VCS Foundation Annual Report 2021 by Victorian Cytology Service

ON TARGET FOR CERVICAL CANCER ELIMINATION ANNUAL REPORT 2021

SAVING LIVES

CERVICAL CANCER IS A COMPLETELY PREVENTABLE PUBLIC HEALTH PROBLEM. YET GLOBALLY, ONE WOMAN DIES OF CERVICAL CANCER EVERY TWO MINUTES. On 26 March 2021, the Minderoo Foundation and C4 announced a first of its kind humanitarian and research effort to eliminate cervical cancer in the Western Pacific. C4 will receive $AUD8.1 million in direct funding which, along with in-kind support from partners, will deliver $30 million to set Papua New Guinea and Vanuatu on the path to elimination. “VCS Foundation is incredibly proud to be involved in this initiative which will ramp up HPV vaccination and provide women with access to world class HPV self-sampling and same-day treatment of pre-cancerous cervical lesions using thermal ablation. It is expected to save the lives of 15,000 women in Papua New Guinea alone.”

Prof Marion Saville, AM Executive Director, VCS Foundation

This is a multi-institutional agreement in partnership with:

CERVICAL CANCER ELIMINATION Cervical cancer is caused by the Human Papillomavirus, or HPV, an extremely common virus that is spread through sexual contact. It is preventable through HPV vaccination and cervical screening, and is one of the most curable cancers if detected early and managed effectively. Yet, cervical cancer is the fourth most common cancer among women globally and over 311,000 women died from the disease in 2018.

On 17 November 2020, following the close of the 73rd World Health Assembly, the World Health Organization (WHO) made an historic announcement to officially launch the Global Strategy to Accelerate the Elimination of Cervical Cancer.

The adoption of the strategy was co-led by Australia, leveraging our strong history of global leadership in cervical cancer prevention programs, technology and research. The HPV vaccine was developed at the University of Queensland by Professor Ian Frazer and the late Dr Jian Zhou, and in 2007, Australia introduced the world’s first nationwide HPV vaccination program.

For the first time ever, the world has committed to eliminate a cancer, aiming to eliminate cervical cancer as a public health problem by reaching an incidence of <4 per 100,000 women in every country within the next 100 years. Research by Adjunct Professor Karen Canfell at the Daffodil Centre found that as many as 74 million cases could be averted and 62 million lives could be saved if 78 of the poorest countries in the world are able to rapidly scale up HPV vaccination, cervical screening and access to cancer treatment services.

Elimination is within the reach of all countries. With political will from governments and the commitment and expertise of health and community organisations in all nations, girls who are born today will live to see a world free of this disease.

accessible and cost-effective screening to the many women in the world living in remote communities.

It is a testament to the importance of the cervical cancer elimination strategy that even in the context of the COVID-19 pandemic, countries around the world have affirmed their support for this global health priority. There is no doubt that the COVID-19 pandemic is going to hamper global efforts to make HPV vaccination and HPV-based screening available to all girls, women and people with a cervix. We must find innovative ways to overcome this new challenge. Self-collected samples, rapid point of care testing and same day treatment will be crucial to providing safe,

+ VACCINATION: 90% of girls vaccinated against HPV by the age of 15 years

To reach elimination, the WHO strategy sets out three targets to be met by every country by 2030:

+ SCREENING: 70% participation in twice-lifetime cervical screening with a high precision approach such as HPV testing + TREATMENT: 90% complete treatment of pre-invasive lesions and invasive cancer

VCS FOUNDATION IS HERE TO CONTROL CERVICAL CANCER FOR THE BENEFIT OF ALL PEOPLE – WE ALWAYS HAVE BEEN

IT IS IMPERATIVE THAT WE OFFER OUR SUPPORT TO LESS WELL-RESOURCED COUNTRIES TO SCALE UP HPV VACCINATION AND CERVICAL SCREENING. SOLUTIONS MUST BE LOCALLY DRIVEN TO ENSURE THEY ARE ACCEPTABLE TO AND SUITABLE FOR LOCAL POPULATIONS AND HEALTH SYSTEMS. VCS FOUNDATION LTD. CAN OFFER ASSISTANCE BY PROVIDING TECHNOLOGICAL EXPERTISE AND SHARING KNOWLEDGE. Professor Marion Saville, AM

GLOBAL HEALTH INITIATIVE AGAINST HPV AND CERVICAL CANCER The Global Initiative Against HPV and Cervical Cancer aims to empower people, communities and societies internationally to reduce the disease burden from HPV and cervical cancers through collective engagement, advocacy, collaboration and education.

VCS Foundation provided continued support and co-sponsorship of the Us vs. HPV Prevention Week in January 2021. This was a one-week series of webinars, social media campaigns, local events, and other initiatives to promote awareness about HPV and HPV-related diseases to clinicians and the public.

WHAT WE DO

VISION

VALUES

YEAR IN REVIEW – CHAIRMAN AND EXECUTIVE DIRECTOR’S REPORT

FINANCIAL SUMMARY

SNAPSHOT OF OUR ACHIEVEMENTS

EXECUTIVE TEAM

VCS FOUNDATION STRATEGIC PLAN 2020-2025

1 – Support Victoria’s efforts to eliminate cervical cancer as a public health problem, in accordance with the Victorian Cancer Plan 2020-2024

2 – Support Australia’s efforts to eliminate cervical cancer as a public health problem by 2035

3 – Support countries in the Indo-Pacific region to scale up to meet the 2030 targets in support of the WHO strategy to eliminate cervical cancer as a public health problem

CONTENTS

4 – Lead and promote the increased uptake of self-sampling 5 – Support the National Bowel Cancer Screening Program in Victoria 6 – Deliver and disseminate the research outcomes of the Compass trial, C4 and other policy relevant research 7 – Diversify the range of VCS Pathology laboratory tests by leveraging our existing expertise and capital investment 8 – Leverage the value of the canSCREEN® and canVAX® platforms for cost effective support of Low to Middle Income Countries and for commercially advantageous opportunities

VCS PATHOLOGY – CORE ACTIVITES

COMMITTEE ENGAGEMENT AND STAKEHOLDERS

OUR PEOPLE

OCCUPATIONAL HEALTH AND SAFETY

FREEDOM OF INFORMATION

PRIVACY

WHISTLEBLOWER PROTECTION

RISK MANAGEMENT

2020/21 RISK ATTESTATION STATEMENT

ACCREDITATION

QUALITY ASSURANCE

DIRECTORS REPORT

AUDITOR’S INDEPENDENCE DECLARATION

FINANCIAL STATEMENTS

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WHAT WE DO

WHAT WE DO Australia is a world leader in achieving cervical cancer control in our population and we are now extending that leadership to supporting global elimination. VCS Foundation is a not-for-profit organisation established in 1965 to make a positive difference in the lives of Victorian women by reducing the impact of cervical cancer. With a 56-year history of contributing to Australia’s National Cervical Screening Program through laboratory services, digital health and registry programs, research and evidence-based policy recommendations, VCS Foundation is well positioned to leverage its expertise to support the World Health Organization’s (WHO) call for all countries to take action to end the suffering caused by cervical cancer. VCS Foundation’s unique suite of services are designed to implement, support, monitor and manage population health programs including cancer screening and vaccination. Our multi-disciplinary team leverages deep expertise and an ability to cost effectively support and deliver large scale programs. VCS Foundation is a trusted advisor to governments locally and globally, participating in numerous committees that are supporting the shift from cytology to HPV screening and the delivery of HPV vaccination in Australia and around the world.

VCS Foundation acknowledges the support provided by the Victorian and Commonwealth Governments which has been invaluable in enabling VCS Foundation to deliver outstanding service to participants in public health programs through its laboratory and registry services.

Through partnerships and collaborations, VCS Foundation encourages and supports health improvements and health equity. We are proud to be a member of the Global Health Alliance, BioMelbourne Network, the Union for International Cancer Control, Public Health Association Australia and Public Pathology Australia.

VCS Foundation is a Company Limited by Guarantee that operates under and complies with the: • Corporations Act 2001 (Cth) • Australian Charities and Not-for-profits Commission Act 2012 (Cth) • Improving Cancer Outcomes Act 2014 (Vic).

A specialist laboratory and medical education service committed to gynaecological health including HPV testing, histopathology, cytology and related molecular microbiology, clinical support and advice. We are Australia’s HPV and cervical screening reference laboratory. SARS-CoV-2 testing was introduced in 2020 to support the Victorian Government response during the pandemic.

Leaders in innovative and integrated digital healthcare solutions and services, offering population health management platforms and a broad range of IT service management expertise. Our award-winning canSCREEN® platform supports the full population health management lifecycle across a broad spectrum of cancer screening and health programs.

An unrivalled combination of experience in delivering and managing population health services through registries, epidemiology, research and evaluation, health information management, reporting and statistics. We understand the complexities of population health and the importance of services which improve the health of our communities in ways that are equitable, safe, appropriate, acceptable and cost effective.

VCS FOUNDATION LTD. ABN 35 430 554 780

ACKNOWLEDGEMENT OF COUNTRY VCS Foundation acknowledges the people and the Elders of the Aboriginal and Torres Strait Islander Nations who are the Traditional Owners of the land and seas of Australia in which we work and live. We pay our respect to Elders past, present and emerging.

VISION To prevent cancer and infectious diseases through excellence in the provision of public health services supporting screening, population-based testing and vaccination.

VALUES FAIRNESS INTEGRITY RESPECT EXCELLENCE

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YEAR IN REVIEW – CHAIRMAN AND EXECUTIVE DIRECTOR'S REPORT

YEAR IN REVIEW CHAIRMAN AND EXECUTIVE DIRECTOR’S REPORT Welcome to the VCS Foundation Annual Report for the 2020/21 financial year. This report highlights our achievements and the emerging challenges for public health organisations during another year under the cloud of the global COVID-19 pandemic. During 2020/21 VCS Foundation has continued to deliver its high-quality services in cervical screening and other supportive routine tests, whilst becoming a key contributor to the Victorian response to COVID-19 – both as a high-volume testing laboratory and in supplying couriers to the quarantine hotels and screening clinics. The VCS Pathology laboratory increased SARS-CoV-2 testing capacity to meet the high demands that occurred during the Victorian lockdowns and outbreaks. With the unwavering support of our staff, the laboratory has seamlessly managed throughput of up to 1,500 SARS-CoV-2 tests per day, with most results provided within 24 hours, whilst continuing to maintain the very high quality of our primary cervical screening laboratory functions. As expected, primary screening tests (HPV) continued to decline due to the transition to five-yearly cycles of HPV testing as part of the renewed National Cervical Screening Program, introduced in 2017. The switch to a longer screening interval has resulted in transitional fluctuations for volumes of tests, with 2020 and 2021 modelled as low volume years before the commencement of the

next five-year cycle in December 2022. This expected reduction in cervical screening test volumes has enabled the laboratory to redirect its focus and resources to the COVID-19 response. There is no doubt that the COVID-19 pandemic will hamper global efforts to make HPV vaccination and HPV based screening available to all adolescents and women. VCS Foundation has continued to find innovative ways to overcome this new challenge. Self-collected HPV samples, rapid point-of-care testing and same day treatment will be critical to providing safe and cost-effective screening into the future for women living in remote communities. Cervical screening rates fell dramatically during the pandemic, coinciding with much-needed public health measures to restrict movement and social contact. To ensure under-screened groups were not disproportionately affected by the pandemic, VCS Foundation launched an innovative initiative to assist clinicians to encourage and support underscreened patients to participate in cervical screening, offering to send home self-sampling kits to patients who were identified as under-screened during a telehealth consultation. Importantly, we designed this service to be embedded within primary care. Healthcare professionals, who also offered routine cervical screening services, ordered the home-based test and received the results, enabling them to discuss the results with their patients and provide any follow-up required. VCS Foundation continued to lead the implementation of the Victorian Government’s Cancer Screening Primary Care and Workforce Strategy 20192022, which includes the provision of education to primary care practitioners

and nurses to improve adherence to cancer screening clinical guidelines across the breast, bowel and cervical screening programs and improve equity and the screening experience for under-screened participants. Due to the pandemic, our education offerings transitioned rapidly to an online model. For example, we launched an accredited online HPV Self-Collection Clinical Audit to support clinicians in encouraging eligible under-screened patients to take up this alternative test. Cancer screening clinical education webinars were delivered in partnership with Cancer Council Victoria to GPs, nurses and practice managers across the state, particularly in areas with lower screening rates and those hit hardest by the pandemic. We also led the implementation of the Victorian Government’s Cancer Screening Data and Surveillance Strategy 20192022, which includes the provision of bowel, breast and cervical screening data and reports, to support service planning, monitoring and evaluation of initiatives, improve screening participation, identify under-screened groups and to support research. We have delivered detailed reports on participation, screens, invitations, bowel kits returned, cervical self-collection and timeliness to diagnostic investigations in addition to a data dashboard providing a snapshot of key cancer screening metrics. Work continues with program partners to access relevant datasets for integration into the VCS Data and Reporting tool for reporting on screening and cancer outcomes. The Population Health Team has continued to deliver the Participant Follow-Up Function on behalf of the Victorian Department of Health for participants who have had a positive

VCS FOUNDATION LTD. ABN 35 430 554 780

CHAIRMAN Mr Tim Humphries

EXECUTIVE DIRECTOR Professor Marion Saville AM

bowel screening test. Despite the impact of COVID-19 and the transition to remote working, the team has been able to significantly improve the rate of follow-up of participants within 28 days, achieving results above 90%. Work to support the Compass Trial has seen agreements reached with the Australian Department of Health and the National Cancer Screening Register (NCSR) on the approach to the transfer of participant records to the NCSR as they exit the trial. This includes the interim transfer of priority participants. A new 2020-2025 Strategic Plan was developed by the Board of Directors which sets out our intention to continue to support and ramp up efforts in Australia and the Indo-Pacific region to eliminate cervical cancer. We acknowledge the need to reshape our business model to adapt to new local and global opportunities, including diversification of our pathology services and leveraging the value of our registry and vaccination digital platforms, canSCREEN® and canVAX®. The work associated with the plan is detailed in this report.

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THE VCS PATHOLOGY LABORATORY INCREASED ITS SARS-COV-2 TESTING CAPACITY TO MEET THE HIGH DEMANDS THAT OCCURRED DURING THE VICTORIAN OUTBREAKS MANAGING THROUGHPUT OF UP TO 1,500 SARS-COV-2 TESTS PER DAY WITH MOST RESULTS PROVIDED WITHIN 24 HOURS.

BOARD MEMBERS Dr Jane Collins stepped down as Board Chairman in 2020, one year before her tenure was due for re-election. Dr Collins continues on the Board as a long-standing Director representing General Practitioners and remains a highly valued contributor to the organisation. We thank Dr Collins for her leadership and contribution. Mr Tim Humphries has accepted the role of Chairman. Ms Fiona Kelly has accepted the role of Treasurer replacing Mr Humphries in this role. The VCS Foundation Board is committed to best practice governance principles and supporting practices. The Board has voluntarily adopted the Australian Institute of Company Directors (AICD) Not for Profit (NFP) Governance Principles (2019) and reflects on its governance annually. The Board of Directors give their time to VCS Foundation voluntarily and we are exceptionally grateful for their expertise and guidance.

Mr Tim Humphries Chairman

Professor Marion Saville, AM Executive Director

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2020/21 FINANCIALS AT A GLANCE

FINANCIAL POSITION

OPERATING RESULT

TOTAL REVENUE

TOTAL EXPENSES

$5,107,489

$31,392,822

$26,448,958

UP FROM $1,511,843 IN 2019/20

UP FROM $26,605,713 IN 2019/20

UP FROM $25,093,870 IN 2019/20

CORE BUSINESS PERFORMANCE 2020/21 $

2019/20 $

2018/19 $

2017/18 $

2016/17 $

Total Revenue

31,392,822

26,605,713

28,797,979

28,104,030

25,349,828

Total Expenses

26,448,958

25,093,870

27,427,872

28,270,185

24,712,316

5,107,489

1,511,843

1,370,107

($166,154)

637,512

31,061,811

28,800,410

31,145,539

24,027,269

23,495,604

7,287,746

10,133,834

14,070,684

8,322,521

7,624,702

23,774,065

18,666,576

17,074,855

15,704,748

18,870,902

NET RESULT Surplus/(Deficit) Total Assets Total Liabilities NET ASSETS Total Equity

THE SUPPORT PROVIDED BY THE VICTORIAN AND COMMONWEALTH GOVERNMENTS HAS BEEN INVALUABLE IN ENABLING VCS FOUNDATION TO DELIVER OUTSTANDING SERVICE TO PARTICIPANTS IN POPULATION HEALTH PROGRAMS THROUGH ITS LABORATORY AND REGISTRY SERVICES.

VCS FOUNDATION LTD. ABN 35 430 554 780

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SUMMARY OF CONSOLIDATED FINANCIAL RESULTS FOR VCS FOUNDATION LIMITED

ANNUAL INCOME BY SOURCE 2020/21

ANNUAL INCOME BY SOURCE $M 2016/17 2017/18 2018/19 2019/20 2020/21

Government Grants Patient Fees Other Operating Income Non Operating Income Capital Purpose Income

Capital Purpose Income Non Operating Income Other Operating Income Patient Fees Government Grants 0

Depreciation

2015/16 2016/17 2017/18 2018/19 2019/20 2020/21

Salaries and Wages

Laboratory Consumables

ANNUAL OPERATING EXPENDITURE $M

OPERATING EXPENDITURE 2020/21

Operating and Administration

Depreciation

Laboratory Consumables Operating & Administration Salaries & Wages 0

PAGE 12

FINANCIAL SUMMARY

FINANCIAL SUMMARY AUDIT AND FINANCE COMMITTEE CHAIRMAN AND DIRECTOR CORPORATE SERVICES REPORT

CHAIRMAN – AUDIT & FINANCE COMMITTEE Ms Fiona Kelly

DIRECTOR CORPORATE SERVICES Dr Michelle Critchley

The consolidated net result for VCS Foundation for the financial year ended 30 June 2021 was a surplus of $5.107 million after taking into account depreciation and amortisation. This was an extremely positive result compared to budget, especially in a year of continuing challenges and change with COVID-19. The result reflects collective efforts across all VCS Foundation business units to continue our core programs and services and secure new business opportunities, all while adapting to our new model of working during the pandemic. Consistent with the prior year, VCS Foundation continued to benefit from the high-capacity molecular analytical capabilities of the VCS Pathology laboratory for the processing of SARS-CoV-2 tests, the causative virus of COVID-19. This was the major

driver for the increase in patient fees compared to 2019/20. At the end of the financial year, VCS Pathology had processed a collective total of 111,621 COVID-19 specimens from IPC Health screening clinics and drive though test sites across metropolitan Melbourne, demonstrating our continued commitment to the Victorian COVID-19 response. The organisation also secured new revenue for the VCS Pathology courier team in collections from the COVID-19 quarantine hotels. The 2020/21 year was the third full year of the Renewed National Cervical Screening Program and the final year of the Federal Government’s four-year Project Agreement commitment to VCS Pathology for laboratory screening services supporting Renewal. As forecast in modelling, the number of HPV primary screening tests undertaken in the year continued to decrease with the transition to the fiveyearly screening cycle. Approximately 122,000 HPV tests were reported in the financial year compared with just over

VCS FOUNDATION LTD. ABN 35 430 554 780

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VCS PATHOLOGY CONTINUED TO MAINTAIN ITS TARGETED MARKET SHARE FOR HPV TESTS, REPORTING ALMOST 50% OF ALL CERVICAL SCREENING TESTS IN VICTORIA.

175,000 tests in the previous year. While volumes are anticipated to increase in 2022/23, the expected low HPV volumes have enabled the laboratory to redirect its focus to COVID-19 testing in the interim. VCS Pathology continued to maintain its targeted market share for HPV tests, reporting almost 50% of all cervical screening tests in Victoria. Further, new investment into automated testing instrumentation has continued to improve productivity in the laboratory, also translating into salary cost savings. In comparison with 2019/20, expenditure on laboratory consumables increased by $2.348 million in the year, in line with our higher SARS-CoV-2 test volumes. Salary expenditure reflected both the end of the Immunisation Replacement Project with State Government and efficiencies gained with new laboratory rostering with the split workforce teams.

The organisation has continued to invest in ICT equipment to support flexible work arrangements during the pandemic. The Board of Directors approved a major capital investment project in early 2021 to refresh our ICT infrastructure and accommodate future growth. There was significant investment to update our VCS Pathology courier fleet for our ongoing cervical screening work and COVID-19 collections. The coming year ahead will see new capital investment into our laboratory screening rooms to increase the staff occupancy capacity with COVID-19 social distancing requirements. We have valued the financial support from both the Commonwealth and Victorian Governments which has enabled VCS Foundation to continue the delivery of service excellence across screening, vaccination and specialist laboratory services, consistent with our purpose. We also acknowledge

the support of the Audit and Finance Committee, the Executive and the finance team in completion of the 2020-21 financial statements during the restrictions of the pandemic.

Ms Fiona Kelly Chairman – Audit & Finance Committee Dr Michelle Critchley Director Corporate Services

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SNAPSHOT

SNAPSHOT OF OUR ACHIEVEMENTS This Annual Report showcases VCS Foundation’s major achievements in what was another significant year. Consistent with our new Strategic Plan 2020-2025, we have continued to support the Victorian Government, the Australian Government and countries in the Indo-Pacific region to work towards eliminating cervical cancer as a public health issue.

$AUD8.1 million when supported by additional funding and in-kind support from other partners will provide almost $30 million to enable C4 and in-country partners to set Papua New Guinea and Vanuatu on the path to eliminating cervical cancer. Read more… page 28

Read more… page 31

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EXECUTIVE TEAM

EXECUTIVE DIRECTOR Professor Marion Saville AM

MEDICAL DIRECTOR POPULATION HEALTH Professor Julia Brotherton

RESEARCH ASSISTANT Tracey McDermott

OPERATIONS DIRECTOR POPULATION HEALTH Genevieve Chappell

DIRECTOR CORPORATE SERVICES Dr Michelle Critchley

OPERATIONS MANAGER Tanya O’Farrell

FINANCE MANAGER Ronda Harrison

SENIOR HEALTH INFORMATION MANAGER Karen Peasley

ASSISTANT ACCOUNTANT Carmaleen Fernando

FOLLOW-UP MANAGER Floriana La Rocca

HR ADVISOR Jessy Warn PAYROLL OFFICER Sujane Choong

VCS FOUNDATION LTD. ABN 35 430 554 780

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VCS Foundation is a registered company limited by guarantee under the Corporations Act 2001 (Vic) and is governed by a Board of up to 11 Non-Executive Directors in accordance with the Constitution. The Executive Director of the Service is not a member of the Board but acts as Secretary. The Board establishes the organisation’s vision, strategic intent, goals and objectives, employs the Executive Director, identifies and monitors the management of corporate risks, and monitors and assesses the Executive Director and the performance of the organisation. There are eight Directors, including the Executive Director, that form the Executive Management Team.

DIRECTOR GLOBAL PROJECTS Krystyne Dillon

DIRECTOR MOLECULAR BIOLOGY Assoc Prof David Hawkes

DIRECTOR CYTOLOGY AND HISTOLOGY Grace Tan

DIRECTOR COMMUNICATIONS AND GOVERNMENT RELATIONS Kate Wilkinson

SOLUTIONS ARCHITECT Matthew Boler

CLINICAL MICROBIOLOGISTS Dr Hiu Tat Mark Chan Dr Linda Chew Dr Vincent Sinickas

PATHOLOGISTS Dr Kristy Dundas Dr Kais Kasem Dr Fong Koh Dr Yi Sun Dr Karen Talia

SENIOR PROJECT OFFICERS Kim Lee Lena Elkman

SENIOR BUSINESS ANALYST Kath Ryan SENIOR ANALYST PROGRAMMER Bhargav Patel SYSTEMS ADMINISTRATOR Simon Chapman

LIAISON PHYSICIANS Dr Alexis Butler Dr Wendy Pakes MOLECULAR SENIOR SCIENTISTS Ellen Ip Joanne Romano Marco Ho Ting Keung DATA INFORMATION MANAGER Sheree Holt

CYTOLOGY & HISTOLOGY SUPERVISOR Diana Stockman MULTIDISCIPLINARY SENIOR SCIENTISTS Domenica Giacomantonio Noni Christou QUALITY Robyn Bower Wen Lan (Jenny) Lou

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VCS FOUNDATION STRATEGIC PLAN 2020-2025

VCS FOUNDATION STRATEGIC PLAN 2020-2025 2020/21 represents the first year of reporting against the VCS Foundation Strategic Plan 2020-2025, developed by the VCS Foundation Board of Directors in consultation with the Executive Team.

Over the next five years, we will commit to assisting the Victorian Government, the Commonwealth and countries in the Indo-Pacific region to eliminate cervical cancer as a public health issue. We continue to support the National Bowel Cancer Screening Program and Victorian Immunisation Program through the delivery of our funded programs. We will build on laboratory service excellence by diversifying the range of VCS Pathology test capabilities.

"THE VICTORIAN DEPARTMENT OF HEALTH ACKNOWLEDGES THE SIGNIFICANT CHALLENGES PRESENTED IN 2019-20 DUE TO THE COVID-19 PANDEMIC AND APPRECIATE VCS FOUNDATION’S AGILITY, INNOVATION AND CONTINUED COMMITMENT TO IMPROVING THE HEALTH OF VICTORIANS." FROM DHV DESKTOP REVIEW

VCS FOUNDATION LTD. ABN 35 430 554 780

The Strategic Plan 2020-2025 has nine key objectives:

Our achievements in the 2020/21 year under Objectives 1 to 8 are outlined in this report.

PAGE 19

Support Victoria’s efforts to eliminate cervical cancer as a public health problem by a target date agreed with the DHS, in accordance with the Victorian Cancer Plan 2020-24.

Support Australia’s efforts to eliminate cervical cancer as a public health problem by 2035

ONE

Support countries in the Indo-Pacific region to scale up to meet the 2030 targets in support of the WHO strategy to eliminate cervical cancer as a public health problem

TWO

THREE

Lead and promote the increased uptake of HPV self-collection

Support the National Bowel Cancer Screening Program in Victoria

FOUR

FIVE

Deliver and disseminate the research outcomes of the Compass Trial, C4 and other policy relevant research

SIX

EIGHT

Leverage the value of the canSCREEN® and canVAX® platforms for cost effective support of Low to Middle Income Countries (LMICs) and for commercially advantageous opportunities

Diversify the range of VCS Pathology laboratory tests by leveraging our existing expertise and capital investment

SEVEN

Reshape the business model to adapt to our new commercial environment and global opportunities: + + + + +

New partnerships Expanded funding model Enhanced profile and reputation Optimised and flexible staffing profile Information and Communication Technology (ICT) support and services.

NINE

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VCS FOUNDATION STRATEGIC PLAN 2020-2025

ONE SUPPORT VICTORIA’S EFFORTS TO ELIMINATE CERVICAL CANCER AS A PUBLIC HEALTH PROBLEM, IN ACCORDANCE WITH THE VICTORIAN CANCER PLAN 2020-2024 VCS Foundation is a valued strategic partner to the Victorian Department of Health and delivers on immunisation functions and key initiatives under the Victorian Cancer Screening Framework. We provide leadership and expertise in cancer prevention and screening, including driving the elimination of cervical cancer; a key priority of the Victorian Cancer Plan 2020-2024.

VICTORIA’S CANCER SCREENING PRIMARY CARE AND WORKFORCE STRATEGY 2019-2022 The Liaison Physician team is supporting the Victorian Government’s Cancer Screening Primary Care and Workforce Strategy 2019-2022 by providing education and training sessions on the three cancer screening programs, cervical, breast and bowel. Face to face sessions were deferred due to the pandemic but have been replaced with webinar sessions. Live sessions of the VCS Foundation Cancer Screening Clinical Education, co-presented with Cancer Council Victoria and St Vincent’s Hospital

Beautiful Shawl breast screening initiative

Melbourne were delivered to the North-West Melbourne and Eastern Melbourne Public Health Networks. Those unable to attend could participate by requesting a recording and could still gain their CPD points. VCS Foundation has been working closely with the Victorian Aboriginal Community Controlled Health Organisation (VACCHO) to offer cervical screening education to Aboriginal Community Controlled Health Organisations (ACCHOs) and increase awareness of screening amongst Aboriginal communities. Amongst this work, VCS Liaison Physicians and our education team have participated in two Women’s Health Days at regional Victorian ACCHOs in March and April 2021 to promote cervical screening and self-collection (part of a year-long program of women’s health events for the Beautiful Shawl breast screening initiative). VCS Foundation and VACCHO have consulted widely with ACCHOs on updating our ‘How to take your own HPV sample’ instruction sheet so that it is culturally appropriate and appealing for Aboriginal and Torres Strait Islander women. This work is still in progress.

VCS FOUNDATION LTD. ABN 35 430 554 780

Genevieve Chappell, DIRECTOR OPERATIONS VCS POPULATION HEALTH

VCS Foundation commenced working in partnership with Cancer Council Victoria to develop a Gender Inclusive Language Guide for cervical screening in Victoria. The purpose is to ensure transgender men with a cervix (an under-screened group) are explicitly included in education and information resources for healthcare practitioners and consumers to: a) prompt healthcare practitioners to offer screening to this cohort, and b) increase the awareness and engagement of this cohort in cervical screening. These activities and resources are expected to be released in the second half of 2021. VCS Foundation, Cancer Council Victoria and Healthily have partnered to develop a series of videos featuring cervical screening participants from diverse cultural backgrounds talking about their experiences of screening, colposcopy and a diagnosis of cervical cancer. These will be available on the Go Share platform for healthcare practitioners to view and share with patients. The videos aim to encourage screening participation amongst those who are reluctant or fearful of having a cervical screening test.

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With its 30-year background in data management, reporting and registry services, VCS Population Health is providing its expertise to support the Victorian Cancer Screening Framework and to lead the Data and Surveillance Working Group with the aim of improving surveillance of the effectiveness and outcomes of the breast, bowel and cervical screening programs in Victoria through an integrated and consistent approach to data collection, use and reporting.

DATA AND REPORTING TOOLS FOR CERVICAL, BOWEL AND BREAST SCREENING PROGRAMS, IN PARTNERSHIP WITH VICTORIAN SCREENING PARTNERS In May 2019, the Victorian Department of Health endorsed a Victorian Cancer Screening Framework, a new governance and funding model for Victoria’s cervical, breast and bowel screening programs. A three-year strategy and annual activity plan has been developed by the Victorian Cancer Screening Steering Committee which consist of members from the Victorian Department of Health, VCS Foundation, BreastScreen Victoria, Cancer Council Victoria and the Victorian Aboriginal Community Controlled Health Organisation. The Committee is working together to reach the annual goals and implement the overall strategy. The Victorian Department of Health and the Victorian Cancer Screening Committee have identified the need for a more integrated approach to cancer screening data and surveillance in Victoria for ensuring that screening program partners can better utilise combined screening data to deliver screening system improvements and drive equitable outcomes. The Victorian Cancer Screening Framework Data Dashboard provides a snapshot of key data from the Bowel, Breast and Cervical Screening Programs to screening program partners. The Dashboard includes data on invitations,

screening numbers, participation, cervical self-collection, time to colposcopy and time to colonoscopy. Data is grouped and presented in a series of tabs containing tables and charts, stratified by parameters such as time period, Aboriginal and Torres Strait islander status, age group, targeted initiatives and geographical area. The Strategy will ensure timely, accurate and rich data is available to the Department, cancer screening agencies, health service providers, researchers and other stakeholders to: + Inform cancer screening service planning at the local, regional and state level + Develop and evaluate initiatives to improve screening program participation, access and performance + Identify under-screened groups and monitor their participation rates, and + Support research and evaluation to improve Victorians’ cancer outcomes. The key objectives of the Cancer Screening Data and Surveillance Strategy are to: + Ensure access to timely and accurate data to support service planning and program delivery across each program’s cancer screening pathway + Utilise data to establish and monitor baseline participation rates and improvements in screening participation outcomes, and + Develop consistency and integration across cancer screening datasets.

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VCS FOUNDATION STRATEGIC PLAN 2020-2025

BOWEL/BREAST AND CERVICAL SCREENING BY AGE 2018

160,000

2019

2020

2021 YTD Example of report from the Cancer Screening Data Dashboard

140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 50-59 60-69 70-74 50-59 60-69 70-74 25-29 30-39 40-49 50-59 60-69 70-74

Bowel

Breast

VCS Population Health, in collaboration with all screening partners, has made significant progress on the establishment activities for 2020/21. Key achievements include: + A three-phase environment mapping exercise of the cancer screening data and reporting environment relating to the Bowel, Breast and Cervical screening programs. The environment mapping exercise provided insights into the data and reports used (Phase 1), data elements collected (Phase 2) and the data and reporting capability (Phase 3) of screening partners to support the delivery of cancer screening in Victoria including activities of the cancer screening framework. The environment scanning project involved accessing publicly available material, seeking input from program partners, undertaking desk-based research, and conducting questionnaires. Findings identified data gaps and inconsistencies, areas of strengths and excellence and future opportunities. + A Cancer Screening Data Dashboard to support the work of the Victorian Cancer Screening Framework Steering Committee. The Data Dashboard, delivered quarterly, displays key data from the Bowel, Breast and Cervical Screening Programs, providing an at-a-glance view of key metrics, trends over time and a focus on priority areas.

Cervical

The Data Dashboard includes data relating to invitations, screening numbers, participation, selfcollection, time to colonoscopy and colposcopy and targeted initiatives. + The delivery of more than twenty reports for the Bowel, Breast and Cervical screening programs. The reports provide detailed data relating to program participation, number of screens, number of bowel kits returned and invitations sent delivered via a series of tables and charts typically stratified by time (month, quarter, year), gender, geography (postcode, LGA, PHN, Health Region), Aboriginal and Torres Strait Islander status, country of birth, language spoken at home, socio-economic status and remoteness.

WORKFORCE EDUCATION AND INCREASE REACH THROUGH AN ONLINE EDUCATION AND TRAINING MODEL The VCS Foundation Liaison Physicians provide free accredited medical education and training to general practitioners, nurses, obstetriciangynaecologist (O&G) specialists, general practitioner and O&G registrars, international medical graduates and overseas trained doctors and Aboriginal health workers each of whom play important roles in promoting and undertaking screening pathways. The training aims to advance medical practitioner skills and confidence, ensuring clinical decision-making aligns with the National Cervical Screening Program. In addition to mainstream general practice, clinical training is delivered across a diversity of clinical settings including rural, remote, regional and community health services, and Aboriginal and Torres Strait Islander health services. Our Liaison Physicians are focused on education around self-collection and are working in partnership with Cancer Council Victoria to actively promote self-collection in Victoria. We know that by advancing local care providers’ knowledge and skills in early detection, we will greatly increase participation in cervical screening.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 23

'JUST WISH TO FEEDBACK THE EXCELLENT SERVICE YOU OFFER IN TERMS OF ANSWERING QUESTIONS REGARDING CST RESULTS & HPV. RAPID, THOROUGH & EXPERT INFORMATION MADE READILY AVAILABLE. VERY FEW SERVICES LIKE IT - THANKYOU'. DR SAMANTHA HARGREAVES, OBSTETRICIAN-GYNAECOLOGIST

The Liaison team manage approximately 63 phone calls a week, predominantly from clinicians across Victoria, seeking information about the current screening guidelines and management of patients. Queries covered include: + HPV and its role in cervical cancer + Sampling techniques and the new Cervical Screening Test (CST) + Key practical implications of the renewed NCSP for clinical practice and women + Applying management recommendations from the new Guidelines (2016) + Co testing and investigation of abnormal vaginal bleeding + Interpreting and explaining results to patients + Accessing and activating the selfcollection pathway. Accredited on-line education and clinical audit activities have been developed and made accessible to health care workers across the country. These activities provide current information on guidelines and screening pathways whilst giving Healthcare providers the opportunity to gain continuing professional development points.

SUPPORTING INDEPENDENCE IN NURSE CERVICAL SCREENING PROVIDERS VCS Foundation has always recognised that nurses play an essential role in the National Cervical Screening Program, particularly in providing screening services for under-screened groups. We have been very fortunate to support the independent practice of Nurse Cervical Screening Providers in Victoria. VCS Pathology receives approximately 13,000 cervical screening tests from Nurse Cervical Cancer Screening Providers each year. In the 2021/22 financial year the funding model for VCS Foundation will change to align VCS Pathology with all other Commonwealth funded laboratories across Australia. This change will require Nurse Cervical Screening Providers to have request forms for cervical screening countersigned by a

practitioner with a Medicare Provider number. This change will negatively impact cervical screening locations where nurses are working in mobile or remote locations where there is no general practitioner on site. Over the medium term, VCS Foundation will be working collectively to raise this issue at a national level with the aim of seeking a solution to enable Australian certified nurses to practise cervical screening independently in the future. This will be supported by information sessions to nurses and the collection of feedback through surveys to gather data on the impact this change will have on the national program, particularly in under-screened communities. Whilst a solution is being sought, VCS Pathology will absorb the costs of tests taken by nurses who cannot arrange for a general practitioner or nurse practitioner colleague to co-sign their cervical screening test request forms.

PAGE 24

VCS FOUNDATION STRATEGIC PLAN 2020-2025

TWO SUPPORT AUSTRALIA’S EFFORTS TO ELIMINATE CERVICAL CANCER AS A PUBLIC HEALTH PROBLEM BY 2035

It is estimated that cervical cancer is likely to be eliminated as a public health problem (incidence <4 per 100,0000) in Australia by 2035, as the achievements of our previous cytology-based screening program, impacts of HPV vaccination and effect of the current HPV-based cervical screening program are realised. Challenges remain however, in ensuring elimination is achieved equitably and that its achievement and maintenance are not undermined by falls in participation in vaccination or screening. As described in the 2021 C4 CRE Monitoring Report (section 6), lower participation rates in cervical screening occur in rural and remote Australia, in areas of socio-economic disadvantage, amongst culturally and linguistically diverse groups of women, and also in Indigenous women. Aboriginal and Torres Strait Islander women continue to carry an inequitable burden of cervical cancer with incidence and mortality rates two and nearly four times higher than other Australians, respectively. HPV vaccination completion rates are also lower amongst Aboriginal and Torres Strait Islander students and those living in remote areas. Whether there is equity in access to and timeliness of treatment for cervical pre cancer and cancer is also currently unknown.

SUPPORTING EQUITY IN ELIMINATION VCS Foundation is committed to practically supporting equity across cervical cancer prevention initiatives and we do this is in the way we work, through our partnerships and advocacy, and providing policy relevant research and evaluation to support best practice. For example, we know that many people face challenges to screening because they may feel unsafe or unsupported to request a cervical screening test from their health care practitioner, may be people living with a disability who experience difficulty accessing suitable screening services, or have experienced trauma and are fearful of or distressed by cervical screening. VCS Foundation led program initiatives such as selfcollection and telehealth consultations will be an alternative pathway in Australia that can help to overcome such barriers to having a clinician-collected cervical screening test. These initiatives, as well as membership of government working parties and successful delivery of contracted tenders and research to support implementation, mean that VCS Foundation is providing our expertise and advocacy to support the likely policy transition to universally available self-collection. We also passionately believe that no person, and no groups of people, should be left behind as Australia pursues elimination. Our partnerships with leading Indigenous researchers and communities are about ensuring we play our part in closing the gap in cervical

cancer burden for Aboriginal and Torres Strait Islander people. Two examples of our work in this important area are:

Yarning about HPV Vaccination: a qualitative study of factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in Australia This project is part of the TACTICS NHMRC Centre for Research Excellence, in which Professor Julia Brotherton co-leads the vaccination and screening stream with A/Prof Lisa Whop from the National Centre for Epidemiology and Population Health, Australian National University. The study is seeking to identify the factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in Australia. The project is a critical step in addressing the burden of cervical cancer among Aboriginal and Torres Strait Islander women. Equitable access to primary prevention through HPV vaccination has the potential to reduce disparities in cervical cancer outcomes for Aboriginal and Torres Strait Islander women in Australia. Refer to the publication – Whop LJ, Butler TL, Brotherton JML, et al Study protocol: Yarning about HPV Vaccination: a qualitative study of factors influencing HPV vaccination among Aboriginal and Torres Strait Islander adolescents in AustraliaBMJ Open 2021;11:e047890. doi: 10.1136/ bmjopen-2020-047890

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 25

VCS FOUNDATION IS COMMITTED TO PRACTICALLY SUPPORTING EQUITY ACROSS CERVICAL CANCER PREVENTION INITIATIVES AND WE DO THIS IS IN THE WAY WE WORK, THROUGH OUR PARTNERSHIPS AND ADVOCACY, AND PROVIDING POLICY RELEVANT RESEARCH AND EVALUATION TO SUPPORT BEST PRACTICE.

PAGE 26

VCS FOUNDATION STRATEGIC PLAN 2020-2025

PREVENT Study VCS Foundation is collaborating in the Australian Department of Health Indigenous Australians’ Health Programme Emerging Priorities funded PREVENT Project. This research project is investigating the acceptability and implementation of point of care HPV self-collection in rural and remote communities. Led by Aime Powell, University of Notre Dame, this grant-funded project will introduce point-of-care HPV testing which utilises self-collection and same day follow-up testing in the Kimberly Region of Western Australia. VCS Foundation is assisting with the study design, analysis and project evaluation. We are also supporting HPV testing including provision of the point-of-care device, training, education and evaluation.

Progress research, evaluation and policy initiatives supporting elimination through the C4 CRE and other research partnerships VCS Foundation is a key partner of Australia’s National Health and Medical Research Council (NHMRC) funded Centre of Research Excellence (CRE) in Cervical Cancer Control. The Centre for Research Excellence in Cervical Cancer Control, known as C4, was established in late 2017 following its awarding by the NHMRC, to bring together cervical cancer prevention experts to undertake research and evaluation of HPV vaccination and screening programs. The work of C4 will ensure the future of cervical cancer prevention is underpinned by world-class research that can reduce the global impact of the disease. The core group consists

of researchers from the Cancer Council NSW, VCS Foundation, the University of Melbourne and the Kirby Institute with combined expertise in epidemiology, public health, laboratory testing, clinical trial implementation, predictive modelling and economic evaluation. Our associate investigators bring additional expertise and perspectives from a range of organisations. For details of our full team, please visit the C4 website at www.cervicalcancercontrol.org.au C4 focuses on: + Evaluating the effectiveness of next generation primary HPV screening and HPV vaccination approach + Developing better tools for monitoring HPV and for predicting abnormalities + Assessing the impact of the HPV vaccination program in Australia, and + Global aspects of cervical cancer control.

VCS FOUNDATION IS A KEY PARTNER OF AUSTRALIA’S NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL (NHMRC) FUNDED CENTRE OF RESEARCH EXCELLENCE (CRE) IN CERVICAL CANCER CONTROL (C4). THE WORK OF C4 WILL ENSURE THE FUTURE OF CERVICAL CANCER PREVENTION IS UNDERPINNED BY WORLD-CLASS RESEARCH THAT CAN REDUCE THE GLOBAL IMPACT OF THE DISEASE.

VCS FOUNDATION LTD. ABN 35 430 554 780

Within C4, we run Australia’s largest clinical trial, Compass, which is providing world-first evidence on the interaction between HPV vaccination and screening. C4 is supporting the WHO strategy for cervical cancer elimination as a public health problem, with contribution of our expertise to multiple areas of research and implementation activity to ensure that this strategy becomes a reality in Australia, our region and beyond. Our key contributions include: + Modelling work to inform the elimination strategy

Within the CRE, VCS Foundation is actively engaged in Australian policy relevant research including the following projects: + STORIES interview study documenting the perceptions of key stakeholders around the implementation of Renewal. + Piloting of a cervical cancer HPV typing system for Australia + VCA funded trial of a universal access to self-collection policy in Victorian practices

+ Membership of WHO expert advisory groups

+ VCA funded study on Improving the benefits of the renewal of the National Cervical Screening Program for Victorian Aboriginal women

+ Working locally with government and key stakeholders to inform strategies for monitoring progress and achieving elimination in Australia

+ Comparison of HPV surveillance approaches using routine screening HPV assay data compared with genotyping using Linear Array.

+ Working regionally with governments and key stakeholders to inform strategies for scale up to meet the WHO strategy targets, and + Developing partnerships and grant applications for the undertaking of implementation research to inform scale up for elimination in our region.

PAGE 27

Establish a pathology advisory service as part of being the Australian HPV Reference Laboratory, supporting validation of novel and affordable HPV tests, particularly point of care tests VCS Foundation is poised to launch its expertise as the Australian HPV Reference Laboratory. Our capacity includes: + Expertise and laboratory services for the evaluation of HPV detection in biological specimens including activities that build capacity + Provision of standardised up-to-date technical information, technical advice, guidance and training on HPV laboratory practices and quality assurance, and + Provision of testing services linked to the development and use of international standard reagents and operating procedures in laboratory HPV testing. Announcements on this new business will be included in the 2021/22 Annual Report.

PAGE 28

VCS FOUNDATION STRATEGIC PLAN 2020-2025

THREE SUPPORT COUNTRIES IN THE INDO-PACIFIC REGION TO SCALE UP TO MEET THE 2030 TARGETS IN SUPPORT OF THE WHO STRATEGY TO ELIMINATE CERVICAL CANCER AS A PUBLIC HEALTH PROBLEM

THE COVID-19 PANDEMIC IS GOING TO HAMPER GLOBAL EFFORTS TO MAKE HPV VACCINATION AND HPV-BASED SCREENING AVAILABLE TO ALL GIRLS AND WOMEN

WE HAVE TO FIND INNOVATIVE WAYS TO OVERCOME THIS NEW CHALLENGE

SELF-COLLECTED SAMPLES RAPID POINT OF CARE TESTING AND SAME DAY TREATMENT WILL BE CRUCIAL TO PROVIDE SAFE AND COSTEFFECTIVE SCREENING FOR WOMEN LIVING IN REMOTE COMMUNITIES

VCS FOUNDATION LTD. ABN 35 430 554 780

On 17 November 2020, following the close of the 73rd World Health Assembly, the World Health Organization officially launched the Global Strategy to Accelerate the Elimination of Cervical Cancer. The adoption of the strategy was co-led by Australia, which has a history of global leadership in cervical cancer prevention programs, technology and research. The HPV vaccine was developed at the University of Queensland by Professor Ian Frazer and the late Dr Jian Zhou, and in 2007 Australia introduced the world’s first nationwide HPV vaccination program. VCS Foundation is committed to support the Australian Government by identifying less well-resourced countries to scale up HPV vaccination and cervical screening. Using our expertise in laboratory, screening and registry services, VCS Foundation can offer solutions that are acceptable to and suitable for local populations and health systems.

MINDEROO PROJECT – A LANDMARK CERVICAL CANCER ELIMINATION PROGRAM IN THE WESTERN PACIFIC, PAPUA NEW GUINEA The Minderoo Foundation together with NHMRC Centre of Research Excellence in Cervical Cancer Control (C4) announced a first-of-its-kind humanitarian and research effort to eliminate cervical cancer in the Western Pacific at the Preventing Cervical Cancer Conference in March 2021. The Western

Pacific has among the highest rates of cervical cancer in the world, and there are an estimated 1,200 deaths in PNG alone every year. Human papillomavirus, or HPV, causes almost all cervical cancers worldwide. HPV infection and disease can be prevented by childhood vaccination, whilst screening women for HPV infection in adult life is highly effective in detecting early disease and preventing cervical cancer. Minderoo Foundation’s conditional grant of AU$8.1 million – when supported by additional funding and in-kind support from other partners – will provide almost $30 million to enable C4 and in-country partners to set Papua New Guinea and Vanuatu on the path to eliminating cervical cancer. The project aligns to the World Health Organization (WHO) strategy to eliminate cervical cancer worldwide by the end of the century, through a ‘triple-intervention’ approach for scale up of vaccination, screening and treatment (the 90/70/90 targets), which sets out three simple targets to place all countries on the path toward elimination by 2030: Within C4, this initiative has been led by Professor Karen Canfell, Director of Cancer Research at Cancer Council NSW; Professor Marion Saville, Executive Director, VCS Foundation; Professor Andrew Vallely, Kirby Institute UNSW Sydney and PNG Institute of Medical Research, Goroka; and Professor Deborah Bateson, Medical Director, Family Planning NSW. The project will put the WHO eliminate cervical cancer concept into practice, leading the world to show how the triple-

Caroline Henao, a cervical cancer survivor, patient advocate and Board Member of the Papua New Guinea Cancer Foundation, said the new initiative would deliver real change in women’s lives. “It would do so much in empowering women to have screening and to know that there is a way forward for them,” she said. “It would also encourage them to know this disease isn't a death sentence but very much curable if detected early.”

PAGE 29

intervention strategy of HPV vaccination, HPV-based screening and cancer treatment can be introduced into a priority region. It will create a sustainable framework for attracting additional partners and will act as a catalyst for cervical cancer elimination globally. VCS Foundation, as a lead member of C4, is proud to provide scientific, population health and digital health expertise and technology using the canSCREEN® population health management platform for this initiative. Partners will work with health officials in PNG and Vanuatu, leveraging opportunities to: + Build and prioritise existing health services + Fast-track HPV vaccines for girls and cervical screening for women in PNG and Vanuatu and deliver training and equipment to build healthcare capacity + The Australian research arm will conduct modelling and analysis to inform the most efficient and effective ways to implement and then expand the initiative, and + The Eliminate Cervical Cancer in the Western Pacific project will be core to a range of active and emerging regional and local partnerships in the Western Pacific region, which will be essential to achieving cervical cancer elimination worldwide.

PAGE 30

VCS FOUNDATION STRATEGIC PLAN 2020-2025

GLOBAL ALLIANCE FOR CHRONIC DISEASES (GACD) FUNDED PROJECTS India VCS Foundation is leading a project to implement self-collected HPV-based cervical cancer screening in vulnerable populations in urban and rural India. Funded through the GACD and the National Health and Medical Research Council (NHMRC), VCS Foundation was awarded a $1.33 million grant for a three-year research project implementing cervical cancer screening in hard-to-reach and vulnerable Indian communities. India is the world’s second most populous nation where the burden of cervical cancer is high, at one-fifth of the total global burden. This equates to 60,000 Indian women dying from cervical cancer every year.

Professor Julia Brotherton is leading the implementation research project with partners in two states of India, Tamil Nadu in Southern India and Mizoram in North-eastern India, along with experts on cancer and disease prevention from the International Agency for Research on Cancer, the Baker Heart and Diabetes Institute and RTI International.

Papua New Guinea Building on previous collaborative and world-leading research supporting the use of HPV-based screen and treat for screening, Professor Andrew Vallely from the Kirby Institute at UNSW Sydney is leading a project on HPV testing and treatment for the elimination of cervical cancer in rural and remote Papua New Guinea. This $1.59 million project is complementary to the Minderoo project and is being conducted in collaboration with VCS Foundation (investigators

Professor Marion Saville and Professor Julia Brotherton), Cancer Council NSW, Family Planning NSW, and the NHMRC Centre of Research Excellence in Cervical Cancer Control (C4), and in-country partners and stakeholders in PNG. VCS Foundation will support the project with our canSCREEN® registry platform plus our laboratory, epidemiological and screening expertise. The project will utilise the novel ‘test and treat’ screening model developed by our collaborative research team, comprising HPV testing of self-collected vaginal specimens followed by same-day treatment using a new battery operated, portable thermal ablation device. This approach proved highly effective, acceptable and cost-effective in previous field trials. The team will now establish how best to reach women in rural and remote communities, where cervical pre-cancer and cancer rates are highest, access to health services most constrained, and the most at-risk women in PNG and other high-burden, low-resource countries live.

NHMRC and GACD funded project in Jawadhi Hills, India. From left to right: Mrs Indrani, Mrs Kavitha, Mrs Revathi (tribal health worker), Mrs Mala (tribal diploma nurse)

Professor Julia Brotherton, MEDICAL DIRECTOR VCS POPULATION HEALTH

‘In a country as complex and large as India, we know there are significant challenges in scaling up preventive health services, particularly in rural and remote areas serving vulnerable Indian women. Cervical cancer is preventable and this research will play a critical role in identifying the key challenges in reaching women to screen, as well as supporting their follow up when treatment is needed.’

VCS FOUNDATION LTD. ABN 35 430 554 780

PROJECT ECHO: WORKING TOGETHER TO SHARE KNOWLEDGE AND EMERGING SOLUTIONS TO MEET ELIMINATION SCALE-UP TARGETS FOR ALL WOMEN IN OUR REGION Project ECHO (Extension for Community Healthcare Outcomes) is a movement to share knowledge and amplify local capacity to provide best practice care for people all over the world. We utilise the ECHO model™ to provide peer-to-peer and expert support to multi-sectorial country teams in the Indo-Pacific answering the WHO call to scale up cervical cancer prevention to eliminate cervical cancer as a public health problem (<4 per 100,000). The SUCCESS (Scale Up for Cervical Cancer Elimination Strategy Success) in the Indo-Pacific ECHO aims to provide ongoing, monthly consultations with practitioners seeking and contributing peer advice and expert input regarding the challenges faced when scaling up to reach the 2030 goals. In establishing the SUCCESS ECHO, we invited and expanded upon the existing community of practice established by the US National

Cancer Institute (NCI) in its 2017-18 APEC cervical cancer prevention ECHO. Using ZOOM, we hold a monthly tele-mentoring session to provide a sustained exchange opportunity with the motto ‘All teach, all learn’. Over 90 minutes, following a short didactic from an expert with discussion, participating country teams, including both WPRO and SEARO WHO region countries, present case studies from their program or scale up projects for feedback and ideas from regional colleagues and international experts. Monthly session themes alternate between the three elimination pillars of screening, treatment and vaccination. Over 230 colleagues from across the region and beyond are signed up to SUCCESS, with 22 sessions held to date. Attendance has been high despite COVID-19, ranging from 18 to 75 participants per session, with an average of 33 attendees per session. Participants are from at least 35 countries and include clinicians, researchers, Ministry of Health staff and NGOs. SUCCESS ECHO is supporting shared learning in relation to elimination and building ongoing networks and collaborations between participants.

PARTICIPATING COUNTRIES

PAGE 31

NO OF ATTENDEES

India

Myanmar

Malaysia

Sri Lanka

Taiwan

Australia

USA

Papua New Guinea

Palau

New Zealand

Brunei

Switzerland (Geneva)

China

Japan

Singapore

Viet Nam

Unknown

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Philippines

British Columbia

Nepal

Thailand

Botswana

Cambodia

Cook Islands

England

Fiji Islands

France

Germany

Hong Kong

Indonesia

Kenya

Maldives

Samoa

Spain

Sweden

PAGE 32

VCS FOUNDATION STRATEGIC PLAN 2020-2025

FOUR LEAD AND PROMOTE THE INCREASED UPTAKE OF SELF-SAMPLING Under the current National Cervical Screening Program (NCSP), most people who participate in cervical screening need to have a sample taken by a doctor or nurse using a speculum. Only people who are overdue or who have never been screened have the option of a self-collected sample. International research published since the shift to HPV testing has shown that self-collection is as accurate as a sample taken by a clinician for anyone participating in the NCSP. VCS Pathology was the first pathology service in Victoria accredited to process self-collected HPV tests, making this test available to eligible participants across the country. VCS Foundation

recognised the need for self-collection testing in 2017 and has NATA approved systems and assays already in place to manage testing. Communications are also available to clinicians to encourage eligible participants to engage in screening. Recent study findings have found that the cross-sectional sensitivity of Polymerase Chain Reaction (PCR)based HPV DNA testing is similar for practitioner or self-collected samples (pooled ratio for detecting cervical intraepithelial neoplasia grade 2 or worse: 0.99; 95% confidence interval, 0.97–1.02). Considering this evidence, the NCSP self-collection policy has been reviewed by government, and the Medical Services Advisory Committee recently supported offering all screen eligible people the choice of providing self-collected vaginal or cliniciancollected cervical samples, access in both cases being mediated by a health care provider.

SELF COLLECTED HPV TESTS PROCESSED BY VCS PATHOLOGY (all national referrals) 300 250 200

VCS Foundation is actively participating in research and committees supporting self-collection policy development and adoption in never and under-screened Australian women. This includes the Australian Government Department of Health: National Cervical Screening Program “Self-Collection Expert Advisory Group”. The use of the self-collection test in the Australian National Cervical Screening Program is a relatively new model of care which will make a significant improvement to equity in cervical screening in Australia. It is reaching never and under-screened populations who are reluctant to have a conventional screening test, that required a pelvic examination and insertion of a speculum by a health professional, by providing a safe and effective alternative which puts the participant in control. Self-collection was identified in the Victorian Cancer Plan as a new model for cancer

VCS PATHOLOGY WAS THE FIRST PATHOLOGY SERVICE IN VICTORIA ACCREDITED TO PROCESS SELF-COLLECTED HPV TESTS

150 100 50 0 Jun-21

May-21

Apr-21

Mar-21

Feb-21

Jan-21

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Oct-20

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Aug-20

Jul-20

SELF-COLLECTION IS EQUALLY AS SENSITIVE FOR THE DETECTION OF CIN2+/AIS AND HPV AS A PRACTITIONER-COLLECTED CST

VCS FOUNDATION LTD. ABN 35 430 554 780

INSTRUCTIONS

HOW TO SELF COLLECT AN HPV TEST Simply follow the step-by-step instructions below:

WHAT DOES THE KIT CONTAIN? A Viba-Brush in a plastic packet Handle

A MODEL OF SELF-COLLECTION FOR USE BY REFERRING PRACTITIONERS IN TELEHEALTH In April 2021, the Medical Services Advisory Committee concluded that the diagnostic performance of HPV testing is not materially different between self-collected samples and cliniciancollected samples. During the COVID-19 pandemic, there has been a strict restriction of movement within the community to protect the health of Victorians. Even though people were able to and encouraged to visit their general practitioner for medical care, VCS Foundation observed a corresponding steep decline in cervical screening activity during Victoria’s lockdown periods, down to as low as 30% of expected volumes. To facilitate screening during the pandemic, VCS Foundation is assisting clinicians to encourage and support under-screened

This initiative empowers screening participants to collect a HPV sample in the privacy of their own home without needing to visit a clinic, and with the support of their health care practitioner. VCS Foundation receives the test request from the clinician, checks the patient’s eligibility for self-collection on the National Cancer Screening Register, then posts a self-sampling kit with instructions to the patient’s preferred address. Home-based screening is expected to be extremely well accepted and welcomed by a range of under-screened cohorts, including groups that the National Cervical Screening Program may never have reached before. For example, transgender men who may feel unsafe or unsupported to request a cervical screening test from their health care practitioner, people with disabilities who may experience difficulty accessing suitable screening services, and patients

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PACKAGING:

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and Address)

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PUT LID ON:

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* This image is adapted from Garrow SC et al. The diagnosis of chlamydia, gonorrhoea, and trichomonas infections by self-obtained • remote Check thatAustralian the details on your low vaginal swabs in northern clinical practice. Sexform Transmand Infect. 2002 Aug; 78 (4):278-81

the plastic tube are correct.

• Ensure that you sign the form and record the date of collection as marked above. • Your sample does not require refrigeration. Just keep at room temperature

• If possible, avoid taking the sample during your monthly period

PUT BRUSH IN THE REMOVER:

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be posted as soon as possible, preferably within 24 hours of collection

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The Commonwealth Government’s expansion of the Medicare Benefits Scheme (MBS) telehealth items in response to the pandemic opened an opportunity to support clinicians to offer this very safe cervical screening service model. Primary care clinics can proactively identify under or never-screened patients in their patient database and reach out to offer home-based cervical screening.

INSTRUCTIONS

Simply follow the step-by-step instructions below: A ReMover plastic container and lid

ancer/Screen

VCS Pathology has reported close to 2,000 self-collected HPV tests in the financial year and has updated its laboratory operations and processes in anticipation of increased volumes in 2022 when the test becomes available to all screening participants aged 25-74 through the Program.

HOW TO PACK & POST THE SAMPLE

Brush

Name

patients to participate in cervical screening, by offering to send home self-sampling kits to patients who are identified as never or under-screened during a telehealth consultation.

DOB

prevention. A specific priority in the Plan is to encourage an additional 10,000 under-screened Victorians to have a cervical screen through the selfcollection pathway by 2024.

PAGE 33

IF YOU REQUIRE A REPLACEMENT KIT, OR FOR MORE INFORMATION CONTACT VCS PATHOLOGY

POST: • Deposit the reply paid envelope into an Australia Post mail box preferably within 24 hours of collection

ON PH: 03 9250 0300

• Your sample must be tested within 28 days of collection. >> Instructions overleaf on how to take a vaginal swab - DO THIS FIRST...

who have experienced trauma and are fearful of or distressed by cervical screening. The initiative has been met with enthusiasm by our cancer screening partners, including the Victorian Department of Health, Cancer Council Victoria and the Victorian Aboriginal Community Controlled Health Organisation. The Victorian Department of Health recently funded VCS Foundation and Cancer Council Victoria to jointly develop and implement a public relations strategy in 2021 targeting healthcare practitioners and consumers to increase awareness about self-collection with the aim to increase self-collection test volumes. A key barrier in cervical cancer screening participation will be removed from 1 July 2022. The Australian Minister for Health has accepted a recommendation from the Medical Services Advisory Committee (MSAC) to provide all eligible Australians with the choice to take their own cervical screening sample if they prefer not to have a speculum examination.

RESEARCH Acceptance of the clinician-supported self-collection pathway among practitioners and participants was unknown. VCS Foundation in collaboration with the University of Melbourne developed a Victorian Department of Health funded study to evaluate the implementation and acceptability of the self-collection cervical screening pathway since commencement of the renewed National Cervical Screening Program from the perspectives of screening participants and primary care practitioners. The research found high acceptability of self-collection to most providers and participants in the pathway but that increasing the accessibility of the self-collection pathway to under-and never screened women could reduce inequities in cervical cancer outcomes for those not participating in the main screening pathway. Practitioners should be provided resources to integrate self-collection into routine practice and to efficiently implement the entire self-collection pathway, to maximise its use and to optimise the experience for screening participants. Creagh, N.S., Zammit, C., Brotherton, J.M., Saville, M., McDermott, T., Nightingale, C. and Kelaher, M. (2021), Self-collection cervical screening in the renewed National Cervical Screening Program: a qualitative study. Med J Aust, 215: 354-358. https://doi.org/10.5694/mja2.51137

PAGE 34

VCS FOUNDATION STRATEGIC PLAN 2020-2025

TELEHEALTH HOME SELF-COLLECTION Home self-sampling kits can be delivered to under and neverscreened patients following telehealth consultation. This initiative aims to ensure under-screened groups are not disproportionately affected by the Victorian lockdown restrictions during the COVID-19 pandemic.

“We are offering a process that’s embedded in primary care, it has to be requested after a telehealth consult with your GP who has to determine that you are eligible for self-collection.”

HPV SELF-COLLECTION CLINICAL AUDIT

Audit Overview

The audit is a five-step process to identify under-screened patients, HPV self-collection can help eliminate INSTRUCTIONS apply the National Cervical Screening cervical cancer by reaching people who HOW TO SELF COLLECT AN HPV TEST Program guidelines to determine have never screened or are overdue eligibility for HPV self-collection and for screening. GPs and Nurse Cervical Simply follow the step-by-step instructions below: appropriate follow up, collect data Screening Providers will play a pivotal to reflect on learnings and identify * role in endorsing cervical screening WHAT DOES THE KIT CONTAIN? practice barriers, and develop quality participation and offering self-collection. • A swab in a plastic tube • A plastic ziplock bag improvement. VCS Foundation developed the • This instruction sheet • The request form provided by your health Royal Australian College of General professional Practitioners’ accredited HPV Self• A padded ‘Reply paid’ envelope Collection Clinical Audit to assist GPs SWAB: and Nurse Cervical Screening Providers POSITION: • Undress from the waist down • to Remove the swab out of its plastic tube, identify under-screened patients just twist and pull it • Get into a comfortable position as shown self-collection, encourage above while holding the swab in your hand • eligible If possible,for avoid taking the sample during your monthly period screening to patients, routine cervical and provide resources and tools for quality improvement. PATI

TAKING THE SAMPLE:

TAKING THE SAMPLE (continued):

RETURN TO PLASTIC TUBE:

• Gently spread open the folds of skin at the vaginal opening with your other hand

• Rotate the swab gently for 10-30 seconds

•

Place the swab into the plastic tube

• There should be no pain or discomfort

•

Tightly screw the cap onto the tube

•

Finish by washing your hands with soap and water

265 Faraday PO Box 178 St Carlton South P: 03 9250 Carlton South VIC VIC 3053 0300 F: 03 3053 9349 1949

Patient Surname

MEDICARE

CARD NUMBER

Given Names

Patient Address

PATHOL

Gender

Date of Birth

*Ref: wiki.cancer.org.a

Emergency Contact Numbers: Business hours: (03) 9250 0300 After hours: 0427 308 373

u/australia/Guide

lines:Cervical_ca

ncer/Screening

Is the patient Torres Strait of Aboriginal or Islander origin?

In which country

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to My Health

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COPY REPORTS

was the patient

(Complete

Medicare Assignment)

Yes

(specify)

Normal

Abnormal

Specimen

(specify)

site

Cervix

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Other

st partum

(specify)

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Requesting

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Date

Name

DOB

Patient’s Signature

Patient Ad dress

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a private or approved day hospital hospital Private patient in a recognised hospital A public patient in a recognised hospital Outpatient of a recognised hospital

Name

Date

Name

DOB

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NUMBER

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MEDICARE

practitioner

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right to benefits 1973). who will render to the approved pathology the requested pathology service(s)

Yes No

/ /

Date

DOB

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Patient Surname

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Date

Name

DOB

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TO:

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Record

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Aboriginal Torres Strait Islander Aboriginal and Torres Strait Islander Not Aboriginal or Torres Strait Islander

(Home)

Practitioner

Your Reference

Telephone

(Provider number,

(Business)

Surname, Initials

and Address)

(indication)*

Patient’s Signature

Date

/ / Path_Pub_3

• Insert the swab into your vagina directed towards your lower back about two inches (5cm), half the length of a finger. This is similar to how you would insert a tampon

* This image is adapted from Garrow SC et al. The diagnosis of chlamydia, gonorrhoea, and trichomonas infections by self-obtained low vaginal swabs in remote northern Australian clinical practice. Sex Transm Infect. 2002 Aug; 78 (4):278-81

>> Instructions overleaf on how to pack and post the sample...

Corp-Mkt-Pub-146 V2

Follow up HPV tests L.B.C only

(indication)*

Clinical Notes

Previous Surname

CST

Co-test

VCS PATHOLOGY Reply Paid 178 CARLTON SOUTH VIC 3053

OGY REQUES

Your Reference

Tests Requested

VCS FOUNDATION LTD. ABN 35 430 554 780

CLARE AND WIFE GEORGE SAY SELFCOLLECTION IS A GREAT CERVICAL SCREENING OPTION FOR THE LGBTIQ+ COMMUNITY.

PAGE 35

GEORGE AND CLARE, SELF-COLLECTION CERVICAL SCREENING ADVOCATES – A LIFE CHANGING STORY

“The test can be done in privacy of a cubicle in the doctor’s office. It was less invasive, not painful and I felt less exposed.”

Clare, 42, describes her experience of discovering she had cervical cancer through a self-collected cervical screening test as the difference between life and death.

When George learnt of Clare’s cancer, she too realised that she had never been screened for cervical cancer and immediately booked an appointment with her general practitioner for a self-collected cervical screening test.

After 20 years of misinformation, believing that the LGBTIQ+ community were considered low risk for cervical cancer, Clare took her doctor’s advice and in the privacy of a cubicle in the general practitioner’s surgery, took her own vaginal swab for HPV – the first cervical screening test she had done in 13 years. The test was positive for HPV and further screening led to a radical hysterectomy to remove cancer. Clare is now living cancer free and encourages her friends in the LGBTIQ+ community to go and speak to their doctor about having a self-collected screening test.

“I was amazed that was even an option. I’m very relieved that it is accessible and I would recommend it.” Clare and George strongly encourage all members of the LGBTIQ+ community including non-binary people and transgender men with a cervix to take the self-collection test. It could save your life. George says “in a moment our life changed; but it’s all good now because of self-collection.” Images courtesy of Conquering Cancer Campaign: To view the campaign stories go to https://www. facebook.com/ConqueringCancerCampaign/

PAGE 36

VCS FOUNDATION STRATEGIC PLAN 2020-2025

FIVE SUPPORT THE NATIONAL BOWEL CANCER SCREENING PROGRAM IN VICTORIA

An important component of the National Bowel Cancer Screening Program (NBCSP) is the follow-up of participants with a positive Faecal Occult Blood Test (FOBT) result. In 2012, VCS Foundation was contracted by the Victorian Department of Health to operate the Participant Follow Up Function (PFUF) to support Victorian bowel screening participants. The PFUF team have consistently met the targets and expectations of the Department and the contract was recently extended to 2023.

The PFUF team assists with the followup of participants who have chosen to participate in the NBCSP and who have had a positive Faecal Occult Blood Test result. The PFUF team call participants who, according to the National Cancer Screening Register (NCSR), have either not followed up their positive FOBT result with their general practitioner/ HCP or have not acted on their referral and progressed to having a colonoscopy. The PFUF team routinely contact the participant, their nominated general practitioners/HCP, their nominated personal representative and/or their treating specialist. The purpose of the contact is to encourage follow-up of the result and progression through the screening pathway, and to accurately update the NCSR PFUF Portal with the current status of the participant. Since the commencement of the program, the PFUF team have followed up 73,354 participants, including 14,651 participants in the 2020/21 financial year.

PFUF TEAM HAVE FOLLOWED UP 73,354 PARTICIPANTS, INCLUDING 14,651 PARTICIPANTS IN THE 2020/21 FINANCIAL YEAR

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 37

SIX DELIVER AND DISSEMINATE THE RESEARCH OUTCOMES OF THE COMPASS TRIAL, C4 AND OTHER POLICY RELEVANT RESEARCH

COMPASS TRIAL AND THE SUPPORTING COMPASS REGISTER The Compass Trial is a key piece of Australian research supporting the National Cervical Screening Program. Compass is the largest clinical trial in Australia, conducted by VCS Foundation and Cancer Council NSW. The roll out of the Compass pilot has already delivered major benefits to the Department and the NCSP by informing the implementation of the renewed screening pathway in December 2017, including laboratory and registry processes. It is expected to inform future changes to the NCSP by confirming that the HPV test is a superior screening method and to assess different ways of deciding which women need further investigations. This is particularly important to understand in the context of Australia’s HPV Vaccination Program, where vaccinated and unvaccinated cohorts are participating in cervical screening. The trial will answer a lot of different

questions for the program around demand, the pathway and safety. Compass recruitment closed in January 2020. VCS Foundation has continued to operate the Compass Register to support healthcare providers and the 76,000 trial participants until the conclusion of the Compass Trial. The Compass Register routinely accepts and records cervical screening test information along with information about related investigations, such as colposcopy, biopsy and treatment in order to provide follow-up services in accordance with the Compass Trial protocols. As women complete their participation in the Trial, the Compass Register manages the exit of participants with their complete records transferred to the National Cancer Screening Register. VCS Foundation is working closely with the Australian Department of Health and Telstra Health to establish and implement processes to facilitate the safe exit of participants from Compass to the National Cancer Screening

Register. The work is overseen by a Governance Committee and supported by key project leads from each organisation committed to ensuring the best possible outcomes for transferring participants. VCS Population Health is leading this work for VCS Foundation. The services of the Compass Register include the following: + The Compass Hotline for participants and healthcare providers + Reminders and communication to women participating in the Compass Trial + Management and provision of screening histories to healthcare providers and laboratories + Monitoring and follow up of trial participants + Provision of reports to healthcare providers to remind them when participants are due for their next Compass screening test, and + Data processing and reporting.

THE COMPASS TRIAL OUTCOMES WILL PROVIDE CRUCIAL EVIDENCE TO GUIDE HEALTH STRATEGIES BOTH IN AUSTRALIA AND OVERSEAS

PAGE 38

VCS FOUNDATION STRATEGIC PLAN 2020-2025

RELEASE OF THE C4 2021 CERVICAL CANCER ELIMINATION REPORT: AUSTRALIA’S PROGRESS TOWARDS THE ELIMINATION OF CERVICAL CANCER AS A PUBLIC HEALTH PROBLEM The NHMRC Centre of Research Excellence in Cervical Cancer Control (C4) brings together Australia’s leaders in cervical cancer control, in both HPV vaccination and cervical screening, with researchers from VCS Foundation, Cancer Council NSW, Kirby Institute at UNSW Sydney, and the University of Melbourne. The work of C4 investigators has underpinned Australia’s major innovations in public health in terms of the successful delivery of HPV vaccination in girls and boys and the implementation of an HPV-based cervical screening program. Led by Prof Julia Brotherton, this inaugural report will be the first in a regular series on Australia’s progress towards the elimination of cervical cancer as a public health problem. The report is based on 11 key indicators grouped into 4 components framed by the World Health Organisation (WHO) ‘90/70/90’ 2030 scale-up targets for elimination, derived from the most recently available data.

Disease outcomes

Reducing cancer incidence and mortality are the goals of cervical cancer control programs. High-grade cervical disease is the precursor to cancer, preventable by vaccination and prevented and detected through screening and precancer treatment. HPV infection is preventable by vaccination and changes in prevalence are detectable earlier than falls in high-grade cervical disease or cancer.

Vaccine coverage

Indicators in this component monitor the ongoing implementation and reach of the vaccine program. Coverage by age 15 years is the standard measure recommended by WHO to allow comparisons over time and between populations, given that the routine age at vaccination is variable but recommended between the ages of 9 and 14 years.

Screening participation

Indicators in this component monitor the implementation and reach of the cervical screening program, considering Australia’s recent transition from a two-year screening interval under the previous cytology-based program to a five-year interval in the HPV-based program.

Treatment uptake

Indicators in this component monitor the rate at which women reach further assessment following a positive screening test and rates of treatment for high-grade cervical disease and cancer. https://www.cervicalcancercontrol.org.au/publications/reports/

This is a multi-institutional agreement in partnership with:

The two goals of the report are to monitor progress towards achievement of targets and to provide recommendations for improving the quality, availability and timeliness of indicator data. The following table shows the four reporting components, framed by the WHO ‘90/70/90’ 2030 scale-up targets for elimination, contained in the report:

2021 CERVICAL CANCER E L I M I N AT I O N PROGRESS REPORT: Australia’s progress towards the elimination of cervical cancer as a public health problem Prepared by the NHMRC Centre of Research Excellence in Cervical Cancer Control

VCS FOUNDATION LTD. ABN 35 430 554 780

CONQUERING CANCER CAMPAIGN VCS Foundation and the C4 CRE are proud sponsors of the Conquering Cancer Campaign, a social impact communications initiative that celebrates the efforts made to eliminate cervical cancer around the world. The Conquering Cancer Campaign will amplify the achievements of countries where elimination is imminent and encourage decision-makers in other nations to advocate for change and urgent action. Over 18 months from September 2020 to April 2022, Moonshine Agency will create, release, promote and publicise a series of original films, photographs, stories and visual communications in 10 languages. These include VCS Foundation’s contribution to the Eliminating Cervical Cancer in Australia and Removing Obstacles to Cervical Screening (Program ROSE) short videos.

This wave of awareness will strengthen the existing movement to eliminate cervical cancer. The campaign is backed by strategically aligned organisations and their members who will engage decision-makers worldwide, with the objective of promoting action by introducing vaccination, screening and treatment programs. To view the campaign, go to https://www.facebook.com/ ConqueringCancerCampaign/

POLICY-RELEVANT RESEARCH AND EVALUATION ACTIVITIES SPECIFIC TO THE VICTORIAN CONTEXT The VCS Population Health research team continues to undertake research and evaluation projects of Victorian public health activities supporting cervical cancer prevention and eventual elimination. Professor Julia Brotherton has assumed a part time position as Professor of Cancer Prevention Policy

PAGE 39

and Implementation in the Evaluation and Implementation Unit of the Centre for Health Policy at the Melbourne School of Population and Global Health, University of Melbourne. Collaborative projects involving the University of Melbourne, and other key partners include: + Victorian Department of Health funded qualitative evaluation of self-collection cervical screening implementation experiences in Victoria from participant and provider perspectives. This was published in the Medical Journal of Australia and received significant media coverage. + Victorian Department of Health funded multimethod evaluation of the North West Melbourne COVID-19 Response Cancer Screening Project, which aims to improve participation in self-collection based cervical screening, bowel screening and hepatitis screening. + Victorian Cancer Agency funded Project Grant Improving the benefits of the renewal of the National Cervical Screening Program for Victorian Aboriginal women. This implementation research study is codesigning strategies to support cervical screening and follow up with VACCHO and ACCHOs across Victoria. A co-designed strategy of offering universal access to self-collection is currently underway at BADAC as part of this Project. + Victorian Cancer Agency Cancer Prevention and Screening Research Grant. Piloting a model of universal self-collection for cervical screening in primary care in Victoria: The solution to a decade of declining participation and to longstanding inequity? This study will support practices to implement a choice of self-collection to all people eligible for cervical screening and evaluate effectiveness of support tools and universal access on uptake of cervical screening in Victoria.

PAGE 40

VCS FOUNDATION STRATEGIC PLAN 2020-2025

SEVEN DIVERSIFY THE RANGE OF VCS PATHOLOGY LABORATORY TESTS BY LEVERAGING OUR EXISTING EXPERTISE AND CAPITAL INVESTMENT

VCS Foundation meets the relevant National Association of Testing Authorities (NATA) regulatory requirements for Australian Laboratories reporting under the National Cervical Screening Program and is accredited to perform tests as part of the Program. The laboratory is accredited to test for: + Human papillomavirus (HPV) + Chlamydia trachomatis (CT) + Neisseria gonorrhoeae (NG) + Trichomonas vaginalis (TV) + Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) + Influenza A, influenza B, RSV, MPV, HRV, PIV, and AdV.

Assoc Prof David Hawkes, DIRECTOR MOLECULAR BIOLOGY

The testing platforms currently operating in the laboratory are the Roche cobas 4800, Roche cobas 6800, Abbott Alinity m, Seegene STARlet/ CFX, Cepheid GeneXpert IV and the new Victorian Department of Health funded BD Onclarity HPV assay. The BD Onclarity HPV assay is the first clinically validated commercial assay to have an approved manufacturer’s claim for HPV testing of self-collected vaginal swabs. This will allow for faster processing of self-collected specimens. The BD Onclarity will expand the capacity of VCS Foundation to process self-collected vaginal swabs for HPV. It strategically aligns with the recent announcement by the Medical Services Advisory Committee regarding Medicare changes for self-collected HPV tests. In 2020, VCS Pathology was accredited for the extension of the stability claim

for self-collected specimens to be tested for HPV as part of the National Cervical Screening Program. This means that VCS Foundation now has accreditation to process self-collected swabs received up to 28 days after patient collection. VCS Pathology has successfully established eight different nucleic acid amplification testing assays and platforms for the testing of SARS-CoV-2 including Seegene, Abbott, Hologic, Cepheid and Roche. The laboratory can process and report over 1,500 SARS-CoV-2 tests per day and provide electronic reports to both the clinical referrers and the Victorian Department of Health within 24 hours.

The new BD COR system will be critical in ensuring VCS Pathology can effectively respond to growing demand for self-collected HPV tests in Victoria and support the Victorian Government in achieving its elimination targets.

VCS FOUNDATION LTD. ABN 35 430 554 780

EIGHT LEVERAGE THE VALUE OF THE CANSCREEN® AND CANVAX® PLATFORMS FOR COST EFFECTIVE SUPPORT OF LOW TO MIDDLE INCOME COUNTRIES AND FOR COMMERCIALLY ADVANTAGEOUS OPPORTUNITIES Through knowledge sharing with countries eager to implement cancer screening strategies, VCS Foundation can now apply its technical expertise to complement and support initiatives for reaching the World Health Organization elimination targets.

VCS Digital Health and VCS Population Health have continued to progress the development roadmap for the proprietary canSCREEN® population health management platform. canSCREEN® is critical to supporting our ongoing projects with government and other organisations and underpins our global partnership opportunities. canSCREEN® and canVAX® have been developed to be configurable and scalable to meet the diverse range of feature and operational requirements, particularly for low and middle-income countries.

Research and Evaluation

Configurable Platform

Changes in Policy Drive Platform Configuration

Scalable for other Programs and Different Resource Settings

Population Health Management Policy

Reporting and Analytics Platform

Integration Points to Suit

Identify Population

Measure Outcomes

Engage via SMS and Digital Channels

Track Participant through Screening Lifecycle

Engage Participants

Manage Care

Alerts for Upcoming and Overdue Actions Proactive Surveillance Manage Patient Safety

Stratify Risk

Configurable Correspondence

Categorise Risk for Participants Prioritise High Risk Participants Configurable Follow-up Rules

PAGE 41

PAGE 42

VCS FOUNDATION STRATEGIC PLAN 2020-2025

OUR COLLABORATION HAS RESULTED IN THE GROUND-BREAKING ROSE PROGRAM PROVIDING MALAYSIAN WOMEN SAFETY, PRIVACY AND DIGNITY THROUGH SELF-SAMPLING, ENCOURAGING MORE WOMEN TO WILLINGLY PARTICIPATE IN SCREENING. Prof Marion Saville and Prof Yin Ling Woo

PROGRAM ROSE: REMOVING OBSTACLES TO CERVICAL SCREENING IN MALAYSIA In order to significantly reduce the incidence of cervical cancer and make it a rare disease in Malaysia, an organised cervical screening program to complement and support local government initiatives has been developed. Program ROSE, a collaboration between VCS Foundation and the University of Malaya, integrates the innovative selfsampling model, primary HPV screening and a digital population health registry developed by VCS Foundation using the canSCREEN® platform.

After women carry out the self-sampling HPV test, their samples are sent to the ROSE Laboratory in Malaysia for HPV testing. Results of the HPV test are then communicated to the women via mobile phone allowing them to seamlessly navigate through an otherwise complex and overwhelming healthcare system. Women with a positive HPV test are also provided with a phone number for counselling and organizing their followup care. 89% of participants who tested positive returned for follow-up care. Furthermore, 67% of positive patients initiated a call back within the same day of receiving their results.

These incredible outcomes were made possible through the hard work of the Program ROSE team in Malaysia, facilitated by canSCREEN®. VCS Foundation provides ongoing support to the ROSE program and has recently assisted with the acquisition of a dedicated a new Roche cobas 4800 system for HPV testing in the ROSE Laboratory, building in-country capacity for testing.

With self-sampling, ROSE embodies privacy and dignity, encouraging more women to willingly participate in cervical screening in a timely manner, while the accuracy and reliability of self-swabs for HPV testing provides greater assurance to women. With the three components of selfsampling, HPV testing and canSCREEN®, ROSE delivers an integrated screening service that is acceptable to women and ensures that women do not “fall through the cracks” with healthcare professionals able to track the progress of every woman screened, regardless of where she was screened.

89% of participants who tested positive returned for follow-up care.

67% of positive patients initiated a call back within the same day of receiving their results.

VCS FOUNDATION LTD. ABN 35 430 554 780

“You are well on your way, and I encourage you to achieve and maintain these levels as your programme scales up nationally. I especially endorse your women-centred approach through use of self-sampling coupled with HPV DNA testing as well as e-health technologies to minimize barriers to uptake of screening services.” Dr. Tedros Adhanom Ghebreyesus Director-General, World Health Organization

PAGE 43

“The innovative work on HPV testing and self-collection that you and your colleagues have conducted, together with VCS Foundation in Australia, will continue to offer valuable information as we strive to help countries achieve the cervical cancer elimination targets. We look forward to learning more insights generated through your work.” Dr Princess Nothemba (Nono) Simelela Assistant Director-General for Strategic Programmatic Priorities, World Health Organization

PAGE 44

VCS FOUNDATION STRATEGIC PLAN 2020-2025

JEAN HAILES FOR WOMEN’S HEALTH: THE NATIONAL ENDOMETRIOSIS CLINICAL AND SCIENTIFIC TRIALS REGISTRY It is estimated that 11.4% of Australian women and girls are living with endometriosis. The National Action Plan for Endometriosis (Department of Health, 2018) called for the first ever national approach to reduce the burden of this debilitating and painful condition. VCS Foundation was selected as the preferred tenderer for the software development to support the National Endometriosis Clinical and Scientific Trials (NECST) Registry Project for Jean Hailes Women’s Health. Using our proprietary award winning canSCREEN® platform, the NECST Registry has been developed as a national resource of standardised patient data collection to understand disease trends and improve patient outcomes for participants with endometriosis and endometriosis-related symptoms. Throughout 2020, VCS Digital Health worked with The Jean Hailes Foundation to develop and deliver the NECST Registry which will be stored and managed in a for-purpose, customised online platform built, and IT managed under contract by VCS Digital, a division of VCS Foundation.

The NECST Registry is designed to consistently collect and securely store 'real-world' data to monitor the health, service utilisation, medication use, surgery and patient-reported outcomes of those receiving care for their endometriosis and/or endometriosisrelated symptoms. The Registry aims to provide data on the whole picture, across the life course, of the care pathway and burden of disease. The NECST Registry was launched in 2020 with the first participant being recruited just prior to Christmas. The NECST Registry will be a critical driver in the facilitation and growth research on endometriosis in Australia – bringing together the endometriosis advocates, clinicians and researchers towards a common goal to improve the healthcare and outcomes for those 1 in 9 of reproductive age living with this debilitating condition. To access the NECST Registry, go to https://www.jeanhailes.org.au/necstnetwork/the-necst-registry

canSCREEN – IMPROVING THE HEALTHCARE AND OUTCOMES FOR THOSE LIVING WITH ENDOMETRIOSIS.

VCS FOUNDATION LTD. ABN 35 430 554 780

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VCS PATHOLOGY

VCS PATHOLOGY CORE ACTIVITIES VCS Pathology is Australia’s largest not-for-profit cervical screening laboratory. VCS Pathology has continued to report almost 50% of all cervical screening tests in Victoria. Cervical screening tests are provided free of charge to women if they have been taken in accordance with national program guidelines.

have the best, and most appropriate, screening test available to them.

The high volumes of cervical screening tests received by VCS Pathology provide us with the capacity to undertake rigorous analysis of trends and quality measures which inform the National Cervical Screening Program. We have provided critical data and knowledge to researchers to help ensure that women in Australia and the Indo Pacific region

Human papillomavirus (HPV) testing fluctuates each year in line with cervical screening testing demand under the five-year testing cycle of the renewed National Cervical Screening Program. In line with modelling, the 2020/21 volumes are the lowest expected in the first five cycle, noting that volumes are anticipated to increase in 2022/23.

As a not-for-profit laboratory service, health care providers can be assured that when choosing VCS Pathology, they are supporting our work with under-served populations in Australia and around the world.

Human papillomavirus and liquid based cytology testing numbers

HPV

LBC

300,000 248,719

200,000 150,000

176,027 139,893

100,000 50,000

122,318 66,081

39,208

54,230

47,782

2019/2020

2020/2021

0 2017/2018

2018/2019

VCS Pathology has reported 686,957 HPV tests since the beginning of the renewed National Cervical Screening Program in December 2017.

PRIMARY TEST STATISTICS

HPV & LIQUID BASED CYTOLOGY TESTING NUMBERS

250,000

If HPV is detected, a reflex Liquid Based Cytology (LBC) is performed on the same specimen.

VCS PATHOLOGY REPORTS ALMOST 50% OF ALL CERVICAL SCREENING TESTS IN VICTORIA

VCS FOUNDATION LTD. ABN 35 430 554 780

HISTOLOGY NUMBERS

VCS PATHOLOGY HAS REPORTED 686,957 HPV TESTS SINCE THE BEGINNING OF THE RENEWED NATIONAL CERVICAL SCREENING PROGRAM IN DECEMBER 2017

A major focus in the histology laboratory is to maintain a competitive 24-hour reporting turn-around time to cater to the specialists who refer histology samples to VCS Pathology. This is made possible through the adoption of new instrumentation in the financial year which have improved capabilities and workflow. The sustained increase in histology samples reported is due to increased disease detection resulting from the National Cervical Screening Program’s transition to the more sensitive primary HPV test. The increased sensitivity for high grade disease is resulting in an initially higher colposcopy referral rate and treatment as existing disease is detected in the renewed NCSP.

HISTOLOGY VOLUMES 5,000

4,720

4,500 3,896

4,000 3,500 3,000

2,741

3,766

2,984 2,628

2,500 2,000 1,500 1,000 500 0 2015/2016 2016/2017 2017/2018 2018/2019

2019/20

2020/21

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The Histology laboratory was successful in receiving support from the Victorian Department of Health for a new state-of-the-art Leica HistoCore Spectra Workstation. The instrument has been implemented and commissioned for use in histology and cytology staining and cover slipping of test slides. We thank the Victorian Government for this valuable support.

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VCS PATHOLOGY

CHLAMYDIA AND GONORRHOEA

CHLAMYDIA TESTING VOLUMES 12,000 10,000

10,647

9,861

10,080

8,193

8,000

7,335 6,344

6,000 4,000 2,000 0 2015/16

2016/17

2017/18

2018/2019 2019/2020 2020/2021

Most chlamydia and gonorrhoea test requests at VCS Pathology are taken from samples received for HPV testing. With the decline in HPV testing, the demand for these two tests has also decreased. A total of 6,344 chlamydia tests were reported in 2020/21 compared to 7,335 cases in 2019/20. Since the introduction of gonorrhoea testing in 2017, the laboratory has reported 12,251 gonorrhoea tests.

COMPASS TESTING GONORRHOEA TESTING VOLUMES 4,500

4,055

4,000 3,500

3,181

3,267

3,000 2,500 2,000

1,748

1,500 1,000 500

The Compass trail seeks to confirm with research evidence the modelled performance of HPV testing compared with cytology testing. The trial has recruited a total of 76,000 Australian women. The target of 36,300 unvaccinated cohort of women born before 1st July 1980 were recruited in the first year of the trial with the 40,000 younger vaccinated cohort of women recruited by December 2019. The testing is now at a steady state and will continue until the conclusion of the trial in 2024.

0 2017/18

2018/2019

2019/2020

2020/2021

When the COVID-19 pandemic arrived in Australia in early 2020 and began to impact on our community, VCS Foundation quickly recognised that we could leverage our existing molecular testing platforms to reorient our services to offer SARS-CoV-2 testing.

COMPASS TESTING VOLUMES 60,000 50,000

50,591

40,000 30,000 21,966

20,000

SARS-COV-2 TESTING

25,078 19,126

16,378

14,220

10,000 0 2015/2016 2016/2017 2017/2018 2018/2019 2019/2020 2020/2021

Since early May 2020, VCS Pathology has processed over 200,000 SARS-CoV-2 samples from various screening clinics and drive-through testing sites across metropolitan Melbourne. With the emergence of the COVID-19 Delta variant in Victoria and associated outbreaks in Melbourne’s West and North, VCS Pathology has increased its

VCS FOUNDATION LTD. ABN 35 430 554 780

capacity to support the test volumes and to meet the reporting times set by the Victorian Department of Health. The laboratory has maintained a rapid turnaround of samples with a combined processing capacity of 1,500 tests per day across five testing platforms – the Abbott Alinity m, the Seegene STARlet, the Cepheid GeneXpert, the Hologic Panther, and now the Hologic Panther Plus.

VCS Pathology has continued to provide support to COVID-19 screening clinics in Melbourne’s western suburbs operated by IPC Health, one of the largest providers of community health services in Victoria. Since the beginning of the COVID pandemic in Victoria, VCS Pathology has supported IPC Health, one of the largest providers of community health services in Victoria, to process COVID-19 samples from their collection sites in the western suburbs of Melbourne. VCS Pathology Director of Molecular Microbiology Assoc Prof David Hawkes and the IPC Health team led by Sofi Milenkovski , Senior Manager Clinical Services have worked as an effective team to review processes and share learnings to ensure Victorians in the western suburbs received COVID-19 tests and results as rapidly as possible. With testing numbers increasing in the peaks of the pandemic, VCS Pathology scaled up pick ups from the collection sites by dedicated VCS COVID couriers. Over 200,000 SARS-CoV-2 samples have been processed from the IPC collection sites at the Deer Park, Hoppers Lane, Sunshine West, Tarneit and Wyndham Vale.

VCS Pathology continues to work closely with IPC Health to keep testing turn-around times to a minimum to reduce the disruption to the lives of the Victorian public being tested at the sites, all of whom wait anxiously for their results. This included working with the Victorian Department of Health to

PAGE 49

introduce electronic ordering of tests through “TestTracker” to speed up the processing of specimens. We extend our thanks to all of the IPC Health staff who have significantly contributed to the COVID-19 effort in Melbourne’s West offering testing and vaccinations.

Please pass on our thanks to all your staff for their extremely hard work this year and for everything that they have done to support our COVID-19 testing. It has been a very challenging and tiring time for us all, and everyone at VCS is always so helpful to our staff and clients. Many times, they have gone above and beyond, and I know everyone has worked long days and hours as we have sent you tens of thousands of tests and had hundreds of positive cases to manage. Danielle Siler, Acting Executive Lead C-19 Rapid Response Collaborative IPC Health

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COMMITTEE ENGAGEMENT AND STAKEHOLDERS

COMMITTEE ENGAGEMENT AND STAKEHOLDERS GOVERNMENT, HEALTH AND PROFESSIONAL RELATIONSHIPS VCS Foundation strongly values its working relationships with our partners, which include: Government Departments both State and Commonwealth, Cancer Councils, medical colleges, universities, major teaching hospitals, sexual and reproductive health services, primary care and community organisations, and technology and device service providers.

VCS Foundation is a key contributor to state, national and international cervical cancer control policy and initiatives. VCS Foundation staff continue to serve in-kind on expert advisory committees and participate in working groups and forums that support both the Commonwealth and Victorian Governments in relation to cancer, cancer screening and immunisation. This includes committees responsible for the success of the renewed National Cervical Screening Program (NCSP) and international committees.

COMMITTEE ENGAGEMENT COMMITTEE

VCS STAFF MEMBER

PURPOSE/CONTRIBUTION

International Taskforce on Cervical Cancer Elimination in The Commonwealth. March 2021

Prof Marion Saville

Australian-led resolution by member states of the World Health Organization (WHO): Cervical Cancer Prevention and Control: Accelerating the Elimination of Cervical Cancer as a Public Health Problem. Australia stands ready to work with the international community to take these commitments forward.

International Papillomavirus Society Policy Committee

Prof Julia Brotherton

Engagement with lead policy makers in HPV and cervical screening.

New Zealand Technical Reference Group - HPV Testing for Primary Screening Project

Prof Marion Saville (Chair)

Close ongoing connections with NZ Ministry of Health in relation to transition to HPV primary screening.

Non-trials workgroup, One dose HPV vaccine consortium (PI PATH, Funding Bill and Melinda Gates Foundation) Member and external advisor

Prof Julia Brotherton

Close ongoing connections with international HPV immunisation experts relating to ongoing research and evaluation of HPV vaccine impact.

WHO Elimination Data Monitoring Group

Prof Marion Saville

Direct engagement with international groups regarding best practice for program monitoring.

WHO Director-General’s Expert Advisory Group on the Elimination of Cervical Cancer

Prof Julia Brotherton

Direct engagement with lead international group strategy setting for global cervical cancer elimination.

Member of the Program Committee and Faculty for Eurogin 2021 meeting, Dusseldorf, Germany

Prof Julia Brotherton

Since its creation three decades ago, the EUROGIN congress has gained a strong reputation as one of the leading international conferences on HPV infection and associated cancers. The meeting offers a forum for high-level scientific exchange involving multiple disciplines, with the aim to translate research into clinical practice.

INTERNATIONAL

VCS FOUNDATION LTD. ABN 35 430 554 780

COMMITTEE

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VCS STAFF MEMBER

PURPOSE/CONTRIBUTION

Rapporteur and technical writer, Strategic Advisory Group of Experts HPV Working Party 2021-2022, World Health Organization, Geneva

Prof Julia Brotherton

Supporting the work of the global expert committee providing advice on use of HPV vaccines.

Chair, Data Monitoring and Safety Board, ADDVAC study

Prof Julia Brotherton

Study assessing The Population-Level Impact of Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania: A Cluster-Randomised Trial. Study Sponsor London School of Hygiene & Tropical Medicine (CIA D Watson Jones).

Invited Council Member, HPV Vaccine Council, CHIC

Prof Julia Brotherton

The Council is a global forum of experts intended to foster efficient translation of implementation research to guide practice and more equitable access to immunization and is part of the Bill and Melinda Gates Foundation funded Coalition to Strengthen the HPV Immunization Community (CHIC) project.

Member of the IPVC 2021 Public Health Workshop Committee

Prof Julia Brotherton

Supporting public health stream of the leading international HPV conference.

INTERNATIONAL

International Agency for Research on Prof Julia Brotherton Cancer (IARC) Working Group for Handbook 18 on Cervical Screening 2020

IARC prepares and distributes authoritative information on the causes and prevention of cancer throughout the world.

Member of the International Collaboration on Cancer Reporting (ICCR) Expert Committee working on the 4th edition cervix cancer dataset

Dr Karen Talia

Information obtained through membership of this Committee is communicated to VCS Pathologists, ensuring that our reporting of cervical biopsies and excision specimens is in line with world's best practice. This is reflected in our recent updating of the histology reporting codes.

Host of the ISGyP LiVE team’s monthly online Journal Club

Dr Karen Talia

Mentor trainees and early career pathologists (including VCS Pathologists) in critically evaluating and presenting journal articles.

Chair of Digital pathology meeting and co-chair of pathology education meeting. International Academy of Pathology (IAP) – Australasian Division

Dr Kais Kasem

Organise and deliver annual program at the IAP conference for both meetings.

Chair, Working Group, National Cervical Screening Program, Guidelines

Prof Marion Saville

Guide the working party in terms of task (developing the guideline) and process (how the group works). Assist the working party to work collaboratively, ensuring a balanced contribution from all members.

17th National Immunisation Conference 2021 - Conference Advisory Committee

Prof Julia Brotherton

Close ongoing connections with Australia’s immunisation experts and community relating to ongoing research and evaluation of HPV vaccine impact which has direct implications for HPV based screening performance i.e. assists in setting future direction of the NCSP.

Australian Government Department of Health: National Cervical Screening Program “Clinical Expert Panel”

Prof Marion Saville

Provision of clinical expertise to the Federal Government as required.

NATIONAL

Prof Marion Saville Australian Government Department of Health: National Cervical Screening Program “Self-Collection Expert Advisory Group”

Supports self-collection policy development and adoption in never and under screened Australian women. Was formerly the Working Group.

National Pathology Accreditation Advisory Council (NPAAC) “Standards Cervical Screening Drafting Committee”

Directly supports Australian laboratory standards for pathology laboratories reporting cervical screening tests.

Prof Marion Saville A/Prof David Hawkes

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COMMITTEE ENGAGEMENT AND STAKEHOLDERS

COMMITTEE ENGAGEMENT COMMITTEE

VCS STAFF MEMBER

PURPOSE/CONTRIBUTION

National Quality Safety Monitoring Committee

A/Prof David Hawkes

Peak committee governing the NCSP quality framework. Includes best practices for data management and reporting.

Horizon Scanning Working Group, a subcommittee of the NCSP Quality and safety monitoring group.

Prof Marion Saville

Networking with advocates and experts in the HIV and sexual health community and providing technical advice in relation to the spectrum of HPV related diseases, screening and vaccination.

RCPA QAP Cytopathology Advisory Committee

Prof Marion Saville

Directly assists the performance monitoring of laboratories reporting services under the NCSP. VCS Foundation provides feedback and support as committee members. This extends to facilitating a “dummy run” with the RCPA QAP to test data entry processes from a lab perspective using ‘Gotomeeting’.

RCPA QAP Molecular Infectious Diseases

A/Prof David Hawkes

Technical advice supporting the quality and testing framework for HPV testing.

National Cervical Screening Program

Prof Marion Saville

Data Dictionary Working Group

Karen Peasley

Assist the Australian Institute of Health and Welfare (AIHW) in the review of the National Cervical Screening Program (NCSP) Data Dictionary Version 1.0 in light of changes to clinical management guidelines, the program or data. This will include the review of data items, performance indicator specifications and coding sheets.

HPV Evaluation Advisory Committee, National Centre for Immunisation Research and Surveillance

Prof Julia Brotherton

Providing input, advice and technical support to a national evaluation of the HPV vaccination program.

RCPA Microbiology Examiner

Dr Hui Tat Mark Chan

Contributing to ensure Clinical microbiologists in training meet adequate standards to practise as independent professionals.

National Cancer Screening Register Cervical Reporting User Forum Member

Karen Peasley Genevieve Chappell

The purpose of this group is to enable information sharing and operational discussion regarding issues and insights related to the National Cancer Screening Register (NCSR) reporting services in relation to the National Cervical Screening Program (NCSP).

Public Pathology Australia Communications Team

Kate Wilkinson

This is a working group comprised of communications staff from Public Pathology Australia member organisations. Its purpose is to collaborate on communications campaigns and strategies to increase community and government awareness of the value of public pathology services in supporting Australian’s health.

Member RCPA Anatomical pathology advisory committee

Dr Kais Kasem

Established to provide expert advice to the Board of Directors regarding training and identification of areas of concern or new initiatives which require review from a political perspective.

NATIONAL

Grace Tan

Genevieve Chappell

Member RCPA Academic committee Dr Kais Kasem

Provide advice on promotion of pathology and develop opportunities in academic pathology at the levels of University education, junior doctors and Registrars.

STATE Cancer Council NSW, Scientific Advisory Committee for cervical stream of ‘Pathways to a Cancerfree future’

Prof Julia Brotherton

Cancer Council Victoria – Self-collection Roll Out Committee

Prof Marion Saville

Assists in setting future direction of the National Cervical Screening Program.

Benefits to National Cervical Screening Program in self-collection and promoting participation in under-never screened women. Assists NCSP implementation and achievement of outcomes.

VCS FOUNDATION LTD. ABN 35 430 554 780

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COMMITTEE ENGAGEMENT COMMITTEE

VCS STAFF MEMBER

PURPOSE/CONTRIBUTION

Victorian Department of Health Victorian Cancer Screening Steering Committee

Prof Marion Saville

The committee provides guidance to support Victoria’s delivery of and investment in cancer screening programs and facilitates collaboration across screening programs to maximise efficiencies and reduce duplication. VCS Foundation provides expertise to support strategic screening priorities including participation and recruitment, data and reporting, research and evaluation and health workforce education.

Victorian Cancer Screening Data and Surveillance Working Group (auspiced by Department of Health Vic)

Genevieve Chappell (Chair)

Chaired by VCS Foundation, this group is responsible for developing and implementing the Cancer Screening Data and Surveillance Strategy 2019-2022. The strategy aims to improve surveillance of the effectiveness and outcomes of the breast, bowel and cervical screening programs in Victoria through an integrated and consistent approach to data collection, use and reporting. Cervical screening data produced will inform Victorian initiatives to improve under and never-screened women’s participation, and support cervical screening research and education activities.

Victorian Cancer Screening Evaluation and Research Working Group [auspiced by Department of Health Vic]

Prof Julia Brotherton

STATE

Karen Peasley John Siddham

This group provides a forum for cancer screening partners and the Department of Health to work together to develop an Evaluation Strategy to monitor the delivery and outcomes of the Victorian Cancer Screening Framework, agree on strategic research priorities for cancer screening programs in Victoria, and enable a coordinated and collaborative approach to sharing research, evidence and best practice in cancer screening.

Victorian Cancer Screening Primary Prof Marion Saville Care and Workforce Working Group Kate Wilkinson (auspiced by Department of Kim Lee Health Vic)

Chaired by VCS Foundation, this group is responsible for developing and implementing the Cancer Screening Primary Care and Workforce Strategy 2019-2022. The Strategy will support an integrated, evidence-based cancer screening education and training approach and supporting systems, resources, tools and communications for the cancer screening workforce to improve adherence to clinical guidelines, increase health care practitioner endorsement of screening, and increase participation of underscreened populations.

Medical Laboratory Quality Network A/Prof David Hawkes Committee

Victorian peer organisation for the development and application of quality frameworks within public laboratories.

Steering Committee, Cancer Prof Julia Brotherton Council Victoria’s Eliminate Cervical Prof Marion Saville Cancer Fund 2020

Providing expertise to progress Victorian Government’s commitment to eliminate cervical cancer. The four-year plan tabled aligns with Cancer Council Victoria’s objective to eliminate cervical cancer by 2030 – possibly becoming the first jurisdiction in Australia to do so.

Victorian Government COVID-19 Laboratory Liaison Group

Dr Kais Kasem

Established to provide expert advice to the Board of Directors regarding training and identification of areas of concern or new initiatives which require review from a political perspective.

BSV Data Hub Project Board Member

Genevieve Chappell

Group responsible for overseeing work to facilitate the transfer of BreastScreen Victoria (BSV) data to VCS Foundation for data and reporting purposes under the Victorian Cancer Screening Framework. The project will establish a data hub to enable ongoing transfer of BSV datasets to VCS Foundation and other external reporting agencies.

HPV Working Group, Positive Life, NSW

Prof Julia Brotherton

Networking with advocates and experts in the HIV and sexual health community and providing technical advice in relation to the spectrum of HPV related diseases, screening and vaccination.

Member Australian Society of Grace Tan Cytology Committee, Victorian Branch

Organise and deliver the scientific program for the local ASC branch.

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COMMITTEE ENGAGEMENT AND STAKEHOLDERS

COMMITTEE ENGAGEMENT AND STAKEHOLDERS STRATEGIC PARTNERSHIPS PARTNER

PROJECT

Cancer Council New South Wales

Compass Trial, Research

Cancer Council Victoria

Supporting the National Cervical Screening Program in Victoria

Victorian Aboriginal Community Controlled Health Organisation Inc.

Supporting the National Cervical Screening Program in Victoria

Clinicians and Nurse Pap Smear Providers

Supporting the National Cervical Screening Program in Victoria

Royal Women’s Hospital

VCS Foundation Tenancy (Carlton) and Research

Public Pathology Australia

National collaborative laboratory relationships

University of Melbourne

Research

University of Sydney

Research

Kirby Institute – University of New South Wales

Research

National Centre for Immunisation Research and Surveillance (NCIRS)

Research

Menzies School of Health Research

Research

Australian National University

Research

University of Malaya

Program ROSE

Public Health Association of Australia

Member

Global Health Alliance

Member

BioMelbourne Network.

Member

Union for International Cancer Control, UICC

Member

Prince of Wales Hospital, NSW

Australian Cervical Cancer Typing Study

Royal Brisbane Hospital, Brisbane, QLD

Australian Cervical Cancer Typing Study

Mercy Hospital for Women/Austin Pathology, VIC

Australian Cervical Cancer Typing Study

Westmead Hospital, NSW

Australian Cervical Cancer Typing Study

Royal Prince Alfred Hospital and Chris O’Brien Lifehouse, NSW Australian Cervical Cancer Typing Study Royal Women’s Hospital, VIC

Australian Cervical Cancer Typing Study

Pathology North, NSW

Australian Cervical Cancer Typing Study

Monash University, VIC

Research relating to Multiple Sclerosis treatments and cervical HSIL/cancer risk

Notre Dame University, WA

Research

Burnet Institute

Research

McGill University, Canada

Research

International Agency for Research on Cancer

Global Alliance for Chronic Diseases project

Baker Heart and Diabetes Institute

Global Alliance for Chronic Diseases project

Christian Medical College Vellore, India

Global Alliance for Chronic Diseases project

Zoram Medical College, Mizoram, India

Global Alliance for Chronic Diseases project

RMI International

Global Alliance for Chronic Diseases project

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 55

VCS FOUNDATION PUBLISHED ARTICLES 2020/21 AUTHORS

JOURNAL

TITLE

REFERENCE

Brotherton JML, Wheeler C, Clifford G, Elfstrom M, Saville M, Kaldor J, Machalek DA.

Preventive Medicine

Surveillance systems for monitoring cervical cancer elimination efforts: focus on HPV infection, cervical dysplasia, cervical screening and treatment.

Prev Med. 2020 Oct 16:106293. doi: 10.1016/j. ypmed.2020.106293.

Cornall A , Saville M, Pyman J, Callegari E, Tan F, Brotherton J, Malloy M, Tabrizi S, Wrede C.D, Garland S.

Vaccine

HPV16/18 prevalence in high-grade cervical lesions in an Australian population offered catch-up HPV vaccination.

Vaccine 2020 Sep 11;38(40):6304-6311. https://doi: 10.1016/j. vaccine.2020.07.037.

Cornall A, Brotherton J., Callegari E, Tan F, Saville M, Pyman J, Phillips Sl, Malloy M., Tabrizi S, Garland S., on behalf of the VACCINE study group.

Vaccine

Assessment of attribution algorithms for resolving CIN3-related HPV genotype prevalence in mixedgenotype biopsy specimens using laser capture microdissection as the reference standard.

Vaccine 2020;38(40): 6312–6319. https:// doi.org/10.1016/j. vaccine.2020.07.036

Dodd RH, Nickel B, Smith MA, Brotherton JML, McCaffery KJ.

Preventive Medicine

Getting the timing right: women’s views on the best time to announce changes to cancer screening policy recommendations.

Preventive Medicine Reports 2020;20:101268. https://doi.org/10.1016/j. pmedr.2020.101268

Martellucci CA, Nomura S, Yoneoka D, Ueda P, Brotherton JML, Canfell K, Palmer M, Manzoli L, Rossi PG, De Togni A, Palmonar C, Califano A, Saito E, Hashizume M, Shibuya K.

BJOG

Human papillomavirus vaccine effectiveness within a cervical cancer screening programme: cohort study.

BJOG 2021 Feb;128(3):532539. doi: 10.1111/14710528.16429. Epub 2020 Aug 10.

Phillips A, Hickie M, Totterdell J, Brotherton J, Dey A, Hill R, Snelling T, Macartney K.

Vaccine

Adverse events following HPV Vaccine. 2020;S0264vaccination: 11 years of surveillance in 410X(20)30825-2. Australia. doi:10.1016/j. vaccine.2020.06.039

Ross J, Greaves J, Saville M, Earls , Pagliuso J.

Pathology

Performance measures for Australian laboratories reporting cervical cytology 2009–2017: the impact of the national HPV vaccination program.

Pathology 2020 52(5):522528

Smith M, Saville M, Canfell K.

Medical Journal of Australia

HPV swab self-collection and cervical cancer in women who have sex with women.

Med. J. Aust., 213: 239-239. e1, 7th September 2020

Stolnicu S, Talia KL, McCluggage WG.

Advances in Anatomic Pathology

The Evolving Spectrum of Precursor Lesions of Cervical Adenocarcinomas.

Advances in Anatomic Pathology. 2020 Sep;27(5):278293. DOI: 10.1097/ pap.0000000000000266.

Subasinghe AK, Wark JD, Phillips S, Cornall A, Brotherton JML, Garland SM.

Sexual Health

The quadrivalent human papillomavirus vaccination is successful in reducing the prevalence of vaccine-targeted genotypes in a young vaccine- eligible age sample of Australian females.

Sexual Health 2020; 17(6) https://doi.org/10.1071/ SH20033

Sultana F, Roeske L, Malloy MJ, McDermott TL, Saville M, Brotherton JML.

PLoS ONE

Implementation of Australia’s Renewed Cervical Screening Program: Preparedness of General Practitioners and Nurses.

PLoS ONE 2020;15(1):e0228042. https:// doi.org/10.1371/journal. pone.0228042.

PAGE 56

VCS FOUNDATION PUBLISHED ARTICLES 2020/21

VCS FOUNDATION PUBLISHED ARTICLES 2020/21 AUTHORS

JOURNAL

TITLE

REFERENCE

Tan J, Jayasinghe Y, Osinski M, Brotherton JML, Wrede CDH.

Aust N Z J Obstet Gynaecol

Recurrent Post Coital Bleeding: Should colposcopy still be mandatory?

Aust N Z J Obstet Gynaecol 2020; 1–8. DOI: 10.1111/ ajo.13247

Teutsch SM, Nunez CA, Morris A, McGregor S, King J, Brotherton JML, Novakovic D, Booy R, Jones CA, Rawlinson W, Thorley BR, Elliot EJ.

Commun Dis Intell.

Australian Paediatric Surveillance Unit (APSU) Annual Surveillance Report 2019.

Commun Dis Intell. 2020;44 (https://doi.org/10.33321/ cdi.2020.44.60) Epub 17/8/2020

Wong RW, Richard Wing-Cheuk, Talia KL, McCluggage WG.

The American Journal of Surgical Pathology

Endometrial Gastric-type Carcinoma: An Aggressive and Morphologically Heterogenous New Histotype Arising From Gastric Metaplasia of the Endometrium.

Am J Surg Pathol. 2020 Dec;44(12):17361737. doi: 10.1097/ PAS.0000000000001473.

Yeasmeen T, Kelaher M, Brotherton JML, Malloy MJ.

PLoS One.

Understanding the participation of breast screening among women born in predominantly Muslim countries living in Victoria, Australia from record-linkage data.

PLoS One. 2020;15(8):e0237341. Published 2020 Aug 7. doi:10.1371/journal. pone.0237341

Atchison-Wright S, Shilling H, Balgovind P, Machalek D, Hawkes D, Garland S, Saville M, Murray G, Molano M, Danielewski J, Phillips S.

Journal of Applied Microbiology

Evaluation of the Roche MagNA Pure 96 nucleic acid extraction platform for the Seegene Anyplex II HPV28 detection assay.

J Appl Microbiol. 2021 May 3. doi: 10.1111/jam.15126

Brotherton J, Machalek D, Smith M, Yuill S, Sherrah Whop L , Evans S, Bateson D, Marshall H, Garland S, Hawkes D, Wrede D, Guy R, Nightingale C, Kaldor J, Saville M and Canfell K.

2021 Cervical Cancer Elimination Progress Report

Australia’s progress towards the https://www. elimination of cervical cancer as a cervicalcancercontrol.org.au public health problem. NHMRC Centre of Research Excellence in Cervical Cancer Control.

Creagh NS, Zammit C, Brotherton JM, Saville M, McDermott T, Nightingale C, Kelaher M.

Medical Journal of Australia

Self-collection cervical screening in the renewed National Cervical Screening Program: a qualitative study.

Med J Aust. 2021 Oct 18;215(8):354-358. doi: 10.5694/mja2.51137. Epub 2021 Jun 18.

Davies C, Stoney T, Hutton H, Parrella A, Kang A, Macartney K, Leask J, McCaffrey K, Zimet G, Brotherton J, Marshall HS, Skinner SR, for the HPV.edu Study Group

Vaccine

School-based HPV vaccination positively impacts parents’ attitudes toward adolescent vaccination.

Vaccine. 2021 Jul 5;39(30):4190-4198. doi: 10.1016/j.vaccine.2021.05.051. Epub 2021 Jun 12.

Jaenke R, Butler TL, Condon J, Garvey G, Brotherton JML, Cunningham J, Anderson K, Tong A, Moore SP, Whop LJ.

Aust N Z Journal of Public Health

Health care provider perspectives on cervical screening for Aboriginal and Torres Strait Islander women: a qualitative study.

Aust N Z J Public Health. 2021 Apr;45(2):150-157. doi: 10.1111/1753-6405.13084

Nesbitt C, Rath L, Cheng AC, Butzkueven H, Wesselingh R, Skibina O, Monif M, Yeh WZ, Brotherton JML, Reddel S, Van der Walt A.

Medical Journal of Australia

Vaccinations in patients with multiple sclerosis: review and recommendations.

Med J Aust. 2021 May;214(8):350-354.e1. doi: 10.5694/mja2.51012. Epub 2021 Apr 18.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 57

AUTHORS

JOURNAL

TITLE

REFERENCE

Ng H YK, Tan JHJ, Marceglia AH, Bittinger S, Dundas K, Talia K, Wrede C.H.

ANZJOG

Outcomes of women with positive oncogenic HPV and reflex cytology showing possible high-grade squamous intraepithelial lesion.

Aust N Z J Obstet Gynaecol https://doi.org/10.1111/ ajo.13408

Obermair HM, Bennett K, Brotherton JML, Smith MA, McCaffery KJ, Dodd RH.

ANZJOG

Australian National Cervical Screening Program Renewal: attitudes and experiences of General Practitioners, and Obstetricians and Gynaecologists.

Aust N Z J Obstet Gynaecol. 2021 Jun;61(3):416-423. doi: 10.1111/ajo.13310. Epub 2021 Jan 29.

Palmer M, Katanoda K, Saito E, Martellucci C, Nomura Z, Ota E, Brotherton JML, Hocking J.

Systematic Reviews

National genotype prevalence and age Syst Rev 2021;10: 135. distribution of human papillomavirus https://doi.org/10.1186/ from infection to cervical cancer in s13643-021-01686-6 Japanese women: A systematic review and meta-analysis protocol.

Selenica P, Alemar B, Matrai C, Talia KL, Veras E, Hussein Y, Oliva E, BeetsTan RGH, Mikami Y, McCluggage WG, Kiyokawa T, Weigelt B, Park KJ, Murali R.

Modern Pathology

Massively Parallel Sequencing Analysis of 71 Gastric-Type Cervical Adenocarcinomas Reveals Mutations in Cell Cycle-Related Genes and Rare Potentially Targetable ERBB2 Mutations.

Modern Pathology 2021: 34:1213-1225.

Smith M, Hall M, Saville M, Brotherton Cancer Epidemiol J, Simms K, Lew J-B, Bateson D, Biomarkers Skinner SR, Kelaher M, Canfell K. Prev.

Could HPV testing on self-collected samples be routinely used in an organised cervical screening program? A modelled analysis.

Cancer Epidemiol Biomarkers Prev. 2021 Feb;30(2):268-277. doi: 10.1158/1055-9965.EPI-200998. Epub 2020 Nov 20.

Smith MA, Winch K, Canfell K, Brotherton JM.

Tumour Virus Research

Effective HPV vaccination coverage in Australia by number of doses and two-dose spacing: what if one or two doses are sufficient?

Tumour Virus Res. 2021 Apr 14:200216. doi: 10.1016/j. tvr.2021.200216. Epub ahead of print

Talia KL, Arora R, McCluggage WG.

International Journal of Gynecological Pathology

Precursor Lesions of Cervical Clear Cell Carcinoma: Evidence For Origin From Tubo-Endometrial Metaplasia.

Int J Gynecol Pathol. 2021 Mar 24. doi: 10.1097/ PGP.0000000000000785. Epub ahead of print.

Talia KL, Naaman Y, McCluggage WG.

International Journal of Gynecological Pathology

Uterine Adenosarcoma Originating in Adenomyosis: Report of an Extremely Rare Phenomenon and Review of Published Literature.

Int J Gynecol Pathol 2021 Jul 1;40(4):342348. doi: 10.1097/ PGP.0000000000000709.

Talia KL, Oliva E, Rabban JT, Singh N, Stolnicu S, McCluggage WG.

International Journal of Gynecological Pathology

Grading of Endocervical Adenocarcinomas: Review of the Literature and Recommendations From the International Society of Gynecological Pathologists.

Int J Gynecol Pathol. 2021 Mar 1;40(Suppl 1):S66-S74. doi: 10.1097/ PGP.0000000000000741.

Talia KL, Parra-Herran C, McCluggage WG.

Histopathology Ovarian Mucinous and Seromucinous Neoplasms: Problematic Aspects and Modern Diagnostic Approach.

Woo YL, Gravitt P, Kheng KS, Ng CW, Saville M.

Preventative Medicine

Histopathology. 2021 May 7. doi: 10.1111/his.14399. Online ahead of print.

Accelerating action on cervical Prev Med. 2021 screening in lower- and middle-income Mar;144:106294. doi: countries (LMICs) post COVID-19 era. 10.1016/j.ypmed.2020.106294. Epub 2021 Mar 4.

PAGE 58

OUR PEOPLE

OUR PEOPLE VCS Foundation continued to attract and develop a highly skilled workforce across all business units despite the many challenges of the pandemic. At 30 June 2021, the organisation employed 140 staff comprising of 80 full time, 55 part time and 5 casual appointments. We aim to recruit and retain the best people to deliver our strategy and run our operations. VCS Pathology has been a major driver of both recruitment and skills development as the laboratory continued to offer respiratory testing and diversify into new technology platforms, consistent with our commitment to excellence in laboratory services.

COORDINATING THE WORKFORCE RESPONSE TO THE COVID-19 PANDEMIC The workforce response to the COVID-19 pandemic has continued to be a major priority for VCS Foundation, supporting our operation as an essential service. A range of new policies and procedures have been introduced in the workplace for the prevention of COVID-19 infections during the pandemic. The organisation has continued to operate under a split team Red/Blue team roster for staff working in the office, which was first introduced on 5 May 2020. The roster was specifically designed to ensure business continuity if a staff member was confirmed with COVID-19. The roster effectively reduced the number of staff working in the laboratory by half. Where possible, staff that could work from home have been provided with flexible work arrangements. VCS Foundation directly supported the Victorian Government’s COVID-19 response by seconding our Medical

VCS Foundation continued to support Victorian tertiary students with the opportunity for work experience and on-thejob training through affiliations with various secondary schools, the Royal Melbourne Institute of Technology (RMIT), the University of Melbourne and Swinburne University. Li Shan Ong, RMIT student in the Cytology and Histology laboratory

Director of VCS Population Health, Professor Julia Brotherton, to the Department of Health. Professor Brotherton is a public health physician and epidemiologist and made a valuable contribution to State Government during this challenging time. There has been excellent uptake of COVID-19 vaccinations by VCS Foundation employees. At the end of the financial year, 73% of staff were fully vaccinated. Overall, our aim is to have all eligible VCS Foundation employees vaccinated with second dose vaccines by mid-July 2021.

TO DATE 73% OF VCS FOUNDATION STAFF ARE FULLY VACCINATED AGAINST COVID-19, SUPPORTING VCS PATHOLOGY’S OPERATION AS AN ESSENTIAL SERVICE There were six RMIT students participating in the 16-week program in the Cytology and Histology work area at VCS Pathology as part of the Master of Laboratory Medicine qualification. One RMIT student participated in a 40-week program in the Cytology and Histology area as part of the qualification for Bachelor of Laboratory Medicine.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 59

DIVERSITY AND INCLUSION VCS Foundation is an equal opportunity employer, consistent with our values of Fairness, Integrity, Respect and Excellence. We recognise that a diverse and inclusive workforce promotes safety, productivity and wellbeing benefits, and underpins our ability to attract new employees. VCS Foundation employs, develops and promotes based on the strengths of an individual. We do not tolerate any form of discrimination, bullying, harassment, exclusion or victimisation. Our Disciplinary Policy and Procedure received a major update in the reporting year. We have continued to provide training to all staff in the financial year to support an inclusive culture and respectful workplace. Our engagement with the Victorian Aboriginal Community Controlled Health Organisation continued with Cultural Safety Training delivered to 15 VCS Foundation staff.

WORKFORCE COMPLIANCE AND SAFETY TRAINING The 2020/21 year saw the successful launch of on-line compliance training to all staff, students and contractors. This acknowledged the necessity for new COVID-19 safe training options which were accessible to all staff, including staff in flexible working arrangements. Compliance training delivered included in the year included Anti-bullying, Discrimination, Cybersecurity, Privacy and Equal Opportunity (employees and managers). In addition, new customised training was delivered to staff and managers on COVID-19 safety compliance and supporting the return to work. For Executives and members of the Corporate Services team, Whistleblower and Fraud training was also conducted. The training was delivered with support from Safetrac.

The year ahead will see the inclusion of customised training in the new VCS Foundation Social Media Policy which was introduced in June 2021. Internal audits were also conducted to confirm our compliance with annual staff confidentiality deeds. Compliance certifications has now transitioned into an online system with automated reminders.

GENDER EQUALITY VCS Foundation embraces the opportunity to provide all employees with the same rewards, recognition, resources and career opportunities for success, regardless of gender. The organisation has long established history of gender equality which is inclusive of a strong female workforce. In the 2020/21 year, our workforce comprised of 72% female employees and 28% male employees. Our Executive Management team comprised of 86% female Executives and 14% male Executives, with 63% of VCS Foundation Board Directors being female and 37% male. In light of the pandemic, our reporting to the Workforce Gender Equality Agency was postponed to the new deadline of August 2021. The organisation continues to actively eliminate discrimination based on gender.

PERFORMANCE, LEARNING AND DEVELOPMENT VCS Foundation continues to encourage and support the career development of employees across the organisation. We recognise that the training of our staff is critical to employee engagement and retention, providing the basis for both succession planning and achieving our strategy. Continuing from the previous year, efforts continued towards upskilling our multidisciplinary VCS Pathology team and introducing flexibility into our workforce. Training opportunities were also provided to our laboratory staff in new assays and equipment platforms for SARS-CoV-2 analysis, the causative agent of COVID-19, cytology, histology and dual stain applications. Training was provided in-house and through accredited training providers. VCS Foundation has continued to utilise its contemporary VESSPA online appraisal system during the financial year for performance appraisals. A major goal for the year ahead will be transitioning to a new payroll, time management and employee self-service system with improved functionality, usability and accessibility.

PAGE 60

OUR PEOPLE

TOTAL WORKFORCE

EMPLOYMENT TYPES Total Staff

FTE

Full Time

Part Time

Casual

120

250

100

200

80 150 60 100 40 50

0 2016/17

2017/18

2018/19

2019/20

2020/21

Total Staff

2016/17

2017/18

FTE

2018/19

Full Time

2019/20

2020/21

Part Time

Casual

150

250 200

100

150

WORKFORCE GENDER BALANCE

AGE WORKFORCE DEMOGRAPHICS 2020/21

100 Men

Women

50 120 0 100

0 2014/15

2015/16

2016/17

2017/18

2018/19

2014/15

2015/16

2016/17

2017/18

20-35 years 36-50 years 51-65 years 66+ years 2018/19

20-35 year 36-50 year 51-65 year 66+ years

80 60 40 20 0 2016/17

2017/18

2018/19

2019/20

2020/21

VCS FOUNDATION LTD. ABN 35 430 554 780

TOTAL WORKFORCE FTE (including casuals)

PAGE 61

2016/17

2017/18

2018/19

2019/20

2020/21

Full Time Equivalent

147

126

120

115

Total Staff

181

166

154

146

140

2016/17

2017/18

2018/19

2019/20

2020/21

Full Time

107

102

Part Time

Casual

2016/17

2017/18

EMPLOYMENT TYPES

WORKFORCE COMPOSITION

2018/19

2019/20

2020/21

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

Board Members

Executive Directors/ Directors (Salaried)

Managers

Medical Professionals

Other Professionals

Scientific / Laboratory Technical staff

Operational and Administration

TOTAL

149

133

122

111

101

WORKFORCE GENDER %

2016/17

2017/18

2018/19

2019/20

2020/21

Women

Men

2016/17 %

2017/18 %

2018/19 %

2019/20 %

2020/21 %

17–19 Years

20–35 Years

36–50 Years

51–65 Years

66+ Years

WORKFORCE AGE DEMOGRAPHIC

PAGE 62

OH&S, FREEDOM OF INFORMATION, PRIVACY, WHISTLEBLOWERS PROTECTION, RISK MANAGEMENT

OCCUPATIONAL HEALTH AND SAFETY

FREEDOM OF INFORMATION

WHISTLEBLOWERS PROTECTION

VCS Foundation’s comprehensive health and wellbeing approach assists the organisation to support the physical and mental wellbeing of all employees. During the year, we continued to identify ways to best support our staff by undertaking a range of health and safety initiatives. This included mental health first aid training, COVID-19 Safety training, facilitating access to COVID-19 vaccinations for our essential workers, flu vaccinations, safe driver training for our courier staff team and the promotion of mental health support.

VCS Foundation is not directly subject to the Freedom of Information (FOI) Act 1982. While some of the organisation's government funded activities may be the subject of FOI requests, these requests should be made to the relevant government department for assessment.

VCS Foundation is committed to the highest standards of legal, ethical and moral behaviour. The organisation seeks to maintain an operating environment where legitimate misconduct concerns can be reported without fear of retaliatory actions or retribution, and are managed expeditiously, confidentially and appropriately.

The services of the Employee Assistance Program continued to be utilised by our employees, with a total of 14 sessions provided in the financial year. This is a decrease from the previous year and likely reflects that staff have settled into the many challenges associated with the COVID-19 pandemic. VCS Foundation staff are regularly encouraged to reach out to this service if they are experiencing mental health difficulties. All sessions are confidential and provided by an external counsellor. Lost Time Injury Frequency Rate (LTIFR) rates totalled 60.32 for the financial year, a decrease from 97.92 in 2019/20. LTIFR is calculated by the number of lost time injuries per million hours worked in the quarter. Only one incident in the year resulted in a WorkSafe claim. Our approach to internal incident reporting was strengthened by updates to our Accident/Incident Reporting Procedure and Form. The Health and Safety Committee continued to meet in accordance with legislative requirements, evidencing our commitment to the health and wellbeing of our workforce and excellence in safety management and best practices. Health and Safety at VCS Foundation is underpinned by a genuine care for our employees, in alignment with our corporate values of Fairness, Integrity, Respect and Excellence.

PRIVACY VCS Foundation understands the importance of protecting the privacy and confidentiality of all personal and health information that is held by the organisation. VCS Foundation collects a range of personal and health information about individuals. VCS Foundation may collect this information from the individual or from another person dealing with that individual, such as their healthcare practitioner. The type of information that VCS Foundation collects and the way in which it may use and disclose that information varies according to the services, activities and programs VCS Foundation provides or undertakes in relation to an individual. VCS Foundation has strict privacy and confidentiality practices in place and all staff are required to abide by these. A Disciplinary Policy and Procedure is in place to ensure staff comply with these practices. All persons who may observe personal and health information held by VCS Foundation are required to sign a confidentiality statement annually. All personal and health information is stored on the premises of VCS Foundation or in cloud-based storage. Backup tapes of the information system and some slides are stored in a secure facility off-site. Where services are contracted out, contractors must comply with VCS Foundation privacy and confidentiality requirements if any personal information is provided to them. Our Privacy Policy was updated in June 2020 and is available at www.vcs.org.au/ privacy-policy

VCS Foundation’s Whistleblower Policy is compliant with the new whistleblower reforms under Part 9.4AAA of the Corporations Act 2001 (Cth). Compliance training in whistleblower protections was delivered to all members of the Executive and Corporate Services teams in early 2021.

RISK MANAGEMENT VCS Foundation records, monitors and reports on risks using the software RiskWare™ which is compliant with ISO 45001:2018 and ISO 31000:2018. The Board of Directors are provided with Quarterly Risk Reports and are immediately notified if a risk is escalated to a High or Extreme rating. The Risk Management Policy and Risk Management Procedure were updated and approved by the Board in May 2020. A continued focus of risk management throughout the year related to controlling the impacts from COVID-19. The VCS Foundation Enterprise Risk Register identified 83 active risks at the end of the 2020/21 financial year. There were no High/Extreme risks at the end of the year compared with one High/Extreme risk at the end of 2019/20 relating to ‘COVID-19 infection in VCS Foundation staff’. The introduction of COVID-19 vaccines, split team rosters, mandatory face masks and various policies and procedures around infection control, have all been major controls in the prevention of infections and supporting a safe work environment.

VCS FOUNDATION LTD. ABN 35 430 554 780

Throughout the year, there was a continued focus on consolidating risks wherever possible, ensuring that risks aligned with our changing business operations and captured the structural and strategic changes occurring across the organisation. Rating

2020/21 2019/20 2018/19

High/ Extreme

Major

Significant

Moderate/ Low

Total

PAGE 63

ACCREDITATION

QUALITY ASSURANCE

VCS Foundation meets the relevant regulatory requirements as necessary by the National Association of Testing Authorities (NATA) for Australian Laboratories reporting under the National Cervical Screening Program (NCSP).

Since its establishment in 1964, VCS Foundation has always regarded the provision of a quality service as the most important aspect of its operation. The Executive Director of VCS Foundation and our staff remain fully committed to the organisation as a Centre of Excellence in cervical screening tests and registry services.

NATA last conducted a Surveillance visit of the VCS Pathology laboratory on 21 August 2019. The outcomes of the surveillance visit were extremely positive, reflecting our commitment to high quality and excellence in pathology governance. A full technical assessment of the laboratory by NATA is scheduled for late 2021. VCS Pathology is committed to meeting all relevant industry standards including the various requirements of NATA, National Pathology Accreditation Advisory Council (NPAAC), the Royal College of Pathologists Australasia (RCPA) and VCS Foundation insurance agencies.

Our quality system comprises the structure, objectives and policies of VCS Foundation and the description of work practices and procedures that promote a high quality of operation in all aspects of our work. Thus, the quality system forms the basis on which the pathology laboratory and registries operate. All staff embrace an ethos of quality improvement and a customer focus. We have a broad perspective of our customer base, seeing this as comprising the health practitioners who send us pathology samples for reporting, the community members from whom the samples are taken, the participants recorded on our registries, and our funding providers. VCS Foundation is committed to meeting all relevant industry standards, including AS ISO 15189:2012 and the various requirements of NATA, NPAAC, the RCPA and our insurers.

2020/21 RISK ATTESTATION STATEMENT I, Marion Saville, certify that VCS Foundation Ltd. has appropriate risk management processes in place consistent with the AS ISO 31000:2018 and has an internal control system in place that enables the Executive Management team to understand, manage and satisfactorily control risk exposures. The Audit and Finance Committee verifies this assurance and that the risk profile of VCS Foundation Ltd. has been critically reviewed within the last 12 months. Professor Marion Saville, AM VCS Foundation Ltd. Executive Director Fiona Kelly Chair, VCS Foundation Ltd. Audit & Finance Committee

Quality system activities are coordinated by the Quality Officers under the guidance of the Executive Director of VCS Foundation. These activities are supported by the quality management software Q-Pulse, which is designed to support key elements of the Quality System. Activities were undertaken in the financial year to support the transition to Q Pulse in the cloud, with the system expected to be fully implemented in early 2022.

PAGE 64

VCS FOUNDATION LTD. ACN 609 597 408

THE VCS FOUNDATION BOARD SETS, APPROVES AND MONITORS THE STRATEGIC DIRECTION OF VCS FOUNDATION

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 65

DIRECTORS REPORT The Directors present their report on VCS Foundation Limited (“the Company”) for the financial year ended 30 June 2021. VCS FOUNDATION BOARD OF DIRECTORS The role of the VCS Foundation Board of Directors is to: + Set, approve and monitor the strategic direction of VCS Foundation + Take responsibility for the overall performance of the organisation including appointing and managing the performance of the Executive Director, monitoring and working in the best interests of the stakeholders. + Monitor and minimise the risks to VCS Foundation + Establish and approve Board policies + Comply with the Constitution of VCS Foundation, State and Federal Laws, Directors’ and insurance responsibilities

The Audit and Finance Committee (a subcommittee of the Board) is responsible for: + Advising the Board on matters relating to the financial strategies and policies, the financial performance, viability, sustainability and capital management. + Reviewing the quality of internal financial reporting to the Board + Ensuring effective governance and financial stewardship in order to assist directors in discharging their responsibility to exercise due care and diligence in relation to: - the selection and application of accounting policies in line with accounting standards and legislation - financial reporting, and - management and internal control procedures + Ensuring the effectiveness and independence of external audit function + Applying appropriate risk management processes contributing to improving the risk management culture in the organisation

The Quality Assurance Committee (a subcommittee of the Board) is chaired by the Executive Director. It uses statistical analyses to monitor of a range of activities including performance targets in the scientific, registries, administration and clerical areas, audits, non-conformances and document control. Results of the activities are presented at the Quality Assurance Committee meetings and any actions identified are assigned and reported. Detailed reports of findings are presented to the Board on a quarterly basis.

PAGE 66

DIRECTORS' REPORT

CHAIRMAN Mr Tim Humphries

VICE CHAIRMAN Mr David Wrede

Mr Tim Humphries - Chairman Mr Tim Humphries was elected Chairman at the 2020 AGM and was previously the Chairman of the Audit and Finance Committee. Mr Humphries joined the Board in 2012 as a Director with expertise in Finance, Commerce or Corporate Management. Mr Humphries holds a Bachelor of Commerce from Flinders University, and Master of Business Administration (MBA) from Deakin University. He is a member of the Certified Practising Accountants (CPA) Australia. Mr Humphries brings a wealth of experience with a career spanning more than 20 years in senior Accounting and Finance roles, and CEO, a position he currently holds. His broad finance experience is complemented with HR, IT, corporate governance, sales and Project Management skills developed in a wide range of industries including health, aged care, transport and logistics, materials handling, recruitment, and not-for-profit sectors in Australia. Mr David Wrede – Vice Chairman Mr David Wrede was appointed to the Board in May 2010 as the Director with gynaecological expertise and was appointed Vice Chairman in 2017. Mr Wrede studied medicine at Cambridge University and St. Thomas’ Hospital London. His post-graduate training was in General Surgery and Obstetrics &

CHAIR AUDIT AND FINANCE COMMITTEE Ms Fiona Kelly

Gynaecology and included two years research into Cervical Cancer and HPV at the St. Mary’s branch of the Ludwig Institute. Previous appointments in the UK’s National Health Service include Consultant posts with interests in Gynaecological Cancer, Minimal Access Surgery and Colposcopy in Scotland and England. Since moving to Australia, his main clinical focus has been in gynaecological cancer prevention at The Royal Women’s Hospital. He is the clinical lead for the Dysplasia (Colposcopy) services at the Womens' and Box Hill Hospitals. His research profile includes being an investigator on a number of cervical cancer screening projects including COMPASS (led by Prof Marion Saville and Prof Karen Canfell), iPAP (led by A/Prof Dorota Gertig) & EXCISE (co-led with A/Prof Paul Cohen) and he is also an Associate Investigator with the NHMRC Centre of Research Excellence for Cervical Cancer Control. He a member of the Clinical Guidelines Working Group for the renewed National Cervical Cancer Screening Program and past Secretary of the Management Committee of the Australian Society for Colposcopy & Cervical Pathology. Mr Wrede is an Honorary Consultant to the Familial Centre Clinic on the Parkville Precinct and Honorary Senior Lecturer to the Department of O&G at the University of Melbourne.

Mr Antonio (Tony) Abbenante

Ms Fiona Kelly – Chair Audit and Finance Committee Ms Fiona Kelly was appointed to the Board in March 2017 as a Director with expertise in Finance, Commerce and Corporate Management and was appointed Chairman of the Audit and Finance Committee at the 2020 AGM. Ms Kelly holds a Bachelor of Economics from Monash University and a Master of Business Administration from the University of Melbourne and is a member of Chartered Accountants Australia and New Zealand. Ms Kelly has extensive leadership and management experience from a broad range of senior roles in the professional services and not-forprofit sectors. With a focus on financial leadership, business performance and operational excellence, this experience spans the areas of finance, HR, legal, management of support services (including IT, property management and procurement), project management, technology implementation and organisational development. She is also a Board member of Carey Baptist Grammar School. Mr Antonio (Tony) Abbenante Mr Tony Abbenante was appointed to the board in October 2018 as a Director with wide expertise in Information Technology and Communications. He has specialist knowledge and experience in enterprise-wide digital

VCS FOUNDATION LTD. ABN 35 430 554 780

Dr Jane Collins

Ms Stephanie Reeves

health. Mr Abbenante holds a Bachelor of Applied Science in Computer Studies from the University of South Australia and is a fellow of the Australian Institute of Digital Health. He has broad experience in governing national and state-wide programs; this provides a wealth of experience and knowledge to the VCS. His career spans more than 27 years in senior digital health roles and he has extensive experience with government. Tony has deep knowledge and experience in sector delivery, governance and digital health outcomes that deliver value-based clinical and business outcomes to the health sector. Dr Jane Collins Dr Jane Collins was Chairman in 2019/20, a position she also held from 2009-2013. Dr Collins was appointed to the Board in February 2008 to fill the role of a Director with expertise in General Practice. Dr Collins is an experienced General Practitioner, business owner and freelance medical writer. She has a special interest in women’s health as well as the provision and organisation of health care in the wider community. Dr Collins is a co-owner and the Clinical Director of the Clifton Hill Medical Group, an inner urban general practice comprising 10 general practitioners. Ms Stephanie Reeves Ms Stephanie Reeves joined the Board in February 2014 as a Director

Dr Christine Selvey

with expertise in Law. She served as Chairman from 2017 to 2019 and was a member of the Audit and Finance Subcommittee of the Board from 2015 - 2020. Ms Reeves has worked as an in-house legal counsel for both small and large ASX Listed companies for many years. She is now Co-Principal of a consultancy business assisting families navigate the ageing process. She is also a Non-Executive Director of the Royal Automobile Club of Victoria (RACV) and is on the Council of the Royal Melbourne Golf Club. Stephanie has previously been a member of the Melbourne Cricket Ground Trust, on the Advisory Board of a start-up law firm, Lexvoco, and a Non-Executive Director and Chairman of Crime Stoppers Victoria. Stephanie has a particular interest in corporate governance in both the commercial and not-for-profit sectors. Dr Christine Selvey Dr Christine Selvey was appointed to the Board in September 2012 as the Director with immunisation expertise. Dr Selvey has had responsibility for the implementation of state immunisation programs in Queensland, the Northern Territory and Victoria. She was a member of the National Immunisation Committee (NIC) from 1999-2007 and has been both the NIC and the Communicable Diseases Network Australia (CDNA) representative on the Australian Technical Advisory Group on Immunisation (ATAGI). Dr Selvey

PAGE 67

Ms Genevieve Webb

has a particular interest in HPV vaccination and was a member of two ATAGI working groups that provided recommendations on the use of HPV vaccines in Australia. With her experience in managing immunisation programs in the two Australian jurisdictions with immunisation registers, and her experience with the Australian Childhood Immunisation Register, Dr Selvey brings a good understanding of the operation of immunisation registers to the Board. Ms Genevieve Webb Ms Genevieve Webb joined the Board in 2019, as a Director with a consumer perspective. Genevieve is a senior executive with extensive experience in health and human services. Her most recent position was Director Quality at BreastScreen Victoria, where she led the client centric care and consumer engagement program. Her previous roles include CEO of Queen Victoria Women’s Centre, GM Corporate Services at Mind, Executive Director of Relationships Australia (Vic) and Associate Director at KPMG. Genevieve has extensive experience in organisational governance, as Chair of the Audit Committee at the State Revenue Office (Vic) and as a board member of a community health service, a TAFE college and other community organisations. She has qualifications in Psychology and IT and is a Fellow of the Australian Institute of Company Directors.

PAGE 68

DIRECTORS' REPORT

DIRECTORS' REPORT MEMBERS GUARANTEE

PRINCIPAL ACTIVITES

VCS Foundation was incorporated under the Corporations Act 2001 on 3 December 2015 and is a company limited by guarantee. If the company is wound up, the constitution states that each member is required to contribute a maximum of $10 each towards meeting any outstanding obligations. At 30 June 2021, the total amount that members of the company are liable to contribute if the company is wound up is $100 (2021: $0).

The principal activity of VCS Foundation during the financial year was to provide public health services, including laboratory and registry services, supporting screening and vaccination.

COMPANY SECRETARY In accordance with the constitution, the person appointed as the Executive Director shall also be the Company Secretary. The Executive Director, Professor Marion Saville AM, has held the position of Company Secretary for the year.

SIGNIFICANT CHANGES TO STATE OF AFFAIRS The COVID-19 pandemic brought about challenges and opportunities for VCS Foundation. Our work in underscreened communities outside of Australia continued to be postponed as these countries battled to bring the virus under control. Our laboratory maximising opportunities for SARSCoV-2 testing. As an essential service, VCS Foundation continued its laboratory and follow-up services while taking proactive steps to minimise risks from COVID-19 infection in the workplace.

The split team roster for staff working in the laboratory and flexible work arrangements have supported business continuity and our ability to continue to process COVID-19 and cervical screening samples with no delay in results to patients.

OPERATING RESULTS The consolidated net result for VCS Foundation for the financial year ending 30 June 2021 was a surplus of $5.107M after taking into account depreciation and amortisation. The surplus was well above budget and reflects the collective efforts of the VCS Pathology team in maximising opportunities for COVID-19 testing and the Executive Team in securing new projects and funding, building on strong relationships with a range of stakeholders.

BOARD MEETINGS ATTENDED 2020/21 Board Meetings Attended

Total Number of Board Meetings

8 7 6 5 4 3 2 1 0 Jane Collins

Stephanie Reeves

David Tim Wrede Humphries

Fiona Kelly

Genevieve Christine Anthony Webb Selvey* Abbenante

* Christine Selvey has temporarily absented from Board activities due to her work on the COVID-19 pandemic

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 69

AUDITOR’S INDEPENDENCE DECLARATION PECUNIARY INTEREST

MEETINGS OF THE BOARD AND ITS COMMITTEES

During the 2020/21 financial year, no Board Director declared a conflict of pecuniary interest in a contract with VCS Foundation.

The following meetings were held during 2020/21: + The Members of the organisation met at the Annual General Meeting 20 November 2020

DECLARATION OF INTEREST During 2020/21 the following Board Members noted their involvement with the Compass Trial:

+ The Board of Directors met on seven occasions either in person or via teleconference/Zoom

Mr David Wrede: Principal investigator – Compass Trial

+ The Board’s Audit and Finance Committee met on five occasions, and

Dr Jane Collins: Investigator – Compass Trial

+ The Board’s Quality Assurance Committee met on 11 occasions for Scientific Quality and four occasions for Operational Quality.

AUDIT AND FINANCE COMMITTEE MEETINGS ATTENDED 2020/2021 Meetings Attended

Number of Meetings

8 7 6 5 4 3 2 1 0 Jane Collins**

Stephanie Reeves**

David Wrede

Tim Humphries

Fiona Kelly

*New Committee Members appointed at 2020 AGM ** Term finished 2020 AGM

Genevieve Webb

The external auditor’s independence declaration for the year ended 30 June 2021 has been received and can be found on page 93 of the financial report. This directors’ report is signed in accordance with a resolution of the Board of Directors. Director Timothy Humphries Dated 22nd November 2021

PAGE 70

FINANCIAL STATEMENTS

VCS PATHOLOGY CONTINUED TO MAINTAIN ITS TARGETED MARKET SHARE FOR HPV TESTS, REPORTING ALMOST 50% OF ALL CERVICAL SCREENING TESTS IN VICTORIA. FURTHER NEW INVESTMENT INTO AUTOMATED TESTING INSTRUMENTATION HAS CONTINUED TO IMPROVE PRODUCTIVITY IN THE LABORATORY, ALSO TRANSLATING INTO SALARY COST SAVINGS.

VCS FOUNDATION LTD. ABN 35 430 554 780

FINANCIAL STATEMENTS 72 Statement of Profit or Loss and other Comprehensive Income 73 Statement of Financial Position 74 Statement of Changes in Equity 75 Statement of Cash Flows 76 Notes to the Financial Statements 92 Directors’ Declaration 93 Independent Auditor's Declaration 94 Independent Auditor's Report

PAGE 71

PAGE 72

FINANCIAL STATEMENTS

VCS FOUNDATION LIMITED ABN 35 430 554 780 Auditor's Independence Declaration under Section 60 40 of the Australian Charities and Not for profits Commission Act 2012 to the Responsible Persons of VCS Foundation Limited and Controlled Entities

STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME FOR THE YEAR ENDED 30 JUNE 2021 Note

2021

2020

Revenue from operating activities

31,255,235

26,109,406

Revenue from non-operating activities

137,587

496,307

Wages and salaries

(14,138,657

(14,926,579)

Operating and administration costs

(4,815,693)

(4,569,273)

Laboratory Consumables

(6,389,678)

(4,041,829)

(59,230)

(81,247)

5,989,564

2,986,785

163,625

(1,045,700)

(1,469,270)

(5,672)

(882,075)

(1,474,942)

5,107,489

1,511,843

Items that will not be reclassified subsequently to profit or loss

Items that will be reclassified to profit or loss when specific conditions are met

5,107,489

1,511,843

Interest expense Net result before capital items and specific items

Capital purpose income Depreciation and amortisation expense Loss on sale of non-current assets

Surplus for the year

Other comprehensive income, net of income tax

Total comprehensive income for the year The accompanying notes form part of these financial statements.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 73

STATEMENT OF FINANCIAL POSITION AS AT 30 JUNE 2021 Note ASSETS CURRENT ASSETS

2021

2020

Cash and cash equivalents

2,448,912

9,870,175

Trade and other receivables

4,744,270

2,097,385

Inventories

876,773

683,608

Other financial assets

16,124,347

12,011,649

Other assets

609,610

413,932

24,803,912

25,076,749

91,905

Right-of-use assets

761,667

1,245,367

Property, plant and equipment

2,092,017

1,324,983

Intangible assets

3,312,310

1,061,406

6,257,899

3,723,661

31,061,811

28,800,410

1,450,073

1,429,316

10(b)

463,026

428,202

Contract liabilities

395,035

2,917,362

Employee benefits

4,091,643

3,901,694

Other liabilities

7,800

42,300

6,407,577

8,718,874

10(b)

523,112

986,138

357,057

428,822

880,169

1,414,960

7,287,746

10,133,834

23,774,065

18,666,576

Total current assets NON-CURRENT ASSETS Other assets

Total non-current assets Total assets LIABILITIES CURRENT LIABILITIES Trade and other payables Lease liabilities

Total current liabilities NON-CURRENT LIABILITIES Lease liabilities Employee benefits Total non-current liabilities Total liabilities Net assets EQUITY Reserves

336,060

Accumulated surplus

23,774,065

18,330,516

23,774,065

18,666,576

Total Equity The accompanying notes form part of these financial statements.

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FINANCIAL STATEMENTS

STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED 30 JUNE 2021 Note

Accumulated

Designated

surplus

funds reserve

Total

18,17

18,330,516

336,060

18,666,576

5,107,489

Amortisation of database upgrade (Phases 1 and 2)

18,17

336,060

(336,060)

Balance at 30 June 2021

18,17

23,774,065

18,17

16,337,936

736,919

17,074,855

79,878

16,417,814

736,919

17,154,733

1,511,843

Amortisation of database upgrade (Phases 1 and 2)

18,17

400,859

(400,859)

Balance at 30 June 2020

18,17

18,330,516

336,060

18,666,576

2021 Balance at 1 July 2020 Surplus for the year

2020 Balance at 1 July 2019 Adjustment on initial application of AASB 16 Adjusted balance at 1 July 2019 Surplus for the year

The accompanying notes form part of these financial statements.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 75

STATEMENT OF CASH FLOWS FOR THE YEAR ENDED 30 JUNE 2021 Note

2021

2020

1,234,299

5,680,489

128,934

374,586

24,958,189

17,218,872

- Payments for wages and salaries

(13,975,254)

(15,897,704)

- Payments to suppliers

(11,601,682)

(9,691,104)

(59,230)

(81,247)

685,256

(2,396,108)

Proceeds from sale of plant and equipment

14,318

137,774

Purchase of property, plant and equipment

(3,579,937)

(983,074)

(Payments for)/redemption of term deposits

(4,112,698)

1,712,826

Net cash provided by/(used in) investing activities

(7,678,317)

867,526

Repayment of lease liabilities

(428,202)

(353,172)

Net cash provided by/(used in) financing activities

(428,202)

(353,172)

(7,421,263)

(1,881,754)

9,870,175

11,751,929

2,448,912

9,870,175

CASH FLOWS FROM OPERATING ACTIVITIES Receipts: - Receipts from trading activities - Interest received - Receipts from grants Payments:

- Interest Paid Net cash provided by/(used in) operating activities

CASH FLOWS FROM INVESTING ACTIVITIES

CASH FLOWS FROM FINANCING ACTIVITIES

Net increase/(decrease) in cash and cash equivalents held Cash and cash equivalents at beginning of year Cash and cash equivalents at end of the financial year The accompanying notes form part of these financial statements.

5(a)

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FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 The financial report covers VCS Foundation Limited, a Company registered on 3 December 2015 in Victoria under the Corporations Act 2001 (previously registered as Victorian Cytology Service Inc., an Association incorporated on 3 September 1991 in Victoria under the Associations Incorporation Reform Act, 2012 (Vic)). In accordance with section 601BM of the Corporations Act 2001, this change does not create a new legal entity. The Company is registered with the Australian Charities and Not‑for‑profit Commission (ABNC) and is therefore also required to comply with the Australian Charities and Not‑for‑profits Commission Act 2012.

Generally the timing of the payment for sale of goods and rendering of services corresponds closely to the timing of satisfaction of the performance obligations, however where there is a difference, it will result in the recognition of a receivable, contract asset or contract liability. None of the revenue streams of the Company have any significant financing terms as there is less than 12 months between receipt of funds and satisfaction of performance obligations. Specific revenue streams

The functional and presentation currency of VCS Foundation Limited is Australian dollars.

The revenue recognition policies for the principal revenue streams of the Company are:

Comparatives are consistent with prior years, unless otherwise stated.

Rendering of services

1 BASIS OF PREPARATION The financial statements are general purpose financial statements that have been prepared in accordance with the Australian Accounting Standards and the Australian Charities and Not for profits Commission Act 2012. The Company is a not for profit entity and therefore applies the additional paragraphs applicable to "not for profit" organisations under the Australian Accounting Standards (“AAS”). The financial statements, except for the cash flow information, have been prepared on an accruals basis and are based on historical costs modified, where applicable, by the measurement at fair value of selected non current assets, financial assets and financial liabilities. Significant accounting policies adopted in the preparation of these financial statements are presented below and are consistent with prior reporting periods unless otherwise stated.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

(A) REVENUE AND OTHER INCOME Revenue from contracts with customers The core principle of AASB 15 is that revenue is recognised on a basis that reflects the transfer of promised goods or services to customers at an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. Revenue is recognised by applying a five step model as follows: 1. Identify the contract with the customer 2. Identify the performance obligations 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations 5. Recognise revenue as and when control of the performance obligations is transferred

Revenue from provision of services is recognised in the accounting period in which the services are rendered. For fixed price contracts, revenue is recognised based on the actual services provided to the end of the reporting period as a proportion of the total services to be provided as the customer receives and uses the benefit simultaneously. Statement of financial position balances relating to revenue recognition Contract assets and liabilities Where the amounts billed to customers are based on the achievement of various milestones established in the contract, the amounts recognised as revenue in a given period do not necessarily coincide with the amounts billed to or certified by the customer. When a performance obligation is satisfied by transferring a promised good or service to the customer before the customer pays consideration or the before payment is due, the Company presents the contract as a contract asset, unless the Company's rights to that amount of consideration are unconditional, in which case the Company recognises a receivable. When an amount of consideration is received from a customer prior to the entity transferring a good or service to the customer, the Company presents the contract as a contract liability. Grant revenue Government grants are recognised at fair value where there is reasonable assurance that the grant will be received and all grant conditions will be met. Grants relating to expense items are recognised as income over the periods necessary to match the grant to the costs they are compensating. Grants relating to assets are credited to deferred income at fair value and are credited to income over the expected useful life of the asset on a straight line basis.

VCS FOUNDATION LTD. ABN 35 430 554 780

Interest income Interest income is recognised on a proportional basis taking into account the interest rates applicable to the financial assets, using the effect interest rate method.

PAGE 77

index upon which the lease payments are based (e.g. CPI) or a change in the Company's assessment of lease term.

Other income

Where the lease liability is remeasured, the right of use asset is adjusted to reflect the remeasurement or is recorded in profit or loss if the carrying amount of the right of use asset has been reduced to zero.

Other income is recognised on an accruals basis when the Company is entitled to it.

Adoption of short term leases or low value asset exception Exceptions to lease accounting

(B) LEASES At inception of a contract, the Company assesses whether a lease exists i.e. does the contract convey the right to control the use of an identified asset for a period of time in exchange for consideration. This involves an assessment of whether: • The contract involves the use of an identified asset – this may be explicitly or implicitly identified within the agreement. If the supplier has a substantive substitution right then there is no identified asset. • The Company has the right to obtain substantially all of the economic benefits from the use of the asset throughout the period of use. • The Company has the right to direct the use of the asset i.e. decision making rights in relation to changing how and for what purpose the asset is used. Lessee accounting The non lease components included in the lease agreement have been separated and are recognised as an expense as incurred. Right of use asset At the lease commencement, the Company recognises a right of use asset and associated lease liability for the lease term. The lease term includes extension periods where the Company believes it is reasonably certain that the option will be exercised. The right of use asset is measured using the cost model where cost on initial recognition comprises of the lease liability, initial direct costs, prepaid lease payments, estimated cost of removal and restoration less any lease incentives received. The right of use asset is depreciated over the lease term on a straight line basis and assessed for impairment in accordance with the impairment of assets accounting policy. Lease liability The lease liability is initially measured at the present value of the remaining lease payments at the commencement of the lease. The discount rate is the rate implicit in the lease, however where this cannot be readily determined then the Company's incremental borrowing rate is used. Subsequent to initial recognition, the lease liability is measured at amortised cost using the effective interest rate method. The lease liability is remeasured whether there is a lease modification, change in estimate of the lease term or

The Company has elected to apply the exceptions to lease accounting for both short term leases (i.e. leases with a term of less than or equal to 12 months) and leases of low value assets. The Company recognises the payments associated with these leases as an expense on a straight line basis over the lease term.

(C) BORROWING COSTS Borrowing costs are recognised as an expense in the period in which they are incurred. (D) INCOME TAX The Company is exempt from income tax under Division 50 of the Income Tax Assessment Act 1997.

(E) CASH AND CASH EQUIVALENTS Cash and cash equivalents comprise cash on hand, deposits held at call with banks and other short term highly liquid investments with original maturities of three months or less, which are readily convertible to known amounts of cash and are subject to insignificant risk of changes in value. Bank overdrafts also form part of cash equivalents for the purpose of the statement of cash flows and are presented within current liabilities on the statement of financial position.

(F) FINANCIAL INSTRUMENTS Financial instruments are recognised initially on the date that the Company becomes party to the contractual provisions of the instrument. On initial recognition, all financial instruments are measured at fair value plus transaction costs (except for instruments measured at fair value through profit or loss where transaction costs are expensed as incurred). Financial assets All recognised financial assets are subsequently measured in their entirety at either amortised cost or fair value, depending on the classification of the financial assets. Classification On initial recognition, the Company classifies its financial assets into the following category, those measured at: • amortised cost. Financial assets are not reclassified subsequent to their initial recognition unless the Company changes its business model for managing financial assets.

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FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 Amortised cost Assets measured at amortised cost are financial assets where: • the business model is to hold assets to collect contractual cash flows; and • the contractual terms give rise on specified dates to cash flows are solely payments of principal and interest on the principal amount outstanding. The Company’s financial assets measured at amortised cost comprise trade and other receivables, cash and cash equivalents and term deposits in the statement of financial position. Subsequent to initial recognition, these assets are carried at amortised cost using the effective interest rate method less provision for impairment. Interest income, foreign exchange gains or losses and impairment are recognised in profit or loss. Gain or loss on derecognition is recognised in profit or loss. Impairment of financial assets Impairment of financial assets is recognised on an expected credit loss (ECL) basis for the following assets: • financial assets measured at amortised cost. When determining whether the credit risk of a financial asset has increased significantly since initial recognition and when estimating ECL, the Company considers reasonable and supportable information that is relevant and available without undue cost or effort. This includes both quantitative and qualitative information and analysis based on the Company's historical experience and informed credit assessment and including forward looking information. The Company uses the presumption that an asset which is more than 30 days past due has seen a significant increase in credit risk. The Company uses the presumption that a financial asset is in default when: • the other party is unlikely to pay its credit obligations to the Company in full, without recourse to the Company to actions such as realising security (if any is held); or • the financial assets is more than 90 days past due.

estimation of lifetime expected credit losses. The Company has determined the probability of non payment of the receivable and multiplied this by the amount of the expected loss arising from default. The amount of the impairment is recorded in a separate allowance account with the loss being recognised in finance expense. Once the receivable is determined to be uncollectable then the gross carrying amount is written off against the associated allowance. Where the Company renegotiates the terms of trade receivables due from certain customers, the new expected cash flows are discounted at the original effective interest rate and any resulting difference to the carrying value is recognised in profit or loss. Other financial assets measured at amortised cost Impairment of other financial assets measured at amortised cost are determined using the expected credit loss model in AASB 9. On initial recognition of the asset, an estimate of the expected credit losses for the next 12 months is recognised. Where the asset has experienced significant increase in credit risk then the lifetime losses are estimated and recognised. Financial liabilities The Company measures all financial liabilities initially at fair value less transaction costs, subsequently financial liabilities are measured at amortised cost using the effective interest rate method. The financial liabilities of the Company comprise trade and other payables and finance lease liabilities.

(G) INVENTORIES Inventories are measured at the lower of cost and net realisable value. Cost of inventory is determined using the first in first out basis and is net of any rebates and discounts received. Net realisable value is estimated using the most reliable evidence available at the reporting date and inventory is written down through an obsolescence provision if necessary.

(H) PROPERTY, PLANT AND EQUIPMENT

Credit losses are measured as the present value of the difference between the cash flows due to the Company in accordance with the contract and the cash flows expected to be received. This is applied using a probability weighted approach.

Each class of property, plant and equipment is carried at cost less, where applicable, any accumulated depreciation and impairment. Assets are capitalised when in excess of $1,000.

Trade receivables

Property, plant and equipment, excluding freehold land, is depreciated on a straight line basis over the assets useful life to the Company, commencing when the asset is ready for use.

Impairment of trade receivables have been determined using the simplified approach in AASB 9 which uses an

Depreciation

VCS FOUNDATION LTD. ABN 35 430 554 780

Leased assets and leasehold improvements are amortised over the shorter of either the unexpired period of the lease or their estimated useful life.

generating unit.

The depreciation rates used for each class of depreciable asset are shown below:

Reversal indicators are considered in subsequent periods for all assets which have suffered an impairment loss, except for goodwill.

Fixed asset class Plant and Equipment

Depreciation rate 5 ‑ 50%

Leased Equipment

20%

Motor Vehicles

25%

Leasehold improvements

5 - 33%

At the end of each annual reporting period, the depreciation method, useful life and residual value of each asset is reviewed. Any revisions are accounted for prospectively as a change in estimate.

(I)

INTANGIBLES Intangible assets represent identifiable non monetary assets without physical substance such as patents, trademarks, and computer software and development costs (where applicable). Intangible assets are initially recognised at cost. Subsequently, intangible assets with finite useful lives are carried at cost less accumulated amortisation and accumulated impairment losses. Costs incurred subsequent to initial acquisition are capitalised when it is expected that future economic benefits will flow to the Company. Amortisation Amortisation is recognised in profit or loss on a straight line basis over the estimated useful lives of intangible assets, other than goodwill, from the date that they are available for use. Amortisation methods, useful lives and residual values are reviewed at each reporting date and adjusted if appropriate. Software and licenses Software and licenses have a finite life and are carried at cost less any accumulated amortisation and impairment losses. It has an estimated useful life of three years.

(J)

PAGE 79

IMPAIRMENT OF NON FINANCIAL ASSETS At the end of each reporting period, the Company determines whether there is any evidence of impairment for its non financial assets. Where an indicator exists and regardless for goodwill, indefinite life intangible assets and intangible assets not yet available for use, the recoverable amount of the asset is estimated. Where assets do not operate independently of other assets, the recoverable amount of the relevant cash generating unit (CGU) is estimated. The recoverable amount of an asset or CGU is the higher of the fair value less costs of disposal and the value in use. Value in use is the present value of the future cash flows expected to be derived from an asset or cash

Where the recoverable amount is less than the carrying amount, an impairment loss is recognised in profit or loss.

(K) TRADE AND OTHER PAYABLES These amounts consist predominantly of liabilities for goods and services. Payables are initially recognised at fair value and then subsequently carried at amortised cost and represent liabilities for goods and services provided to the Company prior to the end of the financial year that are unpaid, and arise when the Company becomes obliged to make future payments in respect of purchase of these goods and services. The normal credit terms are usually Net 30 days.

(L) EMPLOYEE BENEFITS Short term employee benefits Provision is made for the Company’s obligation for short term employee benefits. Short term employee benefits are benefits (other than termination benefits) that are expected to be settled wholly before 12 months after the end of the annual reporting period in which the employees render the related service, including wages and salaries. Short term employee benefits are measured at the (undiscounted) amounts expected to be paid when the obligation is settled. The Company’s obligations for short term employee benefits such as wages and salaries are recognised as a part of current trade and other payables in the statement of financial position. Other long term employee benefits Provision is made for employees’ long service leave and annual leave entitlements not expected to be settled wholly within 12 months after the end of the annual reporting period in which the employees render the related service. Other long term employee benefits are measured at the present value of the expected future payments to be made to employees. Expected future payments incorporate anticipated future wage and salary levels, durations of service and employee departures and are discounted at rates determined by reference to market yields at the end of the reporting period on corporate bonds that have maturity dates that approximate the terms of the obligations. Upon the remeasurement of obligations for other long term employee benefits, the net change in the obligation is recognised in profit or loss as a part of employee benefits expenses. The Company’s obligations for long term employee benefits are presented as non current provisions in its statement of financial position, except where the Company does not have an unconditional right to defer settlement for at least 12 months after the end of the reporting period, in which case the obligations are presented as current provisions.

PAGE 80

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 Superannuation Obligations for contributions to defined contribution superannuation plans are recognised as an employee benefit expense in profit or loss in the periods in which services are provided by employees. The Company has minimal exposure to liability arising from defined benefit plan liability as highlighted in Note 24. In view of this, the amount is not recognised on the basis that it is immaterial.

(M) GOODS AND SERVICES TAX (GST) Revenue, expenses and assets are recognised net of the amount of goods and services tax (GST), except where the amount of GST incurred is not recoverable from the Australian Taxation Office (ATO). Receivables and payables are stated inclusive of GST. Cash flows in the statement of cash flows are included on a gross basis and the GST component of cash flows arising from investing and financing activities which is recoverable from, or payable to, the taxation authority are classified as operating cash flows.

CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS The Directors make estimates and judgements during the preparation of these financial statements regarding assumptions about current and future events affecting transactions and balances. These estimates and judgements are based on the best information available at the time of preparing the financial statements, however as additional information is known then the actual results may differ from the estimates. The significant estimates and judgements made have been described below. Key estimates – Impairment of property, plant and equipment The Company assesses impairment at the end of each reporting period by evaluating conditions specific to the Company that may be indicative of impairment triggers. Recoverable amounts of relevant assets are reassessed using value in use calculations which incorporate various key assumptions. Key estimates – Receivables

(N) ADOPTION OF NEW AND REVISED ACCOUNTING STANDARDS The Company has adopted all standards which became effective for the first time at 1 July 2020, the adoption of these standards has not caused any material adjustments to the reported financial position, performance or cash flow of the Company.

(O) NEW ACCOUNTING STANDARDS AND INTERPRETATIONS FOR APPLICATION IN FUTURE PERIODS The AASB has issued new and amended Accounting Standards and Interpretations that have mandatory application dates for future reporting periods. The Directors have decided against early adoption of these Standards, but do not expect the adoption of these standards to have any impact on the reported position or performance of the Company.

The receivables at the reporting date have been reviewed to determine whether there is any objective evidence that any of the receivables are impaired. An impairment provision is included for any receivable where the entire balance is not considered collectible. The impairment provision is based on the best information at the reporting date. Key judgements – Impacts of COVID 19 Judgement has been exercised in considering the impacts that the Coronavirus (COVID 19) pandemic has had, or may have, on the Company based on known information. There does not currently appear to be either any significant impact upon the financial statements or any significant uncertainties with respect to events or conditions which may impact the Company unfavourably as at the reporting date as a result of the COVID 19 pandemic.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 81

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 4

REVENUE AND OTHER INCOME

VCS 2021 $

2020 $

17,257,356

16,067,994

1,263,500

1,143,500

11,488,959

4,445,981

Project income

955,653

1,510,935

Other revenue from operating activities

289,767

206,080

31,255,235

23,374,490

Operating funding transferred from prior year

5,652,278

Operating funding transferred to following year

(2,917,362)

31,255,235

26,109,406

123,269

340,407

14,318

137,773

9,127

137,587

487,307

Department of Health & Human Services

163,625

Total revenue from capital purpose income

163,625

31,556,447

26,596,713

REVENUE FROM OPERATING ACTIVITIES Government grants: - Department of Health & Human Services Other government subsidies and support Patient fees

TRANSFER UNEXPENDED GRANTS

Total revenue from operating activities REVENUE FROM NON-OPERATING ACTIVITIES Bank interest Profit on sale of non-current assets Foreign currency translation gains Total revenue from non operating activities REVENUE FROM CAPITAL PURPOSE INCOME

Total Revenue

Patient fees Included in patient fees is revenue of $8,316,762 (2020: $1,121,362) which was generated from the testing of specimens for Severe Acute Respiratory Syndrome Coronavius 2 (SARS CoV 2). This activity commenced in May 2020 and was undertaken throughout the year ended 30 June 2021. The increase in respiratory activities is also reflected in the increase in consumables expense.

PAGE 82

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 5

Note

CASH AND CASH EQUIVALENTS Cash at bank and on hand Deposits at call Total cash and cash equivalents

5(a)

2021 $

2020 $

109,004

139,431

2,339,908

9,730,744

2,448,912

9,870,175

The effective interest on short term bank deposits was 0.27% (2019: 0.15%). (A) RECONCILIATION OF CASH 2021 $

Cash and cash equivalents reported in the statement of cash flows are reconciled to the equivalent items in the statement of financial position as follows: Cash and cash equivalents

Balance as per statement of cash flows

TRADE AND OTHER RECEIVABLES

2020 $

2,448,912

9,870,175

2,448,912

9,870,175

2021 $

CURRENT Trade debtors and accrued revenue Provision for impairment of receivables

6(b)

Interest receivable Total current trade and other receivables

2020 $

4,750,647

2,091,325

(23,315)

(16,543)

4,727,332

2,074,782

16,938

22,603

4,744,270

2,097,385

The carrying value of trade receivables is considered a reasonable approximation of fair value due to the short term nature of the balances. The maximum exposure to credit risk at the reporting date is the fair value of each class of receivable in the financial statements.

(A) IMPAIRMENT OF RECEIVABLES The Company applies the simplified approach to providing for expected credit losses prescribed by AASB 9, which permits the use of the lifetime expected loss provision for all trade receivables. To measure the expected credit losses, trade receivables have been grouped based on shared credit risk characteristics and the days past due. The loss allowance provision as at 30 June 2021 is determined as follows, the expected credit losses incorporate forward looking information. 30 June 2021

Current

30 days overdue

90 days overdue

Total

0.49

N/A

0.49

4,750,647

ECL provision

23,315

30 June 2020

Current

90 days overdue

Total

Expected loss rate (%) Gross carrying amount ($)

Expected loss rate (%) Gross carrying amount ($) ECL provision

30 days overdue

90 days overdue

0.79

N/A

0.79

2,091,325

16,543

VCS FOUNDATION LTD. ABN 35 430 554 780

(B) RECONCILIATION OF CHANGES IN THE PROVISION FOR IMPAIRMENT OF RECEIVABLES IS AS FOLLOWS: Balance at beginning of the year Amounts written off as uncollectible: - Movement through provision Balance at end of the year

PAGE 83

2021 $

2020 $

16,543

30,016

6,772

(13,473)

23,315

16,543

The Company measures the loss allowance for trade receivables at an amount equal to lifetime expected credit loss (ECL). The ECL on trade receivables are estimated using a provision matrix by reference to past default experience of the debtor and an analysis of the debtor’s current financial position, adjusted for factors that are specific to the debtors, general economic conditions of the industry in which the debtors operate and an assessment of both the current as well as the forecast direction of conditions at the reporting date. The Company writes off a trade receivable when there is information indicating that the debtor is in severe financial difficulty and there is no realistic prospect of recovery, e.g. when the debtor has been placed under liquidation or has entered into bankruptcy proceedings or when the trade receivables are over 150 days past due, whichever occurs first.

INVENTORIES CURRENT

2021 $

2020 $

At cost:

Medical and surgical supplies

876,773

683,608

Total current inventories

876,773

683,608

2021 $

2020 $

OTHER FINANCIAL ASSETS Financial assets at amortised cost CURRENT

Term deposits

16,124,347

12,011,649

Total current other financial assets

16,124,347

12,011,649

2021 $

2020 $

609,610

413,932

91,905

OTHER ASSETS CURRENT Prepayments NON-CURRENT Security deposit

PAGE 84

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 10 LEASES THE COMPANY AS A LESSEE The Company has leases over a range of assets including land and buildings, and plant and equipment. Information relating to the leases in place and associated balances and transactions are provided below. Terms and conditions of leases The Company has entered into the following lease arrangements: - a premises located in East Melbourne for the term 1 March 2019 to 28 February 2023; and - plant and equipment, 1 x Cobas 6800 system and 2 x Cobas p 480 v2 instruments, from 1 December 2017 to 30 November 2022. Neither of the above lease agreements contain options to extend the term of options to purchase the assets on expiry. (A) RIGHT-OF-USE ASSETS Buildings $

Plant and Equipment $

Total $

815,200

430,167

1,245,367

Depreciation expense

(305,700)

(178,000)

(483,700)

Balance at end of year

509,500

252,167

761,667

1,120,900

608,167

Depreciation expense

(305,700)

(178,000)

(483,700)

Balance at end of year

815,200

430,167

1,245,367

Year ended 30 June 2021 Balance at beginning of year

Year ended 30 June 2021 Balance at beginning of year Initial recognition on adoption of AASB 16 on 1 July 2019 Reclassification of finance leases on initial application of AASB 16 on 1 July 2019

(B) LEASE LIABILITIES Lease liabilities included in the balance sheet at 30 June 2021:

2021 $

2020 $

- Current

463,026

428,202

- Non current

523,112

986,138

Total lease liabilities

986,138

1,414,340

VCS FOUNDATION LTD. ABN 35 430 554 780

11 PROPERTY, PLANT AND EQUIPMENT

PAGE 85

2021

2020

5,340,255

4,512,605

Accumulated depreciation

(4,108,014)

(3,851,679)

Total plant and equipment

1,232,241

660,926

505,462

318,282

(196,330)

(268,622)

309,132

49,660

At cost

1,331,111

Accumulated amortisation

(780,467)

(716,714)

550,644

614,397

2,092,017

1,324,983

PLANT AND EQUIPMENT At cost

MOTOR VEHICLES At cost Accumulated depreciation Total motor vehicles LEASEHOLD IMPROVEMENTS

Total leasehold improvements Total property, plant and equipment

MOVEMENT IN CARRYING AMOUNTS Movement in the carrying amounts for each class of property, plant and equipment between the beginning and the end of the current financial year: Plant and Equipment $

Motor Vehicles $

Leased Improvements $

Total $

Balance at the beginning of the year

660,926

49,660

614,397

1,324,983

Additions

869,161

301,343

1,170,504

Depreciation expense

(297,846)

(41,871)

(63,753)

(403,470)

Balance at the end of the year

1,232,241

309,132

550,644

2,092,017

Year ended 30 June 2021

PAGE 86

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021 12

INTANGIBLE ASSETS

2021

2020

1,200

(1,200)

9,834,174

7,424,742

(6,521,864)

(6,363,336)

Net carrying value

3,312,310

1,061,406

Total Intangibles

3,312,310

1,061,406

Licenses $

Computer Software $

Total $

Balance at the beginning of the year

1,061,406

Additions

2,409,432

Amortisation

(158,528)

Closing value at 30 June 2021

3,312,310

2021

2020

Trade payables

312,897

820,865

GST payable

644,450

72,057

Other payables

492,726

536,394

1,450,073

1,429,316

LICENCES Cost Accumulated amortisation and impairment Net carrying value COMPUTER SOFTWARE Cost Accumulated amortisation and impairment

MOVEMENT IN CARRYING AMOUNTS OF INTANGIBLE ASSETS Year ended 30 June 2021

TRADE AND OTHER PAYABLES CURRENT

Total current trade and other payables

Trade and other payables are unsecured, non‑interest bearing and are normally settled within 30 days. The carrying value of trade and other payables is considered a reasonable approximation of fair value due to the short‑term nature of the balances. (A) TRADE AND OTHER PAYABLES CLASSIFIED AS FINANCIAL LIABILITIES AT AMORTISED COST: Total current trade and other payables

1,450,073

1,429,316

Less: GST payable

(644,450)

(72,057)

805,623

1,357,259

Total trade and other payables classified as financial liabilities at amortised cost

VCS FOUNDATION LTD. ABN 35 430 554 780

14 CONTRACT LIABILITIES

PAGE 87

2021

2020

Government grants

395,035

2,917,362

Total current contract liabilities

395,035

2,917,362

2021

2020

Long service leave

2,293,258

2,294,601

Annual leave

1,798,385

1,607,093

Total current employee benefits

4,091,643

3,901,694

Long service leave

357,057

428,822

Total non‑current employee benefits

357,057

428,822

CURRENT

15 EMPLOYEE BENEFITS CURRENT

NON-CURRENT

ANNUAL LEAVE ENTITLEMENTS Based on past experience, the Company expects the full amount of the annual leave balance to be wholly settled within the next 12 months. Further, these amounts must be classified as current liabilities since the Company does not have an unconditional right to defer settlement of these amounts in the event that employees wish to use their leave entitlements.

16 OTHER LIABILITIES

2021

2020

Amounts received in advance

7,800

42,300

Total current other liabilities

7,800

42,300

2021 $

2020 $

336,060

736,919

(336,060)

(400,859)

Closing balance

336,060

Total reserves

336,060

CURRENT

17 RESERVES Designated funds reserve Opening balance Amortisation of database upgrade

(A) DESIGNATED FUNDS RESERVE The capital funds represent the capital funding received to cover the cost of the upgrade of the VCS/VCCR data base. The amortisation of the upgrade will be allocated against the capital funds over the expected life of the upgrade.

PAGE 88

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021

2021 $

2020 $

Accumulated surplus at the beginning of the financial year

18,330,516

16,337,936

Adjustment on initial application of AASB 16 on 1 July 2019

79,878

18,330,516

16,417,814

5,107,489

1,511,843

336,060

400,859

23,774,065

18,330,516

18 ACCUMULATED SURPLUS

Adjusted balance at the beginning of the financial year Surplus for the year Transfer from designated funds reserve Accumulated surplus at end of the financial year

The accumulated surplus represents the funds of the Company that are not designated for particular purposes.

19 MEMBERS’ GUARANTEE The Company is incorporated under the Australian Charities and Not‑for‑profits Commission Act 2012 and is a Company limited by guarantee. If the Company is wound up, the constitution states that each member is required to contribute a maximum of $10 each towards meeting any outstanding obligations of the Company. At 30 June 2021 the number of members was 8 (2020: 8).

20 CASH FLOW INFORMATION Reconciliation of result for the year to cashflows from operating activities

2021 $

2020 $

5,107,489

1,511,843

1,045,700

1,469,270

(14,318)

(132,101)

(2,646,885)

(458,196)

‑ (increase)/decrease in other assets

(195,678)

(151,462)

‑ (increase)/decrease in inventories

(193,165)

(10,763)

(34,500)

(5,653,158)

20,756

(1,346,260)

(increase)/decrease in contract liabilities

(2,522,327)

2,917,362

‑ increase/(decrease) in employee benefits

118,184

(542,643)

Cashflows from operations

685,256

(2,396,108)

Surplus for the year Non‑cash flows in profit: ‑ depreciation and amortisation expense ‑ net loss on disposal of property, plant and equipment Changes in assets and liabilities: ‑ (increase)/decrease in trade and other receivables

‑ increase/(decrease) in other liabilities ‑ increase/(decrease) in trade and other payables

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 89

FINANCIAL RISK MANAGEMENT The Company's principal financial instruments comprise of deposits with banks, receivables and payables. The totals for each category of financial instruments, measured in accordance with AASB 9 as detailed in the accounting policies to these financial statements, are as follows: Note

2021 $

2020 $

‑ Cash and cash equivalents

2,448,912

9,870,175

‑ Trade and other receivables

4,744,270

2,097,385

- Term deposits

16,124,347

12,011,649

23,317,529

23,979,209

Financial assets Held at amortised cost:

Total financial assets Financial liabilities Held at amortised cost: ‑ Trade and other payables

13(a)

805,623

1,357,259

- Lease liabilities

10(b)

986,138

1,414,340

1,791,761

2,771,599

Total financial liabilities None of the Company’s financial instruments are recorded at fair value.

22 KEY MANAGEMENT PERSONNEL The names of persons who were Board members at any time during the year are set out in the Annual Report. There were no transactions that require disclosure for the years ended 30 June 2021 and 30 June 2020. The Board did not receive any remuneration during the financial years ended 30 June 2021 and 30 June 2020. KEY MANAGEMENT PERSONNEL REMUNERATION Key management personnel remuneration included within employee expenses for the year is shown below: 2021 $ Short‑term employee benefits Post‑employment benefits Total key management personnel remuneration During the 2020/21 year, nil executives resigned and 1 was appointed. As at 30 June 2021, 8 FTEs were employed as executives (2020: 8). There were no transactions between the Company and the executives during the year.

2020 $

1,799,892

2,424,666

169,063

194,952

1,968,955

2,619,618

PAGE 90

FINANCIAL STATEMENTS

NOTES TO THE FINANCIAL STATEMENTS FOR THE YEAR ENDED 30 JUNE 2021

2021 $

2020 $

‑ auditing or reviewing the financial statements

18,570

17,500

‑ assistance with preparation of financial report

2,580

2,500

21,150

20,000

23 AUDITOR’S RENUMERATION Remuneration of the auditor (HLB Mann Judd), for:

Total auditor’s remuneration

24 DEFINED BENEFITS SCHEME The Company contributes to a Defined Benefits Scheme ("the Scheme") maintained by Aware Super Fund ("the Fund") and has an ongoing obligation to share in the future experience of the Fund including favourable or unfavourable variations that may arise should the experience of the Fund differ from the assumptions made by the Fund's actuary in estimating the Fund's accrued benefits liability. The trustee of the Scheme has determined that the notional excess of net assets attributable to the staff who are members of the Scheme for the year ended 30 June 2021 totalled $6,084 (2020: $6,084). The Fund's actuary has advised that the contributions will remain unchanged for the current year.

25 CONTINGENCIES In the opinion of the Directors, the Company did not have any contingencies at 30 June 2021 (30 June 2020: None). The amount disclosed represented a Bank Guarantee for the property leased at Wellington Parade, East Melbourne, payable on default of rent.

VCS FOUNDATION LTD. ABN 35 430 554 780

PAGE 91

26 EVENTS AFTER THE END OF THE REPORTING PERIOD The financial report was authorised for issue on 29 October 2021 by the Directors. The COVID 19 pandemic has created unprecedented economic uncertainty. Actual economic events and conditions in the future may be materially different from those estimated by the Company by the reporting date. As responses by the government continue to evolve, management recognises that it is difficult to reliably estimate with any degree of certainty the potential impact of the pandemic after the reporting date on the Company, its operations, its future results and financial position. Subsequent to year end, a State of Emergency was declared for COVID 19 in the State of Victoria on 16 March 2020 and has been extended to 21 October 2021. Any future changes to the Company's operations relating to COVID 19 will be in response to the Victorian Government's directions. Except for the above, no other matters or circumstances have arisen since the end of the financial year which significantly affected or could significantly affect the operations of the Group, the results of those operations or the state of affairs of the Group in future financial years.

27 STATUTORY INFORMATION The registered office and principal place of business of the Company is: VCS Foundation Limited 265 Faraday Street Carlton South VIC 3053

PAGE 92

DIRECTORS' DECLARATION

265 Faraday Street Carlton South VIC 3053 Phone: +61 3 9250 0300 Fax: +61 3 9349 1977 www.vcs.org.au VCS Foundation Limited ABN 35430554780

DIRECTORS’ DECLARATION The directors of the Company declare that: 1.

The financial statements and notes, as set out on pages 2 to 34, are in accordance with the Australian Charities and Not for profits Commission Act 2012, and: a.

comply with Australian Accounting Standards Reduced Disclosure Requirements; and

give a true and fair view of the financial position as at 30 June 2021 and of the performance for the year ended on that date of the Company.

In the directors’ opinion, there are reasonable grounds to believe that the entity will be able to pay its debts as and when they become due and payable.

In addition: 1.

We certify that VCS Foundation Limited has complied with the terms and conditions of their service agreement with the Department(s).

We certify that VCS Foundation Limited has used funding received from the Department(s) for the year ended 30 June 2021 on the services specified in the service agreement.

This declaration is signed in accordance with subs 60.15(2) of the Australian Charities and Not-for-profits Commission Regulation 2013.

Tim Humphries Chairperson Dated this 22 November 2021

David Wrede Director

VCS FOUNDATION LTD. ABN 35 430 554 780

AUDITOR’S INDEPENDENCE DECLARATION We declare that, to the best of our knowledge and belief, there have been no contraventions of any applicable code of professional conduct in relation to the review of the financial report of VCS Foundation Limited for the year ended 30 June 2021.

HLB Mann Judd Chartered Accountants Melbourne 12 November 2021

Nick Walker Partner

PAGE 93

PAGE 94

REPORT ON THE AUDIT OF THE FINANCIAL REPORT

INDEPENDENT AUDITOR’S REPORT TO THE MEMBERS OF VCS FOUNDATION LIMITED

REPORT ON THE AUDIT OF THE FINANCIAL REPORT Opinion

Basis for Opinion

We have audited the financial report of VCS Foundation Limited (“the Foundation”) which comprises the statement of financial position as at 30 June 2021, the statement of profit or loss and other comprehensive income, the statement of changes in equity and the statement of cash flows for the year then ended, and notes to the financial statements, including a summary of significant accounting policies, and the directors’ declaration.

We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Report section of our report. We are independent of the Foundation in accordance with the auditor independence requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (“the Code”) that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code.

In our opinion, the accompanying financial report of the Foundation has been prepared in accordance with Division 60 of the Australian Charities and Not-for-profits Commission Act 2012, including: In our opinion, the accompanying financial report of the Entity is in accordance with Division 60 of the Australian Charities and Not-for-profits Commission Act 2012 including: (a) giving a true and fair view of the Foundation’s financial position as at 30 June 2021 and of its financial performance for the year then ended; and (b) complying with Australian Accounting Standards – Reduced Disclosure Requirements and Division 60 of the Australian Charities and Not-for-profits Commission Regulation 2013.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Responsibilities of Management and the Directors for the Financial Report Management is responsible for the preparation of the financial report that gives a true and fair view in accordance with the Australian Accounting Standards – Reduced Disclosure Requirements and the Australian Charities and Not-for-profits Commission Act 2012 and for such internal control as management determines is necessary to enable the preparation of the financial report that is free from material misstatement, whether due to fraud or error. In preparing the financial report, management is responsible for assessing the Foundation’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless management either intend to liquidate the Foundation or to cease operations, or have no realistic alternative but to do so. The directors are responsible for overseeing the Foundation’s financial reporting process.

VCS FOUNDATION LTD. ABN 35 430 554 780

Auditor’s Responsibilities for the Audit of the Financial Report

•

Conclude on the appropriateness of the management’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 Fondation’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the financial report or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause the Foundation to cease to continue as a going concern.

•

Evaluate the overall presentation, structure and content of the financial report, including the disclosures, and whether the financial report represents the underlying transactions and events in a manner that achieves fair presentation.

•

We communicate with the directors regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.

Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Australian 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 this financial report. As part of an audit in accordance with the Australian Auditing Standards, we exercise professional judgement and maintain professional scepticism throughout the audit. We also: •

Identify and assess the risks of material misstatement of the financial report, 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 our 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 Foundation’s internal control.

•

Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the management.

PAGE 95

We also provide the directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, related safeguards.

HLB Mann Judd Chartered Accountants Melbourne 12 November 2021

Nick Walker Partner

PAGE 96

LIST OF ACRONYMS

AICD

Australian Institute of Company Directors

LTI

Lost time injury

AIWH

Australian Institute of Health and Welfare

NATA

ATAGI

Australian Technical Advisory Group on Immunisation

National Association of Testing Authorities, Australia

NBCSP

National Bowel Cancer Screening Program

CIRV

Centralised Immunisation Records Victoria

NCSP

National Cervical Screening Program

CRE

Centre of Research Excellence

NCSR

National Cancer Screening Register

CST

Cervical Screening Test

NHMRC

National Health and Medical Research Council

Cth

Commonwealth

NPAAC

DHHS

Victorian Department of Health and Human Services

National Pathology Accreditation Advisory Council

NSW

New South Wales

EAP

Employee Assistance Program

PAIVnG

ECHO

Extension For Community Healthcare Outcomes

Providing Access to Immunisation for Vulnerable Groups

FOBT

Faecal Occult Blood Test

PFUF

Participant Follow Up Function (National Bowel Cancer Screening Program)

FTE

Full time equivalent

RACGP

General Practitioner

Royal Australian College of General Practitioners

HPV

Human Papillomavirus

RCPA

Royal College of Pathologists Australasia

Human Resources

South Australia

ICT

Information Communication Technology

TAT

Turn Around time

ImPS

Immunisation Provider System

VCS

VCS Foundation Ltd.

ISO

International Standards

VMIA

Victorian Managed Insurance Agency

LBC

Liquid Based Cytology

WHO

World Health Organization

VCS Foundation Ltd. ANNUAL REPORT 2020/21 VCS Foundation PO Box 178, Carlton South VIC 3053 265 Faraday Street, Carlton VIC 3053 Telephone: (03) 9250 0300 Website: www.vcs.org.au © VCS Foundation Ltd. ABN: 35 430 554 780 Copies of this report are available online: www.vcs.org.au Printed copies can be ordered from: VCS Foundation Ltd. Telephone: (03) 9250 0322 Email: directorate@vcs.org.au ISSN 2202-4441 VCS Foundation acknowledges the support of the Victorian Government

ABOVE + BEYOND I N 2020

ANNUAL REPORT

VCS Foundation’s Annual Report received a GOLD AWARD from the Australasian Reporting Awards (ARA) in 2019 and 2020. ARA is a not-for-profit organisation established in 1950 to encourage effective communication of financial and business information. Each submission is reviewed by three members of an expert panel comprised of accounting, legal and communication professionals.

VCS Foundation Annual Report 2021

Articles inside

DIRECTORS REPORT

COMMITTEE ENGAGEMENT AND STAKEHOLDERS

3 – Support countries in the Indo-Pacific region to scale up to meet the 2030 targets in support of the WHO strategy to eliminate cervical cancer as a public health problem

6 – Deliver and disseminate the research outcomes of the Compass trial, C4 and other policy relevant research

5 – Support the National Bowel Cancer Screening Program in Victoria

7 – Diversify the range of VCS Pathology laboratory tests by leveraging our existing expertise and capital investment

YEAR IN REVIEW – CHAIRMAN AND EXECUTIVE DIRECTOR’S REPORT

1 – Support Victoria’s efforts to eliminate cervical cancer as a public health problem, in accordance with the Victorian Cancer Plan 2020-2024

2 – Support Australia’s efforts to eliminate cervical cancer as a public health problem by 2035

WHAT WE DO