Welcome to the fourth in our series looking at the CQC Fundamental Standards and what they mean in practice for social care services.
In our previous posts, we looked at Regulation 18, Staffing, Regulation 19, Fit and Proper Persons Employed, and Regulation 16, Receiving and Acting on Complaints. This time, we turn to Regulation 20: Duty of Candour.
Duty of Candour is a straightforward principle: when something goes wrong, providers must be open and honest with the person receiving care and, where appropriate, their representative.
But it is about more than following a process after an incident. Duty of Candour is really about the culture of an organisation and whether people feel able to speak openly when things go wrong.
What exactly is Regulation 20?
Regulation 20 contains two related requirements. Firstly, there is an overarching duty of candour. This requires providers and registered managers to act in an open and transparent way with people receiving care. It is not limited to incidents that meet the formal definition of a notifiable safety incident.
Secondly, there are specific statutory requirements of what you need to do where an incident meets the definition of a notifiable safety incident.
This distinction is important. Not every incident will be a notifiable safety incident, but that does not mean a provider should avoid ensuring the principles of duty of candour are followed when it is not a notifiable incident.
The overarching duty of candour
The overarching duty is about creating a culture where openness, honesty and transparency are part of everyday practice. Providers should make sure that all staff:
- Know how to report and escalate concerns and incidents
- Are encouraged to speak openly when things go wrong
- Understand the importance of being honest with people and their representatives
- Know how to apologise and provide appropriate support
- Understand that incidents should be investigated and used to improve care
The key point is that candour should not only happen when the formal threshold for a notifiable safety incident is reached.
A notifiable safety incident
A notifiable safety incident is an unintended or unexpected incident that occurs during the provision of a regulated activity and results in, or could result in, a specified level of harm.
The precise thresholds of when the regulations dictate that the incident is notifiable can be complex, but may include when the event results in death, significant or prolonged impairment, prolonged pain or psychological harm, or a shortened life expectancy of the person using services.
It is important to remember that a notifiable safety incident does not depend on somebody being at fault.
The distinction can be difficult in practice, so the following examples illustrate the difference. They are intended as practical examples rather than a definitive checklist. The circumstances and level of harm in each individual case will need to be considered.
|
Example in social care |
Likely position |
Why? |
| A person falls and suffers a serious injury requiring hospital treatment, resulting in significant or prolonged impairment. |
Notifiable safety incident |
The incident was unexpected, and the resulting harm may meet the statutory threshold. |
| A person develops a pressure ulcer, and this is painful and impairs their ability to do what they used to. |
Notifiable safety incident |
The harm may meet the relevant threshold and occurred in connection with a regulated activity |
| Medication is administered incorrectly and results in significant physical harm. |
Notifiable safety incident |
The medication error was unintended and has resulted in harm that may meet the threshold. |
| A person unexpectedly chokes during a meal and suffers a serious injury or significant deterioration as a result. |
Notifiable safety incident |
The incident was unexpected and the resulting harm may meet the relevant threshold. |
| A person is injured during a transfer, resulting in prolonged pain and restriction of movement |
Notifiable safety incident |
The incident occurred during the provision of a regulated activity and resulted in harm at a level that may meet the statutory threshold. |
| A person has a minor fall but sustains no injury and requires no treatment beyond routine observation. |
Not normally a notifiable safety incident |
The incident may still need to be recorded and reviewed, but the level of harm is unlikely to meet the statutory threshold. |
| A medication error is immediately identified and causes no harm to the person. |
Not normally a notifiable safety incident |
There may be an incident requiring recording and review, but the formal statutory threshold may not be met. |
| A person complains that staff were rude or communication was poor, but there is no evidence of significant harm. |
Not normally a notifiable safety incident |
This may need to be dealt with under the complaints process and may raise issues under other regulations but would not normally meet the definition. |
An incident may not meet the threshold for a notifiable safety incident, but it may still need to be recorded, investigated and acted upon. For example, one medication error that causes no harm may not trigger the formal Duty of Candour requirements. However, repeated medication errors could indicate a much wider problem with training, systems or staffing.
The question should therefore not simply be ‘Is this notifiable?’ It should also be ‘What is this event telling us about the quality and safety of our service?’ and ‘what do we need to do about it?’
What happens when Regulation 20 applies?
Where an incident does meet the definition of a notifiable safety incident, providers have specific responsibilities.
They should:
- Tell the person what has happened as soon as reasonably practicable and explain what is known
- Apologise. Saying sorry is not an admission of legal liability
- Offer appropriate support to the person affected and, where appropriate, their representative
- Follow up in writing and provide further information as it becomes available
- Keep clear records of the incident, communication, actions taken and learning
You should not wait until every detail has been established before communicating with the person affected. If you do not yet know something, be honest about that and explain what you are doing to find out.
Duty of Candour is therefore about communication, openness, support and follow-up, rather than simply sending an apology letter.
Duty of Candour and Organisational Culture
CQC will want to see whether the organisation genuinely encourages people to speak up, respond openly and learn when things go wrong, and this is whether it is a notifiable incident or not.
If staff are reluctant to report incidents, concerns are not escalated or lessons are not acted upon, this can raise wider questions about leadership, governance and quality of care.
Good Duty of Candour is not just about what you do when something goes wrong — it is about how your organisation responds and what it learns from it.
Regulation 20 Connects to Other Fundamental Standards
Duty of Candour does not operate in isolation and can be seen as a regulation that needs to be understood and met when something else happens within the service.
|
Regulation |
Connection Duty of Candour |
| Regulation 12 – Safe Care and Treatment | An incident may identify a failure in the safety of care. |
| Regulation 16 – Complaints | People may complain if they feel the service has not been open or responsive. |
| Regulation 17 – Good Governance | Providers need systems to record, investigate and learn from incidents. |
| Regulation 10 – Dignity and Respect | People should be treated honestly and respectfully when something goes wrong. |
A significant incident can therefore raise questions about much more than Regulation 20.
Making Duty of Candour Part of Everyday Practice
Providers do not need a complicated system. They need to make sure that openness and honesty are built into the way the service operates.
Staff should understand:
- What Duty of Candour means and when it may apply
- How to report and escalate incidents
- Who is responsible for managing the process
- The importance of clear records
- How incidents lead to learning and improvement
Most importantly, staff need to feel safe to speak up when something goes wrong.
The importance of getting the culture right
The best services are not necessarily those where nothing ever goes wrong. They are the services that are prepared to acknowledge when things do go wrong, be honest about what happened, support the people affected and learn from the experience. That is the real meaning of Duty of Candour.
Services need to understand that being open when things go wrong is not a weakness. It can be a sign of a mature, well-led organisation that is prepared to learn and improve, and this should be recognised and rewarded by CQC during their regulatory assessments.
Take a look at our next instalment in our Fundamental Standards series, covering Regulation 10 – Dignity and Respect.