Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0346, written 22 Sep 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 22 Sep 2023 |
|---|---|
| Reference | 2023-0346 |
| Deceased | Sebastian Daniels |
| Coroner | Robert Simpson |
| Coroner area | Hampshire, Portsmouth and Southampton |
| Category | 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.
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 2 ; CEO Hampshire Hospitals NHS FoundationTrust ; CEO Southern Health NHS Foundation Trust 1 CORONER I am Robert SIMPSON, Assistant Coroner for the coroner area of Hampshire, Portsmouth and Southampton 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 08 July 2021 I commenced an investigation into the death of Sebastian Harry DANIELS aged 26. The investigation concluded at the end of the inquest on 01 September 2023. The conclusion of the inquest was that: On the 4th July 2021 Sebastian Harry Daniels died at the Royal Hampshire County Hospital in Winchester. He died as a result of a hypertriglyceridemia caused by his diabetes, obesity and medication that he required to control his enduring mental health condition. This condition was identified during a blood test on the 30th April 2021 but the result was passed on in a manner which did not trigger a medical review. 4 CIRCUMSTANCES OF THE DEATH Mr Daniels suffered from paranoid schizophrenia and was prescribed clozapine in early 2019. This was effective in controlling his mental health difficulties. Patients taking clozapine require close monitoring of their physical health due to the risks associated with the medication and attend a 4-weekly clinic. Blood samples are taken at these clinics to monitor white blood cell counts. In addition to the regular clozapine clinic Mr Daniels underwent a periodic physical health check in accordance with the relevant guidelines and Southern Health policy. At the check on the 1/4/21 a blood lipid profile (including triglycerides) was not requested as it should have been. The multi-agency Root Cause Analysis (RCA) report identified this as a missed opportunity to monitor Mr Daniel’s blood lipid levels. On the 30/4/21 Mr Daniels attended Basingstoke & North Hampshire Hospital ED due to abdominal pain. Blood tests were requested but Mr Daniel’s self-discharged prior to the results becoming available. Owing to the appearance of the blood sample the testing technician added triglyceride levels to the test results. These were abnormal and significantly raised. The ED doctor preparing the discharge summary included the blood test results but did not flag the triglyceride levels as abnormal or requiring attention by Mr Daniel’s GP. As a consequence, the GP surgery administrative staff filed the discharge note without bringing it to the GP’s attention. Subsequent blood tests reported on the 29/6/21 revealed even higher levels of triglycerides. The GP was concerned about the levels given this leads to a risk of Regulation 28 – After Inquest Document Template Updated 30/07/2021 pancreatitis and took steps to commence treatment. On the 3/7/21 Mr Daniels was taken to hospital by ambulance with abdominal pain. Despite treatment his health deteriorated quickly and he sadly died on the 4/7/21. The medical cause of death was recorded as: 1a Multiple Organ Failure 1b Severe necrotising pancreatitis 1c Severe hypertriglyceridemia due to clozapine therapy, diabetes mellitus and obesity II Hypertensive Heart Disease and paranoid schizophrenia 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) 1 The abnormal triglyceride levels in Mr Daniel’s blood, whilst reported by the lab, were not escalated by telephone as this was not required by the hospital procedure at the time. I am pleased to note that Hampshire Hospitals Trust have updated their procedures to include telephone escalation of raised triglyceride levels. However the RCA report indicated that the findings in this case should be shared with the Royal College of Pathologists with a request that raised triglyceride levels be added to the RCPath guidelines for telephone action. In information received after the inquest the Hampshire Hospitals Trust advised that they could not tell me whether or not this action has been undertaken. 2. The RCA report identifed that the format of discharge summaries provided to GPs by the ED department needed to be reviewed to ensure that actions to be undertaken by GPs were clearly identified. The results of this were to be audited. Following the inquest I was provided with an audit report. This report dated 13/9/21 revealed that the computer system could not be altered as had been hoped and therefore a change of practice was introduced instead. This required clinicians to document actions in a free text section with appropriate flagging for GPs. 20 cases were audited and only half met the standardised national guidance and 8 lacked a clear diagnosis & details of what was expected from GPs. Hamsphire Hospital Trust have informed me that further actions are being taken to address these deficiencies. However as it is now a year since the RCA report was prepared and over 2 years since Mr Daniel’s death I am concerned that this action is not being taken swiftly given the risks to patients. 3. In relation to the blood tests required under the clozapine guidelines I was informed that Southern Health take the monthly blood tests and run these in the clozapine clinic. However the blood tests required of the annual physical health checks are not taken by the Southern Health staff but rather patients are required to attend phlebotomy services elsewhere for the blood to be taken. I heard evidence during the inquest that Mr Daniels had missed some of these blood test appointments which meant his full tests were not carried out when expected. Clozapine is prescribed only to patients suffering from an enduring mental health condition for whom other medication has not been effective which indicates that they may be at risk of having difficulty managing appointments. Regulation 28 – After Inquest Document Template Updated 30/07/2021 I heard evidence from the consultant psychiatrist responsible for Mr Daniel’s treatment that they were not permitted to take the blood samples and submit them to the local laboratory for testing. I was informed that the Southern Health staff had requested to be able to do this to avoid the patient having to attend another appointment. I have reviewed further information provided after the inquest by the Clinical Director of Southern Health. She has explained that they lack the facilities to complete the full blood tests and they lack the resources to take and deliver samples to the laboratories; noting that no community mental health teams in their trust routinely provide phlebotomy services. She has advised that they are focussed on better communication with primary care and assertive outreach where necessary. I remain concerned that patients on high risk medication, who by the nature of their mental health condition may struggle to attend appointments, are required to arrange or attend separate blood tests. I note that clozapine clinic staff take blood monthly and that the phsyical health reviews are carried out by doctors all of whom should be capable of taking a blood sample for submission to a laboratory. 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 November 17, 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 the following Interested Persons I have also sent it to Royal College of Pathologists 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 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: 22/09/2023 Regulation 28 – After Inquest Document Template Updated 30/07/2021 Robert SIMPSON Assistant Coroner for Hampshire, Portsmouth and Southampton Regulation 28 – After Inquest Document Template Updated 30/07/2021
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.
Basingstoke and North Hampshire Hospital Aldermaston Road Basingstoke Hampshire RG24 9NA Mr Robert Simpson H.M. Assistant Coroner for Hampshire, Portsmouth and Southampton Coroner's Office Castle Hill The Castle Winchester SO23 8UL 7 November 2023 Dear Sir Inquest in relation to the Death of Sebastian Harry Daniels I acknowledge receipt of the Prevention of Future Deaths Report dated 22 September 2023 (the “Report”), issued by the Assistant Coroner Mr Robert Simpson for Hampshire, Portsmouth and Southampton, to Hampshire Hospitals NHS Foundation Trust (the “Trust”), under paragraph 7, schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. Firstly, on behalf of the Trust, I offer my sincere condolences to the family of Mr Daniels, to whom I am very sorry for their loss. I note that three concerns have been raised by the Assistant Coroner in the Report, the first and second of which require a response from the Trust and the third which is to be responded to by Southern Health NHS Foundation Trust. I set out below the concerns which relate to the Trust, together with our response. 1. “The abnormal triglyceride levels in Mr Daniel’s blood, whilst reported by the lab, were not escalated by telephone as this was not required by the hospital procedure at the time. I am pleased to note that Hampshire Hospitals Trust have updated their procedures to include telephone escalation of raised triglyceride levels. However the RCA report indicated that the findings in this case should be shared with the Royal College of Pathologists with a request that raised triglyceride levels be added to the RCPath guidelines for telephone action. In information received after the inquest the Hampshire Hospitals Trust advised that they could not tell me whether or not this action has been undertaken.” Hampshire Hospitals NHS Foundation Trust includes Andover War Memorial Hospital, Basingstoke and North Hampshire Hospital and Royal Hampshire County Hospital www.hampshirehospitals.nhs.uk Hampshire Hospitals Registered Charity 1060133 - to donate please contact 01256 312758 or email hh.charity@hhft.nhs.uk Within the multiagency RCA investigation report this action was allocated to our colleagues at the Hampshire and Isle of Wight Integrated Care Board (ICB) and not to our Trust. Prior to the inquest hearing and in order to assist the Court so far as possible, the Trust made contact with the ICB who confirmed to us that they had shared the findings of this case with the Royal College of Pathologists and requested that they consider adding raised triglycerides levels to their guidelines for telephone actions in critical results. The Royal College confirmed to the ICB that they would share and discuss the recommendation with the Hematology Specialty Committee and the lead of the related Royal College guideline, as it was due to be reviewed in any event. Despite numerous attempts by the ICB, they have been unable to obtain any further update from the Royal College. Unfortunately we are unable to comment any further on this point, as whether raised triglyceride levels are added to the Royal College guidelines for telephone action is a decision for the Royal College and not the Trust. We can, however confirm that the NHS, by way of the ICB, did share the findings with the Royal College and request that the guidelines were updated. 2. “The RCA report identifed that the format of discharge summaries provided to GPs by the ED department needed to be reviewed to ensure that actions to be undertaken by GPs were clearly identified. The results of this were to be audited. Following the inquest I was provided with an audit report. This report dated 13/9/21 revealed that the computer system could not be altered as had been hoped and therefore a change of practice was introduced instead. This required clinicians to document actions in a free text section with appropriate flagging for GPs. 20 cases were audited and only half met the standardised national guidance and 8 lacked a clear diagnosis & details of what was expected from GPs. Hamsphire Hospital Trust have informed me that further actions are being taken to address these deficiencies. However as it is now a year since the RCA report was prepared and over 2 years since Mr Daniel’s death I am concerned that this action is not being taken swiftly given the risks to patients.” Following your direction at the inquest hearing, for an update on the action set by the multi-agency Root Cause Analysis (RCA) investigation undertaken following the death of Mr Daniels, the Trust carried out an audit dated 13 September 2023 which identified the requirement for further action to be undertaken by the Trust. The Trust has commissioned a new computer system (Alcidion Miya Emergency) which is set to go live in July 2024. We are working with the developers to ensure that as a function of that system, ED clinicians will be prompted to automatically highlight to GP’s any patients who have abnormal blood results. As there will be several months until full implementation of the new system, the Trust has worked with the IT service to ensure that patients with abnormal blood results will now be allocated a different discharge code, which will then prompt the administration team to physically print the abnormal blood results and attach them to the discharge letter before sending it on to the GP. GPs have been notified of this change via the GP liaison service as per enclosed correspondence. 2 ED clinicians have also been notified that they are required to continue to document significant findings and matters requiring GP attention, under a separate heading within the GP free text notes box, on the Patient First discharge summary. It was felt that compliance of this, as documented within the audit, was likely limited due to the turnover of trainee doctors. In order to ensure that all staff remain aware of this requirement the Trust is in the process of updating its junior doctors induction program to include the above changes in the discharge process. This with take effect from the next induction taking place on 6 December 2023. In order to monitor the impact of these actions the Trust will re-audit a random sample of discharge letters at three and six months. I would also like to take this opportunity to confirm that the recent introduction of the Patient Safety Incident Response Framework (PSIRF), the Trusts approach to investigation of patient safety incidents has changed. Actions in response may now take different forms, ensuring that actions are completed as soon as practicable, with more rapid action undertaken to respond to immediate risk. Developing safety actions in response to system issues identified in learning responses will be undertaken in a collaborative way. Safety actions will be written clearly and will follow SMART (specific, measurable, achievable, relevant, timebound) principles. A Trust-wide safety action log will be held with the aim of reducing duplication and disconnected safety actions. The implementation of safety actions will be overseen by the Divisions, with reporting to the Safety Action Delivery Group. This is a sub-group of the Patient Safety Improvement Group. The Patient Safety Improvement Group will monitor the timeliness and effectiveness of action implementation. This group will also support work to align quality improvement and patient safety approaches. I am confident that the combination of the changes will mitigate the risk of similar circumstances occurring in the future. Should there remain any further concerns, I would welcome the opportunity to address these for you. Yours faithfully Chief Executive Hampshire Hospitals NHS Foundation Trust 3
Sebastian Daniels Regulation 28: Report to Prevent Future Deaths – Trust Response Matter of concern (3): ability to take blood samples in Clozapine clinic The Trust has considered very carefully the point you made both during and following Mr Daniels’ inquest that the inability to take venous blood samples during annual health checks for Clozapine patients was a missed opportunity to facilitate full compliance with these checks. During the inquest, information was provided to you which set out why our Mid and North Hampshire mental health services were not able to provide this for Mr Daniels. The Trust understands you may have heard in live evidence that staff were not ‘permitted’ to take blood in this way. We would like to clarify that it was not the case that permission was actively refused on a point of principle but rather that the infrastructure required to allow this to happen has not historically been in place in this area. On receipt of your Regulation 28 report, a number of meetings took place, chaired by the Trust’s Chief Medical Officer. These meetings included among others, the Clinical and Medical Directors covering the Mid and North Hampshire area, the Trust’s Deputy Chief Medical Officer, the Trust’s Chief Pharmacist and the Transformation Director for Mental Health and Learning Disability services. The matter you raised was also taken to the Trust’s Community Quality Improvement Oversight Group on 19 October 2023. There was confirmation among senior clinical leaders at each of these meetings that the Trust has greater responsibility for the oversight of physical health monitoring among this group of mental health patients. The concerns you raised regarding a missed opportunity were understood and discussed at length. The Trust is pleased to report that whilst the challenges described to you at inquest remain, the consensus view from the meetings that took place was that our aspiration should very much be to seek to overcome these obstacles such as to be able to introduce the changes that you have suggested. The Mid and North area have volunteered to operationalise this as an early adopter and since receipt of the Regulation 28 report have identified the equipment needed, made arrangements to have bloods transported to Andover War Memorial Hospital lab and have developed a rota of who would be able to take blood in each clinic. They are now working through how best to identify which patients need which bloods when, how to record when these have been taken and how to optimise or supplement current patient record systems to be able to track and follow up on results. In addition to this work that is being done in the Mid and North area of the Trust, Pharmacy colleagues have commenced a piece of work seeking to understand the variation in service offering across all Clozapine clinics. Data has begun to be received back and it is clear that variation exists between clinics both in terms of the ability to take blood but also more broadly. This pharmacy-led project will continue, overseen by the Clozapine Committee which will next convene and include this on its agenda on 18 December 2023. The intention is to take the learning from the Mid and North area’s early adoption of this model, combined 1 with good practice identified from this broader Clozapine clinic review, in order to establish a consistent set of principles across all clinics. These will include ensuring the capacity for annual health checks for patients on Clozapine; including taking blood samples on site where the patient prefers this and having robust systems in place for the review of results. At the completion of the project, the Clozapine Policy will be amended to incorporate the agreed changes. 2
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