When is the right time to question a medical decision?
The CQC has announced updated guidance for providers on Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - the duty of candour. A summary of the updated guidance can be found here.
The duty of candour was first introduced in 2014 and places a legal duty on registered providers and managers (known as ‘registered persons’) to act in an open and transparent way with the people using their services (and their families), whether or not something has gone wrong with their care or treatment.
Regulation 20 sets out some specific requirements that providers must follow when a notifiable safety incident occurs, (‘NSI’), including:
Pursuant to Regulation 22(3) – it is an offence for a health service body to fail to comply with the duty, and any breach may affect the body’s CQC rating. The regulation in full can be viewed here.
The updated guidance seeks to support providers so that they can fully understand their duties and the steps they need to take in order to be compliant.
Ted Baker, CQC’s Chief Inspector of Hospitals, explained:
“The duty of candour is a crucial part of a positive, open and safe culture. People using any type of health or social care service have a right to be informed about all elements of their care and treatment - and, all providers have a responsibility to be open and honest with those in their care.
Where the duty of candour is not being carried out properly, there can often be wider concerns around a lack of transparency, staff not feeling able to speak up and mistakes not being learned from.
Candour is integral to a ‘just culture’ and it is vital that we help providers get this right. Candour cannot be an ‘add on’ or a simple matter of compliance - it will only be effective as part of a wider commitment to safety, learning and improvement.
Good progress has been made by many providers, but more needs to be done to ensure that the culture of openness is fully embedded. CQC will keep its focus on this essential element of a safe culture going forward and we have updated the guidance for providers to help them drive further improvements.” (Emphasis added)
One of the key features of the updated guidance has been providing greater clarity to providers over what constitutes a NSI. In seeking to provide a more specific definition of a NSI, the CQC has set out the following criteria which must be met:
Moderate harm is defined as ‘harm that requires a moderate increase in treatment and significant, but not permanent harm’. Whereas, severe harm is defined as ‘a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user's illness or underlying condition.’
The CQC recognises that it simply is not possible to establish guidance which covers all possible events and circumstances that may or may not qualify as a NSI. To assist organisations, it has produced case studies which provide practical examples on how to apply the above criteria, which can be found here.
Another key feature of the updated guidance is an increased emphasis on the fact that ‘saying sorry’ is not an admission of liability, but rather a crucial component of complying with the duty of candour. The CQC recognises that in many cases it is ‘the lack of timely apology that pushes people to take legal action’ and so the guidance is unequivocal that regardless of fault, organisations should apologise for any the harm caused, confirming:
‘The presence or absence of fault on the part of a provider has no impact on whether or not something is defined as a notifiable safety incident. Saying sorry is not admitting fault’
It is hoped the guidance will assist providers in all sectors to fully understand their duties and know practically what they need to do to carry it out, with the hope it will improve the experiences of those who use or need their services.
Kathryn Sheridan is a barrister in the Regulatory team. She is an experienced Regulatory and Criminal law advocate.
Kathryn was called to the Bar in 2014 and joined Kingsley Napley in 2017 having enjoyed tenancy at Furnival Chambers. Whilst at the independent Bar, Kathryn was instructed as sole counsel in allegations of sexual assault, knifepoint robbery, GBH, PWITS and money laundering.
Shannett Thompson is a Partner in the Regulatory Team having trained in the NHS and commenced her career exclusively defending doctors. She provides regulatory advice predominantly in the health and social care and education sectors. Shannett has vast experience advising regulated individuals, businesses such as clinics and care homes and students in respect of disciplinary investigations. She is a member of the private prosecutions team providing advice to individuals, business and charities in respect of prosecutions were traditional agencies are unwilling or unable to act. In addition Shannett has built up a significant niche in advising investors and businesses in the cannabis sector.
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