Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0371, written 3 Nov 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 Nov 2021 |
|---|---|
| Reference | 2021-0371 |
| Deceased | Rhian Rose |
| Coroner | Nicholas Lane |
| Coroner area | Worcestershire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | 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.
WORCESTERSHIRE CORONER AREA PREVENTION OF FUTURE DEATHS REPORT RHIAN EMMA KATE ROSE HM ASSISTANT CORONER NICHOLAS HAYWARD LANE REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1) Chief Executive, Worcestershire Acute Hospitals NHS Trust 1 CORONER I am Nicholas Hayward Lane, HM Assistant Coroner for Worcestershire 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 On 3 December 2019 an investigation was commenced into the death of Rhian Emma Kate Rose. The investigation concluded at the end of the inquest hearing on 21 October 2021 at Redditch Coroner’s Court, in the Worcestershire Coroner Area. The conclusion (a ‘narrative’ conclusion in Box 4 of the Record of ‘medical complications following feticide.’ Inquest) was that Ms Rose’s death was owing to 4 CIRCUMSTANCES OF THE DEATH Rhian Rose was 28 weeks pregnant when she underwent genetic testing which discovered trisomy 21. At 31 weeks Rhian underwent feticide (on 22 November 2019 at the Birmingham Women’s Hospital) and attended, as planned, the maternity unit of Worcestershire Royal Hospital (run by Worcestershire Acute Hospitals NHS Trust (WAHT)) for the second phase of medical termination of pregnancy on 24 November 2019. Rhian’s became unwell during her stay in hospital, evidenced by observations taken between the evening of 24 November 2019 and the afternoon of 25 November 2019. The management plan was for Rhian to progress in labour and deliver vaginally, however Rhian’s condition significantly deteriorated in the early evening on 25 November 2019. This resulted in unconsciousness, an emergency caesarean section and hysterectomy, with Rhian later going into cardiac arrest. Despite significant efforts of resuscitation and a number of returns of spontaneous circulation, Rhian could not be saved, and she died in the evening on 25 November 2019 at the Worcestershire Royal Hospital. A post-mortem examination revealed the following cause of death: 1a – multi organ failure 1b – sepsis 1c – feticide for trisomy 21 Box 3 of the Record of Inquest (which answered how, when and where Rhian came by her death) read as follows: ##DW<<corAddress>> Tel ##DW<<corTel>> | Fax ##DW<<corFax>> ‘Rhian Rose underwent feticide on 22 November 2019 and was admitted to a maternity ward on 24 November 2019 for medical termination of pregnancy. By the evening of her admission, Rhian had clear symptoms of infection, however the sepsis pathway and antibiotics were not commenced until the following morning. Full consideration was not given as to whether an elective caesarean section would be the optimal mode of delivery to attempt infection source control. In the late afternoon on 25 November 2019 Rhian became acutely unwell resulting in unconsciousness, emergency caesarean section and subsequent cardiac arrest. Despite lengthy attempt at resuscitation, Rhian died at 21:06 hours on 25 November 2019 at the Worcestershire Royal Hospital.’ 5 CORONER’S CONCERNS During the course of the investigation and 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) 2) Informed consent and maternal choice regarding mode of delivery – I am concerned that enough emphasis is not being given to maternal wishes regarding mode of delivery. This issue appears to be a recurring theme in obstetric practice, and I am concerned that the culture in this area appears to still not fully accepting of the principles of informed consent set down in case law of the appeal courts (Montgomery) and in NICE guidance (Caesarean Section) and of facilitating the wishes of pregnant women and holding full and frank discussions about the risks and benefits and the pros and cons of the different options. I am concerned that situations might arise, like it appeared happened in Rhian’s case, where maternal requests are being made for re-consideration of the mode of delivery owing to feelings of physical weakness, pain or developing ill health. Evidence heard at Rhian’s inquest demonstrated that there was very little, if indeed any, recorded (in medical records) discussions held between midwives/obstetricians and Rhian regarding mode of delivery, maternal wishes and risk/benefits of differing management plans. Infection risk of retained foetus following feticide – I am concerned that a significant infection risk (retention of a deceased foetus) is not being given due weight in clinical decisions when a mother is attending for delivery (following feticide). There does not appear to be any specific or detailed local, or indeed national, guidance, for obstetricians and midwives which addresses this issue or discusses important considerations such as whether infection can be controlled by antibiotics alone or whether swifter methods of foetal delivery, such as a caesarean section, should be considered, or indeed whether specific microbiology advice needs to be obtained as part of a multi-disciplinary team approach. Cases such as Rhian’s may well be rare, however consideration could be given as to whether more detailed and specific guidance should be made available to assist clinicians when treating mothers in maternity units following feticide. 6 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. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 29 December 2021. I, the coroner, may extend the period. If any request is to be made for this period to be extended, please ensure this is made in writing at least 7 days prior to the above required response date. ##DW<<corAddress>> Tel ##DW<<corTel>> | Fax ##DW<<corFax>> 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 family of Rhian Rose (as Interested Persons), via their legal team. I have also sent it to the following who may find it useful or of interest (although they may wish to confirm receipt or provide a response, they are under no legal obligation to do so): 1) Birmingham Women and Children’s Hospital NHS Trust (‘BWCH’) 2) Royal College of Obstetricians and Gynaecologists (‘RCOG’) 3) Healthcare Safety Investigation Branch (‘HSIB’) 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: 3 November 2021 Signature: Nicholas Hayward Lane HM Assistant Coroner for Worcestershire ##DW<<corAddress>> Tel ##DW<<corTel>> | Fax ##DW<<corFax>>
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.
Coroners – Prevention of Future Death Regulation 28
(Consultant in Fetal medicine)
Lead:
Reference:
Deadline Date:
PFD – Regulation 28
29th December 2021
Coroners Concerns:
Trust Response:
Following an investigation into the care of Ms Rose who died on 25th
November 2019 , an inquest was held on the 21st October 2021 at
Redditch coroners Court , The conclusion was that Ms Rose’s death
was owing to ‘medical complications following feticide’.
During the course of the investigation and inquest the evidence re-
vealed matters giving rise to concern. In the opinion of the coroner
there is a risk that future deaths will occur unless action is taken by
Worcestershire Acute NHS Trust (WHAT). Therefore a regulation 28
was issued as detailed below.
The MATTERS OF CONCERN are as follows:
1) Informed consent and maternal choice regarding mode of
delivery – I am concerned that enough emphasis is not being
given to maternal wishes regarding mode of delivery. This
issue appears to be a recurring theme in obstetric practice,
and I am concerned that the culture in this area appears to
still not fully accepting of the principles of informed consent
set down in case law of the appeal courts (Montgomery) and
in NICE guidance (Caesarean Section) and of facilitating the
wishes of pregnant women and holding full and frank discus-
sions about the risks and benefits and the pros and cons of
A) In relation to Informed consent the National I decide tool has been considered as a tool to
address the concern raised by the Coroner.
IDECIDE is a digital framework for use by healthcare professionals and women/individuals and
their partners during childbirth that results in the woman making an informed decision about
next steps during her labour. It will take users through the following process on a tablet or
electronic device as a guide to discussion:
I – Identify urgency
D – Details of the current situation
Regulation 28 Response to Coroner V4
Coroners – Prevention of Future Death Regulation 28
the different options. I am concerned that situations might
arise, like it appeared happened in Rhian’s case, where ma-
ternal requests are being made for re-consideration of the
mode of delivery owing to feelings of physical weakness,
pain or developing ill health. Evidence heard at Rhian’s in-
quest demonstrated that there was very little, if indeed any,
recorded (in medical records) discussions held between
midwives/obstetricians and Rhian regarding mode of deliv-
ery, maternal wishes and risk/benefits of differing manage-
ment plans.
E – Exchange objective and subjective information (history, organisational context, woman’s
perspective, healthcare professionals’ experience)
C – Choices available (evidence based information will be on the tool – generic at first but in
time individualised)
I – I (the woman) confirm my understanding and seek any further clarification needed
D – Decision is made (by woman) and recorded on the tool
E – Evaluation takes place a few days/weeks later using a recorded experience measure
The I DECIDE tool has already been built into the BadgerNet maternity information system,
however NHSX have asked that CleverMed to hold off on making this available to sites in the
live BadgerNet mode. NHSX want to ensure other vendors have the opportunity to create a
version, and are working on taking the design CleverMed have created into a more generic
specification. CleverMed have asked NHSX for a timescale of when they could start a pilot or
involve BadgerNet sites however this has yet to be agreed.
Worcestershire Acute NHS Trust have expressed an interest in being involved in the pilot.
CleverMed has requested that WAHT contact NHSX to inform them of our interest in
expediting its launch.
See email from CleverMed for further information
B) Following on from a Multi-disciplinary discussion, demonstrating maternal perception and
understanding of balanced and informed consent from documented evidence is difficult.
Therefore we have consulted the local Maternity Voices Partnership (MVP) to include
maternal perception of informed consent within their user feedback surveys. The findings
from these will help shape future practice and the RCOG eLearning module and Clinical
Regulation 28 Response to Coroner V4
Coroners – Prevention of Future Death Regulation 28
Governance advice No 6 – from the RCOG will be used to as a basis for this training if
required.
C) Personalised care plans are being introduced at WHAT in January 2022, this will give
women the ability to complete a birth plan within their BadgerNotes app, the plan must
be discussed, reviewed and authorised by a Healthcare professional.
D) Training at WAHT in maternity is multi professional and this takes place on a monthly
basis. Included within this a section is dedicated to human factors, Informed consent and
reference is made to the Montgomery ruling and balanced counselling and
documentation. This case highlighted the importance of contemporaneous
documentation regarding mode of delivery discussions and decisions.
E) Following the Ockenden Review, one of the immediate essential actions is for review of
management of maternal request for Caesarean Section for both elective cases and
during labour. This is a challenge for all maternity units across the country and is a matter
being considered carefully by the Royal College of Obstetricians and Gynaecologists
(RCOG) and Royal College of Midwives (RCM).
The trust performance and progress with this action will be monitored via the Local
Maternity & Neonatal System (LMNS) as part of the National Perinatal Quality
Surveillance tool. In the first review by NHSEI the trust have received an amber rating for
this as we do not currently have a robust audit process for “in labour” requests for
Caesarean Section. Our initial action to improve this position would be to develop an
achievable process and to appoint an ‘Audit & Guideline Midwife’. This appointment is
already in progress, aiming to recruit within Q4. We also need to confirm a robust
pathway to support maternal request for elective CS which gave us our amber rating.
Regulation 28 Response to Coroner V4
Coroners – Prevention of Future Death Regulation 28
2) Infection risk of retained foetus following feticide – I am
concerned that a significant infection risk (retention of a de-
ceased foetus) is not being given due weight in clinical deci-
sions when a mother is attending for delivery (following feti-
cide). There does not appear to be any specific or detailed
local, or indeed national, guidance, for obstetricians and
midwives which addresses this issue or discusses important
considerations such as whether infection can be controlled
by antibiotics alone or whether swifter methods of foetal de-
livery, such as a caesarean section, should be considered, or
indeed whether specific microbiology advice needs to be ob-
tained as part of a multi-disciplinary team approach. Cases
such as Rhian’s may well be rare, however consideration
could be given as to whether more detailed and specific
guidance should be made available to assist clinicians when
treating mothers in maternity units following feticide.
In relation to Infection risk, Chorioamnionistis is a rare, but significant complication of
feticide.
Feticide is not performed at WAHT; cases are carried out at our tertiary fetal medicine centre.
Retention of a dead fetus also poses a significant risk of infection, therefore in combination
Rhian was at high risk of infection and this does not appear to have been documented.
There is no national guidance on delivery following feticide; as such there is no local guidance.
Following this tragic incident we engaged with the regional Chief Midwife and learnt of a
similar case which had occurred in a separate maternity unit. In light of this information, the
obstetric lead at WHAT has been in contact with the regional Obstetric lead. If guidance is
needed for management of delivery following feticide this would ideally come from a National
body (eg RCOG) or from a tertiary unit where feticide is performed. We are happy to share
our learning from this case and to contribute to national guidance on this matter.
Local guidelines within WAHT highlight the importance of not attributing maternal
temperature solely to the use of misoprostol and to swiftly enact the septic bundle where
there is evidence of maternal infection. This change to local guideline has been made to
reflect learning from this case.
Induction of Labour guidance has recently been updated by NICE NG207 published 4th
November 2021. In response to this WHAT are reviewing the fetal loss local guidance to
reflect these changes and to highlight the additional risk of infection when feticide has been
performed prior to delivery.
The findings from the HSIB investigation have been shared with all staff in various ways
including a local education session. See embedded document
A follow up educational session is planned for the 29th April 2022, where the findings of the
coroner’s inquest and recommendations made will be shared wider.
Action Plan Regulation 28 – Prevention of Future Death
Regulation 28 Response to Coroner V4
Coroners – Prevention of Future Death Regulation 28
Recommendation
Trust Lead for
Recommendation
Actions to be taken
by the Trust
By Whom
By When
How we will know if the
action has been
successful?(KPI’s)
KPI monitored
through (Trust
Forum)
1. Informed consent and
maternal choice regarding
mode of delivery
(Obstetric Lead
Consultant) &
(Director of
Midwifery)
Adopt ‘I Decide
Tool’ to assist with
decision making
around mode of
delivery (including
documentation in
Badgernet)
To include
‘maternal
perception of
informed consent’
within the MVP
user feedback
surveys.
Introduction of
Personalised Care
Plan into
BadgerNotes App
Establish a robust
process to manage
‘in labour’ requests
for Caesarean
Section.
Appointment of
Audit & Guidelines
Midwife
April 2022 (to be
part of the pilot)
Use in practice
Maternity Quality
Governance Meeting
(Obstetric Lead
Consultant)
(Director of
Midwifery)
June 2022 (as
latest survey has
just reported)
Inclusion in MVP user
questionnaire
Maternity Quality
Governance Meeting
Jan 2022
Use in practice
Maternity Quality
Governance Meeting
April 2022
April 2022
Process to be in place
and subsequently
audited by Audit &
Guidelines Midwife
Labour Ward Forum
(then to Maternity
Quality Governance
Meeting)
Maternity Quality
Governance Meeting
(Badgernet Lead
Midwife)
(LW Lead
Consultant &
Matron)
(Divisional
Quality
Governance
Lead -Women
Regulation 28 Response to Coroner V4
Coroners – Prevention of Future Death Regulation 28
& Children’s)
2. Infection risk of retained
foetus following feticide
There are no ongoing actions within the trust for this recommendation. Possible national or regional guidance would be adopted if
available. We currently manage labour following feticide according to our ‘Induction of Labour’ guideline. Within the trust,
amendments and improvements to induction guidelines have already been implemented and learning from this case has already
been shared widely. We will fully engage with any regional or national guideline formation.
Regulation 28 Response to Coroner V4
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