Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0167, written 8 Jun 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Jun 2022 |
|---|---|
| Reference | 2022-0167 |
| Deceased | Jack Hurn |
| Coroner | Emma Brown |
| Coroner area | Birmingham and Solihull |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | University Hospitals Birmingham NHS Foundation Trust · Worcestershire Acute Hospitals 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.
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REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: The Chief Executive of the Worcestershire Acute
Hospitals NHS Trust
CORONER
I am Miss Emma Brown, HM Area Coroner for Birmingham and Solihull
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.
INVESTIGATION and INQUEST
On 14 September 2021 I commenced an investigation into the death of Jack HURN. The
investigation concluded at the end of the inquest on the 27th May 2022. The conclusion of the
inquest was:
"Death was due to a rare but recognised complication of the Astra Zeneca COVID19 vaccination."
CIRCUMSTANCES OF THE DEATH
At the age of 26 Jack Hurn died at the Queen Elizabeth Hospital Birmingham at 13:06 on the 11th
June 2021. He had received a first dose of the Astra Zeneca vaccination for COVID-19 at the
Dudley and Netherton primary care network vaccination centre at the Revival Fires Church on the
29th May 2021. At that time the Joint Committee on Vaccines and Immunisation had advised that it
was preferable for adults aged under 40 years without underlying health conditions to be offered
an alternative to the Astra Zeneca COVID-19 vaccine unless that would cause substantial delay
but people could make an informed choice to receive the Astra Zeneca vaccine to receive earlier
protection. Jack was not given all the information to make an informed choice at the time of giving
his consent to the vaccine. In particular, the risk of complications for his age group was
understated. On the 6th June Jack developed a headache which persisted and worsened leading
to him being admitted to the Alexandra Hospital Redditch on the 8th June 2021. Imaging revealed
extensive superior sagittal sinus thrombosis and he was diagnosed with Vaccine-Induced Immune
Thrombocytopenia and Thrombosis ('VITT'): a new but extremely serious condition caused by a
rare complication of the Astra Zeneca vaccine. Following diagnosis Jack was admitted to a
medical unit, he was not referred to a specialist neurology and haematology team in accordance
with guidance on the management of VITT CVST and the regional VITT pathway. Jack
deteriorated during the afternoon of the 9th June and at approximately 1800 it was identified that
his Glasgow Coma Score had dropped to 11/15 and he had developed dense right hemiplegia.
Imaging showed extension of the previous thrombosis along with new areas of thrombosis and
haemorrhage prompting contact with specialist services at the Queen Elizabeth Hospital into
whose care he was transferred. Despite mechanical thrombectomy and decompressive
craniectomy alongside full supportive measures Jack’s condition deteriorated and became un-
survivable. Death was due to a rare but recognised complication of the Astra Zeneca COVID19
vaccination.
Following a post mortem carried out by Dr
evidence from Dr
determined to be:
, Consultant Haematologist the medical cause of death was
, Consultant Histopathologist, and
1a Cerebral venous sinus thrombosis.
1b Vaccine-induced immune thrombocytopenia and thrombosis (VITT)
1c ChAdOx1 nCOV-19 adenoviral vector vaccination.
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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. –
1. The Level Two Comprehensive Investigation of the Worcestershire Acute Hospitals NHS
Trust ('WAH') concluded the root cause of Jack's death was: “There was no official national
guidance and no approved Trust guidance on managing VITT in place at the time this
patient was admitted to AGH, therefore staff are unlikely to have been aware of the time-
critical need to transfer the patient to a specialist centre (QEHB).” The following care and
service delivery problems were identified: “There was no written Trust or national guidance
on managing VITT at the time the patient was admitted, therefore staff are unlikely to have
been aware of the time-critical need to transfer the patient to a specialist centre (QEHB).”
The following Contributory factors were identified: - The Neurosurgical team at QEHB were
contacted for advice; had the Trust VITT guidance been in place at the time, it would have
stipulated not to contact the Neurosurgical team, but instead to contact Haematology and
Neurology at QEHB.
- The Neurosurgical team at QEHB advised to continue medical management locally (at
WAHT).
- Had the Trust VITT guidance been in place at the time, the WAHT Haematologist would
have been prompted to contact their counterpart Haematologist at QEHB which may
have accelerated the process of transfer; this did not happen until the day after the
patient’s admission.
2. Within the course of the evidence at the inquest it was identified that, whilst there was no
NICE Guidance or a local policy at WAH, there was a number of publications on the
management of VITT and patients presenting with complications post Astra Zeneca
Vaccination:
i. Guidance from the Expert Haematology Panel (EHP) on Covid-19 Vaccine-induced
Immune Thrombocytopenia and Thrombosis (VITT) 28th May 2021
ii. Joint guidance from the Royal College of Emergency medicine, the Society for
Acute Medicine and the Royal College of Physicians 'Management of patients
presenting to the Emergency Department/ Acute Medicine with symptoms 5-42
days post Astra Zeneca vaccine' 24th May 2021
iii. 'Management of Cerebral Venous Sinus Thrombosis following COVID-19
vaccination. A neurosurgical guide.' from the British Society of Neurological
Surgeons 19th April 2021
3. Evidence also identified that the University Hospitals Birmingham NHS Foundation Trust
had also put in place a Regional VITT Pathway that was communicated to Haematologists
and Neurologists across the region in March 2021. Prior to Jack's admission to the
Alexandra Hospital on the 8th June 2021 4 patients had been transferred from the WAH to
the QEH under the pathway including 1 patient from the Alexandra Hospital.
4. The WAH investigation did not identify the above guidance or Pathway and did not provide
any explanation of why they were not followed in Jack's case.
5. Concerns were raised in the management of Jack's care whilst at the Alexandra Hospital,
in particular the emergency department decision to refer to the medical and not neurology
team, the level of observations whilst on ward 11 and the fact that family were reporting a
concern that Jack was deteriorating during the afternoon of the 9th June 2021. The WAH
investigation report does not record that these matters (or any other aspect of clinical care)
were investigated, the conclusions reached or the bass for those conclusions.
6. This raises a concern that the investigation was not sufficient and as such has not served
its purpose of safeguarding patients.
7. No adequate explanation was given in evidence to explain why the investigation was
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incomplete.
8. If WAH serious incident investigations are not sufficient the lessons arising will not be
identified and necessary action will not be taken putting lives at risk.
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ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you have 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
3 August 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.
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested Persons:
Jack’s Family, University Hospitals Birmingham NHS Trust, Dr
(Consenter), Dr
(Clinical Director)
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I have also sent it to the Medical Examiner, CCG and CQC who may find it useful or of interest.
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.
8 June 2022
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Signature:
Miss Emma Brown
HM Area Coroner for Birmingham and Solihull
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.
Office of the Chief Medical Officer Deputy Chief Medical Officer: Divisional Director:Surgery Divisional Director: Specialised Clinical Services Divisional Director: Emergency Medicine Divisional Director: Speciality Medicine Divisional Director: Women and Children Our Ref: CB/TW/2849 Date: 2nd August 2022 Miss E Brown HM Area Coroner for Birmingham and Solihull Via email only Dear Madam Re Regulation 28 Report to Prevent Future Deaths I am writing to respond to your Regulation 28 Report to Prevent Future Deaths sent on 8 June 2022, following the Inquest touching the death of Jack Hurn. In your Regulation 28 report you identified the following matters of concern 1. The Trust’s internal review following Jack’s death did not identify national and local guidance on the recognition and management of VITT that had been published at the time of Jack’s admission to the Alexandra Hospital, or explore why the guidance was not followed. 2. Further, the internal review did not explore the concerns raised at the inquest about Jacks clinical care at the Alexandra hospital and in particular his deterioration during the afternoon of 9th June 2021. who had agreed to re-open the Trust’s review and address the issues identified. I appreciate your concern that if our internal review processes are not sufficiently robust then learning will not be identified and appropriate actions implemented. I understand that you had already raised these concerns during the Inquest with This review started immediately that Regulation 28 report. I also confirm that the Trust has reinstated the serious incident record entry on StEIS (which is the NHS England system for reporting and monitoring of serious incidents across England) and the revised terms of reference for the investigation to include the issues that you have identified. The revised report is now being reviewed independently of the clinical division responsible for the care delivery, by my Deputy Chief Medical Officer, and will be shared with Jack’s family and with our Integrated Care Board by 7th October. had concluded his evidence and prior to receipt of your Worcestershire Acute Hospitals NHS Trust | Executive Suite, Sky Level 3 | Worcestershire Royal Hospital Charles Hastings Way | Worcester | WR5 1DD I confirm that we have discussed the concerns raised with the Care Quality Commission and Clinical Commissioning Group (as was), in particular providing assurance about the actions taken in order that any future patients presenting at our sites are referred appropriately to tertiary services. In terms of concerns about our initial report, we have reflected through our Serious Incident group, as to how the omissions occurred in the original review, which identified an overreliance on assurance obtained from internal expertise. The conclusion from the reflection was the importance of being conscious of the risks of bias influencing how an investigation is approached, rather than methodically carrying out all the steps outlined in our investigation process, which was not fully applied in this case. This would have included communication with the family to offer an opportunity to contribute, including identifying any concerns about care that they wanted to be incorporated in the terms of reference, and conducting an objective review of the medical records to highlight care or service delivery problems to further inform the scope of the investigation. We are ensuring investigators undertake more comprehensive literature and independent evidence reviews when indicated, rather than relying on internal expertise, and ensure that the concerns of patient’s family are sought and addressed in our reports. As part of our reflection we have recognised the need and actioned raising awareness of the Trust’s Library Services who can support literature searches for existing clinical guidelines and publications, to our investigators. You may also be aware that NHS England is due to publish their Patient Safety Incident Response Framework (PSIRF), which describes how providers should respond to patient safety incidents and how and when a patient safety investigation should be conducted. Included as part of the framework are the National Standards for Patient Safety Investigation, published in 2020, designed to support improvement in the quality of patient safety investigation in NHS-funded care and specifies the basic requirements of reviews. The Trust completed a gap analysis of these standards against current practice, which is being used to inform the development of a revised investigation processes and report template as well as guidance for investigators. The Framework supports the National Patient Safety Strategy, to improve understanding of safety by drawing insights from patient safety incidents. To organise for successful implementation, the Trust restructured its central patient safety team in April 2021 to begin alignment of activities with the National Patient Safety Strategy. Plans for further alignment of activity to the national patient safety strategy, the framework and investigation standards continue to be discussed, to ensure we are able to reinforce our existing processes and apply them to ensure that learning is consistently identified and embedded to improve patient safety. I hope that the above addresses your concerns about the quality of our initial review, which did not identify either the family concerns about a deterioration on the afternoon of 9 June 2021, or the existence of national guidance and a regional VITT pathway. I have no representations in respect of publication of your Regulation 28 or this response by the Chief Coroner. I shall be grateful if you could kindly send a copy of my response to anyone to whom copied your Regulation 28 report. Yours sincerely,
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