Prevention of Future Deaths reports · 2017
Regulation 28 report to prevent future deaths, reference 2017-0220, written 17 Sep 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 Sep 2017 |
|---|---|
| Reference | 2017-0220 |
| Deceased | Paul Maddox |
| Coroner | Andre Rebello |
| Coroner area | Liverpool and Wirral |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Wirral University Teaching Hospital NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. 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.
THIS REPORT IS BEING SENT TO:
1. CEO, Wirral University NHS Foundation Trust
2. Clinical Director, Wirral University NHS Foundation Trust
CORONER
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I am André Joseph Anthony Rebello, Senior Coroner, for the area of Liverpool & Wirral
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 19th September 2016 I commenced an investigation into the death of Paul James
MADDOX, Aged 54. The investigation concluded at the end of the inquest on 19th July
2017.
The Medical Cause of Death found at the Inquest was:
Ia Massive Gastrointestinal Bleeding with Disseminated Intravascular coagulopathy
Ib Delayed Post-Pancreatoduodenectomy Haemorrhage
Ic Renal Cancer
II Left Ventricular Hypertrophy, with Ischaemic Heart Disease
The inquest concluded:
Natural causes in part because of a failure to act upon a reducing haemoglobin trend,
when something meaningful could have been done to give Mr. Maddox a chance of life.
CIRCUMSTANCES OF THE DEATH
In January 2016 Paul James Maddox had a renal tumour removed at Arrowe Park. Part
of the tumour had spread to the pancreatic head and he later had a "whipples"
procedure at the Royal Liverpool University Hospital in August 2016. Both surgical
procedures were technically successful. At 8.50 on the 7th September 2016 Mr. Maddox
was admitted to Arrowe Park with coffee ground vomiting and was treated for Acute
Coronary Syndrome with aspiring and low molecular weight heparin. The ambulance
service had started treatment with aspirin but this was not appreciated in the emergency
department as a result of a clerical error in transferring information from the ambulance
report form. It is found that this second dose of 300 mg of aspirin did not contribute more
than trivially to Mr. Maddox demise. It is found that he had a developing coagulopathy
from before his presentation to the emergency department on the 7th September 2016.
In Arrowe Park hospital he was appropriately treated for a presentation of abdominal
sepsis. On admission to hospital Mr. Maddox had a haemoglobin level of 9.5. A staff
nurse in acute medicine ordered a haemoglobin test to be carried out, this was reported
to the clinicians at 13.17 am on the 8th September 2016 showing a falling trend to a
level of 7.2. This was not acted upon and is found to be a missed opportunity to have
detected, investigated and treated internal bleeding. At 23.00 on 8th September 2016
Mr. Maddox had deteriorated and was recognised as a surgical emergency. His
haemoglobin had dropped to 5.8. Mr. Maddox underwent surgery and it was found that
the gastrojejunal anastomosis had perforated with a large clot forcing the operation site
open with perfuse bleeding and gastric content being free in the peritoneal cavity. In
spite of the surgical intervention Mr. Maddox died at 16.10 on 9th September 2016
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CORONER’S CONCERNS
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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. –
In spite of a Trust Root Cause Analysis Report identifying a missed opportunity before
13th April 2017 the court has been told at inquest that strategies to avoid a repeated
failure were still work in progress.
The missed opportunity was not acting upon a reducing trend in a haemoglobin result.
This is simply not good enough as this issue should have been fixed during the Root
Cause analysis investigation and before the report was approved as soon as the error
became evident.
During the course of the inquest evidence was heard from several doctors including a
surgeon and it was suggested that “when there is a downward trend in haemoglobin
of 10% or more the laboratory should always ring through the result as a potential
surgical emergency for the urgent review of clinicians”
The court brings this to the attention of the Trust and for confirmation as to when a
solution to this problem has been implemented
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.
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 13th September 2017. 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.
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested
Persons the family of Mr Maddox.
I have also sent it to the Care Quality Commission who may find it useful or of interest.
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.
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André Rebello
Senior Coroner for the
City of Liverpool
Dated: 17th September 2017
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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.
Chief Executive’s Office
Trust Headquarters
Arrowe Park Hospital
Arrowe Park Road
Upton
CH49 5PE
Tel: 0151 604 7002
Mr Andre Rebello
Senior Coroner Liverpool and Wirral
HM Coroner’s Court
Gerard Majella Courthouse
Boundary Street
Liverpool
L5 2QD
12th September 2017
Dear Mr Rebello
Re: Regulation 28 Report: Paul James Maddox
This letter follows on from my letter dated 21st July 2017 in response to the Regulation 28 Report
dated 19 July 2017 which was sent following the conclusion of the inquest into the death of Mr Paul
James Maddox. You asked for a Trust response to the matters of concern raised within the report,
the proposed actions to be taken by the Trust and a timetable for the events.
The areas of concern highlighted in your report were as follows and I will address each issue
separately:
1. In spite of a Trust Root Cause Analysis Report identifying a missed opportunity before 13th
April 2017 the court has been told at inquest that strategies to avoid a repeated failure were
still work in progress.
2. The missed opportunity was not acting upon a reducing trend in a haemoglobin result. This
is simply not good enough as this issue should have been fixed during the Root Cause
analysis investigation and before the report was approved as soon as the error became
evident. During the course of the inquest evidence was heard from several doctors including
a surgeon and it was suggested that “when there is a downward trend in haemoglobin of
10% or more the laboratory should always ring through the result as a potential surgical
emergency for the urgent review of clinicians”
The Trust acknowledges and apologises to both the Court and the Family of Mr Maddox for the
delay in the implementation of the actions identified in the root cause analysis report. In order to
ensure that we learn from this case and ensure that actions are implemented in a timely fashion the
following actions have now been taken:
#PROUD TO CARE FOR YOU
wuth.nhs.uk
@wuthnhs #proud
• Line management of the Legal Services Team has been moved to the Director of
Corporate Affairs who will ensure that there are no out of date actions when the Trust
presents to families at a future inquest. There may be occasions where actions have to be
revised or reviewed, however the Trust is committed to providing the Court and the family
with the reasons for this, should this be the case.
• The distress that this case caused the family of Mr Maddox has been discussed at the
weekly safety summit on the 27 July 2017, led by the Medical Director, and was included in
the subsequent ‘Safety Bites’ newsletter on 28 July that was cascaded to all staff in the
organisation. This is to ensure that the Trust learns from when things go wrong.
• The case and Regulation 28 Report was discussed at both the Senior Management Team
meeting and the Clinical Governance Group meetings to ensure wider learning.
• A new Serious Incident meeting has been set up and meets on a weekly basis after the
safety summit to review new incidents and the progress of reports. Any issues with out of
date actions can be flagged at this meeting.
• Following an external review the Trust is in the process of revising the quality, safety and
governance structures in place. This will look to streamline and improve the responsibility,
ownership and monitoring processes in place to improve quality and safety in the
organisation.
With regards to the missed opportunity from not acting upon the reducing trend in haemoglobin
results this was reviewed in detail in the Trust. As per previous correspondence it was clear from the
action plan that the Lead Consultant Haematologist and our Laboratory Team had not been involved
in securing a solution at an early stage.
At the time of Mr Maddox’s death the triggers for acting upon a reducing trend in haemoglobin (Hb)
levels was set at a threshold of a Hb level of 70g/L on first presentation, so any result below this
level would result in the verifier phoning the doctor/ward team. The Trust is now aware that this level
is in line with the Royal College of Pathologists guidance although this is currently under review.
The Trust has a delta check in place which is a process that detects discrepancies in patient test
results prior to reporting by comparing current patient values to previous ones. At the time of the
death the delta review was set to flag any Hb level that falls below 25%. Time intervals are flexible
with most hospital laboratories choosing 24 or 48 hour intervals, this Trust flags the most recent
result.
In Mr Maddox’s case, his Hb level of 95g/l subsequently falling to a level of 72g/l did not trigger the
phone alert.
Actions taken following this case and the Regulation 28 report are as follows:
• As above this case has been discussed at the weekly safety summit on the 27 July 2017 and
was included in the subsequent ‘Safety Bites’ newsletter on 28 July that was cascaded to all
staff in the organisation
• Changes to the lab IT system have been made and an action notice has been issued to all
staff informing them of the agreed changes to our standard operating procedure around Hb
reporting
• The delta check value for Hb has changed from 25% to 20%. There is currently no delta
check in the Royal College guidance.
#PROUD TO CARE FOR YOU
wuth.nhs.uk
@wuthnhs #proud
• The telephone criteria for Hb has changed from less than 70g/l to less than 75g/l and
continues to be audited.
• The delta check change and the telephone criteria change have resulted in the system being
more sensitive to changes in patient’s presentation and condition and earlier escalation.
As previously advised the Trust continues to monitor the impact in terms of improving patient safety
and at present whilst escalation levels are manageable, the Trust will keep a watch in brief on the
work of the Royal College of Pathologists to ensure that the Trust continues to learn from others.
Please do not hesitate to contact me if you require any further information regarding this response.
Yours sincerely
David Allison
Chief Executive
#PROUD TO CARE FOR YOU
wuth.nhs.uk
@wuthnhs #proud
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