Lynn Hadley

Care Quality Commission 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 

www.cqc.org.uk 

Senior Coroner, Mr Z Siddique 
Black Country Coroner's Court 
Jack Judge House 
Halesowen Street 
Oldbury 
West Midlands 
B69 2AJ 

Via Email 

12 March 2021 

Care Quality Commission (CQC) 

Dear Senior Coroner, Mr Zafar Siddique 

REGULATION 28:  REPORT TO PREVENT FUTURE DEATHS 

Thank  you  for  your  Regulation  28  prevention  of  future  death  report  dated  18 
January  2021  following  the  inquest  into  the  death  of  Mrs  Lynn  Hadley  whilst 
receiving care from West Midlands Ambulance Service (WMAS) paramedics.  
The role of the CQC (Care Quality Commission) as an independent regulator is to 
register health and adult  social care  service providers in  England and  to  check, 
through inspection and ongoing monitoring, that standards are being met. All GP 
practices in England must be registered with the CQC 

The Care Quality Commission’s (CQC) purpose is to make sure health and social 
care services provide people with safe, effective, compassionate, high-quality care 
and we encourage care services to improve. Our role is to monitor, inspect and 
regulate services to make sure they meet fundamental standards of quality and 
safety and we publish what we find including performance ratings to help people 
choose care. 

Within our role through our inspection of regulated health and social care services, 
we inspect and assess a range of aspects which relate to oxygen cylinders and 
medical gases  including  storage  and  staff  training,  where  we  find that  there  are 
breaches of regulation we take action to address this. It is worthy of note that we 
do not have powers to enter private citizens own homes in community settings and 
regulate where oxygen is self-administered. 

Our powers to regulate are laid out in the Health and Social Care Act 2008 
(Regulated Activities) Regulations 2014. A range of regulations are considered 
when assessing and inspecting the safe storage and use of oxygen and medical 

 
 
 gases. This is dependent on the whether any concerns identified affect, safe use, 
training or safety of equipment. 

Background to the trust 

West  Midlands  Ambulance  Service  University  NHS  Foundation  Trust  (WMAS) 
were last inspected in April 2019. They were rated outstanding overall. We have 
carried out monitoring of data and intelligence since their last inspection. Since the 
pandemic,  we  have  monitored  the  service  via  virtual  meetings,  where  they  are 
considered to be functioning well with suitable systems and processes in place.   

Events of 13 April 2020 

On  the  13  April  2020,  paramedics  attended  Mrs  Hadley’s  home  address  where 
during the administration of oxygen sparks from the neck of the oxygen cylinder 
caused a fire at Mrs Hadley’s home.  Sadly, Mrs Hadley passed away as she was 
unable to be moved away from the fire. 

WMAS  were  transparent,  in  immediately  alerting  us  to  the  incident.  After  initial 
meetings  with  the  Health  and  Safety  Executive  (HSE)  and  the  Medicines  and 
Healthcare Products Regulatory Agency (MHRA) , it was decided that the CQC 
would  lead  on  the  investigation  as  Mrs  Hadley  was  in  receipt  of  care  when  the 
incident  occurred.  However,  primacy  for  the  investigation  later  transferred  to 
MRHA  when  it  was  considered  that  the  equipment  was  the  main  concern  as 
opposed to the delivery of care.  

The trust reacted swiftly to investigate and reviewed the circumstances of this rare 
and  tragic  event.  The  collaboration  between  several  agencies  allowed  a 
coordinated  response  to  mitigating  the  risk  of  reoccurrence,  based  on  the 
knowledge gained from initial investigations. 

As part of the multi-agency meetings which were held it was identified that there 
was a widespread and general lack of awareness across all users of compressed 
oxygen, for medical purposes, about the potential of adiabatic compression and 
particle  impact/combustion  syndrome.  Guidance  and  training  did  not  directly 
reference adiabatic pressure to alert users of oxygen of the risks. 

Immediate actions taken by WMAS 

Three  safety  alerts  were  published  for  all  West  Midlands  Ambulance  Service 
Clinical staff, this was to raise awareness and to address the concerns of general 
medical gas safety, cylinder safety and adiabatic compression.  

We  are  also  aware  of  an  article  in  the  trust’s  Weekly  Briefing  which  was 
disseminated to all staff. In addition, all clinical staff have been asked to sign to 
confirm they have read and understood the contents of the safety notices. 

Ongoing mitigation 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 • 

Improvements  have  been  made 
to  the  mandated  WMAS  training 
programme  for  2020/21  and  beyond,  which  now  includes  a  designated 
session  on  medical  gas  cylinder  safety,  including  adiabatic  compression 
and particle combustion syndrome. 

•  A  30-minute  face  to  face  training  session  was  delivered  to  ALL  WMAS 
clinical staff. The session was available to staff to view prior to attending the 
training  session  and  the  link  for  the  session  was  provided  in  the  weekly 
briefing article.  

•  The training and awareness updates have been inserted into the Associate 
Ambulance  Practitioner  course,  graduate  training,  Patient  Transport 
Services training, and will feature in the next mandated training manual. 

•  All NHS ambulance services within the UK, and relevant partners within the 
region  have  been  sent  the  WMAS  safety  notices  and  training  plans  are 
being made available to all appropriate staff.  

•  Communications  have  taken  place  between  regulators,  providers,  Police 
and  fire  service  representatives  to  ensure  that  lessons  learned  from  this 
tragic event can be shared appropriately across many services. 

•  CQC  continue  to  communicate  regularly  with  WMAS  formally  in  monthly 

meetings, where staff training and incidents are discussed.  

We are satisfied that WMAS took proactive and suitable actions following the death 
of Mrs Hadley to reduce the risk of a similar incident occurring and no enforcement 
action was taken against the trust. 

We will continue to monitor the actions taken by WMAS to improve safety.  

Following the inquest, the matters of concern raised within your report  were 
as follows: 

1.  ‘All agencies involved may wish to consider reviewing and issuing guidance 

for the operation and use of oxygen cylinders. 

As  a  regulator  it  is  unfortunately  outside  of  the  CQCs  remit  to  issue  or  change 
formal  guidance  or  policies  around  oxygen  usage  or  safety.  We  are  not  clinical 
experts  on  oxygen  cylinders  or  have  access  to  the  expertise  which  would  be 
necessary in order to issue safety guidance. This role is more suited to the MHRA 
and HSE from whom I am aware separate responses will be sent to you.  

2.  ‘I  am  particularly  concerned  about  the  use  of  oxygen  cylinders  in  the 
community  in  general  and  would  invite  the  HSE  and  CQC  to  consider 
issuing further guidance urgently’. 

Some community services do come under the scope of regulation. Where this is 
the  case  we  will  have  oversight  of  the  storage  and  use  of  oxygen  and  medical 
gases as part of our regulatory function. Where we identify risks in the course of 
inspections relating to the use and storage of oxygen and medical gases we have 
enforcement powers available to us to enable us to hold providers to account. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 As stated earlier the CQC do not have a remit to regulate the use of oxygen and 
medical gases in private households. 

I  trust  this  makes  clear  our  position  and  the  range  of  actions  which  have  been 
taken in order to be satisfied that the risk has been reduced as far as possible.  

Yours sincerely,  

Chief Executive

K  

Mr Zafar Siddique 

Senior Coroner – The Black Country 

By email 

16th March 2021 

Dear Mr Siddique, 

Health and Safety 
Executive 

Chief Executive 

Redgrave Court 

Merton Road 

Bootle  

Merseyside L20 7HS 

http://www.hse.gov.uk/  

DEATH OF LYNN HADLEY, CORONERS REGULATION 28 REPORT 

Thank you for your report on the inquest into the death of Lynn Hadley and for raising 
your concerns with us that future deaths will occur unless action is taken.   

These incidents are, thankfully, rare but when they do occur the consequences can be 
extremely serious and tragic, such as in this case. 

MHRA are the lead authority, as they are the regulator for the equipment involved in 
this incident.  However, during the investigation a Multidisciplinary Team (MDT), 
comprising the Care Quality Commission, West Midlands Ambulance Service, West 
Midlands Fire Service, MHRA, Medical Gas Solutions and HSE, was established to: 

•  assist the regulators in fulfilling their various investigative and regulatory roles; 

and  

•  consider whether it would be possible to further reduce the possibility of any 

future incidents.   

HSE continues to support MHRA and we believe it would be premature for us to 
consider taking any action before their work is completed.  

Once completed, we will: 

•  use our communication channels and stakeholder networks to promote and 
promulgate any information and/or guidance produced by the MHRA; and 
•  consider if any further action is required by HSE, including whether the HSE 

guidance document INDG459 Oxygen use in the workplace Fire and explosion 
hazards: Fire and explosion hazards (hse.gov.uk) on the safe use of oxygen 
cylinders, including their use in assisting those with breathing difficulties, 
should be updated to reflect any new information and/or guidance produced. 

 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 I trust this provides reassurance that HSE is taking the appropriate steps, in 
conjunction with others, to ensure that oxygen cylinders are used safely. 

Yours sincerely, 

Chief Executive

Mr Siddique 
Coroner, 
Black Country Coroner's Services 
Coroner's Court, 
Jack Judge House, 
Halesowen Street, 
Oldbury, B69 2AJ 

22nd March 2021 

Dear Mr Siddique, 

MHRA 

10 South Colonnade 
Canary Wharf 
London, E14 4PU 
United Kingdom 

www.gov.uk/mhra 

INQUEST INTO THE DEATH OF MRS LYNN HADLEY 

RESPONSE TO THE REGULATION 28 REPORT TO PREVENT FUTURE DEATHS 

I write in response to your regulation 28 report dated 18th January 2021 and received 23rd January.  In 

your report you asked the Medicines and Healthcare products Regulatory Agency (MHRA), Health and 

Safety Executive (HSE), West Midlands Ambulance Service and the Care Quality Commission (CQC) to 

consider reviewing and issuing guidance for the operation and use of oxygen cylinders.  This letter sets 

out the actions the MHRA has taken, and which we propose to take, in response to your concerns. 

The issuing of guidance is not within the remit of the MHRA, however, we are able to provide a degree of 

leadership as the Agency which had primacy in the latter stages of the investigation of this incident. 

As you know, issues around the storage, handling, setting up, operating and monitoring the use of 

oxygen, particularly with respect to oxygen cylinders, were reviewed and discussed in the MHRA report 

of 2nd October 2020, which was provided to assist you, Mrs Hadley’s family and the other Interested 

Persons during the inquest. 

The MHRA, as part of the multidisciplinary team who investigated this incident, which included the CQC 

the West Midlands Ambulance Service, the West Midlands Fire and Rescue Service, the HSE and the 

manufacturer of the oxygen cylinder, Medical Gas Solutions, have determined there are a number of 

actions we can collectively undertake over time to raise awareness of the extremely rare phenomena of 

ignition within valve components of oxygen cylinders leading to a fire.  Many of these actions were 

discussed in the aforementioned report.  However, since the report was produced other actions have 

also been discussed and taken forward. 

Following the inquest, and from our subsequent discussions, it remains clear, because of the widespread 

use of oxygen and oxygen cylinders and the very diverse people and organisations who undertake the 

administration of oxygen to those in need of it, messaging will not be straightforward.  This is particularly 

 so because there are also other issues related to the use of oxygen, as well as those just associated 

with ignition and fire - some of which are also associated with serious patient harm and sometimes death 

- which will all require consideration in the future. 

We believe the MHRA is best placed to take specific leadership action in relation to the risk of incidents 

which can lead to ignition and fire in the context of oxygen cylinders we will firstly engage with all the 

professional organisations who are the most likely to be involved in the administration of oxygen.  Their 

members will be involved in the key stages of setting up of oxygen cylinders and accessory devices 

(required for the administration to a patient) and the monitoring of the progress of the patient when this 

has begun.  It is hoped, in their professional leadership roles, they will be able to understand and shape 

the final messages needed to effect culture change amongst their membership, with our assistance 

where it is within our remit. 

The organisations we have identified to date are below, but we appreciate others may be identified as 

we commence the process of engagement.  They are (in no specific order): 

Royal Colleges and Specialist Societies and Associations 

•  Royal College of Anaesthetists 

•  Association of Anaesthetists 

•  Royal College of Physicians (London and Edinburgh), especially acute medicine cardiology and 

renal medicine 

•  Royal College of Paediatrics and Child Health 

•  The Faculty of Intensive Care Medicine 

•  The Intensive Care Society 

•  Royal College of Emergency Medicine 

•  Royal College of Surgeons (England, Edinburgh, Glasgow) 

•  Royal College of Nursing 

•  National Midwifery Council 

Healthcare Organisations 

•  NHS England and Improvement 

•  NHS Scotland 

•  NHS Wales 

•  NHS Northern Ireland 

•  Association of Independent Healthcare organisations 

•  Defence Medical Services 

Emergency Services 

•  The Fire and Rescue Services 

•  The Ambulance Services Regional Trusts 

Organisations for Future Engagement 

• 

Independent Ambulance Services 

 •  Mountain Rescue 

•  Hyperbaric Facilities 

•  Diving Organisations    

We are taking this approach, because we are hoping this will reach a significant number of those 

involved with oxygen administration and it is based on 2 assumptions.  The first is, in our experience, 

ignitions and fires which lead to patient harm have been invariably associated with the initial operation of 

an oxygen cylinder.  These are circumstances where there is an initial treatment being administered or 

where a changeover of oxygen delivery is taking place (replacing a cylinder or swapping from either a 

pipeline or concentrator supply to a cylinder).  

The second is where oxygen is being administered by a non-medical or nursing professional.  In this 

situation there will be oversight from an appointed clinician or medical director for governance purposes.  

Therefore, the second assumption we are making is, if the medical professional has been engaged with, 

then this will hopefully lead to the appropriate dissemination of the messages to the operators, whose 

organisations we will be able to engage with directly in the future. 

To facilitate this engagement, MHRA have already commenced a dialogue with the Association of 

Anaesthetists (with input to their Safety Committee).  The matter has also been raised with the Safe 

Anaesthesia Liaison Group of the Royal College of Anaesthetists (RCoA) and the other organisations will 

follow. 

For additional information the Association of Anaesthetists has facilitated a multiagency group of its own 

to produce guidance related to the prevention of incidents and the safe evacuation of critical care areas 

in the event of serious incidents, including fire.  This follows the Bath intensive care oxygen fire.  MHRA 

were represented on this group, which hopes to publish its completed guidance once ratified by the 

Councils of both the RCoA and the AA over the next few months. 

We hope these actions, as detailed above, which will be undertaken as soon as we are able to, will 

reassure you the concerns you have identified are being properly addressed and we are doing all we can 

to ensure the relevant users are being informed. 

Yours sincerely 

Dr 
FRCA FFICM FFMLM 
Senior Clinical Adviser - Devices 
On Behalf of the CE MHRA

Your Ref: N/A 

23 Febaury 2021 

Mr Siddique 
Area Coroner for Black Country 
Jack Judge House 
Halesowen Street  
Oldbury 
B69 2AJ 

Dear Mr Siddique 

Re: Regulation 28 Report to Prevent Future Deaths – Lynn Hadley (Deceased) 

Thank you for your email dated 23 January 2020 attaching your Regulation 28 Report.   

On behalf of West Midlands Ambulance Service may I first say how sorry we are that this 
incident  has  occurred  and  may  I  please  take  this  opportunity  to  pass  on  my  sincere 
condolences to the family of Mrs Hadley. 

Please see our response to your requested agency action/s. 

Action: 
All  agencies  involved  may  wish  to  consider  reviewing  and  issuing  guidance  for  the 
operation and use of oxygen cylinders. 

Response:  
WMAS took immediate action as detailed during the Inquest. All frontline WMAS staff were 
swiftly made aware of the specific requirments for assembly/dissasembly of all  medical 
gas cyclinders, awareness of adiabatic compression and particle impact, and furthermore 
a  great  deal  of  input  went  into  sharing  lessons  learned  widely  thoughout  partner 
organisations. The table below provides a summary/timeline of action taken.  

 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 If you require any further assistance, please do not hesitate contact me. 

Yours sincerely 

Chief Executive Officer