Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0202, written 17 Apr 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 Apr 2024 |
|---|---|
| Reference | 2024-0202 |
| Deceased | Thomas Wakefield |
| Coroner | Jacqueline Devonish |
| Coroner area | Cheshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: NHS England 7 and 8 Wellington Place Leeds LS1 4AP 1 CORONER I am Jacqueline DEVONISH, Senior Coroner for the coroner area of Cheshire 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 02 January 2024 I commenced an investigation into the death of Thomas Geoffrey WAKEFIELD aged 79. The investigation concluded at the end of the inquest on 10 April 2024. The conclusion of the inquest was that: Thomas Wakefield died from natural causes. It is not possible to say on balance of probabilities whether Mr Wakefield would have survived if the correct diagnosis had been made on admission. 4 CIRCUMSTANCES OF THE DEATH On 22 September 2023, 79 year old Thomas Wakefield was admitted to Countess of Chester Hospital at 22:22 hours with a three day history of severe stomach pain and sudden collapse at home in the early afternoon. The clinicians were not made aware of the collapse at home. He was promptly assessed in A&E for concerns with acute kidney injury. The plan was to prescribe intravenous fluids due to hypotension. There was a delay in medical assessment. A CT scan was considered at 05:59 but not ordered or completed. This was a missed opportunity to review the diagnosis of pancreatitis on admission and provide a 50% chance of survival. He was sadly found deceased in bed at 16:10 hours on 23 September 2023. Regulation 28 – After Inquest Document Template Updated 30/07/2021 5 CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: During a review of the NICE guidelines entitled “Abdominal Aortic Aneurysm: diagnosis and management”, and the international guidance, it became apparent that there is a lack of caution within the guidance about the recognised risk that abdominal aortic aneurysm and acute pancreatitis are known to be diagnoses misidentified by clinicians. These conditions can have similar presenting features. Whilst the guidance states that if there is uncertainty about a diagnosis of pancreatitis as not all criteria are met, imaging tests should be undertaken, this does not specifically require the exclusion of abdominal aortic aneurysm which is fatal if untreated. The clinical presentation alongside amylase results in this case met the criteria for a diagnosis of pancreatitis. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you (and/or your organisation) have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by June 12, 2024. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons Mr Thomas Wakefield’s family Countess of Chester Hospital I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response about the release or the publication of your response by the Chief Coroner. 9 Dated: 17/04/2024 Jacqueline DEVONISH Senior Coroner for Cheshire Regulation 28 – After Inquest Document Template Updated 30/07/2021
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Jacqueline Devonish
Cheshire Coroner’s Court
The West Annexe
Town Hall
Sankey Street
Warrington
Cheshire
Dear Coroner,
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
12 June 2024
Re: Regulation 28 Report to Prevent Future Deaths – Thomas Geoffrey
Wakefield who died on 23 September 2023.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17 April
2024 concerning the death of Thomas Geoffrey Wakefield on 23 September 2023. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to Thomas’ family and loved ones. NHS England are
keen to assure the family and the coroner that the concerns raised about Thomas’
care have been listened to and reflected upon.
Your Report raises the concern that existing clinical guidance does not provide the
adequate caution about the recognised risk or diagnoses for abdominal aortic
aneurysm (AAA) and acute pancreatitis.
The responsibility for the relevant clinical guidelines does not fall within the remit of
NHS England, who are independent of the National Institute for Health and Care
Excellence (NICE) and the Royal Colleges. NHS England would therefore suggest that
the coroner refer their concerns to the responsible organisations.
Notwithstanding the above, clinical leads within our organisation have reviewed the
concerns raised by the coroner. As well as the NICE guidance referenced in your
Report, the Royal College of Emergency Medicine (RCEM) and the British Society of
Gastroenterology also produce guidance on AAA and acute pancreatitis and outline
when AAA should be considered and the importance of ruling it out in individuals with
presenting symptoms of both conditions. Some relevant sections are referenced
below:
The NICE guideline (ng165) for Abdominal aortic aneurysm: diagnosis and
management states:
“1.1.7 Think about the possibility of ruptured AAA in people with new abdominal and/or
back pain, cardiovascular collapse, or loss of consciousness.
Be aware that ruptured AAA is more likely if they also have any of the following risk
factors:
• an existing diagnosis of AAA
• age over 60
• they smoke or used to smoke
• history of hypertension.
1.1.8 Be aware that AAAs are more likely to rupture in women than men.
1.1.9 Offer an immediate bedside aortic ultrasound to people in whom a diagnosis of
symptomatic and/or ruptured AAA is being considered.
Discuss immediately with a regional vascular service if:
• the ultrasound shows an AAA or
• the ultrasound is not immediately available or it is non-diagnostic, and an AAA is still
suspected.”
The RCEM best practice guidance for the Management and transfer of patients
with a diagnosis of ruptured abdominal aortic aneurysm to a specialist vascular
centre states:
"1. A clinical diagnosis of ruptured abdominal aortic aneurysm (rAAA) should be
considered:
• In patients over the age of 50 years presenting with abdominal/back pain AND
hypotension;
• In patients with a known AAA and symptoms of either abdominal/back pain OR
hypotension/collapse;
• In patients where an alternative diagnosis is considered more likely on clinical
grounds, rAAA still must be excluded, with radiological confirmation made prior to
referral"
The BSG guidelines for the Management of acute pancreatitis state:
"The value of ultrasonography lies in its ability to demonstrate gall bladder stones and
dilatation of the common bile duct, as well as other pathology unrelated to the
pancreas such as abdominal aortic aneurysm. CT is occasionally indicated for
diagnosis, if clinical and biochemical findings are inconclusive, especially when
abdominal signs raise the possibility of an alternative abdominal emergency, such as
a perforation or infarction of the bowel."
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
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.
Yours sincerely,
National Medical Director
2nd Floor
2 Redman Place
London
E20 1JQ
United Kingdom
+44 (0)300 323 0140
14 August 2025
Jacqueline Devonish
HM Senior Coroner
The Coroner’s Court
Museum Street,
Warrington,
Cheshire,
WA1 1JX
Sent via email:
Our reference:
Dear Ms Devonish
Re: Regulation 28 Prevention of Future Deaths Report (Thomas Geoffrey Wakefield)
Further to your regulation 28 report dated 2 May 2024 regarding the very sad death of
Thomas Geoffrey Wakefield, I am writing to update on progress taken since our response
dated 25 June 2024. In this we committed to amend our guideline for pancreatitis (NG104)
from “Diagnosis of acute pancreatitis is confirmed by testing blood lipase or amylase levels,
which are usually raised” to ‘A diagnosis of acute pancreatitis is supported by testing blood
lipase or amylase levels, which are usually raised, although raised blood lipase or amylase
levels may occur in other conditions’.
Our apologies for the delay in providing an update. We can confirm that this action has now
been completed via a post-publication amendment to the guideline. Our sympathies continue
to be with Mr Wakefield’s family and we hope this update and action taken is of some
reassurance to them.
Yours Sincerely,
Professor
Chief Medical Officer, Deputy CEO and Interim Director of the Centre for Guidelines, NICE
Page | 2
2nd Floor
2 Redman Place
London
E20 1JQ
United Kingdom
25 June 2024
Jacqueline Devonish
HM Senior Coroner
The Coroner’s Court
Museum Street,
Warrington,
Cheshire,
WA1 1JX
Dear Ms Devonish
Re: Regulation 28 Prevention of Future Deaths Report (Thomas Geoffrey
Wakefield)
I write in response to your regulation 28 report dated 2 May 2024 regarding the very
sad death of Thomas Geoffrey Wakefield. I would like to express my sincere
condolences to Mr Wakefield’s family.
Our patient safety leads at NICE have discussed the contents of your report and the
summary information given relating to the care given to Mr Wakefield, while
considering the relevant published NICE guidance on this topic.
Our clinical advisers have highlighted that our guideline Abdominal aortic aneurysm:
diagnosis and management (NG156) does provide details of the epidemiological
factors that should be considered as pointers towards the diagnosis, and I have
included a link to these factors below:
Recommendations | Abdominal aortic aneurysm: diagnosis and management |
Guidance | NICE.
In addition, our guideline Pancreatitis (NG104) provides advice on the treatment of
pancreatitis and gives a short outline on diagnostic features. The guidance explains
that “people with acute pancreatitis usually present with sudden-onset abdominal pain.
Nausea and vomiting are often present and there may be a history of gallstones or
excessive alcohol intake. Typical physical signs include epigastric tenderness, fever
and tachycardia. Diagnosis of acute pancreatitis is confirmed by testing blood lipase
or amylase levels, which are usually raised. If raised levels are not found, abdominal
CT may confirm pancreatic inflammation.”
Our patient safety leads have commented that. Although it is not a recommendation,
the guideline also states that a raised amylase level confirms the diagnosis of
pancreatitis. We feel this may be misleading as this can be caused by other conditions,
including mesenteric ischaemia due to an aortic aneurysm.
We are therefore going to take the following action:
Review section 1.2 of the guideline on pancreatitis, and consider whether the wording
should be changed from:
“Diagnosis of acute pancreatitis is confirmed by testing blood lipase or amylase levels,
which are usually raised” to ‘A diagnosis of acute pancreatitis is supported by testing
blood lipase or amylase levels, which are usually raised, although raised blood lipase
or amylase levels may occur in other conditions’.
It is important to add that NICE guidelines cannot cover all clinical circumstances, and
each guideline has a clearly set out and agreed scope. Our guidelines relate to specific
medical conditions, and therefore cannot cover all possible differential diagnoses.
Responsibility for decisions on the most appropriate treatment stays with individual
clinicians, whose role it is to use their professional experience and training to make
the correct decision on treatment for each of their patients. NICE guidelines are a
practical tool to be used in conjunction with and not as a substitute for clinical
judgement.
I hope this information and the action that we are taking is helpful, and would like to
reiterate my sincere condolences to Mr Wakefield’s family.
Yours sincerely,
Chief Executive
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