IR(ME)R annual report 2024/25

Notifications

In 2024/25, we received 291 notifications – this is 19% more than last year (244 notifications). This was primarily due to an increase in the number of incidents involving equipment.

Notification coding was amended this year to reflect national patient safety taxonomy for adverse events and to help share lessons learned. Incidents often arise due to the complex and ever-changing nature of radiotherapy, rather than individual lapses or isolated system flaws. We have therefore moved away from reviewing the detail of incidents at the point of failure, for example practitioner failure or treatment operator error. Instead, we will review the notifications relating to where they occurred in the pathway. This will allow providers to use the information to review their existing systems and benchmark against our data.

We have separated events that have occurred in external beam therapy (EBT) from events in brachytherapy to further facilitate learning.

External beam therapy

Analysis of notifiable incidents in external beam therapy received during 2024/25 is broken down into relevant stages of the patient pathway where the incident occurred. Of the 291 notifiable radiotherapy incidents reported to us, 282 related to external beam therapy.

Incidents in referrals for external beam therapy

Incidents originating at referral stage (15) were predominantly the result of incorrect verification of the diagnosis, extent or stage (including laterality).

Figure 9: Referral incidents in external beam therapy, 2024/25

In these incidents, common points of failure included:

• no process to highlight patients who were waiting for results before being referred
• poor communication of additional information
• inadequate assessment of referrals before planning scans.

Mitigating actions taken in response included:

• amending referral processes and forms to be able to flag patients who were waiting for test results
• formalising communication pathways to include generic email addresses that are always monitored
• creating referral assessment processes and updated procedures to state that concerns relating to the referral must be discussed and documented before delivering the planning scan.

Incidents in pre-treatment external beam therapy

For notifications of incidents occurring at pre-treatment stage (25), 60% related to the documentation for instructions or information relating to treatment, for example immobilisation parameters or annotation of tattoo position. Other factors included authorisation to irradiate and booking events.

Figure 10: Notifications by type of error in external beam therapy pre-treatment stage, 2024/25

A persistent theme within this group of incidents was inaccurate data recording of patient immobilisation devices used to minimise patient movement during treatment. These were mostly attributed to lapses and human factor events. Mitigating actions therefore mainly focused on ensuring that documentation and training was adequate. Incident investigations highlighted the need for:

• a robust referral assessment ahead of scanning
• the importance of the pause and check process
• independent checking of data input.

Incidents in external beam therapy treatment planning

Over a third of planning stage incidents related to target and organ delineation. This could suggest that peer review of contours is still a risk factor.

We have seen on inspection that some centres are managing the peer review process well, using the recording and verification systems in innovative ways to record peer review. However, many centres still do not have systems in place for peer review, or, if they do, there is no formal method of recording the outcomes.

Figure 11: Notifications by type of error in external beam therapy treatment planning, 2024/25

We continue to receive notifications for errors occurring in the production of non-planned treatments, which rely on manual calculations and input. These techniques are often delivered out of hours or as emergency treatments, for example emergency cord compression. Our review of reports for incidents suggests that a common causative factor regarding these techniques is insufficient experience, training, and knowledge.

Departments should aim to assess staff competency for rarer techniques regularly. Some effective interventions included developing processes that would remove the manual element of dose calculation. Moving forward, many departments are considering planning all treatments using the treatment planning system and no longer using manual calculations.

Incidents in external beam therapy treatment

This continues to be the area where most incidents happen in external beam treatment, accounting for nearly half of all external beam notifications (128). Of these:

• 47% were due to incorrect set up or positioning of the patient
• 42% were due to incorrect verification imaging – either the production of the image, or inappropriate approval of the image.

Figure 12: Notifications by type of error in external beam therapy treatment delivery, 2024/25

Accurate patient positioning continues to remain an important area of practice, with many incidents originating from the selection of immobilisation equipment or use of documented patient set up information.

Effective actions to address these challenges included:

• having one single source of information for treatment set up that is not transcribed from the pre-treatment records
• consistent selection of immobilisation equipment and use of indexing on treatment couches, even for non-planned treatments
• using skin-render or photographs for treatments where required
• using surface guided monitoring systems to mitigate patient positioning errors.

The number of notifications relating to image production and approval process are consistent with previous years and reflect the full integration of image guided radiotherapy (IGRT) into the treatment pathway. IGRT is a key element of delivering and developing advanced radiotherapy techniques. It depends on skilled interpretation and decision making while interacting with complex equipment. Therefore, the high level of incidents in this area is the predictable result of human and technological interactions within a complex system.

Incident reports advised that effective changes to practice included:

• protocols that are site-specific with defined imaging frequency and escalation processes
• site-specific imaging pre-sets
• regular departmental imaging audits to monitor compliance and concomitant doses for patients.

Brachytherapy

There were a small number of incidents in Brachytherapy, 44% of which related to the positioning of the applicators or sources.

The nature of brachytherapy treatment means that this remains an area of concern, and common failure points included inadequate work instructions, faulty equipment, and human factor errors.

Mitigating actions included:

• reviewing protocols to ensure they are accurate and reflect practice
• robust pre-treatment checklist with role-specific steps
• ensuring adequate staffing levels
• using retrospective audit.

Inspection and enforcement activity

We carried out 21 inspections of radiotherapy services in 2024/25, which is more than the previous year (15). We have now inspected all providers and have started the second round of inspections using a new inspection methodology.

We have used the new methodology in the most recent inspections, using an IR(ME)R inspection self-assessment questionnaire. This asks the provider to complete a questionnaire and provide evidence that we request as part of the inspection. The inspector reviews all information ahead of the site visit, which allows more time for inspectors to observe clinical practice in all aspects of the patient pathway while they are on site.

Providers report that the process is effective, as it allows them to review their compliance in a systematic way. As part of the process, the questionnaire asks providers to declare any areas of non-compliance, along with any ongoing actions to address them. This gives providers an opportunity to detail how they are mitigating against any areas of non-compliance with the regulations.

We continue to recommend that providers share their experience of inspection to share the learning.

In 2024/25, we issued an Improvement Notice against one provider, compared with 4 in the previous year. We also completed 3 inspections where we did not identify any compliance gaps, compared with our inspection programme in 2023/24 where we made recommendations against every provider inspected. This shows an overall improvement in the application and adoption of the requirements of the legislation for the benefit of patient safety.

Superficial radiotherapy inspection programme

We carried out a targeted inspection programme of services that deliver superficial radiotherapy (SXR), primarily for skin or non-malignant conditions. The programme of 5 inspections used a combination of our standard method and the self-assessment questionnaire inspection method.

We did not issue any Improvement Notices for SXR services during the inspection programme, but we made 4 improvement recommendations for:

• Regulation 6(1)(a): unclear guidance for the exposure of carers and comforters
• Regulation 6(4): clinical protocols were missing for benign/non-malignant treatments
• Regulation 17(1): inadequate training records
• Regulation 17(4): unable to provide evidence of relevant training record(s).

We found examples of good practice, including:

• an SXR-specific study of risk
• cross-site peer reviews
• additional checks for high-dose treatments.

We also noted some limitations across the service, including:

• operator competence acquisition (and maintenance)
• staffing issues
• a lack of clinical audit and non-specific competencies.

There are also concerns regarding the potential fragility of the service nationally. This is due to:

• ageing treatment equipment (the average age of treatment units was 11 years)
• the availability of adequately trained operators and practitioners
• minimal superficial consultants within services.

Improvement Notices

We issued one Improvement Notice this year to a service providing radiotherapy, although the Notice detailed compliance gaps against 5 separate regulations. The following summarises the regulations cited within the Improvement Notice and the actions that the trust took to become compliant:

• Regulation 6(5)(b): The employer must establish quality assurance programmes for written procedures and written protocols. Actions taken include:
• giving consultants more capacity to review clinical protocols
• staggering document review dates over a longer period
• updating the trust’s policy relating to QA.
• Regulation 8(1): Providers must understand the requirements of the legislation in relation to accidental or unintended exposures that are deemed to be clinically significant, and their employer’s procedure must detail the responsibilities of individual IR(ME)R duty holders if a clinically significant incident occurs. Actions taken include:
• updating the incident management policies
• regularly auditing new processes would be regularly audited
• Regulation 14(2): A medical physics expert must be closely involved in every radiotherapeutic practice. Actions taken include:
• implementing a workforce plan with support from the trust, which included a formal rota for medical physics expert cover
• arranging with a neighbouring service to provide support when required
• Regulation 15(1)(b): The employer must draw up, keep up-to-date and preserve an inventory of radiobiological equipment. Actions taken include:
• updating the inventory document
• Regulation 17(4): The employer must keep and have available for inspection by the relevant enforcing authority an up-to-date record of all relevant training undertaken by all practitioners and operators. Actions taken include:
• the trust producing a specific training and competency policy for physics staff and streamlined competency levels
• updating the training records and associated processes for maintaining training records for staff employed at the trust before IR(ME)R 17 was updated, and including those who had been granted entitlement under ’grandparenting’ rights in the training matrix
• implementing electronic training records in the trust.

Improvement recommendations from inspections

In 2024/25, we issued 38 recommendations following 18 inspections. Of these, 37 related to only 4 regulations.

Inspection recommendations for Regulation 6

Regulation 6 relates to the duties of the employer, which includes the management of procedures and protocols, particularly those relating to Schedule 2. We issued 14 recommendations that covered the following:

• procedures and protocols were missing, unclear or did not reflect practice
• controlled documents were printed off at point of use and not updated as required
• procedures and protocols were not reviewed within the timescale specified by the organisation

Complex systems such as radiotherapy services need documented procedures to guide practice. It is imperative that access to the quality management system (QMS) is available at the point of use and includes procedures that reflect practice and are audited regularly. The QMS should be appropriately monitored through governance meetings and resources made available to manage it.

Staffing issues were often cited as a reason for the breach, for example the unavailability of clinicians means they are unable to approve clinical protocols.

We saw examples where the QMS status was either not monitored, where it was monitored and not actioned, and, in good departments, where it was actioned and escalated appropriately.

Providers that demonstrated good practice had common processes to manage the QMS, including:

• a dedicated quality manager
• clinicians’ job allocations included time for tasks such as clinical protocol approval
• a clear process to review documents, with escalation processes and actions for non-adherence.

Inspection recommendations for Regulation 7

Regulation 7 relates to the management of clinical audit in a service, which includes taking appropriate actions following an audit. We issued 5 recommendations against a breach of Regulation 7 as we had identified areas including:

• a poor definition of clinical audit, with multiple references to regulatory audit
• receiving examples of regulatory audit only, rather than examples of clinical audit as requested
• poor or missing procedures relating to managing clinical audits
• inconsistent or missing processes for disseminating audit findings.

Clinical audit relates to improving patient outcomes, whereas regulatory audits assess whether practice reflects the documented process. It is vital that providers clearly define clinical audit, including how to manage it and how to take appropriate actions following completion. This also requires there to be a process to re-audit at a suitable time gap once appropriate actions have been implemented to measure the efficacy of the changes.

Inspections where we made no recommendations all had similarities in how they managed clinical audit, including:

• a clear process showing how clinical is managed within departments, with regular tracking in meetings as standing agenda items – some centres used the QMS for this with good results
• a defined process to disseminate outcomes, to ensure appropriate actions are taken.

Inspection recommendations for Regulation 8

Regulation 8 relates to the management of significant accidental or unintended exposures (SAUE).

We issued 13 recommendations relating to this regulation due to:

• missing or unclear procedures relating to clinically significant accidental or unintended exposures (CSAUE)
• providers not reporting incidents in line with reporting requirements
• poor documentation management relating to incident investigation
• poor management of non-notifiable events

Providers that were compliant with this regulation had clearly identified the process to manage CSAUE events, which included escalation processes. They were also able to demonstrate that this process was followed in practice.

Providers must ensure that all duty holders are aware of the thresholds for reporting to the enforcing authority. Some centres relied on a single individual to code an incident, or decide whether it was notifiable, which had significant points of failure. Effective management included:

• a multi-disciplinary team approach to reviewing and coding events
• keeping investigation reports and related documents in an easily accessible location, for example in incident management systems, QMS or patient notes
• including decision making relating to incidents and their classification in the investigation, for example dose assessments or email chains relating to CSAUE events
• sharing lessons learned from incidents with the whole department or across the organisation as standard practice.

Inspection recommendations for Regulation 17

Regulation 17 relates to the training of duty holders and the associated training records.

We identified 14 instances where training arrangements and records were inadequate. Although we noted an overall improvement in the training records for practitioners. This may be directly attributable to the professional guidance published in 2023 which provides specific advice on the management of training records for clinical oncologists.

We found that multiple employers were transitioning between using paper and electronic records, which sometimes made it difficult to locate records. We also noted that training requirements for entitled operators who were authorised to carry out additional imaging, pre-treatment, or verification imaging is still unclear.

Key themes in radiotherapy

Equipment faults

There has been a marked increase in the number of notifications as a result of equipment faults, with a 90% increase from 2023/24.

Figure 13: Total radiotherapy equipment fault incidents, 2024/25 and 2023/24

The equipment faults in 2024/25 all related to the delivery of external beam treatment using linacs (linear accelerators). Several incidents have affected multiple providers nationally. These included:

• a frame rate error that delivered an increased dose to patients during treatment verification
• CBCT (cone beam computed tomography) that stopped emitting X-rays mid-acquisition, which results in the image being unusable
• communication failures when acquiring kV images.

In all these cases, although the actual dose delivered to the patient was minimal compared with the intended dose, the fault affected multiple patients, in some cases over 1,000 patients were affected, therefore action is needed to minimise the risks associated with these faults.

We also received multiple notifications relating to treatment delivery through a specific section of the treatment couch. Sections of the metallic couch support structure significantly increased attenuation of the treatment beam, resulting in a relative underdose of intended treatment areas under certain geometric conditions. These notifications demonstrated unclear guidance from the manufacturer, and providers were not made aware to prevent treatment through this section of the couch.

Actions that providers took to address the error included:

• using radio-opaque markers applied to the CT couch to identify any patients that could be affected
• improving checking procedures for this subset of patients
• updating treatment planning systems to avoid this structure if possible, and if not, taking the additional attenuation into account.

This type of incident was happening in providers across England, and it is vital that providers report all equipment incidents – including software incidents – to the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates equipment manufacturers. Reporting these incidents ensures that they can be managed at a national level and helps to develop a cohesive programme for monitoring manufacturers’ actions, for example releasing software code adjustments. The MHRA can also issue field safety notices, ensuring all providers are aware of the potential for error so they can take action to prevent incidents.

Staffing levels

Staffing levels and their effect on compliance with the regulations was a persistent theme, particularly their impact on notifiable errors. This related to all duty holders, clinicians, radiographers, and medical physics experts, as well as radiotherapy engineering staff.

The risks associated with low staffing levels were managed inconsistently across organisations. However, we saw that risks were well-monitored and understood by senior leaders, with concerns included on risk registers that were regularly monitored.

Departments that had benchmarked their staffing levels against national guidance were able to demonstrate where their shortfalls were and create business cases for additional staffing. Some departments considered reduced service capacity or created waiting lists for certain treatment groups.

Peer review of patient volumes

Peer review in radiotherapy is an essential step in clinical quality assurance to avoid planning-related errors that can affect patient safety and treatment outcomes. Across some providers, a lack of robust peer review of patient target volumes (the area to be treated) contributed to a large number of notifications received in 2024/25, which is consistent with previous years.

We found that employers did not review treatment volumes of organs at risk consistently. An under-resourced consultant workforce continued to limit the ability to introduce systematic peer review of all target volumes and contributed to a rise in notifications. Where consultants were absent, there was inconsistent cover to effectively continue established peer review procedures.

However, we did see some departments that had developed robust procedures to document how anomalies in patient volumes were picked up and actioned successfully ahead of treatment. These centres were using the QMS or record and verify system to track peer review, with comments from practitioners easily accessible to the treatment planners and operators. Some centres used a RAG rating to code these amendments, which allowed them to be audited and identified where practice needed to be changed or identified training needs.