Prevention of Future Deaths reports · 2019

Gladys Borgogno

Regulation 28 report to prevent future deaths, reference 2019-0286, written 31 Jul 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report31 Jul 2019
Reference2019-0286
DeceasedGladys Borgogno
CoronerSarah Murphy
Coroner areaStoke-on-Trent & North Staffordshire
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 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.

ANDREW BARKLEY

CORONER'S CHAMBERS,
LL.B, Hon DUniv
, 547 HARTSHILL ROAD,
HER MAJESTY’S CORONER STOKE-ON-TRENT ST4 6HF
Tel: (01782) 234777
for the

Fax: (01782) 232074

Stoke-on-Trent and North Staffordshire Email: coroners@stoke.gov.uk

Coroner’s Area

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO: Chief Executive, University Hospital of North Midlands
Chief Executive's Office

Trust Headquarters

City General Site

Newcastle Road

Stoke-on-Trent

ST4 6QG

CORONER

lam Sarah Murphy HM Assistant Coroner for Stoke-on-Trent & North Staffordshire

CORONER'S LEGAL POWERS

| 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

INVESTIGATION and INQUEST

on3” may 2018 an investigation into the death of Gladys Margaret Borgogno was commenced.
The investigation concluded at the end of the inquest on 29th July 2019. The conclusion of the
inquest was that the deceased died due to a recognised complication of a surgical procedure.
The cause of death was:

1a Acute pancreatitis.

1b Gallstones and endoscopic retrograde cholangiopancreatography (ERCP).

ll Hypertensive heart disease.
CIRCUMSTANCES OF THE DEATH

1 )On the 24th April 2018, Mrs Borgogno underwent an ERCP procedure due to symptomatic
bile duct stones. The procedure was uneventful but some stones remained.

2) Mrs Bogogno’s post procedure observations were normal but prior to discharge, she was
noted to vomit bile. This was not regarded as being indicative of a diagnosis of pancreatitis
following a medical review as there were no other clinical symptoms.

3) Mrs Borgogno was discharged home after the standard four hour post procedure hospital
observations and provided with written discharge instructions which warned of seeking further
medical advice if severe symptoms developed which included vomiting.

4) Mrs Borgogno continued to vomit in the car on the way home and at home, but did not seek
further medical attention.

5) Mrs Borgogno was found the following morning lifeless on her living room floor with vomit in
close proximity and was confirmed dead by paramedics at 10am on the 25” April 2018.

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) The length of the post procedure observation period where there has been an episode of |

vomiting in the absence of any other symptoms and normal observations.

] (2) The pre and post procedure written documentation in respect of the advice to seek further

| medical attention if vomiting developed post procedure upon discharge from hospital. In

| evidence at inquest, the treating Consultant Pancreatico-biliary Surgeon advised that he
understood the family’s confusion surrounding the symptom of vomiting given the fact that Mrs
Borgogno had vomited after the procedure but had been discharged from hospital. He advised
that he would recommend that the hospital review its pre and post procedure ERCP

| documentation provided to patients.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you and 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 Friday 27° September 2019. |, 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

| have sent a copy of my report to the Chief Coroner and to the following Interested Persons:

1. HE (son of the deceased)
2. Deputy Legal Services Manager, UHNM

| 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.

31/07/2019
Signature Hl.

Sarah Murphy HM Assistant Corohef Stoke-on-Trent & North Staffordshire

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 (PDF)
INHS|

University Hospitals
of North Midlands

NHS Trust

Trust Ref: INQ/111/18 Royal Stoke University Hospital

Executive Suite

, Springfield

25 September 2019 Newcastle Road

Stoke-on-Trent

Staffordshire

Ms S Murphy ST4 6QG
H M Assistant Coroner

Coroner’s Chambers Tel: 01782 676612

547 Hartshill Road

ST4 6HF A

Dear Ms Murphy
Gladys Margaret BORGOGNO

Further to previous correspondence, | am pleased to provide a response to your report under paragraph 7
of Schedule 5. of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners
(Investigations) Regulations 2013, addressing your concerns surrounding the death of Gladys Margaret
Borgogno. :

Recorded Circumstances of the Death

- On 24 April 2018, Mrs Borgogno underwent an ERCP procedure due to symptomatic bile.duct stones.
The procedure was uneventful but some stones remained. Mrs Borgogno’s post procedure observations
were normal but prior to discharge, she was noted to vomit bile. This was not regarded as being indicative
of a diagnosis of pancreatitis following a medical review as there were no other clinical symptoms.

Mrs Borgogno was sent home after the standard four hour post procedure hospital observations and
provided with written discharge instructions which warned of seeking further medical advice if severe
symptoms developed which included vomiting. Mrs Borgogno continued to vomit in the car on the way
home and at home, but did not seek further medical attention.

Mrs Borgogno was found the following morning lifeless on her living room floor with vomit in close
proximity and was confirmed dead by paramedics at 10am on 25 April 2018.

Cause of death was given as 1a: acute pancreatitis, 1b: gallstones and endoscopic retrograde
cholangiopancreatography (ERCP), Il: hypertensive heart disease

Concerns

During the course of the inquest H M Assistant Coroner, felt that evidence revealed matters giving rise for
concern. In her opinion, there is a risk that future deaths will occur unless action is taken and the matters
of concern are as follows:

1. The length of the post procedure observation period where there has been an episode of vomiting in
the absence of any other symptoms and abnormal observations.

Page’ 1 of 1

2.

The pre and post procedure written documentation in respect of the advice to seek further medical
attention if vomiting developed post procedure upon discharge from hospital. In evidence at the
inquest, the treating Consultant Pancreatico-biliary Surgeon advised that he understood the family’s
confusion surrounding the symptom of vomiting given the fact that Mrs Borgogno had vomited after
the procedure but had been discharged from hospital. ,

He advised that he would recommend that the hospital review its pre and post procedure ERCP
documentation provided to patients.

Action Taken
Following the inquest, the Trust has reviewed matters raised by H M Assistant Coroner and the following
response outlines the Trusts position.

As

Mrs Borgogno’s case has been discussed with the ERCP team and staff who work in the
department. The procedure information sheet advises that the post-procedure observations will be
undertaken for 4 hours and that patients will only be discharged once safe and with their
agreement.

Post ERCP, all the patients have observations every 10 minutes for the first hour, and then every
15 minutes, 30 minutes or every hour until the time of discharge (4 hours after the procedure),
depending on the patients clinical condition.

If concerns are raised during the 4 hour observation period a clinician is asked to review the
patient and the frequency of monitoring, the period of observation in recovery and the time of
discharge (same day discharge or observation overnight in the hospital) is decided.

A single episode of vomiting with no other symptom will not automatically trigger an extended
period of observation.

The Trust has strengthened the information given to patients on discharge following ERCP. | have
attached the draft document for you with the amended information in red. This is currently being
ratified through the Trust's governance processes but it now highlights the importance of returning
to hospital if vomiting, and other symptoms, start at home. This is to cover those uncommon
situations where symptoms develop post 4 hours following the ERCP procedure.

| sincerely hope that this report provides the Coroner with assurance that the University Hospitals of North
Midlands NHS Trust has taken the matters arising from the. inquest touching upon the death of Mrs
Gladys Borgogno seriously. The Trust strives to provide a high standard of care to all patients and | am
grateful to you for raising these concerns on this occasion.

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

Yours,

wicerely

Tracy Bullock
CHIEF EXECUTIVE

Encs: Post procedure patient information leaflet

ah Moy
Page 2 of 1 tin Ws

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