Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0117, written 6 Apr 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 6 Apr 2023 |
|---|---|
| Reference | 2023-0117 |
| Deceased | Alexandra Briess |
| Coroner | Heidi Connor |
| Coroner area | Berkshire |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths · Alcohol, drug and medication 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.
Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH Regulation 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This from is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1. Secretary of State for Health and Social Care, 39 Victoria Street, London, SW1H 0EU. 2. UK Fatal Anaphylaxis Registry. 3. Medicines and Healthcare Products Regulatory Agency, 10 South Colonnade, London E14. 2 CORONER’S LEGAL POWERS I am Mrs Heidi J Connor, Senior Coroner for Berkshire. 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 conducted an inquest into the death of Alexandra Briess, which concluded on 15th December 2022. I recorded a Narrative Conclusion as follows: Alexandra Briess underwent an uneventful tonsillectomy on 22nd May 2021. She suffered post-operative bleeding, and required further surgery. This was carried out on 30th May. During anaesthesia, Alexandra suffered a sudden deterioration and cardiac arrest. Despite extensive resuscitation efforts, she died at Royal Berkshire Hospital, London Road, Reading on 31st May 2021. Subsequent investigations have revealed that the most likely cause of her sudden deterioration was an anaphylactic reaction to Rocuronium. This was a drug she had not had before, and her reaction to it was unpredictable. Alexandra was a bright and well loved young woman, who had planned to study medicine herself. Her cause of death was: I a Anaphylaxis due to Rocuronium used during anaesthesia I b Surgery to repair post operative bleeding 30th May 2021 I c Tonsillectomy 22nd May 2021 This Regulation 28 Report has been deliberately delayed, to allow for careful consideration of guidance to pathologists, police and coroners, and in order to Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH ensure the report is addressed to the correct recipients. Alexandra’s family has been kept updated in this respect. 4 CIRCUMSTANCES OF THE DEATH Alexandra was born on 3rd January 2004. She was 17 at the time of her death. The key facts in this case are as follows: Alexandra had no significant past medical history. She underwent an uneventful tonsillectomy on 22nd May 2021. After returning home, she suffered post-operative bleeding and required further surgery. The second operation was carried out on 30th May. When the anaesthetic was administered on 30th May, Alexandra deteriorated suddenly and suffered a cardiac arrest. A large number of clinicians were involved in trying to assist Alexandra, but tragically, she died at the Royal Berkshire Hospital in Reading on 31st May 2021. There are no concerns about her clinical management. The most likely cause of her sudden deterioration was an anaphylactic reaction to Rocuronium, a drug which she had not had before. 5 CORONER’S CONCERNS Background This is not new territory. Several coroners have raised concerns similar to mine. Those listed below are simply the cases where coroners have sent Regulation 28 reports. There may well be others. Previous cases include : 1. In the case of Shante Turay-Thomas (who I believe was 18 at the time of her death), the Senior Coroner for Inner North London stated: “The issues within this Prevention of Future Deaths report are predominantly national issues, but I heard at inquest that there is no person with named accountability for allergy services and allergy provision at NHS England, or the Department of Health as a whole.” Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH 2. In the case of Robin Bousquet (who I believe was 14 at the time of death), the Coroner for Inner South London stated in a Regulation 28 Report to Prevent Future Deaths: “In my opinion action should be taken to consider establishing a national reporting system which includes timely reporting to local authority and FSA and maintenance of a register of fatalities and their investigations, and consideration be given the feasibility of wider access to AAIs. I believe that the organizations would wish to learn of the circumstances of this death and are in a position to facilitate a collaborative process to mitigate or prevent future deaths.” investigating to 3. In the case of Ms Celia Marsh (who I believe was 42 at the time of her death), the coroner touched on many of the issues I will refer to in this report. She stated the following: “Concerns were raised in relation to the immediate investigation into a suspected death from anaphylaxis, that the evidence obtained at this time, with the right approach, can be invaluable to preventing deaths, but that to achieve this, changes are required. In relation to the Food Standards Agency, the UK Health Security Agency, and the Department of Health and Social Care: To establish a robust system of capturing and recording cases fatal and near-fatal of anaphylaxes, and specifically, anaphylaxis… Such a system could involve, mandatory for notifiable diseases… by reporting of anaphylaxis presenting to hospital analogous to the current system registered medical practitioners have a statutory duty to notify the ‘proper officer’ at their local council or local health protection team of suspected cases of certain infectious diseases. An example of such a reporting system for anaphylaxis already exists in the State of Victoria in Australia, and allows for rapid alerts of serious cases to public health authorities to expedite investigation and evaluate public health risk.” Alexandra’s case Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH It seems clear to all coroners in these cases, and those involved in this area of medical expertise, that the only way to improve understanding and prevent or reduce future deaths is to gather information nationally and fund appropriate research. Appropriate organisations already exist, and there is a lot of goodwill towards improving understanding in this area. It does however require national leadership and “joining up” of these organisations. The matters of concern are as follows: 1. I have tried to make my list of issues clear and succinct. Paragraph 2 below sets out the crux of this ongoing risk. 2. There is significant goodwill and desire to improve amongst numerous organisations involved in anaphylaxis work. What is lacking is national leadership and funding. In my view, consideration should be given to creating a leadership role and responsibility within NHS England to coordinate a national approach. 3. As considered by other coroners before me, it should be mandatory to refer fatal anaphylaxis cases. UKFAR has indicated that they would be prepared to take on the role of receiving these reports (to avoid duplication for reporting clinicians), with the responsibility to forward the relevant information to other organisations such as the MHRA, where appropriate. Whilst my focus is on fatal anaphylaxis, inclusion of non-fatal cases would be a matter for the lead role to consider. 4. Gathering data and using this to research and reduce the risk of future deaths requires funding, and this should be reviewed. 5. Information sharing amongst the organisations referred to in this report should be straightforward. Confidentiality constraints are important, but not the same in the case of a deceased person as they are for a living person. I believe that a confidential advisory group has already started to consider this matter. 6. Consideration of including contact details for the UKFAR in algorithms used by doctors attempting to resuscitate patients – so that there is a clear requirement for referral to UKFAR in the event of an unsuccessful resuscitation. This is currently being considered by the Resuscitation Council UK. For my part, I have taken the following steps to increase awareness in the work that Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH I do : 1. I have taken responsibility for making my fellow coroners aware of the existence of UKFAR and circulated guidance to them to use in anaphylaxis cases. 2. The Royal College of Pathologists is reviewing their guidance, and I intend to circulate interim guidance which coroners can send to their pathologists, pending this more official guidance. 3. I will also send all coroners nationally a guidance note to use for their local police forces in gathering appropriate evidence at the scene of a likely anaphylaxis case. 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 2 June 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 Alexandra’s family. I have also sent this report to the following recipients, who have an interest in this matter: Resuscitation Council UK. , Director of Clinical and Service Development at the Executives. , Clinical Support Manager for Association of Ambulance Chief , President of Paediatric Critical Care Society , Honorary Secretary of Paediatric Critical Care Society. Berkshire Coroner’s Office Reading Town Hall, Blagrave Street, Reading, RG1 1QH President Royal College of Emergency Medicine. , Deputy Medical Director at Learning from Patient Safety Events. , National Medical Examiner Programme and Policy Lead. , Lead Medical Examiner Sudden and Unexpected Child Deaths. , National lead for Designated Doctors for Child Health in , Permanent Secretary at DEFRA. , Chief Executive Officer at Food Standards Agency. , President of the Royal College of Pathologists. , Chief Medical Officer, Royal Berkshire Hospital 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. 6 April 2023 Mrs Heidi J Connor HM Senior Coroner for Berkshire
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.
The Rt Hon. Andrew Stephenson CBE MP Minister of State 39 Victoria Street London SW1H 0EU Mrs Heidi J Connor Senior Coroner for Berkshire Reading Town Hall Blagrave Street Reading RG1 0QG 3 April 2024 Dear Mrs Connor, Thank you for your letter of 6 April 2023 about the death of Alexandra Briess. I am replying as Minister with responsibility for long-term conditions, including allergies, and I am grateful for the additional time in which to respond. Firstly, I would like to say how saddened I was to read of the circumstances of Alexandra’s death, and I offer my sincere condolences to her family and loved ones. Her loss at such a young age must be extremely distressing for them and I agree that it is essential that we learn from this tragic event to prevent future deaths. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with the organisations to which you issued your report to understand the system-wide response to the matters of concern. I am assured that your concerns have been carefully considered. I will not repeat the detail of the responses you have received, which are the responsibility of others. My response will focus on the matters of concern relating to the need for national leadership on allergy to oversee action to prevent similar deaths and register of deaths, as well as capturing and recording cases of fatal anaphylaxis. National leadership on allergy services In relation to national accountability for allergy services, following the reforms initiated by the Health and Social Care Act 2012, NHS England (NHSE) is responsible for clinical policy and strategy in the NHS in England (including for allergies) and is held to account through the annual NHS mandate. While there is indeed currently no National Clinical Director (or ‘Tsar’) for allergy in England, NHSE has a clinical reference group (CRG) for Specialised Immunology and Allergy Services that provides advice on specialised services and commissioning policies and quality standards. The CRG is chaired by NHSE’s National Specialty Advisor (NSA) for clinical immunology and allergy, Dr Claire Bethune, a clinical immunologist, and allergy clinical immunology expert clinicians are among the membership. More generally, NSA and National Clinical Director (NCD) posts within NHSE are specifically aligned with its major clinical programmes of work, which in turn are aligned with the NHS Long Term Plan. NHSE keeps consideration of which areas would benefit from an NCD under review, and new NCDs are appointed as they reason is necessary. An Expert Advisory Group for Allergy (EAGA) has recently been established, which brings together key stakeholders with the aim improving the quality-of-life of people with allergies. Chaired jointly by the Department of Health and Social Care and the National Allergy Strategy Group, the EAGA identifies priority areas for the Department, NHSE and other government department and agencies relating to allergy that require policy change or development and advises on how to best achieve improved outcomes. Capturing and recording cases of anaphylaxis As articulated in your report, recommendations refer to establishing a robust system of capturing and recording cases of anaphylaxis, both food and non-food related. The Department of Health and Social Care notes the recommendation and concurs that it is essential that we learn from tragedies such as Alexandra. Data regarding all anaphylaxis-related deaths in England and Wales are documented by the Office of National Statistics. The British Society for Allergy and Clinical Immunology also holds a register, the UK Fatal Anaphylaxis Registry (UKFAR), referenced in your report, to capture and learn from fatal cases of anaphylaxis, which has been operational since 1992. A link to the register follows: https://www.bsaci.org/professional-resources/bsaci- registries/ukfar/#:~:text=The%20UK%20Fatal%20Anaphylaxis%20Registry,order%2 0to%20influence%20clinical%20outcomes. I understand that NHSE’s National Patient Safety Team is working closely with the UKFAR to develop a mechanism for sharing relevant patient safety anaphylaxis incidents with them and this work is ongoing. I hope this reply is helpful. Thank you for bringing these concerns to my attention. Kind regards, THE RT HON ANDREW STEPHENSON CBE MP MINISTER OF STATE
Heidi Connor
Senior Coroner for Berkshire
Reading Town Hall
Blagrave Street
Reading
RG1 0QG
Dear Mrs Connor
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
12 October 2023
1st
Thank you for your letter to NHS England (
September 2023, regarding Alexandra Briess’ case. Before responding to your letter,
NHS England would first like to express our deep condolences to Alexandra’s family.
dated
We wish to provide you with assurances that there have been active discussions with
various stakeholders on the concerns raised around anaphylaxis and the need to
improve data collection, understanding, and research of anaphylaxis cases.
By way of some initial context, specialised allergy services are commissioned by NHS
England. Expert advice on allergy is provided by NHS England’s Immunology and
Allergy Clinical Reference Group (CRG). The CRG consists of a group of senior
clinicians from across the NHS with expertise in delivering clinical allergy and
immunology services as well as representatives from primary care, public health and
patient groups. The CRG also provides advice on innovation, horizon scanning,
service reviews and how we can reduce variation and deliver increased value. In
addition, it also leads on the development of clinical commissioning policies, service
specifications and quality standards.
Through Patient and Public Voice (PPV) members, it also helps to ensure that any
changes to the commissioning of specialised services involves patients and the public.
Specialist allergy services are defined according to the following specialist allergy
service specification: B (england.nhs.uk). This service specification is currently under
review by the Immunology and Allergy CRG.
In regard to recent developments, following a debate in parliament in May this year
(https://hansard.parliament.uk/Commons/2023-05-11/debates/295069F8-79F3-
40C9-B96C-DEF92C9F14C4/AllergyAwarenessWeek), there has been a preliminary
agreement to establish an Expert Advisory Group for Allergy (EAGA) that would be
jointly chaired by a representative of the Department of Health and Social Care
). Dr
(DHSC) and the National Allergy Strategy Group (chaired by
National Specialty Advisor (NSA) for Specialised Immunology and Allergy at
NHS England) has been invited to represent the CRG on this group where there will
also be representation from other key stakeholder organisations. If established, one
of the aims of this group will be to identify priority areas for DHSC, NHSE and others
relating to allergy that require policy change or development and advise on how to
best achieve improved outcomes.
NHS England’s National Patient Safety Team is also working closely with the UK Fatal
Anaphylaxis Registry to develop a mechanism for sharing relevant patient safety
anaphylaxis incidents with them and this work is ongoing.
The British Society for Allergy & Clinical Immunology (BSACI) has also recently
established the Perioperative Allergy Network Steering Committee which looks to
address recommendations made in the National Audit Project 6 anaphylaxis report. At
the end of August 2023 they published recommendations on referral for assessment
of suspected anaesthesia
related allergy: Perioperative Allergy Network
recommendations of suspected anaesthesia related allergy - BSACI. The BSACI
should be able to provide further information on this if required.
Additionally, the Royal College of Physicians Improving Quality in Allergy Services
accreditation programme (IQAS) https://www.iqas.org.uk/ was set up to improve the
quality of allergy services across the UK. The programme independently measures
services against national standards with the aim of reducing variation across the
country, promotes quality improvement through highlighting areas of best practice and
areas for change and demonstrates the service's dedication to improvement, patient
safety and reducing risk. The programme includes domains relating to clinical care
and performance. The current IQAS standards (2019) are due to be revised in 2024
and NHS England has been assured by the IQAS clinical lead that horizon scanning
means that perioperative anaphylaxis services will be front and centre of the review.
The Royal College should be able to provide further information on this, should you
require it.
NHS England’s NSA for Specialised Immunology and Allergy and the CRG has
provided assurances that they recognise the importance of the issues relating to
investigation and follow up of perioperative anaphylaxis as highlighted in your Report
and will be taking points raised into consideration in the development of the specialised
allergy service specifications and commissioning policies.
NHS England has also been in touch with our DHSC counterparts regarding their
response to you, and we hope that you will hear from them shortly.
I hope that this is helpful to you and please do not hesitate to contact me should you
need any further information.
Yours sincerely,
National Medical Director
See every Prevention of Future Deaths report matching Child Death (from 2015), 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.