Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0225, written 3 Jul 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 Jul 2019 |
|---|---|
| Reference | 2019-0225 |
| Deceased | Jennifer Withey |
| Coroner | Andrew Cox |
| Coroner area | Cornwall and the Isles of Scilly |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) Jennifer Withey, deceased REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. NHS England 2. NHS Pathways CORONER | am Andrew Cox, Acting Senior Coroner for the coroner area of Cornwall and the Isles of Scilly. CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 14/12/17, an inquest was opened into the death of Jennifer Mary Withey who died in Royal Cornwall Hospital Truro on 10/9/17. The inquest culminated in a final hearing on 25 & 26 June 2019 with a narrative conclusion being recorded namely, that Jenny died from a known complication (infection) of an elective surgical procedure. The cause of death identified at post-mortem was: 1A) sepsis 1B) middle back abscess formation 1C) spinal fusion operation (postop) Il immunosuppressive drug intake CIRCUMSTANCES OF THE DEATH Jenny had a past medical history that included rheumatoid arthritis for which she was in receipt of immunosuppressant medication. She had a long-standing back complaint and underwent spinal fusion in Derriford Hospital, Plymouth at the end of July 2017. In mid-August 2017, the wound was noted to have broken down and she had a washout. She rang the 111 service on three occasions over 2 & 3 September 2017. On audit, two of those calls were identified as under compliant. At inquest, | heard from the Medical Director for South-West Ambulance Service Trust, then responsible for the 111 call handlers. During one call, it was recorded that Jenny had worsened from a call made the previous day, could no longer weight bear, had not passed urine for 30 hours and said her left arm and leg felt dead. These matters were recorded in a free text box available for use as part of the NHS Pathways process. In error, the call adviser failed to recognise that this was a complex call and accordingly, did not immediately refer to a clinician. It was also recognised that the three matters recorded in the free text box were all potential signs of sepsis — from which Jenny subsequently died. It was further noted in evidence that the 111 service was separate and distinct from Cornwall Health (Devon Docs) who then provided the out of hours GP service. Both organisations operated within their own timeframes. By way of illustration, the disposition could be reached by a call handler that a patient needed to be contacted by primary care within two hours. The GP could then decide, after speaking to the patient, that an ambulance was required and should attend within a further two hours. 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. — A) The free text box could be set up so that identified symptoms, where appropriate, could generate an automatic red flag. By way of illustration, a non- blanching rash could automatically justify immediate hospital admission by ambulance in a case of suspected meningitis. Similarly, in this case, where a number of sepsis indicators were present, a red flag could have been raised requiring the call adviser specifically to consider a sepsis pathway. This would act as a second level of security, the first step being to allocate a patient to a correct pathway in the first instance. B) is it possible to establish a single patient orientated pathway with a key performance indicator of, for example, ‘patient to be seen within two hours’ rather than two separate time limits for two or more organisations (here, 111 and Cornwall Health) which cumulatively introduces unnecessary and avoidable delay into the process. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you [AND/OR your organisation] have the power to take such action. Would you please consider whether there is merit in using keywords in the free text box to trigger automatic red flags in prescribed circumstances. Would you also please consider whether it is appropriate to have a single patient orientated pathway rather than multiple performance indicators where there are a number of different service providers. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 02/09/2019. |, 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons EES WAST, Royal Cornwall Hospital. lam 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. [DATE] [SIGNED 03/07/2019
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.
Andrew Cox Acting Senior Coroner for Cornwall and the Isles of Scilly The New Lodge Newquay Road Penmount Truro TR4 9AA Email correspondence to: cornwallcoroner@cornwall.gov.uk Your Reference: AJC/LJB Our reference: LT02238 Dear Mr Cox Inquest into the death of Jennifer Mary Withey 1 Trevelyan Square Boar Lane Leeds LS1 6AE 0113 397 3614 22 nd August 2019 I am writing in response to a Regulation 28 report received from HM Senior Coroner, dated 3rd July 2019 and addressed to NHS England and NHS Pathways, and a subsequent letter dated 24 July 2019 addressed to NHS Digital. This follows the death of Jennifer Mary Withey who sadly passed away on 10th September 2017. This was followed by an investigation and inquest which concluded on 26th June 2019. NHS Pathways is the clinical decision support software used by all 111 service providers, and some 999 ambulance service providers including South Western Ambulance 111 Service. I am Darren Worwood, RGN, RSCN, BSc, SPQ and am writing in my capacity as Deputy Clinical Director, NHS Pathways, NHS Digital. HM Coroner has raised the following matters of concern in the Regulation 28 report: 1. The free text box could be set up so that identified symptoms, where appropriate, could generate an automatic red flag. By way of illustration, a non-blanching rash could automatically justify immediate hospital admission by ambulance in a case of suspected meningitis. Similarly, in this case, where a number of sepsis indicators were present, a red flag could have been raised requiring the call advisor specifically to consider a sepsis pathway. This would act as a second level of security, the first step being to allocate a patient to a correct pathway in the first instance: and 2. Is it possible to establish a single patient orientated pathway with a key performance indicator of, for example, ‘patient to be seen within two hours’ rather than separate time limits for two or more organisations (here, 111 and Cornwall Health) which cumulatively introduces unnecessary and avoidable delay into the process. www.digital.nhs.uk enquiries@nhsdigital.nhs.uk HM Coroner asked for confirmation in the letter dated 24 July 2019 that NHS Digital is the organisation with authority, where it is felt to be appropriate, to make changes to all or the relevant NHS pathway(s), and, on that basis, confirmed that NHS Digital should respond to paragraph 5A of the Regulation 28 Report (concern 1 above). HM Coroner also sought confirmation that NHS England was the organisation with responsibility for setting key performance indicators, and, on that basis, suggested that NHS England should respond to paragraph 5B of the Regulation 28 Report (concern 2 above). NHS DIGITAL’S RESPONSE For information, I have provided below a short summary of the functions that NHS Pathways performs and the governance that underpins it. We also provided a Coroner’s Information Pack on 18 July 2019 which provides further details and may be useful for your future reference. Function of NHS Pathways NHS Pathways is a programme providing the Clinical Decision Support System (CDSS) used in NHS 111 and half of English ambulance services. This triage system supports the remote assessment of over 16.5 million calls per annum. These calls are managed by non-clinical specially trained call handlers who refer the patient into suitable services based on the patient’s health needs at the time of the call. These call handlers are supported by clinicians who are able to provide advice and guidance or who can take over the call if the situation requires it. The system is built around a clinical hierarchy, meaning that life- threatening problems assessed at the start of the call trigger ambulance responses, progressing through to less urgent conditions which require a less urgent response (or disposition) in other settings. Governance of NHS Pathways The safety of the clinical triage process endpoints resulting from a 111 or 999 assessment using NHS Pathways, is overseen by the National Clinical Governance Group, hosted by the Royal College of General Practitioners. This group is made up of representatives from the relevant Medical Royal Colleges. Senior clinicians from the Colleges provide independent oversight and scrutiny of the NHS Pathways clinical content. Changes to the NHS Pathways clinical content cannot be made unless there is a majority agreement at NCGG. Alongside this independent oversight, NHS Pathways ensures its clinical content and assessment protocols are consistent with the latest advice from respected bodies that provide evidence and guidance for medical practice in the UK. In particular, we are consistent with the latest guidelines from • NICE (National Institute for Health and Clinical Excellence) • The UK Resuscitation Council • The UK Sepsis Trust www.digital.nhs.uk enquiries@nhsdigital.nhs.uk To specifically answer the points raised with regards to NHS Pathways: 1) HM Coroner asked for confirmation that NHS Digital is the organisation with authority, where it is felt to be appropriate, to make changes to all or the relevant NHS pathway(s). The NHS Pathways system is owned by the Department for Health and Social Care and managed by NHS Digital; the NHS Pathways team is part of NHS Digital. Therefore, it is correct that NHS Digital manages, develops and makes changes to NHS Pathways, subject to the governance processes described above. 2) HM Coroner stated in paragraph 5A of the Regulation 28 Report: The free text box could be set up so that identified symptoms, where appropriate, could generate an automatic red flag. By way of illustration, a non-blanching rash could automatically justify immediate hospital admission by ambulance in a case of suspected meningitis. Similarly, in this case, where a number of sepsis indicators were present, a red flag could have been raised requiring the call advisor specifically to consider a sepsis pathway. This would act as a second level of security, the first step being to allocate a patient to a correct pathway in the first instance. In responding to the concerns raised we would like to address three separate elements: 1. The use and risks of the free text facility within NHS Pathways 2. The recognition of complex calls, and transfer to clinicians 3. The inclusion of current best practice guidance for the recognition of critical illness (including sepsis) within our question algorithms 1) The use and risks of the free text facility within NHS Pathways The free text box is built into NHS Pathways to allow users (whether non-clinical call handlers or clinicians)to add any relevant additional information that may have bearing on the call, for example the patient had seen a doctor last week, or volunteered information about specific medication. Any free text entered into the free text box is displayed in the full report generated at the end of any assessment in red, which can be seen in the picture below highlighted with the green box. This is transferred onwards to the health care professional seeing or speaking with the caller. Wording entered into the free text box does not have any bearing on the NHS Pathways disposition reached but is to inform onward local care providers. In many cases call handlers will not record any free text information. Therefore, each individual 111 and 999 provider produces their own guidance on what information could or should be recorded in the free text box by call handlers and clinicians, based on local operating procedures. www.digital.nhs.uk enquiries@nhsdigital.nhs.uk The structured and hierarchical nature of the NHS Pathways questions enables non-clinical call handlers to move through the assessment in a logical order and at an appropriate speed bearing in mind the clinical risks of various symptoms and need to trigger the fastest dispositions for the most urgent needs. NHS Pathways considers that introducing use of the free text box to record symptoms and trigger dispositions would create the following risks and issues: • • If there was conflict between the questions/answers and the free text this would result in a disposition being unclear and create a situation which non-clinical call handlers were not able to manage (thus requiring transfer to a clinician, as detailed in the complex call procedure below); It is important that the presumed illness/risk posed to a patient following triage is accurate in NHS Pathways, not only to ensure that patients receive the appropriate level of care when seriously ill, but also to ensure that patients are not over-referred. When the questions within NHS Pathways are created, the authoring team must ensure that a careful balance between 'sensitivity' and 'specificity' is struck. By way of brief summary, the ‘sensitivity of a test’ is the ability to correctly identify those with a disease or condition (true positive rate), whereas ‘specificity’ is the ability to correctly identify those without the disease (true negative rate). www.digital.nhs.uk enquiries@nhsdigital.nhs.uk More than 16.4 million calls are triaged every year using NHS Pathways, so it is critically important that the content of the system has an appropriate and safe balance between sensitivity and specificity, since an imbalance in either direction carries significant risks; • The questions and range of answers are developed by clinical authors and assured by the National Clinical Governance Group to achieve the above and ensure an accurate assessment is carried out. Relying on non-clinical call handlers to enter accurate symptom descriptions on a free-text basis introduces risks of incorrect or irrelevant information being used. An accurate free text description of symptoms requires knowledge and discretion that non-clinical call handlers are not expected to have, and that a training programme for individuals who are not medical professionals could not deliver; • It may be in time that technology, natural language processing and artificial intelligence develop such that free text analysis of this nature can successfully be deployed but NHS Pathways do not consider that sufficient expertise or evidence exists currently to safely introduce such a feature. Use of developing technology is something that remains under constant review in NHS Pathways. 2) The recognition of complex calls, and transfer to clinicians In NHS Pathways there are a number of aspects which support the identification of seriously unwell patients and resolution of any uncertainty experienced by non-clinical call handlers as detailed below. When using NHS Pathways call handlers should be guided by the triage questions presented during the assessment, however if there is any doubt the complex call process can be used which enables the call handler to transfer the call to an in-house clinician. The definition and explanation of complex call is defined below: Complex Call Definition and Categories A complex call is defined as ‘any call which isn’t straightforward and where the call handler determines that they are working at or beyond the limits of their knowledge’. This broad definition is necessary to create a culture where call handlers feel able to be honest about situations where they are struggling. This is vital from a clinical safety perspective. What one person finds challenging, another person may not, thus a defined list of what might make a call complex is not helpful and may indeed be unsafe, if it encourages call handlers to try and manage calls they find difficult, just because it’s ‘not on the list’. However, because call handlers are not qualified clinicians there are four situations that will always fall under the definition of a complex call. These are: 1. Multiple symptoms that don’t threaten a patient’s airway/breathing/circulation but where the patient/caller can’t prioritise a main symptom If any of the symptoms have the potential to compromise a patient’s airway, breathing or circulation, the call handler would treat this as the priority and would continue triage. In some cases, a Pathway will cater for multiple symptoms (such as the Colds and Flu Pathway), www.digital.nhs.uk enquiries@nhsdigital.nhs.uk however, where this is not the case, the patient/caller would be asked to prioritise their most troubling/worrying/pressing symptom. If they were unable to do so, the call handler should Early Exit and transfer to a clinician. 2. Difficulty Obtaining Adequate Information Clearly safe triage depends on getting the right information from the patient at the right time. If a call handler is struggling to obtain this information for any reason, the call should be Early Exited and transferred to a clinician. The clinician may or may not be able to obtain more information, however within the scope of their professional registration, accountability structure and clinical expertise, they are better placed to make a professional decision about how best to manage the situation. 3. Medication or Medical Procedure Enquiry It is not within the remit of a call handler to give information or advice relating to medication or medical procedures since this can require a significant breadth and depth of clinical knowledge, so these calls are Early Exited and transferred to a clinician. 4. Declared Medical History It is not reasonable to expect a call handler to understand the wide range of diagnoses a patient might declare, or to be able to understand every piece of medical terminology presented to them. If the caller declares a medical history or uses medical terminology that the call handler feels complicates or might complicate the situation, they should Early Exit and transfer to a clinician. In addition to these four pre-defined categories of complex call, there is also the option to select ‘other’. This facility allows call handlers to transfer any other call where they are working at or beyond the limits of their knowledge. Examples of where this might be used include: • Where there are complex social circumstances complicating the problem. • Where lots of information has been volunteered and it is not clear what is relevant and what isn’t. • ANY other situation where they are unsure about how best to handle the call. The five categories outlined and the option to select ‘other’ are shown in the Early Exit Pathway below. Note that ‘Caller refuses disposition’ is not defined as a complex call but is the route for a call handler to early exit and pass the call to a clinician for further assessment as to why the disposition was refused. www.digital.nhs.uk enquiries@nhsdigital.nhs.uk 3) The inclusion of current best practice guidance for the recognition of critical illness (including sepsis) within our question algorithms NHS Pathways, as part of its routine monitoring and evaluation process, made enhancements to better identify those who are critically ill and at risk of sepsis in release 15. Widescale deployment of release 15 to all providers of NHS111 and all ambulance services in England that use the NHS Pathways system was 4th May 2018, with services then having an 8-week period to update their staff and deploy in their systems. These critical illness enhancements have involved the UK Sepsis Trust and the National Clinical Governance Group and led to the inclusion of the qSOFA (quick Sepsis Related Organ Failure Assessment). The current algorithms are compliant with the NICE guidance (NG51) on Sepsis: recognition, diagnosis and early management. These enhancements include the specific feature of functional impairment (as was demonstrated in this unfortunate case) which we ask about with the question: www.digital.nhs.uk enquiries@nhsdigital.nhs.uk In addition to the above critical ill enhancements across all our relevant symptom algorithms, NHS Pathways has always asked the following questions in the relevant pathways (as these are potentially indicative of septicaemia rash and meningitis). These questions are asked if a positive answer has already indicated that the caller is functionally impaired: A ‘positive’ or ‘not sure’ answer to the above question would result in dispatch of an emergency ambulance (Category 2). www.digital.nhs.uk enquiries@nhsdigital.nhs.uk A positive answer to ‘completely unable to put the chin to the chest’ or ‘completely unable to bear any light’ would result in dispatch of an emergency ambulance (Category 3). In respect of the concern raised at paragraph 5B of the Regulation 28 Report I can confirm that NHS Digital cannot comment on national or locally commissioned performance indicators and this concern should be addressed to NHS England. I am happy to answer any further enquiries from HM Coroner. Yours sincerely Darren Worwood Deputy Clinical Director NHS Pathways www.digital.nhs.uk enquiries@nhsdigital.nhs.uk
OFFICIAL Mr Andrew Cox Acting Senior Coroner for Cornwall and the Isles of Scilly, The New Lodge, Newquay Road, Penmount, Truro, TR4 9AA Email: National Medical Directorate NHS England Skipton House 80 London Road LONDON SE1 6LH Telephone: 0113 825 1692 27th September 2019 Dear Mr Cox, Re: Regulation 28 Report to Prevent Future Deaths – Jennifer Mary Withey, 10.09.2017 Thank you for your Regulation 28 Report (hereinafter the ‘report’) dated 3rd July 2019 concerning the death of Ms Jennifer Mary Withey on 10th September 2017. Firstly, I would like to express my deep condolences to Ms Withey’s family. I note that your recent inquest concluded that Ms Withey’s death was a result of sepsis following complications of infection following an elective surgical procedure. Following the inquest you raised concerns in your report to NHS England regarding: a) The inclusion of keywords in a free text box to trigger automatic red flags for suspected sepsis in prescribed circumstances. b) The establishment of a single patient-oriented pathway with a key performance indicator, rather than separate limits for different organisations on the pathway. I can confirm we have liaised closely with NHS Digital and NHS Pathways on this matter and I have seen their comprehensive response to your report answering point a) above. I would like to build on this by offering a further insight from NHS England as set out below, to address point b) above, which refers to paragraph 5b in your report. NHS Pathways NHS Digital is responsible for the delivery of NHS Pathways and the ‘Directory of Service’ which is a clinical decision tool. Together this system is used throughout England and underpins how the public access all urgent and emergency care High quality care for all, now and for future generations OFFICIAL services such as 999, GP out-of-hours, and NHS 111. It enables patients to be triaged effectively and ensures that they are directed to the most appropriate service available at the time of contact. Regular reviews of NHS Pathways are undertaken to ensure that it follows the latest clinical evidence. Any changes to the NHS Pathways system are iterative and are based on a combination of feedback from Providers, regular review, updated clinical advice and feedback from outside bodies, such as a Coroner. These changes (as appropriate) are then assessed by the Independent National Clinical Governance Group, which is chaired by the Royal College of General Practitioners. NHS England works closely with the NHS Pathways team to ensure the development of this product is appropriate for the evolving Integrated Urgent Care (including NHS111) national and strategic agenda for which it has ownership. NHS England as a result has oversight of any matters of concern in relation to NHS Pathways, and we monitor regularly any risks or issues that may arise. We ensure that these are addressed and escalated through the correct governance routes. NHS Pathways has its own Service Management Board represented by key stakeholders of the NHS 111 service, which reports into the NHS Pathways Programme Board. As mentioned earlier, I note that NHS Digital has already responded separately to you on the specific NHS Pathways recommendations in your referral and I am content that its response suitably covers, and answers, all of the issues you raised. Key Performance Indicators With regard to a single patient-oriented pathway within NHS 111 services, NHS England has a set of national Key Performance Indicators (KPI) which measure the performance of this service. In the past, these KPIs only applied to the NHS 111 call receiving organisations, with other organisations in the patient pathway not monitored. However, this limitation was identified and in July 2018 a new set of national Integrated Urgent Care (IUC) KPIs was introduced alongside the existing KPIs with the intention to remove the disconnect between organisations. This is also supported by new data collections which commenced in January 2019 to measure and monitor KPIs. In addition, since October 2018 we have updated and replaced the standards by which Out-of-hours organisations are measured, ‘National Quality Requirements), with the IUC KPIs. Previously these standards were only ever locally measured, but now both NHS 111 organisations and Out-of-hours organisations need to comply with the same IUC KPIs. (The NHS England and NHS Improvement’s approach to Integrated Urgent Care means that Out-of-hours services are now considered to be part of a unified service accessed via the NHS 111 telephone number. It is a continuous pathway that may involve the patient speaking to more than one person, either by phone or face to face, during the totality of their assessment. This may be clinically necessary depending on the nature and complexity of the case. The requirement of different High quality care for all, now and for future generations OFFICIAL levels of clinical seniority and specialist knowledge may only come to light during the assessment of the patient. As a clinician continues an assessment which has been initiated by a clinical colleague or non-clinical call handler they may decide to revise, (on the basis of their clinical judgement), the timescale for treatment which may be different to that initially given. In all cases the total timescale for treatment to commence should be taken into account. We remain focused on resolving a patient's care needs as early as possible and continue to work to improve patient pathways to deliver appropriate, effective and seamless healthcare within the NHS. Thank you for bringing this important patient safety issue to my attention and please do not hesitate to contact me should you need any further information. Yours sincerely, Celia Ingham Clark Medical Director for Clinical Effectiveness NHS England High quality care for all, now and for future generations
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