Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0515, written 8 Dec 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Dec 2023 |
|---|---|
| Reference | 2023-0515 |
| Deceased | Lindy Aston |
| Coroner | Isobel Thistlethwaite |
| Coroner area | Leicester City and South Leicestershire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Kettering General Hospital NHS Foundation Trust · University Hospitals of Leicester NHS Trust |
| 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 NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: Chief Executive, Kettering General Hospitals NHS Trust via their legal representatives. 1 CORONER I am Miss Isobel Thistlethwaite His Majesty’s Assistant Coroner for the coroner area of Leicester City and South Leicestershire 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 21 October 2021 I commenced an investigation into the death of Lindy Lyanne ASTON aged 67. The investigation concluded at the end of the inquest which took place on 9, 10, 11 and 24 November 2023. The conclusion of the inquest was that: Narrative Conclusion Mrs Aston was a 67 year old female who appropriately underwent a successful total gastrectomy for stomach cancer at the University Hospitals of Leicester NHS Trust on 29 September 2021. Post operatively, whilst at home on 15 October 2021, Mrs Aston suffered a ruptured spleen which requires surgical treatment. Mrs Aston was taken to Kettering General Hospital where, for reasons we don’t understand, surgery did not take place, instead she was kept on the ICU and transferred to the Leicester Royal Infirmary on 16 October 2021 where she underwent surgery but died on 18 October 2021 at 12:40hrs. The cause of death was established as: I a Multi Organ Failure I b Ruptured spleen following a total gastrectomy I c II 4 CIRCUMSTANCES OF THE DEATH Mrs Aston was a 67 year old female who underwent a total gastrectomy for stomach cancer at the University Hospitals of Leicester NHS Trust on 29 September 2021. On 15 October 2021 Mrs Aston began to experience pain in her abdomen, this became progressively worse. EMAS attended and Mrs Aston was transported by emergency ambulance to Kettering General Regulation 28 – After Inquest Document Template Updated 16/05/2023 Hospital. Mrs Aston was initially treated in the Accident and Emergency Department at Kettering General Hospital before being placed on the ICU. She remained at Kettering for almost 24 hours until she was transferred to the University Hospitals of Leicester NHS Trust. On 16 October 2021 Mrs Aston arrived at the Leicester Royal Infirmary at 16:00hrs, she was taken to theatre at 16:10hrs and underwent a splenectomy operation. Mrs Aston remained very unwell post-operatively and died on the 18 October 2021 at 12:40hrs. 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: Pre-amble The inquest heard evidence to confirm that Mrs Aston appropriately underwent a total gastrectomy at the University Hospitals of Leicester NHS Trust on 29 September 2021. There are no concerns about the surgery, care provided at or discharge from the University Hospitals of Leicester NHS Trust. The inquest heard that on 15 October 2021, whilst at her home, Mrs Aston began to experience pain in her abdomen. The pain became progressively worse and 999 was called. East Midlands Ambulance Service attended. The court heard evidence that, on the balance of probabilities, the worsening pain was likely to be the start of a splenic rupture. On 15 October 2021 at 15:31hrs Mrs Aston arrived at Kettering General Hospital, having been transported there by emergency ambulance. The inquest heard that Mrs Aston was “in extremis” on arrival at Kettering General Hospital which is perhaps the most unwell anyone can be. Mrs Aston needed life-saving surgery to stop her bleeding internally. The inquest heard that Mrs Aston should have been categorised as a high-risk “life or limb” Category 1 patient when she arrived at Kettering. As a Category 1 patient Mrs Aston should have been operated on within an hour of her arrival to stop the bleeding, however, instead of undergoing surgery she was placed on the ICU at Kettering where she remained for almost 24 hours, until the afternoon of 16 October 2023, when she was transferred to the University Hospitals of Leicester NHS Trust. On 16 October 2021 at 16:00hrs Mrs Aston arrived at the Leicester Royal Infirmary. Ten minutes later, at 16:10hrs Mrs Aston was in theatre undergoing a splenectomy. Mrs Aston remained very unwell post-operatively and on 18 October 2021, after discussions with her family, the decision to palliate her was taken, Mrs Aston died at 12:40hrs at the Leicester Royal Infirmary. The decision making at Kettering Regulation 28 – After Inquest Document Template Updated 16/05/2023 The inquest heard evidence to confirm that the decision making as to whether a patient is operated on or not is entirely the remit of the surgical team at Kettering General Hospitals NHS Trust. The evidence around why the decision not to operate on Mrs Aston at Kettering was taken that night is confused. Lack of theatre capacity at Kettering was often cited as one of the reasons and the possible complexity of the surgery required being cited as another. The On Call Consultant Surgeon who made the decisions relating to Mrs Aston at Kettering General Hospital NHS Trust on 15 and 16 October 2021 did not attend the inquest as he now lives abroad so was unable to provide clarity around his decision making. The inquest heard the following evidence about the splenectomy surgery that Mrs Aston needed that night: It is possible to undertake a splenectomy at Kettering General Hospital; Undertaking a splenectomy was something that the On Call General Surgeon at Kettering General Hospital that night was capable of (further, even if the surgeon had reservations about the possible complexity of the surgery a highly experienced surgeon from the University Hospitals of Leicester NHS Trust had offered to drive to Kettering to perform the surgery or assist with it, unfortunately despite his repeated offers of assistance he was told there was no theatre space available at Kettering); No emergency surgeries were undertaken at Kettering General Hospital on the night in question and therefore there was theatre capacity at Kettering General Hospital on 15 October 2021 into 16 October 2021 for Mrs Aston to have had her surgery. Concerns 1) Surgical decision making - I am concerned about the fact that the decision about whether to operate on a patient or not lies with one single surgeon with seemingly no checks or balances around their decision making. It concerns me that all of the witnesses at the inquest agreed that Mrs Aston needed immediate life-saving surgery when she presented to Kettering General Hospital yet there was no challenge to the decisions made by the on-call surgeon not to operate. 2) Trust investigations into Mrs Aston’s care – I am gravely concerned about the seeming inadequacies in the investigation and/or incident reporting processes at Kettering General Hospitals NHS Trust. The inquest was advised that a DATIX incident report was not raised in relation to Mrs Aston’s care or death. I am concerned about the fact that Kettering General Hospitals NHS Trust did not look into the care provided to Mrs Aston until such time as the University Hospitals of Leicester NHS Trust contacted them about the inquest. I am further concerned about the fact that when Kettering General Hospitals NHS Trust did look into the care provided to Mrs Aston they did so on the assumption that the clinical decision making had been appropriate, this makes the exploration of the care provided somewhat otiose. The Trust’s exploration of the care provided to Mrs Aston failed to identify the fact Regulation 28 – After Inquest Document Template Updated 16/05/2023 that surgery should have been undertaken within an hour and the fact that, despite some of the assertions to the contrary, it would have been appropriate and possible to undertake that life-saving surgery at Kettering General Hospital. The failure to properly investigate led to the wholly untenable situation where the Kettering General Hospital NHS Trust were alerted for the first time to the questionable clinical decision making and the potential errors in care at the inquest, which took place some 24 months after death (due to witness availability). I am concerned that the lack of robust critical analysis and investigation of the clinical decision making and care provided to Mrs Aston at Kettering General Hospitals NHS Trust before her death has caused a delay to, and led to missed opportunities to learn lessons that are vital to patient safety. My concerns relating to the inadequacy of the Trust’s exploration of the care provided to Mrs Aston and the risks related to that go far beyond just the care provided by the Surgical Team at Kettering General Hospital NHS Trust. The risks have the ability to prevent learning, therefore negatively impact upon patient safety, across the entire Trust. 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 1st February 2024. 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 Aston Family The University Hospitals of Leicester NHS Trust I have also sent it to The CQC 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. Regulation 28 – After Inquest Document Template Updated 16/05/2023 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: 08/12/2023 Miss I THISTLETHWAITE His Majesty's Assistant Coroner for Leicester City and South Leicestershire Regulation 28 – After Inquest Document Template Updated 16/05/2023
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.
HMC Coroner’s Office (Leicester City &
South Leicestershire)
Town Hall
Town Hall Square
Leicester
LE1 9BG
Hospital CEO Office
Rothwell Road
Kettering
Northants
NN16 8UZ
1 February 2024
Dear Madam
Re: Death of Mrs Lindy Aston
On behalf of the Trust I am writing further to the Prevention of Future Deaths report
(Regulation 28) that we recently received in relation to the death of Mrs Aston, to provide
you with an update on progress with the learning and actions that have taken place which
address your concerns raised in the report.
We extend the Trust’s condolences to Mrs Aston’s family, following her sad death.
Surgical decision making
1) Possibility of lack of theatre capacity
2) Surgical decision making on the part of a single consultant
The Trust acknowledges that clear processes need to be in place to ensure emergency
theatre capacity is available when needed to prevent this situation happening again. A
Standard Operating Policy (SOP) is in place which addresses the steps to be taken when
prioritisation of emergency operations needs to be considered. The SOP considers both
obstetric and general surgical emergencies in main theatres and addresses the safe
staffing of emergency theatres throughout the 24-hour period. The safe use of theatres is
monitored and managed through daily theatre safety huddles, (additional huddles are
agreed if required) which are documented, and any risks clearly identified and managed or
escalated as needed. This SOP was put in place following Mrs Aston’s sad death.
Whilst the responsibility for decision making regarding a patient’s care rests with the
named consultant, all members of the clinical team are encouraged to speak up if they
have any safety concerns in real time. One such example is “Stop the Line” which was
been introduced into the treatment centre in May 2023 and which has been rolled out
across the Trust in the last 8 weeks. This is now on Datix so is part of the patient safety
incident form and reporting.
The purpose behind this is that if it does not feel right or if it does not look right, it might not
be right, so speak up and speak out there and then. “Stop the Line” forms part of the ‘who’
checklist, which is used in the daily huddle meetings, this ensures that the members of the
team know each other and empowers even the most junior person to be able to have their
voice heard by the team.
The Trust has a well-developed Freedom to Speak Up process with an active Freedom to
Speak Up Guardian and several specialty-based Freedom to Speak Up ambassadors.
Freedom to Speak Up enables staff to report any concerns if they did not feel able to do so
in the moment and can be done anonymously, whereas Stop the Line is aimed at
empowering staff to speak up ‘in the moment’ if there are any concerns. The Trust does
have safety and raising concerns as a central part of its culture work and will continue to
review existing paths to reinforce raising concerns and challenging a decision.
It is also important to note that decisions to operate are made in consultation with a senior
anaesthetist and inpatients who require higher levels of care, the Intensive Care Unit
Consultant would also be involved in decision making. Where appropriate, advice from a
tertiary centre can be sought to make care safer as part of a multidisciplinary approach.
Trust investigations into Mrs Aston’s care
A concern was raised regarding the inadequacy of the investigation and incident reporting
processes at Kettering General Hospital (KGH), which in turn has led to a delay in learning
with the potential to negatively impact patient safety across the whole Trust.
We have reviewed the Trusts Medical Examiner and Mortality Review and Learning from
Adult Inpatient Deaths Policy (Ref GOV01). The policy is very clear in relation to the
Structured Judgement Review (SJR) outcomes. Section 8 of this policy refers to the
processes to be followed when the outcome of an SJR is deemed very poor or avoidable
with a score of 1-3. More specifically, section 8.5 refers to the process to be followed when
an SJR is referred from an external organisation, for example when a patient was treated
at KGH, then transferred to another hospital, and dies. This section states that these
referred concerns will go through an SJR process and governance process for mortality
reviews.
A round table panel was convened 23/2/2022, following notification from the Coroner of
Mrs Aston’s death. The panel made the decision that no further action need be taken.
The process carried out did not follow Trust policy and consequently the policy section has
been re-written to ensure absolute clarity of the process. The updated policy comes into
effect from 1/2/24 and will read as follows:
•
If a patient has recently attended / admitted to the Trust, and subsequently died where
potential problems in health care are identified by any external care providers, the
following process must be adhered to:
• Formal notification to the Mortality Review Team.
• Case to be logged / overview provided at one of the following committees to ensure
timescales and any actions are formally monitored:
1. Serious Incident Review Group (SIRG)
2.
3. Deteriorating Patient Steering Group (DPSG)
Learning from Deaths Group (LFDG)
2
• KGH notes to be reviewed utilising Structured Judgement Review (SJR) methodology
and where applicable, external care provider notes to be included within local review.
• Should any problems in health care (associated to care provided at Kettering General
Hospital) be identified, this will be detailed in the Structured Judgement Review. Any
case that meets the Structured Judgement Review escalation threshold will be discussed
at a multi-disciplinary ad-hoc Mortality Review Group.
• Findings to be shared and approved with the Medical Director’s Office before disclosing
externally.
A learning brief has been prepared and circulated to ensure consistency of messaging and
understanding of responsibilities.
I hope you find assurance in this letter that the Trust’s response to this tragic death has
been robust and if you would like any further information, please do not hesitate to contact
me.
Yours faithfully
Hospital CEO
3
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