Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0549, written 18 Dec 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 18 Dec 2014 |
|---|---|
| Reference | 2014-0549 |
| Deceased | Robert Stuart and Darren Hughes |
| Coroner | Christopher Woolley |
| Coroner area | Cardiff & the Vale of Glamorgan |
| 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.
REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. The Chief Executive, NHSBT Head Office 2. The Chief Executive, University Hospital of Wales, Cardiff 1 CORONER I am Christopher John Woolley, Assistant Coroner, for the Coroner area of Cardiff and the Vale of Glamorgan 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 27th December 2013 I commenced an investigation into the deaths of Robert James Stuart and Darren Llewellyn Hughes. The investigation concluded at the end of the inquest on 4th December 2014. The medical cause of death for each was: 1.A Meningoencephalitis 1B Halicephalobus nematode meningoencephalitis following renal transplant 1C Halicephalobus nematode infected transplanted Kidney Pneumococcus meningitis. I returned a narrative conclusion as follows: Robert James Stuart Robert James Stuart died from Meningoencephalitis on the 17th December 2013, after undergoing a kidney transplant on the 30th November 2013. The source of the infection was the transplanted kidney and the agent of infection was the Halicephalobus nematode present in this kidney. The kidney had been rejected by several transplant centres before it was accepted for Mr Stuart, either because of its poor function or because of the donor’s cause of death. It was not rejected because of the Halicephalobus nematode, or accepted in spite of it, as this organism is almost unknown to medical science and there was no test for it in the circumstances of this transplant. Robert James Stuart died from the unintended consequences of necessary medical intervention. Darren Llewellyn Hughes Darren Hughes died from Meningoencephalitis on the 19th December 2013, after undergoing a kidney transplant on the 30th November 2013. The source of the infection was the transplanted kidney and the agent of infection was the Halicephalobus nematode present in this kidney. The kidney had been rejected by several transplant centres before it was accepted for Mr Hughes, either because of its poor function or because of the donor’s cause of death. It was not rejected because of the Halicephalobus nematode, or accepted in spite of it, as this organism is almost unknown to medical science and there was no test for it in the circumstances of this transplant. Darren Hughes died from the unintended consequences of necessary medical intervention. 4 CIRCUMSTANCES OF THE DEATH 1 Both Mr Stuart and Mr Hughes underwent a kidney transplant on the 30th November 2013. The kidney was accepted from a donor who had died of meningitis of unknown cause. The kidneys were placed on the fast track scheme and were both accepted by Cardiff UHW after being rejected by other centres either because of cause of death or poor function. Unbeknown to anyone involved in the transplant process the kidneys were infected by the Halicephalobus nematode. This is recorded as having caused deaths in horses but had been noted as the known cause of death in only four human beings previously, all in the USA. The transplant operations were successful and there were no undue concerns after the operations, although Darren Hughes was quite poorly this had been anticipated. Darren Hughes remained in hospital but Robert Stuart was discharged after making excellent progress. On 10th December Robert Stuart became very confused and was re-admitted to hospital. The condition of Darren Hughes also began to deteriorate. Both were admitted to critical care. The hospital sought help from national experts to establish what was wrong with both patients with the working diagnosis being a viral infection. Robert Stuart died on the 17th December 2013 and Darren Hughes on the 19th December 2013. It was only at post-mortem that the agent of the meningoencephalitis was discovered, namely the Halicephalobus nematode. CORONER’S CONCERNS 5 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. – For the Chief Executive, NHSBT (1) The core donor data form could have contained more information as to the second lumbar test performed on the donor and could have given the results of the first lumbar puncture test. (2) There was information available on the medical microbiology report which was not passed on to the accepting transplant centre. Had this information been available to the accepting consultant have caused more questions to be asked and aided in the acceptance process. The Coroner is concerned that NHSBT should employ systems to ensure the capture and transmission of all relevant information to the accepting transplant centre, and that SN- ODs should be in a position if required to certify that all relevant and available information has been transmitted. then it may For the Chief Executive, UHW Cardiff (1) The Kidneys were accepted by the transplant centre following a telephone conversation between the consultant and the transplant coordinator. The Coroner heard that all consultants have access to the EOS system but that the consultant did not use it on this occasion. The Coroner is concerned that a viewing of the EOS system should be standard practice by all accepting consultants/centres before a decision is made, as the information on EOS is much fuller than anything that can be conveyed over the telephone. (2) The kidneys were accepted by the consultant acting alone. The Coroner heard evidence that in many centres the acceptance process is conducted on a “team” basis, with the consultant accepting advice from microbiologists and even other on call consultant surgeons. The Coroner is concerned that a team approach offers the most informed method of decision making, not only over the decision to accept organs but also over the nature and duration of prophylactic anti-viral therapy. The Coroner is concerned to hear about any action that is being taken over this in the transplant centre. (3) The Coroner heard that a standard consent form is used for all operations, and heard evidence that this has proved unsatisfactory for transplant operations where issues have to be covered that are not catered for by the standard form 2 (4) These deaths represent (including the donor) the 5th, 6th and 7th recorded cases in the world of deaths caused by the Halicephalobus nematode. They are the first ever recorded deaths caused by human to human transmission. The Coroner is concerned that a written account of these deaths should be made available to the wider transplant community and that an article should be written for an appropriate journal (subject to consents from the families of the deceased). Such an article could be written in collaboration between the pathologist, the transplant centre and the microbiologists concerned in this inquest. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe that (1) The Chief Executive, NHSBT and the Chief Executive, UHW Health Board Cardiff 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 February 12th 2015. 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 1. 2. I have also sent it to the following persons: 1. Chief Medical Examiner for University Hospital of Wales 2. Dr , Regulation Manager, Human Tissue Authority 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 18th December 2014 C J Woolley Assistant Coroner, Cardiff and the Vale of Glamorgan 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.
Mr C J Woolley Assistant Coroner, Cardiff and the Vale of Glamorgan The Coroner’s Court Central Police Station Cathays Park Cardiff CF10 3NN 10 February 2015 Dear Mr Woolley Head Office Oak House Reeds Crescent Watford Hertfordshire WD24 4QN Tel: www.nhsbt.nhs.uk Sudden deaths of Robert James STUART & Darren Llewellyn HUGHES Regulation 28 Report to Prevent Future Deaths We thank you for the areas highlighted within the Report to Prevent Future Deaths dated 18th December 2014 following the inquest which concluded on 4th December 2014. We note that during the course of the inquest evidence revealed matters which gave rise for concern and that, in your opinion, there is a risk that future deaths will occur unless action is taken. NHSBT has already completed a number of actions to address these areas of concern. Following notification of the sad deaths of both Mr. Hughes and Mr. Stuart in December 2013 NHSBT reviewed the incident thoroughly and we have done so again in light of both the comments made during the inquest and the subsequent verdict. Matters of Concern NHSBT notes your concern that the core donor data form (CDDF) could have contained more information as to the second lumbar test performed on the donor and could have given the results of the first lumbar puncture test. Further, it is noted that you are concerned that there was information available on the medical microbiology report which was not passed on to the accepting transplant centre. You are of the view that had this information been available to surgeon, then it may have caused more questions to be asked and aided in the acceptance process. , the transplanting Your concerns are also noted that NHSBT should employ systems to ensure the capture and transmission of all relevant information to the accepting transplant centre and that specialist nurses should be in a position, if required, to certify that all relevant and available information has been transmitted. NHSBT’s position 1) Systems to capture and provide information to transplant centres The NHSBT Board, at its January meeting, approved expenditure to change the way in which Specialist Nurses record and transmit data electronically to transplant centres. This will simplify the work of the nurses, reduce the risk of errors in recording the data in NHSBT systems and increase the amount of data transmitted to transplant centres via EOS. This is a major IT development and we expect it to be fully operational by April 2016. In the interim period, we continue to remind the nurses of the importance of capturing and providing key information accurately and fully. 2) Specialist nurse certification of information NHSBT shares your concern regarding the ability of capturing all relevant information during donor characterisation however there are many reasons why our specialist nurses in organ donation are not in a position to guarantee the information provided via the CDDF. Throughout the NHS, multiple processes and system are in place which are used to request and report data. Those reports are also issued at uncertain times. Due to the different systems, time scales and methods used in providing and obtaining information, it is not possible to provide this complete reassurance. Often reliant upon the clinical information provided to them by treating clinicians, our specialist nurses are not in a position to certify that all relevant and material information has been made available. This problem could be overcome by the introduction of a single UK-wide unified clinical records system. However, until such time, the specialist nurses are always available by telephone to provide clarification to the recipient teams and to seek and provide further information from treating clinicians if required. Microbiology results 2) Your observations regarding the microbiology report are noted however NHSBT has obtained written confirmation from the independent testing reference laboratory that although the first blood sample taken at the donor hospital on 25th November 2013 was received for testing the same day, the enterovirus, parechovirus, HSV and VZV results were not available until 3rd January 2014. Additional tests of meningococcal and pneumococcal were requested as additional tests on the 2nd January 2014. Further, whilst a second blood sample was taken at the donor hospital on 28th November 2013, received by the testing reference laboratory the following afternoon, the enterovirus, parechovirus, HSV and VZV results were not made available until 3rd December 2014. Similarly, the enterovirus, parechovirus, HSV and VZV results of the CSF sample taken at the donor hospital on 27th November 2013 were not made available until 3rd December 2013. Additional tests of meningococcal and pneumococcal were requested on 10th January 2014 and were made available on 13th January 2014. As such, those results could not have impacted upon the decision to transplant on 30th November 2013. Shared learning This sad case has been shared widely with our specialist nurses in organ donation, as well as transplant surgeons and intensive care staff via the NHSBT governance structure. This has included a brief outline within a previous edition of ‘Cautionary Tales’, which is a method of sharing key cases with the wider transplant community. The decision was made to not include a full summary prior to the inquest as NHSBT did not wish to impact upon proceedings, but a full case review, together with learning points will now be included in the March 2015 edition. Learning from this case has also been shared with the specialist nurses via both a case study presentation and NHSBT memo to highlight the importance of including all available relevant information on the core donor data form. Further, the overview report of and , copies of which were disclosed prior to the inquest to all interested parties, has also been shared with our specialist nurses to ensure that the key learning points from this incident are known. In March 2015 NHSBT will host a working group where we will bring together clinicians, pathologists and other clinical colleagues to discuss what we can do to reduce the risk of a similar recurrence. The recommendations from that meeting will be widely circulated. As a direct result of this incident, NHSBT has commenced an audit in order to review the primary records for organ donors and to assess the accuracy and completeness of the transfer of information from medical case notes to the donor file / EOS. This audit tests the first stage of the donation process and will report on a monthly basis with quarterly and annual reviews. This audit is being undertaken with the cooperation of a number of NHS Trusts. These deaths, and that of the donor, were the 5th, 6th and 7th recorded cases in the world which have been caused by the halicephalobus nematode and I note that you ask for an article to be written in collaboration between the pathologist, the transplant centre and the microbiologists concerned in the inquest. Whilst I appreciate that this recommendation is for the attention of University Hospital of Wales, this work is already underway. During the course of the inquest NHSBT’s Professor , NHSBT’s Associate Medical Director for Organ Donation and Transplantation discussed UHW Medical Director who has kindly agreed to lead on the written formal request of 21st November 2014 for the this point account. I enclose a copy of sake of completeness. Also enclosed are NHSBT’s action plans to illustrate the action already taken by the organisation in response to this incident and the subsequent independent reports. I hope you are assured that NHSBT has undertaken appropriate action to prevent future deaths. Yours sincerely Ian Trenholm Chief Executive
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