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Final Report DEVELOPMENT OF BEST PRACTICE PROFESSIONAL SUPERVISION AND REPORTING STANDARDS FOR RADIOLOGISTS JUNE 2006 2 June 2006 Ms Jane Grimm Manager Quality Use of Diagnostic Imaging Program Royal Australian and New Zealand College of Radiologists Level 9, 51 Druitt Street Sydney NSW 2000 Development of Professional Supervision and Reporting Standards for Radiologists - Final Report Dear Jane In accordance with the project terms of reference, we are pleased to enclose our Final Report in relation to the abovementioned project. The report includes a summary of the information gathered during the scoping stage of the project and includes the proposed Standards developed, regarding professional supervision and reporting. We would like to express our thanks for the assistance and support we have received, from both the College and yourself, throughout the duration of this project. We look forward to working with you again in the future. Yours faithfully AUSTRALIAN HEALTHCARE ASSOCIATES Peter C Geary Director Final Report DEVELOPMENT OF BEST PRACTICE PROFESSIONAL SUPERVISION AND REPORTING STANDARDS FOR RADIOLOGISTS JUNE 2006 Table of Contents Acronyms ................................................................................................................................................4 1. Executive Summary.........................................................................................................................5 2. Introduction....................................................................................................................................10 2.1 The Royal Australian and New Zealand College of Radiologists............................................10 2.2 Project Task............................................................................................................................10 2.3 What is a Standard? ...............................................................................................................10 2.4 The Practice of Radiology.......................................................................................................11 2.5 Assuring Quality .....................................................................................................................11 2.6 Purpose ..................................................................................................................................11 2.7 Scope .....................................................................................................................................11 3. Methodology ..................................................................................................................................12 Stage 1 - Scoping Study ..................................................................................................................12 Stage 2 - Development of Standards...............................................................................................13 Stage 3 - Standards Testing and Implementation Requirements.....................................................13 4. Results............................................................................................................................................15 4.1 Setting the Scene ...................................................................................................................15 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 The Profession of Radiology....................................................................................................................15 Medical Consultative Role in Patient Care ..............................................................................................15 The Components of the Diagnostic Imaging Service...............................................................................16 The Imaging Team – Role and Responsibilities ......................................................................................17 Professional Supervision .........................................................................................................................18 Taking a Quality Systems Approach........................................................................................................18 4.2 Current Regulatory Requirements ..........................................................................................19 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 Overview..................................................................................................................................................19 Medicare Benefits Arrangements ............................................................................................................20 Professional Supervision Requirements..................................................................................................21 Radiation Protection – State and Territory Requirements .......................................................................24 Views about Current Regulatory Requirements ......................................................................................26 4.3 Recent Practice Guidelines, Standards and Requirements ....................................................27 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 Review Method and Limitations...............................................................................................................27 Professional Practice Guidelines and Standards – USA and Canada.....................................................28 Professional Guidelines and Standards – United Kingdom and Europe .................................................32 Health Insurance Remuneration Arrangements– Canada and USA .......................................................33 Conclusions – Similarities, Differences and Lessons Learnt ...................................................................36 5. Discussion......................................................................................................................................38 6. Conclusions and Recommendations ...........................................................................................39 6.1 Professional Competence - Qualifications of Personnel.........................................................39 6.1.1 6.1.2 6.1.3 The Imaging Team...................................................................................................................................39 For Radiologists.......................................................................................................................................39 For Other Health Care Professionals in the Imaging Team.....................................................................40 6.2 The Diagnostic Imaging Service Cycle ...................................................................................42 1 AUSTRALIAN HEALTHCARE ASSOCIATES Table of Contents 6.3 Review of Request and Patient Preparation ...........................................................................43 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 Objectives ................................................................................................................................................43 Key Tasks ................................................................................................................................................43 Key Considerations and Managing Associated Risks .............................................................................43 Radiologist Responsibilities .....................................................................................................................44 Relevant Existing Standards....................................................................................................................44 Proposed Supervision Standard - Review of Request and Patient Preparation......................................45 6.4 Performance of Imaging Examination.....................................................................................46 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 Objectives ................................................................................................................................................46 Key Tasks ................................................................................................................................................46 Key Considerations and Managing Associated Risks .............................................................................46 Radiologist Responsibilities .....................................................................................................................46 Proposed Supervision Standard - Performance of Imaging Examination................................................47 Risk Assessment .....................................................................................................................................48 6.5 Interpretation and Reporting ...................................................................................................48 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 Objectives ................................................................................................................................................48 Key Tasks ................................................................................................................................................48 Key Considerations..................................................................................................................................49 Radiologist Responsibilities .....................................................................................................................49 Relevant Existing Standards....................................................................................................................49 Proposed Supervision Standard - Reports ..............................................................................................50 Other Proposed Standard - Requestor Communication ..........................................................................51 6.6 Summary of Proposed Standards...........................................................................................51 6.6.1 6.6.2 6.6.3 6.6.4 Proposed Supervision Standard - Review of Request and Patient Preparation......................................51 Proposed Supervision Standard - Performance of Imaging Examination................................................52 Proposed Supervision Standard - Reports ..............................................................................................54 Other Proposed Standard - Requestor Communication ..........................................................................54 6.7 Implementation Requirements and Linkages..........................................................................54 6.7.1 6.7.2 Implementation Requirements.................................................................................................................54 Linkages ..................................................................................................................................................57 7. References .....................................................................................................................................60 APPENDICES A. Stakeholder Consultation B. Professional Supervision Requirements for in the MBS C. Intravenous Contrast Media Guidelines D. Organisations Consulted E. USA Professional Supervision F. Canada Professional Supervision G. Risk Management Framework 2 AUSTRALIAN HEALTHCARE ASSOCIATES Table of Contents TABLES Table 4-1: Table 4-2: Table 4-3: Table 4-4: Table 4-5: Table 4-6: Table 4-7: Table 4-8: Components of the Diagnostic Imaging Service ...................................................................17 Medicare - By or On Behalf of Provisions for Diagnostic Imaging Services ..........................21 Medicare – Conditions for Services Rendered ‘On Behalf O” Medical Practitioners .............22 Medicare – Professional Supervision Requirements for Diagnostic Imaging Services..........23 State/Territory Licensing and Registration Conditions ..........................................................24 Professional Supervision and Reporting Requirements for Radiologists - Canada and USA29 Communication in Diagnostic Radiology - Key Principles and Practices, Canada and USA.30 Professional Supervision and Reporting Requirements by Diagnostic Imaging Modality/Examination – Canada and USA ............................................................................31 Table 4-9: Professional Supervision and Reporting Requirements for Radiologists – Ontario, Canada 34 Table 4-10: US Medicare Program – Professional Supervision Requirements for Diagnostic Tests and Procedures............................................................................................................................35 Table 4-11: Definitions of Direct Supervision by Radiologists ................................................................36 Table 6-1: Radiologists’ Qualifications, Registration and Continuing Professional Development (CPD) Requirements........................................................................................................................39 Table 6-2: Additional Professional Competency Requirements for Radiologists Practicing MRI, Diagnostic Mammography and Diagnostic Ultrasound..........................................................40 Table 6-3: Competency Requirements for other Health Care Professionals in the Imaging Team ........41 Table 7-1: Individuals Consulted............................................................................................................65 Table 7-2: Written Submissions Received .............................................................................................66 Table 7-3: Canadian Association of Radiologists - Standards August 2005 ..........................................82 3 AUSTRALIAN HEALTHCARE ASSOCIATES Acronyms ACRONYMS ACSQHC Australian Council for Safety and Quality in Health Care ACR American College of Radiology AHA Australian Healthcare Associates AHMC Australian Health Ministers’ Conference ARPANSA Australian Radiation Protection and Nuclear Safety Agency CAR Canadian Association of Radiologists CT Computed tomography DoHA Australian Government Department of Health and Ageing EAR European Association of Radiology FDA Food and Drug Administration HIC Health Insurance Commission MoU Radiology Quality and Outlays Memorandum of Understanding, June 2003 MRI Magnetic resonance imaging NHMRC National Health and Medical Research Council QUDI Quality Use of Diagnostic Imaging Program JCAHO The Joint Commission on the Accreditation of Healthcare Organizations RANZCR The Royal Australian and New Zealand College of Radiologists RCR The Royal College of Radiologists, United Kingdom 4 AUSTRALIAN HEALTHCARE ASSOCIATES 1. Executive Summary This chapter provides a summary of this report. 1. EXECUTIVE SUMMARY This report represents the outcome of a project to developof professional supervision and reporting standards for radiologists providing diagnostic imaging services. It has been prepared for the Australian and New Zealand College of Radiologists (RANZCR) by Australian Healthcare Associates (AHA About the Project The project had two objectives: to review professional supervision and reporting requirements in the context of current radiology practice and knowledge, emergence of teleradiology and other developments; and to develop uniform best practice professional supervision and related reporting standards for all imaging services provided by radiologists incorporating the specific requirements of teleradiology. The aim was develop professional supervision and reporting standards that promote safe and quality patient care and radiology practice. The project falls under the Quality Use of Diagnostic Imaging (QUDI) program, a four-year initiative to support quality improvement in the use of diagnostic imaging services. One of the program’s priority areas is the examination of the role of the current professional supervision requirements for radiologists. The range of imaging services that the standards cover was set to those that fall within the scope of the Radiology Quality and Outlays Memorandum of Understanding (MoU) June 2003 – namely, diagnostic radiology, computed tomography (CT), ultrasound services (with certain exceptions) and magnetic resonance imaging (MRI) services. The Profession of Radiology Radiology is the field of medicine that deals with the scanning of radiographic images of the body to diagnose illness and disease and evaluate the effects of treatment (RANZCR 2005). It involves the use of a variety of medical imaging techniques, advanced computer technology and complex equipment to study human anatomy, pathology and physiology and to define disease processes. Radiologists are medical specialists who provide imaging services to patients, referred to them by their general practitioner (GPs) and specialist colleagues. Patients are referred to assist in both diagnosis and to decide upon the best management of their health problems. Radiologists, therefore, provide a medical consultative service to other doctors. The Diagnostic Imaging Service A diagnostic imaging service consists of three major parts: review of the request and patient preparation; 5 AUSTRALIAN HEALTHCARE ASSOCIATES 1. Executive Summary the performance of the procedure on the patient to capture the images; and, the reading and reporting of the images by the radiologist. Within each part, there are various components and related tasks. The goal of the imaging service is to maximise the information obtained from the examination, while minimising associated safety risks and ensuring high quality patient care. The outcome of the service is a written report with a medical opinion from the radiologist that addresses the medical problem and questions posed by the requesting doctor, and assists patient care. What is Professional Supervision and Reporting? Diagnostic imaging services are provided in multi-disciplinary teams with members with the required expertise drawn from various professional and other groups (e.g. radiographers, sonographers and medical physicists). Teams are lead by radiologists who supervise the examination, read and interpret results and are responsible for the service. The individual responsibilities of team members are interdependent and collectively enable the effective delivery of the service The radiologist is responsible for the medical imaging service. Responsibility covers selection of the appropriate examination, the care of the patient, the performance of examination, the provision of the interpretation of the images and written report to the referring doctor, and quality assurance of the imaging service. Certain tasks are delegated to team members with the required expertise who undertake these tasks under the radiologist’s supervision. The performance of medical imaging services under the supervision of the radiologist (or other medical practitioners) has become known as professional supervision. Defining Professional Supervision Requirements – Problems and Controversies What constitutes an appropriate set of professional supervision requirements for the range of modalities, tests and examinations that comprise medical imaging has been the subject of much discussion and debate in Australia and overseas. Much of the debate has focussed on the availability and participation of the radiologist or other medical imaging specialist during the performance of the service on the patient and defining levels of supervision. A variety of approaches to defining professional supervision requirements have been developed. Different levels of professional supervision have been defined depending on the nature of the test or examination being performed. They range from general oversight and direction and having an on-site presence to provide direct supervision through to personal attendance on the patient and personal performance of the examination. Current Regulatory Requirements – Overview A range of State/Territory and Commonwealth laws deal with the diagnostic imaging sector. The two main regulatory instruments that deal with professional supervision requirements for radiologists are the Commonwealth Medicare benefits arrangements and State and Territory regulations for radiation protection. 6 AUSTRALIAN HEALTHCARE ASSOCIATES 1. Executive Summary In addition to this legislative framework, there are the policies and processes that organisations, involved in the health service delivery, set to ensure safe and quality care. They include policies and processes for credentialing and defining the scopes of practice of individual medical practitioners and other health professionals, and for establishing standards of practice, clinical governance and clinical risk management arrangements. Medicare Benefits Arrangements and Requirements The Medicare benefits arrangements incorporate a number of approaches to defining professional supervision requirements for diagnostic imaging services. They focus on requirements for the performance of the diagnostic imaging procedure on the patient to capture the required images. Requirements have developed over time and vary to reflect differences in the nature of the modality and test or examination being performed. Two sets of provisions are in place: general conditions that establish a base level professional supervision requirement; and modality or examination specific provisions, that establish higher level professional supervision requirements. Combined, the general and modality/examination specific arrangements establish three levels of professional supervision. They are based on the supervising practitioner’s degree of direct participation in the performance of the procedure on the patient. The supervising practitioner is responsible for the service, interprets the scans and compiles the written report. A variety of terms are used to describe the different requirements including general supervision, direct supervision and personal attendance or personal supervision. There are a number of concerns about the appropriateness and relevance of current Medicare requirements. Concerns centre on the lack of clarity in requirements; resulting administrative difficulties; the current terminology with calls for a new conceptual framework for considering professional supervision and reporting; continuing relevance given development in knowledge, technologies and practice; and lack of attention given to the reporting side. State and Territory Radiation Protection Requirements In Australia, the regulation of radiation protection, like other areas of public safety, is undertaken through national and State and Territory controls. Each jurisdiction administers their own radiation protection legislation. Legislation typically covers the setting of minimum dose limits; licensing of people to undertake practices in radiation; registration of radiation emitting equipment; safety procedures; responsibilities; power of inspection; and enforcement provision and penalties. Licensing requirements vary across jurisdictions. In some jurisdictions, they cover certain types of medical imaging equipment and procedures with conditions applying to radiologist supervision. Diagnostic imaging services funded under Medicare must be provided in accordance with any State/Territory laws relating directly or indirectly to the use of diagnostic imaging procedures or diagnostic imaging equipment. Consequently, if a jurisdiction sets higher professional supervision requirements, they become the regulatory requirement for services rendered under Medicare in that jurisdiction. Requirements vary widely across jurisdictions and, again, different terms are employed across jurisdictions to define supervision requirements. 7 AUSTRALIAN HEALTHCARE ASSOCIATES 1. Executive Summary There are moves to develop a uniform national framework for radiation protection with work being undertaken through the Australian Health Ministers’ Conference (AHMC). States and Territories are at different stages in reviewing their legislation and establishing new legislation that puts into effect the agreed national framework. Licensing conditions, however, appear to remain a matter for each jurisdiction to determine. Recent Practice Guidelines, Standards and Requirements A review of recent radiology practice guidelines, standards and requirements across countries and agencies was conducted in order to understand the requirements in place and approaches used to define the standards, and to consider similarities, differences and lessons learnt. A mix of approaches has been used to define professional supervision and reporting requirements for radiologists. They range from considering requirements in the context of good practice guidelines and standards for a particular modality or examination and the setting of radiologist staffing requirements for medical imaging facilities under accreditation arrangements, through to specifying requirements in payment schedules. Each offers lessons. The American College of Radiology (ACR) and the Canadian Association of Radiologists (CAR) approaches place the radiologist’s professional supervision and reporting responsibilities within a broader quality assurance system approach for a particular modality or examination. They also provide examples of ways for considering principles of good practice in reporting and the report’s content. Payment approaches adopted in Canada show different ways of specifying the components of the imaging service and the radiologist’s roles and responsibilities for the service. Canadian approaches also provide ways for considering ideal requirements and managing the potential risks that occur when the ideal supervision requirement is unable to be met. The UK experience with clinical governance provides some principles to guide clinical risk management in radiology practice. Discussion of Approaches Australian and overseas approaches to professional supervision have traditionally varied according to the modality, test or examination. Implicitly, therefore, resulting levels of supervision have sought to provide ways of managing different levels of associated risk. Stakeholder consultations affirmed that this was an important principle that should underpin professional supervision and reporting standards. The amount and nature of radiologist participation should and will vary with the type and complexity of the medical problem, the type of technology used and type of examination performed. Different modalities and examinations have different technical profiles. For some, these technical requirements can be managed usually through the use of imaging protocols (e.g. plain x-rays and CT scans). Other imaging modalities (e.g. ultrasound) present a different set of technical challenges and are not as protocol driven. Many stakeholders indicated that ultrasound is a highly operator dependent imaging modality, where the use of probes and transducers to produce an image where the probe is pointed, requires flexibility in approach and high levels of expertise. The use of contrast media (e.g. in CT scans) and sedation (e.g. 8 AUSTRALIAN HEALTHCARE ASSOCIATES 1. Executive Summary in MRI) changed the risk profile and required a medical practitioner (not necessarily a radiologist) to be available to treat any adverse reactions or other events. Consultations however have also indicated that radiologists operate in a range of operating environments and the risks associated with each different environment varies significantly. These Standards therefore call for an assessment of risk and development of a range of appropriate procedures to manage this risk by individual radiologists and/or practices. Proposed Standards Most approaches to professional supervision in Australia and overseas have tended to focus on the level and nature of radiologist availability during different types of examinations - for example, whether they should be available on-site or be available to personally attend the patient. These approaches implicitly suggest that radiologists will have appropriate input to the imaging service, if they are available to do so. This approach however, fails to recognise that in many cases, radiologist input to the request review, patient preparation and examination components of the imaging service for example, are dependent on other members of the imaging team, such as radiographers and sonographers, seeking such input. The proposed Standards developed as part of this project and set out in Chapter 6 - Conclusions and Recommendations, place a greater focus on ensuring the effective functioning of the imaging team as a whole. This involves all members of the imaging team having a clear understanding of their roles and responsibilities and involves radiographers and sonographers having a sound appreciation of the circumstances and situations in which they should seek additional radiologist input to the imaging service. The proposed professional supervision and reporting standards set out in this document, recognise that radiologists operate in a diverse range of unique imaging environments, each with their own risks, which should be appropriately managed. The proposed Standards therefore, take a flexible, protocol-based, quality systems approach, rather than a rigid rulesbased approach, representing a significant shift in thinking on this topic. Recognising that the ultimate aim of these Standards should be to ensure radiologist input to the imaging service at the appropriate/critical times, the Standards have a focus on developing an effectively functioning team. This focus manifests itself in the requirement to develop protocols to guide technologists as to when they should seek the input of a radiologist. 9 AUSTRALIAN HEALTHCARE ASSOCIATES 2. Introduction This chapter provides background to the project and details the purpose and scope of the project. 2. INTRODUCTION 2.1 The Royal Australian and New Zealand College of Radiologists The Royal Australian and New Zealand College of Radiologists (RANZCR) is the leading organisation for the promotion of the science and practice of the medical specialties of radiology and medical imaging (diagnostic and interventional) and radiation oncology in Australia and New Zealand. It produces standards documents for radiologists involved in the delivery of radiology services on aspects of practice. The College’s Standards aim to define good practice, advance the practice of radiology and promote the provision of a high quality service to patients. These Standards focus on the professional supervision and reporting responsibilities of radiologists. 2.2 Project Task The project’s task is to establish uniform professional supervision and related reporting standards for all imaging services provided by radiologists including the specific requirements of teleradiology. Specifically, the project requirements are to: 2.3 1. Review current regulatory requirements and the current literature (both local and international) with regard to the professional supervision of imaging services. 2. Identify key policy issues that need to be addressed in relation to the use of teleradiology and assess implications for professional supervision and reporting of diagnostic imaging services. 3. Develop and test, in relation to procedures/examinations supervised by radiologists, best practice standards of: Professional supervision, or personal attendance, by the radiologist, according to a particular modality or procedural group; and Professional supervision of, or personal reporting by the radiologist of the results of a particular modality or procedural groups. 4. Identify any changes that may be required to current regulatory requirements. 5. Identify, develop and test appropriate information for inclusion in relevant material for consumers. What is a Standard? The Australian Council for Safety and Quality in Health Care (ACSQHC) defines a standard as agreed qualities and processes, designed to ensure a product, service or method will perform consistently at a designated level (2005). Standards, therefore, are a means of describing the level of quality, health care providers are expected to meet and against which the level of quality performance can be assessed. As such, the proposed Standards would set requirements for professional supervision and reporting practice that radiologists are expected to meet. 10 AUSTRALIAN HEALTHCARE ASSOCIATES 2. Introduction 2.4 The Practice of Radiology Radiology is the branch of medicine that deals with the scanning of radiographic images of the body to diagnose illness and disease and evaluate the effects of treatment. Radiologists are medical specialists trained in the use of medical imaging techniques to study human anatomy, pathology and physiology and to define disease processes. Radiologists provide a medical consultative service. Medical practitioners refer patients to radiologists with requests for imaging investigation, advice and opinion for the purpose of diagnosis or management. Imaging services are provided in multi-disciplinary teams led by radiologists. Radiologists are responsible for the medical care of the patient while in the radiology practice or department. They supervise the conduct of the imaging examination, read and interpret results, and prepare a report with examination results and professional opinion for the patient’s requesting doctor. This set of responsibilities is termed professional supervision and reporting. 2.5 Assuring Quality The quality of the imaging service provided is dependent on the interplay of many factors. Factors include the knowledge, expertise and experience of the radiologist and other team members; the equipment and facilities used; the capabilities of the imaging modality and test; the quality assurance systems in place; good communication among health care participants, their clear understanding of their responsibilities and how effective the team is in working together. Professional supervision and reporting are concerned with the process of care provided to patients and in assuring the quality of the imaging service. They are central to the roles, responsibilities and accountabilities of radiologists in providing quality medical imaging services to patients and requesting doctors. 2.6 Purpose These proposed Standards define the principles and requirements of professional supervision and reporting that radiologists are expected to meet. They are intended for practitioners in both the public and private sectors working in small and large organisations. They aim to promote safe and quality patient care and radiology practice. 2.7 Scope They focus on diagnostic imaging, not interventional imaging, services provided by radiologists. They cover professional supervision and reporting requirements for four types (or modalities) of diagnostic imaging provided by radiologists: diagnostic radiology; computed tomography (CT); ultrasound (with certain exceptions); and magnetic resonance imaging (MRI). Cardiac ultrasound, obstetrics and gynaecological ultrasound, cardiac angiography and nuclear medicine services fall outside the scope of these Standards. 11 AUSTRALIAN HEALTHCARE ASSOCIATES 3. Methodology This chapter provides an outline of the methodological approach adopted when undertaking the project. 3. METHODOLOGY A three-stage development approach was adopted: Stage 1 - was a scoping study to research, identify and assess key issues, and establish principles and options for standards development; Stage 2 - involved developing the standards; Stage 3 - focused on testing the standards and exploring the implementation requirements. Stage 1 - Scoping Study In broad terms, the first stage scoping study involved: examining current professional supervision and reporting requirements under the Medicare benefits and other regulatory arrangements; seeking views of key stakeholders; reviewing national and international experience and literature, related developments and trends; considering the use of teleradiology and implications for professional supervision and reporting; identifying and assessing key issues and their implications; considering options and future directions; and developing a discussion paper presenting findings and conclusions. The intention was to provide a sound information base for considering project issues and options and establishing future directions. Consultations A series of consultations were held during the first stage in order to advise key stakeholders about the project, to gather information and to seek views. Consultations were targeted at TRG members and 46 government, professional, consumer and industry organisations, as agreed with the RANZCR. A mix of consultation methods were used – face-to-face interviews, telephone interviews and written submissions. In total, 47 consultations were been conducted during this stage. A list of individuals consulted during the course of the project is provided at Appendix A. Discussions were held with key RANZCR staff to discuss the project, context and approach and to gather information and clarify issues. Information about the project was published in RANZCR newsletters to advise Fellows of the project. The I-MED/MIA virtual reporting centre in Camberwell, Victoria was also visited to gain an understanding of the operations and activities of such a facility. At the conclusion of the consultation phase, a Standards Working Group (SWG) was formed to assist in refining the Standards, once developed. Individuals approached to be on the group were those which had shown a particular interest in the project during the consultation process. This small group included 12 AUSTRALIAN HEALTHCARE ASSOCIATES 3. Methodology radiologists, radiographers, an ultrasonographer, a GP and specialist referrer, as well as a consumer representative. Information Gathering and Analysis Information was gathered from a variety of sources including consultations, published reports and other research. Reviews of the published literature on key areas were undertaken. Areas covered national and international professional standards for diagnostic imaging and teleradiology; regulatory requirements under health insurance arrangements across a selection of countries; role, use, and value of teleradiology in delivery of diagnostic imaging; in the medical professional role and responsibilities of radiologists; in standards development; and other imaging developments and trends. Published literature on some of these topics was scant and of variable quality. These matters and their implications are highlighted in subsequent chapters. Stage 2 - Development of Standards In broad terms this stage involved: examining the nature, uses, technical, clinical and practice requirements of each service modality and procedural group; identifying and assessing similarities, differences, key issues and implications for uniform best practice standards; establishing principles, attributes, concepts and definitions to underpin the standards; designing draft uniform best practice standards and identifying alternative approaches within and across standards; assessing identified alternatives against criteria based on guiding principles and attributes for best practice standards; considering how and where they differ to current requirements and implications for modality/procedural group, type of practice and aspects of RANZCR practice and accreditation standards; developing the proposed standards. This stage was complex and time-consuming, due to the range of complicated issues which had to be worked through. Consultation was on-going throughout this stage and a broad range of views continued to be received from key stakeholders. Stage 3 - Standards Testing and Implementation Requirements This stage involved the testing of the proposed standards and the identification of issues associated with their implementation. It also assisted in identifying linkages between this and other QUDI projects. Due to the nature of the proposed Standards, testing focussed on consulting with radioloigists and other members of the imaging team to identify the potential impact of the proposed standards on their practice and imaging environment. As part of this process, we provided the draft Standards to a number of stakeholders, along with the a questionnaire with a number of questions exploring these issues. 13 AUSTRALIAN HEALTHCARE ASSOCIATES 3. Methodology Stakeholders provided with the draft Standards and questionnaire included members of the TRG as well as the SWG formed specifically for this project. The aim was to ensure that the standards are robust and that there are no unintended consequences. Other issues explored via the process included: likely impacts across practices and locations; timing considerations; links to other initiatives; standards promulgation; ongoing review and evaluation arrangements links to other QUDI initiatives. Following this final consultation process, the draft Standards were refined and finalised, and this final report prepared. 14 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results This chapter provides an outline of the key results and findings of consultation and research activities undertaken during the project. 4. RESULTS 4.1 Setting the Scene 4.1.1 The Profession of Radiology Radiology is the field of medicine that deals with the scanning of radiographic images of the body to diagnose illness and disease and evaluate the effects of treatment (RANZCR 2005). It involves the use of a variety of medical imaging techniques, advanced computer technology and complex equipment to study human anatomy, pathology and physiology and to define disease processes. Imaging techniques (or modalities) range from familiar X-rays and ultrasound scans to magnetic resonance imaging (MRI), computed tomography (CT) and nuclear medicine services. Increasingly, radiology is taking on a treatment role through the use of newer imaging techniques to undertake interventional and therapeutic procedures that range from image guided biopsy and drainage procedures to the insertion of vascular stents. Radiologists are medical specialists. They complete medical degrees, a period of at least two years in general clinical training and then a five year specialist training program, that involves the successful completion of examinations (RANZCR 2005). 4.1.2 Medical Consultative Role in Patient Care Radiologists are medical specialists who provide imaging services to patients referred to them by their general practitioner (GPs) and specialist colleagues. Patients are referred for assistance in both diagnosis and deciding upon the best management of their health problems. Radiologists, therefore, provide a medical consultative service to other doctors. The care path for patients requiring medical imaging services is illustrated in the following Chart 4-1. 15 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Chart 4-1: Patient care path for diagnostic imaging services Source: AHA adaptation of material presented by the Canadian Institute for Health Information (2001) 4.1.3 The Components of the Diagnostic Imaging Service A diagnostic imaging service consists of two parts: the performance of the procedure on the patient to capture the images; and, the reading and reporting of the images by the radiologist. Within each part, there are various components and related tasks. They are described in broad terms in the following Table 4-1. 16 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Table 4-1: Components of the Diagnostic Imaging Service Key Component Review of patient and request Description Review of request from doctor for an imaging service Discussion with patient Selection of appropriate test/procedure Explaining the test/procedure and any associated risks to patient Obtaining patient’s informed consent Preparing the patient Preparing and positioning the patient for the test/procedure Performance of imaging test/procedure Performing the test/procedure Monitoring the patient Obtaining images Administering contrast media or sedation, as necessary Assuring image quality Documenting tests/procedures performed All of this is done in accordance with agreed protocols, guidelines and regulations Interpretation Review of images and interpreting results of the imaging test/procedure including review of previous scans, where available Reporting Preparation and provision of written report to requesting doctor Other communication with requesting doctor as situation requires The goal of the imaging service is to maximise the information obtained from the examination, while minimising associated safety risks and ensuring high quality patient care. The outcome of the service is a written report with a medical opinion from the radiologist that addresses the medical problem and questions posed by the requesting doctor, and assists patient care. 4.1.4 The Imaging Team – Role and Responsibilities Diagnostic imaging services are provided in multi-disciplinary teams with members with the required expertise drawn from various professional and other groups. Teams are lead by radiologists who supervise the examination, read and interpret results and are responsible for the service. Team members include radiographers and sonographers who operate the equipment to produce quality images, perform examinations and ensure patient comfort and safety; medical physicists who ensure optimum performance of the equipment; service engineers who maintain and service equipment; and administrative staff who book appointments and undertake other clerical tasks. The individual responsibilities of team members are interdependent and collectively enable the effective delivery of the service (RCR 1998). The team mix varies depending on the type of examination or procedure being 17 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results performed. Services are provided in accordance with agreed protocols and quality assurance procedures. 4.1.5 Professional Supervision The radiologist is responsible for the medical imaging service. Responsibility covers selection of the appropriate examination, the care of the patient, the performance of examination, the provision of the interpretation of the images and written report to the referring doctor, and quality assurance of the imaging service. Certain tasks are delegated to team members with the required expertise and undertaken under the radiologist’s supervision. Radiographers and sonographers usually discuss the examination with the patient, prepare and position the patient, perform the examination to capture the required images and document the studies and procedures performed, with the radiologist selecting the appropriate examination, interpreting the images and preparing the written report. The performance of medical imaging services under the supervision of the radiologist (or other medical practitioners) has become known as professional supervision. The Oxford English Dictionary defines supervision as ‘to direct or watch with authority the work or proceedings or progress, to oversee’. What constitutes an appropriate set of professional supervision requirements for the range of modalities, tests and examinations that comprise medical imaging has been the subject of much discussion and debate in Australia and overseas. Much of the debate has focussed on the availability and participation of the radiologist or other medical imaging specialist during the performance of the service on the patient and defining levels of supervision. A variety of approaches to defining professional supervision requirements have been developed. Different levels of professional supervision have been defined depending on the nature of the test or examination being performed. They range from general oversight and direction and having an on-site presence to provide direct supervision through to personal attendance on the patient and personal performance of the examination. This chapter reviews this experience in order to understand approaches used and requirements. 4.1.6 Taking a Quality Systems Approach The project’s aim is to develop professional supervision and reporting standards that promote safe and quality practice and patient care. It is important to place professional supervision and reporting within a broader quality assurance system. The broad framework of structure, process and outcomes that Donabedian (1998) developed to describe the three components of quality health care provides a useful way of considering this: structure: includes material resources, human resources and organisation – for example, the knowledge and experience of the medical practitioner ordering and using the results of the examination of the patient; the knowledge, skills, expertise and experience of the personnel/ team conducting the test and interpreting the images; continuing medical education and quality assurance; practices, facilities and equipment used; the capabilities of the imaging modality and 18 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results test; funding arrangements; and information available through standards, guidelines and protocols. process: concerns what is done in provision of the imaging service including the activities of the imaging team across the components of the service and professional supervision and reporting requirements for radiologists. outcomes: concerns what is achieved for patients, including the provision of a medical opinion to requesting doctor to assist patient care. Within this framework, many important structural and process factors influence the quality of imaging practice and patient care. Professional supervision and reporting requirements are two aspects of a quality assurance system. They cannot be considered in isolation. At the same time, it is beyond this project’s reach and scope to identify and examine all those factors. Instead, key factors and connections are highlighted. 4.2 Current Regulatory Requirements 4.2.1 Overview This section examines current regulatory requirements for professional supervision and reporting by radiologists in Australia and summarises stakeholder’s views about their appropriateness and effectiveness. A range of State and Territory and Commonwealth laws deal with the diagnostic imaging sector. To set the context for the current regulatory requirements for professional supervision, an overview of the legislative framework is provided. All States and Territories and the Commonwealth have some form of legislation dealing with radiation protection. States and Territories also have regulatory controls over institutions in which diagnostic imaging services are provided. They are responsible for the regulation and management of public hospitals and other health services, the licensing of private hospitals and the registration of medical practitioners and other health professionals. At the Commonwealth level, the Health Insurance Act 1973 covers the major elements of the Medicare program providing medical and hospital services and Commonwealth funding for services. The Act governs the payment of Medicare benefits for diagnostic imaging services. The National Health Act 1953 covers the provision of certain medical, pharmaceutical and dental services. The Act provides the basis for Commonwealth funding for the national breast cancer screening program, BreastScreen Australia. Other relevant Commonwealth legislation includes the Therapeutic Goods Act 1989 that provides a national framework for the regulation of therapeutic goods (e.g. diagnostic imaging equipment) in Australia to ensure their quality, safety and efficacy for marketing and use; and the Customs Act 1901 that covers the import and export of goods into and out of Australia, including restricted items, such as medical radioisotopes. There is also State/Territory and Commonwealth law that regulates the business management of Australian companies incorporated under that legislation and the Trade Practices Act 1974 Act (Commonwealth) that provides protection to consumers against unconscionable conduct, false 19 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results representations, misleading or deceptive conduct and other ‘unfair practices’ in connection with the supply of goods, services and land. All States and Territories have similar legislation. In addition to this legislative framework, there are the policies and processes that organisations involved in the health service delivery set to assure safe and quality care. They include policies and processes for credentialing and defining the scopes of practice of individual medical practitioners and other health professionals, and for establishing standards of practice, clinical governance and clinical risk management arrangements. The remainder of this section focuses on the two main pieces of legislation dealing with professional supervision requirements for radiologists – the Commonwealth Medicare benefits arrangements and State and Territory regulations for radiation protection. 4.2.2 Medicare Benefits Arrangements Services Covered Medicare benefits are provided for people who incur medical expenses in respect of clinically relevant services provided by qualified medical practitioners, and certain dental practitioners and optometrists. Professional services covered include diagnostic imaging services. All services and procedures for which Medicare benefits are paid are contained in the Medicare Benefits Schedule (MBS). A new edition of the MBS takes effect on 1 November each year and updates are issued throughout the year as required. Diagnostic Imaging Services The Diagnostic Imaging Services Table (DIST) of the MBS sets the rules of interpretation, items of diagnostic imaging services and associated schedule fees on which Medicare rebates are calculated. The Table covers diagnostic radiology, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI) and nuclear medicine services. Each professional service is assigned a unique item number. A service covers the performance of the imaging examination on the patient and the reading, interpretation and reporting of the examination. Request Requirements Generally, Medicare benefits for diagnostic imaging services are only payable following the provision of a written request from another medical practitioner. Several exemptions from the written request requirements are provided by the Health insurance Act 1973. They include emergencies, remote area exemptions and pre-existing diagnostic imaging practices. Diagnostic imaging services requiring a written request are classified as R-type (requested) services while those not subject to the requirement are classified as NR-type (not requested) services. Providing Doctors 20 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Services are provided by medical practitioners who are specialists in medical imaging – diagnostic radiologists and nuclear medicine physicians – and other consulting physicians who perform certain types of imaging services in the practice of their speciality. The latter group includes cardiologists performing procedures with cardiac catheters, gynaecologists and obstetricians performing ultrasound examinations, urologists using ultrasound in the management of prostatic disease, and vascular and other surgeons. A medical practitioner must be currently registered or licensed as a medical practitioner under State/Territory law. ‘By Or On Behalf Of’ Provisions As Table 4-2 indicates, diagnostic imaging services are defined as professional services that may be rendered by or on behalf of a medical practitioner. Table 4-2: Medicare - By or On Behalf of Provisions for Diagnostic Imaging Services Unless otherwise stated, a diagnostic imaging service specified in the DIST may be provided by: (a) a medical practitioner; or (b) a person, other than a medical practitioner, who: (i) is employed by a medical practitioner; or (ii) provides the service under the supervision of a medical practitioner in accordance with accepted medical practice. Source: MBS, 1 November 2004 - Category 5 - Diagnostic Imaging Services, Section DIC. What constitutes an appropriate level of supervision that the medical practitioner should provide under these on behalf of provisions has been the subject of much discussion and debate among professional groups (providers and requesters), funders, payers and regulators. Resulting arrangements are known as professional supervision requirements. 4.2.3 Professional Supervision Requirements Approaches Today, the Medicare benefits arrangements incorporate a number of approaches to defining professional supervision requirements for diagnostic imaging services. They focus on requirements for the performance of the diagnostic imaging procedure on the patient to capture the required images. Requirements have developed over time and vary to reflect differences in the nature of the modality and test or examination being performed. Two sets of provisions are in place: general conditions that establish a base level professional supervision requirement; and modality or examination specific provisions, that establish higher level professional supervision requirements. General Conditions General conditions are set out in the MBS. They are summarised in Table 4-3. They establish: 21 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results responsibility for the service - where the service must be billed in the name of the practitioner who must accept full responsibility for the service; and a general supervision requirement – where the supervising medical practitioner need not be present during the performance of the service on the patient but, as a minimum, has established consistent quality assurance procedures for the data acquisition and personally analysed the data and written the report. Table 4-3: Medicare – Conditions for Services Rendered ‘On Behalf O” Medical Practitioners In order that a service rendered by an employee or under the supervision of a medical practitioner can attract a Medicare rebate, the service must be billed in the name of the practitioner who must accept full responsibility for the service. The Health Insurance Commission would need to be satisfied with the employment and supervision arrangements. In this regard, while the supervising medical practitioner need not be present for the entire service, he or she must have a direct involvement in at least part of the service. Although the supervision requirements would vary depending on the test or examination being performed, they would, as a general rule, be satisfied where the medical practitioner has: (i) established consistent quality assurance procedures for the data acquisition; and (ii) personally analysed the data and written the report. Source: MBS General Explanatory Notes, 12.2.2. Modality/Examination Specific Requirements Professional supervision requirements have been specified in the DIST for certain: modalities – CT, ultrasound, MRI and nuclear medicine services; and examinations within modalities – diagnostic mammography and musculoskeletal ultrasound. Approaches have concentrated on defining the types of medical practitioners able to provide (render) imaging services and, therefore, act as the supervising medical practitioner, and associated professional supervision requirements. In some cases, certain aspects of the service that the supervising practitioner must undertake are specified. They are summarised in Table 4-4 while more detailed information for each modality and examination is at Appendix B. Since 2001, qualification requirements for sonographers performing ultrasound examinations on behalf of a medical practitioner have been established for Medicare benefits purposes. Sonographers must be suitably qualified and involved in a relevant and appropriate Continuing Professional Development program and be enrolled on the Register of Accredited Sonographers administered by the HIC. In addition, the sonographer’s name must be recorded in the report of the service; however, it is not required to be included on the copy of the report given to the patient. These requirements are unique to sonographers. 22 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Table 4-4: Medicare – Professional Supervision Requirements for Diagnostic Imaging Services Modality/Examination Rendering/Supervising Medical Practitioner Computed Tomography Specialist in the specialty of diagnostic radiology Available to monitor and influence the conduct and diagnostic quality of the examination and, if necessary, to personally attend on the patient. Diagnostic Ultrasound (excluding musculoskeletal) Specialist or consultant physician in the practice of his or her speciality Available to monitor and influence the conduct and diagnostic quality of the examination and, if necessary, to personally attend on the patient. Musculoskeletal Ultrasound Specialist or consultant physician in the practice of his or her speciality Responsible for the conduct and report of the examination, personally attends during the performance of the scan and personally examines the patient. This is known as the personal attendance requirement. Magnetic Resonance Imaging Is a specialist in diagnostic radiology who satisfies HIC that: Eligible provider is available to monitor and influence the conduct and diagnostic quality of the examination including, if necessary, by personal attendance on the patient. Diagnostic Mammography he or she is a participant of the RANZCR’s Quality and Accreditation Program; and Professional Supervision Requirements the equipment he or she proposes to use for providing the services meets eligible equipment requirements. Nuclear Medicine Credentialled specialists and consultant physicians in nuclear medicine with credentialling by the Joint Nuclear Medicine Credentialling and Accreditation Committee of the Royal Australasian College of Physicians (RACP) and the RANZCR. Personally supervise all components of the service and perform personally certain components of components – namely, a preliminary examination of the patient and the estimation of the dosage, and compiling the final report of the service. Supervising specialist, however, does not have to physically attend during the entirety of each component. This is often called a personal supervision requirement. Source: AHA analysis of MBS DIST 2005. Generally, services provided in emergencies and in remote locations are exempted from these professional supervision requirements. Some examinations may involve administration of contrast media (e.g. CT) and sedation (e.g. MRI). The RANZCR has established guidelines covering these situations and they are summarised at Appendix C. Three Levels of Professional Supervision Combined, the general and modality/examination specific arrangements described above establish three levels of professional supervision. They are based on the supervising practitioner’s degree of direct participation in the performance of the procedure on the patient. The supervising practitioner is responsible for the service, interprets the scans and compiles the written report. A variety of terms are used to describe the different requirements. For the purposes of this analysis, the following classification has been used: 23 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results General supervision requirement: where the supervising medical practitioner is not present during the performance of the service on the patient; has established consistent quality assurance procedures for the data acquisition; and has personally analysed the data and written the report. Direct supervision: where the supervising practitioner is available to monitor and influence the conduct and diagnostic quality of the examination including, if necessary, by personal attendance on the patient; has established consistent quality assurance procedures for the data acquisition; and personally analysed the data and written the report. It applies to CT, diagnostic mammography, MRI and most ultrasound services. Personal attendance requirement: where the supervising practitioner is on site and personally examines the patient and personally attends during the performance of the scan; has established consistent quality assurance procedures for the data acquisition; and personally analysed the data and written the report. It applies to musculoskeletal ultrasound and nuclear medicine services. The MBS is silent on the use of teleradiology. 4.2.4 Radiation Protection – State and Territory Requirements In Australia, the regulation of radiation protection, like other areas of public safety, is undertaken through national and State and Territory controls. Each jurisdiction administers their own radiation protection legislation. Legislation typically covers the setting of minimum dose limits; licensing of people to undertake practices in radiation; registration of radiation emitting equipment; safety procedures; responsibilities; power of inspection; and enforcement provision and penalties. Licensing Requirements across Jurisdictions Licensing requirements vary across jurisdictions. In some jurisdictions, they cover certain types of medical imaging equipment and procedures with conditions applying to radiologist supervision. Diagnostic imaging services funded under Medicare must be provided in accordance with any State/Territory laws relating directly or indirectly to the use of diagnostic imaging procedures or diagnostic imaging equipment. Consequently, if a jurisdiction sets higher professional supervision requirements, they become the regulatory requirement for services rendered under Medicare in that jurisdiction. Jurisdictions were surveyed to establish current conditions relevant to professional supervision requirements for diagnostic imaging. Requirements are shown in Table 4-5. They vary widely across jurisdictions and, again, different terms are employed across jurisdictions to define supervision requirements. Table 4-5: State/Territory Licensing and Registration Conditions New South Wales Conditions of the radiographer’s licence: The licensee must only use fluoroscopic and fluorographic apparatus while working under the general supervision and direction of a licensed radiologist; and/or while working under the direction of a registered medical practitioner who requires fluoroscopy during surgical and other procedures. The licensee must only use computed tomography apparatus while working under the general 24 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results supervision of a licensed radiologist, or a registrar who is training in the discipline of diagnostic radiology at a hospital. Definitions 'general supervision' means supervision by a qualified person who oversees the person being supervised and ensures that the person follows safe radiation work practices in relation to the use of radioactive substances or radiation apparatus. Victoria Condition of registration of radiating apparatus (CT only): The registered person must ensure that the apparatus is only operated by a person who holds the relevant operator licence prescribed in Regulation 11 of the Health (Radiation Safety) Regulations 1994. A radiologist must be immediately available to supervise all stages of a CT procedure as required. Supervision is taken to mean physical presence within the practice. This requirement is waived for emergency inpatient examinations, patients at hospitals with a designated emergency centre, or for urgent “out of hours” provided the radiologist is called immediately and is in attendance as soon as possible, or is able to supervise the examination by an approved remote link teleradiology system. Queensland There are no special conditions regarding professional supervision by radiologists. Western Australia Condition of registration of radiating apparatus The registrant is directed to ensure that fluoroscopic x-ray apparatus is used only by radiographers using the apparatus as part of a procedure while working under the direction and personal supervision of a licensed radiologist who is responsible for that procedure. “general supervision” means the exercise of control over radiation safety without the person exercising such control necessarily being present at the registered premises or field site “personal supervision” means the exercise of control over radiation safety by the person exercising such control being present on the registered premises or field site South Australia There are no special conditions regarding professional supervision by radiologists. Tasmania Conditions of the radiologist’s licence: Licences hold no special conditions relating to professional supervision by radiologists, however, must adhere to certain NHMRC guidelines, as indicated below. Use of electronic products described as “X-ray” in Schedule 1 for diagnostic medical imaging must comply with: NHMRC “Recommendations for Minimising Radiological Hazards to Patients (1985)”, except where a recommendation of that document conflicts with a specific condition laid down on this licence; and NHMRC “Code of Nursing Practice for Staff Exposed to Ionising Radiation (1984)”. Use of electronic products described as “MRI” in Schedule 1 for the purpose of medical imaging must comply with the NHMRC Safety Guidelines for Magnetic Diagnostic Facilities (1991), except where a recommendation of this document conflicts with a specific condition laid down on the licence. All use of the electronic products described as “X-ray” in Schedule 1, for diagnostic dental radiography, 25 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results shall be in accordance with the NHMRC Code of Practice for Radiation Protection in Dentistry (1987). ACT There are no special conditions regarding professional supervision by radiologists. Northern Territory There are no special conditions regarding professional supervision by radiologists. Source: State/Territory Radiation Safety Agencies 2005 Development of a National Framework for Radiation Protection Since the late 1990s, work has been under way, through the Australian Health Ministers’ Conference (AHMC), on the development of a uniform national framework for radiation protection. In July 2004, Ministers endorsed the National Directory for Radiation Protection as the agreed framework for radiation protection (ARPANSA 2004). States and Territories are at different stages in reviewing their legislation and enacting new legislation that puts into effect the agreed national framework. For example, Victoria has introduced a new Radiation Bill 2005 to cover the creation of a regulatory scheme that is consistent with the national framework and with the recommendations of the national competition policy review of the legislation completed in 2001 (Phillips Fox 2005). Licensing conditions, however, appear to remain a matter for each jurisdiction to determine. 4.2.5 Views about Current Regulatory Requirements Views on the appropriateness and relevance of the current professional supervision and reporting requirements were canvassed as part of consultations. Views centred on several key issues. Lack of clarity in current requirements A recurring theme in consultations was the lack of clarity in current Medicare requirements. Many respondents referred to the problems encountered in developing a clear, practical and workable definition for being ‘available to monitor and influence the conduct and diagnostic quality of the examination and, if necessary, to personally attend on the patient’. Many used the example of the proposed ‘15 minute walk rule’ to highlight the problems involved. There were also differing views about whether this requirement meant the on-site physical presence of the supervising radiologist. Resulting administrative difficulties Respondents from the government sector highlighted the resulting problems they faced in monitoring compliance with the current Medicare professional supervision requirements. Inadequacies in current terminology Many respondents commented on the variety of terms used to define different levels of professional supervision (general supervision, personal supervision, direct supervision) with many of them used interchangeably. This resulted in confusion and misunderstandings. There were calls for the 26 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results development of a new conceptual framework for considering professional supervision and reporting requirements with a clear and concise nomenclature. Continuing relevance Many respondents questioned the continuing relevance of aspects of the current requirements given developments in knowledge, technologies and practice. Some respondents focussed on the appropriateness of particular requirements – e.g. personal attendance requirements for musculoskeletal ultrasound services given developments in this field, arguing that they should be treated in the same way as the rest of diagnostic ultrasound services. Others consider that current ways of viewing professional supervision are no longer appropriate given developments in communications technologies and teleradiology and the changes they bring to the way radiology is organised, delivered and practised. There were mixed views about the current role, place and benefits of teleradiology. Some respondents questioned the notion that there is a single rendering practitioner, indicating that it does not accurately reflect the way diagnostic imaging services are delivered in practice. Lack of focus on reporting side Many respondents commented on the tendency for attention to focus on the professional supervision aspects of the diagnostic imaging service, and not the reporting side. The radiologist’s role and responsibility is to supervise, interpret and report the on the service, and ensure quality patient care. The report represents one of the key outcomes of the service. Currently, the content of the report is not specified in the Medicare rules for diagnostic imaging. Standards that set out good practice in reporting and supervision are needed. 4.3 Recent Practice Guidelines, Standards and Requirements 4.3.1 Review Method and Limitations The review covered recent practice standards and guidelines set by peak national and international radiology professional bodies and requirements set for reimbursement purposes under publicly funded health insurance schemes. It focussed on diagnostic radiology and guidelines, standards and requirements set since 2000. A two-stage review process was adopted. The first stage involved scanning and assessing the range of information available across countries and international bodies while the second stage involved targeted analysis for a selection of countries and bodies. A wide variety of information was found in the first stage, however, much of it represented broad policy statements and position statements about the practice of radiology. Consequently, detailed analysis was confined to Canada, the USA, the UK and the European Association of Radiology (EAR). Appendix D provides further information on the professional bodies covered in the review’s first stage search strategy. Making comparisons across countries is inherently difficult given differences in national policies; in the organisation, funding and management of national health programs, diagnostic imaging services and radiology sectors; and in practice. The results of this review are useful for highlighting similarities and differences in approaches to and requirements for radiologist professional supervision and reporting, 27 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results and considering lessons learnt. However, they tell us little about the factors that contributed to the setting of practice requirements and their effectiveness. 4.3.2 Professional Practice Guidelines and Standards – USA and Canada The American College of Radiology (ACR) and Canadian Association of Radiologists (CAR) use similar approaches to practice guidelines and standards development with the Canadian standards drawing on those developed by their US counterparts. Purposes and Scope Both peak bodies aim to develop guidelines and standards to provide assistance to practitioners performing examinations and procedures. Resulting documents address the practice of a particular diagnostic imaging modality (diagnostic radiography, CT, MRI, ultrasound) or particular clinical applications within a modality (diagnostic mammography, ultrasound examinations of female pelvis, breast and antepartum obstetrics), supporting requirements (e.g. administration of contrast media), and reporting requirements. They aim to assist practitioners in delivering effective and safe medical care. They are developed by expert advisory panels through a consensus process. They are reviewed periodically. The resulting radiology practice documents are described in several ways. CAR calls its documents ‘standards’ while the ACR uses the term ‘practice guideline’. Both describe them as representing policy statements that attempt to define principles of practice that should generally produce safe and effective radiological care. They are not intended as rules, nor are they designed to establish a legal standard of care or conduct. Principles and Approaches Both ACR and CAR approaches are based on the principle that safe and effective use of diagnostic (and therapeutic) radiology requires specific training, skills, and techniques. Consequently, practice documents address the required qualifications and responsibilities of the radiologist (or medical imaging specialist); the required qualifications and responsibilities of other team members (e.g. technologists, medical physicists); examination and patient safety considerations; equipment; quality control and improvements; documentation; and reporting. Professional supervision and reporting responsibilities of the radiologist, therefore, are placed within a broader quality assurance system approach for a particular modality or examination. Practice guidelines/standards are supported by technical standards that together have formed the basis for accreditation programs for particular imaging modalities. What Do They Say About Professional Supervision and Reporting? The ACR and CAR practice guidelines and standards emphasise the role and responsibilities of the radiologist in supervising, interpreting and reporting diagnostic imaging examinations. They distinguish between two broad levels of professional supervision - general supervision and direct supervision with the latter requiring the radiologist to be present on-site and immediately available to furnish assistance and direction throughout the performance of the procedure. 28 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Principles and practices for radiologist reporting are addressed through separate practice guidelines or standards for communication for diagnostic radiology, with the Canadian standard drawing heavily on the US reporting guideline. Communication covers the written report and direct communication with the referring doctor. They highlight the central importance of the written report as the final product of the imaging service and recommend a minimum set of items that a report should include. In some instances (e.g. breast imaging), additional reporting requirements are set in line with mandatory national standards. Table 4-6 summarises the key features of general and direct supervision and reporting requirements recommended by the peak Canadian and US radiology professional bodies, while Table 4-7 sets out the key principles and practices recommended for effective communication in diagnostic radiology. Table 4-6: Professional Supervision and Reporting Requirements for Radiologists - Canada and USA General Supervision and Reporting Examinations undertaken under the supervision of and interpreted by the appropriately trained and credentialed radiologists with radiologist responsible for all aspects of the study. Trained and certified technologist, under overall supervision of radiologist, responsible for patient safety and comfort, examination preparation and performance, technical and quality evaluation of images and relevant QA. Direct Supervision and Reporting Examinations undertaken under the supervision of and interpreted by the appropriately trained and credentialed radiologists. Supervising radiologist is present and immediately available to furnish assistance and direction throughout the performance of the procedure. Trained and certified technologist responsible for patient safety and comfort, examination preparation and performance, technical and quality evaluation of images and applicable QA. Reporting in line general standards/guidelines set for Communication: Diagnostic Radiography with additional national requirements for screening and diagnostic mammography. Reporting in line general standards/guidelines set for Communication: Diagnostic Radiography. Source: AHA analysis of ACR Practice Guidelines and CAR Practice Standards 2005 29 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Table 4-7: Communication in Diagnostic Radiology - Key Principles and Practices, Canada and USA Purpose An official interpretation should be generated following any examination, procedure or officially requested consultation. An official interpretation is defined as that written report (and any supplements or amendments thereto) that attach to the patient’s permanent record (ACR). The effective transmission of radiographic information from the radiologist’s mind to the clinician constitutes the report’s purpose (CAR). Diagnostic radiology report A final written report shall be provided with all radiologic studies regardless of site of performance (e.g. hospital, imaging centre, physician office, mobile units). Report should contain the following minimum items: A. Demographics B. Relevant clinical information C. Body of report – procedures and materials, findings, patient limitations, clinical issues and comparative data D. Impression – conclusion or diagnosis that relates to the patient’s health problem and clinical questions posed by the referring doctor. Report shall be clear and concise. Other forms of communication Final written report is the definitive means of communicating results to referring physician. Other methods of direct or personal communication of results are encouraged in certain situations. Timeliness of reporting Timeliness of reporting varies with the nature and urgency of clinical problem. The written radiological report should be made available in a clinically appropriate, timely manner. Source: Source: AHA analysis of ACR Practice Guideline for Communication: Diagnostic Radiology. Effective January 2002 and CAR Practice Standard for Communication in Diagnostic Radiology, first approved in June 1997 and reviewed in September 2001. What are the Modality and Examination Specific Requirements? Table 4-8 compares the policy positions of the ACR and CAR on professional supervision and reporting requirements across the main diagnostic imaging modalities and for diagnostic mammography. The ACR recommends general supervision by the radiologist for all the imaging modalities with the exception of diagnostic mammography, which should be performed under the direct supervision of the radiologist qualified in mammography. The latter requirement is to ensure that the examination is planned and tailored to a patient’s individual needs. There are two key areas where CAR differs from the ACR recommendations. They relate to CT studies and diagnostic ultrasound examinations where CAR refers to ideal requirements. 30 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Table 4-8: Professional Supervision and Reporting Requirements by Diagnostic Imaging Modality/Examination – Canada and USA Requirements General supervision and reporting Canada USA General (plain) radiography Diagnostic radiology MRI Diagnostic CT Diagnostic ultrasound MRI Direct supervision and reporting Diagnostic ultrasound – on site availability ideal requirement for case-by-case consultation Diagnostic mammography CT – direct monitoring of each study an ideal requirement Diagnostic mammography and problem solving breast evaluation Source: AHA analysis of ACR Practice Guidelines and CAR Practice Standards 2005 For CT studies, CAR recommends that the ideal requirement is for the interpreting radiologist to monitor directly the performance of each study (CAR 2002). However, it acknowledges that this ideal is often unable to be met because of time constraints and limitations on radiologist availability. In settings where on-line monitoring is not possible, development of an appropriate CT protocol based on careful review of clinical indications, as well as the availability of prior imaging studies, is recommended. For diagnostic ultrasound examinations, CAR recommends that a sonologist must be available for consultation with the sonographer on a case-by-case basis and that this is best achieved by having the sonologist on site and available to participate actively in the ultrasound examination when required (CAR 2001 to 2005). This is because ultrasound is highly operator-dependent imaging modality that requires a radiologist’s availability to ensure quality examinations. At the same time, CAR acknowledges that the geographic realities in Canada do not permit the presence of an on-site sonologist in all locations. Consequently, CAR recommends strategies to risk manage situations, where a sonologist is not available on site to directly supervise the examination. Strategies include ensuring adequate documentation of each examination with a videotape record as an adjunct to the hard copy images in difficult cases; having a sonologist available by telephone for consultation with the sonographer and the referring physician; and regular sonologist visits to remote facilities to provide on site review of ultrasound procedures and sonographer supervision. The latter has been CAR’s policy position over a number of years and it has been restated in the release of its latest draft practice standard that covers the performance of musculoskeletal ultrasound examinations (2005). As noted already, both ACR and CAR develop practice guidelines and standards through consensus approaches. Appendix E and Appendix F provide further information about the practice guidelines and standards of the ACR and CAR. 31 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results 4.3.3 Professional Guidelines and Standards – United Kingdom and Europe The Royal College of Radiologists (RCR) has adopted a different approach to establishing good practice in clinical radiology. The approach adopted reflects the nature of the UK health system, the organisation and delivery of radiology services and the clinical governance framework set by the UK Government under which National Health Service (NHS) organisations operate to improve the quality of care. Clinical Governance Framework of the NHS Clinical governance is the process whereby individual practitioners are responsible for developing and maintaining standards within their local NHS organisation (Department of Health 1999). Organisations are accountable for continuously improving the quality of their services and maintaining high standards of care. This includes action to ensure risks are avoided; adverse events are detected rapidly, openly investigated and lessons learned; good practice is rapidly disseminated; and systems are in place to support continuous improvements in clinical care. The UK Government has created a series of national initiatives to support local activities. Initiatives include provision of best practice advice in use of new and existing treatments through the National Institute of Clinical Excellence (NICE), clinical guideline development, and national standards and service models for particular services or care groups. Royal College of Radiologists – Defining Criteria for Good Radiological Practice It is against this national policy backdrop and national agenda that the activities of the RCR need to be considered. The RCR has developed and issued a series of guidance documents that define the principles for the delivery of a high quality imaging service and high standards of clinical care in radiology within the NHS and its departments of clinical radiology. They focus on contemporary issues in the NHS. Documents have included advice on reporting (1995), delegation in departments of clinical radiology (1996), inter-professional roles and responsibilities ( 1998), good practice for clinical radiologists (1999), skills mix in clinical radiology (1999), clinical governance and revalidation for radiologists (2000), risk management in clinical radiology (2002), making the best use of a department of clinical radiology (2003) and individual responsibilities – a guide to good medical practice (2004). Together, these documents define the criteria for good radiological practice and the competence, care and conduct expected of a radiologist, in all aspects of their professional work. Professional supervision and reporting responsibilities of the radiologist are set within a broader context of practice within a department of radiology, under the clinical governance framework. European Developments At the European level, the European Association of Radiology (EAR) has issued several good practice guides for European radiologists – Good Practice Guide for European Radiologists (2004) and Risk Management in Radiology in Europe (2004). Both guides draw extensively on the principles set by the RCR. Within Europe there are moves towards the development of uniform standards for radiology training through the EAR (Diagnostic Imaging 2004). In the area of radiation safety, the roles and responsibilities of the radiologist have been enhanced with the setting of a European Union directive for the justification of radiation exposure (EURATOM 1997). Each radiation exposure must be justified and a clinical evaluation of the outcome of each medical exposure documented (ARC 2000, EAR 2004). 32 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Clinical radiologists are also required to monitor their requests for investigation to reduce overall radiation exposure and to assess the risks and benefits of a radiological examination. 4.3.4 Health Insurance Remuneration Arrangements– Canada and USA Review of professional supervision and reporting requirements for radiologists, under publicly funded health insurance schemes in Canada and the USA, has provided mixed results. This outcome reflects in part the variety of approaches adopted, the information available in the public domain, and government health policies and priorities. This section provides an overview of requirements while Appendix E and Appendix F provides additional information. Accredited Facilities Approach In Canada, some provincial government health plans address professional supervision and reporting by radiologists through accreditation requirements for imaging facilities for reimbursement purposes (Alberta and British Columbia). Provincial professional bodies set the guidelines and standards against which facilities are accredited. Professional supervision and reporting are addressed through the establishment of radiologist staffing requirements for a facility and the range of imaging services provided. Remote sites without full-time radiologist coverage are provided for with a series of requirements set to manage possible risks and ensure safe and quality care. Specific requirements may be set for a particular imaging modality and these appear to reflect, in part, the funding policies of a provincial government. For example, in Alberta accredited MRI facilities require the MRI radiologist being on-site for at least 50% of studies in a day and being immediately available (in person or by telephone) during all studies (College of Physicians and Surgeons of Alberta 2005). The MRI radiologist is responsible for approving all protocols on a case-by-case basis and for interpreting all studies in a timely fashion. Accreditation arrangements allow for remote MRI facilities that do not have an on-site radiologist with a series of requirements to manage associated risks and ensure safe and quality care. Requirements include having remote services linked to at least one other fully supervised full-time MRI facility; having an MRIapproved radiologist available to the imaging technologist by telephone during imaging sessions (or by tele-imaging in certain cases) and to review all requisitions, prescribe all imaging protocols and interpret all studies. MRI studies, where direct supervision is the accepted practice standard, are not performed by remote MRI facilities. Physician Payment Schedule Approach Other Canadian provinces specify supervision and reporting requirements through physician payment schedules (Manitoba, Ontario and Saskatchewan). Generally, fees have two components – professional and technical – with descriptors specifying each element of the diagnostic imaging service that a particular fee component covers. The descriptor of the professional fee covers supervision and reporting requirements that the radiologist (or other physician) is expected to perform in claiming the service. It therefore sets out the elements of the service and the roles and responsibilities of the radiologist in providing the service. The level of specification varies across the three provinces with Ontario having the most detailed. Generally, the level of supervision required is specified in the professional fee descriptors for a modality and/or examination. Two levels of professional supervision tend to be used – general clinical 33 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results supervision and oversight, and an on-site professional supervision requirement where the radiologist is required to be present in the facility to provide clinical supervision. Radiologist reporting requirements are built into the professional fee through the setting of an element for interpreting the results of the diagnostic procedure. Some elements of the professional component may be delegated to another physician. However, interpreting the results of the diagnostic procedure must be performed personally by the physician who claims the service. The approach used in Ontario is illustrated in Table 4-9. Table 4-9: Professional Supervision and Reporting Requirements for Radiologists – Ontario, Canada Professional component Technical component A. Preparing the patient for the procedure B. Performing the diagnostic procedure or assisting in the performance of the procedure C. Making arrangements for any appropriate follow-up care D. Providing records of results of the procedure to the interpreting physician E. Discussion with, and providing information and advice to, patient or patient’s representatives(s), whether by telephone or otherwise, on matters related to the service. F. Preparing and transmitting a written, signed and dated interpretation of the procedure to referring physician G. Providing premises, equipment, supplies and personnel for all specific elements of the technical and professional components. A. Providing clinical supervision including approving, modifying and/or intervening in the performance of the procedure where appropriate, and quality control of all elements of the technical component B. Performance of any clinical procedure associated with the diagnostic procedure which is not separately billable. C. Where appropriate, post procedure monitoring, including intervening except where this constitutes a separately billable service. D. Interpreting the results of the diagnostic procedure. E. Providing premises for any aspect(s) of A and D that is (are) performed at a place other than the place in which the procedure is performed. If the physician claiming the fee for the service is personally unable to perform elements A, B and C, these may be delegated to another physician who must personally perform the service. Element D must be personally performed by the physician who claims the service. Source: AHA analysis of Ontario Health Insurance Plan (April 2005) US Medicare Program Requirements The US Medicare program sets physician supervision requirements that apply during the performance (technical component) of diagnostic x-ray, diagnostic laboratory and other diagnostic tests and procedures in physicians’ offices and non-hospital free standing centres. Tests have to be performed under the supervision of a physician. Requirements do not apply to Medicare hospital inpatients or outpatients. They were implemented in 2001 after much discussion with professional and industry bodies about the requirements, their definitions and coverage. There are three levels of supervision that apply to diagnostic tests and procedures provided by radiologists – general, direct and personal. Each item of service in the Medicare Physician Fee 34 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Schedule is assigned a professional supervision level code (e.g. 1 for general, 2 for direct and 3 for personal supervision) that applies for reimbursement purposes. Definitions for each level are set out in Table 4-10, together with examples of the types of imaging examinations covered. Table 4-10: US Medicare Program – Professional Supervision Requirements for Diagnostic Tests and Procedures Level General supervision Direct supervision Personal supervision Definition Examinations/Procedures Means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the nonphysician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician. X-rays (except where contrast is required) Means the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed. CT with contrast Means a physician must be in attendance in the room during the performance of the procedure. X-rays with contrast procedures CT without contrast MRI without contrast Most ultrasound MRI with contrast Certain ultrasound Certain CT procedures Certain MRI procedures Certain ultrasound procedures Source: US Department of Health & Human Services Centers for Medicare & Medicaid Services, Medicare Carriers Manual 2005 Hospital and mammography services are excluded from the supervision requirements with hospitals regulated through the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) while mammography is regulated by the US Food and Drug Administration (FDA). Practices are required to staff their facilities accordingly, in order to comply with the supervision requirements. General supervision means that the physician is not necessarily on-site. In the case of direct supervision, the physician must be present in the office suite and immediately available. This is defined as within earshot (not just reachable by beeper, and not merely in the same building) whereas with personal supervision the physician must actually be present in the room with the patient during the performance of the procedure (Murray 2001). Documentation is required to be kept in order to show compliance. 35 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results 4.3.5 Conclusions – Similarities, Differences and Lessons Learnt A mix of approaches has been used to define professional supervision and reporting requirements for radiologists. They range from considering requirements in the context of good practice guidelines and standards for a particular modality or examination and the setting of radiologist staffing requirements for medical imaging facilities under accreditation arrangements, through to specifying requirements in payment schedules. Each offers lessons. The ACR and CAR approaches place the radiologist’s professional supervision and reporting responsibilities within a broader quality assurance system approach for a particular modality or examination. They also provide examples of ways for considering principles of good practice in reporting and the report’s content. The payment approaches adopted in Canada show different ways of specifying the components of the imaging service and the radiologist’s roles and responsibilities for the service. Canadian approaches also provide ways for considering ideal requirements and managing the potential risks that occur when the ideal supervision requirement is unable to be met. The UK experience with clinical governance provides some principles to guide clinical risk management in radiology practice. In terms of establishing appropriate radiologist supervision requirements, across the range of modalities and examinations that make up diagnostic imaging, all have sought to define levels of supervision, however, that there are differences in the number of levels, in terminology and in definitions: The US Medicare program has set three levels – general, direct and personal while other bodies tend to focus on two levels – general and direct. Under the Australian Medicare arrangements, three levels apply – general, direct and personal attendance. Supervision levels are focussed on establishing the radiologist’s responsibilities and the degree of direct participation (the assistance and direction they provide) during the performance of the examination on the patient. Much attention has focussed on where the radiologist is physically located – off site, on the premises, or in the room where the procedure is being performed. Much of the debate has centred on defining availability and whether it requires on-site presence. The types of assistance and direction required of the radiologist during the performance of an examination, for direct supervision purposes, have been defined in different ways as Table 6-6 illustrates. Table 4-11: Definitions of Direct Supervision by Radiologists Organisation Definition ACR and CAR Supervising radiologist is present and immediately available to furnish assistance and direction throughout the performance of the procedure. Ontario An on-site professional supervision requirement where the radiologist is required to be present in the facility to provide clinical supervision. Providing clinical supervision including approving, modifying and/or intervening in the performance of the procedure 36 AUSTRALIAN HEALTHCARE ASSOCIATES 4. Results Organisation Definition where appropriate, and quality control of all elements of the technical component. Australian Medicare Program Where the supervising radiologist is available to monitor and influence the conduct and diagnostic quality of the examination. US Medicare Program The physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed. Source: AHA analysis 2005 In terms of the requirements for different modalities and examinations, some broad observations can be made: For diagnostic radiology, CT and MRI examinations, there is a trend towards general supervision. There appears to be agreement that diagnostic mammography requires a higher level of supervision with the term direct supervision often used; however, direct supervision is defined in different ways and it is unclear to what extent the establishment of national programs for the prevention and management of breast disease across countries has contributed to this situation. In ultrasound, there are different views about the appropriate level of professional supervision that the radiologist should provide. Those advocating higher levels of radiologist involvement and input, during the performance of the examination on the patient, are doing so because of the operator-dependent nature of ultrasound and the consequent need to ensure quality examinations. However as noted, drawing comparisons across countries and agencies is inherently difficult and little is known about the factors and circumstances that contributed to the setting of a particular requirement. 37 AUSTRALIAN HEALTHCARE ASSOCIATES 5. Discussion This chapter includes a brief discussion of the results, to set the scene for the approach adopted in developing the proposed professional supervision and reporting standards, as set out in Chapter 6 - Conclusions. 5. DISCUSSION Australian and overseas approaches to professional supervision have traditionally varied according to the modality, test or examination. Implicitly, therefore, resulting levels of supervision have sought to provide ways of managing different levels of associated risk. Stakeholder consultations affirmed that this was an important principle that should underpin professional supervision and reporting standards. The amount and nature of radiologist participation should and will vary with the type and complexity of the medical problem, the type of technology used and type of examination performed. Different modalities and examinations have different technical profiles. For some, these technical requirements can be managed usually through the use of imaging protocols (e.g. plain x-rays and CT scans). Other imaging modalities (e.g. ultrasound) present a different set of technical challenges and are not as protocol driven. Many stakeholders indicated that ultrasound is a highly operator dependent imaging modality, where the use of probes and transducers to produce an image where the probe is pointed, requires flexibility in approach and high levels of expertise. The use of contrast media (e.g. in CT scans) and sedation (e.g. in MRI) changed the risk profile and required a medical practitioner (not necessarily a radiologist) to be available to treat any adverse reactions or other events. Consultations however have also indicated that radiologists operate in a range of operating environments and the risks associated with each different environment varies significantly. These Standards therefore call for an assessment of risk and development of a range of appropriate procedures to manage this risk by individual radiologists and/or practices. Most approaches to professional supervision in Australia and overseas have tended to focus on the level and nature of radiologist availability during different types of examinations - for example, whether they should be available on-site or be available to personally attend the patient. These approaches implicitly suggest that radiologists will have appropriate input to the imaging service, if they are available to do so. This approach however, fails to recognise that in many cases, radiologist input to the request review, patient preparation and examination components of the imaging service for example, are dependent on other members of the imaging team, such as radiographers and sonographers, seeking such input. It is therefore appropriate that supervision standards place a greater focus on ensuring the effective functioning of the imaging team as a whole. This involves all members of the imaging team having a clear understanding of their roles and responsibilities and involves radiographers and sonographers having a sound appreciation of the circumstances and situations in which they should seek additional radiologist input to the imaging service. 38 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations This chapter summarises our conclusions and sets out the proposed standards associated with professional supervision and reporting. In addition, it discusses implementation issues associated with the proposed standards and linkages between this and other QUDI projects. 6. CONCLUSIONS AND RECOMMENDATIONS 6.1 Professional Competence - Qualifications of Personnel 6.1.1 The Imaging Team Diagnostic imaging services are provided in multidisciplinary teams with members with the required expertise drawn from various professional and other groups. The following table identifies the members of the imaging team and details their key role. Team Member Radiologists Key Role Team leader with overall responsibility for the radiology service Radiographers/Sonographers Prepare patient, operate equipment, perform examinations Medical Physicists Ensure optimum performance of equipment Service Engineers Maintain and service equipment Nurses Provide clinical support Administrative Staff Book appointments, type reports undertake other clerical staff The team mix varies depending on the type of examination performed. The individual responsibilities of team members are interdependent. Collectively, they enable the effective delivery of the service (RCR 1999). 6.1.2 For Radiologists Radiologists, and the teams they lead, must be appropriately qualified, trained and experienced to provide the requested services. Radiologists providing imaging services must meet certain competency requirements as specified in Table 6-1. Additional requirements apply for radiologists practising MRI, diagnostic mammography and diagnostic ultrasound. Table 6-1: Radiologists’ Qualifications, Registration and Continuing Professional Development (CPD) Requirements Radiologists’ qualification A radiologist must be qualified by a recognised training body to practice diagnostic radiology through one of the following academic awards: Diploma of The Royal Australian and New Zealand College of Radiologists (DRACR)/Fellow of The Royal Australian and New Zealand College of Radiologists (FRANZCR); or National Specialist Qualification Advisory Committee (NSQAC)/Specialist Recognition Advisory Committee 39 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations (SRAC) equivalent. (Standard P.1.1.1) Registration In Australia, a radiologist must be registered with the relevant State or Territory Medical Board which has jurisdiction over the location in which that radiologist carries out his/her practice. In New Zealand, a radiologist must be registered with the Medical Council of New Zealand. (Standard P.1.2.1) A radiologist must hold a current radiation operator’s licence. In Australia, the radiologist must hold a current State or Territory radiation Operator’s Licence, while in New Zealand the radiologist must hold a current Annual National radiation Laboratory Licence. (Standard P.1.2.2) Continuing professional development (CPD) A radiologist shall participate in the RANZCR CDP Program and maintain his/her participation in each triennium of the RANZCR CDP Program. (Standard P.1.3) Source: RANZCR Accreditation Standards for Diagnostic and Interventional Radiology (Version 7 - 2005) Radiologists practising MRI and diagnostic mammography must meet additional qualification and CPD requirements, while radiologists practising ultrasound must meet additional qualification requirements as specified in Table 6-2. Table 6-2: Additional Professional Competency Requirements for Radiologists Practicing MRI, Diagnostic Mammography and Diagnostic Ultrasound MRI MRI Supervising Radiologists of MRI facilities must have evidence of competence in the techniques and application of magnetic resonance imaging. (Standard P1.1.3) Each radiologist interpreting MR images must have accumulated 30 MRI specific CPD points/hours I the past three years. MRI Supervising Radiologists must accrue a minimum of 60 MRI specific CPD points over three years. The MRI CPD activities undertaken must be those recognised by the RANZCR CPD Program. (Standard P.1.3.3) Diagnostic mammography Each radiologist must interpret mammograms on a regular basis. (Standard P.1.1.5) Each radiologist interpreting mammograms must have accumulated 15 mammography specific CPD points/hours in the past three years in Mammography CPD activities recognised by the RANZCR CPD Program. (Standard P.1.3.2) Diagnostic ultrasound A radiologist practising Diagnostic Ultrasound must comply with RANZCR Guidelines For Medical Practitioners Performing and Interpreting Diagnostic Ultrasound – Intercollegiate Consensus Statement (June 1998). (Standard P.1.1.4) Source: RANZCR Accreditation Standards for Diagnostic and Interventional Radiology (Version 7- 2005) 6.1.3 For Other Health Care Professionals in the Imaging Team Other health care professionals who are members of the medical imaging team must meet certain qualification, registration and CPD competency requirements as specified in Table 6-3. 40 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Table 6-3: Competency Requirements for other Health Care Professionals in the Imaging Team Radiographers A radiographer: Must be qualified by a recognised training body to practice radiography ((Standard P.2.1.1) Must hold a current State, Territory or New Zealand Radiographers Board registration, where available (Standard P.2.2.1) Must hold a current State or Territory Radiation Operator’s licence, where available (Standard P.2.2.2) Shall participate in a radiographer’s CPD Program, such as or equivalent to the Australian Institute of Radiography (AIR) CPD Program. (Standard P.2.3.1) Diagnostic mammography radiographers A diagnostic mammography radiographer: In addition to compliance with the requirements of P.2.1.1, possession of a Certificate of Clinical Proficiency from the AIR or equivalent would be an advantage. (Standard P.2.1.2) Within the general requirements for Radiographer CPD, each radiographer performing services in diagnostic mammography must participate in at least 15 hours of mammography-specific CPD every three (3) years. CPD activities include formal programs such as conferences, seminars and meetings of professional bodies; and selfinstruction by way of the study of publications, books and exhibits. (Standard P.2.3.2) Sonographers A sonographer: Must either be on the Register of Accredited Sonographers or Student Sonographers as administered by the Australian Sonographer Accreditation Registry Ltd (ASAR) or be registered directly with the DHA or be eligible for registration with the ASAR/DHA (Standard P.3.1.1) Shall participate in the ASAR CPD Program. (Standard P.3.2.1) MRI radiographers Radiographers who perform MRI examinations: Must have completed or be undertaking training and gaining experience in MRI which is approved by the supervising radiologist (s) (Standard P.5.1.1 – Under Review) Shall participate in a program of MRI-specific CPD activity such as the AIR CPD Program. (Standard P.5.2.1 – Under Review) Nurses Nurses employed in medical imaging practices: Shall hold current State, Territory or New Zealand nursing registration (Standard P.7.1.1) Shall have adequate training/experience in Medical Imaging practice. (Standard P.7.2.1) Source: RANZCR Accreditation Standards for Diagnostic and Interventional Radiology (Version 7- 2005) 41 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations 6.2 The Diagnostic Imaging Service Cycle Usually, a diagnostic imaging service is initiated by a written request from a medical practitioner (requester) and comprises several stages before the radiologist provides a written report with results and opinion to the requester. The stages of the diagnostic imaging cycle are illustrated in Figure 6-1. Figure 6-1: Diagnostic Imaging Service Cycle Adapted from the Royal College of Pathologists of Australasia Chain of Information Custody for Pathology Request - Test Report Cycle in Australia (Guidelines for Pathology Requestors and Pathology Providers), 2004. The patient’s clinician determines on clinical grounds that a diagnostic imaging service is required for patient care and communicates the request for imaging. The responsibility of radiologists commences with the receipt of the request for an imaging test/examination and continues until the outcomes are communicated to the requester. The goal of the imaging service and imaging team is to maximise the information obtained from the examination while minimising associated safety risks and ensuring high quality patient care. The outcome of the service is a written report with a medical opinion from the radiologist that addresses the medical problem and questions posed by the requesting doctor, and assists patient care. Within each stage there are a variety of tasks to be performed with the mix and complexity varying depending on patient, disease, clinical and other factors and body system under investigation and imaging examination required. The quality of the report depends on the stages and steps that comprise the imaging service as illustrated in Figure 6-1. Not all of the tasks will be undertaken by the radiologist personally, however at a minimum, the radiologist should provide appropriate supervision and/or input for each task. The following section 42 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations discusses each of the stages comprising a diagnostic imaging service and sets out standards for supervision and input by radiologists. 6.3 Review of Request and Patient Preparation 6.3.1 Objectives This stage of the imaging service covers the review of the request for imaging and preparation of the patient for the examination. Its objectives are to: Ensure adequate assessment of the patient’s condition and symptoms and clear understanding of the nature of the medical problem and questions to be investigated - based on the information provided by the requesting medical practitioner and, where appropriate, discussions with the patient. Arrange the appropriate investigations for the patient in order to minimise risk and maximise the effectiveness of diagnosis. 6.3.2 Key Tasks It involves: Reviewing request from doctor for imaging service and clinical indications Discussion with patient - including obtaining and recording relevant information on allergies, pregnancy status and previous studies and in the case of MRI examinations, whether the patient has a pacemaker, aneurism clips or any surgically inserted metallic device Reviewing any previous test results where relevant and available Advising on appropriateness of examination Explaining test/procedure and any associated risks to patient and/or requester Obtaining the patient’s informed consent Determining imaging protocol to be followed Preparing and positioning of patient for test/procedure. 6.3.3 Key Considerations and Managing Associated Risks Patients present with a variety of medical problems and complexity. Imaging may be requested for a variety of purposes - e.g. as a non-specific screen, to exclude a specific diagnosis, to confirm specific diagnoses, to narrow a differential diagnosis, to stage a known condition or to monitor a known condition. Information provided on the request may include signs, symptoms or suspected condition(s) pointing to a particular diagnosis or a range of diagnoses or enumerate the possible diagnoses that are being considered and suspected condition(s), the test(s) to be used. Imaging modalities and examinations, and the body systems to be imaged, have different technical and risk profiles. For some, these technical requirements can be managed usually through the use of radiologist-specified imaging protocols. Other imaging modalities or 43 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations examinations are not as protocol-driven. The use of contrast media (e.g. in CT scans) and sedation (e.g. in MRI) alters the risk profile. The patient should always be informed of the name and status of the person performing a task that forms part of an imaging service. 6.3.4 Radiologist Responsibilities The radiologist is responsible for ensuring: Requests received are in line with RANZCR Standard P.1.5.1 Consulting with patients as clinically necessary, as per RANZCR Standard A.2.1.1 Advising on appropriate imaging investigation, methods and preparation, as per RANZCR Standard P1.5.1 and P1.5.3 Receipt of patient’s informed consent Quality of the review and patient preparation stage. 6.3.5 Relevant Existing Standards A number of existing RANZCR Standards are relevant to this component of the imaging service. These Standards, to which reference is made in Section 6.3.4 above, have been included in this section for ease of referral. Standard P.1.5.1 - Requests A diagnostic imaging procedure shall be undertaken upon receipt of a request made by a medical practitioner, or by one of the following practitioners where the imaging procedure requested is directly related to the practitioner’s specialty groups’ recognised field of expertise: a Chiropractor, Dental Practitioner, Oral and Maxillofacial surgeon, Osteopath, Physiotherapist, Podiatrist or Prosthodontist or licensed under State or Territory laws. A request shall be made in a format whereby sufficient information is provided on the clinical indications for the procedure requested. Before undertaking the requested diagnostic imaging procedure, a radiologist shall consider the appropriateness of the procedure requested based on the clinical information provided for diagnosis of the patient’s condition. Standard P.1.5.3 - Additional and Substituted Tests Should the Radiologist determine from the clinical information provided in a request that a different diagnostic imaging procedure or modality would be more appropriate for the diagnosis of the patient’s condition, and where the substituted procedure or modality is one that would be accepted by diagnostic imaging specialists as more appropriate to the clinical information provided, the radiologist shall substitute that diagnostic imaging procedure or modality. The Radiologist shall take all reasonable steps to contact the requesting practitioner before providing the substituted procedure or modality and shall notate this determination in his/her report along with all efforts made to contact the requesting practitioner. Should the radiologist determine on the basis of the results obtained from a requested procedure that an additional service is necessary for the diagnosis of the patient’s condition, the radiologist shall undertake the additional service and notate his/her report accordingly. 44 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Standard A.2.1.1 - Needs Assessment Information relevant to the studies being performed must be obtained and recorded prior to the examination by clerical staff, radiographer, sonographer, nuclear medicine technologists and/or radiologist. Relevant information shall include allergies, pregnancy status and previous studies. Additional specific information must be obtained and recorded prior to patients undergoing special examinations such as MRI, angiography, prostate biopsy. 6.3.6 Proposed Supervision Standard - Review of Request and Patient Preparation The radiologist should have appropriate input and supervision, such that they may be certain all of their responsibilities in relation to the review of the service request and patient preparation, have been adequately met. This may be ensured through at least one of the following: 1. Personally conducting each of the components associated with this stage of the imaging service; or 2. Direct (face to face) supervision of the other members of the imaging team, as this stage of the imaging service is undertaken; or 3. Ensuring the implementation and adherence to appropriate written protocols, to be followed by members of the imaging team, under the radiologist’s direction. The protocols should outline the responsibilities of other members of the imaging team when undertaking components of this stage and the circumstances/situations under which, different members of the team should seek further guidance and/or input from a radiologist. Additional radiologist input, for different circumstances/situations may involve the radiologist: − conducting aspects of this component themselves − providing verbal advice − providing a practical assistance/direction/demonstration − conducting a review of clinical information/diagnoses. Circumstances/situations which may be specified as triggers for seeking additional radiologist input may relate to: − the type/nature of the referral received - emergency, insufficient clinical information, conflicting indications − the type of examination requested - modality/body system or inappropriate or unwarranted examination requested based upon accepted diagnostic imaging algorithms − patient characteristics - age, condition, complicating factors. The protocols may also provide for different triggers for seeking radiologist input, depending on the specific imaging team member undertaking a particular component of this stage of the service, based upon the team member’s: − qualification − experience − specialisation. 45 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations 6.4 Performance of Imaging Examination 6.4.1 Objectives This stage of the imaging service deals with the performance of the examination on the patient. Its objectives are to: Ensure the patient’s comfort and safety Assure a quality examination Obtain images of diagnostic quality. 6.4.2 Key Tasks It involves: Performing the agreed examinations(s) Monitoring the patient for any complications or adverse effects Obtaining images Administering contrast media or sedation as necessary Documenting test/procedures performed Monitoring and reviewing images to ensure their quality and suitability. 6.4.3 Key Considerations and Managing Associated Risks Quality of report depends on a quality imaging examination Performance of examination requires skilled and appropriately trained staff 6.4.4 Radiologist Responsibilities The radiologist is responsible for: Medical care of the patient Setting standards for performance of tests/ examinations including selection of numbers and types of views to be used Meeting those standards for performing examinations where this is the case Monitoring the quality of the examination Managing complications and adverse effects that may arise Providing advice and support Quality assurance of the completed examination - evaluation of technical adequacy (i.e. is the examination complete and adequate for diagnostic purposes?) and clinical relevance (does the examination contribute to solving diagnostic dilemma?) Safety of working environment. 46 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations 6.4.5 Proposed Supervision Standard - Performance of Imaging Examination The radiologist should have appropriate input and supervision, such that they may be certain all of their responsibilities in relation to the examination stage, have been adequately met. This may be ensured through at least one of the following: 1. Personally conducting each of the components associated with this stage of the imaging service; or 2. Direct (face to face) supervision of the other members of the imaging team, as this stage of the imaging service is undertaken; or 3. Ensuring the implementation and adherence to appropriate written protocols, to be followed by members of the imaging team, under the radiologist’s direction. The protocols should outline the responsibilities of other members of the imaging team when undertaking components of this stage and the circumstances/situations under which, different types of team members should seek further guidance and/or input from a radiologist. The protocols should do this while ensuring service quality and patient safety and being cognisant of patient access issues, in areas with a limited radiologist workforce. The types of circumstances/situations which should be specified in the protocols as triggers for seeking additional radiologist input may relate to: − the type/nature of the examination being undertaken - modality/body system − difficulties obtaining an image of the type/quality required − unusual or unexpected imaging results − examination findings requiring urgent reporting − receipt of additional critical verbal information provided by the patient and not included on the request/referral − concerns regarding the proper functioning of imaging equipment − patient characteristics - age, condition, complicating factors, medical history, clinical indications. The protocols should indicate for each circumstance/situation, the additional input a radiologist should be available to provide. The protocols should specify, for example, that for each specified circumstance/situation that a radiologist should be available to either: − immediately personally attend the patient − personally attend the patient within a specified set timeframe − provide immediate verbal advice − provide verbal advice within a specified set timeframe. The protocols may also provide for different triggers, depending on the imaging team member undertaking a particular component of this stage of the service, based upon the team member’s: − qualification − experience − specialisation. 47 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Other members of the imaging team should not proceed with an examination where it is known the radiologist would not be available to provide appropriate additional input, as detailed in the protocols. The protocols should also ensure that: − all regulatory requirements are met (MBS, State/Territory Radiation Protection legislation) − examinations which require the administration of contrast media are not undertaken unless a radiologist or other appropriately credentialed medical practitioner would be available to immediately personally attend the patient − examinations which require sedation of the patient are not undertaken unless a radiologist or other appropriately credentialed medical practitioner would be available to immediately personally attend the patient − examinations of critically ill patients should only be undertaken by, or under the direct (face to face) supervision of, a radiologist or other appropriately credentialed medical practitioner − patients are not required to wait for an excessive period during an examination for additional radiologist input to be sought − an excessive proportion of patients are not required to be called back and re-examined to obtain an image and report of appropriate quality. 6.4.6 Risk Assessment When developing written protocols for the examination component of the diagnostic imaging service, radiologists should have due regard to the relative risk to patient safety and service quality of each type of examination. These risks may be considered by modality and by body system. A basic framework for the consideration of the relative risk of different examinations by body system and modality has been included as Appendix A to this report. 6.5 Interpretation and Reporting 6.5.1 Objectives This stage of the imaging service deals with analysis and interpretation of the images produced and reporting of the results to the requesting doctor. Its objective is to produce a timely written report that provides an answer to the clinical questions posed, together with an assessment of the whole image for relevant and/or unexpected findings (RCR 2006). 6.5.2 Key Tasks It involves: Reviewing images to evaluate their quality and suitability Reviewing and analysing images to establish findings Interpreting results of imaging test/procedure by correlating findings of image analysis with patient, disease, clinical and other factors 48 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Reviewing previous studies where available Preparing and providing written report to requesting doctor Seeking a second opinion where appropriate – e.g. where diagnosis may be difficult or specialist knowledge is required Other communication with requesting doctor as the situation requires 6.5.3 Key Considerations The accuracy and timeliness of the report are a key component of the patient’s care. Interpretation and reporting are central to responsibilities of radiologists. It requires a wide medical knowledge and awareness of the likely accuracy of the examination in the particular patient related to published accuracy of the technique and its applicability to a particular examination (RCR 2006). Accuracy of image interpretation is crucial. 6.5.4 Radiologist Responsibilities Radiologists are responsible for ensuring that reports issued should be accurate, explicit and understandable reports, which record the relevant findings and provide clear guidance to the requester on likely diagnosis and supplementary investigations. Where uncertainty exists, this should be made clear within the text of the report. Reports should contain the following minimum items – demographics; relevant clinical information; body of report that details procedures and materials, findings, patient limitations, clinical issues and comparative data; and impression – conclusion or diagnosis that relates to the patient’s health problem and clinical questions posed by requesting doctor (ACR 2002). The current RANZCR Standard for reports is provided in the following Section 6.5.5 along with the Standard relating to trainee radiologists and their supervision. It should be noted that the current RANZCR report Standard is classified as an administrative standard, rather than a professional standard. 6.5.5 Relevant Existing Standards A number of existing RANZCR Standards are relevant to this component of the imaging service. These Standards, have been included in this section for ease of referral. Standard A.1.4.1 - Reports All studies shall be interpreted and reported by a radiologist or a trainee in a RANZCR accredited training position. All reports shall include: A title; The name and address of the practice, and location/site where the imaging procedure(s) was performed; Referrer’s name; Date of issue of report; 49 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Unique identification of the patient i.e. Full name and date of birth or medical record number; Date of imaging procedure(s); Identification of the modality used; Imaging procedure(s) results and, where appropriate, the units of measurement; Opinions and interpretations where relevant; Name of reporting radiologist. Note: Practice sites shall refer to the ACR Standard for Communication (Diagnostic Radiology) as a guideline for further detail. The radiologist or medical specialist who signs or co-signs a report created by a colleague shall satisfy him/herself that the content of the report has been checked for grammatical errors only but not as to clinical content or accuracy. In addition, practices shall apprise themselves of the relevant legislation in regard to electronic signatures. The written and confirmed report shall be sent to the referrer or other health care provider providing clinical follow-up. The patient may act as a courier for this purpose. Standard P.1.4.1 - Supervision of Trainee Radiologists A qualified radiologist must be available to provide on-site direct supervision of Trainee Radiologists at all times in hours, and be available to provide advice and backup at all times out of hours. Standard A.1.4.5 - Supervision of Trainee Radiologists The timeliness of reporting any radiological study varies with the nature and urgency of the clinical problem. The written report shall be made available in a clinically appropriate, timely manner. ACHS Clinical Indicator for the reporting of in-patient films (24) shall apply to n-patient examinations. Regular QA reviews to be carried out at least once every three years shall be performed on the time between the performance of the study and the issuing of the written report. Note: Practice sites shall refer to the ACR Standard of Communication (Diagnostic Radiology) as a guideline for further detail. Standard A.1.4.6 - Urgent Reports If there are urgent and significant unexpected findings, the radiologist shall use reasonable endeavours to communicate directly with the referrer or an appropriate representative who will be providing clinical follow-up. A record of actual or attempted direct communication shall be maintained. Note: Practice sites shall refer to the ACR Standard for Communication (Diagnostic Radiology) as a guideline for further detail. 6.5.6 Proposed Supervision Standard - Reports All studies must be interpreted and reported by a qualified radiologist or a trainee radiologist under specialist supervision. The radiologist should ensure that an appropriate protocol is in place to ensure that the level of supervision of trainees is adequate. This protocol should include arrangements for 50 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations conducting an appropriate number of validation checks of imaging reports prepared by trainee radiologists, the extent of which, may vary depending on the trainee’s experience and expertise. 6.5.7 Other Proposed Standard - Requestor Communication Radiologists provide a medical consultative service. Communication with requesting doctors should not simply conclude with the issuing of the report. Radiologists should ensure that there are mechanisms in place to enable the requester to discuss imaging findings with the radiologist in order to better understand the implications and reliability of the findings or to provide further clinical information that may affect interpretation. These mechanisms, should also allow radiologists to provide advice to their general practitioner and specialist colleagues regarding imaging strategies, appropriate for particular clinical problems. 6.6 Summary of Proposed Standards This section provides a summary of the proposed Standards set out in this document. These Standards are designed to promote safe and quality patient care and radiology practice. The Standards recognise that professional supervision is only one aspect of ensuring an effectively functioning imaging team and that a diagnostic imaging service includes multiple components, of which, the examination is but one. They recognise that radiologists work in a range of environmental settings and that there is no one best approach to supervision, suitable for all circumstances. The development and adherence to a set of practice-based protocols is but one aspect of ensuring service quality and should be seen as one part of an overall quality system encompassing all of the RANZCR Standards. The Standards therefore, focus on ensuring that radiologists assess the risks associated with delivering radiology services in their unique environment and that they provide clear guidance and direction for other members of the imaging team, as to when they should seek radiologist input to the service. The proposed Standards will require individual radiologists or radiology practices to undertake a systematic analysis of the risks associated with each type of imaging service they undertake. A suggested framework to assist in undertaking this risk profiling is attached at Appendix G. This framework requires consideration of the risks, in terms of service quality and patient safety, associated with different types of examinations, by body system and modality. 6.6.1 Proposed Supervision Standard - Review of Request and Patient Preparation The radiologist should have appropriate input and supervision, such that they may be certain all of their responsibilities in relation to the review of the service request and patient preparation, have been adequately met. This may be ensured through at least one of the following: 1. Personally conducting each of the components associated with this stage of the imaging service; or 2. Direct (face to face) supervision of the other members of the imaging team, as this stage of the imaging service is undertaken; or 3. Ensuring the implementation and adherence to appropriate written protocols, to be followed by members of the imaging team, under the radiologist’s direction. The protocols should outline the responsibilities of other members of the imaging team when undertaking components of this stage and the circumstances/situations under which, different 51 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations members of the team should seek further guidance and/or input from a radiologist. Additional radiologist input, for different circumstances/situations may involve the radiologist: − conducting aspects of this component themselves − providing verbal advice − providing a practical assistance/direction/demonstration − conducting a review of clinical information/diagnoses. Circumstances/situations which may be specified as triggers for seeking additional radiologist input may relate to: − the type/nature of the referral received - emergency, insufficient clinical information, conflicting indications − the type of examination requested - modality/body system or inappropriate or unwarranted examination requested based upon accepted diagnostic imaging algorithms − patient characteristics - age, condition, complicating factors. The protocols may also provide for different triggers for seeking radiologist input, depending on the specific imaging team member undertaking a particular component of this stage of the service, based upon the team member’s: − qualification − experience − specialisation. 6.6.2 Proposed Supervision Standard - Performance of Imaging Examination The radiologist should have appropriate input and supervision, such that they may be certain all of their responsibilities in relation to the examination stage, have been adequately met. This may be ensured through at least one of the following: 1. Personally conducting each of the components associated with this stage of the imaging service; or 2. Direct (face to face) supervision of the other members of the imaging team, as this stage of the imaging service is undertaken; or 3. Ensuring the implementation and adherence to appropriate written protocols, to be followed by members of the imaging team, under the radiologist’s direction. The protocols should outline the responsibilities of other members of the imaging team when undertaking components of this stage and the circumstances/situations under which, different types of team members should seek further guidance and/or input from a radiologist. The protocols should do this while ensuring service quality and patient safety and being cognisant of patient access issues, in areas with a limited radiologist workforce. The types of circumstances/situations which should be specified in the protocols as triggers for seeking additional radiologist input may relate to: − the type/nature of the examination being undertaken - modality/body system − difficulties obtaining an image of the type/quality required 52 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations − unusual or unexpected imaging results − examination findings requiring urgent reporting − receipt of additional critical verbal information provided by the patient and not included on the request/referral − concerns regarding the proper functioning of imaging equipment − patient characteristics - age, condition, complicating factors, medical history, clinical indications. The protocols should indicate for each circumstance/situation, the additional input a radiologist should be available to provide. The protocols should specify, for example, that for each specified circumstance/situation that a radiologist should be available to either: − immediately personally attend the patient − personally attend the patient within a specified set timeframe − provide immediate verbal advice − provide verbal advice within a specified set timeframe. The protocols may also provide for different triggers, depending on the imaging team member undertaking a particular component of this stage of the service, based upon the team member’s: − qualification − experience − specialisation. Other members of the imaging team should not proceed with an examination where it is known the radiologist would not be available to provide appropriate additional input, as detailed in the protocols. The protocols should also ensure that: − all regulatory requirements are met (MBS, State/Territory Radiation Protection legislation) − examinations which require the administration of contrast media are not undertaken unless a radiologist or other appropriately credentialed medical practitioner would be available to immediately personally attend the patient − examinations which require sedation of the patient are not undertaken unless a radiologist or other appropriately credentialed medical practitioner would be available to immediately personally attend the patient − examinations of critically ill patients should only be undertaken by, or under the direct (face to face) supervision of, a radiologist or other appropriately credentialed medical practitioner − patients are not required to wait for an excessive period during an examination for additional radiologist input to be sought − an excessive proportion of patients are not required to be called back and re-examined to obtain an image and report of appropriate quality. 53 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations 6.6.3 Proposed Supervision Standard - Reports All studies must be interpreted and reported by a qualified radiologist or a trainee radiologist under specialist supervision. The radiologist should ensure that an appropriate protocol is in place to ensure that the level of supervision of trainees is adequate. This protocol should include arrangements for conducting an appropriate number of validation checks of imaging reports prepared by trainee radiologists, the extent of which, may vary depending on the trainee’s experience and expertise. 6.6.4 Other Proposed Standard - Requestor Communication Radiologists provide a medical consultative service. Communication with requesting doctors should not simply conclude with the issuing of the report. Radiologists should ensure that there are mechanisms in place to enable the requester to discuss imaging findings with the radiologist in order to better understand the implications and reliability of the findings or to provide further clinical information that may affect interpretation. These mechanisms, should also allow radiologists to provide advice to their general practitioner and specialist colleagues regarding imaging strategies, appropriate for particular clinical problems. 6.7 Implementation Requirements and Linkages 6.7.1 Implementation Requirements This section provides a brief summary of the requirements associated with the implementation of the Standards regarding professional supervision. Some of these are requirements to be addressed by the College, while others will need to be addressed by individual radiologists or radiology practices. Implementation requirements for the RANZCR Key requirements for the College, associated with the implementation of these Standards, are detailed in this section, including requirements to: ensure the sector is aware of the proposed new Standards assist radiologists through the implementation process implement ongoing review and evaluation processes Ensure the sector is aware of the proposed new Standards A key requirement for the College is to ensure the diagnostic imaging sector is aware of the proposed new Standards regarding professional supervision. This is not a requirement unique to this project however, and will be relevant to a number of QUDI projects. While radiologists should be the focus of the College’s information and communication efforts, it may also be appropriate to inform other stakeholders of the new Standards. These stakeholders may include: The Department of Health and Ageing Medicare Australia 54 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations related professional and industry organisations, such as: − The Australian Diagnostic Imaging Association − The Australian Sonograhers Association − Australian Society of Ultrasound in Medicine − The Australian Institute of Radiography − The Australian and New Zealand Society of Nuclear Medicine relevant consumer groups. Information may be provided to radiologists and other stakeholders via a number of methods including: direct communication posting information on the RANZCR website including information in RANZCR newsletters and circulars making announcements at RANZCR conferences, workshops and meetings. It may be more efficient and effective to implement all new Standards developed under the QUDI Program at the one time, to ensure radiologists and stakeholders do not feel overwhelmed by the amount of quality improvement information being received from the College. A singular announcement of a new set of RANZCR Standards would likely be most effective in generating interest and therefore, prompting radiologists to obtain and implement the new Standards. All communications should include detail regarding how the new Standards may be obtained and should include the name and contact details of the person within the College that may be contacted for further information. Assist radiologists through the implementation process The implementation of new Standards regarding professional supervision will involve the development of protocols for radiologist input by individual radiologists and radiology practices. Written practice based protocols, regarding radiologist input may be a new concept for a large segment of the diagnostic imaging sector and the College will, therefore, be required to support radiologists and radiology practices through the implementation process. College support may include facilitating information exchange between radiologists, to allow them to share ideas and ultimately assist them in the development of their individual practice-based protocols. Depending on demand from College members, and if feasible, it may also be beneficial for the College to conduct a series of information sessions and workshops in relation to all of the new Standards, developed under the QUDI Program. In addition, the College may also be able to post good practice examples of protocols on the RANZCR website to allow Radiologists to gain a clearer understanding of what might be included in their own practice’s protocols. 55 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations Implement ongoing review and evaluation processes The College should ensure the new Standards are implemented in conjunction with processes to review and evaluate their relevance, impact and outcomes, on an ongoing basis. It is therefore recommended that prior to the implementation of these proposed Standards, and other Standards to be developed as part of the QUDI Program, that the College develop and implement formal review and evaluation processes. The College’s review and evaluation processes may include: establishing mechanisms for receiving ongoing feedback from radiologists and other stakeholders implementing formal, periodic feedback processes, including: − surveys of relevant stakeholders − forums to discuss impacts, outcomes and potential shortcomings In addition, the College may consider commissioning a formal external review and evaluation of all new Standards implemented as part of the QUDI Program after they have been in place for a period of time. Findings and outcomes resulting from evaluation and review processes, should inform future refinements and/or developments in relation to the Standards. Implementation requirements for radiologists Key requirements for radiologists are detailed in this section, including requirements to: conduct a risk assessment and develop practice-based protocols educate the imaging team, in relation to the protocols and ensure adherence Conduct of risk assessment and develop practice-based protocols The implementation of the new Standards regarding professional supervision will require that radiologists undertake a risk assessment of their unique imaging environment and develop appropriate practice-based operating protocols. Many radiologists and radiology practices will have previously undertaken risk assessments and may already have unwritten protocols in place, regarding the effective functioning of the imaging team. In these circumstances, radiologists will need to develop written protocols in order to codify existing unwritten practices and protocols. For some radiologists and radiology practices, these Standards will require comprehensive review of the functioning of the imaging team, involving a detailed risk analysis of the practice and its operation. The key focus of the risk assessment should be to identify potential risks to patient care, safety and service quality. Risk assessment should take into account key characteristics of the practice, and may encompass, the: type of imaging examinations undertaken at the practice (modality and body system) number and nature of staff employed at the practice (qualifications, training, experience, specialisation) proportion of services undertaken using teleradiology 56 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations practice patient mix (if there are any unique or particular characteristics). Following the conduct of a comprehensive risk assessment, practice based protocols will need to be developed. These protocols should ensure the delivery of quality services and mitigate risks where they exist, through the facilitation of appropriate involvement of radiologists in the delivery of the diagnostic imaging service. Protocols will need to provide direction to the members of the imaging team, regarding radiologist input, to encompass a range of circumstances, as detailed in the Standards. The Standards also require that radiologists consider how protocols impact on patients. Issues such as patient waiting times and/or the need for patients to return to the practice for follow-up or second examinations will need to be addressed. This applies particularly where practices service patients which may be required to travel long distances to reach the practice. It may therefore, be appropriate that protocols include measures to identify patients travelling long distances to reach the practice and to implement practices that minimise the risk of these patients having to return to the practice for a second examination. Educate the imaging team in relation to the protocol and ensure adherence Following the development of appropriate practice-based protocols, radiologists will be required to educate the members of the imaging team based at their practice, in relation to the protocols. This will include providing the protocols to team members and educating and explaining the implications of the protocols for them and their work practices. Subsequent to the protocols being implemented, it will also be the responsibility of the radiologist to ensure all members of the imaging team conduct themselves in accordance with the protocols. This may require radiologists to implement appropriate monitoring and reporting mechanisms in their practice, associated with additional education, where adherence issues are identified. 6.7.2 Linkages This QUDI project, regarding professional supervision and reporting (QS1), has linkages with a number of other QUDI projects. Awareness of these linkages will assist in the overall understanding of how this particular project fits within the broader QUDI context. The identification of the nature of these linkages is also important in ensuring the results, findings and outputs of individual QUDI projects, feed into one another. The following table identifies other QUDI projects with linkages to this project and provides a brief description of this link. QUDI Project CS3 - Develop evidence based diagnostic imaging and intervention guidelines and alternative management options with particular reference to significant Link The findings of project CS3 may inform risk assessments undertaken by radiologists and the development of appropriate practice-based protocols. The professional supervision Standards contained within this document suggest that protocols for radiologist input take into account patient characteristics such as age, condition, complicating factors, medical history and clinical indications. An outcome of Project CS3 may include the identification of specific patient characteristics which give rise to greater 57 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations QUDI Project patient characteristics Link risks, which should therefore, be addressed in protocols developed in response to these professional supervision Standards. CS4 - Develop, pilot and recommend consumer information strategies to address consumer awareness of diagnostic imaging and promote informed choice, financial consent and the consumer benefits of accredited service provision As indicated in this report, one of the responsibilities of radiologists is to ensure patients are informed about the diagnostic imaging procedure for which they have been referred, to ensure the patient can provide informed consent for the procedure. The outcomes of project CS4, have included the identification of strategies which are effective in promoting awareness and informed choice for consumers. These strategies may be adopted by radiologists in exercising their responsibility to obtain informed consent from patients. Radiologists will need to be aware however, that if radiologists delegate responsibility for this aspect of the imaging service to other members of the imaging team, they may need to include provisions in their practice-based protocols for seeking radiologist input in certain circumstances. These circumstances may include those for example, where: a patient requires more clinical or technical information about the imaging service and/or associated risks, which other members of the imaging team are not able to provide it is not clear whether informed consent has been obtained (due to language or other issues) QR3 - Develop best practice standards and guidelines for referral and clinical notes for radiology The outcomes of project QR3 will potentially impact on the nature of the protocols developed, associated with reviewing patient referrals. Higher quality referrals, for example, will enable members of the imaging team, to identify at an early stage, patients/examinations which may require radiologist input. QS3 - Establish roles and standards for nonmedical diagnostic imagers and develop a strategy to attract and retain non-medical DI professionals through tole extension Project QS3 has a direct link with, and impact upon this project, particularly if project QS3 results in the roles of non-medical diagnostic imaging professionals, such as radiographers and sonographers, being extended. QS7 - Establish technical and practice standards for accreditation requirements for clinical teleradiology Should the roles of these members of the imaging team be extended, it may be necessary to revise aspects of these Standards, to include the requirement for the development of protocols encompassing aspects of the imaging service, which were not previously able to be delegated, to other members of the imaging team. The Standards set out in this document, treat teleradiology as a normal component of imaging practice, which is safe and effective, provided appropriate protocols are in place for its use and provided appropriate equipment and technology are used. Project QS7 is critically important in developing appropriate technical Standards for teleradiology and in identifying the type of equipment and technology appropriate for the delivery of these services, in the context of 58 AUSTRALIAN HEALTHCARE ASSOCIATES 6. Conclusions and Recommendations QUDI Project Link providing timely, safe, high quality services. The Standards set out in this document assume that all teleradiology services are provided in accordance with the minimum technical Standards to be developed as part of project QS7. QS8 - Develop credentialing requirements and applications consistent with QUDI Program objectives It may be appropriate, that protocols developed by radiologists, to meet the supervision Standards set out in this document, be reviewed in light of any changes to credentialing requirements resulting from project QS8. ES4 - Evaluate the QUDI Program and identify program outcomes, effectiveness and impact This project represents one component of the QUDI Program and the findings and outcomes of this project will therefore, need to be examined as part of project ES4 as it evaluates the entire QUDI Program. The proposed professional supervision and reporting standards set out in this document, recognise that radiologists operate in a diverse range of unique imaging environments, each with their own risks, which should be appropriately managed. The proposed Standards therefore, take a flexible quality systems approach, rather than a rigid rules-based approach, representing a significant shift in thinking on this topic. Recognising that the ultimate aim of these Standards should be to ensure radiologist input to the imaging service at the appropriate/critical times, the Standards have a focus on developing an effectively functioning team. This focus manifests itself in the requirement to develop protocols to guide technologists as to when they should seek the input of a radiologist. 59 AUSTRALIAN HEALTHCARE ASSOCIATES 7. References This chapter details the references utilised during the conduct of this project. 7. REFERENCES Articles Adam E.J., Is direct radiologist supervision of abdominal computed tomography (CT) scans necessary?, Clinical Radiology, Vol 60(7), 2005, pp 756–757. Ashcroft R.E., Goddard P.R., Review Article: Ethical issues in teleradiology, The British Journal of Radiology, Vol 73, 2000, pp 578-582 Baerlocher M.O., Asch M.R., The future interventional radiologist: clinician or hired gun?, Journal of vascular and interventional radiology, Vol 15(12), Dec 2004, pp1, 385-1,390. Burgul R., Gilbert F.J., Undrill P.E., Methods of measurement of image quality in teleultrasound, The British Journal of Radiology, Vol 73, 2000, pp 1,306-1,312 Chow, K.W., Reflections of a septuagenarian - radiology: past, present and future, Annals of the Academy of Medicine, Singapore, Vol 33(5), Sep 2004, pp 671-675. Ditchfield M.R., Fink A.M., Role of supervision in a radiology practice, Australasia Radiology, Vol 47, 2003, pp 1-7 Dixon G.D., Current status and issues of concern in diagnostic radiology, Missouri medicine, Vol 102(2), Mar-Apr 2005, pp 110-115. Dunnick N.R., Applegate K.E., Arenson R.L., The Inappropriate Use of Imaging Studies: A Report of the 2004 Intersociety Conference, American College of Radiology, Vol 2(5) May 2005, pp 401-406 Farrow B.R.H., Diagnostic accuracy in the new millennium, Australian Veterinary Journal, Vol 83(1-2), Jan-Feb 2005, pp 30-31. Goh V., Halligan S., Anderson J.M., Hugill J., Leonard A., Is direct radiologist supervision of abdominal computed tomography (CT) scans necessary?, Clinical Radiology, Vol 60, 2005, pp 758–761 Goyan M., Debatin J.F., The future of hospital - based radiological imaging, World hospitals and health services: the official journal of the International Hospital Federation, Vol 40(2), 2004, pp 27-31, 42. Grosvenor L.J., Verma R., O'Brien R., Entwisle J.J., Finlay D., Does reporting of plain chest radiographs affect the immediate management of patients admitted to a medical assessment unit?, Clinical Radiology, Vol 58(9), 2003, pp 719–722 Hailey D., Ohinmaa A., Roine R., Study quality and evidence of benefit in recent assessments of telemedicine, Journal of Telemedicine and Telecare; Vol 10(6), 2004, pp 318-324. Hailey D., Roine R., Ohinmaa A., Systematic review of evidence for the benefits of telemedicine, Journal of Telemedicine and Telecare, Vol 8 (Suppl. 1): S1, 2002, pp 1–7. 60 AUSTRALIAN HEALTHCARE ASSOCIATES 7. References Hobbs W.C., Taking digital imaging to the next level: challenges and opportunities, Radiology management, Vol 26(2), Mar-Apr 2004, pp 16-20. Kouri B.E., Parsons R.G., Alpert H.R., Physician Self-Referral for Diagnostic Imaging: Review of the Empiric Literature, American Journal of Roentgenology, Vol 179, Oct 2002, pp 843-850 Mildenberger P, Eichelberg M., Martin E., Introduction to the DICOM standard, European radiology, Vol 12, 2002, pp 920-927. Mozumdar B.C., Jones G., Medico-legal issues in radiological consultation, Radiology management, Vol 25(5), Sep-Oct 2003, pp 40-43. Reiner B.J., Siegel E.L., Siddiqui K., Evolution of the digital revolution: a radiologist perspective, Journal of digital imaging: the official journal of the Society for Computer Applications in Radiology, Vol 16(4), Dec 2003, pp 324-330. Roine R., Ohinmaa A., Hailey D., Assessing telemedicine: a systematic review of the literature, Canadian Medical Association or its licensors, Vol 165(6), 18 Sep 2001, pp 765-771. Siegle R.L., Nelson L., Changing roles: The radiologist in management, Academic radiology, Vol 6(5), May 1999, pp 307-313. Struber J., Tichon J., Minimum technical requirements and evaluating effectiveness of teleradiology, Technology and Health Care, Vol 11(6), 2003, pp 391–398. Williamson E.E., Williamson B. Jr, Radiologist-Patient Interactions: Implications for Picture Archiving and Communications Systems and Teleradiology, Journal of digital imaging: the official journal of the Society for Computer Applications in Radiology, Vol 12(2 Suppl 1), May 1999, pp 137-138. White P., Legal issues in teleradiology—distant thoughts!, The British Journal of Radiology, Vol 75, 2002, pp 201–206. Internet Articles Cannavo M.J., Cost-justifying the purchase of a teleradiology system, Jan 1999 http://www.auntminnie.com/index.asp?Sec=ref&sub=wht&pag=dis&ItemId=608 Murray, C., Medicare's Radiology Supervision Rules, Sep 2001 http://www.imagingeconomics.com/library/200109-13.asp Page D., Teleradiologists must tread carefully in legal mine field, GE Healthcare & EMC, Jun 2005 http://www.diagnosticimaging.com/scar2005/news/?id=164300349 Page D., Legislation tackles offshore teleradiology, May 2005 http://www.diagnosticimaging.com/pacsweb/printer_friendly/?articleID=163105354 Ridley E.L., ACR international teleradiology task force releases white paper, Feb 2005 http://www.auntminnie.com/index.asp?Sec=sup&Sub=pac&Pag=dis&ItemId=65397 Ruth Pollard Health Reporter, Turf war as nurses eye bigger role, May 2005 61 AUSTRALIAN HEALTHCARE ASSOCIATES 7. References http://www.smh.com.au/text/articles/2005/05/08/1115491047100.html?oneclick=true Thompson T.L., Radiologists (mostly) cheer as insurers set imaging rules, Nov 2004 http://www.auntminnie.com/index.asp?Sec=sup&Sub=imc&Pag=dis&ItemId=63469 Williams C.D., Radiologist Assistants Prepare to Enter the Workforce, May 2005 http://www.rsna.org/publications/rsnanews/may05/ra0505.html Documents – USA ACR Practice Guideline For Communication: Diagnostic Radiology, American College of Radiology, Jan 2002 ACR Practice Guideline For General Radiography, American College of Radiology, Jan 2003 ACR Practice Guideline For Performing And Interpreting Magnetic Resonance Imaging (MRI), American College of Radiology, Jan 2003 ACR Practice Guideline For Performing And Interpreting Diagnostic Computed Tomography (CT), American College of Radiology, Jan 2003 ACR Practice Guidelines And Technical Standards, American College of Radiology ACR Practice Guideline For Radiologist Coverage Of Imaging Performed In Hospital Emergency Departments, American College of Radiology, Jan 2003 ACR Practice Guideline For The Use of Intravascular Contrast Media, American College of Radiology, Jan 2002 ACR response to 2001 CMS US Medicare Supervision rules, ACR 2001 Bulletin http://www.acr.org Breast Ultrasound Accreditation Program Requirements, American College of Radiology, Apr 2005 CT Accreditation Program Requirements, American College of Radiology, Oct 2004 Medicare’s Physician Supervision Requirements, American Society for Therapeutic Radiology and Oncology, Jul 2004 MRI Accreditation Program Requirements, American College of Radiology, Apr 2005 Nuclear Medicine/PET Accreditation Program Requirements, American College of Radiology, Dec 2004 Quality Imaging - MEDIC, the Medical Excellence in Diagnostic Imaging Campaign http://www.qualityimaging.org Documents – Canada 62 AUSTRALIAN HEALTHCARE ASSOCIATES 7. References CanMEDs Role Definitions for Diagnostic Radiologists, Jul 2005 Independent Diagnostic Testing Facility (IDTF), HGS Administrators, Nov 2003 Manitoba Physician's Manual, The Minister of Health, Canada, Apr 2005 http://www.gov.mb.ca/health/index.html Pascale Lehoux, University of Montreal, Discussion paper No. 37: Could New Regulatory Mechanisms Be Designed after a Critical Assessment of the Value of Health Innovations?, Commission on the Future of Health Care in Canada, Nov 2002 Saskatchewan Health Payment Schedule for Insured Services Provided by a Physician, Saskatchewan Health, Canada, Apr 2005 Schedule of Benefits for Physician Services under the Health Insurance Act – amended Sep 2003, Ministry for Long-Term Care, Government of Ontario Canada Documents – Australia and New Zealand A National Standard for credentialling and defining the scope of clinical practice of medical practitioners, for use in public and private hospitals, Australian Council for Safety and Quality in Health Care, Jul 2004 Accreditation Standards for diagnostic and Interventional Radiology Ver 6.2, The Royal Australian and New Zealand of Radiologists - The Accreditation Guidelines and Quality Committee, Feb 2004 Clinical Teleradiology Background Paper Draft 1.0, The Royal Australian and New Zealand College of Radiologists Clinical Teleradiology Background Paper Draft 2.0, The Royal Australian and New Zealand College of Radiologists Guidelines for professional conduct for Radiographers, Radiation Therapists and Sonographers, Australian Institute of Radiography, Apr 2003 Guidelines on Mammographic Screening for Cancer for Women with Prostheses, Royal Australian and New Zealand College of Radiologists, Aug 2001 Health Insurance Act 1973 (volume 1), Commonwealth Government Health Insurance Amendment (Diagnostic Imaging, Radiation Oncology and Other Measures) Bill 2002, Commonwealth Government Intravenous Contrast Media Guidelines, The Royal Australian and New Zealand College of Radiologists, Aug 2001 Jones N., Radiologist Workloads, RANZCR Workforce Advisory Board, Apr 2003 Medicine Carriers Manual, Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services, Sep 2001 63 AUSTRALIAN HEALTHCARE ASSOCIATES 7. References Medicare Benefits Schedule: Diagnostic Imaging Services – Category 5, HIC National Accreditation Standards, National Quality Management Committee of BreastScreen Australia, Jul 2002 Policy on Breast Cancer Screening, Royal Australian and New Zealand College of Radiologists, Nov 2002 Policy on the use of thermography to detect breast cancer, Royal Australian and New Zealand College of Radiologists, Aug 2001 Report on the Curriculum Development Project for the Diagnostic Radiology Education Board of the Royal Australian and New Zealand College of Radiologists, Diagnostic Radiology Education Board, Jul 2005 Results of 2004 Royal Australian and New Zealand College of Radiologists Workforce Surveys – 2004 Diagnostic Radiologists and Radiology Trainee Report, Australia, presented to RANZCR Council Meeting: 11 Feb 2005 Review of Victorian radiation safety legislation Discussion Paper, Department of Human Services, State Government of Victoria, Dec 2003 Standards for Accreditation of Nuclear Medicine Practices, Australian and New Zealand Association of Physicians in Nuclear Medicine Inc, Nov 2000 Statement on Mammographic Changes Following Surgical Intervention in the Breast, Royal Australian and New Zealand College of Radiologists, Feb 2004 Documents – UK Good Medical Practice, General Medical Council, May 2001 Quality Assurance Guidelines for Breast Cancer Screening Radiology, NHSBSP Publication No 59, Jan 2005 Documents – Other Guidelines On Teleradiology In Malaysia, Radiology Malaysia Telehealth - delivering health care from a distance, International Organization for Standardization, Oct 2004 64 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix A – Stakeholder Consultation This Appendix provides a summary of the consultations undertaken as part of this project. A STAKEHOLDER CONSULTATION In total, consultations were conducted with 44 individuals and submissions were received from 3 organisations, as detailed in the following tables. Table 7-1: Individuals Consulted Name Organisation Ms Jane Grimm Royal Australian and New Zealand College of Radiologists (RANZCR) Ms Sandra Keogh Royal Australian and New Zealand College of Radiologists (RANZCR) Dr Matthew Andrews Project Technical Reference Group (TRG) Dr Michael Carr Project Technical Reference Group (TRG) Dr Winston Chong Project Technical Reference Group (TRG) Dr Nick Ferris Project Technical Reference Group (TRG) Dr Stacy Goergen Project Technical Reference Group (TRG) Dr Laurence Lau Project Technical Reference Group (TRG) Dr Gary O’Rourke Project Technical Reference Group (TRG) Dr Nick Stephenson Project Technical Reference Group (TRG) Dr Mark Tie Project Technical Reference Group (TRG) Dr Allan Wycherley Project Technical Reference Group (TRG) Dr Liz Wylie Project Technical Reference Group (TRG) Dr Neil Jones RANZCR Fellow – Chair, Workforce Advisory Board Dr George Koperski ACT Health - Radiation Safety Section Dr Fraser Brown Australian and New Zealand Society of Nuclear Medicine (ANZSNM) Mr Matthew Swain Australian Diagnostic Imaging Association (ADIA) Mr Emile Badawy Australian Institute of Radiography (AIR) Mr Geoffrey Dick Australian Institute of Radiography (AIR) Ms Marcia Fleet Australian Institute of Radiography (AIR) Mr Alan Melbourne Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Dr Matthew Andrews Australian Society for Ultrasound in Medicine (ASUM) Dr David Davies-Payne Australian Society for Ultrasound in Medicine (ASUM) Dr Glenn McNally Australian Society for Ultrasound in Medicine (ASUM) Ms Robyn Tantau Australian Sonographers Association (ASA) Ms Elaine Trevaskis Australian Sonographers Association (ASA) Mr Andrew Wilmot Australian Sonographers Association (ASA) 65 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix A – Stakeholder Consultation Mr Michael Irvine Department of Health - Environmental Health Directorate (Western Australia) Dr David Barton Department of Health and Ageing (DoHA) Mr Dale Brooker Department of Health and Ageing (DoHA) Ms Margaret Curran Department of Health and Ageing (DoHA) Mr Chris Sheedy Department of Health and Ageing (DoHA) Mr Russell Robinson Department of Health and Community Services - Radiation Protection (Northern Territory) Ms Joy Batchelor Department of Health and Human Services - Radiation Advisory Council (Tasmania) Dr Gabby Bright Department of Human Services - Radiation Advisory Council (Victoria) Mr Edmund Arozoo Environmental Protection Authority (South Australia) Dr Peter Charlton Health Insurance Commission (HIC) Ms Elizabeth Low Health Insurance Commission (HIC) Dr Paul Davis Industry Advisor - I-Med / MIA Dr John Stubbe Industry Advisor - I-Med / MIA Mr Barry Field New South Wales Environment Protection Agency (EPA) Dr Gary Cohen Practicing Radiologist Ms Kim Osborne Queensland Health - Radiation Health Dr Robert Gibson Royal Melbourne Hospital Table 7-2: Written Submissions Received Organisation Date Australian College of Rural and Remote Medicine (ACRRM) August 2005 Breast Cancer Network of Australia (BCNA) August 2005 The Royal Australasian College of Physicians (RACP) August 2005 66 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix B – Professional Supervision Requirements in the MBS This Appendix describes the professional supervision requirements that apply for particular imaging modalities and examinations listed in Diagnostic Imaging Services Table (DIST) of the Medicare Benefits Schedule (MBS). A description of each modality is also provided. B PROFESSIONAL SUPERVISION REQUIREMENTS FOR MEDICARE BENEFITS ARRANGEMENTS – DIAGNOSTIC IMAGING SERVICES 1. Ultrasound Ultrasound imaging (also known as ultrasound scanning or sonography) is a method of obtaining images from inside the human body through the use of high frequency sound waves. The sound waves’ echoes are recorded and displayed in real time, visual image (RSNA 2005). No ionising radiation is involved in ultrasound imaging. Ultrasound services funded under the Medicare benefits arrangements cover general, cardiac, vascular, urological, obstetric and gynaecological, and musculoskeletal. Generally, ultrasound services must be performed under the professional supervision of a: specialist or consultant physician in the practice of his or her speciality who is available to monitor and influence the conduct and diagnostic quality of the examination and, if necessary to personally attend on the patient. Source: MBS DIST DIK.1 Ultrasound services provided in emergencies and in remote locations are exempted from this professional supervision requirement. Different professional supervision requirements apply to musculoskeletal ultrasound services (items 55800 to 55854). They are known as personal attendance requirements. Services must be provided by a specialist or consultant physician in the practice of their own speciality with Medicare benefits only payable where: The medical practitioner responsible for the conduct and report of the examination personally attends during the performance of the scan and personally examines the patient. Source: MBS DIST DIK.9.1. Services performed because of medical necessity in a remote location are exempted from the personal attendance requirement. The Medicare benefits arrangements also set qualification requirements for sonograhers performing ultrasound examinations on behalf of a medical practitioner. Under these accreditation requirements, sonograhers must be suitably qualified and involved in a relevant and appropriate Continuing Professional Development program and be enrolled on the Register of Accredited Sonographers administered by the HIC (MBS DIST DIK.2). In addition, the sonographer’s name must be recorded in the report of the service; however, it is not required to be included on the copy of the report given to the patient (MBS DIST DIK.2). 67 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix B – Professional Supervision Requirements in the MBS 2. Computed Tomography Services Computed tomography (CT) is a diagnostic technique that involves imaging anatomical information from a cross-sectional plane of the body with each image generated by a computer synthesis of x-ray transmission data obtained in many different directions in a given plane (RSNA 2005). CT scans reveal both bone and soft tissues including organs, muscles and tumours. In some CT examinations, contrast medium is injected into the patient to provide visual contrast in pictures of different tissues or organs. Under the Medicare benefits arrangements, CT services must be performed: under the professional supervision of a specialist in the specialty of diagnostic radiology who is available: (i) to monitor and influence the conduct and diagnostic quality of the examination; and (ii) if necessary to personally attend on the patient. Source: MBS DIST DIL.2 CT services provided in emergencies or of medical necessity in a remote area location are exempted from this professional supervision requirement. 3. Diagnostic Mammography Services Medicare benefits are available for diagnostic mammography, a radiographic examination that uses low dose X-ray with high contrast, high resolution film to create detailed images of the breasts. Diagnostic mammography is used to provide additional information about patients who have signs and/or symptoms of breast disease. Mammography screening services are funded jointly by the Commonwealth, State and Territory governments through for the national breast cancer screening program, BreastScreen Australia. Professional supervision requirements for diagnostic mammography services (items 59300 to 59318) are the same as those for CT services. Diagnostic mammography services must be performed under the professional supervision of a: specialist in the specialty of diagnostic radiology who is available to monitor and influence the conduct and diagnostic quality of the examination and, if necessary, to personally attend on the patient. Source: MBS DIST DM.6.2 Diagnostic mammography services provided in emergencies or because of medical necessity in a remote location are exempted from this professional supervision requirement. 4. Magnetic Resonance Imaging Magnetic resonance imaging (MRI) uses a large magnet, radio waves and computer to scan inside a patient’s body and produce detailed images of tissues and organs. MRI scans are used to diagnose and evaluate conditions. As with ultrasound, MRI does not use ionising radiation. 68 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix B – Professional Supervision Requirements in the MBS Under the Medicare benefits arrangements, MRI services must be performed under the professional supervision of an eligible provider at an eligible location where: Eligible provider Is a specialist in diagnostic radiology who satisfies HIC that: (a) he or she is a participant of the RANZCR’s Quality and Accreditation Program; and (b) the equipment he or she proposes to use for providing the services meets eligible equipment requirements. Professional supervision The eligible provider is available to monitor and influence the conduct and diagnostic quality of the examination including, if necessary, by personal attendance on the patient. Source: MBS, DIST DIO.5 & DIO.6 MRI services provided in emergencies or by medical necessity in a remote area are exempted from this professional supervision requirement. 5. Nuclear Medicine Services Nuclear medicine is a medical speciality where organ function and structure are examined by administering small amounts of radioactive contrast materials to the patient and taking scans with a gamma camera or other device for the purpose of diagnosing or treating disease. Medicare benefits for nuclear medicine services are limited to services provided by specialists and consultant physicians credentialled in nuclear medicine. Credentialling is by the Joint Nuclear Medicine Credentialling and Accreditation Committee of the Royal Australian College of Physicians (RACP) and the RANZCR. The nuclear medicine service may be performed by a credentialled nuclear medicine specialist or on their behalf. The nuclear medicine specialist is responsible for all components of the service. They must perform personally certain components – namely, a preliminary examination of the patient and the estimation of the dosage, and compiling the final report of the service. They are required to personally supervise all other components; however, they do have to physically attend during the entirety of each component. These requirements are defined as personal supervision (MBS 2004, ANZAPNM 2000). They are set out in the Standards of Accreditation of Nuclear Medicine Practices (ANZAPNM 2000). They were developed to reflect the nature of nuclear medicine services with procedures vary in length and complexity and to ensure quality practice. 69 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix C – Intravenous Contrast Media Guidelines This Appendix provides guidelines for use of Intravenous Contrast Media, as set out by RANZCR. Of particular interest is Section 5, which outlines which staff are authorised to administrator intravenous injection of contrast media. C INTRAVENOUS CONTRAST MEDIA GUIDELINES 1. When used for intravenous and other forms of parenteral injection, contrast media infrequently cause adverse drug reactions and very rarely cause patient death. 2. In determining the need for contrast media in the circumstances of the examination, specific risk factors can be identified, including: a. previous reactions to contrast media; b. asthma; c. significant allergic disease; c. cardiac disease; d. renal insufficiency particularly associated with insulin dependent diabetes; f. sickle cell disease, polycythemia and myeloma; g. phaeochromocytoma The practice must have a clear protocol for each of these conditions. 3. Severe hypotension, bronchospasm, cardiac arrhythmia, even anaphylaxis may occur. Staff should be trained and equipped to recognise and deal with all these problems which may require different forms of therapy. 4. Before injecting contrast material, the person performing the injection must check the name of the agent, its concentration and its expiry date. Additional measures to ensure injection of the correct material must be in place. These may include checking of the same details by another person or the implementation of systematic measures to prevent inappropriate injections. 5. A practice or department may decide whether appropriately trained radiographers, nurses and/or nonradiologist doctors may administer intravenous injection of contrast media, taking full consideration of relevant state and territory legislation and any implications for medical malpractice, medical negligence or professional indemnity insurance cover. Radiographers, nurses and/or non-radiologist doctors must not be compelled to perform this procedure. Any liability for an adverse event arising from an intravenous injection of contrast media lies with the radiologist as the employer and/or as the supervising specialist. Documented procedures for the administration of contrast media by radiographers, nurses and/or non-radiologist doctors must be included in the practice procedures manual and must include the following minimum requirements: 70 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix C – Intravenous Contrast Media Guidelines Radiographers and Nurses radiographers and nurses must be trained in venipuncture and resuscitation and receive certification of their competence from the practice; protocols must be confirmed by the radiologist prior to each injection; the practice should limit the number of unsuccessful venipuncture attempts allowed per examination; the practice must identify those patients who are not suitable for injection by radiographers and nurses, eg children, patients with a history of difficult injections or contrast reactions; the supervising radiologist must remain immediately available for 20 minutes following injection in case of any subsequent reactions. Non-radiologist Doctors protocols must be confirmed by the radiologist prior to each injection; non-radiologist doctors injecting patients must remain immediately available for 20 minutes following injection in case of any subsequent reactions. Adopted by RANZCR Council: August 2001 71 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix D – Organisations Consulted This Appendix provides a list of organisations consulted during the course of this phase of the project. D ORGANISATIONS CONSULTED Organisation Abbr. ACT Health - Radiation Safety - American College of Radiology ACR American Institute of Ultrasound in Medicine AIUM Association of University Radiologists AUR Australian and New Zealand Society of Nuclear Medicine ANZSNM Australian College of Rural and Remote Medicine ACRRM Australian Diagnostic Imaging Association ADIA Australian Institute of Radiography AIR Australian Radiation Protection and Nuclear Safety Agency ARPANSA Australian society for ultrasound in Medicine ASUM Australian Sonographers Association ASA Breast Cancer Network of Australia BCNS British Institute of Radiology BIR British Medical Ultrasound Society BMUS Canadian Association of Radiologists CAR Department of Health - Environmental Health Directorate (Western Australia) DoH Department of Health and Ageing DoHA Department of Health and Community Services - Radiation Protection (Northern Territory) DHCS Department of Health and Human Services - Radiation Advisory Council (Tasmania) DHHS Department of Human Services (Radiation Advisory Council (Victoria) DHS Environmental Protection Authority (South Australia) EPA European Association of Radiology EAR European Congress of Radiology ECR European Society for Neuroradiology ESN European Society of Gastrointestinal and Abdominal Radiology ESGAR 72 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix D – Organisations Consulted Organisation Abbr. European Society of Nuclear Medicine ESNM European Society for Therapeutic Radiology and Oncology ESTRO Health Insurance Commission HIC Hong Kong College of Radiologists HKCR International Cancer Imaging Society ICIS International Congress of Radiology and the ISR ICR International Organization for Medical Physics IOMP International Society of Radiology ISR International Radiology Quality Network IRQN Japan Radiologist Society JRS Joint Commission on Accreditation of Healthcare Organisations JCAHO National Health Service NHS National Institute of Clinical Excellence NICE New South Wales Environment Protection Agency EPA Queensland Health -Radiation Health QH Radiological Society of North America RSNA Royal Australasian College of Physicians RACP Royal Australian and New Zealand College of Radiologists RANZCR Royal College of Radiologists RCR Scottish Radiological Society SRS US Food and Drug Administration FDA 73 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision This Appendix provides a summary the professional supervision in United States of America. E UNITED STATES OF AMERICA PROFESSIONAL SUPERVISION American College of Radiology Practice The American College of Radiology (ACR) is the principal organisation of radiologists, radiation oncologists and clinical medical physicists in the United States. The ACR develops practice guidelines and technical standards for radiologic practice. Practice guidelines and technical standards represent policy statements by the College. They are developed through a consensus and review process. They recognise that safe and effective use of diagnostic and therapeutic radiology requires specific training, skills and techniques. They aim to assist practitioners in delivering effective and safe medical care. Types of Guidelines and Standards ACR policy statements fall into three types: Practice guidelines – for a specific modality, examination or procedure; Technical standards - e.g. equipment, teleradiology; Accreditation standards – that draw together aspects of practice guidelines and technical standards. Accreditation Programs The ACR develops and administers accreditation programs that assess the quality of imaging facilities. The programs aim to set quality standards for practices and help them continuously improve upon quality of care they give to patients. The Mammography Accreditation program was introduced in 1987 on a voluntary participation basis and in 1992 the federal government mandated that all mammography facilities be accredited. The ACR has developed other, modality-specific accreditation program including: Radiation oncology (1987); Ultrasound (1992); Stereotactic breast biopsy (1996); MRI (1996); Breast ultrasound (1998); Nuclear medicine (1999); and CT (2002). ACR accreditation programs evaluate the qualifications of personnel, equipment performance, effectiveness of quality control measures, and quality of clinical images. These are considered the primary factors that affect the quality of clinical images and ultimately the quality of patient care. Professional Supervision and Reporting – What Guidelines and Standards Say Key features of ACR practice guidelines that relate to professional supervision and reporting of radiologists are summarised below. Guidelines vary in format and content. Generally, they cover 74 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision qualifications and responsibilities of personnel; examination considerations, equipment; quality control and improvements; documentation and reporting. General Radiography Team Physician, medical physicist and radiologic technologist Physician – qualifications and responsibilities Radiographs must be obtained under the supervision of, and interpreted by, a licensed physician who meets specified criteria for: Certification and training qualifications Maintenance of competence Continuing medical education (CME). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME) and should include CME in diagnostic radiography as is appropriate to his/her practice. Medical physicist qualifications and responsibilities Certification and continuing education in appropriate sub-fields in medical physics (e.g. therapeutic radiological physics, diagnostic radiological physics, medical nuclear physics and radiological physics). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME). Radiologic Technologist qualifications and responsibilities Certification by the American Registry of Radiologic Technologists (ARRT) or an unrestricted state license. Reporting Reporting should be in accordance with ACR Practice guideline for Communication: Diagnostic Radiology. Source: ACR Practice Guideline for General Radiology. Effective January 2003. Diagnostic Computed Tomography The Team Physician, medical physicist and radiologic technologist Physician – qualifications All examinations should be performed under the supervision of and interpreted by a licensed physician who meets specified criteria for: Certification and training qualifications Maintenance of competence Continuing medical education (CME). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME) and should include CME in CT as is appropriate to his/her practice. Physician - responsibilities Medical physicist – Physician shall have the responsibility for: Reviewing all indications for the examination Specifying the use, dosage and rate of administration of contrast agents Specifying the imaging technique including appropriate windowing and levelling Interpreting images Generating written reports Maintaining the quality of both the images and interpretations. Certification and continuing education in appropriate sub-fields in medical 75 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision qualifications and responsibilities physics (i.e. radiological physics and diagnostic radiological physics). Radiologic technologist qualifications Certification by the American Registry of Radiologic Technologists (ARRT) or an unrestricted state license with documented training and experience in CT. Radiologic technologist responsibilities Radiologic technologist responsible for: CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME). patient comfort preparing and positioning the patient during examination obtaining CT data in a manner prescribed by supervising physician performing regular quality control testing of CT system under supervision of medical physicist. Use of Contrast Media By certified and/or licensed radiologic technologists and radiologic nurses, under the direction of a radiologist or his/her physician designee who is personally and immediately available, if the practice is in compliance with institutional and state regulations. See ACR Practice Guideline for Use of Intravascular Contrast Media. Reporting Not covered specifically in guideline. See ACR Practice Guideline for Communication: Diagnostic Radiology. Source: ACR Practice Guideline for Performing and Interpreting Diagnostic Computed Tomography (CT). Effective January 2003. Diagnostic Ultrasound General Diagnostic ultrasound examinations should be supervised and interpreted by trained and qualified physicians. Studies should be performed by qualified and knowledgeable physicians and/or sonographers using appropriate equipment and techniques. The Team Physician and diagnostic medical sonographer. Physician – qualifications and responsibilities Physicians who perform and/or interpret diagnostic ultrasound should be licensed and meet specified criteria for: Certification and training qualifications Maintenance of competence Continuing medical education (CME). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME) and should include CME in ultrasonography as is appropriate to his/her practice. Diagnostic medical sonographer When a sonographer performs an examination, they should be qualified by appropriate training to do so. This qualification can be demonstrated by a nationally recognised certifying body. Reporting Not covered specifically in guideline. See ACR Practice Guideline for Communication: Diagnostic Radiology. Source: ACR Practice Guideline for Performing and Interpreting Diagnostic Ultrasound Examinations. Effective January 2001. Magnetic Resonance Imaging (MRI) The Team Physician, medical physicist/MR scientist and technologist Physician - qualifications Physician should be licensed and meet specified criteria for: Certification and training qualifications 76 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision Maintenance of competence Continuing medical education (CME). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME) and should include CME in MRI as is appropriate to his/her practice. Physician - responsibilities Medical physicist/MR scientist – qualifications Physician has responsibility for all aspects of the study including, but not limited to: reviewing all indications for the examination specifying pulse of sequences to be performed specifying the use and dosage of contrast agents interpreting images generating written reports assuring the quality of both the images and interpretation Certification and continuing education in appropriate sub-fields in medical physics (i.e. radiological physics and diagnostic radiological physics). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME). Medical physicist/MR scientist –responsibilities Medical physicist/MR scientist to carry out acceptance testing and monitoring of MRI equipment Technologist - qualifications Certification as an MRI technologist and licensed in the jurisdiction where he/she practises, if state licensure exists. To assure competence, all technologists must be evaluated by the supervising physician. Technologist – responsibilities Technologist to participate in: assuring patient comfort and safety preparing and positioning the patient for MRI examination obtaining MRI data in a manner suitable for interpretation by physician performing daily quality control testing of MRI system. Administration of contrast and sedation In accordance with institutional policy and state and federal law by a physician, a nurse or technologist with training in cardiopulmonary resuscitation. See ACR Practice Guideline for Use of Intravascular Contrast Media and ACR Practice guideline for Adult Sedation/Analgesia. An appropriately equipped emergency cart must be immediately available to treat serious adverse reactions. Reporting Not covered specifically in guideline. See ACR Practice guideline for Communication: Diagnostic Radiology. Source: ACR Practice Guideline for Performing and Interpreting Magnetic Resonance Imaging. Effective January 2003. Screening Mammography General All mammography must be performed in concordance with the Mammography Quality Standards Act (MSQA) regulations. The Team Interpreting physicians, medical physicists and radiological technologists. Interpreting physician qualifications All physicians interpreting mammograms shall meet the MSQA final rule criteria for: Radiologic technologist - Initial qualifications Continuing experience and education. All mammographic examinations shall be performed by radiologic technologists 77 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision qualifications who meet: General requirements Mammography requirements Continuing education and experience requirements as specified in MSQA final rule. Medical physicist qualifications All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program shall meet: Initial qualifications requirements Alternative initial qualifications requirements Continuing education and experience requirements as specified in MSQA final rule. Performance of examination The examination should be performed by a qualified radiologic technologist with or without a physician present. Reporting – documentation and communication of results Requirements specified. Final reports should include the FDA-approved final assessment categories defined in the ACR Breast Imaging Reporting and Data System (BI-RADS Atlas) 4th edition, 2003. Reporting should be in accordance with ACR Practice Guideline for Communication: Diagnostic Radiology and consistent with MSQA Final Rule. Follow-up imaging studies Follow-up imaging studies should be done under the direct supervision of a qualified mammography physician. Source: ACR Practice Guideline for the Performance of Screening Mammography. Effective January 2004. Diagnostic Mammography Definition Diagnostic mammography is a radiologic examination performed to provide additional information about patients who have signs and symptoms of breast disease, radiographic findings, or in situations where direct supervision of the imaging is deemed appropriate by the interpreting physician. Direct supervision is defined as physician being present and immediately available to furnish assistance and direction throughout performance of procedure. The Team Same as for screening mammography. Qualifications and responsibilities of personnel Same as for screening mammography. Reporting – documentation and communication of results Requirements specified. ACR BI-RADS provides a framework for reporting, lesion assessment, imaging-pathologic correlation, and quality improvement. Reporting should be in accordance with ACR Practice Guideline for Communication: Diagnostic Radiology and consistent with FDA final rule for MSQA that took effect from April 1999. Source: ACR Practice Guideline for the Performance of Diagnostic Mammography. Effective January 2003. Diagnostic Procedures using Radiopharmaceuticals The Team Physician, nuclear medicine technologist and qualified medical physicist or other qualified scientist Physician – qualifications Physicians providing nuclear medicine services must meet specified criteria for: Certification and training Continuing medical education (CME) 78 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision Authorised user of radioactive materials. CME should be specifically related to diagnostic procedures using radiopharmaceuticals, in accordance with ACR Practice Guideline for Continuing Medical Education (CME). Physician may also be required to hold current advanced cardiac life support certification if monitoring patients undergoing cardiac stress studies. Physician - responsibilities Physician is responsible for ensuring: appropriate use of services quality of procedures all aspects of patient and facility safety compliance with applicable government and institutional regulations regarding use of radiopharmaceuticals. The nuclear medicine physician is ultimately responsible for all safety and appropriate utilisation of all radiopharmaceuticals prepared and/or used under his/her direction. Nuclear medicine technologist - qualifications The technologist performing nuclear medicine services should meet specified Certification, licensing and continuing education criteria. Medical physicist or Scientist - qualifications Certification, training and continuing education in appropriate sub-fields in medical physics (i.e. radiological physics and nuclear medicine physics). CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME). Medical physicist or Scientist - responsibilities A medical physicist should be responsible for overseeing the equipment quality control program and for monitoring performance upon installation and routinely thereafter. See ACR Technical Standard for Nuclear Medicine Performance Monitoring of Nuclear Medicine Imaging Equipment. Daily testing and evaluation of nuclear medicine equipment may be performed by the technologist under the supervision of the physician. Reporting Appropriate technical data should appear in the report of the procedure. These include, at a minimum, the radiopharmaceutical, dosage, route of administration and views obtained. Pharmacologic enhancement and other interventions should be documented. Reporting should be in accordance with ACR Practice Guideline for Communication: Diagnostic Radiology. Source: ACR Technical Standard for Diagnostic Procedures Using Radiopharmaceuticals. Effective January 2002. Radiologist Coverage of Imaging Performance in Hospital Emergency Departments Policy ACR policy is that radiologists provide comprehensive imaging services to patients seen in the emergency department (ED) and provide timely consultation services for a patient’s physician. Radiologist responsibilities Services of radiologists in ED setting include: Recommended coverage design and standard of safe and effective radiologic procedures continuing supervision of technical performance and control of quality interpretation of examinations reporting of results appropriate consultation with referring physician. Timely coverage of imaging examinations for ED patients can be accomplished in one of the following ways: By qualified radiologist available to interpret imaging studies in accordance with criteria determined by collaboration between 79 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision radiology departments, ED, medical staff of hospitals depending on resources available in applicable geographic locality. Monitoring preliminary review By qualified radiologist with acceptable teleradiology link to the hospital (see ACR Technical Standards for Teleradiology) Each facility should have a defined mechanisms for: monitoring of any preliminary imaging study review performed by an ED physician timely notification to ED physician and/or primary care physician when there is a substantive discrepancy between the preliminary review and radiologist’ official interpretation. Source: ACR Practice Guideline for Radiologist Coverage of Imaging Performed in Hospital Emergency Departments. Effective January 2003. Use of Intravascular Contrast Media Goal Radiologist and other personnel administering IV contrast media should use these agents appropriately and properly so that imaging studies are optimised and risk to patient is minimised. Policy – administration ACR approves injection of contrast material and diagnostic levels of radiopharmaceuticals by certified and/or licensed radiologic technologists and radiologic nurses under the direction of a radiologist or his/her physician designee who is personally and immediately available, if the practice is in compliance with institutional and state regulations. There must be prior written prior approval by the medical director of the radiology department/service of such individuals; such approval process having followed established policies and procedures, and the radiologic technologists and radiologic nurses who have been so approved maintain documentation of CME related to the materials being injected and to the procedure being performed. The Team Supervising physician, physician designee and radiologic technologist Supervising physician qualifications Supervising physician should be licensed and meet specified criteria for certification and training. CME should be in accordance with ACR Practice Guideline for Continuing Medical Education (CME). Supervising physician – responsibilities Responding to adverse effects The supervising physician has responsibility for: reviewing all indications for the examination specifying type, use, dosage and rate of administration of contrast agents. The supervising physician or his/her physician designee must be immediately available to respond promptly to an adverse effect. Training and proficiency in cardio-pulmonary resuscitation are recommended for those who attend patients undergoing contrast-enhanced examinations. May be administered by technologist or registered nurse with qualifications for performing IV injection of contrast material should be in compliance with current ACR policy standard and existing operating procedures/management of the imaging facility. Radiologic technologist – qualifications and responsibilities The technologist should have responsibility for: patient comfort preparing and positioning patient for examination. Technologist performing IV injections of contrast material should have qualifications that comply with current ACR policy statements and existing 80 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix E – USA Professional Supervision operating procedures or manuals at the imaging facility. Reporting Reporting should be in accordance with ACR Practice Guideline for Communication: Diagnostic Radiology. Source: ACR Practice Guideline for the use of Intravascular Contrast Media. Effective January 2002. Reporting: Diagnostic Radiology Policy An official interpretation should be generated following any examination, procedure or officially requested consultation. Written report - definition An official interpretation is defined as that written report (and any supplements or amendments thereto) that attach to the patient’s permanent record. In health care facilities with a privilege delineation system, such a written report is prepared only by a qualified physician who has been granted specific delineated clinical privileges for that purpose by the facility’s governing body upon the recommendation of the medical staff. Diagnostic radiology report A final written report shall be provided with all radiologic studies regardless of site of performance (e.g. hospital, imaging centre, physician office, mobile units). Report should contain the following minimum items: E. Demographics F. Relevant clinical information and ICD 9 codes as available G. Body of report – procedures and materials, findings, patient limitations, clinical issues and comparative data H. Impression – conclusion or diagnosis. There are specific requirements under MQSA regulations for mammography reporting. Other forms of communication Final written report is the definitive means of communicating results to referring physician. Other methods of direct or personal communication of results are encouraged in certain situations. Timeliness of reporting Timeliness of reporting varies with nature and urgency of clinical problem. Source: ACR Practice Guideline for Communication: Diagnostic Radiology. Effective January 2002. Interventional Clinical Practice The ACR has developed practice guidelines for interventional clinical practice in collaboration with the American Society of Interventional and Therapeutic Neuroradiology (ASITN) and the Society of Interventional radiology (SIR) – Practice Guideline for Interventional Radiology. Effective January 2004. The guidelines focus on developing an interventional clinical practice for inpatient and outpatient clinical services. They provide recommendation about processes for handling referrals, the physician-patient relationship, scheduling of invasive procedures, staffing, clinical space, time dedicated to clinical duties, equipment needs, clerical service and continuous quality improvement programs. They have not been analysed further given their service development focus. 81 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision This Appendix provides a summary the professional supervision arrangements in Canada. F CANADA PROFESSIONAL SUPERVISION Canadian Association of Radiologists The Canadian Association of Radiologists (CAR) is the national peak organisation for radiologists in Canada. It develops standards to provide assistance to practitioners performing examinations and procedures. Standards Development Standards are developed by expert advisory panels through review of evidence and consensus process involving clinicians and experts in the field. In some cases, standards are based on those published by other national bodies. For example, CAR standards for ultrasound are based on those developed by the American College of Radiology (ACR) and the American Institute of Ultrasound. Standards are reviewed periodically. The standards are described in several ways. They are seen as representing a policy statement by CAR. They are “guidelines that attempt to define the principles of practice that should generally produce radiological care”. They are not rules or “intended to establish a legal standard of care or conduct”. “The ultimate judgment regarding the propriety of any specific procedure or course of conduct must be made by the physician and medical physicist in light of all circumstances presented by the individual situation.” Current Standards The current standards of the CAR are listed in Table 7-3. Table 7-3: Canadian Association of Radiologists - Standards August 2005 Modality General (Plain) Radiography Topic Date Approved Skeletal Surveys in Children June 1998 General (Plain) Radiography June 2000 Chest Radiography First adopted in 1994 and revised in June 2000 Cervical Spine in Children and Adults June 2000 Lumbosacral Spine Computed Tomography (CT) June 2000 Diagnostic CT Scans March 2002 82 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Modality Ultrasound Topic Date Approved Diagnostic Antepartum Obstetric Examination September 2001 Female Pelvis Examination March 2002 Abdomen and Retroperitoneum Examination March 2002 Scrotum Examination March 2002 Thyroid and Parathyroid Examination March 2002 Specific Anatomical Areas – Vascular Ultrasound March 2002 Breast Examination October 2003 Musculoskeletal Examination 2005 Draft - awaiting approval Magnetic Resonance Imaging (MRI) MRI June 1999 Breast Imaging Screening and Diagnostic Mammography June 1998 Other Myelography March 2002 Diagnostic Angiography September 2002 Performance of Percutaneous Nephrostomy September 2002 Performance of Adult Dual - or Single-Energy X-Ray Absorptiometry November 2002 Ultrasound Guided Percutaneous Breast Interventional October 2003 Procedures Contrast Media Reporting Pharynx and Oesophagus in the Adult June 1994 Small Bowel in Adults June 1996 Upper Gastrointestinal Tract First approved in June 1995 and reviewed in 2000 Communication in Diagnostic Radiology First approved in June and reviewed in September 2001 Source: CAR 2005 http://www.car.ca/ethics/standards/index/htm The standards vary in approach and format. They recognise that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques as described in each document. Review of Standards CAR standards were reviewed in order to identify professional supervision and requirements relating to radiologists across imaging modalities. Analysis focussed on diagnostic radiology where the radiologist provides a medical consultative role rather than interventional procedures where the radiologist becomes the treating physician. Key features and principles are summarised below. 83 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision General (Plain) Radiography Physician – Qualifications and Responsibilities Physicians involved in the performance, supervision and interpretation of standard radiographs should be Diagnostic Radiologists and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des Médecins du Quebec. Also acceptable are foreign specialist qualifications if the Radiologist so qualified holds an appointment in Radiology with a Canadian University. As new imaging modalities and interventional techniques are developed additional clinical training, under supervision and with proper documentation, should be obtained before radiologists interpret or perform such examinations or procedures independently. Such additional training must meet with pertinent provincial/regional regulations. Continuing professional development must meet with the requirements of the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada. Technologist Qualifications and Responsibilities The medical radiation technologist must have Canadian Association of Medical Radiation Technologist (CAMRT) Certification or be certified by an equivalent licensing body recognized by the CAMRT. Under the overall supervision of the radiologists, the technologist will have the responsibility for: patient comfort and safety examination preparation and performance image technical evaluation and quality and applicable quality assurance. The training of technologists engaged in specialty activities shall meet with applicable and valid national and provincial specialty qualifications. Continued education of technologists is encouraged by the CAMRT and should meet pertinent provincial regulations. The technologist should have training in fluoroscopy either in his/her training curriculum or through special courses and must perform fluoroscopy on a regular basis. Quality Control and Improvement This section of the standard sets out principles and requirements for quality control and improvement designed to minimise patient, personnel and public radiation risks and maximise the quality of the diagnostic information. It covers safety and operation of imaging equipment, assuring image quality, quality control procedures for radiographic examinations, procedures and policies, and monitoring and evaluation of procedures and policies including accuracy of radiological interpretation and appropriateness of examination. Reporting Results will be communicated to referring physician in accordance with CAR Standard on Communication: Diagnostic Radiology. Source: CAR Standards for General (Plain) Radiography. First adopted: June 2000. Computed Tomography (CT) General CT studies should be performed by qualified and knowledgeable physicians and/or technologists using appropriate equipment and technique. Examinations should be supervised and interpreted by appropriately trained and credentialed medical imaging specialists. Physician – Credentials Criteria Physicians involved in the performance, supervision and interpretation of CT should be Diagnostic Radiologists and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Also acceptable are Radiologists qualified in other jurisdictions who hold special licenses within a Canadian University. As new imaging modalities and interventional techniques are developed additional 84 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision clinical training, under supervision and with proper documentation, should be obtained before radiologists interpret or perform such examinations or procedures independently. Such additional training must meet with pertinent provincial/regional regulations. Continuing professional development must meet with the requirements of the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada. Technologist – Credentials Criteria The Medical Radiation Technologist must have Canadian Association Medical Radiation Technologist certification or be certified by an equivalent licensing body recognized by the CAMRT. Under the overall supervision of the Radiologist, the Technologist will have the responsibility for: patient comfort and safety examination preparation and performance image technical evaluation and quality, and applicable quality assurance. The training of Technologists specifically engaged in CT shall meet with applicable and valid national and provincial specialty qualifications. Performance of Examination: Role of Interpreting Physician in On-line Monitoring Ideally each study would be monitored directly by the interpreting physician. However, realities of time constraints and potential limitations on physician availability necessitate that many scans be performed without on-line monitoring. In this setting, optimisation of the CT examination requires development of an appropriate CT protocol based on careful review of clinical indications as well as all prior available imaging studies. Contrast Media Choice of whether or not to administer IV contrast will depend on clinical indication of study. Operators should be knowledgeable concerning various means of administering IV contrast. Source: CAR Standard for Performing and Interpreting Diagnostic CT Scans. Adopted: March 2002. Magnetic Resonance Imaging (MRI) Physician – Qualifications and Responsibilities Physicians involved in the performance, supervision and interpretation of magnetic resonance imaging should be Diagnostic Radiologists and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des médecins du Québec. Also acceptable are foreign Specialist qualifications if the Radiologist so qualified holds an appointment in Radiology with a Canadian University. As new imaging modalities and interventional techniques are developed additional clinical training, under supervision and with proper documentation, should be obtained before radiologists interpret or perform such examinations or procedures independently. Such additional training must meet with pertinent provincial/regional regulations. Continuing professional development must meet with the requirements of the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada. The final judgment regarding appropriateness of a given examination for a particular patient is the responsibility of the radiologist. Medical Physicist – qualifications and responsibilities A medical physicist (on-site or contracted part-time) shall have the responsibility for the initial acceptance testing and for conducting and overseeing quality control testing of the MR scanner. The medical physicist shall be certified by the Canadian College of Physicists in Medicine and shall have specific training and experience in MRI. Training and experience shall include detailed knowledge of the physics of MRI, system components and performance, safety procedures, acceptance testing, and quality control testing. Technologist – The medical radiation technologist must have Canadian Association of 85 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision qualifications and responsibilities Medical Radiation Technologists (CAMRT) certification in magnetic resonance (RTMR) or be certified by an equivalent licensing body recognized by the CAMRT. Under the overall supervision of the radiologists, the technologist is responsible for: patient comfort and safety examination and preparation of patients performing the MRI scans technical and quality evaluation of images and relevant quality assurance. Continued education of technologists is encouraged by the CAMRT and should meet pertinent provincial regulations. Service Engineers – qualifications and responsibilities The service engineer shall be responsible for system installation, calibration, and preventive maintenance at regularly scheduled intervals. The service engineer's qualification will be ensured by the corporation responsible for service and the manufacturer of the MR equipment used at the site. Administration of contrast and sedation When necessary, contrast and sedation shall be administered in accordance with institutional policy and provincial and federal law by a physician, who has trained in cardiopulmonary resuscitation. An appropriately equipped emergency cart must be immediately available to treat serious adverse reactions. MR compatible ventilators, and appropriate patient monitoring should be available at those sites undertaking general anaesthesia and sedation studies. Quality control and improvement Safety guidelines, practices, and policies shall be written, enforced, documented, and reviewed at least annually by the supervising radiologist and the MR charge technologist. Quality control testing of system performance should be conducted routinely under the supervision of the medical physicist (if present on site), with review at least every six months by the supervising radiologist. Source: CAR Standards for Magnetic Resonance Imaging (MRI). Approved: June 1999. Ultrasound – Diagnostic General Diagnostic ultrasound examinations should be supervised and interpreted by trained and credentialed physician imaging specialists. Studies should be performed by qualified and knowledgeable physicians and/or sonographers using appropriate equipment and techniques. Sonologist Credentials Criteria Physicians involved in the performance, supervision and interpretation of ultrasonography should be Diagnostic Radiologists and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des Médecins du Québec. Also acceptable are equivalent foreign Radiologist qualifications if the Radiologist so qualified holds an appointment in Radiology with a Canadian University. As new imaging modalities and interventional techniques are developed additional clinical training, under supervision and with proper documentation, should be obtained before radiologists interpret or perform such examinations or procedures independently. Such additional training must meet with pertinent provincial/regional regulations. Continuing professional development must meet with the requirements of the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada. Sonographer Sonographers should be graduates of an accredited School of Sonography or have 86 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Credentials Criteria obtained certification by the American Registry of Diagnostic Medical Sonographers (ARDMS) or the Canadian Association of Registered Diagnostic Ultrasound Professionals (CARDUP). They should be members of their national or provincial professional organization. Continuing medical education should be mandatory consistent with the requirements of ARDMS or CARDUP. CARDUP will have a national exam process for sonographers in place by 2004. At that time, this will become the accepted standard for sonographers. As an interim measure, individual consideration of training and qualifications by a Task Force consisting of members of relevant societies can be recommended for all those whose training does not fall within appropriate guidelines. Supervision and interpretation A sonologist must be available for consultation with the sonographer on a case by case basis. Ideally the sonologist should be on site and available to participate actively in the ultrasound examination when required. It is recognized however that the geographic realities in Canada do not permit the presence of an on-site sonologist in all locations. Adequate documentation of each examination is critical. A videotape record may be useful as an adjunct to the hard copy images in difficult cases. Despite the geographic isolation of a community the reports must be timely. Furthermore, the sonologist must be available by telephone for consultation with the sonographer and the referring physician. The sonologist should visit the facility on a regular basis to provide on site review of ultrasound procedures and sonographer supervision. Sources: CAR Standards for: Performing and Interpreting Diagnostic Antepartum Obstetric Ultrasound Examination. Approved: September 2001 Ultrasound Examination of the Female Pelvis. Approved: March 2002 Ultrasound Examination of the Abdomen and Retroperitoneum. Approved: March 2002 Ultrasound Examination of the Scrotum. Approved: March 2002 Ultrasound Examination of the Thyroid and Parathyroid. Approved: March 2002 Specific Anatomical Areas (Vascular Ultrasound). Approved: March 2002. Performance of Breast Ultrasound Examination. Approved: October 2003 Performing Musculoskeletal Ultrasound Examination. Draft released in 2005, awaiting approval. Breast Imaging – Screening Mammography Radiologist – credentials criteria and responsibilities Physicians involved in the performance, supervision and interpretation of mammography should be Diagnostic Radiologists and must have a Fellowship or Certification in Diagnostic Radiology with the Royal College of Physicians and Surgeons of Canada and/or the Collège des Médecins du Québec. Also acceptable are foreign Specialist qualifications if the Radiologist so qualified holds an appointment in Radiology with a Canadian University. As new imaging modalities and interventional techniques are developed additional clinical training, under supervision and with proper documentation, should be obtained before radiologists interpret or perform such examinations or procedures independently. Such additional training must meet with pertinent provincial/regional regulations. Continuing professional development must meet with the requirements of the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada. Radiologists practising mammography should participate regularly in mammography continuing education programs. They should adhere to the requirement for CAR mammography accreditation. Technologist credentials criteria and responsibilities The medical radiation technologist must have Canadian Association of Medical Radiation Technologist (CAMRT) Certification or be certified by an equivalent licensing body recognized by the CAMRT. 87 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Under the overall supervision of the radiologist, the technologist will have the responsibility for: patient comfort and safety examination preparation and performance image technical evaluation and quality and applicable quality assurance. The technologist should receive continuous supervision on image quality from the interpreting radiologists. The training of technologists engaged in specialty activities shall meet with applicable and valid national and provincial specialty qualifications. Continued education of technologists is encouraged by the CAMRT and should meet pertinent provincial regulations. The technologist should have training in mammography either in his or her training curriculum or through special courses and must perform mammography on a regular basis. Radiation physicist credentials criteria and responsibilities A medical physicist shall have the responsibility for the initial acceptance testing and for conducting and overseeing quality control testing of the mammographic unit. The medical physicist shall be certified by the Canadian Organization of Medical Physicists or possess equivalent qualifications from the Canadian College of Physicists in Medicine. Training and experience shall include knowledge of the physics of mammography, systems components and performance, safety procedures, acceptance testing, quality control and CAR Mammography Accreditation Program requirements. Free Standing and Mobile Settings Screening mammography may be performed in non-traditional settings where a physician may not be in attendance. Essentially, the examination offered must follow all of the described standards and guidelines cited here as documented protocols. The radiologic technologist should work under the same rules whether in a fixed or mobile setting. The radiologist supervising the facility should be available for consultation and must visit the facility at least monthly to observe the performance of mammograms and assure that safe operating procedures are adhered to. Screening Mammography Report Reporting should be according to the CAR Standards for Communication. As well, the American College of Radiology (ACR) document "Breast Imaging Reporting Data Systems" (BIRADS) has been adopted as a reference document and is available on request from the ACR office. A description of abnormalities detected at screening and recommendations for work up should be included in the report. For abnormalities which are in the highly suspicious category suggestive of malignancy, the report should be communicated to the referring physician directly in a manner that ensures receipt and documentation of the reports, such as by telephone, fax or registered mail. Quality Control A documented quality control program with procedure manuals and logs should be maintained in accordance with the CAR Mammography Accreditation Program's quality control specifications. 1. Radiologist The radiologist will be responsible for ensuring that technologists have adequate training and maintenance of competence; he/she or a designate must ensure that the technologists and physicists perform the appropriate tests on schedule, and that all records are properly maintained and that the quality of clinical images is acceptable. 2. Technologist The radiology technologist will be responsible for various routine tests including darkroom cleanliness, processing quality control, screen cleanliness, viewboxes and viewing conditions, phantom images, visual checklist, repeat analysis, analysis of 88 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision fixer retention in film, darkroom fog, screen film contact and compression. 3. Physicist The medical physicist will be responsible for the mammographic unit evaluation, collimation assessment, focal spot size measurements, kVp accuracy and reproducibility. The American College of Radiology (ACR) Committee on Mammography Quality Assurance has published a document entitled "Mammography Quality Control" addressing, specifically, radiology technologists' and physicists responsibilities. This document has been reviewed and acknowledged by the Task Force on Mammography and is recommended as a reference document. Source: CAR Standard for Breast Imaging. Approved: June 1998 Diagnostic Mammography and Problem Solving Breast Evaluation Qualifications of Personnel The same criteria apply as for screening mammography. Supervision The diagnostic mammogram is planned and tailored for the needs of the individual patient. It should be done under the direct supervision of a radiologist qualified in mammography. Report All areas of clinical or radiologic concern should be acknowledged in the report. The report should describe the pertinent observations, establish a level of suspicion based upon the imaging findings and provide specific recommendations for patient management. The report should also document any other breast imaging studies or procedures which have been performed and should correlate these results with the mammographic findings. Screening recommendations may be included. The same criteria for reporting and communication as for screening mammography apply. Source: CAR Standard for Breast Imaging. Approved: June 1998 Communication in Diagnostic Radiology General The final product of any consultation is the submission of a report on the results of the consultation. In addition, the diagnostic radiologist and the referring physician have many opportunities to communicate directly with each other during the course of a patient's case management. Such communication should be encouraged because it leads to more effective and appropriate utilization of Diagnostic Radiology in addressing clinical problems and focuses attention on such concerns as radiation exposure, appropriate imaging studies, clinical efficacy, and cost-effective examinations. These principles apply to all radiology consultations irrespective of the technology used including teleradiology and PACS. In order to afford optimal care to the patient and enhance the cost-effectiveness of each diagnostic examination, radiological consultations ought to be provided and radiographs interpreted within known clinical settings. The CAR supports radiologists who insist on clinical data with each consultation request. The Diagnostic Radiology Report An authenticated written interpretation shall be performed on all radiographic (imaging) procedures. The report should include the following items: Name of patient and another identifier, such as gender, birth date, pertinent ID number or hospital or office identification number Name of referring (attending) physician Name of most responsible physician Names of other physicians Name or type of examination 89 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Written Communication Date of dictation Date of examination and transcription Time of the examination (for ICU-CCU patients) Body of the report The effective transmission of radiographic information from the radiologists mind to the clinician constitutes the purpose of the report. The report should be clear and concise. Normal or unequivocally positive reports can be short and precise. Whenever indicated, the report should include: - procedures and materials - findings - limitations - clinical issues - comparative data - assessment and recommendations. The timeliness of reporting any radiologic examination varies with the nature and urgency of the clinical problem. The written radiological report should be made available in a clinically appropriate, timely manner. The final report should be proofread carefully to avoid typographical errors, deleted words, and confusing or conflicting statements, and authenticated by a radiologist, whenever possible. Electronic and rubber-stamp signature devices, instead of a written signature, are acceptable if access to them is secure. If this is not possible, the name of the radiologist who dictated the report should appear on the report. A copy of the final report should accompany the exchange of relevant radiographic examinations from one health professional to another health professional. Direct Communication Radiologists should attempt to co-ordinate their efforts with those of the referring physician in order to best serve the patient's well-being. In some circumstances, such co-ordination may require direct communication of unusual, unexpected or urgent findings to the referring physician in advance of the formal written report. Examples include: The probable detection of conditions carrying the risk of acute morbidity and/or mortality which may require immediate case management decisions. The probable detection of disease sufficiently serious that it may require prompt notification of the patient, clinical evaluation or initiation of treatment. In these circumstances, the radiologist, or his or her representative, should attempt to communicate directly (in person or by telephone) with the referring physician or his or her representative. The timeliness of direct communication should be based upon the immediacy of the clinical situation. Documentation of actual or attempted direct communication is appropriate in accordance with department policy, legal advisability, understanding with the referring physician, and individual judgement. Any discrepancy between an emergency or preliminary report and the final written report should be promptly reconciled by direct communication to the referring physician or his or her representative. Source: CAR Standard for Communication in Diagnostic Radiology. First approved in June 1997 and reviewed in September 2001. 90 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Alberta Introduction In Alberta, reimbursement for medical services is available under the Alberta Health Care Insurance Plan. The Schedule of Medical Benefits sets out the services that are insured under the Alberta Health Insurance Act and associated Plan. Claims for services under the radiology (and pathology) sections are not payable unless the physician has been accredited by the Alberta College of Physicians and Surgeons of Alberta to provide these services. The Medical Profession Act provides for the regulation of physicians and practice of medicine in Alberta. This Act gives the College the authority and responsibility to regulate diagnostic and treatment facilities in Alberta except facilities operated by government (local, provincial and federal) and facilities approved under the Hospitals Act. The College provides this service to facilities operating under the Hospitals Act through a contract with Alberta Health and Wellness. Accreditation Standards and Guidelines The College administers an accreditation program for all medical diagnostic imaging in Alberta. It sets the standards and guidelines for diagnostic imaging against which services are accredited. The latest edition is Diagnostic Imaging Standards and Guidelines, Alberta. The College of Physicians and Surgeons of Alberta. June 2005. The College’s Advisory Committee on Radiology and Diagnostic Imaging develops the standards and guidelines for accredited facilities. Its role is to advise the College’s Medical Facility Assessment Committee on medical imaging matters. The aim is to set a high standard of medical practice in diagnostic imaging for Alberta. The standards and guidelines set out the role of the College in accreditation of facilities and cover physician approval, personnel, facility, medical record, quality assurance, manuals, safety, procedures, remote MRI and teleradiology and digital image data management, mobile X-ray equipment and supervision of ultrasound studies. Standards and guidelines fall into three broad groupings - requirements for accreditation (where “shall” is used), recommendations (“should”), and discretionary (“may”). Mammography facilities are accredited through CAR Mammography Accreditation Program (CAR – MAP). Key Features Medical Director The College requires all accredited medical imaging facilities/departments to have a Medical Director (i.e. a practitioner who is registered with the Alberta College of Physicians and Surgeons and licensed to practise medicine in Alberta) who is accountable for the practise of medicine within the facility. A medical imaging facility/department shall be under the complete direction and supervision of a medical director. Medical Directors have to be satisfied as to the standing of other professionals with their respective regulatory bodies and to the safety of their practices. Ideally, the medical director should be an imaging specialist. For facilities where the Medical Director does not have the expertise in the particular imaging modality, the services of a consultant are required. Consultant Physician 91 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision When the medical director is not an imaging specialist, there shall be a consultant physician who is approved for modalities not within the scope of practice of the medical director. The consultant shall be licensed to practise in medicine in Alberta and be a specialist in the modalities for which he/she provides consultative services. MRI Facilities MRI radiologist is a radiologist approved by the College either to interpret studies or direct an MRI facility. The medical director of an MRI facility shall be a radiologist with full approval in MRI and licensed to practise in medicine in Alberta. A physician with full MRI approval shall review a minimum of 20% of the studies performed each month in the facility. All MR protocols shall be approved by an MRI radiologist on a case-by-case basis. All MRI studies shall be interpreted by an MRI radiologist and reported in a timely fashion. An MRI radiologist shall be on site for the majority of the studies performed each day n the facility. An MRI radiologist shall be immediately available (i.e. in person or by telephone) during all studies. Supervision requirements for fully-supervised facilities include an MRI qualified radiologist being on site for at least 50% of studies and the Medical director on site for at least 20% of studies. Liaison physician In hospital facilities that do not have an on site imaging specialist, there shall be a liaison physician who is a local member of the medical staff and appointed to act in concert with the administration and the radiology consultant. Technical personnel Radiological examinations shall be performed by an imaging specialist or technologist or technician who has current registration with their professional association. Areas specified include radiology, technologists and technicians; ultrasound; mammography; MRI; nuclear medicine; and bone densitometry. Provision shall be made for technologists/technicians to regularly attend relevant continuing education programs. Physician Approval Physicians providing services in echocardiography, MRI, nuclear medicine, PET and ultrasound are required to have prior College approval. Cover full approval, restricted approval, re-approval and active practice requirements. Request for consultation Requests for imaging consultations shall be completed for all imaging procedures. 92 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Reports All examinations shall be reported by an appropriately approved imaging specialist as soon as possible after the images are available. Unusual, unexpected or urgent findings which may require immediate case management decisions shall be communicated immediately to the referring practitioner. Report of the interpretation of imaging procedures shall include as per CAR Standards for Communication: Diagnostic Radiology – A. the Diagnostic Radiology Report. All reports should be signed or electronically verified by the interpreting radiologist prior to being issued. Ultrasound – supervision of studies An ultrasonologist shall be on site at the facility for consultation, supervision and interpretation of all ultrasound examinations unless otherwise approved by the College. Teleultrasound is an approved exception subject to specific accreditation standards for teleultrasound services. In unusual circumstances, approval for ultrasound examinations without an ultrasonologist available either on site or be teleultrasound will be considered only upon application and only for specified studies and locations where the absence of ultrasound services could harm patients. Approvals are subject to adequate arrangements for the prompt interpretation of studies by an ulatrsonologist and a process for immediate referral of complex cases. Interpretation of studies by ultrasonographers or others who are not an ultrasonologist is not acceptable. Procedures – fluoroscopy Fluoroscopy shall be performed under the direction and supervision of a radiologist or physician approved by the College. Procedures – Intravascular iodinated contrast agents The use of contrast shall adhere to a policy approved by the radiologist/imaging specialist responsible for imaging in the facility. A physician shall be immediately available during the examination in which an IV contrast agent is administered. All images shall be reviewed and interpreted by a radiologist/imaging specialist. Remote MRI services Remote MRI services are subject to accreditation by the College as a separate imaging facility. The Medical Director of a remote service shall be a Medical director of a least one other accredited fully supervised full time MRI facility. An Alberta MRI-approved radiologist shall review all requisitions, prescribe all imaging protocols and interpret all studies, and be available to the imaging technologist by phone during imaging sessions. The technologist performing studies shall be a qualified MRI technologist. 93 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision MRI studies requiring preliminary view before discharging patients in accordance with generally accepted standards of practice in Alberta shall have and use tele-imaging technology for review by the radiologist of such cases performed at the remote facility. MRI studies with the use of gadolinium shall be performed only under the direct supervision of an appropriately qualified physician and within close proximity of a hospital ED. MRI studies under intravenous sedation or on patients requiring monitoring of vital signs during the imaging procedure are not permitted. Studies for which the generally accepted standard of practice in Alberta is the direct supervision by a radiologist shall not be performed by remote MRI. Teleradiology and Digital Image Data Management Standards have been adapted from the CAR national Standards for Teleradiology. They include requirements and recommendations for the accreditation of teleradiology facilities and digital image data management by the College of Physicians and Surgeons of Alberta. They define qualifications of personnel, equipment guidelines, record storage, quality control and quality improvement for digital image data management and teleradiology. The Alberta Health Care Insurance Plan covers telehealth services. Telehealth service is defined as a physician delivered health service provided to a patient at a designated RHA telehealth site, through use of video technology including store and forward. The patient must be in attendance at the site at the time of video capture. Teleradiology services are not claimable against these telehealth items. 94 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision BRITISH COLUMBIA Introduction The British Columbia Medical Services Plan (MSP) insures medically required services provided by physicians and supplementary health care, prostheses, laboratory services and diagnostic procedures. The Medical Services Commission administers the plan. To practise and be paid by the MSP, practitioners and diagnostic facilities require approval by the Medical Services Commission and accreditation by the Diagnostic Accreditation Program of the College of Physicians and Surgeons of BC. Arrangements cover diagnostic radiology, diagnostic ultrasound, CT, CAT and nuclear medicine scanning. Fees for billing MSP-insured diagnostic services are listed in the Medical Services Commission Payment Schedule. Standards and guidelines for accreditation of providers and facilities have been requested from the College. MSP Payment Arrangements for Diagnostic Imaging Services – Key Features Key features of the payment arrangements relating to diagnostic imaging services are summarised below. General Benefits are limited to services which are medically required for the diagnosis and/or treatment of a patient, which are not excluded by legislation or regulation, and which are rendered personally by medical practitioners or by others delegated to perform them in accordance with the Commission’s policies. Delegated procedures These are set out and require performance of procedure under direct supervision of the physician or a designated alternative physician with equivalent qualification. However, these limitations do not apply to approved procedures rendered in approved “diagnostic facilities” and which are subject to accreditation under the Diagnostic Accreditation Program. Diagnostic facility services These are “medically required services performed in accordance with protocols agreed to by the Commission, or on the order of the referring practitioner, who is a member of a prescribed category of practitioner, in a approved diagnostic facility by, or under the supervision of, a medical practitioner who has enrolled, unless the services are determined by the Commission not to be benefits”. The MSC designates certain diagnostic procedures as diagnostic facility services under the MSC Payment Schedule. Current services include diagnostic radiology, diagnostic ultrasound, nuclear medicine scanning, computerised axial tomography technical fee (CT, CAT), MRI and PET. Diagnostic radiology – use of telemetry Radiology fees or nuclear medicine fees may only be claimed for studies performed by telemetry when: The service meets existing MSC policy on the use of telemetry The use of telemetry will not negatively affect the existing on-site visit schedules of the radiologist or nuclear medicine specialist. 95 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Diagnostic ultrasound – on-site supervision Real time ultrasound fees may only be clamed for studies performed when a physician is on-site in the laboratory for the purpose of diagnostic ultrasound supervision. Diagnostic ultrasound – use of telemetry Real time ultrasound fees may only be claimed for studies performed by telemetry when: The service meets existing MCS policy on the use of telemetry. The facility currently holds a remote site designation from MSC (facilities should recognise that once the volume of services justifies full-time radiologist coverage, remote site designation may be removed). The use of telemetry will not negatively affect the existing on-site visit schedules of the radiologists. The majority of scans will continue to be scheduled when the visiting radiologist is on-site for the purpose of ultrasound supervision. Nuclear medicine – use of telemetry Radiology fees or nuclear medicine fees may only be claimed for studies performed by telemetry when: The service meets existing MCS policy on the use of telemetry The use of telemetry will not negatively affect the existing on-site visit schedules of the radiologist or nuclear medicine specialist. 96 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision MANITOBA Introduction Manitoba reimburses patients through the Health Services Insurance Fund. The schedule of services and fees is set out in the Manitoba Physician’s Manual issued by the Minister of Health. The Manual sets out the fees/benefits payable under the Manitoba Health Services Insurance Act for the cost of insured medical services. The latest version relates to April 2005. In order to be eligible, specialists must be registered with the College of Physicians and Surgeons of Manitoba. Physician Fees – Three Components The schedule separates physician fees into three components: Technical (Column Tec) – benefit for radiographic examinations, including the production of radiographs, supply of contrast media, equipment maintenance, capital cost of replacement equipment, fixed and variable overhead costs of the premises, technical services administration, production of one or more copies of the report by the certified radiologist and collection costs. Professional (Column Pro) – the benefit for supervision of imaging services, advising the referring physician as to the most appropriate imaging modality, maintenance of quality control, imaging interpretation and fluoroscopic assessment. Procedural (Column C) – are intended to cover the procedural portion of the examination and are separate and distinct from the professional supervisory and interpretative fees of professional component (Column Pro.) They represent the additional benefit for the professional procedural portion of the examinations. They are intended to cover compensation for the professional service of placing an instrument and introducing contrast media (except in excretion studies of the biliary and renal tracts, and oral and rectal administration for study of the alimentary canal). The same fees may be charged for similar services associated with diagnostic physiological studies of non-radiological nature, for example – catheterisation for physiological sampling or the transmission of pressure, sound or electrical waves or the therapeutic injection of drugs. They apply to interventional and procedural services only. Itemisation Generally, the itemisation is modality or procedural based with services grouped under body part or type of examination to be performed (e.g. in the case of MRI multi-slice T2 (1or 2 echoes), multi-slice I.R. or T1. or repeat). Radiologist/physician supervision, performance, interpretation and reporting requirements are generally not covered in the itemisation of services. Instead, they are covered in the three fee components. Exceptions are: Breast ultrasound where the itemisation distinguishes between sonologist performed sonography and non-sonologist performed sonography for breast unilateral and bilateral real time studies with the sonologist performed services attracting a higher benefit (97% and 87% more respectively). Items for sonologist performed procedures where sonologist performs all examinations due to particular circumstances – e.g. rural Manitoba no technician available, after hours no technician available, and new or complex procedure no qualified technician. These items are set out in the following table. 97 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Table: Sonologist Performed Procedures – Manitoba Canada Item Descriptor 7362 Portable ultrasound examination performed by sonologist [or the first full thirty (30) minute period and for each additional thirty (30) minute period or portion thereof] 7363 Sonologist performs part of examination for a minimum of ten (10) minutes or less where the sonologist’s input revises the technologist’s initial or provisional finding or changes the management of the patient’s care 7365 Sonologist performs all of examination 7367 Hysterosonography 7368 Sonography, intraoperative real time study performed by radiologist [for the first full thirty(30) minute period and for each additional thirty (30) minute period or portion thereof] Source: Manitoba Physician’s Manual. April 1, 2005. Issued by the Minister of Health. www.gov.mb.ca/health/index/html Special other radiological procedures - where a sonologist provides interventional and/or invasive procedures, he/she shall be eligible to claim tariffs from the Diagnostic Radiological Procedures Schedule regardless of imaging modality. Nuclear Medicine – In Vivo where two fees apply: Technical: includes fees for the technical and physical aspects of the services rendered. The cost of the material is additional. Professional: is the fee for the professional services only, performed by the physician. 98 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision SASKATCHEWAN Introduction The Saskatchewan Medical Care Insurance Plan provides health insurance cover for services provided by physicians, chiropractors and optometrists as well as some services provided by dentists. Saskatchewan Health administers the plan. The plan pays for insured services on a fee-for-service basis in accordance with medical care insurance payment schedule. The latest schedule came into effect from April 2005. The Saskatchewan Health Payment Schedule for Insured Services Provided by a Physician - April 1, 2005 provides some information on professional supervision and reporting requirements for radiologists practising in the province. Some are radiologist specific while others apply to physicians generally. Key features are summarised below. General – services supervised by a physician A service which is insured by Saskatchewan Health when provided by a physician is also insured when provided under the supervision of a physician. Payments can be made to the physician for this supervision as long as the physician is available to intervene promptly if necessary. Supervised services are provided by: (a) a person during the period of registration on the educational register of the College of Physicians and Surgeons as an intern, a resident, an undergraduate junior rotating intern (JURI) or as a person taking other post graduate training in Saskatchewan as a physician, where that service is provided as part of the course of training being undertaken; (b) another physician providing the service as part of a course of instruction being administered by the College of Medicine of the University of Saskatchewan and where that physician does not charge for the service; (c) a person employed by a physician in the physician’s office and for whose work the physician assumes overall responsibility and provides intermittent daily personal supervision, and the service is: (i) a laboratory service; (ii) a diagnostic X-ray procedure; (iii) a diagnostic procedure involving a tracing; (iv) an intra-muscular, intra-dermal, or sub-cutaneous injection; (v) a specimen collection. (d) a person in training as a health care worker under the supervision of the physician for a specific procedure and the worker does not have privileges through either independent licensure or transfer of function to independently perform the procedure (e.g. advanced clinical nurse, respiratory technologist). (e) A person employed by a physician whose practice is restricted to dermatology may provide ultraviolet B therapy when the physician assumes overall responsibility and provides intermittent daily personal supervision. Payment for a supervised service may only be made to the physician providing the supervision. 99 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Radiology Radiology is not insured when: (a) provided in hospital or any facility funded by the District Management Branch, Saskatchewan Health (b) performed by other than a radiologist Diagnostic Ultrasound Ultrasound is an insured service where: it is provided outside a hospital and is not provided to a hospital in-patient or a patient in the Emergency Department it is provided by a physician who is listed by the College of Physicians and Surgeons of Saskatchewan as having qualified to receive payments a hard copy of the diagnostic ultrasound examination (s) plus a written signed interpretation of the report of that examination is retained by the physician providing the service. Payment schedule distinguishes between technical component and interpretation component. Diagnostic Radiology A diagnostic x-ray procedure is an insured service where it is entirely provided outside a hospital by a radiologist. Payment to the radiologist will be made only where he has performed the procedure personally or the technical component was performed by qualified staff for whom he assumes responsibility and provides daily supervision. Payment for diagnostic x-rays of any one region includes payment for a sufficient number of films to establish diagnosis in the average case. Payment includes the customary media and its administration, but not specialist clinic procedures listed in Section A of the Payment Schedule for which an additional payment may be made. Payment schedule distinguishes between technical component and interpretation component. Radiologist Clinical Procedures Certain procedures are insured where provided by a radiologist. Payment is to radiologist is made only where the radiologist has performed the procedure personally. Procedures include angiography, transluminal angioplasty, procedures under fluoroscopic, CT or ultrasonic guidance and selective catheterisation of renal vein by Seldinger technique or cut down. Cardiologists have applicable angiography services in another section (A Section) of the payment schedule. Other procedures (600X to 663X) may be charged by other physicians recognised by the College of Physicians and Surgeons as having adequate training in radiology and confining their practice to radiology. 100 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Therapeutic Radiology, Nuclear Medicine Therapeutic radiology services are not listed in the Payment Schedule because in Saskatchewan these procedures are performed in facilities funded through other government programs. Therapeutic radiology or isotope procedure is an insured service where it is entirely provided outside a hospital and it is provided by a qualified specialist in Therapeutic Radiology. 101 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision ONTARIO Introduction The Ontario Health Insurance Plan (OHIP) provides residents of Ontario with coverage for medically necessary services. The Ministry of Health and Long-Term Care administers the plan. The OHIP Schedule of Benefits and Fees sets out services covered, associated requirements, fees and benefits including those relating to diagnostic imaging. Some are general relating to all physician services while others are imaging specific. Key features are summarised below. General - Delegated Procedure When a procedure(s) is carried out by a physician’s employee(s), under the direct supervision of the physician in his/her office, the usual claims can be made for the procedure(s) which are generally and historically accepted as those which may be carried out by the nurse or other medical assistant in the employ of the physician. Procedures in this context do not include such services as assessments, consultations, psychotherapy, counselling etc. Direct supervision requires that, during the procedure, the physician be physically present in the office or clinic at which the service is rendered. While this dies not preclude a physician from being otherwise occupied, he/she must be in personal attendance to ensure that procedures are being performed competently and he/she must at all times be available immediately to approve, modify or otherwise intervene in a procedure as required in the best interests of the patient. Some procedures may not require the physical presence of a physician for direct supervision. These exceptions to the physical presence of the physician requirement for direct supervision may be made upon recommendation of the Ontario Medical Association and the College of Physicians and Surgeons of Ontario. Only the simple office procedures listed below may be performed by the non-physician without the physical presence of a physician in the physician’s office. The procedure must be rendered in accordance with accepted professional standards and practice [Sec 18 (2) of the Health Insurance Act]. The non-physician performing the procedure must have been properly trained and report to the physician. Professional and Technical Components Procedures are divided into a professional component (P) and a technical component (H) Technical component may only be billed for a service provided in the out-patient department at a hospital or in an off-site premise, operated by the hospital corporation. Some procedures (e.g. diagnostic ultrasound, nuclear medicine) have two levels of professional component – P1 and P2. 102 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision Diagnostic Radiology, MRI and Nuclear Medicine Diagnostic Radiology MRI Nuclear medicine in Vivo Professional component (P or P1) F. Providing clinical supervision including approving, modifying and/or intervening in the performance of the procedure where appropriate, and quality control of all elements of the technical component G. Performance of any clinical procedure associated with the diagnostic procedure which is not separately billable. H. Where appropriate, post procedure monitoring, including intervening except where this constitutes a separately billable service. I. Interpreting the results of the diagnostic procedure. J. Providing premises for any aspect(s) of A and D that is (are) performed at a place other than the place in which the procedure is performed. Applicable Applicable Not applicable Not applicable Applicable If the physician claiming the fee for the service is personally unable to perform elements A, B and C, these may be delegated to another physician who must personally perform the service. Element D must be personally performed by the physician who claims the service. Professional component (P2) A. Interpreting the results of the diagnostic procedure. B. Providing premises for any aspect(s) of the specific elements, that is (are) performed at a place other than the lace in which the procedure is performed. Element A must be personally performed by the physician who claims for the service. Technical component (H) A. Preparing the patient for the procedure. B. Performing the diagnostic procedure or assisting in the performance of fluoroscopy. Not applicable C. Making arrangements for any appropriate follow-up care. 103 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision D. D. Providing records of results of the procedure to the interpreting physician. E. Discussion with, and providing information and advice to, patient or patient’s representatives(s), whether by telephone or otherwise, on matters related to the service. F. Preparing and transmitting a written, signed and dated\ interpretation report of the procedure to the referring physician. G. Providing premises, equipment, supplies and personnel for all specific elements of the technical and professional components except for the premises for any aspect9s) of A and D of the professional component that is (are) not performed at the place in which the procedure is performed. Diagnostic Ultrasound Professional Component P1 A. Being physically present in the ultrasound department or facility to provide clinical supervision, including approving, modifying and/or intervening in the performance of the procedure where appropriate, and quality control of all elements of the technical component of the procedure. B. Either a. the performance of some or al of the procedure; or b. the review of the images obtained before the patient leaves the department/office, so as to be able to modify the examination while the patient is still in the department office. C. Where appropriate, post procedure monitoring, including intervening except where this constitutes a separately billable service. D. Interpreting the results of the diagnostic procedure. E. Providing premises for any aspect of D that is performed at a place other than the place in which the procedure is performed. Elements A, B, C and D must be personally performed by the physician who claims the service. Professional Component P2 A. Interpretation of the results if the physician’s only contact with the examination is a review of its recording by video methods or multi-format images, after the patient has left the department/office. B. Providing the premises for any aspect of A of P2 that is performed at a place other than the lace in which the procedure is performed. Element A must be personally performed by the physician who claims the service. Technical Component H A. Preparing the patient for the procedure. 104 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix F – Canada Professional Supervision B. Performing the diagnostic procedure(s). C. Making arrangements for any appropriate follow-up care. D. Providing records of results of the procedure to the interpreting physician. E. Discussion with, and providing information and advice to, patient or patient’s representatives(s), whether by telephone or otherwise, on matters related to the service. F. Preparing and transmitting a written, signed and dated\ interpretive report of the procedure to the referring physician. G. Providing premises, equipment, supplies and personnel for all specific elements of the technical and professional components except for the premises for any aspect(s) of A of the P2 professional component that is (are) not performed at the place in which the procedure is performed. Where the only professional component provided is P2, the specific elements A and C listed for the professional component P1are included in the specific elements of the technical component. 105 AUSTRALIAN HEALTHCARE ASSOCIATES Appendix G – Risk Management Framework This appendix provides an example of a risk management framework radiologists may use in the development of their practice-based protocols. G RISK MANAGEMENT FRAMEWORK Nervous System Neck Chest Cardiovascular System Digestive System Genitourinary System Female Reproductive System Musculoskeletal System General Radiography Risk? Risk? Risk? Risk? Risk? Risk? Risk? Risk? Ultrasound Risk? Risk? Risk? Risk? Risk? Risk? Risk? Risk? Computed Tomography (CT) Risk? Risk? Risk? Risk? Risk? Risk? Risk? Risk? Magnetic Resonance Imaging (MRI) Risk? Risk? Risk? Risk? Risk? Risk? Risk? Risk? Modality 106 AUSTRALIAN HEALTHCARE ASSOCIATES
