Regulation 20 Duty of Candour

Welcome to episode 21   of Continuous Quality Compliance 

Today  I am talking about…  Regulation 20 Duty of Candour  

The intention of this regulation is to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ (people acting lawfully on their behalf) in general in relation to care and treatment. It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.

The regulation applies to registered persons when they are carrying on a regulated activity.

CQC can prosecute for a breach of parts 20(2)(a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action. Which you can find in the offences section.  

It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology.

Providers must promote a culture that encourages candour, openness and honesty at all levels.

CQC  This should be an integral part of a culture of safety that supports organisational and personal learning. There should also be a commitment to being open and transparent at board level. 

Definitions : 

Openness – enabling concerns and complaints to be raised freely without fear and questions asked to be answered.

• Transparency – allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators.

• Candour – any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.

To meet the requirements of Regulation 20, a registered provider has to:

 Make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use services in carrying on a regulated activity.

Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and provide support to them in relation to the incident, including when giving the notification.

• Provide an account of the incident which, to the best of the provider’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification.

• Advise the relevant person what further enquiries the provider believes are appropriate.

• Offer an apology.

• Follow up the apology by giving the same information in writing, and providing an update on the enquiries.

• Keep a written record of all communication with the relevant person.

We will consider the size and type of services and the relevance of the regulation to the provided

regulated activity.

The registration inspector will check that the provider has robust systems in place to meet the duty of candour regulation. This would include, but is not limited to, training for all staff on communicating with people who use services about notifiable safety incidents; incident reporting forms which support the recording of a duty of candour notification; support for staff when they notify people who use services when something has gone wrong; oversight and assurance.

When they are inspecting the following  KLOE’s will be looked at for  compliance with Duty of Candour. 

S2: Are lessons learned and improvements made when things go wrong?

Prompt 1: Are people who use services told when they are affected by something that goes wrong, given

an apology and informed of any actions taken as a result?

W3: How does the leadership and culture reflect the vision and values, encourage openness and transparency and promote good quality care?

Prompt 9: Does the culture encourage candour, openness and honesty?

Services that are safe ensure that when something goes wrong, people receive a sincere apology and are told about any actions taken to improve processes to prevent the same thing happening again. In services that are well-led; candour, openness, honesty, transparency and challenges to poor practice are the norm. Leadership at all levels in the organisation is central to ensuring a culture that supports this.

Regulation 20 applies to organisations as opposed to individual members of staff.

It requires the provider to ensure that all their staff, regardless of seniority or permanency, understand the organisation’s responsibility to be open and transparent in their communication with relevant persons in relation to a notifiable safety incident. It requires the provider to understand their own role, and to put policy and processes in place to ensure they are supported to deliver it.

Providers should have policies and procedures to support a culture of openness and

transparency, and ensure that staff follow them. Providers should also take action to tackle

bullying, harassment and undermining, and investigate any instances where a member of

staff may have obstructed another in exercising their duty of candour.

Individual members of staff who are professionally registered, are separately subject to the

professional duty of candour, which is overseen by the professional regulatory bodies such

as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the

General Dental Council (GDC). The provider should have a system in place to identify and

deal with possible breaches of the professional duty of candour by staff who are

professionally registered. This is likely to include an investigation and escalation process,

which may lead to referral to their professional regulator or other relevant body.

Notifications  CQC  expect all providers to have systems in place to handle notifiable safety incidents in accordance with Regulation 20 and the other regulatory requirements in relation to such incidents. 

Registered providers, and their registered managers, are required to notify CQC about certain incidents. The requirements relevant to safety incidents are set out in Regulations 16, 17 and 18 of the Care Quality Commission (Registration) Regulations 2009 – this is covered within our guidance for providers on the regulations.

Apology An ‘apology’ is an expression of sorrow or regret in respect of a notifiable safety incident; It is not an admission of guilt.

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