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ACCORD-2 master protocol

Description: CONFIDENTIAL ACCORD-2-001 – Master Protocol TITLE PAGE Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study
Url: /Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-master-protocol.pdf

Annual-report-and-quality-account-2019-20

Description: ANNUAL REPORT AND ACCOUNTS 2019/20 Incorporating the quality account 2019/20 Page 2 University Hospital Southampton NHS Foundation Trust Annual
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/annual-report-and-quality-account-2019-202.pdf

Procedure for USING THE SECA mBCA VALIDATION TEST KIT

Description: NIHR Southampton Biomedical Research Centre The NIHR Southampton Biomedical Research Centre (BRC) has a tight quality assurance system for the writing
Url: /Media/Southampton-Clinical-Research/Procedures/BRCProcedures/Procedure-for-USING-THE-SECA-mBCA-VALIDATION-TEST-KIT.pdf

Annual-report-2018-19

Description: ANNUAL REPORT AND ACCOUNTS 2018/19 incorporating the quality account 2018/19 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 University Hospital Southampton NHS Foundation Trust Annual report and accounts 2018/19 incorporating the quality account 2018/19 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 3 ©2019 University Hospital Southampton NHS Foundation Trust 4 TABLE OF CONTENTS Overview and performance report Welcome from our Chair 7 A word from the chief executive 8 Overview of the Trust Statement of purpose and activities 9 History of UHS 9 Our executive team structure 10 Structure of our services 11 Our vision and values 12 Our priorities, key issues and risks 13 Performance report Going concern disclosure 16 Reporting structure 16 Key performance indicators 17 How we monitor performance 18 Detailed analysis and explanation of the development and performance of UHS 18 Regulatory body ratings 23 Environmental matters 24 Social, community, anti-bribery and human rights issues 25 Accountability report Members of the Trust Board 27 Trust Board purpose and structure 31 Board meeting attendance record 2018/19 32 Well-led framework 33 Strategy and finance committee 34 Quality committee 34 Audit and risk committee 35 External auditors 36 Governance code 36 Performance evaluation of Trust Board and its committees 36 Remuneration 36 Countering fraud and corruption 36 Independence of external auditor 37 Internal audit service 37 Better payment practice code 37 Statement as to the disclosures to auditors 37 Disclosures 37 Income disclosures 38 Governance disclosures 38 Approach to quality governance 38 Council of Governors 40 Annual remuneration statement 49 Remuneration and appointments committee 52 Governors’ nomination committee 54 Staffing report 58 Staff survey results 62 Trade union facility time 66 Statement of chief executive’s responsibilities as the accounting officer 69 Annual governance statement 70 Voluntary disclosures Equality, diversity and inclusion 78 Environmental sustainability and climate change 80 Southampton Hospital Charity 84 Developments in informatics 85 Leading research into better care 85 Investing for the future 86 Quality account and quality report 2018/19 Chief executive’s welcome 88 Our approach to quality assurance 90 Our commitment to safety 90 Duty of candour 91 Our commitment to staff 91 Freedom to speak up 94 Our commitment to education and training 95 Our commitment to staffing rota gaps 96 Our commitment to technology to support quality 97 Our commitment to the Care Quality Commission 98 Our commitment to improving the environment for our patients 100 Review of quality performance 101 Clinical research 101 Review of services 102 CQUIN payment framework 103 Data quality 103 Participation in national clinical audits and confidential enquiries 104 How we are implementing the priority clinical standards for seven day hospital services 105 Learning from deaths 106 Progress against 2018/19 priorities 109 Priorities for improvement 2019/20 128 Conclusion 132 Responses to our quality account 133 Statement of directors’ responsibilities 138 Independent auditor’s report 139 Quality account appendix Appendix 1: Our quality priorities 2019/20 143 Appendix 2: Quality performance data 144 Appendix 3: CQUIN data 151 Appendix 4: Clinical audit and confidential enquiries data 154 Appendix 5: British Society of Urogynaecology 156 Appendix 6: National clinical audit: actions to improve quality 157 Appendix 7: Local clinical audit: actions to improve quality 161 Appendix 8: Shared decision making 173 Appendix 9: Registration with the Care Quality Commission 174 Annual accounts Statement from the chief financial officer 177 Foreword to the accounts 178 Independent auditor’s report 179 Financial accounts and notes 186 5 OVERVIEW AND PERFORMANCE REPORT OVERVIEW AND PERFORMANCE REPORT Welcome from our chair 2018/19 was a year of change in the leadership of UHS. Following the departure of Fiona Dalton in March 2018 to run a hospital group in Canada, David French took on the role of interim chief executive officer. On behalf of the Trust Board I would like to thank David for agreeing to do so and also for doing such an outstanding job. During the year we welcomed three new non-executive directors to the Trust; Jane Bailey, Professor Cyrus Cooper and Catherine Mason. Catherine’s talents were also recognised by Solent NHS Trust and she has since left to help lead their organisation as chair. We were delighted to welcome Paula Head as chief executive in September after a rigorous and robust recruitment process. Paula’s experience as chief executive of Royal Surrey County Hospital NHS Trust and, prior to that of Sussex Community NHS Foundation Trust, shone through and we were confident that under her leadership UHS would continue to develop, grow and improve. Demand for our services continues to rise rapidly as the result of a changing demographic and other factors, and at a rate far greater than our income. Despite this our staff continue to deliver exceptional care. I was delighted that this was recognised by the Care Quality Commission in their recent inspection when they again rated us as Good. The revised NHS Long Term Plan will inevitably require us to adapt to the changing pattern of healthcare, but we do so with enthusiasm. This year has shown just how adept we are as an organisation at responding positively to change, not only rising to the challenges it presents, but thriving with it. This is evident in the significant investments we have made in the Trust’s estate this year. Phase one of our new children’s emergency department is complete thanks to the continued support of the Murray Parish Trust. We also approved one of the largest capital investments in our history with the updating and expansion of our general intensive care unit. We recognised that it was as crucial to invest, not just in the physical environment within which we provide healthcare, but within the digital environment too, acknowledging that UHS is an NHS digital exemplar. We have invested significantly in information technology to enhance accessibility and improve both patient and staff experience. We look forward with confidence to helping lead the NHS into a new phase of delivering health and care for the United Kingdom into 2019/20. Peter Hollins Chair 7 OVERVIEW AND PERFORMANCE REPORT A word from the chief executive Since arriving at UHS to take up my position as chief executive officer, I have heard and witnessed some incredible achievements by staff at the Trust. Dr Joanne Horne was named biomedical scientist of the year at the Advancing Healthcare Awards for her work in histopathology; Dr Beth McCausland, quality improvement fellow in dementia care, was named foundation doctor of the year by Royal College of Psychiatrists; Sarah Charters, consultant nurse and mental health lead for the emergency department was awarded an MBE for services to vulnerable adults and her vulnerable adult support team were also winners of a Nursing Times Award in the emergency and critical care category. The medicine for older people therapy team led by Hannah Wood was named most inspiring team at the national #EndPJParalysis awards while Marie Nelson, matron in research and development, and senior research sisters Jane Forbes and Kirsty Gladas won the silver award for clinical research site of the year at the PharmaTimes International Clinical Researcher of the Year Awards. Jean Piernicki, senior nurse manager in occupational health, was awarded the title of Queen’s Nurse in recognition of her high level of commitment to patient care and nursing practice. Fiona Chaâbane, a senior clinical nurse in neurosciences was named winner of the nursing and midwifery award at the BBC’s The One Show Patients Awards. The medicines advice service, led by Dr Simon Wills, picked up the HSJ Value Award for training and development for its medicines learning portal and Matthew Watts, head of news, was named operational services support worker of the year for the south of England at the Our Health Heroes Awards 2018. We were also delighted that the energy and sustainability team collected the clinical NHS Sustainability Award for its green wards project. These are just a few of the individual and team successes achieved this year. Our entire organisation can also be incredibly pleased and encouraged by the outcome of the recent Care Quality Commission (CQC) inspection, which rated UHS ‘good’ overall, with many individual areas being recognised as outstanding by the CQC. You can find full details of the inspection on page 98 of the quality account. Such positive inspection results link to equally positive staff survey results which saw UHS ranked as the second highest acute trust for staff satisfaction and fifth highest for staff recommending the Trust as a place to work and receive treatment. It’s made me incredibly proud to be able to say that I am part of such a driven team and it’s clear that the UHS team share my drive and determination to improve things for patients and staff every day. This is evident in both the successes I have already mentioned, but also in the pioneering work that is taking place across every department. Informatics has been pioneering new digital initiatives which they recently shared with Hadley Beeman, chief technology adviser to the secretary of state and social care. Surgeons Bhaskar Somani and Stephen Griffin have created a ‘twin surgeon’ model that has revolutionised the treatment of kidney stones in children. Dr John Paisey, consultant cardiologist, and his team were among the first in the world to implant and programme a pacemaker using Bluetooth technology. They performed four of the first five procedures in the world. While Professor Mike Grocott and his team created ‘surgery school’ which is transforming the fitness of patients prior to their operations and thereby reducing length of stay. These are by no means the entirety of our achievements this year and I would like to take the opportunity to thank every single member of staff at the Trust who continues to make UHS one of the leading trust’s in the UK. Paula Head Chief executive officer 8 OVERVIEW AND PERFORMANCE REPORT Overview of the Trust Statement of purpose and activities UHS is a large teaching hospital located on the south coast of England. We have a tripartite mission to provide clinical care, educate current and future healthcare professionals, and undertake research to improve healthcare for the future. Our clinical care encompasses local acute and elective care for 680,000 people who live in Southampton, the New Forest, Eastleigh and Test Valley. We also provide care for the residents of the Isle of Wight for many services. As the major university hospital on the south coast, UHS provides the full range of tertiary medical and surgical specialities (with the exception of transplantation, renal services and burns) to over 3.7 million people in central southern England and the Channel Islands. UHS is a centre of excellence for training the doctors, nurses and other healthcare professionals of the future. We work with the University of Southampton and Solent University to educate and develop staff at all levels, including a large apprenticeship programme, undergraduate and post-graduate education. Our role in research, developed in active partnership with the University of Southampton, is to contribute to the development of treatments for tomorrow’s patients. This work distinguishes us as a hospital that works at the leading edge of healthcare developments in the NHS and internationally. In particular we have nationally-leading research into cancer, respiratory disease, nutrition, cardiovascular disease, bone and joint conditions and complex immune system problems. We are one of the largest recruiters of patients into clinical trials in the country. Over 11,900 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the contributions of over 1,000 volunteers. Our turnover in 2018/19 was more than £878m. History of UHS The Trust has its origins in the 1900s when the Shirley Warren Poor Law Infirmary was built on the site of what is now Southampton General Hospital. In the early half of the century, the site began to expand, including the opening of the school of nursing and the creation of the Wessex Neurological Unit. In 1971 a new medical school was opened in Southampton and the 1970s and 1980s saw a significant building programme encompassing the current footprint of Southampton General Hospital, Princess Anne Hospital and Countess Mountbatten House. During the 1990s, services were increasingly centralised at the general hospital, with the eye hospital and cancer services being relocated from elsewhere in the city. The Wellcome Trust funded a clinical research facility at the hospital in 2001 and this unit remains the foundation for much of the Trust’s groundbreaking medical research. In the last decade, development has continued with the opening of the North Wing Cardiac Centre in 2006, the creation of a major trauma centre with on-site helipad and the opening in 2014 of Ronald McDonald House for the relatives of sick children. Organisationally, Southampton University Hospitals Trust was formed in 1993, creating a single management board for acute services in Southampton. Eighteen years later, University Hospital Southampton NHS Foundation Trust (UHS) was formed (1 October 2011) when Southampton University Hospitals NHS Trust was licensed as a foundation trust by the then regulator, Monitor (now known as NHS Improvement (NHSI)). 9 OVERVIEW AND PERFORMANCE REPORT Our executive team structure Associate director of corporate affairs (interim) Charlie Helps Constitution; Council of governors; legal services; insurance; risk management; policy management; freedom of information (FOI) general data protection regulations (GDPR) Chief executive Paula Head Director of HR Steven Harris Employee relations; pay and reward; resourcing and temporary staffing; staff engagement; staff performance and appraisal; occupational health and wellbeing; childcare services; communications Medical director Dr Derek Sandeman MD for research & development; clinical effectiveness; clinical practices and outcomes; professional regulation & standards; GP relationships Director of nursing & organisational development Gail Byrne Chief financial officer & deputy chief executive David French Clinical governance & patient safety; education; patient experience; clinical practice & outcomes; professional regulation & standards; complaints/PALS; HR/workforce; voluntary services; fundraising Caldicott Guardian Financial management; financial strategy; investment & ROI; audit; procurement; capital programme management; estates; Commercial development Division A Surgery Cancer care Critical care & theatres Chief operating officer Caroline Marshall Major incident planning; security Division B Division C Emergency medicine Women & newborn Specialist medicine/ ophthalmology Pathology Child health Support services Director of transformation & improvement Jane Hayward Division D Cardiovascular & thoracic Neurosciences Trauma & orthopaedics Cost improvement & transformation; information technology; information governance; core platform systems; informatics development; strategy; commissioning; business & capacity planning Senior Information Risk Owner (SIRO) Radiology 10 OVERVIEW AND PERFORMANCE REPORT Structure of our services Our organisation is split into five areas, with our clinical services grouped into four divisions. Within each division there are care groups. Each division, with the exception of Trust headquarters, is led by a divisional management team consisting of: • divisional clinical director (DCD) • divisional director of operations (DDO) • divisional head of nursing/professions (DHN) • divisional research and development lead • divisional finance manager • divisional planning and business development (or strategy) manager • divisional education lead • division HR business partner • divisional governance manager (DGM) The diagram below outlines the five divisions and care groups/services within each. Each care group has a clinical lead, care group manager and matron/s for specific services as a minimum. Division A Surgery Cancer care Critical care Theatres Division B Emergency medicine Medicine for older people Pathology Specialist medicine and ophthalmology Genetics Division C Child health Women and newborn Support services Division D Cardiovascular and thoracic Neurosciences Trauma and orthopaedics Major trauma centre Radiology TRUST HQ Corporate affairs Communications Finance Human resources Informatics Patient support services Claims and litigation Cost improvement and transformation Estates and capital developments Research and development 11 OVERVIEW AND PERFORMANCE REPORT Our vision and values Our Forward vision outlines who we are and what we stand for, as well as describing the current challenges we face and our priorities for the future. It also provides an in-depth review of our three Trust values, which are summarised below: putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien king together king together king together king together king together king together king together king together king together ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving ts first ts first ts first wor wor wor putting patien putting patien putting patien king together king together king together always imparlwovaiynsg imparlwovaiynsg improving Patients and families will be at Our clinical teams will provide the heart of what we do and services to patients and are their experience within the crucial to our success. hospital, and their perception We have launched a leadership ofmtheeasTurruensgtop,aftwiesnuitlslcfbcnigreesptsaosti.euntrs fnigrsptatients first clsintrrikacintageltgomgyetahtnherkraianggtteoegmnetsehuernkrrintegstteoogaeumthresr are engaged in the day-to-day management and governance of the Trust. alw alw alw Our growing reputation in research and development and our approach to education and training will continue ays improtvoinagiyns icmoprropvionagrysaitmeprnoveinwg ideas, technologies and greater efficiencies in the services we provide tients first tients first tients first together together together mproving mproving mproving putti putting pa putti putting pa putti putting pa wo working wo working wo working always i always i always i 12 OVERVIEW AND PERFORMANCE REPORT Our priorities, key issues and risks Our top eight priorities 1 Promote and live our values. We will: • be clearer about the behaviours we expect from our staff • recruit, train and promote people who demonstrably share our values in everything they do 2 Improve safety, quality and productivity. We will: • Sign up to safety and deliver on our promises to patients as part of this campaign • Focus on improving outcomes by measuring and publishing clinical outcomes for all specialties • Focus on improving the whole patient experience, so that patients feel treated with compassion by all staff in every contact • Develop the concept of excellent administrative care, organising our services well so that the patient journey runs smoothly • Commit to productivity improvement across all areas • Develop innovative solutions that allow us to deliver services more efficiently while making better use of our capacity 3 Our staff and education mission. We will: • Attract the best staff by offering them a better deal and the best place to work • Continue to invest in education and training opportunities for our staff including leadership development • Ensure that our leaders and staff understand and deliver our equality and diversity agenda • Prioritise excellent communication that allows the voice of our staff to be heard and acted on • Focus on the staff of the future by developing our education and training capability for clinical and non-clinical staff • Work with our local education providers to offer excellent education opportunities and bring high calibre people into healthcare roles in our hospitals 4 Become a hospital without walls. We will: • Increase the number of patients we care for who are not inpatients within the hospital. Some of these will be cared for in another residential location or at home in partnership between ourselves and other organisations • Be clear about services where we wish to provide end-to-end integrated care, and those where we wish to work with partners to integrate care across organisations • Work with health and social care partners (public, private and third sector), where necessary using new organisational models, to ensure that patients are always cared for in the right setting • Work more closely with general practices and support innovation being led by primary care 13 OVERVIEW AND PERFORMANCE REPORT 5 Specialised services. We will: • Engage with commissioners to plan changes in service models according to national service specifications • Continue to plan and manage the ongoing drift of sub-specialist work particularly in paediatrics and complex surgical services • Maintain and develop the critical mass that is increasingly required to care for complex and specialist patients • Work with Salisbury NHS Foundation Trust, the University of Southampton and other partners to play our part in the genomic revolution, building on the Genomic Medicine Centre and seeking to become a Genomics Central Laboratory Hub for the region • Develop our clinical informatics ability to ensure that we can take advantage of new information available for the benefit of patients 6 Preventative care. We will: • Continue to expand our screening programmes as national policy and commissioning intentions develop • Take every opportunity to further support and improve the health of our staff • Ensure that our clinical translational research programme, much of which is directly relevant to health promotion, accelerates translation of research into benefit for the local population 7 Discovery. We will: • Develop a detailed plan to continue increasing the number of UHS patients who are offered access to clinical trials and maximise the impact of the research we undertake • Work with the University of Southampton to submit a strong bid for the next round of Biomedical Research Centre / Biomedical Research Unit funding opportunities • Support the University of Southampton to create an international centre for cancer immunology to accelerate the development of new immune therapies to treat cancer 8 All stages of life. We will: • Continue to expand our paediatric services in partnership with community and local acute paediatrics and develop the physical infrastructure of a modern children’s hospital as quickly as finances allow • Continue to improve transition and the care of teenagers and young adults • Develop elderly care services that are integrated across the acute and community sectors • Continue to develop our end of life care 14 OVERVIEW AND PERFORMANCE REPORT Key issues and risks 1 Failure to deliver national access targets, which impacts patient experience and patient safety. Whilst we are meeting some of the national constitutional standards in waiting times, we are not meeting them all. A number of actions have been taken in relation to improving responsiveness and working with local health and social care partners to reduce delayed transfers of care. The Trust will continue to work to reduce delayed transfers of care, as well as reviewing the efficiency of discharge processes during 2019/20. 2 Capacity and occupancy, which impacts on patient flow and the quality and timeliness of care. Operational risks have been identified across a number of services/specialties linking to issues around increasing referrals, system capacity and delayed transfers of care. We have mitigated this by implementing daily reviews to assess system capacity and escalation requirements aligning capacity plans with the wider system, developing plans to reduce length of stay with strong clinical leadership and oversight and working with local health and social care partners to reduce delayed transfers of care. 3 Staffing, both in terms of recruitment and retention. To mitigate this risk we will continue to focus on making UHS an attractive employer by: • developing band four posts and apprentices • leveraging the ‘Think UHS’ recruitment brand • continuing to recruit within Europe and further afield • working with universities to increase student nurses • enhancing medical overseas fellows posts • reviewing all junior doctor rotas in light of the new contract • using flexible and temporary staff when needed • creating different roles linked to our research agenda • reviewing training and education to enhance retention. 15 OVERVIEW AND PERFORMANCE REPORT Performance report Going concern disclosure After making enquiries, the directors have a reasonable expectation that the Trust has adequate resources to continue in operational existence for the foreseeable future. For this reason, they continue to adopt the going concern basis in preparing the accounts. Reporting structure As a large NHS university hospital foundation trust, UHS monitors performance within individual teams throughout the year with feedback processes in place to escalate issues to more senior management teams. At a corporate level we have an established executive reporting structure. Monthly Trust Board Public meeting where executive directors present high level summary to chairman and non-executive directors. For further information see page 31. Audit and risk committee Strategy and finance committee Quality committee Trust executive committee (TEC) Review performance/issues/risks in greater depth For further detail on role of these committees please refer to the annual governance statement section on page 70. Trust Board study sessions Trust Board members meet to focus on a specific issue. Performance meetings Operational management team (led by chief operating officer) and division and care group management teams focus on individual patient and service pathways to develop improvement plans. 16 OVERVIEW AND PERFORMANCE REPORT Key performance indicators (KPIs) The Trust publishes a monthly integrated KPI Board report on our website which provides both the Board and the public with an overview of our performance. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. For 2018/19 the format of the monthly report followed the five key Care Quality Commission (CQC) questions: • Are we safe? • Are we effective? • Are we caring? • Are we responsive? • Are we well-led? The monthly report features the following sections: • Overview – Aggregation of commentary supporting all sections of the report • Safe • Effective • Caring • Activity • Emergency access • Referral to treatment and diagnostics • Cancer waiting times • Flow • Staffing • Research and development • Estates • Digital This report also includes summary versions of quarterly reports submitted to the Trust executive committee, which go into greater detail about patient experience, patient safety, clinical effectiveness outcomes, and infection prevention. In addition, a separate finance Board report is submitted to Trust Board on a monthly basis. The Emergency Access, Activity and Flow section have several KPI’s that are relevant to the key risk of delivering the national access target. Some of the KPI’s are: • Number of attendances • Time to initial assessment • Hospital red/black alerts • Delayed transfers of care • Non-elective length of stay The Activity and Flow section have several KPI’s that are relevant to the key risk of capacity and occupancy. Some of the KPI’s are: • Length of stay • New referrals • Number of attendances • Bed occupancy • Hospital red/black alerts The Staffing (HR) section has several KPI’s that are relevant to the key risk of Staffing. Some of the KPI’s are: • Staff turnover • Nursing vacancies • Friends and Family Test – percentage of staff who recommend UHS as a place to work You can see full copies of the monthly report by visiting www.uhs.nhs.uk 17 OVERVIEW AND PERFORMANCE REPORT How we monitor performance In addition to reviewing the data submitted to the Trust Board in these papers, we have a suite of tools available to compare UHS performance to that of comparable trusts around the country. Depending on the measures being monitored, UHS has a number of peer groups to benchmark against including other local providers, major trauma centres and university hospital teaching trusts. Each NHS trust will service a different size and type of population and will offer a slightly different range of services so it is important to understand that this benchmarking provides an initial indication of performance rather than an absolute guide to our position nationally. In 2018/19 we continue to review the National Model Hospital data as it is published from NHS Improvement. The data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. The Trust is engaging with the model hospital team and has a member of staff on the ‘model hospital ambassador program’, as well as reviewing areas highlighted as having potential opportunities alongside finance and operational teams. Detailed analysis and explanation of the development and performance of UHS Activity, capacity and occupancy Over the past three years we have seen significant increases in all types of activity. This is linked to demographic growth, new specialist techniques and services transferring from other providers, including vascular services from Portsmouth. In addition, UHS now has responsibility for surgical services at Lymington. The graph and table below demonstrate this increase in activity. UHS growth in activity – 2016/17 to 2018/19 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 Inpatient spells (inc. day cases) 2013/14 2016/17 Outpatient appointments 2017/18 2018/19 ED attendances (type one) Referrals (excl March) Inpatient spells (inc. day cases Outpatient appointments ED attendances (type one) Referrals (excl March) 2016/17 160,000 630,045 99,273 189,194 2017/18 157,993 658,147 104,616 197,522 2018/19 168,791 695,343 110,771 207,209 Increase 2016/17 to 2018/19 5.5% 10.4% 11.6% 9.5% 18 OVERVIEW AND PERFORMANCE REPORT Hospital alert status The hospital alert status is decided by the operations centre after assessing the bed and staffing position, and is recorded twice daily at the Trust bed meetings (though the status may change at any time). Black alert is the highest level of alert and is issued when there are no empty beds available across the Trust with no expected discharges, the emergency department is full, and if actions are not taken several ambulances are likely to be delayed for long periods of time, stopping them from responding to 999 calls (this is based on a national definition of escalation). Red alert is when the majority of the hospital is under significant operational pressure and is likely to include a mismatch between supply and demand of beds and/or there are no beds available, with patients waiting more than three hours in the emergency department, and patients with a clinical decision for admission but no bed identified for them to move to. The Trust will undertake a wide range of actions in response to this, including the opening of additional overnight beds (usually within day wards), the redistribution of staff or bed capacity to support areas under most pressure, Trust-wide communication to request a focus on actions which will enable patients to be discharged or the admission avoided and the potential review of less urgent elective operations to maintain bed availability for patients with more urgent needs. In 2015/16 a black alert was recorded seven times at the twice daily bed meetings. In 2016/17 this was increased to eleven, in 2017/18 this increased to twenty, however in 2018/19 there were no black alerts. The chart below shows red alerts logged during 2018/19. Red alerts 2018/19 60 Number of AM and PM alerts 45 30 15 0 4/1/18 6/1/18 8/1/18 10/1/18 12/1/18 2/1/19 Contributing to this change has been an increase in day cases and an increase in length of stay (LoS) for elective patients linked to a more complex case mix. UHS delayed transfers of care 2018/19 The chart below shows the total bed days attributable to delayed transfers of care at UHS in 2018/19. 3,600 Percentage of bed days lost 3,200 2,800 2,400 2,000 April 2018 June 2018 August 2018 October 2018 December 2018 February 2019 19 OVERVIEW AND PERFORMANCE REPORT Referral to treatment (18 weeks) performance National target: 92% of all patients on 18 week pathway and not yet treated should have waited 18 weeks or less at the end of the month (incomplete pathways target). How did we do? UHS did not meet the target this year. Achievement of this target in 2018/19 should be set against a rise in patient referrals, which highlights the increased demands being placed on the Trust. The Trust has finished the financial year with no patients waiting greater than 52 weeks, and a total referral to treatment waiting list lower than in March 2018. Emergency department (ED) performance There are three types of emergency departments: Type Type Type ONE TWO THREE 3 24 hour with full resuscitation facilities 3 Consultant-led 3 Designated accommodation for patients admitted via ED 3 Single specialty emergencies (eye or dental) 3 Consultant-led 3 Designated accommodation 3 Minor injuries/walk-in centres 3 Doctor or nurse-led 3 Can be routinely accessed without appointment 3 May be co-located within an ED or sited in the community We run all three types of departments and all three types are subject to the national target and are therefore reflected in our figures. National target: The constitutional standard states that 95% of patients should be treated and either admitted or discharged within fours of arrival into ED. However, NHS Improvement set local targets for all NHS organisations with an ambition that the NHS would return to meet the 95% target by March 2019. The local targets set by quarter (to allow for seasonal variations) for UHS were: Quarter 1 - 90% Quarter 2 - 91.4% Quarter 3 - 90% Quarter 4 - 90-95% How did we do? 2018/19 was another challenging year for emergency patients for the whole Hampshire and Isle of Wight area. Whilst we had a positive start to the year achieving quarter 1 and 2 targets, we did not meet quarter 3 or 4 targets. We did, however, meet out local delivery system targets. 20 OVERVIEW AND PERFORMANCE REPORT The graph below shows our performance against the four hour target over the last year (including all UHS types and Lymington). National 4 hour access target – UHS performance 100% 95% 90% 87.1% 85% 80% 82.1% 82.3% 87.4% 87.4% 93.0% 90.5% 84.7% 82.9% 85.7% 90.7% 88.9% 84.8% 77.9% 81.1% 75% Jan 2018 Feb 2018 Mar 2018 Apr 2018 May 2018 June 2018 July 2018 Aug 2018 Sep 2018 Oct 2018 Nov 2018 Dec 2018 Jan 2019 Feb 2019 Mar 2019 The graph below shows our local delivery system performance against the four hour target over the last year (including all SGH types, Lymington and Southampton Treatment Centre). National 4 hour access target – Local delivery system 100% 95% 91.0% 90% 91.1% 95.1% 92.8% 88.7% 87.1% 89.2% 91.5% 85% 92.9% 88.4% 83.3% 85.9% 80% 75% Apr 2018 May 2018 June 2018 July 2018 Aug 2018 Sep 2018 Oct 2018 Nov 2018 Dec 2018 Jan 2019 Feb 2019 Mar 2019 21 OVERVIEW AND PERFORMANCE REPORT Cancer waiting times There are nine separate cancer waiting times standards (below), each of which can then be split into tumour site specific performance groups. Measures Urgent GP referrals seen in two weeks Breast symptoms referral seen in two weeks Treatment started within 62 days of urgent GP referral Treatment started within 62 days of referral (breast, cervical and bowel screening) 62 day consultant upgrades Treatment started within 31 days of decision to treat Second or subsequent treatment (surgery) started within 31 days of decision to treat Second or subsequent treatment (anti-cancer drugs) started within 31 days of decision to treat Second or subsequent treatment (radiotherapy) started within 31 days of decision to treat Target > 93% > 93% > 85% > 90% > 86% > 96% > 94% > 98% > 98% 18/19 YTD (up to and including Feb 19) 86% 50% 74% 80% Achieved 8 8 8 8 86% 3 93% 8 85% 8 100% 3 100% 3 The number of patients referred under the two week wait urgent suspected cancer protocol seen within two weeks of their referral, rose by 7.7% in 2018/19. The chart below shows the rise in demand for UHS cancer services over the past three years UHS growth in cancer actvity – 2016/17 to 2018/19 (up to and including month 11) 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Two week waits 2016/17 up to and incl Feb 62 day target patients 31 day target patients 2017/18 up to and incl Feb 2018/19 up to and incl Feb For staffing performance, please refer to page 58. For financial performance please see page 177. Paula Head, chief executive officer 28 May 2019 22 OVERVIEW AND PERFORMANCE REPORT Regulatory body ratings Single Oversight Framework NHS Improvement’s Single Oversight Framework provides the framework for overseeing providers and identifying potential support needs. The framework looks at five themes: 1. Quality of care 2. Finance and use of resources 3. Operational performance 4. Strategic change 5. Leadership and improvement capability (well-led) Based on information from these themes, providers are segmented from one to four where ‘4’ reflects providers receiving the most support, and ‘1’ reflects providers with maximum autonomy. A foundation trust will only be in segments three or four where it has been found to be in breach or suspected breach of its licence. Segmentation During 2018/19 the Trust was confirmed as being placed within segment ‘2’. This segmentation information is the Trust’s position as at 31 March 2019. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. Finance and use of resources The finance and use of resources theme is based on the scoring of five measures from ‘1’ to ‘4’, where ‘1’ reflects the strongest performance. These scores are then weighted to give an overall score. Given that finance and use of resources is only one of the five themes feeding into the Single Oversight Framework, the segmentation of the Trust disclosed above might not be the same as the overall finance score here. Area Financial sustainability Financial sustainability Financial sustainability Overall scoring Care Quality Commission ratings: Metric Capital service cover Liquidity Income and expenditure margin Distance from financial plan Agency spend Q1 Q2 Q3 Q4 2 2 1 1 1 1 1 1 1 1 1 1 1 2 2 1 1 1 1 1 1 1 1 1 Overall rating for this trust Are services at this trust safe? Are services at this trust effective? Are services at this trust caring? Are services at this trust responsive? Are services at this trust well-led? Good Requires improvement Outstanding Good Requires improvement Good 23 OVERVIEW AND PERFORMANCE REPORT In December 2018, the CQC inspected four core services; urgent and emergency care, medicine, maternity and outpatients. It also looked at management and leadership, and effective and efficient use of resources. The CQC report (published on the 17 April 2019) rated the Trust as ‘good’ overall and ‘outstanding’ for providing effective services. “Our inspectors found a strong patient-centred culture with staff committed to keeping their people safe, and encouraging them to be independent. Patients’ needs came first and staff worked hard to deliver the best possible care with compassion and respect. Inspectors saw many areas of outstanding practice, with care delivered by compassionate and knowledgeable staff. Several teams led by example with a continuous focus on quality improvement. The Trust did face some challenges especially with the ageing estates. Some patient environments were showing significant signs of wear and tear – but again staff were doing their utmost to deliver compassionate care”. Dr Nigel Acheson Deputy chief inspector of hospitals (South) Environmental matters We recognise that the Trust’s business has an impact on the environment. As a large hospital we undertake a wide range of activities and use a large amount of resources, for example: • The Trust generates approximately 3,000 tonnes of waste yearly, half of which is clinical waste. If not properly treated this huge amount of waste can cause soil, water and air pollution depending on the disposal route. • Due to the large number of visitors and deliveries we attract every day, traffic congestion is regularly experienced on and around the site, which impacts the air quality around the hospital. We are committed to environmental sustainability and consider it as part of the business culture. We acknowledge that reducing waste and minimising the consumption of scarce resources is consistent with financial sustainability. Our sustainability disclosure section on page 80 provides greater detail on the steps we are taking to reduce our activities’ impact on the environment. 24 OVERVIEW AND PERFORMANCE REPORT Social, community, anti-bribery and human rights issues We recognise our responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK), which are relevant to health and social care. These rights include the: • right to life • right not to be subjected to torture, inhuman or degrading treatment or punishment • right to liberty • right to respect for private and family life The Trust is committed to ensuring it fully takes into account all aspects of human rights in our work. At University Hospital Southampton we value our reputation for top quality care and financial probity and conduct our business in an ethical manner. The Bribery Act 2010 was introduced to make it easier to tackle the issue of bribery which is a damaging practice. Bribery can be defined as ‘giving someone a financial or other advantage to encourage them to perform their duties improperly or reward them for having done so’. To limit our exposure to bribery we have in place an Anti-Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Freedom to Speak Up (formerly Raising Concerns) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. We also employ a local counter fraud specialist who will investigate, as appropriate, any allegations of fraud, bribery or corruption. The success of our anti-bribery approach depends on our staff playing their part in helping to detect and eradicate bribery. Therefore, we encourage staff, service users and others associated with UHS to report any suspicions of bribery and we will rigorously investigate any allegations. In addition, we hold a register of interest for directors, staff, and governors and ask staff not to accept gifts or hospitality that will compromise them or the Trust. The Board of Directors carries out its business in an open and transparent way. We are committed to the prevention of bribery as well as to combating fraud and expect the organisations we work with to do the same. Doing business in this way enables us to reassure our patients, members and stakeholders that public funds are properly safeguarded. There are no important events since the year end affecting the foundation trust. No political donations have been made. The Trust has no overseas branches. 25 FR STAND BODY ACCOUNTABILITY REPORT Members of the Trust Board Board member Name Title Paula Head Chief executive officer David French Deputy chief executive officer and chief financial officer Gail Byrne Director of nursing and organisational development Jane Hayward Director of transformation and improvement Biography Declarations Paula joined the Trust as chief executive in September 2018, having been chief executive at the Royal Surrey County NHS Foundation Trust in Guildford and before that at Sussex Community NHS Foundation Trust. She began her career as a pharmacist working in the community, hospitals and at health authorities before moving into general management and her first board position at Kingston Hospital. Since then she has spent time on the boards of commissioners and providers, including director of transformation at Frimley Park Hospital NHS FT. Paula lives in Hampshire and has a daughter studying medicine at the University of Southampton. Daughter is a medical student at University of Southampton; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Executive Delivery Group David joined the Trust in February 2016 and led on finance, procurement, estates and commercial development until March 2018, when he became interim chief executive officer. He read Economics and Social Policy at the University of London before joining ICI plc, where he qualified as a chartered management accountant. David has extensive healthcare experience from the pharmaceutical industry, mostly Eli Lilly and Company where he held many commercial and financial roles in the UK and overseas. He joined the NHS in 2010 as chief financial officer of Hampshire Hospitals NHS Foundation Trust. He also serves as a non-executive director for Vivid Housing Limited, a social housing provider across Hampshire and the Solent. Non-executive director and chair of audit and risk committee, Vivid Housing Limited; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a whollyowned subsidiary of UHSFT; Member of Solent Acute Alliance; Member of Hampshire & Isle of Wight Counter Fraud Board; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Capital Planning Panel (from May 2018) Gail joined the Trust in 2010 as deputy director of nursing and head of patient safety. Prior to this, she has worked at the Strategic Health Authority as head of patient safety, and director of clinical services at Portsmouth Hospital. Gail has also worked in Brisbane, Australia as a hospital Macmillan nurse, and as general manager of a special purpose vehicle company for the private finance initiative at South Manchester Hospitals. Husband is a consultant surgeon in the Trust; Daughter is a midwife at UHS (from March 2019) Jane joined the Trust in 2000 as a clinical services manager for the cardiothoracic directorate after spending two years in Hertfordshire as director of performance and 11 years at Barts and the London Hospitals in various roles including planning, finance and commissioning. Jane has led on human resources, information management and technology, improvement and modernisation and has been chief operating officer. Jane joined the Trust Board in February 2008 and became director of transformation and improvement in January 2014. Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Father and mother are UHSFT simulated patients (voluntary position) Dr Derek Medical Sandeman director Dr Caroline Marshall Chief operating officer Derek was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional endocrine service. Throughout his career he has had extensive clinical leadership experience, most recently serving eight years as clinical director. Derek’s leadership roles have also included programme director for postgraduate education and the Wessex Endocrine Royal College representative. He has a strong history of wider system engagement, working collaboratively with partners to improve systems resilience and pathways. Caroline joined the Trust in 1997 as a consultant hepatobiliary and neuroanaesthetist. She has held the posts of college tutor for the Royal College of Anaesthetists and UHS mentoring and coaching lead. In 2008, she became clinical service director for critical care, and then divisional clinical director for division A between 2010 and 2013. Caroline served as interim chief operating officer between January to December 2014, and was then appointed to the substantive post. Her portfolio includes the executive lead for cancer and the executive lead for major trauma. Director of UHS Pharmacy Limited, a wholly-owned subsidiary of UHSFT; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Clinical Executive Group Daughter is employed within the emergency department at UHS (from 1 August 2018) 27 ACCOUNTABILITY REPORT Non-executive directors Name Title Peter Hollins Chair Simon Porter Senior independent director and deputy chair Dr Mike Non-executive Sadler director Biography Declarations Peter graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, he was appointed in 1992 as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, returning in 1998 to the UK as chief executive officer of
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/annual-report-2018-19.pdf

UHS AR 23-24 Final

Description: 2023/24 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2023/24 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2024 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 37 Directors’ report 38 Remuneration report 62 Staff report 75 Annual governance statement 95 Quality account 111 Statement on quality from the chief executive 112 Priorities for improvement and statements of assurance from the board 115 Other information 180 Annual accounts 207 Statement from the chief financial officer 208 Auditor’s report 210 Foreword to the accounts 217 Statement of Comprehensive Income 218 Statement of Financial Position 219 Statement of Changes in Taxpayers’ Equity 220 Statement of Cash Flows 221 Notes to the accounts 222 5 Welcome from the Chair and Chief Executive Officer This has been another busy and undoubtedly challenging year across the NHS and UK health and social care system, and much of what has impacted the national picture has been reflected in the operational focuses and patient and people priorities for University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) over the last year. Meeting and continuing to overcome the challenges we have faced has required an organisation-wide team effort, and looking back at the successes we feel incredibly proud of the achievements of our 13,000 staff. Particular highlights include: • In the top ten in the country (7th) against government targets for elective recovery performance with 118% of activity compared with 2019. • Top-quartile performance against most performance metrics compared to similar sized teaching hospitals, including Emergency Department access, long-waiting patients on Referral to Treatment pathways, Diagnostics and Cancer performance. • Significant investment in new capacity through building new wards and theatres and refurbishing existing areas of the hospital. • Delivery of our highest ever Cost Improvement Programme saving. These achievements place us among the best performing trusts in England in several areas and are even more remarkable against a backdrop of continued periods of industrial action and increasing demand for our services, with many people coming to us with higher levels of acuity than ever before. The Trust’s performance in terms of elective recovery places it as one of the best-performing trusts in England and demonstrates the impact of the Trust’s decision to invest in additional capacity in prior years by building new wards and theatres. The Trust’s Emergency Department performance in respect of its four-hour waiting target at the end of March 2024 has attracted additional capital funding as part of an incentive scheme. Some of this funding will be used to increase the department’s same-day emergency care capacity during 2024/25. From a financial perspective, balancing the complexities of today’s challenges alongside the need to protect and ensure the long-term stability and quality of our service provision, has required the Board to take a number of considered and crucial efficiency improvement actions this year. Whilst challenging, the Trust has seen significant progress in delivering on both its forecasted finance position for 2023/24 and productivity targets. Achieving long-term financial stability is key to us continuing to invest in much needed upgrades and improvements to the parts of our estate that are ageing, and to developing new state-of-the-art facilities and infrastructure that increases our capabilities and capacity into the future. In the last year parts of the hospital have been transformed, with the opening of new wards, theatres and a skybridge to link the estate. Construction of a sterile services and aseptics facility has begun at Adanac Park and the expansion of our neonatal department, where we treat and care for some of our most vulnerable babies and their families, is underway. The development of a new aseptic facility at Adanac Park will have capacity to serve other hospitals within the region and is a significant opportunity for improved system-wide working. 6 We have also worked with our people to design spaces where they can rest, relax and recharge - including a new wellbeing hub and rooftop garden on the Princess Anne Hospital site. In addition, 40 staff rooms across the site have been refurbished thanks to funding from Southampton Hospitals Charity. During the year, the Trust worked to establish the Southampton Hospitals Charity as a separate charitable company to improve its ability to both raise and spend funds. This process completed on 1 April 2024. Work was carried out to refurbish a children’s ward during the year in partnership with the charity. Our people are our greatest asset, and we are pleased to see improvements from the annual staff survey in several areas - such as how people can work more flexibly, access to learning and development and improved satisfaction in support from line managers. We recognise the pressures and demands that come with working in this environment and will continue to ensure everyone working here feels heard, encouraged and supported when raising concerns. At UHS, every opportunity is taken to recognise and celebrate the incredible things our people do here every day, including the return of our in-person annual awards ceremony, monthly staff recognition events and the first ever ‘We Are UHS Week’. These occasions are an important reminder that, even when faced with challenges, there is so much to be proud of and celebrate across the whole Trust. Working together, both within the Trust and across organisational boundaries, remains one of our core values. The partnership between UHS and the University of Southampton is as strong as it has ever been, with more than 250,000 individuals having now taken part in research studies in Southampton. As the lead partner member for Acute Hospital Services on the Hampshire and Isle of Wight Integrated Care Board, we are proactively working with other trusts and healthcare providers in the region to improve the health of the community we serve. In addition, the Trust has continued to work in partnership with other providers across the system to build a shared elective orthopaedic hub in Winchester. It is anticipated that the health and social care system will continue to be a challenging environment in 2024/25. We recognise that many of the big challenges we face can only be solved in partnership with wider local partners, and we are committed to actively playing our part in delivering system-wide solutions. Equally, we will continue to focus on improving whatever is within our internal control, and to work collaboratively with our people to ensure our patients’ experience, safety and outcomes remain central to our decision-making and the actions of everyone at UHS. Jenni Douglas-Todd Chair 19 July 2024 David French Chief Executive Officer 19 July 2024 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer As with 2022/23, this was another challenging year with continued increasing demand for the Trust’s resources and the need to balance this with the need to deliver quality patient care and at the same time maintain a sustainable financial position. Demand for non-elective care continued to increase with an average of 375 attendances per day to our main Emergency Department. In addition, the number of patients on the 18-week Referral to Treatment pathway rose to 58,000. Patients having no clinical criteria to reside in hospital, but unable to be discharged due to the lack of funded care in a more suitable location, posed and continues to pose a significant challenge for the Trust. The number of patients within this category was as high as 270 at times and was consistently higher throughout the year when compared to 2022/23. Despite this the Trust continued to perform well when compared to other comparable organisations, achieving some of the best Emergency Department and elective recovery fund performance in England. The Trust’s financial position continued to be difficult, which required some difficult decisions in respect of spending controls and controls on recruitment. The Trust focused in particular on controlling spending on temporary and agency staff, but in view of the overall workforce numbers compared to the 2023/24 plan, further controls were implemented in respect of substantive recruitment. Due to the additional controls and the Trust’s best delivery to date on its Cost Improvement Programme (£63.4m), the Trust achieved an end of year deficit of £4.5m, compared to the deficit of £26m anticipated in its 2023/24 plan. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1.3 billion in 2023/24. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to nearly four million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 155,000 inpatients and day patients, including about 70,000 emergency admissions sees over 750,000 people at outpatient appointments deals with around 150,000 cases in our emergency department The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 54% is paid for by NHS England and 43% by integrated care boards, predominantly the Hampshire and Isle of Wight Integrated Care Board (ICB). These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board. The ICP is a statutory committee jointly formed between the NHS integrated care board and all upper-tier local authorities that fall within the ICS area. The ICP brings together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Division B Division C Division D Surgery Critical Care Opthalmology Theatres and Anaesthetics Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values The Trust’s values describe how things are done at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. These values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything its staff had experienced during the COVID-19 pandemic and what had been learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. The Trust’s strategy is organised around five themes and for each of these it describes a number of ambitions UHS aims to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2023/24 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Increasing the number of reported Shared Decision-Making conversations. • Increasing the number of specialities reporting outcomes that matter to patients. • Rolling out the Patient Safety Incident Reporting Framework across the Trust. • Working with patients as partners to improve patient satisfaction. • Treating patients according to need but aiming for no patient to wait, other than through patient choice, more than 65 weeks for treatment. • Delivering national metrics for site set-up time to target for clinical research studies. • Improving the Trust’s position against peers. • Delivering year three of the Trust’s research and innovation investment plan. • Developing the five-year research and development strategy implementation plan and delivery of the first year. • Strengthening and broadening the partnership between the Trust and the University of Southampton. • Supporting delivery of the Trust’s workforce plan for 2023/24. • Reducing turnover and sickness absence rates. • Increasing overall participation in the NHS staff survey and maintaining overall staff engagement score. • Increasing the proportion of appraisals completed. • Delivering the first year objectives of the Inclusion and Belonging strategy. • Working in partnership with acute trusts to agree and implement the acute services strategy. • Producing and embedding an internal framework for network development. • Working with the local delivery system on vertical integration to reduce the number of patients without criteria to reside. • Working with system partners to open a surgical elective hub. • For the Trust to be seen as an ‘anchor institution’ in the local area. • Delivering the Trust’s financial plan for 2023/24. • Engaging the organisation in the challenge to manage demand so that capacity and demand are in equilibrium. • Delivery of the Always Improving strategy priorities. • Delivering the Trust’s capital programme in full. • Entering into a new energy performance contract and delivering the first year of the Public Sector Decarbonisation Scheme. Performance against these objectives was monitored and reported to the Trust’s Board on a quarterly basis. 14 At the end of 2023/24, the Trust had met the objectives set as follows: Corporate Ambition Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future Totals Number of Objectives 5 5 5 5 5 25 Achieved in full 4 3 2 3 2 14 Partially achieved 1 2 2 1 3 9 Not achieved 0 0 1 1 0 2 Particular areas to highlight where the Trust has achieved strong delivery during the year include: • Delivery of quality priorities in Shared Decision-Making and the roll out of the Patient Safety Incident Response Framework. • Achieving the Trust’s 65-week waiter glide path. • Successful delivery of a number of research and development priorities, including work with the University of Southampton. • Maintaining sickness absence and turnover well below the targets set at the beginning of the year, and successfully delivering the first year of the Trust’s Inclusion and Belonging strategy. • Delivery of the Trust’s full available capital budget and completion of the first year of the Trust’s decarbonisation scheme. 15 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2023/24 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families or carers with a highquality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust does not take full advantage of its position as a leading university teaching hospital with a growing, reputable and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for its patients. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme; NHS England imposing additional controls/undertakings; and a reducing cash balance, impacting the Trust’s ability to invest in line with its capital plan, estates and digital strategies and in transformation initiatives. • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2023/24, the Trust saw continued increased demand for its services, particularly in the Emergency Department In addition, the number of patients having no clinical criteria to reside in hospital, but unable to be discharged due to a lack of appropriate care packages was higher than anticipated and spiked during winter, which significantly impacted patient flow through the hospital and required the Trust to engage additional temporary staff. The number of patients in this category peaked at 270 during the winter. There were particular challenges in respect of those patients with a primary mental health care need who would be better cared for in a more suitable alternative setting. 16 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The Trust continued to experience high demand for its services, especially in the Emergency Department, with average demand during the year being around 375 patients presenting per day in the main adult and children’s emergency department. In addition, the Trust experienced a significant impact on flow within the hospital due to a high number of patients having no clinical criteria to reside in hospital but unable to be discharged. This number was as high as 270 at times during winter: an increase of around 50 patients when compared to the prior year. The Trust also saw an increase in the number of referrals with the number of patients on a waiting list under the 18-week Referral to Treatment pathway rising from approximately 55,000 to 58,000 by the end of the year. In common with other trusts, the ongoing industrial action also impacted the Trust’s ability to provide urgent care and deliver on its elective recovery programme. Quality and compliance Despite the challenges, the Trust’s Emergency Department performance was one of the highest in England in March 2024, which resulted in additional capital funding being awarded. In addition, the Trust’s elective recovery performance was one of the best in England at 118% compared to 2019. The Trust continued to monitor the quality of care delivered throughout 2023/24 through a number of established quality assurance programmes. Clinical leaders monitored key quality, safety and patient experience indicators such as falls, pressure ulcers and venous thromboembolisms. Quality peer reviews were carried out, most significantly through Matron-led Quality Walkabouts every week in and out of hours focusing on the five key CQC questions – safe, effective, responsive, caring, and well-led. The Trust’s Clinical Accreditation Scheme builds on this intelligence, with clinical areas completing self-assessments of performance and review teams completing onsite visits. Patient representatives were included in these review teams. Learning was shared at the Clinical Leaders’ Group and via quarterly reports. The Trust was an active partner in a South-East accreditation network, offering advice and a steer to providers who are just setting up or looking to develop their own scheme, and extended that advice and support to other providers in England. 17 On 15 May 2023, the CQC inspected the maternity and midwifery service at Princess Anne Hospital as part of their national maternity inspection programme. The inspection report was published 11 August 2023, and the Trust retained its overall rating of ‘good’. This year UHS introduced its Fundamentals of Care (FOC) initiative. Whilst this is not a new concept, there were concerns that missed fundamental care had been amplified during the COVID- 19 pandemic. This initiative aims to empower and educate staff at all levels to ensure fundamental care is at the heart of what the Trust does. The Trust completed its transition to the Patient Safety Incident Response Framework (PSIRF) and collaborated with the ICB to develop a PSIRF plan and policy to underpin the change. The Trust implemented the requirements in respect of ‘Martha’s Rule’ where patients, relatives and carers have a legal right to a rapid review by a critical care outreach team during an acute deterioration episode in and out of hours. The Trust continued its focus on infection prevention and control, responding rapidly to rises in infection over the winter, and successfully flexing initiatives and innovations to achieve successful management in a responsive manner. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of further quality improvement projects. This included improvements across theatres, inpatient flow and outpatient programmes. During the year, average length of stay was reduced by 1.64%, day theatre cancellations were reduced by 200, and 42,350 patients were placed onto Patient Initiated Follow Up (PIFU) pathways. Further information can be found in the Quality Account. Partnerships The Trust works within the Hampshire and Isle of Wight Integrated Care System, and is an active member of a number of partner groups including the Acute Provider Collaborative Board and the Health and Wellbeing Board. The Trust develops and agrees its annual financial plans with the Integrated Care Board. The Trust is a member of a number of specific partnership groups for particular services, including the Central and South Genomics Medicine Service, the Children’s Hospital Alliance and the Southern Counties Pathology Network. The Trust works actively as a partner with other provider organisations around clinical networks, particularly with acute Trusts within the Integrated Care System and others closely located geographically. The Trust also links closely with the University of Southampton on a number of topics including research, commercial development and education and has a developed meeting structure to oversee this. 18 Workforce The Trust’s key areas of focus during 2023/24 were in respect of increasing the substantive workforce whilst also reducing reliance on bank and agency usage, and reducing staff turnover and sickness. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 331 whole-time equivalents above its plan for 2023/24. The Trust was successful in reducing staff turnover from 13.5% in 2022/23 to 11.4%, achieving the local target of . Cancer Waiting Times - 2 Week Wait Performance Cancer Waiting Times - 2 Week Wait Performance 100% 90% 80% 70% 60% 50% 40% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance % standard met The national target was for 96% of patients to commence treatment within 31 days of diagnosis. In March 2024, the Trust achieved 92% and performed in the range of 86%-94% throughout the year. The Trust has continued to make progress against the target for treatment of cancer within 62 days of an urgent GP referral, improving performance from 64% in April 2023 to 76% in March 2024 (NHS average: 69%). First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performanceUHS vs. NHSE average Cancer waiting times 31 day RTT performance UHS vs. NHSE average 96% 94% 92% 90% 88% 86% 84% 82% 80% 78% 76% Apr-23 May-23 Jun-2 3 Jul-2 3 Aug-23 Sep-2 3 Oct-23 Nov-2 3 Dec-23 Jan-24 Feb-2 4 Mar-24 Performance NHS Average 27 Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average % standard met 1 00% 80% 60% 40% 20% 0% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance NHS Average 28 Quality priorities Priorities for improvement 2023/24 Last year the Trust continued its ambition to deliver the highest quality care shaped by a range of national, regional, local, and Trust-wide factors. During the year the Trust continued to experience unprecedented demand on its services, with flow, capacity, infection prevention and safety all presenting challenges. However, the Trust was confident in its ability to keep a focus on its quality priorities, and its teams worked hard to achieve their goals even in these difficult circumstances. Priorities are aligned to the three core dimensions of quality: • Patient experience – how patients experience the care they receive. • Patient safety – keeping patients safe from harm. • Clinical effectiveness – how successful is the care provided? Out of the six priories set, the Trust achieved five and partially achieved one. Overview of success Quality Priority One Improving care for people with learning disabilities and autistic (LDA) people across the Trust. Supporting staff delivering this care. Outcome against goals: achieved Key achievements: • LDA working group reestablished. • Development of an improvement plan using the NHS Learning Disability Improvement standards. • The LDA team has moved to the virtual enhanced care group in Division B where operational and governance support, leadership, and peer support/learning opportunities has been strengthened. • Sensory Boxes have been introduced for all clinical areas, funded by the Hampshire and Isle of Wight (HIOW) Integrated care board (ICB). These boxes include noise cancelling headphones, fidget toys, communication books and visual cards to support patients and wards. • Recruited additional Learning Disability Champions. • Established links with the parent carer forum (PCF) for the local area and are now attending regular events. A representative from the PCF sits on the LDA working group. The LDA team are working with the Trust lead for patient experience to develop this aspect of the LDA workplan over the next year. Quality Priority Two Supporting patients, service users and staff to overcome their tobacco dependence via a smoking cessation programme. Outcome against goals: achieved Key achievements: • Package of support available to patients who may be smokers and who need to be supported not to smoke during their treatment. • Fully trained team of tobacco advisors working in the hospital and an advisor working in the outpatient setting supporting the patients once they have returned home. • Devised the IT changes the Trust would like to implement to improve its service and referral process. • Recruited 30 smoke-free champions. • Successfully supported 1,131 patients with a self-confirmed quit rate of 45.6% at 28 days. • Supported 109 outpatients who have successfully achieved a 60% quit rate. • On track to achieve the goal to go smoke-free by April 2024 including the removal of smoking shelters. 29 Quality Priority Three Ensure carers are fully supported, involved, and valued across all our services by developing the carers support service across the Trust in partnership with Southampton Hospitals. Outcome against goals: partially achieved Key achievements: • Carers now have a more comprehensive package of concessions and vouchers to help support their cared-for person (e.g. free parking available onsite for blue badge owners is now available). • Listening events were held to put patients at the centre of transforming the way we deliver care is delivered, enabling their voices to improve the quality of care and outcomes for all. • Developed joint working with local partners (e.g. Children’s Society and No Limits to support young carers). Not yet achieved: • The ‘pathway to support, has not yet been developed. Work is ongoing to develop a new strategy. • A charity-funded carers’ support worker has not yet been appointed. • The carers’ training package has not yet been relaunched. Quality Priority Four Put patients at the centre of transforming the way care is delivered, enabling their voices to improve the quality of care and outcomes for all. Outcome against goals: achieved Key achievements: • Work has continued to work across corporate and divisional services to embed patients and carers into quality and service improvement, creating new patient groups (e.g. Mesh Support Group). • Successfully developed our engagement with various local communities, working to ensure that a range of care experiences are considered ( e.g. there is now a Gypsy, Roma, and Irish Traveller community health liaison officer to ensure that these communities are engaged with and brought into work to improve the inclusivity of our services). • Attending multiple public engagement opportunities (Young Carers’ Festival, Mela, University Freshers’ Fayres, Carers’ Listening Lunch, Hoglands Park Play Day, visits to local temples and ‘Love Where You Live’). • Youth and Young Adult Ambassador involvement has increased, including attendance toat meetings of the Council of Governors, and supporting hospital projects. • A Celebration of Carers Week and Volunteers Week were run. • The Trust has analysed its reported outcome measures to identify health inequalities in its services. This information has been used to set a new quality priority for 2024/25. • An SMS friends and family test text survey has been introduced to improve the response rate on patient feedback from the Emergency Department. In the first three months following the survey launch, responses increased from 24 to 424. 30 Quality Priority Five To develop the Trust’s clinical effectiveness process, connecting to the Trust’s Always Improving approach to measuring, understanding, and using outcomes to improve patient care. Outcome against goals: achieved Key achievements: • The Trust has developed its clinical effectiveness process across the Trust with involvement of informatics, governance and management teams, clinical effectiveness leads as well as reporting committees. • Patient representation onhas been included in the clinical assurance meeting for effectiveness and outcomes (CAMEO) to ensure conversations focus on what matters to patients. • The CAMEO template has been changed to focus discussions on areas the specialty is proud of (strong or improving outcomes), areas for improvement (poorly benchmarked or worsening outcomes) and planned actions. • The Trust encourages the use of run and/or statistical process control charts along with benchmarking where available. • Details of NICE and quality standards and national and regional reviews are included to cover breadth of clinical effectiveness. • How the clinical effectiveness team works has been reorganised, aligning each of them to each division giving a named link which helps to deepen understanding and improve links with governance and improvement activities locally. • Working with informatics to establish a core set of clinical outcome measures which are meaningful to patients, which can be reported centrally (starting with surgical specialities). • Starting to develop an education strategy and platform to support staff with a number of tools used in clinical effectiveness as well as clarity on where and how to record and evidence audit and service improvement. • A revised strategy has been drafted. Quality Priority Six Developing a culture where all clinical staff have a basic knowledge of diabetes. Outcome against goals: achieved Key achievements: • Launch of the ‘Start with the Diabasics’ Initiative, designed to help give diabetes visibility across UHS. • Delivered an extensive education programme to clinical staff across the professions and bands, including the introduction of some e-learning and a Diabasics introductory video has been shown at all trust staff inductions since July 2023. • Supported the development of 45 diabetes link nurses, resulting in all ward areas now having a named diabetes link nurse. • Improved triage for referrals. • Established processes for ‘lessons learned’. • Developed IT solutions to improvingimprove alerts and guidance. • A ‘Ketone Wednesdays’ initiative has been created in response to overuse of blood ketone testing (estimated waste cost of £100,000 per year). • The Trust’s lead diabetes specialist nurse and the Diabasics Initiative were both shortlisted for National Quality in the Care Diabetes Awards (October 2023). • The Diabasics Initiative was mentioned as a case study on the Diabetes UK charity website as an example of good practice that could be reproduced elsewhere. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2024/25, in the Trust’s Quality Account for 2023/24. 31 Financial performance The Trust delivered a deficit of £4.5m from a revenue position of over £1.3bn, following receipt of £24.6m one-off cash support from NHS England. UHS started the year with an underlying deficit as a result of a number of cost pressures, notably demand for services being above block contract levels and the cost of national pay awards being above funded levels. The Trust has also continued to face a number of pressures, including high numbers of patients who no longer meet the criteria to reside in the hospital, and high demand for patients with a primary mental health need. In 2023/24, the Trust delivered a record savings level of £63.4m (5%) across a range of programmes. Trust operating income rose by £107m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Trust operating expenses rose by £89m, incorporating funded inflationary costs as well as costs relating to the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investment of over £75m, including investment in new wards, theatres, decarbonisation, digital infrastructure, neonatal expansion and backlog maintenance. Trust cash and cash equivalents finished the year at £79m, a reduction of £24m from the previous year due to the operating loss and capital investment outlined above. Whilst liquidity remained strong in 2023/24 supported by NHS England cash support, the underlying financial deficit means it is likely to decline further in 2024/25. The Trust is continuing to monitor its cash position closely and is considering whether additional cash support may be required in 2024/25. Sustainability The Trust recognises that everyone has a part to play in responding to the climate crisis. In March 2022, the Trust agreed its own green plan in response to the challenge of the NHS becoming the world’s first health service to reach carbon net zero. Now in its third year, the plan identifies the Trust’s key areas of focus and its ambitions and has seen progress across all areas of the plan. The plan sets out the scale of the challenge, the Trust’s commitment to reducing the impact on the environment and the steps to be taken across the following categories: • Estates and facilities • Clinical and medicines • Digital transformation • Supply chain and procurement • Travel and transport • Waste and resources • Food and nutrition • Adaptation • Biodiversity • Wider sustainability The Trust continues to progress through its green plan and has completed the ‘Greener NHS’ reporting tool for several quarters, which has demonstrated good progress. In addition, the Trust is planning to launch its ‘Our Sustainable UHS’ app for staff, which will give tips on sustainability and create personalised travel plans, including identifying potential contacts for car sharing. In addition, the Trust is considering proposals to implement additional solar power, smart metering and expanding the use of LED lighting. 32 In 2022/23, the Trust was successful in bidding for £29.4m of funding through the Public Sector DeCarbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. During the year the Trust successfully bid for £823k in National Energy Efficiency Funding which has been used to upgrade the lighting at Princess Anne Hospital. Social, community, anti-bribery and human rights issues The Trust recognises its responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK). These rights include: • right to life • right not to be subjected to inhuman or degrading treatment or punishment • right to liberty and freedom • right to respect for privacy and family life. These are reflected in the duty, set out in the NHS Constitution, to each and every individual that the NHS serves, to respect their human rights and the individual’s right to be treated with dignity and respect. The Trust is committed to ensuring it fully takes into account all aspects of human rights in its work. An equality impact assessment is completed for each Trust policy. For patients, the Trust’s safeguarding policies protect and support the right to live in safety, free from abuse and neglect and other policies and standards are designed to optimise privacy and dignity in all aspects of patient care. Feedback from patients and the review of complaints, concerns, claims, incidents and audit help to monitor how the Trust is achieving these objectives. The Trust’s green plan, approved by the board of directors in March 2022, recognises the Trust’s broader role and responsibility to address the issues of climate change, air pollution, waste and environmental decline present to the city of Southampton and the impact that these issues have on the health and wellbeing of the local population served. Although the Modern Slavery Act 2015 does not apply to the Trust, its green plan sets out an ambition to stop modern slavery. The Trust is also committed to maintaining an honest and open culture within the Trust; ensuring all concerns involving potential fraud, bribery and corruption are identified and rigorously investigated. The Trust has a Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Raising Concerns (Whistleblowing) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. Anti-bribery is part of the Trust’s work to counter fraud. This work is overseen by the Audit and Risk Committee, which receives regular reports from the local counter fraud specialist on the effectiveness of these policies through its monitoring and reviews, providing recommendations for improvement, as well as an annual report from the freedom to speak up guardian. You can read more about the work of the Audit and Risk Committee and the Trust’s approach to counter fraud in the Accountability Report. Events since the end of the financial year There have been no important events since the end of the financial year affecting the Trust. Overseas operations The Trust does not have any overseas operations. 33 Equality in service delivery NHS trusts have an essential role in tackling health inequalities, both as part of the services they provide, but also through work with the wider system. By working with those in integrated care systems, local authorities and third sector organisations, the Trust can have a significant impact on the health of the local population. The national focus on health inequalities is growing. This comes with new legal duties around reporting information and expectations to report on improvement programmes. In September 2023, a health inequalities steering group was initiated, under the leadership of the Chief Medical Officer, with representation from clinical, operational, transformation, patient experience, research, organisational development and culture, informatics, public health and the Integrated Care Board. The group focused on scoping future priorities aligned to national guidelines, contractual obligations and priorities, regional priorities, feedback from clinical teams and patients, understanding where action is already being taken, and what the data is showing. Overall, the group
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/UHS-AR-23-24-Final.pdf

ACCORD-2 example sub-protocol

Description: CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TITLE PAGE Master Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Sub-protocol Number: ACCORD-2-002 Sub-protocol for Candidate Agent: Bemcentinib Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): EudraCT: 2020-001736-95 IRAS Number: 282769 RHM Number: Date of Sub-protocol: 22 April 2020 Version: Protocol Amendment 01 Caution: In accordance with cardiac exclusion criteria, in particular Exclusion 13, drugs known to cause QT prolongation should be discontinued/replaced, with sufficient time (5 half-lives) for washout. Patients in these categories of potential risk should be discussed directly by telephone with BerGenBio: Prof Hani Gabra, BerGenBio Chief Medical Officer: +44 7810 576112 Dr Akil Jackson, BerGenBio Medical Director: +44 7810 575037 Final, 22 April 2020 1 CONFIDENTIAL Sponsor Signatory: ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TABLE OF CONTENTS TABLE OF FIGURES.............................................................................................................4 PROTOCOL AMENDMENT HISTORY .............................................................................5 1.0 SUB-PROTOCOL SUMMARY .................................................................................6 1.1 Overview of Sub-protocol................................................................................6 1.2 Schedule of Activities .......................................................................................8 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 .........................................................................................................12 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro..........................13 2.2 Dose Justification for Bemcentinib...............................................................14 2.3 Human Experience from Trials in Cancer Patients ...................................16 3.0 STUDY POPULATION ............................................................................................18 3.1 Eligibility Criteria ..........................................................................................18 4.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................19 4.1 Efficacy Assessments .....................................................................................19 4.2 Safety Assessments.........................................................................................19 4.2.1 Adverse Events ..................................................................................20 4.2.2 Clinical Safety Laboratory Assessments ...........................................20 4.3 Pharmacokinetic Assessments ......................................................................20 4.4 Pharmacodynamic Assessments ...................................................................20 5.0 STUDY TREATMENT .............................................................................................21 5.1 Conclusions and Risk Benefit Statement .....................................................21 5.2 Bemcentinib Drug Administration ...............................................................21 5.3 Dose Modifications and Toxicity Management ...........................................22 5.4 Prohibited Concomitant Medications ..........................................................22 5.5 Study Drug Information................................................................................22 5.5.1 Study Medication...............................................................................22 5.5.2 Bemcentinib Storage, Dispensing, and Destruction ..........................23 6.0 REFERENCES...........................................................................................................24 7.0 APPENDICES ............................................................................................................26 Appendix 1 Abbreviations ...................................................................................26 Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index ..........................................................................................27 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator ................................................................28 Figure 1 Figure 2 Figure 3 TABLE OF FIGURES Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells .............................14 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) .....................................................15 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients .............................................................................................................16 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) PROTOCOL AMENDMENT HISTORY Protocol amendment 01 (dated 22 April 2020) replaces the original sub-protocol for bemcentinib (dated 20 April 2020). The amendment incorporates the following main changes: • A change of Sponsor, from BerGenBio ASA to University Hospital Southampton NHS Foundation Trust, with a corresponding change to the named Sponsor signatory. • Addition of exclusion criterion for clinically significant hypokalaemia. • Clarification that for the exclusion criterion of inability to swallow capsules, administration via nasogastric tube is permitted. • Clarification that the physical examination at screening includes height and weight (this is part of the Master Protocol). • Addition of samples for cytokine analysis and PBMC phenotyping on the Schedule of Activities (this is part of the Master Protocol). • Removal of specific blood volumes from the Schedule of Activities. • Clarified that analysis of inflammatory cytokines is part of the Master Protocol. • Clarification regarding known adverse events for bemcentinib. Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.0 SUB-PROTOCOL SUMMARY 1.1 Overview of Sub-protocol Bemcentinib is a small molecule AXL kinase inhibitor developed by BerGenBio ASA (the candidate agent owner) which has demonstrated potent and selective inhibition of AXL in biochemical and cell-based kinase inhibition assays. AXL is a recognised therapeutic target for the treatment of cancer. AXL regulates cancer cell survival and immunosuppressive modulatory effects, particularly in driving immunosuppressive features of the innate immune compartment in the tumour microenvironment, including activation of the myeloid derived suppressor cells, the M2 macrophage state, and suppressor regulatory dendritic cells that inhibit activated T cell function. Further, AXL is an important negative regulator of type I interferon (IFN) responses that are important for anti-cancer treatments. Bemcentinib is currently being developed for the treatment of cancer, particularly in non-small cell lung carcinoma, acute myeloid leukaemia (AML), myelodysplastic syndrome, and other cancers. The AXL receptor mediates entry of enveloped viruses such as Zika and Ebola through “apoptotic mimicry”. Phosphatidylserine (PS) on the viral envelope is tethered to AXL by its bound ligand, growth arrest-specific 6 (GAS6), leading to viral internalisation. Viruses also activate AXL signal transduction that antagonises anti-viral type-I IFN responses. Preclinical data show that AXL-mediated internalization and IFN suppression may extend to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and that bemcentinib can inhibit coronavirus entry and replication. The hypothesis is therefore that bemcentinib is a potentially effective treatment for COVID-19 disease. Additionally the Sponsor’s understanding of the mechanism supports testing the hypothesis that bemcentinib may be an effective preventive/prophylactic therapy for COVID-19. This sub-protocol describes the approach for study conduct of the bemcentinib arm within the ACCORD-2 multicentre, Phase 2 adaptive randomisation platform study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised patients. Key differentiating features of this sub-protocol include the following: (a) Bemcentinib is an oral 100-mg capsule, recommended Phase 2 dose (RP2D) is 200 mg given once daily, following a loading dose (400 mg) given once daily for 3 days. Although the Master Protocol plans for 15 days of treatment, this sub-protocol can provide up to 21 days of bemcentinib treatment if required for patients. (b) A specific eligibility criterion has been added to exclude patients based on electrocardiogram (ECG) QT interval on screening above 450 msec (a lower exclusion limit than that stated in the Master Protocol, 500 msec), as well as significant cardiac comorbidity. Any concomitant medication with QT prolongation risk must be stopped at screening and direct discussion between the investigator and Sponsor Medical Monitors will allow support in risk management. Serial ECG measurements have been added in Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) order to pragmatically monitor any QT interval change with bemcentinib, coupled to a sparse pharmacokinetic (PK) sample schedule, in the hospitalised COVID-19 population. Within the clinical development programme to date, over 286 patients have been treated without any observed cardiac adverse events (AEs). (c) Translational and pharmacodynamic (PD) sampling is included in this protocol. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. (d) Selected secondary endpoints from the Master Protocol will be considered as key secondary endpoints for the purposes of this sub-protocol. Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.2 Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria STUDY INTERVENTION Randomisation Administration of bemcentinibc Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Day -1 or Day 1 Day 1 X X X X X X Days 1-3 400 mg loading daily X X X X Daily Until Hospital Discharge X 200 mg maintenance X X Day 15a (±2 days) X Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Clinical assessmentse Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2f 12-lead ECGg SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationh Pregnancy test for females of childbearing potential RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis Blood (sodium heparin tube) for PBMC phenotypingl Day -1 or Day 1 X X Xi Xi Day 1 Xd Xd Xd X X X X X Xd,j X X Daily Until Hospital Discharge X X X X X X X See schedule belowg Days 3, 5, 8, 11 (all ±1 day) if hospitalised Day 8 Day 8 Day 15a (±2 days) X X X X X X Xk X X Day 29a (±3 days) X X X X X Xk X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Saliva for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)m X Day 8 X Blood (EDTA) host genome (host DNA)m X Mid-turbinate nasal swab viral genomem X Blood samples for PD and translational studiesn X See schedule belown X X X PK samplingn X See schedule belown X ECG=electrocardiogram; EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PD=pharmacodynamic; PK=pharmacokinetic; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) c Although the Master Protocol plans for 15 days treatment, this sub protocol can provide up to 21 days bemcentinib treatment if required for patients. Bemcentinib should be taken once per day, in the morning, on an empty stomach with water. Patients should not consume anything other than water for at least 1 hour after taking study drug. d Baseline assessments should be performed prior to study drug administration. e Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. f If done as part of SoC, blood gases results to be fully recorded with date and time. g ECG to coincide with selected PK and PD sampling timepoints, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. h For parameters, see Master Protocol i Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. j Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. k Additional safety laboratory evaluations to be performed on Days 15 and 29 only if patient is still hospitalised. l Samples collected for immediate laboratory processing and frozen storage. m Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. n Procedures for the collection, processing, storage and shipment of the PK and PD samples will be provided in the Study Laboratory Manual. Sample collection to coincide with the ECGs, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 Nonclinical in vitro and in vivo data suggest that bemcentinib might be useful for the treatment of early SARS-CoV-2 infection for which no medical countermeasures are currently approved, and support testing the efficacy of bemcentinib treatment among hospitalised adults with COVID-19. The AXL receptor tyrosine kinase promotes the infection of a wide range of enveloped viruses including pox-, retro-, flavi-, arena-, filo-, and alpha-viruses (Shimojima 2006, Brindley 2011, Meertens 2012, Dowall 2016, Meertens 2017). AXL increases viral infection through two mechanisms: 1) enhanced viral entry through “apoptotic mimicry”; and 2) suppression of anti-viral type I IFN responses. The AXL receptor and related receptors (Tyro3 and MerTK, collectively TAM) are important for the clearance of apoptotic cells (efferocytosis) by macrophages (Lemke 2019). Enveloped viruses co-opt this mechanism to expand tropism and enhance viral entry. GAS6, the AXL ligand, binds PS exposed on the surface of the viral envelope, tethering the viral particle to the AXL receptor and promoting uptake by phagocytosis. This mechanism of viral entry, based on PS exposure, is common to most enveloped viruses and is termed viral “apoptotic mimicry” (Mercer 2008, Bhattacharyya 2013). Binding of the viral particle to GAS6-AXL potently activates signal transduction through its tyrosine kinase domain to suppress type I IFN signalling and facilitate viral replication (Bhattacharyya 2013, Meertens 2017). AXL expression is induced by inflammation and serves as an innate immune checkpoint. AXL signalling suppresses viral-induced IFN responses via suppressor of cytokine signalling (SOCS)1/3, leading to increased viral replication in infected cells and decreased anti-viral defences of neighbouring cells (Huang 2015, Chen 2018, Strange 2019). Consequently, Axl-null mice are resistant to Zika pathogenesis likely due to a combination of reduced virus entry and enhanced IFN responses (Hastings 2019), indicating a potential role for AXL inhibitors as therapeutics during viral infection. Therapeutic AXL receptor inhibition ameliorated pulmonary pathology resulting from primary viral infection in experimental models, indicating an important role for AXL within the lung (Shibata 2014). During primary respiratory syncytial virus (RSV) infection, AXL inhibition increased the number of IFNg–producing T cells and natural killer (NK) cells, suppressed RSV replication and whole lung levels of interleukin (IL)-4 and IL-13. Also, the lethal effect of intrapulmonary H1N1 infection inflammation was reduced by AXL inhibition. AXL inhibition in infected mice increased the number of IFN-b–producing macrophages and dendritic cells and suppressed neutrophil infiltration. Final, 22 April 2020 12 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Bemcentinib is a clinical-stage, oral, selective small molecule AXL kinase inhibitor with well documented anti-viral effects in several systems. Bemcentinib is reported to block dengue, Ebola and Zika virus infections in several cell types including epithelial, fibroblast, endothelial, neuronal and myeloid cell types in in vitro cell culture and organoid systems. Bemcentinib treatment is associated with increased IFN signalling and reduced viral replication (Dowall 2016, Meertens 2017, Strange 2019). During the 2013/2014 Ebola virus (EBOV) outbreak, bemcentinib was 1 of 60 compounds evaluated by Public Health England as an experimental therapy for EBOV, using its Biosafety Containment Level 4 facilities at Porton Down. Bemcentinib 200 mg/kg/day starting 6 hours post viral challenge protected 1/6 EBOV infected guinea pigs from weight loss and early mortality in an 18-day in vivo mortality study (Dowall 2016), compared with 1/6 untreated animals surviving to Day 18 but exhibiting weight loss during the observation period. The authors concluded that bemcentinib may have had some protective effect in this model. 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro Professor Wendy Maury, University of Iowa, conducted a preliminary analysis of the anti-viral effects of bemcentinib on SARS-CoV-2 in a Vero E6 cell line. As shown in Figure 1, bemcentinib incubation starting 1 hour prior to virus inoculation potently inhibited SARS-CoV-2 infection of Vero E6 cells in a dose-dependent manner. Other studies using vesicular stomatitis virus pseudotyped with SARS-CoV spike protein and a mouse betacoronavirus (mouse hepatitis virus [MHV]) showed that bemcentinib may both inhibit uptake and activate the IFN-mediated antiviral gene, ISG15, to control viral infection. SARS-CoV-2 cell tropism is likely to include PS dependent viral uptake and may target critical immune cell populations (eg, macrophages, dendritic cells) that produce IFN and mobilize anti-viral immunity. Importantly, delayed IFN signalling is characteristic of pathogenic human betacoronaviruses and correlates with disease severity in animal models, suggesting that early intervention with IFN-activating treatment may provide therapeutic benefit (Channappanavar 2016). Thus, AXL targeting is expected to attenuate SARS-CoV-2 pathogenesis both by limiting viral uptake and promoting innate antiviral immunity. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 1 Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells Vero E6 cells (60,000) in a 48-well format were incubated (1 hour) with bemcentinib prior to addition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (MOI 0.0005). Cells were lysed at 24 hours and viral load was analysed by quantitative reverse transcription polymerase chain reaction (RT-PCR) for spike protein gene expression as normalized to the housekeeping gene Cyclophilin. W.Maury et al., unpublished results Importantly, recent data that differentiate SARS-CoV-2 from severe acute respiratory syndrome (SARS) have emerged that support the hypothesis that AXL may have a more dominant role in SARS-CoV-2 infection, and therefore that bemcentinib may have specifically a more important role to play in inhibiting this viral infection: • SARS-CoV-2 has similar replication kinetics to SARS-CoV, but demonstrates differential sensitivity to type I interferon treatment (One of 2 mechanisms of action of Bemcentinib through AXL inhibition) (Lokugamage 2020). • Structural analysis of the spike (S) protein of SARS-CoV-2 showed that its S protein has weaker binding to the angiotensin converting enzyme (ACE)2 receptor on human cells compared with strong affinity of human SARS coronavirus (Dong 2020) – supporting the large magnitude effect we have observed for inhibition of viral replication using clinically appropriate doses of bemcentinib in ACE2 receptor +ve cells. 2.2 Dose Justification for Bemcentinib Bemcentinib’s antiviral action stems from a cellular effect, inhibiting AXL kinase to prevent viral attachment and intracellular viral replication (through maximisation of the early type-I interferon rather than a direct antiviral action). From estimates of pooled data, the half maximal inhibitory concentration (IC50) at 24 hours for bemcentinib inhibition of viral load is approximately 140 nM and the approximate concentration required for 90% of maximum inhibition (IC90) is 650 nM. This broadly corresponds to cancer cell data demonstrating high Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) potency of bemcentinib to inhibit AXL. This high potency is reflected in translational data from clinical trials that demonstrate that at the RP2D steady state, AXL kinase is completely inhibited in myeloblasts from AML patients on bemcentinib (Figure 2). Clinically, at RP2D, AXL kinase target demonstrates complete kinase inhibition (Figure 2), thus the maximal possible antiviral effect with this mechanism of action is accessed at the current clinical dose. Clinically, frequent monotherapy complete responses are observed in AML at RP2D (Figure 2). Bemcentinib PK exhibits a prolonged enteral absorptive phase which overlaps with prolonged elimination kinetics after the second dose, to proportionately reduce peak-to-trough difference in plasma concentration-time profile, over a 24-hour dose interval, resulting in smooth steady state without noticeable peak to trough variation (Figure 3). Thus, at the clinical RP2D it is predicted that bemcentinib would be a highly potent antiviral against SARS-CoV-2, and potentially as efficacious as its main use an anticancer therapeutic. Figure 2 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) C=cycle; D=day; Pat=patient Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 3 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients Bemcentinib is given orally as 100-mg capsules. Early clinical development in oncology patients identified the RP2D; dose administration of bemcentinib in this study will utilise the same dosing regimen, ie, a loading dose (400 mg) given once daily for 3 days followed by a maintenance dose of 200 mg once daily. Planned duration of bemcentinib treatment is for a total of 15 days, with the possibility of extension to 21 days for in-patients, at the discretion of the clinical investigator. In preclinical and Phase 1 clinical studies, it was shown that systemic exposure to bemcentinib increased dose proportionately. The terminal half-life was 45.6 to 88.7 hours in man. Modelling of the PK data from this study indicated that the most effective approach to rapidly achieving steady state is to administer 3 daily loading doses followed by a lower daily maintenance dose. 2.3 Human Experience from Trials in Cancer Patients Experience has been gained in the use of bemcentinib in the treatment of many types of cancer (including over 286 patients treated with AML, lung cancer, breast cancer, melanoma, and pancreatic cancer) in Phase 2 clinical studies. This has helped to define the safety profile, recommended dose and schedule as a monotherapy (Loges et al 2018). The safety profile of bemcentinib, initially ascertained in normal human volunteers is tolerable and allows monotherapy approaches as well as combinations with chemotherapy (low dose cytosine arabinoside or with docetaxel), targeted therapy (epidermal growth factor receptor inhibitors) and immunotherapy (pembrolizumab). Bemcentinib is given as two oral capsules once daily (200 mg) following three daily 400 mg loading doses, to achieve steady state. Its principal significant AEs are a low incidence of diarrhoea (28% , with 6% Grade 3/4), asymptomatic QT prolongation (6% Grade 3/4), asthenia, and nausea at the RP2D (Loges et al 2018). Many patients have received bemcentinib without untoward effects for over 2 years at full dose. In particular, there were no QTc related cardiac sequelae observed with either monotherapy or combination therapy in over 286 cancer patients, including elderly multimorbid patients (as presented in the Investigator’s Brochure). Evidence of monotherapy efficacy has been Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) documented in heavily pre-treated patients with AML. Complete response rates of approximately 40% have been observed in AXL expressing AML patients (Loges et al 2018), indicating on-target potency and specificity of bemcentinib as a monotherapy, through complete inhibition of the AXL kinase target. Treatment was well tolerated by most subjects, including the frail elderly. Bemcentinib was well tolerated when combined with pembrolizumab, demonstrating synergy with programmed cell death-1 (PD-1) antagonists through targeting of AXL-dependent immune suppressive mechanisms (M2 macrophages, suppressor dendritic cells, regulatory T cells, and myeloid derived suppressor cells). Collectively, bemcentinib mediated activation of innate immunity within the tumour microenvironment synergizes with immune checkpoint therapy (Krebs et al 2019). Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 3.0 STUDY POPULATION 3.1 Eligibility Criteria Overall inclusion and exclusion criteria are presented in Sections 5.1 and 5.2 of the Master Protocol, respectively. Additional exclusion criteria that are specific to the sub-protocol are as follows: 12. Inability to swallow capsules (administration via nasogastric tube is permitted) 13. Current treatment with any agent known to cause QT prolongation. See Appendix 2 for list of relevant medications. The treatment can be discontinued, with sufficient time (5 half-lives) for washout, to allow inclusion of the patient. 14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 450 ms 15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once. 16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. 17. Previous bowel resection that would interfere with drug absorption Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.0 STUDY ASSESSMENTS AND PROCEDURES In addition to the study assessments and procedures described in Section 8.0 of the Master Protocol, assessments specific to the sub-protocol will be performed as described in the following sections. The Schedule of Activities (SoA) for this sub-protocol is presented in Section 1.2. 4.1 Efficacy Assessments Efficacy assessments will be included as per the Master Protocol. The following endpoints, secondary endpoints in the Master Protocol, will be considered as key secondary endpoints for the purposes of this sub-protocol: Table 1. Bemcentinib Sub-protocol Specific Key Objectives and Endpoints Objectives • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. • To evaluate SARS-CoV-2 viral load. Endpoints • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). Exploratory studies will define the role of PD biomarkers. Exploratory endpoints relate to the translational plan. 4.2 Safety Assessments For ECG assessments see the SoA (Section 1.2). Timing of the PK and PD evaluations will be matched to the ECG assessments. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.2.1 Adverse Events 4.2.1.1 Adverse Events from Indications Under Investigation Bemcentinib is a relatively safe investigational therapeutic agent. A few patients may experience tiredness and gastrointestinal disturbance (nausea, diarrhoea). Occasionally there may be some changes to blood tests relating to liver function (transaminitis) and some changes on ECG tracing (QT prolongation). These AEs are temporary and lasting only a few days. 4.2.1.2 Adverse Events of Special Interest (AESI) Not applicable. 4.2.1.3 Disease-related Events and/or Disease-related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events Not applicable. 4.2.2 Clinical Safety Laboratory Assessments See Master Protocol for the list of clinical laboratory tests to be performed for this sub-protocol, and the SoA (Section 1.2) for the timing and frequency. 4.3 Pharmacokinetic Assessments Venous blood samples for PK analysis will be collected according to the SoA (Section 1.2). The samples will be analysed for plasma bemcentinib and additionally for bemcentinib metabolites (to be defined). Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. Plasma samples for determination of bemcentinib concentration will be analysed by BerGenBio’s Bioanalytical Services vendor using the validated liquid chromatography with tandem mass spectrometry method. 4.4 Pharmacodynamic Assessments Blood samples for PD analysis will be collected according to the SoA (Section 1.2) and stored for future analysis in both the bemcentinib arm and the control arm. The samples will be analysed for soluble AXL, GAS6 (which could be predictive, PD, and mechanism biomarkers and hence require comparison with control group not receiving bemcentinib), and other blood proteins. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. This analysis will be in addition to the inflammatory cytokine analysis detailed in the Master Protocol. Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.0 STUDY TREATMENT 5.1 Conclusions and Risk Benefit Statement Bemcentinib has shown in vitro evidence of antiviral effect against SARS-CoV-2 infection at concentrations below those achieved at the proposed dose regimen for use in this trial. This dose matches the RP2D derived from multiple studies in various cancer populations. Treatment at this dose in 286 patients over a range of 6 weeks up to 2 years demonstrates that monotherapy or combination is largely well tolerated; therefore short term administration (15 to 21 days) in the context of hospitalized patients with SARS-CoV-2 infection is anticipated to be well tolerated. A non-severe, asymptomatic effect on QTc interval has been noted. Regular ECG/continuous ECG monitoring is included in the clinical trial enabling early identification of prolonged QTc and early stopping rules given the high morbidity and potential mortality of SARS-CoV-2 in hospitalised patients, there is a favourable balance of potential benefit: risk in the proposed clinical investigation of bemcentinib treatment for COVID-19 within the context of this clinical trial. 5.2 Bemcentinib Drug Administration Bemcentinib will be administered as a 400 mg oral loading dose on Days 1, 2, and 3, followed by 200 mg once-daily oral maintenance dose for 15 days with the possibility of extension to 21 days for in patients at the discretion of the clinical investigator. Bemcentinib should be taken once per day, in the morning after an overnight fast. Tablets should be taken with 100 mL water. Patients should not consume anything other than water for at least 1 hour after taking study drug. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.3 Dose Modifications and Toxicity Management Note: this modified guidance has been added to the Investigators’ Brochure under relevant section of treatment of COVID-19 Event Recommended Bemcentinib Dose Modification Estimated creatinine clearance decreases Study medication should be withheld until estimated creatinine by more than ≥50% from baseline clearance returns to baseline ALT or AST increases to > 5 ULN Study medication should be withheld until ALT and AST returns to baseline Dose Modification of Bemcentinib Daily Dose for QTc Prolongation QTcF Recommended Bemcentinib Dose Modification > 501 ms 1st occurrence Discontinue permanently Ventricular arrhythmia 1st occurrence Discontinue permanently ALT=alanine aminotransferase; AST=aspartate aminotransferase; QTcF= QTc interval according to Fridericia correction; ULN=upper limit of normal Notes: Serum calcium, magnesium and potassium should be measured regularly whilst receiving bemcentinib; all abnormal results should be corrected; check for use of concomitant medication that are associated with QT prolongation. 5.4 Prohibited Concomitant Medications Administration of bemcentinib is contraindicated in patients requiring treatment with concomitant medications known to prolong QTc interval and promote Torsade de Points (TdP) listed in Appendix 2. Patients already in receipt of such medications should be excluded unless medications are discontinued and a sufficient wash out period is allowed prior to starting bemcentinib. Medicines with both cytochrome P450 (CYP) 3A4 and TdP liabilities are particularly hazardous and their concomitant use is a reason for exclusion of patients. Concomitant medications that are CYP3A4 substrates are not reasons for exclusion of patients, however they should be discontinued or used with caution. Treatment with histamine receptor 2 inhibitors (cimetidine, ranitidine) or protein pump inhibitors (omeprazole) is permitted provided that administration is in the evening. 5.5 Study Drug Information 5.5.1 Study Medication The drug product is presented in a single strength: 100 mg bemcentinib in size 0, Swedish Orange hydroxypropyl methylcellulose capsules for oral administration. Bemcentinib capsules Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) consists of a wet granulated blend of 40% drug substance with standard excipients (lactose monohydrate, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone, colloidal silicon dioxide, and magnesium stearate). Bemcentinib has been manufactured according to appropriate Good Manufacturing Practice standards. Bemcentinib capsules are packaged in 50-mL white opaque round high density polyethylene bottles containing 22 capsules. The bottles are closed with opaque 32-mm child-resistant screw caps and sealed with tamper-resistant tape. Refer to the current version of the Bemcentinib Investigational Medicinal Product Dossier/Investigator’s Brochure for additional information on the physical, chemical and pharmaceutical properties of bemcentinib. 5.5.2 Bemcentinib Storage, Dispensing, and Destruction Bemcentinib will be shipped to the participating site by PCI Pharma Services, UK, and must be stored at the site in a secure location under ambient temperature conditions (<25°C). Accountability for study treatment is the responsibility of the Investigator. The Investigator/designee must ensure that the bemcentinib will only be dispensed to patients in accordance with the dosing instructions in this protocol. Study staff should refer to the Bemcentinib Pharmacy Manual for specific instructions regarding the handling, storage, dispensing and destruction of bemcentinib. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 6.0 REFERENCES Bhattacharyya S, Zagórska A, Lew ED, et al. Enveloped viruses disable innate immune responses in dendritic cells by direct activation of TAM receptors. Cell Host Microbe 2013;14:136-47. Brindley MA, Hunt CL, Kondratowicz AS, et al. Tyrosine kinase receptor Axl enhances entry of Zaire ebolavirus without direct interactions with the viral glycoprotein. Virology 2011;415:83-94. Channappanavar R, Fehr AR, Vijay R, et al. Dysregulated Type I Interferon and Inflammatory Monocyte-Macrophage Responses Cause Lethal Pneumonia in SARS-CoV-Infected Mice. Cell 2016;19:181-93. Chen J, Yang YF, Yang Y, et al. AXL promotes Zika virus infection in astrocytes by antagonizing type I interferon signalling. Nat Microbiol 2018;3(3):302-9. Dong N, Yang X, Ye L, Chen K, Chan EW, Chen S. Genomic and protein structure modelling analysis depicts the origin and pathogenicity of 2019-nCoV, a new coronavirus which caused a pneumonia outbreak in Wuhan, China [version 2; peer review: 1 not approved]. F1000Research 2020, 9:121 (https://doi.org/10.12688/f1000research.22357.2) Dowall SD, Bewley K, Watson RJ, et al. Antiviral Screening of Multiple Compounds against Ebola Virus. Viruses 2016;8(11). pii:E277. Hastings AK, Hastings K, Uraki R, et al. Loss of the TAM Receptor Axl Ameliorates Severe Zika Virus Pathogenesis and Reduces Apoptosis in Microglia. iScience 2019;13:339-50. Huang MT, Liu WL, Lu CW, et al. Feedback regulation of IFN-αβ signalling by Axl receptor tyrosine kinase modulates HBV immunity. Eur. J. Immunol. 2015;45:1696-705. Krebs M et al. A phase II study of bemcentinib (BGB324), a first-in- class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis. SITC 2019, oral presentation in High Impact Clinical Trials session. Lemke G. How macrophages deal with death. Nat Rev Immunol. 2019;19(9):539-49. Loges S et al. Comprehensive Analysis of the Dose Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS ASH 2018, presentation. Lokugamage KG, Hage A, Schindewolf C, Rajsbaum R, Menachery VD. SARS-CoV-2 is sensitive to type I interferon pretreatment. bioRxiv preprint doi: https://doi.org/10.1101/2020.03.07.982264.Meertens L, Carnec X, Lecoin MP, et al. The TIM Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) and TAM Families of Phosphatidylserine Receptors Mediate Dengue Virus Entry. Cell Host Microbe 2012;12(4):544-57. Meertens L, Labeau A, Dejarnac O, et al. Axl mediates ZIKA virus entry in human glial cells and modulates innate immune responses. Cell Rep 2017;18(2):324-33. Mercer J, Helenius A. Vaccinia virus uses macropinocytosis and apoptotic mimicry to enter host cells. Science 2008;320(5875):531-5. Shibata T, Habiel DM, Coelho AL, Kunkel SL, Lukacs NW, Hogaboam CM. Axl Receptor Blockade Ameliorates Pulmonary Pathology Resulting from Primary Viral Infection and Viral Exacerbation of Asthma. J Immunol. 2014;192(8):3569-81. Shimojima M, Takada A, Ebihara H, et al. Tyro3 family-mediated cell entry of Ebola and Marburg viruses. J Virol. 2006;80(20):10109-16. Strange DP, Jiyarom B, Pourhabibi Zarandi N, et al. Axl promotes Zika virus entry and modulates the antiviral state of human Sertoli cells. mBio 2019;10(4):e01372-19. Final, 22 April 2020 25 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 7.0 APPENDICES Appendix 1 Abbreviations Abbreviation ACE AE AML BP CYP EBOV ECG GAS6 IC50 IC90 IFN IL MHV NK NYHA PD PD-1 PK PS QTcF RP2D RSV SARS SARS-CoV-2 SoA SOCS TAM TdP Definition Angiotensin-converting enzyme Adverse event Acute myeloid leukaemia Blood pressure Cytochrome P450 Ebola virus Electrocardiogram Growth arrest-specific 6 Half maximal inhibitory concentration Concentration required for 90% of maximum inhibition Interferon Interleukin Mouse hepatitis virus Natural killer New York Heart Association Pharmacodynamic Programmed cell death-1 Pharmacokinetic Phosphatidylserine QTc interval according to Fridericia correction Recommended Phase 2 dose Respiratory syncytial virus Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Schedule of Activities Suppressor of cytokine signalling Tyro3, AXL, MerTK Torsade de Points Final, 22 April 2020 26 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index For any concomitant medication, please check the following website for the drug’s Torsades de Pointes (TdP) risk: https://crediblemeds.org/oncosupport/. Drugs with known (TdP) risk are reason for EXCLUSION. For drugs with a conditional risk, please review the product label and correct any abnormalities, eg, hypokalaemia. Common medication Associated with a Risk of QT Prolongation and TdP – USE PROHIBITED AS CONCOMITANT MEDICATION t½ less than 6 hours Azithromycin 2-4 hours$ Clarithromycin 3-4 hours$ Cocaine 0.6 – 1.3 hours$ Droperidol 2 hours$ Erythromycin 2 hours$ Ondansetron 3 hours$ Procainamide 2.5-4.75 hours$ Terfenadine 3.5 hours** t½ between 6 – 12 hours Cisapride 10 hours ** Disopyramide 6.7 hours$ Ketoconazole 3 – 10 hours$ Moxifloxacin 12 hours$ Quinidine 6 hours **$ Voriconazole 6 hours$ t½ greater than 12 hours Amiodarone 50 days$ Astemizole 24 hours ** Chloroquine 1-2 months$ Citalopram 35 hours$ Escitalopram 30 hours$ Fluconazole 30 hours$ Haloperidol 15 – 27 hours$ Methadone 25 – 55 hours$ Petamidine 10 – 14 days$ **also CYP3A4 substrates $ also TdP risk Pimozide 55 hours ** Sotalol 10 – 20 hours$ Thioridazine 21 – 24 hours$ Sensitive CYP3A4 Substrates With A Narrow Therapeutic Margin THESE MEDICATIONS SHOULD BE DISCONTINUED BEFORE ENROLMENT t½ less than 6 hours t½ between 6 – 12 hours t½ greater than 12 hours alfentanyl 90-111 minutes dihydroergotamine & ergotamine 2 hours Fluticasone 3 – 8hours Terfenadine 3.5 hours astemizole 7 – 9 hours cisapride 12 hours cyclosporine 8.4 hours Fentanyl 8 – 10 hours quinidine 6 hours tacrolimus (FK506) 12 hours pimozide 55 hours sirolimus 63 hours Woosley RL, Heise CW , Gallo T, Tate J, Woosley D and Romero KA, www.CredibleMeds.org, QTdrugs List, [14Apr2020], AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755 Final, 22 April 2020 27 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator PROTOCOL TITLE: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients SUB-PROTOCOL NO: ACCORD-2-002 SUB-PROTOCOL FOR CANDIDATE AGENT BEMCENTINIB VERSION: Amendment 01 This sub-protocol is a confidential communication of the Sponsor. I confirm that I have read this sub-protocol, I understand it, and I will work according to this sub-protocol, in conjunction with the Master Protocol for the overall platform study. I will also work consistently with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and the applicable laws and regulations. Acceptance of this document constitutes my agreement that no unpublished information contained herein will be published or disclosed without prior written approval from the Sponsor. Instructions to the Investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the name of the study centre in which the study will be conducted. Return the signed copy to the Contract Research Organization/Sponsor. I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Signature of Investigator: Printed Name: Investigator Title: __________________________ ___________________________ ___________________________ Date: ________ Name/Address of Centre: ___________________________ ___________________________ ___________________________ Final, 22 April 2020 28
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Loyal friends

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Annual-report-24-25-final

Description: 2024/25 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2024/25 Presented to Parliament
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Annual ward staffing review January 2025

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UHS AR 22-23-6

Description: 2022/23 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2022/23 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2023 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 33 Directors’ report 34 Remuneration report 57 Staff report 71 Annual governance statement 91 Quality account 106 Statement on quality from the chief executive 107 Priorities for improvement and statements of assurance from the board 110 Other information 188 Annual accounts 222 Statement from the chief financial officer 223 Auditor’s report 224 Foreword to the accounts 230 Statement of Comprehensive Income 231 Statement of Financial Position 232 Statement of Changes in Taxpayers’ Equity 233 Statement of Cash Flows 234 Notes to the accounts 235 5 Welcome from the Chair and Chief Executive Officer University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) experienced another challenging year during 2022/23. Nonetheless, the Trust and its staff have continued to deliver for patients and the wider system in which it operates. Trust highlights from 2022/23 include: • Delivering an 8% increase in activity (compared to 2019/20) under the elective recovery programme, which places us as one of the top performing trusts in England. • Being recognised in the NHS staff survey as the seventh highest trust for recommendation as a place to work nationally and the best performing trust in opportunities for career development. • Celebrating 50 years as a medical school with the University of Southampton and continuing to pioneer UK and world-first research studies. • Enhancing the reputation of our specialist care – for example our bone marrow transplant team at UHS have the best patient outcomes in Europe. However, as was the picture across the country, UHS had an extremely challenging winter with attendances at our emergency department often in excess of 400 a day. This was driven in part by high prevalence of streptococcus A (strep A) in the community along with other seasonal illnesses such as influenza and high incidences of COVID-19 at times. Moreover, the lack of availability of care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore we have been operating at or near to capacity throughout the year. At the time of writing, there continues to be operational pressures due to industrial action by the Royal College of Nursing and British Medical Association. Throughout the disputes, we have attempted to balance the right of our staff to strike with the need to minimise the impact on the Trust’s operations and patients and ensure that safety was not compromised. Our leadership team has engaged proactively with the unions to agree, where possible, derogations (i.e. services that will continue to be staffed during strikes) to ensure that the running of our hospitals can continue and that patients remain safe. We would like to express our thanks to all staff who have gone over and above during these periods of industrial action by being willing to do different work to usual, often at anti-social times of the day. While we cannot influence national negotiations, we are focusing on what we can control within UHS. Our people strategy published last year sets out how we will grow and deploy our workforce of today and the future as part of a thriving community to deliver world-class patient care. Building on this, we have recently launched our inclusion and belonging strategy so that as a leadership team we can deliver what is required for all our workforce to feel they can belong and thrive at UHS. The Trust achieved its Cost Improvement Plan (CIP) target of £45.6m for 2022/23, the highest in our history but despite this, ended the year with a deficit of £11m. The deficit was driven by a combination of factors including a substantial increase in energy prices, higher costs of medicines and equipment and temporary staffing costs as well as changes in recent years in respect of the NHS funding infrastructure, which adversely impacted the Trust relative to others during the year. In terms of the broader context, the Hampshire and Isle of Wight Integrated Care System, in which the Trust operates, reported an overall deficit for 2022/23 driven in part by a significant increase in staffing numbers when compared to 2019/20 as well as structural factors. 6 We have continued to make progress on our estates strategy, building new theatres and carrying out improvements to existing facilities, as well as opening a new park and ride for staff at Adanac Park and progressing plans for a new innovation campus there. During 2022/23 we invested over £88m of capital expenditure to meet our ambition of increasing capacity and improving services in order to manage the increasing demand. All development is underpinned by our green plan, which sets out areas of focus for decarbonising UHS and achieving the net zero target set by the NHS. The Trust has continued to support the Hampshire and Isle of Wight Integrated Care System, which was formed on 1 July 2022 to facilitate integration and collaboration across health and social care partners in the region. In particular, UHS has worked closely with the Integrated Care Board and other providers in the development of the operating plan for 2023/24. We have also continued to work with other partners in the region, including local authorities and the University of Southampton. The 13,000 staff of UHS are our greatest asset and we would like to express our gratitude to them for continuing to go above and beyond to put patients first under very challenging circumstances. Without our staff, we would be unable to fulfil our ambition to be a world-class organisation with world-class people delivering world-class care. Jenni Douglas-Todd Chair 26 June 2023 David French Chief Executive Officer 26 June 2023 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer The Trust experienced another challenging year with the need to balance the delivery of quality patient care with a significant increase in demand for the Trust’s resources and the need to do so whilst maintaining a sustainable financial position. The Trust saw the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. Despite this, however, the Trust was successful in reducing the number of patients waiting more than 104 weeks to nil and in reducing the number of patients waiting more than 78 weeks to 14 by the end of the year. In addition, the Trust’s performance under the elective recovery programme placed it as one of the topperforming trusts in the country. Demand for non-elective care also significantly increased during the year with the emergency department seeing more than 400 attendances per day at some points, especially during the winter months. The industrial action seen in the latter part of 2022/23 placed further pressure on the Trust and resulted in a need to cancel elective procedures and outpatients appointments. However, on balance, the Trust was able to manage these events through effective planning and the engagement and support of its staff. Although the Trust was successful in recruiting to substantive roles, especially in terms of reducing the number of Health Care Assistant vacancies, the anticipated reduction in use of bank and agency staff was not seen. This, among other factors, such as the substantial increase in energy costs and the rate of inflation, posed a significant challenge in terms of the Trust’s financial position. Despite achieving savings of £45.6m, the Trust reported a deficit of £11m for 2022/23. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2022/23. It is based on the coast in southeast England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 160,000 inpatients and day patients, including about 75,000 emergency admissions sees over 650,000 people at outpatient appointments deals with around 150,000 cases in our emergency department delivers more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 55% is paid for by NHS England and 43% by the Hampshire and Isle of Wight Integrated Care Board. These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System (ICS) when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board (ICB). The ICP is a statutory committee jointly formed between the NHS integrated care board and all uppertier local authorities that fall within the ICS area. The ICP will bring together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The establishment of ICBs resulted in clinical commissioning groups (CCGs) being closed down. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Public and foundation trust members Council of Governors Board of Directors Executive Directors Division B Division C Division D Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these it describes a number of ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2022/23 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Recovery, restoration and improvement of clinical services • Introducing a robust and proactive safety culture • Empowering and developing staff to improve services for patients • Always Improving strategy • Delivering a high-quality experience of care for all • Delivery of year two of the research and innovation investment plan • Strategy and partnership working • Growing, developing and innovating our workforce • A great place to work, develop and achieve • Compassionate and inclusive workplace for all • We Work in partnership with Integrated Care System and Primary Care Networks • Integrated Networks and Collaborations • Establishing Southern Counties Pathology Network • Establishing the Wessex Imaging Network • Develop Collaborations strategy • Creating a sustainable financial infrastructure • Making our corporate infrastructure fit for the future to support a leading university teaching hospital in the 21st century • Recognising our responsibility as a major employer in the community of Southampton and our role in delivering a greener NHS Performance against these objectives will be monitored and reported to the Trust’s Board on a quarterly basis. 14 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2022/23 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families with a high-quality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position and support prioritised investment as identified in the Trust’s capital plan within locally available limits (capital departmental expenditure limit (CDEL)). • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2022/23, the Trust continued to experience the impact of the COVID-19 pandemic. The need to ensure a safe environment for patients through stringent infection control processes impacted the Trust’s capacity due to the need to isolate patients with COVID-19 in separate areas of the hospital. In addition, outbreaks of norovirus during the winter months placed further pressure on hospital capacity. The impact of the pandemic continued to be felt in terms of staff absence due to becoming infected with COVID-19 as well as the significant impact on staff mental health. The higher than normal (i.e. pre-COVID) levels of staff absence placed additional strain on the Trust’s operations and led to increased expenditure due to the requirement to enlist bank and/or agency staff to maintain safe staffing levels. 15 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The pressures of the COVID-19 pandemic led to increases in the waiting times for patients and the number of patients waiting for more than a year increased significantly. During the year, the Trust achieved its goal of no patients waiting more than 104 weeks by July 2022 and finished the year with only 14 patients waiting for more than 78 weeks. However, the length of time patients are waiting for treatment remains one of the key risks for the Trust. This situation was compounded by the sustained demand for non-elective activity, which saw attendances at the emergency department rise to over 400 patients per day during some periods of 2022/23 and was consistently higher than previously was the case. The significant increase in referrals, often requiring more complex treatment, has seen the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. In addition, the industrial action during the year placed further strain on the Trust’s ability to both provide urgent care and manage its elective recovery programme. Quality and compliance Furthermore, difficulties in obtaining care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore the Trust has been operating at or near to capacity throughout the year. The Trust continued to monitor the quality of care delivered throughout 2022/23. The Trust continued its focus on infection prevention and control, which had proven successful during the COVID-19 pandemic. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of 84 quality improvement projects. In addition, the Trust continued to implement the patient safety incident response framework as well as taking other steps to drive a safety culture within the organisation. Furthermore, the Trust conducted further trials of shared decision making between clinicians and patients and is a leading site nationally for shared decision-making principles. Further information can be found in the Quality Account. 16 Partnerships The new arrangements for integrated care systems were implemented in July 2022 with the Trust becoming part of the Hampshire and Isle of Wight Integrated Care System. As such, the Trust’s senior management frequently meets with peers from across the system to consider and agree matters of wider concern across the system. In addition, the Trust worked with the Integrated Care Board in order to develop its financial and capital plans for 2023/24 and beyond. The Trust also attends the Southampton Health and Wellbeing Board at Southampton City Council and in the Hampshire and Isle of Wight Acute Provider Partnership Board. During 2022/23, the Trust continued to progress research activities and opportunities with the University of Southampton and Wessex Health Partners. Workforce In addition, work continued in the development of an elective hub at Winchester with Hampshire Hospitals NHS Foundation Trust, which will provide the Trust with additional capacity to carry out its elective programme. The Trust’s key areas of focus during 2022/23 were in respect of increasing the substantive workforce and reducing staff turnover. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 1,068 whole-time equivalents above its plan for 2022/23. Included in this figure is the TUPE transfer of genomics staff from Salisbury. A particular area of focus was the recruitment of Health Care Assistants where the Trust was successful in reducing the number of vacancies from 27% to 18%. Whilst the Trust was successful in reducing staff turnover from 14.9% in 2021/22 to 13.5%, it remained above the 12% target. However, the Trust did experience a reduction in staff absence from 4.7% in April 2022 to 4.3% in March 2023, and initiatives to improve staff wellbeing were an area of focus during the year. Estate Innovation and technology The industrial action in late 2022 and early 2023 posed significant challenges for the Trust, including in terms of the need to engage additional temporary staff to ensure patient safety. The Trust continued to invest in and develop its estate during 2022/23 including successful completion of the Paediatric Intensive Care Unit project, which delivered single rooms and specialist accent lighting alongside delivery of a ‘twin care’ room. There were a number of other significant projects during the year, including refurbishments of wards and work on creating new theatres as well as projects to improve staff wellbeing. These were part of over £88m of capital expenditure in 2022/23 that also included equipment, digital and the backlog maintenance programme. The Trust continued to promote research and development during 2022/23, including through partnerships with the University of Southampton and Wessex Health Partners. Furthermore, the Trust continued to examine ways to make use of technology to improve its service delivery. In particular, the Trust has promoted the use of MyMedicalRecord, which gives patients the ability to co-manage their healthcare online and through an app. 17 Sustainable financial model The Trust did not achieve breakeven status at the end of 2022/23 and reported a deficit of £11.037m at year-end. This was due to a number of factors, including the Trust’s underlying deficit as well as the increase in energy prices. The Trust was more exposed than most to fluctuations in the wholesale price of gas due to its reliance on a gas-powered energy supply. In addition, the Trust’s 8% uplift in elective activity when compared to 2019/20 was not fullyfunded, which placed further pressure on the Trust’s existing financial resources, which had been used to ensure a breakeven position in 2021/22. The continued use of bank and agency staff as well as the costs of industrial action in late 2022 and early 2023 further eroded the Trust’s financial position. Notwithstanding the above, the Trust did succeed in obtaining a number of sources of nonrecurrent funding during the year, including a successful bid for £29.4m of funding through the Public Sector De-Carbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. The financial outlook across the NHS continues to appear very challenging during 2023/24 and the Hampshire and Isle of Wight Integrated Care System is forecasting one of the highest deficits in England. 18 Performance analysis COVID-19 Impacts Although the pandemic has ended and serious cases of COVID-19 have reduced significantly, the Trust continued to be impacted by COVID-19 during 2022/23. Heightened infection prevention control measures in respect of patients with COVID-19 placed additional stress on the Trust’s capacity due to the need to isolate those patients and there was a consequential reduction in the Trust’s ability to make most efficient use of its available spaces. Furthermore, the ongoing impact on the Trust’s staff has led to higher staff absence than was the case prior to the pandemic, particularly due anxiety, infectious diseases and colds and flu. • The Trust experienced an average number of 98.7 patients per day who tested positive for COVID-19. During the winter months, this number increased substantially to nearly 200. • During the year, an average of 3.6 intensive care/high-dependency beds per day were occupied by COVID-19 patients. However, at times this increased to as much as ten. • Although staff sickness rates remained higher than pre-pandemic, the Trust saw a decrease in the absence rate from 4.7% at the beginning of 2022/23 to 4.3% by the end of the period. COVID-19 Cases UHS average number of confirmed COVID-19 patients in bed (08:00 census) 250 200 150 100 50 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 Intensive care/higher care beds UHS average number of confirmed COVID-19 patients in an ICU/HDU bed (08:00 census) 12 10 8 6 4 2 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 19 Number of patients Emergency access through the emergency department The Trust continued to experience high demand from patients presenting to receive care in the emergency department throughout the year above that seen prior to the COVID-19 pandemic. In particular, during the period between January and March 2023, the Trust averaged 352 attendances per day compared to 301 during the same period in 2019/20, an increase of 17%. The Trust also saw a significant increase in attendances during December due to both seasonal illnesses, but also due to the prevalence of streptococcus A in the community with attendances sometimes over 400 per day. Furthermore, the industrial action during the latter part of 2022 and early 2023 placed further pressure on the Trust’s ability to deliver services. In addition, the difficulties in discharging patients in need of care either at home or in another setting resulted in reduced flow from the emergency department to the relevant ward(s), which placed further strain on the Trust’s performance. During the year, in order to reduce emergency department attendances, the Trust trialled using General Practitioners to triage and see more straightforward patients who would otherwise have presented to the emergency department. Although this trial did result in a slight reduction in terms of number of patients and waiting times in ambulatory majors and majors, the affordability and value for money of this scheme is under review. Number of patients presenting to the emergency department 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 As a result of the increase in demand upon the emergency department, there continued to be a significant adverse impact on timeliness of care. The Trust failed to meet the national target of 95% of main emergency department/type 1 attendances seen within four hours, achieving 64.5% in March 2023, although this performance was above average in England. 20 % standard met Emergency access 4hr standard UHS vs NHSE average Type 1 performance 70% 0 10 60% 20 50% 30 40 40% 50 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Ambulance handovers are an area of focus for NHS England, with a target of all handovers having to take place within 15 minutes and none waiting more than 30 minutes. The Trust performed well in this area with an average handover time of 17 minutes, having made the conscious decision to ensure that patients did not queue in ambulances at the expense of patients being queued within emergency department majors – thus impacting the Trust’s four-hour target, but meaning that ambulances were not queued outside the hospital as was seen in other areas of the country. Elective Waiting times Demand The year saw a continuation of the trend of increasing elective referrals experienced in 2021/22 following the pandemic, and referral rates continued to be above those seen prior to the pandemic. UHS Accepted Referrals 30,000 25,000 20,000 15,000 10,000 5,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Number of accepted referrals 21 Activity The Trust experienced significant increases in terms of the number of hospital appointments, diagnostic tests and elective admissions during the year, exceeding levels in previous years. The Trust was one of the top performing trusts in terms of its elective recovery programme, achieving an 8% increase in its elective activity during the year when compared to 2019/20. However, performance in this area and in terms of outpatients appointments was negatively affected by the industrial action by nurses, junior doctors and other members of staff, which took place in late 2022 and early 2023 due to the need to cancel non-urgent procedures and appointments in favour of maintaining safe staffing levels in areas such as the emergency department. In addition, the continued presence of COVID-19 as well as other illnesses such as influenza and norovirus placed significant pressure at times on the Trust’s capacity due to the need to implement appropriate infection prevention control measures. Furthermore, difficulties in discharging patients fit to be discharged, but in need of a care package, placed additional strain on the Trust’s capacity. Elective admissions (including day case) Post-COVID-19 pandemic Elective (including day case) recovery (% of same month compared between March 2019 – February 2020) 105% 100% 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 % recovery Outpatient attendances Post-COVID-19 pandemic outpatient seen recovery (% of same month compared between March 2019 – February 2020) 140% 0 90% 10 20 40% 30 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 UH S UHS rank amongst NHSE trusts % recovery Rank 22 Diagnostics The Trust measures performance on a total of 15 frequently used diagnostic tests. In March 2023, 22% of patients were waiting more than six weeks for diagnostics compared with the national target of less than 1%. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) UHS diagnostic waiting list volume 12,000 11,500 11,000 10,500 10,000 9,500 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Diagnostic waiting list volume Percentage of patients waiting over 6 weeks for a diagnostic test to be performed Diagnostic 6 week wait performance UHS vs. NHSE average 35% 30% 25% 20% 15% 10% 5% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 23 Referral to Treatment The Trust continued to see an increase in the number of patients being referred for treatment during 2022/23 with just over 55,000 patients on a waiting list under the 18-week referral to treatment pathway at the end of the year. Averaged across the year, the volume of referrals exceeded the Trust’s theoretical capacity by around 3.5%. Due to this significant demand, the Trust only achieved 63.2% of patients being treated within 18 weeks of referral in March 2023 compared with the monthly target of more than 92%. However, despite this, the Trust remained in the top quartile when compared to other teaching hospitals, reflecting that this growth in demand continues to be a national challenge. During 2022/23, the national target was to ensure that there were no patients waiting over two years for treatment by July 2022, and that there were no patients waiting more than 78 weeks by the end of March 2023. Long-waiting patients were an area of particular focus for the Trust during the year with no reported two-year waits since November 2022 and only two between the period June-November due to patients choosing to delay their treatment. This was a significant improvement compared to the peak of 171 patients reported in December 2021. Similarly, the Trust made progress in reducing the number of patients waiting over 78 weeks for treatment. In February 2023, the Trust reported 84 patients in this category compared to the peak of over 900 patients in September 2021. By the end of March 2023, the Trust had managed to further reduce this number of patients to 14, with those in breach of the target all due to the complexity of the cases. UHS referral to treatment waiting list 56,000 54,000 52,000 50,000 48,000 46,000 44,000 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 24 Number on waiting list % standard met Percentage of patients waiting up to 18 weeks between referral and treatment RTT 18 week performance UHS vs. NHSE average 70% 65% 60% 55% 50% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Percentage of patients waiting more than 52 weeks between referral and commencement of a treatment for their condition Number of patients Rank UHS Referral to treatment patients waiting more than 52 weeks 3,000 0 2,500 10 2,000 20 1,500 30 1,000 40 500 50 0 60 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts % of RTT patients RTT % of patients waiting more than 52 weeks UHS vs. NHSE average 5.0% 0 4.5% 20 40 4.0% 60 3.5% 80 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts Rank 25 % standard met Cancer Waiting Times The Trust is one of 12 regional cancer centres in the UK offering treatment for rare and complex cancers as well as cancer in children and brain cancer. The Trust has historically been in the upper quartile, relative to teaching hospital peers. Due to loss of key members of staff and industrial action, the Trust’s performance has slipped over the year with 72.5% of patients seen within two weeks in March 2023 following referral by a General Practitioner for suspected cancer (national target: > 93% per month). Cancer waiting times - 2 week wait performance UHS vs NHSE average 100% 0 80% 50 60% 100 40% 150 Apr-22May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Referrals for January to March 2023 were at the highest for that month for the past five years and overall referral volumes in 2022/23 averaged 2,049 patients per month, 8% higher than in 2021/22 and 28% higher than in 2019/20. The national target was for 96% of patients to commence treatment within 31 days of diagnosis. However, in March 2023, the Trust only achieved 87.9%, but this figure hides considerable variation dependent on the tumour site and type of cancer with a range of 100% for haematology and children’s cancers to 71% for skin. The high rate of referrals led to a significant backlog in terms of patients waiting longer than 62 days for treatment. However, the Trust took steps to reduce this backlog by more than 50% through a dedicated recovery programme. In March 2023, the Trust treated 54.8% of patients within 62 days of referral compared to the target of more than 85%. Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer waiting times 62 day RTT performance UHS vs. NHSE average 80% 60% 40% 20% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 26 First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performance UHS vs. NHSE average 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Quality priorities The Trust set eight quality priorities in 2022/23, which were aimed at ensuring it continued to deliver the highest quality of care. The quality priorities were shaped by a range of national and regional factors as well as local and Trust‐wide considerations. The Trust recognised the overriding issues of significant operational pressures being felt right across the health and social care system, including those associated with the previous two years of the COVID-19 pandemic. The challenge was to deliver the best quality care in the context of these operational pressures, and the Trust set its quality priorities accordingly. Out of the eight priories set, the Trust achieved five and partially achieved three. Priority One: Enhancing capability in Quality Improvement (QI) through our Always Improving strategy The transformation team has grown to over thirty team members including project support officers, project managers, benefit realisation managers. This has allowed the Trust to develop that systematic organisational approach to guide and support its staff in their QI projects. The Trust originally set a target of delivering fifty quality improvement projects but have successfully supported a total of 84 (55 local and 29 flow improvements). These are local change projects which were identified, proposed, led, and delivered by the people who do the work. To date over 1500 people have been trained in the Trust’s improvement approach, which exceeds the original target of 500. The Trust also developed a QI project register and held an Always Improving conference. Priority Two: Developing a culture of kindness and compassion to drive a safety culture The Trust only partially achieved this priority as plans to fully deliver training were affected by operational pressures. However, during the year a variety of communication platforms were used to make sure staff understood the Trust’s vision and were kept up to date with plans and progress. The Trust worked to develop and embed a ‘just culture’ allowing staff to speak up and ask, “what happened and how do we learn?” and developed ‘stop for safety’ staff huddles. Priority Three: We will improve mental health care across the Trust including support for staff delivering care The Trust only partially achieved this priority as several key quality improvement projects have not yet been delivered, and the mental health strategy not yet been finalised. However, a training needs analysis was completed and significant staff training and an education scheme were introduced in response to the findings of the analysis. Mental health champion training has been delivered to 153 staff and IT systems have been improved to help capture vital data to help shape the Trust’s service. 27 Priority Four: Recognising and responding to deterioration in patients During 2021/22 the Trust successfully introduced national Paediatric Early Warning System (nPEWS) into its Southampton Children’s Hospital and UHS is now part of the national test and trial of nPEWS which is assessing the usability of the scoring system. The Trust has also explored how nPEWS can be adapted for children with complex medical conditions requiring interventions (including non-invasive ventilation) as part of their normal care. A daily heat map of escalation times over a 24-hour period was piloted in 2022 and will be rolled out across all adult’s inpatient areas during 2023. The Trust has also performed well with its cardiac arrest audits, and training and education programmes have consistently been delivered. September 2022 saw the implementation of a 24-hour paediatric outreach service. There is a deteriorating patient group and several successful QI projects have been introduced. Priority Five: Improving how the organisation learns from deaths The Trust only partially achieved this priority as it has been unable to establish a learning from deaths steering group. The Trust has introduced a mortality governance coordinator/analyst and grown its bereavement care service. Priority Six: Shared Decision Making (SDM) The shared decision models started at UHS in 2021/22 and have continued to grow with investment in pilot roles to expand these models, which include several advanced nurse practitioner roles, models in paediatrics bringing Shared Decision Making to patients who are transitioning from paediatric to adult services, while in maternity we have introduced SDM in birth planning. When assessing delivery of SDM against NICE guidelines, UHS performs well, especially in targets related to Trust buy-in, governance and practices of pilot areas. This year the Trust has implemented training through key platforms and expanded patient involvement in the project. As a leading site nationally for SDM principles, UHS have worked with NHS England on creating materials for others to learn from. Priority Seven: Working with our local community to expose and address health inequalities During the year the Trust refocused its efforts on making sure that its involvement and participation activities support the health inequalities agenda, while also working to deliver responsive information and advice to patients, carers, and families. Priority Eight: Ensure patients are involved, supported, and appropriately communicated with on discharge During the year the Trust has focused on improved patient, carer and family involvement, and improved communication during the discharge process as well as prompting a more collaborative working between social and health care staff. Strong partnership working with external agencies has been developed to support a system approach to hospital discharge, develop digital solutions, develop the patient hub to support discharge and delivered education to UHS staff. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2023/24, in the Trust’s Quality Account for 2022/23. 28 Financial performance The Trust delivered a deficit of £11 million from a revenue position of over £1.2 billion, once items deemed as “below the line” by NHS England, such as the financial position of the Southampton Hospitals Charity, were removed. The Trust was unable to deliver the planned breakeven position. Several material cost pressures were incurred, including unfunded high-cost drugs costs and energy prices. These were unable to be off set in full by a savings programme, despite delivery of £45.6m of efficiencies (2021/22: £15m). Trust operating income rose by £64m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Income reduced from the prior year in relation to ending a nationally funded project regarding testing for COVID-19. The Trust has however been successful in increasing funding for research and development. Trust operating expenditure rose by £78m, incorporating funded inflationary costs as well as the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investmen
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