Dear Sir,

Regulation 28 Report on the death of Mr David Morris – Ref:

Thank you for your Regulation 28 Report of 04 July 2024. Barking, Havering and Redbridge University Hospitals NHS Trust (the Trust) has carefully considered the matters of concern raised by the learned Coroner in the Regulation 28 Report, and guidance has been sought from specialists within the Trust to address them.

I will now outline the matters identified in the Regulation 28 Report, and address them in turn:

1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust.

Mr Morris’s treatment plan and diagnosis was delayed and complicated in part due to being downgraded in severity on the Patient Tracker List which led to a breakdown in communication between clinical pathways. With Immediate effect, no patients that are currently on a Patient Tracker List for any cancer diagnosis can be removed or deferred without approval of the responsible consultant. This is to ensure that administrative processes have a clear oversight of a senior clinician who takes full responsibility for the treatment plan.

In addition, a restructure of the cancer administration pathways is underway by the Speciality Manager for cancer performance; under the oversight of the Chief Operating Officer. This restructure is proposed to finish by 30 September 2024, with its implementation expected to result in new clinical oversight and streamlined communication.

2. During the evening of 3rd May 2022 going into the early hours of 4th May 2022, Doctors and nurses failed to identify the extent of Mr Morris’s gastrostomy leak and the onset of sepsis. After identifying symptoms of sepsis, staff failed to treat and escalate Mr Morris’s care resulting in a delay of three and a half hours before a medical review commenced emergency treatment.

The Trust has implemented an increase in our Critical Care Outreach Team (CCOT) model since April 2024. Previously this service was offered between the hours of 8am to 8pm with no dedicated service outside of these hours. Since April 2024 this is now a dedicated twenty-four-hour service delivered seven days a week to ensure continuity and access to specialised teams as required.

Acting This team visits patients within the ward environment and provides local therapeutic intervention to decrease the likelihood of requiring higher dependency treatment. The CCOT team is also a source of escalation for staff when they feel that a patient is deteriorating, and this is done in conjunction with informing the medical team.

Additionally, the Trust is currently in the process of designing and implementing Martha’s Rule, which is based upon the case of Martha Mills who died in 2021 after developing sepsis in hospital. In response to hers and other cases related to the management of deterioration, the Secretary of State for Health and Social Care and NHS England committed to implementing ‘Martha’s Rule’; to ensure the vitally important concerns of the patient and those who know the patient best are listened to and acted upon.

Formal launch is planned for November 2024 and its implementation will enable patients and relatives to also refer to this service independently; and enable a review of any patient with a perceived deterioration. In particular, the focus of Martha’s rule for BHRUT includes:

1. All staff in NHS trusts must have 24/7 access to a rapid review from a critical care outreach team, who they can contact should they have concerns about a patient.

2. All patients, their families, carers, and advocates must also have access to the same 24/7 rapid review from a critical care outreach team, which they can contact via mechanisms advertised around the hospital, and more widely if they are worried about the patient’s condition.

Finally, there is now a deteriorating patient panel group which meets weekly and reviews patients that have had a deterioration in clinical condition and uses this information/learning to change practice both locally and Trust- wide. To assist in the familiarity of the process and policy for deteriorating patients, this is now included in Basic Life Support training which is an essential requirement for all clinical staff. There is also a development of an online training for the recognition of deteriorating patients.

3. During Mr Morris’s ward-based treatment on 3rd & 4th May 2022 clinical records were either of a poor standard or were non-existent. The absence of clear records impeded the effective investigation of this death by the Trust’s governance teams and the Coroner.

The standard of documentation was highlighted as being of a poor quality. The Trust is in the process of preparing for the introduction of an Electronic Patient Records (EPR) system, which is due to be adopted in May 2025. Adopting the EPR system will involve a process where contemporaneous and clear clinical documentation is made during clinical episodes of care; and this practice will be highlighted as a mandatory part of the medical and nursing induction process for all new starters.

In August 2024, the Medical Directorate has established a Quarterly Health Records Group where both best practice and learning opportunities will be presented and reviewed with action plans as appropriate.

In addition, the Trust lead for mortality is reviewing the possibility of performing CRABEL audits (an audit tool designed by CRAwford – BEresford – Lafferty) as a tool for the assessment of the quality of medical record keeping, with the ability to standardise audit and improvement across areas. A plan is due to be presented for approval in November 2024 following the second meeting of the Health Records Group.

4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval.

Acting Since October 2023 there has been a change in the process of investigating significant patient safety incidents at BHRUT. This has now been changed to the Patient Safety Investigation Response Framework (PSIRF) which uses multidisciplinary investigations and reviews with multiple responsible authors. In line with NHS England guidance, the Investigating Officer is centrally allocated by the Quality and Safety team and, whenever possible, these are allocated outside of the Clinical Group where the incident occurred.

There is a weekly Incident Oversight Learning Group (IOLG) whereby all incidents that are considered of concern are discussed with specific terms of reference. This includes background information and a review of the entire pathway which a patient has encountered when systems issues are identified; thereby including any omissions that may have occurred with the previous Serious Incident Framework. The Incident Oversight Learning Group meetings are chaired by either the Medical Director for Patient Safety and Patient Experience or the Director of Nursing for Quality and Safety, and this group decides when to commission a further PSIRF learning response.

On completion of Patient Safety Incident Investigations (PSIIs) there is a Learning Review Group (LRG) which reviews the contents of the reports to ensure adequate exploration of key issues has occurred; that the family has had an opportunity to input into the investigation; and ensures the improvement action plan both aligns with learning identified and is sufficiently robust to counteract the existing safety issues identified. The Terms of Reference for this meeting have been updated and now include a Board Executive (or nominated deputy) who must be in attendance for quoracy when signing off investigations.

For additional oversight and support, colleagues from the North East London Integrated Care Board (ICB) are members of all improvement and review panels, including the IOLG and the LRG. Once reports are approved by the Medical Director for Patient Safety and Patient Experience, in conjunction with the Director of Nursing for Quality and Safety, they are submitted to the ICB who monitor learning from provider organisations and use this information to share insights across organisations and services to improve safety across the Integrated Care System.

5. The Trust did not have effective controlled drug management systems in place to detect a prolonged and persistent course of conduct from an employed nurse who was stealing and self- administering controlled drugs in the workplace.

In light of the concerns raised by the learned Coroner, the Trust is trialing a digital key system on each ward, together with exploring installing CCTV into the Medicine Preparation rooms. An initial discussion with suppliers took place in July 2024.

An external review of the Controlled Medication practices is currently being planned for September 2024 by the Metropolitan Police Controlled Drug Liaison Officer. It is envisaged that the Metropolitan Police Controlled Drug Liaison Officer would provide an external review and highlight areas of concern that will be taken forwards by the Pharmacy team for action as required.

To assist with compliance with the medication policies, a Medicine Management Nurse is being introduced within the Trust and the recruitment process is currently underway. Advertising of the post should begin in October 2024 with appointment following this.

A change in the process of Controlled Medication Keys is already in place since the incident, with individuals identified at the start of each shift with sole responsibility and ownership of these.

At the learned Coroner’s request during inquest, the Trust reached out to the previous employee who had been removing controlled medication without authorisation, but the employee unfortunately did not respond.

Acting The Trust has taken the issues identified by the learned Coroner very seriously, and taken positive action to address them.

I would be happy to meet to discuss this response if that would be helpful to the learned Coroner.

Dear Mr Irvine,

CEC 191775: Regulation 28 Report – David John Morris

I would like to thank you for your email dated 4 July 2024 regarding the Regulation 28 Report for the death of David John Morris; we appreciate you bringing this report to our attention.

Firstly, I would like to express our condolences to the Morris family and our thoughts are with them at this difficult time.

As you are likely aware, the MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment, including medical devices, are used safely and meet appropriate standards of safety, quality, performance, and effectiveness.

The MHRA assesses the balance of risks and benefits of medical devices throughout their use in clinical practice through the collection of information and assessment of any potential risks, followed, when necessary, with communications and regulatory action to minimise those risks. The MHRA does not have a role in providing medical advice or guidance relating to medical practice or care quality and therefore cannot comment on those aspects of this case.

From the timeline of events, from the Regulation 28 report, the MHRA understands that Mr Morris underwent a surgical gastrostomy, due to an oesophageal stricture, and a feed leak was observed on multiple occasions, but no actions were taken by the clinical staff.

Without information regarding the specific brand and manufacturer of the gastrostomy device within the Regulation 28 report the MHRA have not been able to review the specific Instructions for Use (IFU) for the product, however, in general gastrostomy devices do include warnings regarding checking for leaks and stopping treatments and potentially replacing the

device if leaks do occur. Additionally, it is stated that the device was removed and tested and appeared functional, therefore there does not appear to be a particular fault with the device that would be within the remit of the MHRA to address.

It is important to note that the MHRA did receive a safety report in December 2022 from NHS England from the National Reporting and Learning System (NRLS) regarding a fatality with a gastrostomy balloon device. Whilst the NRLS report did not include all the same details as this Regulation 28 report, the MHRA are confident that this is regarding the same patient due to the timeline of events. The NRLS report focussed on the possibility of human error and confusion between the enteral feeding port and the balloon port. The MHRA contacted all manufacturers for balloon gastrostomy devices who confirmed that they had received no similar reports and that they were implementing ENFit standards for their devices with the last of the non-ENFit products being available in June 2023. ENFit is the standard to ensure enteral tubing connectors are designed to be mechanically incompatible with connectors from other areas of therapy, to minimize misconnection risks. ENFit implementation began in 2015 throughout the UK and was a phased approach to allow manufacturers time to produce ENFit compliant products. For this reason, the investigation into this issue was considered closed in August 2023.

If the brand name and manufacturer of the gastrostomy device used on Mr Morris is available, please provide this and we will be able to check the wording in their specific product information to ensure the appropriate advice on checking for leaks is present.

I would like to thank you once again for contacting us regarding this sad case and I hope the information provided is useful. Please do not hesitate to contact me if I can be of further assistance.

Dear Graeme,

Thank you for the Regulation 28 report of 4 July sent to the Department of Health and Social Care about the death of David John Morris. I am replying as the Minister for Patient Safety, Women’s Health and Mental Health.

Firstly, I would like to say how saddened I was to read of the circumstances of Mr David John Morris’ death, and I offer my sincere condolences to his family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention.

The report raises concerns across multiple fronts over the care provided by the Trust and its processes, in particular:
1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust.
2. Failure to identify the onset of Sepsis and to treat and escalate once it was diagnosed leading to delay of care before a medical review commenced emergency treatment.
3. Poor standard or lack of clinical records during ward-based treatment which impeded the investigation of this death by the Trust’s governance teams and the coroner.
4. No effective review by the Trust upon how the initial serious investigation report gained executive approval as it was unfit for purpose.
5. Lack of effective controlled drug management systems in place for employees at the Trust. In preparing this response, my officials have worked with NHS England (NHSE), the Care Quality Commission (CQC) and the Medicines & Healthcare products Regulatory Agency (MHRA) to ensure we adequately address your concerns. I understand that the Barking, Havering & Redbridge University Trust will also be responding separately to your concerns and that the London region of NHS England is

From Baroness Gillian Merron Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health

39 Victoria Street London SW1H 0EU

engaging directly with the Trust on the concerns you have rightly raised about the care provided to Mr Morris. The CQC has confirmed that they are reviewing this case, and will consider what further action should be taken, and whether any monitoring of the trust, or regulatory response, is required. The Chief Safety Officer at the MHRA is also providing a response to your report. And I have received assurances that they have carefully considered the concerns raised. I will not duplicate their response concerning the gastrostomy device mentioned in your report, as they are best placed to answer your concerns. As per the request from MHRA, you may wish to share the brand name and manufacturer of the gastrostomy device used on Mr Morris and MHRA will be able to check the wording in their specific product information to ensure the appropriate advice on checking for leaks is present. I wholeheartedly agree with you regarding the importance of organisations across the health system working together to ensure effective cancer diagnosis, and I regret that this did not occur in Mr Morris’ case. It is important to ensure that the issues you outlined in your report are not repeated. Thus, we will continue to work alongside NHSE and local systems to reduce waiting times and deliver on the NHS Long-Term Plan ambitions to diagnose 75% of cancers at stage 1 and 2 by 2028. I recognise how devastating Sepsis can be, and my deepest condolences are shared with Mr Morris’ loved ones. As you know, sepsis can be challenging to diagnose early as it can vary in presentation. An effective response relies on sepsis being both identified and treated rapidly, and it is critical to treat patients early with antibiotics once sepsis is suspected. It is my understanding that to support rapid diagnosis, the National Early Warning Score (NEWS2) is used as a clinical screening and decision support tool for the recognition of acutely unwell and deteriorating patients, including those with suspected sepsis. Although NEWS2 has been implemented across 98.4% of acute trusts and 100% of ambulance trusts in England, some patients with sepsis, including Mr Morris, are still not being put onto the appropriate care pathway quickly enough. Recognising this, the National Institute for Health and Care Excellence (NICE) guidance on the recognition, diagnosis and early management of sepsis was updated in March 2024, following the publication of the Academy of Medical Royal Colleges’ ‘Statement on the initial antimicrobial treatment of Sepsis’, in May 2022: Overview | Suspected sepsis: recognition, diagnosis and early management | Guidance | NICE. Furthermore, NICE has additional guidance under development, informed by the latest evidence. It is important that we facilitate and support a robust understanding of updated guidelines amongst a wide range of healthcare professionals.

From Baroness Gillian Merron Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health

39 Victoria Street London SW1H 0EU

With the aim of improving our understanding of sepsis and its impacts, the Department works with NHSE and the UK Health Security Agency to monitor trends in infection incidence and deaths from sepsis, which are often complex and multifactorial issues. The National Institute for Health and Care Research (NIHR) also funds several studies into sepsis. In 2022, NIHR awarded £3.2m funding to the Sepsis Trials In Critical Care study (SepTIC), which will look to answer critical questions on sepsis diagnostics and treatment. It is our hope that continuing to improve our understanding of sepsis and how it can be better managed will improve outcomes for patients and reduce preventable deaths occurring in the future. It is vital that lessons are learnt collectively, and changes are made to reflect where things have gone wrong, which is essential to ensure the NHS provides safe, high-quality care.    I hope this response is helpful. Thank you for bringing these concerns to my attention.