The duty of candour provisions in the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill were given Royal Assent in April 2016 and will come into force, alongside the Duty of Candour Procedure (Scotland) Regulations on 1 April 2018. The Act also establishes a new criminal office of ill-treatment or wilful neglect.

The duty of candour covers all health, care and social work services and will require services to take specific steps to act when an unintended or unexpected incident occurs. The test is whether, in the opinion of a registered health professional, the incident appears to have resulted, or could have resulted, in death, permanent lessening of bodily function or some other harm.

The service provider must give an apology, which is defined as “a statement of sorrow or regret” however this in itself will not amount to an admission of negligence or a breach of a statutory duty.

Key differences: Scotland v England & Wales

The implementation of the duty of candour in Scotland follows the same process as was introduced in England and Wales by the Health and Social Care Act 2008 (Regulated Activities) Regulations in 2014 and 2015. However, there are some slight differences:

  • Firstly, the regulations in Scotland are more prescribed than in England and Wales. The Regulations set out the requirements imposed on organisations in the event of a notifiable incident. These regulations cover communication with the person affected, the offer of a further apology, the invitation to a meeting, a review of the circumstances which led or contributed to the incident and the keeping of appropriate written records
  • Secondly, in Scotland, the person determining whether a notifiable incident has occurred must not have been involved in the incident itself
  • Thirdly, in Scotland the person involved in the incident should be given a choice as to whether they want to receive further information about it

Responsible person

The Act and Regulations place a number of requirements upon the “responsible person.” This role covers:

  • A Health Board
  • A person (other than an individual) who has entered into a contract, agreement or arrangement with a Health Board
  • The Common Services Agency for the Scottish Health Service
  • A person (other than an individual) providing an independent health care 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 made arrangements with other person to assist with the provision of the service
  • A person (other than an individual) who provides a social work service

The responsible person is required to ensure all employees who carry out the duty of candour procedure receive relevant training and guidance, and must support any employee who is involved in an incident.

Reporting and compliance

The responsible person must also prepare an annual report on the duty of candour at the end of each financial year. The report must not identify individuals but must contain detail of:

  1. The number and nature of any incidents
  2. An assessment of the extent to which the responsible person followed the required procedure
  3. Information about policies and procedures for identifying and reporting incidents and support available to staff and those affected; and
  4. Changes to policies and procedures as a result of notifiable incidents

On publishing a report, the person responsible must notify either Healthcare improvement Scotland (independent health care service), Scottish Ministers (other health service) or Social Care and Social Work Improvement Scotland (care or social work service).

If organisations have not applied the duty of candour procedure when it appears that they should have or could have, then this will be reviewed through the range of existing mechanisms for reviewing and supporting improvements in the quality of care. The Act confirms that a notice may be served to require the organisation to provide information about any matter relating to their implementation of the duty of candour procedure. Healthcare Improvement Scotland, Care Inspectorate and the Scottish Government are also currently considering recommendations from the Monitoring and Reporting Sub-Group and further information is awaited in relation to this.

In England and Wales the Care Quality Commission (CQC) has the power to take formal regulatory action or prosecute if there is a failure to comply with the duty of candour. However, this is unlikely to occur unless there is evidence of deliberate withholding or manipulation of information. The CQC recognises that a breach of the duty of candour is likely to inform the inspection and monitoring of registered providers, rather than resulting in large numbers of prosecutions.

It appears to be recognised that the threat of criminal prosecution is unlikely to result in the desired culture shift towards openness and transparency.

Practicalities

To ensure compliance with the duty of candour we advise all Scottish care, health and social work providers to take the following practical steps:

  • Preparing guidance documents for all staff on the definition of an unintended or unexpected incident and the steps to be taken when a notifiable incident occurs
  • Training for staff who might be required to offer an apology as to the best way to do this, in an open and patient-focussed way
  • Preparing a template notification letter to be sent to the service user affected to give an account of the incident, explanation of the action to be taken in accordance with the duty of candour procedure and an explanation in the event the notification is more than one month after the date the incident occurred
  • Preparing policy documents setting out a commitment to openness and compliance with the new duty
  • Training to staff members on their role in identifying and reporting notifiable incidents
  • Ensuring adequate support is in place for those invoking the procedure and those affected by the incident
  • Reviewing the way in which best practice and learning points are shared throughout your organisation when incidents of harm occur