Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0204, written 19 Jun 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 19 Jun 2019 |
|---|---|
| Reference | 2019-0204 |
| Deceased | Tien Phung |
| Coroner | Sarah Bourke |
| Coroner area | Inner North London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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Coroner ME Hassell HM Senior Coroner Inner North London REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: . Medical and Research Director NHS Blood and Transplant 500 North Bristol Park Filton Bristol BS34 7QH 2, President British Transplantation Society Chester House 68 Chestergate Macclesfield SK11 6DY CORONER lam: HM Assistant Coroner Sarah Bourke Inner North London Poplar Coroner’s Court 127 Poplar High Street London E14 OAE 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 25 January 2019, HM Senior Coroner Mary Hassell commenced an investigation into the death of Tien Dong PHUNG (age 59 years). The investigation concluded at the end of the inquest which was conducted by me on 13 June 2019. The medical cause of Mr Phung’s death was: 1a pulmonary strongyloidiasis 2 renal transplant (IgA nephropathy) and hypertension. | returned a narrative conclusion which is set out in Box 4 below. CIRCUMSTANCES OF THE DEATH Mr Phung had a kidney transplant on 26 September 2018 and was given immuno-suppressant treatment to prevent rejection of the transplanted kidney. In December 2018, he attended the Royal London Hospital complaining of abdominal pain. He was initially treated for constipation then discharged. He returned to the hospital on 17 December and was admitted for further investigations. Investigations including CT scans, blood tests, ultrasound examination, blood and urine cultures were undertaken but the reason for Mr Phung’s symptoms could not be identified. Mr Phung showed signs of infection on 20 December. He was given broad spectrum antibiotics and fluids for presumed sepsis. He became fluid overloaded and showed signs of chest infection. He had a cardiac arrest on the afternoon of 21 December. He was transferred to the ITU where he received supportive treatment. In addition, changes were made to his antibiotics and antivirals were prescribed to protect him against opportunistic infection. A CT scan was unable to identify the source of the infection. Mr Phung continued to deteriorate and treatment was withdrawn. Mr Phung died in hospital on the afternoon of 25 December 2018. On post-mortem examination, Mr Phung was found to have strongyloides stercoralis forms in his lungs. This is a parasitic infection which can persist for many years and is commonly identified through stool sampling which was not undertaken in this case. The disease is rare in the UK and is most prevalent in tropical and sub-tropical region. Generally, the disease is chronically asymptomatic. However, strongyloides hyperinfection syndrome can develop where a person’s immune system is compromised, for example through the use of corticosteroids or immuno-suppressants associated with organ transplantation. IL 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 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. — (1) Strongyloides stercoralis forms are not routinely screened for prior to transplant surgery. If identified early, they are treatable (2) Strongyloides hyperinfection syndrome presents with non-specific symptoms such as abdominal pain, vomiting, intestinal obstruction, cough, wheezing and chest pain. It can evolve into respiratory distress and multi-organ failure. (3) Strongyloidiasis is estimated to affect up to 300 million people worldwide. The infection is particularly prevalent in tropical and subtropical regions including a number of common travel destinations such as Thailand and Brazil. Mr Phung was born in Vietnam but had lived in the UK for many years. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you and your organisation has the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 14 August 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: BB vi:0. of Mr Phung) | have also sent it to Rv -cics Director, Royal London Hospital) who may find it useful or of interest. | 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. Pass CORONE? 19 June 2019
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.
Private & Confidential Ref: OMcG/JF/SW 12th August 2019 HM Senior Coroner ME Hassell Poplar Coroners Court 127 Poplar High Street LONDON E14 0AE Clinical Governance Team Newcastle Blood Centre Holland Drive Barrack Road Newcastle upon Tyne NE2 4NQ Tel. 0191 2026626 Fax. 0191 2026633 Website: www.nhsbt.nhs.uk Dear HM, Senior Coroner, ME Hassell Re: Regulation 28 Report, 19th June 2019 On behalf on NHS Blood and Transplant (NHSBT), and The British Transplantation Society (BTS), we would first like to take this opportunity to offer our condolences to the family and friends of Tien Dong Phung following his death at the Royal London Hospital on 25 December 2018. We are providing a joint response on behalf of NHSBT and BTS as we work closely and collaboratively together within transplantation. Professor is responding on behalf of NHSBT as he is the Medical Director for the Organ Donation and Transplantation Directorate. We note the matters of concerns; 1. Strongyloides stercoralis forms are not routinely screened for prior to transplant surgery. If identified early, they are treatable 2. Strongyloides hyperinfection syndrome presents with non-specific symptoms such as abdominal pain, vomiting, intestinal obstruction, cough, wheezing and chest pain. It can evolve into respiratory distress and multi-organ failure 3. Strongyloidiasis is estimated to affect up to 300 million people worldwide. The infection is particularly prevalent in tropical and subtropical regions including a number of travel destinations such as Thailand and Brazil. Mr Phung was born in Vietnam but had lived in the UK for many years We will respond to the matters of concern as noted above as 1,2 & 3. Background 1. Transplant Recipient Screening The BTS represents all professionals involved in transplantation in the UK and is actively involved in developing national policy and guidelines for transplant centres, which includes management of patients both pre-and post-transplant. NHS Blood and Transplant is a Special Health Authority within the National Health Service. However, transplant centres can themselves screen patients for a range of conditions according to their local protocols. Some national guidance is published in collaboration with both NHSBT and the BTS. However, local transplant policies are written by the local hospital/organisation. Currently, there are no national guidelines recommending universal or targeted screening of solid organ transplant recipients for Strongyloides infection. This is done on a case by case clinical basis. 2. Potential Donor Screening The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) produces guidance on risks of donor-transmitted diseases. Its remit also includes providing advice on the microbiological safety of gametes and stem cells, in liaison with the relevant regulatory authorities. The Committee will provide independent advice on risk management for Ministers, UK Health Departments, UK Blood and Transplant Services and the wider NHS to consider. NHSBT also adhere to The Quality and Safety of Organs Intended for Transplantation Regulations (2012), which stipulate that minimum data should be available to support decision making in accepting an organ for transplant. This includes the results of specific microbiological investigations. Review of microbiology results are a mandatory requirement for the acceptance of tissue for transplantation, in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations (2007). NHSBT are responsible for ensuring donors are characterised thoroughly prior to organ offering and acceptance by any transplant centre. The assessment includes gathering of medical, social, behavioural and travel information and microbiological testing. The donor's family and/or the most relevant life partner should be interviewed, and supporting information obtained from relevant health professionals such as the donor's General Practitioner (GP). Routine microbiological results will always be available pre-donation: currently, screening for Strongyloides stercoralis does not form part of the routine tests completed in any donor irrespective of country-of-birth or travel history. 3. Strongyloidiasis In the United Kingdom, strongyloidiasis is seen predominantly in migrants and returning travellers from endemic areas in the tropics and subtropics. Public Health England (PHE) guidance exists on migrant health care in relation to geographically restricted infections, but the asymptomatic nature of chronic infection poses difficulties with identifying those individuals that could benefit from testing. NHS Blood and Transplant is a Special Health Authority within the National Health Service. Action taken 1. NHSBT first became aware of a Strongyloides infection at the end of May 2019 having been contacted by the recipient trust. NHSBT wanted to confirm if the infection was a reactivation of the patient’s own infection or if it was transmitted from the donor to the recipient as a result of transplantation. NHSBT reviewed the donor’s clinical information which included medical history, social, behavioural and travel history. At the request of NHSBT further testing was completed at the Public Health Laboratory (PHE) of the donor’s serum. The recipient’s Trust requested PHE test the recipient’s pre-transplant serum. The results confirmed that Mr Phung had evidence of Strongyloides infection prior to the transplant, which resulted in uncontrolled spread under immunosuppression in the post-transplant period. 2. Direct liaison between NHSBT and the transplant centre resulted in a national survey of transplant centres to gauge frequency of similar events and practices regarding this helminth infection. All 31 transplant centres were sent a survey, there was a 42% response rate. The results, from the responses received indicated that no other centres had seen a case of Strongyloides infection in their recipient population. There is recognition that this rare infection can cause significant morbidity and mortality in transplant recipients and as a result of this infection we are proposing the actions below. Proposed Actions NHSBT and BTS together will ensure the actions listed in the table below are actioned: No Action 1 Write to SaBTO to formally advise them of this case and ask for a clear position on donor screening Organisation NHSBT 2. BTS to discuss with their standards committee about any future guidance on Strongyloides infection in transplantation 3. Write to Transplant Centre 4. Directors to inform anonymously of this case for awareness Include information on this infection as part of shared learning in NHSBTs Medical Bulletin and Cautionary Tales BTS NHSBT NHSBT Date By 31st August 2019 31st October 2019 By 31st August 2019 By 30th September 2019 NHS Blood and Transplant is a Special Health Authority within the National Health Service. Should you have any further questions then please do not hesitate to contact NHSBT/BTS and we will endeavour to assist in any way we can. Your sincerely Professor Medical Director – Organ Donation & Transplantation Professor President - British Transplantation Society NHS Blood and Transplant is a Special Health Authority within the National Health Service.
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