Dear Ms Mutch, Re: Regulation 28 Report to Prevent Future Deaths - Sandra Adina Lomax 25th June 2022 Thank you for your Regulation 28 Report dated 10th February 2023 concerning the sad death of Sandra Adina Lomax on the 25th June 2022. On behalf of NHS Greater Manchester Integrated Care (NHS GM), I would like to begin by offering our sincere condolences to Mrs Lomax’s family for their loss. Thank you for highlighting your concerns during Mrs Lomax’s inquest which concluded on the 4th of January 2023. On behalf of NHS GM, I apologise that you have had to bring these matters of concern to our attention, but it is also very important to ensure we make the necessary improvements to the quality and safety of future services. Following the inquest, you raised concerns in your Regulation 28 Report to NHS Greater Manchester (GM) that there is a risk future deaths will occur unless action is taken. The medical cause of Mrs Lomax’s death was 1a) bronchopneumonia; 1b) oesophageal granulation on the background of a stent; 1c) oesophageal cancer (treated with chemo/radiotherapy). I hope the response below demonstrates to you and Mrs Lomax’s family that NHS GM has taken the concerns you have raised seriously and will learn from this as a whole system. This letter addresses the issues that fall within the remit of NHS GM and how we can share the learning from this case. The inquest heard evidence that the development of oesophageal strictures such as Mrs Lomax’s was a relatively new development as a consequence of advances in chemo/radiotherapy that meant that surgery was not the only option for oesophageal cancers. However the management of theses strictures was complicated and there was no detailed national guidance on management of them and in particular when and how stenting should be approached. The development and implementation of detailed National Guidance was the inquest was told key to improving outcomes for patients such as Mrs Lomax across England; The development of this national guidance would be the responsibility of the National Institute for Health and Care Excellence (NICE). NICE is an executive non-departmental public body sponsored by the Department of Health and Social Care. The topics chosen for guidance development are referred to NICE from NHS England, the Department of Health and Social Care and the Department for Education. A1 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

On receipt of this Regulation 28 Report, we contacted NICE to understand if there was a current national guidance in relation to management of oesophageal strictures. NICE advised that cases need to be managed on an individual basis with a multi-disciplinary team (MDT) – one which is made up of a variety of specialists which could include a oncologist and specialist radiologist. NICE did note that although there is no specific national guidance on the management of oesophageal strictures, the principles of stenting are covered in the recommendations in the NG83 Oesophago-gastric cancer. The associated NICE Quality Standard QS176, which covers assessing and managing adults with oesophaggastric cancer, does not mention stenting however, it does highlight the need for MDT decision-making in these complex cases Mrs Lomax was treated by The Christie NHS Foundation Trust. The service provided by the Trust is commissioned by NHS England, and not Greater Manchester Integrated Care, because cancer is included within the list of prescribed specialised services. Prescribed specialised services are services which support people with a range of rare and complex conditions, and unlike the majority of NHS care, which is arranged locally, these services are planned nationally and regionally. This is because the services are delivered by specialist teams of doctors, nurses and other health professionals who have the necessary skills and experience, and as a result they are not available in every local hospital. Cancer is one of six specialist services commissioned by NHS England known as Programmes of Care (NPoC). Each NPoC brings together clinical and commissioning leadership, an empowered patient and public voice, and policy expertise to:
• Contribute to the development and delivery of strategy and policy objectives, such as the NHS Long Term Plan.
• Support regions to commission specialised services which meet population needs, provide consistently high-quality care and excellent patient experience, as part of an integrated care system and patient pathway transformation. The NPoCs principally operate through a network of affiliated Clinical Reference Groups, who provide guidance and oversight. NHS England have confirmed that they are going to take this Regulation 28 Report into consideration and review management of stents through the relevant Clinical Reference Group that covers oesophageal cancer. Within Greater Manchester the inquest was told that the Christie were seeking to develop a specialist service for these complex cases but funding of a commissioned pan GM service was fundamental to a successful roll out that would benefit such patients as Mrs Lomax. The absence of such a service meant that cases such as Mrs Lomax’s could arise going forward given that in most hospitals even experienced radiologists/gastroenterologists would have limited experience on how to manage such cases; On receipt of this Regulation 28 Report we contacted NHS England’s Regional Specialised Commissioning Team who are the responsible commissioner of the services provided by The Christie NHS Foundation Trust. They will be continuing to engage with The Christie in relation to the development of services and will review and consider any proposal from The Christie in relation to A2 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

specialised services for these complex cases. The inquest also heard evidence that to support management of cases such as Mrs Lomax there was a regular GM Upper GI MDT led by Salford Royal Hospital. However staffing issues meant that there was not a regular presence for all Trusts at the meeting. This impacted effective communication and impacted patient care; Staffing issues reflecting on effective multidisciplinary team working is a known pressure. Over the past 25 years, there has been little change to the format of multidisciplinary team meetings (MDTMs) despite significant changes in cancer care. With the move towards fewer specialist cancer centres with higher case volume, there has been a significant increase in the number of patients discussed at MDTMs. That, coupled with increasing treatment options, more clinical trials, a more complex case mix and an ageing demographic has led to an increased challenge to deliver an effective and succinct MDTM. This results in limited opportunity for clinical teams to have meaningful discussion of more complex cases. Recognising the challenges in relation to MDT working, the Greater Manchester Cancer Alliance have an improvement programme in place in relation to MDT reform: MDT Reform - Greater Manchester Cancer (gmcancer.org.uk) The benefits to be realised because of this programme include:
• Improving the effectiveness of cancer MDT’s, ensuring streamlined processes and standards of care pathways are developed and implemented to make the best use of clinical time and resources.
• Improving patient outcomes through robust auditing processes.
• Improved effectiveness of the time all members of the MDT in general and radiologists and pathologists in particular, spend on MDTMs.
• Specialism attendance will be assured, allowing for comprehensive discussion and decision making, including access and suitability for clinical trials.
• Standardising the method in ensuring patients psychosocial needs are taken into consideration.
• Reduced variation in MDT functioning. This was compounded by the fact that the inquest heard evidence that the MDT did not have a system of effective communication of agreed actions and recommendations for individual patients discussed at the MDT. As a consequence local clinicians were unsighted as to the recommended way forward. The inquest was told that an effective and consistent pan GM approach to sharing the outcomes of MDTs would improve patient outcomes. The Greater Manchester MDT reform programme has developed Cancer MDT Standards that providers are working towards. These are based on the national guidance. These standards include detailed sections setting out principles for the communication of outcomes of MDT discussions with referring clinicians, patients and their families. This work is ongoing with yearly audits being undertaken against these standards. There has also recently been a best practice event looking at how information sharing across digital systems can aid and improve communication particularly, where service pathways span more than one provider. A3 4th Floor, Piccadilly Place, Manchester M1 3BN Tel: 0161 6257791 www.gmintegratedcare.org.uk

Actions taken or being taken to share learning across Greater Manchester:
1. Learning to be presented and shared with the Greater Manchester System Quality Group. This meeting is attended by commissioners, including commissioners of specialist services, localities, regulators, Healthwatch and NICE. Through sharing in this forum, we expect members to review and ensure learning is incorporated into their commissioned services.
2. Shared learning from this and similar cases at Greater Manchester and borough level will be cascaded to professionals through relevant governance and learning forums to ensure that learning is incorporated into their services. In conclusion, key learning points and recommendations will be monitored to ensure they are embedded within practice. NHS GM is committed to improving outcomes for the population of Greater Manchester. I hope this response demonstrates to you and Mrs Lomax’s family that NHS GM has taken the concerns you have raised seriously and is committed to working together as a system including with our service users, carers and families to improve the care provided. Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths - Sandra Adina Lomax who died on 25th June 2022. Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 10 February 2023 concerning the death of Sandra Lomax on 25th June 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deepest condolences to Sandra’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Sandra’s care have been listened to and reflected upon. I am grateful for the further time granted to respond to your Report, and I apologise for any anguish this delay may have caused to Sandra’s family or friends. I realise that responses to Coroner Reports can form part of the important process of family and friends coming to terms with what has happened to their loved ones and appreciate this will have been an incredibly difficult time for them. National guidance for the use of stenting in cases of oesophageal/gastro­ oesophageal cancers The National Institute for Health and Care Excellence (NICE), who develop national guidance on referral from NHS England, the Department of Health and Social Care and the Department of Education, do cover the principles of stenting in its guidance on Oesophago-gastric cancer in adults: Oesophago-gastric cancer: assessment and management in adults (NG83) (nice.org.uk). This guidance references the use of stenting in oesophageal/gastro-oesophageal cancers in cases where the cancer is not suitable for surgery, or where there is a need to relieve the symptoms of dysphagia. NHS England does not provide guidance covering every aspect of care. This is particularly pertinent for management of complex cases and cancers, such as Sandra’s, which require management on an individual basis with input from a multi­ disciplinary team (MDT) within the relevant Trust and NICE does make clear that that MDT decision-making is important in these complex cases. A5

NICE are currently consulting on a partial update to their guidance on Oesophago­ gastric cancer, with publication expected on/or around 4 July 2023. This includes consideration of treatments offered to patients who have had stents inserted. In response to your Report and the concerns raised, NHS England plans to discuss your Report and the NICE guidance with the Cancer Clinical Advisory Group, in advance of the publication of updated NICE guidance relating to oesophago-gastric cancer, to consider whether any further immediate actions need to be taken. NHS England would be happy to write to the the Coroner again in due course to provide an update if she so wishes. In addition, the national Regulation 28 Working Group will ensure that your Report and the concerns raised are shared with System Quality Groups for onward sharing to relevant Trusts and clinicians across NHS England, so that they may take learnings from this case. Commissioning arrangements and requirements for complex cancer cases and stenting Due to its complexity, the management of oesophageal cancer falls under the remit of NHS England’s Specialised Commissioning function. Commissioned providers are required, under the NHS Standard Contract, to comply with national service specifications and have regard to guidance published by NICE. I am able to confirm that the relevant service specification is due to be updated in the next 12 months, which will provide an opportunity to incorporate any specific recommendations from the updated NICE oesophago-gastric cancer guidance about stenting and chemo-radiotherapy. Importantly, the current published service specification does set out that chemo-radiotherapy is the responsibility of the specialist MDT. NHS England’s Regional Specialised Commissioning Team for the North West will review and consider any proposal from The Christie to support the delivery of the service specification requirements relating to chemo-radiotherapy and stenting. In addition, the national Regulation 28 Working Group will ensure that your Report and the concerns raised are shared with System Quality Groups for onward sharing to relevant Trusts and clinicians across NHS England, so that they may take learnings from this case, to include the importance of holding effective and frequent MDT meetings for complex cancer cases. GM are the appropriate organisation to respond to your concerns around GM staffing issues and ineffective communication between the MDT. I have been sighted on their response and welcome the Greater Manchester Cancer Alliance improvement programme for MDT reform. I also note that they will be sharing learning from Sandra’s death across the Greater Manchester System. I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed A6

by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action. Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.