Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0041, written 26 Feb 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 26 Feb 2023 |
|---|---|
| Reference | 2023-0041 |
| Deceased | Katie Wilkins |
| Coroner | Kate Ainge |
| Coroner area | Liverpool and Wirral |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Alder Hey Children's NHS Foundation Trust |
| 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 Secretary of State for Health and Social Care, Mr S Javid 1 CORONER I am Kate Ainge, Assistant Coroner for the coroner area of Liverpool and Wirral 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 01 July 2021 I commenced an investigation into the death of Katie Julia WILKINS aged 14. The investigation concluded at the end of the inquest on 26 May 2022. The conclusion of the inquest was that: Katie was a 14 year old girl with a diagnosis of Acute Promyelocytic Leukaemia (APML) which is known to have an associated and serious coagulopathy. Management and the treatment of the APML must also include treatment and management of the associated coagulopathy, that being a critical and basic element of the treatment of the condition. Katie initially presented at Warrington Hospital for concerns around pain and soreness in her vaginal area. She was diagnosed with a suspected labial abscess. Katie had no medical history of note and was not sexually active, this being an unusual presentation. Katie presented to the hospital initially on the 1/7/20 and subsequently on 5 further and separate occasions on the 2/7/20, 7/7/20, 14/7/20 and 15/7/20 and on the 21/7/20, each time relating to the unresolved labial abscess, pain and with tachycardia, including latterly with spiking temperatures. Despite the presentation on the 14/7/20 being the 4th occasion in which she was noted to be tachycardic, that increasing severity in the abscess was noted and there was an identified need for surgery the following day, no clinical review was undertaken or pre-operative blood tests directed. Those investigations were a basic part of the medical attention and treatment Katie required at that time. On the 26/7/20 Katie collapsed at home and was presented again to Warrington Hospital, at this time blood tests were instigated. Katie had a suspected diagnosis of APML and once stabilised, was transferred to Alder Hey Children’s Hospital where she received a formal diagnosis and treatment for the APML and also the associated coagulopathy. The associated coagulopathy poses a significant risk of bleeding in APML patients and as such Katie's treatment plan was complex and multifaceted and involved the use of fibrinogen concentrate amongst other blood products, with regular blood testing to monitor the blood levels. Katie suffered a drop in fibrinogen levels on the 28/7/20 at 10pm and further falling levels were noted in the early hours of 29/7/20. Katie's plan of treatment for her coagulopathy was for treatment with fibrinogen concentrate when her levels fell below 1. Despite her initial falling levels from 28/7/20, the fibrinogen concentrate was not administered in accordance with treatment plan once the blood results were known. Further on the 29/7/20 at around 9:30am Katie was urgently prescribed further fibrinogen concentrate to be given immediately. Also on or around 9:30am, she also complained of a mild headache which was more likely than not evidence of the commencement of a intracerebral haemorrhage when taken with her low fibrinogen levels. Despite fibrinogen concentrate having been part of Katie's treatment plan when fibrinogen levels fell below 1, and the same being advised for immediate administration at 9:30am that day, that being a basic part of the medical Regulation 28 – After Inquest Document Template Updated 30/07/2021 treatment Katie required to manage her condition, it was not administered and Katie suffered a catastrophic intracerebral haemorrhage. Katie was taken urgently for a decompressive craniectomy surgery with evacuation of the intracerebral haemorrhage. Despite the surgery on the 29 July 2020 Katie did not recover. Having been assessed and undergoing an MRI scan, Katie was found to have no brain activity and deemed brain stem dead, she was subsequently extubated and passed away on the 31/7/20. 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: The inquest has highlighted an ongoing concern that Oncology Consultants will continue to be the lead Consultants for care of APML patients at Alder Hey Trust. The most significant risk of death in such patients is due to the risk of serious bleeding due to the associated and significant coagulopathy. Coagulopathy management should be led by a Haematologist to prevent future deaths due to this issue, that was recognised by a Consultant Haematologist who gave evidence to the inquest as a expert witness and as supported by a leading Haematologist at the Trust. There is nationally a shortage of Haematologists which leaves Alder Hey Trust without resources available to them to address this matter of concern or to recruit. 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 July 21, 2022. 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 I have also sent it to Alder Hey Childrens NHS Foundation Trust 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 Regulation 28 – After Inquest Document Template Updated 30/07/2021 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: 26 May 2022 Kate AINGE Assistant Coroner for Liverpool and Wirral 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.
• Department of Healtlil & Social Care Kate Ainge Assistant Coroner The Coroner's Court and Offices Gerard Majella Courthouse Boundary Street Liverpool L52QD Dear Ms Ainge, From Will Quince MP Minister ofState for Health ?Jnd Secondary Care 39 Victoria Street London SW1H0EU 2 February 2023 Thank you for your letter of 26 May 2022 to the then Secretary of State for Health and Social Care Sajid Javid, about the death of Katie Wilkins. I am replying as Minister with responsibility for Health and Secondary Care, and thank you for the additional time allowed. I would first like to say how deeply saddened I was to -read of the circumstances of Ms Wilkins's death and I offer my most heartfelt condolences to her family and loved ones. It is, of course, vital that we take learnings where they are identified ta improve NHS care and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with NHS England, Health Education England, i:lS well as the relevant regulator in this case, the Care Quality Commission (CQC). With regards to the concerns related to Alder Hey Children's NHS Trust that you raise within your report, my officials have informed me that the Trust undertook a Root Cause Analysis (RCA) fallowing Ms Wilkins's death, particularly in relation to the delay in the administration of fibrinogen concentrate. As a result, the Trust identified a number of areas for improvement, including a review of the handover arrangements in place for the haematology/oncology rotas so it includes the management of potentially critical patients, which should be documented in a Standard Operating Procedure, and, where a child has two teams involved in their care, out of hours advice should be sought from both consultants at the same time via conference call. The learning from the RCA was shared with the specialty teams involved, and through the Divisional Integrated Governance meeting. In addition to this, the CQC followed up the Trust's action plan and monitored compliance through regular engagement until all actions were completed in December 2021. The action plan included changes to the allocation of specialities in cases similar to Ms Wilkins's, and patients are now referred to a consultant haematologist rather than an oncologist. There is also now specific guidance on the use and administration offibrinogen (RiaStrap) available to all staff. Turning to the concern regarding a shortage of haematologists, whilst we have made some progress, we know that there is more to do on staffing within haematology departments in England. In August 2022, there were 953 full time equivalent consultants working in the specialty of haematology in NHS hospital trusts in England, which is an increase of 342 (55.9%) since August 2010. However, Health Education England and NHS England are working collaboratively to review the distribution of medical specialty training posts across the country. The aim of this work is to ensure there is a more equitable distribution of training places and therefore more fairly distributed medical workforces across the country. This work will support patients and the wider NHS by ensuring that we have the appropriate number of doctors in the places where they are needed. It is recognised that no area in England is considered 'over doctored' and this programme is about ensuring the resource and workforce supply we currently have is distributed equitably. The programme has initially looked at three specialties, including haematology. This is a long-term programme, with post movement commencing from Autumn 2022, and will take place over the next 10-15 years. In addition, haematology has seen a moderate expansion as part of investment in the cancer a.nd diagnostic workforce in the last two years. An additional eight training places have been established beginning in 2022. With current planning, an extra four places are expected to be created in 2023 and in 2024 as part of cancer and diagnostic workforce growth. Health Education England is also working with colleagues across the specialty to refine future training solutions for paediatric haematology, as well as ensuring there are sufficient training programmes that contain haematology rotations and that trainees get the right experience to meet haematology training requirements. Further, haematology is also one of the specialties under review for investment to support the recovery of services following the pandemic and discussions are ongoing with NHS England and the Department on possible further expansion. In addition to this, the Government has funded an additional 1,500 undergraduate medical school places each year for domestic students in England, a 25% increase over three years. The first graduates from this expansion entered foundation training in August this year. The Government is committed to ensuring that the number and distribution of medical school places are in line with England's workforce requirements and continues to monitor the effectiveness of current arrangements. To support long-term workforce planning, the Department has commissioned Health Education England to produce a report looking at the long-term strategic drivers of workforce demand and supply. Building on this work, the Department has also commissioned NHS England to develop a long-term workforce plan. The plan will build on the foundations of the NHS People Plan. NHS England is due to complete this work by the end of 2022 and the key conclusions will be shared in due course. We are also taking action. to increase the retention of doctors, including haematologists, and supporting them to progress into long-term careers. The Enhancing Junior Gloctors' Working Lives programme, led by Health Education England, is delivering a range of initiatives to improve the quality of life of doctors in training. This work, which is ongoing, offers flexible training opportunities and measures to improve wellbeing, which, in the long-term, will support more trainees to complete training and continue into long careers in the NHS. Finally, the Department is currently analysing the responses received to the cancer call for evidence to develop the forthcoming 1 O Year Cancer Plan. It will set out plans to ensure that the appropriate workforce is in place to support all cancer patients and the plan will address all cancer types, including blood cancer. Diagnostic checks are a key part of many elective care pathways, including cancer. £2.3bn was awarded at SR21 to transform diagnostic services over the next three years, including for non-specific symptoms like those with potential blood cancer. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, WILL QUINCE MP MINISTER OF STATE
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