Guidance

Guidance for radiology and advanced radiographic practice in the NHS Breast Screening Programme

Updated 16 February 2023

Applies to England

This guidance is to support all staff working as a radiologist, breast clinician, radiographic consultant practitioner or radiographic advanced practitioner in the NHS Breast Screening Programme (NHS BSP). It outlines NHS BSP expectations relating to the clinical and working practices of staff, and in relation to cancer detection, screening specificity and sensitivity.

It should be read in conjunction with other breast screening programme guidance, and specifically publications relating to:

• the NHS BSP screening pathway requirements specification
• best practice guidance on leading a breast screening service
• image reading guidance
• clinical guidelines for breast cancer screening assessment
• use of tomosynthesis in assessment within the NHS BSP
• reporting, classification and monitoring of interval cancers and cancers following previous assessment
• interval cancers and the duty of candour toolkit
• how to record vacuum-assisted excisions
• organising higher risk screening
• higher risk women surveillance protocols
• higher risk technical magnetic resonance imaging (MRI) guidance
• implementing remote image reading
• reporting breast images from home

1. Accountability

The director of breast screening is accountable for the quality of breast screening service delivery. They should make sure that the best practice outlined in this guidance is delivered. In accordance with the guidance on leading a breast screening service, where the director of breast screening is not a consultant radiologist, radiographic consultant practitioner or breast clinician directly experienced in the full range of triple assessment, the lead radiology advisor has delegated responsibility to ensure full compliance with this guidance.

Mammography readers should, by repeated self-assessment, audit of practice and continuing education, strive to maintain and improve their skills. This should ensure that all women attending for mammographic screening receive an excellent service with minimal adverse effects.

The Royal College of Radiologists (RCR) is responsible for professional standards in radiology and for approving training of radiologists. Professional standards for radiographers are prescribed and defined by the Society and College of Radiographers (SCoR).

2. Standards for working practice

2.1 Requirements by staff groups

2.1.1 Radiologists and breast clinicians

To achieve the quality standards, radiologists and breast clinicians must:

• be employed for a minimum of 3 programmed screening activities dedicated to clinical care and audit activities as below
• be skilled and involved in all aspects of breast screening, including image reading, screening assessment and multidisciplinary team (MDT) meetings
• undertake training at a nationally approved breast screening training centre (see section 2.3 below)
• have been trained for the tasks they carry out and undertake appropriate training for any new tasks or techniques
• comply with the requirements for training and continuing medical education (CME) / continuing professional development (CPD) as prescribed by the appropriate Royal College or Society, and with local appraisal which may include reflective practice (see the annual appraisal template that accompanies this document)
• attend MDT meetings at which screening cases are discussed
• have access to pathology and/or surgical follow-up data

Radiologists and breast clinicians working in breast screening must make sure their knowledge and skills are up to date. This must include:

• participation in external quality assurance activities (EQA schemes), the results of which are used to compare with ‘real life’ data annually
• at least 25% of CPD credits being in breast radiology (62.5 credits over a 5 year period), which may include attendance at scientific meetings and reflective practice, with a minimum of 5 external points per year
• participation in audit, including film reader QA (FRQA) and interval cancer review
• development of new skills to address new technology challenges for example vacuum-assisted biopsy, MRI and MRI-guided biopsy
• completion of the duty of candour training if they are involved in disclosure of audit/duty of candour consultations
• attend regional screening educational meetings where appropriate

Professional standards for screening and symptomatic breast imaging prepared by the RCR Breast Group are available (login required).

It is good practice to have training in communication and breaking bad news (as referred to in appendix 4 of the RCR guidance on screening and symptomatic breast imaging).

2.1.2 Radiographic consultant practitioners

To achieve the quality standards, consultant radiographic practitioners must:

• be employed for a minimum of 3 screening sessions or equivalent hours dedicated to clinical care and audit activities as below
• be skilled and involved in all aspects of breast screening, including image reading, screening assessment and multidisciplinary team (MDT) meetings
• have undertaken training at a nationally approved breast screening training centre (see section 2.3 below)
• have been trained for the tasks they carry out and undertake appropriate training for any new tasks or techniques
• demonstrate evidence of professional leadership, research and teaching as set out in guidance on screening QA for mammography and radiography
• comply with the requirements for training and continuing medical education (CME) / continuing professional development (CPD) as prescribed by the appropriate regulatory body, Royal College or Society; and with local appraisal which may include attendance at scientific meetings and reflective practice
• attend MDT meetings at which screening cases are discussed
• have access to pathology and/or surgical follow-up data

Professional standards for screening and symptomatic breast imaging prepared by the RCR Breast Group are available (login required).

Radiographic consultant practitioners working in breast screening must make sure their knowledge and skills are up to date. This should include:

• participation in external quality assurance activities (EQA schemes), the results of which are used to compare with real life FRQA data annually
• participation in audit, including film reader QA (FRQA) and interval cancer review
• development of new skills to address new technology challenges, for example vacuum-assisted biopsy, magnetic resonance imaging (MRI) and MRI-guided biopsy
• completion of the duty of candour training if they are involved in disclosure of audit/duty of candour consultations
• attend regional screening educational meetings where appropriate

It is good practice to have training in communication and breaking bad news (as described in appendix 4 of RCR guidance on screening and symptomatic breast imaging).

The Society and College of Radiographers (SCoR) can provide accreditation of advanced and radiographic consultant practitioners regarding the 4 core domains of practice, which are:

• expert clinical practice
• professional leadership
• education training and development
• research and evaluation

Radiographic consultant practitioners work autonomously and are involved in clinical decision making about the women under their care. Their job description must include all 4 core domains of consultant practice as outlined in the generic guidance for Allied Health Professional Consultant roles. A multiprofessional consultant-level practice capability and impact framework is available from Health Education England (HEE), listed on their reports and publications page.

2.1.3 Radiographic advanced practitioners

To achieve the quality standards radiographic advanced practitioners must:

• have undertaken training at a nationally approved breast screening training centre (see section 2.3 below)
• have been trained for the tasks they carry out and undertake appropriate training for any new tasks or techniques
• demonstrate evidence of CPD to retain Health and Care Professions Council (HCPC) registration as a radiographer, as part of SCoR accreditation, and local appraisal which may include reflective practice and attendance at scientific meetings
• attend MDT meetings regularly
• have access to pathology and/or surgical follow-up data

Radiographic advanced practitioners working in breast screening image reporting must make sure their knowledge and skills are up to date. This should include:

• participation in external quality assurance activities (EQA schemes), the results of which are used to compare with real life FRQA data annually (if reporting mammograms)
• participation in audit in areas of advanced practice and interval cancer review (where applicable)
• attending regional screening educational meetings where appropriate

The knowledge, understanding and skills required for this role are provided in the Education and Career Framework for the Radiography Workforce. Radiographic advanced practitioners work to an agreed job plan within a defined supervisory framework.

2.2 Appraisal

During annual appraisal, a consultant radiologist, breast clinician, radiographic consultant practitioner or advanced practitioner should discuss:

• personal image reading data – including recall rates, positive predictive value (PPV), cancer detection rate and discrepant cancer rate
• assessment data – including B1 and core biopsy outcome data
• participation in interval cancer review and same site assessment reviews
• participation in clinical audits
• appropriate minimum breast imaging or clinical CPD
• participation in breast screening MDT meetings

A template annual appraisal form accompanies this guidance.

2.3 Training centres

The national training centres have a continuing role in:

• training new entrants into the specialty
• organising refresher courses
• providing individual tuition for radiologists with a specific problem
• reacting to the training needs identified by the various professional QA groups

Contact addresses of the NHS BSP training centres are available.

E-learning for healthcare (e-LfH) contains a number of educational modules relating to breast disease and breast screening which are available free to all.

3. Guidance for screening image reading

The guidance for image reading details the requirements for image reading within the NHS BSP. It also details the required facilities and personnel required to undertake image reading.

4. Guidance for screening assessment

The clinical guidelines for breast cancer screening assessment detail the process of conducting assessment within the NHS BSP. It also details the required facilities and personnel required for assessment.

5. Facilities and equipment

Guidance on quality control and testing of equipment used within the NHS BSP is available.

5.1 Image reading

Guidance on the facilities and equipment required for image reading is available.

5.2 Assessment

Detailed guidance regarding the facilities and equipment required for assessment is available in the clinical guidelines for screening assessment

5.3 MRI

Guidance is available for using MRI to undertake screening for higher risk women

Additional details are included in NHS BSP image reading guidance.

6. Understanding quality standards for radiology

Quality standards for radiology are available in the NHS BSP standards document. Achieving the standards is fundamental to the programme’s aim to reduce breast cancer mortality.

Data quality is the responsibility of all individuals working in the breast screening service. Valid and complete data collection is essential to allow reliable monitoring of the NHS BSP. Each breast screening professional inputs, directly or indirectly, into the 2 IT systems used within the NHS BSP – National Breast Screening System (NBSS) and Breast Screening (BS) Select. BS Screening is the call and recall database. NBSS contains information about the appointments and clinical outcomes of all women invited for screening. Standard reports from both systems are uploaded into the Breast Screening Information System (BSIS).

The Screening histories information manager (SHIM) uses information from NBSS and the cancer registration database (ENCORE) to assign a screening history to each eligible woman diagnosed with breast cancer. It is anticipated that this screening history information will be available on BSIS in the future.

NHS BSP data is used by SQAS in their quality review of services. SQAS also have a role in resolving queries in SHIM.

Confidence intervals are used in many of the standards. Further information about confidence intervals accompanies this document.

6.1 General radiological quality standards

The core programme standards in the NHS BSP standards document that are particularly relevant to radiology cover:

• screen to date of first offered assessment appointment (BSP-S09)
• recall rate (BSP-S07)
• non-operative diagnosis rates (BSP-S12)
• open biopsy rates (BSP-S11)
• positive predictive value (PPV) of referral (BSP-S13)
• standardised detection ratios (SDRs) for invasive cancers (BSP-14) and small (<15 mm diameter) invasive cancers (BSP-15)
• interval cancer rates (BSP-S17)

Commissioners, service representatives and screening QA service (SQAS) should regularly discuss data reflecting the quality of the breast screening pathway at programme board meetings, to examine where compliance with standards has not been met and to understand how improvements can be achieved. Delayed results and high recall rates result in unnecessary anxiety for women screened and create an avoidable burden on the screening assessment process.

6.2 Monitoring breast screening service quality

The breast screening information system (BSIS) contains data information, including annual KC62, surgical and interval cancer data. See the accompanying BSIS user guide for more details.

6.2.1 Invasive cancer detection

The NHS BSP uses cancer detection as a surrogate measure of programme quality in the absence of real-time mortality data.

If a breast screening service’s cancer detection falls below the acceptable level, they should examine aggregated data for the last 3 years. The service, with the advice of SQAS, should undertake an investigation to establish possible reasons for this trend.

Examine the standardised detection ratio (SDR) data in conjunction with:

• referral to assessment rates and PPV of referral
• annual trends in detection rates
• individual analysis of film reader quality assurance (FRQA) statistics within the service
• interval cancer analyses

Always consider SDR values for short periods of time in the context of longer-term quality data. It may be advisable to combine prevalent screen and incident screen SDRs over time. Further information regarding SDRs and how to calculate them accompanies this document.

6.2.2 Invasive tumour size

The aim of the NHS BSP is to detect breast cancers when they are small. Cancers detected that measure less than 15mm have a better prognosis and treatment outcomes are more favourable. At breast screening service level, the number of tumours detected that are less than 15mm in diameter gives a reliable measure of quality (confidence limits are smaller than for the number of tumours of 10mm or less). The expected standard is that 55% of screen-detected invasive cancers will be less than 15mm in maximum diameter for both prevalent and incident screens. This is based on analyses of the results of the Swedish two-county trial.

Use histological size of invasive carcinoma (fixed specimen) where available. Where no histology is available, use the best available size from mammography, ultrasound or clinical examination. Histological size might not be accurately recorded when size is recorded as ‘less than’ as opposed to ‘less than or equal to’, therefore pathologists should give a precise measurement and not round up histological sizes.

6.2.3 Non-invasive cancer detection

The number of non-invasive carcinomas expected includes ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), pleomorphic LCIS and microinvasive disease. Detection of DCIS at screening, particularly high-grade types, is assumed to be a factor contributing to long-term reduction in mortality (although no firm scientific evidence currently exists to confirm this). The majority of DCIS detected at screening is of the high-risk type.

Standard BSP-S16 relates to non-invasive cancer detection rates. DCIS numbers include in situ carcinoma and in situ carcinoma with possible or definite microinvasion. This is based on 10% of the total target cancer detection rate. No achievable standard or upper limit is set because there is evidence that high DCIS detection rates are associated with high SDR.

Guidance on recording vacuum-assisted excisions on NBSS includes recording of LCIS.

6.2.4 Positive predictive value (PPV) of referral to assessment

Standard BSP-S13 measures the proportion of women referred for assessment with a final outcome of breast cancer (invasive and non-invasive). PPV of referral to assessment gives an indication of how effective the breast screening service is in identifying true cancers in those women referred to assessment for further tests. Breast screening services should aim to maximise the number of cancers detected whilst minimising the number of women recalled to assessment.

Examine PPV of referral data in conjunction with referral to assessment rates and SDRs.

6.2.5 Short-term recall (STR)

Standard BSP-S08 applies to women recalled for screening assessment at an interval shorter than the normal screening interval (currently 3 years) after a previous screen and attendance for assessment. All women on STR should have previously attended for assessment. Do not use STR as a routine outcome following assessment.

Make every effort to obtain a definitive diagnosis at initial assessment. Only use STR in exceptional circumstances and with fully informed consent, as it is associated with significant anxiety (see Obadina and others, 2015).

6.2.6 Non-operative diagnosis

Standard BSP-S12 outlines the programme expectation in relation to non-operative diagnosis rates. A non-operative diagnosis of malignancy is highly desirable as it allows informed pre-treatment counselling of the patient and enables one-stage treatment. Only include definitive diagnoses of malignancy (B5 or E5) in the rates.

A definitive diagnosis should be achieved in the minimum number of assessment visits. Women should not have to make more than 2 visits for interventional procedures (see standard BSP-S10). Repeated attendances for assessment or needle biopsy during a single screening episode are likely to be associated with unnecessary anxiety. Core biopsy is the expected standard for biopsy procedures. Vacuum-assisted biopsy should be considered if diagnostic difficulty is anticipated or for vacuum-assisted excision.

6.2.7 Open surgical biopsies

Wherever possible, obtain a definitive diagnosis by non-operative techniques adhering to programme standards, thereby avoiding the need for surgical excision. However, benign biopsy may be unavoidable where imaging, clinical or cytological/ histological features, or the woman’s choice, mean that formal surgical excision is needed to obtain a definitive diagnosis.

In order to minimise unnecessary surgery, the number of open surgical biopsies performed as a result of screening that prove to be benign should be as small as possible (see standard BSP-S11). Therapeutic excision biopsy of known benign lesions undertaken at the request of the woman or her surgeon are excluded from the benign biopsy standards.

6.2.8 Waiting times

Screening can be stressful for women, so procedures at all stages of the pathway should be undertaken in a timely fashion (in accordance with the relevant standards).

Having a core biopsy causes particular anxiety and the service is expected to inform women of the results of these procedures without significant delay. The NHS BSP screening pathway requirements specification recommends that all biopsy results are given in person. However, providing benign results by telephone as part of the extended clinical nurse specialist (CNS) role is now established practice in most breast screening services.

6.2.9 Interval cancer reporting

Guidance on reporting, classification and monitoring of interval cancers is available. Interval cancers are reported for women in the very high risk and routine programme, but interval cancer rates only include women screened within the routine screening programme. This includes the process for cancers following previous assessment.

Expected interval cancer rates are outlined in standard BSP-S17.

Review of interval cancers can lead to disclosure of audit and duty of candour discussions, which should follow the guidance provided in the interval cancers and duty of candour toolkit.

Interval cancers are inevitable in any screening programme but their numbers should remain at a minimum. A high proportion of interval cancers reduces the likelihood of breast cancer mortality reduction in the screening population. Individual breast screening services should participate actively in the collection and collation of interval cancer data. These should be examined alongside other screening data (such as invasive cancer detection rates and SDRs) when considering the quality of a breast screening service.

Auditing the proportions of interval and screen-detected breast cancers and classifying their types helps in the evaluation of the NHS BSP in the longer term. These data enable estimates of overall programme sensitivity for example, and may highlight areas needing further attention.

6.2.10 Quality performance indicators (QPIs)

The national breast screening audit produced in conjunction with the Association of Breast Surgeons (ABS) has a series of QPIs which all breast screening services are monitored against. There are discipline-specific QPIs which are considered and chosen by the multidisciplinary Screening Audit Group based on consideration of the main events of a woman’s journey through the breast screening, diagnostic and treatment processes. Some measures are taken from the NHS BSP standards, but others are ways to examine qualitative rather than quantitative aspects of programme delivery.

The national pathology audit contains data which are relevant to radiologists. Data within this audit does not only reflect the quality of those aspects of the screening pathway delivered by pathologists. Many parameters are multi-factorial, influenced by accuracy of the operator taking the sample; for example the radiological threshold for sampling, and the availability and use of vacuum assisted techniques.

6.3 Improving image reading

Details of the information available on the BSIS and requirements of individual image readers and directors of breast screening are outlined in NHS BSP image reading guidance.

6.4 Organisation of breast screening radiology quality assurance

Quality assurance is integral to the breast screening programme. Formal visits and ongoing monitoring ensure that acceptable standards are maintained and service improvement is encouraged. All staff should participate fully in QA activities. Details are provided in the programme specific operating model.

Each sub-regional radiology professional and clinical advisor (PCA) is appointed by the regional head of QA and has a (renewable) 3-year term of office. PCAs provide expert advice to SQAS. This involves supporting regional SQAS by chairing professional networking meetings and supporting breast screening services as part of the visiting team at QA visits, in addition to providing ongoing advice as required.