Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0184, written 8 Jun 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Jun 2023 |
|---|---|
| Reference | 2023-0184 |
| Deceased | David Wilson |
| Coroner | Kevin McLoughlin |
| Coroner area | West Yorkshire (Eastern) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Mid Yorkshire 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 THIS REPORT IS BEING SENT TO: 1. Mid Yorkshire Hospitals NHS Trust 1 CORONER I am Kevin Mcloughlin, Senior Coroner, for the Coroner area of West Yorkshire (Eastern area) 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 18 January 2023 I commenced an investigation into the death of David Barnet WILSON, aged 67. The investigation concluded at the end of the Inquest on Tuesday 6 June 2023. The conclusion of the Inquest was a Narrative based upon the following medical cause of death; 1 a Sepsis 1 b Bowel Perforation (Sigmoidoscopy Procedure Undertaken on 30.12.22) 1c lschaemic Colitis, II End Stage Renal Failure, Abdominal Aortic Aneurysm (operated), lschaemic Heart Disease. 4 CIRCUMSTANCES OF THE DEATH Mr D B Wilson was admitted to hospital on 27 December 2022. A CT scan indicated an inflammation in the distal section of his colon. The established diagnostic procedure to identify the cause of the suspected colitis was a flexible sigmoidoscopy. A recognised complication of this procedure was a colonic perforation. This happened in this case and resulted in his death the following day, 31 December 2022, at Pinderfields Hospital, Wakefield . 5 CORONEWSCONCERNS 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 Consent form signed by Mr Wilson was a standard pre-printed form. It did not attempt to provide any statistical rating for the risks identified, which would have enabled Mr Wilson to evaluate the risks. (2) No attempt was made to interpret or tailor the risks inherent in the procedure in the light of his extensive medical history and co-morbidities. (3) The Consent Form did not refer to the risks of death, which befell him. He was thus not in a position to make a truly informed consent to undergo the sigmoidoscopy. (4) The Consent Form did not identify those clinicians involved in discussing the who obtained his signature at a decision with him, save for time when he was under the influence of morphine sedation . The objective of the Consent process should be to demonstrate a patient has made a truly informed decision at a time when he is able to evaluate the risks clearly. 1 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation has 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 Tuesday 1 August 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 Medical Centre, Ferrybridge, WF11 8NQ, who may find it useful or of interest. (wife). I have also sent it to , Ferrybridge 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 SIGNED KEVIN MCLOUGHLIN SENIOR CORONER, WEST YORKSHIRE (EAST) Thursday 8th June 2023 2
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.
Date: 31 August 2023 Mr Kevin McLoughlin HM Senior Coroner West Yorkshire (Eastern District) HM Coroner’s Service 71 Northgate Wakefield WF1 3BS Chief Medical Officer Trust Headquarters and Education Centre Pinderfields Hospital Aberford Road Wakefield WF1 4DG Dear Mr McLoughlin Re Inquest of David Barnet WILSON (dcd) – 26.03.1955 to 31.12.2022 – I am responding on behalf of Mid Yorkshire Teaching NHS Trust (MYTT; the Trust) to the Regulation 28 Report to Prevent Future Deaths that you issued on 8 June 2023 upon the conclusion of the abovenamed inquest. The Matters of Concern raised in your report were: 1) The Consent form signed by Mr Wilson was a standard pre-printed form. It did not attempt to provide any statistical rating for the risks identified, which would have enabled Mr Wilson to evaluate the risks. 2) No attempt was made to interpret or tailor the risks inherent in the procedure in the light of his extensive medical history and co-morbidities. 3) The Consent Form did not refer to the risks of death, which befell him. He was thus not in a position to make a truly informed consent to undergo the sigmoidoscopy. 4) The Consent Form did not identify those clinicians involved in discussing the decision with him, save for influence of morphine sedation. who obtained his signature at a time when he was under the The objective of the Consent process should be to demonstrate a patient has made a truly informed decision at a time when he is able to evaluate the risks clearly. I would like to thank you for bringing these matters to MYTT’s attention. We have carefully considered and discussed the concerns you’ve raised and their implications for the Trust. Following a review of our processes, we will implement a number of measured actions in response. Pre-printed consent forms and inclusion of statistical ratings of risks; advising patients of increased risks and the risk of death The Trust utilises a bank of consent forms for the most common procedures performed. The consent forms used in MYTT are based on national guidance issued by the Department of Health and Social Care. Of note, we currently have generic forms and hundreds of procedure-specific consent forms across all specialties. The procedure-specific consent forms are pre-populated with the most frequently associated risks for the particular procedure. The forms are reviewed and amended as required to align with contemporary medical knowledge and practice. Up to now, the Trust has typically not included the statistical chances of a specific risk occurring. However, as a form comes up for review, it will be updated to include whether the chances of a specific risk occurring is: very common (1 in 10); common (between 1 in 10 and 1 in 100); uncommon (between 1 in 100 and 1 in 1,000); rare (between 1 in 1,000 and 1 in 10,000); and very rare (between 1 in 10,000 and 1 in 100,000). These ranges adopt World Health Organization classifications.1 As it is proposed to include risk ranges, to a certain degree these will inherently account for varying medical histories and co-morbidities of patients. But in instances where a specific risk is greater due to a particular patient’s unique circumstances, this medical advice will be clearly noted. We will also update and strengthen our consent process through our internal policy to reflect this requirement (see below). The Trust also appreciates that the risk of death is a possibility in every procedure that is undertaken, and that even if it is a remote possibility, the risk of death would be a material consideration for patients in assessing whether to go ahead with a procedure.2 To date, it has been the Trust’s practice to leave the decision about discussing the risk of death to the clinical judgement of its clinicians when evaluating the specific circumstances of their patients. However, the Trust will work with clinical teams to encourage its clinicians to undertake these discussions at an earlier stage, and we will introduce an additional specific risk of death as a risk that is required to be canvassed as part of our consent process (see below). Identifying clinicians involved in the consent process; and capacity to consent I fully concur with your statement that “the objective of the Consent process should be to demonstrate a patient has made a truly informed decision at a time when he/she is able to evaluate the risks clearly”. 1 Whilst these ranges will be a starting point for all consent forms, a specialty may choose to be more explicit in detailing the specific risks of a particular procedure. In accordance with Montgomery v Larnarkshire Health Board [2015] SC11 [2015] 1 AC 1430 2 As you are aware, the process of consenting a patient for a procedure is an ongoing one that starts with a conversation with the patient about treatment options and culminates with the signing of the consent form. The form itself is merely the final “ok” from the patient to go ahead after a number of steps have taken place over a length of time, to obtain fully informed consent from the patient. The consent process regularly involves a number of staff from the clinician undertaking the initial conversation with the patient about the procedure and placing the patient on a waiting list; to others providing follow-up advice, e.g. in response to pre-procedure questions from the patient after reading the relevant patient information leaflet; to those involved in the pre-admission process; and finally to the clinician and/or assistant who will perform the procedure on the day. As these are all clinical conversations, the Trust expects staff to have appropriately documented an accurate record of them in the patient’s medical notes, which would also include a note of any patient information leaflets that have been provided. When reviewing the patient’s records pre- procedure, this documentation provides assurance to the clinician performing the procedure that the patient understands, and is fully cognisant of the risks and benefits of the procedure, and has consented to it. Ideally the final consent form would list all MYTT staff who have been involved throughout the entire consenting process of the patient for a particular procedure. Unfortunately, time and resource constraints make this suggestion impracticable for implementation by the Trust. In relation to the capacity to consent, the Trust will work with clinical teams to ensure that as part of the consent process, the question of a patient’s capacity – regardless of the circumstances – is considered, taken into account, and properly documented. The issues surrounding capacity will also be further highlighted in the Trust’s internal policy (see below). Other actions Of course, the Trust regularly offers training to staff on consent as well as having an internal policy that provides guidance on consent to examination and treatment. The consent policy undergoes a planned review every three years unless it is updated earlier, i.e. “refreshed”, when new guidance becomes available. Previous iterations have incorporated, amongst other matters, refusal of treatment and advance decisions; consent for transfusion; the Montgomery ruling; and latterly the General Medical Council’s Guidance on professional standards and ethics for doctors: Decision making and consent (November 2020). Overall, I concur that the matters of concern you’ve raised regarding how we consent our patients require action on our part and I thank you for bringing these to the Trust’s attention. Accordingly we undertake to address these matters (as outlined above) and “refresh” our consent policy ahead of its triennial review, currently scheduled for March 2024. In closing, I acknowledge that your concerns arose out of your investigation into the death of Mr Wilson, and on behalf of Mid Yorkshire Teaching NHS Trust, I would like to take this opportunity to offer our sincere condolences once again to Mr Wilson’s family in relation to his sad death. Yours sincerely Chief Medical Officer
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