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.

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 Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA

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.

Dear Mr Siddique, 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.

Dear Mr Siddique, 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.