As a response to the Francis Inquiry, a statutory duty of candour was introduced under Regulation 20 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This has applied to all Care Quality Commission (CQC) registered providers of health and social care services since 1 April 2015. Although the statutory duty only applies to organisations, it is expected that an organisation’s staff will co-operate to ensure the obligation is met.
Regulation 20(1) sets out a general duty to act in an open and transparent way and applies to all interactions with patients about care and treatment.
Regulation 20(2) sets out a specific duty that must be followed when things go wrong. The specific duty applies, as soon as reasonably practicable, after becoming aware there has been a notifiable safety incident (NSI).
In addition, the General Medical Council and Nursing & Midwifery Council give guidance on the professional duty of candour and the National Health Service (NHS) Standard contract requires all providers of services to NHS patients to comply with a contractual obligation of candour.
The definition of an NSI depends on whether an organisation is a NHS body or not.
For NHS bodies, an NSI is an unintended or unexpected incident that could result in, or appears to have resulted in:
For non-NHS bodies (including independent healthcare providers), an NSI is an unintended or unexpected incident that appears to have resulted in :
The intention for having two definitions was to reduce the administrative burden caused when the statutory duty of candour was introduced, given the different notification systems for NHS bodies and all other providers.
The threshold for when the statutory duty of candour applies is lower for NHS Trusts than it is for primary care and private providers. Although a primary care or private provider may choose to be open when there has been an incident which has the potential to cause harm, they are under no statutory obligation to do so.
Providers can demonstrate this by having policies and procedures, to support and promote a culture of openness, providing staff training, treating untoward incidents seriously and immediately considering whether an NSI has occurred.
If an NSI has occurred, the patient (or any person entitled to act on their behalf) must be notified as soon as is reasonably practicable and reasonable and support must be provided. Where the degree of harm is not clear but could fall into one of the NSI categories, the patient must be informed.
The first notification must be given in person and :
This must be followed by a written notification covering all of the issues discussed in person. When deciding who should notify the patient, it is important to consider a range of factors including seniority, relationship to the patient and expertise.
One purpose of having a statutory duty of candour is to move away from a defensive approach when things go wrong to a more open one which, promotes candour and honesty and supports learning. Failure to comply with the statutory duty can lead to regulatory action from CQC and, in the most serious and persistent cases, a criminal prosecution.