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 South West 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 5 March 2025 to North and East Devon Screening Service which is commissioned by NHS England South West.

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(s), commissioner and external organisations
information collected during pre-review visits to North and East Devon prior to the 5 March 2025 and information shared with the SQAS as part of the visit process

The screening service

The North and East Devon breast screening service is provided by InHealth (an independent sector provider) in a standalone facility based at Matford Park Business Centre, Exeter which is located approximately 4 miles from the RDUH East hospital site (Royal Devon University Healthcare) in Exeter. The service also provides screening on two mobile vans, covering the population in surrounding areas. The service provides only breast screening and assessment; symptomatic patients are managed separately by the breast unit at the RDUH East. All screening assessment clinics take place at Matford Park. The Royal Devon University Healthcare NHS foundation Trust (RDUHFT) was established in April 2022 following the integration of the Royal Devon and Exeter Foundation Trust (RD&E) and Northern Devon Healthcare NHS Trust (NDHT) based in Barnstaple.

The South West Vaccination and Screening Team, NHS England (South West) commissions the breast screening service from InHealth. Subcontracted services for MRI (magnetic resonance imaging) surgery and pathology are supplied by the RD&E. Patients requiring surgery who live in North Devon can choose to have surgery at North Devon District Hospital (RDUH North). A pathology service for screening cases that require excision is provided at RDUH North. Those requiring MRI guided biopsy are referred to North Bristol Trust or Northwick Park Hospital, London.

Findings

The service is run by a dedicated team that have maintained service delivery despite significant challenges with breakdown of aged equipment.

Service level agreements (SLA’s) with RDUHFT remain outstanding for the provision of pathology and surgical services for breast screening women.

Mammography staffing levels falls short of the expected numbers for the population.

The number of incidents reported to SQAS is low compared to other breast screening services and some incidents on the internal InHealth incident summary report provided as evidence had not been reported to SQAS. However, those incidents that had been reported were managed very thoroughly by the programme manager and lead mammographer.

Immediate concerns

No immediate concerns were identified.

High priority findings

The QA visit team identified 5 high priority findings as summarised below:

service to formalise a service level agreement (SLA) between the breast screening service to include surgery and pathology carried out at North Devon District Hospital (RDUH North)
mammography staffing levels should reflect the national guidance
service to run the screening open episode report (SQOE) monthly to ensure all open episodes are managed appropriately
a second healthcare professional should be present alongside the Breast Clinical Nurse Specialist (BCNS) when delivering a cancer diagnosis to ensure appropriate patient advocacy and emotional support
North Devon District Hospital pathology lab to develop standard operating procedures (SOPs) for issuing of provisional and amended pathology reports at MDT

Examples of practice that can be shared

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

a ‘folder’ is used to store details of single read cancers which are used to give individual feedback to the readers involved and as a teaching resource providing examples of practice that can be shared
interval cancers are reviewed in a timely fashion and outstanding cases are displayed on a whiteboard in the reading room
the RD&E is a national training centre for oncoplastic breast surgery with a high rate of immediate breast reconstruction

Recommendations

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

No.	Recommendation	Reference	Timescale	Priority	Evidence required
Governance and leadership
01	Formalise a service level agreement (SLA) between the breast screening service to include surgery and pathology carried out at RDUH East and RHUH North (Royal Devon University Healthcare NHS Foundation Trust)	Best practice guidance on leading a breast screening service, Nov 2018	3 months	High	Signed and dated copy of SLA
02	Manage all screening patient safety incidents and serious incidents in accordance with ‘Managing Safety Incidents in NHS Screening Programmes’	Managing Safety Incidents in NHS Screening Programmes’	3 months	Standard	Amended InHealth policy
03	Ensure the service meets the national acceptable standard for uptake and shares a copy of the Health Equity Audit with SQAS and the commissioners	Breast screening guidance: reducing inequalities Updated 27 September 2024	6 months	Standard	Copy of audit
04	Service to undertake an annual client satisfaction survey capturing all aspects of the screening pathway	Service Specification No. 24	6 months	Standard	Copy of survey results
Infrastructure
05	Ensure mammography staffing levels reflect the national guidance	Guidance for breast screening mammographers	6 months	High	Confirmation to SQAS
06	Provide a time scaled replacement plan (agreed with the lead MPE) for the mammography unit in room 1 and the MA04 mobile, which considers the age and reliability of the current equipment and maintenance arrangements	The relationship between age of digital mammography systems and number of reported faults and downtime Published in: Phys Med. 2022; NHSBSP specification for mobile trailers	3 months	Standard	Notification of the planned timescale for replacement of the mammography unit in room 1 and MA04.
07	Audit the downtime caused by equipment delays since the downgraded maintenance contract and review contracts in line with the outcome of the audit	Publication: The relationship between age of digital mammography systems and number of reported faults and downtime Published in: Phys Med. 2022	3 months	Standard	Outcome of audit and associated review of maintenance contracts
08	Ensure tolerances in the QA Test Manual V25 reflect NHSBSP guidance for 2D Mammography	NHSBSP Equipment Report 1303 and NHSBSP Equipment Report 1406	3 months	Standard	Copy of updated local QA test manual
Identification of cohort
09	Service to run the screening open episode report (SQOE) monthly to ensure all open episodes are managed appropriately	NHS Breast screening programme screening standards valid for data collected from 1 April 2017	3 months	High	Confirmation to SQAS
Diagnosis
10	Update assessment standard operating procedure (SOP) to ensure the assessment process is more robust particularly for small indeterminate features and potential benign disease	NHSBSP Clinical guidance for breast cancer screening assessment	6 months	Standard	Assessment SOP (standard operating procedure) to SQAS, focusing on quality of assessment outcomes and ensuring all assessment cases returned to routine screening are reviewed by a second assessor either at the time of assessment clinic or at a later date, prior to routine results letter being sent
11	Audit B3 biopsy rate for 2024 and 3 yearly (2022-24)	Breast screening: quality assurance guidelines for breast pathology services	6 months	Standard	Audit
12	Implement a pathology intradepartmental review meeting of difficult cases and organise difficult cases to be sent for second opinion	Breast screening: quality assurance guidelines for breast pathology services	12 months	Standard	Confirmation to SQAS.
13	Ensure the SLA with RDUHFT (Royal Devon University Healthcare NHS Foundation Trust) reflects adequate pathology staffing at RDUH North to support the reporting of surgical resections for breast screening patients	RCPath guidelines for workforce and staffing (G107)	6 months	Standard	Signed copy of SLA to SQAS
14	RDUH North pathology to provide a copy of the standard operating procedure (SOP) on transferring samples to external laboratories	Breast screening guidance: transferring specimens between laboratories	6 months	Standard	Copy of standard operating procedure (SOP)
Intervention and outcome
15	A second healthcare professional should be present alongside the breast clinical nurse specialist (BCNS) when delivering a cancer diagnosis to ensure appropriate patient advocacy and emotional support	Guidance Clinical Nurse Specialist in Breast Screening -Section 2.5 – Extended roles	6 months	High	Confirmation to SQAS
16	The breast clinical nurse specialist should attend relevant operational and programme board meetings to ensure clinical input and patient advocacy are represented in service planning at board level	Guidance Clinical Nurse Specialist in Breast Screening – Section 3.2	3 months	Standard	Confirmation of attendance at programme board
17	Review audiovisual facilities for multidisciplinary meetings (MDT) at the RDUH East and RDUH North to support remote attendance	Breast screening: quality assurance guidelines for breast pathology services	12 months	Standard	Confirmation to SQAS
18	RDUH North Pathology Lab to develop SOPs for issuing of provisional and amended pathology reports at MDT	Breast screening: quality assurance guidelines for breast pathology services and RCPath guidelines	6 months	High	Copy of standard operating procedures (SOPs)
19	Provide a specimen X-ray machine in theatres to support intraoperative assessment of specimens	Best Practice Guidelines for Surgeons in Breast Cancer Screening	6 months	Standard	Confirmation to SQAS
20	Continue to review margin re-excision rates to bring levels down to national average levels including an external pathology review of relevant cases where the final whole tumour size is discordant with the imaging size	Best Practise Guidelines for Surgeons in Breast Cancer Screening	6 months	Standard	Confirmation to SQAS

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 hand over letter to the provider and commissioners summarising progress made and will outline any further action(s) needed.

Screening Quality Assurance visit report – North and East Devon

Scope of this report

Summary

Quality assurance purpose and approach

The screening service

Findings

Immediate concerns

High priority findings

Examples of practice that can be shared

Recommendations

Next steps

Appendix C: References

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Scope of this report

Summary

Quality assurance purpose and approach

The screening service

Findings

Immediate concerns

High priority findings

Examples of practice that can be shared

Recommendations

Next steps

Appendix C: References