David Moore

Care Quality Commission 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 

15 July 2024 

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: 
https://www.cqc.org.uk/guidance-providers/nhs-trusts.  

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.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 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. 

Yours sincerely, 

Deputy Director of Operations

Dr Karen Henderson 
Record Office  
Orchard Street 
Chichester 
PO19 1DD  

Dear Coroner, 

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

4th March 2024 

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 
2013 
flange 
tracheostomy 
(tracheostomy.org.uk),  red  flags  for  tracheostomy  emergencies,  which  includes 
displacement, as well as day-to-day management and checks.  

(NTSP  Manual 

including 

tubes, 

tubes 

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 

                                                                                                                       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 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. 

Yours sincerely, 

National Medical Director

4th March 2024 

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. 

Yours Sincerely 

President 
Royal College of Anaesthetists 

President 
Association of Anaesthetists 

References 
1. 

 UK National Tracheostomy Safety Project, Faculty of Intensive Care Medicine and Intensive 
Care Society, “Guidance for tracheostomy care”, 2020 
(https://ficm.ac.uk/sites/ficm/files/documents/2021-11/2020-
08%20Tracheostomy_care_guidance_Final.pdf)  

2.  Website of the (UK) National Tracheostomy Safety Project. www.tracheostomy.org.uk 

3.  NHS England Improving Tracheostomy care National Patient Safety Improvement Program. 
https://www.england.nhs.uk/long-read/improving-tracheostomy-care-during-the-covid-19-
pandemic/  

4.  BA McGrath, N Ashby, M Birchall, P Dean, C Doherty, K Ferguson, et al. Multidisciplinary 

guidance for safe tracheostomy care during the COVID
Patient Safety Improvement Programme (NatPatSIP). Anaesthesia 2020; 75 (12), 1659-1670 

19 pandemic: the NHS National 

‐

5.  BA McGrath, AN Thomas. Patient safety incidents associated with tracheostomies occurring in 
hospital wards: a review of reports to the UK National Patient Safety Agency. Postgraduate 
Medical Journal 2010; 86 (1019), 522-525 

6.  AN Thomas, BA McGrath. Patient safety incidents associated with airway devices in critical 

care: a review of reports to the UK National Patient Safety Agency. Anaesthesia 2009; 64 (4), 
358-365 

7.  BA McGrath, S Wallace, J Lynch, et al. Improving tracheostomy care in the United Kingdom: 
results of a guided quality improvement programme in 20 diverse hospitals. British Journal of 
Anaesthesia 2020; 125 (1), e119-e129