Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0405, written 24 Oct 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 24 Oct 2023 |
|---|---|
| Reference | 2023-0405 |
| Deceased | Tracy Gambrill |
| Coroner | Susan Evans |
| Coroner area | South Yorkshire (Western) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. The Royal College of Surgeons of England 2. The General Medical Council 3. NHS England 4. The Society of British Neurological Surgeons 1 CORONER I am Susan EVANS, Assistant Coroner for the coroner area of South Yorkshire (West) 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 the 29th of November 2016 I commenced an investigation into the death of Tracy Gambrill. The investigation concluded at the end of the inquest on 20th October 2023. The conclusion of the inquest was On the 7th of November 2016 Tracy Gambrill underwent a neurosurgical operation at the Royal Hallamshire Hospital, intended to ameliorate her seizure symptoms of epilepsy. An incision made from the insular and intended to find the temporal horn was made at the wrong trajectory. Prior to that incision it is probable that her head position, previously fixed, had moved, a matter of which the surgeon remained unaware. The incision made was excessively deep and caused significant damage to Tracy's brain. Two further attempts were made at different trajectories to locate the temporal horn with the last utilising a neuro-navigation system to assist. Both were excessively deep. On being woken from the anaesthetic it was immediately apparent that Tracy had sustained serious brain injury. She died in hospital on the 19th of November 2016. On the balance of probability, it is likely that Tracy would have died as a result of the damage caused by the first incision. The cause of death was recorded as: 1a Cerebral oedema and focal infarction 1b Iatrogenic damage to diencephalic and brain stem structures 1c Refractory epilepsy (operated 7th November 2016) 4 CIRCUMSTANCES OF THE DEATH On the 7th of November 2016 Tracy Gambrill underwent an amygdalohippocampectomy using the Trans-Sylvian approach. The Sylvian fissure was opened without incident. From there the surgeon made three incisions from the insular, intending to find the Temporal Horn. The first incision was measured from post-mortem images as being 5- 6cm in length. Having not found the Temporal Horn a second incision was made at a different trajectory. This again failed to find the Temporal Horn and was measured (post- mortem) at 6-7cm. The third trajectory was made with the assistance of a neuronavigational system and measured (post-mortem) 5cm. Tracy died following the operation. CONTROLLED From the evidence it is likely that Tracy would have died following the first incision. Prior to that incision it is probable that her head position, previously fixed, had moved, a matter of which the surgeon remained unaware. 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 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] Each of the three surgical incisions were far too deep considering the average distance between the insular and the Temporal Horn. Only the second incision was measured intra operatively using a cannula and this was after the completion of the incision. From the evidence it is apparent that this operation is undertaken with surgeons relying on anatomical landmarks and head position to perform the procedure safely. The inquest did hear from an expert neurosurgical witness whose practice it was to measure the length of his incisions intra-operatively at appropriate times. This practice resulted in him having aborted an operation after failing to find the Temporal Horn within expected limits. Post-operatively he discovered that the patient’s head had moved from the correct position. I am concerned that it remains the position that it is not current and expected practice to measure the incision from the insular to the Temporal Horn at appropriate times during the operation. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe 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 the 19th of December 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 Person: Tracy Gambrill’s family Sheffield Teaching Hospitals NHS Trust 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 24th October 2023 CONTROLLED
2 responses 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.
15 December 2023 Miss Susan Evans Assistant Coroner South Yorkshire (West) Dear Miss Evans Regulation 28: Report to Prevent Future Deaths (ref: 1413738) I am very sorry to hear of the tragic circumstances Tracy Gambrill’s death. I extend my sincere condolences to Tracy’s family and to others affected. You raise the concern in your report that it is not current and expected practice for surgeons to measure the incision from the insula to the temporal horn at appropriate times during a transsylvian amygdalohippocampectomy. We do not provide guidance on clinical procedures, and other organisations who hold the expert clinical knowledge will be better placed to address your concern more directly, but I will explain where our standards and guidance will support actions taken to address your concern. Our role in setting professional standards for doctors We set the knowledge, skills, values and behaviours expected of all doctors working in the UK, and support them to understand and meet these professional standards. Our guidance is high level because it applies to all doctors, and at every stage of their careers and in every specialty. We expect doctors to use their professional judgment and apply the principles in our guidance to their specific circumstances. Through a process called revalidation, linked to annual appraisals, we seek assurance that doctors continue to meet these professional standards throughout their careers. Our core guidance, Good medical practice, requires doctors to be competent in all aspects of their work, to keep their professional knowledge and skills up to date, and to recognise and work within the limits of their competence. It requires them to demonstrate through the revalidation process that they work in line with the principles and values of the guidance. Lifelong learning We also provide guidance on Continuing professional development (CPD) to support all doctors in their professional development and practice, outside of undergraduate education or postgraduate training. It stresses the importance of updating their learning to reflect changes in practice, and to keep up to date. The GMC is a charity registered in England and Wales (1089278) and Scotland (SC037750) Our role in overseeing doctors’ education and training As the medical regulator, we set the standards doctors and those who train them need to meet, and help them achieve them. We work with partners to make sure that education and training outcomes prepare doctors to deliver good, safe patient care across the UK. We do this by approving the undergraduate and postgraduate training programmes and assessments doctors must pass, and by carrying out reviews and regular monitoring. The educational standards we set are high level as they apply to all levels of medical education, and across all specialties. The standards require postgraduate curricula to be mapped against a framework of shared generic and specialty-specific outcomes. The Generic professional capabilities framework sets out the essential capabilities which underpin professional medical practice and are a fundamental part of all postgraduate training programmes. Under relevant capabilities in the framework, we say that doctors in training must learn to: ⚫ locate and use clinical guidelines appropriately ⚫ participate in continuing professional development to keep their knowledge, skills and capabilities up to date ⚫ recognise limits of their own competence and refer patients to colleagues with appropriate expertise. Neurosurgery training The curricula for specialty training are set by individual medical royal colleges and faculties, and we approve them against the standards for postgraduate curricula. The neurosurgery curriculum was developed and is owned by the Joint Committee on Surgical Training (JCST), and we approved it in 2021. It provides the approved UK framework for the training of doctors to the level of independent consultant practice in neurosurgery. The curriculum requires doctors to demonstrate technical skills and procedures in generic surgical skills such as incision placement and scalpel ability, but not at a level of detail which describes how doctors should carry out specific procedures. Addressing your concern As the standards we set for medical education and practice don’t describe the details of specific procedures, we would refer queries on these to the National Institute for Clinical Excellence (NICE), medical royal colleges or specialty bodies. I note that The Society of British Neurological Surgeons (SBNS) has already responded to your concern with immediate action, writing to all SBNS members, asking them to recognise the importance of measuring depth intraoperatively, and empowering them to abort surgery when findings are not consistent with expectations. gmc-uk.org 2 We welcome the publication of this Report to Prevent Future Deaths as an important measure to raise awareness of the incident with those who can take action to prevent future deaths. I hope this information provides reassurance that our work to promote high standards in medical education and practice, alongside actions taken by others, will ensure a similar incident does not happen again. Yours sincerely Medical Director and Director of Education and Standards gmc-uk.org 3
25 Octcober 2023 Dear SBNS Members Re: Regulation 28 We have recently been informed of the sad death of a patient as a consequence of injuries sustained during a trans-sylvian amygdalohippocampectomy. The coroner has written to the SBNS, the RCS, the GMC, and NHS England under Regulation 28 of the coroners (Investigations) Regulations 2013. The objective of the report is to prevent future deaths. As a recipient body we are required to provide a response to the Coronial service which will be sent to the Chief Coroner and "Properly Interested Persons" and may be published. On considering the coroner’s report, I consider that sharing a précis of the case, as presented to me, is appropriate so that points raised by the coroner can be considered by members performing amygdohippocampectomy. “The case concerned an elective procedure for the amelioration of epilepsy. During surgery "an incision ... to find the temporal horn ... was made at the wrong trajectory... it is probable that [the patient's] head position ... had moved... The incision was made excessively deep and caused significant damage to [the patient's] brain... Two further attempts were made at different trajectories to locate the temporal horn with the last using a neuro-navigation system to assist. Both were excessively deep... On being woken .... it was immediately apparent that [the patient] had sustained serious brain injury. On the balance of probability, it is likely that [the patient] would have died as a result of the damage caused by the first incision." The three incisions "from the insular" were measured at postmortem as being 5-6cm, 6-7cm and 5cm in length. The coroner concluded that the incisions were "far too deep" and that "only the second incision was measured intra-operatively with a cannula and this was after completion of the incision". An expert witness advised the coroner that it was his practice to "measure the length of his incisions intra-operatively as appropriate times". The expert witness reported that he had "aborted an operation after failing to find the temporal horn within expected limits". Post-operatively this was attributed to a change in position in the patient's head. The coroner is concerned that "it is not current and expected practice to measure the incision from the insult to the temporal horn at appropriate times during the operation". I thank you for reading this e-mail and advise surgeons to reflect upon their surgical techniques, with particular regard to gauging depth, selection of trajectory, considering potential inadvertent movement of the patient's head and the reasonableness of aborting the case when findings are not consistent expectations. If you are the Service Line Lead, please share this information with colleagues who might not be on the SBNS mailing list. I hope that sharing this knowledge will help avert future morbidity and mortality from similar causes. Yours sincerely Peter Whitfield SBNS President
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