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.

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

10 January 2025

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.

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 , Clinical Chair for Diagnostic and Therapies, , Consultant Chemical Pathologist, , Chief Medical Officer, and , Consultant Obstetrician who was present throughout the inquest.

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

Dr Simon Fox KC Assistant Coroner for Avon

By email only 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.

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.

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.

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.

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 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, Senior Professional Guidelines Officer The Royal College of Pathologists 6 Alie Street; London; E1 8QT Tel: 02 07451.6704 why