IR(ME)R annual report 2023/24

Notifications received in 2023/24

• 244 notifications (compared with 270 notifications in 2022/23)
• this represents 30% of all notifications received across all modalities
• 97% of notifications were from NHS acute trusts
• planning and verification imaging accounted for 44% of all radiotherapy notifications received

Figure 4: Notifications from radiotherapy by sub-modality, 1 April 2023 to 31 March 2024

Source: CQC SAUE notifications data 2023/24
Note: Percentages have been rounded up to the nearest whole number to add up to 100%

In 2023/24, we received 244 notifications in radiotherapy, which was lower than the previous year (270 notifications). This was expected, as in April 2023, we amended the thresholds for notifications relating to planning and verification imaging to reflect changes in episode regimes. This resulted in an expected reduction in planning and verification notifications from 146 to 108, which affected the overall number received.

Types of error

As in the previous year, the most common error related to treatment verification imaging (69 notifications). Although there were fewer than in 2022/23 because of the changes to the notification threshold, they still accounted for the highest proportion of the notifications reported from radiotherapy (figure 5).

Figure 5: Notifications from radiotherapy by detailed error type, 1 April 2023 to 31 March 2024

• Tier 1: The duty holder from whom the error originated
• Tier 2: The point in the pathway where the error first occurred
• Tier 3: What went wrong

Tier 1: Referrer: (18 notifications)

Tier 1: Practitioner (11 notifications)

Tier 1: Operator (168 notifications)

Tier 1: Equipment (40 notifications)

Tier 1: Other (7 notifications)

Total radiotherapy notifications: 244

Source: CQC SAUE notifications data 2023/24

Inspections and enforcement

We carried out 15 inspections, 4 of which were of brachytherapy services. From these inspections, we issued 6 Improvement Notices and made 26 recommendations, which included:

• Regulations 6(1) and 6(5)b: reviewing the employer’s procedures to ensure they reflect clinical practice, with an appropriate quality assurance process (9 recommendations)
• Regulation 7: ensuring that employer’s procedures include provision for carrying out clinical audit as appropriate, with particular focus on managing clinical audits within departments (6 recommendations)
• Regulation 8(1): ensuring a clear process relating to managing clinically significant unintended and accidental exposures and overall management of incidents (2 recommendations)
• Regulation 8(4): ensuring that all significant, accidental or unintended exposures that meet the threshold for notification are reported to the enforcing authority and that incidents are managed appropriately (2 recommendations)
• Regulation 15(2) and 15(6)c: ensuring that equipment QA processes are robust, and that the equipment inventories contain the correct information (3 recommendations)
• Regulations 17(1) and 17(4): training records for duty holders, with particular focus on practitioners (4 recommendations)

We issued Improvement Notices against:

• Regulations 6(5)b: where there was a failure to follow an established quality assurance programme for written procedures and written protocol
• Regulation 8(4): where the service did not have an adequate process for incident management and therefore multiple incidents were not reported to the regulating authority in line with the regulations
• Regulation 11(5): where there were no authorisation guidelines to enable operators to authorise exposures in the practitioner’s absence
• Regulation 15(2): where the equipment inventory did not contain the correct information

Key themes in radiotherapy

Through our work in radiotherapy over 2023/24, we have identified some concerns and themes in specific areas. We’ve taken the learning from these to provide some actions that employers can implement to help encourage improvement in these areas.

Error management

The incident investigations we received as the enforcing authority showed that human factor errors form a large portion of the notifications. Human errors were often attributed to slip-ups or lapses in concentration as a direct result of staffing issues or working longer hours without an appropriate break.

We found that the management of human factor errors was inconsistent: some providers attributed the incident to the operators who were directly involved, whereas others would take a more systemic approach, assessing the whole process that led up to the incident to target the cause.

We found that where there was a systemic approach to reviewing the entire process that was affected by the error, there appeared to be more robust actions taken using the lessons learned.

Analysing trends of both reportable and non-reportable incidents is a vital part of applying lessons learned and reducing SAUE events. We noted during the year that this aspect of incident management was not happening as often as a direct result of lower staffing levels and fewer resources. This has a direct impact on the assessment of common errors, their causative factors and producing preventative procedures to enhance patient safety.

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. A lack of robust peer review across some providers of patient target volumes (the area to be treated) contributed to a large number of notifications received in 2023/24.

We found that routinely reviewing and discussing patient volumes in multi-disciplinary meetings of appropriately trained and experienced peer professionals was not happening in some services as there was no process for this. An under-resourced consultant workforce limited 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.

As a result, documentation of peer review recorded on planning communication sheets was variable, and detailed changes were not always carried out effectively. However, we saw some effective use of established peer review processes that used the record and verify systems appropriately. Here, using specific activity codes for peer review tasks enabled clear oversight and management.

The investigation reports we received from radiotherapy departments that had established robust peer review procedures highlighted how anomalies in patient volumes were picked up and actioned successfully ahead of treatment.

Staffing levels

Staffing levels and their effect on compliance with the regulations was a persistent theme, particularly their impact on notifiable errors. Several organisations had noted an increase in the number of notifications submitted to us, as well as events that did not meet the SAUE criteria. 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 – some were well monitored and understood by senior leaders and others were poorly tracked. Providers that managed this well monitored their risk register regularly at both departmental and executive levels and assessed risks levels regularly. 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. In extreme circumstances, organisations had considered reducing their capacity to provide services or created waiting lists for certain treatment groups. We also saw that some had cut down on non-essential tasks to reduce the workload on treatment staff.