Guidance

Breast screening: agreement for medical physics services template

Updated 25 September 2019

1. Explanatory notes

This is intended to be a generic agreement for use by breast screening services when procuring medical physics services. It represents the minimum standard. Where additional services are required, these should be agreed by the breast screening service and the medical physics service and specified as additional clauses in the agreement. Similarly, if tests are to be performed more frequently than the minimum standard, this should be specified in the agreement.

A written agreement should be in place, outlining the important expectations of service provision, regardless of whether the medical physics providers are internal or external to the host organisation.

Different sections of the agreement may be provided by different medical physics services, in which case separate service agreements will be required. In a hub and spoke model breast screening service, it should clear to the director of breast screening and wider senior leadership team which medical physics service is responsible for each piece of equipment at each site.

The following is a template agreement for medical physics services provided by (insert name of your medical physics service) to the breast screening service managed by (insert name of your host organisation).

2. Introduction

This is an agreement for medical physics services provided to the breast screening service (BSS) in relation to the x-ray mammography systems, ultrasound scanners and associated equipment used for breast screening and assessment. There needs to be assurance of appropriate physics support for any imaging and associated equipment used in the clinical pathway.

The screening service has a responsibility to inform the medical physics provider and seek guidance on equipment procurement, replacement and changes in equipment performance on an ongoing basis.

3. Summary of services

1. Provision of a Medical Physics Expert (MPE) as required under Regulation 14 of the Ionising Radiation (Medical Exposure) Regulations 2017 (IRMER). The MPE will provide advice and support in line with relevant NHS Breast Screening Programme (BSP) and other professional guidance.

2. Performance testing of mammographic x-ray systems and associated equipment as required by Ionising Radiation (Medical Exposure) Regulations 2017 (IRMER) and in compliance with recommended Institute of Physics and Engineering in Medicine (IPEM) and NHS BSP standards.

3. Provision of a Radiation Protection Advisor (RPA) as required by the Ionising Radiations Regulations 2017 (IRR).

4. Performance testing of breast ultrasound and associated equipment in accordance with national protocols.

5. Support for in-house user quality control (QC).

6. Respond to ad-hoc queries whether by phone, email or site visit in a timely manner

The service is to be provided for each piece of equipment listed under the schedule in section 3. Any changes to the list of equipment will be agreed jointly by the BSS and the medical physics service.

4. Services to be provided

4.1 Medical physics service

The service to be provided will comply with the latest NHS BSP guidance for medical physics services.

4.2 Advice on equipment selection

Screening services should contact the medical physics service for expert advice on the selection of equipment for breast screening. This includes all the items in the schedule of X-ray and other equipment and instruments used for performing quality control tests.

Such advice will include the purchase of new equipment, the relocation of existing equipment, the need to replace existing equipment and the timing of such replacement.

4.3 Acceptance testing and commissioning of imaging equipment

The medical physics service will conduct acceptance and commissioning tests on all new imaging equipment before clinical use (see schedule of x-ray and other equipment).

All tests will be performed according to current NHS BSP standards and guidance.

As part of commissioning, the medical physics service will work in conjunction with the supplier and the user to make sure the image quality and radiation dose are optimised and achieve at least the minimum standards of performance.

4.4 Performance testing of imaging equipment

The medical physics service will undertake performance testing of imaging equipment no later than 4 weeks after the date indicated by the frequency specified in the schedule of x-ray and other equipment.

All tests will be performed according to current NHS BSP standards and guidance.

Relevant tests will also be performed in the following circumstances: after replacement of the X-ray tube or detector, ultrasound probe, monitor, or after major breakdowns and software upgrades. These will be done before the unit re-enters clinical service. See IRMER 2017.

4.5 Reporting of test results

A written report including a record of the test results and any consequent recommendations for action to remedy faults or deficiencies will be sent to the director of breast screening director or their delegated representative(s).

Data relating to performance testing must be provided as required to SQAS or the national breast screening programme.

Recommendations requiring urgent action will be immediately communicated in writing to the director of breast screening or their delegated representative(s).

The medical physics service will submit a written report to the director of breast screening or their delegates within 4 weeks of completing the testing. The report will comprise of a summary sheet and supporting technical details in an agreed format. It will either confirm satisfactory performance or include recommendations on corrective action where remedial or suspension levels are exceeded. The medical physics service must inform the RPA promptly of any faults or incidents which have consequences for radiation protection.

4.6 Patient dosimetry

Screening services should contact the medical physics service to inform them when the patient dose survey is due and provide the data required as specified by the medical physics service.

When requested, the medical physics service will calculate the mean glandular dose for at least 50 women every 3 years per X-ray machine. This should also be done soon after commissioning new units and major equipment changes. A report should be sent to the director of breast screening or their delegated representative(s).

Medical physics services should advise the screening service about the establishment and review of diagnostic reference levels.

4.7 Ongoing provision of advice

The medical physics service will be available to provide advice on:

• the implications for optimisation (radiation dose and image quality) of any planned or unplanned changes in screening practice
• the practice and results of routine user QC of equipment performance
• breakdowns and emerging concerns about the performance of the equipment
• compliance with radiation regulations as part of an annual audit and on an ongoing basis as necessary

4.8 Radiation protection adviser (RPA)

It is the responsibility of the employer of the screening service to consult with their appropriate appointed RPA promptly regarding radiation safety of staff and the public as required under IRR 17. The RPA role is not part of this agreement.

(Amend above as appropriate if RPA services are to be included in this agreement and are to be provided by the medical physics provider).

4.9 Service conditions

Medical physics staff

The lead physicist must be a clinical scientist and a registered medical physics expert with particular experience in mammography.

(If the physics service is delivering ultrasound only support, the lead individual must have particular experience in ultrasound physics).

All staff providing medical physics services to the NHS BSP must have the appropriate qualifications, experience and training as set out in NHS BSP guidance.

The medical physics team should have sufficient staffing capacity for the breast screening service in line with European recommendations.

Physics providers not meeting the minimum NHS BSP requirement in terms of number of services supported or individual staffing competencies requirements will have a formal arrangement in place with another physics service.

Assessment of medical physics service

The medical physics service will be subject to evaluation and quality assurance in accordance with the breast screening programme specific operating model.

The medical physics service will maintain the records as outlined in the breast screening programme specific operating model and make them available on request to the national breast screening programme and the screening quality assurance service (SQAS).

External audit of the medical physics service will be undertaken by SQAS at the QA visit.

Test instruments

The medical physics service must have sufficient test instruments available to carry out the tests covered by this agreement.

It must have sufficient sets of test instruments to enable emergency investigation of a suspected fault or incident.

Calibration of test instruments must meet the requirements of NHS BSP guidance and standards.

Coordination, liaison and representation.

The medical physics service will participate in any surveys and evaluations requested by Public Health England (PHE).

(Insert here any additional services to be provided).

5. Schedule of X-ray and other equipment covered by this agreement

(To be amended by the BSS as appropriate – detailing the number and location of equipment. Any specific information regarding arrangements for access should also be listed here).

Equipment	Test period	Number, make and location
Mammography equipment and associated attachments and functions such as tomosynthesis	6 months
Ultrasound scanners and probes	6 months
Imaging displays devices	12 months
Specimen x-ray cabinets	12 months
Emerging technologies, for example contrast enhanced spectral mammography (CESM)	6 months

6. NHS BSP standards and guidance documents

Standards and guidance documents relating to medical physics and equipment are generally under the section headings:

• Quality control and testing
• General equipment guidance
• Screening equipment and medical physics services