Lisa Gale

Dr Simon Fox KC 
Assistant Coroner for Area of Avon 
Avon Coroner’s Office 
37 Old Weston Road  
Bristol  
BS48 1UL  

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

10 January 2025  

Dear Coroner, 

Re: Regulation 28 Report to Prevent Future Deaths – Lisa Gale who died on 5 
April 2023 

Thank  you  for  your  Report  to  Prevent  Future  Deaths  (hereafter  “Report”)  dated  12 
November 2024 concerning the death of Lisa Gale on 5 April 2023, addressed to NHS 
England’s Chief Midwife. I am responding on behalf of the organisation in my capacity 
as National Medical Director but would like to assure you that NHS England’s Chief 
Midwifery Officer has also reviewed your Report and been sighted on this response. 

In advance of responding to the specific concerns raised in your Report, I would like 
to express my deep condolences to Lisa’s family and loved ones. NHS England are 
keen to assure the family and the Coroner that the concerns raised about Lisa’s care 
have been listened to and reflected upon.   

Your  Report  raised  concerns  over  the  Royal  College  of  Pathologists’  guidelines  for 
urgent reporting of liver function tests (LFTs) undertaken on pregnant women, despite 
pregnancy specific conditions such as Acute Fatty Liver of Pregnancy (AFLP) being 
potentially  fatal  at  much  lower  levels  of  abnormal  LFTs.  Specialist  Maternity, 
Obstetrics  &  Midwifery  colleagues  at  NHS  England  have  been  consulted  on  my 
response to the Coroner.  

NHS  England  has  led  the  establishment  of  Maternal  Medicine  Networks  (MMNs) 
across  England,  so  that  all  women  can  receive  specialist  advice  and  care  for  the 
management  of  chronic  and  acute  medical  problems  before,  during  and  after 
pregnancy. All 14 Networks have been operational for two years as of December 2024.  

The  National  Service  Specification  for  Maternal  Medicine  Networks,  published  in 
October 2021, describes the care pathways and clinical dependencies of MMNs and 
maternal medicine centres (MMCs). Every Network is responsible for agreeing shared 
protocols  on  the  management  and  escalation  of  medical  problems  that  pre-exist  or 
arise in pregnancy and in the puerperium (6 week postpartum period). Every Network 
has at least one MMC, which provides advice or care for the highest risk cases, along 
with advice, training and education for local units across the Network. Where specialist 
advice or care has been provided at an MMC, this will continue for as long as deemed 
medically necessary.  

                                                                                                                       
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 Diagnosis of rare conditions such as acute fatty liver of pregnancy can be challenging 
due  to  the  differences  in  physiology  for  pregnant  and  non-pregnant  women.  Whilst 
maternal  medicine  networks  would  be  expected  to  drive  up  the  quality  of  care  for 
women with acute medical conditions in pregnancy, such as acute fatty liver, and raise 
awareness around presentation, the problem identified was a delay in diagnosis owing 
to an abnormal result in a pregnant woman not being recognised as such and so not 
urgently  reported.  NHS  England  would  therefore  support  the  revision  of  the  Royal 
College of Pathologists’ guidelines to incorporate different urgent reporting levels for 
results  of  tests  taken  during  pregnancy,  and  we  note  that  the  Coroner  has  also 
addressed your Report to the College. 

I  would  also  like  to  provide  further  assurances  on  the  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 events, such as the sad death of Lisa, 
are shared across the NHS at both a national and regional level and helps us to 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

Dr Simon Fox 
His Majesty’s Senior Coroner Area of Avon 
The Coroners Court 
Old Weston Road, 
Flax Bourton 
BS48 1UL 

17 January 2025 

Dear Dr Fox 

Re: Lisa Gale - deceased 
Your ref: 

Thank you for your Regulation 28 Report to Prevent Future deaths following the inquest into 
the death of Lisa Gale dated 12 November 2024. 

This loss is a devastating tragedy for the immediate and the wider family, and the healthcare 
professionals  involved.  We  would  like  to  begin  by  extending  our  deepest  and  heartfelt 
condolences to Lisa’s family for their profound 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 Lisa died of natural 
causes subsequent to developing a rare but serious condition, Acute Fatty Liver of Pregnancy 
(AFLP). 

We also recognise the matters of concern as outlined in your letter as follows,  

1.  Blood was taken for liver function test (LFTs) on admission before her condition was 

diagnosed. 

2.  Lisa’s LFT’s were grossly elevated (normal range in brackets)  

a.  ALT 612 (10-50) 
b.  Bilirubin 122 (<21) 
c.  Creatinine 168 (45-84)  

3.  This was due to a potentially fatal condition AFLP from which she subsequently died. 
4.  Despite being grossly elevated, the results once obtained in the laboratory were not 

phoned through by the laboratory staff to the clinical staff. 

5.  This was because the Royal College of Pathologists guidelines for urgent reporting only 
provides for the same levels above 750 ALT, 300 for bilirubin and 354 for creatinine 
and does not provide for different reporting levels for those taken in pregnant women. 

Page 1 of 3 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 6.  This is despite pregnancy specific conditions such as AFLP being potentially fatal at 
much lower levels of abnormal LFTs that those set currently by the Royal College of 
Pathologists. 

7.  As  a  result  there  was  a  delay  in  diagnosing  her  ALFP  and  starting  appropriate 

treatment. 

Following  review  of  the  Regulation  28  Report  it’s  recognised  that  there  are  key  themes 
identified here which the College has provided clarity on over the past few years through its 
various initiatives. These include development of clinical guidance and good practice papers 
recommending  appropriate  escalation  of  clinical  concerns,  multidisciplinary  working  and 
seeking timely advice from clinical experts especially in case of rare medical conditions. Lisa 
had developed a complication of pregnancy that is very rare. In such situations, it is essential 
that  the  wider  multidisciplinary  team  including  obstetric  physicians,  anaesthetists  and 
intensivists are involved in care provision, especially when there are severely abnormal test 
results and/or clinical deterioration. 

This  case  highlights  the  delay  in  diagnosis  of  the  severity  of  condition,  resulting  from  the 
laboratory  not  using  pregnancy  specific  levels  of  liver  enzymes  for  reporting  of  abnormal 
results. The guidelines from the Royal College of Pathologists ‘The communication of critical 
and  unexpected  pathology  results’  (2017)  recognises  that  there  are  variation  in  results 
phoned and suggests that this should be set by local need. The RCOG will review the response 
from the Royal College of Pathologists following this Regulation 28 Report and ensure that 
this  is  appropriately  communicated  with  its  members  and  included  within  relevant  clinical 
guidance.  

The RCOG however, recognises that there is also an obligation for clinical teams requesting 
investigations  to  review  the  results  in  a  timely  manner,  depending  on  the  severity  of  the 
clinical condition. In the current digital era, laboratory results are available on clinical systems 
and  these  should  be  reviewed  by  staff  caring  for  the  woman.  Guidance  on  the  clinician 
responsibilities is outlined in the GMC Good Clinical Practice 2009, NMC Code of Conduct 
2008  and  the  BMA  Acting  upon  electronic  test results  (updated in  June  2024).  Individual 
trusts/organisations will have specific guidelines applicable to their electronic patient records 
and  it  is  expected  that  these,  in  line  with  GMC  and  BMA  guidance,  would  outline  the 
responsibilities of the clinical staff and potential time scales expected. The RCOG feel that this 
responsibility lies at the organisational level and should be communicated to the NHS-England 
& NHS in the devolved nations. 

There is no RCOG guidance on the diagnosis and management of AFL in pregnancy. This is due 
to the rarity of the condition and the requirement for early intervention by specialist teams 
should  the  condition  be  suspected.    The  College  does  provide  an  online  learning  resource 
outlining  the  key  clinical  features,  investigations,  differential  diagnosis,  and  management 
options.  This resource can be found at: Acute fatty liver of pregnancy Key elements of care 
relate  to  the  early  diagnosis  and  escalation  to  the  multidisciplinary  team  which  includes: 
haematologists, hepatologists, anaesthetists, intensivists and the local or regional liver units.  

Page 2 of 3 

 
 
 
 
 
 
 
 
 
 
 The RCOG emphasised the importance of escalation as a key priority in provision of safe care 
within its Each Baby Counts and the Avoiding Brain Injury in Childbirth Programmes. There 
are  a  number  of  resources  available  through  the  College  to  support  Trusts  in  a  Quality 
Improvement approach to improve escalation in clinical situations.  

We  are  aware  that  you  have  written  to  the  Royal  College  of  Pathologists,  and  we  would 
suggest  that  their  guidance  and  the  thresholds  contained  within  ‘The  communication  of 
critical and unexpected pathology results’ is reviewed and amended to take account of the 
needs of pregnant women.  

The College’s commitment firmly lies in improving maternity safety. This encompasses 
elevating care standards through clinical guidance and multidisciplinary training. The College 
strongly advocates the importance of the Trust’s guidelines being aligned with national 
guidelines.  

Thank you for bringing this to our attention. I hope this is a helpful response to this matter.  

Yours sincerely, 

CEO Royal College of Obstetricians and Gynaecologists 

Page 3 of 3

From:

To:

cc:

Sent: Thu Nov 21 2024 10:54:15 GMT

Subject: RE: Death of Lisa Gale Regulation 28 Report (ref:

Dear

| hope you're well.
Please see The Royal College of Pathologists’ (RCPath) response below:

With regards to the RCPath document on The Communication of Critical and Unexpected Pathology
results, this document is published as ‘advice to pathologists’ and is offered as a basis on which
pathologists can construct their own local guidelines after discussion with relevant stakeholders. It is
clearly stated that it is vital that this document is seen as guidance for pathology providers to set their own
criteria on how, when, and why particular laboratory results are required to be communicated to clinical
professionals in an expedited manner. Whilst recommendations are made within the Appendix on cut offs
which can be used, it is recommended that individual cut offs are agreed locally with clinicians, and this
could be for a variety of clinical conditions with might include pregnancy. The need to agree local cut offs
with clinicians will be emphasised in the next revision of this document.

Kind regards,

L

Senior Professional Guidelines Officer

The Royal College of Pathologists
6 Alie Street, London, E1 8QT
Tel: 02 07451 6704

ir

Trust Headquarters  
Marlborough Street 
Bristol 
BS1 3NU 
 Tel: 0117 342 3720  
Switchboard (Bristol): 0117 923 0000  
Switchboard (Weston): 01934 636363  

Email: 

Website: www.uhbw.nhs.uk  

9 January 2025  

Dr Simon Fox KC 
Assistant Coroner for Avon  

By email only to: 

Dear Dr Fox  

Inquest of Lisa Gale  

I am writing in response to the Regulation 28 Report to Prevent Future Deaths dated 12 November 
2024.  I would like to begin by extending my deepest condolences to the family of Ms Gale.  I hope 
that my response provides both you, and Ms Gale’s family, with assurance that the Trust has taken 
this further opportunity to carefully consider any actions we can take which may improve patient 
care in the future.  

In order to respond to the Matters of Concern set out in your report, I have sought the assistance 
of 
,  Consultant  Chemical 
Pathologist, 
, Consultant Obstetrician who was 
present throughout the inquest. 

,  Clinical  Chair  for  Diagnostic  and  Therapies, 

, Chief Medical Officer, and 

We  have  carefully  considered  the  issue  of  setting  a  lower  threshold  for  the  urgent  reporting 
reference range for Liver Function Tests (LFTs) in pregnant women.  On reflection, we consider 
that one hospital Trust changing the reference range in isolation will not address the broader issue 
which has the potential to affect all pregnant women at a national level.  UHBW is a tertiary level 
referral  hospital,  treating  women  from  across  the  South-West  region.    We  are  concerned  that 
developing  guidance  in  respect  of  reference  ranges  for  LFTs  in  pregnant  women  in  UHBW  in 
isolation, could potentially create more risk to patients rather than reduce it, as hospitals within the 
region, and across the country, would be working to different guidance.  

To safely implement any recommended changes to reference ranges for LFTs in pregnancy we 
would ordinarily consider national guidance from the Royal Colleges.  We have therefore written 
to both the Royal College of Pathologists and the Royal College of Obstetricians asking them to  

Joint Chair: 

     Joint Chief Executive: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 consider your report and the development of national guidance on this important issue.  Given our 
knowledge of this case, we are happy to work alongside the Royal Colleges in the development 
of guidance. 

The Royal College of Pathologists have advised that their guideline ‘The Communication of Critical 
and  Unexpected  Pathology  Results’  is  published  as  advice  to  pathologists  and  is  offered  as  a 
basis on which pathologists can construct their own local guidelines after discussion with relevant 
stakeholders.  The Royal College of Pathologists recommend that individual cut offs are agreed 
locally  with  clinicians,  and  this  could  be  for  a  variety  of  clinical  conditions  with  might  include 
pregnancy.  

At the time of writing, we are awaiting the response from the Royal College of Obstetricians.  In 
the meantime, we have also raised the issue with the regional obstetric lead, who we understand 
is liaising with the national obstetric lead on this issue.  

Once  national  guidance  has  become  available  regarding  a  recommended  reference  range  for 
urgent reporting of LFTs in pregnancy, UHBW will set up a task and finish group, led by Dr Bennett, 
Dr Willis, and Dr Liebling to implement these across the Trust in a safe and robust manner. 

In the event of no national guidance, UHBW would look to change our reference range locally with 
guidance from our obstetric and laboratory teams.  

We hope that the above response provides you, and Ms Gale’s family, with assurance that the 
Trust  has  carefully  considered  your  report  and  identified  the  safest  way  of  proceeding.    We 
continually challenge ourselves to consider any further action we can take to strengthen patient 
safety across our hospitals, whilst recognising that some aspects of patient safety are best raised 
at a national level. 

Yours sincerely  

Hospital Managing Director 

Joint Chair: 

     Joint Chief Executive: