Dear Coroner,

Re: Regulation 28 Report to Prevent Future Deaths – David Bryan Moore who died on 14 June 2021.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 8 January 2024 concerning the death of David Bryan Moore on 14 June 2021. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to David’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about David’s care have been listened to and reflected upon.

In your Report you raised the matter of concern over a lack of guidelines for the anaesthetic or intensive care management of a flanged tracheostomy tube.

Your Report was addressed to the Chief Executive of Health Education England (HEE). On 3 April 2023 Health Education England and NHS England legally merged to create a new single organisation. Following this transfer, NHS England assumed responsibility for the activities previously undertaken by HEE, including planning and recruitment for the workforce and ensuring that it has the right values, behaviours and skills to support delivery of healthcare to patients and the public. Many of these responsibilities now sit with NHS England’s Workforce, Training and Education (WTE) Directorate.

NHS England notes that you have also addressed your concerns to the Association of Anaesthetists Great Britain and Ireland and the Royal College of Anaesthetists. These organisations are better placed to respond to your concerns over national guidance for flanged tracheostomy tubes.

The National Tracheostomy Safety Project (NTSP) exists to provide a wide range of resources, materials and e-learning to support healthcare professionals with responsibility for providing care for patients with tracheostomies, for both general and emergency care. The website includes guidance on the different types and features of tracheostomy tubes, including flange tubes (NTSP Manual 2013 (tracheostomy.org.uk), red flags for tracheostomy emergencies, which includes displacement, as well as day-to-day management and checks.

The NTSP, together with the Faculty of Intensive Care Medicine and the Intensive Care Society have also published national guidance for Tracheostomy Care which outline key standards to improve the quality of care for all patients requiring a National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

4th March 2024

tracheostomy. The document includes the following statement that the “position and orientation of the tracheostomy tube must be checked and documented, with the patient in the position that they will be nursed in (rather than the insertion position). This should include the distance from the carina, which is especially important for adjustable flanged tubes. A tube that is considered inadequately positioned must be changed whilst the team and airway equipment are all available.” You may wish to refer to the NTSP and the other organisations involved in the development of this guidance.

You may also wish to engage with the National Institute for Health and Care Excellence (NICE) who are responsible for producing a wide range of guidelines and guidance for health and social care professionals. Their existing guidance for evidence-based recommendations on translaryngeal tracheostomy can be found here: Overview | Translaryngeal tracheostomy | Guidance | NICE.

Commissioners and providers have a responsibility to ensure local policies and guidance are appropriately developed and implemented within their local context and regarding national guidance/guidelines. NHS England has engaged with Queen Victoria Hospital NHS Foundation Trust on the concerns from your Report and understand that a new local protocol they have developed 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.

Dear Dr Henderson,

Re: Regulation 28: Report to Prevent Future Deaths in the matter of David Bryan Moore

Thank you for sending us a copy of your report regarding the sad death of Mr David Moore. We have jointly reviewed the information available to us in the report via our Safe Anaesthesia Liaison Group (SALG). SALG is a collaborative project between the Association of Anaesthetists, NHS England’s Patient Safety team and the Royal College of Anaesthetists. One of its core objectives is to analyse anaesthesia-related serious incidents and to share the learning with the specialty across the UK. We have also consulted with the Faculty of Intensive Care Medicine (FICM), the Intensive Care Society (ICS) and the National Tracheostomy Safety Project (NTSP).

Your prevention of future deaths report highlighted your concern regarding the “Guidelines for the anaesthetic and/or Intensive Care management of a flanged tracheostomy tube.” The College, FICM and ICS have worked with the NTSP to develop, publish and disseminate guidelines for tracheostomy care since 2012. This was in response to critical incident analysis research that identified recurrent themes in the management of tracheostomies in anaesthesia, critical care and hospital wards that led to patient harm. We have summarised key references below, and summarise key points from these existing documents below, with respect to general tracheostomy care and in the specific case of adjustable flanged tracheostomy tubes.

The NTSP first published guidance in 2012. The guidelines are supported by a comprehensive bank of learning materials available on the www.tracheostomy.org.uk website. The College co- developed tracheostomy e-learning resources with the NTSP which are available from the NHS e- learning for healthcare program. Guidance has been disseminated through a number of national Quality Improvement projects, including an NHS England National Patient Safety Improvement Program (NatPatSIP) in 2020. Detailed formal guidance for tracheostomy care in the critical care setting was developed by NTSP and endorsed by FICM and ICS, last revised and published in
2020. This standards document, which is freely available via the FICM website, contains specific guidance for the management of adjustable flanged tracheostomy tubes, and states that "The position and orientation of the tracheostomy tube must be checked and documented, with the patient in the position that they will be nursed in (rather than the insertion position). This should include the distance from the carina, which is especially important for adjustable flanged tubes." The resources hosted on the NTSP website, which is signposted from the guidance, states that “It is essential to review the position of the flange (hence the length of the tube) on a daily basis. If the patient has neck swelling, as this worsens or resolves, the flange may need adjusting."

The executive summary of the most relevant guidance to the index case (the NTSP, FICM and ICS standards) makes it clear that local critical care units and teams need to train, support and equip their staff in order to safely care for this vulnerable patient group. From Section 1(Executive Summary):

“There is increasing evidence from national and international quality improvement programs that a multidisciplinary tracheostomy team that reviews and coordinates the

management of tracheostomy patients can bring benefits for the quality and safety of care, including organisational efficiencies and significant cost savings.

“All patients with tracheostomies admitted to critical care units should expect safe care to be delivered by appropriately trained, equipped and supported staff. Patient-centred high-quality care also focusses on communication, vocalisation, mobilisation, information and a prompt return to oral intake. Improving the quality and safety of patients with tracheostomies and laryngectomies is a hospital-wide issue, and our speciality is well placed to lead and to contribute to the safe management of this vulnerable patient group.”

The sad case of Mr Moore highlights a number of common problems with tracheostomy management in the critically ill patient. We do not have the specific clinical details, but several important details are clear from your report:

• Mr Moore was critically ill following his severe burn. This significantly reduces the physiological reserve of a patient to tolerate any problems with the airway or breathing and means that even minor blockages or displacements can lead to rapidly life- threatening situations.
• There is inevitable swelling associated with a severe burn, which can be dramatic. Swelling around the head and neck, in combination with extensive burns dressings, can make the maintenance and management of artificial airway devices difficult, even for expert teams following appropriate guidance.
• The reason for the displaced tracheostomy tube in Mr Moore’s case was that the tube became displaced during a roll to facilitate a change of dressings.
• Mr Moore’s tracheostomy was approximately 8 days old, and presumably performed using an open surgical technique. The tracheostomy stoma (the opening between the trachea and the skin on the front of the neck) would be expected to be sufficiently mature by this time to facilitate attempts at tracheostomy tube reinsertion. Given the nature of his critical illness and the likely difficult and swollen neck anatomy, reinsertion of a tracheostomy tube can still be difficult, or even impossible in this situation.

Our clinical experts recognise that neck swelling can be a dynamic process, particularly in patients with severe burns affecting the head, neck and chest. This can lead to migration of any artificial airway device, including oral tubes and tracheostomy tubes. This is often the reason why adjustable flanged tracheostomy tubes are chosen in cases such as Mr Moore’s. Assessment of the condition of any artificial airway device in a critically ill patient is part of routine medical and nursing care and is recommended to be undertaken “at least once per nursing shift (8-12 hours)” in the FICM/ICS/NTSP standards.

The NTSP had agreed with the Difficult Airway Society in 2023 to review and revise the current guidelines for tracheostomy emergency management. The Royal College of Anaesthetists, Association of Anaesthetists, Faculty of Intensive Care Medicine and the Intensive Care Society will be stakeholders in this update, which will ensure that updated guidance will be appropriately disseminated. Other stakeholders representing the multidisciplinary team involved in tracheostomy care will also be involved, including head and neck surgery, nursing, physiotherapy, and speech and language therapy. We anticipate publication of updated guidelines in 2025. Index cases such as the case of Mr Moore help to inform updates to such guidance where necessary and we thank you for bringing this case to our attention.

SALG publishes regular Patient Safety Updates, which are distributed to all members of the Association of Anaesthetists and Royal College of Anaesthetists. FICM publishes regular Safety

Bulletins, which are distributed to all their members. We will use these publications to highlight the learning from Mr Moore’s death and re-promote the guidance to our members.

We would be happy to respond to any questions that you might have.

Dear Dr Karen Henderson, HM Assistant Coroner for West Sussex, Brighton, and Hove

Re Regulation 28 Report Prevention of Future Deaths Report.

We write further to the Regulation 28 report that you made following the inquest into the sad death of Mr David Bryan Moore. Under Section 5 of your report entitled Coroners Concerns you noted: 1. “Guidelines for the anaesthetic and/or Intensive Care management of a flanged tracheostomy tube” and that this relates to an “ongoing risk that future deaths could occur unless action is taken.”

As you are already aware the Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. We make sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage care services to improve. We monitor, inspect, and regulate services and publish what we find. Where we find poor care, we will use our powers to act.

All providers must comply with the regulations as set out in The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (RAR 2014). The regulations that would be most relevant to any reviews around acute care of patients in hospital would include, but not be limited to, the following:
• Regulation 9 (Person-Centred Care)
• Regulation 12 (Safe Care and Treatment including the safe use of medicines)
• Regulation 17 (Good Governance).

As part of our assessment of providers CQC routinely checks the management of services in respect of leadership, governance, staff levels, staff competency and training, policies and procedures, and environment and equipment provision. We include on our website guidance for providers on our role and the regulations:

We have given careful consideration to the concerns raised and have come to the conclusion the concerns identified, namely; ‘that there is a lack of guidance for the anaesthetic and/or Intensive Care management of a flanged tracheostomy tube’ regretfully sits outside of CQC remit.

Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA

As our role is to monitor, inspect and regulate services we assess the application of national guidance within a trust. We do not write guidance on how to safely care or support people directly ourselves. In this instance, any additional national guidance in relation to adjustable flanged tracheostomy care would be assessed by us for its application when relevant, on our assessment and/or engagement with acute services.

As a regulator we can provide a unique view on the quality of health and adult social care in England, helping to share learning and encourage improvement across the sectors. We carry out and publish reviews and specific assessment programmes that focus on particular aspects of health and social care, including:
• the experiences of certain groups of people;
• how different services work together to care for people; and
• the quality of particular services, or all services, in an area.

None of these reviews or reports include the writing of specific pieces of guidance.

Other bodies who may be able to assist with the writing of specific guidance could include the Association of Anaesthetists Great Britain and Ireland, the Royal College of Anaesthetists or Health Education, England, all of whom I note have been included in your report.

Should you require any further information then please do not hesitate to contact us.