Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0284, written 4 Aug 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 4 Aug 2023 |
|---|---|
| Reference | 2023-0284 |
| Deceased | Harry Stobie |
| Coroner | Tom Osborne |
| Coroner area | Milton Keynes |
| 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.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 Milton Keynes University Hospital 1 CORONER I am Tom OSBORNE, Senior Coroner for the coroner area of Milton Keynes 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 03 April 2023 I commenced an investigation into the death of Harry Arthur STOBIE aged 77. The investigation concluded at the end of the inquest on 20 July 2023. The conclusion of the inquest was that: Narrative Conclusion - Died as a result of a haemoperitoneum after insertion of a PEG tube, that is a recognised complication of a necessary medical procedure. 4 CIRCUMSTANCES OF THE DEATH The deceased suffered a stroke on 15th February 2023 and was admitted to Milton Keynes University hospital and transferred to John Radcliffe hospital for a thrombectomy and was repatriated back to Milton Keynes on the 20th February 2023, he underwent a PEG insertion on the 23rd March 2023 caused a large haemoperitoneum that was not recognised at the time. His condition deteriorated and he died on 26th March 2023. 5 CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern) That once the PEG tube was inserted at Milton Keynes Hospital it seems that the deceased's deteriorating condition was not monitored closely even though he was complaining of abdominal pain soon after the procedure was completed . His concerns were not escalated to a senior doctor for consideration of a possible bleed. The procedures and protocols following PEG insertions should be reviewed. 6 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. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, Regulation 28 – After Inquest Document Template Updated 30/07/2021 namely by September 29, 2023. 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 I have also sent it to who may find it useful or of interest. 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 person who I believe may find it useful or of interest. 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 Dated: 04/08/2023 Tom OSBORNE Senior Coroner for Milton Keynes Regulation 28 – After Inquest Document Template Updated 30/07/2021
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.
Mr Tom Osborne HM Senior Coroner Milton Keynes Council 06 September 2023 Dear Mr Osborne Regulation 28 Report following an Inquest into the death of Mr Harry Stobie I am writing following receipt of a regulation 28 Report dated 04 August, following on from the Inquest concluded on 20 July 2023. Mr Stobie died because of haemoperitoneum after insertion of a PEG tube. As you note in the regulation 28 report, this was a recognised complication of a necessary medical procedure. In the regulation 28 report, you assert that Mr Stobie’s deteriorating condition was not monitored closely enough even though he was complaining of abdominal pain soon after the procedure was completed. His concerns were not escalated to a senior doctor for consideration of a possible bleed. You state therefore that the procedures and protocols following PEG insertion should be reviewed. I was disappointed to have received the regulation 28 report in the context of members of the Trust’s staff not having been called to give oral evidence at Inquest. The written have been reviewed after the inquest statements of and are all felt to be comprehensive and thorough. I do not believe that the Trust was offered the opportunity to respond to your emerging concerns during the inquest – which I would have thought might have been preferable for all parties. By way of a summary of Mr Stobie’s care on the day of PEG insertion: There was a clear indication for PEG insertion following the ischaemic stroke for which he was being treated (and dysphagia was improving more slowly than other symptoms). Mr Stobie had undergone video fluoroscopy prior to insertion. The procedure itself was straightforward and he was transferred back to the ward. Three sets of observations were undertaken over the first four and a half hours back on the ward. Whilst the frequency of observation should ideally have been higher over the first two hours, the observations recorded were not significantly deranged. It was noted that Mr Stobie did report some pain and vomiting. A ward doctor was involved in his assessment at this stage, and fluids and analgesia were administered. The quantification, recording and monitoring of his pain may have benefited from being more objective / standardised – see below. Five hours following return to the ward, Mr Stobie appeared less well, and observations were promptly repeated. He was hypotensive and this was escalated to our rapid response nursing team and the on-call medical team. At this point, Mr Stobie was found to have a tender abdomen. Within half an hour, a working diagnosis of bowel perforation was made, and a plan for an urgent CT scan was made. His antibiotics (broad spectrum antibiotics having been administered earlier) were continued. He was already on intravenous fluids following the earlier episode of vomiting. Within a further 60 minutes, surgical and ICU referrals had been made whilst Mr Stobie was en-route to CT. A definitive diagnosis was made within two hours of the first abnormal observations, with appropriate measures put in place in the interim. A consultant intensivist and a consultant surgeon attended Mr Stobie late in the evening. An active decision was made for palliation. Mr Stobie died 3 days later. The key questions appear to be (1) whether Mr Stobie’s symptoms of some pain and vomiting should have been seen as potential signs of significant internal bleeding before his physiological observations began to deteriorate and, if so, (2) whether they should have prompted earlier imaging and, in turn, (3) whether this might have led to alternative action (i.e., a surgical approach to address the haemorrhage). On review of the inquest statements and medical records: • Mr Stobie was well with normal vitals and was comfortable when he left the endoscopy room ( ). • Mr Stobie was returned to the ward from PEG at 13:45 hours. He complained of stomach pain and had been vomiting. He was prescribed an antiemetic (anti sickness injection) and had an injection of pain killer… In the course of the afternoon, Mr Stobie remained relatively stable ( ). • A nursing entry in the electronic patient notes written during the afternoon but verified at 20:15 (i.e., following the deterioration in observations / escalation) references: Had episode of vomiting and Ondansetron given as prescribed, vomited (40mls). Paracetamol, and [subsequently] morphine, given for pain. PEG site was checked – no oozing. Patient re-positioned and made comfortable (SN Amoah). As you note, bleeding is a recognised complication of PEG insertion. Routine CXR (to assess for pneumoperitoneum) is not undertaken following PEG placement as a degree of pneumoperitoneum is common post-PEG insertion, and retroperitoneal issues could not be adequately assessed. Such X-rays would be challenging to interpret. I raise this point as we initially understood (between the inquest and receipt of your regulation 28 report) that this may have been a specific concern. A ‘discharge protocol following PEG insertion’ is sent back to the ward with patients. An alert box within the protocol currently states: In Mr Stobie’s case, the key issue (in terms of compliance with existing protocol) is whether he experienced ‘prolonged or severe pain’ post-procedure. Prompted by your regulation 28 report, there have been further discussions with Ward 7 staff who were caring for Mr Stobie on the day in question. It does not seem that Mr Stobie’s pain in the earlier part of that afternoon was so pronounced as to have mandated earlier escalation. He was not exhibiting symptoms consistent with peritonism at that point. It is felt that he had an abrupt deterioration around the time his observations deteriorated. By the same token, clinicians do not consider it likely that an earlier diagnosis would have led to a different outcome (given that fluids and intravenous antibiotics had already been administered prior to the deterioration in observations): general anaesthetic and laparotomy would not have been an attractive prospect in view of co-morbidities. However, I recognise that the post-procedure guidance could be clearer, and the opportunity for subjectivity could be reduced. I have asked the wider gastroenterology team to review the ‘discharge protocol following PEG insertion’ with a view to determining whether it would be possible or prudent to render the pain element of these cautions more objective (i.e., to use a pain scale or to reference a failure to respond to specific medicines). This work is progressing well and the team has elected to incorporate use of a pain score and/or a trigger of an AMBER score on the NEWS-2 system in order to prompt earlier escalation and to reduce the threshold for consideration of a CT scan. See the enclosure – appendix 3 to the relevant policy and procedure. They will also liaise with the relevant specialist society (British Society of Gastroenterology) to see whether they are able to signpost excellent practice in respect of post-procedural protocols and/or whether this is an area they could seek to advance towards a national consensus view. As part of our discussions in response to this regulation 28 report, we have also identified a potential gap in practice in relation to the post-procedural observation of patients undergoing other endoscopic interventions. In the small number of cases where patients are admitted to hospital following a higher risk endoscopic procedure (non-PEG) for observation, we need to be explicit about the nature and level of observation expected by the lead clinicians. The gastroenterology MDT will review this aspect at a planned meeting in September. I would of course wish to conclude by recognising the very sad circumstances of Mr Stobie’s death and passing my condolences on to his family. His untimely death must be particularly distressing for them given the pretty positive trajectory of his recovery from his major stroke (swallowing aside) after thrombectomy. I trust that this response is helpful. Yours sincerely, Chief Executive Enclosed Ward nursing care plan for patients post PEG and PEJ insertion: Day 1 (appendix 3 to policy and procedures for pre and post insertion management)
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