IR(ME)R annual report 2024/25
Downloads
Nuclear medicine
Notifications
This year we saw a 9% decrease in the number of SAUE notifications received in nuclear medicine (117 in 2024/25 compared with 128 in 2023/24).
Figure 14: Nuclear medicine notifications by sub-modality
Despite this overall trend, we have seen an increase in notifications relating to PET-CT and PET-MR imaging of 13%. As a result, we have completed a separate analysis of notifications in this sub-modality to identify key themes specific to this field.
PET-CT/PET-MR notifications
In England, approximately 43% of PET-CT imaging is delivered by independent healthcare providers, resulting from the national contract. These services usually deliver only PET-CT imaging and are not part of a conventional nuclear medicine department. Many scans are performed using mobile facilities, which move between different host sites, and staff involved in delivering these exposures may be peripatetic.
Equipment-related incidents
The patient exposure pathway for PET imaging is broadly similar to conventional nuclear medicine. However, the shorter tracer uptake and image acquisition times means that when equipment breaks down, more patients are likely to have been already injected and therefore receive an unintended exposure if their examination cannot go ahead. As a result, equipment-related notifications are more likely to be reported due to the application of the ‘multiple’ complementary SAUE notification code. This is reflected by the proportion of equipment-related incidents in PET.
Equipment-related incidents are more prevalent in PET (35%) than in the other 3 sub-modalities (21% in diagnostic imaging, in vitro studies and radionuclide therapy combined).
Of these equipment-related SAUEs in PET, 62% result from hardware faults, (malfunction of the imaging system itself), with the remainder split between software problems and failure of ancillary equipment, such as power supply or air conditioning systems. The high proportion of these types of notification, as well as the number of patients affected when these systems fail, illustrates the need for regular preventative maintenance, robust quality control testing and risk management for scanners reaching the end of life or with impaired performance.
Actions for employers
Ensure that you have procedures in place to verify the correct functioning of imaging equipment and supporting systems before administering radiopharmaceuticals to patients.
Radiopharmaceutical errors
The next most common source of notifications in PET-CT was misadministration of radiopharmaceuticals. These included:
- incorrect radiopharmaceuticals
- extravasation
- incorrect administered activity.
Administrations of the wrong radiopharmaceutical are always reportable under SAUE code 7, which was introduced in April 2023.
Since the introduction of a broader range of tracers into routine practice, more patients in PET-CT are receiving the wrong radiopharmaceutical, such as fluorine-18 FDG instead of fluorine-18 PSMA. In some cases, incidents originate when administrative staff incorrectly add referrals to the radiology information system (RIS). Patients may be booked to attend sites where FDG is the only tracer in use, and so it may be less likely for operators to detect this mistake.
Actions for employers
Consider whether tasks performed by administrative staff constitute practical aspects due to the impact on the potential exposure and therefore whether these staff should be considered operators. IR(ME)R requires operators to be adequately trained and to comply with written employer’s procedures.
Referral information and PAUSED checks
In line with persistent trends, we continue to see notifications caused by poor quality referrals. This includes incidents where:
- the wrong patient had a scan (accidental exposure)
- requests made for the wrong modality (for example, instead of CT or cardiopulmonary exercise test (CPET))
- incorrect timing
- using outdated forms.
It is difficult to eliminate referral errors completely, which is why we expect the exposure pathway to include checks that may detect these mistakes, such as PAUSED. These checks should be used by practitioners and operators and are most effective when duty holders have the resources to check each patient’s previous imaging and clinical history. But we have found that this is not always possible in PET-CT services, due to a lack of connectivity between RIS and other electronic patient records. Operators rely on the information provided in the initial referral, which may be incorrect or incomplete.
Similarly, there have been incidents involving incorrect justification, authorisation, or protocolling of exposures, which could have been detected if previous imaging or patient history were checked.
The regulations were amended in October 2024 to introduce a new requirement under Regulation 6A, which sets out the duty of co-operation between IR(ME)R employers. This regulation requires employers to work together to ensure that information about patient exposures or potential exposures is shared appropriately, enabling each employer to comply with their obligations under IR(ME)R. Employers should also consider how clinical and imaging history is accessed, and where such access is not available, clarify who is responsible for providing the necessary information to support safe and appropriate use of radiation.
Diagnostic nuclear medicine (including in vitro studies)
The highest proportion of notifications in this sub-modality were due to errors during the preparation of radiopharmaceuticals. Most were linked to failures in the PAUSED check process, for example where operators did not identify that the radionuclide calibrator was set to the wrong isotope, or where there was incorrect labelling of vials or syringes. This further highlights the importance of embedding PAUSED checks within the exposure pathway. This process is significantly strengthened when another operator carries out a second, independent check.
Only a small number (4 notifications) related to in vitro studies, with no clear trends. All reported SAUEs involved glomerular filtration rate (GFR) assessments and were notifiable due to multiple patients being affected. These incidents typically involved equipment failures, incorrect use of equipment, or errors in sample preparation.
Therapeutic nuclear medicine
There were 6 SAUEs reported to us involving radionuclide therapies. Of these, 3 resulted from issues during the administration of the radiopharmaceutical, particularly where high vial residues were identified but the underlying cause was not understood or investigated.
In addition, there were incidents caused by:
- faulty administration lines
- incorrect calculation of prescribed activity
- use of contrast during CT imaging 2 weeks before iodine-131 ablation.
Inspection and enforcement activity
We carried out 28 comprehensive inspections of nuclear medicine services. We issued 9 Improvement Notices, comprising 18 significant compliance gaps in total, and we made 97 quality improvement recommendations in our inspection reports.
Analysis of the regulations involved in this activity demonstrates the key areas of non-compliance identified during our inspections of nuclear medicine services.
Procedures and protocols
A total of 25 breaches were identified in relation to procedures, protocols, and other key documents. In most cases, this was due to missing or inadequate employer’s procedures, or because procedures were not accessible to staff or not being followed in practice. Employers must ensure that procedures are fit for purpose and that they provide effective support for staff to enable them to carry out their duties in line with IR(ME)R.
Training and records
We identified 14 instances where training arrangements and records were inadequate. Of particular concern were cases where operators undertook tasks beyond their normal professional scope and training, such as clinical scientists evaluating imaging studies, without documented evidence of assessed competence.
Actions for employers
Make sure practitioners and operators are adequately trained and competent to perform the tasks assigned to them. Individual entitlement and scope of practice should be clearly linked to up-to-date training and competency records.
Referral guidelines
We identified 12 breaches relating to the provision of referral guidelines. Regulation 6(5)(a) requires employers to establish referral criteria and make them available to all referrers, but guidelines are often missing or not easily accessible, particularly for external referrers. Referral guidelines are essential to support appropriate referrals and ensure exposures are justified. They should clearly state:
- who can refer
- how to refer (including the system or process)
- what information is needed (for example, patient ID and clinical history)
- the clinical criteria for referral, including indications, contraindications, and dose information.
Commercially available tools can provide a helpful starting point, but local adaptation is essential. In many services, referral guidelines align closely with authorisation guidance, and linking the two can improve consistency and support compliance.
Carers and comforters
We identified 11 breaches relating to the arrangements for carers and comforters, highlighting ongoing gaps in understanding and implementation across many nuclear medicine services. Some departments mistakenly believed that designation depends on a dose threshold or constraint. However, under IR(ME)R, designation is based on the nature of the exposure, not the dose. In last year’s report, we outlined what compliant procedures could look like to support services in meeting this requirement, and further detail is available in professional guidance.
We also took multiple actions relating to:
- authorisation arrangements
- quality assurance of procedures
- study of risk
- clinical audit
- equipment performance and inventory
- incident management.
We encourage employers to review the relevant IR(ME)R requirements, consult guidance from professional bodies, and collaborate with other services to strengthen their compliance and share good practice.
Key themes in nuclear medicine
Employer’s procedures
We continue to see, and in some cases take regulatory action, where these are not fit for purpose. Often, they are too generic, do not reflect actual practice, or fail to meet the requirements of IR(ME)R Schedule 2. Recommendations and enforcement commonly relate to procedures that do not support staff in complying with the regulations or ensuring safe, consistent practice.
Under IR(ME)R, the employer’s written procedures are a legal requirement. Their primary purpose is to guide staff in performing their roles in compliance with the regulations and in line with the employer’s own processes. This means procedures must be tailored to reflect the unique workflows, risks, and responsibilities involved in individual nuclear medicine services.
A good procedure in nuclear medicine should be:
Clear and specific: Avoid vague or generic instructions. Procedures must be easy to follow and describe clearly what is required, for example, how to make pregnancy enquiries and what to do in response, or how to measure activity and where to record it.
Relevant: Tailored to the service model, staff roles, and local equipment. Procedures must address nuclear medicine-specific requirements, including arrangements for breastfeeding and the provision of written instructions to patients. They should cover both diagnostic and therapeutic studies, with appropriate measures in place for each, for example, pregnancy enquiries.
Aligned with IR(ME)R: Procedures must address all the requirements of Schedule 2.
Accessible: They should be available where and when needed (for example, injection rooms, scanner control rooms, dispensing areas) and in usable formats.
Up to date: Reviewed regularly and updated when practice, equipment, or legislation changes.
Implemented: Actively followed in practice – not just held in a policy folder. Audits, incident reviews, and staff feedback should be used to ensure they are fit for purpose and being applied correctly.
Supported by training: Staff must understand not only what the procedures require, but also why they matter and how to apply them safely in the nuclear medicine context.
Ultimately, ensuring procedures are service-specific, reflect Schedule 2, and embedded into practice is fundamental to both regulatory compliance and patient safety.
Multiple notification code
Regulation 8 of IR(ME)R explains the employer’s duties around statutory notifications about accidental or unintended exposures. When these are judged to be ‘significant’, they need to be notified to the enforcing authority under Regulation 8(4).
The multiple notification category is a complementary notification code, where a single incident or theme involves multiple patients and is particularly relevant to nuclear medicine and PET/CT.
During inspections, we have noticed a misunderstanding around reporting multiple code incidents. Some departments were not reporting incidents as they thought the patient dose received by each individual person needed to hit the dose threshold detailed in the SAUE guidance for providers, and some departments were not reporting theme incidents if only one patient had been affected in each incident.
Examples of incidents under multiple codes
- A single incident that involved multiple patients: This incident reported to us involved multiple patients attending for a Glomerular Filtration Rate (GFR) test. An error with the standard was identified during the processing stage, which meant all the GFR tests were non-diagnostic, and the patients were re-booked.
- Recurring incident: This notification of an incident involving Sentinel Lymph Node (SLN) injections. was identified during an audit, where 5 patients over a 7-month period received a SLN injection, but the surgery did not go ahead.
- Similar, separate incidents: An error occurred on the PET/CT scanner during PET reconstruction, which led to data being lost. Similar incidents occurred over a 3-month period resulting in 3 patients being recalled for a repeat PET/CT appointment and was reported as a theme.
- Radiopharmacy-related incident: A multiple incident reported involved 5 renal patients who were injected with MAG3, but the images were undiagnostic due to a mis-labelling error possibly due to an error using a heat block. All 5 patients were re-booked.
The multiple complementary code does not depend on patient dose. It should be used when:
- a single error or failure affects multiple patients, or
- similar incidents recur over time affecting more than one patient.
Study of risk for therapeutic nuclear medicine
Regulation 8(2) requires employers to include a study of the risk of accidental or unintended exposures within their quality assurance (QA) programme. This applies to all exposures for radiotherapeutic purposes, including therapeutic nuclear medicine. However, this requirement is often poorly understood, and many departments do not yet have an appropriate, documented study of risk in place.
The study of risk must be clearly directed at identifying failures that could lead to accidental or unintended exposures, distinct from general safety or radiation protection risk assessments. It should span the full therapeutic pathway, from referral and justification through to treatment delivery, follow-up, and incident management. Proactive risk assessment helps organisations understand the likelihood and impact of possible failures and supports a preventive safety culture.
A range of methods can be used to meet this requirement, and these are outlined in guidance.
A recent project presented at the British Nuclear Medicine Society demonstrated how failure mode and effects analysis (FMEA) can be effectively applied to therapeutic nuclear medicine. Four NHS centres collaborated to assess common therapies (for example, iodine-131 for thyroid cancer, radium-223, lutetium-177 DOTATATE). Using detailed process maps, they identified up to 60 points of failure for each treatment pathway. Common high-risk failures included:
- missed pregnancy checks
- failure to identify carers/comforters
- incomplete incident learning.
Comparison with local incident records and CQC IR(ME)R reports helped identify additional gaps, demonstrating the value of this structured approach.
To be effective, the study of risk should:
- be multidisciplinary (for example, involving MPEs, clinicians, technologists)
- be repeated periodically, and especially when introducing new techniques or after incidents
- be specific to the service and well-documented
- feed into quality improvement and learning processes.
Employers should ensure staff are trained in risk assessment techniques and supported with time and resources to complete this work. Failing to implement a robust study of risk not only breaches IR(ME)R but may leave departments exposed to avoidable harm and regulatory action.
Examples of notifiable accidental and unintended exposures and actions taken
PAUSED check failure in PET-CT
A patient was referred for a fluorine-18 FDG scan using a handwritten referral form. The referral was legible and included all necessary clinical information. The IR(ME)R practitioner justified and protocolled the request in line with the intended FDG scan after it was transcribed onto the electronic booking system.
However, administrative staff incorrectly booked the patient for a fluorine-18 PSMA scan on the radiology information system (RIS). According to local procedures, the electronic record of authorisation should have been printed and attached to the referral, with RIS updated if any changes were required.
On the day of the scan, the authorisation record was not attached. The patient attended, received a fluorine-18 PSMA injection, and was scanned accordingly. The error was identified only after the scan, when the operator reviewed the images against the original authorisation record.
Lessons identified
- PAUSED checks must be embedded throughout the entire patient pathway, including administrative stages such as data entry and appointment booking.
- Printed authorisation records must be attached to the referral.
- Operators must review the day’s referrals in the morning huddle and make a final check of referral and authorisation details before administration of radiopharmaceuticals.
Making, amending and cancelling referrals
A patient was referred for both ultrasound parathyroid and nuclear medicine (NM) parathyroid imaging during a clinic consultation. The plan was explained to the patient, who expected both scans before their next appointment with a consultant.
Following the parathyroid ultrasound, the findings indicated that the NM scan was not necessary. The referrer cancelled the NM request on the electronic patient record (EPR). However, this cancellation did not propagate to the radiology information system (RIS), which is the system NM staff use to track referrals, and the NM team was unaware as they were not contacted directly to inform them of the cancellation.
The patient subsequently attended for their NM scan. The radiographer, seeing a valid referral on RIS and receiving confirmation from the patient that they were expecting the scan, proceeded with the examination. As a result, the patient received an unnecessary radiation exposure.
The investigation found the following points:
- The radiographer acted appropriately based on available information – a live referral on RIS and patient confirmation.
- The root cause was the referrer not following the correct process for cancelling referrals, which requires direct communication with the NM team.
Lessons identified
- The case illustrates a recurring issue where referrers fail to cancel unnecessary referrals appropriately, resulting in avoidable exposures.
- Referrals must be cancelled according to the correct local procedure, ensuring that all relevant systems are updated and that the imaging department is informed directly.
- This reinforces the importance of complying with the new procedure mandated in the 2024 amendment to IR(ME)R for making, amending, and cancelling referrals.
- Clear communication and system integration are critical to prevent similar incidents and uphold patient safety.