Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0077, written 7 Feb 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 7 Feb 2025 |
|---|---|
| Reference | 2025-0077 |
| Deceased | Amelia Ridout |
| Coroner | Elizabeth Gray |
| Coroner area | Cambridgeshire and Peterborough |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
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: National Institute for Health and Care Excellence (NICE) British Society for Haematology (BSH) NHS England 1 CORONER I am Elizabeth GRAY, Area 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 27 June 2022 I commenced an investigation into the death of Amelia Alexandra Anuszka RIDOUT aged 6. The investigation concluded at the end of the inquest on 21 March 2024. The conclusion of the inquest was that: Amelia Ridout underwent a bilateral bone marrow aspirate and trephine procedure at Addenbrookes Hospital on 16th June 2022 following a diagnosis of pancytopenia. A bilateral bone marrow aspirate and trephine procedure was carried out by a Paediatric Oncology Specialist Doctor whose understanding at the time was that Amelia Ridout’s differential diagnosis still included the possibility of a solid cancer which would require a bilateral bone marrow aspirate and trephine procedure to ensure accurate diagnosis. The Senior Clinical Fellow in Paediatric Haematology who had asked for the bone marrow aspirate and trephine procedure to proceed had not specified whether the bone marrow aspirate and trephine procedure was to be a unilateral or bilateral procedure. The bone marrow aspirate and trephine procedure was carried out under general anaesthetic with a Consultant Anaesthetist in attendance. Amelia Ridout was positioned on her left side for the bone marrow aspirate and trephine procedure. The right sided bone marrow aspirate and trephine procedure was completed. Following the completion of the left sided bone marrow aspirate and trephine procedure the Paediatric Oncology Speciality Doctor carrying out the bone marrow aspirate and trephine procedure noted a spurt of blood on removal of the trephine needle and queried the sample extracted. The supervising Consultant Haematologist was called in to review and confirmed that there was no signs to raise concern and that the bone marrow aspirate and trephine procedure should be concluded. Amelia Ridout remained positioned on her left side for the bone marrow aspirate and trephine procedure in line with the training and practise adopted by the Paediatric Oncology Specialist Doctor. Shortly after the conclusion of the left sided bone marrow aspirate and trephine procedure at 11.32am, Amelia Ridout started to decompensate and rapidly went into Pulseless Electrical Activity arrest (PEA arrest). Full Advanced Paediatric Life Saving procedures were commenced. The paediatric resuscitation team attended promptly, the on call Paediatric Surgeon was alerted and it was rapidly established and agreed based on Amelia Ridout’s differential diagnosis that Amelia Ridout was suffering an internal bleed as a result of the bone marrow aspirate and trephine procedure which needed to be dealt with through surgical intervention as a priority. The clinical team arranged for an operating theatre to be made available as a matter of Regulation 28 – After Inquest Document Template Updated 30/07/2021 emergency, a vascular surgeon was requested to attend and interventional radiological solutions were explored and excluded. AR’s resuscitation and stabilisation, continued and she was transferred to an operating theatre at 13.05. Amelia Ridout was prepared for an emergency laparotomy by the Anaesthetic team. Central Venous lines and arterial access were sited by the Anaesthetic team,to allow them the ability to provide life saving resuscitation to Amelia Ridout inter-operatively. On arrival at the Operating Theatre, Amelia Ridout was relatively stable as a result of the continued resuscitation efforts. The clinical team managing the emergency laparotomy anticipated that invasive surgery could lead to a rapid destabilisation in Amelia Ridout’s condition. Shortly after the start of Amelia Ridout’s surgery, Amelia Ridout went into PEA arrest and needed chest compressions. internal injury and identified a defect in the anterior arterial wall of the external iliac artery, the appearances of which were consistent with the anticipated needle injury caused by the bone marrow aspirate and trephine procedure. Amelia Ridout’s condition continued to deteriorate despite continued resuscitation efforts. The clinical team took the decision that continued efforts would be futile and Amelia Ridout was declared deceased. The surgical team continued to treat Amelia Ridout’s 4 CIRCUMSTANCES OF THE DEATH 6-year-old girl with suspected aplastic anaemia attended the paediatric day unit on 16th June for a minor surgical procedure under general anaesthetic (a bone marrow aspirate and trephine). During the procedure, the trephine needle accidentally penetrated through the pelvic bone and pierced the iliac vessels causing massive, catastrophic bleeding internally. Following prolonged resuscitation, she was transferred to theatre under paediatric and vascular surgical teams, but the bleeding could not be stopped, and after further prolonged resuscitation attempts, she died in theatre. 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) To consider the development and publication of a national guidelines and standard operating procedure for the carrying out of Bone Marrow Aspirate (BMA) and trephine biopsy to include recommended methodology. To consider the development of a data base to record these procedures and their outcomes. 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 April 08, 2025. 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; Regulation 28 – After Inquest Document Template Updated 30/07/2021 1. 2. Partnership (Father) (Mother) c/o , Solicitor from Legal Solutions 3. Addenbrookes Hospital 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: 11/02/2025 Elizabeth GRAY Area Coroner for Cambridgeshire and Peterborough Regulation 28 – After Inquest Document Template Updated 30/07/2021
3 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.
Tel: 020 7713 0990 email: info@b-s-h.org.uk 3 April 2025 Ms Elizabeth Gray Area Coroner for Cambridgeshire & Peterborough By email Dear Ms Gray, Re: Regulation 28 Prevention of Future Deaths Report in respect of Amelia Alexandra Anuszka Ridout Thank you for providing us the opportunity to respond to your Regulation 28 report, dated 11 February 2025, regarding the tragic death of Amelia Ridout from a bone marrow biopsy. Firstly, we would like to convey our sincere condolences to Amelia’s family. Amelia suffered a truly tragic outcome from a routine procedure required for diagnosis and monitoring of haematological disease. There has been much discussion about actions we can take to minimise the risk of the procedure and ensure such a tragedy does not happen again. These actions include: 1. Gather data, via survey to trainee haematologists, to understand the training, competencies and support they receive in undertaking this procedure, both for adults and children. 2. Gather data, via a Blood Cancer UK survey, on experiences of adult patients and parents of children who have received the procedure. 3. Review the literature and evidence regarding adverse outcomes after bone marrow aspirate and trephine biopsy on adults and children, and safest techniques. 4. With these sources of information, develop a national guideline for recommended methodology and include recommendations for training and competency assessment. 5. Improve existing consent processes to include the rare risk of death and add these to the guideline. 6. Explore the possibility of developing a registry of complications to inform future guidelines. 7. Establish an audit process for Trusts to monitor their performance and ensure proper implementation of national guidance. Registered in England and Wales as a Company Limited by Guarantee, No 02645706 and as a charity, No 1005735 Registered Office: 100 White Lion Street London N1 9PF Continued 8. Name the recommended method Millie’s method, in accordance with Mr Ridout’s request. Whilst we acknowledge that completion of these actions will take time, we are pleased to confirm that the wheels are already in motion. Additionally, we have been in communication with NICE, who has offered to contribute as needed, in the guideline production and implementation. Yours sincerely, President British Society for Haematology Consultant Haematologist Oxford University Hospitals NHS FT The British Society for Haematology
Ms Elizabeth Gray
HM Area Coroner
Cambridgeshire and
Peterborough Coroner’s Service
Lawrence Court
Princes Street
Huntingdon
PE29 3PA
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
2 May 2025
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Ameila Alexandra
Anuszka Ridout who died on 16 June 2022
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 11
February 2025 concerning the death of Amelia Alexandra Anuszka Ridout on 16 June
2022. In advance of responding to the specific concerns raised in your Report, I would
like to express my deep condolences to Amelia’s parents and family. NHS England
are keen to assure the family and the Coroner that the concerns raised about Amelia’s
care have been listened to and reflected upon.
I am grateful for the further time granted to respond to your Report, and I apologise for
any anguish this delay may have caused to Amelia’s parents and family. I realise that
responses to Coroners’ Reports can form part of the important process of family and
friends coming to terms with what has happened to their loved ones, and I appreciate
this will have been an incredibly difficult time for them.
Your Report raises that there should be development and publication of national
guidelines and a standard operating procedure (SOP) for the carrying out of Bone
Marrow Aspirate (BMA) and trephine biopsy, and consideration of developing a
database to record these procedures and outcomes.
It would not sit within the remit of NHS England to produce the relevant clinical
guidelines or SOP for BMA and trephine biopsy, although we have engaged with the
National Institute for Health and Care Excellence (NICE) and the British Society for
Haematology (BSH) on the concerns raised in HM Coroner’s Report and have been
sighted on the responses from NICE and the BSH to the Coroner.
BMA and trephine biopsy are common diagnostic procedures, used for a variety of
reasons. Our National Specialty Advisor for Blood and Marrow Transplantation (BMT)
has considered your Report and confirmed that the procedures do not sit within the
NHS England commissioned BMT pathway or within specialised children’s services. It
is therefore a service directly commissioned by Integrated Care Boards (ICBs), who
would be expected to ensure that Hospital Trusts have the appropriate processes in
place to deliver the procedure safely and effectively. The Coroner may wish to engage
with the relevant ICB in this matter, although my regional Clinical Quality colleagues
for the East of England have been made aware of your Report and the circumstances
that led to Amelia’s death, and they can liaise with the local ICB directly.
Bleeding due to vascular injuries is recognised as a known, although adverse, risk of
bone marrow biopsy and NHS England are aware of individual Trust Patient
Information Leaflets (PILs) that outline the risks and details of the procedure, for
example: Bone marrow biopsy | The Rotherham NHS Foundation Trust and pl-964.1-
bone-marrow-biopsy.pdf.
NHS England have however communicated to the BSH that it would be supportive of
them developing the relevant national guidance for clinicians. Our national Patient
Safety Team have advised that they would consider issuing a National Patient Safety
Alert (NatPSA) to support and raise awareness of key recommendations, although this
would have to be weighed against the existing NatPSA criteria. We are aware that the
BSH has already published a demonstration video on ‘How to perform bone marrow
aspiration and trephine biopsy’.
Regarding the development of a database to record BMA and trephine biopsy
procedures and their outcomes, my colleagues with responsibility for national
databases and registries have considered this, together with your Report. NHS
England do not consider there is a need for us to develop a registry at this point,
however we will undertake to:
1. Investigate further to understand the evidence in this area, to determine the
potential root cause, for example, are there any training and / or supervision
issues associated with this practice.
2. Review relevant national guidance and understand how this translates into local
policies.
On review of the above and depending on the evidence, NHS England will take any
necessary and proportionate steps to minimise potential future harm.
We also note many of the actions being undertaken by the BSH, as the responsible
professional society for the procedure, and outlined in their response to you which
include improving existing consent processes, their exploration of the possibility of a
registry of complications and establishing an audit process for Trusts.
I would also like to provide further assurances on the national NHS England work
taking place around the Reports to Prevent Future Deaths. All reports received are
discussed by the Regulation 28 Working Group, comprising Regional Medical
Directors, and other clinical and quality colleagues from across the regions. This
ensures that key learnings and insights around events, such as the sad death of
Amelia, are shared across the NHS at both a national and regional level and helps us
to pay close attention to any emerging trends that may require further review and
action.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
2nd Floor
2 Redman Place
London
E20 1JQ
United Kingdom
+44 (0)300 323 0140
18 March 2025
Ms Elizabeth Gray
Area Coroner for Cambridgeshire and Peterborough
Sent via email:
Our reference:
Dear Ms Gray,
Re: Regulation 28 Prevention of Future Deaths Report in respect of Amelia Alexandra
Anuszka Ridout
I write in response to your regulation 28 report, dated 11 February 2025, regarding the very
sad death of Amelia Ridout. I would like to express my sincere condolences to Amelia’s family.
We would like to thank you for including NICE in this important report. We have reflected on
the circumstances surrounding Amelia’s death and the concerns raised. We note your request
to consider the development and publication of a national guideline and standard operating
procedure for carrying out Bone Marrow Aspirate (BMA) and trephine biopsy to include
recommended methodology.
This is a truly tragic outcome from a widely used intervention that is essential in haematological
practice. Bleeding due to vascular injuries is recognised as a rare, but possible adverse
outcome of the procedure. NICE have not published any specific procedural guidance on bone
marrow aspirate and trephine biopsy however, NICE guidance refers to the need to carry out
the procedure for diagnosis1. NICE are not asked to develop guidance on all conditions and
our recommendations do not cover all clinical circumstances. Our guidance focuses on the
management and treatment of conditions and although we may outline recommendations on
when an investigation or diagnostic test is necessary, it is not within our remit to produce
detailed guidance on how clinicians should carry out a standard diagnostic procedure.
NICE is not the only organisation that produces guidance and standard operating procedures;
we would expect that hospital trusts or individual clinicians also follow guidance from
professional bodies, Royal Colleges and local care pathways developed by commissioners
such as integrated care boards and NHS England.
1 Haematological cancers: improving outcomes
We note that you have also written to the British Society for Haematology (BSH) and NHS
England and as part of our process, our consultant clinical advisors have been in
communication with these two organisations and will contribute as needed in the production
of a good practice paper for bone marrow aspirate and trephine biopsy, which is being led by
the BSH.
NICE has offered to work with the BSH on the development of this paper, ensuring that any
references to NICE guidance are included where applicable. Through our organisation-wide
approach to prioritisation and topic selection, NICE’s prioritisation board could then consider
any new recommendations made by the BSH guidance and whether they require updates to
existing guidance or development of new NICE guidance on this topic if this is considered
appropriate.
I hope this response has helped outline our role and the placement of our guidance within the
wider healthcare system. We will continue to liaise with colleagues at the BSH and NHS
England on the development of an appropriately placed guidance document if appropriate. I
would like to reiterate my sincere condolences to Amelia’s family.
Yours sincerely,
Chief Executive
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