Dear Mrs Louise Hunt,

Thank you for your Regulation 28 report to prevent future deaths dated 05/04/2024 on the death of Tracey Ann Farndon. I am replying as Parliamentary Under Secretary of State (Minister for Mental Health and Women’s Health Strategy). I was saddened to read of the circumstances of Tracey’s death, and I offer my sincere condolences to her 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. Your report raises concerns over a failure to identify and treat sepsis within the emergency department at Queen Elizabeth Hospital in Birmingham, and highlights the following matters of concern:
1. The Emergency Department (ED) was, and continues to be, overwhelmed with patients with insufficient staff to care for, monitor and manage those patients. There is also continued regular use of agency staff.
2. Staff failed to consider a diagnosis of sepsis throughout Ms Farndon’s admission. This raises the concern that staff do not fully understand the variable signs and symptoms of sepsis.
3. Ms Farndon’s blood pressure (BP) was not recordable when she first presented at the emergency department. It was likely to be very low. This was not considered by the staff and no further attempts were made to assess Ms Farndon’s BP. This raises concern that staff do not understand the implication of a low BP, the importance of continued observations when a key parameter cannot be recorded and that this may indicate the patient is seriously unwell.

In preparing this response, DHSC officials have made enquiries with NHS England. NHS England also consulted with University Hospitals Birmingham NHS Trust on local actions taken. The following response addresses each of your matters of concern in turn.

Sepsis can be a devastating condition and patients rightly expect the NHS to be able to recognise and diagnose it early and provide the highest quality treatment and care. We must do all we can to learn from tragic incidents such as Ms Farndon’s death to ensure the safety of health services and prevent future deaths.

Your report raised concerns about the demand and capacity in Queen Elizabeth Hospital’s Emergency Department. I recognise the significant pressure the urgent and emergency care system is facing. That is why we published our ‘Delivery plan for recovering urgent and emergency care services’, which aims to deliver sustained improvements in waiting times. Our ambitions include improving the Accident and Emergency (A&E) Department waiting times and reduce overcrowding, so that, by March 2025, 78% of patients are admitted, transferred, or discharged from A&E within four hours. A&E waiting times have improved this year following the delivery plan’s publication, with national A&E 4-hour performance improving from 71.5% in March 2023 to 74.2% in March 2024.

A key part of the plan has been to increase hospital capacity to reduce overcrowding in A&E. We have delivered 5,000 more staffed, permanent beds this year compared to 2022-23. A whole-system approach is needed to ensure people get the emergency care they need. This is why £1.6 billion of funding has been made available over two years to support the NHS and local authorities to ensure timely and effective discharge from hospital, helping to free up beds and reduce long waits for admission from A&E. The commitment to improving patient safety is highlighted in the first NHS Patient Safety Strategy. This spring, NHS England will launch a deterioration toolkit called ‘PIER’ which stands for Prevention, Identification, Escalation and Response. This suite of resources will be accompanied by improvement support delivered by Patient Safety Collaboratives and targeted at Integrated Care Systems to improve deterioration pathways. This programme of work will also incorporate the implementation of ‘Martha’s Rule’, which will be rolled out to at least 100 acute NHS trusts in 2024-25. ‘Martha’s Rule’ will allow inpatients and families to request a rapid review 24 hours a day when a patient’s physiological condition is thought to be deteriorating. We aim for all acute trusts in England to use PIER to create and implement deterioration improvement plans, alongside Matha’s Rule. This will help staff to ensure an individual’s vital sign baseline (including blood pressure) is understood and that a range of risk assessment tools and methods are used to identify, monitor and mitigate their risk of deterioration. We must ensure clinicians, and other NHS staff, can recognise unwell and deteriorating patients. The National Early Warning Score (NEWS2) is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside to support clinicians in identifying acutely unwell patients, including those with suspected sepsis. Since 2018, NEWS2 has been implemented across 98.4% of acute trusts and 100% of ambulance trusts in England. Despite the widespread use of NEWS2, some patients who deteriorate with sepsis are still not diagnosed quickly enough. To address that, ‘Recording of NEWS2 score, escalation and response time for unplanned critical care admissions’ was identified as a clinical priority area for the NHS over 2023/2024. It was included in the Commissioning for Quality and Innovation (CQUIN) scheme in 2023/2024, which aimed to incentivise the use of NEWS2 to improve care by ensuring appropriate steps are taken to record and respond to deterioration. Sepsis requires early recognition and prompt treatment with antibiotics. In May 2022, the Academy of Medical Royal Colleges published a position statement on the initial antimicrobial treatment of sepsis. Subsequently, in March 2024, the National Institute for Health and Care Excellence (NICE) updated Guideline 51 on suspected sepsis. It is critical

that updates to national sepsis guidance are disseminated and well recognised amongst a wide range of healthcare professionals who may encounter sepsis and acute deterioration. NHS England has developed several sepsis training and education resources, including e- learning, sector specific toolkits, and the ‘sepsis educational digital game,’ an accessible introduction to sepsis for clinical and non-clinical staff. We will continue to work with NHS England to understand what resources are needed ensure that healthcare professionals recognise and respond appropriately when patients deteriorate. Furthermore, there is a commitment to drive evidence generation in this area. In 2022, the National Institute for Health and Care Research (NIHR) awarded £3.2m of funding to the Sepsis Trials In Critical Care study (SepTIC), which will look to answer critical questions on sepsis diagnostics and treatment. NIHR continues to fund many ongoing studies into sepsis and welcomes applications for further research in this area. Your report also raised concerns regarding the assessment of Ms Farndon’s low blood pressure. I note you have shared your report and concerns with University Hospitals Birmingham NHS Foundation Trust, to respond directly to your matters of concern. I have included below some of the local actions that the Trust has committed to in response to the concerns in your report. Firstly, the trust has acknowledged the need for further clinical skills training for nursing staff, which includes being competent and confident in taking manual blood pressure readings. Queen Elizabeth Hospital’s A&E department has also recognised that an alternative method of assessing perfusion, such as checking the radial pulse, is needed in addition to manual blood pressure. The Trust have agreed to include this in its induction programme along with an educational update to increase awareness and compliance. The A&E standard operating procedure will be updated to reflect that any observations that are incompletely documented must be handed over to the patient's nurse, with the need to repeat the observations being clearly documented. In addition, feedback has been given to all staff involved in Ms Farndon’s care. The Trust has recognised that further education is required by clinical staff to be able to identify patients with possible sepsis having back pain, gastrointestinal symptoms and/or being afebrile. This learning will be shared at Morbidity and Mortality meetings, through local training and via the ED Safety Newsletter. The Trust has also acknowledged the need for a review of both the “Role & Responsibility Action Cards” for staff leads on shift, and the escalation procedures within ED.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Best Wishes,

MARIA CAULFIELD

Dear Mrs Hunt

Inquest touching the death of Tracey Ann Farndon Response to Regulation 28 Report to prevent future deaths

I am writing in response to the Regulation 28 notice issued following the conclusion of the inquest on 5th April 2024, into the sad death of Tracey Ann Farndon on April 25th, 2023, at Queen Elizabeth Hospital Birmingham (part of University Hospitals Birmingham NHS Foundation Trust (UHB)). I extend my sincere condolences to Mrs Farndon’s family.

I note your narrative conclusion as “Natural causes contributed to by a delay in diagnosis and treatment of sepsis. Her death was contributed to by neglect.” I further note your concerns regarding risks of future deaths, which have been addressed in turn below. The focus of the actions has been at the Queen Elizabeth Hospital Birmingham (QEHB), but the learning identified in this response has been shared with each of the responsible Hospital Medical Directors and Directors of Nursing covering QEHB, Heartlands Hospital and Good Hope Hospital, respectively, for implementation.

Concern 1:

The inquest heard how the Emergency Department at QEHB was, and continues to be, overwhelmed with patients with insufficient staff to care for, monitor and manage those patients. There is continued regular use of agency staff. This directly impacts patients' safety and is a risk of future deaths.

It is recognised that Emergency Department (ED) crowding, where the demands on the department exceed the capacity, can have a negative impact on patient outcomes and staff (Royal College of Emergency Medicine: The Management of Emergency Department Crowding, January 2024). Solutions require whole systems interventions. Causes and interventions to minimise the risk of crowding can be considered in terms of:

1) Output – The inability of patients to leave the ED once their care is completed.

UHB has Trust wide Standard Operation Procedures for Trust Capacity Escalation, and for circumstances where the Emergency Departments reach full capacity. These are followed in conjunction with the operational policy for managing ambulance offload delays. At each site, there are bed meetings held throughout the day to identify beds for patients requiring admission to ward areas. A member of the site team is present in each of the

UHB Emergency Departments between the formal bed meetings to liaise with the nurse in charge and Consultant and ensure patients are transferred to the allocated beds as soon as they become available. There are dedicated escalation processes in place with Birmingham and Solihull Mental Health Foundation Trust and Birmingham and Solihull Integrated Care Board to ensure that patients with mental health issues requiring admission are transferred from the ED as soon as possible.

At QEHB, for patients awaiting medical review who are likely to be able to be discharged following appropriate investigation and management, we have increased the number of patients referred to the acute medicine Same Day Emergency Care (SDEC) area, and created a frailty SDEC in November 2023, where frailer patients can receive the appropriate medical and therapy input. Through reconfiguration of the QEHB ED, we have reintroduced an Emergency Observation Unit (EOU) for patients that do not require admission but may require additional monitoring or investigation prior to discharge from the ED. The QEHB EOU was opened March 2024.

2) Throughput – processes within the ED

a) ED staffing

i. Nursing

A staffing matrix is used as a forward look to ensure sufficient staffing for each level of seniority on every shift, with an escalation process for predicted shortfalls. ED staff utilise shift logs and quality and safety checklists to ensure patients receive the appropriate care, monitoring, and management.

There has been an improvement in nursing recruitment, with a significant reduction in the use of agency staff in ED at QEHB. In May 2023, over 600 shifts per month were filled with external registered staff. This has reduced to 164 shifts in April 2024, with a projection to withdraw external agency requests at the end of June 2024.

ii. Medical

Due to under-recruitment, medical middle grade rosters (Specialist Registrar level or equivalent) in QEHB ED remain reliant on locum staff, but the majority of shifts are filled by doctors who work regular shifts in the department and are therefore familiar with hospital processes.

Since May 2023, at QEHB there has been an additional dedicated Consultant in the ED Ambulatory Area (EDAA) until midnight, with the aim of improving flow.

b) Reconfiguration of the department

We have recognised that the current layout of the ED at QEHB causes significant challenges to operational performance. The EDAA area was initially created to mitigate the physical distancing demands of the Covid pandemic, but its layout and location away from the main department poses risks to patients clinically and staff logistically. We will therefore be reducing the size of the EDAA to treat minor injuries and referrals to the on-site urgent care GP led service only. This will occur from June 2024, and will allow us to focus staff to provide care within the main ED footprint.

c) Rapid Assessment and Triage and eTriage

In conjunction with the physical reconfiguration of the department, we will be introducing eTriage to help identify the high acuity patients earlier on in their arrival before the full triage, and to help prioritise sicker patients in a busy ED. This system utilises the Manchester Triage System and is expected to be implemented at QEHB ED in June 2024. Introduction of eTriage will follow at our other Emergency Departments as soon as possible.

A Rapid Assessment and Triage (RAT) process is being re-established for ambulance and walk in patients. This will ensure that all patients will be reviewed by a senior decision maker and senior nurse soon after arrival, with an initial investigation and management plan instigated. RAT will be in place at QEHB by early June 2024, and will increase the safety of walk-in patients and patients in the waiting room. The effectiveness of current assessment and triage pathways at Heartlands and Good Hope Hospitals is also under review and the feasibility and utility of introducing RAT in these EDs is being considered.

3) Input – influences before the patient arrives at the ED

We have worked with system partners to introduce measures to try and reduce the number of patients presenting to each of our EDs.

At QEHB, this includes:

a) Reintroducing direct GP referrals to the Same Day Emergency Care area run by Acute Medicine – this was implemented in January 2024, and has seen a marked increase in the number of GP referrals to SDEC. b) In December 2023, a “Call before you convey” process was introduced across the West Midlands region. This facilitates ambulance clinicians to access acute and community teams for a joint clinical discussion to support the right care for patients aged over 60 years. c) UHB works closely with West Midlands Ambulance Service and the ED has an agreed Standard Operating Procedure for managing Ambulance Offloads.

Concern 2:

The inquest heard how staff failed to consider a diagnosis of sepsis throughout Ms Farndon's admission. There is a concern that staff do not fully understand the variable signs and symptoms of sepsis and there is a risk of future deaths.

There is a dedicated Trust Sepsis Group which proactively audits compliance with sepsis pathways across the organization. The emergency department at QEHB routinely identifies and successfully manages a large number of patients with sepsis. Between January and April 2024, the department identified 900 patients with sepsis, 847 (94%) of whom received antibiotics intravenously within an hour of their diagnosis.

In response to events surrounding Ms Farndon’s death, the ED department at QEHB has initiated a programme of sepsis training. This includes:

• Identifying sepsis champions at all grades of staff
• Utilising Trust and Sepsis UK resources for educational events, with focussed sepsis events planned for May and June 2024. Pre and post education assessments will evaluate whether training improves knowledge.
• Displaying sepsis specific information on safety boards

A rolling audit programme of completion of the Sepsis 6 Bundle has been established, and sepsis training is included in the induction programme for all new staff and in regular educational training updates. Sepsis is part of the educational and training programmes for all junior medical staff.

The Trust utilises sepsis screening using NEWS2, which is automatically calculated from the physiological observations recorded in the electronic medical records’ system. Alerts to consider sepsis are generated automatically when the NEWS2 is equal to or greater than 5. However, a significant focus of training is “call for concern” where a patient may have sepsis, but the NEWS2 score is less than 5.

Sepsis screening will be embedded in the Rapid Assessment and Triage process, and the early involvement of senior clinicians in the review process for walk in and ambulance patients will facilitate recognition of sepsis across the spectrum of presentation.

Concern 3:

Ms Farndon’s BP was not recordable when she first presented at the emergency department. It was likely to have been be very low. This was not considered by the staff concerned and no further attempts were made to assess Ms Farndon’s BP. There is a concern staff do not understand the implication of a low BP, the importance of continued observations when a key parameter cannot be recorded and that this may indicate the patient is seriously unwell. This raises a concern of future deaths.

A programme of manual blood pressure training and competence was commenced for all Emergency Department staff at QEHB in March 2024. This includes education regarding the limitations of electronic blood pressure measurement, for example the unreliability when patients have atrial fibrillation, and the escalation process for situations when blood pressure cannot be recorded. All band 6 and band 7 staff who are not on extended leave have completed this training, with all band 5 staff expected to have completed training by the end of May 2024. There is always a dedicated senior emergency doctor in all areas to escalate to for urgent review if the blood pressure is unable to be recorded through automatic or manual means. Training also includes education regarding additional means of assessing perfusion such as palpation of radial pulse and capillary refill time. The Trust Clinical Guidelines for taking a Non-Invasive Blood Pressure Measurement in adult patients have been disseminated to all staff. The Rapid Assessment and Triage process will ensure that there is a senior nurse and senior decision maker on initial review.

Mindful of the relevance of this concern to UHB ward areas, a Moodle educational package has been created for all UHB staff which covers fundamental observations including how to complete a manual blood pressure. The clinical skills team will be running drop-in sessions for staff to refresh their knowledge in this skill.

I would like to assure you that the concerns raised within the Regulation 28 Report have been taken extremely seriously, which I hope is demonstrated in the steps we have taken in reviewing and strengthening our systems, processes and training provision to our teams.