Organisational Duty of Candour: non-statutory guidance - revised March 2025

Annex B – Summary of the Duty of Candour Procedure and Key Definitions

The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 received Royal Assent on 6 April 2016 and introduced a new organisational duty of candour on providers of health, care, and social work services. The procedure to be followed is set out in the Duty of Candour Procedure (Scotland) Regulations 2018, which came into force on 1 April 2018.

In this document:

• “care service” has the meaning given by section 47(1) of the Public Services Reform (Scotland) Act 2010, except that it does not include a service mentioned in paragraph (k) of that section (child minding)
• “health service” means services under the health service continued under section 1 of the 1978 Act, and an independent healthcare service mentioned in section 10F(1) of the 1978 Act
• “social work services” has the meaning given by section 48 of the Public Services Reform (Scotland) Act 2010

The organisational duty of candour procedure applies to incidents that the responsible person becomes aware of after 1 April 2018. For example, after 1 April 2018, if the responsible person becomes aware of unexpected psychological harm that occurred because of care provided to a relevant person before 1 April 2018, the organisational duty of candour procedure should be activated.

• “incident” means the unintended or unexpected incident by virtue of which section 21(2) of The Act applies to a person

The overall purpose of the organisational duty of candour is to ensure that organisations are open, honest and supportive when there is an unexpected or unintended incident resulting in death or harm, as defined in The Act.

In this document:

• “The Act” means the Health (Tobacco, Nicotine, etc. and Care) (Scotland) Act 2016
• “The 1978 Act” means the National Health Service (Scotland) Act 1978

The Responsible Person

The Act defines the “responsible person” as:

• a Health Board
• a person (other than an individual) who entered into a contract agreement or arrangement with a Health Board to provide a health service
• the Common Services Agency for the Scottish Health Service
• a person (other than an individual) providing an independent healthcare service
• a local authority
• a person (other than an individual) who provides a care service
• an individual who provides a care service and who employs, or has otherwise made arrangements with, other persons to assist with the provision of that service
• a person (other than an individual) who provides a social work service

The responsible person has responsibility for:

• carrying out the procedure
• undertaking any training required by regulations
• providing training, supervision and support to any person carrying out any part of the procedure as required by regulations
• reporting annually on the duty

Incidents that activates the duty

The organisational duty of candour procedure must be carried out by the responsible person as soon as reasonably practicable after becoming aware that an individual who has received a health, care, or social work service has been the subject of an unintended or unexpected incident, and in the reasonable opinion of a registered health professional has resulted in, or could result in:

• the death of the person
• a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions (“severe harm”)
• harm, which is not severe, but which results in:
  • an increase in the person’s treatment
  • changes to the structure of the persons body
  • the shortening of the life expectancy of the person
  • an impairment of the sensory, motor or intellectual functions of the person which has lasted, or is likely to last, for a continuous period of at least 28 days
  • the person experiencing pain or psychological harm which has been, or is likely to be, experienced by the person for a continuous period of at least 28 days
• the person requiring treatment by a registered health professional to prevent:
  • the death of the person
  • any injury to the person which, if left untreated, would lead to one or more of the outcomes mentioned above
• “registered health professional” means a member of a profession to which section 60(2) of the Health Act 1999 applies

The procedure

• “the procedure” means the actions set out in Regulations 2 to 7 of the Duty of Candour Procedure (Scotland) Regulations 2018

The 2018 Regulations detail the specific actions and recording of information required by the responsible person when carrying out each stage of the procedure.

The key stages of the procedure include:

1. to notify the person affected (or family/relative where appropriate)

2. to provide an apology

3. to carry out a review into the circumstances leading to the incident

4. to offer and arrange a meeting with the person affected and/or their family, where appropriate

5. to provide the person affected with an account of the incident

6. to provide information about further steps taken

7. to make available, or provide information about, support to persons affected by the incident

8. to prepare and publish an annual report on the organisational duty of candour

The relevant person

• “relevant person”, as set out in section 22(3) of The Act means the person who has received the health service, the care service or the social work service, or where that person has died, or is, in the opinion of the responsible person, lacking in capacity or otherwise unable to make decisions about the service provided, a person acting on behalf of that person.

Additional definitions

• “written” includes an electronic communication, as defined in section 15(1) of the Electronic Communications Act 2000
• “procedure start date”, as outlined in The 2018 Regulations, is the date on which an opinion referred to in section 21(2)(b) of The Act is provided to the responsible person
• “provide”, as set out in 25(1) of The Act, in relation to a health service, a care service and a social work service means to carry on or manage such a service