Appendix 2: The statutory duty of candour for care organisations across the UK
The CQC has put in place a requirement for healthcare providers to be open with patients and apologise when things go wrong. This duty applies to all registered providers of both NHS and independent healthcare bodies, as well as providers of social care from 1 April 2015. The organisational duty of candour does not apply to individuals, but organisations providing healthcare will be expected to implement the new duty throughout their organisation by making sure that staff understand the duty and are appropriately trained.
Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 intends to make sure that providers are open and transparent in relation to care and treatment with people who use their services. It also sets out some specific requirements that providers must follow when things go wrong with care or treatment, including informing people about the incident, providing reasonable support, giving truthful information and apologising when things go wrong. The CQC can prosecute for a breach of parts 20(2)a and 20(3) of this regulation.
In January 2015, former Northern Ireland Health Minister Jim Wells MLA announced plans to introduce a statutory duty of candour for Northern Ireland. This announcement followed the publication of the Donaldson Report, which examined the governance arrangements for making sure health and social care is of a high quality in Northern Ireland. The annual report of the chief medical officer for Northern Ireland 2014, published in May 2015, restated the commitment to introduce a statutory duty of candour in Northern Ireland.
‘In response to the Donaldson review the Minister announced plans to introduce a statutory duty of candour for Northern Ireland. That duty came to prominence in England as a result of conclusions from the Francis report – a public inquiry into the Mid Staffordshire NHS Foundation Trust. Openness and transparency are crucial elements of patient safety. When things go wrong, patients, service users and the public have a right to expect that they will be communicated with in an honest and respectful manner and that every effort will be made to correct errors or omissions and to learn from them to prevent a recurrence.
‘The Health and Social Care service in Northern Ireland already operates under statutory duties of both quality and involvement. Meaningful engagement with patients and clients, carers and the public will improve the quality and safety of services. It is not the intention of the duty of candour to promote a culture of fear, blame and defensiveness in reporting concerns about safety and mistakes when they happen.’
The Healthcare Quality Strategy for NHS Scotland is aiming to achieve an NHS culture in which care is consistently person-centred, clinically effective and safe for every person, all the time.
The Scottish Patient Safety Programme is a national initiative that aims to improve the safety and reliability of healthcare and reduce harm.
Following public consultation between October 2014 and January 2015, the Scottish Government published the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill on 5 June 2015.47 The purpose of the duty of candour provisions of the Bill are to support the implementation of consistent responses across health and social care providers when there has been an unexpected event or incident that has resulted in death or harm, that is not related to the course of the condition for which the person is receiving care.
The duty of candour procedure (which will be set out in regulations to be made using powers in the Bill) will emphasise learning, change and improvement – three important elements that will make a significant and positive contribution to quality and safety in health and social care settings.
The new duty of candour on organisations will create a legal requirement for health and social care organisations to inform people (or their families/ carers acting on their behalf) when they have been harmed (physically or psychologically) as a result of the care or treatment they have received.
There will be a requirement for organisational emphasis on staff support and training to ensure effective implementation of the organisational duty.
The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 place a number of duties on responsible bodies providing NHS care. This includes a duty to be open when harm may have occurred:
‘where a concern is notified by a member of the staff of the responsible body, the responsible body must, where its initial investigation determines that there has been moderate or severe harm or death, advise the patient to whom the concern relates, or his or her representative, of the notification of the concern and involve the patient, or his or her representative, in the investigation of the concern’.
The Welsh Government’s Health and Care Standards Framework, includes a standard called ‘listening and learning from feedback’. In meeting this standard, the framework advises that ‘health services are open and honest with people when something goes wrong with their care and treatment’. The standards provide a framework for how services are organised, managed and delivered on a day-to-day basis.
The Minister for Health and Social Services has confirmed that findings from the recent independent reviews of complaints handling by NHS Wales and of Healthcare Inspectorate Wales will inform an NHS Wales Quality Bill Green Paper by the end of 2015, which is likely to include further consideration of a duty of candour.