Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0432, written 23 Dec 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 23 Dec 2021 |
|---|---|
| Reference | 2021-0432 |
| Coroner | Laurinder Bower |
| Coroner area | Nottingham City and Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Nottingham University Hospitals NHS 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 NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 Chief Executive, Nottingham University Hospitals NHS Trust 1 CORONER I am Miss Laurinda Bower , HM Assistant Coroner for the coroner area of Nottingham City and Nottinghamshire 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 I commenced investigations into the deaths of William DOLEMAN, Anita BURKEY, Peter SELLARS and Carol Christine COLE. The investigation concluded at the end of the inquests, heard together, between 15 November 2021 and 17 December 2021. The conclusion of the inquests were as follows: “Bill died on 1 April 2020, at the Queens Medical Centre, Nottingham, as a result of medical complications following an ERCP procedure performed on 19 March 2020, in which he suffered a recognised complication, namely a perforation to his duodenum, likely caused as a result of catheter trauma. At the time, the procedure was not clinically indicated, and ought not to have gone ahead. If the procedure had been postponed for further imaging, Bill would not likely have died when he did and in the manner that he did. Failures in his pre-procedure care directly contributed to his death. There were missed opportunities to have diagnosed and treated Bill’s perforation during the procedure, and while this would likely have reduced his risk of dying, it might not have prevented his death.” “Anita died on 5 April 2020, at the City Hospital, Nottingham, as a result of medical complications following an ERCP, performed on 19 March 2020, in which she suffered an iatrogenic perforation to her oesophagus. The procedure should never have been performed on this date and in the circumstances as it was unsafe to do so when Anita’s capacity and consent had not been appropriately assessed, and her history of dysphagia had not been explored. Anita died as a direct result of the procedure which was performed as a result of significant failings in her care.” “Peter died on 8 November 2020, at the Queens Medical Centre, Nottingham, from multi- organ failure caused by necrotising pancreatitis, which occurred as result of an ERCP procedure performed on 4 September 2020. Pancreatitis is a recognised complication of this procedure, which was necessary in order to treat Peter’s symptomatic choledocholithiasis.” “Carol died on 11 September 2020, at the Queens Medical Centre, Nottingham, as a result of acute haemorrhagic pancreatitis, that was induced by an ERCP performed to treat choledocholithiasis, on 10 September 2020. Carol was at an elevated risk of developing this complication based on patient and procedure risk factors.” Regulation 28 – After Inquest Document Template Updated 30/07/2021 4 CIRCUMSTANCES OF THE DEATH All four patients died from endoscopic retrograde cholangio-pancreatography related complications, within a 6-month period, caused by the same doctor, during his training for this high-risk procedure. 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: 1. A lack of robust patient pathway to ensure that all patient factors relevant to the clinical indication for, and safety of, ERCP are identified in advance of the procedure and discussed with the patient. 2. A lack of robust system for the recording of vetting of the procedure, capturing what information has been considered as part of this process. 3. Consent is not personalised, contrary to recommendations made by the ESGE in December 2019. 4. A Lack of accountability between professionals for ensuring robust vetting and consent. 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, namely by February 17, 2022. 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 Nottingham University Hospitals NHS Trust Dr The families of the Deceased Care Quality Commission I have also sent it to The British Society of Gastroenterology The Joint Advisory Group on GI Endoscopy The European Society of Gastrointestinal Endoscopy Guidelines Committee 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. Regulation 28 – After Inquest Document Template Updated 30/07/2021 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: 23 December 2021 Miss Laurinda Bower HM Assistant Coroner 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.
Please ask for the Medical Director’s Personal Assistant 9 February 2022 STRICTLY CONFIDENTIAL Miss Laurinda Bower HM Assistant Coroner for Nottingham City and Nottinghamshire HM Coroner’s Court The Council House Market Square Nottingham NG1 2DT Dear Miss Bower Inquest: ERCP and Prevention of Future Death Notification Medical Director’s Office 3rd Floor, Trust Headquarters City Hospital Campus Hucknall Road Nottingham NG5 1PB www.nuh.nhs.uk Please find attached a commentary that I have prepared in response to the Preventing Future Deaths Report issued to Nottingham University Hospitals NHS Trust following the inquest into four patients who died following endoscopic retrograde cholangio-pancreatography related complications, within a 6-month period at the Trust. I was not present at the inquest but note that there are four broad matters of concern identified in the PFD notification. My response to each of the concerns identified in the PFD have been informed following work undertaken by colleagues involved in the Gastroenterology Service, the Surgical and Medical Divisions and other teams and individuals in the organisation, including the Deputy Medical Director who is also the Chair of the Trust’s Consent Committee. The actions either taken or planned in response to the learning from the inquest are summarised below. The oversight of the delivery of these actions will be through the Surgical Division’s Governance Committee. The Quality and Safety Oversight Group will be receiving reports on progress and the Quality Assurance Committee, a sub-committee of the Trust Board will be updated. I hope that this commentary provides assurance that we are committed to learning from this, and other incidents to significantly enhance the care of patients undergoing ERCP at Nottingham University Hospitals NHS Trust. Yours sincerely Dr Medical Director cc: , Inspections Manager, CQC ( Response to concerns identified through the PFD 1. A lack of robust patient pathway to ensure that all patient factors relevant to the clinical indication for, and safety of, ERCP are identified in advance of the procedure and discussed with the patient. The following actions have been taken to address this concern: • The referral pathway has been completely re-designed and will move away from the old ‘NOTis’ based information system to Medway orders (the current information system in use in the Trust) from 14 February 2022. The Medway order will incorporate: information on the indication, latest blood tests, date and findings of relevant imaging, capacity for consent, awareness of LPA, highlighting potential factors for “higher risk” procedures, and seek history or symptoms of dysphagia for any procedure with side-viewing endoscopes (ie EUS and ERCP). • The Medway referrals will be vetted daily by consultants who undertake ERCPs in dedicated job planned time. • Outcomes of vetting will be recorded as Medway notes (including referrals not accepted) and if accepted will be listed for procedures (either sedation or general anaesthetic) by the NUH endoscopy administration teams. • The new fields on the NUH internal Medway orders will be replicated on the specific “NUH tertiary endoscopy referrals” form that are completed for referrals from outside NUH (eg from surrounding networking trusts) and will also be reviewed in the vetting clinics described above. • Two new 2-hour clinics have been set up, that will run 52 weeks a year, staffed by consultants who undertake ERCPs. These sessions have already commenced and permanent funding is currently being agreed. This clinic time will be used to meet, either virtually or in person, with all out-patients referred for ERCP to discuss the indications, risks and alternatives. • We have already formally extended our post-ERCP recovery time to a minimum of 2 hours, with clinical review and if any significant changes to baseline observations or ongoing symptoms this period of observation is extended, or results in hospital admission for observation, investigations or treatment. 2. A lack of robust system for the recording of vetting of the procedure, capturing what information has been considered as part of this process. • As above this will now be recorded through a clinical note on the Medway information system. This will be visible to all clinicians caring for the patient. 3. Consent is not personalised, contrary to recommendations made by the ESGE in December 2019. It is not currently possible for individual personalised risk to be calculated precisely although there are aspirations for this at some point in the future. It is possible to provide estimates of the relative risk to an individual patient in relation to the wider population risks and to ensure that this is documented in the patient record. A number of actions to support this have already commenced: • Endoscopy outreach nurses will supply patient information booklets to ward in-patients but consent will be conducted by the ERCP endoscopist on in-patient ward reviews before attending the endoscopy unit. • Where patients give their agreement, family members will be actively sought to contribute to the consent process. • NUH has been accepted as part of the EIDO pilot study of home consent. This will include developing a video explainer similar to one already developed at NUH relating to colonoscopy: https://www.youtube.com/watch?v=D42s37HXIoQ • Patient information and consent forms will be amended to include a statement that “I understand that you cannot give me a guarantee that particular person will perform the procedure. The person performing the procedure will have appropriate experience or expert supervision”. • Consent forms will be amended to include the opportunity for clinicians to document enhanced risk where it is appropriate. • Audit of the NUH ERCP practice over the last 3 years shows that pre-procedure administration of rectal NSAIDs (eg diclofenac 100mg; which reduces the risk of post-ERCP pancreatitis) is consistently above 95%, in line with ESGE 2019 guidelines. • A cross-departmental (HPB endoscopy, HPB surgery and interventional radiology) meeting with key stakeholders has been convened to design pathways for the best approach for complex HPB cases (eg endoscopic versus percutaneous approaches to treating complex strictures or difficult bile ducts stones; combined laparoscopic cholecystectomy and laparoscopic bile duct exploration versus pre-operative ERCP then laparoscopic cholecystectomy) on 9 March 2022. 4. A Lack of accountability between professionals for ensuring robust vetting and consent. • It is expected that the vetting and consent arrangements described above will resolve this issue. In addition to the above, we have developed our specialist HPB endoscopy team so that 5 out of 6 (previously 3 out of 6) endoscopists can perform lower-risk diagnostic EUS and only proceed if appropriate to ERCP (eg if any residual uncertainty regarding presence of bile duct stones) rather than having to delay treatment for repeat imaging or cancel procedures “on the day”. No other UK HPB endoscopy unit has this level of combined EUS/ERCP service provision. Summary The actions set out above are intended to address the matters of concern identified in the Preventing Future Deaths report in relation to: 1. A lack of robust patient pathway to ensure that all patient factors relevant to the clinical indication for, and safety of, ERCP are identified in advance of the procedure and discussed with the patient. 2. A lack of robust system for the recording of vetting of the procedure, capturing what information has been considered as part of this process. 3. Consent is not personalised, contrary to recommendations made by the ESGE in December 2019. 4. A Lack of accountability between professionals for ensuring robust vetting and consent. Some of these have already been implemented and dates have been provided for completion of the remainder. As Medical Director, I will, via the Quality and Safety Oversight Group, ensure that these actions are monitored to completion.
See every Prevention of Future Deaths report matching Nottingham University Hospitals NHS Trust, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.