National Radiation Safety Committee Annual Report 2014

National Radiation Safety Committee Annual Report 2014 Easy Access Public Confidence Staff Pride

1. Forward from the Chairperson I am pleased to present the National Radiation Safety Committee (NRSC) Annual report for 2014. This committee was established in 2007 by the Director General (DG) of the Health Service Executive (HSE), under Statutory Instrument (SI) 478 (2002) to advise on the protection of patients in relation to medical exposure to ionising radiation in both public and private radiological facilities. I would like to thank committee members for their commitment and expertise which has allowed the NRSC to deal with a considerable workload during the year. I wish also to acknowledge the crucial and positive support we received from Dr. Philip Crowley, National Director, Quality and Patient Safety Division (QPSD), HSE, who is the DG s delegated officer and Ms. Edwina Dunne, Director of Healthcare Audit, QPSD. The work of the NRSC is predominantly reliant on the Medical Exposure Radiation Unit (MERU). I would like to convey my particular thanks to the executive, administrative and specialist advisers for their invaluable input. A special word of thanks to the four centres listed below for facilitating the NRSC by hosting the meetings throughout the year: Galway University Hospital St James s Hospital Beacon Hospital Hermitage Medical Centre Visiting these sites allowed the NRSC to meet frontline staff, listen to their concerns first hand and hear about the innovative practice taking place nationwide. It also gave frontline staff an opportunity to meet the committee members and learn what role the NRSC has in protecting patients. This practice of holding meetings on-site was considered worthwhile by all concerned and will be continued in 2015. The accompanying report outlines the activity and progress across a number of key themes. The regular analysis of patient radiation safety incidents is ongoing and the national clinical audit report has been compiled. The Unique Patient Identifier (UPI) was introduced into legislation in July 2014. This is a welcome initiative as UPI will help monitor and reduce unnecessary repeat procedures and assist in the measurement of individual cumulative doses to patients. Early and complete roll out of this crucial monitoring feature is urged. In 2013, the Department of Health agreed to the development of proposals on the transition of the function of Competent Authority to the Health Information and Quality Authority (HIQA). Legislation will be required to fulfil this transfer. The NRSC considers this an ongoing priority and will support the preparatory work and transition of the function to HIQA. I am aware of the difficulties with resourcing this development but it is important that a resolution is found and the transition to HIQA is not unduly delayed. In September 2014, MERU submitted a proposal to audit Section Four - Patient Pregnancy Protocols and Section Seven - Diagnostic Reference Levels of the Patient Radiation Protection Manual. This proposal was accepted by the Director of Healthcare Audit, QPSA, in November 2014 and is scheduled to commence in January 2015. 1

Welcome new members in 2014: A warm welcome was extended to the following new members of the NRSC and sub committees. Dr. Peter Wright, Public Health Specialist Mr. Brian Keane, Chief Executive Officer, St Vincent s Private Hospital Dr. Declan Sheppard, Consultant Radiologist Sub Committees: Ms. Mandy Lewis, Principal Physicist, Mater Misericordiae University Hospital Dental Sub Committee Mr. Fintan Bradley, Chief Physicist, Cork University Hospital; Radiotherapy Sub Committee Prof. Brendan McClean, Chief Physicist, St Luke s Oncology; Radiotherapy Sub Committee Dr. Fred Vernimmen, Consultant Radiation Oncologist, Cork University Hospital; Radiotherapy Sub Committee Dr. Peter Wright, Public Health Specialist; Population Dose and Optimisation Sub Committee Retirement of members in 2014: The committee and sub committees wish to express gratitude to the following members who retired during 2014. We would also like to thank them for their expert guidance and support during their time on the committee. Ms. Annette Jolly Dr. Tim Scanlon Mr. Peter Finnegan Ms. Patricia Cunningham Dr. Maurice Fitzgerald Dr. Goran Bjelkengren Mr. Martin Sheridan With the absence of a MERU Manager and limited administration support, both the NRSC and sub-committee activities were exceptionally compromised. We are hopeful for a resolution in the near future. In conclusion, the NRSC and its advisors are very mindful of their responsibilities and the reliance that the system has on them to provide effective reassurance that medical radiation exposure is at optimum level. The committee will continue to make every effort to optimise their impact with full commitment and diligence. Pat Harvey, Chair, National Radiation Safety Committee 2

2. Introduction The European Medical Exposure Directive 97/43 transposed into Irish law by the Statutory Instrument (SI) 478(2002) requires that appropriate mechanisms are in place to protect patients from the harmful effects of ionising radiation. To meet this statutory requirement, the DG of the HSE established the NRSC in 2007 to advise on matters pertaining to ionising radiation exposure. This committee consists of no more than 10 members, appointed by the DG for a period not exceeding five years. The NRSC is required to meet twice a year at a minimum and met four times in 2014. Please see Appendix 1 for the NRSC membership list. The roles of the NRSC include: Advise the DG, HSE, on measures or arrangements that are necessary to protect the health and safety of patients, the general public and persons employed in radiological facilities. Receive reports from the clinical auditors and inspectors. Produce 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 is 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 The Medical Exposure Radiation Unit (MERU) was established following the recommendation from the HSE Task Force on the Implementation of SI 478. MERU regulates patient radiation protection practices in radiological facilities, both private and public, and is the executive, administrative and advisory unit for the NRSC. The regulatory roles of MERU include: Conducting and overseeing clinical audit in facilities using medical ionising radiation. Managing the mandatory incident reporting system. Developing and providing guidance on direction to holders, practitioners, other staff and statutory bodies on relevant matters as guided by the NRSC. Ensuring quality assurance programmes are in place in radiological facilities. Maintaining a register of installations. Supporting and managing the work of the NRSC and its sub committees. The unit is appreciative of the significant input of statutory and professional bodies such as the Department of Health, the Health Information and Quality Authority, the Medical Council, the NRSC End of Year Report 2014 3

Dental Council, the Faculty of Radiologists and the Environmental Protection Agency/ Office of Radiological Protection to advance the common agenda. The guidance of the advisors to MERU, the NRSC and its subcommittees has been key to the success of achievements to date. 3. Work of the NRSC and MERU in 2014 The NRSC is supported by MERU and its advisors. The NRSC convened four times in 2014 and the sub committees met nine times in this same period. HIQA representation was unavailable to attend the NRSC meetings. The advisors to the MERU in 2014 were as follows: Ms. Bernadette Moran, Radiographic Advisor Ms. Mandy Lewis, Physicist Advisor Dr. Peter Wright, Public Health Specialist Advisor Dr. Andrew Bolas, Dental Advisor Dr. Fintan Bradley, Chief Physicist in Radiotherapy 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. An update from each subcommittee and MERU is a standing item on the agenda for the NRSC meetings. Please see Appendix 2 for subcommittee membership details. Patient Radiation Incidents There are over 100 public and private radiological facilities licensed to deliver medical ionising radiation in Ireland. The MERU Radiation Protection (RP) Manual was published in 2013 to support the practical application of the safe and optimal use of medical ionising radiation. Section three of the RP Manual defines and categorizes incidents and directs all facilities using medical ionising radiation to report to MERU notifiable incidents upon discovery and to forward a final investigation report within three months. Those incidents considered nonnotifiable or a near miss must be reported to MERU annually. Incidents Reported to MERU in 2014 In total, 555 incidents were reported in the annual returns from 47 radiation facilities. These incidents consisted of 310 near miss events, 210 non-notifiable and 35 notifiable incidents. 19 sites reported that no incidents or near miss events occurred and the remaining facilities made no returns. The tables below outline details of the incidents reported in 2014. NRSC End of Year Report 2014 4

Figure 1: Notifiable incidents reported from each speciality in 2014 Figure 2: Causes of Notifiable Incidents reported in 2014 NRSC End of Year Report 2014 5

Figure 3: Types of notifiable incidents reported in Radiotherapy Figure 4: Types of notifiable incidents reported in Radiology All notifiable incidents were assessed by MERU advisors when reported and the annual returns were reviewed and analysed once they were received. The fundamental role of incident reporting is to improve practice and enhance patient safety. Data analysis for 2014 suggests that radiological facilities recognise the importance of shared learning and the role it plays in enhancing patient safety. However, it is noted 19 radiological facilities reported that no incidents or near miss events occurred in the year and many facilities made no returns whatsoever. MERU and the NRSC consider this a risk to patient safety and NRSC End of Year Report 2014 6

locations not reporting incidents or near miss events will be the focus of external auditing in 2015. Practice can only be improved if there is shared learning from adverse events and near misses which informs quality improvement initiatives. Radiological facilities must view incident data as a quality measure and encourage an open culture where staff understands their responsibility and report incidents appropriately. This culture 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 promptly. MERU wish to acknowledge the co-operation, goodwill and proactive approach to reporting incidents and near miss events taken by the management and staff at the majority of radiological facilities. However, it is clear that there is considerable work still to be done. National Clinical Audit In 2007, the HSE commissioned the UK Quality Assurance Reference Centre (QUARC) to undertake a national audit to establish the level of compliance with SI 478 in radiology and radiotherapy, covering arrangements for clinical audit, justification and optimisation of ionising radiation equipment. QUARC produced three separate surveys, dealing with radiology and nuclear medicine, radiotherapy and dentistry. In 2012, the HSE undertook a national follow-up audit by means of a self assessment questionnaire to assess compliance with the legislation. This audit was coordinated by a clinical audit sub-committee of the NRSC and included members of MERU. In September 2014, MERU submitted a proposal to audit Section Four - Patient Pregnancy Protocols and Section Seven - Diagnostic Reference Levels of the Patient Radiation Protection Manual. This proposal was accepted by Ms. Edwina Dunne in November 2014 and is scheduled to commence January 2015. Unique Patient Identifier The Committee consider that the introduction of a unique patient identifier (UPI) will be significant in monitoring patient radiation protection nationwide and would urge for its early implementation across the service. The Committee is aware of the inherent challenges involved and of the programme of work commissioned by the DG of the HSE. 4. Work of the NRSC Subcommittees Population Dose and Optimisation Subcommittee This committee is responsible for assessing radiation dose to the population which is a requirement under SI 478. In 2014, the committee reached the end of one data collection and analysis cycle of medical radiation doses (excluding the radiotherapy doses). The data collected was used in the 2014 publication from the Environmental Protection Agency (EPA) entitled Radiation Doses received by the Irish Population. The committee met four times in 2014. NRSC End of Year Report 2014 7

In 2014, this committee was re-titled the Population Dose and Optimisation Committee. Adding the word optimisation to the title recognised the value of dosage data in optimising the risk benefit ratio from medical exams involving ionising radiation. Data collection established benchmarks of typical radiation doses known as dose reference levels (DRLs). DRLs allow the comparison of performance against typical levels in order to reduce the range of doses and remove unnecessary outliers. DRLs in Ireland are similar to international standards. DRLs for the most common and the highest dose diagnostics were published as an update to the Patient Radiation Protection Manual in December 2014. In 2014, the positron emission tomography-computed tomography (PET-CT) and dual X-ray absorptiometry (DXA) scans were added to the list of more common cycles of DRL data collection. Whilst the work has been significant and produced dividends in terms of radiation safety, considerable time and resources were needed to compile data manually which in the end, had limited statistical power. Indeed the European Union recognises that such tasks may costs member states in the order of 250,000 per annum. Manual data collection results in a staggered approach and long intervals in collection cycles. For example, Computed Tomography (CT) doses which account for 40% of population dose were audited in 2009 but since then, new technology, such as iterative reduction which uses powerful software rather than extra radiation to reduce unwanted noise in CT scans, has been introduced in many radiological facilities. Technology and technique have advanced considerably since the initial survey conducted in 2009. Recognising that data collection cycles must be shorter and that new technology exists which allows for dose tracking, the committee issued guidance recommending that all centres with interventional radiology and cardiology systems, and CT scanners, acquire dose index tracking software by 2017. This dovetail into the legally mandated February 2018 implementation time for the European Basic Safety Standards Directive 59/13 which requires that dose information be available to the practitioner for every procedure involving radiation. In this respect, the committee recognises the good foresight of the HSE National Integrated Medical Imaging System (NIMIS) to include the Radimetrics/ Bayer dose tracking system as part of their procurement. This means that dose data will be available from all NIMIS enabled hospitals. Pilot studies on the software have allowed identification of outliers and processes to reduce high and low doses have already been initiated. In addition, some major hospitals have put in place software that allows dose tracking and establishment of dose reference levels where the Radimetrics/Bayer system is not in-situ. Other hospitals have instituted more basic vendor and RIS base solutions. These have led to better data collection and analysis, high profile publications and contributions to major international conferences. They also have identified patients who have the potential to develop erythema or other deterministic effects, thereby improving patient care as radiation induced effects can be over looked or mistaken for other pathologies which may result in inappropriate care. The pilot studies of dose tracking systems showed the need for greater standardisation of protocols. The committee recognises the importance of data in population and individual health protection and the technological challenges to implement such software and validate the data collected. To that end, they have proposed the establishment of a principal physics post to implement and administer dose tracking software on behalf of the HSE and to advise and work with other institutions to develop and implement similar systems. This would assist in assessing population doses, improving quality of procedures, developing systems to identify NRSC End of Year Report 2014 8

patients who are at risk of other deterministic effects, post exposure analysis and risk assessment for foetal exposures. All of these would help towards the legally mandated goals of the HSE in assessing and optimising population dose for service users. During 2014, the Heads of the European Regulatory Competent Authorities (HERCA) requested data on Irish population dose for inclusion in a Europe wide publication on population dose and DRLs. In addition, a survey on Paediatric Dose Data was requested by the European Society of Radiology (PiDRL) and available data was submitted to contribute to a Europe wide publication on DRLs in paediatric radiology. The committee recognises that the nomenclature and concepts used in establishing DRLs can be ambiguous and lead to confusion. To address this, in two workshops were held in 2014 one in Tallaght Hospital, organised by Ms. Bernadette Moran of MERU and a second, Radiation Safety Officer (RSO) day in the Bon Secours Hospital, organised by Dr. Lesley Malone. Going forward, more in-house and online training will be made available. The valuable contribution made by the Schools of Radiography and the Faculty of Radiology is noted with gratitude. National Radiotherapy Subcommittee A Radiotherapy Incident Management Workshop held in March 2014 was considered a success by all involved. A letter was issued by the committee in July recommending the adoption of online imaging by all radiotherapy centres and that all local policies are amended accordingly. A dosimetry audit was started in 2014 to determine if Irish radiotherapy centres conform to international standards. The committee decided that an effective method to obtain a standardised measurement of radiation dose delivered was to use Intensity Modulated Radiation Therapy (IMRT) of the prostate. The objective of this audit was to confirm if IMRT systems of the prostate were within agreed levels. The chief physicist in each location had responsibility for implementing the practical aspects of the audit. MERU contacted the MD Anderson Cancer Centre, Houston, Texas, which is an internationally renowned treatment centre, to arrange for their collaboration and the phantom, a model used to replicate how radiation is delivered to the prostate, was supplied by them to every radiological facility. The approximate cost of each phantom was 1500euro which was borne by each radiological facility. The phantoms were tested by all facilities and returned to MD Anderson Cancer Centre for analysis. The prostate IMRT phantom tested basic dosimetry of a single photon beam and also the hospital systems and approach to a more complex modern treatment. Results were returned directly to each site and they are required to submit the findings to MERU by January 2015. Once these findings have been collated by MERU and analysed by the committee, a report will be published with recommendations. Ongoing audit in radiotherapy is required to maintain and improve consistency in the delivery of radiotherapy treatment to patients. National Dental Subcommittee Under SI 478, dentists are required to appoint a Medical Physics Expert (MPE) to have responsibility for ionising radiation equipment. The MPE and the Radiation Protection Advisor (RPA) may, in most cases, be the same individual. The MPE acts or gives advice on dosimetry, the development and use of complex techniques and equipment, optimisation, quality assurance, including quality control, and other matters concerning radiation protection and exposure. The RPA does not have responsibility for the patient safety aspect in the use of ionising radiation. NRSC End of Year Report 2014 9

In 2009, a HSE subgroup established to identify the role of the MPE produced an acceptable checklist for MPE tasks in line with SI 478. In September 2012, MERU surveyed all RPA s working in dentistry to identify what MPE service they were providing and to determine if they were willing to carry out the full MPE service, if not already doing so. Results showed that all RPA s were willing to provide the full MPE service to dentists. In August 2013, MERU issued a letter to all dentists regarding the provision of the MPE service. Dentists were asked to contact their RPA to make the necessary arrangements to ensure that the full MPE service would be provided in their facility. Feedback from dentists was positive and as most dental x-ray licences are due for renewal in 2016, appointment of the RPA can be verified at that time. 5. Transition of MERU to HIQA The DG of the HSE is the designated Competent Authority for regulating medical ionising radiation under SI 478 and MERU was established by the HSE to regulate patient protection practices in public and private radiological facilities. Considering that the HSE is the main provider of radiological services and MERU is the regulator, the HSE is therefore regulating itself when it comes to medical ionising radiation exposure. Also, the legislation does not allow MERU to inspect radiological facilities. To address this conflict of interest and lack of inspection, it was agreed between the DOH, HSE and HIQA that the regulatory function move to HIQA which is the independent health regulator. In 2013, a review group was commissioned by the Chief Medical Officer of the Department of Health (DOH) and chaired by the Deputy Chief Medical Officer, DOH. The aim was to develop a proposal on the transition of the function of Competent Authority and the inspection function to HIQA. This proposal will address the issues of transfer, the establishment of an inspection function, timeframes involved and the resources needed. Legislative changes to the Health Act (2007) are required in order to undertake this transfer of responsibilities. NRSC End of Year Report 2014 10

6. Work themes for the NRSC in 2015 1. Manage, review and redefine the incident reporting process 2. Visits to Holders; in order to ensure engagement with and share an understanding of expected responsibilities 3. Pursue the programme for transfer of responsibilities to HIQA (SI478) 4. Support the Subcommittees o National Radiotherapy sub committee o The Population Dose and Optimisation sub committee o The Dental sub committee 5. Dosimetry Audit in Radiotherapy 6. Audit of pregnancy protocols in radiology 7. Audit of incident reporting in radiology 8. Review and update the Radiation Protection Manual 9. Monitor and analyse population dose data 10. Set Guidelines for Patient Radiation Safety 11. Prepare for and participate in the International Atomic Energy Agency / Integrated Regulatory Review Service Mission 12. Continue with the programme for E-learning Radiation Safety Training NRSC End of Year Report 2014 11

7. Appendices Membership of the National Radiation Safety Committee Dr. Andrew Bolas Dr. Andrew Bolas, Deputy Principal Dental Surgeon in Sligo/Leitrim. Lecturer in Dublin Dental School. Dental Advisor to MERU. Ms Edwina Dunne Ms Edwina Dunne, Assistant National Director, Quality and Patient Safety, HSE, Dr Steevens Hospital. Dr Stephen Fennell Dr Stephen Fennell, Radiation Protection Regulation, Office of Radiological Protection, Environmental Protection Agency Dr. David Fitzpatrick 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 of the RCPI. Mr. Paddy Gilligan Mr. Paddy Gilligan is a Principal Medical Physicist, Mater Private Hospital; Chair Population Dose Subcommittee. Mr. Pat Harvey, Chair Mr. Pat Harvey, Harwyn Management Consultants. Former CEO of the North Western Health Board. Mr Brian Keane Mr. Brian Keane, Chief Executive Officer, St. Vincent s Private Hospital; Council Member of the Independent Hospitals Association of Ireland (IHAI). Ms. Catherine McKenna Ms. Catherine McKenna, Radiation Therapy Services Manager, St. Luke s Hospital Dublin; Member of the Radiographers Registration Board (RRB); RSM chair on the Council of the Irish Institute of Radiographers and Radiation Therapists (IIRRT). Ms. Anne O Connell Ms Anne O Connell, Regulation, Health Information and Quality Authority (HIQA) in Cork. Mr. Declan Sheppard Consultation Radiologist, Diagnostic Directorate, Roscommon/Portiuncula Hospitals, Roscommon Dr Peter Wright Dr. Peter Wright, Specialist in Public Health Medicine. Advisers to MERU Ms. Mandy Lewis Ms. Mandy Lewis, Radiation Protection Advisor, Principal Physicist in the Mater Hospital, Dublin. Currently Physics Advisor to the MERU. Ms. Bernadette Moran Ms. Bernadette Moran is Director of the MSc in Medical Imaging, Trinity College. Former Radiographic Services Manager, St. James Hospital. Currently Radiographic Advisor to the MERU. NRSC End of Year Report 2014 12

Appendix 2. Subcommittees 2014: The subcommittees of the NRSC have similar terms of reference to the NRSC and report to the NRSC. They provide additional expertise and advice on speciality-specific issues. National Dental Subcommittee Meetings in 2014: 2 Membership in 2014: Dr Andrew Bolas Mr Eamon Croke Mr Terry Farrelly Ms Niamh Galvin Mr Paddy Gilligan Maurice Quirke Ms Tanya Kenny National Radiotherapy Subcommittee Meetings in 2014: 3 Membership in 2014: Dr David Fitzpatrick chair. Ms Tanya Kenny Ms Catriona McDonald Ms Catherine McKenna Ms Bernadette Moran Dr Frederick Vernimmen Prof. Wil van der Putten National Population Dose Subcommittee Meetings in 2014: 4 Membership in 2014: Ms Noeleen Cunningham Ms Liz Darcy Mr Shane Foley Mr Paddy Gilligan, Chair Ms Mandy Lewis Mr Brendan McCoubrey Mr Michael Maher Ms Lesley Malone Ms Bernadette Moran Dr Neill O Donovan Dr Peter Wright NRSC End of Year Report 2014 13