National Audit of Medical Radiological and Radiotherapy Practices (2012) Patient Radiation Protection

Transcription

1 National Audit of Medical Radiological and Radiotherapy Practices (2012) Patient Radiation Protection HSE Medical Exposure Radiation Unit (MERU)

2 Table of Contents Abbreviations...2 EXECUTIVE SUMMARY Introduction: Radiology and Radiotherapy Clinical Audit in Ireland Background Objectives and Scope Methodology Main Findings Questionnaire Section 1 (Radiology and Radiotherapy) Governance and oversight arrangements - Radiation Safety Committees (RSCs) Governance and arrangements for radiological clinical audit Clinical audit reports Patient identification (ID) protocols Pregnancy status protocols Patient consent protocols in radiology Patient consent protocols in radiotherapy Main Findings Questionnaire Section 2 (Radiotherapy Only) Record and verify systems Dosimetry system Imaging procedures for treatment verification Imaging commencement and throughout treatment Recommendations Conclusion References...23 Appendix A: Audit Questionnaire...24 National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 1

3 Abbreviations GM/CEO CT RPII EPA EURATOM HIQA HSE MERU MRI MU s NRSC PET QUARC R&V General Manager / Chief Executive Officer Computed Tomography Radiological Protection Institute of Ireland* Environmental Protection Agency European Atomic Energy Community Health Information and Quality Authority Health Service Executive Medical Exposure Radiation Unit Magnetic Resonance Imaging Monitor Units National Radiation Safety Committee Positron Emission Tomography Quality Assurance Reference Centre (North East, Yorkshire and The Humber) Record & Verify RSC Radiation Safety Committee SI Statutory Instrument RP-100 Radiation Protection -100 *August The RPII merged with the EPA and became the EPA Office of Radiological Protection National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 2

4 EXECUTIVE SUMMARY 1. BACKGROUND In 2007, the HSE commissioned the UK Quality Assurance Reference Centre (QUARC) to undertake a national audit to establish a baseline of current compliance with SI478 in radiology and radiotherapy, covering arrangements for clinical audit, justification and optimisation of ionising radiation equipment. QUARC produced three separate surveys, dealing with the separate areas of radiology and nuclear medicine; radiotherapy; and dentistry. The resulting report indicated that Irish facilities are committed to the principles of SI478. However challenges were evident, in a number of areas including uncertainty about how to undertake clinical audit, lack of resources to ensure that clinical audit is properly embedded into practice; a lack of quality improvement initiatives and structures to support them. Forty recommendations were made where challenges were evident, particularly concerning the structures and governance necessary to support a process for effective clinical audit. In 2012, the HSE undertook a national follow-up audit by means of a self assessment questionnaire to assess current compliance of facilities with the regulations. The follow-up audit was coordinated by a clinical audit subcommittee of the NRSC, including some members of the HSE Medical Exposure Radiation Unit (MERU). 2. OBJECTIVES The objective of this audit was to ascertain radiology and radiotherapy facilities current compliance with SI478. The 2012 audit was designed to include medical facilities using ionising radiation for radiology and radiotherapy applications in both the public and private sectors. The focus of this audit was on legislative requirements in radiological practices, with an emphasis on specific areas of practice. The scope of the audit included all 113 facilities, both public and private using medical ionising radiation for diagnosis or treatment. The audit did not include chiropractic, dexa or dental practices using medical ionising radiation. 3. SIGNIFICANT FINDINGS 5.1 Governance and oversight arrangements Radiation Safety Committees (RSCs) All questionnaire respondents stated that they had an RSC in place; this is an improvement from the results of the 2008 QUARC report in which 81% of facilities had an RSC. Ninety nine percent had RSCs comprised of the required membership, and their RSCs were accountable to the hospital GM/CEO. The majority of hospitals (68%) had minutes of meetings held within the last six months, while a further 28% of hospitals had minutes of meetings held within the last 6 to 24 months 5.2 Governance and arrangements for radiological clinical audit More than half of questionnaire respondents had elements of the recommended governance arrangements in place for radiological clinical audit. The percentage of facilities with radiological clinical audit programmes, however, was much lower than the percentage of facilities with RSCs in place; this is an area in radiology which needs assistance in implementing audit to comply with SI Clinical audit reports In radiology, there is broad variation in the range of data returned on written protocols (27% -83%). The area with the lowest number of written protocols was reject analysis (27%). Only 58% of radiology facilities had protocols for referral criteria, although this is a requirement of SI478. Forty three per cent of facilities reported having a written protocol on DRLs while 55% of facilities reported conducting audit on this subject; this is an area that requires further validation. Other areas which require auditing on a continuing basis include: patient identification, pregnancy status questioning, and patient consent. In respect of radiotherapy, all 12 facilities indicated they had protocols in place in relation to patient ID, pregnancy status questioning, patient consent, treatment preparation/verification, treatment prescription, planning procedures, treatment delivery, imaging for treatment verification, and record and verify systems. 5.4 Patient ID protocols In radiology, there is a high level of incidents in relation to patient ID reported to MERU and, as such, this subject requires consistent monitoring by internal and external audit. Ninety per cent of facilities reported having a written protocol for identifying patients for radiological practices, and all radiotherapy facilities (100%) had an additional requirement with photo identification. Only 71% of facilities asked the patient to state full name, address and date of National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 3

5 birth ; it is important that this is specified in all patient ID protocols. 5.5 Pregnancy status protocols Ninety eight per cent of facilities reported having a written protocol for the management of the potentially pregnant patient; however, only 30% had completed an audit on this protocol. This is an important area where audits need to be conducted on a regular basis to ensure compliance with SI478. Forty seven per cent of facilities reported not having a protocol in place to estimate the inadvertent dose to the foetus; this is important as Medical Council Policy (amended RP100) states that, where the foetus is exposed, an estimate of dose/risk is required prior to a planned exposure or after an inadvertent exposure. 5.6 Patient consent protocols in radiology Responses to the self-assessment questionnaire indicated an inconsistent approach to patient consent in radiology, and it was estimated that consent is implied in the majority of radiology procedures. It is unclear from the responses if patient consent for procedures includes consent specific to the radiation risk involved. 5.7 Patient consent protocols in radiotherapy There is a more consistent approach to patient consent in radiotherapy. All 12 radiotherapy facilities reported having a written protocol on patient consent. Patient information in relation to the benefit/risks of the treatment procedure was available in all radiotherapy facilities and written consent was required. 6.1 Radiotherapy - Record and verify (R&V) systems R&V systems were developed to reduce the risk of treatment errors in radiotherapy, especially data transfer errors. All 12 radiotherapy facilities surveyed reported having an R&V system in place, as well as the practitioner in charge or an assigned individual with responsibility to ensure that the R&V protocol is implemented appropriately. 6.2 Radiotherapy - Dosimetry system Eleven of the 12 radiotherapy facilities reported that there was some form of dosimetry system employed to measure the radiation dose received by the patient; the most popular device used was diodes followed by portal imaging and semi conductors. All of the facilities with a dosimetry system in place also had a written protocol to support its use and a designated practitioner with responsibility for its implementation. Best practice recommends that the initial patient dose measurements in respect of radiation received by the patient should be taken and recorded within the first two days of treatment; 9 of the 11 facilities with a dosimetry system had a protocol which fulfils this requirement. Ten facilities used recording systems to place the dosimeters on the patient s skin or surface entrance where the radiation beam strikes the patient; in three facilities an exit dosimeter was also used. In four of the facilities, the action level for follow up investigation was set at a discrepancy of +/- 10% of the prescribed dose; the remaining facilities use threshold levels other than +/- 15% or +/- 20%. 6.3 Radiotherapy - Imaging procedures for treatment verification All 12 radiotherapy facilities reported using MV imaging to validate the correct treatment location. One location recorded ultrasound as a method of imaging for treatment verification. Eleven facilities reported having a written protocol for treatment verification in place, and the practitioner in charge/designated individual has a responsibility to ensure that the protocol is being implemented properly. 6.4 Radiotherapy - Imaging commencement and throughout treatment The most popular frequency reported for imaging throughout treatment was weekly portal imaging, with 10 out of the 12 centres performing imaging at this rate. In those centres that had cone beam CT imaging, five out of nine indicated a weekly frequency. The centre that used ultrasound performed the imaging on a daily basis. kv orthogonal imaging was used in four facilities on every fraction with the remaining three performing it weekly. 4. PRINCIPLE RECOMMENDATIONS 1. The audit highlighted issues which need to be resolved in clarifying accountability and responsibilities in relation to the local Radiation Safety Committees. The MERU and NRSC should work together to clarify and provide guidance on any issues relating to these responsibilities. 2. The HSE should follow up with the nine organisations that did not respond to the self-assessment audit. 3. Further to the NRSC Guidance (2010), hospital RSCs should meet at least every six months and RSCs at radiotherapy facilities should meet every three months. Minutes of these meetings should be available for review and audit. 4. A radiological clinical audit working group with a reporting line to the hospital GM/CEO should be in place in all facilities using ionising radiation. Minutes of these meetings should be available for review and audit. Protocols National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 4

6 for radiological clinical audit should be established at all facilities. Records of audits undertaken and findings implemented to support change must be documented and available for review. All facilities should have evidence that audits are conducted, outcomes of these audits are addressed, and plans are in place to re-audit. 5. All facilities must have protocols in place for justification/referral criteria, patient dose/drls, reject analysis, and image quality and optimisation. These protocols should be developed immediately. 6. All facilities should review the online irefer guidelines, facilitated by MERU. 7. All facilities should ensure that written patient ID protocols include the requirement to ask patient to state full name, address and date of birth. They should address situations where patients are incapacitated and therefore unable to identify themselves; and specify that the patient ID is checked at every point of the interaction with health service personnel & for every visit. All facilities should ensure that there is documentary evidence that each request (electronic or written) is matched to patient ID; and that, immediately prior to procedure/treatment, the operator checks that the procedure/treatment matches the patient ID. All facilities should ensure that incidents relating to patient ID are recorded and dealt with in a manner that minimises the recurrence of these incidents, and that learning is shared. 8. All facilities should have a written protocol for the management of the potentially pregnant patient, and a policy to audit the implementation of this protocol. Evidence of audit should be available for review when required. The protocol must require that the pregnancy status of females of childbearing age is recorded, and it should also address situations where the person is unable to respond to the enquiry, e.g., deafness, language barrier, children, etc. Where a pregnant patient has received a procedure using ionising radiation, all facilities should have a process to calculate and record the dose to the foetus as well as a system to record incidents of irradiation of the foetus and take appropriate action to minimise the recurrence, where possible. 9. All facilities should use the HSE National Consent Policy as the basis for the development of guidelines for valid patient consent. MERU should issue guidance on patient consent to facilities in the near future; this should also be included in the next update of the MERU Template for Developing a Patient Radiation Protection Manual (2013). This guidance should include the recommendation that a written protocol for patient consent in high dose radiology procedures is available in all facilities. 10. Radiotherapy facilities only: All radiotherapy facilities should have the ability to record the radiation doses received by patients during their treatment; this should be a real time device that gives an instantaneous reading. All facilities should ensure that the written protocol for in vivo dosimetry dictates that the initial patient dose measurements are taken and recorded within the first two days, and that there is documentary evidence that this is carried out in practice. In terms of action level, all facilities should agree on and implement the same threshold levels for the different individual treatment sites. Radiotherapy facilities should perform imaging on day one of treatment for all patients being treated on mega voltage machines. All facilities should have, at a minimum, one weekly imaging protocol verification. 5. CONCLUSION The findings from this audit provide an insight into current practices and protocols in relation to clinical audit in radiology and radiotherapy in Ireland. Clinical audit, which is a requirement of SI478, is progressing slowly in many facilities. It is important that all facilities have evidence that audits are being performed and the outcomes of these audits are addressed. Furthermore, facilities should have a plan in place to re-audit the changes implemented. The findings from this audit have highlighted issues which need to be resolved in clarifying accountability and responsibilities in relation to the local Radiation Safety Committees. The HSE (MERU) and the NRSC should work together to clarify and provide guidance on any issues relating to these responsibilities. A number of areas were recommended for future audits or reviews in order to enhance clinical audit in radiology and radiotherapy in Ireland, including: site visits to review documentary evidence of compliance; analysis of RSCs governance; evaluation of clinical audit working groups and representation; and external audit of services to ascertain compliance with standards and legislation. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 5

7 1.0 Introduction: Radiology and Radiotherapy Clinical Audit in Ireland Clinical audit is the systematic review and evaluation of current practice against research based standards with a view to identifying gaps that exist in clinical care and subsequently improving clinical care for service users. The Health Service Executive (HSE) recognises clinical audit as a reliable method of: Proactively measuring the effectiveness and performance of healthcare against agreed standards for high quality. Improving the quality of care provided to service users by identifying action to bring practice in line with these standards. Providing the assurance of quality to service users, practitioners and to the health system as a whole. The Department of Health and Children report of the Commission on Patient Safety and Quality Assurance (2008) observes that clinical audit constitutes the single most important method any healthcare organisation can use to understand and assure the quality of the service that it provides. A significant number of publications and legislation have been introduced, specific to radiological practices. European legislation requires all member states to ensure regular clinical audit of practice. The terms of the Treaty establishing the European Atomic Energy Community (EURATOM) established uniform safety standards to protect the health of workers and of the general public against the dangers arising from ionising radiation. The Medical Exposure Directive 97/43/EURATOM (30 June 1997) relates specifically to radiation protection of patients and other individuals submitted to medical exposure. Article 6.4 of the directive states that clinical audit shall be carried out in accordance with national procedures. The European Commission also published Guidelines on Clinical Audit for Medical Radiological Practices (Diagnostic Radiology, Nuclear Medicine and Radiotherapy) (2009) to support the related directives. Statutory Instrument SI478 (2002) European Communities (Medical Ionising Radiation Protection) Regulations 2002 transposed 97/43/EURATOM into Irish law. Section 15.1 of SI478 pertains to clinical audit, and states that that Irish Medical and Dental Councils should adopt criteria for audit in consultation with the Faculty of Radiologists of the Royal College of Surgeons of Ireland (RCSI). This was undertaken and published as the Requirements for Clinical Audit in Medical Radiological Practices (Diagnostic Radiology, Radiotherapy and Nuclear Medicine) (2011). Article 15.3 states that Each holder shall ensure that the clinical practice conducted in his or her installation or installations, is audited in accordance with the criteria adopted under paragraph 15.1 at least once every five years and the first audit under these regulations shall be undertaken not later than three years from the date of adoption of the criteria for clinical audit specified in paragraph In 2010, the HSE National Radiation Safety Committee (NRSC) issued guidance to holders of medical/dental ionising radiation equipment in Ireland in respect of their responsibility for patient radiation protection, to ensure compliance with SI478. The document addressed some of the key responsibilities of holders to assist them to comply with the relative provisions of the regulations. It also provided some advice on implementation issues, such as governance structures 2.0 Background 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. Clinical audits have the ability to inform the health system about essential elements of quality through comparing every day practices National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 6

8 in the health service against standards set, and identifying gaps that exist in clinical care. Audit highlights areas for improvement and provides reassurance on areas such as safety and efficacy, all of which are essential in creating an environment of continuous development. In 2007, the HSE commissioned the UK Quality Assurance Reference Centre (QUARC) to undertake a national audit to establish current compliance with SI478 in radiology and radiotherapy in Ireland. It was expected that this audit would establish a benchmark against which future audits could be conducted, contributing to a continuous quality improvement for the benefit of the patient. The objective of the audit was to ascertain compliance with SI478 which cover arrangements for clinical audit, justification and optimisation of ionising radiation equipment in medicine and dentistry. QUARC produced three separate surveys, dealing with the separate areas of radiology and nuclear medicine; radiotherapy; and dentistry. All holders of ionising radiation equipment were identified by the register held by the Radiation Protection Institute of Ireland (RPII). The resulting report (2008) indicated that Irish facilities are committed to the principles of SI478. However challenges were evident in a number of areas including uncertainty about how to undertake clinical audit; lack of resources to ensure that clinical audit is properly embedded into practice; and a lack of quality improvement initiatives and structures to support them. Forty recommendations were made where challenges were evident, particularly concerning the structures and governance necessary to support a process for effective clinical audit. In 2012, the HSE undertook a national follow-up audit by means of a self assessment questionnaire to assess current compliance of facilities with the regulations. The follow-up audit was coordinated by a clinical audit sub-committee of the NRSC, including some members of the HSE Medical Exposure Radiation Unit (MERU). However, changes in MERU staff necessitated the revalidation of some audit data and a report produced by current staff of MERU. 3.0 Objectives and Scope The objective of this audit was to ascertain radiology and radiotherapy facilities current compliance with SI478. It was designed to include medical facilities using ionising radiation for radiology and radiotherapy applications in both the public and private sectors. The focus of the audit was on legislative requirements in radiological practices, with an emphasis on specific areas of practice in radiology and radiotherapy. The scope of the audit included all facilities, both public and private, using medical ionising radiation for diagnosis or treatment. These facilities included 113 public and private hospitals, varying from small hospitals with a simple diagnostic X-ray unit, up to larger hospitals offering more complex services such as PET/CT and radiotherapy. The audit did not include chiropractic, dexa or dental practices using medical ionising radiation. 4.0 Methodology In order to achieve the objectives of this audit, a committee was established to advice on the development and design of the national baseline self-assessment questionnaire (see Appendix A). The aim of the questionnaire was to obtain an insight into the way in which clinical audit is structured and carried out at local level. The questionnaire was informed by a number of documents relating to: governance of radiation safety; clinical audit processes; patient identification protocols; pregnancy protocols, and patient consent. Related documents are listed in Section 9.0 References of this report. The questionnaire was divided into two parts. The first part contained general questions relating to both radiology and radiotherapy. The second part related specifically to radiotherapy to assess compliance on issues and concerns from a patient safety perspective in respect of the 12 public and private radiotherapy centres in Ireland. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 7

9 The questionnaire was piloted at four hospitals. Following feedback from the pilots and necessary revisions, the final questionnaire was circulated to the 113 public and private hospitals included in the audit. Facilities varied in both size and complexity ranging from providing general diagnostic X-ray services up to very complex services including radiotherapy. Data returned was signed off by each facility s GM/CEO, the Practitioner in Charge, and the Radiography / Radiotherapy Services Manager. Responses were analysed and, where the team felt questionnaires were incorrectly completed or responses were ambiguous, data was validated at individual hospitals to verify responses. Some facilities advised that they had difficulty supplying accurate data due to the absence of good data collection systems. NB: Please note in all graphs included in this report, N/R stands for no response to the question posed. 5.0 Main Findings Questionnaire Section 1 (Radiology and Radiotherapy) There was an excellent response rate of 92% (104) from the 113 facilities included in the audit. 5.1 Governance and oversight arrangements - Radiation Safety Committees (RSCs) As per the NRSC Guidance (2010), all facilities using radiation are required to have a Radiation Safety Committee (RSC) as a licence requirement under SI NO 125 (2000) (with the exception of single x-ray unit departments); the RSC also has a responsibility to monitor compliance with SI NO 478 OF The hospital GM/CEO has corporate responsibility for the RSC. It is recommended that committees meet at minimum twice per year (four times per year in radiotherapy) and be integrated in to the governance, risk and safety framework of the organisation. As per Figures 1 and 2 below, all questionnaire respondents stated that they had an RSC in place; this is an improvement from the results of the 2008 QUARC report in which 81% of facilities had an RSC. In the 2012 audit 99% of facilities had RSCs comprised of the required membership, and their RSCs were accountable to the hospital GM/CEO. The majority of hospitals (68%) had minutes of meetings held within the last six months, and overall 97% of hospitals reported having minutes of meetings held within the last two years. Figure 1: Governance and Oversight of RSCs National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 8

10 Figure 2: When RSC meetings took place and minutes available Recommendations regarding governance and oversight arrangements for compliance with SI478: Further to the NRSC Guidance (2010), hospital RSCs should meet at least every six months and RSCs at radiotherapy facilities should meet every three months. Minutes of these meetings should be available for review and audit. 5.2 Governance and arrangements for radiological clinical audit Clinical audit is a multi-disciplinary and multi-professional activity. It requires representatives from all disciplines working in radiology and radiotherapy. Local audit groups should ensure that there are representatives from all aspects of the service. According to the NRSC (2010), there is a requirement for a clinical audit group to be established in all facilities using ionising radiation. The clinical audit group is responsible for developing local protocols appropriate to the facility to support patient safety. The audit group should ensure that all aspects of the service, structure, process and outcomes are focused on. The practitioner in charge has the responsibility to ensure the facility has a radiological clinical audit programme in place. The Medical Council Criteria for Clinical Audit (2004) advises that an audit committee within the Radiological installation should be led by a senior clinical radiologist, nuclear medicine physician or radiation oncologist, and should be broadly based with participation by all sectors of the departmental staff, management representatives and representatives of the department s customers i.e. referring physicians and patients. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 9

11 Figure 3: Governance and Oversight of Radiological Clinical Audit As per Figure 3 above, more than half of questionnaire respondents had elements of the recommended governance arrangements in place for radiological clinical audit. The percentage of facilities with radiological clinical audit programmes, however, was much lower than the percentage of facilities with RSCs in place. As previously stated, this is an area in radiology which needs assistance in implementing audit to comply with SI478. All facilities are required to have a clinical audit programme and working group in place. External audit may prompt facilities of the requirement to implement these necessary structures. Recommendations regarding governance/ arrangements for radiological clinical audit: A radiological clinical audit working group with a reporting line to the hospital GM/CEO should be in place in all facilities using ionising radiation; the clinical audit group may report through the RSC. Minutes of these meetings should be available for review and audit. Protocols for radiological clinical audit should be established at all facilities using ionising radiation for diagnostics or treatment. Records of audits undertaken and findings implemented to support change must be documented and available for review. 5.3 Clinical audit reports Facilities were requested to report what clinical areas had been audited from 2010 to They were also asked what audit reports were available and whether recommended changes were implemented as a result of the audits. The following Figures 4 and 5 outline the status of audits conducted in a number of clinical areas. Please note: Figure 4 illustrates the responses specific to diagnostic radiology and nuclear medicine, whilst Figure 5 illustrates the responses to radiotherapy. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 10

12 Figure 4: Clinical Audit Status Diagnostic Radiology In Diagnostic Radiology only (Figure 4 above) there is broad variation in the range of data returned on written protocols (27% -83%). The area with the lowest number of written protocols was reject analysis (27%) whilst pregnancy status questioning had the highest number of protocols (83%). With the advent of digital systems in radiography, there is no longer a simple method to conduct reject analysis, and this remains a challenge for facilities. Previously, the majority of facilities used film screen combination which facilitated the reject analysis process. Only 58% of radiology facilities had protocols for justification /referral criteria. It is hoped that the online irefer guidelines, provided by MERU to each facility, will improve these results. SI478 states in section 14.2 that The practitioner in charge of an installation shall recommend referral criteria for prescribers and in 14.3 The holder shall ensure that the criteria referred to in paragraph 14.2 are advised to prescribers. In relation to patient dose diagnostic reference levels (DRLs), there appears to be some confusion. Forty three per cent of facilities reported having a written protocol on DRLs while 55% of facilities reported conducting audit on this subject. This implies that audits may have been conducted in a number of facilities without related written protocols in place. This is an area that requires further validation, preferably by external audit. It is stated in SI478 section 11.1 that The Medical and Dental Councils shall promote the establishment and the use of standard diagnostic reference levels. The following areas were of particular concern and require auditing on a continuing basis. 81% of facilities indicated they had a written protocol for patient ID whilst only 38% had completed an audit on patient ID protocols. The majority of facilities (83%) reported they had a written protocol on the pregnancy status questioning with only 27% reporting that they had audited this protocol. 45% of facilities indicated they had a written protocol for patient consent whilst only 7% had completed an audit on patient consent. Consent in radiology is an area of some concern as National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 11

13 valid consent in radiology needs to be defined. Valid consent is required particularity in high dose and high risk areas. Recommendations regarding clinical audit: All facilities using ionising radiation must have protocols in place for justification/referral criteria, patient dose/drls, reject analysis, and image quality and optimisation. These protocols should be developed immediately. All facilities should review the online irefer guidelines, provided by MERU to each facility. It is important that all facilities have evidence that audits are conducted and the outcomes of these audits are addressed. Furthermore, facilities should have a plan in place to re-audit the changes implemented, in accordance with the Requirements for Clinical Audit in Medical Radiological Practices (2011). The facilities that were identified as not having performed any audits will be communicated with directly. This will help ensure that all facilities understand the requirement under SI478 to have a clinical audit process in place. Figure 5: Clinical Audit Status - Radiotherapy In respect of radiotherapy facilities, as outlined in Figure 5 above, 75% - 100% of facilities had written protocols for the clinical audit areas listed; but audit reports were available in only 8% - 67% of the clinical audit areas. All radiotherapy facilities indicated they had a Patient ID/Pregnancy and consent protocol in place. They also indicated that they had a protocol for treatment preparation/verification protocol, treatment prescription, planning procedures, treatment delivery protocol, imaging protocols for treatment verification and record and verify written protocols in place. Eleven out of the 12 facilities indicated they had an in vivo dosimetry system in place. Further to the self-assessment questionnaire administered as part of this audit, a number of facilities indicated that they had implemented changes in their approach to clinical audit and were planning a number of subsequent audits and re-audits. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 12

14 5.4 Patient identification (ID) protocols In radiology, there is a high level of incidents in relation to patient ID reported to MERU and, as such, this subject requires consistent monitoring by internal and external audit. Patient ID errors are common in radiology but not in radiotherapy; in radiotherapy, there is a more rigorous patient ID process in place as the three point ID policy along with photo identification has almost eliminated this type of incident occurring. This subject is covered in Section 5: Patient Protocols of the MERU document Template for Developing a Patient Radiation Protection Manual (2013). Whilst there are a number of recommendations for what should be included in Patient ID protocols, a critical component is that the practitioner should specifically ask the patient to state their full name, address and date of birth. As per Figure 6, 90% of facilities reported having a written protocol for identifying patients for radiological practices, and all radiotherapy facilities (100%) had an additional requirement for photo identification. Due to the ongoing problems encountered in radiology, all facilities should have written protocol and audit of this protocol available. Only 71% of facilities asked the patient to state full name, address and date of birth ; it is important that the protocol specifies that the patient is asked to state the full name, address and date of birth, as patients may answer to an incorrect name or several patients may have similar names. Figure 6: Protocols Relating to the Identification of Patients for Ionising Radiation Examination or Treatment National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 13

15 ***Incidents concerning patient misidentification in the period 2010 to 2011** A separate query was posed seeking to know how many incidents concerning patient misidentification were recorded at each facility (radiology and radiotherapy) from Jan 2010 through to December Out of a total of 98 responses, (53%) reported they had no patient misidentification incidents during this time. Twenty five per cent of facilities reported between two and five incidents and 13% reported a single incident. Six per cent reported they had between 6 to 19 incidents. In radiology, frequent incidents of patient misidentification occur and are reported to MERU. It is unlikely that more than 80% of the facilities had no incidents concerning patient ID in a two year period; the fact that a number of facilities did not record incorrect patient ID incidents does not mean that they did not occur. Facilities should check the availability of records of patient ID misidentification with regular audits. Recommendations regarding patient ID protocols: All facilities should ensure that written patient ID protocols include the requirement to ask patient to state full name, address and date of birth ; that they address situations where patients are incapacitated and therefore unable to identify themselves; that they specify that the patient ID is checked at every point of the interaction with health service personnel & for every visit. All facilities should ensure that there is documentary evidence that each request (electronic or written) is matched to patient ID; and that, immediately prior to procedure/treatment, the operator checks that the procedure/treatment matches the patient ID. All facilities should ensure that incidents relating to patient ID are recorded and dealt with in a manner that minimises the recurrence of these incidents, and that learning is shared. 5.5 Pregnancy status protocols SI478 requires that medical exposures carried out on pregnant females shall be done in accordance with procedures approved by the Medical and Dental Councils. The RPII Guidelines on the protection of the unborn child during diagnostic medical exposures (2010), which were developed in collaboration with the Medical Council, provide a concise summary of the actions to be taken when dealing with women of childbearing age. This requires that, for relevant examinations, the pregnancy status of female patients be established and certain processes followed thereafter. It is important that all facilities are compliant with the RPII Guidelines. This subject is also covered in Section 4: Patient Pregnancy Protocols of the MERU document Template for Developing a Patient Radiation Protection Manual (2013). As per Figure 7, good compliance was reported in this area with 98% of facilities stating they had a written protocol for the management of the potentially pregnant patient; however, only 30% reported having audited this protocol. This is an important area where audits need to be conducted on a regular basis to ensure compliance with SI478. In 93% of facilities, the written protocol requires that the pregnancy status is recorded. This is a legislative requirement, and all facilities should be required to record the pregnancy status of females of childbearing age. Thirty eight per cent of facilities reported that, in the event of a foetus being exposed to ionising radiation, either intentionally in the case of a clinical waiver (justification) or inadvertently, there is a protocol in place to estimate the dose to the foetus. Forty seven per cent of facilities reported not having a protocol in place to estimate the inadvertent dose to the foetus and 15% stated they have a partial protocol in place. This is important as Medical Council Policy states that, where the foetus is exposed, an estimate of dose/risk is required prior to a planned exposure or after an inadvertent exposure. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 14

16 Figure 7 Protocols relating to the pregnancy status for female patients of child-bearing age ** Incidents concerning irradiation of the foetus recorded from 2010 to 2012 ** A separate query was posed seeking how many incidents concerning irradiation of a pregnant patient were recorded at each facility from April 2010 to December % of facilities reported between two and five incidents of inadvertent exposure of the foetus and 13% reported a single incident. 82% of facilities reported no incidents. Any significant incidents of a radiation dose to the foetus are reportable to the MERU and the EPA s Office of Radiological Protection. Recommendations regarding pregnancy status protocols: All facilities must have a written protocol for the management of the potentially pregnant patient, and a policy to audit the implementation of this protocol. Evidence of audit should be available for review when required. The protocol must require that the pregnancy status of females of childbearing age is recorded, and it should also address the situation where the person is unable to respond to the enquiry, e.g., deafness, language barrier, children, etc. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 15

17 All facilities should have a process in place to calculate and record the dose to the foetus where a pregnant patient has had a procedure using ionising radiation. Each facility should have a system in place to record incidents of irradiation of the foetus and take appropriate action to minimise the recurrence, where possible. 5.6 Patient consent protocols in radiology Valid consent is required for radiology procedures and all radiotherapy treatments, and each department should have a protocol in place for patient consent. The HSE National Consent Policy requires that the patient is informed, understands the risks and benefits and is given time to enable them to exercise the right to make an informed decision about their investigations and treatment. This subject is referenced in Section 5: Patient Protocols of the MERU document Template for Developing a Patient Radiation Protection Manual: For facilities using medical ionising radiation (2013). The self-assessment questionnaire posed a number of queries in relation to patient consent protocols, although they did not did not address whether or not the radiation aspect of the procedure was included in the protocols. The responses to this question indicate an inconsistent approach to patient consent in radiology. It was estimated that consent is implied in the majority of radiology procedures. Findings were as follows, by modality: General X-ray: Thirty per cent of facilities reported they had a written protocol on patient consent, with 6% reporting that written consent is required. The vast majority of facilities reported that consent for general x-ray procedures is implied. Three per cent of facilities reported that if verbal consent is obtained this is documented in the patient s healthcare record. 27% of facilities reported that the patient is given information related to risk-benefit in general x-ray. Interventional/Fluoroscopy: This is an area in radiology where procedures can deliver high radiation doses to patients. Sixty nine per cent of facilities have a written protocol on patient consent, with 76% reporting that written consent is required. Twenty nine per cent of facilities indicated that if verbal consent is given it is documented in the patient healthcare record. Seventy nine per cent of facilities reported that the patient is given information related to risk-benefit in interventional/fluoroscopy. Computed Tomography (CT): CT is an area in radiology where procedures can deliver high radiation doses to patients. Only 32% of facilities have a written protocol on patient consent, with 15% reporting that written consent is required. Thirty five per cent of facilities reported that verbal consent is required, although only 6% report documenting this in the patient healthcare record. Thirty two per cent of facilities reported that the patient is given information related to risk-benefit in CT. Nuclear Medicine:. Thirty one per cent of facilities reported they had a written protocol on patient consent, with 12% reporting that written consent is required. The majority of facilities reported that consent for nuclear medicine procedures is verbal although no facility report documenting this in the patient healthcare record. Sixty five per cent of facilities reported that the patient is given information related to risk-benefit in Nuclear Medicine. Positron Emission Tomography/Computed Tomography (PET/CT): PET/CT is an area in radiology where procedures can deliver high radiation doses to patients due to the combined modalities of PET and CT. Fifty seven per cent of facilities reported they had a written protocol on patient consent. No facilities reported that written consent is required. The vast majority of facilities reported that consent for PET/CT procedures is verbal although only 14% report documenting this in the patient healthcare record. Twenty nine per cent of facilities reported that the patient is given information related to risk-benefit in PET/CT. Dexa: Twenty nine per cent of facilities reported they had a written protocol on patient consent, with 7% reporting that written consent is required. Fifty one per cent of facilities reported that consent for National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 16

18 DXA procedures is verbal, with 7% report documenting this in the patient healthcare record. Fifty one per cent of facilities reported that the patient is given information related to risk-benefit in DXA. Patient consent in radiotherapy There is a more consistent approach to patient consent in radiotherapy. All 12 radiotherapy facilities reported having a written protocol on patient consent. Patient information in relation to the benefit/risks of the treatment procedure was available in all radiotherapy facilities and written consent was required. The question asked in the questionnaire related to consent for the procedure overall, and it did not address whether or not the risks/benefits of the radiation aspect of the procedure was included in the consent policy. It is important to note that obtaining patient consent for a procedure does not cover the ionising radiation risks involved in the process. Recommendations regarding patient consent protocols: All facilities using medical ionising radiation should use the HSE National Consent Policy as the basis for the development of guidelines for valid patient consent. MERU should issue guidance on patient consent to radiology and radiotherapy facilities in the near future; this should also be included in the next update of the MERU Template for Developing a Patient Radiation Protection Manual (2013). This guidance will include the recommendation that a written protocol for patient consent in high dose radiology procedures should be available in all facilities. 6.0 Main Findings Questionnaire Section 2 (Radiotherapy Only) There are 12 radiotherapy centres throughout Ireland, three of which operate under a common public network.. The twelve centres include public and private facilities. To assess compliance on S478 from a patient safety perspective, the radiotherapy section of the audit focused on very specific issues. 6.1 Record and verify systems Record and verify (R&V) systems were developed to reduce the risk of treatment errors in radiotherapy, in particular data transfer errors. R&V systems are comprised of software modules that independently record and validate the treatment parameters the patient receives during their treatment. These have recently evolved into complete radiotherapy information management systems that interface with imaging, treatment planning computers and treatment delivery systems. As per Figure 8 below, all twelve radiotherapy facilities surveyed reported having an R&V system. One department has an external beam device that is not linked to the R&V system. There are procedures in all facilities for checking the R&V system prior to treatment. In all facilities the practitioner in charge or an assigned individual has responsibility to ensure that the R&V system protocol is being implemented appropriately. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 17

19 Figure 8 Use of R&V Systems in Radiotherapy 6.2 Dosimetry system Dosimetry systems are used to record patient doses. There are a number of measuring devices and methods available to monitor radiation dose delivered to the patient. Eleven of the 12 radiotherapy facilities (91%) reported that there was some form of dosimetry system employed to measure the radiation dose received by the patient; the one centre without a dosimetry system at time of audit has installed a system since this audit was conducted. The most popular device used was diodes followed by portal imaging and semi conductors. There should be a written set of instructions outlining the practical use of the measuring device, the tolerance limits, and the subsequent actions in the event of these being exceeded. As per Figure 9, all of the facilities that reported having a dosimetry system in place also reported having a written protocol to support its use and a designated practitioner with responsibility for its implementation. Figure 9 Protocols Relating to the Use and Timing of In-vivo Dosimetry for Radiotherapy Best practice recommends that the initial patient dose measurements in respect of radiation received by the patient should be taken and recorded within the first two days of treatment. In nine of the 11 facilities that have a dosimetry system, the dosimetry protocol requires a measurement of the radiation dose received by the patient to be performed within the first two days of treatment. In the remaining two facilities, the time frame for the first measurement is on day three/four of the treatment, or at the discretion of the practitioner. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 18

20 Almost all (10 out of 11) of the facilities using a dosimetry system use recording systems which require placement of the dosimeters on the patient s skin or surface entrance where the radiation beam strikes the patient. The dosimeters are either placed on the central or in an off axis location. In three of the facilities an exit dosimeter is also used. In answer to the question does the protocol specify action required to be taken at the following thresholds, the action level for follow up investigation was set at a discrepancy of +/- 10% of the prescribed dose in four out of the 11 facilities using dosimetry devices. The remainder use threshold levels other than +/- 15% or +/- 20%. Recommendations regarding dosimetry systems: All radiotherapy facilities should have the ability to record the radiation doses received by patients during their treatment. This should be a real time device that gives an instantaneous reading. All radiotherapy facilities should ensure that the written protocol for in vivo dosimetry dictates that the initial patient dose measurements should be taken and recorded within the first two days, and that there is documentary evidence that this is carried out in practice. In terms of action level, all radiotherapy facilities should agree on and implement the same threshold levels for the different individual treatment sites. 6.3 Imaging procedures for treatment verification There are two fundamental prerequisites for the successful delivery of radiotherapy to ensure the patient receives the correct radiation dose to the correct anatomy. The first part is achieved by the use of a radiation monitor, as discussed in the previous dosimetry section. The second part, ensuring the correct anatomy is treated, is monitored by imaging the treatment site either before or during treatment. There are various devices or imaging modalities used to perform this function with the vast majority using some form of ionising radiation (MV or kv). MV is employing the lowest photon beam from the linear accelerator which refers to a diagnostic type energy obtained from an x-ray unit attached to the Linac. With kv imaging, this can either be used as a cone beam CT system or a conventional x-ray imaging modality. All twelve radiotherapy facilities reported using MV imaging to validate the correct treatment location. One location recorded ultrasound as a method of imaging for treatment verification. A written protocol for treatment verification indicates the frequency and number of images required for each treatment course. Eleven (91%) facilities reported having a written protocol for treatment verification in place, and the practitioner in charge/designated individual has a responsibility to ensure that the protocol is being implemented properly. In one department that employs MV imaging, the MUs (Monitor Units) used in verification are included in the overall planned treatment dose. 6.4 Imaging commencement and throughout treatment Radiotherapy facilities were asked at which point they commence imaging and how frequently throughout treatment. The most popular frequency reported for imaging throughout treatment was weekly portal imaging, with ten out of the twelve centres performing imaging at this rate. One centre performed portal imaging on every fraction with one other department not specifying the frequency. In those centres that had cone beam CT imaging, five out of nine indicated a weekly frequency, with the remaining four performing cone beam CT at frequencies other than daily, weekly or bi-weekly. The centre that used ultrasound performed the imaging on a daily basis. kv orthogonal imaging was used in four facilities on every fraction with the remaining three performing it weekly. National Audit of Medical Radiological and Radiotherapy Practices (2012): Patient Radiation Protection 19