Prevention of Future Deaths reports · 2020
Regulation 28 report to prevent future deaths, reference 2020-0159, written 14 Aug 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 14 Aug 2020 |
|---|---|
| Reference | 2020-0159 |
| Deceased | Brenda Elmer |
| Coroner | Penelope Schofield |
| Coroner area | West Sussex |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Product 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 THIS REPORT IS BEING SENT TO: Sir Simon Stevens Chief Executive NHS Engalnd PO Box 16738 Redditch B97 9PT And Mr Duncan Selbie Chief Executive Public Health England Wellington House 133-155 Waterloo Road London SE1 8UG 1 CORONER I am PENELOPE SCHOFIELD, senior coroner, for the coroner area of WEST SUSSEX 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 22nd January 2018 I commenced an investigation into the death of Brenda Elmer aged 81 years. The investigation concluded at the end of the inquest on 5th February 2020 The conclusion of the inquest was a Narrative Conclusion which was recorded as:- Brenda Elmer died from complications associated with a Listeria infection that she had contracted from a contaminated sandwich provided by an external supplier whilst an inpatient at St Richard's Hospital, Chichester. This was part of a national outbreak. At the conclusion of the Inquest indicated that I was minded to make a Regulation 28 report. Regretably whilst the indication to make a Regulation 28 report was made at the Inquest the issue of the prevention of duture death report has been delayed due to the additional workload that has ensured due to the current pandemic for which I apologise. 1 4 CIRCUMSTANCES OF THE DEATH Mrs Elmer underwent an operation at St Richards Hospital on 1st May 2019 and was discharged on 3rd May 2019. In preparation for this operation she attended the Hospital on the 5th February, 25th April and 30th April. Unfortunately on one of these occasions she consumed a contaminated sandwich which led to her acquiring a listeria infection. On 2nd June 2019 she became very unwell and was admitted to Tunbridge Wells Hospital, which was her local hospital. She was treated for this infection but despite active treatment, over a prolong period, she sadly did not recover from this infection and she died on 17th July 2019. 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. – First Concern 1. Mrs Elmer attended St Richards Hospital, Chichester, for elective surgery. She had attended the hosptial for a Pre Operation Assessment on 25th April 2019 and was admitted for her surgery on 30th April 2019. Whilst attending the hospital she acquired a Listeria infection from a chicken sandwich although this was not know at the time. Mr Elmer did not live in Sussex and following her treatment she returned home to Kent on 3rd May 2019. 2. Western Sussex Hosptial Trust, NHS England and Public Health England (PHE) first become aware of a possible outbreak on Listeria on 19th May 2019 when blood cultures from another patient ast the Worthing Hospital site confirmed a listeria infection. On 26th May 2019 NHS England notified all hosptials of a national outbreak of Listeria and a possible link to sandwiches that has been provided by the Good Food Company, a supplier to a number of Trusts. 4. 3. Whilst it was accepted that details of the possible outbreak were shared locally with other medical professionals (and therefore there was a local knowledge of the Listeria outbreak) there did not appear to be any attempt by NHS England or PHE (by way of a Public Health message) to communicate with those patients who were treated within the Trust but who were now out of the area in different parts of the Country. It was unfortunately that when Mrs Elmer fell ill, neither her GP who initially treated her, nor her family had any idea that her illness may be connected to the Listeria outbreak. This meant that she was not prioritised for a blood test and this delayed her being treated appropriately for Listeriosis. This diagnosis was only made when she was admitted to Tunbridge Wells Hospital, her local hospital in Kent following an emergency admission. It is unknown whether earlier treatment would have changed the outcome but it may have eased Mrs Elmer’s sufferning. 5. Consideration needs to be given to how communications should be disseminated following such an outbreak so that as many patients as possible, who had been in the hospital at the relevant time, are made aware and can seek medical assistance if they become unwell. Second Concern. 1. During the course of the Inquest evidence was given by the representative of Public Health England that there was no legal requirement for Private Laboraties who identifiy Listeria in food to share the Listeria isolate with PHE or indeed keep this isoloate for any period of time. If a problem is subsequentlhy identified 2 by PHE then it makes it particulary difficult to check if particular products have been implicated. 2. Similary there is no legal requirement of Hospital Trusts to send in Listeria isolates when Listeria has been identified. This therefore does not allow PHE to match particular strains and identify outbreaks which are connected earlier. In both these circumcumstances this leads to missed opportunities to deal with any outbreak. 3. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation has 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 9th October 2020. 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:- The family of Brenda Elmer Western Sussex Hosptial Trust 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 Date 14th August 2020 Penelope Schofield, H M Senior Coroner 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.
,,,~" Public Health 1England Protecting and improving th e nation 's l1ealth Public Accountability Unit Wellington House 133-155 Waterloo Road London SE1 8UG T 020 8327 6920 www.gov.uk/phe By post Coroner's Service County Record Office Orchard Street Chichester West Sussex PO19 1 DD Our ref: 20/08/kl/1073 Dear Penelope Schofield, · 28 October 2020 Re: Inquest into the death of Brenda Elmer on 05 February 2020 Thank you for sending the attached report for Public Health England's (PHE) consideration. Under the Coroners and Justice Act 2009, please find below PH E's response in relation to the investigation of the death of Br~nda Elmer. I will address your concerns in the order raised. First Concern Establishment and Action of PHE Incident Management Team: The Manchester Health Protection ,Unit within PHE North West, held a meeting after notification of a local cluster of two deceased cases of listeriosis (26 April and 6 May 2020) in Manchester University NHS Foundation Trust on 7 May 2019. These cases were shown to have an identical whole genome sequence profile on 16 May 2019 in · PHE Gastrointestinal Bacteria Reference Unit (PHE GBRU). PHE North West then became the incident lead. PHE North West with PHE National Infection Services implemented an Incident Management Team (IMT) with relevant local and national partners on 21 May 2019. On 22 May 2019, the implicated sandwich manufacturer was consequently inspected by the local authority environmental health team (Stafford Borough Council). Subsequent third, fourth and fifth cases of listeriosis with identical genotype were identified on 23 May 2020, 2019, it was reported that a third case had consumed chicken and mayonnaise sandwiches supplied by the implicated sandwich manufacturer, while an inpatient in une 2020 and 7 June 2020, respectively. On 24 May a different NHS Trust. The primary hypothesis was developed by the IMT that sandwiches supplied to the hospitals were the source of L. monocytogenes infection. At an IMT meeting on 25 May 2019, the risk assessment surmised that this cluster of cases represented an exposure that occurred between late March and mid-late May 2019, and intelligence on the supply chain indicated that it affected inpatients in 43 National Health Service (NHS) organisations in England, possibly one NHS facility in Wales and one in Scotland, where the sandwich manufacturer had distributed the implicated products PHE also issued a letter to the supplier of the sandwiches on 25 May 2019 and to all NHS hospitals on 26 May 2020, stating an outbreak of listeriosis on sandwiches served in hospitals by Good Food Chain. The Food Standards Agency (FSA) issued a hazard warning on the implicated food processing facility, Good Food Chain, early in the outbreak. The Good Food Chain voluntarily ceased trading on the 5 June. A chicken sample from the Good Food Chain tested positive for the outbreak strain on 6 June 2019. Altogether, 28 Incident meetings were hold during the outbreak period of 7 May to 19 June 2019. PHE issued public briefing notes and proactive media statements on the outbreak on 28 May, 31 May,7 June, 14 June and 2 July 2019. Furthermore, PHE and FSA gave public notifications on their website on the outbreak. Public Notification of Outbreaks: PHE agree that communications to the public need to be improved. However, as an executive agency, PHE investigates incidents and outbreaks. Any briefing regarding the incidents is conveyed to NHS England and individual NHS hospitals (which are independent statutory bodies themselves) and the local authorities. They are responsible for communicating, warning and informing their patients, local GPs (via the CCGs) and the public, respectively. PHE can inform the public about national investigations through the gov.uk website. Updates were posted on 7 June,14 June, 17 June, 26 June and 7 August for this particular incident and high-risk groups were alerted. National and local media were also alerted to these notifications to make the public aware. Advice about medical conditions is provided by NHS England and the public were signposted to NHS website for further medical advice. PHE has a standard protocol in place to investigate food borne outbreaks and listeria incidents. Due to the severity of listeriosis in vulnerable patient groups (pregnant, immunocompromised, elderly, chronic illness), all clinically compatible patients are screened for listeriosis by bacterial culture, strains are submitted to PHE for whole genome sequencing to be compared by bioinformatic methods to previous patient, food and environmental isolates. Even a single case with matching listeria genotype with a food and/or environmental sample is investigated further and full investigation carried out in the food facility if indicated. Action taken: PHE hosted a multi-agency lessons learnt exercise following the outbreak. This was organised by ERO and chaired by P ro fesso r_ , Medical Director and Director for Health Protection. This included ~need to review hospital food policies. 2 Second concern Under EU legislation (2073/2005) there is a legal requirement for food business operators to report adverse results to the FSA. An adverse incident will be when L. monocytogenes is detected above the legal limit of 100 colony forming units. Commercial food testing laboratories also test foods for the presence of L monocytogenes, usually for quality control checks for food businesses. There is a voluntary arrangement for them to submit cultures to the reference laboratory. There is no legal obligation for submission of low-level contamination of food or those of the environment. PHE manages a network of laboratories testing food and water and approximately 25,000 samples at tested each year for the presence of Listeria. Similarly, publicly funded laboratories are located in Wales, Scotland and Northern Ireland. Approximately 800 isolates of Listeria monocytogenes recovered from food or the environment in England are submitted to the reference laboratory for comparison with isolates from clinical cases. Furthermore, on a voluntarily basis, listeria isolates from the food and the environment are sent to PHE Food, Water and Environmental reference laboratory for sequencing and comparison with human isolates. During 2019, altogether 821 listeria food or environmental isolates were received, 28 (3 % ) of them were from private laboratories. Out of those 28, 8 were from this outbreak and specifically asked for. Currently approximately 900-1,000 cultures of L monocytogenes have been tested by whole genome sequencing to compare isolates from clinical cases of listeriosis with those from food and the environment. Almost all of these isolates come from clinical pathology laboratories and the publicly funded food and water laboratories in PHE. All isolates are tested by whole genome sequencing and the comparison of isolates from unrelated 'routine' testing by PHE food testing laboratories with cultures from clinical cases is the most common way to detect outbreaks of listeriosis. Hospitals do not take food or environmental samples. There is a legal requirement under the Health Protection Notification Regulations 2010 (UK) to report cases of listeriosis to PHE. We agree that NHS Trusts should send all the Listeria isolates to the Reference laboratory for rapid detection of incidents. PHE have written to the national microbiological standards on 20 May 2020. They have taken action and the updated SOP (standard operating manual for identification of Listeria) dated June 2020 advices hospital laboratories to refer all isolates from patients to PHE. Laboratories have been submitting the listeria isolates for further whole genome sequencing typing on a voluntary basis, and almost all isolates are received. During 2019, out of 142 listeriosis cases, 136 listeria strains were received in PHE GBRU. Confirmation of identification of Listeria species and L. monocytogenes and typing by WGS identification for L. monocytogenes isolates and Listeria species are undertaken at the GBRU, Colindale. PHE is an executive agency and is not directly involved with patient care. The role of PHE is to provide guidance on the implementations to be taken, based on best scientific practices in order to retain good health and prevent deaths. PHE has a mandate to investigate the incident but has no legislative power to implement action on NHS or to implement food safety measures. The latter of which is an FSA mandate. 3 The percentage of listeria isolates from foods sent to PHE FW&E laboratory is small overall. Most isolates are sent by publicly funded laboratories. PHE support submission of strains for further typing and would need a more extensive database of strains to identify vehicles DHSC has undertaken a review on hospital food, including listeria in sandwiches. Publication of this report is on hold due to the Covid- 19 pandemic. Please do not hesitate to contact PHE should we be of any further assistance in this matter. Yours sincerely, FOi Team _, 4
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