Source · Prevention of Future Deaths

Carrianne Franks

Ref: 2024-0032 Date: 21 Dec 2023 Coroner: Laurinda Bower Area: Nottingham City and Nottinghamshire Responses identified: 3 / 3 View PDF

Inadequate TB exposure guidelines for healthcare professionals, overly narrow "close contact" definitions, insufficient staff education, and failures to include all staff in notifications for highly transmissible cases.

Date 21 Dec 2023

56-day deadline 21 Mar 2024 est.

Responses identified 3 of 3

Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary

View full coroner's concerns

1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure.
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB.
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing. Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.

The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.

Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.

The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process, rather than applying the same broadly to all staff who worked on the unit at the relevant time.

Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.

I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF. This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.

I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.

Responses

3 respondents

NHS England NHS / Health Body

21 Dec 2023 PDF

Action Taken

NHS England developed the TB Action Plan for England, 2021-2026 and commissioned a GIRFT review of TB service provision. They also supported professional awareness resources, a TB eLearning resource, and issued a TB service specification. (AI summary)

View full response

Dear Coroner

Re: Regulation 28 Report to Prevent Future Deaths – Carrianne Franks who died on 27 August 2021.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 21 December 2023 concerning the death of Carrianne Franks on 27 August 2021. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Carrianne’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Carrianne’s care have 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 Carrie’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.

In your Report you raised the concern that current clinical and public health guidelines do not identify healthcare professionals as a group at heightened risk of TB exposure. The Tuberculosis (TB) Programme Team at NHS England works closely with the TB Unit in the UK Health Security Agency (UKHSA) on TB issues, who we note your Report was also sent to. This has included the development and publication of the TB Action Plan for England, 2021- 2026 and day to day operational and service delivery issues. This includes monitoring TB epidemiology at a local and national level. Most recently NHS England commissioned the GIRFT (Getting It Right First Time) Programme to review TB service provision across England through a series of 10 questionnaires. This was linked to Hospital Episode Statistics (HES) and national TB surveillance data. This work is being fed back to Trusts, Integrated Care Boards (ICBs), UKHSA and NHS regions to improve patient outcomes. This included questions on Occupational Health screening of new staff and contact tracing but did not specifically address healthcare workers.

NHS England, together with UKHSA, is committed to working collaboratively with its external partners and doing all that it can to increase awareness, reduce the impact of National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

11 March 2024

TB and prevent future deaths occurring through the work of the action plan referenced above and the GIRFT TB project.

Clinical guidelines are provided by the National Institute for Health and Care Excellence (NICE). Their guidelines on TB can be found here: Recommendations | Tuberculosis | Guidance | NICE) and NHS bodies are under the same duties to have regard to the guidance, as they are with other NICE guidance. The NICE guidance, which was last updated in 2019, defines ‘close contact’. Healthcare staff are not specifically referred to in the section on contact tracing in healthcare settings. Any change to the guidance sits with NICE, however the action plan referenced above includes an action and deliverable to work with NICE on updates to their guidance. UKHSA have approached NICE regarding updating the guidance and are meeting with them shortly. NHS England has wider information available on its website to support health care services and inform patients. The Green Book is the guide to the vaccination schedules for infectious diseases. It has a chapter on TB and Bacillus Calmette-Guerin (BCG) and identifies health care workers as at higher risk. The role of the RAF Occupational Health for staff potentially working overseas is also an opportunity to raise additional awareness of TB as an infection risk. The information provided by UKHSA for the diagnosis, screening and management of TB is extensive and updated regularly to reflect the latest published evidence. The Royal College of Nursing (RCN) has also published Case Management TB | Publications | Royal College of Nursing (rcn.org.uk). This includes a chapter on contact investigations and references workplace contacts. In 2016, Public Health England (the predecessor organisation of UKHSA) published a detailed analysis on TB in healthcare workers. This reported that there was ‘no increased risk of TB in healthcare workers compared with non-healthcare workers after stratifying by country of birth for all but two countries of birth, combined with the very small number of cases with a molecular and epidemiological link consistent with nosocomial transmission, suggests that TB diagnosed in healthcare workers in the UK is generally not acquired as a result of UK occupational exposure’. It also highlighted that only 10 nosocomial (in healthcare) acquired cases of TB occurred in healthcare workers between 2010 and 2012 – approximately three cases per year in over one million healthcare workers. UKHSA is currently undertaking an updated analysis of TB disease in healthcare workers and is expected to publish this in the next 12 months. This analysis will enable an up to date understanding of transmission of TB in health care settings. The action plan recognises the impact of the COVID-19 pandemic on TB services and those affected by TB and the role of Occupational Health. Its five priorities of Recovery from Covid-19, Prevention, Detection and Control of TB and Workforce are supported by a number of actions and deliverables which, as well as those referenced above, include:

• Development and implementation of national contact tracing guidance and /or toolkits for HPTs, TB services and occupational health services including national, evidence-based guidance on occupational health screening for TB.
• Working with NICE to update contact tracing guidance with a focus on strengthening prevention, detection and treatment of active TB and/or LTBI in higher risk groups including healthcare workers through occupational health departments.
• Improved messaging for patients and staff on how to access TB services, face to face and virtual. UKHSA and NHS England meet regularly with stakeholders including patient representatives to monitor progress of the action plan deliverables. World TB Day is an annual event held on the 24 March. This date is used to raise awareness of TB with many TB services holding education sessions and running stalls in their hospital and/or public areas. Information is provided by UKHSA for use by local services. NHS England has previously supported publication of posters for display in all hospital departments and within primary care settings. This is in addition to leaflets, cards and short animation videos. Some of these can be viewed at Professional awareness and education - The Truth About TB. These resources were in paper format and are still available electronically for local printing. Anecdotally, many departments and GPs still have these posters on display. We have also supported a TB eLearning resource, which is available on the Royal College of General Practitioners (RCGP) and is open to all healthcare professionals. NHS England has also issued a TB service specification. It is not mandatory, so ICBs and Trusts can use it to reflect local commissioning and service delivery arrangements. The document references informing all appropriate services including Occupational Health departments re the transfer and discharge of patients. This specification includes a section on evidence-based contact tracing. NHS England has also engaged with NHS North West London on the concerns raised in your Report. We note that Chelsea and Westminster Hospital NHS Foundation Trust’s internal investigation found that there was no evidence of direct contact between Carrianne and the patient with TB. We have also been sighted on the Trust’s updated policy for TB infection control, which we understand has also been shared with the coroner. 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.

UK Health Security Agency Other

1 Mar 2024 PDF

Action Taken

The UKHSA co-developed and co-owns the National TB Action Plan with NHS England. It has developed and delivered a series of webinars on TB available to healthcare professionals, and contributed to the RCN competency framework for TB nurses. (AI summary)

View full response

Dear Miss Bower,

Regulation 28 Report to Prevent Future Deaths following Inquest into the death of Carrianne Franks

Thank you for the Regulation 28 Report (“the Report”) dated 21 December 2023 addressed to the UK Health Security Agency (“UKHSA”), NHS England (“NHSE”) and the National Institute for Health and Care Excellence (“NICE”) which was received on 8th January 2024. We write to provide UKHSA’s response which we have discussed with NHSE and NICE. We anticipate NHSE and/or NICE will separately return any comments they feel relevant to their own organisational remits.

Firstly, on behalf of UKHSA, we wish to express our sincere condolences to the family of Carrianne Franks who tragically died of tuberculosis (TB) on 27 August 2021. UHKSA staff were very saddened to hear of Ms Franks’ death and our thoughts remain with her family.

UKHSA is committed to working collaboratively with its external partners and doing all that it can to increase awareness of TB, reduce any harmful health impact and prevent future deaths occurring.

UKHSA provides expert public health scientific expertise, data and analysis, surveillance capabilities and operational response to strengthen public health protection and health security capability across the UK. UKHSA has several workstreams in place to build on improvements in the prevention, detection and control of TB in England achieved over the past 10 years to reduce TB incidence in all our communities. In particular, UKHSA has co- developed and co-owns with NHS England the National TB Action Plan (Tuberculosis (TB): action plan for England - GOV.UK (www.gov.uk)). This is a comprehensive five-year action plan covering the period 2021 to 2026. The aim of the action plan is to improve the

2 prevention, detection, and control of TB in England. Within this document there is a strong focus on preventing TB.

UKHSA notes the three Matters of Concern listed in the Report and responds to each in turn below:

1. Current clinical and public health guidelines do not identify healthcare professionals as a group at heightened risk of TB exposure. 

UKHSA supports the organisations that develop clinical guidance and is responsible for the production and updating of specific public health guidance documents. In addition, UKHSA produces and publishes analysis to provide evidence that supports guidance development by other organisations.

UKHSA’s guidance document, ‘Immunisation against Infectious Disease’ (otherwise known as the Green Book), contains comprehensive recommendations on the indications for immunisations, including for TB. This highlights healthcare staff as high risk for exposure to tuberculosis and recommends BCG vaccination to this group (Greenbook chapter 32 - tuberculosis (publishing.service.gov.uk). Provision of vaccination for relevant healthcare staff is the responsibility of the employing organisation.

We produce regular annual reports on TB epidemiology and also produce quarterly reports (Tuberculosis in England: national quarterly reports - GOV.UK (www.gov.uk). These data are used to support planning and commissioning of TB services across the country by NHSE and other organisations, including highlighting delays in diagnosis and treatment.

In 2016, Public Health England [one of the predecessor organisations which now make up UKHSA] published a detailed analysis of TB in healthcare workers (https://thorax.bmj.com/content/thoraxjnl/72/7/654.full.pdf). A key finding from this report was “no increased risk of TB in HCWs compared with non-HCWs after stratifying by country of birth for all but two countries of birth, combined with the very small number of cases with a molecular and epidemiological link consistent with nosocomial transmission, suggests that TB diagnosed in HCWs in the UK is generally not acquired as a result of UK occupational exposure.” It also highlighted that only 10 nosocomial [i.e., healthcare] acquired cases of TB occurred in healthcare workers between 2010 and 2012 – approximately 3 cases per year in over 1 million healthcare workers.

UKHSA is currently undertaking analysis of data on active TB disease in healthcare workers in the National TB Surveillance system (NTBS) and will aim to publish this within the next 12 months. UKHSA has, in addition, initiated a review of the epidemiology and genetic typing (whole genome sequencing, WGS) of TB transmission in healthcare settings; this detailed analysis will require approximately one year to complete and will enable up to date understanding of transmission in health care settings.

2. The current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB 

3 UKHSA produces analysis and evidence to support guideline development and supports public health risk assessment of TB exposures within the community and other settings. Whenever asked to do so, UKHSA regional Health Protection Teams support NHS trusts to undertake their risk assessments of TB exposures. 

In common with many other countries where there is a low incidence of TB, the UK operates the established ‘stone in the pond’ approach for TB contact tracing. The 'stone in the pond' approach commences contact tracing with the closest contacts (those with most exposure, typically household contacts). If sufficient latent or active TB is found to raise clinical suspicion of a highly transmissible strain or highly infectious individual, another tier of contacts are traced, and so on. Workplace and healthcare worker contacts usually occur in this second tier of contact tracing by identifying those who have had a risk of exposure.

A recent rapid evidence review was undertaken in UKHSA: Contact tracing strategies for detecting tuberculosis in people exposed to tuberculosis in low incidence countries (publishing.service.gov.uk). This review found no relevant randomised control trial (RCT) evidence to identify optimal contact tracing strategies. The Netherlands recently published a scientific paper on the effectiveness of the “stone in the pond“ approach and determined that this approach strengthened the efficiency of contact tracing without reducing effectiveness. (Tuberculosis contact investigation following the stone-in-the-pond principle in the Netherlands - Did adjusted guidelines improve efficiency? - PubMed (nih.gov))

This approach is also highlighted in the Royal College of Nursing TB guidance for the case management of TB [RCN guidance Case Management TB | Publications | Royal College of Nursing (rcn.org.uk)] The definition of ‘close contact’ used in UK practice is contained within the NICE TB guidelines (Recommendations | Tuberculosis | Guidance | NICE). This was last updated in 2019. UKHSA agrees with the Coroner that the definitions of close contact within this guidance would not include most staff in healthcare. Healthcare staff are not specifically referred to in the section on contact tracing in healthcare settings.

UKHSA’s TB unit approached NICE in 2023 to ask for information on when the guideline is likely to be further updated. The TB unit has a meeting planned with NICE on 6th March 2024 to discuss this.. Following this Regulation 28 report UKHSA will work collaboratively with NICE as required to support them with any updating of their guidance.

There is also an objective in the TB Action Plan to develop a contact tracing handbook. UKHSA has drafted a contact tracing handbook with the aim to publish this handbook in 2024 after consultation with TB teams in the NHS and UKHSA Health Protection Teams. UKHSA will incorporate relevant findings of the coroner’s report into our current work with NHSE on occupational health and infection control aspects of TB in healthcare settings.

3. Insufficient education measures in place to inform NHS staff of the TB symptoms to look out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing. 

UKHSA supports NHS organisations in their staff education by the provision of a wide range of educational materials. Training and education of individual staff is the responsibility of the employing health service organisation

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, Deputy Director, TB, Acute Respiratory Infections, Zoonotic and Emerging Infections and Travel Health Division, UKHSA

National Institute for Health and Care Excellence Other

4 Mar 2024 PDF

Action Planned

NICE will share the report with their guideline surveillance team to check for new evidence on TB contact tracing. They also plan to discuss the report with the UK Health Security Agency. (AI summary)

View full response

Dear Miss Bower,

I write in response to your regulation 28 report regarding the very sad death of Carianne Franks. I would like to express my sincerest condolences to her family.

We have considered the circumstances surrounding Ms Franks’ death and I have addressed below the matters of concern raised.

In the NICE guideline on tuberculosis [NG33] we have made recommendations on contact tracing (see section 1.6.1) and define ‘close contacts’ as people who have had prolonged, frequent or intense contact with a person with infectious TB.

When developing the guideline, the committee felt that the studies they considered did not give a clear definition of close contacts and it was therefore difficult to give guidance on whom to trace.

They acknowledged that it would be useful to give an objective definition of close contacts, but there was insufficient evidence to make a recommendation on factors such as length of time spent in the same room without ventilation before 'close contact' is deemed to have occurred.

Your report has been shared with our guideline surveillance team to see if there is new evidence relating to contact tracing for TB. We also plan to meet with colleagues from the UK Health Security Agency to further consider your report and how we can jointly address the concerns raised.

I hope that you find this information helpful.

Report sections

Investigation and inquest

Carrianne Franks died on 27 August 2021, at the Bassetlaw District Hospital, Nottinghamshire, as a result of Tuberculosis. She was a Flight Sergeant in the Royal Air Force Nursing Service. A coronial inquest into her death was opened on 21 July 2022. An inquest before a jury concluded on 26 May 2023.

Circumstances of the death

The Jury recorded the following salient conclusions on the Record of Inquest: Carrianne was exposed to, and infected with, tuberculosis from a patient with active TB (smear positive) who was nursed on the Acute Assessment Unit of a London Hospital, where Carrianne was working as a nurse between 23 and 24 November 2020. Carrianne was not an NHS employee, rather she had volunteered through the RAF to undertake a placement at an NHS hospital, to assist throughout the Covid-19 pandemic. Carrianne was not classed by the hospital as a “close contact” of the infected patient, so she did not benefit from contact tracing, a warn and inform letter, or any education on the signs of TB infection to look out in the coming months. By the time Carrianne became unwell with respiratory symptoms in June 2021, neither she, her GP, nor the RAF’s Occupational Health Department had been informed that she had been working on a hospital ward where a patient had tested positive for TB (smear positive). It would have been of assistance to the doctors treating Carrianne to have known about her occupational proximity to a patient with active smear positive TB, as they would have conducted tests to seek to rule the condition in or out, and in this case, would have arrived at a diagnosis far sooner and in time to start treatment that would have prevented her death. The lack of knowledge of her heightened risk of TB because of occupational exposure to a smear positive case, significantly delayed her diagnosis and treatment, which in turn contributed to her death.

Similar PFD reports

Shared signals

Related inquiry recommendations

Report details

Reference: 2024-0032
Date of report: 21 December 2023
Coroner: Laurinda Bower
Coroner area: Nottingham City and Nottinghamshire

Responses identified

Responses identified 3 of 3

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 21 Mar 2024 (estimated).

Sent to

National Institute for Clinical Excellence

NHS England

UKHSA

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.