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

13. Records and Reporting

Organisations must keep a written record for each incident where the organisational duty of candour procedure is applied, including a copy of every document or piece of correspondence relating to the procedure. The written record should be retained by the organisation in accordance with the organisation’s local policies and procedures. This could be part of your electronic incident management system or in a SAER core file.

The Act sets out that an organisation (responsible person) that provides a health, care, or social work service during a financial year must prepare an annual report, as soon as reasonably practicable after the end of that financial year. Annual report templates have been provided in Annex E.

Organisations may find themselves, by the time they come to publish their annual report, with procedures partly completed or still underway. In this case, organisations may choose to publish an addendum part way through the year that provides an overview of the cases that have been completed since the report’s publication. An example addendum has been included alongside the report templates (Annex E).

Things to consider:

A responsible person is defined under section 1.1 of this guidance. The definition includes a person (other than an individual) who has entered into a contract agreement or arrangement with a Health Board to provide a health service. This applies to general practitioners, dentists and independent contractors. The mechanism for preparing a report is up to local decision, but responsible persons must ensure a report for their setting is covered. For instance, there may be a process within a board to develop a shared primary care report across all general practitioners.

13.1 What to include in the report

The report must include, in relation to the reporting year:

• information about the number and nature of incidents to which the organisational duty of candour procedure has applied in relation to a health service, a care service, or a social work service provided by the responsible person
• where single incidents have affected multiple people, information on the number of those affected for each occurrence should be detailed
• an assessment of the extent to which the organisation completed the necessary steps required by the organisational duty of candour procedure
• information about the organisation’s policies and procedures in relation to the organisational duty of candour procedure, including information about procedures for identifying and reporting incidents, and support available to staff and to persons affected by incidents
• information about any changes to the responsible person’s policies and procedures as a result of incidents to which the organisational duty of candour procedure has applied
• such other information as the responsible person thinks fit

The report must not mention the name of any individual or contain any information that could identify any individual.

The report must be published in a manner the organisation considers appropriate. It should be published somewhere that is publicly accessible. For instance, clearly signposted on an organisation’s website.

Organisations should include the number of incidents where the procedure is applied (complete and ongoing), in their annual report. However, careful consideration should be given how to publish these figures so as to not to identify individuals. This should be done by taking account of the high level detail provided in reports about categories and the need to balance public interests in the publication of organisational duty of candour reports. They may also wish to report the reasons why organisational duty of candour was not considered to apply for nationally reported incidents. For example, where Category 1 Adverse Events are notified nationally but they have not triggered the organisational duty of candour.

13.2 Notification requirements

When an organisation has published an annual report, they must notify:

• Healthcare Improvement Scotland, in the case of a report published by an organisation which provides a registered independent healthcare service (within the meaning of section 10F(1) of the NHS (Scotland) Act 1978) – Healthcare Improvement Scotland will ask for information about whether registered independent healthcare services have published their organisational duty of candour report in the annual return each year
• Scottish Ministers, in the case of a report published by any other organisation which provides a health service – please send the notification to dutyofcandour@gov.scot
• The Care Inspectorate, in the case of a report published by an organisation which provides a care service or a social work service – The Care Inspectorate will ask for information about whether care and social work services have published their organisational duty of candour report in the first set of Annual Returns following the end of the financial year after which the report must be published.

Healthcare Improvement Scotland, Scottish Ministers and The Care Inspectorate may, for the purpose of monitoring compliance with the organisational duty of candour provisions, serve a notice on an organisation, requiring them to provide information about any of the matters listed in section 13.1, within the time specified in the notice. As a result, they may publish a report on the organisation’s compliance.

Where organisations have published a report that does not include the minimum required information as outlined in The Act, Scottish Government may ask responsible persons for further information as to why this is the case.

The Scottish Ministers, Healthcare Improvement Scotland, and Social Care and Social Work Improvement Scotland may publish a report on compliance with the legal duties on responsible persons under The Act.