Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0245, written 3 May 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 May 2024 |
|---|---|
| Reference | 2024-0245 |
| Deceased | Michael Clarke |
| Coroner | Alison Mutch |
| Coroner area | Manchester South |
| 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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1) NHS England 2) Greater Manchester Integrated Care 1 CORONER I am Alison Mutch Senior Coroner, for the coroner area of South Manchester 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 1st August 2023 I commenced an investigation into the death of Michael Clarke. The investigation concluded on the 28th March 2024 and the conclusion was one of Narrative: Died from the complications of urosepsis following a previous medical procedure, contributed to by his underlying health conditions. The medical cause of death was 1a) Multiple organ failure 1b) Urosepsis on the background of a cystoscopy on 26/07/23 II) Diabetes mellitus, end stage kidney disease, atrial fibrillation, hypertension. 4 CIRCUMSTANCES OF THE DEATH Michael Clarke had a complex medical history that included diabetes, end stage renal failure, hypertension, and atrial fibrillation. He required dialysis three times a week. On 20th July 2023 Michael Clarke saw his GP for a suspected urinary tract infection and reported blood in his urine. He was prescribed antibiotics for the suspected infection and referred on the 2 week pathway for investigation of the cause of the bleeding. On 26th July 2023 he was seen in the cystoscopy clinic under the 2 week wait referral pathway. The urine culture from the sample on 21st July showed mixed growth. The cystoscopy found no evidence of cancer although there was evidence of significant bladder debris that was cleared out. On 28th July 2023 Michael Clarke felt very unwell. At 21:20 a 1 call was placed to Northwest Ambulance Service by the out of hours nurse indicating they were concerned he had sepsis and an ambulance was required. The call was categorised as a category 3 which meant an ambulance should have been dispatched in 1 hour. Due to demand the wait was in excess of 4 hours. The nurse indicated 1 hour was an acceptable time frame. After 1 hour no ambulance attended and a further call was made. The category remained at 3. At 23:38 a further call was made and the call was categorised as a category 2 call. An ambulance arrived and took him to hospital. At Tameside General Hospital he was diagnosed with suspected urosepsis probably triggered by the cystoscopy. He was started on intravenous antibiotics and was moved to the Intensive Care Unit for full organ support. He continued to deteriorate and died at Tameside General Hospital on 30th July 2023. 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 will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – 1. The inquest was told that due to significant demand the wait time for an ambulance in category 3 was in excess of 4 hours rather than the target 1 hour. The inquest was told that this was not unusual and was still an ongoing issue. The evidence was that this was not unique to NWAS but the general picture in England. The inquest was told that there had been improvements in category 1 and 2 response times but to achieve this category 3 calls continued to have these significant delays. 2. The inquest was told that the initial call to NWAS was made by the out of hours nurse. She made it clear that she felt the ambulance response needed to be within 1 hour. As this was in theory the response time consistent with a category 3 response, she accepted the categorisation. This acceptance did not appear to take into account that on that evening a category 3 call was not going to result in an ambulance within 1 hour. 3. The evidence before the inquest was that there were no specific sepsis trigger questions on the ambulance pathway. The nurse suspected sepsis and gave that indication but that did not trigger a faster response despite the recognition that where sepsis is suspected antibiotics need to commence as a priority. 2 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you 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 28th June 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. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely on behalf of the family, Tameside General Hospital who may find it useful or of interest. 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 Alison Mutch HM Senior Coroner 03/05/2024 3
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.
Inquest Index ~S1 | ~S3 | ~S4 | SECTION A – Responses Document Date Author Pages Regulation 28 Response - NHSE Regulation 28 Response - GMIC 26/06/2024 A1 – A4 08/07/2024 A5 – A7 ~E ~E ~E Ms Alison Mutch HM Senior Coroner South Manchester Coroner's Court 1 Mount Tabor Street Stockport SK1 3AG National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG 26 June 2024 Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Michael Clarke who died on 30 July 2023. Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 3 May 2024 concerning the death of Michael Clarke on 30 July 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Michael’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Michael’s care have been listened to and reflected upon. 1. National waiting times for ambulances Your first concern is centred on the significant demand and waiting times for a Category 3 ambulance which was more than four hours rather than the one-hour target. NHS England recognises the significant pressure on ambulance services since the Covid-19 pandemic, which has seen longer response times across all categories than before the pandemic, as well as issues associated with handing over ambulance patients in a timely way at some NHS Trusts. NHS England has prioritised improving ambulance performance during 2023/24, supported by the Delivery plan for recovering urgent and emergency care services, which was published in January 2023. The plan outlined key actions to recover and improve urgent and emergency care services, including improving ambulance response times, increasing ambulance capacity through growing the workforce (for example, increasing clinical capacity in control rooms), alongside broader system actions to improving flow through hospitals and reducing handover delays, speeding up discharges from hospitals and expanding new services in the community, all of which should help ambulance crews to get back on the road to the next waiting patient more rapidly. Whilst ambulance response times have not returned to pre-pandemic levels, there were improvements in ambulance response times nationally during 2023/24. The 2023/24 year-end Category 3 Mean time to respond was 2 hours 4 minutes 14 seconds which is 31 minutes 4 seconds quicker than 2022/23 and the 2023/24 year- end Category 2 Mean was 36 minutes 23 seconds which is 13 minutes 37 seconds quicker than 2022/23. For 2024/25, the Delivery Plan continues to focus on the improvement of ambulance response times, with ambulance services expected to maintain the increases in capacity achieved throughout 2023/24, alongside the continued development of alternative referral pathways (e.g. urgent community response) to ensure that patients receive timely and high-quality care. A1 2. Categorisation of the ambulance You also raised a concern that the initial call to North West Ambulance Service (NWAS) was made by an out of hours Nurse who requested an ambulance within one hour as this is consistent with Category 3 response call-outs. It was not considered that on that evening a Category 3 call was not going to result in an ambulance attending within one hour. When Healthcare Professionals (HCP) request emergency admissions they will be asked several questions to determine the category of response required. Michael was conscious, breathing and it was confirmed there was no threat to life, limb or sight requiring immediate emergency admission. An HCP Category 3 ambulance response was generated and following audit this was found to be safe and appropriate. At the time the estimated response time was 4 hours 15 minutes, and this was communicated to the HCP requesting admission. If a decision is made to upgrade a call from the allocated category this could severely impact the response given to calls allocated a higher priority with their initial triage on their patient's current presentation. The further 999 calls received for Michael were triaged by NWAS call takers utilising NHS Pathways to determine the correct categorisation for the patient's presentation. Audit confirmed the Category 3 outcome was appropriate to the second call. When the patient deteriorated NWAS were contacted back as per escalation advice. 3. Sepsis trigger questions on the ambulance pathway Your third concern raised was regarding there being no specific sepsis questions on the ambulance pathway. The NHS Pathways triage system is a clinical decision support system (CDSS) supporting the assessment of patients presenting to urgent and emergency services, such as ambulance services. The system is owned by the Department for Health and Social Care and delivered by the Transformation Directorate of NHS England. NHS Pathways’ clinical content updates and changes are overseen by an independent National Clinical Advisory Group (NCAG). This is hosted by the Academy of Medical Royal colleges and is chaired by the Royal College of General Practitioners. That group includes experts from professional bodies, including the Royal College of Emergency Medicine. Alongside this independent oversight, NHS England ensures that the clinical content and assessment protocols in the NHS Pathways system are consistent with the latest advice from respected bodies that provide evidence and guidance for clinical practice in the UK. This includes latest guidelines from NICE (National Institute for Health and Care Excellence), the UK Resuscitation Council and the UK Sepsis Trust. Sepsis is considered in many routes in the NHS Pathways CDSS. The product offers all callers a symptom-based assessment (whether members of the public or healthcare professionals (HCP)) based on a clinical hierarchy presenting a series of questions in order that the most appropriate clinical response or disposition may be determined based on the presenting symptoms. Following the implementation of the Ambulance Response Programme response model, NHS England published a A2 national framework which NHS Pathways adhere to, relating to ambulance responses for Healthcare Professionals (HCPs) requesting ambulances, and sets out four levels of response. Where the caller is an HCP, calling to arrange an emergency ambulance or non-urgent transfer, full symptom-based assessment is offered but is not mandatory. Rather, if the HCP requests dispatch of emergency services but does not require further help with assessing the patient’s symptoms, then they are asked to specify the main problem (illness, injury, or other health problem) and this is documented by free text into the assessment record. Even if full assessment is not required questions present to identify time-sensitive conditions, where delay is likely to be associated with significant clinical deterioration. This includes an option to select “suspected sepsis, septicaemia or meningitis” – which should have been the case in this instance. NEWS2 is a tool that is for use in both acute hospital and ambulance settings NHS England » National Early Warning Score (NEWS) . Whilst NEWS2 is not the same as ‘trigger questions’ the clinical indicators needed to inform a NEWS2 score are of similar effect. On selecting “suspected sepsis, septicaemia, or meningitis” the HCP will be asked for the patient’s NEWS score1. A NEWS score of 7 or above generates a Category 2 ambulance response, in concordance with the national framework for healthcare professional ambulance responses2. A NEWS score of 5 or 6 will also generate a Category 2 response in the presence of ‘suspected sepsis, septicaemia or meningitis’ being previously identified. Where the NEWS score is unknown, or is below 5, the HCP will be asked if there is a clinical reason why an emergency ambulance must be dispatched immediately. If the clinician specifies a clinical reason, then this is documented within the assessment and a Category 2 response is generated. This ensures that the clinical judgement of the HCP (who has knowledge of individual patient risk factors and circumstances) is considered when an emergency response is requested. For those with no clinical reason identified as requiring an immediate Category 2 emergency response at this point, triage will continue to identify whether a 1,2-,3- or 4-hour response is needed. I would also like to provide further assurances on 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 preventable deaths are shared across the NHS at both a national and regional level and helps us 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. 1 The National Early Warning Score, NEWS, is a system in widespread use by clinicians and ambulance trusts across England to identify acutely ill patients, including those with sepsis. 2 https://www.england.nhs.uk/wp-content/uploads/2019/07/C1172-aace-national-framework-for-hcp- ambulance-responses.pdf A3 Yours sincerely, National Medical Director A4 E: Date: 08 July 2024 Private & Confidential Ms Alison Mutch H M Senior Coroner Coroner’s Court 1 Mount Tabor Street Stockport SK1 3AG Dear Ms Mutch Re: Regulation 28 Report to Prevent Future Deaths Thank you for your Regulation 28 Report dated 3rd May 2024 regarding the sad death of Michael Clarke. On behalf of NHS Greater Manchester Integrated Care (NHS GM), We would like to begin by offering our sincere condolences to Michael’s family for their loss. Thank you for highlighting your concerns during the inquest which concluded on the 28th of March 2024. On behalf of NHS GM, we apologise that you have had to bring these matters of concern to our attention. We recognise it is very important to ensure we make the necessary improvements to the quality and safety of future services. During the inquest you identified the following cause for concern: - The inquest was told that due to significant demand the wait time for an ambulance in category 3 was in excess of 4 hours rather than the target 1 hour. The inquest was told that this was not unusual and was still an ongoing issue. The evidence was that this was not unique to NWAS but the general picture in England. The inquest was told that there had been improvements in category 1 and 2 response times but to achieve this category 3 calls continued to have these significant delays. As you will be aware, the NHS remains a system in recovery following the COVID-19 pandemic and the pressures arising from it and the societal response. As part of this, NHS England has published a series of recovery plans, including one for Urgent and Emergency Care. This contains nine key workstreams covering capacity, workforce, hospital discharge and care outside hospitals. One specific workstream covers increasing ambulance capacity, as it recognises the increased complexity of ambulance call-outs and amount of care provided at scene. The national plan sets a goal to reduce the Category 2 mean performance to 30 minutes this year – itself recognising that resolving the response time issue needs longer-term changes, including additional vehicles and workforce. The plan sets out several specific objectives to be delivered across all ambulance services: 4th Floor, Piccadilly Place, Manchester M1 3BN A5 B2034-delivery-plan-for-recovering-urgent-and-emergency-care-services.pdf (england.nhs.uk) By improving Category 2 response times this in turn should improve Category 3 and 4 response times. In acknowledgement of these pressure English Ambulance Services have also received extra funding to facilitate improvements in ambulance response times and to build extra capacity for the services in not only their ambulance responses but also in their control centers for extra call taking capacity and extra clinicians to aid decision making and telephone triage lower acuity 999 calls to reduce the need to dispatch emergency ambulances and find appropriate care in the community where possible. In the period of 2022/23 NWAS received an extra £20 million recurrent funding to support this and in 2023/24 an extra £23.5 million from commissioners. This work and investment has seen improvement and achievement of the UEC Recovery Plan target of category 2 mean response time of 30 minutes with NWAS achieving 28 minutes 44 seconds for the year 2023/24, and currently at time of writing this response, year to date for 2024/25 is achieving 23 minutes 4 seconds. In July 2023, the time when Mr Clarke sadly died and an ambulance was requested, the average response for category 3 response, which the national Ambulance Response Target (ARP) target is 1 hour mean or 2 hour 90th centile, was 2 hours 10 minutes 49 seconds for mean response and 5 hours 6 minutes for 90th centile. The work to improve all response times has continued in 2024/25 with year to date for NWAS on category 3 response times achieving 1 hour 42 minutes and 9 seconds for the mean target and 3 hours 46 minutes 31 seconds for the 90th centile. We acknowledge this is still not achieving the national standards which is why for 2024/25 achieving all ARP standards, not just the NHS England UEC recovery plan of category 2 mean, is part of the North West Ambulance Improvement Plan being monitored by the North West Ambulance and 111 commissioning team and UEC ICB leads at the Strategic Partnership and Transformation Board which includes NHS England UEC Regional representation. The inquest was told that the initial call to NWAS was made by the out of hours nurse. She made it clear that she felt the ambulance response needed to be within 1 hour. As this was in theory the response time consistent with a category 3 response, she accepted the categorisation. This acceptance did not appear to take into account that on that evening a category 3 call was not going to result in an ambulance within 1 hour. When a Health Care Professional (HCP) requests an emergency admission they will be asked a number of questions to determine the category of response required. In Mr. Clarkes case an audit of the admission request was found to be safe and appropriate and identified that Mr. Clarke was conscious, breathing and required admission to hospital. It was also confirmed that there was no threat to life, limb or sight requiring immediate emergency admission. The primary reason for admission was vomiting, fever, query sepsis. Based on the answers given to the questions asked by the call handler, a HCP category 3 ambulance response was generated. The national standards for ARP for a Category 3 response is 1 hour mean and 2 hours 90th centile. At the time of the HCP call the estimated response time for a category 3 was 4 hours and 15 minutes and this delay was communicated to the HCP requesting admission. It should be noted if a decision is made to upgrade a call from the allocated category this could also have an unintended consequence of severely impacting the response given to calls allocated a higher priority with their initial triage on their patient’s current presentation. The further 999 calls received for this patient were triaged by NWAS call takers utilising NHS England’s NHS Pathways to determine the correct categorisation of call required for the patient’s presentation, it 4th Floor, Piccadilly Place, Manchester M1 3BN A6 4th Floor, Piccadilly Place, Manchester M1 3BN T A7
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