Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0218, written 18 Jul 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 18 Jul 2022 |
|---|---|
| Reference | 2022-0218 |
| Deceased | Graham White |
| Coroner | Graeme Irvine |
| Coroner area | East London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Barking, Havering and Redbridge University Hospitals NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
MR G IRVINE SENIOR CORONER EAST LONDON East London Coroner's Court, Adult Learning College, 127 Ripple Road, Barking, IG11 7PB REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) Ref: 14947560 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: • • • , Chief Executive, The Barking Havering and Redbridge University NHS Trust, Queen's Hospital, Rom Valley Way, Romford, Essex RM7 0AG Email: , Chief Executive, British Association of Urological Surgeons Ltd, Royal College of Surgeons, 38 - 43 Lincoln's Inn Fields, London WC2A 3PE Email: The Secretary of State for Health and Social Care, 39 Victoria St, Westminster, London SW1H 0EU Email: 1 CORONER I am Graeme Irvine, acting senior coroner, for the coroner area of East London 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. http://www.legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7 http://www.legislation.gov.uk/uksi/2013/1629/part/7/made 3 INVESTIGATION and INQUEST 1 On 20th August 2021 I commenced an investigation into the death of Mr Graham Edgar White aged 72 years. The investigation concluded at the end of the inquest on 13th July 2022. I made a determination of a narrative conclusion incorporating a finding of neglect; Mr Graham Edgar White died in hospital on 18th August 2021 following surgery to remove a antegrade ureteric stent of his right ureter. The stent was inserted in November 2019 and should have been removed after three months. The stent deteriorated causing a urinary tract infection and a right peri-nephric abscess. On multiple occasions in a 20-month period the deterioration of the stent was observed but no action was taken to remove it. Mr White's death was contributed to by neglect. Mr White’s medical cause of death was determined as; 1a Sepsis 1b Right Perinephric Abscess 1c Urinary tract infection in relation to longstanding ureteric stent inserted for ureteric stone II Ischaemic Heart Disease 4 CIRCUMSTANCES OF THE DEATH Mr Graham Edgar White was treated for a ureteric stone in November 2019 by the insertion of an antegrade ureteric stent. The stent was intended to be a temporary measure that should not have remained in place longer than three months. Over the next 20 months, the deterioration of the stent was observed through imaging on at least four occasions, despite this, it was not until Mr White suffered a urinary tract infection and a right perinephric abscess that the stent was removed during difficult surgery in July 2021. Mr White developed Sepsis and died on 18th August 2021. 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 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. Trust did not have in place a registry of those fitted with stents that would facilitate monitoring and recall of patients. 2. At the time of the inquest the Trust are unable to assess whether they have patients with stents inserted prior to May 22 who are at risk of a similar deterioration. 3. The Trust did not successfully identify and escalate this death through its governance procedures as a serious incident for investigation until the issue was raised by the Coroner. 6 ACTION SHOULD BE TAKEN 2 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 Tuesday 13th September 2022. 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 Mr White and the CQC. I have also sent it to the local Director of Public Health 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 other 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. 9 [DATE] 18th July 2022 [SIGNED BY CORONER] 3
3 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.
BAUS Response to HSIB document BAUS and the BAUS Section of Endourology acknowledges the Healthcare Safety Investigation Branch (HSIB) investigation into the delayed removal of a JJ stent, the specific need to log and track ureteric stents and the benefit of improved GP and patient communication for patients in whom a JJ stent has been inserted. We agree that ensuring patients and their GP are aware of the potential symptoms from stents, including symptoms mimicking urinary tract infection (UTI), as well as confirmed symptomatic microbiologically confirmed UTI that could be caused by a stent. We also agree that a clear plan of when, where and how the stent should be removed should be explicitly communicated to both the patient and the GP. We confirm that we have noted the following key findings of the report: • There is currently no national stent register being used across the NHS. • Hospitals deploy a range of systems to track and log stent insertion. Some trusts also have systems to reconcile stent removal (that is, to log the removal of each patient’s stent against the record of its insertion). Paper-based stent logging/tracking appears to be effective in the absence of electronic systems. • The combination of human oversight and effective stent logging/tracking systems may be beneficial in preventing delayed removal of stents. Systems should not rely solely on human oversight. • Other medical specialties which use ureteric stents may not use the same stent logging/tracking systems as the urology team. • Patients being discharged with stents in situ need clear and consistent communication, both verbally and in writing. • Involving patients in their care has been shown to improve the quality and experience of care. • The written advice available for patients with ureteric stents is inconsistent across the country. • Poor communication may lead to loss of opportunity for patients to self-care and be aware of potential complications with their stents. • Clear information given to patients with tethered stents (stents that can be removed by the patient) ensures compliance with their planned removal schedule. • GPs and other clinical staff working in primary and urgent care services may not be aware of the side effects and complications associated with ureteric stents. • Hospital discharge letters and other communications do not carry standardised information for healthcare professionals about ureteric stents. • The Summary Care Record system (which makes an electronically collated version of patients’ healthcare records accessible to a range of clinical services) does not currently have a ‘flag’ or other method of identifying patients with ureteric stents. In response to the report, the issues raised have been discussed at length during BAUS Section of Endourology committee meetings, and further input has been sought from the Urology GIRFT Joint National Clinical Leads ( ), in his role as NHSE National Clinical Lead for Innovation, and for Urology. , NCIP National Clinical Lead The theme of these meetings has been to agree that the morbidity of an inappropriately prolonged JJ stent dwell time is considerable and that encrusted stents represent a complex endourological challenge for their removal and subsequent patient management, including the possibility of loss of renal function. However, whist we fully appreciate the consequences of the individual cases where this occurs and share the HSIB goal to improve patient safety by mitigating the risk of overdue stent removal or change, there is no clear picture as to the scale of the problem of delayed stent removal. We do not have access to data that gives either the numerator of the number of encrusted stents in the UK per year, nor the denominator for the total number of stents that are inserted or changed in the UK per year. We feel that this data is vital to our understanding the scale of the problem of delayed stent removals and the impact of this on patients, as well as the associated medico-legal costs to the NHS. Furthermore, as has been clearly elucidated in the HSIB report, stent tracking is a complex process requiring considerable IT and human resources. It relies on accurate record keeping for both the initial stent insertion as well as subsequent removal or exchange of that stent. The solutions will therefore require investment both in IT and personnel, as well as time to achieve the goal of reduced stent-dwell morbidity. On this background, we have answered the HSIB report’s Safety recommendations and observations as follows. Safety recommendation R/2020/091: It is recommended that the British Association of Urological Surgeons, in collaboration with other relevant specialties (such as the Royal College of Radiologists and British Transplant Society), develops national standards which support electronic and paper-based systems for stent logging/tracking. These standards should include guidance on monitoring and human oversight. We agree with the HSIB recommendation that the insertion of a JJ stent should be a clear part of the operation note and discharge summary. In addition, we agree that some form of localised stent tracking is mandatory, but in the absence of a centralised NHS digital solution for tracking temporary implantable devices (such as stents and catheters), it is difficult for BAUS and partner organisations to develop consistent national standards. We recognise that Trusts across the country employ a range of mechanisms to track ureteric stents currently, and that these vary in terms of the human oversight required as well as in their integration with existing electronic patient care records. As a minimum standard, we suggest that: 1. Reasons for, and details of the ureteric stent insertion are clearly recorded in the operative record, or on a specific proforma which is to be attached to the patient’s notes (an example can be found in Appendix 1). 2. All urology departments have a system in place to track ureteric stent insertion, change and removal, although we recognise that at present, the format of such tracking systems will vary. 3. Human oversight of the stent database is essential at present as there is no standardised IT solution which will alert the clinician to an overdue stent exchange or removal. Clinicians and administrative staff working within urology should be allocated time in their job plan to allow oversight of such a database, which represents a considerable amount of work. 4. Urologists should liaise with other colleagues who insert/manage patients with ureteric stents (principally radiologists, oncologists, transplant surgeons and gynaecologists) to ensure all patients with stents are monitored appropriately regardless of the clinical setting. Safety recommendation R/2020/092: It is recommended that the British Association of Urological Surgeons works with the Patient Information Forum to review its stent patient information leaflet. This should include accessibility and clinical considerations, especially with regards to side effects and complications, and advice on the action to take should concerns arise. This point has been addressed by the new BAUS patient information leaflet (PIL) (“Living with a stent”) published in 2022. The PIL has been updated with all the relevant information regarding stent symptoms, and now includes a section at the back of the leaflet which is to be filled in and given to the patient upon their discharge. This will provide patients with individualised information regarding their intended stent dwell time as well as with contact information for the relevant clinical team members (Appendix 2). We hope that this improved PIL containing bespoke information will empower patients to take a role in shared-care of their stent as highlighted in the HSIB report. Safety recommendation R/2020/093: It is recommended that the British Association of Urological Surgeons provides guidance for staff working within the stone care pathway to promote consistent advice to patients as part of discharge planning. In addition to the standardised information about stents in the newly updated BAUS PILs as detailed above, we have incorporated stent information as part of the BAUS Endourology/NHS GIRFT acute stone pathway, which was published last year. This GIRFT pathway emphasises the importance of primary treatment of obstructing stones unlikely to pass spontaneously (ideally within 48 hours) by means of extracorporeal shockwave lithotripsy (SWL) or ureteroscopy (URS). The pathway contains exemplars of best practice to demonstrate how this aspirational target can be achieved, including utilisation of urology area networks (UANs) to ensure patients have rapid access to necessary treatment. By encouraging the primary treatment of ureteric calculi, it is hoped that fewer “temporising stents” will be inserted in such patients over time. Information regarding the GIRFT acute stone pathway has been disseminated widely at both the Section of Endourology annual meeting in October 2021 as well as at the main BAUS congress in 2022. We would encourage all urology units to continue to develop their localised pathways using the GIRFT best practice examples to guide them. Safety recommendation R/2020/094: It is recommended that the British Association of Urological Surgeons encourages members to include information in discharge letters and other communication sent to GPs and patients regarding patients’ stent status, potential complications and the possibility of a retained stent. We agree with this recommendation, and we would encourage that information regarding stent insertion and follow up is detailed clearly in the operative record. We have concerns that discharge information may already be long and complex, and information regarding stents is only one aspect that may need to be communicated to the GP. Due to variance in hospital IT systems, it is impossible to implement a digital “flag” which will be applied uniformly across the NHS. As a minimum standard, we feel that GPs should be made aware of the following information on discharge letters/summaries. • The reason for the insertion of the J-J stent • The intended stent dwell time and whether it is intended that it will be removed or changed We would suggest that all discharge information should be copied to patients and/or their carers. An example of a standardised discharge pro-forma that could be sent to GPs can be found in Appendix 3. Time will be needed for busy GPs to ensure that this information is read and understood, and education programmes will be needed to help GP practices appreciate the similarities in symptoms of UTI and those that might be more directly attributable to a JJ stent. Urinalysis (ideally formal microbiological culture rather than dipstick analysis) should be encouraged before patients are started on empirical antibiotics, unless they are febrile or otherwise systemically unwell. We have also noted the additional safety observations in the report. Safety observation R/2020/073: The NHS Summary Care Records (SCR) system is being developed to allow for specific patient groups to be flagged. It may be beneficial for the British Association of Urological Surgeons to liaise with NHSX should opportunities arise in the future to use SCR to flag patients with ureteric stents to aid communication with primary/urgent care services. We agree that there is a need for a digital / technological solution for stent tracking. However, it is apparent that there is no immediate solution to the technical problem of building a system to track temporary implanted devices – extending beyond stents to vascular access catheters, urinary catheters etc. There seems to be no immediate prospect of device tracing being developed within the NHS, by device companies or by entrepreneurs as the practical issues are considerable, and the potential commercial return from developing and running such a system are uncertain. Safety observation R/2020/074: The National Institute for Health and Care Excellence guidance for the management of urinary tract infections does not include ureteric stents as a cause of urinary symptoms which could mimic a urinary tract infection. It may be beneficial for this potential complication to be considered in the next review of this and other clinical practice guidance. We agree and would be very pleased to collaborate with the authors of this guidance. Conclusions Having taken all the above into account, we feel that the encrusted stent issue does not lie fully within BAUS’ remit, nor within the GIRFT Urology programme and therefore wish to “flag up” that the problem is complex, short of data, and remains unresolved, despite this timely and important HSIB report. We are pleased to have published the updated BAUS stent PIL and we feel that it provides patients with some clarity regarding stent symptoms, expected stent dwell time and contact details of the team responsible for management of their stent. It is however contingent on members of the clinical team filling in the information accurately. Ultimately, improved information delivery will allow patients to act as equal partners in their stent care and they will hopefully feel more confident to alert clinicians to potential stent issues including delays to removal/change. Importantly, we feel that clarity is needed with regard to “ownership” of the delayed stent removal issue, in particular as to which parts of the NHS should be taking a lead going forward. As an example of this, we feel that a large part of the issue is fundamentally one that should sit within individual trust clinical governance systems and yet there are no recommendations for action by trust medical directors in the HSIB report. Finally, we suggest the following as points of action for BAUS and GIRFT to undertake. 1. Basic clinical governance responsibilities mean that there is a need for GIRFT and BAUS to flag up that the HSIB report has highlighted that patients remain at risk. GIRFT and BAUS will need to write to the National Director for Patient Safety (Aiden Fowler). The advice would be, at the very least, to request all medical directors of acute trusts to ensure that they have effective stent tracking processes in place, as detailed above. 2. BAUS will consider carrying out an audit of contemporary stent management practices. This could identify current approaches to stent tracking and attempt to quantify the problem of delayed removal of stents. 3. GIRFT could enquire about medico-legal costs through the GIRFT links with NHS Resolution. 4. To discuss with the Medical Device Safety Programme team how temporary device safety will be incorporated into their work. 5. BAUS may liaise with the Royal College of General Practitioners to discuss how information regarding stent symptoms and the importance of timely stent removal can best be disseminated to GPs. Ex-Chair BAUS Section of Endourology – Honorary Secretary of BAUS Section of Endourology – President of BAUS –
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Barking, Havering and Redbridge
University Hospitals
NHS Trust
Legal Services Department
Queen's Hospital
Rom Valley Way, Romford, RM7 0AG
PRIVATE & CONFIDENTIAL
FAO: Mr G Irvine
HM Senior Coroner
Walthamstow Coroner's Court
Queens Road
London
E17 8QP
13th September 2022
Dear Mr Irvine,
Following a serious incident and review it was highlighted that Barking, Havering and Redbridge University
Hospitals NHS Trust (BHRUT) did not have a robust process for tracking and dealing with ureteric stents put into
patients. This can clearly cause harm to patients.
This led to the development and implementation of a new electronic stent register which can track and warn staff
of stents that are about to become overdue so appropriate actions can be taken. This stent register went live in
August 2022.
This stent register is automatically populated when an electronic admission proforma is completed on the Trusts
Careflow (electronic patient care) system. The system sends any patient listed for a urological stent through to
the electronic stent register which is then monitored on a weekly basis to ensure that all patients are tracked,
with suitable dates for removal or exchange offered. It should be noted that due to available slots these are
sometimes beyond the normal dates for removal or exchange, but these patients remain on the stent register
until removal or exchange. This new system is designed to provide a robust process by which all stents will be
properly monitored and therefore removed within appropriate timeframes going forward.
To ensure there were no other patients with stents that were missed, the Trust committed to carrying out a
retrospective review of all stents inserted over the preceding 3 years. This was done to ensure any patients that
had been missed could be contacted and appropriate harm reviews carried out so these patients can be treated
appropriately and as quickly as possible. To provide a robust mechanism of tracking and assurance a retrospective
review of all stent insertions was conducted for patients attending BHRUT between 1st April 2019 and 5th August
2022.
A data review was conducted of all patients on the following criteria:
•
•
•
•
•
•
•
Cystoscopy, and insertion or exchange of stent;
Rigid ureteroscopy, laser stone fragmentation and stent insertion/ exchange;
Flexible ureteroscopy, laser stone fragmentation and stent insertion/exchange;
Ureteroscopy, biopsy and stent insertion/exchange;
Percutaneous nephrolithotomy {PCNL) and mini PCNL;
antegrade ureteroscopy insertion or exchange of stent; and
antegrade stent performed by interventional radiology.
These were then searched through the Trusts PAS system via an SQL data query and resulted in 2748 entries.
These entries were then reviewed, and duplicate entries removed i.e. one patient record for stent insertion and
one for removal, verified by using the NHS Number. This led to a total of 1234 patients who were under the care
of Urology at BHRUT during the period 1st April 2019 to 5th August 2022.
Those patients who had a stent entry but not documented removal were then cross checked to see if the stent
should have been removed during the agreed timescale.
Through using the above audit BHRUT has highlighted there are 23 patients that have been documented with a
stent insertion during this time period but have not had an entry detailing a date for planned surgery. These
patients are currently being contacted to ensure whether they have been seen at an alternative provider and a
clinical harm review conducted if there has been a delay in surgery. They will be allocated to the next available
date for planned surgery if appropriate.
In addition to this process there is a drive to reduce the need for stent insertion with the introduction of a
lithotripsy service within BHRUT. Training is planned to start in December 2022 which should reduce the number
of patients who require the insertion of urological stents and the subsequent removal and or exchange. There has
also been financial approval for the appointment of a third Urology Consultant to reduce the wait times for
specialist urological opinion and subsequent surgical intervention. Currently the Job Description is with the Royal
College for approval.
In respect of the Coroner's concern around the Trust's delay in identifying this as a serious incident for
investigation, whilst a serious incident report was completed, which has resulted in key actions and
recommendations as described above, that process should have commenced at an earlier stage and in
accordance with the BHRUT's own governance procedures. BHRUT has reviewed its governance procedures for
the detection of potential incidents and via the Quality and Safety Team, the need to internally report incidents
has been emphasised within the Divisions. In addition, BHRUT has introduced incident reporting of all new
inquests to formalise divisional review, with the aim of capturing any incidents that may not have been incident
reported prior to the opening of an inquest.
BHRUT hopes that the measures described above provide reassurance in respect of the concerns raised by the
Coroner.
Yours sincerely,
Chief Executive
From Neil O’Brien MP Parliamentary Under Secretary of State for Primary Care and Public Health 39 Victoria Street London SW1H 0EU Graeme Irvine Acting Senior Coroner Coroner Area of East London Walthamstow Coroner’s Court Queens Road Walthamstow E17 8QP 15 February 2023 Dear Mr Irvine, Thank you for your letter of 18 July 2022 about the death of Mr Graham Edgar White. I am replying as Minister with responsibility for Health and Secondary Care and I thank you for the additional time allowed. Firstly, I would like to say how saddened I was to read of the circumstances of Mr White’s death and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with NHS England and the Care Quality Commission. The Care Quality Commission (CQC) inspected the Barking, Havering and Redbridge University Trust in November 2021 where the Urgent Care and Emergency Services (UEC) at the Queen’s Hospital were inspected. Concerns were identified and the Trust worked with local system partners to create an action plan to address these. CQC intends to inspect the UEC at the Queen’s Hospital again and will consider the Trust’s response to the Coroner in these inspection plans. In the meantime, CQC will monitor the Trust’s review of this patient group through regular engagement. After Mr White’s death, CQC carried out an initial management review and agreed to seek assurance that the Trust was taking action to mitigate risk, establish oversight of patients with stents, and address the governance concerns regarding the escalation of the incident. The Trust informed CQC that they had initially commenced a review of all 1,200 patients that had been fitted with a stent over the previous three years and had agreed to extend the review for all patients who have since had their stent removed. Early findings were that the COVID-19 Pandemic had impacted their oversight of this patient group. Barking, Havering and Redbridge University Trust has completed a comprehensive Serious Incident/Root Cause Analysis following Mr White’s death. They have made several recommendations including: providing patients with information leaflets and stent cards that confirm when a stent should be taken out and a contact number providing a direct line to the admissions office if no appointment has been confirmed within 12 weeks; an electronic stent register that has been operational since May 2022, providing alerts and prompts to the service for timely removal of stents; the need for a standard operating procedure across the Trust for optimal stent management; a requirement to investigate non-attendance at clinics before patients are discharged; an audit of all patients with stents inserted between 1 April 2019 and 31 March 2022; to undertake an assessment of demand and capacity for treating stone patients; and to strengthen the process of incident reporting and the detection of potential incidents. NHS England will be working with providers, patient representatives and partners, such as specialist societies, to implement outcome registries across implant procedures, including urology and stent procedures. These registries will enable secure patient level data collection that includes the devices used and the patient outcomes. They will improve device vigilance in direct care, and the monitoring of patient safety and outcomes. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours Sincerely NEIL O’BRIEN MP
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