Duty of candour
The duty of candour was introduced through Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It applies to NHS organisations such as trusts and foundation trusts, GP practices, dental practices and care homes.
The intention of the regulation is to ensure healthcare providers are open and transparent with service users when errors occur. The Regulations set out the steps that need to be taken once a notifiable incident has occurred.
What is a notifiable safety incident?
In relation to a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in:
- the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition, or
- severe harm, moderate harm or prolonged psychological harm to the service user.
Within the Regulations prolonged psychological harm is defined as psychological harm which the service user has experienced, or is likely to experience, for a continuous period of at least 28 days. Prolonged pain is defined as pain which a service user has experienced or is likely to experience, for a continuous period of at least 28 days.
Steps to be taken if a notifiable safety incident occurs
As soon as is reasonably practicable after becoming aware that a notifiable safety incident has occurred it is important:
- To notify the relevant person that the incident has occurred and
- Provide reasonable support to them in relation to the incident including giving notification
The notification must be given in person by one or more representatives of the registered person and must include an account of all of the facts of the incident that are known at that time. It is also important that the relevant person is advised of what further enquiries will be carried out and that an apology is also given. A written record of the notification should be kept securely.
The initial oral notification must be followed by a written notification containing the information already provided, the details of any enquiries to be undertaken and the results of those further enquiries. The written notification must also include an apology.
If the relevant person cannot be contacted in person or declines to discuss the incident, a written record should be kept of the attempts to contact and speak to them.
Consequences of non-compliance
If the patient is harmed by a notifiable incident it is an offence under Regulation 22(3)
- Not to notify the patient that the incident occurred
- To give false information
- To give partial information
- Not to apologise
- Not to keep records
- Not to give notification as soon as is reasonably practicable
Failure to comply is a summary offence and the CQC can prosecute for a breach of the Regulations without first serving a warning. Prosecution can lead to a fine up to £2,500.
Reporting concerns – colleagues
One of the most difficult situations faced by any clinician is when you are concerned that a colleague’s behaviour, health or professional performance may be placing patients at risk.
Doctors must ensure that, when entering into employment, they do not sign contracts with “gagging clauses” written into them, which forbid them to raise concerns about colleagues or procedures in the workplace. Doctors must also be careful when leaving employment that they do not sign compromise agreements which contain gagging clauses.
The GMC, in Raising and acting on concerns about patient safety
, says: “You must not enter into contracts or agreements with your employing or contracting body that seek to prevent you from or restrict you in raising concerns about patient safety. Contracts or agreements are void if they intend to stop an employee from making a protected disclosure.”
Deciding what to do when you have concerns about a colleague’s behaviour is always uncomfortable. However, the GMC has given clear advice in Good Medical Practice (2013). The relevant advice is found under the heading “Respond to risks to safety” (paragraphs 24 – 25). You must promote and encourage a culture that allows all staff to raise concerns openly and safely.
The guidance makes it clear that the safety of patients must come first at all times. This means that a doctor who has concerns that a colleague may not be fit to practice must take prompt, appropriate action. They should explain their concerns clearly and honestly to an appropriate person from the contracting or employing body.
Any specific local procedures should be followed, and concerns should usually be documented in writing. In such circumstances you may want to seek advice from Medical Protection about how to raise such concerns, to ensure that your position is protected.
Trying to decide whether an issue should be made public is difficult, and can be very stressful. If you have done all you can by raising the concerns within the organisation, but the risk remains, the GMC advises that you may consider making your concerns public. The GMC provide further guidance on this issue Raising and acting on concerns about patient safety
“You can consider making your concerns public if you:
- have done all you can to deal with any concern by raising it within the organisation in which you work or which you have contract with, or with the appropriate external body, and
- have good reason to believe that patients are still at risk of harm, and
- do not breach patient confidentiality.
But, you should get advice before making a decision of this kind.”
In such circumstances you should ensure your concerns, and the steps you have taken, have been properly documented, and contact Medical Protection before raising any such matter publicly to ensure that your position is protected at all times.