Guidance

Duty of candour

Updated 5 October 2020

The intention of the duty of candour legislation is to ensure that providers are open and transparent with people who use services. It sets out some specific requirements providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.

The approach of being open and transparent should be no different in NHS screening programmes. However, because of the nature of screening programmes, sometimes it can be hard for screening services to know how to distinguish between a false negative or false positive that has occurred because of the limitations of screening, and a false negative or false positive that has occurred because something has gone wrong.

1. Duty of candour regulations

Duty of candour regulations apply as soon as reasonably practicable after the screening service has become aware that a notifiable safety incident has occurred.

The following extract is taken from Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20.

In relation to a health service body, ‘notifiable safety incident’ means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in:

• the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, or
• severe harm, moderate harm or prolonged psychological harm to the service user

In relation to a registered person who is not a health service body (clinician), ‘notifiable safety incident’ means any unintended or unexpected incident that in the reasonable opinion of a health care professional appears to have resulted in:

• the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition
• an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days
• changes to the structure of the service user’s body
• the service user experiencing prolonged pain or prolonged psychological harm, or
• the shortening of the life expectancy of the service user

Or, requires treatment by a health care professional in order to prevent:

• the death of the service user, or
• any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned above

If the answer is yes to any of the indicators outlined above, then duty of candour applies.

1.1 Duty of candour and NHS screening programmes

There are circumstances when a person who has been screened may experience severe or moderate harm. This may be because:

• the condition screened for has not been detected and it is not treated early enough to improve the outcome for the patient – examples can include breast cancer, fetal anomaly and abdominal aortic aneurysm
• the person with or without the target condition is harmed by the procedure for detecting the condition – examples include loss of a fetus due to amniocentesis and death from bowel rupture following colonoscopy
• they experience psychological harm from being told they are screen positive (or screen negative) and then finding out that their true result is different

These are recognised harms of a screening programme and are therefore not ‘unexpected’ if the programme is operating within agreed standards.

Therefore, when these events occur they should not be automatically treated as notifiable safety incidents.

However, when a patient has come to either moderate or serious harm in a screening programme a review (audit) should be carried out to understand why this has occurred. If the audit reveals something has gone wrong in the screening process, then this should be treated as a notifiable safety incident and duty of candour regulations will apply.

Notifiable incidents should be managed in accordance with Managing safety incidents in NHS screening programmes (Public Health England 2015) and The serious incident framework (NHS England 2015).

The guidance on screening safety incidents applies to all organisations that provide NHS screening programmes in England, whether an NHS trust, NHS foundation trust, general practitioner or private provider.

The guidance details the accountabilities for reporting, investigating and managing incidents in NHS screening programmes. It covers the management of safety concerns, safety incidents and serious incidents. It is written for staff working in local NHS-funded screening services, organisations that host screening services, commissioners of screening, Public Health England (PHE) screening and immunisation teams, the screening quality assurance service (SQAS), national screening programme teams, PHE regions and centres and local authority directors of public health.

2. Supporting a culture of openness and transparency

People who are invited for screening should be aware of the potential harms as well as the potential benefits of being screened. Screening services should provide people with the information they need, in formats they understand, in order to make informed decisions about whether to take up the offer of screening.

This information should include the fact that the screening programme may sometimes fail to pick up the condition or the risk factor.

When a person is diagnosed with a condition or disease after a negative screening result, the screening service should let them know that it will review (audit) why this has happened. If the person wants to know the findings of this review, then the screening service should provide that information. This approach will help ensure the organisation is open and transparent.

3. The value of audits

The screening pathway involves a number of steps: invitation, sample taking, examination (carrying out the screening ‘test’) and reporting, results, intervention and diagnosis. At any one or more of these steps there may be suboptimal provision or an existing abnormality may not have been identified despite an effective programme.

Audit helps to identify potential problems at any one or more of these steps. It also helps improve the whole process for patients in the future. Without audit, the opportunity to learn vital lessons from individual cases would be lost.

In many cases audits will not find that something has gone wrong. Disclosing the results of audits to patients, regardless of their findings, shows that an organisation is being open and transparent.

3.1 Using audits effectively

Audits should review the specific part of the pathway where an error may have occurred that could have contributed to a patient being seriously or moderately harmed. This is most often the screening test (for example, ultrasound, grading of images, mammography, cytology) or the diagnostic element of the pathway (for example, amniocentesis, breast screening assessment, colposcopy, colonoscopy or histology).

Where an error may have occurred in the screening test or diagnostic part of the screening pathway, the review should explicitly consider and document:

• was the process for undertaking the screen or diagnosis correctly carried out according to NHS screening guidance?
• is the programme operating to national standards and the national specification?

If the answer to either of these questions is no, then the audit review should:

• document that there has been a failure in screening process (handle in accordance with Managing safety incidents in NHS screening programmes (PHE 2015) and The serious incident framework (NHS England 2015)
• specifically consider whether the failure to follow process has (or could have, in the reasonable opinion of a health care professional) contributed to the person being seriously or moderately harmed

The audit should then consider whether or not staff carrying out the screening or diagnostic test did so to a standard that most staff could be expected to achieve. If the conclusion is that most staff would not have made a similar error of interpretation and that this error led to serious or moderate harm, then this should be documented as an error due to interpretation performance below an expected standard.

Therefore, if the audit finds that there was either a process failure and/or if interpretation performance fell below an expected standard and this contributed to serious or moderate harm to the screened person, then something has gone wrong. This should then be recorded as a notifiable safety incident and duty of candour regulations should be followed, including the offer of an apology.

4. When to apply duty of candour

Use this process when someone receives a positive diagnosis following a negative screen.

1. Conduct review of case (audit).

2. Has something gone wrong?

Yes: Notifiable safety incident where someone has been harmed. Duty of candour regulations apply.

No: Nothing has gone wrong.

3. Disclose audit results according to patient wishes.

5. How to disclose audit results

This section advises how to disclose information after an audit of screened cases where there has been an unexpected affected result or diagnosis. It is in addition to any local policies, protocols or guidelines. It is not intended to replace or supersede them.

The process of disclosure of audit should be built around an individual’s needs. Health literacy should be taken into account when explaining what has happened and when using written material to support discussions. Some individuals with certain disabilities or those with mental health issues may lack capacity and be subject to the Mental Capacity Act. Provision should be made for advocates, key workers or carers to be included in relevant discussions.

Clinicians should read and ensure they understand the audit results and information relating to the individual patient before the interview.

It is important to take into account the psychological needs of patients and the basic medico-legal requirements. A disclosure process is separate from - and does not preclude or replace - the complaints process or medico-legal processes.

See the process for disclosing audit results in the breast screening programme.

5.1 Informing the patient or their family

In some circumstances this may include other individuals such as the legal guardian of an affected baby.

It is recommended that when a patient or family attends the first appointment to receive a positive diagnosis following a negative screening result, they are informed:

• that the screening programme routinely reviews all previous screening results
• that if they would like to discuss these findings at any time, they should inform their clinician responsible for the treatment or intervention

Written rather than verbal information may be most appropriate at this stage.

It is good practice to repeat this information at later appointments and to include it in all written information given to patients.

The clinician responsible for the treatment or intervention should always respect a patient’s wish to decline information at any time. The patient may change their mind at any point during or after treatment. Letting patients and family know that this decision will be routinely reviewed a year after diagnosis can allow patients time to consider how they wish to deal with information from an audit.

Where an audit has been undertaken and the results show that a diagnosis or treatment intervention could possibly have been made at an earlier stage in the screening pathway, the patient should be made aware of the audit and offered the opportunity to discuss their screening history and the result of the audit.

5.2 Disclosing the information

Ideally, the clinician responsible for the treatment or intervention should be the one to undertake the discussion with the patient’s key worker or specialist nurse, where applicable.

There will be instances where the clinician responsible for the treatment or intervention is employed by a different organisation to the one where the screening episode took place. In these circumstances it is important that clear agreement is reached between the organisations about how the information is given and by whom.

Both organisations should document this agreement and share the outcome of any discussions with the patient about the findings of the audit and action taken.

5.3 When to give the information

It is important that clinicians are flexible and any information disclosure occurs at a time suited to the patient’s needs.

The provider of the service where the diagnosis is made is responsible for ensuring that:

• the screening service is aware of the diagnosis
• the result of the subsequent audit is locally documented, once known

The optimum time for the audit result to be offered can then be identified during the patient’s treatment journey.

The best time for information disclosure is likely to become clear during or after treatment, by which time a rapport may have built up between the patient and the clinician responsible for the treatment or intervention.

It may be appropriate that such discussions happen after treatment has finished unless the patient requests information about their screening history during conversations about their care.

The offer of audit disclosure will also be included in the patient information and by the key worker (where applicable) during the patient journey.

In screening programmes, the time and method for communicating with individuals may be affected by local circumstances and the context of the individual case. If a decision is taken to delay communication because of individual and/or population needs, the clinician should clearly document the reasons.

6. How to give the information

The patient should be given the opportunity for a friend, relative, carer or advocate to be present at the discussion.

At the disclosure interview the clinician should:

• check the patient’s understanding of why he or she has asked for the information
• find out how much the patient wants to know
• discuss the relevant reports and their implications
• allow the patient time to voice his or her comments and concerns

The results of the audit should form the basis of the discussion and the clinician should allow themselves enough time to prepare. A scripted interview is not recommended but clinicians may find it helpful to prepare in advance a list of points to cover in the course of the meeting. If the discussion is not undertaken by the radiologist or screen interpreting lead it may be helpful to discuss the audit findings with them in advance of the meeting with the patient.

Before offering explanations, it is important to check the patient’s understanding and find out what they need or want to know about their screening history. The results should be used to guide the discussion and the amount of information given at this stage.

Clinicians should give patients time to voice any comments or concerns about their care. There should also be time for the clinician to respond, checking the patient’s understanding and whether further information or explanation is wanted or required.

6.1 If patients decline information

It is important to respect the patient’s wishes if they decline the offer. The clinician should make it clear that the individual can request the information at a future date should they change their mind. If the patient changes their mind following discharge from treatment they should be informed that they can either contact their screening service or their GP, who can make the necessary arrangements.

If the patient or their family has indicated previously that they do not wish to know the results of the audit and this has been documented, including cases where the result of the audit has led to a notifiable safety incident, then the organisation is not required to write to the patient with an apology.

6.2 Record keeping

The results of the discussion should be clearly documented by the clinician in the patient’s hospital record. A record of the discussion should also be sent to the GP and the patient.

6.3 Access to further information/resources

A number of provider organisations offer training in breaking bad news which clinicians may wish to access.

Local guidelines and protocols should be adhered to.

Explaining to a patient or their family why their condition was not detected can be complex. Use of visual aids to explain the occurrence of interval cancers in breast screening can support these conversations.

The Nursing and Midwifery Council, in conjunction with the General Medical Council, have guidance on Openness and honesty when things go wrong: the professional duty of candour.