Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0450, written 15 Nov 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 Nov 2023 |
|---|---|
| Reference | 2023-0450 |
| Deceased | Calogero Di Blasi |
| Coroner | Debbie Rookes |
| Coroner area | Avon |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | University Hospitals Bristol and Weston NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
M. E. Voisin
Her Majesty’s Senior Coroner
Area of Avon
15 November 2023
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Secretary of State for Health
2. University Hospitals Bristol & Weston NHS Foundation Trust
3.
4. The Royal College of Physicians
5. Chief Coroner
, daughter of the Deceased
1
CORONER
I am Debbie Rookes, Assistant Coroner for the Coroner Area of Avon
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 December 2022 an investigation was commenced into the death of Calogero Di
Blasi. The investigation concluded at the end of the inquest on 15th November 2023.
The conclusion of the inquest was:
The deceased died as a result of a recognised complication of an investigative medical
procedure in circumstances where underlying cirrhosis and resultant varices were
unknown, and not recognised as a possibility, by the Endoscopist
The cause of death was recorded as:
1a) Haemorrhagic shock
1b) Perforated gastric varix (post surgical procedure)
1c) Portal hypertension due to chronic alcoholic liver disease
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL
4
CIRCUMSTANCES OF THE DEATH
On 10 August 2022, Calogero Di Blasi was referred by his GP to the Upper Gastro-
intestinal team at the Bristol Royal Infirmary for possible stomach cancer. He
underwent an endoscopy on 18 August 2022 where biopsies were taken. The results
showed abnormal cells. On 15 September, Mr Di Blasi was referred by a GP to the
Lower Gastro-intestinal team for possible bowel cancer and had a CT scan on 4
November 2022. The CT scan revealed cirrhosis with portal hypertension and gastric
varices, which were new incidental findings. The Lower GI team had been made aware
of the investigations ongoing by the Upper GI team, but the upper GI team were
unaware of the Lower GI team’s involvement. Both referrals were made on the 2 week
cancer referral pathway. The CT Scan was reported on 14 November, and double
reported on 16 November 2022. However, the referring clinician did not review the
report until the day after Mr Di Blasi’s death, on 2 December 2022. The incidental
findings were not considered to be ‘significant’ by the Radiologists and were not
therefore warrant an alert being sent to the referring clinician, leaving the report to be
reviewed when they were able to. My investigation revealed that the timeframe for
seeing patients on the cancer referral pathway is the date of the first appointment and
there are no other target dates in respect of investigations of subsequent treatment.
Mr Di Blasi underwent a further endoscopy on 30 November 2022. The Endoscopist
was unaware of these incidental findings. A biopsy was taken from an area which
looked abnormal but was actually a gastric varix. As a result of this, Mr Di Blasi suffered
a massive bleed and despite maximal supportive measures, he died on 1 December
2022 at the Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW.
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 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) That one of the teams caring for Mr Di Blasi was completely unaware of the input
from another specialty team, despite both referrals being made under the 2-week
urgent referral pathway. The lack of communication between these teams meant that
timely sharing of results did not occur. Even the very knowledge of the fact that a CT
scan had taken place would have alerted the endoscopist to check those results, and it
is likely that the second endoscopy would not have gone ahead. I understand this to be
a national issue and is likely to apply to other investigations being carried out.
(2) That the reporting timeframes on the 2-week urgent cancer pathway referral does
not take into account timeframes for reporting investigative procedures or subsequent
review by the referring clinicians.
(3) The current training for Endoscopists for JAG certification requires the performance
of 200 endoscopies. However, these tend to focus on the clinician’s area of specialty
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL
and therefore there is a danger that lesion recognition will be limited and insufficient to
ensure that endoscopists are able to recognise less frequently occurring lesions. With
the need for an increasing number of endoscopists, action should be taken.
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL
6
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you, the
Secretary of State for Health, have the power to take such action, and that University
Hospitals Bristol & Weston also have the power to take such action on a local level.
7
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 10 January 2024. 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
Chief Coroner. I have also sent a copy to The Royal College of Physicians who I
understand are involved in the training of Endoscopists.
the daughter of the Deceased, and to the
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.
9
15th November 2023
Debbie Rookes
Assistant Coroner
The Coroner's Court, Old Weston Road, Flax Bourton, BS48 1UL
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.
The Rt Hon. Andrew Stephenson CBE MP
Minister of State
39 Victoria Street
London
SW1H 0EU
5th March 2024
Dear Debbie,
Thank you for your letter of 15 November 2023 about the death of Calogero Di Blasi.
I am replying as Minister with responsibility for Health and Social Care.
Firstly, I would like to say how saddened I was to read of the circumstances of
Calogero Di Blasi’s death and I offer my sincere condolences to their family and loved
ones. The circumstances your report describes are very concerning and I am grateful
to you for bringing these matters to my attention.
In preparing this response, Departmental officials have made enquiries with NHS
England. The matters of concern you raise relate to the local management and
implementation of national policies and procedures. As such, I requested NHS
England liaise with the North Somerset and South Gloucestershire Integrated Care
Board (ICB) responsible for University Hospitals Bristol and Weston NHS Foundation
Trust.
From advice received from NHS England, my understanding is that the ICB has looked
into the circumstances of Mr Di Blasi’s death and acknowledges the findings set out in
the coroner’s report. I understand that the ICB has made several recommendations to
the Trust to address the issues in question which I hope will help the trust to ensure
that the events leading up to Mr Di Blasi’s death will be avoided in the future of care
of other patients. I understand the Trust also plan to write directly to you setting out
action they have planned, and taken locally, in response.
Since the death of Mr Di Blasi, NHS England and the Department have reformed
cancer waiting time standards, following a clinically led review. This has replaced the
two-week wait standard with the Faster Diagnosis Standard (FDS) for patients to get
a cancer diagnosis or all-clear within 28 days of an urgent referral. The FDS moves
focus away from process to deliver a clear clinical outcome – either diagnosing or
ruling out cancer. This represents an improvement on the preceding 2-week wait
standard, which was simply to “see a specialist” and addresses the coroners concerns,
as the new standard takes into account times for reporting and reviewing diagnostic
procedures. The reform also consolidated cancer standards from nine to three to
reduce bureaucracy of reporting against a large number of standards.
I hope this response is helpful. Thank you for bringing these concerns to my attention.
Kind regards,
THE RT HON ANDREW STEPHENSON CBE MP
MINISTER OF STATE
Trust Headquarters
Marlborough Street
Bristol BS1 3NU
10 January 2024
Ms Debbie Rookes
Assistant Coroner for Avon
PFD RESPONSE
Dear Ms Rookes,
Deceased: Calogero Di Blasi
I am writing in response to the Regulation 28 Report to Prevent Future Deaths dated 15 November
2023.
I would like to begin by extending my deepest condolences to the family of Mr Di Blasi. I hope that
my response provides his family with assurance that the Trust takes their loss seriously and has
taken this further opportunity to consider actions which may prevent this from recurring.
In order to respond to the matters of concern set out in your report and provide assurance to you
on the actions taken to mitigate the risk of future deaths, I have sought the assistance of
Chief Clinical Information Officer. In addition, I have consulted with
,
Clinical Chair for the Division of Surgery, who has clinical responsibility for the Colorectal and
Upper GI teams, and
the inquest and has clinical responsibility for Radiology.
, Clinical Chair for Diagnostic and Therapies, who was present at
Matters of concern
1) Issues arising from parallel clinical pathways
I acknowledge your concern around the communication between specialties when a patient is on
two active pathways. I recognise the importance of such knowledge, given the increasing
complexity of the patient demographic we treat.
I understand that you heard evidence from the clinical team around the additional question on the
pre-procedure checklist for endoscopy. A patient is now asked whether they have had any
investigations within the last 6 weeks, and I was pleased to hear that this has been effective in
identifying such investigations.
and the witnesses to consider whether any further action could be taken to
I asked
strengthen the pre-procedure checklist. I am advised that they have identified an additional
potential change in practice. The Division of Surgery will undertake a scoping exercise to assess
the feasibility of the administrative teams reviewing the patient list and identifying any patients who
are on a parallel clinical pathway. The endoscopist would then be notified to review the electronic
records and ICE and any relevant investigations before the procedure. Upon completion of the
scoping exercise, the Division will consider whether a pilot may be offered for the endoscopy team.
As many patients are treated out of the region or in private or satellite institutions, the subsequent
check by the clinician, through a discussion with the patient, provides another opportunity to
identify relevant investigations, thereby ensuring there is a robust process in place.
I trust that this is striking the balance between maintaining the number of investigations for those
patients on the urgent referral pathway, whilst ensuring that relevant investigations are identified
for each patient.
2) The reporting timeframe on two 2 week urgent cancer pathway referral does not take
into account timeframes for reporting investigative procedures or subsequent review
by the referring clinicians.
As you heard in evidence, there is, regrettably, a national shortage of Radiologists. I therefore
envisage that the Secretary of State for Health may wish to add to the below response from the
Trust.
Firstly, I attach the guidance on diagnostic imaging reporting turnaround times issued by NHSE in
August 2023. Whilst this national guidance was issued after Mr Di Blasi’s death, it provides a
maximum turnaround time of 3 days for outpatients on a cancer pathway.
The Trust recognises that this best practice relies upon there being full staffing available to deliver
it. Furthermore, the guidance considers that adherence to the turnaround times relies upon good
digital connectivity and IT infrastructure; I will turn to the Trusts’ digital strategy below.
Regrettably, in parallel with a number of organisations across the country, the Trust is not meeting
this timeframe. The following mitigations have been put in place:
• The Trust is actively recruiting to the vacancies for radiologists.
• Outsourcing is used to maximise the number of reports which can be achieved within the
timeframe
• Locum radiology cover can be arranged.
• Additional sessions are in place for existing radiologists
• The Division is undertaking a scoping exercise to increase the resource of radiographers
who could support the radiologists.
All of the above actions will increase reporting capacity and seek to enact the recommendations
from the national guidance. In addition, the Radiology team have added a risk to the risk register
around turnaround times. This will ensure that this remains a priority for the Division.
Secondly, the guidance confirms that local Standard Operating Procedures (SOPs) should identify
‘urgent’, ‘emergency’ and ‘time critical’ findings. You heard in evidence that the Trust’s SOP on
Incidental Findings will be reviewed, with a view to updating this to reflect the recent national
recommendations of the royal colleges.
Aligned to this, I have received an update in respect of the paper reports for radiology; these will be
discontinued from 1 May 2024. Results will continue to be available via the ICE and PACS
electronic reporting systems. As part of the transition away from paper results, the Trust plans to
set up specialty specific reporting systems within our existing digital platforms.
Alerts
I thought it important to update on the action the Trust has considered but would be unable to
implement.
I understand that it was explored in evidence whether an alert could be added to the electronic
records for varices. It would not be practicable to highlight chronic conditions in alerts.
Notwithstanding the fact that their purpose is to identify standardised alerts, such as allergies and
the need for an interpreter, expanding this to include a new diagnosis, would not be feasible.
Furthermore, it may be helpful to explain that the alerts do not pop up when a clinician opens the
electronic record, they must be accessed, and there is a risk that adding new alerts could increase
risk.
The Trust has therefore carefully assessed this option but considers that it would not improve
patient safety and would be outwith our understanding of how other Trusts are utilising alerts on
electronic records.
3) The current training for Endoscopists for JAG accreditation requires the
performance of 200 endoscopies. However, these tend to focus on clinician’s area of
specialty and therefore there is danger that lesion recognition will be limited and
insufficient to ensure that endoscopies are able to recognise less frequently
occurring lesions. With the need for an increasing number of endoscopists, action
should be taken.
I note that the Regulation 28 Report was shared with the Royal College of Physicians, who I
understand are responsible for the Joint Advisory Group on GI Endoscopy (JAG) and will be
providing you with a response from a national perspective.
The Trust has taken further action, over and above those completed for the PSII, to address this
concern:
•
operates 5 training lists each week, in his capacity as Clinical Lead. He is able to
share his knowledge of lesion recognition with junior doctors, to build upon the 200
endoscopies they are required to take in their own training. The current schedule includes
10 dedicated training lists, in addition to ad-hoc training and hosting fellows in Lower GI
Endoscopy and Advanced Hepatobiliary Endoscopy. The Trust collaborates with other
Bristol endoscopy institutions to provide training courses on upper gastrointestinal
haemostasis and colonic polypectomy, both JAG-certified courses. Trainees of all
endoscopic disciplines are encouraged to attend lists where they are likely to encounter a
broad range of pathology.
• Learning from this case has been shared at our pan-UHBW Endoscopy Users Group
(EUG), in addition to local Gastroenterology and Hepatology education meetings.
• Endoscopists have access to an online endoscopy learning platform (GIEQs online;
accredited by the European Society for Gastrointestinal Endoscopy (ESGE) and American
Society for Gastrointestinal Endoscopy (ASGE)). We are able to audit uptake of the online
content prior to quarterly EUG meetings. We are also collaborating with the South-West
Endoscopy Training Academy (SWETA) to create a mandatory local learning resource that
will form a part of the Trust statutory training for staff involved in gastrointestinal endoscopy.
• The PSII has also been shared at the Patient Safety Group, which has representation from
all of the Clinical Divisions at the Trust, to ensure learning is cascaded across all
specialties.
Digital Strategy
UHBW and NBT will shortly appoint a joint Chief Executive and Chair. The Chief Digital Information
Officer has already been appointed across both Trusts and is in the process of launching a Digital
Strategy, with the aim of converging the IT systems across the provider collaborative.
As a tertiary centre, the Trust receives referrals from across the region and recognises the
importance of integrated working. The challenge of multiple systems for records is a national one.
The overarching aim of the strategy will be to ensure that clinical information is digital and in one
place, thereby avoiding paper records. I therefore hope that you will begin to see a united
approach across the two Trusts who serve the jurisdiction. I am hopeful that the improved
infrastructure will help to support the delivery of the turnaround times discussed above.
I understand that Mr Di Blasi’s family requested that the learning from this inquest be shared with
the Clinical Endoscopist who performed the first endoscopy, but who no longer works at the Trust.
The Trust will endeavour to achieve this. Lastly, it may be helpful to confirm that the Endoscopy
team is auditing photo documentation during an endoscopy as part of the recurring audit plan.
We trust that the above actions provide you, and the stakeholders you have shared the Regulation
28 Report with, assurance that the Trust has learnt from this death. We are consistently
challenging ourselves to consider further action we can take to strengthen patient safety, whilst
recognising that a number of the concerns raised are at a national level.
Yours sincerely
Interim Chief Executive
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