Organisational duty of candour: guidance

Annex B

Summary of the Duty of Candour Procedure

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 health, care and social work services. The procedure to be followed is set out in the Duty of Candour Procedure (Scotland) Regulations 2018, which comes into effect on 1 April 2018.

The 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 the relevant person in 2015, the Duty of Candour procedure should be activated.

The overall purpose of the 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.

The responsible person

The Act defines the "responsible person" as:

• a Health Board;
• a person (other than an individual) who has 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.

This means that the new Duty applies to organisations and not individuals. It is placed upon health, care and social work organisations.

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.

Incident which activates the duty:

The 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;
• an increase in the person's treatment;
• changes to the structure of the person's 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 in order to prevent:
  • the death of the person; or
  • any injury to the person which, if left untreated, would lead to one or more of the outcomes mentioned above.

The procedure:

The 'duty of candour procedure' means the actions to be taken by the responsible person in accordance with regulations made by the Scottish Ministers. The 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:

(a) to notify the person affected (or family/relative where appropriate);

(b) to provide an apology;

(c) to carry out a review into the circumstances leading to the incident;

(d) to offer and arrange a meeting with the person affected and/or their family, where appropriate;

(e) to provide the person affected with an account of the incident;

(f) to provide information about further steps taken;

(g) to make available, or provide information about, support to persons affected by the incident;

(h) to prepare and publish an annual report on the duty of candour.