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Clinical Research in Southampton
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Lenvatinib
Description
Chemotherapy Protocol THYROID CANCER LENVATINIB Regimen • Thyroid – Lenvatinib Indication • The treatment of differentiated thyroid cancer after radioactive iodine where all the
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Endocrinecancer/Lenvatinib.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 Ada
Url
/Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-example-sub-protocol.pdf
Everolimus Ver 1
Description
Chemotherapy Protocol PANCREATIC NEUROENDOCRINE CARCINOMA EVEROLIMUS This protocol may require funding Regimen PNET - Everolimus Indication The first or second line treatment
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Endocrinecancer/Everolimus-Ver-1.pdf
Neuroendocrine-Sunitinib Ver 1
Description
Chemotherapy Protocol NEUROENDOCRINE SUNITINIB Regimen Neuroendocrine - Sunitinib Indication The 1st, 2nd or 3rd line treatment of pancreatic neuroendocrine carcinomas that are biopsy proven and well differentiated No previous treatment with a VEGF inhibitor WHO Performance status 0, 1 Toxicity Drug Sunitinib Adverse Effect Cardiac failure, QT interval changes, hypertension, hypothyroidism, fatigue, skin/hair colour changes, palmar-plantar erythrodysaesthesia, diarrhoea, taste disturbances, oedema, epistaxis, mucositis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBCs, LFTs and U&Es prior to each cycle for the first three cycles, this may reduce to every other cycle if stable Blood pressure weekly for the first 4 weeks then every 6 - 12 weeks Thyroid function tests at baseline then every 3 months. Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems or in the elderly. Repeat every three to six months as clinically indicated. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Version 1 (Oct 2014) Page 1 of 6 Neuroendocrine-Sunitinib In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. For sunitinib dose modifications should occur in 12.5mg steps and are applied based on individual safety and tolerability. Daily dose should not be decreased below 25mg. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to cycle 1 the following criteria should be met; Criteria Neutrophil Platelets Eligible Level 1x109/L 75x109/L Thereafter; Neutrophils (x109/L) Dose Modifications 1 or greater less than 1 Platelets (x109/L) 100% Delay until recovery to 1x109/L or greater. If recovery occurs within 7 days then continue with the last dose dose. If the recovery takes longer than 7 days then reduce dose by 12.5mg. Dose Modifications 75 or greater Less than 75 100% Delay until recovery to 75x109/L or greater. If the recovery occurs within 7 days then continue with full dose. If recovery takes longer than 7 days then reduce the dose by 12.5mg. Hepatic Impairment Drug Child Pugh Class Starting Dose (pNET) Sunitinib A 37.5mg daily B 37.5mg daily C No information There is no information on dosing in patients with an AST or ALT greater than 2.5xULN (or more than 5xULN with liver metastases) as these patients were excluded from clinical trials. Version 1 (Oct 2014) Page 2 of 6 Neuroendocrine-Sunitinib Renal Impairment Drug Sunitinib Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose modification required 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. In the treatment of pNET the dose of sunitinib should not exceed 50mg once a day. Cardiovascular Hypertension should be treated initially as per the NICE guidelines(1). For persistently high blood pressure of more than 140/90mmHg despite standard hypertensive therapy, reduce the sunitinib dose in 12.5mg steps and continue to monitor. If hypertension persists discontinue the sunitinib. Gastro-intestinal Diarrhoea is a frequent complication of sunitinib therapy. Patients should be advised to limit consumption of high fibre or spicy foods, caffeine, alcohol and dairy products. Laxatives should be avoided. For a NCI-CTC grade 1 or 2 diarrhoea continue treatment at the same dose and attempt dietary and dehydration management. Anti-diarrhoeal medicines, such as loperamide, may be necessary. For a NCI-CTC grade 3 adverse reaction reduce the dose by 12.5mg. For a NCI-CTC grade 4 adverse reaction stop the sunitinib until it resolves to at least NCI-CTC grade 2. Treatment may be re-started with a 12.5mg dose reduction in the first instance. Endocrine Hypothyroidism can occur and should be managed according to standard medical practice. There is no need to discontinue or dose reduce the sunitinib. Skin Palmar-plantar erythrodysaesthesia can occur. Patients should be advised to apply moisturiser to their hands and feet regularly throughout treatment, and to minimise activities that put pressure on feet or hands. Refer to a chiropodist if appropriate. A NCI-CTC grade 1 reaction should be treated symptomatically. There is no need to interrupt therapy with sunitinib or reduce the dose. For a NCI-CTC grade 2 effect delay treatment with sunitinib until it resolves to at least NCI-CTC grade 1. The sunitinib may be re-started with a 12.5mg dose reduction. The development of palmar-plantar erythrodysaesthesia at NCI-CTC grade 3 should result in treatment being delayed until it resolves to NCI-CTC grade 1. The sunitinib can be re-started with a 12.5mg dose reduction. Version 1 (Oct 2014) Page 3 of 6 Neuroendocrine-Sunitinib Regimen 28 day cycle until disease progression or unacceptable toxicity occurs (6 cycles will be set in ARIA) Drug Sunitinib Dose 37.5mg Days 1-28 incl. Administration Oral Dose Information Sunitinib is available as 12.5mg, 25mg, 37.5mg and 50mg capsules Additional Therapy Mouthcare for the prophylaxis or treatment of mucositis in accordance with CSCCN guidelines Loperamide 4mg oral after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). Additional Information The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to sunitinib. It must be made clear to all staff, including those in the community, that sunitinib should only be prescribed under the supervision of an oncologist. Coding Procurement – X71.5 Delivery – X73.1 References 1. Raymond E, Dahan L, Raoul JL et al. Sunitinib for the treatment of pancreatic neuroendocrine tumours. N Engl J Med 2011; 364 (6): 501-513. Version 1 (Oct 2014) Page 4 of 6 Neuroendocrine-Sunitinib REGIMEN SUMMARY Sunitinib Day One Take Home Medicines 1. Sunitinib 37.5mg once a day for 28 days oral Version 1 (Oct 2014) Page 5 of 6 Neuroendocrine-Sunitinib Version Date 1 Oct 2014 DOCUMENT CONTROL Amendment Written By Approved By None Dr Deborah Wright Pharmacist Dr Luke Nolan 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 Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1 (Oct 2014) Page 6 of 6 Neuroendocrine-Sunitinib
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Endocrinecancer/Neuroendocrine-Sunitinib-Ver-1.pdf
Recovering after intensive care - patient information
Description
This factsheet is a guide to your recovery after a stay on one of the intensive care units (ICUs).
Url
/Media/UHS-website-2019/Patientinformation/Visitinghospital/Recovering-after-intensive-care-2684-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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UHS Inclusion and Belonging Strategy
Description
Our strategy sets out clear actions we will take to make UHS a place where every person feels they belong and feels safe to carry out their work free from violence, bullying, harassment and abuse, and it sets the direction for us to ensure our workforce is representative of the communities we serve.
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DH IVIg approved indications full guidance July 2011
Description
DH INFORMATION READER BOX Policy HR / Workforce Management Planning / Clinical Performance Document Purpose Gateway Reference Title Author Publication Date Target Audience Estates Commissioning IM & T Finance Social Care / Partnership Best Practice Guidance 16290 ROCR Ref: ROCR approval applied for Clinical guidelines for immunoglobulin use: update to second edition Department of Health 01 Aug 2011 PCT CEs, NHS Trust CEs, SHA CEs, Foundation Trust CEs , Medical Directors, Directors of Finance, GPs, Communications Leads, Emergency Care Leads, Chief Pharmacists Circulation List #VALUE! Description The Clinical Guidelines for Immunoglobulin Use were implemented in 2008. The Guidelines were developed utilising an evidence review and extensive consultations. This Update fulfills the commitment to undertake a biennial review from 2009. The Second Edition Guidelines remain in place and this Update should be used in conjunction with them. Cross Ref Superseded Docs Action Required Timing Contact Details Clinical Guidelines for Immunoglobulin Use (Second Edition) N/A N/A N/A Tina Lee Blood Safety & Supply Team Room 30 Wellington House 133-155 Waterloo Road London SE1 8UG 020 7972 4750 0 For Recipient's Use Clinical guidelines for IMMUNOGLOBULIN Use seCOND eDITION UPDATe second edition Update Working Group Dr Jennie Wimperis Consultant Haematologist, Norfolk and Norwich NHS Trust Dr Michael Lunn Consultant Neurologist, National Hospital for Neurology and Neurosurgery Dr Alison Jones Consultant Immunologist, Great Ormond Street Hospital Dr Richard Herriot Consultant Immunologist, NHS Grampian Dr Philip Wood Consultant Immunologist, Leeds Teaching Hospitals NHS Trust Dr Denise O'shaughnessy Blood Policy, Department of Health Mr Malcolm Qualie Pharmaceutical Advisor Department of Health CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Contents ...................................................................................... 2 eXeCUTIVe sUMMARY ....................................................................... 6 Selection criteria for appropriate use of immunoglobulin .................................. 6 Efficacy outcomes to assess treatment success ........................................... 6 Modification of existing indications and inclusion of new indications .................... 7 Commissioning of immunoglobulin ........................................................... 7 INTRODUCTION ................................................................................ 8 Insights from the National Immunoglobulin Database ..................................... 8 CONTeNTs Changes to the colour-coded prioritisation employed in the Demand Management Programme ...................................................................... 8 Automatic assignment of Red and Blue prioritisation ................................. 9 Grey indications ............................................................................. 9 Reclassification of diseases .............................................................. 10 11 12 12 13 14 14 14 15 16 18 26 27 27 Introduction of specific selection and outcome criteria in the Demand .................................................................... Definitions of duration of immunoglobulin treatment ..................................... Recommended dosing of immunoglobulin ................................................ Ideal body weight-adjusted dosing of immunoglobulin .................................. Western Australia pilot study ............................................................. Hospital Corporation of America ........................................................ The Ohio State University Medical Centre, Columbus, Ohio ........................ Infusion rates for intravenous immunoglobulin ............................................ Subcutaneous administration ............................................................... sUMMARY TABLes .......................................................................... sUMMARY Of GReY INDICATIONs ...................................................... Removed from Grey ........................................................................... INDICATIONs fOR WHICH IVIG Is NOT ReCOMMeNDeD .......................... Management Programme CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Replacement pages IMMUNOLOGY HAeMATOLOGY ............................................................................... .............................................................................. 29 35 Primary immunodeficiencies (replacing relevant content on pages 28-29) Coagulation factor inhibitors (replacing relevant content on pages 32-33) Haemolytic disease of the foetus and newborn (replacing relevant content on pages 32-33) Immune thrombocytopenic purpura (replacing relevant content on pages 34-35) NeUROLOGY ................................................................................. 40 Introduction (replacing relevant content on page 41) Chronic inflammatory demyelinating polyradiculoneuropathy (replacing relevant content on page 41) Inflammatory myopathies (replacing relevant content on page 42) TRANsPLANTATION ........................................................................ 43 Antibody Incompatible Transplant (AIT) (replacing relevant content on page 65) Antibody-Mediated Rejection (AMR) (replacing relevant content on page 65) Viral pneumonitis (replacing relevant content on page 65) CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Summary table of conditions for which intravenous immunoglobulin use is appropriate Condition Primary and secondary antibody deficiency states Primary immunodeficiencies Thymoma with immunodeficiency HSCT in primary immunodeficiencies Specific antibody deficiency Secondary antibody deficiency (any cause) Haematology Acquired red cell aplasia Alloimmune thrombocytopenia (foeto-maternal/neonatal) Autoimmune haemolytic anaemia Coagulation factor inhibitors (alloantibodies and autoantibodies) Haemolytic disease of the newborn Haemophagocytic syndrome Immune thrombocytopenic purpura (acute and persistent, excluding chronic*) Post-transfusion purpura Neurology Chronic inflammatory demyelinating polyradiculoneuropathy** Guillain-Barr? syndrome Inflammatory myopathies Myasthenia gravis (including Lambert-Eaton myasthenic syndrome) Multifocal motor neuropathy Paraprotein-associated demyelinating neuropathy (IgM, IgG or IgA) Rasmussen syndrome Stiff person syndrome short duration Long duration continued * Chronic immune thrombocytopenic purpura is a grey indication ** The disease should be life-threatening to allow database entry as red CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Summary table of conditions for which intravenous immunoglobulin use is appropriate continued Condition Others Autoimmune congenital heart block Autoimmune uveitis Immunobullous diseases Kawasaki disease Necrotising (PVL-associated) staphylococcal sepsis Severe or recurrent Clostridium difficile colitis Staphylococcal or streptococcal toxic shock syndrome Toxic epidermal necrolysis, Stevens Johnson syndrome Transplantation (solid organ) short duration Long duration CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use eXeCUTIVe sUMMARY The Clinical Guidelines for Immunoglobulin Use were implemented in 2008. The Guidelines were developed utilising an evidence review and extensive consultations with clinicians and other stakeholders. This update fulfils the commitment made in the Second Edition to undertake a biennial review from 2009. The Second Edition Guidelines remain in place and this update should be used in conjunction with the Second Edition. This update did not review all of the Second Edition Guidelines content, but limited its focus to three key areas: defining selection criteria for appropriate use; efficacy outcomes to assess treatment success; and reassignment of existing indications /inclusion of new indications. should be fulfilled if immunoglobulin is to be used, including particular disease characteristics, disease severity and any requirement for other treatments to have been demonstrably unsuccessful before immunoglobulin is considered. This reflects the approach taken by the National Blood Authority in Australia in defining appropriate prescribing of immunoglobulin. efficacy outcomes to assess treatment success The Guidelines did not include efficacy tracking of immunoglobulin treatment, although Immunoglobulin Assessment Panels (IAP) were encouraged to request parameters by which efficacy could be assessed. This update provides efficacy outcomes to be measured in all indications (except primary immunodeficiencies), and it is expected that all Grey indications will have efficacy parameters defined and monitored on a case by case basis. Efficacy outcomes are expected to play an important role in the IAP decision-making process for patients in whom continuation of immunoglobulin treatment is requested beyond the short- and long-term durations defined in this update. This change reflects the wider change of focus in the NHS to patient outcomes, as presented in The NHS Outcomes Framework. selection criteria for appropriate use of immunoglobulin The Guidelines did not provide explicit selection criteria for the appropriate use of immunoglobulin. Review of data in the National Immunoglobulin Database showed a considerable volume of immunoglobulin was used in patients for whom no specific diagnosis was provided. Clearly, this was less than optimal and caused concern among commissioners. This update provides criteria that CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Modification of existing indications and inclusion of new indications Changes to existing indications required proponents to submit new evidence to the Update Working Group for review. However, allocation of diseases to Red, Blue or Grey did not solely depend on the level of evidence presented, but included expert clinical advice and the availability of effective alternative therapies or treatment approaches. The British Transplantation Society made a strong case to change certain defined transplant cases to Blue, despite limited high-quality evidence for some of the clinical scenarios and the Update Working Group accepted the Society's view. For complex regional pain syndrome, although randomised evidence from a small study showed benefit, this was regarded by the Update Working Group as an emerging indication for refractory cases; a number of important questions concerning optimal treatment doses and duration of treatment remain unanswered. Therefore, this disease has been added to the Grey list. It remains the responsibility of the local IAP to decide with the PCT (or specialised commissioning group) if treatment with immunoglobulin is appropriate on a case by case basis. Other Grey indications have been updated and others, for which there was little or no prescribing recorded in the database, deleted. Grey indications are now listed as immune-mediated disorders with limited evidence of immunoglobulin efficacy, or presumed immune-mediated disorders with little or no evidence of efficacy. Review of Red and Blue indications identified a number of disease entities with the same underlying pathophysiology that were listed separately; these are now grouped together under single disease headings. Commissioning of immunoglobulin Ensuring immunoglobulin prescribing is consistent with the evidence-base and restricted to those patients for whom there are no alternative treatments and for those most likely to benefit is the central aim of these guidelines. But from a commissioner's viewpoint, cost-effectiveness and affordability play an important role in their discussions with IAPs regarding prescribing. The commissioning aspects of this guideline update are included in a separate document and this should be reviewed to understand the requirements of commissioners around immunoglobulin prescribing, in particular regarding National Immunoglobulin Database entry and treatment duration. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use INTRODUCTION This update of the Department of Health's (DH) immunoglobulin guidelines fulfils the commitment made in the Second Edition to undertake a biennial review from 2009. This review was informed by changes in the clinical evidence base for immunoglobulin, the findings of the National Immunoglobulin Database (Reference number ROCR/ OR/0221), and a change of focus in the NHS to patient outcomes, as presented in The NHS Outcomes Framework. The DH has consulted widely in this review and the changes have been discussed at length with clinicians and commissioners involved in the demand management of immunoglobulin. National Immunoglobulin Database was launched on 2nd June 2008. These documents and the National Immunoglobulin Database are accessible through the immunoglobulin website www.ivig.org.uk. The first data review from the National Immunoglobulin Database, published in January 2010, contained data on immunoglobulin prescribing in 5119 patients, and offered a unique, detailed view of prescribing practice of immunoglobulin in England as well as providing, for the first time, a baseline of immunoglobulin use. This was a major step forward in establishing the Demand Management Programme and, in particular, gave insights into the appropriate use of this treatment across all indications. Generally, the data demonstrated appropriate and controlled prescribing of immunoglobulin for a wide range of conditions, most of which was evidence based. The review also identified a number of issues regarding the Demand Management Programme, which are addressed in this guideline update. Insights from the National Immunoglobulin Database The DH's Demand Management Programme for Immunoglobulin was a key output from the 2006 review that assessed the opportunities available to secure the supply of immunoglobulin. The review recommended two complementary work streams, one based on securing supply and the other giving structure to the process of fulfilling demand (the Demand Management Programme). The Demand Management Programme was fully launched in late May 2008, when DH published the Second Edition of `Clinical Guidelines for Immunoglobulin Use' and the `Demand Management Plan for Immunoglobulin Use' (Gateway reference 10012 and 10013). The Changes to the colour-coded prioritisation employed in the Demand Management Programme Automatic assignment of Red and Blue prioritisation The Demand Management Programme introduced colour coding to reflect the prioritisation of immunoglobulin treatment CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use in times of shortage, based on the availability of alternative treatments and strength of clinical evidence. The database review showed many cases for which diseases were mis-assigned to an incorrect prioritisation. In particular, there were many cases of misassignment of diseases to Red and Blue. `Red' indicates conditions for which treatment is considered the highest priority because of a risk to life without treatment. The intention remains that Trusts will protect supply for these high-priority diseases in times of immunoglobulin shortage, particularly for patients with primary immunodeficiencies. To ensure accurate prioritisation assignment, the database will now automatically assign the colour coding upon patient entry on the basis of patient characteristics. The Immunoglobulin Assessment Panels (IAP) at Trusts should continue to manage local demand for immunoglobulin; in times of shortage, local panels should continue to identify Red indications as those of most clinical need. The database will automatically assign diseases to `Blue', but prescribing of immunoglobulin in Blue indications will continue to require prior approval of the IAP . because the disease is rare. Approval from both the local IAP and the Primary Care Trust (PCT) (or specialised commissioning group) is required for immunoglobulin treatment. As previously specified in the Demand Management Plan for Immunoglobulin Use, treatment should be considered on a caseby-case basis, and prioritised against other competing demands for immunoglobulin, especially in times of shortage. It is not possible or desirable to list every disease that could potentially be prescribed immunoglobulin. In cases of `unlisted' diseases, it is important to restate that those not listed in the guidelines are to be considered as Grey. The database review showed a considerable volume of immunoglobulin prescribed without a specific diagnosis being provided. Even if the disease is unlisted, the diagnosis and agreed efficacy criteria are to be recorded in the database. Grey indications are now listed as immune-mediated disorders with limited evidence of immunoglobulin efficacy, or presumed immune-mediated disorders with little or no evidence of efficacy. It is accepted that the lack of an evidence base may reflect the rarity of these diseases; it remains the responsibility of the local IAP to decide with the PCT (or specialised commissioning group) if treatment with immunoglobulin is appropriate on a caseby case basis. Grey indications `Grey' indications are those diseases for which the evidence is weak, in many cases 10 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Reclassification of diseases 1. Grey to Blue The database review identified two of the top 10 immunoglobulin-using indications as Grey (secondary antibody deficiencies and antibody-mediated rejection following solid organ transplantation). In many Trusts, commissioners have permitted pre-approval of immunoglobulin use for these indications despite the limited evidence base. Therefore, these indications were reviewed in detail and the evidence base was reassessed. Secondary antibody deficiencies were identi- Acquired von Willebrand disease has now been included with acquired haemophilia, in the general disease grouping of `Coagulation factor inhibitors', which is listed under appropriate use of immunoglobulin. Immunoglobulin use carries selection criteria, including that these rare and severe bleeding disorders are managed in a comprehensive care centre for haemophilia. Polymyositis and Inclusion body myositis have now been grouped with dermatomyositis under the general disease grouping of inflammatory myopathies, with strict selection criteria. Post-transfusion hyperhaemolysis has now been fied by a number of stakeholders as a key area for revision. In the previous edition, they were listed under immunosuppressive pharmacotherapy, and separately under some of the haematological malignancies such as CLL, without listing other mature B-cell malignancies such as non-Hodgkin's lymphoma. These have been revised into a single indication. The outcome of this review is that use of immunoglobulin for these indications is appropriate and is now listed as Blue (see replacement page 30). Antibody-mediated rejection following solid grouped under the more general heading of haemolytic anaemia. SLE with secondary immunocytopenias should be considered under the relevant immune cytopenia. 2. Blue to Red Specific antibody deficiency, as a recognised primary antibody deficiency disorder, has been reclassified as a Red indication (for those cases where immunoglobulin replacement therapy is required). Haemolytic disease of the newborn has been organ transplantation and antibody-incompatible transplantation were reviewed, and a single grouping of `Transplantation (solid organ)' has been introduced and listed as Blue. updated to reflect recommendations in NICE clinical guideline 98 on neonatal jaundice [1]. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 11 Introduction of specific selection and outcome criteria in the Demand Management Programme Selection criteria The database review also raised an important issue over patient diagnosis ? a considerable volume of immunoglobulin was used in patients in which there was no specific diagnosis listed (13% of total recorded immunoglobulin use). Clearly, this was less than optimal and caused concern among commissioners. In addition, this showed that improvements were required before the database was sufficiently robust to be able to link to payments by use. Further feedback from commissioners indicated widespread approval of the system used in Australia, with each indication for immunoglobulin carrying specific selection criteria for use, in particular, the need to use immunoglobulin as second- or third-line treatment in diseases for which there are a number of alternative treatment options. This approach, with selection criteria for each approved indication for immunoglobulin, has now been adopted in this guideline update. The need to employ selection criteria before prescribing will largely remove the need for panel decisions on prescribing, reducing the burden on IAPs and increasing focus on assessing patient outcome. Efficacy outcomes The database was not successful in the capture of data regarding the efficacy of immunoglobulin. Panels were encouraged to request up to three parameters by which efficacy could be determined in each patient [e.g., platelet count in patients with immune thrombocytopenic purpura (ITP)]. The purpose of this exercise was both to obtain preliminary data about efficacy in various conditions (fully accepting that lack of diagnostic criteria and other issues would make this a very crude analysis) and to provide feedback to individual Panels about the quality of their decision making. For example, if Panels repeatedly approved indications prioritised as Grey by the Demand Management Programme and the treatment was largely ineffective, review of these findings would improve IAP decision making. The decision has been taken to introduce efficacy outcomes for most indications. Monitoring of efficacy outcomes by commissioners may result in withholding payments to Trusts if efficacy outcomes have not been recorded in the database. Efficacy outcomes are expected to play an important role in the decision-making process of IAPs in cases in which continuation of immunoglobulin treatment is requested beyond the short- and long-term durations defined in the next section. 1 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Definitions of duration of immunoglobulin treatment The definitions of short-term and longterm treatment durations are refined in this update, with each approved indication for immunoglobulin now approved on the basis of short-term (3 months) and long-term (3 months) treatment needs. The definitions of duration of treatment are included in the table below. IAPs and commissioners together will make decisions on treatment extensions. short-term treatment Three prescribed doses of up to 2 g/kg, given at appropriate clinical intervals 3 months The treatment episode ends at 3 months. The National Immunoglobulin Database will record treatment re-initiation as a new treatment episode based on a new panel decision. It is expected that the IAP decision will be influenced by the outcome measures recorded on the database. 3 months Treatment reviews should be conducted annually. The National Immunoglobulin Database will record treatment re-initiation as a new treatment episode based on a new panel decision. It is expected that the IAP decision will be influenced by the outcome measures recorded on the database.* Long-term treatment *The primary immunodeficiencies are exempt from funding termination at 1 year. Recommended dosing of immunoglobulin The Second Edition of the Clinical Guidelines did not provide specific dosing recommendations; it is widely accepted that the standard immunomodulatory dose of 2 g/kg is usually divided into five daily infusions of 0.4 g/kg, although some physicians prefer to use two daily doses of 1 g/kg each. The database infusion records were incomplete and, therefore, it was not possible to fully interpret the data and decipher the dosing that had been used. This update to the guidelines now provides specific dosing recommendations for each of the conditions for which prescribing is regarded as appropriate. Immunoglobulin users are expected to record the dosing employed in the national database. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 An ongoing issue for diseases that require long-term immunoglobulin treatment is that once responsiveness to intravenous immunoglobulin (IVIg) is proven for a patient using standard immunomodulatory dosing, the `maintenance' dosing required to maintain the therapeutic response is not well characterised. In this update, the dosing recommendations for some neurological indications include `time to relapse' as the interval between doses. This approach is supported by recent evidence from The Oxford Programme for Immunomodulatory Immunoglobulin Therapy, which was set up to review multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) treatment with immunoglobulin. In view of the uncertainty of both remission and disease progression in CIDP and MMN, The Oxford Programme reviewed the dose and infusion frequency of patients on a regular basis and showed that increasing the infusion interval proved successful in some patients and resulted in treatment discontinuation [2]. The study also indicated that the precise dose and infusion interval to keep each patient asymptomatic was not predictable, but the authors suggested a rough guide: patients in whom responses last 20% more than IBW, prescribers should consider using adjusted-bodyweight dosing of immunoglobulin. Infusion rates for intravenous immunoglobulin Initial intravenous infusion rates are low, and if well tolerated, the rate of administration may be increased, as specified in the products' Summary of Product Characteristics (SPC). For certain products, the SPC indicates that if the higher rate is tolerated, the rate may be further increased in primary immunodeficiency (PID) patients to the maximum infusion rate. Higher infusion rates may lead to improved convenience for patients and may reduce nursing time and the need for hospital resources. Infusion rates for each of the licensed immunoglobulins are provided in the table below. Immunoglobulin should be administered according to the manufacturers' recommendations. The table below gives the infusion rates, and the infusion time at maximum infusion rate of 1 g/kg dose in a 70 kg person. Infusion rates Infusion time of 0 g in minutes at max. rate 100 250 500 640 125 200 125 241 83 Product Baxter Kiovig BPL Gammaplex BPL Vigam Biotest Intratect CsL Privigen Grifols flebogamma Grifols flebogamma 10 Octapharma Octagam Octapharma Octagam 10 Initial 0.5 mL/kg/h for 30 mins 0.01?0.02 mL/kg/min for 15 mins 0.01?0.02 mL/kg/min for 30 mins 1.4 mL/kg/h for 30 mins 0.3 mL/kg/h 0.01?0.02 mL/kg/min for 30 mins 0.01 mL/kg/min for 30 mins 1 mL/kg/h for 30 mins 0.01?0.02 ml/kg/min for 30 mins Maximum 6 mL/kg/h (8 ml/kg/h in PID) 0.04?0.08 mL/kg/min 0.04 mL/kg/min (max. 3mL/min) 1.9 mL/kg/h 4.8 mL/kg/h (7.2 mL/kg/h in PID) 0.1 mL/kg/min 0.08 mL/kg/min 5 mL/kg/h 0.12 ml/kg/min 1 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use subcutaneous administration Subcutaneous immunoglobulin (SCIg) as replacement therapy for primary immune deficiency disease and as immunomodulatory therapy for some autoimmune diseases, including peripheral neuropathies, can be a safe, effective, and convenient alternative to intravenous therapy. Subcutaneous administration can offer advantages that may be important for many patients [3]. Although SCIg is typically administered weekly by infusion pump, administration by a rapid push technique may provide a greater degree of convenience, and recent evidence suggests it is a safe and effective method. Seventy-four patients with primary immune deficiency disease received an average SCIg dose of 32 g/month split into an average of three times per week. Volume per site ranged from 3 to 20 mL, typically administered over 5?20 min. Mean serum IgG levels did not differ significantly compared with those receiving infusion and only two patients discontinued therapy because of an adverse event [4]. Recent evidence suggests that individualising the dosage based on measured serum IgG levels and the clinical response is preferable to using mean pharmacokinetic parameters [5]. Findings from the Oxford Self Infusion at Home Programme for CIDP and MMN also suggest that the dose of immunoglobulin and the serum IgG trough level are individual to each patient [2]. Recommendation Prescribers should consider the comparative advantages of intravenous and subcutaneous administration for individual patients requiring immunoglobulin treatment where this is clinically appropriate. Table. Subcutaneous immunoglobulin products licensed in the UK CSL Vivaglobin Baxter Subcuvia Octapharma Gammanorm BPL Subgam CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 RefeReNCes 1. NICE clinical guideline 98. Neonatal Jaundice. Nice, 2010. 2. Lucas M, Hugh-Jones K, Welby A, et al. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol 2010;30 Suppl 1:S84?9. 3. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol 2004;112:1?7. 4. Shapiro R. Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J Clin Immunol 2010;30:301?7. 5. Berger M, Rojavin M, Kiessling P, Zenker O. Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficiencies. Clin Immunol 2011;139:133?41. 1 sUMMARY TABLes PRIMARY AND seCONDARY ANTIBODY DefICIeNCY sTATes selection criteria A specific PID diagnosis must be established by a clinical immunologist Outcome measures are not required Condition s L Outcomes for review Dosing Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Primary immunodeficiencies (associated with significant antibody defects) Profound B cell depletion and/or significant antibody deficiency Outcome measures are not required Thymoma with immunodeficiency HSCT in primary immunodeficiencies PID patients undergoing HSCT Outcome measures are not required CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Specific antibody deficiency Approval by a clinical immunologist, AND Severe, persistent, opportunistic or recurrent bacterial infections despite continuous oral antibiotic therapy for 3 months, AND Documented failure of serum antibody response to unconjugated pneumococcal or other polysaccharide vaccine challenge Underlying cause of hypogammaglobulinaemia cannot be reversed or reversal is contraindicated; OR Hypogammaglobulinaemia associated with NHL, CLL, MM or other relevant B-cell malignancy confirmed by haematologist; AND ? Recurrent or severe bacterial infection despite continuous oral antibiotic therapy for 3 months ? IgG 1 dose required if thrombocytopenia persists Clinical suspicion in antenatal or neonatal setting based on clinical and laboratory features: Thrombocytopenia or spontaneous haemorrhage in the foetus; OR Thrombocytopenia with or without haemorrhage in the neonate; OR Unexplained foetal death in a previous pregnancy and the presence of maternal platelet-specific allo-antibodies that are known or suspected to cause this condition (most commonly HPA-1a or HPA-5b) Symptomatic or severe anaemia (Hb 15, acute rising Any significant clearance of C. diff. creatinine and/or signs/symptoms Duration of hospital in-patient stay of colitis) not responding to oral vancomycin 125 mg qds, highdosage oral vancomycin +/- iv metronidazole 500 mg tds is recommended; the addition of oral rifampicin (300 mg bd) or IVIg may be considered. If multiple recurrences, especially if evidence of malnutrition, wasting etc., consider IVIg Severe or recurrent Clostridium difficile colitis 0.4 g/kg, one dose, and consider repeating continued Other selection criteria Diagnosis of streptococcal or staphylococcal TSS, preferably with isolation of organism; AND Failure to achieve rapid improvement with antibiotic therapy and other supportive measures; AND Life-threatening Diagnosis by a dermatologist; AND Involved body surface area > 10%; AND When other treatments are contraindicated; OR The condition is life-threatening Resolution of the disease 2 g/kg, preferably as a single dose, or divided over 3 consecutive days Improvement of FBC, ALK, CPK Reduction in hospital inpatient stay Survival (yes/no) 2 g/kg as a single dose continued Outcomes for review Dosing Condition s L Staphylococcal or streptococcal toxic shock syndrome Toxic epidermal necrolysis, Stevens Johnson syndrome Transplantation (solid organ) AIT Up to 2 g/kg to be repeated as per DSA, in renal desensitisation at 0.1 g/kg for 8?12 doses AMR Up to 2 g/kg to be repeated for 2?3 doses Viral pneumonitis 0.5 g/kg for 5 days CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Antibody Incompatible Transplant AIT and AMR* (AIT) Renal Patients in whom renal, heart or Type of renal transplant lung transplant is prevented HLA class DSA because of antibodies Rejection episodes Patient survival Antibody Mediated Rejection Graft survival (AMR) Renal function = eGFR (MDRD) Patients experiencing steroid Cardiothoracic resistant rejection or where other DSA therapies are contraindicated after Patient survival renal, heart and/or lung transplant Length of ITU and hospital stay Graft function (heart = ejection Viral pneumonitis fraction; lung = spirometry) Patients experiencing viral pneumonitis following heart and/or Viral pneumonitis* lung transplant (viruses to include Cardiothoracic HSV, VZV, CMV, RSV, but excluding Virus type influenza virus) Reversal of radiological infiltrates Length of hospital stay Survival *These parameters will be reviewed after one year, at which time specific outcome criteria will be formulated. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use sUMMARY Of GReY INDICATIONs Grey indications are those diseases for which the evidence is weak, in many cases because the disease is rare. Approval from both the local IAP and the PCT is required for immunoglobulin treatment. In cases of `unlisted' diseases, those not listed in the guidelines are to be considered as Grey. Even if the disease is unlisted, the diagnosis and locally agreed efficacy criteria are to be recorded in the database. Immune-mediated disorders with limited evidence of immunoglobulin efficacy Acute disseminated encephalomyelitis (if high-dose steroids have failed) Autoimmune encephalitis (including NMDA and VGKC antibodies, among others) Catastrophic antiphospholipid syndrome Cerebral infarction with antiphospholipid antibodies Chronic ITP Complex regional pain syndrome CNS vasculitis Intractable childhood epilepsy Neuromyotonia Opsoclonus Myoclonus Post-exposure prophylaxis for viral or pathogenic infection if intramuscular injection is contraindicated, or treatment when hyperimmune immunoglobulins are unavailable Pyoderma gangrenosum Systemic juvenile idiopathic arthritis Systemic vasculitides and ANCA disorders Urticaria (severe, intractable) Presumed immune-mediated disorders with little or no evidence of efficacy Acquired red cell aplasia NOT due to parvovirus B19 Acute idiopathic dysautonomia Aplastic anaemia/pancytopenia Atopic dermatitis/eczema Autoimmune neutropenia Chronic facial pain Diabetic proximal neuropathy Haemolytic uraemic syndrome PANDAS Paraneoplastic disorders that are known not to be B- or T-cell mediated POEMS SLE without secondary immunocytopenias (including juvenile) CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Removed from Grey: ? Secondary antibody deficiencies INDICATIONs fOR WHICH IVIG Is NOT ReCOMMeNDeD (now Blue) ? Acquired vWd (now Blue) ? Post-transfusion hyperhaemolysis (now with haemolytic anaemia) ? Graft versus host disease (delete) ? SLE with secondary immunocytopenias (included in the relevant cytopenias) ? Infection following BMT or HSCT (included in Blue) ? Polymyositis (now Blue) ? Transplantation indications (now Blue) ? Immunodeficiency secondary to paediatric HIV infection ? Autologous BMT ? Adrenoleukodystrophy ? Alzheimer's disease ? Amyotrophic lateral sclerosis ? Chronic fatigue syndrome ? Critical illness neuropathy ? Multiple sclerosis ? Rheumatoid arthritis ? Neonatal sepsis (prevention or treatment) ? Sepsis in the intensive care unit not related to specific toxins or C. difficile ? Asthma ? Graves' ophthalmopathy ? IVF failure ? Recurrent spontaneous pregnancy loss CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Next section contains the replacement pages of second edition CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Update for pages 28?30 IMMUNOLOGY Primary immunodeficiency disorders (associated with significant antibody defects) Antibody deficiencies may arise as primary disorders with a known or suspected genetic basis or secondary to a variety of other diseases, drugs and environmental or iatrogenic factors. They may occur in isolation or in association with defects in other effector components of the immune system (combined defects). Significant primary antibody deficiencies collectively account for the majority of primary immunodeficiency syndromes encountered in clinical practice [1,2]. The hallmark clinical presentation is recurrent or persistent bacterial infection, but these disorders are also associated with a heterogeneous variety of other infectious and non-infectious complications and with a high incidence of chronic, structural tissue damage, particularly in the respiratory tract. Clinical recognition of primary antibody deficiency is frequently delayed with consequent acute and chronic ill health, diminished Common Common variable immunodeficiency group (CVID) X-linked agammaglobulinaemia quality of life, and decreased life expectancy. Primary antibody deficiency can present at any age. Taken together, the primary antibody deficiency disorders account for at least half of all primary immunodeficiency syndromes. For some conditions, internationally-agreed diagnostic criteria have been established [3], but in other disorders formal case-definition criteria are lacking. The evidence base for current practice in the recognition, diagnosis and management of antibody deficiency has recently been reviewed [4]. Disorders which generally require immunoglobulin replacement as a central component of their management are presented below. Diagnosis, particularly of primary deficiencies, is frequently delayed or overlooked [1,5]. Many patients present with established structural tissue damage, especially in the lungs, which is essentially irreversible even with optimal treatment. Diagnostic aims are to a) identify, or exclude, significant antibody deficiency, b) differentiate primary from secondary disease and c) delineate, where possible, a precise diagnosis. Less common Germinal centre class switch recombination defects (`Hyper-IgM syndromes') Other primary antibody deficiency (XLA) (including unclassifiable disorders) Combined immunodeficiencies (including severe combined immunodeficiency (SCID) and unclassifiable disorders) 0 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use The goals of management are to prevent complications or retard their progression, optimise quality of life, working capacity and life expectancy and, in children, ensure optimal growth and development [6]. Replacement therapy with polyclonal human normal immunoglobulin is the cornerstone of management for significant primary antibody deficiency disorders. No viable alternatives exist to this essential, basic component of treatment, particularly in the context of severe, persistent or recurrent bacterial infections. For most patients, replacement therapy is a lifelong requirement. Existing formulations replace deficient IgG only and are given by either intravenous or subcutaneous infusion in a hospital setting or, increasingly, within domestically-based programmes. Subcutaneous and intravenous preparations are therapeutically equivalent [7]. All preparations carry risks of adverse, infusion-related reactions and both real (hepatitis C) and theoretical (vCJD) risks of transmissible disease. Replacement therapy increases life expectancy and reduces the frequency and severity of infections, antibiotic usage and hospital admissions [4]; however, patients remain susceptible to sporadic breakthrough infections [8]. Optimal dosing and target levels for IgG are not known but higher doses are more effective than low-dose regimens in reducing infection rates and risk of chronic tissue damage. However, even apparently adequate treatment may fail to completely retard progression of established disease complications such as bronchiectasis [9]. Replacement therapy is frequently targeted at achieving a sustained or pre-infusion trough serum IgG level within the normal range (6?16 g/L). There is evidence that improved outcomes, particularly in respect of respiratory infection, are associated with higher serum IgG levels up to at least 10 g/L [10]. Dosage should generally be initiated at 0.4?0.6 g/kg/month, but individual patients may require higher doses in the long term. The goal of therapy in individual cases should be to improve clinical outcome rather than achieve a minimum target level of serum IgG [11]. Dose requirements are commonly increased in the context of secondary structural tissue damage (especially in the respiratory tract) or co-existent chronic inflammatory conditions. Risk assessments for ongoing therapy with immunoglobulin should be carried out regularly (including the need to continue with active treatment). Recommendation Replacement immunoglobulin therapy in patients with significant, symptomatic primary defects of antibody production or function should be tailored to individual patient outcomes with the minimum aim of maintaining serum IgG levels within the age-related normal range (grade B recommendation, level IIb evidence). CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 Other specific Disorders Thymoma with immunodeficiency (Good's Syndrome) Good's syndrome is a complex CVID-like condition where thymoma is found in association with profound B cell lymphopenia and quantitative or functional antibody deficiency. Infection frequencies correlate better with numerical B-cell depletion than with hypogammaglobulinemia. Thymectomy rarely results in normalisation of immunoglobulin levels and the syndrome may therefore constitute, and be classified as, a primary rather than secondary defect and, in respect of any antibody deficiency, be treated as for other primary antibody defects [2,12]. diagnosis is established. Pre-existing infection in the high-risk situation of a combined primary immunodeficiency reduces the chances of a successful outcome from a haemopoietic stem cell transplant. Treatment with immunoglobulin should be continued following transplantation until reconstitution of B cells and antibody production has been achieved. In some cases, prolonged immunoglobulin replacement therapy is required. Recommendation Immunoglobulin replacement therapy should be considered an important adjunct to haemopoietic stem cell transplantation in the management of some primary immunodeficiency disorders. Duration of treatment should be based on individual reconstitution of B-cell function post-transplantation (grade C recommendation, level III evidence). Recommendation Immunoglobulin replacement is recommended for patients with thymoma associated with profound B-cell depletion and/or significant antibody deficiency (grade C recommendation, level III evidence). specific antibody deficiency Specific antibody deficiency is characterised by an inability to mount adequate humoral responses to polysaccharide antigens, with otherwise normal immunoglobulins [13]. Robust case definition is currently hampered by a lack of consensus on in-vitro diagnostic criteria. Consequently, uniform recommendations for treatment are yet to be developed. Most cases appear to have a relatively mild clinical phenotype (encompassing mainly respiratory infections) which Combined immunodeficiencies requiring haemopoietic stem cell transplantation In this group of disorders, including Severe Combined Immunodeficiency and occurring predominantly in children, immunoglobulin therapy is required as a central measure to protect against infection and should be implemented as soon as possible after the CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use can be managed with prophylactic antibiotics and acute treatment of breakthrough infections. Immunoglobulin replacement is reserved for those cases where prophylactic antibiotics fail to control either the frequency or severity of breakthrough infections. Recommendation Immunoglobulin replacement therapy may be required in a proportion of infants with prolonged physiological delay of native immunoglobulin production. Where required, the planned duration of therapy should be defined prior to initiation of active treatment (grade C recommendation, level III evidence). Recommendation Immunoglobulin replacement therapy is recommended in specific antibody deficiency in cases of failure of prophylactic antibiotic treatment where severe, persistent, opportunistic or recurrent breakthrough infections are encountered (grade C recommendation, level III evidence). secondary antibody deficiency Secondary antibody defects are found in a wide range of circumstances (in association with drugs, malignant disease, chronic infections, protein-losing states, systemic inflammatory diseases, trauma and iatrogenic factors such as splenectomy). Infections associated with low measured antibody levels appear to be relatively uncommon in secondary deficiencies, with the exceptions of hypogammaglobulinaemia linked with haematological malignant disease, occasional cases of drug-associated deficiency and rare cases of nephrotic syndrome [15]. Dosage and treatment duration are important factors in drug-associated deficiencies. The deficit may, or may not, be reversible on cessation of therapy. The selection criteria for IVIg to treat hypogammaglobulinaemia linked with haematological malignancy includes the requirement to document failure of serum antibody response to Transient hypogammaglobulinaemia of infancy Hypogammaglobulinaemia in young children is often transient, reflecting delayed maturation of the immune system. In the majority of such children, immunoglobulin levels normalise by the age of around 4 years, but in a minority this can be delayed until 11 or 12 years of age. Most of these children are affected by frequent, minor infections, which can be managed with early, acute antibiotic usage or antibiotic prophylaxis [14]. However, in a small minority, infections are more severe and cannot be controlled or prevented with antibiotics alone. In such circumstances, immunoglobulin replacement is required until normalisation of endogenous antibody production. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use unconjugated pneumococcal or other polysaccharide vaccine challenge. Although this may sound onerous from a practical point of view, the intention is simply to ensure that a patient's response to polysaccharide vaccination is included as a component of the evaluation for IVIg therapy. For example, if a patient received pneumococcal polysaccharide vaccine 3 months previously and their specific antibody levels are low, it would seem reasonable to prescribe immunoglobulin. However, if the patient was vaccinated many years previously, it would be reasonable to vaccinate again and assess the functional antibody response before immunoglobulin was prescribed. Recommendation Immunoglobulin replacement therapy is recommended in secondary antibody deficiency if the underlying cause of hypogammaglobulinaemia cannot be reversed or reversal is contraindicated, or is associated with B-cell malignancy where severe infections with encapsulated bacteria are persistent despite prophylactic antibiotic therapy (grade C recommendation, level III evidence). RefeReNCes 1. Eadles-Perner A-M, Gathmann B, Knerr V, et al. The European internet-based patient and research database for primary immunodeficiencies: results 2004-06. Clin Exp Immunol 2007;177:306?12. 2. Geha RS, Notarangelo LD, Casanova JL, et al. for the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol 2007;120:776?94. 3. Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Clin Immunol 1999;93:190?7. 4. Wood P, Stanworth S, Burton J, et al. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol 2007;149:410?23. 5. Seymour B, Miles J, Haeney MR. Primary antibody deficiency and diagnostic delay. J Clin Pathol 2005;58:546?7. 6. Folds JD, Schmitz JL. Clinical and laboratory assessment of immunity. J Allergy Clin Immunol 2003;111(Suppl. 2):S702?11. 7. Chapel HM, Spickett GP, Ericson D, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin therapy. J Clin Immunol 2000;20:94?100. 8. Pettit SJ, Bourne H, Spickett GP. Survey of infection in patients receiving antibody replacement treatment for immune deficiency. J Clin Pathol 2002;55:577?80. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 9. Kainulainen L, Varpula M, Liippo K, et al. Pulmonary abnormalities in patients with primary hypogammaglobulinemia. J Allerg
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Papers Trust Board - 5 November 2024
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Date Time Location Chair Apologies Agenda Trust Board – Open Session 05/11/2024 9:00 - 11:30 The Ark Conference Centre, HHFT/Microsoft Teams Jenni Douglas-Todd Diana Eccles 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 Minutes of Previous Meeting held on 10 September 2024 Approve the minutes of the previous meeting held on 10 September 2024 3 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. 4 QUALITY, PERFORMANCE and FINANCE 9:10 Quality includes: clinical effectiveness, patient safety, and patient experience 4.1 Briefing from the Chair of the Audit and Risk Committee Keith Evans, Chair 4.2 Briefing from the Chair of the Finance and Investment Committee Dave Bennett, Chair 4.3 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood, Chair 4.4 Briefing from the Chair of the Quality Committee Tim Peachey, Chair 4.5 Chief Executive Officer's Report 9:25 Receive and note the report Sponsor: David French, Chief Executive Officer 4.6 Performance KPI Report for Month 6 9:35 Review and discuss the report Sponsor: David French, Chief Executive Officer 4.7 Finance Report for Month 6 9:55 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 4.8 ICB Finance Report for Month 6 10:10 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer 4.9 Recovery Support Programme (RSP) Undertakings - Self Assessment 10:20 Review and discuss the self-assessment Sponsor: David French, Chief Executive Officer 4.10 10:30 People Report for Month 6 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 4.11 Cancer Patient Experience Survey Results 2023 10:45 To receive and discuss the results Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Ali Keen, Head of Cancer Nursing 5 STRATEGY and BUSINESS PLANNING 5.1 Corporate Objectives 2024-25 Quarter 2 Review 11:00 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendees: Martin De Sousa, Director of Strategy and Partnerships/Kelly Kent, Head of Strategy and Partnerships 5.2 Board Assurance Framework (BAF) Update 11:10 Review and discuss the update Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Craig Machell, Associate Director of Corporate Affairs and Company Secretary 6 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 6.1 Feedback from the Council of Governors' (CoG) Meeting 23 October 2024 11:15 (Oral) Sponsor: Jenni Douglas-Todd, Trust Chair 6.2 Register of Seals and Chair's Actions Report 11:20 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 Any other business 11:25 Raise any relevant or urgent matters that are not on the agenda Page 2 8 Note the date of the next meeting: 7 January 2025 9 Items circulated to the Board for reading 9.1 CRN: Wessex 2024-25 Q2 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 10 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. Page 3 Agenda links to the Board Assurance Framework (BAF) 5 November 2024 – Open Session Overview of the BAF Risk 1a: 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. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do 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. 2a: We do not take full advantage of our 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 our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail 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. 4a: We do 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. 5a: We are 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/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our 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. Appetite (Category) Minimal (Safety) Cautious (Experience) Minimal (Safety) Open (Technology & Innovation) Open (workforce) Open (workforce) Open (workforce) Cautious (Effectiveness) Cautious (Finance) Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) Current risk rating 4x5 20 3x3 9 4x4 16 3x3 9 4x5 20 4 x3 12 4x3 12 3x3 9 3x5 15 4x5 20 3x4 12 2x3 6 Target risk rating 4 x 2 Apr 6 27 3 x 2 Mar 6 26 2 x 3 Apr 6 27 3 x 2 Mar 6 25 4 x 3 Mar 12 26 4 x 2 Mar 8 27 3 x 2 Mar 6 25 3 x 2 Apr 6 25 3 x 3 Apr 9 25 4 x 2 Apr 8 27 3 x 2 Apr 6 27 2 x 2 Dec 4 24 Agenda links to the BAF No Item 4.6 Performance KPI Report for Month 6 4.7 Finance Report for Month 6 4.8 ICB Finance Report for Month 6 4.9 Recovery Support Programme (RSP) Undertakings – Self Assessment 4.10 People Report for Month 6 4.11 Cancer Patient Experience Survey Results 5.1 Corporate Objectives 2024-25 Quarter 2 Review Linked BAF risk(s) 1a, 1b, 1c 5a 5a 5a 3a, 3b, 3c 1b All Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x Minutes Trust Board – Open Session Date Time 10/09/2024 9:00 – 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Dave Bennett, NED (DB) Gail Byrne, Chief Nursing Officer (GB) Jenni Douglas-Todd, Chair (JD-T) Diana Eccles, NED (DE) (9:00-10:00 and 12:00-13:00) 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) Joe Teape, Chief Operating Officer (JT) Alison Tattersall, NED (AT) 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 6.1) Jane Fisher, Head of Health and Safety Services (JF) (item 7.2) Danielle Honey, Named Nurse for Safeguarding Children (DH) (item 5.13) Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant (DHu) (item 5.10) Duncan Linning-Karp, Deputy Chief Operating Officer (DLK) (item 5.5) Corinne Miller, Named Nurse for Safeguarding Adults (CMi) (item 5.13) Jenny Milner, Associate Director of Patient Experience (JM) (item 5.11) Jessica Bown, Midwifery Quality Assurance and Safety Matron (shadowing Gail Byrne) 1 member of the public (item 2) 5 governors (observing) 1 members of staff (observing) 2 members of the public (observing) Apologies Diana Eccles, NED (DE) (from 10:00-12:00) 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. 2. Patient Story Allan Peters was invited to relate his experience as a cancer patient, who had been diagnosed with stage 4 lymphoma, and, in particular, his experience of CAR-T cell therapy, which had been successful, with no reappearance of the cancer for more than a year. It was noted that the patient had had a positive experience with staff, and, when he collapsed, had been impressed by the reaction of a student nurse. Page 1 3. Minutes of the Previous Meeting held on 25 July 2024 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 25 July 2024. 4. Matters Arising and Summary of Agreed Actions It was noted that action 1165 could be closed, and the relevant paper had been updated with the correct information. There were no other matters arising or actions overdue. 5. QUALITY, PERFORMANCE and FINANCE 5.1 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 19 August 2024. It was noted that: • The committee had reviewed the Finance Report for Month 4 (item 5.7), noting that whilst the Trust was slightly off-plan, it was maintaining its trajectory in terms of an improved position. • The Trust was making progress in terms of its Always Improving programme with some reduction in length of stay. • There were a number of risks to the Trust’s achievement of its 2024/25 plan, including costs incurred from industrial action, insufficient funding for the pay award, and non-delivery of system transformation programmes. The Trust was also delivering £10m of unpaid activity. • The committee received a report from Estates, noting that there had been an improvement in the Trust’s ability to recruit staff. 5.2 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 21 August 2024. It was noted that: • The committee had reviewed the People Report for Month 4 (item 5.9), noting that the Trust was below its target workforce level, although there had been an increase in use of bank staff due to the holiday period. The Trust was benefitting by £1.5m a month from these savings in staff numbers. • It was expected that the Trust would go above its planned staff numbers in September 2024 due to factors such as higher than assumed numbers of patients having no criteria to reside. • The committee received an update on violence and aggression in the context of the recent riots. 5.3 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 19 August 2024. It was noted that: • The committee reviewed the Trust’s main quality indicators and noted that the indicators in respect of infection prevention were of concern. However, there had been a reduction in Emergency Department waiting times. • The Trust’s progress in implementing the measures under ‘Martha’s Rule’ was noted. • The committee received the annual medical safety report and reviewed consultant job planning. • There had been difficulties with porting over documents to a new IT system in Ophthalmology. Page 2 5.4 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: • The 2024/25 pay award for Agenda for Change staff was due to be paid in October. In addition, the Government had made an offer to junior doctors, which appeared likely to be acceptable. There were concerns about the extent to which these pay awards would be fully funded. • The Trust had been formally notified of a collective pay grievance for healthcare support workers, which potentially impacted over 1,000 staff and was for up to six years of back pay. • The civil unrest in late July 2024 had had a significant impact on staff, especially from those from black and minority ethnic communities. • The New Hospitals programme had been paused, and the situation regarding the proposed new hospital near Basingstoke was unclear. Separately, the ‘Save Winchester Action Group’ had written to board members of the Hampshire and Isle of Wight Integrated Care Board (HIOW ICB) expressing concerns about the proposed downgrade of Winchester hospital. • The Care Quality Commission had published its adult inpatient survey for 2023, which showed a deterioration in people’s experiences since 2020. • The Trust’s aseptic unit had received a positive audit report and had been assessed as being ‘low risk’. • An inspection of the Trust’s mortuary arrangements had been carried out by the Human Tissue Authority in August 2024. The outcome was awaited. • The NHS’s long-term plan process had commenced, with an expected emphasis on digital and moving away from hospitals to focus on the community and prevention. • The report by Lord Darzi on the NHS had been published. This indicated a variation in both quality of and access to NHS services across the country. • A workshop was scheduled in October 2024 regarding violence and aggression, with the focus now being on there needing to be a limit on what the Trust will tolerate and there being consequences, including exclusion of individuals. 5.5 Patient Safety and Quality of Care in Pressured Services Joe Teape was invited to present the paper ‘Patient Safety and Quality of Care in Pressured Services’, the content of which was noted. It was further noted that: • NHS England had sent all integrated care boards, integrated care partnerships, regional directors and NHS trusts and foundation trusts a letter on 26 June 2024 regarding urgent and emergency care, and requiring boards to assure themselves that the Trust is doing all it can to provide alternatives to Emergency Department attendance and admission, and to maximise in- hospital flow. • The Trust chose to queue patients in the Emergency Department, rather than in ambulances in order to be able to release ambulances. It was considered that this approach was safer than having patients remain in ambulances. • The Trust was able to provide good assurance based on its performance against the standards. • The HIOW ICB was proposing to introduce an initiative to reduce ambulance delays whereby patients would be released to the Emergency Department after 45 minutes. Page 3 5.6 Performance KPI Report for Month 4 Joe Teape was invited to present the Performance KPI Report for Month 4, the content of which was noted. It was further noted that: • The Trust was in the top quartile for seven out of nine measures. Of those where the Trust was below top quartile, one was 78-week waits due to the shortage of corneal transplant material, and the other was the 31-day standard, although improvement was expected. • The Trust was aiming to reduce its 65-week waiters to single digits by the end of September 2024. • There had been an increase in the relative mortality rate, the causes of which were being investigated. • The Trust had not had to open surge capacity. • Ward D4 had been closed for deep-cleaning to tackle candida auris. In terms of the spotlight on waiting lists, it was noted that: • The Trust’s waiting list had increased slightly in year by c.1,500, although the growth was in outpatients waits, not patients waiting for a procedure. • There was an opportunity to triage referrals, with use of advice and guidance for General Practitioners in particular. However, it was noted that GPs were not obliged to accept advice and guidance as an alternative to a referral, and the expected industrial action by GPs was seen as a risk. • The Trust had been successful in stabilising its waiting list, it would now be necessary to reduce it from c.60k to c.40k in order to meet the 18-week Referral To Treatment standard. Action: Gail Byrne agreed to look into the increase in ‘red flag’ staffing incidents in July 2024. 5.7 Finance Report for Month 4 Ian Howard was invited to present the Finance Report for Month 4, the content of which was noted. It was further noted that: • The Trust had recorded an in-month deficit of £3.9m and £16.9m year-to-date. The monthly position continued to improve month-on-month, and the Trust’s cost base remained relatively stable. • The Trust’s Elective Recovery performance would be key to achievement of its 2024/25 plan. There remained significant uncertainties in respect of the costs of industrial action, pay award funding, payments for 2023/24 Elective Recovery Funding (ERF), and 2024/25 ERF. • The reasons for the Trust’s variance to plan were largely driven by costs of industrial action, pay awards, unidentified Cost Improvement Programme (CIP), and non-delivery of system mental health and non-criteria to reside programmes. • Identification of CIP and pay controls were working well, and the Trust had delivered 126% ERF performance. • The Trust was anticipating a deficit of £3.8m and 128.5% ERF performance in Month 5. 5.8 Break 5.9 People Report for Month 4 Steve Harris was invited to present the People Report for Month 4, the content of which was noted. It was further noted that: Page 4 • At the end of July 2024, the Trust was 288 Whole Time Equivalents (WTE) below its overall workforce plan. However, over the following months a significant increase in workforce numbers was expected due, largely, to the onboarding of newly-qualified nurses. • The Trust’s plan was predicated on the delivery of system programmes to reduce the number of patients having no criteria to reside and mental health patients. The assumed improvements in mental health patient numbers represented approximately 160 WTE. • There was a dispute with the Trust’s porters, with Unite threatening industrial action. 5.10 Guardian of Safe Working Hours Quarterly Report Diana Hulbert was invited to present the Guardian of Safe Working Hours Quarterly Report, the content of which was noted. It was further noted that: • The previous year had been a difficult one for foundation year doctors due to the industrial action and associated press around this. • Changes in the structure of doctors’ postings and training had resulted in a loss of the previously firm structure and had generated uncertainty for those impacted. It was necessary to ensure that F1 and F2 doctors felt part of the UHS family. • Improvements in the induction process for F1 doctors were required. A twoweek shadowing period had been received positively. 5.11 Learning from Deaths 2024-25 Quarter 1 Report Jenny Milner was invited to present the Learning from Deaths report for Quarter 1 of 2024/25, the content of which was noted. It was further noted that: • Nationally, the Trust continues to benchmark lower than the expected death rates. • The morbidity and mortality reviews process required refining, as sharing of learning could be inconsistent as was the quality of reviews. A mobile application was being developed to help share learnings. • A recurrent theme had emerged via incident reporting in respect of out-ofhours paediatric palliative care advice and support, as no out-of-hours service had been commissioned. • There had been an increase in the number of complaints relating to the location of the death due to a lack of side rooms. Similarly, there was a lack of private spaces to have sensitive conversations. • A palliative care box had been trialled on Ward D3. Use of charity funding was being considered to enable this to be rolled out elsewhere. 5.12 Medical Appraisal and Revalidation Annual Report including Board Statement of Compliance Paul Grundy was invited to present the Medical Appraisal and Revalidation Annual Report, the content of which was noted. It was further noted that: • The report was intended to enable the Trust to provide assurance that its professional standards processes meet the requirements of the Medical Profession (Responsible Officers) Regulations 2010 and related guidance. Page 5 • This was the second year of using a portal as part of the appraisals process, which had resulted in an improved user experience. • Compliance rates had continued to improve, and there was a good process in place to remind individuals to complete their appraisals. • There had been an increase in the number of appraisers and these were wellrated. Decision: Having reviewed the Annual Report, the Board approved the Statement of Compliance tabled to the meeting, and authorised either the Chair or Chief Executive Officer to sign the Statement on behalf of the Trust. 5.13 Safeguarding Annual Report 2023-24 Corinne Miller and Danielle Honey were invited to present the Safeguarding Annual Report for 2023/24, the content of which was noted. It was further noted that: • There had been a continued increase in activity across most services, and there had been a sustained increase in the number of Deprivation of Liberty Safeguards (DoLS) applications across the Trust along with requests for support with complex Mental Capacity Act case management. • The year had been challenging due to a loss of key staff. • The Trust had undertaken work to update its policies and Level 3 Safeguarding Adult Training had been rolled out via the Virtual Learning Environment (VLE). • A key area of work had been to review the pathway for adults with local authorities. The response from local partners remained challenging due, largely, to budgetary constraints at these other organisations. • The Trust’s children’s safeguarding team had carried out the self-assessment audit required by section 11 of the Children Act 2004, which highlighted no areas of specific concern or gaps. There had been an 28% increase in referrals as well as an increase in the level of complexity. • The adult safeguarding team had won the ‘UHS Champions Team of the Year’ award. 6. STRATEGY and BUSINESS PLANNING 6.1 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 relevant Executive Director(s) since the BAF was last presented to the Board, with an extensive review having been carried out in December 2023 and in April 2024. • Following review by the Finance and Investment Committee in August 2024, risk 5c had been modified to better reflect the Trust’s estates-related risks. • The NHS was designing a dynamic risk assessment framework. • Work was ongoing to compare the Care Quality Commission’s Well-Led framework with the Trust’s BAF, and to identify any gaps. Page 6 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 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’. 7.2 Health and Safety Annual Report 2023-24 Jane Fisher was invited to present the Health and Safety Annual Report for 2023/24, the content of which was noted. It was further noted that: • There continued to be a number of incidents of late reporting of work-related absence, although steps were being taken to streamline the process and to make reporting easier. • There had been a number of losses in staff over the year, which had impacted the FFP3 mask-fitting team in particular. • Improved training had been made available through the Virtual Learning Environment, and health and safety training received was now listed as a skill on staff members’ HealthRoster profile. • Thirty-nine incidents had been reported under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR). • The main causes of injuries were as a result of collisions, slips, trips and falls, sharps, and incidents of violence and aggression. With the exception of the latter, these incidents were generally accidents or a result of human error, with nursing and healthcare assistants being the most likely groups to be injured. 7.3 People and Organisational Development Committee Terms of Reference It was noted that the People and Organisational Development Committee had reviewed its terms of reference at its meeting held on 21 August 2024. Decision: Following discussion, it was further noted that whilst the committee had proposed no changes to the terms of reference, it was agreed that the terms of reference should include specific reference to the CQC’s quality statements given the emphasis within the CQC’s latest framework on equality, diversity and inclusion related matters. 8. Any other business There was no other business. 9. Note the date of the next meeting: 5 November 2024 10. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. Page 7 11. 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 8 List of action items Agenda item Assigned to Deadline Status 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. 27/02/2025 Pending Update: Item tentatively scheduled for TBSS on 27/02/2025. 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. Trust Board – Open Session 10/09/2024 5.6 Performance KPI Report for Month 4 1175. 'Red flag' staffing incidents Byrne, Gail Explanation action item Gail Byrne agreed to look into the increase in ‘red flag’ staffing incidents in July 2024. 05/11/2024 Pending Page 1 of 1 Agenda item 4.1 Committee Chair’s Report to the Trust Board of Directors 5 November 2024 Committee: Audit and Risk Committee Meeting Date: 14 October 2024 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The committee reviewed the year end process for 2023/24, and associated ‘lessons learned’. Many of the issues encountered ought to be mitigated by the introduction of a new finance system, together with a ‘rehearsal’ of the year end accounts process to be carried out early in 2025. • The Trust’s National Cost Collection submission for 2024 went well with no validation errors requiring re-submission and data quality was good. Whilst the output will be presented to the Finance and Investment Committee, initial indications were that the Trust was more efficient than the average. • The committee received an update on the Procurement Act 2023 and the potential impact on the Trust. It was noted that the additional reporting requirements had been delayed until February 2025 due to issues with the digital reporting platform development. • The committee received updates in respect of Information Governance and Legal. • The committee received an update on Data Quality, including work ongoing to review cancer waiting times data. • A report on a local proactive exercise in respect of Bank/Agency staff identity fraud showed that whilst the Trust was following the majority of the recommendations to reduce the risk of this type of fraud, current practice could be improved. The committee agreed with the report. 6.2 Board Assurance Framework (BAF) Level of Assurance: Substantial • All risks had been reviewed with the relevant executive director(s). • It is intended that agenda items at Board meetings will be more clearly linked to the BAF risks. • In addition, division-level ‘BAFs’ are under consideration to provide a clearer idea of overall risk at the divisional level to bridge the gap between the operational risk register and Board-level BAF. • 90% of operational risks had been reviewed, an indicator of wellembedded risk management within the organisation. The Trust’s Fraud, Bribery & Corruption Annual Report 2023/24 highlighted no particular areas of concern. The committee reviewed the performance of the Trust’s internal and external auditors. In addition, the committee held a discussion with the external auditors without management present. Substantial Assurance Reasonable Assurance There is a robust series of suitably designed internal controls in place upon which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. There is a series of controls in place, however there are potential risks that may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Page 1 of 2 Limited Assurance No Assurance Not Applicable Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Page 2 of 2 Agenda item 4.2 Committee Chair’s Report to the Trust Board of Directors 5 November 2024 Committee: Finance and Investment Committee Meeting Date: 21 October 2024 Key Messages: • • • • • • The Trust has received significant additional cash in October 2024 through deficit support funding and additional payments for 2023/24 ERF performance. The Trust’s financial position remains challenging with a year-to-date deficit of £8m. The Always Improving programme continues to make progress, but will need to go further and faster. The Trust’s data centre arrangements remain a risk and design work is ongoing in respect of a solution. The risk associated with cyber incidents also remains high. The committee supported a business case for possible expansion of UHS Pharmacy Limited and recommends it to the Board. The committee reviewed the proposed financial recovery plan and recommends to the Board its submission to the ICB. The main risk to the achievement of the Trust’s 2024/25 plan remains the need for the ICS transformation programmes to deliver. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.8 Finance Report for Month 6 Level of Assurance: Substantial • The Trust has received £11.2m of deficit support funding as well as £6.5m of additional funding in respect of 2023/24 Elective Recovery performance. • The year-to-date deficit is c.£8m, with an underlying deficit of c.£6m per month. • The Trust’s monthly income remains strong and ERF performance in September 2024 was 130%. However, costs are gradually increasing, and further investigation is required into pay expenditure. • The full amount of 2024/25 CIP has now been identified. • The most significant risk to the Trust’s achievement of its 2024/25 plan remains delivery of the system transformation programmes. 6.2 Board Assurance Framework Level of Assurance: Reasonable • Risks 5a, 5b and 5c have been updated, following discussions with the respective Executive Directors. • Risk 5a will be reassessed following the Trust’s self-assessment against the Recovery Support Programme undertakings to ensure that the risk rating and target are appropriate. • A new scoring framework is being developed to improve consistency in the rating of risks. Any Other Matters: The additional cash received in October 2024 means that it is now likely that the Trust will not need additional cash until February 2025, whereas this was previously expected to be the case in November 2024. The Trust has in place effective controls to monitor its cash position, and a regular report on cash will be provided to the Finance and Investment Committee. Page 1 of 2 Substantial Assurance Reasonable Assurance Limited Assurance No Assurance Not Applicable There is a robust series of suitably designed internal controls in place upon which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. There is a series of controls in place, however there are potential risks that may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Page 2 of 2 Agenda item 4.3 Committee Chair’s Report to the Trust Board of Directors 5 November 2024 Committee: People and Organisational Development Committee Meeting Date: 21 October 2024 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The Trust remains below its plan in terms of workforce numbers. However, from October 2024 onward, this position is expected to change. • The risk of non-delivery of ICS transformation programmes is significant. The Trust has assumed a significant reduction in workforce based on delivery of these schemes. • The committee examined the progress against actions designed to improve the lives of resident doctors. It was noted in particular that there was an issue with a lack of availability of office/desk space. • The Trust had been notified that Unite was commencing a ballot of its members commencing on 21 October 2024 as part of the ongoing dispute with porters. 5.11 People Report for Month 6 Level of Assurance: Substantial • The Trust was 249 WTE below its plan. However, this position was expected to change significantly with the onboarding of newly qualified nurses etc. in the autumn. • In addition, the Trust’s plan assumed that the ICS transformation programmes would begin to deliver significant reductions from October 2024 onward. • Turnover and sickness remain below target at 11.1% and 3.6% respectively. Bank and agency rates also remain low. • Appraisal rates remain low at 73%. The Trust was considering a move away from the current ESR system in order to make the appraisal process easier. The Trust had held constructive discussions with Unison as part of the Band 2/3 pay dispute. Substantial Assurance Reasonable Assurance Limited Assurance No Assurance Not Applicable There is a robust series of suitably designed internal controls in place upon which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. There is a series of controls in place, however there are potential risks that may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Page 1 of 1 Agenda item 4.4 Committee Chair’s Report to the Trust Board of Directors 5 November 2024 Committee: Quality Committee Meeting Date: 14 October 2024 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The Trust was making good progress against its 2024/25 Quality Priorities. • There were concerns regarding the consistency of approach to infection prevention and control in the Trust. Action plans were being produced and the ‘Fundamentals of Care’ programme is also intended to address many of these concerns. • A never event due to wrong site surgery had been recorded. This is the fifth never event reported during 2024. • The closure of Ward D4 had not been effective in eradicating the candida auris infection with four new cases reported. • There was insufficient resource to roll out National Safety Standard for Invasive Procedures (NatSSIPS) 2 in a comprehensive and systematic manner. • In its review of mental health work, the committee noted the following top three risks: lengths of wait for onward care; parity of esteem for patients; and the level of support from local mental health trusts. 6.2 Board Assurance Framework Level of Assurance: Reasonable • Risks 1a, 1b, 1c and 4a have been updated, following discussions with the respective Executive Directors. • It was agreed that the likelihood of achieving the target risk level for risk 1c (infection prevention and control) by April 2025 should be reviewed. • Staffing remains the main concern for the Trust’s Maternity services. • The possibility of support from Salisbury NHS FT to manage the increasing number of caesarean sections was being explored. Substantial Assurance Reasonable Assurance Limited Assurance No Assurance Not Applicable There is a robust series of suitably designed internal controls in place upon which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. There is a series of controls in place, however there are potential risks that may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Page 1 of 1 Agenda item 4.5 Report to the Trust Board of Directors, 5 November 2024 Title: Sponsor: Author: Purpose Chief Executive Officer’s Report David French, Chief Executive Officer Craig Machell, Associate Director of Corporate Affairs (Re)Assurance Approval Ratification Information x Strategic Theme Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future x x x x Executive Summary: The CEO’s Report this month covers the following matters: • Autumn Statement • Portering Dispute • BAM Dispute • Change NHS • Review into the Operational Effectiveness of the Care Quality Commission • Proposed Legislative Changes • New Hospital Programme – Hampshire Together • Hampshire and Isle of Wight Healthcare • Charity Priorities • Staff Survey • National Patient Safety Award Contents: Chief Executive Officer’s Report Risk(s): N/A Equality Impact Consideration: YES / NO / N/A Chief Executive Officer’s Report Autumn Statement On 30 October 2024, the Chancellor of the Exchequer presented her Autumn Statement. The statement was said to be based on the principles of restoring economic stability and increasing investment. A summary can be found from NHS Providers website: autumn-budget-2024-on-the-day-briefing.pdf The statement set out measures to raise an additional £40bn in taxation. This includes an increase in employer’s national insurance contributions by 1.2% to 15% from April 2025, increases in the rates of capital gains tax, changes to inheritance tax, abolition of the nondomicile tax regime, increased stamp duty on second homes, an increase in the rate of the windfall tax on energy companies, and removal of the VAT exemption for private schools. The Chancellor said that she would reduce wasteful spending and has set a 2% productivity savings target for all departments. The Government will publish its ten-year plan for the NHS in Spring 2025 and re-committed to reducing waiting times to 18 weeks by delivering on its manifesto commitment for 40,000 extra hospital appointments each week. The key announcements for health and care include: • Day-to-day spending for the Department of Health and Social Care will increase by £22.6bn from 2023/24 to 2025/26. This is a two-year average real terms NHS growth rate of 4% – the highest since 2010 (excluding the years affected by the COVID-19 pandemic). • Capital spending will increase by £3.1bn in 2025/26 (compared to 2023/24 outturn) – rising to £13.6bn. This is a two-year average real terms growth rate of 10.9%, although it is still lower than the overall value of the maintenance backlog (£13.8bn). This includes £1.5bn for new surgical hubs and diagnostics scanners, and £1bn towards backlog maintenance. There remains some uncertainty regarding the implications of the additional revenue funding and whether any of the funding announced will provide in-year relief in addition to values already confirmed as part of pay award and Elective Recovery Framework funding. Overall, the commitment to additional capital and revenue investment to the NHS is extremely welcome. We will assess the implications for HIOW ICS and to UHS over the coming weeks and months. The national proposed rise in the minimum wage to £12.21 in April 2025 will exceed the current lowest level within the NHS of £12.08. The national staff council will be working with NHS unions to review the implication of this and how it is addressed at a national level. Portering Dispute The Trust has been formally notified by UNITE the union that it has initiated a strike ballot of its members employed within the portering department at University Hospital Southampton. The ballot commenced on 21 October and will run until 11 November 2024. UNITE is balloting members on a range of issues including conduct, culture and working conditions. Prior to the ballot, and having been made aware of staff concerns, the Trust commissioned an independent external review, seeking views of all the portering department. The ballot has attracted media coverage from the BBC and some other local sources, and the Trust provided a response to the issues raised. The Trust is in active discussions with UNITE and local portering representatives to address the issues being raised and will continue to work constructively to resolve the dispute. Page 2 of 6 Meanwhile, the Trust is actively considering plans to ensure patient services and safety are maintained in the event a strike takes place. This will include enacting the Trust’s business continuity processes through the hospital incident management structure. The Board will be kept informed as plans are finalised and on conclusion of the ballot. BAM Dispute While the Trust was proceeding with the development of the east wing annex, concerns were raised by external structural engineers over the capacity of the existing building to cope with the expected additional weight the development would put on the existing structure. In 2022, the Trust raised a formal issue with BAM, the principal contractor of the existing east wing annex building. Over the last two years the Trust, with the support of DAC Beachcroft, has been trying to get BAM’s representatives to the mediation table to resolve the issues raised on the building. In September 2024, the decision was taken to commence arbitration proceedings against BAM Construction over the inability to agree to a mediator or mediation date. The Trust continues to work closely with DAC Beachcroft during this process, aiming for completion in early 2025. Change NHS On 21 October 2024, the Department for Health and Social Care launched an online portal for individuals to share their views, experiences and ideas to assist in the development of the Government’s 10 Year Health Plan. Staff and members of the public have been asked to: • Give their views on the NHS and health and care. • Tell the Government what they feel is working well and what needs improving. • Share their experiences. • Post their ideas for improving health and care in the future. More information can be found at: Change NHS: help build a health service fit for the future GOV.UK Review into the Operational Effectiveness of the Care Quality Commission On 15 October 2024, the Government published an independent report by Dr Penny Dash, who had been commissioned in May 2024 to review the operational effectiveness of the Care Quality Commission (CQC). The review heard from over 300 people from across the health and care sectors and within the CQC, and analysed the CQC’s performance data. The review found significant failings in the internal workings of the CQC, which have led to a substantial loss of credibility, a deterioration in the CQC’s ability to identify poor performance and support a drive to improve quality. The review summarised these failings as follows: • Poor operational performance – there has been a stark reduction in activity compared with 2019. • Significant challenges with the provider portal and regulatory platform. • Delays in producing reports and poor-quality reports. • Loss of credibility within the health and care sectors due to the loss of sector expertise and wider restructuring, resulting in lost opportunities for improvement. • Concerns around the single assessment framework and its application. • Lack of clarity regarding how ratings are calculated and concerning use of the outcome of previous inspections to calculate a current rating. • There are opportunities to improve the CQC’s assessment of local authority Health and Care Act 2022 duties. • ICS assessments are in early stages of development with a number of concerns shared. • The CQC could do more to support improvements in quality across the health and care sector. • There are opportunities to improve the sponsorship relationship between the CQC and the Department of Health and Social Care. Page 3 of 6 The full report can be read at: Review into the operational effectiveness of the Care Quality Commission: full report - GOV.UK Proposed Legislative Changes The Government has proposed a number of significant reforms to employment legislation through its Employment Rights Bill. These changes include: • From 2026, employees will have immediate entitlement to paternity leave, unpaid parental leave, and bereavement leave from the first day of employment. Protections for pregnant women and mothers will also be strengthened. • ‘Exploitative’ zero-hours contracts will be banned, giving workers the right to move to guaranteed hours contracts after a 12-week reference period.
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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 Level, Centre Block, SGH/ Microsoft Teams Chair Jenni Douglas-Todd Apologies Gail Byrne (Natasha Watts to deputise) In attendance Kerrie Montoute, Head of Programmes, CDO Directorate at NHSE (shadowing Jenni Douglas-Todd) 1 9:00 2 3 9:15 4 5 5.1 9:20 5.2 9:25 5.3 9:30 5.4 9:35 5.4.1 Chair’s Welcome, Apologies and Declarations of Interest Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 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. Minutes of Previous Meeting held on 6 June 2024 Approve the minutes of the previous meeting held on 6 June 2024 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. QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience Briefing from the Chair of the Audit and Risk Committee (Oral) Keith Evans, Chair Briefing from the Chair of the Finance and Investment Committee (Oral) Dave Bennett, Chair Briefing from the Chair of the People and Organisational Development Committee (Oral) Jane Harwood, Chair Briefing from the Chair of the Quality Committee (Oral) Tim Peachey, Chair Maternity and Neonatal Safety 2024-25 Quarter 1 Report 5.5 Chief Executive Officer's Report 9:45 Receive and note the report Sponsor: David French, Chief Executive Officer 5.6 Performance KPI Report for Month 3 10:15 Review and discuss the report Sponsor: David French, Chief Executive Officer 5.7 Break 10:45 5.8 Finance Report for Month 3 11:00 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 People Report for Month 3 11:15 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.10 Annual Complaints Report 2023-24 11:30 Receive and discuss the report Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Natasha Watts, Interim Deputy Chief Nursing Officer 6 STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2024-25 Quarter 1 Review 11:45 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendees: Martin De Sousa, Director of Strategy and Partnerships/Kelly Kent, Head of Strategy and Partnerships 6.2 Research and Development Plan 2024-25 12:00 Discuss and approve the plan Sponsor: Paul Grundy, Chief Medical Officer Attendees: Karen Underwood, Director of R&D/Marie Nelson, R&D Head of Nursing and Health Professions 6.3 Board Assurance Framework (BAF) Update 12:20 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 Feedback from the Council of Governors' Meeting 24 July 2024 (Oral) 12:30 Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 Register of Seals and Chair's Actions Report 12:35 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 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: 10 September 2024 10 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. 11 Follow-up discussion with governors 12:45 Page 3 Minutes Trust Board – Open Session Date 06/06/2024 Time 9:00 – 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Gail Byrne, Chief Nursing Officer (GB) 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) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.3) Christine Mbabazi, Equality & Inclusion Advisor/Freedom to Speak Up Guardian (CM) (item 5.12) Jenny Milner, Associate Director of Patient Experience (JM) (item 5.11) Suzy Pike, Divisional Director of Nursing/Professions, Division B (SP) (item 5.13) Clare Rook, Chief Operating Officer, CRN: Wessex (CR) (item 6.1) Julian Sutton, Interim Lead Infection Control Director (JS) (item 5.10) 1 member of the public (item 2) 5 governors (observing) 6 members of staff (observing) 2 members of the public (observing) Apologies Dave Bennett, NED (DB) Diana Eccles, NED (DE) Alison Tattersall, NED (AT) 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 Diana Eccles, Alison Tattersall and Dave Bennett. The Chair provided an overview of her activities since April 2024, including visits to hospital departments, meetings with peers and other key stakeholders. 2. Patient Story Hannah Pilka was invited to relate the story of her father, Karol Pilka, who died suddenly in hospital on 31 December 2023. The care and compassion shown by the nurse caring for Karol Pilka was highlighted. This greatly assisted the family with the grieving process. The Trust’s bereavement team was also praised. The Board noted the importance of care and compassion by the Trust’s staff. Page 1 3. Minutes of the Previous Meeting held on 28 March 2024 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 28 March 2024. 4. Matters Arising and Summary of Agreed Actions It was noted 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 20 May 2024. It was noted that: • The committee reviewed the Trust’s National Cost Collection submission for 2023/24. • A report on waivers of competitive tendering was received, and it was noted that these were mostly due to urgent requirements or where there was only a single supplier. • The committee reviewed the Trust’s draft Annual Report and Accounts for 2023/24. • The draft internal audit report for 2023/24 was expected to provide a ‘clean’ opinion and there were no outstanding actions from previous audits. • The Trust received a ‘green’ assessment from the review against the Counter- Fraud Functional Standard. 5.2 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 May 2024. It was noted that: • The committee reviewed the People Report for Month 1 (item 5.9) and noted that performance in this area was positive. • The additional workforce controls appeared to be working in terms of managing the size and composition of the Trust’s workforce. • The controls in respect of use of bank and agency staff also appeared to have had a significant effect. • The committee received an update on the Trust’s Inclusion and Belonging Strategy, noting that a number of initiatives were underway. • The committee reviewed progress against the objectives for year three of the Trust’s People strategy and expressed concern with the level of resource available to deliver these. 5.3 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 3 June 2024. It was noted that: • The committee reviewed the Finance Report for Month 1 (item 5.7) and received an update in respect of the Trust’s annual plan for 2024/25. • The committee received an update on the Trust’s Cost Improvement Programme, noting that it had achieved £2.5m to date out of the £82m target. • UHS Estates was broadly on budget and was delivering and a positive report was also noted in respect of Wessex Procurement Limited. Page 2 5.4 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 3 June 2024. It was noted that: • The committee noted an increase in the number of high-harm falls, which was a concern. • The committee also expressed concern at the resource demand posed by Inquests and post-mortems, particularly in terms of the number of witnesses now being called by Coroners. • The committee had reviewed a draft of the Trust’s Quality Account for 2023/24. • In reviewing the relative risk of mortality, it was noted that patients were 16% less likely to die at the Trust compared to the average mortality rate. • In terms of infection prevention and control, it was noted that this was at a higher rate than was acceptable, although there was a national issue in terms of infection prevention and control (item 5.10). 5.5 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: • It was the 80th anniversary of Operation Overlord, the Allied landings in Normandy. • The Infected Blood Inquiry had published its report on 20 May 2024. As a result of which, the UK Government has established a compensation scheme for those impacted. In addition, NHS England had commissioned an ongoing patient support service for those affected, and it was expected that the Trust would be one of the two providers in the region offering this service. • The Prime Minister had announced that a general election would be held on 4 July 2024. As a result, there were a number of implications for the Trust as a public body during the ‘pre-election period’. • Further industrial action by junior doctors was scheduled to take place between 27 June 2024 and 2 July 2024. The Trust was taking appropriate steps to manage this. • Paula Melhuish, Deputy Director of Estates and Capital Development, had received the Outstanding Service Award from the Health Estates and Facilities Management Association on 13 May 2024. • The Trust had been awarded additional capital funding due to its Emergency Department performance at the end of 2023/24. It was likely that some of this funding would be used to increase same-day emergency care capacity. • The Trust’s plan for 2024/25 had yet to be agreed in common with other trusts across NHS England. • Discussions were ongoing in respect of the Integrated Care Board’s transformation programmes, and it was noted that David French had been appointed to head the workforce transformation programme. 5.6 Performance KPI Report for Month 1 Joe Teape was invited to present the Performance KPI Report for Month 1, the content of which was noted. It was further noted that: • The data for March 2024 showed that the Trust was in the top-half or top- quarter in terms of its comparative performance. • There were 15 patients waiting longer than 78 weeks for a corneal transplant due to a lack of available materials beyond the Trust’s control. • Emergency Department performance had improved during May 2024 with use of surge capacity of only 14 per day (out of 50) and a reduction in the number Page 3 of patients with no criteria to reside of about 10%, although this was mostly due to the time of the year. • The Trust’s Diagnostics performance had been good over the period, with all but two areas achieving the 95% target. Recovery plans were in place for the areas not achieving the target and the Trust had informed trusts with cardiac magnetic resonance imaging capability that referrals would no longer be supported. • The Trust’s overall key performance indicators showed good or improving performance. However, there were concerns about the sustainability of this trajectory and some areas were vulnerable to loss of key personnel. • The Quality Committee was to carry out a deep-dive into falls and pressure ulcers, and a hydration trial to reduce the number of falls was being considered. The Board noted the reported ransomware attack against Synnovis on 3 June 2024, which had impacted trusts in London as well as the NHS Blood and Transplant service. It was noted that the Trust did use the supplier, but was unaffected by the incident. However, the impact on the NHS Blood and Transplant service would likely cause potential issues for the Trust in terms of the availability of blood and transplant services. Action: JT agreed to include Digital as an agenda item at a future Trust Board Study Session. 5.7 Finance Report for Month 1 Ian Howard was invited to present the Finance Report for Month 1, the content of which was noted. It was further noted that: • Planning for 2024/25 was still ongoing, and a further submission was to be made on 12 June 2024. As a result of the delays in the planning process, there was currently no formal reporting to NHS England. • The Trust had recorded a deficit of £3.8m during the month, which was in line with its current plan. • The Trust’s underlying deficit was between £4-4.5m per month. However, during month 1, this was nearer to £6m due to lower elective recovery performance during the period. 5.8 Break 5.9 People Report for Month 1 Steve Harris was invited to present the People Report for Month 1, the content of which was noted. It was further noted that: • There had been an overall reduction in whole-time equivalents during April 2024, with a reduction in bank and agency use. It was noted that 60-80 agency staff were related to patients with a mental health-related care need. • The Trust’s annual workforce plan had been submitted, but this was reliant on delivery by the Integrated Care System on a number of assumptions in terms of patients with no criteria to reside and provision of mental health care. • The Trust had received a silver award under the Defence Employer Recognition Scheme. Page 4 • The Trust was the second-lowest user of bank and agency staff in the southeast region. This represented a significant turnaround within a short period, although it was noted that there were some areas of fragility within the Trust. 5.10 Infection Prevention and Control 2023-24 Annual Report Julian Sutton was invited to present the Infection Prevention and Control 2023/24 Annual Report, the content of which was noted. It was further noted that: • There were a number of concerns stemming from application of ‘fundamentals of care’, such as a failure to apply risk reduction measures appropriately. • There had been seven cases of Methicillin-resistant Staphylococcus aureus (MRSA) during the year. • An update was provided in respect of the candida aureus outbreak, with approximately 70 patients colonised. • Rapid upper gastro-intestinal tract testing had resulted in benefits due to the speed of detecting infections and/or ruling them out quicker, thereby freeing up capacity. • An update was provided in respect of the incidence of measles since April 2024, which necessitated a significant amount of work to carry out contact tracing and to notify those potentially exposed. • There was a general increase in the infection rate nationally, and the Trust generally was in the middle in terms of its performance, dependent on the particular infection category. 5.11 Learning from Deaths 2023-24 Quarter 4 Report Jenny Milner and Paul Grundy were invited to present the Learning from Deaths report for Quarter 4, the content of which was noted. It was further noted that: • In line with a national trend, there had been an increase in the number of deaths during the fourth quarter. • A new application was being trialled to facilitate the sharing of the learnings from morbidity and mortality meetings. Work was also being carried out to standardise morbidity and mortality meetings, which would further facilitate the dissemination of learning. • Due to performance by the current provider below the standard expected, the Trust was tendering for a new supplier for baby funerals. • The Medical Examiner service was prepared for the changes due to be implemented nationally in September 2024 requiring the review of all deaths. • Based on the whole-year average, the Trust had the fifth-lowest mortality rate in England. • The Trust’s bereavement service had some constraints on resources, which was impacting out-of-hours and weekend support. 5.12 Freedom to Speak Up Report Christine Mbabazi was invited to present the Freedom to Speak Up Report, the content of which was noted. It was further noted that: • Between the period November 2023 – May 2024, the Trust had recorded 56 Freedom to Speak Up cases, compared to 44 during the same period in 2022/23. Page 5 • The reintroduction of face-to-face meetings following the COVID-19 pandemic had resulted in quicker resolution of issues. • The Trust was moving away from the term ‘whistleblowing’ owing to the possible negative connotations of the term, in favour of ‘speaking up’. • Investigations into cases raised via the Trust’s Freedom to Speak Up service always had involvement by an individual who was independent. • There was an issue with complaints found to be untrue where the complainant was anonymous and how to handle these cases, especially in terms of where an individual was subject to an unfounded allegation of wrongdoing. • The cases raised were similar in terms of the themes as the rest of the country. • Freedom to Speak Up should be a last resort, where possible, concerns should be dealt with at the local level. • Although most cases were resolved satisfactorily, communicating the outcome could be a challenge due to the need to preserve confidentiality in respect of matters such as disciplinary processes. • Support was provided to the Trust’s Freedom to Speak Up champions, including mental health/wellbeing support where appropriate. 5.13 Fuller Inquiry Report Suzi Pike was invited to present the Fuller Inquiry Report, the content of which was noted. It was further noted that in November 2021, an independent inquiry was established to investigate how an NHS estates member of staff was able to carry out inappropriate and unlawful actions in the mortuary of Maidstone and Tunbridge Wells NHS Trust, and how and why this activity went unnoticed for so long. The inquiry was split into two phases, and this report was to provide detail of the 17 recommendations arising from the inquiry’s phase one report and the Trust’s response to these. 6. STRATEGY and BUSINESS PLANNING 6.1 CRN Wessex 2023-24 Annual Performance Report Clare Rook and Paul Grundy were invited to present the CRN Wessex 2023/24 Annual Performance Report, the content of which was noted. It was further noted that: • The network was assessed against three high-level objectives concerning recruitment onto commercial and non-commercial studies and experience survey participation rates. • The network did not meet the objective in respect of open studies, but was close to the target for non-commercial studies. The network did achieve the experience survey participation objective. • The changes in the research network were expected to result in positive opportunities, although were consuming significant amounts of time managing the HR aspects of the transition. Page 6 6.2 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework (BAF) update, the content of which was noted. It was further noted that: • The BAF had been reviewed and updated since it was last presented to the Board in March 2024. • The likelihood rating of the Estates risk (risk 5b) had increased, resulting in an increase from 16 to 20. • Work was being carried out to further embed the Trust’s risk appetite and to link the Trust’s operational risks with the BAF. This included consideration of the creation of an intermediate, division-level risk register in order to bridge the gap between the operational and BAF risks. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (CoG) Meeting 1 May 2024 The Chair provided an overview of the Council of Governors’ meeting held on 1 May 2024. It was noted that the Council of Governors had considered the following matters: • A report from the Chief Executive Officer • The Trust’s 2024/25 corporate objectives • Non-NHS activity • The annual report and quality account timetable • Terms of Reference • Governor vacancies and elections • Membership engagement 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. 9. Note the date of the next meeting: 25 July 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 Hulbert, Diana 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. Update: 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 24/10/2024 Explanation action item JT agreed to include Digital as an agenda item at a future Trust Board Study Session. Pending Update: This item is tentatively scheduled for TBSS on 24/10/2024. Page 1 of 1 Report to the Trust Board of Directors Title: Agenda item: Sponsor: Author: Date: Purpose: Issue to be addressed: Maternity & Neonatal (MatNeo) Safety Report 2024-25 Quarter 1 (Qtr.1) 5.4.1 Gail Byrne, Chief Nursing Officer Emma Northover, Director of Midwifery and Professional Lead for Neonatal Services Jess Bown, Quality & Safety Midwifery Matron Hannah Mallon, Quality & Safety Neonatal Matron Marie Cann, MatNeo Safety Lead 25 July 2024 Assurance or reassurance Approval Ratification Information This report constitutes the agreed Maternity & Neonatal (MatNeo) Services Qtr.1 safety report, provides a key overview of our services in, providing assurance to the members for the following: 1. Perinatal Quality Surveillance Qtr.1 (Appendix 1) 2. Serious Incidents (Appendix 2), Learning Slide (Appendix 2a) 3. Perinatal Mortality Review Tool (PMRT) (Appendix 3) 4. ATAIN Qtr.1 Report (Appendix 4) 5. Quality & Safety Shared Learning Slide (Appendix 5 MNSI QRM) 6. Culture Score Survey 7. MatNeo Service User Feedback (Appendix 6 CQC Maternity Survey Improvement plan/Birth trauma enquiry response) 8. MNVP Update 9. Trust Claims Scorecard 10. Midwifery Staffing Report 11. Maternity Safety Champions & Quad Team Update 12. NHSR (Maternity Incentive Scheme Year 6) NB 2, 6, 7, 8, 9 & 10 are reportable as per NHSR Year 6 NB Appendices 1-6 available in iBabs Documents. Response to the issue: 1. Perinatal Quality Surveillance – Maternity Neonatal Dashboard (Appendix 1) The Maternity & Neonatal Dashboard provides a perinatal quality surveillance overview of indicators for our services. The dashboard outcomes continue to be scrutinised by the Quality and Safety Team and reported to the MatNeo Safety Champions. The following section of the report will provide an update on the key indicators. The remaining red flags on the dashboard are ‘ongoing’, with no new concerns identified. As requirements change additional indictors will be added with recent changes including: • Late fetal losses (16+0-23+6) • Intrapartum stillbirths • PROMPT obstetric emergencies training (work in progress) • Newborn Life Support (NLS) (Data coming) • Maternity Day Assessment Unit (MDAU) Triage times. Page 1 of 9 1.1 % of Bookings by 9+6 weeks (NICE recommendation) Overall compliance for Qtr.1 was 31%. The action plan discussed in the previous report has been extended to continue for 3 months, taking us until the end of July 2024. This remains as a feature (Risk 815 Red 15) on the Risk Register until further notice. NB. As a result of the action and improvement plan mentioned above the number of bookings in May was 633, which is a significant increase from 448 in April. This increase should settle now that the backlog has been cleared. April 5.8% May 30% June 58% 1.2 Timeliness of testing KPI for sickle cell and Thalassemia screening Overall compliance for Qtr.1 was 36%. This surveillance indicator is set against a national benchmark and provides the indicator for the proportion of pregnant women and birthing people having had antenatal sickle cell and thalassemia screening for whom a screening result is available ≤10 weeks + 0 days gestation. This result enables prompt partner testing and the offer of prenatal diagnostic testing if required. The improvements seen in respect to compliance levels in screening have been as a direct result of the changes made to the booking processes. We anticipate further improvements to the screening data as service changes within the self-referral team become formalised. April 6.4% May 33% June 68% The action plan discussed in the previous report has been extended to continue for 3 months, taking us until the end of July 2024. This remains as a feature (Risk 37 Red 15) on the Risk Register until further notice. To note this indicator is intrinsically linked to the % of Bookings by 9+6 weeks and as this compliance increases so will screening compliance. 1.3 Booked onto Continuity of Carer (CoC) pathway The Maternity Continuity of Care Model (MCoC) is a key model that ensures all families, particularly those most vulnerable, have safer and improved outcomes. The outcomes are as follows: • Total booked onto a CoC pathway Current rate for Qtr.1 is 13%, within the target being > 35%. • Global Majority booked onto a CoC pathway Current rate for Qtr. 1 is 23%, which has increased from 14.7% in March, target being > 51%. This workstream has additional team lead oversight to ensure we are targeting those most at risk. April 24% May 22% June 22% Page 2 of 9 • Total booked who are living in IMD1 area booked onto a CoC pathway Current rate for Qtr. 1 is 65%, these women/birthing people are being identified early to ensure they are booked onto a CoC pathway and close oversight by the senior leadership team and NEST team leads. April 41% May 56.5% June 98% 1.4 Education and Training NHSR Year 6 - Safety Action 8 asks Trusts to evidence compliance of 90% for the 3 ‘in-house’ one day multi-professional training days. The Quality and Safety Team have close oversight working with the education leads to ensure progress is maintained for training and education. The need has been identified early and provision sought for additional training days, due to increased acuity operationally and staff being redeployed to work clinically, with the additional resources we are on track to meet compliance by 30 November 2024. 1.5 Neonatal Life Support (NLS) NHSR Year 6 – Safety Action 8 also asks Trusts for evidence of compliance of 90% for neonatal life support. This is included within PROMPT for Maternity Services but is taught separately within Neonatal Services. Targeted education is planned for Autumn 2024 to ensure compliance will be met by the end of the reporting period (November 2024). The process for providing the annual NLS updates within Neonatal Services is being reviewed to apportion it across the year, which includes having an allocated time within the doctor’s induction and adding to the rolling education rota. 2 Serious Incidents (SI) including Maternity and Newborn Safety Investigations (MNSI) and PMRT cases Appendix 2 provides assurance to the members that the appropriate reporting has taken place for Qtr.1. The report includes all new MNSI cases, of which there were 2, and any PSII cases. Also providing an update on all cases closed within the same timeframe, together with any thematic learning identified. Information will also be included which relates to new and closed perinatal mortality cases even where there are no patient safety care concerns for the service to continue to be transparent. 2.1 Appendix 2 also includes a summary of the Moderate incidents reported in April/May 2024 to date. There were 2 cases closed in Qtr.1 and the learning slides featured within the last report: • MNSI 029127 case closed Trust shared learning slide • MNSI 031668 case closed Trust shared learning slide. 2.2 Appendix 2a highlights the Iodine skin prep case learning slide which has been shared with the Local Maternity and Neonatal System (LMNS), case currently an ongoing PSII. 3 Perinatal Mortality Review Tool Report (PMRT) See Appendix 3 for a summary of Qtr.1 PMRT cases and learning. The MatNeo service can confirm that there is high level oversight of reported and processed cases to ensure reviews and feedback from and to families are captured within appropriate timeframes. Page 3 of 9 Case information is reviewed at a level where the service can look to identify any themes or vulnerable groups. Learning has been identified within the information and is shared with our LMNS. 4 ATAIN Qtr.1 Report For Qtr.1 2024/25, there were a total of 41 unexpected admissions. The process for reviewing term admissions has changed and the reasons for admission have also been amended slightly. However, poor perinatal adaptation continues to be the most common reason for admission. Appendix 4 provides a deep dive into Quarter 1 admissions. 5 Quality and Safety Shared Learning Our service continues to drive quality and ensure that safe care is provided to our families. Appendix 5 provides Committee members with an overview of the key learning from the Trust’s quarterly MNSI review meeting. 6 Perinatal Culture Score Survey The Trust is holding feedback sessions with the workforce, facilitated by Korn Ferry (the Score Survey provider), looking to obtain further narrative to support and inform the Change Team (improvement leads) to ensure meaningful results and a positive improvement. 7 MatNeo Service User Feedback 7.1 Friends & Family Overall, for Qtr.1 the Friends and Family feedback continues to be above Trust target at 32.0% with 89% recommending our service. This feedback is reviewed by the senior team and any thematic concerns are identified and improvements planned. 7.2 CQC Maternity Survey Action Plan Appendix 6 outlines the Maternity Improvement Plan following the 2023 CQC Women’s Experiences of Maternity Care Survey, combined with the themes identified in the recent Birth Trauma Enquiry report. Locally we have reviewed the results and have developed an action plan to address the findings. 8 Maternity & Neonatal Voices Partnership (MNVP) Chair Update The Hampshire and Isle of Wight ICB advertised the MNVP chair role on the 24 May 2024, with the closing date of 7 July 2024, subject to recruitment the Trust hopes to have a chair in place soon to support the MatNeo Service to ensure the patient voice is heard and service user engagement in shaping our MatNeo service. 9 Trust Claims Scorecard Qtr.1 Claims Scorecard will be reviewed by the Safety Champions and targeted interventions aimed at improving patient safety would be developed. This will come to the Quality Committee in August for noting as per NHSR Year 6 reporting requirements. Page 4 of 9 10 Midwifery Staffing Report 10.1 A clear breakdown of BirthRate Plus (BR+) or equivalent calculations to demonstrate how the required establishment has been calculated In line with national drivers for assurance in relation to safe staffing levels within maternity services, UHS Maternity Services currently utilise BirthRate Plus (BR+) as a system and framework for workforce planning and strategic decision making. The last assessment of UHS Maternity Services by BR+ in 2018 suggested an overall clinical establishment based on a midwife V birth ratio of 1:24, calculated against an annual birth rate of 5500 births. At the time, the required total establishment as calculated by BR+ to ensure safe staffing levels equated to 226.55 WTE which was inclusive of support staff contribution. UHS recently commissioned a revised BR+ review in March 2024. Whilst we await our final report, early indicators show our service to be operating in a staffing deficit, which indeed feels accurate on a day-to-day basis. Despite a lower birthrate in 23/24 of around 5000, the growing complexity of maternity calls for more input and midwifery care hours throughout pregnancies across the service, whilst also increasingly requiring wider MDT input. Birthrate Plus data shows that UHS continues to see a higher than average case mix with 77% of people falling within the highest acuity / care requirement categories compared to 68% in 2018. In July 2023, we saw a peak in this activity where 91% of women / birthing people delivered on our labour ward or in theatre. This rate has continued into 2024 with the average only falling to around 88% each month. Our normal birth rate has stabilised with an average of 45% however the rising trend we have seen over the last 12 months in caesarean section births, continues to be high and consistently account for over 40% of all births in our service. 10.2 In line with Midwifery staffing recommendations from Ockenden, Trust Boards must provide evidence of funded establishment being compliant with outcomes of BirthRate+ or equivalent calculations Over the last 3 years, UHS Maternity Services have at times been working with midwife V birth ratios that are more suggestive of 1:27. This has felt uncomfortable but with contingency frameworks in place, the service has remained safe. With a vacancy rate of 22.49 WTE currently for registered staff we are presently operating a 1:29 midwife V birth ratio. This situation is further compounded by short-term sickness, an increased national demand for education and training and a high maternity leave rate of 9%. This inevitably results in a workforce that is significantly overstretched carrying an overall headroom percentage of 31%. We have increased staff support in the clinical environment in addition to pastoral and psychological support to enhance retention of the workforce. We are pleased to say that with this initiative, we have retained 100% of our newly qualified preceptees who started with us in November 2023. UHS Maternity Services has a very detailed, robust escalation and contingency plan which is activated when the service is under pressure to maintain safety and improve maternal and neonatal outcomes. The leadership team, including the Director of Midwifery, commit to a 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. Page 5 of 9 Whilst effective in bridging gaps for the most part, this is not a sustainable way of working and it is resulting in burnout across the midwifery leadership team. 10.3 Where Trusts are not compliant with a funded establishment based on BirthRate+ or equivalent calculations, Trust Board minutes must show the agreed plan, including timescale for achieving the appropriate uplift in funded establishment. The plan must include mitigation to cover any shortfalls In support of the BR+ acuity tool, UHS Maternity Services have developed a systematic process for workforce planning in the form of a monthly dashboard. This live data is reflective of total staff unavailability to include vacancy rates, sickness ratios, maternity leave, and study time, all of which is compared alongside the budgeted versus actual staffing establishment overall. The data recorded within the monthly dashboard is lifted directly from maternity Erostering and ESR systems. As such the staffing ratios are recorded in real time and will represent staffing levels in their most accurate form. The monthly dashboard not only records an accurate position for midwifery staffing at the current time but also offers a projected forecast for staff unavailability in the months going forward. This ensures and supports an ongoing process for rolling recruitment, involving both qualified and unqualified staff groups. Utilising the dashboard in this way will see the Maternity Service reduce the current vacancy rate down from a predicted 26.58WTE in October 2024 to fully recruited as per our current funded establishment by 1st February 2025, assuming that we are able to maintain engagement from all our new recruits. With national evidence directly linking reduced midwifery staffing levels and poor maternity and neonatal outcomes for families, recruitment to clinical maternity roles, both registered and unregistered has been supported by the Trust Board and prioritised at recruitment panels. With this support, Maternity Services have continued to recruit to vacant posts and following a successful newly qualified midwife recruitment drive, we are expecting 34WTE B5 midwives to join UHS Maternity Services on our preceptorship programme in November 2024. Recognising the level of support that our new colleagues will need, and to create a balanced skill mix across our workforce, we also have a rolling B6 recruitment process which is returning a steady stream of experienced B6 midwives also joining our service. 10.4 Midwifery red flag reporting – Evidencing compliance that all women / birthing people receive 1:1 midwifery care in active labour and the protected supernumerary status of the labour ward coordinator UHS Maternity Services record our staffing V acuity data every 4 hours across the intrapartum areas using the BR+ tool. Within our staffing template the labour ward coordinator is rostered and protected to maintain a supernumerary status at all times. This standard is achieved and maintained across the entirety of every shift, not just the start which is the reportable required standard. The skillset of this staff group is pertinent to the safe running of the labour ward, our most acute and high risk clinical area. The table below offers assurance to the Trust Board that UHS Maternity Services consistently meet this safety standard with no red flag events recorded for the whole of 2023 and to date in 2024. The labour ward coordinator team recognise the specialist nature of their role and reliably respond to cover unexpected vacant shifts. Across our operational Page 6 of 9 and leadership teams, we have staff who also hold the labour ward coordinator skillset as a dual or previous role which offers extra flexibility and redeployment options at times where a substitute coordinator may be required. At UHS, the labour ward coordinator does not take responsibility for any patients nor do they cover breaks for other members of staff enabling them to have continuous oversight of their clinical environment. Red Flag Report - Labour Ward (scheduled assessments only) Red Flag Red Flag Description 2023 total Jan Feb Mar Apr May Any occasion when 1 midwife is not able to provide continuous RF9 one-to-one care and 0 0000 0 support to a woman during established labour RF10 Labour ward coordinator not supernumerary status 0 0000 0 Red Flag Report - Broadlands (scheduled assessments only) Red Flag Red Flag Description 2023 total Jan Feb Mar Apr May Any occasion when 1 midwife is not able to provide continuous RF9 one-to-one care and 0 00 0 0 0 support to a woman during established labour Another red flag that is closely monitored and reportable to the Trust Board as a measure of good practice is the assurance that all women / birthing people receive 1:1 care in active labour across all birth environments. At UHS Maternity Services we respond quickly and effectively to the fast paced, unpredictable nature of intrapartum care and evoke our maternity escalation plan to source additional midwives for intrapartum care. Currently midwives are redeployed often to meet the needs of the service which can cause uncertainty and frustration for them at times. Morale and job satisfaction levels are low amongst midwives who are continuously called upon for support, however all would agree that safe care is the priority. It is only through this escalation that we continue to provide safe care to the women / birthing people accessing our service in the right place, at the right time and by the right people. If we cannot provide 1:1 care in active labour, UHS Maternity Services will declare the highest level of escalation, OPEL 4, and look to divert incoming people in labour to neighbouring Trusts across the region. Since the start of 2024, UHS Maternity Services have escalated to OPEL 4 on 23 occasions. Across the whole of 2023 OPEL 4 was declared 28 times. This is a significant and stark increase in service pressure that our Maternity Service Page 7 of 9 is experiencing with staffing and acuity accounting for the majority of cases. Whilst we report that 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. 10.5 Maternity Workforce Development – Next Steps/Way Forward Over the last year, an extensive listening exercise has taken place to help inform the future direction and structure of the Maternity Service workforce. To align with current service needs, and with staff wellbeing as a central focus, the Director of Midwifery and Midwifery Senior Leadership Team are reviewing the way the service is delivered with the potential of a workforce restructure. Ensuring that an appropriately skilled practitioner is available to meet service demands in the most responsive and efficient way remains pivotal in the success of this potential project. This will be pertinent to models and pathways of care provision, operating both in and out of the hospital setting, including homebirth and intrapartum services within our low-risk birth centres. Drivers around flexible working, retention and restorative practice will all underpin the direction and future of the way in which we work. In terms of strategic workforce planning, there is currently a significant focus around the issue of supply and demand for maternity staff, particularly registered midwives. Some options for workforce development see alternative training pathways for health care workers who previously may not have benefitted from such openings and include shortened midwifery conversion courses for registered nurses, return to practice midwifery courses, midwifery apprenticeship models and foundation programmes for aspiring maternity support workers. It is anticipated that by broadening the gateway into careers within maternity services, whilst allowing training and education to be both accessible and affordable, a wider audience of prospective candidates will be achieved. In these current times where maternity workforce tensions are so prominent, we recognise that succession planning is of prime importance, and therefore are busy creating new opportunities for staff upskilling and professional development. UHS Maternity Services are committed to investing in their people and as such have dedicated programmes for career development starting at band 2 and progressing to band 9. Our prime focus is to consider new ways in which we can future proof our maternity services going forward, whilst investing wholly in the health and wellbeing of our existing workforce. 11 Maternity & Neonatal Safety Champions & Quad Team Update Safety Champions Gail Byrne (Exec) Tim Peachey (Non-Exec) Victoria Puddy (Neonatal) Jillian Connor (Obstetric) Marie Cann (Midwifery) QUAD Bala Thyagarajan (Care Group Clinical Lead) Ganga Verma (Obstetric Clinical Lead) Hannah Kedzia (Care Group Manager) Marie Cann (Midwifery) The Safety Champions and Quad met on the 1 May 2024 for a joint meeting and safety walkabout of the service. There were no additional concerns or actions identified, just the ongoing challenges around staffing and estates recognised. Page 8 of 9 12 NHSR – Maternity Incentive Scheme year 6 The last Quality Committee report provided an exception report for the 10 safety actions. The Trust met with the LMNS on the 27 June 2024 for the first quarterly review meeting, to assess progress against the 10 safety actions, and the trajectory for complete submission is on track. The next review meeting is planned for August, to review progress, ahead of end of the reporting period on the 30 November 2024. Implications: (Clinical, Organisational, Governance, Legal?) The risk implications for the UHS Trust and MatNeo services sit within several frameworks including: • Reputational – Safety concerns can be raised by the public to both NHS Resolution and the CQC. • Financial – Compliance with NHS Resolution Maternity Safety Actions to meet all ten safety actions remains to be an expectation for maternity safety requirements. • Governance – Safety concerns can be escalated to the Care Quality Commission for their consideration and to NHS England, the NHS Improvement Regional Director, the Deputy Chief Midwifery Officer, the Regional Chief Midwife. • Safety - Non-compliance with requirements or recommendations would have a detrimental impact on the women and their families leading to increased poor outcomes and staff wellbeing. MNSI can raise concerns regarding the safety of MatNeo services and instigate reviews. Risks: (Top 3) of Top Risks: carrying out the • 788 (Red) Elective theatre capacity change / or not: • 258 (Red) Maternity staffing • 259 (Red) Capacity and demand in Maternity services • 260 (Red) MDAU • 262 (Red) Induction of Labour Summary: This Qtr.1 MatNeo services safety report provides an overview of the key safety Conclusion workstreams and aims to provide committee members with the actions and and/or mitigations in place to improve areas of significant concern. The report recommendation: encompasses the perinatal quality surveillance minimum requirements and aims to fulfil the reporting requirements for NHSR MIS year 6. The report will continue to be adapted and responsive to safety concerns or issues within our service providing assurance around safety improvements impacting our families, services and staff. The MatNeo dashboard provides the board with the Perinatal Quality Surveillance information and will continue to be refined to provide a platform for clear oversight of key outcomes and measures. We continue to work on ways to ensure the dashboard clearly highlights any action and improvement plans where areas of risk have been identified. The information provided is for assurance and reassurance, whilst meeting the requirements of NHSR Year 6, and highlights the safety improvement work and learning from all aspects of the services including serious incident and MNSI cases. We ask members to continue to support the MatNeo Services and provide monitoring and scrutiny as required. Page 9 of 9 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 5.5 David French, Chief Executive Officer 25 July 2024 Assurance Approval or reassurance Ratification Information X My report this month covers updates on the following items: • General Election • COVID-19 Inquiry • Forgotten Generation • Ligature Risk • Care Quality Commission • Haemophilia Treatment • LIMS system 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 5 General Election On 4 July 2024, the UK’s general election result was a clear mandate for the Labour party, returning 412 Members of Parliament which represents a 174-seat majority. Labour’s manifesto commitments in terms of health included: • Using spare capacity in the independent sector to ensure that patients are diagnosed and treated more quickly. • Reform of the NHS to ensure that mental health is given the same attention and focus as physical health. • Modernising the Mental Health Act to address treatment of people with autism and learning difficulties, and racial inequalities perpetuated by the Act. • Implement professional standards and regulate NHS managers. • Set an explicit target to close the black and Asian mortality gap. • Implement the expert recommendations of the Cass Review, the independent review of gender identity services. • Ensure the publication of regular, independent workforce planning across he
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