National Radiation Safety Committee

Annual Report 2016

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The 2016 Annual Report presents the work undertaken by the National Radiation Safety Committee (NRSC), its three national subcommittees and the Medical Exposure Radiation Unit (MERU).

The NRSC is a statutory committee, established under SI 478 (2002), to advise the Director General (DG) of the Health Service Executive (HSE), on patient radiation safety issues in public and private radiological facilities. The NRSC is supported by MERU and convened on a quarterly basis in 2016. Work was delivered through the three subcommittees which are chaired by members of the NRSC.

Patient Radiation Incidents

The fundamental role of incident reporting is to enhance patient safety. Analysing reports, identifying trends and mitigating risks are essential components of any risk management framework. Incident reporting and analysis should be viewed as a tool to help practitioners know and understand the value of learning from adverse events.

All radiology locations are directed to report notifiable adverse events to MERU, using the MERU Patient Radiation Protection Manual as guidance. MERU also receives monthly reports from the National Incident Management System of all safety incidents reported by radiology and radiotherapy departments in public hospitals.

At the time of writing this report, 60 locations had completed and returned the annual returns template to MERU for 2016. These returns consisted of 34 notifiable incidents 311 non-notifiable and 536 near miss events.

The analysis outlined in the report and subsequent discussion indicate a reduction in notifiable incidents reported by radiology and radiotherapy departments compared to previous years which is, perhaps, a positive reflection of a robust incident management system nationally. However, it must also be noted that no notifiable incidents were reported involving interventional radiology or any medical speciality, other than radiology or radiotherapy, that routinely administers ionising radiation to patients.

The most common cause of error reported involved the operator, referrer or administrator identifying the wrong patient for a diagnostic procedure and a campaign to highlight the importance of applying a triple identification policy is recommended. Although a relatively small number of notifiable incidents were attributed to equipment failures, there are concerns and a plan to work closely with the Health Products Regulatory Authority (HPRA) has been initiated. Work on updating the Patient Radiation Protection Manual is progressing well and the drafting of a national policy to standardise the care of pregnant patients in radiology and radiotherapy is underway.

Executive Summary

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MERU wishes to acknowledge the positive and proactive approach to reporting incidents demonstrated by the majority of radiology and radiotherapy locations. Incident data is a quality measure and patient radiation safety is the responsibility of all practitioners.

Achievements

Congratulations to the MERU team who published the article entitled ‘Improving Patient Radiation Safety in Ireland’ and also presented a poster at the 2016 National Patient Safety Conference entitled ‘Radiation safety incidents reported to the HSE MERU in 2015’.

Head of European Radiological Competent Authority (HERCA)

The focus in HERCA has been on the principles of optimisation and justification and a review of the justification process in diagnostic radiology across all member states has been initiated. The Irish contribution to this review will include the findings from a national survey of the justification process and a national clinical audit, both of which are scheduled to commence in January 2017.

Transposition of the European Basic Safety Standard (BSS) Legislation

The new BSS Directive 2013/59/EURATOM, has been issued by the European Commission and is required to be transposed into Irish law by February 2018.The transposition process is being led by the Department of Health, with significant input from MERU. The NRSC recommends the following priorities are considered in the transposition process:

• Governance of patient radiation safety

• The principle of justification

• The principle of optimisation

• Professional competency

• Accidental exposures and incident reporting

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National Subcommittee Updates

The National Population Dose and Optimisation Committee was convened four times in 2016. Recruitment of a principal physicist has been approved by the HSE and is underway. Population dose surveys of computed tomography and mammography have been commissioned and are due to commence in early 2017. Work is ongoing to develop a national policy for managing pregnant patients in radiology and radiotherapy departments. A radiation safety workshop was held to educate dental vendors and engineers on patient safety issues, which proved to be very successful.

The National Radiotherapy Subcommittee was convened three times in 2016. An audit of incident reporting in radiotherapy was commissioned and findings suggested that there was a lack of clarity in the Patient Radiation Safety Manual regarding the categorisation of incidents. There was confusion concerning what constituted a notifiable incident to MERU and an incident that was non-notifiable to MERU but still needed to be recorded locally. The auditors noted that all of the incidents reviewed were reported promptly and managed appropriately, which was a positive finding. The committee plans to conduct an audit of head and neck intensity modulated radiation therapy in 2017.

The National Dental Subcommittee did not convene in 2016. Work on the development of the first National Radiation Protection Manual for Dentists was ongoing throughout the year.

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Legislative Framework for Radiation Protection 2016

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1. National Radiation Safety Committee Chair’s Foreword

I am pleased to present the National Radiation Safety Committee (NRSC) Annual Report which reviews our performance for 2016. This committee was established under SI 478 (2002) and its amendments SI 303 (2007) and SI 459 (2010), to advise the DG of the HSE on matters relevant to medical ionising radiation exposure.

I wish to thank members of the committee for their expertise and enthusiasm throughout the year, and to acknowledge the support and commitment of the DG’s Delegated Officer, Mr. Patrick Lynch, National Director of the Quality Assurance and Verification

Division. In particular, I wish to thank the HSE MERU team Mr. Gavin Maguire, administrators and advisors for their continuous hard work and attention to detail.

I would like to extend gratitude to Dr. Stephen Fennell for his dedication to the committee during his tenure as a member and wish him every success with his new role. I would like to take this opportunity to thank Dr. Edwina Dunne for her contribution and commitment to the NRSC and wish her the best in her retirement. I would also like to welcome the following new members to the committee:

• Ms. Tanya Kenny, Environmental Protection Agency / Office of Radiological Protection

• Mr. Sean Egan, Health Information and Quality Authority

• Dr. Mary T. O’ Mahoney, Director of Public Health, Cork

• Dr. Rachel Ennis, Consultant Radiologist, Faculty of Radiology

• Mr. Fintan Bradley, Radiotherapy Physicist, Cork University Hospital

Thank you to the staff at St. Vincent’s Private Hospital, Letterkenny General Hospital and Limerick University Hospital for hosting the NRSC meetings throughout the year. These site visits facilitated the sharing of good practice regarding patient radiation safety, allowed the NRSC to highlight ongoing national projects and gave frontline staff the opportunity to meet committee members in person and discuss any concerns or issues that had arisen during the year. Progress was made across a number of key ventures and our achievements reflect the interest and commitment of stakeholders to promote evidence based practice and patient safety.

In conclusion, the NRSC and its advisors, mindful of their duty to provide reasonable assurance that medical radiation exposure is maintained at optimum levels and that patient safety remains the number one priority, continue to urge for progress on several themes. Among them, I would mention three in particular: (a) introduction

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of a ‘unique patient identifier’ – fundamental to any patient safety endeavours; (b) full engagement of MERU advisors who have expertise in all equipment and related computer software procurement; and (c) renewed and concerted initiative to ensure all practitioners (prescribers, providers) are adequately trained and accredited. In particular, this refers to the many involved in the service but who are not integral to the dedicated radiology and radiotherapy units.

Pat Harvey, Chair

National Radiation Safety Committee

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The European Medical Exposure Directive 97/43, transposed into Irish law by SI 478 (2002), requires that patients are protected from the harmful effects of medical ionising radiation. The DG of the HSE, as the designated Competent Authority under SI 478 (2002), established the NRSC in 2007 to advise on medical ionising radiation exposure. This committee consists of no more than 10 members, appointed by the DG for a period not exceeding five years. However, in 2016, this tenure was extended in the terms of reference to ensure continuity of work and facilitate a smooth transition of regulation to the Health Information and Quality Authority (HIQA) in 2018. The NRSC is required to meet twice a year at a minimum and met four times in 2016.

Please see Appendix 1 for the NRSC membership list.

The roles of the NRSC include the following:

• Advise the DG, HSE, on the necessary arrangements to protect the health and safety of patients, the general public and staff employed in radiological facilities.

• Receive reports from clinical auditors and inspectors.

• Produce an annual report.

• Receive reports on radiation incidents as required and advise where appropriate.

• Gather lifetime data on equipment and an assurance that each piece is maintained appropriately.

• Issue guidance notes where applicable.

• Review relevant new clinical risk practices to ensure that the exposure and outcome for the patient are in line with international best practice and provide advice where applicable.

• Establish the total exposure level of ionising radiation to the population.

• Monitor radiation dose reference levels as established by Irish Medical and Dental Councils.

• Any other appropriate matters that may arise.

The Medical Exposure Radiation Unit (MERU)

MERU was established in 2007 following the recommendation from the HSE Task Force on the Implementation of SI 478 (2002). MERU regulates patient radiation protection practices in all radiological facilities and is the executive, administrative and advisory unit for the NRSC.

The regulatory roles of MERU include the following:

• Support and manage the work of the NRSC and its sub committees.

2. Introduction

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• Commission and support clinical audit in radiological facilities.

• Manage the mandatory incident reporting system.

• Develop and provide guidance to holders, practitioners, other staff and statutory bodies on relevant matters as guided by the NRSC.

• Ensure quality assurance programmes are in place in radiological facilities.

• Maintain a register of installations.

The guidance of MERU Advisers, the NRSC and subcommittees has been crucial to the achievements to date.

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3. Work of the NRSC and MERU 2016

The NRSC is supported by MERU and was convened four times in 2016.

The MERU team consists of Mr Gavin Maguire, Assistant National Director, Ms Janet Wynne, manager and Ms. Rose Lindsay, senior administrator, and includes the following advisors:

Ms. Bernadette Moran, Radiographic Advisor

Ms. Mandy Lewis, Diagnostic Physicist Advisor

Mr. Fintan Bradley, Radiotherapy Physicist Advisor

Dr. Andrew Bolas, Dental Advisor

The work of the NRSC is delivered through the subcommittees which are established by the NRSC and chaired by a member of the NRSC. Updates from each subcommittee and MERU are standing items on the agenda for NRSC meetings.

Please see Appendix 2 for subcommittee membership details.

Patient Radiation Incidents

The fundamental role of incident reporting is to enhance patient safety. Analysing reports, identifying trends and mitigating risks are essential components of any risk management framework and the need to raise alerts to prevent the occurrence of significant adverse events is critical. Incident reporting and analysis should be viewed as a tool to help practitioners know and understand the value of learning from adverse events.

All patient safety incidents are reported and managed through the local risk management department. In public hospitals, these incidents are reported nationally through the National Incident Management System (NIMS), which is governed by the State Claims Agency. Private facilities operate independently of this and have their own local reporting framework.

However, all radiology locations are also directed to report notifiable incidents and near miss events to MERU, using the MERU Patient Radiation Protection Manual as guidance. This manual supports the practical application of the safe and optimal use of medical ionising radiation and categorises incidents as notifiable1, non-notifiable2

and near miss events3. Notifiable incidents are reported to MERU upon discovery and a final investigation report is forwarded to MERU within three months. Those incidents considered non-notifiable or a near miss are reported to MERU annually.

1 A notifiable incident occurs when medical ionising radiation is administered to the wrong patient or when the delivery of radiation during a therapeutic or diagnostic procedure is different to that intended. Dose variation due to patient factors is not considered an incident.2 A non-notifiable incident occurs where an inadvertent dose below the notifiable level is administered to a patient which may indicate a failure of process but does not require notification to MERU.3 Near miss events are potential errors identified outside routine checking procedures.

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Incidents Reported to MERU in 2016

There are almost 100 public and private radiology and radiotherapy locations in Ireland licensed to administer medical ionising radiation to patients. At the time of writing this report, 60 locations had completed and returned the annual returns template to MERU for 2016. These returns consisted of 34 notifiable incidents, 311 non-notifiable and 536 near miss events.

In 2016, MERU worked closely with the State Claims Agency to incorporate the MERU incident reporting template into NIMS to ensure that the important information in relation to radiation safety was routinely captured. MERU now receives monthly reports from NIMS of all safety incidents reported by radiology and radiotherapy departments in public hospitals. These reports support the information reported to MERU by individual public hospitals. Private locations do not have access to NIMS and continue to self report patient safety incidents to MERU.

The figures below and subsequent discussion describe the incidents recorded by MERU in 2016 and indicate a reduction in notifiable incidents compared to previous years which is, perhaps, a positive reflection of a robust incident management system nationally. However, it must be noted that no notifiable incidents were reported involving interventional radiology or any medical speciality, other than radiology and radiotherapy, that routinely administers ionising radiation to patients.

All notifiable incidents identified through NIMS, or reported to MERU by the individual radiology or radiotherapy location, were assessed by MERU advisors and the annual returns were reviewed and analysed once they were received.

Figure 1: Notifiable incidents per modality reported to MERU in 2016

Notifiable incidents per modality

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Figure 2: Causes of notifiable incidents in 2016

Figure 3: Types of notifiable incidents reported in radiology.

Causes of Notifiable Incidents 2016

Radiology Notifiable Incidents 2016

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Figure 4: Types of notifiable incidents reported in radiotherapy.

Analysis of the data presented above illustrates that there has been a reduction in notifiable incidents reported to MERU in comparison to last year. In addition, analysis of the annual returns data demonstrates that the reporting of non-notifiable and near miss events have reduced. The monthly NIMS reports issued to MERU support this trend.

The most common cause of error reported involved the operator, referrer or administrator identifying the wrong patient for a diagnostic procedure. This finding is important and the NRSC recommends that all locations initiate an awareness campaign in 2017 to highlight to practitioners the importance of complying with a triple identification policy.

A relatively small number of notifiable incidents were attributed to equipment failures. However, analysis of the non notifiable and near miss incidents reported through NIMS and the annual returns indicate that equipment failure is an issue. MERU has contacted the HPRA to address concerns and to seek a memorandum of understanding regarding the sharing of information in 2017. In addition, a training workshop to be organised by the NRSC, with the support of HPRA, to learn from incidents involving equipment failures is proposed for 2017. The Patient Radiation Protection Manual is currently under review and a reference to equipment failures and the work of the HPRA will be included.

There were no notifiable incidents reported to MERU which involved interventional radiology or non-radiology / radiotherapy medical specialities that routinely administer ionising radiation to patients. Some non-notifiable incidents and near miss events were identified in the annual returns and NIMS reports. It is worth noting that there were no notifiable incidents reported by non radiology/radiotherapy specialities in 2015 and 2014 also. Considering that these are emerging medical fields where

Radiotherapy Notifiable Incidents 2016

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radiology intervention has increased and new practices are being introduced, the NRSC recommends a focus on these areas of practice going forward into 2017.

There were five notifiable incidents reported in radiotherapy in 2016, three of which concerned administering a dose of radiation to a patient who later reported that they were pregnant. The HSE national audit of pregnancy management in radiology, conducted in 2015, identified inconsistencies in how pregnant patients are managed and made a recommendation to standardise practice. A working group of relevant stakeholders was established and throughout 2016, progress has been made on developing a national policy to meet this recommendation. It is anticipated that the national policy will be ratified and published in 2017. The NRSC will endorse this policy and support the subsequent education campaign.

The findings from this analysis indicate that perhaps a robust incident reporting culture has become embedded in the majority of radiology and radiotherapy locations and that practitioners are raising alerts before serious events occur. Thus, when systems fail and the inevitable safety incident occurs, the outcome for the patient is often less serious and not notifiable to MERU. However, the HSE healthcare audits of incident reporting in radiology and in radiotherapy, in 2015 and 2016 respectively, identified a lack of understanding as to what constituted an incident notifiable to MERU. Considering this, a review of the Patient Radiation Protection Manual is now underway and expected to be completed in 2017, which the NRSC anticipates will provide clarification.

A good understanding by all practitioners of the benefits of using a tool like incident reporting to mitigate risks and help identify trends is essential to ensure a robust risk management system. Radiation safety is the responsibility of all practitioners and must be considered our first priority when treating the patient.

MERU wishes to acknowledge the positive and proactive approach to reporting incidents demonstrated by the majority of radiology and radiotherapy locations. Incident data is a quality measure and appropriate risk management requires an open culture where practitioners are encouraged to report, investigate, disseminate and implement learning form adverse events promptly. This environment appears to be evident from the data analysed, however, there is always potential for improvement.

Achievements

Congratulations to the MERU team who wrote an academic paper about incident reporting in radiology departments, entitled ‘Improving Patient Radiation Safety in Ireland’, which was accepted for publication by a peer review journal in September.

The MERU team were also proud to highlight the important work carried out on

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radiation safety incident reporting and trending at the 2016 National Patient Safety Conference held in December, with a poster entitled ‘Radiation safety incidents reported to the HSE MERU in 2015’.

Head of European Radiological Competent Authority (HERCA)

The MERU radiographic advisor, Ms. Bernadette Moran, is a member of the HERCA Working Group on Medical Radiation Exposures and attended workshops in Madrid, Spain and Bern, Switzerland, in 2016. These workshops focussed on the principles of justification and optimisation, with the view to harmonising good practice across all member states and identifying areas for improvement.

A review of the justification process in diagnostic radiology across all member states was initiated and it is anticipated that recommendations on the practical aspects of assessment of justification and optimisation within diagnostic radiology will be published on the HERCA website in 2017.

The Irish contribution to this review will include the findings from a national audit of the justification process across six locations scheduled to commence in January 2017 and a national survey of the process across all radiology locations over the same period.

Unique Patient Identifier

The NRSC continues to support the introduction of a unique patient identifier which will help monitor population dose exposure, reduce unnecessary repeat imaging procedures and improve patient radiation protection nationally. This committee is aware of the inherent challenges involved, nevertheless would urge for its early implementation across the service.

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4. Transposition of the European Basic Safety Standard Legislation

The current regulatory framework for medical exposure to radiation is covered by SI 478 (2002) which is based on EU Directive 97/43/EURATOM, with associated amendments SI 459 (2010) and SI 303 (2007). A new directive called the Basic Safety Standards Directive 2013/59/EURATOM, has been issued by the European Commission which is required to be transposed into Irish law by February 2018.The transposition process is being led by the Department of Health, with support from the HSE MERU.

Pictured above are the team from the Environmental Health Office in the Department of Health and the HSE MERU team: Ms. Mandy Lewis, MERU; Ms. Janet Wynne, MERU; Mr. Gary Connolly, DOH; Ms. Siobhan McEvoy, DOH; Ms. Audrey Hagerty, DOH; Mr. Gavin Maguire, MERU; and Ms. Bernadette Moran, MERU.

The NRSC has reviewed the BSS 2013/59/EURATOM and recommends the following issues are considered when transposing the European legislation into Irish legislation:

1. Governance of patient radiation safety

Currently, the DG of the HSE is the designated Competent Authority for regulating medical ionising radiation under SI 478 (2002) and MERU is delegated with patient radiation safety regulation.

Agreements are in place between the Department of Health, the HSE and HIQA to transfer the competent authority and regulatory function to HIQA in February 2018, to ensure an independent regulator for patient radiation protection. Work is ongoing in relation to the legislative changes required to facilitate this transition.

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2. The principle of justification

Justification is a fundamental principle of patient radiation protection and the process requires that the benefit of each medical imaging procedure outweighs the possible risk caused by radiation exposure. The referrer (medical specialist / dentist / nurse referrer) making the referral, the practitioner in charge (radiologist) accepting the referral and the professional (usually a radiographer) undertaking the procedure have a role in the justification process.

Knowing what roles and responsibilities are assigned to each practitioner is essential to enable robust governance, ensure clear lines of accountability and promote patient safety. Justification has been defined in SI 478 (2002) as a statement; however, a justification process is required.

Currently, there is no formal governance structure to review generic justification, no process to assess new practices involving medical ionising radiation and no specific requirements for justifying procedures for asymptomatic individuals.

3. The principle of optimisation

Optimisation is a complex process whereby all medical radiation exposures are kept as low as reasonably achievable to obtain the required diagnostic outcome for the patient.

Typically, there is no written delegation of responsibility from the practitioner in charge to other healthcare professionals engaged in the process. There is no mandatory requirement to maintain records of medical exposures and specific patient protocols are required to be developed.

4. Professional competency

It is essential that all staff working with medical ionising radiation are appropriately trained and competent in radiation protection. This includes staff making a referral, those responsible for maintaining radiological equipment, those who administer the radiation dose and those who assess the outcome to the patient.

Currently, radiation protection training for medical and dental practitioners is mandatory but it does not require oversight from professional bodies or governance from employers. There is no requirement for continuous professional development for medical specialists in relation to radiation safety. There is no recognised radiation safety training programme in existence for non-radiographers operating equipment. Chiropractors and sports scientists administer ionising radiation without being recognised under SI 478 (2002). In addition, registration of medical physics experts with a professional body is not mandatory.

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5. Accidental exposures and incident reporting

An open, transparent and robust incident management process is essential to minimise risks to patients. The role of incident reporting is to enhance patient safety by identifying trends in adverse and near miss events, and to facilitate the sharing of learning when issues arise.

Currently, radiation safety incident reporting to MERU is self regulated and MERU has no inspection or enforcement powers. The Patient Radiation Protection Manual offers guidance but implementing this is not mandatory. In the new BSS directive, there is a requirement to report, analyse and record unintended radiation exposures in radiology, nuclear medicine and radiotherapy.

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5. Work of the NRSC Subcommittees

National Population Dose and Optimisation Subcommittee

This committee has responsibility for assessing radiation dose to the population, advising on optimisation and establishing diagnostic reference levels for common radiological procedures. It reports to and assists the NRSC as requested on assessing clinical practices to ensure that the exposure and outcome for the patient are in line with international best practice. The committee consists of a maximum of 14 members, appointed by the NRSC, for a period

not exceeding three years. However, this tenure has been extended in the terms of reference to maintain continuity of work in the transfer of regulation to HIQA. The committee was convened four times in 2016.

Recruitment of a Principal Physicist

The HSE approved the recruitment of a principal physicist to work as a technical resource between the Quality Assurance and Verification Division and the Acute Hospitals Division. The purpose of this post was to analyse dose data collection systems to allow accurate dosimetry, highlight trends and identify outliers. Outliers are noted when the dose delivered to a patient during a procedure is above or below the recommended diagnostic reference level. These anomalies can result in poor diagnostic quality if the dose is too low or adverse health outcomes for the patient if the dose is too high. All dose tracking systems should be operational before 2018 and the enrolment of the principal physicist is in progress.

Education and Training

In October, a one day training workshop for dental engineers was organised by this committee in association with the Dental Council, the Irish Association of Physicists in Medicine and the HPRA. The course, entitled ‘Radiation Safety Course for Dental Radiology Equipment Vendors and Engineers’, brought the relevant professionals together to discuss the common radiation safety issues faced by all working in this field. It was well received by all who participated and highlighted the need for radiation safety training to promote the best outcomes for patients. Considering this, the committee proposes to provide further radiation safety training workshops in 2017.

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Population Dose

Under SI 478 (2002), the committee is obliged to publish annual reports on population dose and a national survey of computed tomography (CT) imaging activity will be undertaken in 2017 to determine the level of exposure to patients from CT and to update existing national diagnostic reference levels. In addition, a national survey of all mammography imaging centres will be undertaken by the National Cancer Screening Service on behalf of the committee in 2017.

The committee and its members also contributed to European (DIMOND, PIDRL) and academic-projects on dose reference levels and encouraged the implementation of the European Society of Radiology Eurosafe Imaging Stars Programme which was achieved by a number of Irish Hospitals.

National Pregnancy Policy

The HSE healthcare auditors published the report entitled ‘Audit of patient pregnancy protocols and diagnostic reference levels as outlined in the MERU Patient Radiation Protection Manual’ in 2015, with a recommendation that patient pregnancy protocols are standardised nationally. Subsequently, a national working group of relevant professionals was established and work began to develop a national policy for managing the pregnant or potentially pregnant patient in radiology. This work was ongoing throughout 2016 and the policy is expected to be ratified in 2017.

Strategic Objectives for 2017

The key strategic objectives of the committee in 2017 are:

1. Progress the recruitment of a principal physicist.

2. Oversee a survey of dose reference levels in CT scanning.

3. Oversee a survey of dose reference levels in mammography.

4. Input to the new Irish legislation based on the transposition of the European BSS Directive EU 2013/59.

5. Preparation of an online tutorial to educate practitioners establishing and utilising dose reference levels.

6. Extension of the dental engineers training course to other areas of therapeutic and diagnostic radiology as part of the NRSC work plan.

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National Radiotherapy Subcommittee

The role of this committee is to assess relevant new clinical practices in radiotherapy to ensure that the exposure and outcome for the patient is in line with international best practice. The committee consists of a maximum of 10 members, appointed by the NRSC for a period not exceeding three years. However, this tenure was extended in the terms of reference to maintain continuity of work in the transfer of regulation to HIQA.

The committee was convened three times in 2016 and committee members were pleased to welcome new member, Dr. Aileen Flavin, Consultant Radiation Oncologist, from Cork University Hospital.

The audit of dosimetry calibration of prostate intensity modulated radiation therapy (IMRT) systems published in 2016 demonstrated Irish compliance with international standards. The enthusiastic response from all 12 radiotherapy locations to this audit has been positive and encouraging for the committee. The committee plans to conduct a similar audit of head and neck IMRT in 2017.

Incident Reporting

Incident reporting in radiotherapy is still considered low, although Ireland is ahead internationally with the classification of incidents as minor, major and critical. The Patient Radiation Protection Manual is currently under review and this classification of radiotherapy incidents will continue in the updated version. The committee advises that all major and critical incidents are reported to MERU within 24 hours and minor or near miss incidents are reported annually. If there is any doubt regarding incident categorisation, the location should submit the details to MERU for clarification.

In 2016, the HSE healthcare audit team conducted an audit of incident reporting in radiotherapy entitled ‘Audit of incident reporting and learning in radiotherapy as outlined in section three of the MERU’s Patient Radiation Protection Manual’. Four locations were examined and findings suggested that local interpretation of the manual had led to some confusion as to what constituted an incident notifiable to MERU. The audit team was of the opinion that this may have contributed to the lower number of incidents/near misses reported in previous years. This issue is expected to be resolved pending the update of the Patient Radiation Protection Manual. In the majority of locations audited, all radiotherapy incidents reviewed were appropriately reported, investigated and acted upon.

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National Dental Subcommittee

The National Dental Subcommittee reports to and assists the NRSC, as requested, on assessing relevant clinical practices to ensure that the exposure and outcome for the patient is in line with international best practice. The committee advises the NRSC on relevant issues, such as radiation dose reference levels, incident reports, guidance documentation and clinical audit. The committee should consist of a maximum of 12 members, appointed by the NRSC for a period

not exceeding three years. However, the term of the Dental Council came to an end in 2015 and a number of dentists who would normally sit on the committee are now unavailable. Applications have been sought to fill vacancies on the committee and it is hoped that the committee will schedule a meeting in 2017.

This committee supported colleagues on the National Population Dose and Optimisation Committee with the organisation and delivery of the radiation safety training workshop for dental engineers, held in October 2016. As mentioned previously, this course was well received by all participants and it is proposed that further radiation safety training workshops will be provided in 2017.

Work on the development of the first National Radiation Safety Manual for Dentists has been ongoing throughout 2016 and this guidance document is expected to be published in 2017.

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6. NRSC Work Themes for 2017

1. Support the work of the Subcommittees:

National Radiotherapy Subcommittee

The National Population Dose and Optimisation Subcommittee

The National Dental Subcommittee

2. Undertake site visits for NRSC meetings.

3. Manage, review and report on the incident reporting process.

Continue to record, review and analyse radiology incidents reported to MERU through the National Incident Management System and by individual locations.

Review and update the Patient Radiation Protection Manual.

Develop and publish a Radiation Protection Manual for Dentists.

Agree a memorandum of understanding with the Health Products Regulatory Authority in relation to incidents involving equipment failure and present a training workshop.

4. Support the Department of Health with transposing the European Basic Safety Standard legislation into Irish law and pursue the programme for transfer of responsibilities to the Health Information and Quality Authority.

5. Review the justification process in diagnostic radiology by conducting a national survey and by commissioning a national clinical audit, to inform the HERCA European review of the justification process.

6. Support the development of the National Guidance Document on Patient Pregnancy Protocols in Radiology and Radiotherapy.

7. Monitor and analyse population dose data

Support the HSE in the recruitment of a principal physicist

Commission a CT Population Dose Survey

Commission a Mammography Dose Survey

8. Promote patient radiation safety, including a campaign to highlight the importance of implementing a triple identification policy.

9. Support the implementation of the Unique Patient Identifier legislation.

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7. Appendices

Appendix 1

Membership of the National Radiation Safety Committee

Mr. Pat Harvey, Chair, Harwyn Management Consultants. Former Chief Executive Officer, North Western Health Board.

Mr. Paddy Gilligan, Principal Medical Physicist, Mater Private Hospital. Chair, National Population Dose and Optimisation Subcommittee.

Dr. David Fitzpatrick, Consultant Radiation Oncologist, St. Luke’s Hospital, Dublin and St Luke’s Radiation Oncology Centre, Beaumont Hospital. Member of the Faculty of Radiologists, Royal College of Surgeons in Ireland. Chair, National Radiotherapy Subcommittee.

Dr. Andrew Bolas, Deputy Principal Dental Surgeon in Sligo/Leitrim. Lecturer in Dublin Dental School. Chair of the National Dental Subcommittee.

Mr. Fintan Bradley, Chief Physicist, Medical Physics Department, Cork University Hospital.

Dr. Stephen Fennell, Manger, Radiation Protection Regulation, Office of Radiological Protection, Environmental Protection Agency.

Ms.Tanya Kenny, Senior Scientific Officer, Medical Physicist, Radiation Protection Regulation, Office of Radiological Protection/Environmental Protection Agency.

Mr. Brian Keane, Chief Executive Officer, St. Vincent’s Private Hospital. Council Member of the Independent Hospitals Association of Ireland.

Mr. Sean Egan, Acting Head of Healthcare Regulation, Health Information and Quality Authority.

Ms Louise Diamond, Radiography Services Manager, University Hospital, Waterford

Dr. Mary T. O’Mahony, Director of Public Health, Cork.

Dr. Rachel Ennis, Consultant Radiologist, Faculty of Radiology.

Medical Exposure Radiation Unit Team

Mr. Gavin Maguire, Assistant National Director

Ms. Janet Wynne, Manager, MERU

Ms Rose Lindsay, Senior Administrator, MERU

Ms. Mandy Lewis, Principal Physicist, Radiation Protection Advisor, Mater Misericordiae University Hospital. Physics advisor to MERU.

Ms. Bernadette Moran, Radiographic Advisor to MERU.

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Appendix 2

National Dental Subcommittee

Dr. Andrew Bolas, Chair; Deputy Principal Dental Surgeon Sligo/Leitrim; Lecturer in Dublin Dental School

Mr. Eamon Croke, Dentist, Molesworth House, Dublin 2

Mr. Terry Farrelly, Dentist, Roscrea, Co Tipperary

Dr. Niamh Galvin, Assistant National Oral health Lead, Tralee General Hospital, Kerry

Mr. Paddy Gilligan, Chief Medical Physicist, Mater Private Hospital, Chair of the National Population Dose and Optimisation Subcommittee

Dr. Maurice Quirke, Dental Surgeon, Member of the Irish Dental Association

Ms.Tanya Kenny, Senior Scientific Officer, Medical Physicist, Project Manager, Radiation Protection Regulation, Office of Radiological Protection/Environmental Protection Agency

National Radiotherapy Subcommittee

Dr. David Fitzpatrick, Chair, Consultant Radiation Oncologist, St. Luke’s Hospital, Dublin and St Luke’s Radiation Oncology Centre, Beaumont Hospital. Member of the Faculty of Radiologists of the Royal College of Surgeons in Ireland

Mr. Fintan Bradley, Chief Physicist Medical Physics Department Cork University Hospital

Ms. Tanya Kenny, Senior Scientific Officer, Medical Physicist, Project Manager, Radiation Protection Regulation Office of Radiological Protection Environmental Protection Agency

Ms. Catriona McDonald, Manager of Operations, Chief Radiotherapist, UPMC Whitfield Cancer Centre, Waterford

Ms. Catherine McKenna, Radiation Therapy Services Manager (RSM), St. Luke’s Hospital Dublin, Member of the Radiographers Registration Board, RSM chair on the Council of the Irish Institute of Radiographers and Radiation Therapists

Ms. Bernadette Moran, Radiographic Advisor to MERU

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National Population Dose and Optimisation Subcommittee

Mr. Paddy Gilligan, Chair, Chief Medical Physicist, Mater Private Hospital, Member of the National Dental Subcommittee

Ms. Noeleen Cunningham, Radiation Protection Regulation, Radiological Protection Institute, Ireland

Ms. Liz Darcy, Clinical Specialist Radiographer, Wexford General Hospital, Wexford

Dr. Shane Foley, Radiography Programme Coordinator, University College Dublin

Dr. Neill O’Donovan, Consultant Radiologist, South Infirmary, Victoria University Hospital, Cork

Ms. Mandy Lewis, Principal Physicist, Radiation Protection Advisor, Mater Misericordiae University Hospital, Physics advisor to MERU

Mr. Brendan McCoubrey, RSO Clinical specialist, St. James’s Hospital, Dublin

Dr. Peter Wright, Specialist in Public Health Medicine

Prof. Michael Maher, Consultant Radiologist, Cork University Hospital, Cork

Ms. Bernadette Moran, Radiographic Advisor to MERU

Dr. Lesley Malone, Radiation Protection Advisor, Faculty of Radiologists, Trinity College Dublin