Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0338, written 17 Sep 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 17 Sep 2023 |
|---|---|
| Reference | 2023-0338 |
| Deceased | Kimberley Sampson and Samantha Mulcahy |
| Coroner | Catherine Wood |
| Coroner area | Central and South East Kent |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REPORT TO PREVENT FUTURE DEATHS
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1.
2.
1
CORONER
, President, Royal College of Obstetricians &Gynaecologists
, Chief Executive NHS England
I am Catherine Wood, assistant coroner, for the coroner area of Central and South East
Kent.
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
INVESTIGATIONS and INQUESTS
An investigation into the deaths of Kimberley Sampson who died on 22 May 2018 and
Samantha Mulcahy who died on 4 July 2019 both from herpes simplex infections initially
led to a discontinuation of both investigations on 2 October 2019. The investigations
were reopened on 4 January 2022 as concerns were raised about a possible common
source of infection. The investigations concluded at the end of the inquests which were
held jointly and final conclusions handed down on 26 July 2023.
The cause of death for both young women determined at the inquests was:
1a) Multi- Organ Failure
1b) Disseminated Herpes Simplex type I infection
1c) Herpes Simplex virus acquired before or around the time of delivery
2. Third trimester pregnancy
A narrative conclusion was reached in both inquests and both narratives are set out
below:
“Kimberly Sampson died as a consequence of disseminated Herpes Simplex 1 infection
with the initial infection having been acquired before or around the time of the delivery of
her baby. There was a delay in instituting antiviral therapy, the known treatment for her
illness, due in part to the presence of a concurrent bacterial infection but also due to a
delay in recognising and linking the cause of her deteriorating liver function as being a
symptom of a viral infection.”
“Samantha Mulcahy died as a consequence of disseminated Herpes Simplex 1 infection
with the initial infection having been acquired before or around the time of the delivery of
her baby. Antiviral therapy, the known treatment for her illness, was not instituted as her
symptoms were unclear and her previous obstetric cholestasis had complicated the
picture.”
4
CIRCUMSTANCES OF THE DEATHS
The circumstances in relation to Kimberley Sampson’s death were that she had been fit
and well when she became pregnant in 2017. She underwent a caesarean section for
failure to progress on 3 May 2018 which was complicated by some bleeding. She went
home on 5 May 2018 but was readmitted to Queen Elizabeth the Queen Mother hospital
on 10 May 2018 with signs of sepsis and she was treated with broad spectrum
intravenous antibiotics. An abdominal collection was drained on 12 May 2018 by way of
a laparotomy. Some samples sent to the laboratory had grown gram positive bacteria
and she was treated and her antibiotics were adjusted. She became more unwell on 16
May 2018 and her liver was showing signs of failure and a further laparotomy was
performed which was essentially negative. She continued to deteriorate and by 18 May
2018 discussions were held with Kings College hospital and advice given by them to
commence Acyclovir and she was transferred to Kings College hospital liver unit the
following day. By this stage she was 16 days post delivery and showing signs of multiple
organ failure with cardiovascular instability, respiratory and liver failure as well as a
severe coagulopathy and signs of acute kidney injury. Despite full resuscitative
measures including ECMO she died from multiple organ failure as a consequence of her
disseminated herpes simplex infection on 22 May 2018.
The circumstances in relation to Samantha Mulcahy’s death occurred very shortly after
the death of Kimberley Sampson and clinicians in common were involved in looking after
both mothers. I found that their index of suspicion should have been raised and indeed a
viral cause and possible treatment was suggested by one Obstetrician but following a
discussion with a Microbiologist was not instituted.
Samantha Mulcahy had a past medical history of oesophageal hernia, polycystic
ovaries, gallstones and underactive thyroid when she became pregnant in 2017. She
developed obstetric cholestasis in the latter stages of her pregnancy and required a
caesarean section for failure to progress on 26 June 2018 which was complicated by a
tear to the broad ligament. On 28 June she developed signs of sepsis and was
commenced on broad spectrum intravenous antibiotics. She did not improve and her
respiratory function deteriorated and investigations including a CTPA on undertaken to
rule out a pulmonary embolism as a cause of her symptoms. Antiviral medication was
discussed by the obstetrician and microbiologist on 30 June 2018 but a decision made
that it should not be commenced. She was transferred to Intensive care unit on the
morning of the 30 June and she was considered to be suffering from respiratory failure
secondary to abdominal distension with a possible pneumonia and she improved slightly
over the course of the day with treatment. A CTPA was undertaken on 2 July 2018 to
rule out a pulmonary embolism as a cause of her symptoms which showed no PE but
some patchy shadowing in her lungs and bilateral pleural effusions. She deteriorated
significantly overnight between the 2 and 3 July 2018 with a decrease in urine output
and her liver function tests the next morning showed fulminant liver failure and she had
also developed ascites. There was a delay in recognising a viral cause of her illness as it
was thought that she may be suffering from steatosis plus sepsis and discussions with
the liver unit at Kings College hospital led to recommendations to commence antifungal
not antiviral medication. She continued to deteriorate and discussions were held about
ECMO with the team arriving around 2am on 4 July 2018. She was transferred to
theatres to set up ECMO and operate if necessary. Despite all attempts to improve her
situation she continued to deteriorate and died around 07.15 that morning.
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) The inquest heard evidence of steps having been taken to try to establish if the
deaths of both women were linked and if there was a common source of
infection. In both inquests the women had been treated in separate hospitals but
within the same Trust and two members of staff had been involved in treating
both women. The inquest heard that Public Health England were involved in the
investigation following the deaths and advice on testing staff was unclear which
meant neither of the members of staff involved with both women were tested.
The inquest was however unable to establish if the strain of the virus was the
same in both women as the evidence on this was inconsistent and on balance
the evidence did not support a conclusion that both women were infected by the
same source.
(2) Evidence given at the inquest revealed that Herpes Simplex can be fatal if
contracted in pregnancy and whilst deaths are rare there is no specific guidance
in relation to treating women in the post-partum period with anti-viral therapy. It
was accepted by all who gave evidence that antiviral medication would have
been the recognised treatment for Herpes Simplex (specifically Acyclovir). The
Trust has made some minor amendments to its protocols but there is no
national guidance either in place back in 2018 or currently in 2023 on
prescribing antiviral medication to women who present with signs of systemic
infection. Had Acyclovir been prescribed at an earlier stage it is likely to have
significantly reduced the risk of death from progression of the disease. Sepsis
protocols cover antibiotic therapy but not antiviral therapy. What was abundantly
clear from the evidence before the court was that this is a rare but often fatal
disease if contracted in the peripartum period and more needs to be done to
raise awareness of it as a potential diagnosis to exclude in sepsis pathways and
for early consideration of the use to Acyclovir.
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 12 November 2023. 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 namely the families, and East Kent Hospitals University NHS Foundation Trust.
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
17 September 2023
Catherine Wood
Assistant Coroner
Central and South East Kent
2 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.
Catherine Wood
Central and South East Kent Coroner Service
Cantium House
Sandling Road
Maidstone
ME14 1XD
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
11 December 2023
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Kimberley Sampson who
died on 22 May 2018 and Samantha Mulcahy who died on 4 July 2019.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17
September 2023 concerning the deaths of Kimberley Sampson and Samantha
Mulcahy. In advance of responding to the specific concerns raised in your Report, I
would like to express my deep condolences to Kimberley’s and Samantha’s family and
loved ones. NHS England are keen to assure the family and the coroner that the
concerns raised about the care that Kimberley and Samantha have received has been
listened to and reflected upon.
I am grateful for the further time granted to respond to your Report, and I apologise for
any anguish this delay may have caused to Kimberley’s and Samantha’s family or
friends. I realise that responses to Coroner Reports can form part of the important
process of family and friends coming to terms with what has happened to their loved
ones and appreciate this will have been an incredibly difficult time for them.
Strain of Herpes Simplex Virus contracted by Kimberley and Samantha
The first matter of concern in your Report was that the inquest was unable to establish
if the strain of Herpes Simplex 1 infection suffered by both Kimberley and Samantha
was of the same strain and came from the same source and that the evidence on
whether this was the case was inconsistent.
NHS England are not the appropriate organisation to provide comment on any
investigation into the source of Herpes Simplex Virus (HSV) 1 infection contracted by
Kimberley and Samantha. You may wish to refer this matter of concern to East Kent
Hospitals University NHS Foundation Trust (hereafter “the Trust”) or to the UK Health
Security Agency (UKHSA), who assumed many of the public health and health
protection responsibilities following the disbandment of Public Health England (PHE)
in October 2021.
NHS England has however engaged with UKHSA and the Trust following receipt of
your Report. We have been sighted on a letter sent from PHE to the Trust on 12
September 2018, following phylogenetic analysis of the HSV samples that were
provided to them following the deaths of Kimberley and Samantha. NHS England
notes PHE’s findings that while the sequences within both samples are identical, due
to the evolutionary rate of HSV this does not mean that the virus will have the same
common source or that they are part of a transmission chain.
NHS England also understands that the Trust has taken on board recommendations
and implemented several actions following investigations into the deaths of Kimberley
and Samantha and have been sighted on the Trust’s Improvement Plans. Actions have
included developing guidance for women and their families about HSV which has been
added to postnatal discharge leaflets and a full Infection Prevention Control (IPC)
review within the Trust which has included ensuring staff are aware of IPC guidelines
related to HSV infections as well as sharing learnings from these cases across the
Trust.
National guidance for prescribing antiviral medication for postpartum women
who present with signs of systemic infection
Your second concern related to the delays in prescribing the antiviral medication
Acyclovir to Kimberley and Samantha and that there was no national guidance in
relation to prescribing antiviral medication in such cases, and that more needed to be
done to raise awareness of the possibility of HSV to exclude in sepsis pathways.
The relevant national guidance does not come under the remit of NHS England. The
Royal College of Obstetricians & Gynaecologists (RCOG), who you also addressed
your Report to, are one of the organisations responsible for the national guidance on
diagnosing and treating sepsis during pregnancy and we note their response to you
that they are in the process of updating their Green-top Guidelines on Sepsis in
pregnancy (No. 64a) and Bacterial sepsis following pregnancy (No. 64b). The update
will result in a new combined guideline titled Identification and management of
maternal sepsis during and following pregnancy (No. 64), which will include guidance
on the timely and routine identification and treatment of herpes simplex. NHS England
notes that this is scheduled for publication in March 2024.
The UK National Screening Committee (UK NSC) does not currently recommend
screening for genital herpes in pregnant women. This is because it is not known how
many women in the UK are infected with HSV-1 and HSV-2, how accurate screening
tests are in pregnant women, how effective treatments are to stop women passing
HSV to their babies and how effective treatments are to stop pregnant women from
catching the disease.
NHS England notes some of the actions included in the Trust’s Improvement Plans,
which have included implementation of a new HSV-1 pathway with the aim to improve
early diagnosis and teaching of care of deteriorating women within their Skills Update
in Maternity (SUM) training day, which includes Modified Early Obstetric Warning
(MEOW) scores and necessary escalations.
I would also like to provide further assurances on national NHS England work taking
place around the Reports to Prevent Future Deaths. All reports received are discussed
by the Regulation 28 Working Group, comprising Regional Medical Directors, and
other clinical and quality colleagues from across the regions. This ensures that key
learnings and insights around preventable deaths are shared across the NHS at both
a national and regional level and helps us pay close attention to any emerging trends
that may require further review and action.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
Catherine Wood Assistant Coroner Central and South East Kent 10 November 2023 Dear Ms Wood, Re: Samantha Mulcahy– deceased Re: Kimberley Sampson– deceased Thank you for your Regulation 28 Report to Prevent Future deaths following the inquest into the deaths of Samantha Mulcahy and Kimberley Sampson dated 19th September 2023. The loss of a young woman is a devastating tragedy for the wider family and healthcare professionals involved. We would like to begin by extending our deepest and heartfelt condolences to Samantha and Kimberley’s family for their deep loss. This response has been developed following input from members of the RCOG Patient Safety Committee and Senior Officers of the College. We recognise and respect the narrative conclusion from the inquest that Samantha and Kimberley died as a result of 1a.Multi-organ failure 1b. Disseminated Herpes Simplex 1 Infection 1c. Herpes simplex virus acquired before or around the time of delivery 2. Third trimester pregnancy We also recognise the matters of concern, in particular concern 2; Evidence given at the inquest revealed that Herpes Simplex can be fatal if contracted in pregnancy and whilst deaths are rare there is no specific guidance in relation to treating women in the post-partum period with anti-viral therapy. It was accepted by all who gave evidence that antiviral medication would have been the recognised treatment for Herpes Simplex (specifically Acyclovir). The Trust has made some minor amendments to its protocols but there is no national guidance either in place back in 2018 or currently in 2023 on prescribing antiviral medication to women who present with signs of systemic infection. Had Acyclovir been prescribed at an earlier stage it is likely to have significantly reduced the risk of death from progression of the disease. Sepsis protocols cover antibiotic therapy but not antiviral therapy. What was abundantly clear from the evidence before the court was that this is a rare but often fatal disease if contracted in the peripartum Page 1 of 2 period and more needs to be done to raise awareness of it as a potential diagnosis to exclude in sepsis pathways and for early consideration of the use to Acyclovir. The College is currently in the process of updating its Green-top Guidelines on Sepsis in pregnancy (No. 64a) and Bacterial sepsis following pregnancy (No. 64b). The new name of the combined guideline will be Identification and management of maternal sepsis during and following pregnancy (No. 64). We will ensure that this updated version will contain guidance on the timely identification and treatment of herpes simplex. This is currently scheduled for publication in March 2024. The RCOG is committed to improving the standard of care provided for women by working collaboratively with all stakeholders, including Coroners. Yours faithfully, CEO Royal College of Obstetricians and Gynaecologists Page 2 of 2
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