Prevention of Future Deaths reports · 2024

Anne Leake

Regulation 28 report to prevent future deaths, reference 2024-0696, written 16 Dec 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report16 Dec 2024
Reference2024-0696
DeceasedAnne Leake
CoronerDuncan Ritchie
Coroner areaStaffordshire and Stoke on Trent
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUniversity Hospitals of North Midlands NHS Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO:

1. 

 – Chairman of University Hospitals of North Midlands

NHS Trust

1

CORONER

I am Duncan Ritchie, assistant coroner for the coroner area of Staffordshire & Stoke-on-
Trent.

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 13th June 2024 I commenced an investigation into the death of Anne Patricia Leake,
aged 67. The investigation concluded at the end of the inquest on 9th December 2024.

The medical cause of death was:

1a Hypoxic brain injury
1b Cardiac arrest
1c Ventricular arrhythmia

The narrative conclusion was:

Natural causes contributed to by neglect.

4

CIRCUMSTANCES OF THE DEATH

Mrs Leake suffered arrhythmia and cardiac arrest on 17th April 2024.  She was admitted
to the Royal Stoke University Hospital and a multi-disciplinary team (MDT) of doctors
decided that she was to have heart valve surgery and have an Implantable Cardioverter
Defibrillator (ICD) fitted before she was released from hospital.  The purpose of the ICD
was to prevent Mrs Leake from suffering future cardiac arrhythmia and cardiac arrest.

A few days later, Mrs Leake underwent heart valve surgery as planned, but she was
then mistakenly released from hospital without having fitted the ICD which she needed.

Three days after she was released from hospital Mrs Leake suffered a cardiac
arrhythmia of the type which an ICD is designed to address, and she died as a result.

I found that the failure to fit the ICD was causative of Mrs Leake’s death and it amounted
to neglect.

The decision of the MDT to fit the ICD was overlooked by the doctors who released Mrs
Leake from hospital because the note of the MDT meeting which made this decision was
not recorded on the medical notes which they were working from.

1

 5

CORONER’S CONCERNS

During the course of the inquest the evidence 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.  –

(1)  Mrs Leake received treatment from three hospital teams: cardiology,

cardiothoracic surgery and coronary intensive care.  Each team uses their own
ward-based medical notes which are not accessible by the other teams.  Whilst
each team has access to the iPortal system on which Mrs Leake’s MDT decision
was stored, it was apparent that this was not accessed and acted upon.  As a
result, the MDT decision regarding Mrs Leake’s ICD was overlooked.

(2)  Plans to introduce electronic patient records to which all medical teams have
access are still at an early stage and no date has been identified for moving
over to a single electronic notes system.

(3)  The steps which the Trust has taken as a result of Mrs Leake’s death to address
the risk of MDT decisions being missed in the future still rely upon the manual
transcription of decisions from one set of medical notes to another, with the
continuing potential for human error and important decisions about treatment
being overlooked.

6

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and I believe that your
organisation has 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 10th February 2025. 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
Person:

 

 (Mrs Leake’s husband)

I am also under a duty to send the Chief Coroner a copy of your response.

The Chief Coroner may publish either or both in a complete or redacted or summary
form. She may send a copy of this report to any person who she 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

16th December 2024

                                                 D J Ritchie

2

 3

Responses

1 response 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.

Response from University Hospitals of North Midlands NHS Trust (PDF)
Trust Ref:    

11 February 2025 

STRICTLY PRIVATE & CONFIDENTIAL 
Mr Duncan Ritchie 
Assistant Coroner 
Stoke on Trent and North Staffordshire 

Sent via email: 

Dear Mr Ritchie  

Anne Patricia LEAKE 

Executive Suite 
Springfield Building 
Royal Stoke 
Newcastle Road 
Stoke on Trent 
ST4 6QG 

Further to your letter dated 16 December 2024, I am pleased to provide a response under paragraph 7 of 
Schedule  5  of  the  Coroners  and  Justice  Act  2009  and  Regulations  28  and  29  of  the  Coroner’s 
(Investigations) Regulations 2013, addressing your concerns surrounding the death of Anne Patricia Leake.  

Recorded Circumstances of the Death 
Mrs Leake suffered arrhythmia and cardiac arrest on 17 April 2024.  She was admitted to the Royal Stoke 
University Hospital and a multi-disciplinary team (MDT) of doctors decided that she was to have heart valve 
surgery  and  have  an  Implantable  Cardioverter  Defibrillator  (ICD)  fitted  before  she  was  released  from 
hospital.  The purpose of the ICD was to prevent Mrs Leake from suffering future cardiac arrhythmia and 
cardiac arrest. 

A  few  days  later,  Mrs  Leake  underwent  heart  valve  surgery  as  planned,  but  she  was  then  mistakenly 
released from hospital without having fitted the ICD which she needed. 

Three days after she was released from hospital Mrs Leake suffered a cardiac arrhythmia of the type which 
an ICD is designed to address, and she died as a result.  

I found that the failure to fit the ICD was causative of Mrs Leake’s death and it amounted to neglect. 

The decision of the MDT to fit the ICD was overlooked by the doctors who released Mrs Leake from hospital 
because the note of the MDT meeting which made this decision was not recorded on the medical notes 
which they were working from. 

Concerns 
During the course of the inquest, you felt that evidence revealed matters giving rise for concern. In your 
opinion, matters for concern are as follows: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 1.  Mrs  Leake  received  treatment  from  three  hospital  teams:  cardiology,  cardiothoracic  surgery  and 
coronary  intensive  care.    Each  team  uses  their  own  ward-based  medical  notes  which  are  not 
accessible by the other teams.  Whilst each team has access to the iPortal system on which Mrs 
Leake’s MDT decision was stored, it was apparent that this was not accessed and acted upon.  As 
a result, the MDT decision regarding Mrs Leake’s ICD was overlooked. 

2.  Plans to introduce electronic patient records to which all medical teams have access are still at an 
early stage and no date has been identified for moving over to a single electronic notes system. 

3.  The steps which the Trust has taken as a result of Mrs Leake’s death to address the risk of MDT 
decisions being missed in the future still rely upon the manual transcription of decisions from one 
set of medical notes to another, with the continuing potential for human error and important decisions 
about treatment being overlooked. 

You  reported  this  matter  under  Paragraph  7,  Schedule  5  of  the  Coroners  and  Justice  Act  2009  and 
Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.  

In your opinion, action should be taken to prevent future deaths.  

Action Taken 
The University Hospitals of North Midlands NHS Trust has taken the issues highlighted during the inquest 
seriously and indeed, I am grateful that you have  raised your concerns to which a response is provided 
below.  

Response to all Concerns Raised 
In considering the points of concern set out above, the Trust accepts that a Trust wide electronic patient 
record (EPR) to provide a single source of patient information is likely to have ensured that the MDT decision 
regarding  the  need for Mrs  Leake’s ICD  was  known to  all  the teams  providing  her  care.  Such  a system 

would ideally, in addition, include alerts to ensure that she was discharged safely.  

As an immediate action, the development of a new alert within iportal will be implemented – this will be 
populated by the multidisciplinary team to inform clinicians that an ICD is required prior to discharge. The 
team are going to introduce teaching into the resident doctor induction to ensure this is checked prior to 
discharge. 

However, at the current time, the Trust currently uses  many digital systems, in addition to being heavily 
reliant upon paper records. The clinical systems used, are bespoke to the needs of specific clinical teams 
and their patients, but unfortunately, cannot always share information with, or be accessed by, other teams 
and specialties.  

For an organisation the size of UHNM, with a wide range of specialist services, a single  EPR cannot be 
achieved by consolidating the current systems, which have struggled under growing requirements. As such, 
it is acknowledged that there is a continued risk of transcription and/or human error in relation to sharing of 
important clinical information until these issues have been addressed. This matter remains as a significant 
risk on the corporate risk register and is frequently assessed. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 Whist the Trust aspires to acquire a new, highly sophisticated, purpose-built single EPR system, this will 
necessitate securing significant capital investment, development and time to ensure safe deployment. To 
support this ambition, the trust is currently engaged in setting out a new digital vision and strategy,  which 
includes the goal for a new EPR across the whole Integrated Care System (ICS).  

The UHNM digital team together with the ICS, are drafting a business case to apply for NHS funding for an 
EPR that will meet our growing needs and provide the functionality and interoperability required to prevent 
the events that contributed to Mrs Leake’s death.  

It is hoped that the issue of a Regulation 28 from HM Coroner will further highlight the urgency of a new 
system and the financial support it requires. Once funding is secured, the safe development and deployment 
of a system should take a minimum of 18-24 months. Until this time, we are limited by the capability of our 
current information and technology infrastructure.  

Ongoing work to optimise the digital systems aligned to the highest clinical risks will continue within UHNM. 
This will be undertaken alongside continued work to understand the patient safety risks across all of our 
current  digital  systems  in  order  to  develop  mitigating  actions.  As  you  are  aware,  those  specific  to  Mrs 
Leake’s case have already been outlined in an after action review (AAR) following an investigation of the 
case.  

We do hope that the above information provides assurance that the Trust has taken the concerns raised at 
the inquest seriously and that both you and Mrs Leake’s family are content with the response that has been 
provided. 

Should you wish to discuss any aspect of this report further, please do not hesitate to contact me directly. 

Yours sincerely 

CHIEF EXECUTIVE

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