Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0399, written 17 May 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 May 2024 |
|---|---|
| Reference | 2024-0399 |
| Deceased | Antony Waring |
| Coroner | James Adeley |
| Coroner area | Lancashire & Blackburn with Darwen |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Lancashire & Blackburn with Darwen Coroners Dr James Adeley Senior Coroner Date: 17 May 2024 Our Ref: REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: East Lancashire Hospitals Trust 1. Coroner I am Dr James Adeley, Senior Coroner for the Coroner area of Lancashire & Blackburn with Darwen. 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/para graph/7 http://www.legislation.gov.uk/uksi/2013/1629/part/7/made 2. INVESTIGATION and INQUEST On 29 June 2020 I commenced an investigation into the death of Antony Waring 70. The investigation concluded at the end of the inquest . The conclusion of the inquest was: Antony WARING died on 24 June 2020 at Royal Blackburn Hospital following a highly inappropriate choice of urological surgical technique for the insertion of the suprapubic catheter causing perforation to the small bowel and resulting in a major laparotomy and admission to the Intensive Therapy Unit. Subsequent necessary feeding via a nasogastric tube in the oesophagus resulted in an aspiration Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752 pneumonia. Mr Waring's death was contributed to by neglect. 1a Aspiration pneumonia following inadequate placement of nasogastric tube; 1b Laparotomy for small bowel perforation and bladder repair; 1c Supra pubic catheter insertion. II Multiple Sclerosis 3. Circumstances of the death Antony Waring was 71 years of age on the date of his death of 24 June 2020 at Royal Blackburn Hospital operated by East Lancashire Hospitals Trust. In 2002 Antony suffered from Multiple Sclerosis Waring had undergone a cystoplasty in which a loop of small bowel was brought down into the pelvis. There was a second laparotomy due to adhesions a week later. On 20 March 2020 Antony Waring attended an Urology outpatient appointment for the insertion of a suprapubic catheter insertion, which was necessary due to complications caused by an indwelling catheter. For the insertion of a suprapubic catheter, Consultant 1 described Antony Waring's insertion of a suprapubic catheter as a "difficult and risky" procedure due to the previous surgery. As a result, to manage this risk, Antony Waring was listed for a catheter insertion with ultrasound guidance. The only guidance available in Europe and North America concerning the insertion of suprapubic catheters published by the British Association of Urological Surgeons guidance. This is a document by a committee that is subsequently peer-reviewed and consulted upon before being published in a journal. There is no NICE guidance for the insertion of suprapubic catheters. The 2010 BAUS guidance relevant at the time states as follows: "In the patient with either a history of lower abdominal surgery or a bladder that cannot be adequately distended, the SPC should either be inserted using an open technique or with the adjunct of imaging that can reliably exclude the presence of bowel loops on track. An open procedure must be the performed in a manner that will reliably identify the bladder and allow mobilisation of any interposing intestine away from the catheter track." intended catheter Consultant 1 informed Antony Waring that an open procedure was not in his best interests. Consultant 1 made no request for Antony Waring Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752 to be allocated to a urological consultant who use CT scanning, nor made any arrangements for the presence of an interventional radiologist to provide ultrasound guidance and allocated Antony Waring to a Core List where it was a matter of chance if ultrasound guidance would be used. The Trust has at least two consultant urological surgeons who routinely use ultrasound. On 12 June 2020 Antony Waring attended hospital for the insertion of a suprapubic catheter. Consultant 2 was aware of consultant 1's views that ultrasound guidance was necessary. Consultant 2 made no attempt to manage the increased risk of interposing bowel on the suprapubic catheter insertion track by arranging either ultrasound or undertaking an open procedure. Consultant 2 inflated Antony Waring's bladder and inserted the suprapubic catheter perforating two loops of small bowel during the introduction. Antony Waring was admitted to intensive care unit with peritonitis and died 12 days later. The adequacy of the Trust's Maintaining Health Professional Standards investigation and adequacy of the consent process have been dealt with by separate correspondence. 4. Coroner's Concerns The MATTERS OF CONCERN are as follows: (1) the Trust made no progress on the introduction of an SOP recommended in the internal review for almost 4 years. A draft SOP had been proposed in the weeks leading up to the inquest. (2) The expert evidence at the inquest was that the Trust's proposed action plan using CT scanning at an unspecified time before a suprapubic catheter insertion was sub optimal and inferior to ultrasound as bowel may move between the date of the CT scan and the catheter insertion; (3) in the four years since Antony Waring's death, the Trust has not provided a single ultrasound teaching session provided by the Trust to any consultant who is not capable of using ultrasound. (4) the allocation of high-risk patients to Core Lists where a specific ancillary prophylactic measure such as ultrasound is left to either chance or to an administrator; (5) The expert evidence at the inquest was that the research provided on the risk of complications after insertion of a suprapubic catheter into patients with lower abdominal surgery is inappropriate the patient such as Antony Waring and provides false reassurance as to the level of risk posed to these patients. 5. Action should be taken In my opinion action should be taken to prevent future deaths and I Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752 believe you have the power to take such action. 6. Your response You are under a duty to respond to this report within 56 days of the date of this report, namely by 12 July 2024. I, the coroner, may extend the period, but after the extensive inquest, he interval between the inquest and the service of this Report and that you have been on notice during this period, only with exceptional reasons. 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. 7. Copies and publication I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: 1. Antony Waring's family 2. CQC 3. Relevant ICB 4. British Association of Urological Surgeons 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. Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752 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. Yours sincerely Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752 James Adeley HM Senior Coroner Lancashire & Blackburn with Darwen Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, PR2 9NB Tel: (01772) 536536 Fax: (01772) 530752
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.
Royal Blackburn Teaching Hospital
Trust Headquarters
Haslingden Road
Blackburn
BB2 3HH
Enquiries to:
Telephone No:
Ext:
Email
12th July 2024
Dr James Adeley
HM Senior Coroner
Lancashire and Blackburn with Darwen
Sent via email only
Dear Dr Adeley
Regulation 28 Report – Response by East Lancashire Hospitals NHS Trust
Inquest relating to the death of Antony Waring
This letter comprises the formal response of East Lancashire Hospitals NHS Trust (“the Trust”)
pursuant to section 7(2) to Schedule 5 of the Coroners and Justice Act 2009 and Regulation 29
Coroners (Investigations) Regulations 2013, to the issues raised in the Regulation 28 Report to
Prevent Future Deaths, dated 17 May 2024, made following the inquest into the death of Antony
Waring, which concluded on 12 April 2024.
I would like to start the response by offering our sincere condolences to Antony’s family for their
loss. The Trust fully accepts the findings of HM Coroner and are truly sorry that Antony did not
receive the treatment and care we would expect him to receive.
The Prevention of Future Deaths report identifies a number of areas of concern, and I will
address these in this response, with details of the actions we have undertaken and those that
we plan to undertake in the near future, along with details of the improvements made to date.
Matters of Concern
(1) The Trust made no progress on the introduction of an SOP recommended in the
internal review for almost 4 years. A draft SOP had been proposed in the weeks
leading up to the inquest.
Response
I am pleased to confirm that the Trust’s SOP for ‘Minimising the risks of supra-pubic catheter
insertion in complex cases of patients who have had previous abdominal or bladder surgery’
has now been approved and ratified following the inquest hearing.
The Trust would like to assure both HM Coroner and Antony’s family that the SOP has been
embedded as an additional safety mechanism as a result of additional learning. Following the
evidence heard at Mr Waring’s inquest the Trust has reflected on the guidance that was in place
at the time and made the necessary changes to the clinical processes. The Trust SOP does not
replace the British Association of Urological Surgeons (“BAUS”) SPC (suprapubic catheter)
2020 guidelines but is to be used in conjunction, with careful consideration of the individual
patient on a case by case basis.
The SOP is for all healthcare professionals involved in the assessment, planning and insertion
of a suprapubic catheter in ‘non-routine’, complex cases where a patient has a previous history
of bowel, bladder or abdominal laparoscopic surgery, and is in accordance with the BAUS
suprapubic catheter practice guidelines.
As an organisation we constantly strive to improve patient safety and I can confirm these
changes have been confirmed by both the Urology and Radiology Departments. In order to
ensure the SOP is fully embedded, an assurance process is now in place for monitoring and
escalation, with regular audits being introduced and associated assurance reporting.
The Clinical Director for Urology has confirmed that all clinical staff are aware of the new
guidance and how it is implemented. This process will be audited annually by the Clinical
Director and any deviation from policy will be escalated as part of the Trust’s incident reporting
framework. I am advised that since Mr Waring’s inquest an SPC incident was raised and a
Patient Safety Review undertaken, which confirmed that all appropriate steps were taken and
the BAUS SPC 2020 guidelines followed.
(2) The expert evidence at the inquest was that the Trust's proposed action plan
using CT scanning at an unspecified time before a suprapubic catheter insertion
was sub optimal and inferior to ultrasound as bowel may move between the date
of the CT scan and the catheter insertion.
Response
As indicated above at point (1), the Trust has reflected on the evidence presented at Mr
Waring’s inquest and changes have been made to clinical processes in place with the
introduction of the SOP for ‘Minimising the risks of supra-pubic catheter insertion in complex
cases of patients who have had previous abdominal or bladder surgery’.
With regards to the concern regarding ultrasound scanning I can confirm that under the new
SOP complex SPC insertions are now listed as a scheduled joint procedure with a Consultant
Urological Surgeon and Consultant Radiologist in the theatre suite at Royal Blackburn Hospital.
This will ensure the availability and presence of a Consultant Radiologist (with expertise in
ultrasound scanning) and the ultrasound scanner itself.
These patients will be listed as ‘complex SPC catheter insertion’ and the procedure will be
undertaken by the designated responsible Consultant Urologist who has seen and counselled
the patient (rather than being placed on a core/pooled urology waiting list).
The new process under the SOP is specifically applicable to those who are at higher risk of
bowel injury during SPC insertion and include those:
• who have undergone previous lower abdominal surgery, bowel surgery (including
laparoscopic surgery, where the bladder has been mobilized), bladder reconstruction
procedure, complex open or laparoscopic pelvic/gynaecological surgery;
• with a lower abdominal scar where the nature of previous surgery is not known; and
• where there is an inability to distend the bladder sufficiently.
All routine, non-complex SPC insertions will continue to be undertaken in compliance with the
British Association of Urological Surgeons (BAUS) guidelines for the insertion of SPC 2020.
(3) in the four years since Antony Waring's death, the Trust has not provided a single
ultrasound teaching session provided by the Trust to any consultant who is not
capable of using ultrasound.
Response
I can confirm that Suprapubic Catheter placement is only performed by clinicians who are
trained and confident to perform that procedure.
All Consultant Urologists are trained to scan patients to a standard level, however cases such
as Mr Waring’s are extremely rare and complex, and requires a level of scanning expertise and
skill that is practically not feasible to train Urology Consultants up to. Therefore on these
occasions a Consultant Radiologist is now required to use the ultrasound scanner as indicated
above.
Under the new processes in place at the Trust, complex SPC insertions are listed as a
scheduled joint procedure with a Consultant Radiologists who is trained and has the expertise
to use USS (ultrasound scanning).
(4) the allocation of high-risk patients to Core Lists where a specific ancillary
prophylactic measure such as ultrasound is left to either chance or to an
administrator.
Response
By way of assurance I would like to clarify the process the Trust has in place for identifying high-
risk patient procedures and ensuring theatre lists (‘Core Lists’) are managed appropriately.
I can confirm that weekly meetings are scheduled to review each individual theatre list and
these are attended and led by the Trust’s Clinical Director for Urology. At each weekly meeting
the individual theatre list for the next two weeks is reviewed, looking at each individual patient
case and ensuring that these are suitable.
Once the lists are fully booked, a finalised theatre list is sent to the treating clinician who will
check the suitability of patients as well in advance of the surgery taking place.
On the day of the procedure itself, a pre-list check and brief is already embedded within
theatres In which equipment is discussed including if the ultrasound machine is required, and
the Surgeon receives this list in advance. A post-list debrief also takes places to identify any
concerns or any opportunities for learning.
(5) The expert evidence at the inquest was that the research provided on the risk of
complications after insertion of a suprapubic catheter into patients with lower
abdominal surgery is inappropriate the patient such as Antony Waring and
provides false reassurance as to the level of risk posed to these patients.
Response
The Trust has reflected on the evidence and research presented at the inquest, and has
subsequently introduced changes to clinical processes as outlined above.
I hope that I have provided reassurances around the steps that we have taken to address the
issues of concern contained within your report. I would like to assure you that the Trust takes
your concerns extremely seriously, and, as a learning organisation, constantly strives to improve
the clinical services it delivers to patients.
Our thoughts remain with Antony’s family.
Yours sincerely,
Martin Hodgson
Chief Executive Officer
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