Duty of Candour: Frequently Asked Questions

Summary

These FAQs on the Duty of Candour were produced by the Patient Safety Management Network in collaboration with experts from the Care Quality Commission (CQC) and NHS Resolution, and address the most pressing concerns about Duty of Candour.

Read more about how and why these FAQs were developed.

Content

These FAQs should be read in conjunction with the published CQC guidance Regulation 20: Duty of Candour and are accurate as of March 2025. Any updates to the CQC guidance beyond this date will not necessarily be reflected in these FAQs and the CQC guidance should be the primary source of guidance. 

You can download a pdf of the FAQs here:

PSMN_Duty of Candour FAQs_040425.pdf

The Professional Duty of Candour

1.    What is the Professional Duty of Candour?

The Professional Duty of Candour applies to individual healthcare professionals, requiring them to be honest with patients when something goes wrong with their care. This includes taking responsibility, apologising, explaining what happened and working to prevent future occurrences. It is enforced by professional regulatory bodies such as the General Medical Council (GMC) and the Nursing and Midwifery Council (NMC).

The Statutory Duty of Candour – an outline

2.    What is the Statutory Duty of Candour?

The Statutory Duty of Candour applies to every health and social care provider that the Care Quality Commission (CQC) regulates. It is a legal obligation that requires registered providers and registered managers (known as ‘registered persons’) to act in an open and transparent way with people receiving care or treatment from them.

3.    Who does the Statutory Duty of Candour apply to?

The Statutory Duty of Candour applies to all health and social care providers regulated by CQC. This includes NHS and private healthcare organisations, care homes and other regulated services.

4.    When must the Statutory Duty of Candour be applied?

There are two parts of the Statutory Duty of Candour:

• The overarching duty to be open and transparent with people receiving care. This part applies at all times, in all cases.
• Notifiable Safety Incidents (NSI). Where an NSI has occurred, the regulation specifies exactly how the Duty of Candour must be applied.

The Statutory Duty of Candour – What is a Notifiable Safety Incident (NSI)?

5.    What is a NSI?

A NSI is a specific term defined in the regulations and it should not be confused with other types of safety incidents or notifications. An NSI must meet all of three of the following criteria:

1. It must have been unexpected or unintended
2. It must have occurred during the provision of an activity regulated by CQC
3. In the reasonable opinion of a healthcare professional, it already has, or might, result in death, or severe or moderate harm to the person receiving care. The levels of harm are defined differently depending on the type of provider, as set out in Table 1 below, but mean it is possible to trigger the harm threshold for NHS trust, but not for other service types, or vice versa.

Table 1

6.      What does the first criterion about unintended or unexpected mean? What does it mean in relation to known complications?

The CQC guidance states:

You should interpret "unexpected or unintended " in relation to an incident which arises in the course of the regulated activity, not to the outcome of the incident. By "regulated activity" we mean the care or treatment provided. By "outcome" we mean the harm that occurred or could have occurred. So, if the treatment or care provided went as intended, and as expected, an incident may not qualify as a Notifiable Safety Incident, even if harm occurred.

 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.

Additionally, CQC guidance states that an NSI can still occur even if a patient consented to the procedure.

Take these hypothetical scenarios, which illustrate the potential difference:

• Case A – A patient undergoes hip replacement surgery. A recognised complication is a venous thrombo-embolism (VTE) (blood clot). The consent process was followed and the risk was clearly explained. The patient received all appropriate chemical and mechanical prophylaxis and the surgery went as intended. However, the patient suffered a stroke.
• Case B – The circumstances are the same as Case A, however, this patient did not receive prescribed chemical prophylaxis.

In Case A, although harm occurred, it occurred in relation to the outcome; that is, nothing unintended or unexpected happened in the care and treatment provided that contributed to that harm. In Case B, the same harm occurred but something unintended or unexpected happened in the care and treatment (prescribed prophylaxis was not given) that contributed to the harm.

The provider would be required to act in an open and transparent way in both cases (the first part of the Statutory Duty of Candour), but Case B is also a Notifiable Safety Incident and therefore specific actions must be taken.

7.    What does the second criterion about a regulated activity mean?

Providers must register with CQC if they provide one or more of the Regulated Activities set out in Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. A description of each of the Regulated Activities is available in CQC’s Scope of Registration Guidance.  

8.    Is a patient receiving a regulated activity as soon as they call 999?

Once the 999 call is transferred to the ambulance service then yes, this is captured under the Regulated Activity for Transport Services, Triage, and Medical Advice Provided Remotely.

 9.    Under criterion 3, what is considered ‘reasonable’ in determining harm levels?

The ‘reasonableness’ is about whether, given the same information, another healthcare professional would come to the same conclusion. 

10. Should ambulance services contact receiving hospitals to confirm the level of harm?

It would not be reasonable to expect a service to routinely commission advice from an external healthcare provider in order to answer this question in every case (although there may some incidents where this is done). It is possible that a receiving provider may be of the opinion that something in the ambulance service’s care and treatment contributed to harm, in which case they should follow the CQC Guidance: NSI occurred in a different provider:

“If you discover a notifiable safety incident that occurred in a different provider, you should inform the previous provider.

You must also be open and transparent with the person receiving care about whatever you have discovered. But you do not need to carry out the specific procedures relating to notifiable safety incidents.

The provider where the incident happened must carry out the notifiable safety incidents procedures.”

 11. Are incidents that trigger professional Duty of Candour always NSIs?

No. An incident must meet all three NSI criteria to qualify. Some incidents may require professional openness without meeting NSI thresholds.

 The Statutory Duty of Candour – What to do if an NSI occurs

12. What actions are required if an NSI has occurred?

If a NSI has occurred, the provider must, as soon as reasonably practicable:

• Tell the relevant person (the service user who was harmed or someone acting lawfully on their behalf), in person, that an NSI has occurred.   
• Apologise for what happened.
• Provide a true account of what happened, explaining what you know at that point.
• Explain to the relevant person what further enquiries or investigations you believe to be appropriate.
• Follow up by providing this information, and the apology, in writing, and provide an update on any enquiries.
• Keep a secure written record of all meetings and communications with the relevant person.

Duty of Candour is complete once all the above steps have been followed. Any new information that comes to light at a later date may require further communication with the relevant person. If the relevant person cannot, or refuses to, be contacted, then you may not be able to carry out the actions outlined above, but you must keep a written record of all attempts to make contact.

Throughout this process you must give reasonable support to the relevant person, both in relation to the incident itself and when communicating with them about the incident. This will vary with every situation but could include, for example:

• Environmental adjustments for someone who has a physical disability.
• An interpreter for someone who does not speak English well.
• Information in accessible formats.
• Signposting to mental health services.
• The support of an advocate.
• Drawing their attention to other sources of independent help and advice.

13. What does ‘as soon as reasonably practicable’ mean? Why are there no defined timescales?

Providers are expected to act promptly as soon as an NSI has been discovered. No defined timescales are given as each NSI, and the circumstances of the relevant person who has been affected, will be different. For example, the relevant person may not be contactable for a period of time.  

14. Does the apology for a NSI have to be given face-to-face?

The legislation states that the apology must be given in person and the CQC guidance interprets this as face-to-face; so that should be the case where possible, if it best meets the needs of the service user. However, if face-to-face is not possible or not in the best interest of the service user, it may be given in person another way, such as by telephone or virtually. The key principle is ensuring openness and transparency.

15. Is an apology an admission of liability?

No, an apology under the Duty of Candour is not an admission of legal liability. In many cases it is the lack of a timely apology that pushes people to take legal action. NHS Resolution’s ‘Saying Sorry’ leaflet confirms that apologising will not affect indemnity cover.

16. Can NHS Resolution’s 'Being Open' be used instead of Duty of Candour to simplify compliance?

No. The statutory Duty of Candour has two parts:

1. A general duty to be open and transparent at all times.
2. A specific process that must be followed if an NSI occurs.

Being Open aligns with part one but does not replace statutory obligations in relation to NSI.

The Statutory Duty of Candour – Illustrative examples

17. Whose responsibility is it to enact Duty of Candour when ambulances are delayed because of waits in other providers, and there is no learning for the ambulance services to share?

Duty of Candour is primarily about being open and transparent with service users, which may involve an element of sharing learning, but that is not the primary driver and therefore ‘not having any learning’ does not mean that the duty is not triggered. The specifics of the regulation still need to be carried out if it is an NSI. In this scenario, the requirement to tell the relevant person about the appropriate enquiries or investigations might, for example, include work being done across the system to reduce waits.

18. How does Duty of Candour apply to delays in diagnosis or treatment?

In terms of the unexpected or unintended criterion, there is the need to consider whether the delay contributed to the harm experienced. If the delay did not affect the patient outcome, then it is unlikely to meet this criterion.

19. Should a follow-up letter be sent if a porter apologises for accidentally injuring a patient by catching their arm?

A letter is only required if the incident is a NSI. It seems unlikely that the harm levels would be met in this scenario, but if they are (and the other criterion are also met) then it would be a NSI and all actions, including following up the face-to-face notification with a written letter, must be carried out.

20. Who is responsible for informing a patient’s family if an incorrect ambulance referral results in death?

In this scenario, the receiving provider should inform the referring provider that they believe an NSI has occurred (see question 10). The referring provider can assess whether the incident is an NSI and it is they who should carry out the specifics of the regulation as required.  

The Statutory Duty of Candour – the role of CQC

21. How is the Statutory Duty of Candour enforced?

The ultimate responsibility for ensuring the Statutory Duty of Candour is carried out rests with the registered provider or manager. Where CQC believe that it is not happening, they can use powers of enforcement, including action plan requests, warning notices, imposition of conditions and criminal prosecution. Any decisions will follow CQC’s Enforcement Policy and Decision Tree.

Regulatory bodies such as the CQC in England, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, and the Regulation and Quality Improvement Authority (RQIA) in Northern Ireland monitor compliance.

The Statutory Duty of Candour – interactions with the Patient Safety Incident Response Framework (PSIRF)

22. If an incident is not a NSI, should the patient still be involved in the investigation?

Yes. PSIRF promotes compassionate engagement. Patients should be given an informed choice about their level of involvement in a learning response, as set out in the ‘Engaging and involving patients, families and staff following a patient safety incident’ guidance.

23. How does Duty of Candour, PSIRF and compassionate engagement align?

• Duty of Candour ensures openness and transparency, requiring healthcare providers to inform, apologise, and support patients and families after a NSI.
• PSIRF shifts focus from blame to learning and improvement, ensuring proportionate responses to patient safety incidents rather than automatic investigations.
• Compassionate engagement is central to both, ensuring empathetic, meaningful involvement of patients, families and staff in the response process.

Together, these principles promote trust, learning and system-wide safety improvements.

The Statutory Duty of Candour – other issues

24. What has happened with the review into the Duty of Candour? Were the consultation figures low?

A review into the statutory Duty of Candour was announced in the Government's response to the Hillsborough disaster report in December 2023. A call for evidence closed in May 2024, with the findings of the call for evidence published in November 2024. The published findings state there were 261 responses, which is a small response rate given its wide applicability. A final response to the review has not yet been published by the Department of Health and Social Care (DHSC).

25. Why is there little focus in the guidance on applying statutory Duty of Candour in mental health services?

The statutory duty applies to any provider registered by CQC. While there is a mental health example in CQC’s guidance it is about a medication error that has occurred in a mental health setting. Once the situation regarding the DHSC review of the duty is clearer, CQC will look to strengthen the guidance and provide further examples for this sector.

26. Should there be a Duty of Candour towards staff?

Any legislative changes to create a statutory Duty of Candour for staff would require action from the DHSC. However, CQC’s assessment framework emphasises:

• A culture where staff can raise concerns without fear.
• Workforce wellbeing, ensuring staff feel supported and valued.

You can download a pdf of the FAQs here:

PSMN_Duty of Candour FAQs_040425.pdf

Last updated 4 April 2025.