Guidance

Breast screening: programme specific operating model

Updated 24 August 2021

This document describes the programme specific operating model (PSOM) for quality assurance (QA) of the NHS breast screening programme (BSP).

This PSOM was developed by a working group led by the national portfolio lead (NPL) for breast screening along with members of the regional SQAS teams and, where applicable, colleagues from NHS England and Improvement.

The PSOM describes how SQAS works with, supports and quality assures breast screening services.

SQAS works to implement the PHE screening inequalities strategy by:

• checking that delivery of the NHS BSP contributes to reducing health inequalities
• making sure SQAS processes support the identification of inequalities in the screening pathway to enable screening services and commissioners to address the issues raised

A separate document explains the quality assurance process of the NHS BSP.

Overview of quality assurance activities

Service engagement

A named senior quality assurance advisor (SQAA) or quality assurance advisor (QAA) acts as visit lead and will be linked to each screening service and the NHS England and Improvement (NHSEI) public health commissioning team (PHCT).

Throughout the remainder of the document the named SQAS visit lead will be referred to as S/QAA.

The S/QAA or deputy will attend screening service steering or programme boards to:

• identify and monitor screening issues
• support the identification of risks and potential incidents
• monitor progress against QA recommendations
• support service improvement including work to reduce screening inequalities
• update screening services on changes in national policy
• share learning

Analysis of data and intelligence

PHE Screening and SQAS will collect and/or review data in specified time periods. See data and intelligence from quality assurance.

Services are benchmarked using national screening standards.

SQAS and PCAs (where applicable) annually review data and intelligence at a national, regional or sub regional level. This data and intelligence is used to prioritise SQAS activities.

Further information and intelligence may be obtained from attendance at screening service steering or programme boards and by other means including regular PHE screening reports, published studies, discussions with screening services and national screening programmes.

Visits and reviews

The QA visit process includes all screening services delivering the full screening pathway or part of it. This includes private providers commissioned to deliver NHS screening programmes.

The frequency of QA visits and other QA activity is based on findings from the annual prioritisation exercise. The maximum interval for a full visit for all screening services is 5 years.

SQAS may undertake a visit or assessment within the 5-year period if needed. Changes in service provision via re-procurement or reconfiguration will be considered as part of the annual prioritisation exercise with the flexibility for in year adjustment if required.

The QA visit and review of screening services will include:

• programme management and governance
• the screening pathway
• referral to relevant diagnostic or treatment services
• public health system leadership and commissioning

NHSEI and screening services are informed of scheduled visits/targeted interventions to give adequate preparation time.

Following a QA visit or targeted intervention a report is produced and sent to the screening service and commissioner(s). Where recommendations are made the screening service should develop an action plan with the commissioner.

The QA report executive summary is published on GOV.UK unless consent is withdrawn by either the screening service or commissioners.

The QA visit process is described in detail in the QA visit preparation section.

Support with incidents

The role of SQAS in screening safety incidents is set out in PHE’s guidance Managing safety incidents in NHS screening programmes. The role includes:

• developing guidance and processes for managing and monitoring screening safety incidents and serious incidents
• developing resources and training packages to support the management of screening incidents
• collating and disseminating the learning from incidents at national, regional and local level

SQAS supports patient safety by:

• providing expert advice to screening services and public health commissioning teams so that safety concerns, safety incidents and serious incidents are assessed, investigated and managed effectively
• accessing specialist clinical and policy advice for specific incidents from PHE Screening’s national programme team and from professional and clinical advisors who work with regionally based SQAS teams
• working with the Public Health Commissioning and Operations team in NHSEI on incidents that require a national response

Networking and support

A variety of approaches to networking are used across SQAS. Feedback from attendees shows these events are valued by both SQAS and screening service representatives.

Network meetings are used by SQAS to share information relating to new screening standards, guidance and national programme developments. They provide an opportunity to share data, discuss support needs, and enable feedback. They help identify quality issues and potential risks which could inform future QA activity.

Meetings allow staff working in screening services to develop networks and share tasks such as development of protocols.

Meetings may have input from external speakers or include sharing of local audit information. SQAS and the national screening programme manager work together where applicable to develop a joint agenda for these meetings.

The frequency of meetings will vary by professional group. There will be a minimum of 3 per year per region. They will involve different staff groups depending on prioritisation and current issues. This is likely to include some or all of:

• admin and clerical meeting held every 4 months (may have a training event in addition)
• radiography (lead radiographers) meeting held every 6 months - the medical physics PCA should also be invited to attend (user quality control (QC) radiographers may meet annually and chaired by the PCA for radiography or medical physics)
• medical physics event held annually (may incorporate a training event)
• radiology educational event held annually
• directors of breast screening business meeting held every 6 months
• programme managers meeting held every 6 months, if required, depending on the local area (this standalone group may be required if they are not included in any of the other groups)
• pathology educational event held every 6 months - where feedback of EQA and pathology data is delivered
• surgery business and educational event held annually - all surgeons involved in the NHS BSP should normally be present at more than 50% of meetings of the regional screening surgeons’ group in a 3-year period, as per QA guidance
• nursing business meeting held annually (may include educational components, as decided locally)
• interval cancer reviews, with frequency to be agreed locally

Data and intelligence

Data sources

National breast screening system

The national breast screening system (NBSS) is the system used to administer the breast screening programme. It is a single system rather than a single database, as each service has its own copy. Defined structured reports or Crystal reports are pieces of software used to extract information from the NBSS. The system is used to:

• invite women to screening once their details have been received from Breast Screening Select
• record details of attendance, imaging, recall to assessment, cancers diagnosed, and interval cancers as indicated
• notify women and GPs of results
• manage the high-risk programme

The system also produces the KC62 return (a standard dataset used to produce official national statistics on the outcomes of the NHS breast screening programme), standardised reports and feeds into the Breast Screening Information System (BSIS).

Breast screening select

This database is fed from a link via National Health Applications and Infrastructure Services (NHAIS). This demographic feed is planned to be replaced by a link to the Spine during 2020 to 2021. Breast Screening Select specifies batches of women for screening by general practitioner (GP) practice (although not by individual GP) and geographic area.

The system is used to:

• identify women eligible for screening
• record screening histories and ensure these follow women when they move area
• trace women who have moved and need to be contacted in the light of an incident
• apply the randomisation algorithm designed for the AgeX trial to the appropriate age groups
• provide a dashboard of activity used to inform the monthly assurance process

The system also produces the ceased women extract and a single national KC63 return (a standard dataset used to produce official national statistics on coverage for the eligible population) which is fed to BSIS to produce coverage statistics. Coverage is available at service, local authority and GP level.

Breast screening information system

The breast screening information system (BSIS) is a bespoke tool commissioned by PHE to collect, collate, analyse and present breast screening data. The system is developed on PHE’s behalf by NHS Digital and is hosted on the same platform as BS Select.

Access to BSIS is restricted and users will be provided with personal login details. A unique identifying code is also available to clinicians so they can compare their professional performance to others’. All SQAS users will be able to see data for their region; all providers will be able to see data for their service (anonymised at individual level). Directors of breast screening and SQAS staff will have the key to all relevant identifying codes. The system works by receiving downloads from individual NBSS instances using specified reports.

The system currently includes the following modules:

• film reading
• surgery (currently restricted to data upload and validation functions only, with some reporting available to national users)
• KC62
• KC63/coverage

Screening histories information manager

Screening histories information manager (SHIM) is a tool that classifies the screening status of breast cancers utilising data from the cancer registry system, the English national cancer online registration environment (ENCORE), and NBSS.

This classification allows the identification of interval cancers, which are important to quantify in order to provide information on whole screening programme performance. The tool allocates cases to the responsible screening service and SQAS region, based on screening episode data obtained from NBSS. It has been shown to be capable of automatically categorising 90% of cases; the remainder require the relevant SQAS regional office to investigate and resolve.

SQAS should liaise with their local screening services regarding interval cancer cases in line with the national interval cancer manual. They should request that these cases be reviewed locally and recorded on NBSS with full details of the cancer including the radiological classification.

The screening status classification of cancers are returned to ENCORE and available to researchers. The radiological classifications are not available for research purposes.

English national cancer registration and analysis service

Data to support the adjuvant and survival aspects of the NHS breast screening programme and Association of Breast Surgery (ABS) audit (NHS BSP and ABS audit) are currently received from ENCORE. The cohort and data items are defined by the audit and the exercise is undertaken annually by dedicated analysts.

Data that supports the routes to diagnosis reports are shared by SQAS with national cancer registration and analysis service (NCRAS) so that women diagnosed through screening can be identified. These data are available to external researchers through NCRAS.

KPIs

Screening key performance indicators (KPIs) define consistent performance measures for a selection of public health priorities, using terminology that is clear and common across all NHS screening programmes, so performance can be understood, assessed and compared. They are a subset of screening standards and relate to a limited range of screening priorities that are not in themselves sufficient to quality assure or performance manage screening services. The KPIs reflect areas where consistency and an understanding of variation across England are important.

KPIs are collated and reported quarterly, unless numbers are small, in which case aggregated data is reported in the public domain annually. Small number KPIs are available for PHE Screening staff for quality assurance purposes, including monthly KPIs. These KPIs are contained within the Section 7a agreements between the Department of Health and Social Care (DHSC) and NHSEI and in the Public Health Outcomes Framework (PHOF). Further information about screening standards and service specifications are available for each programme.

Screening pathway reporting

PHE Screening is committed to publishing data required to support quality assurance of screening standards. Standards are reported annually unless they are also KPIs in which case they are usually reported on quarterly and annual figures are aggregated.

PHE screening co-ordinates an annual collection and analysis of standards data. The submitting organisation is responsible for timely submission of data and making sure that only accurate data is submitted. Good quality data is important for monitoring and improving screening services. Screening providers may want to refer to the guidance for providers on the false or misleading information (FOMI) offence, which sets out the responsibility of providers to supply and publish accurate data.

BSIS has a document outlining the responsibilities of the different organisations involved in data collection with respect to the expectations of data accuracy and analysis.

The current list of outline reports and frequency are:

• KC62 - twice a year/annually
• KC63 - annually
• uptake - quarterly/annually
• referral to assessment (previous/inclusive) - quarterly/annually
• short term recall - quarterly/annually
• screen Round Length - monthly/quarterly
• waiting times for results - monthly/quarterly
• invasive cancer detection (previous/inclusive) - twice a year/annually
• ductal carcinoma in situ (DCIS) cancer detection (previous/inclusive) - twice a year/annually
• standardised detection ratios - twice a year/annually
• standardised detection ratio <15mm - twice a year/annually
• technical recall/repeats - monthly/quarterly
• non-operative diagnosis (invasive/DCIS) - twice a year/annually
• benign biopsies (previous/inclusive) - twice a year/annually
• waiting time from screen to offer on an assessment appointment – monthly/quarterly
• film reader quality assurance (FRQA) - annually
• film reading numbers - annually
• surgery - annually
• pathology - annually
• pre-visit data booklet - at the QA visit

Data analysis

Core data analysis, in line with the data specification agreed for QA purposes, will be produced via BSIS and accessed locally by providers and regionally by SQAS staff.

Data analysis will be reviewed by regional SQAS staff in a timely manner with advice from the relevant PCA and/or national portfolio lead as required. Specific action will be taken by regional SQAS staff as required.

SQAS will comply with the set national screening methodologies as these are developed.

Performance will be compared, where available, to the national average. Comparison to regional averages should not be undertaken in these instances.

Data quality and completeness of data is reviewed using national guidance and other data validation operating procedures (manual and/or automatic). BSIS is programmed with appropriate data validation checks which prevents the upload of erroneous data into the system.

Where not available on BSIS, data analysis is undertaken by national or regional data analysts. The level of data reporting for QA purposes is provided in the detailed specification of breast data. The direction of travel for breast QA data is to provide data at a professional (individual) level where meaningful. It is recognised that this level of analysis for the 2016/19 pathology QA data will not be available. This will be reintroduced in future iterations of these data.

Analysis of data which is outside the scope of normal breast screening QA processes defined below should only be undertaken with clear justification, for example in response to a specific performance concern where additional data would assist regional SQAS staff in their assessment of risk and to advise stakeholders accordingly. The rationale for such investigations should be clearly documented as part of the prioritisation process and agreed by the regional portfolio lead.

Template audits are tools used by SQAS to investigate any areas of concern at a given service. They are available for some of the more frequent areas where further investigation is required. These templates should be utilised when these data points are identified and require input from services to complete. The routine production of additional, non-core data to support QA activities is not indicated and should not occur. The regional breast portfolio lead should ensure that no routine data extraction, reporting and analysis outside that identified for breast QA is being undertaken.

The above description excludes additional analysis indicated by a variation in screening or patient management present in selected services, for example as a result of participating in a trial. In such instances the regional portfolio lead should agree and pilot a data intervention with the national portfolio lead.

Data reporting

Reporting and analysis is done once, nationally where possible. Dissemination of data not already in the public domain to screening services is via BSIS or the SQAS regional teams.

Although the national service specification requires more frequent reporting of the KC62 report, these data are not incorporated into BSIS due to the incompleteness of the data at these timepoints.

Data sharing

Routine data sharing between PHE Screening and NHSEI for all 11 NHS screening programmes is underpinned by the Memorandum of Understanding (MoU) signed by both organisations. This MoU extends to any onward sharing to any third party, for example, PHE centre directors, providers of screening services, local authority, clinical commissioning groups (CCGs), voluntary organisations and other health professionals using screening data to improve and monitor services. This is for the purpose of improving the quality of screening services. The set of data items covered by the MoU is shared prior to publication and for management purposes only. Data flows, schedules and the list of data items shared are managed by the national data and information team. All data shared under the MoU is also available to PHE screening staff.

Non- routine data requests from commissioners and service providers should be discussed with SQAS regional teams and/or Research Advisory Committees (RACs) who will consider requests in line with data release principles including, but not limited to, the following questions:

1. Has the data already been shared via the MoU or is it available in the public domain?
2. Is the data likely to support population health improvement?
3. Is the data likely to improve the quality of screening services?
4. What is the level of anonymisation required (ranging from open government licence to potentially identifiable and identifiable information)?
5. What are the resources and costs required to extract, collate, quality assure and release the data set?

SQAS regional teams will, if necessary, involve the national portfolio lead and the national data and information technician in the initial discussion of non-routine data requests and seek advice from RACs where appropriate. All requests for data not aggregated to the information standards board (ISB) for health and social care anonymisation standard is discussed with the PHE office for data release.

The RAC application process and a detailed flowchart are available.

All data requests and releases will be centrally logged and tracked. External data requests may incur a charge.

Data escalation

The responsibility for the review and, where indicated, the investigation of data lies with the regional SQAS team. There should be critical discussion, justification of further investigation and clear documentation and communication of agreed actions as a result of any unusual data findings.

If performance is of concern, regional SQAS teams should escalate in the first instance to the relevant local programme board for further discussion and agreement of actions informed by regional SQAS advice. If there is no evidence of improvement, the regional portfolio lead should highlight this performance to the regional SQAS management groups. At this forum it may be decided to escalate further within SQAS and PHE.

A trigger point system for the consolidated standards is being developed. This system identifies when a data point ‘triggers’ escalation. The current proposal is that performance which lies outside 2 standard deviations would require escalation from regional to national review. Once finalised, the trigger points table will be published on the BSIS platform.

A detailed outlier management process has been published to support the appropriate governance of data produced as part of the NHS BSP and ABS audit’s quality performance indicators (QPIs). QPIs are used by the NHS BSP and ABS audit group. They are used to examine more qualitative aspects of the screening process to encourage consideration of the quality of experience within the screening process in addition to complying with high technical standards. In summary, the process requires regional SQAS to inform their trusts where there is performance outside normal variation. The individual trusts are then required to investigate these instances internally, checking in the first instance the accuracy of the data.

Information governance

PHE acts as the sole or joint data controller for certain data. This includes data within national information communication technology (ICT) systems which is used to deliver the call recall part of the screening pathway. It also includes data which is processed to assure the quality, safety and efficacy of screening. These systems are usually ones that PHE has directly commissioned or has a role in establishing.

PHE holds a responsibility to ensure that any data we control is processed in line with the relevant legal and ethical requirements. Because we process personal confidential data without gaining prior consent from patients, PHE requires permission to set aside the legal duty of confidence (this is the obligation that medical services have to keep information they hold on patients secure and confidential and not share it with third parties, such as PHE).

The legal authority to set aside the duty of confidence comes from approval by the Health Research Authority’s Confidentiality Advisory Group (HRA CAG). This is commonly referred to as Section 251 (S251) support. PHE has approval to process confidential data for a specific set of circumstances required to deliver safe, effective screening. Specifically, PHE has Section 251 support to discharge its duty to oversee the delivery of screening, its quality assurance and its evaluation.

PHE does not have S251 support to undertake research. Researchers cannot claim PHE’s S251 support as their own without an explicit data processing agreement between PHE and the processor and a letter of amendment from the HRA CAG.

QA visit preparation

Objectives

The objectives of the QA visit are to:

• examine the performance of the screening service
• confirm if national screening standards are met
• identify variance from screening standards
• support professionals working in the screening service to maintain and improve performance against screening standards
• identify areas for shared learning and disseminate these to all screening services
• share experiences and understanding of current problems or concerns in NHS breast screening services and contribute to national development

The QA visit team

The QA visit team is selected by SQAS, led by the visit chair and supported by the:

• SQAA and/or
• QAA/quality assurance facilitator (QAF)

Members of the team include:

• administration and clerical
• radiography
• medical physics
• radiology
• pathology
• surgery
• breast care nursing
• commissioning

QA visit team members are asked to declare conflicts of interest before the visit. If this raises concerns about the use of a PCA for a visit, SQAS will take advice within PHE.

A maximum of 2 observers may be present at a QA visit, for training and education purposes. The observers are not involved with providing feedback and will not input into the interviews or decision-making processes.

Role of the QA visit chair and QA advisor

For breast screening, the visit chair is the regional portfolio lead (RPL) or a PCA who has received specific training to perform this role. If the visit chair is also a PCA they are not expected to act in their usual PCA role during the QA visit unless agreed in advance.

The visit chair is responsible for:

• chairing and directing the conduct of the QA visit
• providing considered, consistent feedback on the QA visit findings
• managing sensitively and appropriately any serious issues or concerns raised prior to or on the day of the QA visit
• facilitating the exchange of knowledge and ideas and encouraging productive networking

The S/QAA supporting the visit chair is responsible for adequate preparation before the QA visit including:

• notification of the visit date to the provider organisation chief executive (CE) and commissioner 6 months before the visit
• making sure the screening service knows what to prepare for the QA visit
• arranging any preliminary meetings between SQAS and the screening service
• acting as a point of contact for any queries relating to organising and co-ordinating the QA visit
• identifying and managing the QA visit team who are accountable to the QA visit chair up to and including production of the final report and executive summary
• making sure PCAs are contracted appropriately and agreements are signed prior to undertaking QA activity
• making sure all PCAs selected have completed the required training
• making sure the evidence to support the QA visit is submitted via the screening division IT system known as Marvin and any observational pre-visits are completed
• identifying late submission or missing evidence and escalating as appropriate
• reviewing the evidence submitted and identifying areas for discussion
• developing agendas for the pre meeting, QA visit and feedback sessions
• making sure adequate preparatory work is complete
• supporting the visit chair to collate feedback during the QA visit

Following the QA visit, the S/QAA is responsible for:

• making sure PCAs provide feedback in a timely manner to allow drafting of the factual accuracy report within the agreed timescales
• making sure an accurate final report of the QA visit is issued within the agreed timescale and sent to provider CE(s) and NHSEI screening and immunisation leads (SILs)
• making sure recommendations are followed up and monitored within the agreed timescale and escalated where progress is not made
• making sure the executive summary is uploaded to GOV.UK in accordance with SQAS guidance

Skills and experience of QA visit team

Members of the QA visit team need skills in:

• report writing
• interview techniques
• an understanding of screening incident identification and management
• analytical skills

They should also:

• have programme specific QA training
• understand public health aspects of screening
• have the opportunity to observe a QA visit

Specialist skills required of the individual PCAs are documented in the breast screening PCA person specification/role description.

Locations to be visited

The QA visit will assess the screening service and screening pathway(s). If a service has sites located away from the main provider unit it may not be possible to visit all screening sites on the same day. Where needed the S/QAA will arrange visits to other sites before the main provider unit QA visit takes place.

Screening service personnel

Depending on service configuration the QA visit should be attended by:

• director of breast screening
• programme manager
• office manager
• lead radiographer
• lead physicist
• service manager
• lead radiologist
• lead surgeon
• lead pathologist
• lead breast care nurse
• screening and immunisation lead (SIL) and/or a nominated experienced screening and immunisation manager (SIM)
• screening and immunisation manager
• head of commissioning/public health commissioning manager

Evidence considered

The QA team review:

• pre-visit questionnaires completed by the screening service (where applicable)
• commissioning
• supporting evidence and documents submitted to SQAS
• interviews undertaken during the QA visit
• observational visits (where applicable)
• case reviews (where applicable)
• analysis of annual report data and routine data for the preceding 36-month period
• the QA visit data booklet
• programme specific inequalities evidence guide to identify inequalities in the screening pathway

Preparation

SQAS will agree the QA visit date with the screening service and commissioners. At least 6 months’ notice is given. The screening service should identify a contact person to co-ordinate arrangements. They are responsible for evidence submission, booking meeting rooms for interviews on the day and providing relevant contact details.

The date of the QA visit will not be changed once it is agreed, except in exceptional circumstances, and only with the agreement of both parties.

SQAS informs the CE(s) of the host trust, stakeholder trusts, providers of any associated services, treatment providers and commissioners of the QA visit. They are required to attend or send a suitable representative to the QA visit feedback session and subsequent discussions as appropriate.

Preliminary meeting

A preliminary meeting between SQAS and the screening service or commissioners may take place. This will vary by programme, for example, SQAS may attend the next scheduled screening service steering or programme board meeting or operational group meeting once the QA visit date is agreed.

If no meeting is scheduled prior to the QA visit SQAS may request a bespoke meeting around 3 months before the QA visit date.

SQAS will use the meeting to inform the screening service about arrangements for the QA visit. This includes arrangements for any observational visits, an outline of the agenda and answering any questions that the screening service and its stakeholders may have.

Information to be provided

In preparation for a QA visit the screening service is asked to provide:

• action plans from previous QA recommendations (where not already available to SQAS)
• action plans from pre-visit questionnaire or desk top review (where applicable)
• completed pre-visit questionnaire (where applicable)
• supporting documents and protocols as outlined in the pre-visit questionnaire or documentation
• performance reports as requested
• information on any incidents that have occurred in the last 12 to 24 months
• information on venue organisation, the location of the QA visit including rooms for interviews and feedback sessions
• other relevant information requested by SQAS

This information should be provided to SQAS at least 12 weeks prior to the QA visit date. There is no flexibility to extend the deadline for evidence submission unless it is agreed by the S/QAA, RPL and visit chair.

Evidence should be submitted via the screening division’s Marvin IT system. SQAS will provide details of how to upload evidence.

Evidence transfer must conform to information governance rules. No patient identifiable or sensitive information should be transferred to SQAS. SQAS information governance protocols should be followed.

Evidence submitted that is out of date, for example policies or guidelines, is not assessed, but is used to inform decisions about screening service governance.

Where needed, the S/QAA leading the QA visit will request clarification of evidence submitted or for further evidence to be provided.

Where evidence is not submitted the S/QAA will escalate within the screening service and with the commissioner/SIL.

Review of evidence

The evidence is reviewed by the visit chair, lead S/QAA and PCAs.

The lead S/QAA completes the context grid (summary document) and reviews the evidence with the visit chair to determine initial key lines of enquiry (KLOE). The final KLOE are agreed with the PCAs following the evidence review meeting.

The standing QA team

SQAS regional teams work with a defined group of PCAs who provide expert advice for breast screening. These PCAs are known as the standing QA team. They support regional QA professional networking opportunities and form the QA visit team in addition to providing ongoing advice as required.

Information for the QA visit team

The information pack includes:

• contact details of visiting PCAs
• list of screening service personnel
• agenda for the QA visit day (including details of venue and rooms booked)
• overview of the screening service (context grid where applicable)
• copy of last QA visit report and progress against action plan (where applicable)
• all documents submitted by the screening service
• outcome of the observation of clinical practice and premises (where applicable)
• outcome of the observation of administration practice (where applicable)
• data relating to performance of the screening service

The information pack is available at least 2 weeks before the QA visit.

Pre-visits

The breast screening PCAs will generally undertake a pre-visit to complete aspects of the visit process such as compiling case notes and undertaking slide and imaging reviews.

Radiology film reviews

The purpose of the review of the assessment cases, interval and previously assessed cancers is to:

• understand and review internal processes
• review the quality of documentation
• review the distribution of case types between assessors
• review effective use of the multidisciplinary team (MDT) process
• review the classification of interval and previously assessed cancers
• create a forum to have a full discussion of cases/representative issues
• highlight specific areas of good practice

It is important that all cases in the clinic list are provided so that a complete review of consecutive cases can be undertaken. A minimum of 5 assessment cases should be reviewed for each assessing professional. Specific additional cases will also be reviewed. These cases will be identified by SQAS 4 weeks prior to the visit. The responsible assessor should be available to the radiology PCA so that they have an opportunity to present their cases in order to maximise the value of this part of the visit.

The mandatory cases to be reviewed are:

• full assessment clinic(s) for each responsible assessor (minimum 5 cases per responsible assessor)
• all previously assessed interval cancers and screen detected cancers from the previous 3 years categorised as unsatisfactory and at least 25% each of satisfactory with learning points (via completed previous assessment review forms) and cases classified as satisfactory
• cases returned to normal screen at assessment, which are subsequently recalled or who require additional assessment following review by 2nd reader (cases to be determined via NBSS if possible, or by local audit)
• interval cancers (all unsatisfactory cases in the last three years and at least 25% of satisfactory with learning points in the last 12 months).
• non-concordant localisations
• cases identified through review of the data where indicated

The service should suggest optional cases as a result of a service led assessment of their current challenges where they believe that input from the visiting PCA would be most constructive. These may come from one of the following areas:

• B5 with subsequent benign surgery.
• cancers from short term recall.
• short term recall to second short term recall.
• short term recall cases
• cancers with no preoperative diagnosis of malignancy
• benign surgical biopsy cases
• malignant core with no subsequent surgery
• B1 core returned to RR
• cases with over four visits for a cancer diagnosis
• cancers detected by only one of two readers.
• any cases brought for discussion by the local team

Pathology slide reviews

The purpose of the review is to:

• understand and review internal processes
• ascertain if sampling/levels meet national guidelines
• review the quality of documentation/completion of RCPath/NHSBSP minimum datasets
• effective use of the MDT process
• create a forum to have a full discussion of cases/representative issues
• highlight specific areas of good practice

The review does not intend to ‘check’ the accuracy of the diagnosis. If concerns are identified a separate process common to all screening programmes and disciplines should be followed.

At least 5 cases should be reviewed for each reporting pathologist and include a selection of:

• pre-operative specimens
• surgical cases
• open diagnostic biopsies
• potential false positive cases

The PCA may select types of cases following review of the data.

The pathology PCA will also undertake a review of 10 anonymised reports per pathologist, including:

• 5 core/vacuum-assisted biopsies
• 5 surgical excision specimens (including examples of carcinomas)

The total number of slides reviewed will depend on the number of histopathologists within a Unit that are reporting breast screening specimens and is at the discretion of the pathology PCA.

For all cases selected, the department being visited should provide all sections and matched histology reports.

Surgeon case note reviews

The purpose of the review is to:

• understand and review internal processes
• review the quality of documentation
• review effective use of the MDT process
• explore themes identified from the data
• highlight specific areas of good practice

The review does not intend to check the appropriateness of the management. If concerns are identified SQAS should follow a separate process common to all screening programmes and disciplines

No formal record of the review will be retained; a summary report of the review will be included in the final QA report.

The review will consist of:

• 5 cases per surgeon and one benign operated case
• cases identified by SQAS following the review of the data

Surgical teams are encouraged to review their cases prior to the review by the surgical PCA. A template for case review has been developed to assist this process.

For visits to large services supported by large numbers of surgeons at dispersed sites the visit chair may decide, following agreement from HQA and after discussion with the surgical PCA, to adjust this process and instead request the surgeons to use the template to audit the cases and the results of which should be reviewed by the surgical PCA. Either a face to face or virtual meeting can take place afterwards to discuss the findings from the internal audits.

Administration and clerical

Review of ‘right results’ processes

The right results walkthrough is conducted at a similar time and in conjunction with the administrative and radiographic pre-visits. The review should be conducted by the administration PCA and radiography PCA and a member of the local SQAS team should usually be present. The members of staff from the screening service required to be present are the programme manager, screening office manager and clinical radiographic lead (or equivalents to these roles).

During the review, other members of staff will also be required. The team will observe them undertaking the tasks associated with the right results walkthrough. The team will make these observations alongside an in-depth review of the policies, procedures and work instructions mainly detailing the journey from a woman’s attendance to issuing of results and onwards referral following assessment. Other parts of the service including training, non-conformance, audit and high risk are also covered.

The walkthrough will usually take one full working day, though may take longer depending on the size and set up of the service being audited. The walkthrough will be undertaken using the right results audit tool. An overall assessment is to be given on the Service’s adherence to the right results procedures, and recommendations made where the service risks non-compliance.

The NHS breast screening programme visit guidance requires the QA representative to review the accuracy of the data held on the screening office system. This involves:

• random sampling of normal and abnormal results held on the system against the screening files (10 cases)
• assessment of the unit’s internal data audit procedures
• identification of anomalies in the current KC62 return
• review of the outcomes of recent assurance reports and the annual BS Select audit

Radiographer image review

The purpose of the review is to:

• ascertain that the national standards are being met in terms of the routine screen imaging
• highlight specific areas of good practice

The radiography PCA will review a minimum of 5 cases per mammographer using the national image assessment tool which sets out the criteria for the review.

MDT review

A clinical member of the MDT (surgeon PCA, pathology PCA, radiology PCA, or CNS PCA) will observe a live breast multidisciplinary meeting (MDT) to enable comment on the adequacy of facilities, clarity of inter-professional communication, arrangements for pathology case review and approaches to discrepancies in diagnosis.

Management meeting

The core management team may wish to attend specific professional meetings on the day of the visit therefore the management meeting can be held in advance. The service management will meet with the HQA/visit chair and a SQAA or QAA). The following representatives from the service should attend as a minimum:

• director of breast screening
• programme manager
• management representatives of the host trust any associate trusts representatives (if required)

The service can choose to invite additional members of staff.

The purpose of the meeting is to:

• review the management arrangements and structure
• discuss the governance arrangements
• ascertain the resilience of the service
• discuss the audit/quality culture across the service
• discuss incidents; occurrence, identification and management
• review professional working relationships
• review health promotion activities

Briefing for visit chair, PCAs and S/QAA

The QA visit team meets either before or on the day of the QA visit and will:

• introduce the members of the QA visit team
• give PCAs an accurate overview of the main elements of the screening service
• initiate discussions and highlight potential areas of concern
• triangulate initial findings from pre-visit evidence review such as KLOEs generated by the PCAs and SQAS
• make sure the visiting QA team are aware of their roles and responsibilities

QA visit day

Presentation from the screening service

The director of breast screening or designated representative is asked to give a short 10 to 15-minute presentation which outlines the service, including:

• changes since the last QA visit
• activity
• achievements
• any challenges or particular issues

The presentation will be given at the start of the day. A template will be provided by the SQAA in advance of the visit. The presentation should be submitted to the SQAA one week in advance of the visit.

The presentation will be attended by the visiting QA team and the observers. It is a local decision as to whether the whole team should also attend the presentation.

Multidisciplinary review of cases

A QA visit may contain a multidisciplinary case review session as an option if identified and agreed at the annual prioritisation assessment meeting. The need for this element may be informed by findings in the clinical data review, concerns regarding multidisciplinary working or incidents arising due to areas such as documentation and communication with the MDT. Eight to 10 cases will be selected in advance of the QA visit by the relevant PCAs from a list of cases provided by the SQAA. The screening service may also select up to 3 additional cases that are of interest.

All cases should be presented by the MDT from the screening unit with all relevant documentation (patient case notes and breast unit records), images and pathology slides available. This meeting should ideally take place in the regular MDT meeting facilities enabling projection of images and pathology slides. It is considered best practice for the unit to put these cases through a routine MDT meeting(s) prior to the visit so that all members are aware of the cases and familiar with their details and challenges.

The visiting QA team attendees for this meeting should be the PCAs for surgery, radiology, pathology and nursing as well as the SQAA and/or QA visit chair if not participating in meetings held at the same time.

The case review meeting should be used to explore MDT processes, decision making and documentation. It should be seen primarily as an opportunity to gain a greater understanding of how a service works and its internal processes and protocols, not as a forum to correct practice.

If at any point during a QA visit a case is identified where there is concern regarding its management, this will be followed up outside the visit process. A separate letter will be sent to the medical director identifying the case, the concern noted and asking for the case to be discussed again at the service’s MDT meeting.

Individual interviews

Each PCA ideally meets their professional counterpart(s) in the screening service. The PCA uses the interview to help determine whether national screening standards are met. They may also assess the relationships within the screening service.

The PCA summarises the discussion, feeds back the main issues and checks for mutual understanding at the end of the interview.

Preparation for feedback sessions

The QA visit team meets to discuss and triangulate the findings from interviews. They focus on areas of risk, recommendations and shared learning. Findings are summarised and fed back to the screening service.

Feedback sessions

Feedback on the day may be given in 2 sessions.

The visit chair and S/QAA meet with the provider chief executive(s) and NHSEI PHCT representative, for example SIL, to give a verbal summary of risks, high level findings and recommendations. This session may be used to raise concerns regarding performance of an individual or concerns for patient safety which would not be appropriate to raise in a wider audience.

This session usually, but not always, takes place before the main feedback session and is likely to last no longer than 15 minutes.

All interviewees are invited to the main feedback session where the visit chair gives a summary of the main findings and recommendations. All screening service staff and invited stakeholders are welcome to attend.

Senior management representatives of the provider trust/organisation(s), CE(s), CCG representatives (where applicable), NHSEI PHCT representatives and other stakeholders identified by the screening service are also invited to attend this session. Directors of public health (DoPH) or their nominated representative can be invited to attend by the PHCT.

The feedback session highlights:

• areas for shared learning
• risks
• high level recommendations
• the intention to publish the executive summary of the QA visit report on GOV.UK

This feedback session usually lasts no longer than 30 minutes.

Where immediate safety concerns are raised the S/QAA informs the RPL. Within 2 working days the RPL writes to the CE of the screening service and the lead commissioner outlining the main concerns and required actions. The letter is copied to the regional head of QA (RHQA) and to the national lead SQAS. PHE screening division director and national programme manager may also be informed. The provider is asked to send a written response within 7 working days.

Where urgent recommendations are made, the RPL writes to the programme manager and commissioner within 2 working days outlining the main concerns and required actions. The provider is asked to send a written response within 14 working days with an action plan to resolve the urgent recommendation within 3 months or sooner.

Management meeting following feedback session

The visit can optionally be concluded by a management meeting. This meeting can be attended by the director of breast screening, programme manager, executive representative(s) from the stake holding trust(s), representatives from the screening and immunisation team and the visit chair and S/QAA.

The purpose of the meeting is to discuss the outline recommendations given in the feedback, provide clarification on the context and provide a forum for discussion between the relevant parties to achieve a timely completion.

Post QA visit

Feedback questionnaire

Screening services are asked to complete online feedback questionnaires to evaluate the QA visit process and provide feedback for SQAS to help improve processes.

QA visit report

The QA visit team submits a summary of their findings to the lead S/QAA within 1 week of the QA visit (or earlier as agreed). The lead S/QAA produces a draft report for factual accuracy checking by the screening service and commissioners within 30 working days of the QA visit. Day 1 is the first working day after the QA visit takes place.

The final report is completed within 10 weeks of the QA visit.

The QA visit report is completed using the agreed report template, written in plain English and conforms to the PHE style guide. It includes:

• summary descriptions of screening service organisation and leadership arrangements
• comments on the adequacy of resource, accommodation, and equipment to meet national screening standards
• areas of shared learning
• variance from national screening standards
• strengths and weaknesses within the screening service
• recommendations to address issues identified and improve quality

Circulation of the final report

A copy of the report is sent via email (copying in the director of breast screening and programme manager) to:

• provider CE(s)
• NHSEI, PHCT representative, for example SIL and the head of public health commissioning (HoPHC)

The CE and SIL are asked to share the report with relevant colleagues including those in the local health economy and public health centres who have a responsibility for screening services. Details of where the executive summary will be published is shared.

Unless consent is withdrawn, the executive summary of the QA visit report is published on the GOV.UK website 8 weeks after the final report is issued (18 weeks after the QA visit).

Where consent is not given SQAS will publish an acknowledgement that a QA visit took place to the named provider however consent to publish the executive summary was declined. A similar note is placed on GOV.UK if NHSEI commissioners decline publication.

The full report can be requested by a member of the public using a Freedom of Information request and may be released by PHE if requested.

The action plan

SQAS supports the screening service and commissioner through the action planning process.

SQAS specifies the evidence used to check whether screening services have met nationally agreed screening standards and any statutory or national guidance or guidelines that apply at the time of the visit.

Recommendations are written so that action plans can be developed. They include the evidence needed to show the action is complete and the criteria for closure.

Timescales for recommendations should be specific, with clear completion dates.

It is the responsibility of the NHSEI PHCT SIL (the commissioner) to make sure the recommendations made in the QA visit report are implemented. It is the responsibility of the screening service to develop an action plan to address the recommendations made.

The action plan is agreed with the SIL or HoPHC within 4 weeks of receipt of the final report. It is good practice for this to be submitted to the next screening service programme board or equivalent governance structure within 3 months of the QA visit.

The SIL makes sure progress against the action plan is maintained using relevant commissioner oversight mechanisms and levers. SQAS should be kept informed via screening service programme boards and direct contact with the providers and commissioners.

SQAS works with commissioners to monitor activity and progress in response to the recommendations for 12 months from receipt of the final report. This enables enough time for at least one response to all recommendations. SQAS sends a letter to the provider CE and commissioners summarising progress made and asking for their direct intervention to address any remaining issues.

Escalation process

SQAS escalates if progress against recommendations is not made. Initially this is through the screening service programme boards or equivalent governance structure and NHSEI PHCT including to the HoPHC where necessary.

Training and development

All staff taking part in QA activity have training related to the role. SQAS staff and PCAs should have the skills and knowledge needed to address inequalities. The training requirements for professional and clinical advisors are set out in the relevant role outlines which are available from SQAS.

All SQAS staff and PCAs should be aware of the eligible age range of the programme.

Continuous improvement

SQAS is committed to improving processes and measuring the impact of QA. SQAS therefore requests feedback from screening services and commissioners on the QA process and QA visit. Feedback will be requested within 2 weeks via an online Select Survey following the QA visit. Feedback received is shared in relevant forums, or individually where applicable, to improve the QA process.

Purpose and scope

The PSOM outlines the agreed QA process for the NHS BSP. SQAS staff and any professional clinical advisors (PCAs) supporting the SQAS team must follow the PSOM to make sure the approach to QA is consistent across all screening services.

Breast screening QA incorporates both the routine and high-risk elements. It begins with the identification of eligible women through batch specification and includes mammography, the assessment of presumptive signs of malignancy, diagnostic and therapeutic surgery and associated pathology. The pathway ends at the closure of the screening episode. This end point is currently being reviewed.

The age at which women should stop being invited for screening is set out in the national service specification. Breast screening is currently offered at 3-yearly intervals to women aged from 50 up to their 71st birthday in England.

Women will first be invited for screening within the 3 years after their 50th birthday, although in some areas they will be invited from the age of 47 as part of the age extension trial.

The age extension (AgeX) trial aims to assess the risks and benefits of one extra screening invitation before the age of 50 (47 to 49) and separately of one extra invitation after the age of 70 (71 to 73). Active recruitment into the trial ceased in May 2020 and it is expected to report in 2026.

Women may be eligible for breast screening before the age of 50, and/or at different screening intervals, if they have a very high risk of developing breast cancer. The QA activities described in this framework reflect this offer, where appropriate.

There are consolidated standards published for the programme. These are reviewed annually. They are a subset of the outcome measures used to quality assure the programme.