Section 3 – When the duty of candour applies
11.This section explains when the duty of candour in Part 3 will apply. When the duty applies, an NHS body must take certain steps in accordance with a procedure set out in regulations made under section 4.
12.For the purpose of this Part an NHS body is a local health board, an NHS trust, a special health authority and a primary care provider. A primary care provider is a person who provides general medical services (GP services), general dental services, general ophthalmic services or pharmaceutical services on behalf of a local health board. In accordance with section 11(7), the application of the duty to special health authorities extends to special health authorities established under section 22 of the National Health Service (Wales) Act 2006, but does not include any cross-border special health authority (within the meaning of section 8A(5) of that Act) apart from NHS Blood and Transplant in relation to the exercise of its functions in Wales.
13.The duty of candour procedure will have to be followed where the two conditions in subsections (2) and (3) are met.
14.The first condition is that the service user to whom health care is being or has been provided by the NHS body has suffered an adverse outcome. A service user is treated as having suffered an 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 meaning of “more than minimal harm” will be set out in guidance issued by the Welsh Ministers under section 10 of the Act. The guidance will be developed having regard to existing definitions of harm, such as those used in the National Reporting and Learning System which is the existing system for reporting adverse patient safety incidents in the NHS. For the purpose of the duty of candour, harm includes psychological harm.
15.The duty is triggered not only when harm is known to have occurred but in cases where harm could occur in the future; for example, where an error in the administration of medication may cause an adverse outcome at a future point. The duty may be triggered by an action taken by an NHS body during the provision of health care or by a failure to take action. The harm must be unintended or unexpected which means that the duty does not apply where undesirable outcomes occur as a result of a medical condition.
16.The second condition is that the provision of the health care was or may have been a factor in the service user suffering the outcome. The outcome must therefore 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, however, be certain that the health care caused the harm; it is sufficient that the health care may have been a factor. The application of the duty does not indicate that the NHS body has acted negligently.