Guidance

Breast screening: reporting equipment faults, incidents and issues

Published 23 July 2021

Applies to England

Breast screening services have a responsibility to share information about equipment issues, faults and incidents occurring within the NHS breast screening programme (BSP).

The nature of an equipment concern determines the required reporting route. Typically, concerns fall into 3 broad categories:

• faults
• incidents
• issues

This guidance relates to all equipment used for diagnostic purposes within the NHS BSP, including (but not exclusively):

• mammography equipment and any attachments such as biopsy devices or stereo attachments
• ultrasound scanners and transducers
• acquisition monitors
• reporting workstations
• specimen cabinets
• picture archiving and communication system (PACS) and image transfer processes

Faults and incidents relating to magnetic resonance imaging (MRI) scanners are not within the scope of this guidance. Breast screening services should manage these in accordance with local employer procedures. However, where these faults and incidents have impacted women who have attended screening, they should also be reported to the local screening quality assurance service (SQAS). For example, if a service is unable to invite very high-risk women for an MRI due to an equipment fault.

Equipment faults

Equipment faults are those occurrences that require engineer or applications intervention, or where the breast screening service is repeatedly having to correct the fault themselves. Reportable faults may include ones identified during routine testing of equipment and which are the subject of a medical physics provider recommendation for an engineer visit ahead of the next service.

The National Coordinating Centre for the Physics of Mammography (NCCPM) is contracted to provide specialist physics advice to the NHS BSP. Services should record equipment faults via the NCCPM equipment database, which is accessed by designated individuals within a breast screening service. Services should ensure there are sufficient staff trained to use the database, to support timely reporting and to ensure proper handover procedures for changes of staff. Contact the NCCPM to request access for additional members of staff (email rsc-tr.NCCPM@nhs.net).

Guidance for reporting faults is available and includes details about the type of faults that require recording within the NCCPM database.

Services should report details of equipment faults via the database as soon as is practicable – ideally, on the same day the fault occurred – and even if the fault has not yet been resolved. They should update the record with the fault root cause once known.

Timely reporting of faults is important. Breast screening services should report faults as they happen, and not save information about faults to enter in bulk at a later date. We recommended breast screening services have a low threshold for reporting faults to make sure that as much information is captured as possible. Timely reporting of faults allows national feedback quickly and directly to manufacturers which supports improvement in mammographic equipment performance and design.

Services should inform local medical physics providers of equipment faults (either directly or via the equipment database). Local physics providers must therefore have access to the fault database for the breast screening services to which they provide medical physics expert (MPE) services.

Breast screening services should seek advice from medical physics and radiography professional and clinical advisors (PCAs) and the NCCPM (email rsc-tr.NCCPM@nhs.net) if they are concerned about the severity of a fault, or the potential for wider implications. SQAS should be included in this communication.

It is the NCCPM’s responsibility to:

• monitor the faults reported via the database and escalate as appropriate to manufacturers
• work with breast screening services and equipment suppliers and/or service agents to make sure faults are resolved in a timely manner
• support the national programme team in writing communications to breast screening services as appropriate where information regarding a fault requires dissemination
• follow up with breast screening services if no faults are reported within a defined time period, to check this is accurate
• analyse trends, feeding back to breast screening services as necessary
• produce summary reports of reported faults, which are discussed at relevant clinical professional group (CPG) meetings

Equipment-related incidents

An equipment-related incident is where:

• actual or possible harm was caused to women or staff as a result of equipment malfunction, including increased radiation dose
• a recurring issue impacts on service delivery, for example, repeated equipment failures resulting in the cancellations of appointments

Services should follow local employer policies for the reporting of equipment-related incidents internally. They should also report them to the SQAS and screening and immunisation teams (SITs) in accordance with guidance on managing safety incidents in NHS screening programmes.

Seek advice from the local medical physics expert (MPE) where the incident involves accidental or unintended exposure to ionising radiation.

The following steps outline the stages of reporting, assessment and escalation of a suspected screening incident that involves equipment used within the NHS BSP during the diagnostic pathway. Details of individual responsibilities are included.

1. The local breast screening service notifies the SQAS and SIT of the suspected incident using the screening incident assessment form (SIAF). Breast screening services contact the NCCPM (rsc-tr.NCCPM@nhs.net) for advice at this stage in case it is not an isolated incident and is potentially part of a bigger issue. Make clear in the SIAF whether NCCPM advice has been sought. Share copies of all relevant email communications with the SQAS and the local medical physics provider. The NCCPM informs and works with the national breast screening team. In parallel, breast screening services make sure that the incident is reported internally, and where necessary, externally (for example to the Medicines and Healthcare products Regulatory Agency (MHRA) via the yellow card scheme), in accordance with local processes.

2. Once notified, the SQAS informs the regional professional and clinical advisors (PCAs) for medical physics and radiography. PCAs communicate with the NCCPM regarding any immediate actions. Additionally, SQAS may seek radiology PCA input depending on the incident. The SQAS completes section 2 of the SIAF, based on NCCPM advice and any additional suggestions from PCAs.

3. The SQAS formally notifies the national breast screening team of the suspected incident, copying in the NCCPM. This should include details of the SIAF (either include a full copy or copy/paste the relevant sections)

4. The screening provider is responsible for investigating the incident. The SQAS continues to follow up in accordance with the NHS screening incident management guidance. The national breast screening team and the NCCPM discuss the incident with the appropriate supplier and/or service agent. If no further investigation is required, any appropriate advice on actions to be taken is fed back to SQAS, the PCAs and the breast screening service by NCCPM and/or the national breast screening team.

5. Where further action is required, the national breast screening team and the NCCPM requests that the appropriate supplier and/or service agent investigates and reports back. Where remedial action is identified, this should be implemented by the supplier and/or service agent as quickly as possible for the safety of service delivery. Discussions around actions are reported back to the SQAS, PCAs and the breast screening service by NCCPM and/or the national breast screening team. The SQAS continues to follow up and close the incident when appropriate, in line with NHS screening incident management guidance.

6. If remedial action is indicated but is not possible, the incident should be fully investigated by the supplier and/or service agent in conjunction with the NCCPM and the national breast screening team. An alternative resolution should be identified collaboratively by the NCCPM, national breast screening team and the supplier/service agent, and the recommendations actively monitored to ensure roll-out to all affected breast screening services. The SQAS and SIT close the incident once all agreed actions have been completed.

Where there are wider implications, and in parallel to steps 5 and 6, the supplier and/or service agent should identify other affected breast screening services in order to rectify the issue fully. The national breast screening team will communicate the incident details to local breast screening services, medical physics providers and the NCCPM via established reporting processes.

Equipment-related issues

An equipment-related issue is something that may be useful for other breast screening services or medical physics providers to be aware of in a timely manner. These issues are not in themselves serious, but alerting other breast screening services to them will raise awareness and prevent others from spending time trying to resolve them in isolation. Examples of issues which have previously been shared include:

• where a supplier and/or service agent makes a minor modification to their equipment which impacts on the time taken for the system to reach maximum image quality following switch on – this may influence user quality control (QC) measurements
• a change to a default setting following an equipment upgrade

Issues do not automatically require formal notification (unlike faults or incidents).

Breast screening services, in conjunction with their local medical physics provider, should raise issues with the NCCPM. The NCCPM then works with the supplier and/or service agent. Where it is appropriate to do so, the NCCPM also discusses the issue with the national breast screening team and agrees on any shared learning. This is communicated to local breast screening services and medical physics providers via established reporting processes.