Incidents reported to MERU, HSE in Diagnostic Radiology (including Nuclear Medicine) and in Radiotherapy The MERU, HSE (2013)

Transcription

1 Incidents reported to MERU, HSE in Diagnostic Radiology (including Nuclear Medicine) and in Radiotherapy The MERU, HSE (2013)

2 CONTENT Executive summary.. 2 Introduction 3 Incidents reported in Notifiable Incidents Notifiable incidents in Diagnostic Radiology (including Nuclear Medicine) 5 Notifiable incidents in Radiotherapy.. 6 Conclusion.. 7 Recommendations. 8 1

3 Executive summary The MERU, HSE is committed to supporting the principles of SI 478, which is to minimise the radiation dose given to the patient population, whilst maximising on the benefits of diagnostic information and the associated treatments. To further support this, the National Radiation Safety Committee (NRSC) issued national guidelines on the reporting of patient incidents. In 2008, the National Baseline Audit on the Implementation of Statutory Instrument (SI) 478 (2002) recommended the establishment of a notification system for incidents to patients to be managed by the Medical Exposure Radiation Unit (MERU), HSE. Subsequently, systems have been put in place by the MERU, HSE in relation to the classification and reporting of incidents (notifiable incidents and near-misses). A template was developed and has been disseminated to support the reporting of incidents in all locations. The fundamental role of the incident reporting system is to enhance patient safety by learning from reported incidents and near misses in the health system. The information obtained from each location, collectively provides useful data from which comparisons can be made of local practices in terms of national averages. The dissemination of the findings can inform practices through the implementation of actions to prevent the occurrence of similar incidents. This report presents the findings from the incidents reported to the MERU, HSE between 2010 and Based on the findings, recommendations are made that support consistency in data collection, monitoring, analysis and learning through the issue of new guidelines to support and maintain good local governance procedures and effective risk management. Clinical audit, ongoing training and education of staff and reviewing and updating of procedures in line with good practice are all areas that the MERU, HSE engage upon and support. 2

4 Introduction This report provides an analysis of the data submitted to the MERU from locations to comply with the 2010 MERU guidelines, in relation to patient ionising radiation incidents. Notifiable incidents are classified as those which must be reported immediately, an investigation carried out by the location and a report forwarded to the MERU, HSE. Statistics on the total number of incidents, including those of a less serious nature, termed non-notifiable, from each location are reported upon by the MERU annually. The rate of ionising radiation incident returns to the MERU, HSE for Radiology in 2012 is in the region of 0.02% of estimated workload. This may be an underestimate and is expected to increase over time as awareness and understanding of the incident reporting guidelines improves. The Radiation Protection Manual (2013) outlines processes and procedures that support practice development and promote patient safety in radiotherapy, and specifically introduces a standardised reporting template for incidents. Incidents reported in 2012 In 2012, a total of 890 incidents were submitted to the MERU and were reported upon. Year on year, since 2010 there has been a 35% increase in the level of incidents reported. This has been attributed to an increased awareness of, and compliance with, the reporting requirements. In 2013, the guidelines were revised to bring clarity to the definitions and have been issued with the Radiation Protection Manual. A reduction in the number of locations submitting data on patient radiation incidents has been recorded; 79% in 2012 and 85% in The importance of participating in data collection and the benefits to patient safety from shared learning when data is disseminated is emphasised. 53% of locations stated that they had no incidents or near misses in Locations with a history of poor participation in the incident reporting process are more likely to be the focus of external auditing in % of locations engaged in the process, with near misses accounting for 63% of the incidents reported. This indicates that protocols are in place to correct potential incidents prior to patient examination/therapy. These are important from a learning perspective and are, therefore, included in the analysis of incidents. Of the 890 incidents reported in 2012, 70% were from Radiotherapy departments, with 3% (18) of these falling into the category of Notifiable Incident. The majority of Notifiable Incidents were relating to a dose variation from the intended fractional dose or from the total prescribed dose. The locations reported that these dose variations had no clinical impact in each case. Within Diagnostic Radiology/Nuclear Medicine, 9% (26) of incidents were categorised as notifiable, of which 68% involved patient identification errors arising either from the wrong patient being referred or due to operators failing to follow the patient identification procedure and irradiating the wrong patient. No clinical impact for the patients was reported by the locations. 3

5 Overall, analysis of the data gathered in 2012 indicates that the root cause of 45% of reported incidents is human error. Referrer error accounted for a further 31% of incidents reported, similar to the 34% referrer error reported by the Care Quality Commission in the UK for Notifiable Incidents In 2012, there was a 50% increase in the notifiable incidents reported compared to 2010, when the incident reporting process commenced. This correlates with the experience of implementing other incident reporting processes and reflects the increased awareness and compliance with guidelines. There was an increase in notifications for Radiotherapy Incidents reported in 2011, which is attributed to an increased awareness of the incident reporting structure, the development of an incident reporting template and the work of the Radiotherapy sub-committee of the National Radiation Safety Committee and the MERU, HSE. Figure 1 outlines the trend of Notifiable Incidents by Speciality in 2010, 2011 and Figure 1 Notifiable Incidents by Speciality in 2010, 2011 and 2012 Between 3% and 9% of incidents recorded at locations fell into the notifiable category. Table 1 presents a breakdown of notifiable incidents for radiology and radiotherapy, as reported in 2011 and Table 1 - Notifiable incidents as a percentage of total incidents recorded Radiology 3.10% 9.30% Radiotherapy 4.40% 3.10% Once an initial notification is received, the reporting template for both radiology and radiotherapy is forwarded to the location by the MERU, HSE. The template is also available for electronic download from the MERU Website. The template captures all the relevant information to the incident. Some reports are submitted in a variety of formats, which can result in inconsistencies in the level of information obtained, and on occasion necessitates further requests for clarification. 4

6 From the data, there would appear to be no correlation between the decision to inform the patient of the incident and the incident type or severity. In 2012, 38% of patients were informed that an incident had occurred relating to them. The decision to inform the patient remains a clinical decision, based on individual circumstances. The MERU advocate that each location should have a written policy in relation to patient disclosure. An Open Disclosure Policy is due to be launched by the HSE, and locations should take this into consideration when devising their own written policy relating to the disclosure of information to patients in the event of radiological incidents. Notifiable incidents in Diagnostic Radiology (including Nuclear Medicine) Near misses of an incident that meets the guidelines are reported to MERU for the purposes of learning and prevention of recurrence which might lead to an actual incident. Near miss levels range from 25%-45% of notifiable incidents. Figure 2 Incidents and Near Misses Radiology Over the past three years, the data indicates that incorrect patient identification accounts for a significant portion of all notifiable incidents, ranging from 44% in 2010 to 68% in Examples of Incorrect Patient Identification are incidents whereby patient identification procedures are not correctly followed by the referrer or by the radiology department, and a patient who was not intended to receive any ionising radiation examination is irradiated. The vast majority (88%) of incorrect patient identification incidents have been reported in the area of CT, where the patient dose is at the higher end of the scale. Incidents relating to Patient Identification in the diagnostic environment have been highlighted by the Radiological Protection Institute of Ireland during their inspections in recent years. Despite their intervention this error continues to recur. Figure 2 provides a comparison of Notifiable Radiology Incidents in 2012, 2011 and

7 Figure 3 Incidents by Type Notifiable incidents in Radiotherapy Near misses of an incident in Radiotherapy that meets the guidelines are reported to MERU for the purposes of learning and to prevent recurrence which potentially might lead to an actual incident. No near misses were reported in 2010 or 2011, with 2 near miss incidents reported in Radiotherapy for The total number of notifiable incidents in Radiotherapy have increased year on year as the external reporting process becomes embedded into the internal incident reporting structures at locations. Figure 4 Incidents and Near Misses Radiotherapy The most common incident over the past three years fell into the category of Dose variation from a fractional dose. In the majority of fractional variation incidents correction was possible during subsequent treatment fractions to maintain the overall prescribed dose, and locations reported no clinical impact for the patient. The root cause of the variation in fractional dose was difficult to 6

8 determine in many cases. It is anticipated that the utilisation of the Radiotherapy template form should alleviate difficulties in identifying the root cause of incidents. There is increased awareness of the incident reporting process from radiotherapy locations. It would appear that continued engagement and a consistent approach to incident management within the radiotherapy community, facilitated by the radiotherapy subcommittee have contributed to increasing awareness. Figure 3 presents the Notifiable Radiotherapy Incidents in 2010, 2011 and Figure 3 Notifiable Radiotherapy Incidents by year 7

9 Conclusion By locations reporting radiology and radiotherapy incidents to the MERU, HSE an ethos of working towards a safer radiotherapy service is promoted. The information submitted provides for the creation of a data base that can inform best practice and promote safety for patients in the health service. The process of data collection and analysis facilitates collaborative learning through the sharing of findings and assists the MERU, HSE in working towards a more comprehensive system, whereby all incidents are reported upon, reviewed, and where necessary, further investigated. Radiographic staff play a pivotal role in the protection of service users, staff and members of the public from the risks of ionising and non-ionising radiations. It is imperative that radiation protection is promoted and included in each individual s continuous professional development. Radiation regulations sets out the legal capacity in which practices should be undertaken and it is the MERUs intention to support professional responsibility and accountability in all locations. This goal will be achieved by informing locations of areas for further improvements and the ongoing development of system infrastructure to promote and improve safety for patients. To support the achievement of this goal, certain recommendations have been made based on the findings from the incidents reported. These recommendations are now presented. 8

10 Recommendations Specific areas emerged during data analysis that determined key conclusions to be drawn from the findings. Based on these, the following recommendations are being made: 1. The category any other radiation exposure incident to patient is commonly recorded at locations. This category requires further development and clarity to explicitly establish a uniform approach to what is being reported. 2. From January 2014, all locations will be required to report incidents using the standard template circulated. This will support consistency of information collected and analysed. a. The Radiation Protection Manual (2013) has been distributed to all locations to support good practice and the implementation of specific processes and procedures (including the standardised reporting incident template). 3. Specific locations will be identified (those with no recorded incidents or near misses) for further education, training and changes to protocols to further engagement with incident reporting and learning processes. 4. On the release of the HSE Information Disclosure Policy, locations will be advised on the development of a written policy relating the disclosure of information to patients in the event of a radiological incident. 9