NHS England » Screening Quality Assurance visit report

Scope of this report

	Covered by this report?	If ‘no’, where you can find information about this part of the pathway
Underpinning functions
Uptake and coverage	Yes	Not applicable
Workforce	Yes	Not applicable
IT and equipment	Yes	Not applicable
Commissioning	Partly	NHS England East of England Public Health Commissioning Team
Leadership and governance	Yes	Not applicable
Pathway
Cohort identification	Yes	Not applicable
Invitation and information	Yes	Not applicable
Testing	Yes	Not applicable
Results and referral	Yes	Not applicable
Diagnosis	Yes	Not applicable
Intervention / treatment	Yes	Not applicable

Summary

The NHS Breast Screening Programme aims to reduce mortality from breast cancer by finding signs of the disease at an early stage.

The findings in this report relate to the quality assurance visit on 02 October 2024 to Norfolk and Norwich Breast Screening Service, which is commissioned by NHS England East of England Public Health Commissioning team.

Quality assurance purpose and approach

Quality assurance (QA) aims to achieve and maintain national standards and promote continuous improvement in breast screening. This is to ensure all eligible people have access to a consistent high-quality service wherever they live.

QA visits are carried out by the NHS England Screening Quality Assurance Service (SQAS).

The evidence for this report comes from the following sources:

monitoring of routine data collected by NHS England
data and reports from external organisations
evidence submitted by the provider, commissioner and external organisations
information collected during pre-review visits from 19 September to 01 October 2024
information shared with the SQAS as part of the visit process

The screening service

The Norfolk and Norwich breast screening service is hosted by Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH). The service has an eligible population of 85,665 and is commissioned by the NHS England East of England Public Health Commissioning Team.

The breast screening service offers screening at 2 static sites located at Norwich Community Hospital and Cromer Hospital, and from 2 mobiles units which cover 15 locations. Assessment clinics are held at NNUH on Monday, Wednesday and Thursday afternoons where up to 12 patients are booked into each assessment clinic. Breast pathology is reported at NNUH, with some specimens being outsourced when required due to capacity issues. Breast surgery is performed at NNUH.

The medical physics service is delivered by The East Anglian Regional Radiation Protection Service (EARRPS), with MRI medical physics provided by NNUH.

A very high risk (VHR) breast screening programme is provided by the service, which has an eligible population of 116 service users. VHR service users receive a mammogram at one of the screening locations and MRI, when required, at NNUH. MRI guided biopsies are referred to Cambridge University Hospitals NHS Foundation Trust (CUH). All results are discussed at the Norfolk and Norwich breast screening service multidisciplinary team (MDT) meeting.

Findings

The Norfolk and Norwich breast screening service has succeeded in maintaining service delivery despite the continuous workforce challenges. Staff working in the service are to be commended on their open and honest approach towards the QA visit process, allowing for the service and SQAS to work together to identify areas for improvement.

Immediate concerns

The QA visit team identified no immediate concerns.

Urgent recommendations

The QA visit team identified 3 urgent recommendations. A letter was sent to the director of breast screening and the chief executive of NNUH on 04 October 2024 asking that the following items are addressed:

Provide a detailed accountability structure and governance process for breast screening, with clear details of escalation routes. Ensure clarity regarding the responsibilities of key service staff and the arrangements for the management and oversight of the screening budget, incidents, risks, and subcontracted services.
Produce a risk assessment for the pathology provision following the planned move of pathology services from The Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust to Norfolk & Norwich University Hospitals NHS Foundation Trust.
Develop an equipment replacement and facilities development plan.

An action plan for these recommendations was received within 14 working days.

High priority findings

In addition to the urgent recommendations, the QA team identified 2 high priority findings as summarised below:

Establish regular meetings with trust management to discuss the needs of the service.
Agree a workforce plan for radiography and pathology and a succession plan for radiography, pathology, administration and nursing to ensure NHS BSP standards are maintained and a robust service is in place.

Example of practice that can be shared

The QA visit team identified several areas of practice for sharing, including:

weekly pathology team education meetings held which includes challenging cases for consensus diagnosis, educational case discussion and NHS BSP guidance updates
a minimum of 3 film readers attends consensus meetings, with a method of alternating those who provide the first outcome to ensure equal contribution and weighting of readers decisions
a range of localisation methods utilised by the service providing resilience to service delivery
all radiographers receive robust user quality control training, providing sufficient knowledge to ascertain when results are out of tolerance and actions to take without the use of a formatted Excel document.

Recommendations

The following recommendations are for the provider to action unless otherwise stated.

No.	Recommendation	Pathway theme	Reference	Timescale	Priority	Evidence required
Urgent recommendations
01	Provide a detailed accountability structure and governance process for breast screening, with clear details of escalation routes. Ensure clarity regarding the responsibilities of key service staff and the arrangements for the management and oversight of the screening budget, incidents, risks, and subcontracted services.	Governance and leadership	Breast screening: best practice guidance on leading a breast screening service	14 days 3 months	Urgent	Submission of action plan. Submission of the final governance structure detailing the management, accountability and escalation process. Confirmation that longstanding IT issues are resolved, and the use of temporary solutions are removed.
02	Produce a risk assessment for the pathology provision following the planned move of pathology services from The Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust to Norfolk & Norwich University Hospitals NHS Foundation Trust.	Diagnosis	Breast screening: best practice guidance on leading a breast screening service Breast screening: quality assurance guidelines for breast pathology services	14 days 3 months	Urgent	Submission of action plan. Copy of the risk assessment and mitigations. Confirmation that the risk assessment has been presented and discussed at the relevant governance forum. Copy of the subcontract for pathology services to Source BioScience.
03	Develop an equipment replacement and facilities development plan.	Infrastructure	Service specification 2024/25	14 days 3 months	Urgent	Submission of action plan. Copy of a breast screening equipment replacement and facilities development plan. Outcome of a review to network both screening mobiles. Confirmation the new ultrasound unit has been installed. Summary of the escalation processes for NCH leased facilities.

No.	Recommendation	Reference	Timescale	Priority	Evidence required
Service provider and population served
No recommendations
Governance and leadership
04	Ensure service resilience and continuity by developing a service level business continuity plan.	Service specification No. 24	6 months	Standard	Copy of the business continuity plan.
05	Update the director of breast screening and programme manager job descriptions in line with NHS BSP guidance.	Breast screening: leading a service	3 months	Standard	Copy of revised job descriptions.
06	Establish regular meetings with Trust management to discuss the needs of the service.	Breast screening: leading a service	3 months	High	Confirmation of process in place and discussion items.
07	Undertake a review of service level agreements (SLAs) for outsourced services and develop SLAs where missing, ensuring they meet NHS BSP guidance. Establish a clear process for regular review and performance monitoring of outsourced services.	Breast screening: leading a service Service specification No. 24	6 months	Standard	Confirmation that all SLAs have been reviewed. Copy of SLAs for pathology outsourcing and MRI guided biopsies. Outline of the process for regular review of SLAs.
08	Develop and maintain a non-conformance log for administration and radiography.	Service specification No. 24 Breast screening: Right results checklist	6 months	Standard	Copy of non-conformance log and copy of work instructions.
09	Ensure the management of screening safety incidents is consistent throughout the screening pathway.	Service specification No. 24 Managing safety incidents in NHS screening programmes	3 months	Standard	Copy of local screening incident reporting work instructions. Confirmation that all staff working within the breast screening programme are aware of and adhere to the work instructions for the management of screening safety incidents.
10	Ensure the contractual requirements of reducing health inequalities are executed.	Service specification No. 24	6 months	Standard	Completed health equity audit and inequalities action plan.
11	Maintain and regularly audit quality management system (QMS) documentation.	Service specification No. 24	6 months	Standard	Confirmation that the QMS review process includes a full audit with documented changes and version control.
12	Ensure accurate data entry throughout the screening pathway.	Service specification No. 24 Breast screening: leading a service	3 months	Standard	Outcome of a review of the audit schedule compared to the NHS BSP recommended audit schedule. Confirmation of synoptic clinical form use within pathology. Outline the process for second review of data entry. Confirmation of the process for ensuring pathology data accuracy and quality.
Infrastructure
13	Agree a workforce plan for radiography and pathology and a succession plan for radiography, pathology, administration and nursing to ensure NHS BSP standards are maintained and a robust service is in place.	Service specification No. 24 Breast screening: leading a service	3 months	High	Copy of workforce and succession plan(s).
14	East Anglian Regional Radiation Protection Service (EARRPS) to perform equipment performance surveys and issue reports within 4 weeks.	Quality Assurance guidelines for medical physics services.	6 months	Standard	Confirmation that surveys reports are issued timely for the Norfolk and Norwich Breast Screening Service.
15	Ensure robust user quality control process are in place.	Routine quality control tests for full-field digital mammography systems Routine quality control tests for breast tomosynthesis (radiographers) Breast screening: Testing biopsy systems guidance	3 months 3 months 3 months	Standard Standard Standard	Copy of TORMAM spreadsheets and work instructions. Copy of clinical needle testing spreadsheets and work instructions. Copy of reporting workstations daily user quality control spreadsheets and work instructions.
16	Revise employer’s procedures in line with NHS BSP guidance and IR(ME)R regulations.	Guidance on implementation of Ionising Radiation (Medical Exposure) Regulations	12 months	Standard	Copy of revised IR(ME)R documentation.
17	Ensure equipment faults are reported immediately to the National Coordinating Centre for the Physics of Mammography (NCCPM).	Breast screening: reporting equipment faults, incidents and issues	3 months	Standard	Confirmation that faults are recorded on the NCCPM database.
Identification of cohort
18	Develop and implement a robust process for the exchange of MRI information to allow consistent monitoring and reporting and ensure correct allocation of NTDD.	Breast screening: guidance for organising a Very High Risk (VHR) screening programme	6 months	Standard	Confirmation of the agreed process.
Invitation, access and uptake
No recommendations
The screening test – accuracy and quality
19	Develop work instructions for collecting, recording, monitoring and reporting technical recalls and technical repeats.	Guidance for breast screening mammographers	6 months	Standard	Copy of work instructions.
20	Develop a process for undertaking regular image reviews.	Guidance for breast screening mammographers	6 months	Standard	Confirmation of the agreed process.
Referral
No recommendations
Diagnosis
21	Ensure a clear pathway for very high risk (VHR) clients requiring MRI guided biopsy.	Service specification No. 24 Breast screening: leading a service Technical guidelines for MRI for the surveillance of women at higher risk of developing breast cancer	6 months	Standard	Confirmation of the agreed pathway.
22	Ensure relevant members of staff have access to PACS to remove operational issues.	Service specification No. 24	3 months	Standard	Confirmation of access.
23	Ensure accurate documentation of continued professional development, EQA participation and SQAS network meeting attendance for all breast screening pathologists, including locums reporting breast screening cases.	Breast screening: quality assurance guidelines for breast pathology services	6 months	Standard	Confirmation of the process in place to ensure a complete record.
24	Review the 2022/23 lymphovascular invasion (LVI) rate to ensure data quality. Undertake an audit of LVI positivity rates if the data is found to be accurate.	Breast screening: quality assurance guidelines for breast pathology services	6 months	Standard	Review LVI one year data and confirm data accuracy. If the data is found to be correct, complete an audit of LVI positivity rates. Confirmation of process in place to ensure long term data accuracy.
25	Produce an action plan to address the limitations in achieving the NHS BSP standard of patients receiving surgery results within 10 workings days.	Breast screening: quality assurance guidelines for breast pathology services	6 months	Standard	Copy of action plan.
Intervention and outcome
26	Ensure the requirements of NHS BSP guidance is met by: a) Ensure CNSs meet women at the start of the assessment process to help manage anxiety and distress. b) Ensure CNSs record a physical, psychological and social history for all women seen at assessment. c) Undertake an audit of women’s experience of the assessment process, regardless of diagnosis, at a minimum of once every screening round	Clinical nurse specialists in breast screening	6 months 6 months 12 months	Standard Standard Standard	Confirmation of process in place. Confirmation of process in place. Copy of questionnaire and audit results.
27	Ensure formal guidance documentation for surgical practice including the use of targeted axillary dissection and the use of imaging modalities for staging.	Best practice guidelines for surgeons in breast cancer screening	6 months	Standard	Copy of guidance documents.
28	Audit the 2020-23 data for the use of Sentinel Lymph Node Biopsy (SLNB) for non-invasive disease in breast conserving surgery.	Best practice guidelines for surgeons in breast cancer screening	6 months	Standard	Copy of audit and summary of findings.

Next steps

The screening service is responsible for developing an action plan in collaboration with the commissioners to complete the recommendations contained within this report.

SQAS will work with commissioners to monitor activity and progress of the recommendations for 12 months after the report is published. After this point SQAS will send a letter to the provider and commissioners summarising progress made and will outline any further action(s) needed.

Appendix C: References

Best Practice Guidelines for Surgeons in Breast Cancer Screening Guidance Platform – Association of Breast Surgery
Breast screening care pathway Breast screening care pathway
Breast screening guidance for breast screening mammographers Breast screening: guidance for breast screening mammographers
Breast screening guidance on collecting recording and reporting repeat examinations Breast screening: repeat mammograms
Breast screening pathway requirements specification Breast screening pathway requirements specification
Breast Screening: arbitration guidance Breast screening: arbitration guidance
Breast Screening: digital breast tomosynthesis Breast screening: digital breast tomosynthesis
Breast screening: identifying and reducing inequalities Breast screening: identifying and reducing inequalities
Breast screening: issuing provisional or verbal pathology reports Breast screening: issuing provisional or verbal pathology reports
Breast screening: programme specific operating model Breast screening: programme specific operating model
Breast screening: transferring specimens between laboratories Breast screening: transferring specimens between laboratories
Clinical Guidelines for Breast Cancer Screening Assessment (4th Edition) Breast screening: clinical guidelines for screening assessment
Consolidated Guidance on Standards for the NHS Breast Screening Programme Breast screening programme: standards
Failsafe Batches Breast screening: failsafe batches
Guidance for clinical nurse specialists Breast screening: guidance for clinical nurse specialists
Guidance for NHS commissioners on equality and health inequalities legal duties hlth-inqual-guid-comms-dec15.pdf
Guidance on applying duty of candour and disclosing audit results NHS screening programmes: duty of candour
Guidance on partial or incomplete screening mammography Breast screening: guidance on partial or incomplete screening mammography
Guidance on reporting breast images from home Breast screening: reporting breast images from home
Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening (RCPath) Cancer datasets and tissue pathways
Implementing remote image reading in the NHS BSP Breast screening: implementing remote image reading
Key Performance Indicators NHS screening programmes Antenatal, newborn, young person and adult NHS population screening: reporting data definitions
Leading a breast screening service Breast screening: leading a service
Maintaining and achieving the 36 month round length Breast screening: set and maintain round length
Managing Safety Incidents in NHS Screening Programmes Managing safety incidents in NHS screening programmes
NHS England Serious Incident Framework – Supporting learning to prevent recurrence (March 2015) serious-incidnt-framwrk-upd2.pdf
NHS Patient Safety Incident Response Framework NHS England » Patient Safety Incident Response Framework
NHS population screening standards NHS population screening standards
Opting out of breast screening Opting out of breast screening
Organising very high risk (VHR) screening Breast screening: organising very high risk (VHR) screening
Protocols for the surveillance of women at higher risk of developing breast cancer Breast screening: very high risk women surveillance protocols
Quality assurance for medical physics services Breast screening: quality assurance for medical physics services
Quality Assurance Guidelines for Breast Cancer Screening Radiology (2nd Edition) Breast screening: quality assurance standards in radiology
Quality Assurance Guidelines for Breast Pathology Services Breast screening: quality assurance guidelines for breast pathology services
Remote radiographic supervision Breast screening: remote radiographic supervision
Reporting, classification and monitoring of interval cancers and cancers following previous assessment Breast screening: interval cancers
Retention, storage and disposal of mammograms and screening records Retention, storage and disposal of mammograms and screening records
Right results audit & checklist Breast screening: Right Results audit
Screening office management guidance Breast screening: screening office management
Section 7a service schedules FutureNHS Collaboration Platform – FutureNHS Collaboration Platform
Technical guidelines for MRI for the surveillance of women at higher risk of developing breast cancer Breast screening: using MRI with higher risk women
Guidance on implementation of Ionising Radiation (Medical Exposure) Regulations Breast screening: guidance on implementation of Ionising Radiation (Medical Exposure) Regulations (2017) – GOV.UK (www.gov.uk)
Image reading guidance Breast screening: guidance for image reading – GOV.UK (www.gov.uk)
Routine quality control tests for full field digital mammography systems. Equipment report 1303: fourth edition Breast screening: routine quality control tests for FFDM – GOV.UK (www.gov.uk)

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