Patient Radiation Protection Manual 2017

National Radiation Safety Committee LEGISLATION OPTIMISATION HOLDER RESPONSIBILITIES JUSTIFICATION Patient Radiation Protection Manual 2017 RADIATION SAFETY INCIDENTS APPENDIX QUALITY ASSURANCE POPULATION DOSE CLINICAL AUDIT PATIENT PROTOCOLS Medical Exposure Radiation Unit

Contents Page 1 Introduction - Purpose, background and scope of the Patient Radiation Protection Manual 1 - National Standards for Better, Safer Healthcare 2 - Key performance indicators 3 - Disclaimer 3 - Legislative framework 3 - National arrangements for patient radiation protection 4 2 Governance and Responsibilities - Relevant themes from the National Standards 6 - Key performance indicators 6 - Governance and responsibility 6 3 Patient Radiation Safety Incidents - Relevant themes from the National Standards 7 - Key performance indicators 7 - Background 7 - Equipment related safety incidents 8 - Radiation safety incidents 8 4 Quality Assurance of Medical Ionising Radiation Equipment - Relevant themes from the National Standards 15 - Key performance indicators 15 - Quality assurance and the medical physics expert 15 - Guidance to Holders on criteria of acceptability for radiological equipment 16 - Special attention 16 5 Guidance on Developing Protocols for the Management of Patients - Relevant themes from the National Standards 18 - Key performance indicators 18 - Developing patient protocols 19 - Justification process 19 - Patient identification and information 20 - Consent 21 - Optimisation 21 - Legislation governing the protection of females of childbearing age 22 - Imaging Protocols 23 - Biomedical and medical research 23 - Health screening 24

6 Clinical Audit - Relevant themes from the National Standards 25 - Key performance indicators 25 - Clinical audit 25 - Undertaking clinical audit 26 - The benefits of clinical audit 26 - Supporting documentation for audit 27 - Examples of criteria for clinical audit 27 7 Population Dose and Diagnostic Reference Levels - Relevant themes from the National Standards 28 - Key performance indicators 28 - Population dose 28 - Diagnostic reference levels (DRLs) 29 - National and local DRLs 29 8 Appendix A. Example of a Tool to Monitor Key Performance Indicators 32 B. Radiation Protection Legislation 33 C. NRSC Guidance to Holders on their Responsibilities 2010 34 D. Incident Reporting Template for Diagnostic Imaging 43 E. Incident Reporting Template for Radiotherapy 46 F. Annual Returns Template to Record Patient Radiation Incidents 51 G. Letter from the NRSC National Radiotherapy Subcommittee to clarify the use of online imaging 53 H. National Diagnostic Reference Levels 2017 54 I. National Diagnostic Reference Levels for Paediatric CT scans 58 J. List of contributors to the Patient Radiation 59 Protection Manual 2017 9 References 60

Abbreviations ARSAC BSS CEO CT DAP DLP DRL EPA/ORP GM HIQA HPRA HSE ICPM KPI MERU msv MPE NRSC NM PET-CT PPPG QA RPA RSC RSM RSO RTSM SI Administration of Radioactive Substance Advisory Committee Basic Safety Standard Chief Executive Officer Computed Tomography Dose Area Product Dose Length Product Diagnostic Reference Level Environmental Protection Agency / Office of Radiological Protection General Manager Health Information and Quality Authority Health Products Regulatory Authority Health Service Executive Irish College of Physicists in Medicine Key Performance Indicator Medical Exposure Radiation Unit Milliseverts Medical Physics Expert National Radiation Safety Committee Nuclear Medicine Positron Emission Tomography Computed Tomography Policies, Procedures, Protocols and Guidelines Quality Assurance Radiation Protection Advisor Radiation Safety Committee Radiography/Radiology Services Manager Radiation Safety Officer Radiotherapy Services Manager Statutory Instrument

1. Introduction This manual published on 1 May, 2017 is a revised edition of the original Radiation Protection Manual distributed in 2013 by MERU Purpose, background and scope of the Patient Radiation Protection Manual National Standards for Better, Safer Healthcare Key performance indicators Disclaimer Legislative framework National arrangements for radiation protection Purpose, Background and Scope of the Patient Radiation Protection Manual This manual is a guide to support the practical application of the safe and optimal use of medical ionising radiation. The manual is designed to support radiological facilities in developing local policies. By using this manual, the service provider should have an understanding of their legislative responsibilities and assurance that they have arrangements in place to promote patient safety using medical ionising radiation. The objectives of this manual are: To keep all personnel informed of their roles and responsibilities under legislation relating to patient safety and medical ionising radiation. To provide guidance on specific topics relating to areas of responsibility which contribute to patient radiation safety. To assist locations in complying with regulatory requirements, national healthcare standards, accreditation and future licensing requirements. To aid in the training and education of personnel involved in the use of medical ionising radiation. Background The National Radiation Safety Committee (NRSC) is tasked with providing expert advice to the Director General of the Health Service Executive (HSE) on the use of ionising radiation. In 2010, the NRSC recommended that all Holders keep a radiation protection manual onsite. The manual was developed by the HSE Medical Exposure Radiation Unit (MERU) using an evidence based approach where possible and distributed to all radiological facilities in 2013. Patient Radiation Protection Manual 2017 Page 1

Scope The Patient Radiation Protection Manual applies to all public and private radiological facilities that administer medical ionising radiation to patients. The practitioner in charge is responsible for ensuring that the manual is made available to all staff and is used to support the staff induction programme. The manual provides guidance on the development of local policies and procedures in relation to patient radiation safety. National Standards for Safer Better Healthcare The manual is designed to incorporate themes outlined in the National Standards for Safer Better Healthcare (hereafter known as the National Standards) (HIQA, 2012). Figure 1: Eight themes of quality and safety outlined in the National Standards: Patient Radiation Protection Manual 2017 Page 2

Key Performance Indicators Key Performance Indicators (KPIs) are measureable indicators that demonstrate progress towards a specific target. They are listed within every section of the manual to assist locations in demonstrating legislative compliance and/or improvement in patient radiation protection. They can be used as a basis for inspection, audit or hospital licensing and will be reviewed on a regular basis. Appendix A gives an example of a tool to monitor KPIs. Disclaimer This document does not purport to be comprehensive or to be a legal interpretation of medical ionising radiation legislation but offers professional guidance to Holders, practitioners and all staff involved with medical ionising radiation. Legislative Framework for Radiation Protection INTERNATIONAL COMMISSION FOR RADIOLOGICAL PROTECTION EUROPEAN ATOMIC ENERGY COMMUNITY TREATY (EURATOM) BASIC SAFETY STANDARDS 96/26/EURATOM Medical Exposure Directive 97/43/EURATOM PROTECTION OF WORKERS AND GENERAL PUBLIC PROTECTION OF PATIENTS OFFICE OF RADIOLOGICAL PROTECTION / ENVIRONMENTAL PROTECTION AGENCY SI 125 DEPARTMENT OF HEALTH SI 478/303/459 HEALTH SERVICE EXECUTIVE MERU Patient Radiation Protection Manual 2017 Page 3

The system of radiation protection used throughout Europe is based on the recommendations of the International Commission for Radiological Protection. The core principles of radiation protection are justification, optimisation and dose limitation. Justification and optimisation will be outlined in the manual but dose limitation concerns workers and the general public and does not apply to patients, so will not be described. The principles are embodied in various European directives, most notably the Basic Safety Standard (BSS) 96/29/EURATOM and the Medical Exposure Directive 97/43/ EURATOM. The BSS was transposed into Irish legislation by statutory instrument (SI) 125 (2000) whereas the Medical Exposures Directive 97/43 EURATOM was transposed by SI 478 (2002), with associated amendments SI 303 (2007) and SI 459 (2010). The Medical Exposure Directive 97/43 EURATOM deals with the protection of individuals against the dangers of ionising radiation in relation to medical exposure. This directive is the main legal instrument for the protection of patients undergoing diagnostic and therapeutic procedures using ionising radiation. Appendix B lists pertinent Irish legislation. The Medical Exposure Directive has been incorporated into the revised BSS 2013/59/ EURATOM which will be transposed into Irish law in 2018. National Arrangements for Patient Radiation Protection The NRSC was established under SI 478 (2002) in 2007. It is a statutory committee tasked with: Providing advice to the Director General of the HSE on measures that are necessary to protect patients in both public and private facilities from the unnecessary harmful effects of ionising radiation. Producing an annual report which includes a report on population dose from medical exposure to ionising radiation. Receiving reports of audits, incidents and inspections. Gathering lifetime data on equipment and an assurance that each piece of equipment is recorded as being maintained. Monitoring diagnostic reference levels. Advising on guidance and direction to Holders, practitioners, other staff and statutory bodies on relevant matters. MERU is the executive, administrative and advisory unit for the NRSC and regulates Patient Radiation Protection Manual 2017 Page 4

patient radiation protection practices in both public and private radiological facilities. MERU is tasked with: Supporting and managing the work of the NRSC and its subcommittees. Commissioning and supporting audits of radiological facilities using medical ionising radiation. Managing the mandatory incident reporting system. Developing and providing guidance and 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 which administer medical ionising radiation to patients. Maintaining a register of installations. Patient Radiation Protection Manual 2017 Page 5

2. Governance and Responsibilities Knowing who is accountable and where responsibilities sit in a radiology department is essential to ensure patient safety and maintain operational efficiency. This section outlines the following: Relevant themes from the National Standards Key performance indicators Governance and responsibility Relevant Themes from the National Standards Theme 5 (Leadership and Governance) Theme 6 (Workforce) Key Performance Indicators Membership and Terms of Reference of the local Radiation Safety Committee (RSC) meet NRSC guidelines. Minutes and record of attendance of RSC meetings are available. A record of actions taken following recommendations of the RSC is available. Induction and on-going radiation protection training programmes for all staff working with medical ionising radiation are provided and reviewed regularly by the RSC. Governance and Responsibility The Holder, who is the Chief Executive Officer (CEO) or General Manager (GM), has overall responsibility for patient safety in locations that administer medical ionising radiation to patients. All clinical departments which use ionising radiation report to the hospital RSC which reports to the Quality and Risk Committee, or equivalent. This committee is then accountable to the executive management team which reports to the CEO / GM. The senior most accountable person in radiology / Clinical Director has responsibility for the governance of the radiology department and must document in writing any delegations of responsibility. Please see Appendix C for NRSC Guidance to Holders on their Responsibilities issued in 2010 to all Holders of medical ionising radiation equipment. Patient Radiation Protection Manual 2017 Page 6

3. Patient Radiation Safety Incidents Optimising patient safety and reducing risk are the aims of all incident reporting frameworks. Promoting an open, transparent culture where incidents are reported and managed in a well structured, timely fashion is essential and learning must be shared. This section outlines the following in relation to patient radiation safety incidents: Relevant themes from the National Standards Key performance indicators Background Equipment related safety incidents Radiation safety incidents Relevant Themes from the National Standards Theme 3 (Safe Care and Support) Theme 5 (Leadership, Governance and Management) Key Performance Indicators An annual record is kept of all patient radiation safety incidents. All notifiable incidents are reported to MERU and appropriately investigated. Evidence of quality improvement initiatives resulting from investigations. Evidence of staff awareness of incident investigation procedures. Background The fundamental role of incident reporting is to enhance patient safety by identifying trends in adverse and near miss events, and by facilitating the sharing of learning when issues do arise. All radiation safety incidents must be reported locally and managed in line with the service provider s risk management policy. This manual provides guidance on the types of incidents that are notifiable to MERU, those that are non-notifiable to MERU and what constitutes a near miss. It should be noted that not every incident scenario can be included. All facilities using medical ionising radiation must report to MERU notifiable incidents upon discovery using the standard MERU reporting template (Appendix D) and forward a copy of the final investigation report within three months (Appendix E). All incidents whether notifiable, non-notifiable or near miss, must be reported to MERU annually for trending purposes (Appendix F). Patient Radiation Protection Manual 2017 Page 7

MERU has a monitoring role in relation to the management of radiation safety incidents. MERU consults with a team of subject matter experts in relation to incidents reported by locations but does not have a direct role in investigations. The location has responsibility for the incident management process and for ensuring the patient is kept informed of progress. The roles of MERU are as follows: 1. To receive notification of patient radiation incidents and review the immediate assessment and management of the incident to ensure best practice was adhered to. 2. To receive the investigation report to assess the outcome of the incident and measures put in place to reduce the likelihood of recurrence. 3. To identify incident trends nationally and initiate measures to address them at a national level. Equipment Related Safety Incidents All equipment related safety incidents should be notified to the Health Products Regulatory Authority (HPRA). The HPRA works closely with hospitals to drive quality improvement in medical device safety by focusing on three inter-related areas - the dissemination of safety information, the development of the role of designated person / vigilance officer and the encouragement of user reporting. In relation to the dissemination of safety information, the HSE has developed a National Medical Device ealert System designed to streamline the management of the HPRA medical device safety notices within the public health system. As the national competent authority for medical devices, the HPRA publishes notices relating to the safety and/ or quality of medical devices on its website www.hpra.ie. Radiation Safety Incidents A radiation safety 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. However, dose variation due to patient factors does not constitute a radiation incident but the location may report the event to MERU if they perceive a risk to patients. Routine checking procedures are designed to catch potential errors before they occur and issues identified outside of these are considered near miss events. That is, potential errors identified and mitigated, resulting in no adverse outcome for patients. Near miss events must be monitored locally and reported annually to MERU for trending purposes. Patient Radiation Protection Manual 2017 Page 8

A non-notifiable incident occurs where an inadvertent radiation dose below the notifiable level is administered to a patient which may indicate a failure of process. This incident does not require notification to MERU but is managed locally through the risk management framework and is reported annually to MERU for trending purposes. All notifiable incidents must be reported to the local risk manager and to MERU upon discovery. If in doubt as to whether or not the incident is notifiable, it may be reported verbally to MERU, which will advise if formal reporting is required. Figure 1 below describes notifiable incidents reportable to MERU. This list is not exhaustive and any radiation incident considered to have serious patient safety implications should be reported to MERU. The use of online and offline imaging was clarified by the NRSC National Radiotherapy Subcommittee in a letter to hospital CEO s in 2015 (Appendix G). Patient Radiation Protection Manual 2017 Page 9

Figure 1: Notifiable incidents reportable to MERU Notifiable Incidents No dose intended/incorrect patient exposed to > 1 millisivert (msv). Incorrect procedure. Incorrect anatomy. Incorrect radiopharmaceutical. Diagnostic overexposure of an adult of more than twice the exposure intended that leads to >10mSv or 20 times the dose intended. Diagnostic over exposure of a child of more than twice the exposure intended that leads to >3mSv or 15 times the dose intended. Dose to foetus >1mSv. Dose to the breastfed child >1mSv. Deterministic effects as a result of interventional radiology. Administration of a skin dose of 15Gy in a diagnostic environment. Therapeutic dose given instead of diagnostic dose e.g. radioiodine. Therapeutic nuclear medicine - administered activity different by 20% than intended. Deterministic effects as a result of radiotherapy treatment. Radiotherapy dose or volume variation from the total prescribed >10%. Radiotherapy dose or volume variation from the fraction prescribed >20%. Dose given to comforters and carers without consent greater than Medical Council guidelines of 3mSv for adults under 60 years of age and 6mSv for those over 60. Any other radiation exposure incident considered to have serious patient safety implications. MERU recommends using the HSE Safety Incident Management Policy (HSE, 2014a) and the HSE Guidelines for System Analysis Investigation of Incidents and Complaints (HSE, 2012a) when investigating and reporting on radiation safety Patient Radiation Protection Manual 2017 Page 10

incidents. Also, the HSE Open Disclosure Policy 2013 (HSE, 2013a) should be activated, where indicated. Figure 2 outlines the classification of incidents in radiotherapy, the individuals to be notified and timescale for notification. Figure 2: Classification of incidents in radiotherapy Incident Severity Examples Individuals to be Notified 1 Minor Incident 2 Potential Serious Incident Dose or volume variation from prescribed total dose <5% and fractional dose 10 20%. Near miss or unsafe condition which could potentially cause a treatment error. A near miss that could have been a serious incident. Hospital Risk Manager, Clinical Specialist or Senior Radiation Therapist, Radiotherapy Services Manager (RTSM), Treating Consultant only if actual patient impact, RSC Chairperson. Hospital Risk Manager, Clinical Specialist or Senior Radiation Therapist, Time Scale Within 24 hours Within 24 hours 3 Serious Incident Dose or volume variation from prescribed total dose 5-10% and fractional dose > 20%. Radiation dose or medication error causing side effects that require minor treatment or ongoing monitoring and assessment. Hospital Risk Manager, RTSM, Head of Physics, Treating Radiation Oncologist. RSC Chairperson. Within 24 hours Set up variation > 1cm - no critical structures included. 4 Potential Major Incident A near miss that could have been a major incident. Hospital Risk Manager, CEO / General Manager, RTSM, Head of Physics, Director of Nursing, Treating Radiation Oncologist Within 24 hours 5 Major Incident Dose or volume variation from prescribed total dose of 10-20%. Radiation dose or medication error causing side effects requiring major treatment and intervention or hospitalisation. Hospital Risk Manager, CEO / General Manager, RTSM, Head of Physics, Director of Nursing, Treating Radiation Oncologist, RSC Chairperson. Immediate Set up variation that will/could impact on normal tissue e.g. heart, lung, eyes, kidney. 6 Critical Incident Radiation dose or medication error causing death or disability. Dose or volume variation from prescribed total dose > 20%. Incorrect volume. Hospital Risk Manager, CEO / General Manager, Clinical Director, RTSM, Head of Physics, Director of Nursing, Treating Radiation Oncologist, RSC Chairperson. Immediate Patient Radiation Protection Manual 2017 Page 11

Figure 3 describes the escalation process for managing major and critical incidents in radiotherapy. Figure 3: Major and critical radiotherapy incident management Major and Critical Radiotherapy Incident Management 1. Treatment is to cease immediately and no further treatment is to take place without the approval of the patient s consultant or the consultant-on-call. 2. The consultant is to be informed of the incident. If unavailable, the consultanton-call is to be informed. 3. The consultant is to inform the patient. 4. The staff member who discovers the error is to immediately inform the head of department. 5. The head of department is to inform the hospital risk manager, chief executive officer and clinical director and if these are unavailable, at least one member of the senior executive management team. The heads of departments / sections of radiation therapy, physics and nursing are to be informed. 6. The head of physics will direct a senior member of their staff to undertake a preliminary physics incident investigation and report. 7. A review of all patients receiving similar treatment protocols is to be undertaken. 8. An emergency meeting of the RSC, or equivalent committee, is to be held which the patient s consultant will attend. 9. The RSC will consider the preliminary incident report and decide what action should be taken. Overleaf are examples of patient radiation safety incidents reported in radiology, radiotherapy and nuclear medicine. Patient Radiation Protection Manual 2017 Page 12

Figure 4: Examples of patient radiation safety incidents Radiotherapy Radiology Nuclear Medicine (NM) Notifiable A patient receives a total dose or volume variation 20% greater than the prescribed dose. Two patients with similar names and dates of birth are in the waiting area. Patient A is waiting for a chest x-ray and patient B is waiting for a chest CT scan. The radiographer calls patient B but patient A responds. Patient A receives a chest CT scan instead of a chest x-ray. A patient is referred to the NM department for a renal scan. The incorrect radiopharmaceutical is prepared and administered. When the patient is scanned, it is noted that the radiopharmaceutical for a bone scan has been administered in error. Nonnotifiable A patient receives a total dose or volume variation <5% greater than the prescribed dose. However, this can be compensated for during the course of treatment. A patient is referred for a check x-ray of the hip. There are no clinical details recorded on the referral and the patient receives a chest x-ray instead of a hip x-ray. A patient is referred for a radionuclide lung perfusion scan. During radiopharmaceutical administration, the dispensed injection was measured incorrectly and the dose injected was more than 20% than intended. Near Miss Event The prescription states that the patient s left breast is to be treated. Whilst being prepared, the patient states that their right breast requires treatment. The procedure is stopped, the referrer contacted for clarification and no inadvertent dose is given to the patient. A patient is referred from the emergency department for an abdominal scan. Whilst being prepared for the scan, the patient asks why their abdomen is being scanned when they came in with a head injury. The radiographer stops the procedure and contacts the referrer who confirms that the wrong scan had been ordered. No inadvertent radiation dose is administered to the patient. An inpatient is referred for a thyroid scan and several days later this same patient is inadvertently re-scheduled for the same scan. When the patient arrives in the NM department, they are recognised by the radiographer, their details are checked and it is confirmed the repeat scan is not required. No inadvertent radiation dose is administered and the patient returns to the ward. Patient Radiation Protection Manual 2017 Page 13

Incident Management in the Radiology Department 1. The staff member who discovers the error is to immediately inform the RSO or RSM. 2. The incident should be reported using internal risk management incident forms and the RPA informed. 3. The consultant radiologist responsible for the patient is to be informed of the incident. The clinical referrer is to be informed of the incident. 4. The radiologist has responsibility for informing the patient. The task may be delegated to the radiographer or referrer where appropriate. 5. The RPA or RSO will advise if the incident is notifiable to an external agency. 6. For incidents that are to be externally notified, the hospital risk manager, chief executive officer and clinical director shall be informed. 7. A senior member of physics and radiography will undertake a preliminary incident investigation and report to the radiologist and hospital risk manager. 8. In the case of a serious incident, a review of all patients receiving similar treatment protocols is to be undertaken. 9. The incident will be tabled at the next RSC, or equivalent committee. For serious incidents, an emergency RSC committee meeting should be considered. 10. The RSC will consider the preliminary incident report and decide what action should be taken. Patient Radiation Protection Manual 2017 Page 14

4. Optimisation of Medical Ionising Radiation Equipment The safe and optimal use of medical ionising radiation equipment by appropriately trained and qualified staff is essential to ensure that patient exposure to radiation is kept at a minimum. This section outlines the following: Relevant themes from the National Standards Key performance indicators Quality assurance programme Medical physics expert Guidance to Holders on criteria of acceptability for radiological equipment Special attention Relevant Themes from the National Standards Theme 3 (Safe Care and Support) Theme 5 (Leadership and Governance) Theme 7 (Use of Resources) Key Performance Indicators A named Medical Physicist has been appointed. A quality assurance programme is in place, up-to-date and fit-for-purpose. Test results are available and there is evidence of actions that require follow up have been completed All equipment service records are up-to-date. Replacement dates are anticipated and planned for. Evidence of consultation with the Medical Physics Expert (MPE) on the optimisation of imaging equipment, with particular emphasis on high dose, paediatric and health screening procedures. Documentary evidence of decisions made in relation to the continued use of equipment beyond the replacement date is available. Quality Assurance Quality assurance (QA) is essential to ensure that equipment is both safe and optimised for patient use. SI 478 (2002) requires the Holder to assign a named MPE to each installation and to consult the MPE on optimisation, QA, evaluation of patient doses and matters relating to radiation protection concerning medical exposures. Patient Radiation Protection Manual 2017 Page 15

A QA framework must be approved by the MPE and / or Radiation Protection Adviser (RPA), and comply with EPA/ORP licence requirement, to include: assessment of patient dose and image quality a proposed replacement date for each piece of equipment evidence of compliance with legislative requirements. Medical Physics Expert The similar qualifications and training of a RPA and MPE may blur the distinction between the two roles. In practice the MPE and RPA may be the same individual, although not all RPA s are qualified to act as MPE. The holder must ensure the named MPE is qualified and competent for appointment. The European Commission Radiation Protection No174 (EC, 2014) gives guidance on the education, training and competency for MPE recognition and recommended staffing levels. The Irish College of Physicists in Medicine (www.icpm.ie) maintains a voluntary register of Medical Physics Experts in the specialities of Diagnostic Radiology / Imaging Physics and Therapeutic Applications of Ionising Radiation Guidance to Holders on Criteria of Acceptability for Radiological Equipment SI 478 (2002) outlines the general principles of radiation protection of individuals in relation to medical exposure to ionising radiation. The ultimate responsibility for the protection of patients from the harmful effects of ionising radiation rests with the Holder. SI 478 (2002) defines the Holder as any natural or legal person who has the legal responsibility under national law for a radiological installation. SI 478 (2002) requires that radiological and nuclear medicine equipment, apparatus and installations being used for diagnostic or therapeutic purposes, shall comply with the criteria as may be specified by the competent authority from time to time. It also requires that the Holder shall maintain an inventory of equipment; dates of installation; dates on which it was inspected by any duly authorised person; and projected date of replacement of the equipment (or components of that equipment). The NRSC advises that eight years is the appropriate lifespan for equipment that has the potential to produce high radiation exposure (for example, CT / interventional / cardiology equipment) and twelve years for low dose equipment (for example, dental / DEXA / general x-ray equipment). Legislation requires the NRSC to decide on the continued use of equipment beyond the replacement date. However, the frequency of NRSC meetings is not sufficient to meet clinical need. Patient Radiation Protection Manual 2017 Page 16

To address this, the NRSC recommends the following: The MPE should certify to the practitioner-in-charge that the equipment meets the criteria outlined in the QA programme. The radiographic services manager or clinical specialist radiographer should certify that the equipment is suitable for use. The engineer or agency contracted to service the equipment should certify that the equipment is operating within specification and provide a statement regarding the continued availability of replacement parts. The practitioner-in-charge should certify that, having consulted with the MPE, the patient dose levels arising from the use of the equipment and image quality are within acceptable limits. Upon completion of these steps, the practitioner-in-charge recommends the certification to the RSC and the RSC confirms the recommendation to the Holder. Based on the advice given, the Holder may decide to limit or suspend the use of equipment. The Holder has responsibility for the continued use of equipment beyond replacement dates and documentary evidence must be available to support any decisions made in this regard. In setting criteria of acceptability, a review of the Criteria of Acceptability of Radiological Equipment (RP-162) (EC, 2012) may be useful to the MPE. However, it is recognised that some of the tests included in RP-162 may not be practicable in all locations. It is recommended that the MPE also take into consideration recognised standards issued by professional bodies. Special Attention The Holder shall ensure that special attention is given to the radiological equipment, practical techniques, ancillary equipment and quality assurance programmes, including quality control measures and patient dose or administered activity assessment for medical exposure of children, as part of a health screening programme or for radiological procedures involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy. Patient Radiation Protection Manual 2017 Page 17

5. Guidance on Developing Protocols for the Management of Patients Delivering care that is appropriate, evidence based and standardised is in the best interest of the patient. Developing and implementing patient care protocols for common radiology procedures will help to reduce errors and promote a culture of patient safety. This section outlines the following: Relevant themes from the National Standards Key performance indicators Developing patient protocols Justification process and referral criteria Patient identification and information Consent Optimisation Legislation governing the protection of females of childbearing age Imaging Protocols Biomedical and medical research Health screening Relevant Themes from the National Standards Theme 2 (Effective Care and Support) Theme 3 (Safe Care and Support) Key Performance Indicators Evidence of imaging protocols for routine examinations. Evidence of the justification process. Evidence of availability and use of referral guidelines. Evidence of policies and local audit of compliance in relation to: - Patient identification and procedure matching checks. - Patient consent was obtained from the patient or their guardian. Evidence that imaging protocols have been optimised and approved by the Practitioner in Charge, advised by the MPE. Evidence that exposures of target volumes are individually planned by the MPE, taking into account doses to non-target volumes, for all radiotherapeutic procedures. Evidence of a policy and local audit of compliance relation to check the pregnancy status of females of childbearing age. Patient Radiation Protection Manual 2017 Page 18

Evidence that biomedical and medical research using medical ionising radiation is advised by the radiologist or MPE, by appointment to the Research Ethics Committee. Evidence that health screening complies with the requirements of SI 459 (2010). Developing Patient Protocols A framework for policies, procedures, protocols and guidelines (PPPG) is essential to advance the quality of health care delivered to patients and to improve organisational effectiveness. The HSE national framework sets out the standards that must be applied when developing PPPGs. Click on link below: https://www.hse.ie/eng/about/who/qualityandpatientsafety/resourcesintelligence/ Quality_and_Patient_Safety_Documents/PPPG_Document_Development_and_ Inventory/ The purposes of patient protocols are to: Provide instructions and guidance on the most appropriate actions to be undertaken in specific circumstances. Promote best evidence based practice. Standardise practice and service delivery. Reduce duplication. Ensure that legislative and regulatory requirements are met. Ensure employees and line managers are clear on their roles and responsibilities. Facilitate effective staff induction. Act as educational tools. Act as a basis for audit, evaluation and continuous improvement. Ensure standards are met. Justification Process SI 478 (2002) Article 7 defines justification as a medical exposure which shows a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefit it produces, including the direct health benefits to an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving less exposure to ionising radiation.the principle of justification necessitates the following: Patient Radiation Protection Manual 2017 Page 19

7.1 A prescriber (referrer) shall state in writing on each individual prescription his or her reason for requesting the particular procedure and the practitioner shall make arrangements to satisfy himself or herself that the procedure as prescribed is justified. 7.2 The prescriber and the practitioner shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure. SI 478 (2002), Article 2 defines clinical responsibility as responsibility regarding individual medical exposures attributed to a practitioner, notably: justification; optimisation; clinical evaluation of the outcome; co-operation with other specialists and the staff, as appropriate, regarding practical aspects; obtaining information, if appropriate, of previous examinations; providing existing radiological information and/ or records to other practitioners and/or prescribers, as required; giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate. Thus, while the practitioner is assigned clinical responsibility for the medical exposure, which includes justification, the referer also has responsibilities. Referral Criteria In 2012, the Royal College of Radiologists in the United Kingdom produced referral criteria guidelines called the irefer Guidelines (RCR, 2012) and the NRSC and Faculty of Radiologists in Ireland have endorsed these guidelines. irefer is made available to all referrers through the HSE Radiology Programme. SI 478 (2002) Article 14 states: 14.2. The practitioner in charge of an installation shall recommend, having regard to these regulations and subject to the approval of the Holder, the referral criteria for referrers when referring patients for a radiological procedure. The Holder shall ensure that the criteria referred to in paragraph 14.2 are advised to referrers, for example, clinicians, GPs, independent nurse referrers. Patient Identification and Information Each department must have a protocol in place to correctly identify patients who are undergoing a medical ionising radiation procedure. An exposure must not be undertaken if patient identification cannot be verified. The referrer is responsible for ensuring that sufficient detail is included on the request form and the practitioner is responsible for accepting this referral. In practice, however, confirmation of patient identification prior to examination is regularly delegated to the radiographer who Patient Radiation Protection Manual 2017 Page 20

performs the imaging procedure. Identifying the patient is an active rather than passive procedure in radiology. A three point identification check is required where the patient is asked to give their full name, date of birth and hospital record number and this is checked against the written information provided. In addition in radiotherapy, photo identification is also used to identify patients. The procedure referred should be checked against the documentation provided and, where possible, confirmed with the patient or guardian prior to commencement of exposure. Consent All radiological facilities must have an appropriate protocol in place for obtaining consent for imaging procedures and for undertaking radiotherapy treatment. Patients must be given verbal and written information on the risks and benefits of exposure to medical ionising radiation so that an informed decision about treatment can be made. All information must be presented in a way the patient understands and time must be given for answering questions and repeating explanations when required. Patient information should include the potential benefits, risks and the likelihood of success of any proposed intervention, as well as that of any available alternative. The NRSC recommends the use of the HSE National Consent Policy 2014 (HSE, 2014b) which dictates that the person obtaining the consent is suitably trained and qualified. Optimisation SI 478 (2002) Article 7 defines optimisation as: 7.5(a) All doses due to medical exposure for radiological purposes except radiotherapeutic procedures referred to in Regulation 4.1 shall be kept as low as reasonably achievable consistent with obtaining the required diagnostic information, taking into account economic and social factors. 7.5(b) For all medical exposure of individuals for radiotherapeutic purposes, as mentioned in Regulation 4.1 (a), exposures of target volumes shall be individually planned, taking into account that doses of non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure. Patient Radiation Protection Manual 2017 Page 21

Thus, all radiological locations must have optimisation protocols in place to ensure that doses due to medical exposure are kept as low as reasonably achievable. (see Chapter 4 on Optimisation / QA) Legislation Governing the Protection of Females of Childbearing Age All locations administering medical ionising radiation must have protocols for the determination of pregnancy in patients referred for medical ionising radiation procedures. A recent national audit by the HSE Healthcare Audit team (HSE, 2015) highlighted inconsistencies with radiation safety procedures in relation to the management of pregnant, potentially pregnant and breastfeeding patients. As a result, a national committee has been established to undertake a review and standardise practice. MERU will update this section once the review is completed and recommendations are made. SI 478 (2002) Article 20 - Special Protection during Pregnancy and Breastfeeding 20.1. In the case of a female of childbearing age, the prescriber, the practitioner, the radiographer, or persons referred to in regulations 13 and 16 shall inquire whether she is pregnant or breast feeding, if relevant, and shall record her answers in writing. 20.2(a) In the case of a female of childbearing age if pregnancy cannot be excluded or where the records fail to indicate whether the patient is pregnant or not, the prescriber, the practitioner, the radiographer and persons referred to in regulations 13 and 16 shall treat the patient as if she were pregnant. 20.2(b) If pregnancy cannot be excluded, depending on the type of medical exposure, in particular if abdominal and pelvic regions are involved, special attention shall be given to the justification, particularly the urgency, and to the optimisation of the medical exposure taking into account the exposure both of the expectant mother and the unborn child. 20.3. In the case of a female who is breast feeding, in nuclear medicine, the prescriber, the practitioner, the radiographer or persons referred to in regulations 13 and 16 shall in recording their justification for continuing with a procedure have specific regard and make written reference to that fact. Special attention shall be given to the justification, particularly the urgency, and to the optimisation of the medical exposure, taking into account the exposure for both the mother and for the child. 20.4. Procedures to be conducted on pregnant or breast feeding females shall be done in accordance with procedures approved by the Medical and Dental Councils. Patient Radiation Protection Manual 2017 Page 22

Also, Medical Exposure Directive 97/43/EURATOM Article 10.3 states: Without prejudice to Article 10 (1) and (2), any measure contributing to increasing the awareness of women subject to this Article, such as public notices in appropriate places, could be helpful. In addition, the EPA/ORP produced a document entitled Guidelines for the Protection of the Unborn Child During Diagnostic Medical Exposures 2010 (RPII, 2010) which is recommended reading. Imaging Protocols Imaging protocols vary depending on the type of clinical procedure being performed. Protocols must be available for each clinical procedure requiring radiological exposure and should include the following: Number of radiographic views required for each procedure. Radiographic technique appropriate for each procedure. Exposure factors and positioning technique. Separate exposure charts should be available for each piece of equipment, as appropriate. Bio-medical and Medical Research SI 478 (2002) Article 10 states: 10.1. Medical exposure for bio-medical and medical research shall not be permitted, save in accordance with such criteria as may be directed by the Medical or Dental Councils and approved by the local medical ethics committee. 10.2. Without prejudice to the generality of paragraph 10.1, the practitioner shall ensure that for each biomedical and medical research project, each participating individual shall participate voluntarily, the practitioner shall seek where practicable to obtain previous diagnostic information or medical records relevant to the individual, that the individual is informed about the risks of this exposure and that he or she gives his or her informed consent in writing and that a dose constraint is established for that individual. 10.3. In the case of patients who voluntarily accept to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner. Patient Radiation Protection Manual 2017 Page 23

Health Screening Population screening programmes are designed to identify diseases before symptoms become apparent to the individual, thereby allowing for early intervention and improving prognosis. SI 478 (2002) defines health screening as a procedure using radiological installations for early diagnosis in population groups at risk. SI 459 (2010) outlines the procedure to be followed when providing a health screening programme which involves medical ionising radiation exposure. Patient Radiation Protection Manual 2017 Page 24

6. Clinical Audit Conducting clinical audit ensures the delivery of an effective and efficient service by identifying good practice and highlighting areas for improvement. Practitioners can use clinical audit as a means to ensure their practice remains evidence based and in the best interest of the patient. This section outlines the following: Relevant themes from the National Standards Key performance indicators Clinical audit Undertaking clinical audit The benefits of clinical audit Supporting documentation for audit Examples of criteria for clinical audit Relevant Themes from the National Standards Theme 2 (Effective Care and Support) Theme 3 (Safe Care and Support) Theme 5 (Leadership, Governance and Management) Key Performance Indicators Minutes of audit meetings are up-to-date and available. Evidence that regular clinical audit is undertaken with findings and appropriate recommendations. Evidence that action plans are developed and implemented with improved outcomes as a result. Clinical Audit The Medical Exposure Directive 97/43/EURATOM defines clinical audit as a systematic examination or review of medical radiological procedures. It seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures, and results are examined against agreed standards for good medical radiological procedures. Modifications of the practices are implemented where indicated and new standards applied if necessary. Patient Radiation Protection Manual 2017 Page 25

Clinical audit is the systematic review and evaluation of current practice against research based standards with a view to improving clinical care (HSE, 2013). Figure 1 outlines the clinical audit cycle. Figure 1: Clinical Audit Cycle (HSE, 2013) 1: Clinical Audit Cycle (HSE, 2013) Planning for audit Sustaining Improvement Standard / Criteria Selection Making Improvement Measuring Performance Undertaking Clinical Audit The Medical Practitioner Act (2007) Section 7 requires all registered medical practitioners to participate in clinical audit and recommends that a minimum of one hour per month is allocated to audit activity. SI 478 (2002) places a requirement on radiological facilities to engage an external auditor to review practice every five years. The Benefits of Clinical Audit Proactively measures the effectiveness and performance of healthcare against agreed quality standards. Patient Radiation Protection Manual 2017 Page 26

Improves patient outcomes by identifying deficits in practice and informing action plans to address these. Provides assurance that practice conforms to agreed quality standards. It is recommended that small radiological practices should develop links with the Radiation Safety Committee or Clinical Audit Committee of larger organisations under the same governance structure, to ensure audit remains a priority and best practice guidelines are adhered to. Supporting Documentation for Audit The HSE published guidelines for undertaking clinical audit, local structures that should be in place, the governance framework required and potential performance indicators (HSE, 2011a). The HSE publication A Practical Guide to Clinical Audit 2013 (HSE, 2013b) is also recommended reading. In addition, the European Commission Guidelines on Clinical Audit for Medical Radiological Practices (Diagnostic Radiology, Nuclear Medicine and Radiotherapy) 2009 (EC, 2009) should be considered. Examples of Criteria Suitable for Clinical Audit Verification of correct procedure. Record of number of images per examination and reject rates. Skin dose levels for interventional procedures. Patient Radiation Protection Manual 2017 Page 27

7. Population Dose and Diagnostic Reference Levels Knowing the total exposure of the population to medical ionising radiation and the radiation dose delivered during an individual diagnostic or therapeutic procedure are important. Benefits of exposure must be measured against the associated risks to ensure the best outcome for the patient. This section outlines the following: Relevant themes from the National Standards Key performance indicators Population dose Diagnostic reference levels (DRLs) National and local DRLs Relevant Themes from the National Standards Theme 2 (Effective Care and Support) Key Performance Indicators Evidence that data on examination frequency and average dose is recorded for all routine examinations. Evidence that patient dose data is collected and used to set local DRLS, reviewed annually against the national DRLs. Evidence of justification for local DRLs that are significantly higher or lower than National DRLs. Evidence of action taken to improve local DRLs, where appropriate. Population Dose The HSE has a legal obligation under SI 478 (2002) to annually collect and publish statistics on population dose. This is carried out through the NRSC National Population Dose and Optimisation Subcommittee, with the support of MERU. This subcommittee is responsible for assessing radiation dose to the population and advising the NRSC on optimisation. Population dose refers to the total population exposure to ionising radiation. In assessing population dose, two parameters are needed: the number of examinations and the median dose per procedure. Being aware of population dose allows Ireland to benchmark performance against other European countries and internationally. It also allows for the estimation of health effects associated with medical imaging on the population and informs strategies to reduce patient dose. Patient Radiation Protection Manual 2017 Page 28

Service providers are required to record the median dose to 30 patients, randomly selected for all routine examinations. Service providers must also record the frequency of each examination. Frequency of an exam is defined and the number of patients undergoing an examination (for example, a patient undergoing a CT TAP examination is counted as 1 examination, even if several anatomical areas are scanned). The data on median dose and examination frequency must be made available to MERU on request, for the purposes of computing population dose. Diagnostic Reference Levels The concept of diagnostic reference levels (DRLs) was introduced by the International Commission on Radiological Protection (ICRP) as part of the process for optimising the doses delivered to patients. In particular, the purpose of DRLs is to avoid unnecessarily high doses to patients. The second aspect of the optimization process is image quality. The image quality associated with any dose delivered must be in keeping with the diagnostic purposes of the examination. DRLs are defined as dose levels for typical examinations for groups of standard sized patients for broadly defined types of equipment. DRLs provide a benchmark for comparison of the same examination between centres, but are not regulatory limits on the dose that can be administered. If the dose delivered by an imaging facility consistently exceeds the DRL, it is an indication that the facility may need to further optimise their imaging protocols. DRLs should be applied with flexibility to allow higher doses when justified by the practitioner. National and Local DRLs National DRLs for the most common Irish procedures have been established by MERU, approved by the NRSC and are updated regularly. National DRLs provide a useful tool to benchmark local practice. Each National DRL is derived using the methodology recommended by the European Commission in RP-109 and RP-180. Data on the median patient dose for 30 patients is collected by MERU from multiple locations involved in performing a particular examination. From this, the 75th percentile of the dose distribution is chosen as the national DRL. Service providers are required to establish and use Local DRLs for each of their routine procedures. Local DRLs are recommended as the first step in optimisation of procedures, as they are most relevant to the patient cohort, examination type and equipment available locally. To promote best practice, it is recommended that local DRLs for all common studies are reviewed annually by a team of relevant practitioners Patient Radiation Protection Manual 2017 Page 29

(radiologist, radiographer and medical physicist) and by the Radiation Safety Committee. Annual review is evidenced by signatures of the relevant practitioners. To calculate the local DRL, take the median dose for at least 30 typical exams (50 for Mammography) for randomly selected patients (of all sizes). Care should be taken to record the dose units on each x-ray system and convert to the standardised units of the national DRL, where necessary. It is good practice to have a chart of local and national DRLs in each procedure room, displayed in the dose units used on the equipment installed, to inform radiographic staff of the recommended levels. Alert levels may be set based upon the national or local DRLs. To take account of weight range, the 90th percentile of your local data is an appropriate level at which the operator should consider an alert, review justification and / or change the technique factors. Some systems may have the ability to pre-set alert levels. Any significant local variance from national DRLs must be recorded and justified. Risk from radiation exposure varies considerably with age and sex, with higher risk for infants and children. Typical doses from common imaging procedures are presented in the irefer Guidelines (RCR, 2012), made available to all referrers through the HSE. National DRLs for 2017 are listed in Appendix H. Patient Radiation Protection Manual 2017 Page 30

8. Appendix A. Example of a Tool to Monitor Key Performance Indicators B. Radiation Protection Legislation C. NRSC Guidance to Holders on their Responsibilities 2010 D. Incident Reporting Template for Diagnostic Imaging E. Incident Reporting Template for Radiotherapy F. Annual Returns Template to Record Patient Radiation Incidents G. Letter issued in 2015 by the NRSC National Radiotherapy Subcommittee to clarify the use of online imaging H. National Diagnostic Reference Levels 2017 I. List of contributors to the development of the Patient Radiation Protection Manual 2017 Patient Radiation Protection Manual 2017 Page 31

Appendix A: Example of a Tool to Monitor Key Performance Indicators Key Performance Indicator: All equipment service records are up-to-date with replacement dates anticipated and planned for. List the evidence to support the existence of this KPI. Where to find this evidence. Named person responsible for monitoring and reporting on this KPI. Date of review. Date of next review. Patient Radiation Protection Manual 2017 Page 32

Appendix B: Radiation Protection Legislation Basic Safety Standard 2013/59/EURATOM (to be transposed into Irish law in 2018) SI 459 (2010) European Communities (Medical Ionising Radiation Protection) (Amendment)Regulationshttp://www.irishstatutebook.ie/eli/2010/si/459/made/ en/print SI 303 (2007) European Communities (Medical Ionising Radiation Protection) (Amendment) Regulations - http://www.irishstatutebook.ie/eli/2007/si/303/ made/en/print Safety, Health and Welfare at Work Act (2005) http://www.hsa.ie/eng/legislation/acts/safety_health_and_welfare_at_work/ SI 875 (2005) Radiological Protection Order (Control of High-Activity Sealed Radioactive Sources) http://www.irishstatutebook.ie/eli/2005/si/875/made/en/print SI 478 (2002) European Communities (Medical Ionising Radiation Protection) Regulations http://www.irishstatutebook.ie/eli/2002/si/478/made/en/print Radiological Protection (Amendment) Act, (No. 3 of 2002) http://www.irishstatutebook.ie/eli/2002/act/3/enacted/en/print SI 125 (2000) Radiological Protection Act (Ionising Radiation) http://www.irishstatutebook.ie/eli/2000/si/125/made/en/print SI 218 (2000) Pregnant Employees Regulations http://www.irishstatutebook.ie/eli/2000/si/218/made/en/print Radiological Protection Act (1991) http://www.irishstatutebook.ie/eli/1991/act/9/enacted/en/html Patient Radiation Protection Manual 2017 Page 33

Appendix C: NRSC Guidance to Holders on Their Responsibilities To: Holders of Medical Ionising Radiation Equipment From: National Radiation Safety Committee, HSE Date: 04 March 2010. RE: Guidance on Responsibilities in European Communities (Medical Ionising Radiation Protection) Regulations (SI 478 (2002), as amended by the European Communities (Medical Ionizing Radiation Protection) (Amendment) Regulations (SI 303 (2007). These regulations are intended to protect the patient from harmful effects of exposure to ionising medical/dental radiation. The National Baseline Audits conducted in 2008 in Radiology, Nuclear Medicine, Dentistry and Radiotherapy in 2008 recommended that The HSE and the National Radiation Safety Committee should clarify and promote the requirements of SI 478 and ensure that all Holders of ionising radiation equipment are aware of these. This document is an initial guidance from the National Radiation Safety Committee to Holders of Medical/Dental Ionising Radiation Equipment in Ireland. It addresses some of the key responsibilities of Holders to assist them to comply with the relative provisions of the regulations. It also provides some advice on implementation issues, such as governance structures. Disclaimer This document is intended to act as a guideline to the regulations. It must be read in conjunction with the regulations referred to above and other laws, regulations or other responsibilities attaching to these roles. It does not purport to be comprehensive or to be a legal interpretation or to constitute legal or professional advice. Further guidance documents and changes in the regulations can be expected in the future that will necessitate the update of this guidance in due course. The advice given is wideranging and does not undermine an employer s legal responsibilities for implementing compliant local procedures. This regulation concerns important issues of quality and patient safety. Currently, a national review is being undertaken to implement the recommendations from the Report of the Commission on Patient Safety and Quality Assurance, 2008. This and other national developments will have consequences for the implementation of SI 478 (2002) in the future. The National Radiation Safety Committee may issue further guidance in this regard. Patient Radiation Protection Manual 2017 Page 34

Holders Responsibilities - Guidelines Significant responsibility for the protection of patients from the harmful effects of ionising radiation rests with the Holder who must ensure that appropriate provisions are put in place to meet the requirements of the regulations. The Holder means any natural or legal person who has the legal responsibility under national law for a radiological installation. In almost all cases the Holder will also be the undertaking [licensee with the Radiological Protection Institute of Ireland] as defined under SI 125 (2000) and will have additional responsibilities set out in that statutory instrument. Practitioners in Charge, Practitioners, Radiographers, Medical Physics Experts and Prescribers and each person involved in the use of ionising radiation for the purpose of medical/dental exposures to patients also have the duty to comply with the provisions of the regulations. 1. Governance and Structures The regulations state that a holder may establish a local radiation safety committee in respect of a particular installation and that committee shall have regard to the advice of the National Radiation Safety Committee. A number of other responsibilities are required of Holders. The National Radiation Safety Committee has reviewed these and recommended the following to assist Holders in fulfilling their legal requirements. National Radiation Safety Committee Recommendations The National Radiation Safety Committee has made the following recommendations to assist Holders in fulfilling their legal requirements and has provided advice on a local governance framework. (a) Radiation Safety Committees. Radiation Safety Committees are recommended to be in place in organisations that have a large volume of procedures and/or higher risk practices. This does not generally apply to smaller practices, for example a dental practice or DEXA scanning practice. Many Holders have established Radiation Safety Committees to meet the licence requirements of the Radiological Protection Institute of Ireland, under SI 125 (2000). Where these committees exist, it is recommended that their terms of reference are expanded to additionally advise the Holder on the following: Ensure and monitor compliance with SI 478/303 Monitor risks and incidents Monitor quality assurance programme Review and prioritise clinical audit Patient Radiation Protection Manual 2017 Page 35

Monitor equipment, maintenance and replacement criteria Monitor staff education and training Monitor patient dose levels Other responsibilities as may be delegated by the National Radiation Safety Committee or the Competent Authority Note: Arrangements similar or additional to above, such as risk or clinical audit committees, particularly in radiotherapy, that achieve the same aims within the quality, safety and risk framework of the facility may also be considered to be appropriate. These would need to demonstrate good governance and have an integrated approach to ensure the above agenda is delivered on. It is recommended that committees meet at minimum twice per year (4 times per year in radiotherapy) and be integrated in to the governance, risk and safety framework of the organisation. It is recommended that membership includes, at a minimum: The CEO/ Hospital Manager*, or their representative, should ideally chair the Committee Risk Manager Practitioner in Charge at a minimum and the possibility for an additional Consultant Radiologist and/or Consultant Radiation Oncologist as appropriate Radiography Services Manager and/or Radiation Therapy Services Manager as appropriate Radiation Safety Officer (RSO) Radiation Protection Adviser** / Medical Physics Expert A representative from each department using ionising radiation for patients Nurse, where nurses are prescribers/operators Representation from satellite hospitals/clinics, as appropriate Consultant in Public Health Medicine Dental Practitioner, where applicable Note * The CEO/hospital manager has the corporate responsibility and should ideally chair the committee but may nominate a suitable person to chair. ** The responsibilities of the Radiation Protection Adviser are set out in SI 125 (2000) and in the conditions that the Radiological Protection Institute of Ireland attach to its licences. Patient Radiation Protection Manual 2017 Page 36

Dental Radiation Safety Committees Where these exist, it is recommended that their terms of reference are similarly extended. Their membership will differ to the above but should be reviewed and modified, where appropriate. There may be some cases where the National Radiation Safety Committee will advise a Holder to establish a Radiation Safety Committee and the National Radiation Safety Committee will make contact directly with that Holder. (b) Radiation Protection File It is recommended that all Holders keep a Radiation Protection File on site. The Medical Exposure Radiation Unit will distribute guidelines on the contents and upkeep of this file to all Holders in 2010. This file will be expected to be made available, if requested, to the Medical Exposure Radiation Unit, HSE which has a responsibility to audit clinical practice. 2. Personnel Engagement and training of persons involved in the use of ionising radiation. It is recommended that the Holder ensures that all persons involved in the use of ionising radiation have the appropriate qualifications, authorisation, registration and training required to carry out their functions in compliance with the regulations and are aware of their responsibilities. It is recommended that the holder ensures that appropriate ongoing induction and training is provided, particularly when new or updated practices are introduced and when there is a change of personnel. The Holder is required to: Designate one individual as Practitioner in Charge (a Practitioner has a specific definition in SI 478(2002)) who will recommend referral criteria for use of the facility. Designate a named Medical Physics Expert for the facility. 3. Equipment Equipment Suitability In addition to the requirements placed on the Holder by the Radiological Protection Institute of Ireland, SI 478 (2002) requires that the Holder has and maintains a written inventory of all radiological equipment and the National Radiation Safety Committee recommends that it is available if requested. Patient Radiation Protection Manual 2017 Page 37

The Holder must ensure that their equipment complies with criteria of acceptability and take appropriate action if it fails to meet the criteria, based on the advice or action of the Medical Physics Expert. National Radiation Safety Committee Recommendation The National Radiation Safety Committee is considering the use of the draft version of the European Commission Radiation Criteria for Acceptability of Radiological, Nuclear Medicine and Radiotherapy Installations (RP91). This is available to download at http://ec.europa.eu/energy. The recommendation of the National Radiation Safety Committee will be notified to Holders in a separate guidance document. The regulations currently require that the National Radiation Safety Committee authorises the extended use of all equipment beyond its anticipated lifetime. The National Radiation Safety Committee will issue guidance to Holders on how to inform the committee on the extended use of equipment. 4. Systems Adverse Incident Reporting It is recommended that Holders ensure they have systems in place to prevent and report adverse incidents. Notwithstanding the incident reporting requirements of the Radiological Protection Institute of Ireland, the National Radiation Safety Committee will issue recommendations and guidance to all Holders in 2010 on an external reporting mechanism for the reporting of adverse incidents. Clinical audit The Holder should ensure that the clinical practice is externally audited in accordance with the criteria adopted by the Irish Medical / Dental Councils at least once every five years. The National Radiation Safety Committee plans to issue guidance on external and internal clinical audit in agreement with the Irish Medical / Dental Councils. All guidance will be developed within the context of national developments resulting from the Report of the Commission on Patient Safety and Quality Assurance, 2008 and the Adverse Event, Clinical Audit and Patient Safety Protocols being developed. Quality Assurance Quality Assurance means all those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily and comply with agreed standards. Holders must ensure that appropriate quality assurance programmes are implemented. Patient Radiation Protection Manual 2017 Page 38

5. Protocols and Standards Referral criteria The Holder must ensure that referral criteria are advised to prescribers, based on the recommendation of the Practitioner in Charge. Diagnostic Reference Levels Diagnostic Reference Levels means dose levels in medical radio diagnostic practices or, in the case of radio-pharmaceuticals, levels of activity for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment. These levels are expected not to be exceeded for standard procedures when good and normal practice regarding diagnostic and technical performance is applied. Those that have been established nationally are available at http://www.hse.ie/eng/ about/who/publications_and_annual_report.html Other Responsibilities In addition to Holders responsibilities, personnel involved in the use of medical and dental ionising radiation have been assigned particular responsibilities in SI 478/303. The following is a summary and must be read in conjunction with the regulations and other laws, regulations or other responsibilities attaching to these roles. Responsibility of the Practitioner in Charge (in addition to responsibilities of the Practitioner) Recommend referral criteria. It is expected that most departments already have criteria in place for many procedures. For example, the Faculty of Radiologists has recommended the use of the RCR (UK) referral criteria recommendations for diagnostic practice and these would be an acceptable foundation on which to base local criteria. Approve adjustments to be made to the equipment that are considered necessary by the Medical Physics Expert. Responsibility of the Practitioner Clinically responsible (along with his/her colleagues) for all ionising radiation exposures performed in their institution. Clinical responsibility means responsibility regarding individual medical exposures attributed to a Practitioner, notably: justification; optimisation; clinical evaluation of the outcome; co-operation with other specialists and the staff, as appropriate, regarding practical aspects; obtaining information, if appropriate, of previous examinations; providing existing radiological information and/or records to other Practitioners and/or prescribers, as required; giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate. Patient Radiation Protection Manual 2017 Page 39

Authorise radiological procedures subject to the conditions in the regulations. May not authorise the use of a practice which has been considered by the Medical and Dental Councils and which has not been approved by them. Make arrangements to satisfy himself / herself that the procedure prescribed is justified. Consult with the Medical Physics Expert assigned to the installation on optimisation, including the consistent production of adequate diagnostic information or therapeutic outcome, patient dosimetry, and quality assurance, including quality control and the assessment and evaluation of patient doses or administered activities, and on matters relating to radiation protection concerning medical exposures. Responsibility of the Prescriber Shall state in writing reason for requesting the particular procedure. Shall enquire as to and provide the Practitioner with the pregnancy status of relevant With the Practitioner, shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure. Responsibility of the Medical Physics Expert Medical Physics Expert conducts the following activities or gives advice on the following: Patient dosimetry. The development and use of complex techniques and equipment. Optimisation, particularly in therapeutic and high dose procedures, paediatric, pregnancy and breast feeding. Quality assurance, including quality control. Periodic examinations of equipment and records, agree such adjustments to be made to the equipment subject to the approval of the Practitioner in charge, maintain a record of each examination and adjustment of equipment. Acceptance testing of new equipment and checking of equipment after major maintenance. The Medical Physics Expert must express their views on continued suitability of use of equipment beyond its anticipated lifetime, based on equipment criteria. Other matters relating to radiation protection. Patient Radiation Protection Manual 2017 Page 40

Responsibility of the Radiographer Ensure adherence to justification procedures. Advise on dose optimisation. A Radiographer appointed as Radiation Safety Officer in designated locations records and maintains records of regular Quality Control tests. The Radiation Safety Officer, records and audits patient dose information for compliance with DRLs. In Clinical Audit, the Radiographic Services Manager ensures that agreed standards and protocols are in place and adhered to. In Adverse Incident reporting relating to medical ionising radiation, the Radiographic Services Manager ensures incidents are recorded and managed according to agreed protocols. Radiation Protection in Dental Practices Dental radiography differs from medical radiography in that, in the majority of cases, the dentist acting in a single handed capacity is defacto the prescriber, the radiographer and the radiologist when a radiographic examination is required. The dentist may also, by way of being a single handed practitioner, automatically become the Practitioner in Charge for the purposes of the legislation. Outside of large organisations such as the HSE dental and orthodontic services and the Dental Schools, the majority of dental practitioners operate in a general dental practice setting with some practitioners in specialist / limited practice. As private dental practices will often be staffed by the dental practitioner, occasionally an associate and his / her support staff, it would be impractical to have a Radiation Safety Committee. Instead, dentists who are RPII x-ray licence holders are required to hold a file of compliance on site. The practice Dental Radiation or Compliance File should contain the following: A copy of the current x-ray licence including schedules 1, 2 and 3 Personnel Dosimetry reports to be held for 7 years Commissioning reports - to be held for the life time of the equipment Annual service reports to be held for the life time of the machine Maintenance reports to be held for the life time of the machine Reports from the Radiation Protection Advisor Reports from the Medical Physics Expert, including a record of the annual number of exposure per machine type, where possible Patient Radiation Protection Manual 2017 Page 41

Copy of the safety operating procedures (local rules) Clinical Audit reports and associated data Details of radiation Incidents and reports, guidelines to follow Quality assurance program data to be held for the lifetime of the machine and a record of the replacement review date for each machine Staff training and induction reports Evidence of safe disposal of developer chemistry and lead foil Any correspondence relating to the radiographic practice at that location Note: this is not an exhaustive list and additional documents may be considered necessary for inclusion. February 2010 National Radiation Safety Committee Patient Radiation Protection Manual 2017 Page 42

Appendix D: Incident Reporting Template for Diagnostic Imaging Radiological Location: Medical Record Number: PATIENT SAFETY RADIATION INCIDENT: DIAGNOSTIC IMAGING Date of Birth: Referring Clinician: Near Miss Event: Yes No Treating Clinician: INCIDENT DETAILS Date and Time of Incident: Discovered by (name & title): Estimated Effective Dose in msv: Details of Incident: Immediate Actions taken to Prevent Recurrence: INVESTIGATION Investigation policy / methodology used HSE Safety Incident Management Policy 2014 Yes No If no, please specify policy followed: Causal Factors: Patient Radiation Protection Manual 2017 Page 43

Contributory Factors: Recommendations: Reviewed by Local Radiation Safety Committee or equivalent Yes No Date: Was the HSE Open Disclosure Policy (2012) activated? Yes No If yes, please outline details of communication with patient / carer: INCIDENT TYPE Level 1: Notification to MERU not required Incorrect patient <1mSv Dose greater than intended (below notifiable levels) Incorrect anatomy (below notifiable levels) Therapeutic Nuclear Medicine administered activity different by 10-20% of that intended Inadvertent foetal dose <1mSv Level 2: Notification to MERU required Incorrect patient >1mSv Incorrect anatomy Inadvertent foetal dose >1mSv Therapeutic Nuclear Medicine given instead of diagnostic dose Child: Diagnostic overexposure (> twice) of 3mSv or 15 times dose intended Therapeutic Nuclear Medicine administered activity different by 20% of that intended Adult: Diagnostic overexposure (> twice) of 10mSv or 20 times dose intended Deterministic effects Dose given to carers without consent > medical council guidelines Any other incident (notification depends on dose) Administration of >15gy skin dose in interventional radiology Patient Radiation Protection Manual 2017 Page 44

NOTIFICATION OF STAKEHOLDERS Patient / Carer Yes No Date: Local Radiation Safety Committee or equivalent Yes No Date: Chief Executive Officer / General Manager Yes No Date: MERU Yes No Date: Other regulatory agencies, where necessary Yes No Details of agency and date notified: SIGNATURES Risk Manager: Date: Practitioner in Charge: Date: Radiology Services Manager or Radiation Safety Officer: Date: Radiation Protection Adviser / Medical Physics Expert: Date: Patient Radiation Protection Manual 2017 Page 45

Appendix E: Incident Reporting Template for Radiotherapy Radiological Location: Medical Record Number: PATIENT SAFETY RADIATION INCIDENT: RADIOTHERAPY Date of Birth: Referring Clinician: Near Miss Event: Yes No Treating Clinician: INCIDENT DETAILS Date and Time of Incident: Discovered by (name & title): Area of Discovery: CT-Sim Planning Simulator Treatment Unit Physics Check Other Radiation Therapist Check Please specify: Number Fields / Fractions involved: Radiation Dose (to be completed by physicist): <5% total dose 5-10% total dose >10% dose >20% in any one fraction Set up variation (cm) Recoverable, should this be correctable? Yes No Details of Incident: Immediate Actions taken to Prevent Recurrence: Patient Radiation Protection Manual 2017 Page 46