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Duodenal atresia - patient information

Description: A scan has shown that your baby may have a condition called duodenal atresia.
Url: /Media/UHS-website-2019/Patientinformation/Pregnancyandbirth/Duodenal-atresia-2828-PIL.pdf

Congenital diaphragmatic hernia (CDH) - patient information

Description: This factsheet has been designed to accompany the individualised discussions you will have about your care and the care of your baby both during pregnancy and after your baby's birth.
Url: /Media/UHS-website-2019/Patientinformation/Pregnancyandbirth/Congenital-diaphragmatic-hernia-CDH-2825-PIL.pdf

Skin cancer nurse specialists - patient information

Description: During your treatment for skin cancer, you will be looked after by our skin cancer nurse specialists who will be responsible for coordinating your care.
Url: /Media/UHS-website-2019/Patientinformation/Cancercare/Skin-cancer-nurse-specialists-1581-PIL.pdf

Welcome to ward D10 (infectious diseases and cystic fibrosis unit) - patient information

Description: This factsheet explains what the D10 (infectious diseases and cystic fibrosis) unit is and introduces the team who will be caring for you.
Url: /Media/UHS-website-2019/Patientinformation/Visitinghospital/Welcome-to-ward-D10-infectious-diseases-and-cystic-fibrosis-unit-3502-PIL.pdf

Vinflunine

Description: Chemotherapy Protocol BLADDER Regimen VINFLUNINE • Bladder – Vinflunine Indication • Bladder cancer that has failed to r
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Bladdercancer/Vinflunine.pdf

Ipilimumab Ver 1

Description: Chemotherapy Protocol SKIN CANCER IPILIMUMAB Regimen Skin – Ipilimumab Indication Ipilimumab is recommended, within its marketing authorisation, as a
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Skincancer/SkinIpilimumabVer1.pdf

Mental wellbeing support on the neonatal intensive care unit (NICU) - patient information

Description: Patient information factsheet Mental wellbeing support on the neonatal intensive care unit (NICU) If your baby is unwell or has been born prematurely, they may need to stay in the neonatal intensive care unit (NICU) for treatment. Understandably, this can be a very distressing and exhausting time. Parents of babies who have a stay in the NICU are at greater risk of anxiety, depression and post-traumatic stress disorder (PTSD) for months, or sometimes years, to come. This factsheet provides information about the support we can offer parents to help them look after their emotional and mental health. If you have any further questions or concerns, please speak to a member of your healthcare team who will be pleased to help you. Emotional support Many parents often describe being on the NICU as an ‘emotional rollercoaster’. Your emotions may feel overwhelming, foreign or confusing at times, but these are all natural responses to a difficult situation. Every parent copes differently, but you may feel: • helpless in the face of so many uncertainties • overwhelmed • shocked and numb • guilty or in some way responsible for having a premature or unwell baby • like you’re not a ‘proper’ parent • stressed, tearful or low • angry • distant and find it difficult to ‘think straight’ or remember things • detached and want to avoid being with your baby • worried and find it difficult to leave your baby • ‘on edge’ and panicky • joy at meeting your baby • pride in seeing them develop • relief that your baby is receiving appropriate medical care We will offer you emotional support throughout your time in the neonatal unit. Many parents find it helpful to talk about their feelings. Our neonatal counsellor and psychologist both have specialist training in helping families who have a sick or premature baby. We are here to listen, to think with you about what’s happening, and to help you find a way through your time on the unit. www.uhs.nhs.uk Patient information factsheet Leaving hospital with your baby Leaving the neonatal unit for the first time with your baby can be one of the most challenging times for you as parents. You may experience several emotions, including: • feeling a huge sense of responsibility • feeling scared to leave the support of nurses and doctors • feeling overwhelmed • feeling isolated from friends and family • having flashbacks of conversations and challenging days in the NICU • feeling guilty • fearing for the future It is important to understand that the experience of your baby’s stay in the NICU may continue to affect your mental and emotional wellbeing in the years ahead. Additional challenges Parents often find that there are additional challenges that come from having a baby on the NICU. Challenges include: • coping with feelings of uncertainty when your baby is transferred to another area or unit • maintaining a helpful and supportive relationship with your partner • communicating about what’s happening with family and friends • adapting to changes in your roles and expectations • having open and helpful communication with medical and nursing staff • organising family life outside the hospital • supporting other children in your family • facing financial stress and uncertainty How can speaking to a neonatal counsellor or psychologist help? Speaking to a neonatal counsellor or psychologist may be a new experience for you, but parents often find that they need some help adjusting to what can be a very unexpected and stressful time on the NICU. Spending time with a neonatal counsellor or psychologist can help you to: • express and explore your emotions in a supportive environment • understand your emotional reactions and explore ways to cope with them • help you manage the effects of your experience on your family relationships and relationships with your baby’s medical team • find ways to solve problems and make use of your strengths and skills • help you think through decisions you need to make about your baby’s treatment Talking about how you are feeling will help you get through the exciting yet challenging time of becoming a parent. It doesn’t matter who you talk to, but it is worth having someone in mind that you can trust and who can support you if needed. Our neonatal counsellor and psychologist both have special training to help people make sense of how they feel, think and act, and aim to reduce distress and help people cope by using talking therapies. www.uhs.nhs.uk Patient information factsheet How to book an appointment for support Speak to the nurse or doctor caring for your baby and tell them you would like to see a neonatal counsellor or psychologist, either on your own or as a couple. They will be able to organise an appointment for you. Usually you can be seen on the ward in a private room near to your baby. If you would like a break from the unit, there are also rooms at other locations in the hospital. There may be a short wait for appointments. We will always let you know when you are likely to be seen. Confidentiality We may write to your GP to let them know you have been seen by us so they can continue to provide care for you once your baby has left the hospital or moved to a different setting. Information that you share with a counsellor or psychologist will be kept confidential. Parents sometimes find it helpful to share some information with the medical team to improve communication and care. If there is a risk of harm to yourself or to others, then this information may need to be shared with other professionals. If this occurs, the psychologist will discuss this with you whenever possible. Finding other sources of support There are a number of other sources of support which may help you during your baby’s NICU stay. Here are some different options to try: Attend a support group When you first arrive in the neonatal unit, we will welcome you and explain the resources that are available to you. Please ask us when the unit runs support groups, as these are a great way for you to meet other parents who are in a similar position. Bliss, the premature baby charity, also runs support groups across the UK. Look out for ‘parentcraft sessions’ Parentcraft sessions aim to involve parents in the care of their own child. Sessions include: • what to expect when your baby is here • how to help comfort your baby • medicines • meet the pharmacist Join the ‘Holding Little Hands’ Facebook group Holding Little Hands is a Facebook support group for parents where you can share your experiences and make new friends. You may then decide to form your own friendship group. Parents who make friends with other mums and dads in the neonatal unit often find that their shared experience makes them friends for life. Read up on premature birth Neonatal care is complex and the terminology can be overwhelming. The medical team caring for your child will do their best to explain, but it may help to read up on the subject of premature birth. For some people, this helps them to feel empowered and more able to make difficult decisions affecting their baby’s care. We recommend reading ‘The Preemie Parents’ Companion’ by Susan L. Madden. www.uhs.nhs.uk Patient information factsheet Mindfulness The Mind charity have published a series of relaxation tips and exercises that you can do regularly, or whenever feels right. To find out more, please visit www.mind.org.uk/ information-support/tips-for-everyday-living/relaxation/relaxation-exercises They also recommend spending time in green places, such as your local park, where you can tune out from your worries and experience mindfulness. Music therapy may also help. Practice kangaroo care Kangaroo care is the process of holding your baby to your skin. It has been shown to have many benefits including stress reduction and bonding. Make time for yourself It’s common for parents to experience tunnel vision in the neonatal unit. We know that you want to be at your baby’s cotside as much as possible, but for your mental and emotional wellbeing, you must make time for yourself. Head home or to the hospital accommodation and relax in a warm bath, have a walk or take a nap. Share how you feel We all process trauma in different ways. However, ignoring your emotions and not talking about your feelings can lead to extreme stress. Some parents find it helpful to write an emotional wish-list to communicate their thoughts and feelings to friends and family. www.uhs.nhs.uk Patient information factsheet Contact us If you need urgent help, speak to the NICU nursing team who will be able to arrange psychological support. If your mental wellbeing gets worse, please visit www.mentalhealth.org.uk and call one of the helplines available, such as the Samaritans. If you are concerned that you are developing a mental health problem, you should seek the advice and support of your GP. If you are in distress and need immediate help, and are unable to see a GP, you should visit your local emergency department. Neonatal intensive care unit (NICU) Telephone: 023 8120 6001 Neonatal secretaries Telephone: 023 8120 4643 or 023 8120 6007 Email: neonataladmin@uhs.nhs.uk Useful links www.bliss.org.uk www.nhs.uk/conditions/pregnancy-and-baby/baby-special-intensive-care If you need a translation of this document, an interpreter or a version in large print, Braille or on audio tape, please telephone 023 8120 4688 for help. Version 1. Published August 2019. Due for review August 2022. 2291 www.uhs.nhs.uk
Url: /Media/UHS-website-2019/Patientinformation/Neonatal/Mental-wellbeing-support-on-the-neonatal-intensive-care-unit-NICU-2291-PIL.pdf

Papers Trust Board - 10 September 2024

Description: Agenda Trust Board – Open Session Date 10/09/2024 Time 9:00 - 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd Apologies Diana Eccles (10:00-12:00) In attendance Jessica Bown, Midwifery Quality Assurance and Safety Matron (shadowing Gail Byrne) 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 25 July 2024 9:15 Approve the minutes of the previous meeting held on 25 July 2024 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Finance and Investment Committee (Oral) 9:20 Dave Bennett, Chair 5.2 Briefing from the Chair of the People and Organisational Development 9:25 Committee (Oral) Jane Harwood, Chair 5.3 Briefing from the Chair of the Quality Committee (Oral) 9:30 Tim Peachey, Chair 5.4 Chief Executive Officer's Report 9:35 Receive and note the report Sponsor: David French, Chief Executive Officer 5.5 Patient Safety and Quality of Care in Pressurised Services 9:55 Review and discuss the report Sponsor: Joe Teape, Chief Operating Officer Attendee: Duncan Linning-Karp, Deputy Chief Operating Officer 5.6 Performance KPI Report for Month 4 10:05 Review and discuss the report Sponsor: David French, Chief Executive Officer 5.7 Finance Report for Month 4 10:30 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.8 Break 10:40 5.9 People Report for Month 4 10:55 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.10 Guardian of Safe Working Hours Quarterly Report 11:10 Receive and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Diana Hulbert, Emergency Medicine Consultant and Guardian of Safe Working Hours 5.11 Learning from Deaths 2024-25 Quarter 1 Report 11:25 Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Jenny Milner, Associate Director of Patient Experience 5.12 Medical Appraisal and Revalidation Annual Report including Board 11:40 Statement of Compliance Receive and note the Annual Report. Approve the Statement of Compliance. Sponsor: Paul Grundy, Chief Medical Officer 5.13 Safeguarding Annual Report 2023-24 11:55 Receive and discuss Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Corinne Miller, Named Nurse for Safeguarding Adults/ Danielle Honey, Named Nurse for Safeguarding Children 6 STRATEGY and BUSINESS PLANNING 6.1 Board Assurance Framework (BAF) Update 12:10 Review and discuss the update Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager Page 2 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Register of Seals and Chair's Actions Report 12:20 Receive and ratify In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 Health and Safety Annual Report 2023-24 12:25 Receive and discuss Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Jane Fisher, Head of Health and Safety Services 7.3 People and Organisational Development Committee Terms of Reference 12:35 Review and approve Sponsor: Steve Harris, Chief People Officer 8 Any other business 12:40 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 5 November 2024 10 Items circulated to the Board for reading 10.1 CRN: Wessex 2024-25 Q1 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 11 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 12 Follow-up discussion with governors 12:45 Page 3 Minutes Trust Board – Open Session Date Time 25/07/2024 9:00 – 13:00 Location Anaesthetic Seminar Room (CE95/99)/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Dave Bennett, NED (DB) Jenni Douglas-Todd, Chair (JD-T) Diana Eccles, NED (DE) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Tim Peachey, NED (TP) (until 12:00) Joe Teape, Chief Operating Officer (JT) Alison Tattersall, NED (AT) Natasha Watts, Interim Deputy Chief Nursing Officer (NW) (for G Byrne) In attendance Martin De Sousa, Director of Strategy and Partnerships (MDeS) Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.3) Kelly Kent, Head of Strategy and Partnerships (KK) (item 6.1) Marie Nelson, R&D Head of Nursing and Health Professions (MN) (item 6.2) Karen Underwood, Director of R&D (KU) (item 6.2) Kerrie Montoute, Head of Programmes, CDO Directorate at NHSE (shadowing JDT) 1 member of the public (item 2) 3 governors (observing) 3 members of staff (observing) 2 members of the public (observing) Apologies Gail Byrne, Chief Nursing Officer (GB) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Gail Byrne. The Board welcomed Alison Tattersall, who joined the Board as a non-executive director on 1 June 2024. The Chair provided an overview of her activities since June 2024, including visits to hospital departments, meetings with peers and other key stakeholders. 2. Patient Story Georgia Blackman and her parents were invited to relate their story following Georgia’s admission with serious head and abdominal injuries after a car accident in November 2023. She had not been expected to survive, but had instead made Page 1 a very good recovery and was undergoing rehabilitation and had regained some sight. The family related their experience of being told that their daughter was going to die and the importance of how this message is delivered was highlighted. It was further noted that where a patient is between 16 and 18 years old it was necessary to consider whether they are managed as a child or as an adult in terms of their care. 3. Minutes of the Previous Meeting held on 6 June 2024 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 6 June 2024. 4. Matters Arising and Summary of Agreed Actions It was noted that there were no matters arising or overdue actions. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee The chair of the Audit and Risk Committee was invited to provide an overview of the meeting held on 27 June 2024 and the subsequent meeting of a committee authorised to approve the final annual report and accounts for 2023/24 held on 16 July 2024. It was noted that the annual report and accounts had been submitted to NHS England on 19 July 2024 and that the Trust’s external auditor had provided a ‘clean’ audit opinion. 5.2 Briefing from the Chair of the Finance and Investment Committee The chair of the Finance and Investment Committee was invited to provide an overview of the meeting held on 22 July 2024. It was noted that: • The committee had reviewed the Finance Report for Month 3 (item 5.8). • The committee had examined the Trust’s progress on its transformation programme, and noted in particular the success in reducing length of stay by 5% for P0 patients as part of the discharge programme. • The committee received a report on the Trust’s productivity and noted that the national methodology used created a confusing position and did not incorporate the impacts of certain factors which should be included. • The committee reviewed the Trust’s activities in the digital space and noted that capital in this area was primarily used for maintenance rather than development and that there was a significant infrastructure risk due to the Trust’s current data centre set up. It was further noted that better understanding of the benefits of digital development and timescales was required. • The Trust had agreed to participate in establishing a separate legal entity to seek investment to exploit intellectual property rights jointly developed by the Trust and the University of Southampton. 5.3 Briefing from the Chair of the People and Organisational Development Committee The chair of the People and Organisational Development Committee was invited to provide an overview of the meeting held on 22 July 2024. It was noted that: • The committee reviewed the revised People Report for Month 3 (item 5.9), noting that the workforce plan was at risk if there was no reduction in patients having no criteria to reside and mental health demand. • The committee had reviewed the Trust’s Employee Relations activities and received an update on an investigation into comments made on social media. Page 2 5.4 5.4.1 5.5 • In its review of the Board Assurance Framework (item 6.3), it was agreed that culture also needed to be reflected in the people-related risks. Briefing from the Chair of the Quality Committee The chair of the Quality Committee was invited to provide an overview of the meeting held on 15 July 2024. It was noted that: • In its report from the Quality Governance Steering Group, the committee noted that there were two new never events under investigation. In addition, there were national shortages of certain medicines. The committee also noted an increase in violence and aggression linked to the increasing number of patients with mental health issues. • The committee reviewed the Fundamentals of Care programme and noted that it was very comprehensive. • The committee also received updates following a visit by Southern Health and the impact of demand by patients with mental health issues on the Trust. • The committee also noted a report by the Royal College of Radiologists on the Trust’s radiotherapy department, which provided positive feedback, and noted the expansion in use and scope of the service. • In its review of the Board Assurance Framework (item 6.3), the committee noted that the risk of staff availability could be due to both unaffordability as well as national lack of availability of qualified individuals. Action Craig Machell agreed to add an item covering the impact of technology over the next 5-10 years to a future Trust Board Study Session agenda. Maternity and Neonatal Safety 2024-25 Quarter 1 Report The chair of the Quality Committee was invited to provide an overview of the Maternity and Neonatal Safety 2024/25 report for the first quarter, the content of which was noted. It was further noted that: • Under the terms of the NHS Resolution Maternity Incentive Scheme, the Board had delegated review of the report to the Quality Committee. • There had been sustained improvement in meeting the required timescales for booking of appointments and screening since April 2024. • The continuity of carer need should be focused where it could make the most difference. • Appointment of a community partner by the Integrated Care Board was expected soon. • The Trust was approximately 40 members of staff short. However, plans were in place to address this deficit, including use of newly qualified nurses on rotations and the 36 new entrants expected between November 2024 and March 2025. Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • David French had met with the new Secretary of State for Health and Social Care on 19 July 2024 where the Secretary of State had outlined his priorities in terms of urgent and emergency care and addressing the backlog in elective care through using private sector capacity. In addition, it was noted that the intention for the longer term was to focus on preventative health and digital. • Following the General Election, there were also a number of new Members of Parliament for the area served by the Trust. Page 3 • On 1 July 2024, the new pathology laboratory information management system had been rolled out across the region. There had been some initial issues with providing information to primary care providers. • David French had been asked and had agreed to remain as the provider representative on the Hampshire and Isle of Wight Integrated Care Board until September 2024. • A new referral system for Ophthalmology had been launched, which would use A/I in supporting the booking process. 5.6 Performance KPI Report for Month 3 Joe Teape was invited to present the Performance KPI Report for Month 3, the content of which was noted. It was further noted that: • The Trust’s performance was in the top quartile for six out of nine measures and the top half for two others. • There had been a fairly stable period with better occupancy levels and improvements in timings of discharges. • There were ~220 patients no longer meeting criteria to reside during June 2024, and the Trust was considering a new plan with local partners for a local system delivery plan. • The Trust’s cancer performance continued to be impacted by the challenge posed by increasing demand. • The Trust’s performance against the 31-day standard had fallen to the third decile, with capacity issues in radiology and prostate services. • Further understanding of who was being referred under cancer pathways was required, as this could identify health inequality concerns in terms of who was accessing the Trust’s services. • Increases in referrals could be due to national campaigns which raise public awareness of certain forms of cancer and the possible symptoms. 5.7 Break 5.8 Finance Report for Month 3 Ian Howard was invited to present the Finance Report for Month 3, the content of which was noted. It was further noted that: • Nationally, the NHS’s deficit was above £1bn, representing 4-5%. The Hampshire and Isle of Wight Integrated Care Board had recorded a £57m deficit (6%) for month 3. The average deficit for university teaching hospitals was 4.1%. • The Trust had recorded a £13m deficit (year-to-date) and an in-month deficit of £4.5m. • There had been some early signs of improvement with the underlying position having improved since month 1. • The Trust’s elective recovery performance was 128% and there had been improvements in length of stay. • The Trust’s workforce numbers and pay costs were below plan, and agency numbers had halved since summer 2023. • The underlying monthly deficit was c.£5m, with approximately £1m of this attributable to unfunded pay awards and costs of industrial action. • Meeting the Trust’s plan for Quarter 2 of 2024/25 was expected to be challenging, as it assumed that the Integrated Care System’s transformation programmes would begin to deliver. • The Trust’s cash reserves were now below £30m, and the Trust might need to consider the need for additional cash from NHS England. • The Trust would continue to focus on its transformation programmes. Page 4 • The level of the anticipated pay award for 2024/25 and a likely shortfall in funding for the award was a risk to the Trust’s financial position. 5.9 People Report for Month 3 Steve Harris was invited to present the People Report for Month 3, the content of which was noted. It was further noted that: • A number of improvements were in the process of being made to the report to incorporate a ‘heat map’ and provide additional focus on culture. • The Trust was under its overall workforce plan by 313 whole-time equivalents (WTE) at the end of June 2024. However, in terms of its overall plan, ~200 WTE were reliant on improvements in the non-criteria to reside and mental health position. • Violence and aggression remained a key concern, with increasing use by the Trust of its warning and exclusion policy. • Work was ongoing to review the number of statutory and mandatory training courses with a view toward rationalising the number. • The ‘We Are UHS’ Champions award ceremony was to be held in October 2024. • The Integrated Care Board recruitment control panel appeared to be limiting the number of requests for recruitment likely due to improved filtering taking place by the individual trusts. 5.10 Annual Complaints Report 2023-24 Natasha Watts was invited to present the Annual Complaints Report for 2023/24, the content of which was noted. It was further noted that: • The number of complaints received had decreased slightly compared to the previous year, and the number of complaints upheld or partially upheld had decreased compared to the previous year and remained lower than the national average. • There had been four cases reviewed by the Parliamentary and Health Service Ombudsman, of which two were closed and two were partially upheld. • The overall quality of responses to complaints had improved. 6. STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2024-25 Quarter 1 Review Martin De Sousa was invited to present the Corporate Objectives 2024/25 Quarter 1 Review, the content of which was noted. It was further noted that: • The Trust’s performance was largely positive with 11 (out of 16) objectives on track to be delivered in full. • The major risks for achievement of the objectives were the Trust’s financial position and the possible impact of this on the workforce, and the Trust’s ability to reduce the number of patients not having criteria to reside. • Inclusion of a predicted future rating for each objective in reports was to be considered. Page 5 6.2 Research and Development Plan 2024-25 Karen Underwood was invited to present the Research and Development Plan for 2024/25, the content of which was noted. It was further noted that: • During 2023/24, the Trust had recruited its 250,000th participant and had launched its Research for Impact strategy. • Income for 2024/25 was predicted to be lower than previously due to the impact of Covid-19-related studies on prior years. • Vacancies and the reliance on clinical support services would be a challenge for 2024/25. Decision Having discussed the proposal, the Board approved the Research and Development Plan for 2024/25. Action Ian Howard agreed to obtain clarification regarding the discrepancy between the Return on Investment table and Appendix 4 in the plan. 6.3 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework, the content of which was noted. It was further noted that: • All risks had been reviewed by the Executive leads since June 2024. • The recorded gaps and controls were being checked and the BAF would differentiate between actions and aspirations in terms of the Trust’s steps to mitigate or address areas of risk. • It was intended to more closely link the BAF risks to the Board’s agenda. • The maturity assessment undertaken during 2023/24 as part of the audit of risk management carried out by KPMG would be reviewed to determine where the Trust would be against its aspirations by the end of the year. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (CoG) Meeting 24 July 2024 The Chair provided an overview of the meeting of the Council of Governors held on 24 July 2024. It was noted that the meeting had addressed the following matters: • The appointment of Shirley Anderson as the new Lead Governor. • Reports from the Chief Executive Officer and Chief Financial Officer. • The Trust’s annual report and accounts for the year ended 31 March 2024. 7.2 Register of Seals and Chair’s Actions Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’. 8. Any other business There was no other business. Page 6 9. Note the date of the next meeting: 10 September 2024 10. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 7 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 28/03/2024 4.14 Guardian of Safe Working Hours Quarterly Report 1127. Junior Doctors Grundy, Paul 24/10/2024 Pending Explanation action item Paul Grundy and Diana Hulbert agreed to include an item regarding junior doctors on a future Trust Board Study Session agenda. Due to industrial action on 27 June, this item has been deferred to the next TBSS on 24/10/2024. Trust Board – Open Session 06/06/2024 5.6 Performance KPI Report for Month 1 1152. Digital Teape, Joe Explanation action item JT agreed to include Digital as an agenda item at a future Trust Board Study Session. 24/10/2024 Pending This item is tentatively scheduled for TBSS on 24/10/2024. Trust Board – Open Session 25/07/2024 5.4 Briefing from the Chair of the Quality Committee (Oral) 1163. Impact of technology Machell, Craig 27/02/2025 Pending Explanation action item Craig Machell agreed to add an item covering the impact of technology over the next 5-10 years to a future Trust Board Study Session agenda. Update: Item tentatively scheduled for 27/02/25 Study Session. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 25/07/2024 6.2 Research and Development Plan 2024-25 1165. Discrepancy Howard, Ian 10/09/2024 Pending Explanation action item Ian Howard agreed to obtain clarification regarding the discrepancy between the Return on Investment table and Appendix 4 in the plan. Page 2 of 2 Report to the Trust Board of Directors Title: Agenda item: Sponsor: Date: Purpose: Issue to be addressed: Response to the issue: Chief Executive Officer’s Report 5.4 David French, Chief Executive Officer 10 September 2024 Assurance Approval or reassurance Ratification Information X My report this month covers updates on the following items: • NHS Pay Offers • National Unison Campaign – Collective Pay Grievance for Healthcare Support Workers • Civil Unrest • Hampshire Together • Maternity Services and Sustainable Staffing • CQC Annual Hospital Inpatients Survey • Annual Regulation and Oversight Survey • Cass Review Implementation • Aseptic Preparation Audit • Human Tissue Authority inspection The response to each of these issues is covered in the report. Implications: Any implications of these issues are covered in the report. (Clinical, Organisational, Governance, Legal?) Summary: Conclusion The Board is asked to note the report. and/or recommendation Page 1 of 9 NHS Pay Offers On 29 July 2024, the Government announced that it would accept in full pay review body advice on NHS staff salaries and would make a pay offer to junior doctors in an attempt to end the ongoing industrial action. The Government accepted the 2024/25 recommendations of the NHS Pay Review Body for a 5.5% increase, backdated to 1 April 2024, for all Agenda for Change staff. This increase is expected to be reflected in October pay. In addition, intermediate pay bands will be created for Band 8 and 9 staff. In line with national guidance UHS will also offer back pay payments to be spread out over six months if individuals request this to help mitigate any impact on universal credit. The offer made to the junior doctors represents a 22.3% uplift over two years. This comprises an additional average of 4.05% for 2023/24 on top of the existing 8.8% implemented last year, taking the average uplift to 13.2%. In addition, 2024/25 pay would increase by an average of 12.4% against current 2023/24 payscales. The British Medical Association junior doctors committee recommends acceptance of this offer. Voting opened on 19 August and closes on 15 September 2024. The Government has also announced its intention to repeal the Strikes (Minimum Service Levels) Act 2023, which provides a mechanism to require workers in particular sectors, such as health, education, fire and rescue, and transport, to guarantee certain minimum levels of service during periods of industrial action. This will form part of a range of employment law modifications the government is considering, and the Board will be updated with further details once these are finalised. National Unison Campaign – Collective Pay Grievance for Healthcare Support Workers During August, UHS formally received a collective grievance relating to pay for Healthcare Support Workers (HCSWs). This is a national campaign led by UNISON pushing for recognition of duties carried out by these staff, formal re-grading of pay band, and appropriate back pay. UHS has over 1,200 individuals in these roles. The Chief People Officer is formally meeting with UNISON to discuss how the matter can be resolved. Whilst this is a national campaign, we have been told not to expect national resolution and Trusts have been directed to resolve locally as appropriate. Civil Unrest The nation experienced significant violent and racially motivated civil unrest during August. Farright anti-immigration rallies were planned in a number of cities across the UK, including Southampton. Healthcare workers had been directly targeted in some parts of the country by farright groups. This understandably generated fear and concern from our black, minority ethnic communities which was raised through various routes to leaders at the Trust. Communication was sent by the Chief Executive Officer and Chief Nursing Officer to all staff setting out our stance on the situation and proposed practical measures, coupled with local support from managers to those who were concerned. Led by the Chief Nurse through the Trust's incident management process, we rapidly implemented practical measures in addition to wider wellbeing and psychological support. Measures included additional security, additional transport and other local actions to help with people's safe journey to work on the day of planned demonstrations. Friday prayers were also attended by the Chief Medical Officer and the Director of OD and Inclusion to provide support to our Muslim communities. The unsavoury events have also triggered a collective drive to push again to focus on the violence and aggression issues at UHS. Staff still experience unacceptable violence, aggression and hate crimes by patients and service users at UHS and across the whole NHS. A multistakeholder workshop, including police partners, is planned for 2 October 2024 to re-energise Page 2 of 9 delivery of our existing commitments. We also want to use the expertise and advice of a range of people to explore and plan where we can go further and be bolder with this important agenda. At the national level, NHS England wrote to all integrated care boards, NHS trusts and foundation trusts, GP and dental practices, pharmacy contractors, and general ophthalmic service contractors on 12 August 2024 emphasising the NHS position that ‘discrimination is unacceptable, and the NHS should have a zero tolerance of racism towards our patients and colleagues’. NHS England also sets out some guidance in the following areas for organisations to listen to and support affected staff: • Ensuring staff can access the support they need • Involving staff networks in the organisational response • Dealing with instances of racism and discrimination • Demonstrating ongoing commitment to equality, diversity and inclusion The response can be read at: https://www.england.nhs.uk/long-read/nhs-response-to-2024-riots/ Hampshire Together HM Government has announced that it is pausing approval of the business cases for the ’40 new hospitals’, of which Hampshire Hospitals is one. Public consultation had recently been completed and submission of the final business case was anticipated before the end of this year but the timing of submission and approval of the business case is now uncertain pending the national review. Separately, the ‘Save Winchester Action Group’ has written to board members of HIOW ICB with concerns regarding the proposed changes at Winchester Hospital, specifically around the loss of acute services from the Winchester site. The overall programme was discussed at the ICS board meeting on 4 September 2024. The executive has a planned session with Hampshire Hospital NHS Foundation Trust executives at the end of September to discuss ideas around future models for services across all sites. Maternity Services Safe and Sustainable Staffing In August 2024, the Trust produced a briefing paper for the Care Quality Commission which provided a summary of the Trust’s action plan in respect of staffing of its Maternity services. The paper is attached as Appendix A. CQC Annual Hospital Inpatients Survey On 21 August 2024, the Care Quality Commission (CQC) published its adult inpatient survey for 2023. The survey examines the experiences of people over 16 who stayed at least one night in hospital during November 2023. The results showed a deterioration in people’s experiences of inpatient care since 2020, although the results for 2023 remained broadly consistent with those in 2022 and 2021. Most respondents reported a positive experience in their interactions with doctors and nurses, such as being treated with respect, dignity, kindness and compassion and being included in conversations. However, discharge from hospital remains a challenging part of people’s experience of care, with 29% saying that they had little to no involvement in decisions about their discharge, and only 48% saying that they were given enough notice about when they were going to leave. In addition, 23% of elective patients said they would have liked to have been admitted ‘a bit sooner’ and 19% ‘a lot sooner’, and 43% of elective patients believed that their health had deteriorated while waiting to be admitted. Page 3 of 9 The survey results can be viewed at: https://www.cqc.org.uk/publications/surveys/adult-inpatientsurvey Annual Regulation and Oversight Survey NHS Providers published the results of its annual regulation and oversight survey on 8 August 2024. According to the survey, trust leaders had reported an increased regulatory burden during the year, particularly noting a lack of coordination between regulators and questioning whether reporting requirements are proportionate or realistic. There were also questions as to whether regulators appropriately recognised the level of risks trusts had been absorbing in balancing the demands of financial and operational performance. Seventy-two per cent of trust leaders believed that the burden of integrated care board (ICB) regulation had increased, compared to 48% from NHS England and 36% from CQC. Less than a third of trusts were comfortable with the role of ICBs as performance managers and 62% saw their activity as duplicating that of NHS England. Respondents also questioned CQC’s credibility, feeling its judgements were not objective enough and inspection teams lacked sector-specific expertise. In addition, the majority of trust leaders would like to see a move away from the CQC’s one-word ratings, seeing it as too simplistic, often demoralising for staff, and confusing for patients. The survey report can be viewed at: https://nhsproviders.org/a-pivotal-moment-for-regulationregulation-and-oversight-survey-2024 Cass Review Implementation On 7 August 2024, NHS England published its plan to implement the advice from the Cass Review – the review of gender identity services for children and young people. This plan includes establishment of regional centres and changes to the referrals process to help trusts to deliver holistic, therapeutic and evidence-based care. The implementation plan can be read at: https://www.england.nhs.uk/long-read/children-andyoung-peoples-gender-services-implementing-the-cass-review-recommendations/ The Trust continues discussions with NHS England regarding whether Southampton could or should be one of these new regional centres. Aseptic Preparation Audit On 1 August 2024, the Trust was informed of the outcome of the external audit of unlicensed preparation of medicines for the pharmacy aseptic unit at Southampton General Hospital conducted on 4 June 2024. The unit’s operation was assessed as posing a low risk with respect to the quality of the medicines produced within it. The report also stated that the unit ‘is well managed and has good pharmaceutical quality systems in place’. Human Tissue Authority (HTA) inspection The HTA conducted an inspection of our mortuary arrangements in August. The formal feedback report has not been received but informal feedback has been shared by the inspection team. We expect the report to have no significant findings but we do anticipate a number of minor procedural and documentation recommendations. The inspection team advised us that the failings at Maidstone and Tunbridge Wells mortuary which enabled criminal activity to go unnoticed have triggered a recent ‘raising of the bar’, particularly regarding security / access arrangements. We will share the final inspection report when it is received, along with our response and action plan. Page 4 of 9 Appendix A UHS Briefing Paper to CQC Title: Maternity Services Safe and Sustainable Staffing Sponsor: Gail Byrne, Chief Nursing Officer Author(s): Emma Northover, Director of Midwifery Carly Springate, Head of Midwifery Marie Cann, Maternity and Neonatal Safety Lead Date: August 2024 Purpose: The purpose of this report is to note the current challenges in maternity staffing and provide assurance on the mitigations to maintain appropriate and safe staffing levels, which, in turn, ensures the delivery and support of high-quality care. Issue(s) to be addressed: Over recent weeks and months our Maternity Service has faced significant operational challenges, leading to more frequent than usual service diversions. This has led to impacts not only on the experience of our families and staff but across the wider Local Maternity and Neonatal System (LMNS). As from the beginning of July 2024, UHS Maternity Services have escalated to OPEL 4 on 23 occasions from the start of this year. Across the whole of 2023 OPEL 4 was declared 28 times. This shows a significant increase in service pressure that our Maternity Service is experiencing with staffing and acuity accounting for the majority of incidents. Whilst we are compliant with providing 1:1 care in active labour and we are safe, we are seeing an increase in other reportable red flags such as delays in induction and being unable to facilitate birthplace choices. In terms of our current position, staffing levels across the Maternity Service have remained challenging with vacancy rates across the registered workforce currently sit around 14%, equating to around 30 Whole Time Equivalents (WTE). Addressing these staffing challenges will require a coordinated effort and it is hoped that by collaborating with our partners we can develop a more comprehensive and effective approach to improving workforce provision. The enclosed plan of action sets out to address the staffing issues as much as possible until the newly qualified midwives start and vacancy is significantly reduced The DoM and the Senior Midwifery Leadership Team are committed to ensuring safe and sustainable staffing levels across UHS Maternity Services. We remain open and honest around our changing clinical environment as well as being sensitive and responsive to any rapidly changing picture. Escalation processes and frameworks are robust and well established. Further to this we have excellent engagement from our 1|Page Page 5 of 9 Maternity Safety Champions with whom we meet with regularly. This includes full support from Gail Byrne, Chief Nursing Officer and Executive Maternity Safety Champion, and Tim Peachey, Non-Executive Director and Maternity Safety Champion, who together ensure that the DoM has a platform and a voice at Trust Board. Despite the immediate challenges in respect of the Maternity Services workforce at UHS, we are looking to offer assurances to the CQC in terms of the actions both short and longer term that are being taken and the mitigations in place to reduce harm and maintain safety to our service users. Risks (top 3) of carrying out the change or not: Summary/ conclusion • 285 - Red 20 Maternity Staffing during peaks of activity • 259 - Red 16 Capacity and Demand in Maternity Services • 617 - Orange 12 Lack of postnatal care provision (staffing) • 815 - Red 15 Poor compliance with NICE guidance for Antenatal Bookings The CQC are asked to review this report and the mitigations in place and seek further assurance if required. Page 6 of 9 2|Page Maternity Staffing Action Plan Issue/Action Progress Lead Date 1. Following a successful newly • Our current preceptorship programme (18 months in hos- Practice Aug 2024 qualified midwife recruitment pital) has been recently reviewed in terms of content and Education lead drive, 34 WTE band 5 midwives structure to ensure that these staff are retained. to join UHS Maternity Services in November 2024. 2. Utilisation of contingency • Provides contingency measures in releasing and redeploy- Head of Aug 2024 framework ing additional staff. Midwifery RAG G 3. Utilise birthrate plus as a • The last assessment of UHS Maternity Services by BR+ in Director of framework for workforce planning 2018 suggested an overall clinical establishment based on Midwifery and strategic decision making a midwife V birth ratio of 1:24, calculated against an annual birth rate of 5500 births. This is soon to be recalculated Sept 2024 A 4. Increased staff support in the • We have retained 100% of our newly qualified preceptees Head of Aug 2024 G clinical environment in addition to who started with us in November 2023. Midwifery pastoral and psychological Practice support to enhance retention of Education Lead the workforce. 5. The senior leadership team, • To review how we maintain this going forward to ensure Director of Aug 2024 G including the Director of sustainability Midwifery / Chief Midwifery (DoM), commit to a Nursing Officer high number of out-of-hours on- calls to support the service when in escalation and when staffing does not match the acuity and activity across the acute clinical areas. 3|Page Page 7 of 9 6. Two fixed term matron roles have • This provides additional cushioning to the matron team and Director of been appointed to oversee a development opportunity for our existing workforce. Midwifery antenatal and postnatal pathways. 7. Development of a systematic • This live data is reflective of total staff unavailability in- Maternity process for workforce planning in clude vacancy rates, sickness ratios, maternity leave, and Business the form of a monthly dashboard. study time, all of which is compared alongside the budg- Support eted versus actual staffing establishment overall. Manager 8. The labour ward coordinator will • This enables the labour ward coordinator to have continu- Head of not take responsibility for any ous oversight of their clinical environment and oversee Midwifery patients, or cover breaks for other safety. members of staff. 9. An extensive listening exercise • To align with current service needs, and with staff wellbe- Director of has been undertaken place to ing as a central focus, the DoM and Senior Midwifery Midwifery help inform the future direction Leadership Team are reviewing the way the service is de- and structure of the Maternity livered with the potential of a workforce restructure. Service workforce. 10. 12 – 16 Registered nurses are to • Divisions seeking staff who are interested in supporting Director of be seconded to maternity in this and with the right skillset. Midwifery interim period to help release midwife time with roles such high • A review will be undertaken to see if this could be a dependency, vaccination, longer-term proposition to support the maternity workforce fundamentals of care 11. Dedicated programmes for career • Our prime focus is to consider new ways in which we can Director of development starting at band 2 future proof our Maternity Services going forward, whilst Midwifery and progressing to band 9. investing in our people. 12. A NHSP Incentive Scheme has been agreed to run over the summer months • This action has enabled staff to feel valued and appreciated Director of for all their gestures of good will and their contributions to Midwifery Page 8 of 9 Aug 2024 G Aug 2024 G Aug 2024 G Aug 2024 A Aug 2024 A Aug 2024 A Aug 2024 A 4|Page the workforce that are worked outside of contractual commitments. 13. A review to look at tipping points • Contact to be made with the ED to review learning and any Head of (as happens in Emergency processes and systems. Midwifery Department) to be scoped introduced 14. A roster review will be • Full review of the roster template to ensure fit for purpose Maternity undertaken to ensure the correct and staff allocated correctly. Business staffing levels and skills are in Support place. Manager Aug 2024 A Aug 2024 A 15. To introduce legacy midwives • Review of legacy midwives roles and recruitment Director of Aug 2024 A (recently retired midwives) to processes. Midwifery support newly qualified staff and Practice education Education Lead R Red: Immediate remedial action required A Amber: Action in progress G Green: Complete Page 9 of 9 5|Page Report to the Trust Board of Directors Title: Agenda item: Sponsor: Author: Date: Purpose: Issue to be addressed: Patient Safety and Quality of Care in Pressurised Services 5.5 Joe Teape, Chief Operating Officer Duncan Linning-Karp, Deputy Chief Operating Officer 10 September 2024 Assurance Approval or reassurance X Ratification Information Urgent and Emergency Care (UEC) services are under significant pressure nationally, with some high-profile cases of poor care highlighted, including in the press. In response NHSE has asked Trust Boards to assure themselves that they are doing all they can to: • Provide alternatives to emergency department attendance and admission, especially for those frail older people who are better served with a community response in their usual place of residence. • Maximise in-hospital flow with appropriate streaming, senior decision-making and board and ward rounds regularly throughout the day, and timely discharge, regardless of the pathway a patient is leaving hospital or a community bedded facility on. Response to the issue: This paper will outline UHS’s response to the above issues, including the improvement programmes focused on flow and the Emergency Department, the response to the UEC recovery plan year two document, work taking place across the local system and mitigations that take place when the Emergency Department becomes over-crowded. Implications: Clinical, organisational, governance, legal (Clinical, Organisational, Governance, Legal?) Risks: (Top 3) of carrying out the change / or not: • Harm to patients in the Emergency Department through prolonged waits and / or overcrowding. • Harm to patients who remain in hospital longer than necessary because of delayed discharge. • Harm to patients on an elective waiting list who are delayed because of a lack of capacity due to high levels of patients not meeting the criteria to reside. Summary: Conclusion Trust Board is asked to note this report. and/or recommendation Page 1 of 10 Introduction NHS England wrote to all NHS Trusts (see Appendix 1) to ask Trust Boards to assure themselves that Trusts, and wider systems, were doing all they can to reduce demand on Emergency Departments, improve flow across the UEC pathways including out of hospital, ensure basic standards of care are in place across all care settings and ensure executive visibility and leadership, and non-executive presence. This paper provides assurance to the Board, addressing the key requests outlined in the letter and benchmarks UHS’s response to the year two UEC plan. It also outlines work taking place in the local system to support admission avoidance and reduce delayed discharge. Finally, it outlines mitigations the organisation has put in place to manage risk at times when the Emergency Department (ED) is overcrowded, and to support flow through the hospital. Patient Safety and Quality of Care in Pressurised Services NHSE wrote to all Trusts to outline key actions Boards were required to assure themselves on to ensure patient safety and quality of care is maintained in pressurised services. The table below outlines those actions and UHS’s compliance against them. Request Provide alternatives to emergency department attendance and admission, especially for those frail older people who are better served with a community response in their usual place of residence. Maximise in-hospital flow with appropriate streaming, senior decision-making and board and ward rounds regularly throughout the day, and timely discharge, regardless of the pathway a patient is leaving hospital or a community bedded facility on. Their organisations and systems are implementing the actions set out in the UEC Recovery Plan year 2 letter. Basic standards of care, based on the CQC’s fundamental standards, are in place in all care settings. Services across the whole system are supporting flow out of ED and out of hospital, including making full and appropriate use of the Better Care Fund. Executive teams and Boards have visibility of the Seven Day Hospital Services audit results, as set out in the relevant Board Assurance Framework guidance. There is consistent, visible, executive leadership across the UEC pathway and appropriate escalation protocols in place Assurance There are community alternatives in place, including Urgent Community Response and virtual wards. More work is taking place to set-up Integrated Neighbourhood Teams. In-hospital flow is something UHS is continuously seeking to improve via the inpatient flow programme, focusing on all aspects of flow within the hospital’s control and ensuring patients only remain in hospital when necessary. Ward rounds take place daily with appropriate input from a senior decision maker. UHS is compliant with these actions, outlined in the following section. Fundamentals of care standards have been rolled out across the organisation. A CQC Oversight Group, chaired by the CNO, provides assurance on compliance against the standards. The wider system does support flow out of ED and the wider hospital, and the Better Care fund is used. However, the system continues to struggle with a high number of patients remaining in hospital who do not meet the criteria to reside. Seven Day Hospital Services are reported via the annual Quality Account to the Board and the Trust is compliant. A further audit is due in 2024. There is consistent, visible executive leadership across the UEC pathway including a fortnightly ED meeting chaired Page 2 of 10 every day of the week at both trust and system level. Regular non-executive director safety walkabouts take place where patients are asked about their experiences in real time and these are relayed back to the Board. by the Chief Executive, a monthly UEC Board chaired by the COO, a monthly CQC Oversight meeting chaired by the CNO and regular executive walkabouts. UHS has an internal escalation plan as does the wider system. The Trust appointed a clinical Director for Urgent and Emergency Care. Non-executive directors undertake walkabouts as part of Trust Board. Year two UEC Plan Benchmarking against the second year of the UEC plan shows that UHS is compliant against the key metrics. There has, however, been a reduction rather than an increase in some out of hospital capacity because of the financial challenges facing the ICB, Local Authorities and wider system. Request 1A. Maintain acute G&A beds at the level funded and agreed through operating plans in 2023/24. 1B. Maintain ambulance capacity and support the development of services that reduce ambulance conveyances to acute hospitals. 1C. Focus on reduction in ambulance handover delays to support system flow. 1D. Expand bedded and non-bedded intermediate care capacity, to support improvements in hospital discharge and enable community step-up care. 1E. Improve access to virtual wards through improvements in utilisation, access from home pathways, and a focus on frailty, acute respiratory infection, heart failure, and children and young people. 2A. Focus on reductions in admitted and non-admitted time in ED. Assurance UHS’s 2024/25 plan included the dual aspirations of halving the number of patients not meeting the criteria to reside and reducing length of stay by 5%. If these were both met, it is unlikely that we would require all current beds. However, while beds that are not needed would not be staffed, they will remain available if needed. In recent months routine surge capacity has remained closed b
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Papers Trust Board - 25 July 2024

Description: Agenda Trust Board – Open Session Date 25/07/2024 Time 9:00 - 13:00 Location Anaesthetic Seminar Room (CE95/99), E
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Ipilimumab-Nivolumab

Description: Chemotherapy Protocol SKIN CANCER IPILIMUMAB (3mg/kg)-NIVOLUMAB (1mg/kg) Regimen • Skin – Ipilimumab (3mg/kg)-Nivolumab (1mg/kg) Indication • Ipilimumab in combination with nivolumab is recommended for the treatment of advanced, unresectable metastatic melanoma. • WHO performance status 0, 1 Toxicity Drug Ipilimumab Nivolumab Adverse Effect Colitis, diarrhoea, dermatitis, neuropathy, hypothyroidism, hepatotoxicity, infusion related reactions, hypophysitis Fatigue, rash, pruritis, pneumonitis, diarrhoea, nausea, electrolyte disturbances, hepatitis and other immune-related adverse reactions. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, LFTs and U&Es prior to day one of each cycle • Blood pressure prior to treatment • Thyroid function tests prior to staring treatment and then before each administration (cycle) or when clinically indicated. Dose Modifications The dose modifications listed are for haematological, liver and renal function and some drug specific toxicities. Ipilimumab and nivolumab belong to the immunotherapy class of cancer treatments. Autoimmune toxicities are most frequently noted and can be life threatening. If autoimmune toxicities occur delaying treatment should be considered while investigations or treatments are organised. Some, but not all, toxicities mandate cessation of treatment. Please seek guidance from relevant site specific specialist teams or oncologists / haematologists with experience of prescribing these agents. Clinicians should be aware that the current funding approval for ipilimumab and Version 1.3 (July 2019) Page 1 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) nivolumab precludes further treatment after an interruption of 12 weeks or longer; this situation may change. Refer to the latest version of the European Society of Medical Oncology guidelines; Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(1). Haematological Consider blood transfusion or erythropoietin if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL There is little need to adjust the dose of ipilimumab or nivolumab for haematological toxicity. Instead dose delay criteria apply for all drug-related adverse events (regardless of whether or not the event is attributed to nivolumab, ipilimumab, or both). Both drugs must be delayed until treatment can resume. Hepatic Impairment For patients with pre-existing mild hepatic impairment no dose adjustment is recommended for either ipilimumab or nivolumab. Immune related hepatic reactions are associated with ipimumab and nivolumab. For a hepatitis associated with an AST / ALT of 3-5xULN and / or a total bilirubin of 1.5-3xULN then withhold treatment and administer corticosteroids. Upon improvement to NCI-CTC grade 1 hepatic injury begin to taper the corticosteroid over a period of one month. The combination may be re-started when the liver function remains at NCI-CTC grade 1 following corticosteroid taper. Both ipilimumab and nivolumab should be permanently discontinued when the hepatic injury does not improve to at least NCI-CTC grade 1 within 12 weeks of the last dose, the corticosteroid dose cannot be reduced to 10mg or less of prednisolone or equivalent per day within 12 weeks or any NCI-CTC grade 3 or above reaction. The combination should be permanently discontinued in the first instance when hepatitis develops that is associated with an AST / ALT equal to or greater than 5xULN or where the bilirubin is greater than 3xULN. Renal Impairment No dose adjustment is required in patients with pre-existing mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population. Severe nephritis or renal dysfunction has been observed with ipilimumab and nivolumab treatment. Patients should be monitored for signs and symptoms of nephritis and renal dysfunction. Most patients present with asymptomatic increases in serum creatinine. Disease-related aetiologies should be ruled out. For NCI-CTC grade 2 or 3 serum creatinine elevation, both agents should be withheld and corticosteroids initiated. Upon improvement to NCI-CTC grade 1 initiate corticosteroid taper over at least one month. Treatment may be resumed when the Version 1.3 (July 2019) Page 2 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) reaction remains at NCI-CTC grade 1 or below following tapering of the corticosteroid. The combination should be permanently discontinued when the serum creatinine does not improve to at least NCI-CTC grade 1 within 12 weeks of the last dose, the corticosteroid dose cannot be reduced to 10mg or less of prednisolone or equivalent per day within 12 weeks or in the case of a recurrent NCI-CTC grade 3 reaction. For NCI-CTC Grade 4 serum creatinine elevation, the ipilimumab and nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Ipilimumab and nivolumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity, likely to be related to its pharmacology. Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Most occur during treatment, however, onset months after the last dose has been reported. Unless an alternate aetiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and ipilimumab-related. Early diagnosis and appropriate management are essential to minimise life threatening complications. Endocrine Ipilimumab and nivolumab can cause inflammation of the endocrine system organs, specifically hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism. This may present with nonspecific symptoms resembling other causes such as brain metastasis or underlying disease. If there are any signs of adrenal crisis such as severe dehydration, hypotension, or shock, immediate administration of intravenous corticosteroids with mineralocorticoid activity is recommended, the patient must be evaluated for presence of sepsis or infections. If there are signs of adrenal insufficiency but the patient is not in crisis, further investigations should be considered including laboratory and imaging assessment. Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated. If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy is recommended to treat the gland inflammation. The scheduled dose of ipilimumab and nivolumab should be omitted. It is currently unknown if the corticosteroid treatment reverses the gland dysfunction. Appropriate hormone replacement should also be initiated. Long-term hormone replacement therapy may be necessary. Once symptoms or laboratory abnormalities are controlled and overall patient improvement is evident, treatment with ipilimumab and nivolumab may be resumed and initiation of corticosteroid taper should be based on clinical judgment. Version 1.3 (July 2019) Page 3 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) Hypophysitis can present as a diffuse, heterogenous enlargement of the pituitary on a brain MRI but can be completely normal. When hypophysitis with pituitary dysfunction is suspected, blood tests including thyroid stimulating hormone (TSH), free T4, adrenocorticotropic stimulating hormone, cortisol, leutinizing hormone, and follicle-stimulating hormone should be obtained in women, and the first four plus testosterone in men. Typically the anterior pituitary axis is involved, affecting thyroid, gonadal, and adrenal function, but isolated axis dysfunction can be seen. Hypophysitis will cause low free T4 as well as TSH. Hypophysitis with clinically significant adrenal insufficiency and hypotension, dehydration, and electrolyte abnormalities such as hyponatremia and hyperkalemia constitutes adrenal crisis. Hospitalization and intravenous steroids with mineralocorticoid activity, such as methylprednisolone, should be initiated while waiting for laboratory results. Infection and sepsis should be ruled out with appropriate cultures and imaging. Prednisolone 1 mg/kg by mouth should be administered if patients are clinically stable. Steroids can usually be tapered over 30 days to achieve physiologic replacement levels. Thyroid hormone and/or testosterone replacement therapy may not be permanent, as the need for those hormones may wane over months in some patients. Cortisone replacement may also not be permanent in a modest portion of patients. Gastrointestinal Gastro-intestinal immune reactions include diarrhoea, increased frequency of bowel movements, abdominal pain or haematochezia, with or without fever. Diarrhoea or colitis occurring after initiation of ipilimumab and nivolumab must be promptly evaluated to exclude infectious or other alternate causes. Immune-related colitis is often associated with evidence of mucosal inflammation, with or without ulcerations and lymphocytic and neutrophilic infiltration. NCI-CTC grade 1 or 2 diarrhoea or suspected mild to moderate colitis may continue on the combination. Symptomatic treatment and close monitoring are advised. If mild to moderate symptoms recur or persist for 5-7 days, the scheduled dose of the agents should be omitted and consideration given to prescribing prednisolone 1 mg/kg orally once a day. If resolution to NCI-CTC grades 0-1 or return to baseline occurs, the ipilimumab and nivolumab may be resumed at the next scheduled dose. Doses omitted due to an adverse reaction must not be replaced. Consider endoscopy to confirm or rule out colitis if there is persistent NCI-CTC grade 2 diarrhoea or NCI-CTC grade 1 - 2 diarrhoea with bleeding. Ipilimumab and nivolumab must be discontinued if NCI-CTC grade 3 or 4 diarrhoea, colitis, peritoneal signs of bowel perforation, ileus or fever occur. High-dose intravenous corticosteroid therapy should be initiated immediately unless bowel perforation is present. Once diarrhoea and other symptoms are controlled, the initiation of corticosteroid taper should be based on clinical judgment (tapering over 6-8 weeks). In clinical trials, rapid tapering (over periods of less than 1 month) resulted in recurrence of diarrhoea or colitis in some patients. Consider alternative immunosuppressive therapy (eg single dose of infliximab 5mg/kg) if symptoms do not respond to steroids in 5-7 days. Neurological Unexplained motor neuropathy, muscle weakness, or sensory neuropathy lasting more than 4 days must be evaluated and other causes excluded. Version 1.3 (July 2019) Page 4 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) For patients with NCI-CTC grade 2, neuropathy likely related to be related to ipilimumab or nivolumab omit the scheduled dose. If the neurologic symptoms resolve to baseline, the patient may resume treatment at the next scheduled dose. Ipilimumab and nivolumab must be permanently discontinued in patients with NCICTC grade 3 or 4, sensory neuropathy. Patients must be treated according to local guidelines for management of sensory neuropathy. Skin A diffuse, erythematous maculopapular rash that can be intensely pruritic was observed in 47% to 68% of patients, starting an average of 3 to 4 weeks after ipilimumab or nivolumab. NCI-CTC grade 1 or 2 skin reactions may remain on therapy with symptomatic treatment such as topical corticosteroids and antihistamines. For mild to moderate rash or pruritus that persists for 1 to 2 weeks and does not improve with topical corticosteroids consider oral corticosteroid therapy (e.g. prednisolone 1 mg/kg once a day). For patients with NCI-CTC grade 3 symptomatic skin reactions, the scheduled dose of ipilimumab and nivolumab should be omitted. If initial symptoms improve to NCICTC grade 1 or resolve then the therapy may be resumed at the next scheduled dose. Ipilimumab and nivolumab must be permanently discontinued in patients with a NCI-CTC grade 4 rash or grade 3 pruritus and consideration given to systemic corticosteroid therapy. Other Immune-Related Adverse Reactions The following additional adverse reactions, suspected to be immune-related, have been reported and include uveitis, eosinophilia, lipase elevation, and glomerulonephritis. In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported. If these occur at NCI-CTC grade 3 or above then consider immediate high-dose corticosteroid therapy and discontinuation of ipilimumab and nivolumab. For ipilimumab and / or nivolumab-related uveitis, iritis, or episcleritis, topical corticosteroid eyedrops should be considered as medically indicated. Regimen 21 day cycle for 4 cycles Drug Ipilimumab Nivolumab Dose 3mg/kg 1mg/kg Days 1 1 Route Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Intravenous infusion in 50ml sodium chloride 0.9% over 30 minutes Version 1.3 (July 2019) Page 5 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) Followed by; 14 day cycle starting 3 weeks after the last dose of the combination of nivolumab and ipilimumab and continued for as long as clinical benefit is observed or until no longer tolerated Drug Dose Days Route Nivolumab 240mg 1 Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes OR 28 day cycle starting 6 weeks after the last dose of the combination of nivolumab and ipilimumab and continued for as long as clinical benefit is observed or until no longer tolerated Drug Dose Days Route Nivolumab 480mg 1 Intravenous infusion in 100ml sodium chloride 0.9% over 60 minutes Please note that due to the different cycle lengths the combination treatment will be set up as one regimen. This can then be discontinued and single agent nivolumab started. Dose Information • Ipilimumab will be dose banded according to the agreed bands • Nivolumab will be dose banded according to the agreed bands Administration Information Extravasation • Ipilimumab – neutral • Nivolumab - neutral Other • The nivolumab must be administered first during the combination phase of treatment. 30 minutes should elapse between both agents. • Ipilimumab should be administered using a low protein binding filter • The final concentration of ipilimumab should be between 1-4mg/ml • Nivolumab should be administered via a 0.2-1.2 micron a low protein binding filter. The polyethylene lined giving sets used for paclitaxel with a 0.22 micron filter are appropriate. Version 1.3 (July 2019) Page 6 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) Additional Therapy • No antiemetics are required • When required for infusion related reactions - chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions - hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions - paracetamol 1000mg oral when required for the relief of infusion related reactions • Gastric protection with a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. There is evidence that proton pump inhibitors may reduce the efficacy of the combination of ipilimumab and nivolumab Additional Information • The use of systemic corticosteroids, before starting treatment with ipilimumab should be avoided ipilimumab because of their potential interference with the pharmacodynamic activity and efficacy of ipilimumab. However, systemic corticosteroids can be used after starting ipilimumab to treat immune-related adverse reactions. The use of systemic corticosteroids after starting treatment does not appear to impair the efficacy of ipilimumab. Coding • Procurement – X70.8 • Delivery – X72.9 References 1. Haanen J, Carbonnel F, Robert C, Kerr K.M , Peters S, Larkin J, Jordan J on behalf of the ESMO Guidelines Committee. Management of toxicities from immunotherapy. ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 2017; 28 (suppl 4): 119-142. 2. National Institute for Health and Clinical Excellence. Nivolumab in combination with ipilimumab for treating advanced melanoma. Technology Appraisal Guidance TA 400 (July 2016). Version 1.3 (July 2019) Page 7 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) REGIMEN SUMMARY Ipilimumab (3mg/kg)-Nivolumab (1mg/kg) Cycle 1, 2, 3 1. Nivolumab 1mg/kg intravenous infusion in 50ml sodium chloride 0.9% over 30 minutes Administration Instructions Ensure the patient has been given a nivolumab patient alert card. Administer before the ipilimumab infusion. Please leave 30 minutes between the administration of both agents 2. Ipilimumab 3mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes 3. Chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions 4. Hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions 5. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Cycle 4 6. Warning – Consider single agent nivolumab Administration Instructions Consider prescribing single agent nivolumab 7. Nivolumab 1mg/kg intravenous infusion in 50ml sodium chloride 0.9% over 30 minutes Administration Instructions Ensure the patient has been given a nivolumab patient alert card. Administer before the ipilimumab infusion. Please leave 30 minutes between the administration of both agents 8. Ipilimumab 3mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes 9. Chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions 10. Hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions 11. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Version 1.3 (July 2019) Page 8 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg) DOCUMENT CONTROL Version Date Amendment Written By Approved By Infusion time for nivolumab 1.3 1mg/kg changed to 30min and July 2019 details of follow on monotherapy updated accordance with current Rebecca Wills Pharmacist SmPC Title change to include doses of 1.2 agents. July 2019 PPI recommendation changed Dose reduction removed from Dr Deborah Wright Pharmacist dose modification section 1.1 Feb 2018 Nivolumab 1mg/kg infusion volume changed to 50ml Dr Deborah Wright Pharmacist 1 Sept 2016 None Dr Deborah Wright Pharmacist Dr Deborah Wright Pharmacist Dr M Wheater Consultant Medical Oncologist Stuart Martin Pharmacist Dr M Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.3 (July 2019) Page 9 of 9 Skin-Ipilimumab(3mg/kg)-Nivolumab(1mg/kg)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Skincancer/Ipilimumab-Nivolumab.pdf

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