Duty of Candour Policy

The Women’s Clinic adheres to the procedures set out in the Duty of Candour Procedure (Scotland) Regulations 2018, which came into force on 1 April 2018 and which is part of The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016. We are also compliant with the Scottish Government’s March 2025 revised guidance for Organisational Duty of Candour.

The act and these regulations require organisations providing health services, care services and social work services in Scotland to follow a formalised procedure when there has been an unintended or unexpected incident that results in death or harm (or additional treatment is required to prevent injury that would result in death or harm).

The purpose of this new duty is to ensure that providers are open, honest, supportive, and providing a person-centered approach. Below we show what these procedures are and, in the footer, we provide a link to the full and detailed Duty of Candour guidelines published by the Scottish Government.

About the Duty of Candour

The key principle of the duty of candour is that care organisations have a general duty to act in an open and transparent way in relation to care provided to patients. The statutory duty applies to organisations, not individuals.

When must the duty of candour procedure be activated?

Organisations (as responsible persons) must activate the duty of candour procedure as soon as reasonably practical after becoming aware that:

• an unintended or unexpected incident occurred in the provision of the service provided by the organisation as the responsible person.
• in the reasonable opinion of a registered health professional, not involved in the incident, that outcome relates directly to the incident rather than to the natural course of the person’s illness or underlying condition.

The relevant outcomes are as follows:

• A. The death of the person.
• B. Permanent lessening of bodily, sensory, motor, physiologic or intellectual functions (including removal of the wrong limb or organ or brain damage) (“severe harm”).
• C. Harm which is not severe harm but which results in one or more of the following criterion:
  • 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.
• D. The person requires treatment by a registered health professional in order 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 in paragraph B or C.

It is important to note that where the duty of candour procedure start date is later than one month after the date on which the incident occurred, an explanation of the reason for this has to be provided to the relevant person.

Procedure

All staff have a responsibility to adhere to the policy and procedures around duty of candour, regardless of seniority or permanency.

As soon as reasonably practical after becoming aware that a safety incident has occurred that falls into the moderate harm or more serious categories the healthcare professional must-

1. Notify the ‘relevant person’ (this is usually the patient but may in some circumstances be the relative, carer, or advocate) that the incident has occurred and;
2. Provide reasonable support to the relevant person in relation to the incident

The notification must:

• (a) Be given in person by one or more members of staff
• (b) Provide an account of all the facts known about the incident to date
• (c) Advise the person what further enquiries into the incident will be undertaken
• (d) Include an apology and/or a sincere expression of regret, and;
• (e) Be recorded in writing in the notes

This notification must be followed up in writing to the relevant person.

The member of staff should be clear in the first meeting that the facts may not yet have been established, tell the relevant person only what is known and believe to be true, and answer questions honestly and as fully as they can.

The aim of the Duty is to ensure that patients are told when harm occurs because of the care they receive. Where the degree of harm is not yet clear but may fall into the moderate or above categories, then the relevant person must be notified.

It is not necessary to inform a person where a ‘near miss’ has occurred, so long as the incident has resulted in no harm to the person.

Arrangements must be in place to notify a person affected by an incident who lacks capacity to decide about their care, including ensuring that a person acting lawfully on their behalf is notified, as the relevant person.

Other than in the exceptions outlined above, information should only be disclosed to family members or carers where the service user has given express or implied consent.

The information must be given in a manner that the relevant person can understand, and if necessary, assisted by interpreters, advocates, or other communication aids, having given due consideration to breaches of confidentiality.

• The information should also include what further enquiries are to be made (if any).
• The clinic will also ensure that a meaningful apology is given.
• We will also ensure that all reasonable support is provided to the relevant person to help them overcome the physical, psychological, and emotional impact of the incident, including:
  • Treating the person with respect, consideration, and empathy
  • Offering direct emotional support during the process of notification, perhaps from a family member, friend, care professional or advocate
  • Offering help to understand what is being said, perhaps through an interpreter, nonverbal communication aids, Braille etc.
  • Providing access to treatment and care to recover from or minimise the harm caused if appropriate. Following the notification in person, written notification will also be provided, even though enquiries may not yet be complete. The written notification must contain all the information that was given in person, including an apology, as well as the results of any enquiries that have been made since the face to face meeting.

Section 23(1) of the Act states that “an ‘apology’ means a statement of sorrow or regret in respect of the unintended or unexpected incident.” The Act sets out that “‘an apology’ or other step taken in accordance with the duty of candour procedure does not of itself amount to an admission of negligence or a breach of a statutory duty.”

Responsibilities and information

After becoming aware that a notifiable safety incident has occurred,

• Notify the relevant person as soon as is reasonably practicable.
• Provide reasonable support, such as providing an interpreter for any discussions, or giving emotional support to the patient.

Notification must:

• Be given in person by at least one representative of the clinic with the incident
• Provide a true and correct account of the incident
• Provide advice on what further enquiries into the incident are needed
• Include an apology
• Be recorded in a written record, which should be kept securely

Reference:

Organisational Duty of Candour guidance March 2025 Scottish Government