Guidance

National invasive cervical cancer audit

Updated 29 September 2021

This guidance sets out the national procedures for auditing cases of invasive cervical cancer as part of the NHS Cervical Screening Programme (CSP) in England. It includes information about:

• how to audit and review
• how to analyse and monitor audit data
• roles and responsibilities during audits

It defines the national protocol for audit of cases of invasive cervical cancer so that standardised data can be collected and analysed.

The purpose of audits are to:

• monitor quality and effectiveness of the NHS CSP
• compare the screening histories of individuals who develop cervical cancer with those who do not
• identify areas of good practice and show where quality improvements might be made
• support learning and development for organisations and the NHS CSP
• make sure people are given information about their screening history review (if they wish to receive it)

The information which can be disclosed during the audit process is defined by the data collected and may change over time. Refer to the disclosure of audit results toolkit.

Audits may not cover every interaction the individual has had with the screening programme. This will be dependent on the information collected.

All parties in the NHS CSP must follow the national protocol for auditing cases.

Cases should be reviewed based on the guidance in place at the time the case was diagnosed.

Cases diagnosed from 1 October 2021

Use this version of the guidance for audits involving cases of cervical cancer diagnosed from 1 October 2021.

Cases diagnosed before 1 October 2021

Audits based on cases diagnosed before 1 October 2021 should follow the version of the guidance in place at the time the case was diagnosed.

Previous editions of the national guidance for auditing cases of invasive cervical cancer and related professional guidance are available to view and download to support audits.

1. Local audit policies

All organisations providing NHS CSP services must have a policy outlining how each invasive cervical cancer will be identified and audited.

The policy will have been developed and agreed by the organisation’s multi-disciplinary NHS CSP team and should have been approved by the organisation’s main clinical governance committee or equivalent.

It should be consistent across the organisation, regardless of whether aspects of screening are carried out on different sites. The policy must operate in all hospitals within a single organisation in line with national guidance. It will include details of local patient treatment pathways.

The policy will state:

• the need for clear communications with organisations that accept tertiary cancer referrals
• that results be disseminated to individuals in line with national guidance for audit and disclosure

2. Diagnosing a cervical cancer

Cases of invasive cervical cancer can be identified via:

• colposcopy clinic
• gynaecology clinic
• sexual health clinic
• oncology clinic
• gynaecological oncology or colposcopy multi-disciplinary team (MDT) meeting
• histology laboratory
• referral for treatment of a patient diagnosed in the private sector
• national cancer registry

The diagnosing organisation is the one the patient attended for the colposcopic or gynaecological investigation (histologically or non-histologically). It is this organisation which is responsible for co-ordinating the audit data collection.

Depending on which came first, the date of histological diagnosis is either when:

• the primary cervical cancer was excised, or
• a diagnostic biopsy was taken of the primary cervical cancer (for example, the date of colposcopy appointment)

A non-histological diagnosis would include imaging. In this instance, diagnosis date is the date of imaging. These cases will be checked with the cancer registry by the screening quality assurance service (SQAS) and fed back to the diagnosing organisation to confirm inclusion or exclusion in the audit.

Individuals diagnosed with cervical cancer while resident in England should be included in the audit irrespective of whether they are registered with a GP or not.

Recurrent cervical cancers and metastasis to the cervix should be excluded from audits. SQAS will follow up these cases to work out if there are any potential quality issues. A recurrent cervical cancer will involve an individual who has remained in the NHS CSP after their initial treatment (very early stage cervical cancer).

3. Roles and responsibilities

Diagnosing organisation responsibilities

The diagnosing organisation is responsible for:

• making sure health professionals have sufficient time and support to carry out audit activities (the greater the number and complexity of cases diagnosed each year will increase the amount of time needed)
• retaining the primary patient record of each audit case according to local data retention policies

Roles within organisations

There are a number of important roles in the NHS CSP audit process.

Some roles may be carried out by the same individual, for example, the cervical screening provider lead (CSPL) and lead colposcopist may be the same person. Delegating is acceptable (for example, by the CSPL to a designated audit lead) but responsibility still sits with the individuals as described below.

Audit reviews must be carried out by individuals who:

• are qualified to work in the NHS CSP
• meet the training requirements and standards for the programme, as defined in national screening programme guidance

CSPL

The CSPL at the diagnosing organisation is responsible for co-ordinating the audit by organising and collating the review results. This is regardless of whether the individual is treated at the diagnosing organisation.

The CSPL must be supported by a sufficient level of designated administrative staff to ensure that the audit is completed to the timescales as described in the national guidance for audit and disclosure.

The CSPL in the diagnosing organisation is responsible for:

• implementing the locally developed and agreed audit protocols in line with national guidance on audit and disclosure
• making sure all new cases of invasive cervical cancer diagnosed in individuals referred to the provider for investigation (from any source) are:
  • promptly registered with SQAS
  • put on the agenda of the next available colposcopy MDT meeting to note for audit purposes (not for discussion)
  • audited in accordance with the guidelines and timescales set out in this document

In addition, CSPLs are responsible for:

• making sure a failsafe system is in place to be notified of all invasive cervical cancers diagnosed in the organisation – for example, linking with gynaecological oncology (monthly or quarterly checks should be carried out to ensure all cases are included)
• identifying the diagnosing and treating clinician
• checking for any previous histological diagnoses or colposcopy attendances
• making contact with the relevant clinician at the treating organisation (if the individual is being treated at a different organisation to where their diagnosis was made)
• contacting all relevant parties and initiating reviews of human papillomavirus (HPV) processing, cytology, histology and colposcopy
• requesting retrieval of cytology or histology slides from all laboratories (including where the original reporting laboratory no longer undertakes screening) with assistance provided by SQAS as required
• arranging for slides to be sent safely to the relevant laboratory for review along with clearly identified paperwork
• making sure there are documented procedures and a suitable tracking system to monitor slide movement in their organisation
• making sure that there is a suitable process for recording the progress of individual audit cases which ensures completeness of all data items
• ensuring review and disclosure processes are completed within the maximum period of 12 months from diagnosis – providing an update on progress at 6 months to the treating clinician if the case is not already complete
• informing the treating organisation of the results of the review
• assisting with feedback to patient as required
• sending complete and accurate audit information to SQAS
• informing SQAS at the earliest opportunity should the audit uncover a possible screening incident
• including any local outcomes and learning in the CSPL’s annual report and ensuring discussion in relevant internal meetings (for example, colposcopy operational group or laboratory management meetings)
• carrying out an annual audit of offers of disclosure to individuals diagnosed with cervical cancer
• checking that the lead colposcopist has evidence that all clinicians involved in disclosure discussions have undertaken the required training

Diagnosing clinician

Responsible for:

• notifying the CSPL and the lead colposcopist of the invasive cervical cancer diagnosis
• following local protocols in line with national disclosure guidance

The diagnosing clinician must be a patient facing clinician, not a pathologist.

Lead for HPV testing

Responsible for making sure the necessary HPV process review data is provided in the required timeframe to the diagnosing CSPL for all cases.

Lead consultant in cytology in cervical screening hub laboratories

Responsible for:

• co-ordinating the required cytology reviews or identifying a co-ordinator to do this on their behalf
• ensuring that an appropriately experienced cytologist who has not previously authorised the sample report undertakes the reviews
• ensuring that outcomes of reviews are completed in the required timeframe and reported to the diagnosing CSPL

Lead consultant in cervical histology

The lead consultant in cervical histology in laboratories holding histology cases are responsible for:

• co-ordinating the required cervical histology reviews or identifying a co-ordinator to do this on their behalf
• making sure that an appropriately experienced pathologist or consultant biomedical scientist who has not previously authorised the specimen report, where possible, undertakes the reviews (SQAS will provide support in identifying a location for a review to take place when this is not possible due to very small numbers of staff)
• reporting outcome of reviews in the required timeframe to the requesting CSPL

Lead colposcopist in diagnosing organisation

Responsible for:

• co-ordinating the required colposcopy reviews or identifying a co-ordinator to do this on their behalf
• making sure colposcopy histories from all hospital sites within the organisation are included
• making sure the senior experienced colposcopist undertaking the review of colposcopic assessments and management was not involved in the patient’s care
• reporting the outcome of the review in the required timeframe to the requesting CSPL
• nominating an appropriately trained clinician to offer disclosure to the individual (this could be a consultant gynaecological oncologist if most appropriate)
• making sure all colposcopists involved in disclosure discussions have undertaken the required training

Call and recall staff

Responsible for:

• identifying controls by running the designated report and supplying screening information to SQAS as required
• making sure any request for invasive cancer audit data is processed within 5 working days and provided securely to the requestor and SQAS (if different)
• provide additional information, such as the dates of invitations sent, if requested by SQAS

NHS England commissioners

Responsible for:

• making sure providers take part in the audit and achieve the required timescales (achieved through programme boards and working with other commissioners and contracts)
• making sure audit findings from the CSPL’s annual report are discussed at programme boards

SQAS

Responsible for:

• chairing and administering the invasive cervical cancer audit and disclosure management group which provides professional advice into the audit and disclosure process
• co-ordinating the invasive cervical cancer audit at a regional and national level
• developing and maintaining a national invasive cervical cancer audit (ICCA) database
• linking audit data together to ensure a complete case history for each patient
• supplying screening histories and available details of organisations involved in the patient’s history to the diagnosing CSPL
• requesting control data from call and recall staff and uploading control data into the ICCA database
• classifying the screening history of all invasive cervical cancers through the ICCA database
• validating HPV processing, cytology, histology and colposcopy review processes and seeking further information or clarification from providers where necessary
• liaising between regional SQAS teams (where necessary) to obtain HPV, cytology, histology and colposcopy data and to organise reviews, feeding back results of reviews to the diagnosing CSPL
• administering and distributing reviews for SurePath cytology slides requested by laboratories who do not have members of the network within their host laboratory
• monitoring progress and outcome of audits that have been notified to SQAS, including advising on additional reviews (should this be necessary)
• providing support and expert advice on all aspects of the audit to CSPLs, including maintaining contact details for CSPLs
• collating the national return of data and anonymising data for analysis
• securely exchanging cervical cancer data with the cancer registry to make sure all cases are accounted for
• supplying the cancer registry with a cervical screening status flag for each individual diagnosed with invasive cervical cancer
• identifying outcomes and learning from CSPL annual reports discussed at local programme boards
• arranging professional network meetings on a national and/or regional basis to disseminate learning from the audit
• producing an annual SQAS national report of the lessons learned and action points for the programme

4. Screening records

Individuals in UK countries other than England

Occasionally patients may have been diagnosed or treated in a UK country other than England, although some parts of their screening history are held in England. Similarly, the screening history needed for a case diagnosed in England may be held in another part of the UK.

In these cases, arrangements need to be agreed on a case by case basis. Advice should be sought from the English national cervical screening SQAS team, who will co-ordinate requests for information.

All information transfers in these circumstances must be made using secure electronic means.

Individuals with screening history in the private sector

Sometimes an individual will be diagnosed privately or be in the process of being treated privately. A cervical screening history review must take place provided:

• they have been screened or treated within the NHS CSP in the previous 10 years
• the NHS is aware of their cervical cancer diagnosis

The CSPL of the diagnosing organisation should take responsibility for co-ordinating the audit. This is most likely to be via the gynaecological oncology MDT.

Historic non-NHS test results may appear in a screening record if they were provided to the call and recall services and recorded before 2020 according to call and recall administration best practice. From 2020, the results of non-NHS screening tests have not been recorded in an individual’s NHS screening record. These samples should not form part of the screening history review.

5. Carrying out the screening history review

A review of all records connected to an individual’s cervical screening history from the past 10 years should be undertaken as part of invasive cervical cancer audits. This includes cervical screening tests and any medical investigations related to cervical screening.

Review is not possible if individuals have no previous screening history or their most recent history is more than 10 years before they were diagnosed. Old cytology samples will have been destroyed in these cases.

Audits do not currently involve the review of primary care records or a detailed review of call and recall processes. These are being assessed for inclusion in future.

HPV Primary screening

Cervical screening changed to HPV Primary screening in December 2019. All screening samples that are HPV positive are put onto a slide to be checked under a microscope for abnormal cells (cytology).

These cytology slides will be reviewed as part of an audit. Samples that are only HPV tested (HPV negative result and not put onto a slide) are not reviewed as they are not kept. However, they are subject to an HPV process review.

HPV test results and cytology screening history can be obtained from the national call and recall system which holds an individual’s invitation and screening history. Demographic details such as name and date of birth are required to search on the call and recall system.

Screening history search

The screening history obtained from the search should identify:

• the full history of screening invitations, including invitations not acted upon
• results
• laboratories involved in reporting the screening test
• the source of samples
• colposcopy records

All local colposcopy clinics should be contacted for relevant records. The record should include:

• the dates of all appointments
• whether the patient attended
• what was done
• colposcopic impression and treatment
• a record of histology results to produce a complete picture of the patient history and create a slide review

There is no longer a requirement to arrange for external reviews of cytology, histology samples, or colposcopy cases for routine audit purposes. However, SQAS may request that additional reviews are completed outside of the audit process. This might be:

• where there are potential concerns about quality of care
• to investigate unusual themes arising from the audit results

Movement of packages

The movement of packages between organisations should be kept to a minimum to reduce the chance of damage or loss. Care should be taken to securely package slides where there is a requirement to send between organisations. Arrangements for transporting slides or information must be clearly documented. Slides should be returned to the laboratory promptly after the review is completed.

The result of all reviews must be recorded on the appropriate audit forms and either provided to the CSPL or uploaded directly to the ICCA database. Please refer to the forms for details of the fields that need to be reported.

Review classifications

Categorise all elements of the screening history reviewed for the invasive cervical cancer audit as:

• satisfactory
• satisfactory with learning
• unsatisfactory

This is as described in the review and classification of previous screening results in the cytology slide review process.

Classifications should be included in the invasive cervical cancer audit form and uploaded to the ICCA database.

A screening incident assessment form should be submitted to SQAS for review if a case review is classified as unsatisfactory. For audit purposes, there is no need for more than one person to review each slide or case if the first review is ‘satisfactory’. However, if the review is ‘satisfactory with learning points’ or ‘unsatisfactory’ then:

• at least 2 members of appropriately qualified staff should review the case
• a consensus opinion should be reached

HPV process review

HPV samples can not be retained in the same way as cytology and histology samples. Therefore there is no sample to go back and review. An administrative process review should be carried out instead. This should be completed for all HPV negative and HPV unreliable tests in the last 10 years. It should include:

• testing platform name
• original result
• valid run data from either the Roche archive viewer or downloaded run data stored on laboratory IT systems (where available)
• external quality assessment reports

At the moment, only 2 HPV testing platforms are in use within the English CSP. Equivalent information will be required if other platforms are used in the future.

Cytology slide review

For audit purposes, review of slides is a different activity to that of routine reporting of screening tests for patient management purposes. Case review takes place in the full knowledge of the original result. This helps to identify any information which could help explain how a cervical cancer may have developed.

There is no requirement to review slides taken more than 10 years prior to diagnosis, even where these are still available on file. This also goes for any abnormal samples that were reported as high grade or worse (including borderline changes in endocervical cells since February 2020). This is provided these were taken within 3 months of diagnosis and led to the immediate referral of the individual.

Review all slides relating to cases which SQAS has informed the diagnosing CSPL/audit lead about (other than those excluded).

The review (known as a ‘local review’ in previous guidance) must be undertaken in the hub laboratory by a consultant pathologist or consultant biomedical scientist (BMS) who routinely reports on cervical cytology on behalf of the NHS. They must satisfy current NHS CSP criteria for reporting. The person carrying out the review must also not have reported on the slide previously. Access to the original report is essential.

Do not remove any dots from the slide. If new dots are added, these must be made using a different colour of ink, and their addition should be noted on the audit proforma/ICCA database which records this information.

Refer to the SurePath guidance when carrying out reviews of cytology slides prepared using SurePath liquid-based cytology (LBC) technology.

Make a note on the forms/ICCA database if cytology slides are not available for review.

Reviews undertaken by other laboratories apart from the diagnosing hospital must be returned to the diagnosing CSPL within a month of receipt.

Audit reviews should use accepted NHS CSP terminology including cytology reporting codes and the revised terminology for abnormal cervical cytology from the British Society of Cervical Cytology (BSCC).

Colposcopy management review

Do not routinely review any colposcopic examination associated with the index referral cytology and made within 18 weeks of the subsequent diagnosis of cervical cancer.

Review any colposcopic examinations that predate the index referral by up to 10 years. This is because these examinations (and the associated management of the individual) may have impacted on the development of cervical cancer.

The capacity to record a digital image of the colposcopic findings and/or use of adjunctive (additional) technology has become standard practice in some clinics. For the purpose of the review, images and the findings from adjunctive technology should be included. However, the opinion of the colposcopist, rather than the adjunctive technology, is taken. The findings of the technology should be noted on the audit form.

The reviewer must check whether the colposcopic management of the woman reflected the relevant NHS CSP guidelines in place for England at the time. The invasive cervical cancer audit colposcopy review process spreadsheet is provided to support this process. Retain the colposcopy review process spreadsheet locally in the patient record and do not send to SQAS.

Histological slide review

Audits of cervical cancers will include a full review of all relevant histological material. This includes cervical biopsies and cervical excisions (for example, treatment specimens including those taken under general anaesthetic). The screening history of the individual will help indicate when an individual was referred for colposcopy and therefore when histology specimens were likely to have been taken.

All relevant histology samples taken over the 10 years before diagnosis must be reviewed, with the exception of the diagnostic sample and any samples taken after the diagnostic sample.

Histology can be identified by review of the pathology laboratory information management system. Local hospitals will know their own referring patterns. This may involve contacting other centres not involved in reporting cervical samples. The colposcopy history review may also identify centres where colposcopy was undertaken, and hence where histological material may be kept.

Best practice is for the reviewer not to have reported the specimen originally. The reviewer must have access to the original report.

The review prepared for the gynaecological cancer MDT meeting as part of the NHS CSP audit of invasive cervical cancers may be used – providing the above criteria is met.

Only existing slides should be reviewed. There is no need to cut new sections.

The review should also include a macroscopic examination of any blocks if there is any suggestion that all pieces have not been cut into or where there is a clear discrepancy found in the review.

7. Importance of control groups

Screening histories from people who did not develop cancer (controls) are required to compare with those diagnosed. This allows rigorous evaluation of the programme.

The selection of controls is done automatically using the call and recall system. Only call and recall staff and SQAS staff will have access to control data. Comparison of anonymised screening histories will be done at a national level only.

8. Audit data

Audit data will be analysed and published at least every 3 years alongside other nationally collected data for consistent analysis. Reports will include:

• monitoring of themes and trends
• assessment of the age distribution of cervical cancers
• time since last screening test

Publishing audit data allows the NHS CSP to evaluate the impact of participating in screening and to see whether the age ranges and screening intervals for the programme are appropriate.

Previous CSP data reports are available.

Other reports will be produced as determined by the invasive cervical cancer audit and disclosure management group.

SQAS will produce an annual summary report and will monitor themes and trends arising from the audit from a quality and safety perspective.