Candour In Healthcare: A Legal Duty's Evolution

The duty of candour is a legal obligation imposed on healthcare professionals and organisations to be open and honest with patients when something goes wrong with their treatment or care. The duty of candour was introduced in the UK as part of the Health and Social Care Act 2008 and came into effect for NHS bodies in 2014 and for all other bodies regulated by the Care Quality Commission (CQC) in 2015. The duty of candour requires healthcare workers to inform patients, or their representatives, about incidents that have occurred, provide reasonable support, offer truthful information, and a timely apology. Organisations that fail to comply with the duty of candour may be subject to fines and other enforcement actions.

Duty of candour regulations

The duty of candour is a regulation under the Health and Social Care Act 2008 and a crucial part of care. It is now embedded into the NHS contract and Care Quality Commission (CQC) regulations. The duty of candour is the obligation placed upon healthcare professionals and organisations to be open and honest when something goes wrong.

The duty of candour regulations apply as soon as reasonably practicable after the screening service has become aware that a notifiable safety incident has occurred. A notifiable safety incident is an unintended or unexpected incident that occurred during a regulated activity and has, or might, result in severe harm or death.

The duty of candour is made up of two duties: professional and statutory. The professional duty of candour states that all healthcare professionals must tell the service user, or their family, advocate or carer, when something has gone wrong. This is regulated by specific healthcare professions such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC) and the General Dental Council (GDC).

The statutory duty of candour was introduced after the professional duty of candour and also aims to ensure care providers are open and transparent. It covers all care providers registered with and regulated by the CQC. The statutory duty of candour contains specific requirements for situations known as notifiable safety incidents. For nurses, both the professional and statutory duty of candour apply.

The duty of candour regulations outline the following requirements for care providers:

• Notify the appropriate person, explaining what is known about what happened and offering an apology.
• Put the notification in writing and inform the appropriate person about the investigation that will be carried out.
• Explain the potential short- and long-term effects of what has happened.
• Feed back the findings of the investigation to the appropriate person.
• Provide reasonable support.
• Provide truthful information.

The duty of candour is an important element of providing high-quality care. It allows for steps to be taken to mend the relationship between the service user and the care provider, and ensures the service user and their family are not left in the dark about an incident. It also allows care providers to offer guidance, support and remedies, and to take internal action to prevent the mistake from occurring again.

Duty of candour and NHS screening programmes

The duty of candour is a legal obligation imposed on all NHS and non-NHS providers of services to NHS patients in the UK. It requires providers to be open and transparent, following specific guidelines when issues arise with care and treatment. This includes informing patients about incidents, providing support, and offering truthful information and apologies when necessary. The duty of candour is outlined in Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

The duty of candour applies to NHS screening programmes, aiming to ensure openness and transparency for individuals undergoing screening. However, distinguishing between false negatives/positives due to screening limitations and those resulting from errors can be challenging.

Notifiable Safety Incidents

Notifiable safety incidents refer to unintended or unexpected incidents that occur during the provision of a regulated activity, which could or have resulted in severe harm, moderate harm, or prolonged psychological harm to the service user. When a patient experiences moderate or serious harm during screening, a review (audit) should be conducted. If the audit reveals that something went wrong in the screening process, it is treated as a notifiable safety incident, triggering the duty of candour regulations.

Guidance for Screening Services

Screening services should inform individuals about the potential harms and benefits of screening. They should also disclose that the screening programme may not always detect the condition or risk factor. When an individual is diagnosed after a negative screening result, the service should initiate a review and provide the findings to the individual upon request.

Audits

Audits are crucial for identifying potential problems and improving the screening process. They should focus on the specific steps where errors may have occurred, such as the screening test or diagnostic element. If the audit uncovers a process failure or interpretation performance below the expected standard that contributed to serious or moderate harm, it is recorded as a notifiable safety incident, triggering the duty of candour regulations.

Disclosing Audit Results

When disclosing audit results, it is essential to consider the individual's needs, health literacy, and psychological requirements. Clinicians should offer individuals the opportunity to have a friend, relative, carer, or advocate present during discussions. They should also respect the individual's wishes if they decline the information.

Breast Screening Example

Public Health England (PHE) published a toolkit and e-Learning module to support breast screening services in communicating information about interval cancers to women previously screened. The toolkit includes an information flyer for women diagnosed with breast cancer between screening appointments, providing guidance on communication, disclosure, and best practices.

Supporting a culture of openness and transparency

The duty of candour is a regulation under the Health and Social Care Act 2008 and a crucial part of care. It is now embedded in the NHS contract and Care Quality Commission (CQC) regulations. The duty of candour requires healthcare workers to be open and honest with patients when something goes wrong with their treatment or care. It is a legal obligation that care providers must inform the people affected by the incident, offer reasonable support, provide truthful information and a timely apology.

The concept of being open and honest when something goes wrong during treatment or care has been expected of professionals for a long time, however, it wasn’t specifically enforced or regulated. Therefore, the CQC introduced the duty of candour as a regulation that came into effect for NHS bodies in 2014 and all other bodies regulated by CQC in 2015. This ensures that every care professional carries out the duty of candour to the same standards.

The duty of candour is an important element of providing high-quality care. Service users and their loved ones deserve to know the details of the care they are receiving and the truth about any incidents that occur. It is also a key part of providing person-centred care by respecting service users through honesty and involving them in their care.

A survey conducted by the Behavioural Insights Team in 2018 revealed that only 31% of medical patients felt they received an apology after a mistake. 63% of patients were given no explanation, and 71% believed the organisation did not conduct an investigation into their incident. This highlights the importance of the duty of candour to ensure patients do not feel left in the dark or misled when it comes to medical accidents or incidents.

A crucial part of the duty of candour is apologising. Apologising acknowledges that something could have been better and is the first step to learning from the incident and preventing it from reoccurring. However, it is important to note that while apologising is always the right thing to do, it is not an admission of liability.

The duty of candour also allows for steps to be taken to mend the relationship between the service user and the care provider after an incident. It ensures that the service user and their family or carers are not left in the dark over an incident and that they receive a genuine apology for what happened from the people involved. Care providers are able to offer guidance and support, or remedy the mistake, and take internal actions to prevent the mistake from occurring in the future.

Understanding duty of candour legislation is incredibly important for anyone working in health and social care. This will help them to prepare for potential incidents where they will need to put this guidance into practice. The duty of candour is part of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. It sets out specific requirements that providers must follow when things go wrong in treatment or care, ensuring that care providers are open and transparent with service users, their family, carers and advocates.

When to apply duty of candour

The duty of candour should be applied when something goes wrong with a patient or service user's care, which results in harm. Harm can be organised into different severities ranging from moderate to severe, and even resulting in death.

• Moderate harm: A service user with hay fever was advised by a pharmacist to take antihistamines every eight hours. This information was not passed on to other staff or updated in their care plan, and the user went without antihistamines for 24 hours, suffering from allergies as a result.
• Severe harm: An occupational therapist advised that grab rails were needed in a service user's bathroom, and that staff should support the user with washing until the rails were installed. Staff forgot to assist the user the next morning, and the user fell while getting out of the bath, breaking their arm.
• Death: Staff were treating a service user for a small scratch on their arm, wearing latex gloves. The staff member was unaware of the user's latex allergy, and the user suffered anaphylactic shock and passed away.

In all of these cases, the incident meets the criteria of a 'notifiable safety incident', and therefore the duty of candour procedures should be followed.

A 'notifiable safety incident' is defined as an unintended or unexpected incident that occurs during a regulated activity and has resulted in, or might result in, severe harm or death.

It is important to note that even if an incident does not qualify as a notifiable safety incident, there is still an overarching duty of candour to be open and transparent with people using the service.

How to disclose audit results

In the UK, the duty of candour is a legal requirement imposed on all NHS and non-NHS providers of services to NHS patients. It mandates that healthcare providers be open and transparent with patients when things go wrong with their care and treatment. This includes informing patients about incidents, providing reasonable support, and giving truthful information and an apology.

Now, here is a detailed guide on how to disclose audit results, adapted from official guidelines:

• Build a process around the individual's needs: Take into account the patient's health literacy and psychological needs. Consider if they have a mental health issue or disability that may impact their understanding. Involve advocates, key workers, or carers in relevant discussions if needed.
• Prepare the information: Clinicians should read and understand the audit results and information relating to the individual patient before any discussion. Ensure you have a clear understanding of the patient's screening history and the specific steps of the screening pathway.
• Choose the right time and place: Flexibility is important. The disclosure should occur at a time and place that suits the patient's needs. It may be appropriate to wait until after treatment when a rapport has been established with the clinician.
• Offer the presence of a supporter: The patient should be given the option to have a friend, relative, carer, or advocate present during the discussion to provide support.
• Check the patient's understanding: At the beginning of the discussion, check why the patient has requested the information and how much they want to know.
• Discuss the audit results and implications: Go through the relevant reports and explain the implications. Allow the patient time to voice their comments, concerns, and questions. Ensure the patient understands the information presented.
• Respect the patient's wishes: If a patient declines the offer of information, respect their wishes. Make it clear that they can request the information at any time in the future and that this decision will be reviewed a year after diagnosis.
• Document the discussion: Clearly document the results of the discussion in the patient's hospital record. Send a copy of the record to the patient and their GP.

Additionally, when disclosing audit results, it is crucial to maintain confidentiality and protect sensitive information. This is especially important when dealing with privileged materials that may be attractive to third parties, such as litigation adversaries or regulators. In such cases, seeking legal advice and understanding the relevant privileges and protections is essential.

Frequently asked questions