What is duty of candour?
The principle of the duty of candour is that care organisations have a general duty to act in an open and transparent way in relation to care provided to patients. The statutory duty applies to organisations, and “registered persons”.
What is Regulation 20, duty of candour and what does it mean for me as a GP?
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 created a statutory duty of candour affecting GP practices.
On 1 April 2015, the CQC introduced a new regulation (regulation 20, duty of candour) that makes it a legal duty for GP practices to have systems in place to capture notifiable safety incidents and to both inform and provide support to patients. The statutory duty applies only to “registered persons” so GPs will have an obligation to ensure that their practices have such systems in place.
Further general advice in relation to the duty of candour can be found here.
Is this a new duty?
No. While the regulation is new, GPs and GP practices have had both a professional (GMC) and contractual obligation (Standard Contract’s Service Conditions (SC35) and GMS Contract (para 20.1)) to have systems in place to identify adverse incidents and to investigate in order to put things right and learn from mistakes.
The GMC has also produced joint guidance with the Nursing and Midwifery Council (NMC) regarding the duty of candour, Openness and honesty when things go wrong, which sets out a registered medical practitioner’s obligations.
What is a notifiable safety incident?
The regulation states that there are two meanings of a notifiable safety incident; one for a health service body, the other for registered persons – registered persons being GPs and primary care dental practitioners. According to the regulation: “In relation to a registered person who is not 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 –
(a) appear 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,
- an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,
- changes to the structure of the service user’s body,
- the service user experiencing prolonged pain or prolonged psychological harm, or
- the shortening of the life expectancy of the service user; or
(b) requires treatment by a health care professional in order to prevent –
- the death of the service user, or
- any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).”
What is harm?
“Harm”, as listed above, is further defined in the regulation as:
- Prolonged psychological harm – means psychological harm that a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.
- Prolonged pain – means pain that a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.
What should I do if I become aware of a notifiable safety incident?
Both the practice and individual GPs would be bound to take any requisite action in relation to an incident that was captured by regulation 20. A pragmatic approach should be taken as to who is best placed to take the lead in relation to each specific case.
The specific approach would be dependent on the nature of the systems error and the relative involvement of the healthcare professionals (which may, of course, include non-clinical staff). This may include a significant event analysis in order to identify the issues that led to the error and for the practice to take reasonable and proportionate steps to minimise the risk of recurrence. The patient/family will need to be notified of such incidents and fully informed about the investigations and steps taken. Patients should also receive an appropriate apology.
The CQC do have the power to take various types of enforcement action against both providers and individuals and this is set out in their Enforcement Policy.
The incident relates to a system failure: what are my obligations as a GP?
Your obligation remains the same. The practice and GPs should take steps as above. If a system failure is identified then steps to rectify it should be undertaken as soon as possible.
What happens if care was provided in both primary and secondary care?
In circumstances when the obligations under the duty of candour are triggered in both the primary and secondary care settings, both the primary and secondary care organisation would have an obligation to take the requisite action.
Will this duty lead to practices and GPs receiving more complaints or claims?
It is not possible at this early stage to predict the impact of the duty of candour in relation to the number of complaints and/or claims.
If the patient subsequently pursues a complaint, then the complaint should be handled in accordance with the NHS complaints procedure. Claims should be promptly notified to the relevant MDO(s).
The principles that apply to the obligations under the duty of candour are very similar to those that would apply in relation to responding to a complaint. There should be no conflict in relation to the duty of candour and providing a response in accordance with the NHS complaints procedure.
By offering an apology will I be admitting liability?
MPS has always advised and encouraged adopting a transparent approach in circumstances when there has been an adverse incident, and to provide an appropriate apology. This should not be seen as an admission of guilt. An apology cannot be used as an admission of liability should a claim then be pursued, as set out in s2 of the Compensation Act 2006, which states:
“An apology, an offer of treatment or other redress, shall not of itself amount to an admission of negligence or breach of statutory duty.”
Further, the GMC’s guidance also encourages apologising to patients after things have gone wrong.
Does MPS have advice on discussing adverse incidents with patients?
MPS workshops are available for members (free of charge) and non-members (at a small charge) on how to deal with difficult situations with patients, including offering an apology.
These workshops can be booked online below:
Do I have to notify MPS if there is a notifiable safety incident in my practice?
No, MPS does not require notification of all such incidents. However, if you would like to discuss any issue arising then please contact us.
Will my subscription rate increase if I contact MPS for advice?
No. We encourage members to contact us for advice in relation to meeting the obligations of the duty of candour when they are unsure.
MPS’s response to the consultation on ‘Proposals to Introduce a Statutory Duty of Candour for Health and Social Care Services’
21 January 2015
MPS responds to the CQC proposal to introduce the Statutory Duty of Candour
23 April 2014
MPS and DPL comment on encouraging candour through professional regulation
28 August 2013
MPS comments on CQC’s changes to the way it regulates, inspects and monitors care
29 July 2013
All consultation responses
Two in three doctors believe there is still a blame and shame culture in the NHS, MPS survey reveals
27 April 2015
67% of doctors in Scotland do not believe legal duty will improve openness
23 January 2015
MPS comments on duty of candour review
07 March 2014
MPS maintains that a culture of openness is more effective than ‘tick box’ legislation
26 March 2013
All press releases