PFD report

Lisa Gale · Prevention of Future Deaths report

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Issued 12 Nov 2024•Avon

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
2

Raised in this report

Recipients
5

Named on the report

Responses found
4

Of 5 recipients

Stated actions
11

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Failure of urgent liver function test reporting thresholds to account for pregnancy-specific conditions
    Part of recurring concern: Failure to ensure clinical investigation results are reliably available, interpreted and acted upon
  2. Failure to communicate grossly abnormal liver function test results from laboratory staff to clinical staff
    Part of recurring concern: Failure to ensure clinical investigation results are reliably available, interpreted and acted uponPart of recurring concern: Unreliable laboratory notification of safety-critical problems and results
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.6

  1. Action

    Request that the Royal Colleges consider the report and develop national guidance on urgent LFT reporting reference ranges in pregnancy.

    Stated by Bristol NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.
  2. Action

    Raise the issue with the regional obstetric lead for liaison with the national obstetric lead.

    Stated by Bristol NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.
  3. Action

    Set up a task and finish group to implement nationally recommended urgent LFT reporting reference ranges safely across the Trust.

    Stated by Bristol NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 13 November 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    The Royal Colleges are asked to consider and develop national guidance on urgent LFT reference ranges in pregnancy.

    Stated by Bristol NHS Foundation TrustRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure of urgent liver function test reporting thresholds to account for pregnancy-specific conditions

Wider context from the report

“(1) Blood was taken for liver function tests (LFTs) on admission before her condition was diagnosed; (2) Lisa’s LFT’s were grossly elevated (normal range in brackets) – ALT 612 (10-50), bilirubin 122 (<21), creatine 168 (45-84); (3) This was due to a potentially fatal condition – Acute Fatty Liver of Pregnancy – from which she subsequently died; (3) Despite being grossly elevated, the results once obtained in the laboratory were not phoned through by the laboratory staff to the clinical staff; (4) This was because the Royal College of Pathologists’ guidelines for urgent reporting only provides for the same with levels above 750 for ALT, 300 for bilirubin and 354 for creatinine – and does not provide for different reporting levels for those taken in pregnant women; (5) This is despite pregnancy specific conditions such as AFLP being potentially fatal at much lower levels of abnormal LFTs than those set currently by the Royal College of Pathologists; (4) As a result there was a delay in diagnosing her AFLP and starting appropriate treatment. ”

Is this part of a recurring concern?

Yes — Failure to ensure clinical investigation results are reliably available, interpreted and acted upon.

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Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to communicate grossly abnormal liver function test results from laboratory staff to clinical staff

Wider context from the report

“(1) Blood was taken for liver function tests (LFTs) on admission before her condition was diagnosed; (2) Lisa’s LFT’s were grossly elevated (normal range in brackets) – ALT 612 (10-50), bilirubin 122 (<21), creatine 168 (45-84); (3) This was due to a potentially fatal condition – Acute Fatty Liver of Pregnancy – from which she subsequently died; (3) Despite being grossly elevated, the results once obtained in the laboratory were not phoned through by the laboratory staff to the clinical staff; (4) This was because the Royal College of Pathologists’ guidelines for urgent reporting only provides for the same with levels above 750 for ALT, 300 for bilirubin and 354 for creatinine – and does not provide for different reporting levels for those taken in pregnant women; (5) This is despite pregnancy specific conditions such as AFLP being potentially fatal at much lower levels of abnormal LFTs than those set currently by the Royal College of Pathologists; (4) As a result there was a delay in diagnosing her AFLP and starting appropriate treatment. ”

Is this part of a recurring concern?

Yes — Failure to ensure clinical investigation results are reliably available, interpreted and acted upon; Unreliable laboratory notification of safety-critical problems and results.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Request that the Royal Colleges consider the report and develop national guidance on urgent LFT reporting reference ranges in pregnancy.

Verbatim wording from the response

“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”

Source location

Response from University Hospitals Bristol and Weston NHS Foundation Trust
Page 1 · response
Published 13 November 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Raise the issue with the regional obstetric lead for liaison with the national obstetric lead.

Verbatim wording from the response

“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.”

Source location

Response from University Hospitals Bristol and Weston NHS Foundation Trust
Page 2 · response
Published 13 November 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Set up a task and finish group to implement nationally recommended urgent LFT reporting reference ranges safely across the Trust.

Verbatim wording from the response

“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.”

Source location

Response from University Hospitals Bristol and Weston NHS Foundation Trust
Page 2 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review the Royal College of Pathologists’ response to the report regarding pregnancy-specific thresholds for urgent liver-function-test reporting.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Communicate the review outcome to members and incorporate relevant learning into clinical guidance.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Emphasise the need to agree local critical-result cut-offs with clinicians in the next document revision.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Pathologists
Page 1 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The Royal Colleges are asked to consider and develop national guidance on urgent LFT reference ranges in pregnancy.

Verbatim wording from the response

“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”

Source location

Response from University Hospitals Bristol and Weston NHS Foundation Trust
Page 1 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Changing urgent LFT reference ranges in one Trust alone may create risk through inconsistent guidance and would not address the national issue.

Verbatim wording from the response

“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.”

Source location

Response from University Hospitals Bristol and Weston NHS Foundation Trust
Page 1 · response
Published 13 November 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Responsibility for communicating clinical staff obligations on reviewing electronic results lies with organisations and NHS England or devolved health services.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Local pathology providers and clinicians are responsible for agreeing communication cut-offs; the guidance does not prescribe universal thresholds.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Pathologists
Page 1 · response
Published 13 November 2024

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.5

  1. 1

    Provide an online learning resource covering acute fatty liver of pregnancy’s clinical features, investigations, differential diagnosis and management options.

    Stated by Royal College of Obstetricians and GynaecologistsStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.
  2. 2

    Develop clinical guidance and good-practice papers recommending escalation of concerns, multidisciplinary working and timely specialist advice for rare conditions.

    Stated by Royal College of Obstetricians and GynaecologistsStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.
  3. 3

    Establish and operate Maternal Medicine Networks across England to provide specialist advice and care for acute and chronic medical problems during pregnancy.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.
  4. 4

    Discuss Regulation 28 reports through the national working group and share relevant learning and insights across NHS national and regional services.

    Stated by NHS EnglandStated in progressThe respondent said that this action was in progress when they made their response on 13 November 2024.
  5. 5

    Publish the National Service Specification for Maternal Medicine Networks, defining care pathways and clinical dependencies for networks and maternal medicine centres.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 13 November 2024.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The College does not provide dedicated AFLP diagnosis and management guidance because the condition is rare and requires early specialist-team intervention.

    Stated by Royal College of Obstetricians and GynaecologistsUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Provide an online learning resource covering acute fatty liver of pregnancy’s clinical features, investigations, differential diagnosis and management options.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Develop clinical guidance and good-practice papers recommending escalation of concerns, multidisciplinary working and timely specialist advice for rare conditions.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Establish and operate Maternal Medicine Networks across England to provide specialist advice and care for acute and chronic medical problems during pregnancy.

Verbatim wording from the response

“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.”

Source location

Response from NHS England
Page 1 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Discuss Regulation 28 reports through the national working group and share relevant learning and insights across NHS national and regional services.

Verbatim wording from the response

“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.”

Source location

Response from NHS England
Page 2 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Publish the National Service Specification for Maternal Medicine Networks, defining care pathways and clinical dependencies for networks and maternal medicine centres.

Verbatim wording from the response

“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.”

Source location

Response from NHS England
Page 1 · response
Published 13 November 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The College does not provide dedicated AFLP diagnosis and management guidance because the condition is rare and requires early specialist-team intervention.

Verbatim wording from the response

“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.”

Source location

Response from Royal College of Obstetricians and Gynaecologists
Page 2 · response
Published 13 November 2024

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026