Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0270, written 24 Jul 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 24 Jul 2023 |
|---|---|
| Reference | 2023-0270 |
| Deceased | Christine Nakafeero |
| Coroner | Graeme Irvine |
| Coroner area | East London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
MR G IRVINE
SENIOR CORONER
EAST LONDON
East London Coroner's Court, 124 Queens Road Walthamstow, E17 8QP
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
Trust
1.
2.
, Chief Executive Officer, Barts Health NHS Foundation
, National Medical Director, NHS England
3. Rt Hon Steve Barclay MP, Secretary of State for Health & Social Care
1
CORONER
I am Graeme Irvine, senior coroner, for the coroner area of East London
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.
http://www.legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7
http://www.legislation.gov.uk/uksi/2013/1629/part/7/made
3
INVESTIGATION and INQUEST
On 22nd June 2022 this Court commenced an investigation into the death of Christine
Nakafeero, age 56 years. The investigation concluded at the end of the inquest between
20th and 21st July 2023. The court returned a narrative conclusion.
“Christine Goodfriday Nakafeero died at home on 21st June 2022 due to a pulmonary
embolism caused by a deep vein thrombosis ("DVT"). The DVT was made more likely
by: a medical condition, uterine fibroids and the treatment for that condition, tranexamic
acid.
1
In 2019 Ms Nakafeero was referred to the gynaecology clinic with a recommendation
that she underwent a hysterectomy to effectively treat her uterine fibroids. Due to a
breakdown of communication between Ms Nakafeero and the Trust, the surgery was not
undertaken. Had the surgery taken place, Ms Nakafeero would probably not have
developed a pulmonary embolism in June 2022.”
Ms Nakafeero’s medical cause of death was determined as:
1a Pulmonary Emboli; 1b Deep Vein Thrombosis; II Uterine Fibroids
4
CIRCUMSTANCES OF THE DEATH
Christine Goodfriday Nakafeero was found unresponsive at home on the evening of 21st
June 2022. Despite the best efforts of her family and emergency services she was
declared deceased that evening.
Her death was caused by a pulmonary embolism, in turn caused by a deep vein
thrombosis.
Earlier that day Ms Nakafeero had been discharged from hospital having presented with
symptoms of menorrhagia and associated pain and anaemia on 19th June 2022.
Whilst an inpatient, Ms Nakafeero was assessed for risk of venous-thrombo-embolism
(“VTE”) risk utilising the Trust’s VTE policy, she was categorised as having zero risk of
thrombo-embolism.
Ms Nakafeero had been diagnosed with uterine fibroids since 2019 and had been
prescribed tranexamic acid and pain relief to control the symptoms.
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. Ms Nakafeero was assessed at a Gynae-oncology clinic in early 2019. The
patient was diagnosed as not suffering from any form of cancer and was
therefore referred on to the “benign” gynaecology team.
Ms Nakafeero was advised that it was likely that the most effective treatment for
her condition was a hysterectomy. It was expected that the likely wait for this
treatment would be 6 months.
Ms Nakafeero was not allocated an appointment and therefore had not received
the necessary surgery by the time of her death in June 2022. Had the surgery
been undertaken it is probable that she would not have developed a pulmonary
embolism.
Although the trust has investigated these circumstances and implemented
change, no clear explanation could be offered for why the deceased slipped out
of this care pathway. I am not satisfied that the risk of re-occurrence has been
properly addressed.
2. The clinicians treating Ms Nakafeero assessed her VTE risk utilising an
established algorithm based on national guidance. The assessment was
undertaken appropriately but it failed to identify two risk factors which made the
2
formation of a DVT more likely, namely, large uterine fibroids and the use of
tranexamic acid. I have concerns that the omission of these factors in the
assessment criteria limited the effectiveness of the risk assessment.
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 Monday 18th September 2023 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 the family of Ms Nakafeero. I have also sent it to the local Director of Public
Health who may find it useful or of interest.
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 other 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.
9
24/07/2023
3
2 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.
Trust Executive Office
Ground Floor
Pathology and Pharmacy Building
The Royal London Hospital
80 Newark Street
London E1 2ES
Group Chief Medical Officer
14 September 2023
Mr Graeme Irvine
Area Coroner – East London
Walthamstow Coroner’s Court
Queen’s Road
London
E17 8QP
Dear Mr Irvine
Re: Regulation 28 Report to Prevent Future Deaths
I write regarding your letter of regarding your concerns relating to the death of Christine Nakafeero at
Newham University Hospital. I hope this letter will provide assurance to you of the steps that we are
taking to address the concerns you have outlined. I will respond to these concerns in turn.
1. Patients lost to follow-up on the Gynaecology pathway
We are implementing a fully electronic outpatient outcome system using outpatient organiser on our
Cerner millennium system. This provides real time outcoming within clinics, and an electronic audit
trail to track the patient along the pathway.
Alongside the use of electronic outcome forms, the Trust is rolling out LUNA, a digital monitoring tool
for patient tracking lists which will replace our current electronic waiting list tool at the end of
September 2023. LUNA has the ability to pick up errors allowing staff to make corrections. It has an
AI tool that reviews letters for key text which can indicate where incorrect discharge is matched with
a letter stating the patient should be seen again. Therefore, this can be corrected, and a follow up
appointment sent to the patient .
2. Limitations of the VTE risk assessment
You raised concerns that the use of tranexamic acid and the presence of pelvic fibroids may have
have limited the national risk assessment tool for prevention of venous thromboembolism although
the national tool was used correctly.
The Trust has discussed this matter at the Venous Thromboembolism Prevention Committee and
reviewed the available published evidence regarding the relative risk of these two factors and any
other available guidance. Current evidence of relative risk is very limited and subject to debate
nationally and there are no specific College or National guidelines available dealing with these
specific topics.
In addition, the Trust has sought advice from
Thrombosis and Haemostasis at Kings College Hospital and Director of the National VTE Exemplar
Centres Network in England as well as previously Clinical Lead for the National VTE Prevention
Programme. The Trust has been advised that the use of the tool was appropriate and at this time
there is not enough evidence to adapt or change this. In addition, in a patient who was experiencing
recurrent heavy bleeding the use of enoxaparin was not indicated and there was no indication for
anti-embolic stockings.
The Trust’s VTE committee will continue to monitor the information received from national bodies as
part of the overarching vigilance regarding preventable venous thromboembolism.
who is Professor of
Thank you for bringing your concerns to my attention. I trust that you are assured that I have
taken them seriously and that the hospital has investigated them appropriately and is taking
appropriate action. Please let me know if you require clarity on any of the points above.
Yours sincerely
Chief Medical Officer
Barts Health NHS Trust
From Maria Caulfield MP
Parliamentary Under Secretary of State for
Mental Health and Women's Health Strategy
Department of Health & Social Care
39 Victoria Street
London
SW1H 0EU
Mr Graeme Irvine
Senior Coroner East London
East London Coroner's Court
124 Queens Road Walthamstow
E17 8QP
13 May 2024
Dear Mr Irvine,
Thank you for the Regulation 28 (Preventing Future Deaths) report of 24th July 2023 in
relation to the death of Christine Nakafeero. I am replying as Minister with responsibility for
patient safety.
Please accept my sincere apologies for the delay in responding to this matter. I would like to
assure you that the Department is mindful of the statutory responsibilities in relation to PFD
reports and we are prioritising responses as a matter of urgency.
I would like to begin by saying how saddened I was to read about the circumstances of Ms
Nakafeero’s death and would like to offer my sincere condolences to her family and loved
ones. It is vital that we learn from incidents where we can to improve NHS care.
I have noted the concerns raised in your report. The first relates to the Trust’s failure to
allocate an appointment for Ms Nakafeero to undergo a hysterectomy, coupled with the
absence of a clear explanation as to why she slipped out of this care pathway. You also
expressed concern that Ms Nakafeero’s venous-thrombo-embolism (VTE) risk was
assessed by utilising an established algorithm based on national guidance but that despite
this being done appropriately, it failed to identify two risk factors which made the formation
of a deep vein thrombosis more likely.
I understand that the Care Quality Commission (CQC) engaged with Barts Health NHS
Trust following Ms Nakafeero death, to understand what actions it was taking to address
your concerns. The Trust explained that it was in the process of improving how it monitors
outpatient outcomes and how it tracks patients along the pathway. To facilitate this, the
Trust confirmed that it was implementing an improved digital monitoring tool for patient
tracking lists to replace its electronic waiting list tool. I understand that CQC is monitoring
the impact of this implementation and how the Trust assures itself that it is effectively
monitoring all patients across care pathways.
The Trust also explained to CQC that it was seeking expert advice from Professor Roopen
Arya, Professor of Thrombosis and Haemostasis at King’s College Hospital and Director of
the National VTE Exemplar Centres Network in England. Professor Arya advised the Trust
that the use of the tool to assess VTE risk and determine intervention was appropriate and
that at that time there was insufficient evidence to adapt or change this. I am aware that the
Trust is also continuing to monitor the information it received from national bodies that
informed how it implements best practice on prevention of VTE.
I would like to assure you that ensuring patients are safe is a priority for this Government.
We have taken significant action over the last decade to advance patient safety and the
response to harm in the NHS and, with our system partners, will continue to do all we can
to stop harmful events from ever happening.
Thank you again for bringing your concerns to my attention.
Yours sincerely,
MARIA CAULFIELD
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