Know your duty? Duty of Candour requirements & the NHS in Wales
Building on Putting Things Right, in April 2023 the statutory duty of candour came into force in Wales requiring all NHS bodies to be open and honest with service users when things go wrong – supporting existing healthcare professional duties.
From 1 April 2023, all Welsh NHS bodies including LHBs, Trusts, Special Health Authorities (including NHS Blood and Transplant in relation to its Welsh functions) and primary care providers in Wales in respect of the NHS services they provide are under a legal requirement to exercise a duty of candour. The duty is triggered not only when harm is known to have occurred but in cases where harm could occur in the future. The duty applies at an organisational level, and not on individual health care staff.
The Duty of Candour, Wales
The duty, introduced by the Health and Social Care (Quality and Engagement) (Wales) Act 2020 (“the Act”), requires Welsh NHS Bodies to:
- talk to service users about incidents that have caused harm;
- apologise and support them through the process of investigating the incident;
- learn and improve from these incidents; and
- find ways to stop similar incidents from happening again.
The duty requires NHS providers to follow the process, set out in The Duty of Candour Procedure (Wales) Regulations 2023 (“the Regulations”), when a service user suffers an adverse outcome which has or could result in unexpected or unintended harm that is more than minimal and the provision of health care was or may have been a factor. The focus is on organisational learning and improvement, rather than blame, so breach of the duty is not a criminal offence in and of itself. The duty is placed on NHS Wales at an new = organisational level and is intended to complement existing professional duties of candour – see for example the GMC & NMC joint guidance joint guidance on the professional duty of candour.
Welsh Minsters have also exercised their powers under the Act to issue statutory Duty of Candour Statutory Guidance 2023 to Welsh NHS bodies (“the Guidance”) which details that the duty is triggered when:
- i. a service user has suffered an adverse outcome that is of a moderate degree or more serious; and
- ii. the provision of health care was or may have been a factor in the adverse outcome.
The Guidance was developed with stakeholders as is designed to be a practical document to aid in the implementation of the duty and provides guidance on what “more than minimal harm” means near miss incidents such as the administering of the wrong medication that was averted or disease progression is not considered to trigger the duty.
The duty of candour is triggered where the provision of the health care was or may have been a factor in the service user suffering the outcome with Annex A of the Guidance setting out a helpful flowchart here.
Procedure of notifying service users
The Regulations set out that Welsh NHS bodies will need to evidence that they have notified the service user or person with authority to action their behalf (if they have been assessed to lack capacity to make decisions about their care), upon ‘first becoming aware’ that the duty of candour has come into effect. The NHS body must explain what has happened, what the next steps are and make a meaningful apology “in-person” (which can be over call, video call or face to face). This must be followed up in writing confirming what was discussed within five working days.
NHS bodies will then undertake an investigation (in accordance with the Putting Things Right) to ascertain what happened and how it can be prevented in future – though such investigations must not delay the provision of an “in-person” notification.
Any notification made more than 30 working days after the date the NHS body first became aware of a ‘notifiable adverse outcome’ will require an explanation. NHS bodies must provide staff who are involved in a ‘notifiable adverse outcome’ with details of support services, and that these should take the circumstance of the incident and the staff member’s own needs into account.
Data and reporting
Welsh NHS Bodies must be mindful of and comply with UK GDPR obligations when investigating incidents and processing personal data. They may use the Datix Cymru reporting and management digital platform for incidents and concerns, however this is not mandatory. Records made in relation to the incident may be disclosable to the individual under UK GDPR (if their personal data) or to the general public under the Freedom of Information Act 2000 (if not personal data). Staff should also involve their organisation’s Data Protection Officer (when a notifiable adverse outcome appears to involve a personal data breach as there may also trigger reporting requirements to the Information Commissioners Office).
NHS bodies will be required to keep accurate records and report annually on their compliance with the duty.
Governance considerations
Welsh NHS Bodies should integrate and monitor the effective implementation of the the duty of candour into existing corporate governance frameworks, processes and procedures. Assurance should be sought to confirm that all elements of the procedure are being implemented when they should be, and that there are ways of supporting continuous improvements so as to discharge legal responsibilities.
Welsh Government will monitor the content of the annual reports alongside other sources of information, such as serious incidents reported in line with the National Patient Safety Incident Reporting policy. Compliance with the duty will also form part of the matters considered by Healthcare Inspectorate Wales (HIW) when inspecting and reviewing the NHS in Wales.
How we can help
Blake Morgan has significant expertise in advising and training on NHS bodies, including primary care providers on their duty of candour, including in relation to complex and cross-border arrangements, services commissioned from non-NHS bodies in Wales and beyond as well as how to investigate complaints or concerns. If you have any questions regarding this, then please do contact Eve Piffaretti, Trish D’Souza or Claire Rawle.
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