The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 came into force in April 2015 for all providers of health and social care services that are registered with the Care Quality Commission.
Before the implementation of the regulations, organisations may have been subject to a contractual ‘duty of candour’. That has now been replaced by a statutory duty of candour (outlined in Regulation 20 of the new act), which has potential implications for insurance coverage.
Put simply, the duty of candour is the duty to be open and honest when untoward events occur.
Should a ‘notifiable incident’ occur during the provision of a regulated activity – such as providing personal care, providing maternity services, or treating a disease/injury – the provider is required to and carry out the following steps:
- Notify the relevant person (which can be the service user or their representative).
- Provide an account of all of the facts known at the time of notification, true to the best of their knowledge.
- Advise about other relevant enquiries and investigations.
- Include an apology (defined as an expression of sorrow or regret).
- Make a written record of the account and keep it securely.
The original notification should be conducted in person by a representative of the service provider, and be followed up by a written notification sent as soon as possible after the event.
A notifiable incident is defined as any unintended/unexpected incident which, in the reasonable opinion of a healthcare professional, could result in the death of a service user, severe or moderate physical harm, or prolonged psychological harm.
Each insurer will no doubt take its own view on this matter and, as is usual, each civil claim will be considered on its own merits. It is therefore imperative that you seek the advice and guidance of your insurers/consultants in relation to this duty, and how you may respond to it.
In our view, it has long been accepted in law that an apology is not an admission of legal liability or a breach of duty. The introduction of a statutory duty of candour does not change that position – although an issue might arise over the wording of an apology.
In terms of how to apologise, you should state that your organisation is sorry for any suffering and distress felt. The apology should be a straightforward written account of the facts known and any relevant enquiries being carried out. However, you should never comment on the cause of the incident or admit to any failings or liability.
To comply with the new rules, organisations should:
Prepare step-by-step guidance for staff regarding what to do when a notifiable incident occurs, including:
- A notification process that incorporates who the incident should be reported to and the escalation and subsequent actions protocol.
- Details of who can provide support to the service user to ensure that they are involved and updated as the investigation progresses.
Prepare a template notification letter.
Prepare content for a letter of apology, but ensure that staff understand that this needs to be highly personalised and relevant to the actual notification involved.
Consider preparing a policy that sets out the company’s commitment to openness and candour.
Conduct staff training to support and implement the new guidance and policies.
Review crisis communications and PR strategies.
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