Guidance

Cervical screening pathway requirements specification

Updated 16 August 2021

Applies to England

This document provides an overview of NHS cervical screening by describing what should happen at each stage of the pathway. It should be read alongside other guidance, including:

• the cervical screening programme standards and guidance on programme management (see Cervical screening: professional guidance)
• the programme specific operating model (PSOM) relating to quality assurance (QA) of cervical screening

Local commissioners and providers should also review schedules 2, 4 and 6 of the NHS Cervical Screening Programme service specifications (number 25) held by the NHS England (NHSE) public health commissioning and operations team.

Please also read the general information relevant to all the NHS screening programme pathways.

Cervical screening

The aim of NHS cervical screening is to reduce the incidence of and mortality from cervical cancer by delivering a systematic, quality assured, population-based screening programme for all eligible women. The NHS offers cervical screening to all women and people with a cervix aged 24.5 to 64 years in England. Every person who has a cervix and is within the screening age range is eligible for NHS cervical screening regardless of their gender identity.

Cervical screening looks for high-risk types of the human papillomavirus (HPV) which can cause abnormal cells on the cervix. A sample taker takes a cell sample from the cervix (usually in a primary care or sexual health clinic setting) and sends it to a laboratory for HPV testing. If HPV is detected, a cytology test is used as a triage to check for any abnormal cells. If HPV infection and abnormal cells are detected, a referral to colposcopy is made. A referral to colposcopy is also made when HPV infection persists after 24 months, even if cytology is negative.

Colposcopy is an examination to check for abnormal cells on the cervix, and if present, how serious they are. Colposcopy and programme management guidance provides further information on management and referral.

All screening providers must have systems in place to:

• make sure clear internal governance systems are in place including business continuity processes, and for appropriate providers, that the cervical screening provider lead (CSPL) role is in place
• make sure that all information on data systems is high quality and validated to support accurate data collection and reporting, to monitor the efficacy of the screening service
• make sure an annual report of screening services is produced by the CSPL and is signed off by the organisation, for presentation at the local programme board
• make sure there is regular monitoring and audit of the screening service and, as part of the organisation’s clinical governance arrangements, the local programme board is assured of the quality and integrity of the screening service
• comply with Screening Quality Assurance Service (SQAS) requests in relation to quality and safety requirements
• undertake invasive cancer audit reviews for all individuals diagnosed with cervical cancer in accordance with national guidance including disclosure of audit results

End-to-end pathway

The pathway for cervical screening has been subdivided into 3 parts:

• invitation for screening, sample taking and HPV testing and cytology triage
• colposcopy (including histopathology)
• abnormal colposcopy management (including sample taking, colposcopy and histopathology)

Pathway part 1: invitation for screening, sample taking and HPV testing and cytology triage

Pathway part 2: colposcopy and histopathology

Pathway part 3: abnormal colposcopy management (sample taking, colposcopy and histopathology)

The dotted boxes and numbered labels show how the different parts of the screening pathway map to the pathway themes used as section headings below.

1. Invitation for screening

These requirements relate to making sure that screening is offered to the correct people.

The call and recall service must have systems in place to:

• make sure the eligible population are offered cervical screening in line with national guidance on call and recall
• send national invitation and reminder letters to the eligible population
• work with secure and detained settings to identify eligible persons for screening
• signpost to or provide nationally developed supporting information about cervical screening to everyone invited, so they can make an informed choice about whether or not to be screened
• use the National Health Application and Infrastructure Services (NHAIS) system to manage and monitor individuals within the programme in line with programme failsafe guidance (see ‘4. Call and recall system’ in Cervical screening: cytology reporting failsafe (primary HPV))
• manage people who are ceased from cervical screening in accordance with programme ceasing guidance
• send out result letters to all individuals who have had cervical screening
• return people to routine recall if they are HPV negative, or for early recall if they are HPV positive with no abnormal cells found, or require follow-up tests prior to routine recall
• re-invite people for screening again in 3 months’ time if they receive an inadequate or unavailable test result
• make sure that all people referred to colposcopy are sent a copy of the programme information leaflet on having a colposcopy
• make sure that people receive their screening results in line with test standard CSP-S03: timely receipt of result letter

Coverage

Coverage measures the proportion of the eligible population that are tested and have a result documented within appropriate timescales for screening.

The call and recall IT system provider must have arrangements in place for the call and recall IT system to return data for:

• coverage standard CSP-S01: coverage under 50 years
• coverage standard CSP-S02: coverage 50 years and above

2. Sample taking

These requirements relate to the processes of taking the sample for cervical screening, usually in primary care.

The sample taker provider must have systems in place to:

• make sure all sample takers are qualified (or being trained) in accordance with sample taker training guidance
• take a sample in line with sample taker training guidance
• make sure samples and request forms are correctly labelled according to sample acceptance guidance
• make sure effective failsafe measures are applied consistently across the programme in line with programme cytology reporting failsafe guidance
• offer and book appointments for those who are eligible and due to be screened
• offer screening for eligible people not registered as ‘female’ or ‘indeterminate’, either via the person’s GP practice or, where appropriate, a gender clinic healthcare team – further further details are available in information on screening for trans and non-binary people.

3. HPV testing and cytology triage

These requirements relate to the laboratory processes for testing samples for HPV and abnormal cells (cytology).

The cervical screening laboratory service must have systems in place to:

• make sure that effective failsafe measures (see ‘6. Laboratory failsafe’ in Cervical screening: cytology reporting failsafe (primary HPV)) are applied consistently across the programme
• report HPV test and cytology results informing the call and recall status for each individual
• make sure, where information is provided on human immunodeficiency virus (HIV) status, that HIV-positive people within the screening age range are recalled annually or in accordance with programme guidance
• collaborate and communicate specific issues effectively between all services involved in the screening pathway
• undertake quality control measures and regular audits in accordance with programme laboratory guidance on HPV testing and cytology services
• supply and distribute consumables to sample-taking venues
• transport samples to the laboratory enabling people to receive screening results in line with test standard CSP-S03: timely receipt of result letter
• make sure that the laboratory is accredited by the United Kingdom Accreditation Service (UKAS) and that programme guidance on sample acceptance is followed
• make sure that laboratory equipment has been evaluated and accepted for use by NHSE and that it is used in line with guidance on acceptable HPV tests
• make sure that samples are recorded and tracked on the laboratory information management system (LIMS), according to national guidance
• store samples in line with the manufacturer’s requirements
• make sure that samples requiring HPV testing and cytology triage are processed in line with national laboratory guidance and so that people receive screening results in line with test standard CSP-S03: timely receipt of result letter
• make sure that all staff who process or review slides are appropriately trained
• produce timely, accurate and validated monthly, quarterly and annual data returns (KC61 and QA data reports) for the laboratory to the SQAS, including data for:
  • test standard CSP-S04: minimise false negative reporting
  • test standard CSP-S05: inadequate samples
  • test standard CSP-S06: cytological positive predictive value (PPV)
  • test standard CSP-S07: cytological abnormal predictive value (APV)
• make sure that samples are tested according to the screening pathway, examined by checkers where necessary, and forwarded to a pathologist or consultant biomedical scientist for reporting
• make sure quality control and assurance processes are in accordance with national guidance on laboratory testing for HPV
• refer people with HPV-positive results directly to colposcopy, following the programme protocol for HPV primary testing outlined in colposcopy management and referral guidelines
• make sure a 2 week gynaecological referral is made for people with a cytology result of glandular neoplasia (non-cervical)
• participate and contribute fully to multidisciplinary team (MDT) meetings
• participate in programme requirements for external quality assessment (EQA), covering gynaecological cytopathology EQA and cytology samples EQA

4. Colposcopy

These requirements relate to the further examination of any screen positive participants in the colposcopy clinic who have:

• a cytological report of borderline changes or worse
• received 2 subsequent positive HPV tests and negative cytology 24 months after their initial cervical screening
• received 2 consecutive inadequate cytology or HPV unavailable screening test results

Further examination is necessary for:

• providing a diagnosis
• carrying out treatment where indicated
• following up participants after colposcopy examination and/or treatment

The screening colposcopy clinic must also accept referrals for difficult and complex cases where sample taking is unable to be performed in primary care.

Screening colposcopy clinics must have systems in place to:

• provide services in line with all programme standards and British Society of Colposcopy and Cervical Pathology (BSCCP) standards and guidance, including accreditation of colposcopists
• comply with programme and colposcopy management guidance
• participate and contribute fully to MDT meetings
• make sure that individuals are provided with the necessary information and advice in advance of their colposcopy appointment, including information relating to HPV and see-and-treat options (when appropriate)
• make sure individuals are fully informed and counselled during the colposcopy consultation
• make sure the colposcopist the individual is referred to takes responsibility for their management, including failsafe and arranging further follow-up (see ‘6. Laboratory failsafe’ in Cervical screening: cytology reporting failsafe (primary HPV)) (either in the colposcopy clinic, primary care or a gynaecology clinic as indicated)
• inform the individual and their GP (or responsible clinician) of the outcome of the examination, including any further investigation performed so that test standard CSP-S08: colposcopy – timely biopsy result letter sent is met
• inform the call and recall service of next test due dates by completing the discharge template for all relevant individuals discharged from colposcopy
• produce timely, accurate and validated quarterly and annual data returns (KC65 and QA data reports) for each clinic to the SQAS

Screening colposcopy clinics must have systems to collect and validate data, including data for:

• intervention/treatment standard CSP-S09: colposcopy – 12 month follow-up after treatment
• intervention/treatment standard CSP-S10: colposcopy – inadequate referral
• intervention/treatment standard CSP-S11: colposcopy – 6 week appointment
• intervention/treatment standard CSP-S12: colposcopy – high grade referral 2 week appointment

Cases needing referral for treatment for cervical cancer are managed via local gynaecology services and are outside the screening pathway.

5. Histopathology

These requirements relate to the processes for reporting cervical biopsies (taken in colposcopy) in the histopathology laboratory.

The histopathology laboratory service must have systems in place to:

• comply with programme histopathology reporting guidelines
• be accredited by the United Kingdom Accreditation Service (UKAS) or equivalent, and provide a comprehensive histology service to support HPV/cytology and colposcopy services
• process and report diagnostic and treatment specimens taken by the colposcopy service (including those taken under general anaesthetic) in a timely manner to allow colposcopy to meet test standard CSP-S08: colposcopy – timely biopsy result letter sent
• send results securely to the originating clinician and to the laboratory performing cytology triage
• participate fully in the cancer registration process for CIN3 (cervical intraepithelial neoplasia grade 3), CGIN (cervical glandular intraepithelial neoplasia) and cervical cancer results
• participate in and contribute fully to MDT meetings
• maintain clinical skills and undertake training as required in programme histology reporting guidance, including the British Association of Gynaecological Pathologists (BAGP) E-learning in cervical histopathology module