Duty of candour
The duty of candour is a legal requirement for NHS bodies in Wales to be open and honest with service users receiving care and treatment. The duty stems from the Health and Social (Quality and Engagement) (Wales) Act which became law in 2020, and becomes operational from 1 April 2023.
All registered doctors are already subject to a professional duty of candour. The GMC guidance states that: Every health and care professional must be open and honest with patients and people in their care when something that goes wrong with their treatment or care causes, or has the potential to cause, harm or distress.
The organisational duty places legal requirements on NHS bodies that broadly complement the existing professional duty, and provides a framework to support organisations to respond appropriately when things go wrong.
The BMA view on the duty of candour
BMA Cymru Wales generally supports the introduction of an organisational-level duty of candour which, implemented appropriately, could play an important role in helping to create an NHS with an operational culture that is not rooted in blame, but supports and encourages learning and improvement.
In responding to consultations on both the Health and Social Care (Quality and Engagement) (Wales) Bill, and the specific draft duty of candour regulations and guidance, BMA Cymru Wales welcomed the aspiration to embed a culture of openness, transparency and candour in the Welsh health and care sectors but also called for mitigations to the potentially burdensome impact of the Bill.
We have expressed particular concerns about the operation of the duty in primary care, as well as calling for further guidance to enable healthcare workers to define the point at which the duty is triggered, and where accountability lies in the interface between primary and secondary care.
We also queried the short timescale in the regulations being laid prior to commencing and whether there would be any implementation period. The Senedd Legislation, Justice and Consultation Committee wrote to the Welsh Government regarding these issues, resulting in a response from the Minister for Health & Social Services.
We remain unconvinced that sufficient changes have been made to fully address our concerns. BMA Cymru Wales will monitor the implementation of the duty, and continue to call for improvements to ensure the valuable aims and ambitions of the duty are realised without unintended consequences and over-burdening of the already stretched workforce.
Duty applies to NHS bodies in Wales
The duty applies to NHS bodies in Wales, defined in regulations as: a Local Health Board, an NHS trust, a Special Health Authority or a primary care provider. For the purposes of the Duty of Candour regulations, primary care providers are defined as NHS bodies for services they provide under a contract or arrangement with a Local Health Board.
Conditions required for duty to be triggered
The duty is triggered when two conditions are met:
- service user to whom health care is being or has been provided has suffered an adverse outcome; and
- the provision of health care was or may have been a factor in the service user suffering that outcome.
A service user is treated as having suffered a notifiable adverse outcome if the service user experiences, or if the circumstances are such that the service user could experience, any unexpected or unintended harm that is more than minimal.
The notifiable adverse outcome must relate to the provision of the care by the NHS body rather than being solely attributable to the person’s illness or underlying condition. It need not be certain that the health care caused the harm; it is sufficient that the health care may have been a factor.
The trigger review is illustrated at Annex A of the statutory guidance.
Harm that is considered ‘more than minimal'
Harm that is, or could be, considered ‘more than minimal’ is set out in guidance. The definition is aimed at capturing unexpected or unintended moderate or severe harm, or death.
Moderate harm may occur if a service user experiences a moderate increase in treatment and significant but not permanent harm, and the care provided by the NHS did or may have contributed. For example, they are given medication despite this being documented in their notes as an allergy, and this leads to a significant reaction requiring four or more days in hospital before recovery.
Severe harm may occur if the service user experiences a permanent disability or loss of function and the NHS care did or may have contributed. For example, they are given medication despite this being documented in their notes as an allergy, and this leads to brain damage or other permanent organ damage.
This definition would also capture instances where NHS care contributed, or may have contributed, to the death of a service user. For example, they are given medication despite this being documented in their notes as an allergy, and this leads to their death.
The broad range of circumstances that medical professionals and services users face make it particularly difficult to provide a clear and consistent definition of harm that is ‘more than minimal, and that is easily applicable in all instances.
Additional resources have been developed to support the decision-making process, including case study examples which can be found in Annex H of the statutory guidance.
The outcome of the duty being triggered
The candour procedure is detailed in regulations and guidance, setting out what the ‘responsible body’ is required to do, and what the ‘relevant person’ can expect to happen, following a notifiable adverse outcome.
The 'responsible body' is the NHS body in relation to which the duty of candour has come into effect and the 'relevant person' is the service user (or someone acting on behalf of that service user, in some instances).
On first becoming aware that the duty of candour applies, the responsible body must notify the service user by telephone, video call or face to face. The responsible body should offer an apology, provide an explanation of what is known at that time, offer support, explain the next steps and provide point of contact details.
The responsible body must then, within five days of the in-person notification, write to the service user confirming the details of the discussion, issuing a written apology, and providing a description of any initial consideration of the adverse outcome.
An investigation must then be undertaken to find out what happened and why, and how it can be prevented from happening again. This should take place according to the NHS Wales ‘Putting Things Right’ Procedure.
Making an apology
An apology is defined in the regulations as an expression of sorrow or regret in respect of the notifiable adverse outcome. An apology or other step taken in accordance with the candour procedure does not amount to an admission of negligence or a breach of a statutory duty.
Other requirements and responsibilities
The responsible body must take reasonable steps to ascertain the relevant person’s preferred method of communication and, and ensure any communication is in a manner that the relevant person can understand.
The responsible body must keep a written record of notifiable adverse outcomes where the candour procedure is followed. This must include all documents and correspondence related to the adverse outcome, such as records of attempts to contact the relevant person and all documentation relating to the investigation.
The responsible body must ensure that staff receive relevant training and guidance on the candour procedure. This includes those involved in the provision of health care, those involved in investigating or managing notifiable adverse outcomes and any other relevant members of staff who are involved in performing or exercising functions in connection with the candour procedure.
For primary care providers, an online training package will be available including a short awareness video for all staff to view with general principles and guidance on candour and a much fuller education package for those individuals likely to be involved in processing candour incidents or liaising with those patients affected.
Each responsible body must designate a person to be responsible for maintaining a strategic oversight of its operation of the candour procedure. Where the responsible body is a Local Health Board, an NHS Trust or a Special Health Authority, that person must be one of its non-officer members or non-executive directors, as appropriate.
Alongside this, each responsible body must designate a “responsible officer” to take overall responsibility for the effective day-to-day operation of the candour procedure and ensure that the responsible body complies with the regulations. In the case of a Local Health Board, NHS Trust or Special Health Authority, the responsible officer must be a person who is an officer member or executive director of that body.
In the case of a primary care provider, the responsible officer will typically be one of the partners in the GP practice or the sole partner for single handed practices. The functions of the responsible officer may be performed by any person they authorise to act on their behalf, provided that the person is under the direct control and supervision of the responsible officer.
Under the duty, NHS bodies will be required to report annually on compliance with the duty and publish their reports. Primary care providers must provide its report as soon as practicable after the end of each financial year. LHBs will be required to collate information from primary care providers from whom they commission services and publish a combined report.
Reports are required to set out whether the duty of candour has applied during the year, how often, a brief description of the circumstances in each case, and a description of the steps taken by the provider with a view to preventing similar circumstances from arising in the future.
Primary care providers will be expected to complete an annual report to their health board on whether the duty of candour has come into effect by 30 September each year.
It is anticipated that the updated Datix Cymru system (available to all bodies covered by the duty) whilst not mandatory, will help to support record management and inform the development of annual reports without creating additional burdens.