Guidance

Disclosure of cervical screening history review results and applying duty of candour

Updated 20 October 2021

Applies to England

The purpose of this document is to describe the process by which disclosure should happen within the NHS Cervical Screening Programme and to support the application of duty of candour.

More details on the overarching principles of applying duty of candour in screening programmes can be found in guidance for the NHS screening programmes on duty of candour, which should be read in conjunction with this more detailed guidance for the cervical screening programme.

Cervical cancer and cervical screening

The NHS Cervical Screening Programme (NHS CSP) aims to reduce the incidence of, and mortality from, invasive cervical cancer. It does this through a systematic, quality assured population-based screening programme for eligible individuals (women and people with a cervix who are within the screening age range), so that abnormalities that might otherwise develop into invasive cancer can be identified and treated.

In England cervical screening currently prevents 70% of cervical cancer deaths. If everyone attended screening regularly, 83% could be prevented.

Screening is the process of identifying healthy people who may be at increased risk of a disease or condition. Screening tests:

• cannot offer 100% sensitivity (ability of the test to correctly identify all true positives – those with the condition or disease)
• cannot offer 100% specificity (ability of the test to correctly identify all true negatives – those without the condition or disease).

In every screening programme there are false positives (wrongly reported by the test as having the condition) and false negatives (wrongly reported by the test as not having the condition).

In addition, the disease screened for, for example cancer, can occur between screening episodes.

Both false positive and false negative results can result in harm to an individual. However, these are not unexpected findings and occur in all screening programmes.

Review of all cases of cervical cancer, along with those individual’s interactions with the screening programme, and comparing them with individuals who do not develop cervical cancer, is important. This includes people presenting symptomatically who have had interaction with the screening programme in the preceding 10 years.

Audit of invasive cervical cancer

The main purpose of the NHS CSP audit of invasive cervical cancer is to:

• support the continuous learning and development of health professionals involved in the programme
• monitor the effectiveness of the cervical screening programme by comparing the screening histories of individuals who develop cervical cancer with those who do not
• identify areas of good practice and indicate where improvements might be made to support evidence-based policy and practice

In order for the information to be reported consistently, all parties in the NHS Cervical Screening Programme must follow the same national protocol for auditing cases of invasive cervical cancer.

The audit also allows individuals diagnosed with cervical cancer who have previously participated in the cervical screening programme to have information about what their screening history review found (if they wish to receive this). The information available to be disclosed is defined by the data collected by the audit, which may change over time. Depending on the information collected as part of the audit, it may not cover every interaction the individual may have had with the screening programme.

Responsibilities of cervical screening services

Services delivering cervical screening have the responsibility to operate with effective disclosure, meeting all statutory requirements and adhering to guidance issued by the NHS CSP.

Organisations providing screening services take responsibility for undertaking nationally required audits of screening histories in a timely way, and for offering screening participants disclosure of their audit results in line with nationally published guidance and the screening service specifications.

The organisation’s medical director takes overall responsibility for ensuring this guidance is followed.

The organisation’s cervical screening provider lead (CSPL) has operational responsibility for overseeing these activities. Guidance on the role of the CSPL is available.

The organisation in which the clinician gives the individual their diagnosis of cervical cancer is responsible for offering them information about the screening history review and how they can receive the results if they wish to have them. This organisation’s CSPL oversees the activities described in this document and works with other CSPLs as needed.

This organisation is also responsible for having processes in place to ensure that the screening history review is completed in a timely manner in order to:

• allow individuals to be offered the results of the review of their cervical screening history at the earliest opportunity
• allow services to identify learning points about cervical screening performance and alert services to any practice outside programme guidance which may need further investigation
• facilitate an early response to information requests arising from disclosure of screening history reviews and duty of candour cases

Informing individuals about their cervical screening history review

The initial consultation when results of diagnosis are given is not an appropriate occasion to discuss the review in detail, unless the person asks questions about their screening history. However, a general reference must be made that the review will take place. At this consultation an information leaflet and response form must be included in the documentation given to the individual for them to refer to at their own convenience.

The response form is for the individual to indicate that they have understood the content of the leaflet, and say whether they would like to know the outcome of their screening history review. The form is required so that a clear audit trail exists regarding the person’s wishes.

The individual can return the response form at this point for inclusion in their notes. However, they will be contacted again once the results of their review are ready and, if they prefer, can complete and return the response form then.

Review process

Offer all individuals the results of the review of their screening history if a review is possible. Review is not possible if they have no previous screening history or their most recent history is more than 10 years prior to diagnosis (in which case old samples will have been destroyed).

A flowchart documenting the review process is available, as well as suggested checklists for the CSPL and disclosing clinician for the management of the review process within the diagnosing organisation and disclosure of the review results.

When the CSPL of the diagnosing organisation is informed of a cervical cancer they should log the case and add it to the agenda for the next available colposcopy multidisciplinary team (MDT) meeting. The colposcopy MDT is the recommended forum for discussion of invasive cervical cancer audit cases as it has multi-disciplinary clinical representation, and the proceedings are documented for audit and governance purposes.

The review and disclosure process should be completed within a maximum period of 12 months from diagnosis, with the CSPL providing an update on progress at 6 months if the case is not already complete. Update reports should be recorded in the notes of the meeting. At the meeting where the final review results are discussed and the case assessed, the lead colposcopist (or designated deputy) should nominate an appropriately trained clinician to offer disclosure to the individual. This could be a gynae-oncologist if most appropriate (see section below on communicating the results of the screening history review to individuals).

When other organisations are involved in the individual’s treatment, the CSPL is responsible for communicating with them to find out when their treatment is complete. The CSPL should enable this by agreeing and documenting a set of contacts between the organisations involved.

Disclosure of the review result must be offered by the organisation where the individual received their diagnosis rather than the treating organisation (where these are different). In rare circumstances where the individual requests disclosure from their treating organisation instead, both organisations involved in the person’s care must work collaboratively to ensure that this happens.

It is essential that disclosure discussions are always undertaken by individuals who have a detailed knowledge of the NHS CSP, and who have undertaken appropriate disclosure training. An e-learning module on disclosure of audit results and duty of candour in cervical screening is available.

Should any issues come to light during the review which could indicate a potential screening incident, inform the Screening Quality Assurance Service (SQAS) immediately. This ensures appropriate advice is accessed in line with national guidelines on the management of potential screening incidents.

The CSPL must carry out an annual audit of the offer of disclosure of the review outcomes to patients, to ensure that there is full implementation of national guidance and that there is equal treatment of all individuals diagnosed with cervical cancer.

Where an individual is being treated privately, a cervical screening history review must still take place if they have been screened or treated within the NHS CSP in the previous 10 years. In this situation, the CSPL of the organisation in which the person first comes to NHS attention in relation to their cervical cancer should take responsibility for co-ordination.

Occasionally patients may be diagnosed or treated in the UK but outside of England, whilst elements of their screening history may be held in England and may be needed to contribute to disclosure. In these cases, specific arrangements need to be agreed on a case by case basis and advice should be sought from SQAS.

Being open and transparent

Once results of the screening history review are available, if the individual has not already returned their response form contact them promptly using their preferred method of communication.

Communicating the offer of results is a 2-stage process. The service should initially determine whether or not the individual wishes to know the results of their screening history review.

Send the individual:

• a letter informing them that their review results are available, and contact details of the relevant nurse specialist should they wish to discuss the offer of disclosure before making a decision
• the information leaflet
• the response form and a request to complete and return it

If the individual has not responded within 3 months of the letter being sent, it can be assumed that they do not wish to know the results of their review. The disclosing clinician must ensure that the CSPL, treating organisation and person’s GP are informed and that the patient notes reflect this.

If the individual responds to say they do wish to receive the results of their review, send a further letter depending on the outcome of the review results as follows.

Letter A (nothing found)
Thank you for returning your form indicating that you would like to receive the results of your cervical screening history review. Your review did not identify any problems with your care. If you would like to discuss this further, either by telephone or in person, please contact the nurse specialist to arrange this.

Letter B (findings to discuss)
Thank you for returning your form indicating that you would like to receive the results of your screening history review. We would like to invite you to a meeting to discuss the findings.

Letter B must not include any details regarding the review findings, but it must include:

• an offer for the individual to bring their partner, a family member or friend if desired
• contact details of a nurse specialist or other suitable individual to arrange the review
• details of the clinician who will meet with the individual on request
• an offer to send the results of the review in writing if preferred

If the individual responds to say they do not want their results at present and requests a reminder in 6 months’ time, the disclosing clinician must inform the CSPL who will note this for audit purposes. The diagnosing clinician is responsible for sending the reminder offer letter at the appropriate time.

Individuals who do not want to know their review results

If someone does not wish to receive the results from the review of their screening history, advise them that they can change their mind at any point and that if they subsequently choose to know the results, they can contact their consultant or their GP (if they have been discharged) to make the necessary arrangements. Inform the GP of their decision and the process to follow – which is to notify the relevant organisation should the patient change their mind in future.

When to apply duty of candour

In a very small number of cases, once the results of the review are known, duty of candour will apply.

A discussion regarding whether or not duty of candour applies should take place at the meeting of the MDT of the diagnosing organisation where the results of the review of screening history are presented. The MDT should consider whether the review results are categorised as:

• satisfactory
• satisfactory with learning points
• unsatisfactory

Refer to the guidance provided on review and classification of screening results. Cases identified as ‘satisfactory’ or ‘satisfactory with learning points’ are not classified as a duty of candour cases. The findings must, however, be disclosed to the individual if they have asked for disclosure of their review results.

Duty of candour applies to cases with an assessment of ‘unsatisfactory’. For these cases the organisation must follow its duty of candour policy.

In cases where duty of candour applies but the individual has indicated on their response form that they do not wish to know the results of their review, this decision must be respected.

In cases where duty of candour applies but the individual has not returned their response form, send a second communication. If the person still does not respond, follow organisational policies on duty of candour.

Communicating the results of the screening history review to individuals

All individuals who request an appointment to discuss the outcome of their personal screening history review must be seen in a timely way. Only a clinician who has appropriate counselling skills and training in duty of candour, and has completed the e-learning on disclosure of audit results and duty of candour (at least once online) should undertake these meetings.

An appropriate time (60 to 90 minutes) must be set aside to undertake the consultation so that the individual has the time they require. This consultation cannot be rushed, and must include some time at the end for reflection and writing up notes and the summary letter to the individual and their GP. The meeting must take place in confidential, comfortable surroundings with no interruptions.

Clinicians must include the following points at the consultation with the individual, whether or not duty of candour applies. To aid effective communication:

• invite the patient to express their concerns and raise any questions they may have
• discuss the effectiveness and limitations of the screening programme as described in the patient information leaflet
• have an open discussion about whether the cancer could have been prevented from developing or found earlier
• do not speculate (if asked) on the impact on prognosis where a delay in diagnosis is evident – this is a complex issue and should not be commented on unless there is a degree of certainty or the clinician has particular expertise in this specialist area
• concentrate the discussion on the clinical aspects of the patient’s care – 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 organisation protocols)
• provide information to any patient wishing complain or seek advice on litigation on how to proceed via the Patient Advisory Liaison Service (PALs) and be informed of the organisation’s complaints procedure
• include an apology where appropriate
• explain what will happen as a result of the collection of information from the review and how it will help improve the learning and education of staff and overall performance of the programme
• discuss the possibility of accessing further counselling and support if the patient requires it
• end the meeting with the offer of a follow-up telephone call or meeting at the patient’s convenience if required

After the consultation, the clinician should document the discussion and send an outline of it to the patient, their GP, the CSPL and the treating clinician for their notes

Applying local organisation policies

All organisations providing cervical screening services must have a policy outlining how the necessary screening history review following a cervical cancer diagnosis is carried out. There must also be a local protocol in place outlining how the process of the review is managed within the organisation, including how the results of the review are offered to the individual concerned.

These policies must be developed and agreed by the organisation’s multi-disciplinary cervical screening business meeting, chaired by the CSPL, and approved through local organisational processes. They must be consistent across the organisation, regardless of whether aspects of screening are carried out on different sites (the same policy should operate in all hospitals within a single organisation). The policies must follow the relevant NHS CSP guidance documents. Text included within this guidance may be used to form the basis of local organisation policies.

All organisations must have over-arching policies to deal with incident management and applying duty of candour, which must be followed in conjunction with NHS CSP guidance. This includes corresponding with relatives where an individual has died and duty of candour applies. We suggest that all situations where the outcome of the screening history review is ‘satisfactory with learning points’ or ‘unsatisfactory’ are recorded on organisational reporting systems.

If an individual requests copies of their medical records, the organisation’s policies for this must be followed.

If a legal question arises or legal teams request medical records, contact the organisation’s legal team for advice.