Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 Explanatory Notes

Duty of candour procedure
Section 21 – Incident which activates duty of candour procedure

85.Section 21 describes incidents which give rise to the duty of candour procedure. The responsible person (defined in section 25) is required to follow the duty of candour procedure where the person has provided someone with a health service, a care service, or a social work service, and in the course of providing that service an unintended or unexpected incident has occurred which has resulted in certain outcomes. The outcomes need to relate to the incident rather than being attributable to the person’s illness or condition. The decision as to whether the outcome relates to the incident is to be made by a registered health professional who was not involved in the incident itself.

86.The outcomes are set out in subsection (4) and cover a range of physical and psychological effects as well as death.

87.Subsection (5) provides the Scottish Ministers with the power to make regulations to amend the list of outcomes in subsection (4). Under section 32(2), any such regulations would be subject to the affirmative procedure.

Section 22 – Duty of candour procedure

88.The duty of candour procedure, which covers actions to be taken by responsible persons, will be set out in regulations made using the power in subsection (1). Those regulations will be subject to negative procedure. Responsible persons are defined in section 25(1) and include Health Boards (both territorial and Special Health Boards), the Common Services Agency (which operates under the name of NHS National Services Scotland), independent health care services, local authorities and other providers of care services and social work services. Generally, individuals providing health, care or social work services are not included in the “responsible person” definition. However, for care services, individuals providing a service who make arrangements with others to assist with the provision of the service, are included in the definition of “responsible person”.

89.Subsection (2) gives detail as to what the regulations may, in particular, make provision about. This includes taking actions to meet with and apologise to the “relevant person” (see paragraph 92 below) and provide support to them, as well as asking the “relevant person” whether they would like to receive an account of the incident or information about further steps taken Subsection (2) also includes detail on recording and monitoring incidents and providing training and support to those carrying out the duty of candour procedure.

90.Subsection (3) gives a definition of ‘relevant person’ for the purposes of the section and the duty of candour procedure, which is the person who has received the health service, care service, or social work service, or a person acting on behalf of that person where that person has died or lacks capacity, or for other reasons cannot make decisions about the service provided to them.

Section 23 – Apologies

91.Section 23 defines ‘apology’ in relation to the duty of candour provisions and subsection (2) provides that any apology or other steps taken which are in accordance with the duty of candour procedure set out in regulations made under section 22 cannot be taken by itself to be an admission of negligence or a breach of a statutory duty. This means that there is not to be taken to be a link between giving an apology (or otherwise following the duty of candour procedure) in relation to an incident and acknowledgment of any wrong-doing. This does not prevent individuals affected from taking further action in relation to an incident.

Section 24 – Reporting and monitoring

92.Responsible persons who provide health services, care services or social work services in a financial year are required to prepare and publish reports. These reports are not to identify individuals. The reports must include the following information (but responsible persons can also include other information if they wish)—

  • details about the incidents that have occurred,

  • information on the organisation’s compliance with the duty of candour procedure,

  • information about policies and procedures and whether there have been changes to these policies and procedures resulting from incidents that have occurred.

93.In order to assist with monitoring the extent to which the duty of candour procedure has been followed, there is a power for certain bodies to require responsible persons to provide them with information. These same bodies are to be notified when the annual reports are published. The particular bodies with the power to require information (and who are to be notified) vary depending on the responsible person. So, for example, Health Boards are linked to the Scottish Ministers, independent health service providers are linked to Healthcare Improvement Scotland, while providers of care services or social work services are linked to Social Care and Social Work Improvement Scotland (SCSWIS, which operates under the name of the Care Inspectorate).

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