Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0004, written 3 Jan 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 Jan 2024 |
|---|---|
| Reference | 2024-0004 |
| Deceased | James Holgate |
| Coroner | Lorraine Harris |
| Coroner area | East Riding and Hull |
| Category | Hospital Death (Clinical Procedures and medical management) 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 (2)
NOTE: This form is to be used before an inquest.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. The Minister for Health –
1
CORONER
I am Miss Lorraine Harris, Area Coroner, for the coroner area of East Riding of
Yorkshire and City of Kingston Upon Hull.
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
On 2nd November 2023 I commenced an investigation into the death of James
Arthur HOLGATE, aged 89 years. The investigation has not yet concluded, and
the inquest has not yet been held.
Mr HOLGATE’s medical cause of death has been given as:
1a Traumatic Intracranial Haemorrhage
1b Fall
2 Mitral Valve replacement (on warfarin), Hypertension, Atrial Fibrillation,
Frailty
4
CIRCUMSTANCES OF THE DEATH
On 30th October 2023 Mr HOLGATE age 89 years was admitted to Hull Royal
Infirmary with recurrent falls, progressive confusion, slurred speech and
progressive decline.
While in the care of the Emergency Department Mr HOLGATE sustained a fall. A
CT scan showed evidence of a traumatic head injury, Mr HOLGATE was deemed
very unwell and not for surgical intervention. Mr HOLGATE deteriorated further
and another CT scan showed an ongoing bleed with mass shift which had not
been evident on the original CT. Mr HOLGATE was reviewed again and still
deemed not fit for intervention and placed on a palliative care pathway. Mr
HOLGATE died on 1st November 2023.
5
CORONER’S CONCERNS
The MATTERS OF CONCERN are as follows. –
This matter was referred to this court and is a case where it is entirely suitable
to proceed to inquest without the need for a post mortem examination.
Evidence regarding the cause of death will be provided at inquest by way of a
statement from the treating clinician with the CT scans showing the sequence of
events.
The family indicated that it had been Mr HOLGATE’s wishes, and indeed
something that they supported, for his body to be donated for medical
science/research.
This process has long been a way of researching illness and disease as well as
assisting in the training of doctors. It is recognised as fundamentally important
to progressing the understanding of medicine and treatment.
Each receiving medical research/training establishment have a criteria, one of
which is that, unless there are exceptional circumstances, the deceased should
not have undergone a post mortem examination. This is understandable, and
exceptions allow in certain instances this to be waivered.
In Mr HOLGATE’s case the local medical research/training establishment had full
capacity and were unable to accept him. As is normal the family/Coroners
Officer were referred to an alternative establishment at Nottingham.
Nottingham politely declined, they indicated that they were prevented from
accepting due to what appears to be an anomaly in the law. As the matter was
subject of a coronial inquest they could not accept the donation.
In non-inquest matters reported to the coroner, where post mortem
examination is not required and the coroner is content there is no requirement
to investigate further, a form A is signed to indicate this and the coroner is then
able to return the deceased back in to the care of their family/personal
representative/funeral director to allow funeral arrangements or body donation
to proceed. In these instances medical research/training establishments are
able to accept donation.
Where a coroner is likely to hold an inquest in a situation where a post mortem
is not necessary as a cause of death statement can be obtained and the coroner
is content that there is no further need to retain the deceased for any further
examination, the coroner must also ensure that the deceased is returned back
to the care of the family/personal representative/funeral director as soon as
practicable. This normally allows for funeral arrangements to proceed.
In both instances the coroner authorises release of the deceased, in majority of
cases the person is cremated ie they will not be available nor required for the
coroner, even when the matter is proceeding to inquest. All relevant enquiries
have to be made and sufficient evidence obtained before the release is
authorised.
It is surprising therefore that the medical research/training establishments are
stating that they are prevented from accepting people that are to be the subject
of an inquest due to the Human Tissue Act. I fully accept there may be some
circumstances where it would be inappropriate however if the coroner has no
reason to object then the fact that the death is the subject of an inquest should
not prevent the donation.
On reading the legislation, the establishments are either indicating an anomaly
in the law or interpreting it incorrectly and guidance may be required.
Human Tissue Act 2004 covers donation. Section 11 covers permission required
from a coroner, it reads:
11 Coroners
(1)Nothing in this Part applies to anything done for purposes of functions of a coroner or
under the authority of a coroner.
(2)Where a person knows, or has reason to believe, that—
(a)the body of a deceased person, or
(b)relevant material which has come from the body of a deceased person,
is, or may be, required for purposes of functions of a coroner, he shall not act on authority
under section 1 in relation to the body, or material, except with the consent of the coroner.
However the medical research/training establishments refer to section 1(3) of the act
which explicitly states the body cannot be accepted unless the death has been
registered. Section 1 Subsection (3) HTA states:
1 Authorisation of activities for scheduled purposes
1(3)The use of the body of a deceased person for the purpose of anatomical examination
shall be lawful if done—
(a)with appropriate consent, and
(b)after the death of the person has been registered—
(i)under section 15 of the Births and Deaths Registration Act 1953, or
(ii)under Article 21 of the Births and Deaths Registration (Northern Ireland) Order 1976.
Matters that proceed to inquest are not registered until the close of the
inquest. Some inquests are dealt with in a very timely manner, however some
may take some months to conclude.
It appears that the consent in Section 11 may have the ability to override the
consent required in Section 1(3), if it is then organisations are not interpreting it
this way.
6
ACTION SHOULD BE TAKEN
In my opinion urgent action should be taken to prevent future deaths and I
believe you have the power to take such action.
This may be by way of clarification or guidance if S11 overrides the need to
register before acceptance.
Donations of this kind further the advancement of medicine, treatments and
training and as such prevent many deaths. It appears that those people who
are subject of an inquest should not be prevented from donating their bodies
when the coroner is content it is entirely appropriate to do so and it is the
wishes of those making the arrangements.
7
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this
report, namely by 28th 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 family of James Arthur HOLGATE. I have also sent it to
The Royal College of Surgeons 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.
9
[DATE] 3rd January 2024 [SIGNED BY CORONER]
Lorraine Harris
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.
OFFICIAL
From Maria Caulfield MP
Parliamentary Under Secretary of State
Department of Health & Social Care
39 Victoria Street
London
SW1H 0EU
Miss Lorraine Harris, Area Coroner, for the coroner
area of East Riding of Yorkshire and
City of Kingston Upon Hull Coroner’s Service,
The Guildhall
Alfred Gelder Street
Hull HU1 2AA
26 March 2024
Dear Miss. Harris,
Thank you for your letter of 3 January 2024 about the death of Mr. James Arthur Holgate. I am
replying as Minister with responsibility for sponsorship of the Human Tissue Authority.
Firstly, I would like to say how saddened I was to read of the circumstances of Mr. Holgate’s
death, and I offer my sincere condolences to their family and loved ones. Your report describes
the circumstances in which Mr Holgates body was declined for donation because it was
subject to an inquest. I am grateful to you for bringing this matter to my attention.
In this case, the research establishment could have accepted Mr. Holgate’s body for lawful
storage if certain conditions had been met. The research establishment could have lawfully
stored the body in anticipation of potentially using it for anatomical purposes, as per section
1(2) of the Human Tissue Act.
However, Section 11 of the Human Tissue Act 2004 provides that any of the activities specified
under section 1 of the Act should not take place where a person knows or has reason to
believe that the body is, or may be, required by a coroner unless the coroner consents.
The Department appreciates that the need for coroners’ consent in section 11 of the Human
Tissue Act could allow room for confusion with regards to the criteria for storage and use of a
deceased body for anatomical purposes under Section 1, particularly where a coroner is
holding an inquest but has released the body. We propose therefore to discuss with the
Human Tissue Authority how they can ensure that their guidance and codes of practice provide
OFFICIAL
OFFICIAL
clarity on the criteria required for the storage and use of bodies with regards to each of the
specified activities as set out in Schedule 1 of the Human Tissue Act 2004, including
anatomical examination, and its interaction with Section 11.
Lastly, I agree that body donation is a vital resource for training healthcare professionals and
for research. I would recommend that for any further concerns relating to statutory
interpretation of the Human Tissue Act, that you write to my officials at the Department of
Health and Social Care (health.ethics@dhsc.gov.uk).
I hope this response is helpful. Thank you for bringing this matter to my attention.
Best Wishes,
MARIA CAULFIELD
OFFICIAL
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