Prevention of Future Deaths reports · 2014

Katie Davies

Regulation 28 report to prevent future deaths, reference 2014-0255, written 6 Jun 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report6 Jun 2014
Reference2014-0255
DeceasedKatie Davies
CoronerAlan Walsh
Coroner areaManchester (West)
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedSheffield Teaching Hospitals NHS Foundation Trust · Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. The Right Honorable Mr Jeremy Hunt MP, Secretary of State for Health
Richmond House, 78 Whitehall, London, SW1A 2NS

CORONER

I am Alan Peter Walsh, Area Coroner for the Coroner Area of Manchester West
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.

INVESTIGATION and INQUEST

On 27" December 2012 I commenced an investigation into the death of Katie
Louise Davies, 21 years, born on 9" October 1991. The investigation concluded
at the end of the inquest on 22™ May 2014.

The medical cause of death was 1a Massive Cerebral Venous Sinus Thrombosis.
The conclusion of the inquest was Katie Louise Davies died as a consequence of
Cerebral Venous Thrombosis arising from a combination of naturally occurring

inflammatory bowel disease and the use of oral contraception.

CIRCUMSTANCES OF THE DEATH

1. Katie Louise Davies died at the Royal Albert Infirmary, Wigan on the 26
December 2012.

. Katie was using oral contraception and in the summer of 2012 she was
diagnosed as suffering from Crohn’s Disease, which is an inflammatory
bowel disease. She was prescribed Humira by injection for the
treatment of Crohn’s Disease.

. On the 22 December 2012 the deceased started to feel unwell whilst
shopping at the Trafford Centre, Manchester and, later the same day,
she attended at the Accident and Emergency Department at the Royal
Albert Edward Infirmary, Wigan with a history of severe headache and
vomiting. She had a CT scan which revealed a Cerebral Venous Sinus
Thrombosis and the diagnosis was confirmed by a CT venogram on the
following day.

When the CT venogram confirmed the diagnosis the deceased was
referred to the Regional Centre for Medical Neurosciences at Salford
Royal Hospital, Salford for advice in relation to treatment of the
Cerebral Venous Sinus Thrombosis and further advice as to whether the
deceased should be transferred to the Regional Centre at Salford Royal
Hospital for treatment

. The Neurology Registrar at Salford Royal Hospital supported by the
Consultant Neurologist on call, advised treatment with low molecular
weight Heparin and Warfarin, as anticoagulant treatment, with regular
neurological examinations including fundoscopy and visual fields.

The advice was that the deceased should be treated at the District
General Hospital namely the Royal Albert Edward Infirmary in Wigan and
the Regional Unit at Salford Royal Hospital should be contacted for
further advice if needed. The purpose of regular neurological
examinations was to observe the patient for signs of neurological
deterioration. Further advice was given that the deceased should be
referred to the visiting Neurologist at the Royal Albert Edward Infirmary,
Wigan

. On the 24 December 2012 the Regional Centre for Medical
Neurosciences at Salford Royal Hospital was contacted by a Clinician
from the Royal Albert Edward Infirmary, Wigan in relation to whether the
deceased should be discharged from hospital as there were no available
Neurologists visiting the Hospital for two weeks. The Neurology
Registrar at Salford Royal Hospital was informed by the Clinician that the
deceased remained clinically stable without any neurological
deterioration and the Registrar advised that the deceased should remain
in Hospital at Wigan until her symptoms settled and until she was on a
therapeutic warfarin dose.

. The deceased remained at the Royal Albert Infirmary, Wigan and,
although she showed some signs of deterioration on the 25" December
2012, her observations were stable until she was found unresponsive on
the 26" December 2012 at 7.20am when she had a cardiac arrest and
died.

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 will 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. During the Inquest evidence was heard that:-

i. In the course of investigations at the Royal Albert Edward
Infirmary, Wigan, in relation to the failure of Doctors to respond
to contact by use of the internal bleeper system during the

deceased’s admission, it was discovered that there were two

blind or blank spots within the precincts of the Hospital, where
bleepers could not be activated. The blind or blank spots were
previously unknown but were rectified so that bleepers can now
be activated within all precincts of the Hospital.

Evidence was given that it is believed that similar problems may
exist at other Hospitals in the United Kingdom and Hospitals may
be unaware of the existence of blind or blank spots within the
Hospital.

I have concerns that if blind or blank spots exist within Hospitals
that there would be a delay in the response of Clinicians to
emergencies and patients requiring urgent treatment and in my
opinion there is a risk that future deaths will occur unless action
is taken.

Expert evidence was considered at the Inquest from a Consultant
Neurosurgeon at Salford Royal Hospital and Consultant
Neurologists from London Edinburgh and Liverpool. The Experts
agreed that, on the balance of probabilities, the deceased would
have died when she did irrespective of her management after her
admission to the Royal Albert Edward Infirmary, Wigan on the
22™ December 2012.

However, evidence was given that in parts of the United
Kingdom, and in particular in London and Cambridge, the
management of patients diagnosed with Cerebral Venous Sinus
Thrombosis involved the transfer patients from a District General
Hospital to a Regional Neuroscience Centre, as soon as
reasonably practicable after a confirmed diagnosis to, allow the
patient to receive treatment in a Regional Centre where
Specialties and Sub-Specialties exist, including Consultant
Neurosurgeons, Consultant Neurologists and Consultant
Neuroradiologists together with appropriate resources and
facilities available on a 24 hour a day 365 day year basis.

The evidence confirmed that the treatment of Venous
Thrombosis or Venous Stroke is different to the treatment of
Cerebral Artery Thrombosis or Cerebral Stroke. The Experts
agreed that the treatment of Cerebral Venous Sinus Thrombosis
requires initial anticoagulation treatment and monitoring with
regular neurological examinations and neurological observations
and, where there is a significant deterioration, invasive
procedures should be considered including Thrombolysis,
Thrombectomy or Clot Extraction and Craniectomy, which can
only be carried out at a Regional Neuroscience Centre.

Following the deceased’s death, a full investigation in relation to
the treatment of patients with Cerebral Venous Sinus Thrombosis
was conducted by NS Consultant Neurologist and
Clinical Director of Medical Neurosciences at Salford Royal
Hospital who, together with Consultant

ACTION SHOULD BE TAKEN

YOUR RESPONSE

Neurologist Specialising in Cerebrovascular Diseases has
produced a policy and guidelines for the assessment and
management of adult patients with Cerebral Venous Thrombosis
in Greater Manchester, a copy of which is attached hereto.

The document is extensive and refers to the expectation that all
patients suffering Cerebral Venous Thrombosis will be transferred
from the District General Hospital to the Regional Medical
Neuroscience Centre after a confirmed diagnosis of the condition
to enable the patient to have the benefit of the Specialties,
resources, facilities and invasive procedures only available at the
Regional Centre.

The evidence at the Inquest indicated that policies and guidelines
similar to those produced “| do not
exist in many parts of the United Kingdom. In my opinion, there
is a risk that future deaths will occur unless action is taken to
review the policy and guidelines for the assessment,
management and treatment of patients suffering Cerebral
Venous Thrombosis in all parts of the United Kingdom.

2. I request you to consider the above concerns and to carry out a review
with regard to the following:-

i. The bleeper systems in all Hospitals in the United Kingdom to
consider whether blind spots or blank spots exist within the
precincts of Hospitals to ensure coverage of all areas of each
Hospital by the local bleeper system to enable response and
appropriate action by Clinicians in relation to bleeper calls at all
times.

ii. The policy and guidelines for the assessment, management and
treatment of patients diagnosed with Cerebral Venous
Thrombosis in all areas of the United Kingdom, particularly with
regard to the diagnosis of the condition and the transfer of
patients from a District General Hospital to a Regional Medical
Neuroscience Centre, as soon as practicable, after a confirmed
diagnosis to enable patients to have the benefit of the
Specialties, resources, facilities and invasive procedures, which
are only available at Regional Centre.

In my opinion urgent action should be taken to prevent future deaths and I
believe you and/or your organisation have the power to take such action.

You are under a duty to respond to this report within 56 days of the date of this
report, namely by 1* August 2014. 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:-

Wigan, Wrightington & Leigh NHS Trust

Salford _ NHS Foundation Trust

Sheffield Teaching Hospitals NHS Foundation Trust

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. 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.

Signed eZ
“u_.

Alan Peter Walsh

Dated 6" June 2014

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 Department of Health (PDF)
Ea we CEIVED
“09 MAR 2015

Department
of Health

2 2 0 0 0 ont ln me Sr ee =

Section Head

515 Richmond House
79 Whitehall

London

SWIA 2NS

Alan Walsh

HM Area Coroner

H M Coroner's Office
Paderborn House
Civic Centre

Bolton

BL1 10Y

26 November 2014

pats He. MehA

Our ref.

Thank you for your letter to HE bout her response to your Regulation 28
report on the death of Katie Davies. | am responding on her behalf.

Firstly, please accept my apologies for the delay in my response while | discussed
the issues raised in your letter of 18 September with colleagues across the
Department.

Your letter requested that,

¢ all trusts to be made aware of the issue of potential ‘blind spots’ for bleepers
and pagers on their estates; and

e the next edition of the National Clinical Guidelines for Stroke consider the
concerns you have raised.

It may be useful for me to explain that individual Trusts are responsible for their own
operations and the Department of Health does not have a “command and control”
function.

While individual Trusts remain responsible for their technology and protocols, we
recognise the salient points you have raised and have considered how we might
raise awareness within the bounds of our remit.

We have talked to colleagues in NHS Estates and Facilities about this. They have
agreed that a safety alert will be sent to all Trusts in England making them aware of
the concerns that you have raised about potential blind spots, and asking them to
investigate and take action where necessary. We will also ask that the devolved
nations are included in this alert, although you will appreciate that we are not
responsible for the NHS outside England.

On the issue of clinical guidance in the area of stroke (j j erebral
Venous Sinus Thrombosis), we have again cone tein stir
Clinical Director for Stroke at NHS England. He has agreed to ask for the issues you
raise to be reviewed as part of the process of developing the next edition of the

National Clinical Guidelines for stroke.

Additionally, although NICE have no plans at the moment to update their guidelines

on acute stroke, we have also passed the Coroner’s concerns to an
who is Centre for Clinical Practice Director at NICE, for information.

We thank you for your diligence in this case and hope that I hope that this response
is useful

Yours sincerely,

—————

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