Guidance

Interval cancers and applying duty of candour

Updated 18 February 2021

Dates to apply duty of candour

The duty of candour regulations set out the actions which providers must follow when things go wrong with care and treatment in the NHS Breast Screening Programme. They came into force in November 2014 for NHS bodies and April 2015 for all other organisations.

If an incident happened before the regulations came into force, the Care Quality Commission (CQC) may not be able to take formal regulatory action or prosecute over a breach of the duty.

For interval cancers diagnosed before 27 November 2014, individual trusts should decide themselves whether duty of candour applies.

There are 2 scenarios when duty of candour must apply to interval cancers in the screening programme. These are when:

• a screening test was performed before 27 November 2014 and an interval cancer was diagnosed after that date
• a screening test was performed after 27 November 2014 and an interval cancer was diagnosed

Interval cancers

Interval cancers are an inevitable part of the breast screening programme. They are cancers that are diagnosed in between routine screening episodes.

There are 3 types of interval cancer.

1. Newly detectable cancers that have developed since the last screening appointment (common).

2. Cancers that were visible at the last screen but not recalled for further tests because the signs of cancer were very subtle and thought to be normal (less common).

3. Cancers that were visible at the last screen but not recalled for further tests because the signs were missed (rare).

There are 3 reasons to report and monitor all interval cancers.

1. To monitor rates of interval cancers in conjunction with rates of screen-detected cancer to provide information on whole programme performance.

2. To support education and learning objectives for screening services and individuals. This helps improve the quality of the service provided to women.

3. To enable women who have had an interval cancer to have further information about what was found when they were previously screened if they wish.

Interval cancers occur in around 3 in every 1,000 women screened. The majority of these cancers were not seen at the previous screen. When a woman is diagnosed between screens (symptomatically), it is important that the screening service is informed so a review of the previous screening images can be undertaken as soon as possible.

The Breast screening: interval cancers explained infographic summarises the prevalence of interval cancers.

Role of symptomatic services

It is essential there is timely communication about interval cancers between symptomatic and screening services.

This is to allow screening services to undertake a radiological review of interval cancers within 6 months of the cancer diagnosis. The review compares the diagnostic mammogram with the previous screening mammogram.

The purpose of this timely review is to:

• identify any learning points about image reading performance and alert services to any practice outside programme guidance at the earliest opportunity
• allow services enough time to obtain screening images and related pathology information and undertake the radiology review
• facilitate an early response to information requests arising from disclosure of audit and duty of candour cases

Women can ask for the results of an interval cancer review. If a woman was assessed at the previous screening episode, the review must be completed within 4 months of the symptomatic presentation.

This timescale ensures that the wait for the outcome of a review is minimised for women.

To allow timely review of interval cancers, symptomatic services need to:

• ask the woman at the time of diagnosis if she has been screened in the last 3 years (if she is aged from 50 up to her 71st birthday, or 47 to 73 if taking part in the age extension trial)
• ask if the woman is having screening as part of the high risk screening programme and has been screened within the last year
• give the woman the national information flyer Information for women diagnosed with breast cancer between screening appointments if she had been screened within the past 3 years (or the past year if part of the high risk programme)
• inform the breast screening unit if the woman wants to know the outcome of the radiology review
• contact the service where the woman was screened and arrange for the diagnostic images to be sent to them electronically

The symptomatic service that diagnosed the cancer should not initiate discussion of what has happened, or appearances on previous screening films, before the screening service has completed the review of the interval cancer.

Similarly, the symptomatic radiology report should not give an opinion on the previous screening images. The outcome of the review cannot and should not be pre-empted until there has been a full interval cancer radiology review by the screening unit.

Role of screening services

Services that provide both breast screening and symptomatic clinics

Early identification of interval cancers is important. This is the responsibility of local services and the Screening Quality Assurance Service (SQAS).

Services should:

• routinely record women diagnosed with breast cancer who are of screening age to check if they have recently been screened at the symptomatic multidisciplinary meeting
• follow the interval cancer guidance and undertake radiological review if interval cancers are identified
• ensure good links are maintained with any neighbouring symptomatic services where screened women may be treated in addition to the local symptomatic service
• ensure there is a local protocol for the exchange of diagnostic images and the notification of interval cancers in a timely way

Services that provide breast screening only

Early identification of interval cancers is important. This is the responsibility of local services and SQAS.

Services should:

• ask for diagnostic images from symptomatic services as soon as they become aware of an interval cancer (this is usually via SQAS from the screening histories information management system (SHIM))
• ensure good links are maintained with local symptomatic services where screened women are treated so there is an agreed mechanism for exchange of diagnostic images, relevant pathology data and timely notification of interval cancers
• follow the interval cancer guidance and undertake radiological review if interval cancers are identified

Informing women about interval cancer review

The NHS Breast Screening Programme informs women about the possibility of interval cancers in the national Helping you decide invitation leaflet, which states:

We will review your previous screening test results if you are diagnosed with breast cancer between routine screening appointments. You can see the results of this review if you wish.

The information leaflet about interval cancers, Information for women diagnosed with breast cancer should be given to all women at the following 2 points.

1. At diagnosis, if it is suspected they have an interval cancer.
2. At a suitable point in the treatment pathway. This is at the discretion of the treating team and may be during a health care needs assessment appointment, following the completion of treatment, or at follow-up.

The leaflet should also be given if the woman requests the results of the radiology review at any point.

Being open and transparent with women

All interval cancers are categorised by radiologists according to the guidance on interval cancers. All women have a right to request the outcomes of the radiology review.

In a very small number of cases, duty of candour will apply. Within the screening programme, in cases where duty of candour applies, the screening service should write to the woman to ask if she would like to know the outcome of her interval cancer review. It is her choice whether she accepts this offer.

The letter must include:

• the fact that screening tests are not 100% accurate and that false positive and false negative results are a feature of all screening programmes (see page 5 of Duty of Candour guidance)
• information about the process of review of previous screening films
• the offer of a visit to discuss the outcomes of the radiology review
• the offer for the woman to bring her partner, family member or a friend if desired
• contact details of a breast care nurse specialist or other suitable individual to arrange the review (where requested)
• details of the clinician who will meet with the woman on request (this could be the screening director, or designated radiologist, with the offer to discuss it with her breast surgeon if preferred)
• the offer to send the results of the review in writing if preferred
• information to specify that the woman may not want to know the outcome of the review at this time but can change her mind at any point by contacting their GP or hospital consultant to arrange this
• a section on the letter for sign-off by the woman to say she has understood the content of the letter and whether should would/would not like to know the outcome of the radiology review (for return to the screening service)

The letter should not include any specific details relating to the outcome of the radiology review.

Communicating results of the radiology review to women

Women who request a consultation to discuss the outcomes of the radiology review should be seen in a timely way.

Before the consultation

Only a specialist breast care nurse and clinician (screening radiologist or breast surgeon) who have appropriate counselling skills and have completed the e-learning on duty of candour (as a minimum once online) should undertake these meetings.

The image readers or responsible assessor directly associated with the woman’s previous screening episode should not conduct the duty of candour consultation. Screening is a team effort and the communication is most effectively undertaken by a clinician who is fully appraised of the case but not directly involved.

The breast care nurse should ideally make contact with the woman to arrange the meeting. If the woman expresses directly what she wants from the meeting, this should be shared with the clinician prior to the meeting.

Consider an appropriate time to set aside to undertake the consultation so that the woman has the time she requires. This cannot be rushed and should include some time at the end of the consultation for reflection and writing up notes and the summary letter to the woman.

The meeting should take place in confidential, comfortable surroundings with no interruptions.

The woman should meet with the breast care nurse initially and the nurse should support her as necessary throughout the consultation.

To aid effective communication:

1. It must be remembered that most interval cancers are not seen on previous imaging following review. However, clinicians should include the following points at the consultation with the woman whether disclosure of audit or duty of candour applies.
2. The patient should be invited to express her concerns and raise any questions she may have.
3. The effectiveness and limitations of the screening programme described in the information leaflet should be discussed.
4. There should be an open discussion about whether the cancer could have been found earlier.
5. The clinician may be asked about the impact on prognosis where a delay in diagnosis was evident. This is a complex area and should not be speculated upon in this consultation unless the clinician has particular expertise in this specialist area.
6. The discussion should concentrate on the clinical aspects of the woman’s care and it is not appropriate to discuss any possible litigation which may or may not already have commenced. Litigation issues must be handled separately according to trust protocols.
7. Patients who wish to complain or seek compensation (where it may apply) should be given information on how to proceed via the Patient Advisory Liaison Service (PALs) and be informed of the trust’s complaints procedure.
8. Clinicians are encouraged to include apologies where appropriate.
9. The clinician should explain what will happen as a result of the collection of information from the review and how it will help improve performance of the programme.
10. Clinicians should discuss the possibility of accessing further counselling and support if the patient requires it.
11. After the interview, the clinician should document the discussion and send an outline of it to the patient, her GP and treating surgeon for their notes.
12. The woman’s specialist breast care nurse should end the meeting with the offer of a follow-up telephone call at the woman’s convenience.

Information transfer from screening service to symptomatic service

Some women will request a discussion with their symptomatic care team (treating consultant surgeon and keyworker/nurse) about the outcome of their radiology review. In these circumstances, it is important that the screening service sends (as a minimum) to the care team:

• the date of previous screening
• a brief outline of the review process undertaken
• confirmation of whether any abnormality was seen on the previous screening mammogram and, if so, what it was and giving the category of interval cancer as below
• a brief discussion about the 3 categories of interval cancers:
  • satisfactory – normal or benign mammographic features at previous screening
  • satisfactory with learning points – lesion seen with hindsight but difficult to perceive as not obviously malignant (may provide learning and not all readers would have recalled)
  • unsatisfactory – lesion appearance is obviously malignant at previous screen and should have been recalled (all readers reviewing the films agree that they would recall)

If the woman was assessed following the previous screening episode (within the last 3 years), you should complete the previous assessment review form. You should ensure any handwritten information is legible. You should send a copy of the form to the symptomatic team for discussion with the woman, along with any information about what could have been done differently.

Applying local trust policies

All trusts will have policies to deal with incident management and applying duty of candour. These should be followed in conjunction with NHS Breast Screening Programme guidance.

If a legal question arises or legal teams request medical records, you should approach the trust’s legal team for advice.