Duty of Candour Policy

Issued: 23/01/2024
Reviewed by: Dr Scaravilli
Next Review Due: January 2025

Introduction

The duty of candour is a general duty to be open and transparent with people receiving care from you. It applies to every health and social care provider that CQC regulates. The duty of candour requires registered providers and registered managers to act in a safe, open and transparent way with people receiving care or treatment from them. This statutory duty of candour was brought into law in 2014 for NHS Trusts

• Regulation 20: Duty of candour - Care Quality Commission (cqc.org.uk)-regulation in full.

There are two types of duty of candour, statutory and professional.

• CQC Regulation 20 Duty of candour-regulates statutory duty
• GMC and NMC regulate professional duty.

Definitions

• Openness: enabling concerns and complaints to be raised freely without fear and questions asked to be answered. A culture of “being open” should be fundamental in a Practice’s relationships with (and between) patients, the public, Practice Staff and other healthcare organisations.
• Transparency: allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators.
• Candour: any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it. Duty of Candour Policy Page 3 of 11 The intention is that there is a culture of openness and truthfulness to improving the safety of patients, staff and visitors to the Practice, as well as raising the quality of healthcare systems. If patients or employees have suffered harm as a result of using their services, a Practice should be able to confidently investigate, assess and if necessary apologise for and explain what has happened.

What is a Notifiable Safety incident:

A notifiable safety incident must meet all 3 of the following criteria:

1. It must have been unintended or unexpected.
2. It must have occurred during the provision of an activity regulated by CQC
3. In the reasonable opinion of a healthcare professional, already has, or might, result in death, or severe or moderate harm to the person receiving care. This element varies slightly depending on the type of provider.

If any of these three criteria are not met, it is not a notifiable safety incident but remember that the overarching duty of candour, to be open and transparent, always applies.

This does not mean that known complications or side effects of treatment are always disqualified from being Notifiable Safety Incidents. In every case, the healthcare professionals involved must use their judgement to assess whether anything occurred during the provision of the care or treatment that was unexpected or unintended.

Definition of Harm

• Low: An incident that required extra observation or minor treatment and caused minimal harm, to one or more persons receiving care.
• Moderate: An incident that resulted in a moderate increase in treatment (e.g. increase in length of hospital stay by 4-15 days) and which caused significant but not permanent harm, to one or more persons receiving NHS-funded care.
• Severe: An incident that appears to have resulted in permanent harm to one or more persons receiving care.
• Moderate increase in treatment: An unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care)
• Prolonged pain: Pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.
• Prolonged psychological harm: Psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

Summary of main points

Practices must:

• Acknowledge, apologise and explain when things go wrong;
• Carry out investigations into incidents affecting Patient Safety;
• Provide support for those involved in the incident (patients and staff) to cope with the physical and emotional impact.
• Reassuring patients, families and carers that lessons learned will prevent any patient safety incidents happening in future;
• Report on any incident that falls under the CQC concerns at the earliest opportunity
• Keep a written record of all communication with the relevant person.
• Give a timescale for the enquiries to be made and reported

Saying sorry is:

• always the right thing to do
• not an admission of liability
• fulfils the duty of candour
• acknowledges that something could have gone better
• the first step to learning from what happened and preventing it recurring.”

The Practice must ensure that a meaningful apology is given, in person, by one or more appropriate representatives of the Practice to relevant persons. An apology is defined in the regulation as an expression of sorrow or regret. The NHS Resolutions has produced guidance on making an apology, NHS Resolution - Saying Sorry.

When Incident has occurred

The relevance of the Duty of Candour begins with an acknowledgement that as the result of a safety incident, a patient has suffered moderate or major harm, or has died.

As soon as an incident has occurred or been identified;

• Clinical care must be administered to prevent further harm.
• If any additional treatment is necessary, it should happen as soon as reasonably practicable after discussing with the patient (or carer if the patient is unable to participate in discussion) and with the appropriate consent.

Moderate / severe incidents, or any incidents that result in the death of a patient, must be reported to the patient or next of kin (with the appropriate consent) within a maximum of 10 working days from the incident being reported.

The initial notification of the incident must be verbal (face to face where possible), unless the patient/carer/family cannot be contacted or decline notification.

The Patient/Carer must be offered a written notification of the incident along with a sincere apology. A step -by-step explanation of the incident must be offered as soon as it is practicably possible, even if this is an initial view pending investigation of the incident.

The Practice must maintain full written documentation of any letters, discussions, and meetings during this investigation, including the response from any of the patients/carers. If any meetings or interviews are offered and declined, then there must be a record of this.

Once the investigation has been completed and a final report has been made, the results should be shared with patient/relatives/carers within 10 working days. The Practice is not required by the regulation to inform a person using the service when a ‘near miss’ has occurred, and the incident has resulted in no harm to that person.

There must be appropriate arrangements place to notify the person using the service who is affected by an incident if they are;

• 16 years and over and
• lack capacity to make a decision regarding their care or treatment (as determined in accordance with sections 2 and 3 of the 2005 Mental Capacity Act)

This includes ensuring that a person acting lawfully on their behalf (e.g. persons acting as Carer) is notified as the relevant person.

A person acting lawfully on behalf of the person (e.g. persons acting as Carer) using the service must be notified as the relevant person where the person using the service is under 16 and not competent to make a decision regarding their care or treatment. A person acting lawfully on behalf of the person (e.g. persons acting as Carer) using the service must be notified as the relevant person, upon the death of the person using the service.

Other than the situations outlined above, information should only be disclosed to family members or carers where the person using the service has given their express or implied consent.

In making a decision about who is most appropriate to provide the notification and/or apology, the Practice should consider seniority, relationship to the person using the service, and experience and expertise in the type of notifiable incident that has occurred. The Practice must give the relevant person all reasonable support necessary to help overcome the physical, psychological and emotional impact of the incident.

This could include all or some of the following:

• Treating them with respect, consideration and empathy.
• Offering the option of direct emotional support during the notifications, for example from a family member, a friend, a care professional or a trained advocate.
• Offering access to assistance with understanding what is being said e.g. via interpretative services, non-verbal communication aids, written information, Braille etc.
• Providing access to any necessary treatment and care to recover from or minimise the harm caused where appropriate.
• Providing the relevant person with details of specialist independent sources of practical advice and support or emotional support/counselling.
• Providing the relevant person with information about available impartial advocacy and support services, their local Healthwatch and other relevant support groups, for example Cruse Bereavement Care and Action against Medical Accidents (AvMA)Overview - Action Against Medical Accidents (AVMA) - NHS, to help them deal with the outcome of the incident.
• Arranging for care and treatment to be delivered by another professional, team or provider if this is possible, should the relevant person wish.
• Providing support to access its complaints procedure.

The Practice must ensure that written notification is given to the relevant person following the notification that was given in person, even though enquiries may not yet be complete.

The written notification must contain all the information that was provided in person including an apology, as well as the results of any enquiries that have been made since the notification in person.

The outcomes or results of any further enquiries and investigations must also be provided in writing to the relevant person through further written notifications, should they wish to receive them.

The Practice must make every reasonable attempt to contact the relevant person through all available communication means. All attempts to contact the relevant person must be documented.

If the relevant person does not wish to communicate with the Practice, their wishes must be respected and a record of this must be kept. If the relevant person has died and there is nobody who can lawfully act on their behalf, a record of this should be kept

Appendix 1: Actions and Timescales for Duty of Candour requirements

Requirement under Duty of Candour

Patient or their family/carer informed that incident has occurred (moderate harm, severe harm or death)

Timeframe

Maximum 10 working days from incident being reported

Requirement under Duty of Candour

A verbal notification of incident (preferably face-to-face where possible) unless patient or their family/carer decline notification or cannot be contacted in person. A Sincere expression of apology must be provided verbally as part of this notification.

Timeframe

Maximum 10 working days from incident being reported

Requirement under Duty of Candour

Offer of written notification made. This must include a written sincere apology.

Timeframe

Maximum 10 working days from incident being reported

A record of this offer and apology must be made (regardless if it has been accepted or not)

Requirement under Duty of Candour

Step-by-step explanation of the facts (in plain English) must be offered.

Timeframe

As soon as practicable This can be an initial view, pending investigation, and stated as such to the receiver of the explanation.

Requirement under Duty of Candour

Maintain full written documentation of any meetings.

Timeframe

No timeframe

If meetings are offered but declined this must be recorded

Requirement under Duty of Candour

Any new information that has arisen (whether during or after investigation) must be offered.

Timeframe

As soon as practicable

Requirement under Duty of Candour

Share any incident investigation report (including action plans) in the approved format (Plain English)

Timeframe

Within 10 working days of report being signed off as complete and closed

Requirement under Duty of Candour

Copies of any information shared with the patient to the commissioner, upon request.

Timeframe

As necessary