Dear Mr Dillon Re: Regulation 28 Prevention of Future Deaths Report in respect of Megan Ceris Williams I write in response to your regulation 28 report regarding the tragic death of Megan Ceris Williams. I would like to express my sincere condolences to Megan’s family and loved ones. We did acknowledge receipt of your report but, due to a miscommunication, we did not follow up with our formal response. I would like to apologise to you, and to Megan’s family, for our error. I, with colleagues in NICE’s patient safety oversight group, did review and reflect on the concerns raised within your report shortly after we received it. On this occasion, we do not consider that there are any actions from NICE that would address the issues raised. Once again, I am sorry for the delay in confirming NICE’s position.

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Megan Ceris Williams who died on 5 May 2022.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 24 July 2024 concerning the death of Megan Ceris Willliams on 5 May 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Megan’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Megan’s care have been listened to and reflected upon.

I note that you have also addressed your Report to East Kent Hospitals University NHS Foundation Trust (EKHT), and it is appropriate that they respond to each of the concerns raised by the Coroner, as these concerns do not fall under NHS England’s remit and are all local issues for the Trust to address.

However, my regional colleagues in the South East are engaging with NHS Kent and Medway Integrated Care Board on the concerns raised, and NHS England has asked to be sighted on the Trust’s response to you. We will consider their response to the Coroner once received and whether any further actions are required. We would be happy to update the Coroner further if this is the case.

I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed 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 events, such as the sad death of Megan, are shared across the NHS at both a national and regional level and helps us to 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.

Dear Sir

Re: Ms Megan Ceris Williams

I write to you following the concluded inquest into the death of Miss Megan Ceris Williams on 20th June 2023. At the outset, I would like to offer my sincere condolences to her family and I hope they have received answers to their concerns in relation to the care and treatment provided by the Trust.

I refer to your request for further information following the conclusion of the inquest, namely the below points:

1. That there was a lack of knowledge, among clinical staff, of the Acute Abdominal Pain Pathway (AAPP).

The reinforcement of the AAPP is a continuing process and has been happening throughout the last two years within the Trust. The Trust have a monthly joined Emergency Medicine and Surgical teaching session. This is a platform for these Departments to present and discuss cases they face in order to improve patient safety continuously. It is important to note that cases surrounding acute abdomen are frequent and therefore often require discussion of the AAPP. The AAPP is a feature of these discussions each time a relevant case is discussed.

This approach forms part of well-established forums in which clinicians can discuss and share insight into cases and share learning. The Trust considers the current training regime is sufficient to ensure that all staff understand the appropriate process for the emergency management of patients with adult abdominal pain (explained further below).

2. Given what was said about how clear the AAPP was, that EKHT should provide evidence of what further work has been done make it clearer and accessible to clinicians.

Enclosed with this letter is the Acute Abdominal Pain Pathway (AAPP) (Document 1). As explained above, the Trust have a monthly joined Emergency medicine and Surgical teaching session which involves clinical staff from both departments. The AAPP has been a constant part of the discussion to ensure that: a) All clinical staff members understand the appropriate process for the emergency management of patients with adult abdominal pain. b) All clinical staff know when the AAPP needed to be initiated. c) All clinical staff know the teams they needed to escalate concerns to, and when these concerns need to be escalated. In addition, the Trust’s Updated Action Plan implemented a procedure whereby a copy of the AAPP needs to be fully completed when a patient is admitted to the Emergency Department with complaints of abdominal pain. This process was implemented on 07 September 2022. Furthermore, as of 13 September 2022, the AAPP has now been added to the My ED App, this is to ensure it is readily and easily accessible to clinical staff assessing patients with complaints of abdominal pain.
3. That the hospital SI process did not include information from family and other interested persons or parties as part its fact-finding exercise.

Since the conclusion of the inquest, the Trust has changed the SI process to the new Patient Safety Incident Response Framework. The Trust Patient Safety Incident Response Policy (Document 2) and Plan (Document 3) have been agreed and are attached for information.

Section 9 of the policy outlines how patients, families and staff are all to be involved following a Patient Safety Incident. The guiding principle of the policy is that learning and improvement following a patient safety incident can only be achieved if supportive systems and processes are in place. These systems and processes focus on compassion and collaboration. The policy therefore promotes the Trust to work with those affected by Patient Safety Incident’s to answer any questions they may have, signpost them to support and include their comments within the final report. As such, the Patient Safety Incident Framework unlike the SI process prioritizes obtaining information from the family and other interested persons as part of its fact-finding exercise. One element of the principles of engagement for drafting a Patient Safety Incident Framework is that the investigative process will be collaborative; with the patient, staff and investigators working together to achieve learning that will ensure improvements are made. To ensure a collaborative approach the principle of patient and family involvement is threaded throughout the policy.

The Trust transitioned to the Patient Safety Incident Framework on 10 June 2024 and incidents have been reviewed and managed in accordance with the Trust Policy and Plan from that date.

To support implementation of the Patient Safety Incident Response Policy and Plan, the Trust has updated the governance structure to ensure the thorough review of incidents of concern or interest. Attention to the involvement of the patient and their family is incorporated into the incident review processes via the Terms of Reference for the Incident Review Panel (Document 4 – 3.4) and proforma which supports the review of incidents presented at the Incident Response Panel.

In addition to the Policy and Plan, the Trust is adopting the NHS Engaging and involving patients, families and staff following a patient safety incident. The Trust’s Incident Management Policy has been updated (pending ratification) to ensure that patient and family involvement is strengthened. Similarly, the Trust’s Duty of Candour Policy (Document 5) will be reviewed and updated. For

instance, to ensure that the Trust flowchart on page 10, is aligned to the requirements of the NHS engagement and involvement process (see below).

The Patient Safety Incident Response Framework and our Trust plan requires the use of a Patient Safety Incident Investigation (PSII) methodology for certain incident types. The Trust has adopted the national template for PSII reports (Document 6). This includes recording of the patient and family involvement in the investigation process. The other learning response reports that the Trust will be using e.g. After Action Review, Swarm, also prompt the inclusion of the patient and family perspective.

Under the oversight requirements for the Patient Safety Incident Response Framework, the NHS Oversight roles and responsibilities specification details the leadership and management requirements for oversight for providers, commissioners and regulators. The provider executive lead responsibilities are to:  Ensure the organisation meets the NHS National patient safety incident response standards (2024) – which include engagement and involvement of those affected by patient safety incidents.  Ensure PSIRF is central to overarching safety governance arrangements.  Quality assure learning response outputs.

The Trust will be replacing the previous Serious Incident Approval Panel with the Learning Response Approval Panel to approve Patient Safety Incident Investigations. The Care Group Triumvirates will be responsible for oversight and approval of some learning responses. In both instances the Trust will adopt the questions to guide local oversight of patient safety incident responses.

The Trust is implementing the Learning response review and improvement tool to enable peer review of reports. This includes the descriptor, “People affected by incidents are meaningfully engaged and involved”. This tool will be used by learning response leads and the Peer Review Panel described within the Trust Policy (section 12).

In summary, the Trust has commenced implementation of Patient Safety Incident Framework and strengthened the processes to ensure the engagement of the patient, family and other stakeholders with the oversight of the Incident Review Panel. The planned implementation of the Peer Review Panel and the Learning Response Approval Panel will further strengthen the oversight of the inclusion of information from the patient, family and other stakeholders. In addition, the Trust also plans to consider how assurance of adherence to the patient safety incident response standards will be sourced and reported.
4. There was not a clearly documented and recorded process for patients who self-discharge from hospital.

As per the Updated Action Plan, the Trust have implemented a new process whereby all patients who re-attend the Emergency Department within 48 hours of discharge for the same complaint are seen by the discharging team, this review is documented, and forms part of the patients records. This additional process is to ensure that the patient was not discharged when further investigation and/ or treatment was required. The discharging team will review the patient on re-attendance, ensure no additional investigations are required and either admit or discharge accordingly.

To ensure a repeat of similar incidents does not re-occur, the Trust has also updated its policy relating to patients who self-discharge from hospital. Enclosed with this letter is the Trust’s updated Missing Persons Policy (Document 7) and the Discharge Criteria policy (Document 8). This has been through 3 separate reviews and updates since May 2022 and ensures that the duties of staff members relating to missing patients and patients who are attempting to self-discharge are clearly established. It also now includes an updated Patient Risk Assessment so that staff members can

document if a patient is at high risk of going missing or if they will suffer harm from self-discharging. The updated policy has been approved by the Safeguarding Assurance Committee and the attached version was disseminated across the Trust on 30 May 2024.

In addition, the Trust has updated the Hospital Discharge and Criteria to Reside Policy. The Policy was updated and issued to all staff at the Trust on 16 February 2023. The updated policy directs staff to always consider the following when a patient indicates that they want to self-discharge:

a) Does patient have capacity? Has this been evidenced by completion of an assessment under the Mental Capacity Act as appropriate? b) Has a Deprivation of Liberty checklist been completed? c) Inform and discuss with medical staff, matron, or care manager as required. d) If out of hours, liaise with Operational Site Manager. e) Inform and discuss with GP and any other relevant agency. f) Ensure patient has prescribed medications to take away. g) Inform next of kin, if known and appropriate. h) Self-discharge form should be completed. i) Document clearly within medical and nursing notes all actions taken. Of key importance is that patients are asked to review the Self Discharge Form which must then be filed within the patient’s case notes. The Self Discharge Form sets out the risks of discharging against medical advice and asks a patient to consider these risks before signing the form. This is to ensure that patients have weighed the risks of self -discharge and ensures that there is a recorded process. The Policy also mandates that following discharge, if on a ward, then a welfare check telephone call be made to ensure the patient has arrived home safely. I hope this letter provides you with the relevant clarification to your queries and I would be happy to assist further.