The first half of 2024 has seen continued, targeted, enforcement action by the Care Quality Commission (CQC) and the Health and Safety Executive (HSE) against organisations and individuals operating in the health and social care sectors.
In this briefing, Steve Panton who leads Stephens Scown's regulatory enforcement and compliance practice, summarises the outcomes of recent prosecutions and other legal developments relevant to the healthcare sector that have occurred over the last six months or are coming around the corner.
Servicer User Deaths, Coroner's Investigations & Inquests
Changes to the death certification scheme in England and Wales are shortly due to come into effect which will lead to the independent review of all deaths in healthcare settings (including in the community) without exception.
In September 2024, the Medical Certificate of Cause of Death Regulations 2024, the Medical Examiners (England) Regulations 2024, the National Medical Examiner (Additional Functions) Regulations 2024 and the Medical Examiners (Wales) Regulations 2024 come into force creating a statutory independent medical examiner system.
The Regulations are part of the ongoing reforms around the death certification process in England and Wales and will increase safeguards to avoid cases such as those involving Harold Shipman, Lucy Letby and Mid Staffordshire NHS Foundation Trust.
From 9 September 2024 all deaths in any healthcare setting that are not referred to the coroner in the first instance will be subject to independent medical examiner scrutiny prior to the Medical Cause of Death Certificate (MCCD), which will replace the existing MCCD certificate to reflect the introduction of medical examiners, being submitted to the Registrar.
The relevant attending medical practitioner will be required to;
- review the deceased's relevant health records, the results of any physical examination of the deceased's body and "any other information which the practitioner considers relevant", and thereafter
- prepare and sign a MCCD and make this, along with the deceased's relevant health records, available to an appropriate medical examiner for scrutiny or where they are not able to establish the cause of death, refer the death to the relevant senior coroner for investigation.
Where the appointed medical examiner is satisfied that the cause of death is accurate, they are required to countersign the MCCD and send this to the registrar. The representative of the deceased will be notified at the same time that they can now contact the registrar to arrange the registration of the death.
However, if the medical examiner is not able to verify the cause of death or, for whatever other reason, the examiner's duty to notify the senior coroner is triggered, a referral to the senior coroner must be made.
In readiness for the new statutory medical examiner system, health and social care providers need to make sure that they have suitable arrangements in place to be able to share deceased's medical records with the local medical examiner's office.
Also, given that medical examiners will be able to "make whatever enquiries the examiner considers necessary" and "take into account any other information which the examiner considers relevant", providers should expect great scrutiny of the circumstances of a service user's death. The importance of gathering and securely storing information that is, or may be relevant, to the cause of death can therefore not be underestimated.
Prosecutions: CQC & HSE
The following cases have a recurring theme; the importance of safeguarding those with cognitive impairment & psychiatric conditions and controlling some of the main foreseeable risks associated with caring for older persons, namely falls, choking hazards and the inability to appreciate and avoid increased risks to their health, safety and welfare. The impact of registered providers failing to meet their duty of candour requirements has also been brought home, following on from the first (duty of candour) prosecution of its kind involving University Hospitals Plymouth NHS Trust in September 2020.
In terms of CQC enforcement action, so far this year we has seen the successful prosecution of several organisations. These include;
Woodbourne Priory (Priory Healthcare Limited) were fined £650,000 plus costs of over £43,000 in March 2024 after an unsupervised 23-year old NHS patient sectioned under Section 2 of the Mental Health Act 1983 was able to leave the grounds of an acute and psychiatric intensive care unit. The patient died in September 2020 after being struck by a train approximately 14 hours after leaving Woodbourne Priory.
Priory Healthcare Limited had previously been the subject of several successfully prosecutions over recent years, including fines of £300,000 and £140,000 respectively associated with the deaths of 14 year old Amy El-Keria in 2019 and Francesca Whyatt in 2023.
Derwent Lodge Nursing Home (Sure Care (UK) Limited) who were ordered to pay £37,000 by Liverpool & Knowsley Magistrates' Court in April 2024 after pleading guilty to failing to provide safe care and treatment to Joseph Leighton, a dementia patient. Two days after his wife died, who had also resident at Derwent Lodge receiving palliative care, Mr Leighton forced his first-floor bedroom window open and climbed out, holding onto the windowsill before dropping to the ground. He died several months later and a post-mortem examination provided Mr Leighton's cause of death was partly due to the fractures he sustained during the fall on 6 June 2021.
CQC's investigation found that Sure Care (UK) Limited failed to ensure Derwent Lodge Nursing Home was fitted with HSE compliant window restrictors. The lack of window restrictors had been identified during a local authority quality improvement visit on 5 July 2019, and again in an audit of Mr Leighton's room on 7 June 2021.
The CQC investigation also found invoices for window restrictors dated 13 May 2021 and 20 May 2021, however these had not been fitted.
Wildacre Care Services Limited paid over £45,000 in fines and costs after 74-years old Alfie Dunkley died on 5 January 2021 after choking whilst eating breakfast. He had previously been assessed by Speech and Language Therapy (SaLT) as being at risk of choking following two previous incidents.
Wildacre, and the registered manager Julian Sanderson who was also fined and ordered to pay £21,481 in fines, costs and a victim surcharge, were found to have failed to make sure appropriate staff training, supervision, policies and guidance had been put in place for managing the risk of choking.
Claremont Care Services Limited was fined over £24,000 in May 2024 after failing to protect 75-yeard old resident John Bowles from significant risk of avoidable harm due to the risk of falls and also failing in their duty of candour.
Mr Bowles suffered an unwitnessed fall on the day of his admission, but no injury was recorded. Three days later, on 28 December 2019, he suffered another unwitnessed fall and developed a lump on his head. He was taken to hospital where a scan found no head injury. This was the only time medical treatment was sought for Mr Bowles following a fall.
Up to 8 February 2020, Mr Bowles fell a further seven times, three of which caused him a head injury, but staff sought no medical treatment. On the morning of 9 February 2020, he suffered another unwitnessed fall resulting in a head injury. Staff took physical observations but didn't have any previous recordings to compare against. They offered to contact emergency services, but Mr Bowles declined, and staff complied with his wishes however, this went against NICE guidelines.
Later that evening, staff heard a loud bang from Mr Bowles' room. He said he banged the back of his head on the wall. Staff didn't see an injury and didn't seek medical treatment. A few hours later that night, staff found him walking in the corridor. He requested a specialist and staff offered to call emergency services but again he declined. Staff again didn't follow NICE guidance.
The next morning, on 10 February 2020, staff found Mr Bowles unresponsive in bed and called 999. He was pronounced dead at hospital and was later determined to have died from a traumatic head injury. It was found that the service's falls and head injury guidance didn't advise staff to seek emergency care for people on blood thinning medication if they suffered a head injury, contrary to NICE guidelines. Mr Bowles' care plan was also incomplete and did not reflect the number of falls he had suffered. A falls risk assessment was not completed until he had already fallen five times.
Claremont also failed to discharge its duty of candour obligations by not informing and apologising to Mr Bowles' family promptly enough after the incident and his death.
HSE healthcare sector enforcement action so far in 2024 has been along a not dissimilar vein. This has included prosecutions brought against;
The operators of Springfield Bank Care Home a purpose-built care home offering nursing and nursing dementia care, who were fined £400,000 by Edinburgh Sheriff Court on 22 February 2024 following an investigation arising from the death of resident Susan Greens.
On the night of 16 December 2021, Susan Greens, a resident at Springfield Bank Care Home, could not be found on the premises. After a search around the site in Bonnyrigg near Edinburgh, care assistants found the 95-year-old in her nightwear lying in an external courtyard. Mrs Greens had fallen and struck her head in the courtyard where she had been in the cold for some time. She was admitted to Edinburgh Royal Infirmary and sadly died in hospital two days later.
The company pleaded guilty to breaching Section 3(1) the Health and Safety at Work etc. Act 1974 after HSE's investigation found;
- Mrs Greens died because she was able to access the courtyard while unsupervised and had fallen, spending up to an hour and a half outside before staff came to her aid;
- had the doors been kept locked at night or had there been a system where staff would be told if the doors to the courtyard had been opened, the accident could have been avoided.
Fife Council were fined £100,000 in April 2024 following the death of a 66-yeard old vulnerable service user in supported living accommodation who choked after eating a sandwich unsuitable for his prescribed diet.
A fine of £220,000 was imposed on Lothian Health Board on 19 March 2024 following the deaths of two vulnerable patients in 2017 and 2021. One patient, a 55 year old in the care of a Neurosurgical Ward, fell 11 metres to his death from a second floor window whilst attempting to take his own life as a result of a failure by the Health Board to restrict the opening (window) gap to the required 100mm gap.
The other, a 79 year old being cared for on a Medical Assessment Unit, died after falling from a similarly insecure first floor window.
The cases referred to all revolve around the same interconnected themes; identifying the risks associated with service users with particular vulnerabilities, deciding what needs to be done to protect them and how to keep on top of things when a plan has been put in place.
The key is to properly assess the risks specific to service users at the outset, keep arrangements for the safe delivery of care under review, and that staff are trained, encouraged and empowered to identify when changes need to be made and, importantly, challenge and report shortcomings.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.