Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0151, written 8 Apr 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Apr 2019 |
|---|---|
| Reference | 2019-0151 |
| Deceased | Ronald Clark |
| Coroner | David Clark |
| Coroner area | Portsmouth and South East Hampshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
ANNEX A REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. The Medicines and Healthcare Products Regulatory Agency 2. NHS Improvement 1 | CORONER | am David Clark Horsley, senior Coroner for the Coroner area of Portsmouth and South East Hampshire. 2 | CORONER’S LEGAL POWERS | 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 21 May 2018 | commenced an investigation into the death of Ronald CLARK age 64. The investigation concluded at the end of the inquest on 15 February 2019. The conclusion of the inquest was cause of death: 1a. Multi-organ Failure, 1b. Necrotising Pancreatitis, 2. Chronic Obstructive Pulmonary Disease. Ronald CLARK died due to an Accident. 4 | CIRCUMSTANCES OF THE DEATH On the Nineteenth January 2018 Ronald CLARK underwent the insertion of a stent in his common hepatic duct. The incorrect sized stent was inadvertently inserted and this, on the balance of probabilities, significantly contributed to his death at Queen Alexandra Hospital, Portsmouth on Second of April 2018. 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. | was told in evidence that the stents used at the hospital are all supplied in identical packaging with only a small label identifying the size of the stents inside. | was also told that stents in this sort of packaging are in general use in most, if not all, NHS hospitals. 2. | believe action should be taken by the purchasing agencies of the NHS to ensure that stent manufacturers should supply different sizes of stents in different coloured packaging to make it easier for them to be identified during medical procedures and to obviate the risk of the wrong-sized stent being used, as was the case with Mr Clark. 6 | ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe your organisation have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4" June 2019. |, 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons Mr Clarks family and Queen Alexandra Hospital, Portsmouth. | 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. 08 April 2019 David Cfark Horsley AO
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 David C Horsley LLB, Solicitor Her Majesty’s Coroner for Portsmouth and South East Hampshire The Coroner’s Court 1 Guildhall Square Portsmouth PO1 2GJ Wellington House 133-155 Waterloo Road London SE1 8UG 6th June 2019 Dear Mr Horsley Regulation 28 Report – Mr Ronald CLARK Thank you for the Regulation 28 report dated 8 April 2019, that was received on 23 April 2019. Although your report was directed at NHS Improvement, NHS England and NHS Improvement have been operating as a single organisation since 1 April 2019. This response is provided in my capacity as the National Director of Patient Safety, NHS Improvement. I am grateful to you for sharing your findings from the inquest with us and highlighting that actions could prevent future deaths. The main action that you highlight relates to changes to manufacturer’s packaging so that different-sized stents are in different-coloured packaging. I note that the Regulation 28 report has also been sent to the Medicines and Healthcare products Regulatory Agency and, as changes to packaging falls within their remit, they are the more appropriate body to respond on this specific action. The related action that I have been able to take, to reduce the potential for such incidents from happening again, is detailed below. The National Patient Safety Team, being part of NHS Improvement, is in the process of reviewing the National Safety Standards for Invasive Procedures (NatSIPPs). These are a set of high-level, national standards for all invasive procedures that have been produced to support local providers in developing and maintaining their own more detailed standardised local procedures and in order to reduce the likelihood of Never Events occurring. The NatSIPP on prosthesis verification is being updated to reflect developments in implant selection and verification processes and will include the potential for future scanning for all prothesis/implants. NHS England and NHS Improvement I hope you will be able to share my reply with Mr Clark’s family. I was very sorry to hear that this error occurred, and I hope it will give the family some comfort that we are taking steps to prevent this type of error in future. I trust that you will find this information of assistance and should you require any further detail, please do not hesitate to contact me. Yours sincerely, Dr Aidan Fowler, MBBS, FRCS National Director of Patient Safety NHS Improvement NHS England and NHS Improvement
See every Prevention of Future Deaths report matching Hospital Death (Clinical Procedures and medical management) related deaths, 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.