Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0476, written 30 Aug 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 30 Aug 2024 |
|---|---|
| Reference | 2024-0476 |
| Deceased | Rachel Gibson |
| Coroner | Philip Barlow |
| Coroner area | Cambridgeshire and Peterborough |
| 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. , President of Royal College of Anaesthetists 1 CORONER I am Philip BARLOW, Assistant Coroner for the coroner area of Cambridgeshire and Peterborough 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 20 July 2022 I commenced an investigation into the death of Rachel Gibson, age 47. The investigation concluded at the end of the inquest on 21 August 2024. The conclusion of the inquest was: Medical Cause of Death: 1a Hypoxic-Ischaemic Brain Injury 1b Cardiorespiratory arrest caused by infiltration of local anaesthetic during surgery 1c Right hip replacement (April 2022) Narrative conclusion: Rachel Gibson sustained irreversible brain damage following cardiac arrest caused by administration of excessive local anaesthetic (Ropivacaine) during surgery. 4 CIRCUMSTANCES OF THE DEATH Dr Rachel Gibson had severe osteoarthritis and underwent hip replacement surgery at Spire Lea Hospital, Cambridge on 12 April 2022. Towards the end of the procedure an infiltration of Ropivacaine was used in excess of the recommended dose. Upon return to her room she suffered an unwitnessed cardiac arrest. She was resuscitated and transferred to Addenbrooke’s Hospital where she was found to have sustained irreversible brain damage. She died at Addenbrooke’s Hospital on 14 July 2022. The evidence was that it is routine practice before the procedure for the anaesthetist to give oral instructions to the scrub nurse specifying the type and dose of local anaesthetic to be used to infiltrate the operation site. Towards the end of the operation the scrub nurse hands the local anaesthetic to the surgeon who then carries out the infiltration. The intention in this case was for a 0.2% solution of Ropivacaine to be diluted 50/50 with normal saline before it was infiltrated. The evidence suggested that this was not done. The result was that excessive Ropivacaine was administered by mistake. The evidence at the inquest was that this type of practice is common nationally. Regulation 28 – After Inquest Document Template Updated 30/07/2021 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) 1. The responsibility for checking and administering the local anaesthetic is unclear: 1. 2. 3. 4. The instruction was given orally and not written down by the anaesthetist (the prescriber). The anaesthetist did not check what the nurse had written down. The nurse drew up the local anaesthetic from a stock bag and checked this with another nurse, but not with the anaesthetist. The nurse then handed the drawn-up anaesthetic to the surgeon to administer. 2. 3. There is inconsistency in the way the local anaesthetic was prescribed. The evidence was that the drug was sometimes specified in millilitres and sometimes in milligrams. This is of particular concern when the intention is for the drug to be diluted. If the drug is always prescribed in milligrams then the scope for error may be reduced. The hospital in question has now introduced a system for labelling and countersigning the drug that is being given during the operation. However, the evidence at the inquest was that, on a national basis, there is wide variation in the way local anaesthetic is prescribed, checked and administered in this type of procedure; and that it is common to use similar practice to that which occurred during this operation. This is why I believe I am under a duty to draw it to your attention. 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 29 October 2024. 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. COPIES and PUBLICATION 8 I have sent a copy of my report to the Chief Coroner and to the following Interested Persons 4. Dr Gibson’s family Regulation 28 – After Inquest Document Template Updated 30/07/2021 Spire Lea Hospital 5. 6. 7. 8. I have also sent it to I have also sent it to Addenbrooke’s Hospital (where Dr Gibson died) who may find it useful or of interest. (who gave expert evidence) and to and 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: 30/08/2024 Philip BARLOW Assistant Coroner for Cambridgeshire and Peterborough 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.
29th October 2024 Dear Mr Barlow, Re: Regulation 28: Report to Prevent Future Deaths in the matter of Rachel Gibson Thank you for sending us a copy of your report regarding the tragic death of Dr Gibson. We have reviewed the information available to us in the report via our Safe Anaesthesia Liaison Group (SALG). SALG is a collaborative project between the Association of Anaesthetists, NHS England’s Patient Safety team and the Royal College of Anaesthetists. One of its core objectives is to analyse anaesthesia-related serious incidents and to share the learning with the specialty across the UK. You highlighted concerns regarding the wide variation in the way local anaesthetic is prescribed, checked and administered in procedures where local anaesthetic is infiltrated into the operation site. We agree that for any procedure where this surgical technique is used there should be a clear protocol in place that is understood and followed by the entire theatre team. This should include: • Agreement during the multidisciplinary team brief prior to the procedure, about the type and dose of local anaesthetic to be given to each specific patient. The team should agree the maximum safe dose of local anaesthetic that can be given to the patient, calculated in milligrammes. The concentration of local anaesthetic should be described in milligrammes per millilitre and used to calculate the total allowable volume that can be injected by the surgeon and/or the anaesthetist. In accordance with the National Safety Standards for Invasive Procedures, all staff members who undertake an active role in the invasive procedure should be present, including the most senior members of the anaesthetic and surgical teams1. Some units have reported that they found it helpful to write the agreed drug dose and volume on the theatre whiteboard near to the swab counts. • How and where the prescription for local anaesthetic should be documented. For example in units that use electronic systems, it might be appropriate to document on the e-prescribing system rather than the anaesthetic chart or in the surgeon’s operating notes. We recommend that local anaesthetic prescriptions are recorded as ‘the volume in ml of a solution containing a specified number of mg/ml of a named local anaesthetic’ to simplify any calculations of the total dose of local anesthetic received. We strongly encourage manufacturers to make the concentration in mg/ml more prominent on their product labelling rather than using percentages. • Mandated pause prior to the surgeon undertaking the infiltration during which the whole theatre team verbally confirm that the correct drug, volume and concentration has been provided. Human factors science indicates that engineered solutions are far more effective at reducing the risk of similar events occurring than procedural steps. The use of pre-filled syringes have been shown to reduce the risk of drug error by up to seventeen times and the use of a pre-filled syringe of local anaesthetic at the correct dilution would have substantially reduced the chance of an overdose of local anaesthetic2. We recommend that pre-filled syringes are used by default where available. Where manufactured pre-filled syringes are not available, we recommend that doses are standardised for specific operations by patient weight and that dilutions are drawn up prior to the start of the procedure, potentially by colleagues within pharmacy to minimise the manipulation of medicines in clinical areas3. Additionally, we recommend that local anaesthetics intended for intraoperative local anaesthetic infiltration are not provided in volumes larger than 100mls per bag to further reduce risk. We will disseminate these key safety messages through our regular Patient Safety Update publication, which is distributed to all members of the Association of Anaesthetists and Royal College of Anaesthetists. Since improvements in practise require multidisciplinary cooperation, we have reached out to our surgical colleagues to agree these proposals and ensure that the same key safety messages are shared with members of the Royal College of Surgeons of England and the Royal College of Surgeons of Edinburgh through the Confidential Reporting System in Surgery (CORESS) reports. In the longer term, our next National Audit Project (NAP) is concerned with the complications of regional anaesthesia. NAPs study rare, but potentially serious complications related to anaesthesia in order to improve anaesthetic practice and patient outcomes. Local anaesthetic toxicity is one of the complications that will be looked at during the next study. The project is currently in the planning stages and we have asked the researchers leading the project to ensure that severe local anaesthetic toxicity secondary to surgical infiltration, as happened to Dr Gibson, is captured as part of this project. We would be happy to respond to any questions that you might have. Yours Sincerely President Royal College of Anaesthetists President Association of Anaesthetists References 1. Centre for Perioperative Care, National Safety Standards for Invasive Procedures 2 (NatSSIPs),2023 (https://cpoc.org.uk/guideline/guidelines-resources-guidelines/national- safety-standards-invasive-procedures-natssips) 2. Adapa RM, Mani V, Murray LJ, et al. Errors during the preparation of drug infusions: a randomized controlled trial. British Journal of Anaesthesia 2012; 109: 729–34. 3. Royal Pharmaceutical Society, Professional Guidance on the Safe and Secure Handling of medicines, 2018 (https://www.rpharms.com/recognition/setting-professional-standards/safe- and-secure-handling-of-medicines/professional-guidance-on-the-safe-and-secure-handling- of-medicines)
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