainty exists, I am required to draw attention in my auditor’s report to the related disclosures in the financial statements or, if such disclosures are inadequate, to modify my opinion. My conclusions are based on the audit evidence obtained up to the date of my auditor’s report. However, future events or conditions may cause the Entity to cease to continue as a going concern; and

evaluate the overall presentation, structure and content of the financial statements, including the disclosures, and whether the financial statements represent the underlying transactions and events in a manner that achieves fair presentation.

PART 4 FINANCIAL MANAGEMENT 114A

I communicate with the Accountable Authority regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that I identify during my audit.

Australian National Audit Office

Sean Benfield

Executive Director

Delegate of the Auditor‐General

Canberra

23 August 2019

NBA ANNUAL REPORT / 2018–19114B

PART 4 FINANCIAL MANAGEMENT

NBA ANNUAL REPORT / 2018–19114C

APPENDIX 1. COMMITTEE AND BOARD MEMBER PROFILES

APPENDIX 2. FRESH BLOOD COMPONENTS SUPPLIED UNDER CONTRACT BY THE BLOOD SERVICE IN 2018-19

APPENDIX 3. PLASMA AND RECOMBINANT PRODUCTS SUPPLIED UNDER CONTRACT IN 2018-19

APPENDIX 4. MANDATORY REPORTING

APPENDIX 5. LIST OF REQUIREMENTS

APPENDIX 6. ACRONYMS AND ABBREVIATIONS

INDEX

APPENDICES

PART 5

APPENDIX 1. COMMITTEE AND BOARD MEMBER PROFILES

NBA Board Members (L to R) Associate Professor Alison Street AO, Ms Penny Shakespeare (proxy for Mr Mark McCormack), Professor Chris Brook PSM, Professor Lyn Beazley AO, Ms Gayle Ginnane (Outgoing Chair), Mr Paul Bedbrook and Mr Geoffrey Bartle.


NBA Board Members

Dr Amanda Rischbieth - ChairDr Amanda Rischbieth has over 30 years’ experience in health and academia including CEO and non-executive directorship roles across health care delivery, clinical (critical care), public health, research, ethics, and corporate governance. She is a Fellow of the Australian Institute of Company Directors, an Adjunct Associate Professor at the University of Adelaide, a Governor’s Leadership Foundation Fellow, and a former Telstra Business Women Awards Finalist in two categories.

Following her twelve month Harvard Advanced Leadership Fellowship in 2017, Dr Rischbieth was invited back as a Visiting Scientist to join Harvard’s Culture of Health project – a partnership between Harvard Chan School of Public Health and Harvard Business School - a role she continues to hold. Her previous directorships include the Australian Organ and Tissue Authority, the National Heart Foundation of Australia SA, Australian College of Critical Care Nurses (National President), South Australian Public Health Council, Urban Renewal Authority, and the South Australian Motor Sport Board (V8 Supercars Adelaide 500).

Formerly a Director of Research for Calvary Health Care where she led the establishment of an international cancer clinical trials unit, Dr Rischbieth established and co-led a private cardiac and general Intensive Care Unit. Dr Rischbieth has received various awards and recognition for her business and community contributions. In 2018, she joined a humanitarian project team in Sri Lanka fitting prosthetic hands to over 240 land-mine and other victims.

Dr Rischbieth was appointed Chair of the NBA Board in March 2019.

Mr Geoffrey Bartle – Community RepresentativeMr Bartle has over thirty years of experience at an executive and strategic level in technology enabled business transformation and the design and implementation of business solutions. Prior to retirement, he was a management consultant and had a proven track record of delivering genuine business benefits for his clients in Western Australia and the Northern Territory.

His consulting roles included Strategy, Governance, Business Architecture, Benefits Management, Organisational Transformation, Procurement, Change Management, Business and System Analysis, Strategic Business Cases, Program Design, Business Process Improvement, Business Continuity and Disaster Recovery, and the design of technology enabled solutions to optimise business outcomes.

Mr Bartle’s industry experience included human services, disability services, health, police, education, superannuation, government services, insurance, small business, sustainability and Green IT, mining, taxation, racing and wagering, social welfare, public housing and smartcards; delivered in government, university and private sector environments.

Mr Bartle has also had extensive experience in a diverse range of Senior Executive Service roles in the public sector in Australia and New Zealand including national administration of large legislative, compliance, business and client service programs. The diverse range of roles undertaken by Mr Bartle during his career has equipped him with sound business acumen, and an unusual breadth of knowledge and experience, that he drew upon to deliver high calibre consulting services. His

PART 5 APPENDICES 159

pragmatic approach to problem solving, together with his skill in engaging with clients and stakeholders at all levels of an organisation, and his broad exposure to a variety of proprietary and industry methodologies and processes, enabled him to take on a range of challenging engagements.

He understands that a holistic and consumer-centric approach across the entire healthcare continuum is essential, and holds a number of community representative roles including:

• National Blood Authority – Haemovigilance Advisory Committee

• Australian Digital Health Agency – Secure Messaging and Interoperability Steering Committee

• NPS MedicineWise – Opioids Working Group

• WA Primary Health Alliance – Chronic Heart Failure Steering Committee

• WA Primary Health Alliance – Health Care Home Governance Group

• WA Primary Health Alliance – Chair, Metropolitan Community Advisory Council

• WA Department of Health Cardiovascular Health Network Executive Advisory Group

Mr Bartle was appointed to the NBA Board as the community representative in October 2017.

Professor Lyn Beazley AO – State and Territory Representative (Small Jurisdiction) After graduating from Oxford and Edinburgh Universities, Professor Lyn Beazley built an internationally renowned research team in neuroscience that focused on recovery from brain damage, with much of her investigations undertaken as Winthrop Professor at the University of Western Australia. Currently Professor Beazley is Adjunct Professor of Science at Murdoch University.

Professor Beazley was the Chief Scientist of Western Australia from 2006 to 2013, advising the WA government on science, innovation and technology, as well as acting as an Ambassador for science locally, nationally and internationally. Professor Beazley chairs several boards/councils including the Terrestrial Ecosystems Research Network, WA Innovator of the Year and Royal Perth Hospital Research Foundation and serves on others including the Royal Institution Australia. Professor Beazley was a Trustee of the Western Australian Museum from 1999 to 2006 and currently is Patron of the Friends of the Museum, along with many other educational, environmental, social and health-related organisations.

In 2009 Professor Beazley was awarded Officer of the Order of Australia. In that year she was elected a Fellow of the Australian Academy of Technological Sciences and Engineering and in 2019 became a Fellow of the Academy of Science. In 2011 Professor Beazley was inducted into the inaugural Western Australian Women’s Hall of Fame and was elected a Fellow of the Australian College of Educators and a Companion of Engineers Australia. Professor Beazley has worked to promote science, technology, engineering and mathematics to the community, especially to young people. In 2015 she was inducted into the Western Australian Science Hall of Fame and was announced as the 2015 WA Australian of the Year.

Professor Beazley was appointed to the NBA Board in January 2017.


Mr Paul Bedbrook — Financial ExpertMr Paul Bedbrook has had a connection with blood issues via his personal involvement with haemophilia for three decades. He is the father of two adult sons with haemophilia. For much of this time Mr Bedbrook has been involved with the Haemophilia Foundation NSW (HFNSW) and the Haemophilia Foundation Australia (HFA). Mr Bedbrook is a past President of HFNSW and past Treasurer of HFA. He brings his personal experiences with blood issues to the Board as well as feedback from a community of individuals who rely on the blood and plasma products distributed to Australia’s health services under the auspices of the NBA.

Professionally, Mr Bedbrook has had over thirty years of experience in financial services. His current roles include: Chairman of Zurich Financial Services Australia Ltd, Independent non-executive Director of Credit Union Australia (CUA) Ltd and Independent Chairman of ASX listed Elanor Investors Group.

Mr Bedbrook was a senior executive for over twenty years with the Dutch global banking, insurance and investment group, ING. Mr Bedbrook’s early career was as an Investment Analyst and Investment Portfolio Manager at ING, and between 1987 and 1995, he was the General Manager Investments and Chief Investment Officer for the Mercantile Mutual (ING) Group in Sydney. In the decade to 2010, Mr Bedbrook was in turn, President and CEO of INGDIRECT Canada, CEO and Director of ING Australia and Regional CEO of ING Asia Pacific based in Hong Kong.

Mr Bedbrook has been a member of the NBA Board since May 2011 and was appointed to his current Board role as financial expert in August 2013. Mr Bedbrook is also a member of the NBA Audit Committee.

Professor Chris Brook PSM — State and Territory Representative (Large Jurisdiction) Professor Chris Brook was a senior executive in Victorian Health for thirty years, fulfilling both professional (Chief Medical Officer and Director, Public Health) and management roles (Regional Director; Director Acute Health; Director Rural Health and Aged Care; and Executive Director Wellbeing, Integrated Care and Ageing).

Professor Brook has been part of blood and blood policy since 1988 and a national champion since the 1990s, including the several transformations in that time. He is especially proud of how treatment for people with haemophilia has utterly transformed in his time.

Professor Brook was re-appointed to the Board in January 2017.


Ms Penny Shakespeare – Australian Government RepresentativeMs Penny Shakespeare is Deputy Secretary of the Health Financing Group in the Australian Government Department of Health. This includes the Technology Assessment and Access Division, Medical Benefits Division, Provider Benefits Integrity Division.

Since joining the Department of Health in 2006, Ms Shakespeare has held a number of senior leadership positions. Penny was the First Assistant Secretary of the Technology Assessment and Access Division, where she led the division through a period of significant change to further build on the division’s capabilities in Health Technology Assessment.

Ms Shakespeare has also previously led the Health Workforce Division, Medical Benefits Branch and Private Health Insurance Branch.

Prior to joining the Department of Health, Ms Shakespeare was:

• an industrial relations lawyer in the Department of Employment and Workplace Relations,

• in regulatory policy roles, including as head of the ACT Office of Industrial Relations.

• a member of the National Occupational Health and Safety Commission

• a member of the Workplace Relations Ministers’ Advisory Council.

Ms Shakespeare has a Bachelor of Laws, a Masters degree in International Law and is admitted as a Barrister and Solicitor.

Ms Shakespeare was appointed on the NBA Board in May 2018.

Associate Professor Alison Street AO – Public Health Expert Professor Alison Street graduated in 1971 from Monash University with first class honours in medicine. After completing postgraduate training in clinical and laboratory haematology in Melbourne and Sydney, Professor Street spent three years in clinical research in Boston. Professor Street returned to Melbourne to work with Monash University and Alfred Health in 1984, where she retired from the positions of Head of Laboratory Haematology and Haemostasis-Thrombosis (including Haemophilia) in 2012.

Professor Street’s main professional interests were in haemostasis-thrombosis, transfusion medicine and teaching. During her tenure at Alfred Health, Professor Street was Chief Examiner in haematology for the Royal College of Pathologists of Australasia between 2001 and 2006, and President of the Haematology Society of Australia and New Zealand between 1996 and 1998.

Professor Street was a Board member with the World Federation of Hemophilia (WFH) between 2002 and 2012 (Vice-President Medical between 2008 and 2012) and a Board member of the Blood Service between 1998 and 2004.

Professor Street’s other appointments are:

• Clinical Adjunct Associate Professor in the Department of Immunology and Pathology, Monash University

• Chair of the NBA Haemovigilance Advisory Committee, and

• Member of the Steering Committee for the Asia-Pacific Haemophilia Working Group.

Professor Street received the Award of Officer in the Order of Australia in 2006 for services to haematology and the community of people with congenital bleeding disorders, and is an honorary life member of the Haematology Society of Australia and New Zealand, Australian Society of Thrombosis and Haemostasis and the Australian and New Zealand Society of Blood Transfusion.

Professor Street was appointed to the NBA Board in January 2017.


Audit and Risk Committee ChairMr Ken BarkerUntil 2009 Mr Barker had some forty two years of experience in the New South Wales Government. He worked for New South Wales Health for twenty four years where his last appointment was as Chief Financial Officer. He is now director of his own company, which specialises in financial management and provision of strategic advice, mainly to government agencies. He is also a member of a number of state government governance boards and of several New South Wales agency audit and risk committees.

Mr Barker has worked with the former New South Wales Blood Transfusion Service, and has made important contributions to many of the key decisions and events that have shaped the current Australian blood sector: the establishment of the Australian Red Cross Blood Service and the NBA; provision of national indemnity arrangements for blood and blood products; the Stephen Review of the Australian Blood Banking and Plasma Product Sector; and the 2008 KPMG business study of the Blood Service.

Mr Barker was appointed to the NBA Interim Board and has served as a full Board member since the inception of the NBA. He was reappointed in May 2011 and his term extended until August 2013. He served as Chair of the NBA Audit Committee between 2003 and 2007 and continued to serve as an Audit Committee member, until his appointment as Chair in October 2013.


APPENDIX 2. FRESH BLOOD COMPONENTS SUPPLIED UNDER CONTRACT BY THE BLOOD SERVICE IN 2018-19


TABLE 5.1 Fresh blood components supplied under contract by the Blood Service, 2018-19

Product Type Name Presentation JBC Price

Red blood cells Whole blood (WB) red cells leucodepleted

>200ml1 $428.05

WB paediatric red cells leucodepleted (set of 4)

25-100ml1 $450.55

WB washed red cells leucodepleted >130ml1 $434.13

Platelets WB platelet pool leucodepleted >160ml1 $294.51

Apheresis platelet leucodepleted 100-400ml1 $661.57

Paediatric apheresis platelet leucodepleted (set of 4)

40-60ml1 $843.79

Clinical fresh frozen plasma (FFP)

WB clinical FFP 295ml+/-10%1 $185.96

WB paediatric clinical FFP (set of 4) 60-80ml1 $219.61

Apheresis clinical FFP 295ml +/-10%1 $278.54

Cryoprecipitate WB cryoprecipitate 30-40ml1 $165.05

Apheresis cryoprecipitate 54-66ml1 $346.33

Cryo-depleted plasma WB cryo-depleted plasma 215-265ml1 $148.05

Apheresis cryo-depleted plasma 495-605ml1 $337.52

Other products Autologous donation NA $428.05

Directed donation complying with AHMAC guidelines

NA $428.05

Serum eye drops Single Collection $975.98

Plasma for Fractionation

Plasma for Fractionation2 Presentation size NA, but costed per kg

$394.45

1 The presentation volume for a typical unit content is specified in the Australian Red Cross Blood Service Blood Component Information, 2012. URL: http://resources.transfusion.com.au/cdm/ref/collection/p16691coll1/id/18.

2 Plasma for Fractionation is supplied to CSL Behring (Australia) Pty Ltd for manufacturing plasma derived products.


http://resources.transfusion.com.au/cdm/ref/collection/p16691coll1/id/18

APPENDIX 3. PLASMA AND RECOMBINANT PRODUCTS SUPPLIED UNDER CONTRACT IN 2018-19

TABLE 5.2 Plasma and recombinant products supplied under contract 2018-19

Product Type Name Presentation Supplier Price

Albumin (plasma derived - domestic)

Albumex 20% 10ml CSL Behring (Australia) Pty Ltd

$15.501

20% 100ml $67.621

4% 50ml $15.501

4% 500ml $67.621

Factor VIIa (recombinant - imported)

NovoSeven 1mg Novo Nordisk Pharmaceuticals Pty Ltd

$1,333.77

2mg $2,667.51

5mg $6,668.78

8mg $10,670.07

Factor VIII Anti-Inhibitor (plasma derived - imported)

FEIBA 500 IU Shire Australia Pty Limited

$1,200.00

1000 IU $2,400.00

2500IU $6,000.00

Factor VIII (plasma derived - domestic)

Biostate 250 IU CSL Behring (Australia) Pty Ltd

$218.141

500 IU $436.291

1000 IU $872.571



Factor VIII (recombinant - imported)

Advate 250 IU Shire Australia Pty Limited

$75.00

500 IU $150.00

1000 IU $300.00

1500 IU $450.00

2000 IU $600.00

3000 IU $900.00


Eloctate 250 IU Sanofi-aventis Australia Pty Ltd

*

500 IU *

1000 IU *

2000 IU *

3000 IU *

Factor IX (recombinant - imported)

Alprolix 250 IU Sanofi-aventis Australia Pty Ltd

*

500 IU *

1000 IU *

2000 IU *

3000 IU *


Xyntha 250 IU Pfizer Australia Pty Ltd $90.00

500 IU $180.00

1000 IU $360.00

2000 IU $720.00

3000 IU $1,080.00

Factor IX (plasma derived - domestic)

MonoFIX 1000 IU CSL Behring (Australia) Pty Ltd

$872.571


BeneFIX 250 IU Pfizer Australia Pty Ltd $197.50

500 IU $395.00

1000 IU $790.00

2000 IU $1,580.00

3000 IU $2,370.00


Adynovate 250 IU Shire Australia Pty Limited

*

500 IU *

1000 IU *

2000 IU *

*Extended half-life products supplied under limited and interim arrangements with no additional cost to the NBA budget.




Rixubis 250 IU Shire Australia Pty Limited

$196.50

500 IU $393.00

1000 IU $786.00

2000 IU $1,572.00

3000 IU $2,358.00

Factor XI (plasma derived - imported)

Factor XI 1 IU CSL Behring (Australia) Pty Ltd

$12.60

Factor XIII (plasma derived - imported)

Fibrogammin 250 IU CSL Behring (Australia) Pty Ltd

$195.08

1250 IU $975.38

Factor XIII (recombinant - imported)

NovoThirteen 2500IU Novo Nordisk Pharmaceuticals Pty Ltd

$30,000

Human prothrombin complex (plasma derived - domestic)

Prothrombinex 500 IU CSL Behring (Australia) Pty Ltd

$278.141

Fibrinogen Concentrate (plasma derived – imported)

RiaSTAP 1g CSL Behring (Australia) Pty Ltd

$785.83

Human C1 esterase inhibitor concentrate (plasma derived – imported)

Berinert 500 IU CSL Behring (Australia) Pty Ltd

$924.20

Protein C concentrate (plasma derived - imported)

Ceprotin 500 IU Shire Australia Pty Limited

$1,075.00

1000 IU $2,150.00

Antithrombin III concentrate (plasma derived - domestic)

Thrombotrol VF 1000 IU CSL Behring (Australia) Pty Ltd

$1,407.021

Intravenous IVIg (plasma derived – domestic)

Intragam P 3g/50ml CSL Behring (Australia) Pty Ltd

$175.481

Intravenous IVIg (plasma derived – domestic)

Intragam 10 2.5g/25ml CSL Behring (Australia) Pty Ltd

$146.231

10g/100ml $584.931

20g/200ml $1,169.861

SCIg (plasma derived – domestic)

Evogam 16% 0.8g/5ml CSL Behring (Australia) Pty Ltd

$46.791

15% 3.2g/20ml $187.181

IVIg (plasma derived - imported)

Flebogamma DIF 5% 0.5g/10ml Grifols Australia Pty Ltd $22.50



5% 2.5g/50ml $112.50

5% 5g/100ml $225.00

5% 10g/200ml $450.00

5% 20g/400ml $900.00

10% 5g/50ml $225.00

10% 10g/100ml $450.00

10% 20g/200ml $900.00

IVIg (plasma derived - imported)

Privigen 5g/50ml CSL Behring (Australia) Pty Ltd

$225.00

10g/100ml $450.00

20g/200ml $900.00

40g/400ml $1,800.00

SCIg (plasma derived - imported)

Hizentra 1g/5ml CSL Behring (Australia) Pty Ltd

$59.15

2g/10ml $118.31

4g/20ml $236.61

10g 50ml $591.53

Normal Ig NIg (plasma derived - domestic)

Normal Ig VF 2ml (0.32gm) CSL Behring (Australia) Pty Ltd

$31.651

5ml (0.80gm) $51.891

CMV Ig (plasma derived - domestic)

CMV Ig 1.5 million units CSL Behring (Australia) Pty Ltd

$1,203.131

Hepatitis B Ig (plasma derived - domestic)

Hepatitis B Ig 100 IU (2ml) CSL Behring (Australia) Pty Ltd

$43.981

400 IU (5ml) $100.691

Rh (D) Ig (plasma derived - imported)

Rhophylac 1500 IU CSL Behring (Australia) Pty Ltd

$403.16

Rh (D) Ig - VF (plasma derived - domestic)

Rh (D) Ig 250 IU CSL Behring (Australia) Pty Ltd

$29.791

625 IU $74.441

Tetanus Ig (plasma derived - domestic)

Tetanus Ig VF 250 IU CSL Behring (Australia) Pty Ltd

$43.471

4000 IU $695.481

Zoster Ig (plasma derived - domestic)

Zoster Ig VF 200 IU CSL Behring (Australia) Pty Ltd

$272.751

* Extended half-life products supplied under limited and interim arrangements with no additional cost to the NBA budget.1 The price does not include the starting plasma provided to CSL Behring (Australia) Pty Ltd by the Australian Red Cross Blood Service.


APPENDIX 4. MANDATORY REPORTING

Work health and safety • Refer Part 3

Statistics on employees who identify as Indigenous• Refer Part 3

Procurement Initiatives to Support Small BusinessThe National Blood Authority supports small business participation in the Commonwealth Government procurement market. Small and Medium Enterprises (SME) and Small Enterprise participation statistics are available on the Department of Finance’s website: www.finance.gov.au/procurement/statistics-on-commonwealth-purchasing-contracts

The following initiatives employed by the National Blood Authority support small business:

• the Commonwealth Contracting Suite for low-risk procurements valued under $200,000

• Australian Industry Participation plans in whole-of-government procurement where applicable

• the Small Business Engagement Principles (outlined in the government’s Industry Innovation and Competitiveness Agenda), such as communicating in clear, simple language and presenting information in an accessible format

• electronic systems or other processes used to facilitate on-time payment performance, including the use of payment cards.

The National Blood Authority recognises the importance of ensuring that small business are paid on time. The results of the Survey of Australian Government Payments to Small Business are available on the Treasury’s website: www.treasury.gov.au


http://www.finance.gov.au/procurement/statistics-on-commonwealth-purchasing-contracts

http://www.treasury.gov.au

Advertising and market research Section 311A of the Commonwealth Electoral Act 1918 requires particulars of all amounts greater than $13,800 paid during a financial year to advertising agencies, market research organisations, polling organisations, direct mail organisations and media advertising organisations. The NBA made no payments of this kind in 2018-19. The NBA did not conduct any advertising campaigns in 2018-19.

Ecologically sustainable development and environmental performance The NBA continued to pursue activities that support the ecologically sustainable principles outlined in Section 3A of the Environment Protection and Biodiversity Conservation Act 1999. During 2018-19 this included the following examples:

• continued use of audio and video conferencing and online collaboration in preference to face-to-face meetings requiring interstate or international travel

• recycling into three streams of waste – co-mingled material, paper and printer cartridges

• encouraging staff to recycle and re-use existing stationery before ordering new supplies

• maintaining paper use reduction initiatives such as defaulting printer settings to print double sided and in black and white and using 100 per cent recycled paper

• running the air conditioning systems on timers and occupancy sensors to ensure operation only during business hours when the immediate area is occupied

• participating in Earth Hour – the office was fully compliant and all staff were encouraged to participate

• ensuring that through purchasing activities further improvements were made within blood product supply contracts

• electronic document and records management system in place.

In summary, Table 5.3 provides information on the impact the NBA’s activities have on the natural environment. The NBA continues to look at ways to further reduce the impact on the environment.


TABLE 5.3 NBA Environmental performance indicators

Theme Performance measure Indicator(s) 2017-18 2018-19

Energy efficiency

Total consumption of energy

Amount of electricity consumed (kWh) 162,224 kWh 171,682 kWh

Amount of gas consumed (MJ) 0 MJ 0 MJ

Amount of other fuels consumed ($/kWh/MJ/L)

0 0

Air travel distances (km) 552,703 kms 543,656 kms

Total consumption of green energy

Amount of green energy purchased/consumed ($/kWh)

0 kWh 0 kWh

Greenhouse gas emissions

Amount of greenhouse gases produced (tonnes)

0 tonnes 0 tonnes

Relative energy uses Amount of green energy purchased divided by the amount of electricity consumed

0% 0%

Amount of total energy consumed (kWh) per employee

1,840 kWh 2,183 kWh


Waste Total waste production Amount of waste produced (tonnes) 11.01 tonnes 11.82 tonnes

Un-recyclable waste production

Amount of waste going to landfills (tonnes)

2.13 tonnes 1.90 tonnes

Recyclable waste production (excluding office paper)

Amount of waste going to recycling facilities (tonnes)


Paper waste production

Amount of waste paper going to recycling facilities (tonnes)


Amount of paper sourced from recyclable sources (tonnes)


Percentage of paper sourced from recyclable sources (per cent)

99.8% 99.7%

Use of renewable/recyclable products

Amount of products sourced from renewable/recyclable sources (tonnes)


Relative waste production

Amount of total waste (tonnes) per employee




Water Total consumption of water

Amount of water consumed (L) 462,433 L 413,133 L

Grey water/rainwater capture and use

Grey Water not applicable to NBA tenancies

na na

Relative consumption/use of water

Amount of total water use (L) per employee

5,245 L 5,255 L


Grant programsInformation on grants awarded by the NBA during the period 1 July 2018 to 30 June 2019 is available at www.blood.gov.au/governmental-compliance

Disability reporting Since 1994, non-corporate Commonwealth entities have reported on their performance as policy adviser, purchaser, employer, regulator and provider under the Commonwealth Disability Strategy. In 2007–08, reporting on the employer role was transferred to the Australian Public Service Commission’s State of the Service Report and the APS Statistical Bulletin. These reports are available at www.apsc.gov.au. From 2010–11, entities are no longer required to report on these functions.

The Commonwealth Disability Strategy has been overtaken by the National Disability Strategy 2010-2020, which sets out a 10-year national policy framework to improve the lives of people with a disability, promote participation and create a more inclusive society. A high level two-yearly report will track progress against each of the six outcome areas of the strategy and present a picture of how people with disability are faring. The first of these report was published in late 2014, and can be found at www.dss.gov.au.

Information Publication Scheme statementEntities subject to the Freedom of Information Act 1982 (FOI Act) are required to publish information to the public as part of the Information Publication Scheme (IPS). This requirement is in Part II of the FOI Act and has replaced the former requirement to publish a section 8 statement in an annual report. Each agency must display on its website a plan showing what information it publishes in accordance with the IPS requirements.

A copy of the NBA IPS Plan and associated published documents can be located at: http://www.blood.gov.au/ips.

ErrataNil.


http://www.blood.gov.au/governmental-compliance

http://www.apsc.gov.au

http://www.dss.gov.au

http://www.blood.gov.au/ips

Agency resource statements The agency resource statement provides details of the funding sources that the NBA drew upon in 2018-19. In addition, it provides information about special accounts balances to be carried over to 2019-20.

TABLE 5.4 Agency resource statement

Actual AvailableAppropriation

for 2018-19$’000

Paymentsmade

2018-19$’000

Balance 2018-19

$’000

(a) (b) (a) - (b)

Ordinary Annual Services1

Departmental appropriation2 6,299 5,908 391

Total 6,299 5,908 391

Administered expenses

Outcome 13 3,404 3,404

Total 3,404 3,404

Total ordinary annual services 9,703 9,312

Special Accounts4

Opening balance 198,683

Appropriation receipts5 9,312

Non-appropriation receipts to Special Accounts 1,267,086

Payments made 1,298,298

Total Special Accounts 1,475,081 1,298,298 176,783

Total resourcing and payments 1,484,784 1,307,610 1 Appropriation Act (No. 1) 2017-18 and Appropriation Act (No. 3) 2017-18. This may also include Prior Year departmental appropriation and section 31 relevant agency receipts.

2 Includes an amount of $0.061 million in 2018-19 for the Departmental Capital Budget. For accounting purposes this amount has been designated as ‘contributions by owners’.3 Includes an amount of $nil in 2018-19 for the Administered Capital Budget.4 Does not include ‘Special Public Money’ held in accounts like Other Trust Monies account (OTM). Services for other Government and Non-agency Bodies accounts (SOG), or Services for Other Entities and Trust Monies Special accounts (SOETM).5 Appropriation receipts from National Blood Authority annual appropriations for 2018-19 included above.


Resource for outcomesThis table provides details of the total funding for each outcome. In 2018-19 the NBA operated under a single outcome.

TABLE 5.5 Agency expenses by outcome

Outcome 1: Australia’s blood supply is secure and well managed

Budget*2018-19

$’000

Actual Expenses

2018-19$’000

Variation 2018-19

$’000

(a) (b) (a) - (b)

Program 1.1: National Blood Agreement management

Administered expenses

Ordinary Annual Services (Appropriation Bill No. 1) 3,404 3,404 -

Special Accounts 1,253,439 1,221,895 31,544

Departmental expenses

Departmental appropriation1 6,299 5,908 391

Special Accounts 9,631 9,883 -252

Expenses not requiring appropriation in the Budget year

392 1,575 -1183

Total for Program 1.1 1,273,165 1,242,665 30,500

Total expenses for Outcome 1 1,273,165 1,242,665 30,500

2017-18 2018-19Average Staffing Level (number) 52 56

* Full year budget, including any subsequent adjustment made to the 2018-19 Budget.1 Departmental Appropriation combines “Ordinary annual services (Appropriation Act No. 1)” and “Revenue from independent sources (s31)”.


TABLE 5.6 Report on Financial Performance Summary

Entity Resource Statement subset Summary Current Report Period (2018-19)

Actual Available

Appropriation for 2018-19

$’000

Payments made 2018-19

$’000

Balance2018-19

$’000

(a) (b) (a) - (b)

Departmental

Annual appropriations - ordinary annual services 5,908 5,908 -

Total departmental annual appropriations 5,908 5,908 -

Special accounts 8,090 8,090

Total special accounts receipts 10,311 9,883 428

less departmental appropriations drawn from annual/special appropriations and credited to special accounts

5,908 5,908 -

Total departmental resourcing (A) 18,401 9,883 8,518

Administered

Annual appropriations - ordinary annual services 3,404 3,404 -

Total administered annual appropriations 3,404 3,404 -

Special accounts 190,593 - 190,593

Total special accounts receipts 1,266,087 1,288,415 -22,328

less administered appropriations drawn from annual/special appropriations and credited to special accounts

3,404 3,404 -

less payments to corporate entities from annual/special appropriations

- - -

Total administered resourcing (B) 1,456,680 1,288,415 168,265

Total resourcing and payments for NBA (A + B) 1,475,081 1,298,298 176,783


APPENDIX 5. LIST OF REQUIREMENTS

Outlined in this section is the information provided in accordance with the Department of Finance’s Resource Management Guide No. 135 Annual reports for non-corporate Commonwealth entities as at July 2019.

na denotes that the requirement was not applicable to the NBA during 2018-19.

nil denotes that this aspect was not reported on for the NBA in 2018-19.

TABLE 5.7 List of requirements

PGPA RuleReference

Part of Report Description Requirement Page

17AD(g) Letter of transmittal

17AI A copy of the letter of transmittal signed and dated by accountable authority on date final text approved, with statement that the report has been prepared in accordance with section 46 of the Act and any enabling legislation that specifies additional requirements in relation to the annual report.

Mandatory iii

17AD(h) Aids to access

17AJ(a) Front Pages Table of contents. Mandatory iv

17AJ(b) Index Alphabetical index. Mandatory 189-195

17AJ(c) Appendix 6 Glossary of acronyms and abbreviations. Mandatory 186-188

17AJ(d) Appendix 5 List of requirements. Mandatory 178-185

17AJ(e) Front Pages Details of contact officer. Mandatory ii


PGPA RuleReference


17AJ(f) Front Pages Entity’s website address. Mandatory ii

17AJ(g) Front Pages Electronic address of report. Mandatory ii

17AD(a) Review by accountable authority

17AD(a) A review by the accountable authority of the entity.

Mandatory 3

17AD(b) Overview of the entity

17AE(1)(a)(i)

Part 1 A description of the role and functions of the entity.

Mandatory 2-3

17AE(1)(a)(ii)

Part 1 A description of the organisational structure of the entity.

Mandatory 4,88

17AE(1)(a)(iii)

Part 2 A description of the outcomes and programs administered by the entity.

Mandatory 22-32,85

17AE(1)(a)(iv)

Part 1 A description of the purposes of the entity as included in corporate plan.

Mandatory 2

17AE(1)(aa)(i)

Part 1 Name of the accountable authority or each member of the accountable authority

Mandatory 3

17AE(1)(aa)(ii)

Part 1 Position title of the accountable authority or each member of the accountable authority

Mandatory 3

17AE(1)(aa)(iii)

Part 1 Period as the accountable authority or member of the accountable authority within the reporting period

Mandatory 3

17AE(1)(b) An outline of the structure of the portfolio of the entity.

Portfolio departments - mandatory

na

17AE(2) Where the outcomes and programs administered by the entity differ from any Portfolio Budget Statement, Portfolio Additional Estimates Statement or other portfolio estimates statement that was prepared for the entity for the period, include details of variation and reasons for change.

If applicable, Mandatory

na

17AD(c) Report on the Performance of the entity Annual performance Statements

17AD(c)(i); 16F

Part 2 Annual performance statement in accordance with paragraph 39(1)(b) of the Act and section 16F of the Rule.

Mandatory 22


PGPA RuleReference


17AD(c)(ii) Report on Financial Performance

17AF(1)(a) Part 4 A discussion and analysis of the entity’s financial performance.

Mandatory 104-110

17AF(1)(b) Part 4 A table summarising the total resources and total payments of the entity.

Mandatory 109

17AF(2) Part 4 If there may be significant changes in the financial results during or after the previous or current reporting period, information on those changes, including: the cause of any operating loss of the entity; how the entity has responded to the loss and the actions that have been taken in relation to the loss; and any matter or circumstances that it can reasonably be anticipated will have a significant impact on the entity’s future operation or financial results.

If applicable, Mandatory.

148

17AD(d) Management and Accountability Corporate Governance

17AG(2)(a) Part 3 Information on compliance with section 10 (fraud systems).

Mandatory 87

17AG(2)(b)(i)

Part 3 A certification by accountable authority that fraud risk assessments and fraud control plans have been prepared.

Mandatory iii,87

17AG(2)(b)(ii)

Part 3 A certification by accountable authority that appropriate mechanisms for preventing, detecting incidents of, investigating or otherwise dealing with, and recording or reporting fraud that meet the specific needs of the entity are in place.

Mandatory iii,87

17AG(2)(b)(iii)

Part 3 A certification by accountable authority that all reasonable measures have been taken to deal appropriately with fraud relating to the entity.

Mandatory iii,87

17AG(2)(c) Part 3 An outline of structures and processes in place for the entity to implement principles and objectives of corporate governance.

Mandatory 78-81

17AG(2)(d) – (e)

A statement of significant issues reported to Minister under paragraph 19(1)(e) of the Act that relates to non-compliance with Finance law and action taken to remedy non-compliance.


na


PGPA RuleReference


External Scrutiny

17AG(3) Part 3 Information on the most significant developments in external scrutiny and the entity’s response to the scrutiny.

Mandatory 87

17AG(3)(a) Part 3 Information on judicial decisions and decisions of administrative tribunals and by the Australian Information Commissioner that may have a significant effect on the operations of the entity.


87

17AG(3)(b) Part 3 Information on any reports on operations of the entity by the Auditor-General (other than report under section 43 of the Act), a Parliamentary Committee, or the Commonwealth Ombudsman.


87

17AG(3)(c) Part 3 Information on any capability reviews on the entity that were released during the period.


87

Management of Human Resources

17AG(4)(a) Part 3 An assessment of the entity’s effectiveness in managing and developing employees to achieve entity objectives.

Mandatory 88-100

17AG(4)(aa) Part 3 Statistics on the entity’s employees as an ongoing and non-ongoing basis, including the following:

• (a) statistics on full time employees;• (b) statistics on part time employees;• (c) statistics on gender;• (d) statistics on staff location.

Mandatory 94

17AG(4)(b) Part 3 Statistics on the entity’s APS employees on an ongoing and non-ongoing basis; including the following:

• Statistics on staffing classification level;• Statistics on full-time employees;• Statistics on part-time employees;• Statistics on gender;• Statistics on staff location;• Statistics on employees who identify

as Indigenous.

Mandatory 90-96


PGPA RuleReference


17AG(4)(b) Part 3 Statistics on the entity’s APS employees on an ongoing and non-ongoing basis; including the following:

• Statistics on staffing classification level;• Statistics on full-time employees;• Statistics on part-time employees;• Statistics on gender;• Statistics on staff location;• Statistics on employees who identify

as Indigenous.

Mandatory 90-96

17AG(4)(c) Part 3 Information on any enterprise agreements, individual flexibility arrangements, Australian workplace agreements, common law contracts and determinations under subsection 24(1) of the Public Service Act 1999.

Mandatory 96

17AG(4)(c)(i)

Part 3 Information on the number of SES and non-SES employees covered by agreements etc identified in paragraph 17AD(4)(c).

Mandatory 99

17AG(4)(c)(ii)

Part 3 The salary ranges available for APS employees by classification level.

Mandatory 97

17AG(4)(c)(iii)

Part 3 A description of non-salary benefits provided to employees.

Mandatory 97

17AG(4)(d)(i)

Part 3 Information on the number of employees at each classification level who received performance pay.


na

17AG(4)(d)(ii)

Information on aggregate amounts of performance pay at each classification level.


na

17AG(4)(d)(iii)

Information on the average amount of performance payment, and range of such payments, at each classification level.


na

17AG(4)(d)(iv)

Information on aggregate amount of performance payments.


na

Assets Management

17AG(5) Part 4 An assessment of effectiveness of assets management where asset management is a significant part of the entity’s activities.

If applicable, mandatory

111

Purchasing

17AG(6) Part 4 An assessment of entity performance against the Commonwealth Procurement Rules.

Mandatory 112


PGPA RuleReference


Consultants

17AG(7)(a) Part 4 A summary statement detailing the number of new contracts engaging consultants entered into during the period; the total actual expenditure on all new consultancy contracts entered into during the period (inclusive of GST); the number of ongoing consultancy contracts that were entered into during a previous reporting period; and the total actual expenditure in the reporting year on the ongoing consultancy contracts (inclusive of GST).

Mandatory 112-113

17AG(7)(b) Part 4 A statement that “During [reporting period], [specified number] new consultancy contracts were entered into involving total actual expenditure of $[specified million]. In addition, [specified number] ongoing consultancy contracts were active during the period, involving total actual expenditure of $[specified million]”.

Mandatory 112

17AG(7)(c) Part 4 A summary of the policies and procedures for selecting and engaging consultants and the main categories of purposes for which consultants were selected and engaged.

Mandatory 113

17AG(7)(d) Part 4 A statement that “Annual reports contain information about actual expenditure on contracts for consultancies. Information on the value of contracts and consultancies is available on the AusTender website.”

Mandatory 112

Australian National Audit Office Access Clauses

17AG(8) Part 4 If an entity entered into a contract with a value of more than $100 000 (inclusive of GST) and the contract did not provide the Auditor-General with access to the contractor’s premises, the report must include the name of the contractor, purpose and value of the contract, and the reason why a clause allowing access was not included in the contract.


na


PGPA RuleReference


Exempt contracts

17AG(9) Part 4 If an entity entered into a contract or there is a standing offer with a value greater than $10 000 (inclusive of GST) which has been exempted from being published in AusTender because it would disclose exempt matters under the FOI Act, the annual report must include a statement that the contract or standing offer has been exempted, and the value of the contract or standing offer, to the extent that doing so does not disclose the exempt matters.


112

Small business

17AG(10)(a) Part 4 A statement that “[Name of entity] supports small business participation in the Commonwealth Government procurement market. Small and Medium Enterprises (SME) and Small Enterprise participation statistics are available on the Department of Finance’s website.”

Mandatory 113

17AG(10)(b) Part 4 An outline of the ways in which the procurement practices of the entity support small and medium enterprises.

Mandatory 113

17AG(10)(c) Part 4 If the entity is considered by the Department administered by the Finance Minister as material in nature—a statement that “[Name of entity] recognises the importance of ensuring that small businesses are paid on time. The results of the Survey of Australian Government Payments to Small Business are available on the Treasury’s website.”


113

Financial Statements

17AD(e) Part 4 Inclusion of the annual financial statements in accordance with subsection 43(4) of the Act.

Mandatory 114-155

Executive Remuneration

17A(da) Part 3 Information about executive remunderation in accordance with Subdivision C of Division 3A of part 2-3 of the Rule

Mandatory 99


PGPA RuleReference


17AD(f) Other Mandatory Information

17AH(1)(a)(i)

Part 4 If the entity conducted advertising campaigns, a statement that “During [reporting period], the [name of entity] conducted the following advertising campaigns: [name of advertising campaigns undertaken]. Further information on those advertising campaigns is available at [address of entity’s website] and in the reports on Australian Government advertising prepared by the Department of Finance. Those reports are available on the Department of Finance’s website.”


171

17AH(1)(a)(ii)

Part 5 If the entity did not conduct advertising campaigns, a statement to that effect.


171

17AH(1)(b) Part 5 A statement that “Information on grants awarded to [name of entity] during [reporting period] is available at [address of entity’s website].”


174

17AH(1)(c) Part 5 Outline of mechanisms of disability reporting, including reference to website for further information.

Mandatory 174

17AH(1)(d) Part 5 Website reference to where the entity’s Information Publication Scheme statement pursuant to Part II of FOI Act can be found.

Mandatory 174

17AH(1)(e) Part 5 Correction of material errors in previous annual report.

If applicable, mandatory

174

17AH(2) Part 5 Information required by other legislation

Mandatory

Work health and safety (Schedule 2, Part 4 of the Work Health and Safety Act 2011).

Mandatory 100

Ecologically sustainable development and environmental performance (Section 516A of the Environment Protection and Biodiversity Conservation Act 1999).

Mandatory 171-173

Agency Resource Statements and Resources for Outcomes.

Mandatory 175-176

Report on Financial Performance Summary

Mandatory 177


APPENDIX 6. ACRONYMS AND ABBREVIATIONSABDR Australian Bleeding Disorders RegistryACSQHC Australian Commission on Safety and Quality in Health CareACT Australian Capital TerritoryAHCDO Australian Haemophilia Centre Directors' OrganisationAHMAC Australian Health Ministers' Advisory CouncilAHPRA Australian Health Practitioner Regulation AgencyANAO Australian National Audit OfficeANZAN Australian & New Zealand Association of NeurologistsANZSBT Australian and New Zealand Society of Blood TransfusionAnti-D Rh D ImmunoglobulinAPS Australian Public ServiceAPSC Australian Public Service CommissionARCBS Australian Red Cross Blood ServiceASCIA Australasian Society of Clinical Immunology and AllergyASX Australian Stock ExchangeBlood Service Australian Red Cross Blood Service

BloodNET BloodNET 3 - Australia's online blood ordering and inventory management systemBloodSafe eLearning transfusion practice and patient blood management education online system

BloodSTAR BloodSTAR 5 - blood system for tracking authorisations and reviewsBCP Business Continuity PlanBEA BloodSafe eLearning AustraliaBURG BloodNet user reference groupCE Chief ExecutiveCOAG Council of Australian GovernmentsCPC Clinical Principal CommitteeCSL Behring CSL Behring (Australia) Pty LtdCUA Credit Union AustraliaDAPI discards as a percentage of net issuesEA Enterprise AgreementEAP Employee Assistance Program


EHL extended half-lifeERG expert reference groupFAA Funding and Administrative AgreementFEIBA factor VIII anti-inhibitorFFP/FP fresh frozen plasma/frozen plasmaFIX factor nineFIXa factor nine aFTE full-time equivalentFVIII factor eightGST goods and services taxHAA annual scientific meeting of the HAA–Haematology Society of Australia and New

Zealand–HSANZ, the Australian & New Zealand Society of Blood Transfusion–ANZSBT, and the Australasian Society of Thrombosis and Haemostasis–ASTH (now Blood)

HAC Haemophilia Advisory CommitteeHFA Haemophilia Foundation AustraliaHFNSW Haemophilia Foundation New South WalesHTC Haemophilia Treatment CentreICT Information Communications TechnologyICU intensive care unitIg immunoglobulinIPS Information Publication SchemeIU International UnitsIVIg Intravenous ImmunoglobulinJBC Jurisdictional Blood CommitteeKPI key performance indicatorkWh kilowatt hourLHD Local Health District (NSW)LIS Laboratory Information SystemNSW MoH Ministry of Health (NSW)MSAC Medical Services Advisory Committee

MyABDR MyABDR is a secure app for smartphones and web site for people with bleeding disorders or parents/caregivers to record home treatments and bleeds

NaFAA National Fractionation Agreement for AustraliaNBA National Blood AuthorityNBSCP National Blood Supply Contingency PlanNIg Normal immunoglobulinNIGAC National Immunoglobulin Governance Advisory CommitteeNIMF National Inventory Management FrameworkNMF National Managed FundNSP&B National Supply Plan and BudgetNSQHS National Safety and Quality Health Service


NSRS national service requirements and standardsOBFM Output Based Funding ModelPBM patient blood managementPGPA Ac Public Governance, Performance and Accountability ActRCPA Royal College of Pathologists of AustraliaR&D research and developmentrFIX recombinant factor ninerFVIIa recombinant factor seven (A)rFVIII recombinant factor eightRMA Rural Medicine AustraliaSCIg subcutaneous immunoglobulinSES Senior Executive ServiceSME small and medium enterprisesSPF staff participation forumSTIR Serious Transfusion Incident ReportingSWG specialist working group


INDEX

A

accountability and management, 78–100

see also finance; patient blood management

Accountable Authority, 3

statement by, 22

acronyms and abbreviations list, 186–188

administered finances, 109–110

special account, 104, 105

administrative tribunal decisions, 87

advertising and market research, 171

age demographic of staff, 92

agency resource statements, 175–177

Akers, Christine, 72

alpha1-proteinase inhibitor deficiency, 59

anaemia, 71

annual performance reporting statement, 22–75

annual reports, 60

errata, 174

list of requirements, 178–185

Anti-D (Rh D immunoglobulin), 28, 69

apheresis plasma, 38, 39, 165

donors, 8, 45

assets and asset management, 107, 111

administered items, 110

Audit and Risk Committee, 23, 24, 80, 81, 85, 163

Australian Bleeding Disorders Registry (ABDR), 9, 60, 64

Australian Blood Sector Systems and Data Roadmap 2018-22, 27

Australian Commission on Safety and Quality in Health Care (ACSQHC), 61, 70

Australian Haemophilia Centre Directors’ Organisation, 48

Australian Haemovigilance Minimum Data Set, 60

Australian Information Commissioner, 46, 87

Australian Institute of Health and Welfare, 61

Australian National Audit Office (Auditor-General), 80, 87

Australian Public Service Commission Employee Census, 88–89

Australian Red Cross Blood Service (Blood Service), 10, 34, 44–46, 53

data security breach, 46

National Managed Fund (Blood and Blood Products) Special Account, 105

Output Based Funding Model (OBFM), 44, 45, 109

see also fresh blood

B

balance sheet, 107

Bio-Rad Laboratories Pty Ltd, 35, 50

Bioverativ Australia Pty Ltd, 35

bleeding disorders (haemophilia), 9, 60, 64

see also clotting factors

Blood 2018 Awards, 72

blood cells, see red blood cells

blood donors, 8, 45, 46


Blood Management Standard, 29, 69, 70

Blood Service, see Australian Red Cross Blood Service

BloodNet, 8, 11, 63, 64, 66

laboratory interface, 28, 66

BloodNet User Reference Group, 63

BloodSafe eLearning Australia, 14, 58, 70, 71

BloodSTAR, 57, 60, 66

NSW roll-out, 53, 65

Board, 15–19, 85, 158–163

budget, see finance

Business Committee, 80, 85

Business Continuity Plan, 62

Business Plan, 85

C

C1 Esterase, 39, 168

Canadian Bleeding Disorders Registry, 64

Canberra, 46

capability reviews, 87

Chief Executive (General Manager), 3, 24, 51, 80, 81

remuneration, 99

review of year, 10–14

classification of staff, 90–92, 97

clinical demand, 25, 37, 39–43

clotting factors, 40–42, 59

see also Factor VIIa; Factor VIII; Factor IX

Comcare, reportable incidents lodged with, 100

Commonwealth Ombudsman, 87

communication and promotion, 69

see also information communication technology

competitive tendering and contracting, 112

conferences and events, 12, 51, 69, 72

consultants, 112–113

contingency events, 25

contingency plan, 25, 62

contracts, see purchasing

Corporate Plan, 23

Council of Australian Governments (COAG) Health Council, 3, 85

Criteria for the clinical use of intravenous immunoglobulin in Australia, 53, 55–58

critical care PMM module, 68

CSL Behring Pty Ltd, 34, 46–47, 49–50, 51, 166, 167, 168, 169

plasma collection target, 39

D

data developments, 60



Deed of Agreement, Red Cross, 10, 44–46


demand, 25, 37, 39–43

Deputy Chief Executives, 12, 24, 51, 80, 81, 82

remuneration, 99

diagnostic reagent products, 8, 35, 50

disability reporting, 174

discards, see wastage and discards

donors and donor management, 8, 45, 46


E

ecologically sustainable development, 171–173

education and training, 70–71

BloodSafe eLearning Australia, 14, 58, 70, 71

BloodSTAR sessions, 53

immunoglobulin governance, 58

staff, 93, 100

emicizumab, 59

employees, 11–12, 32, 80, 88–100

enterprise agreement, 95, 96

environmental performance, 171–173

establishment of NBA, 79

Executive Management Team, 81

exempt contracts, 112

expenditure, see finance

Extended Half-Life (EHL) clotting factor products, 12, 40, 41, 48

external scrutiny, 87

FFactor VIIa, 41–42, 166

Factor VIII (rFVIII) products, 39, 40, 166–167Anti-Inhibitor (FEIBA), 39, 41–42, 50, 59

Extended Half-Life (EHL), 12, 40, 48

supply contracts, 48, 50, 166–167

Factor IX (rFIX) products, 39, 41

Extended Half-Life (EHL), 12, 41, 48

supply contracts, 48, 167, 168

finance, 3–4, 104–155, 175–177Blood Service, 36–37, 45, 105; Output Based Funding Model (OBFM), 44, 45, 109grant programs, 174staff remuneration, 96–99see also purchasing

financial assets, 107

financial statements, 114–155

audit report, 106

fractionation, see plasma and recombinant products

fraud control, 87

freedom of information, 174

fresh blood, 33, 34, 36–39, 44–47, 165

donors, 8, 45, 46

plasma for fractionation, 37, 39, 46–47, 165

platelets, 9, 38, 67, 72, 165

see also Australian Red Cross Blood Service; patient blood management; red blood cells

full-time employees, 90–92, 94

Ggender of employees, 90–91, 94

General Manager, see Chief Executive

governance, 78–82

Board, 15–19, 85, 158–163

immunoglobulin program, 52–58

grant programs, 174

Grifols Australia Pty Ltd, 35, 47, 49, 50, 51, 168

Hhaemophilia, see bleeding disorders

haemovigilance, 60, 61, 72

Haemovigilance Advisory Committee, 61

human resources, 11–12, 32, 80, 88–100

IImmulab Pty Ltd, 35, 50

immunoglobulins (Ig), 27, 39, 43, 67, 168–169

Annual Report, 60

Governance Program, 52–58

grams issued, 9


imported supplies, 9, 35, 39, 43, 47, 49, 168–169

Rh D, 28, 69

see also BloodSTAR

income, see finance

Indigenous employees, 96

information communication technology (ICT), 27, 64–66

BloodNet, 8, 11, 63, 64, 66; laboratory interface, 28, 66

BloodSTAR, 57, 60, 66; NSW roll-out, 53, 65


eLearning, 32, 93, 100; BloodSafe, 14, 58, 70, 71

website visitors, 9

Information Publication Scheme statement, 174

internal audit and risk program, 81

internal auditors, 80, 81

international environment, 12, 51

inventory management, 30

Blood Service, 45

imported immunoglobulin, 49

imported plasma and recombinant products, 50

plasma for fractionation (CSL under CAFA and NaFAA), 47

see also BloodNet; wastage and discards

iron deficiency anaemia, 71

JJohnson & Johnson Medical Pty Ltd, 35, 50

judicial decisions, 87

Jurisdictional Blood Committee (JBC), 12, 13, 27, 29, 59, 62

plasma collection target, 39

Kkey performance indicators, see performance indicators/criteria

LLearnhub, 93

legal decisions and actions, 87

legislation, 15, 61, 78, 79, 104, 105

Public Governance, Performance and Accountability Act 2013, 23, 104, 105, 112

Public Governance, Performance and Accountability Rule 2014 (PGPA Rule), 23, 87

Public Service Act 1999, 104; determination under Section 24(1), 96

liabilities, see assets

location of employees, 94, 96

MMcMaster University, 64

management and accountability, 78–100

Accountable Authority, 3; statement by, 22

see also finance; patient blood management

market research and advertising, 171

maternity care, 68, 69

medical PMM module, 68

Medical Services Advisory Committee, 59

Ministers, 3

MyABDR portal, 64

NNational Blood Account, 104, 105

National Blood Agreement, 67, 73, 78, 79, 104

approval under Schedule 3, 85

evaluations undertaken under Schedule 4, 59

revenue returned to governments, 109

National Blood and Blood Product Wastage Reduction Strategy, 27

National Blood Authority Act 2003, 15, 61, 78, 79, 104, 105

National Blood Product Management Improvement Strategy, 60, 69


National Blood Sector Research and Development Program, 73–74

National Blood Sector Research and Development Strategic Priorities 2013-16, 73

National Blood Supply Contingency Plan, 25, 62

National Data and ICT strategy, 27

National Fractionation Agreement for Australia, 46–47

National Haemovigilance Report, 60

National ICT and Data Strategy, 27

National Ig Interest Group, 58

National Immunoglobulin Governance Advisory Committee (NIGAC), 58

National Inventory Management Framework (NIMF), 30

National Managed Fund (Blood and Blood Products) Special Account, 104, 105

National Patient Blood Management (PBM) Guidelines, 28, 29, 68, 70

National Patient Blood Management Implementation Strategy, 28, 69

National Policy: Access to Government Funded Immunoglobulin Products in Australia, 53–54, 55, 57

National Safety and Quality Health Service Standards, 29, 61, 70

National Supply List, 59

National Supply Plan and Budget (NSP&B), 33–43, 85

National Wastage Reduction Strategy, 27

neonatal and paediatric PMM module, 68, 70

New South Wales Ministry of Health, 53

non-English speaking backgrounds, employees from, 96

non-financial assets, 107

non-ongoing employees, 90, 91–92, 94, 96

non-salary benefits, 97–98

Novo Nordisk Pharmaceuticals Pty Ltd, 35, 49–50, 166, 168

Oobjectives, 33–74

obstetrics and maternity, 68, 69

occupational health and safety, 32, 100

Office of the Australian Information Commissioner, 46, 87

Ombudsman, 87

ongoing employees, 90, 91–92, 94, 96

online services, see information communication technology

operating result, 106–110

Blood Service, 37, 45

organisation and structure, 2–19, 78–82

organisation charts, 4, 78, 79, 82

Ortho-Clinical Diagnostics, 35, 50


PParliamentary committees, 87

part-time employees, 90–92, 94

Pathology Queensland, 66

patient blood management, 28–30, 68–75

BloodSTAR, 57, 60, 66; NSW roll-out, 53, 65

Patient Blood Management (PBM) Guidelines, 28, 29, 68, 70

people management, 11–12, 32, 80, 88–100

Performance Improvement Strategy for the Immunoglobulin Governance Program, 27, 54

performance indicators/criteria, 25–32

Australian Red Cross Blood Service, 44–45

business plan objectives, 85

environmental performance, 172–173

haemovigilance, 60

immunoglobulin governance, 54

imported immunoglobulin, 49

imported plasma derived and recombinant products, 49–50


plasma for fractionation (CSL under CAFA and NaFAA), 47

wastage, 27

performance pay, 99

performance reporting statement, 22–75

perioperative PMM module, 68

Perros, Alexis, 72

Pfizer Australia Pty Ltd, 35, 49–50, 167

planning framework, 83–86

contingencies, 25, 62

plasma and recombinant products, 33, 34–35, 39–43

supply contracts, 49–50, 166–169

supply risk mitigation, 62

see also immunoglobulins

plasma for fractionation, 34, 39, 46–47, 165

plasma only donor collection centres, 46

plasmapheresis, see apheresis plasma

platelets, 9, 38, 67, 72, 165

policy and policy advice, 31

Portfolio Budget Statements, 23

prices, 37, 39–40, 165–169

privacy incident, 46

procurement, see purchasing

productivity gains, 99

promotion and communication, 69


Prothrombinex, 39, 168

Public Governance, Performance and Accountability Act 2013, 23, 104, 105, 112

Public Governance, Performance and Accountability Rule 2014, 23, 87

Public Service Act 1999, 104

determination under Section 24(1), 96

publications distributed, 9

purchasing, 112–113, 170–171

purchasing of blood and blood product supply, 3–4, 33–51, 165–169

contract management, 44–50

savings, 10, 37, 39, 43

variance between actual and NBA estimate, 26

see also inventory management

Rrecombinant products, see plasma and recombinant products

red blood cells, 9, 37–38, 165

demand, 37, 39

diagnostic reagent products, 8, 35, 50

supply change management, 45

wastage and discards, 9; performance criteria and results, 26, 30

remuneration of staff, 96–99

research and development, 30, 72–74

Blood Service, 46

resource statements, 175–177

returns to government, 37, 109

revenue, see finance

Rh D (Anti-D) immunoglobulin, 28, 69

risk management, 62, 81, 87

role, 2


Ssafe and efficient use, see patient blood management

salary and remuneration, 96–99

Sanofi-aventis Australia Pty Ltd, 35, 48, 49–50, 167

satisfaction with Blood Service, 45

savings, 10, 37, 39, 43

sector monitoring, 67

security of supply, see supply

Service Charter, 85–86

Shire Australia Pty Ltd, 34, 48, 49–50, 166, 167–168

small business, procurement initiatives to support, 113, 170

special accounts, 104, 105

Specialist Working Groups, 55, 58

staff, 4, 11–12, 32, 80, 88–100

Staff Participation Forum, 80

standards, 29, 61, 70

STARS, 60

Statement on National Stewardship Expectations for the Supply of Blood and Blood Products, 69

Strategic Framework for the National Haemovigilance Program, 60, 61

supply, 8, 33–67, 165–169

evaluation of new products, 59

National Supply Plan and Budget, 33–43, 85

performance criteria, 25–28

supply chain management, see inventory management

Ttenders, see purchasing

Therapeutic Goods Administration, 61

Townsville, 46

training, see education and training

tribunal decisions, 87

Vvalues, 89

Wwastage and discards, 27

BloodNet Fate Module, 8

red blood cells, 9, 26, 30

website services, see information communication technology

whole blood, 38, 39, 165

donors, 45

work health and safety, 32, 100

work plans, 24, 60

workforce, 4, 11–12, 32, 80, 88–100


ANNUAL REPOR T2018–19 - Blood · ANNUAL REPOR T 2018–19 . ... 1.1 NBA Organisation as at 30...

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