Improving patient radiation safety in Ireland

The fundamental role of incident reporting is to enhance patient safety; the need to raise alerts to prevent the occurrence of significant adverse events is critical. The merits of incident reporting are discussed below, along with incident reporting practice in Ireland, statistics for 2015 and the plans for the current year.

There is increasing concern among areas of government, healthcare providers and radiological departments that adverse events and near misses, particularly in relation to patient radiation safety, are under-reported. It is widely agreed that many incidents could be avoided if healthcare personnel were more aware of how the safety culture of other industries, for example the aviation industry, could be applied to radiology. Comparing reports and applying the learning from adverse events in radiology internationally is difficult, as there is no agreed taxonomy of adverse events, no conformity on methods used for data collection and no standardised definitions of incidents. Sources of error have been attributed to both human and system failures.

Manmoun identifies the four ‘Cs of patient safety as:¹

• Changing the culture

• Collecting and sharing data through incident reporting systems

• Calculating risk to the patient

• Clinical audit.

He suggests that applying the four Cs will require:

• Acknowledgement that human error occurs in all areas of life

• Development of a robust incident reporting communication process and a systematic framework for analysis

• Education of staff on the importance of self reporting.

Incident reporting will enhance patient safety and radiology personnel should view this as a tool for trending and learning. By reporting and analysing incidents and near miss events, alerts can be raised before issues become significant. The Health Service Executive (HSE) National Open Disclosure Policy² and Safety Incident Management Policy³ support this and advise that staff must know and understand the value of learning from incidents.

The National Radiation Safety Committee (NRSC) is a statutory committee established under Statutory Instrument (SI) 478 (2002) to advise the HSE on radiation safety issues.⁴ In 2010, the NRSC issued Guidelines on holders’ responsibility for patient radiation protection to assist radiological facilities in complying with radiation protection legislation and to standardise the classification, reporting and learning from medical ionising radiation incidents.⁵ Using these guidelines will enable radiological facilities to provide assurance that appropriate systems are in place to manage any patient radiation safety incident that may occur.

Some incidents, depending on severity, are reportable to the HSE Medical Exposure Radiation Unit (MERU) which is the regulator for radiological locations and charged with monitoring patient safety. The MERU patient radiation protection (RP) manual⁵ defines an adverse event in relation to the administration of medical ionising radiation to a patient, and categorises incidents into those that are notifiable to MERU, non-notifiable and near miss events.

The Euratom Directive 2013/59 will be transposed into national law by February 2018 and it is anticipated that the regulation of patient radiation protection will transfer to the Health Information and Quality Authority (HIQA). This legislative change has many other implications for both licence holders and practitioners, which are not discussed here.

Current situation

All radiological facilities are advised to use the radiation protection (RP) manual to guide practice. The manual states: “A patient radiation incident occurs where the delivery of radiation during an imaging procedure or treatment is different to that intended or where there is none intended for the patient, resulting in unnecessary variation in exposure, unless due to patient factors.”⁵ Variation in dose due to patient factors is not considered an incident but if there are safety implications, the location may consider reporting the event to MERU.

All patient radiation safety incidents are reported through the local risk management framework. The RP manual specifies the criteria for notifying incidents to MERU but acknowledges that not all criteria can be listed. Notifiable incidents are reportable to MERU immediately with a completion time for investigation of approximately three months. A non-notifiable incident is one that does not meet the criteria for reporting to MERU but does require local risk management involvement to ensure patient safety concerns are addressed. 

A near miss event is one where an issue has been identified before a procedure takes place so that a potentially significant event has been avoided. This does not include errors that are identified through the normal checking process which is designed to pick up flaws in the system. All notifiable, non-notifiable and near miss incidents are reported annually to MERU on a standardised template which requires the signatures of the practitioner in charge, the radiation safety officer and the chief executive officer before submission.

Table 1 gives notifiable, non-notifiable and near miss examples of patient radiation safety incidents in radiotherapy, radiology and nuclear medicine.

 (click to enlarge)

Publicly funded radiological facilities have an obligation to report all incidents and near miss events to the National Incident Management System (NIMS), a national reporting framework managed by the State Claims Agency (SCA). The SCA is currently working with MERU to update the radiological reporting section in NIMS to reduce duplication of work and to ensure a consistent and standardised approach to incident reporting. Private radiological facilities will continue to report to MERU as before.

A healthcare audit of incident reporting in four radiological facilities was conducted by the HSE in 2015 using key performance indicators outlined in the RP manual.⁶ These key performance indicators are aligned with the National Standards for Safer Better Healthcare, namely Theme Three – Safe Care and Support.⁷

Four locations were audited and Table 2 outlines findings in relation to adverse events reported to MERU in 2014. The evidence suggested that incidents and near miss events were under-reported to MERU and the auditors proposed that this was due to confusion about what constituted a notifiable incident and a lack of appreciation for the value of learning from adverse events. A trending analysis of all incidents reported to MERU between 2013 and 2015 supports these findings.

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Walker et al⁸ conducted a review of radiotherapy incident reporting in the Anderson Cancer Centre in Texas, and found that there were 189 self-reported incidents among 13,899 patients, of which 37% were treatment planning incidents, 30% treatment delivery incidents and 33% in other steps of the process. The overall rate of radiotherapy incidents was 136 per 10,000 patients. Unfortunately, unlike radiotherapy, international practice in relation to incident reporting in radiology is not standardised and it is not possible to compare Irish data with other jurisdictions.⁹

In Ireland, there are over 100 public and private radiological facilities licensed to administer medical ionising radiation to patients and all are required to self report adverse events to MERU. However, in 2015, only 53 facilities returned incident and near miss data to MERU. These reports consisted of 53 notifiable incidents, 468 non-notifiable incidents and 597 near miss events; 14 sites reported that no incidents or near miss events had occurred and the remaining facilities made no returns.⁴

Figures 1 and 2 detail the notifiable incidents reported to MERU by radiological facilities in 2015.

Figure 1. Notifiable incidents reported to MERU from each radiological modality in 2015(click to enlarge)

Figure 2. Causes of notifiable incidents reported to MERU in 2015(click to enlarge)

The fundamental role of incident reporting is to enhance patient safety and it is disappointing to note the number of radiological facilities that either made no returns to MERU or reported that they had no incidents or near miss events to report in 2015. Practice can only be improved if there is shared learning from adverse events and incident trending to inform quality improvement initiatives. 

Radiological facilities must view incident data as a quality measure and promote a just, proportionate and consistent approach to the management and investigation of incidents and near misses. Safety incident management occurs within the framework of the principles of open disclosure, integrated risk management, just culture and fair procedures.³ This requires support and leadership from the most senior people in the organisation who promote an environment where staff are encouraged to report, investigate, disseminate and implement learning from incidents and near misses promptly.

Next steps

International practice is standardised in relation to incident reporting in radiotherapy.⁸ An audit of incident reporting in radiotherapy sites will be conducted by the HSE in 2016. It is anticipated that the findings will give an indication of where Ireland ranks internationally in relation to radiotherapy and patient safety.

Work between MERU and the SCA is ongoing and the MERU incident reporting template is currently being piloted in the NIMS. This is intended to capture all notifiable incidents in public hospitals, reduce duplication of work for the practitioner and allow for national trending reports to be generated when required. Privately funded radiological facilities do not use the NIMS and will continue to report adverse events to MERU in the traditional way. The transposition of the Euratom Directive 2013/59 into Irish law is in progress. This will have implications for both licence holders and practitioners in relation to their roles and responsibilities and scope of practice. Also, it will affect the training and education they require and the reporting and management of adverse events. It is anticipated that this legislation, once enacted, will transfer the regulatory function of MERU to HIQA, allowing for inspection and enforcement where non-compliance is evident. 

The lack of understanding in relation to what constitutes a notifiable incident and the suggestion that there is no merit to learning from adverse events must be addressed in order to optimise patient safety and ensure it remains a priority. The MERU RP manual can offer guidance but action plans to tackle these issues locally will only be effective when championed by the most accountable senior person in the organisation. Incident reporting must be simplified, standardised and mandatory, and should include information on near misses to help identify trends and prevent serious events before they occur.

Promoting a fair, transparent and just culture of incident reporting and patient safety is challenging but a quote from Sir Liam Donaldson, speaking at the World Alliance for Patient Safety in Washington in 2004, sums up its importance: “To err is human, to cover up is unforgivable, and to fail to learn is inexcusable.”

References

1. Manmoun J. Introduction to patient safety. J Medical Imaging 2009; 40(3): 123-133
2. National Open Disclosure Policy. Health Service Executive 2013. Available at: www.hse.ie/publications
3. Safety Incident Management Policy. Health Service Executive 2014. Available at: www.hse.ie/publications
4. National Radiation Safety Committee Annual Report 2015. Health Service Executive 2015. Available at: www.hse.ie/NRSC
5. Patient Radiation Protection Manual. Health Service Executive 2013. Available at: www.hse.ie/MERU
6. Audit of incident reporting and learning as outlined in section 3 of the Medical Exposure Radiation Unit (MERU) Patient Radiation Protection Manual Summary Report. Health Service Executive 2015. Available at: www.hse.ie/auditservices
7. National Standards for Safer, Better Healthcare. Health Information and Quality Authority 2012. Available at: www.hiqa.ie/publications
8. Walker G, Johnson J, Edwards T et al. Factors associated with radiation therapy incidents in a large academic institution. Practical Radiation Oncology 2015; 5: 21-27
9. Incidents reported to the Medical Exposure Radiation Unit in Diagnostic Radiology (including Nuclear Medicine) and Radiotherapy 2013-2015.Health Service Executive 2015. Available at: www.hse.ie/MERU