ISTITUTO SUPERIORE DI SANITÀ. Guidelines for quality assurance and technical requirements in teleradiology

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3 ISTITUTO SUPERIORE DI SANITÀ Guidelines for quality assurance and technical requirements in teleradiology English translation and revision of Rapporti ISTISAN 10/44 Edited by Antonio Orlacchio (a), Placido Romeo (a), Maria Cristina Inserra (a), Mauro Grigioni (b) and Daniele Giansanti (b) (a) Società Italiana di Radiologia Medica, Roma (b) Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma ISSN Rapporti ISTISAN 13/38

4 Istituto Superiore di Sanità Guidelines for quality assurance and technical requirements in teleradiology. English translation and revision of Rapporti ISTISAN 10/44. Edited by Antonio Orlacchio, Placido Romeo, Maria Cristina Inserra, Mauro Grigioni and Daniele Giansanti 2013, ix, 33 p. Rapporti ISTISAN 13/38 Guidelines for quality assurance in teleradiology were elaborated in the framework of the activities on quality assurance in diagnostic and interventional radiology of the Istituto Superiore di Sanità (the National Institute of Health in Italy) and of the Istituto Superiore per la Prevenzione e Sicurezza del Lavoro. In this document criteria for the application of teleradiology are discussed together with their clinical and quality control aspects. In the annexes, organizations schemes as well as technological aspects and elements of costs are described. Key words: Guideline; Quality assurance; Teleradiology Istituto Superiore di Sanità Linee guida per l assicurazione di qualità e requisiti tecnici in teleradiologia. Traduzione e revisione in inglese di Rapporti ISTISAN 10/44. A cura di Antonio Orlacchio, Placido Romeo, Maria Cristina Inserra, Mauro Grigioni e Daniele Giansanti 2013, ix, 33 p. Rapporti ISTISAN 13/38 (in inglese) Nell ambito dell attività dell Istituto Superiore di Sanità Superiore e dell Istituto per la Prevenzione e Sicurezza del Lavoro in tema di assicurazione di qualità in radiologia diagnostica e interventistica sono state elaborate delle linee guida per l assicurazione di qualità in teleradiologia. Nel documento vengono illustrati ambiti e criteri di applicabilità delle telegestione. Vengono inoltre discussi gli aspetti clinici nonché i controlli di qualità. Il documento contiene una serie di allegati relativi agli schemi organizzativi, agli aspetti tecnologici, nonché agli elementi da contabilizzare in questo settore. Parole chiave: Linee guida; Assicurazione di qualità; Teleradiologia Per informazioni su questo documento scrivere a: daniele.giansanti@iss.it; aorlacchio@sirm.org Questo rapporto è la versione inglese rivista e corretta del volume: Gruppo di Studio per l Assicurazione di Qualità in Radiologia Diagnostica ed Interventistica (Ed.). Linee guida per l assicurazione di qualità in teleradiologia. Roma: Istituto Superiore di Sanità; (Rapporti ISTISAN 10/44). Il rapporto è accessibile online dal sito di questo Istituto: Citare questo documento come segue: Orlacchio A, Romeo P, Inserra MC, Grigioni G, Giansanti D (Ed.). Guidelines for quality assurance and technical requirements in teleradiology. English translation and revision of Rapporti ISTISAN 10/44. Roma: Istituto Superiore di Sanità; (Rapporti ISTISAN 13/38). Presidente dell Istituto Superiore di Sanità e Direttore responsabile: Fabrizio Oleari Registro della Stampa - Tribunale di Roma n. 131/88 del 1 marzo 1988 (serie: Rapporti e congressi ISTISAN) Redazione: Paola De Castro e Sandra Salinetti La responsabilità dei dati scientifici e tecnici è dei singoli autori. Istituto Superiore di Sanità 2013 viale Regina Elena, Roma

5 Composition of the Study Group for Quality Assurance in Diagnostic and Interventional Radiology in the 2010 Corrado Bibbolino Francesco Campanella Patrizia Cenni Stefania delle Canne Adriano Fileni Fiorenzo Gasparri Biagio Merlino Vittorio Miele Antonio Orlacchio Renato Padovani Rosario Palma Roberto Ropolo Veronica Rossetti Antonio Rotondo Massimo Silva Giustina Simone Vincenza Viti Istituto Nazionale Malattie Infettive Lazzaro Spallanzani Istituto di Ricovero e Cura a Carattere Scientifico, Roma Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, Roma AUSL di Ravenna, Ravenna Ospedale Fatebenefratelli, Isola Tiberina, Roma Istituto Nazionale di Riposo e Cura Anziani, Istituto di Ricovero e Cura a Carattere Scientifico, Roma ASL di Frosinone, Presidio Ospedaliero di Sora Università Cattolica del Sacro Cuore, Roma Azienda Ospedaliera San Camillo-Forlanini, Roma Policlinico Tor Vergata, Roma Azienda Ospedaliera Santa Maria Misericordia, Udine Azienda Sanitaria Locale Napoli 1, Napoli Azienda Ospedaliera San Giovanni Battista, Torino Ospedale San Giovanni Antica Sede, Torino Seconda Università degli Studi, Napoli Ospedale A. Cardarelli,Napoli Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma Organizing secretary in the 2010 Franca Grisanti Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma The drafting of guidelines in Italian for quality assurance in teleradiology has been edited by: Giustina Simone Coordinatore Giampietro Barai Giacomo Belli Corrado Bibbolino Anna Maria Canevari Adriano Fileni Mauro Grigioni Daniele Giansanti Graziano Lepri Antonio Orlacchio Luisa Pierotti Antonio Rotondo Massimo Silva Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma Azienda Ospedaliera Carlo Poma, Mantova Azienda Ospedaliera Careggi, Firenze Istituto Nazionale Malattie Infettive Lazzaro Spallanzani Istituto di Ricovero e Cura a Carattere Scientifico, Roma Ospedale San Martino, Genova Istituto Nazionale di Riposo e Cura per Anziani, Istituto di Ricovero e Cura a Carattere Scientifico, Roma Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Roma Azienda Sanitaria Locale n.2 dell Umbria, Perugia Policlinico Tor Vergata, Roma Policlinico San Orsola Malpighi, Bologna Seconda Università degli Studi, Napoli Ospedale A. Cardarelli, Napoli The revision of the guidelines in Italian was carried out by the whole study group. i

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7 TABLE OF CONTENTS Acronyms... v Presentation of the English version... vii Introduction... 1 Definition... 2 Distance learning and teleconference... 2 Teledistribution... 2 Teleconsultation and teleconsultancy... 2 Remote management of diagnostic imaging... 3 Scope and criteria for application of diagnostic imaging exam remote management... 5 Quality control... 6 Clinical aspects... 7 Activities, qualifications, responsibilities and training of staff... 7 Radiologist... 7 Radiology technician... 7 Medical physic expert... 8 Computer expert... 8 Administrative personal staff... 8 System administrator of the radiological area... 8 Responsible for the digital storage... 9 Radiological clinical act and medicolegal aspects: professional responsibility, report, and informed consent... 9 Requesting physician and/or present during the execution of the exam... 9 Radiology technician... 9 Radiologist Conclusions Bibliograhy Appendix A - Correct organization flow chart Appendix B - Technological requirements Appendix C - Quality controls Appendix D - Diagram of informed consent for exam execution and its transmission to remote Appendix E - Example of a request form for remote service in remote Appendix F - Items of expenditure Appendix G - Entry requirements for the organization of teleradiology Appendix H - Document for radiological skills identification iii

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9 ACRONYMS BIT in computer science and information theory, the word bit has two very different meanings depending on the context in which it is used, and respectively: a bit is the unit of information measurement (from the English binary unit), defined as the minimum amount of information used to distinguish between two possible alternatives with the same probability. This bit concept was introduced by the Claude Shannon information theory in 1948 and is used in the field of data compression and digital transmissions; the term bit indicates a binary digit, (in English binary digit ) i.e. one of the two symbols of the binary number system, classically called zero (0) and one (1). CDN Content Delivery Network CR Computed Radiography CT Computed Tomography GD General Director DI Diagnostic Imaging DICOM Digital Imaging and Communications in Medicine DoS Denial of Service DR Digital Radiography DSL Digital Subscriber Line HIS Hospital Information System IHE Integrating the Healthcare Enterprise ISDN Integrated Services Digital Network PACS Picture Archiving and Communication System PC Personal Computer PIXEL Picture Element: the smallest piece of information in an image ED Emergency Department RIS Radiology Information System RIS-PACS Integration of a RIS with a PACS RT Radiology Technician OU Operating Unit VPN Virtual Private Network WAN Wireless Access Network v

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11 PRESENTATION OF THE ENGLISH VERSION Teleradiology the ability to obtain images in one location, transmit them over a distance, and view them remotely for diagnostic or consultative purposes has been explored for nearly 50 years and is part of the more encompassing concept of telemedicine, i.e. the delivery of health care services over a distance (1-2). Teleradiology is one of the most established and most widely used forms of a larger entity called telemedicine (3-6). In a narrow definition, teleradiology has been defined as obtaining a specialist opinion by transmission of digital x-ray images to a radiologist elsewhere (often in a tertiary centre) (7). A wider definition by the Canadian Association of Radiologists in 2008 (8) says that teleradiology is the electronic transmission of diagnostic imaging studies from one location to another for the purposes of interpretation and/or consultation. This definition covers both interfacility PACS networks as well as remote teleradiology. American College of Radiology definition in 2002 (9) adds educational aspects by saying that teleradiology may allow even more timely interpretation of radiological images and give greater access to secondary consultations and improved continuing education; images may be viewed simultaneously by users in different locations. According to American College of Radiology, when appropriately utilized, teleradiology can improve access to high-quality radiological interpretations and thus significantly improve patient care. A suitable for most purposes definition is the following: teleradiology is the ability to obtain images in one location, transmit them over a distance, and view them remotely for diagnostic or consultative purposes (1-2). According to the European Society of Radiology, teleradiology is the electronic transmission of radiographic images from one geographic location to another for the purposes of interpretation and consultation (10). The following encyclopedic definitions are the most usual ones: teleradiology concerned with the transmission of digitized medical images (as X-rays, CT scans, and sonograms) over electronic networks and with the interpretation of the transmitted images for diagnostic purposes (11); radiology done through remote transmission and viewing of images (12); radiology through remote transmission and viewing of images (13); imaging a format for delivering imaging services by transmitting digitalized images from angiography, CT, MRI, PET scanning, ultrasonography, and other imaging devices by satellite or telephone cabling to radiologists who may be located at a distance from the imaging site; conducting radiology image exchange and/or image interpretations electronically, usually via videoconferencing or messaging (14); the interpretation of digitized diagnostic radiologic images transmitted by modem over telephone lines (15); the interpretation of digitized diagnostic images transmitted over telephone lines (16). Prior to 1990, telemedicine applications, including teleradiology, were relatively unimportant and largely ignored by state practice of medicine statutes or professional societies (1-2). In 1994, the American College of Radiology published the ACR Standard for Teleradiology (17). In this technical standard, the American College of Radiology stated that physicians providing official interpretations with teleradiology methods should maintain licensure at both the initiating and receiving sites and should hold staff credentials if a hospital was the originating site of an examination. Before the introduction of the teleradiology, radiologists were protected in their practice sinecures by a variety of barriers to competition and vii

12 had wide latitude to look at life according to their own viewpoints and self-interests. To their credit, most radiologists have not taken inappropriate advantage of this protected situation and have practiced at a high level of integrity and quality. Nonetheless, teleradiology is eclipsing the protected state of the radiology practice and replacing it with a new less-protected practice environment in which the unmet needs and expectations of patients, referring physicians, and hospitals in terms of better quality and service can now be readily addressed through choice among radiology providers. It is likely that major consolidation in the practice of radiology will be fostered by means of teleradiology to achieve benefits of scale, provide more timely service, provide access to subspecialist clinical expertise, and better match supply with demand. Radiologists can be the initiators of this consolidation and realize many important benefits for themselves, including the preservation of their practices. The increasing use of advanced imaging methods, the consolidation of hospitals into regional delivery systems, and heightened expectations of patients and referring physicians for timely service have fostered the increasing use of teleradiology. These aspects (1-2) have also helped underwrite the creation of new models of care that cannot be ignored. It is likely that the application of teleradiology to routine practice will now rapidly increase since it affords a means of more efficiently matching the supply of radiologists with demand for their services than can be achieved through the distribution of radiologists on the basis of their physical presence in different practice locations. Teleradiology offers the promise to improve quality of care and quality of service to patients and referring providers while simultaneously improving the efficiency of the health care system and the productivity and quality of work life of radiologists. The correct use of teleradiology offers thus the opportunity to simultaneously improve medical care delivery and improve the quality of work life for radiologists. Furthermore teleradiology can also improve both the efficiency, efficacy and productivity of the Health Care process. One direction that appears to offer major opportunity is that of radiologists using teleradiology to support each other in their practices and even create new connection and practice models over the Networks using the advances of the Information and Communication Technologies and collaborating with all of the actors involved in teleradiology. A basic issue is thus to support the working in quality in the heterogeneous process of care using teleradiology. These guidelines for quality assurance in teleradiology were elaborated in the framework of the activities on quality assurance in diagnostic and interventional radiology of the Istituto Superiore di Sanità (ISS) and of the Istituto Superiore per la Prevenzione e Sicurezza del Lavoro. In 2010 they published in Italian the report Linee guida per l assicurazione di qualità in teleradiologia (Rapporti ISTISAN 10/44) (18). In the document criteria for the application of teleradiology are discussed together with their clinical and quality control aspects. In the annexes organizations schemes, as well as technological aspects and elements of costs, are described. As the content is still valid and current, it has been translated into English to improve and enlarge its dissemination. This version contains also few passages smoothed and revisited in the language to better adhere to the objective. The Società Italiana di Radiologia Medica (SIRM) and the ISS have edited this work. References 1. Thrall JH. Teleradiology. Part I. History and clinical applications. Radiology 2007;243(3): Thrall JH. Teleradiology. Part II. Limitations, risks, and opportunities. Radiology 2007;244(2): Reponen J. Teleradiology changing radiological service processes from local to regional, international and mobile environment. Oulu, Finland: University of Oulu, (Acta Univ. Oul. D 1077). 4. Wootton R. Telemedicine: a cautious welcome. BMJ 1996;313(7069): viii

13 5. Roine R, Ohinmaa A, Hailey D. Assessing telemedicine: a systematic review of the literature. CMAJ 2001;165(6): Ruotsalainen P. Privacy and security in teleradiology. Eur J Radiol 2010;73(1): Wootton R. Recent advances: Telemedicine. BMJ 2001;323(7312): Canadian Association of Radiologists. CAR Standards for teleradiology. Ottawa: Canadian Association of Radiologists; American College of Radiology. ACR Standard for Teleradiology. Reston VA: ACR; Teleradiology. In: Merrian-Webster Medical Dictionary online. Available from last visited 30/9/ Teleradiology. In: Mosby s medical dictionary, 8th edition. Philadelphia PA: Elsevier; European Society of Radiology. Teleradiology in the European Union - White Paper VII. Vienna: ESR; Available from: Telerad_Summary_Web.pdf; last visited 4/8/ Teleradiology. In: Miller-Keane encyclopedia and dictionary of medicine, nursing, and allied health. Seventh edition. Philadelphia PA: Saunders, Elsevier; Teleradiology. In: McGraw-Hill concise dictionary of modern medicine. New-York: The McGraw- Hill Companies Inc.; Teleradiology. In: Farlex Partner Medical Dictionary. Huntingdon Valley, PA: Farlex; Teleradiology. In: Medical dictionary for the health professions and nursing Huntingdon Valley, PA: Farlex; American College of Radiology. ACR standard for teleradiology. Reston VA: ACR; Gruppo di Studio per l Assicurazione di Qualità in Radiologia Diagnostica ed Interventistica (Ed.). Linee guida per l assicurazione di qualità in teleradiologia. Roma: Istituto Superiore di Sanità; (Rapporti ISTISAN 10/44). ix

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15 INTRODUCTION Technological advances, the expansion of digital imaging systems, the ability to transmit and view remotely in a relatively short time a large number of images without significant degradation, have opened new perspectives for the application of of teleradiology. However, while the use of teleradiology offers new perspectives, on the other hand, we are faced with new problems, related to the method and its application, which necessarily must be addressed and resolved to preserve the quality criteria of the medical radiological activity. Teleradiology must not only be considered as a simple electronic transmission of images in different locations, from where they are produced, but in order to assure the right dignity to clinical diagnosis, it should keep intact the quality criteria of diagnostic radiology and accomplish the standard principles of medical radiology. Therefore, it is necessary to define the different areas of application and to establish specific requirements for its successful implementation in order to prevent an indiscriminate and consequently dangerous use for population, instead of having a good potential resource. Teleradiology, in its various applications, makes part of the telemedicine organization, and has to be considered as an innovative element in the rational planning of the Units of Diagnostic Imaging, in order to optimize the response to local needs. Therefore its use, established exclusively to ensure the diagnosis and treatment, can be justified only by the state of health of the patient in the particular circumstances of time and place. The use of teleradiology cannot justify the failure to purchase or the denial of the renewal of diagnostic imaging equipment or the lack of recruitment of radiologists needed to make functional the work equipment, according to the standard requirements for the accreditation of health facilities. Therefore, the use of teleradiology cannot be applied in the outpatient radiological activity (public and private), which must necessarily have a responsible radiologist on-site. Teleradiology should also not justify the purchase and installation of equipment in health facilities where there is not an Operational Unit (OU) of Diagnostic Imaging (DI). The use of teleradiology must be exercised in compliance with rules and principles necessary to maintain its proper use and must be designed taking into account the needs of global quality, both technical and medical. Its aim should not be to optimize costs versus benefits but ensure the accessibility to the diagnostic imaging and to the correct diagnosis throughout the country. The use of teleradiology requires a rigorous organization under the responsibility of radiologists, based on strict rules, known by all operators and formalized by protocols, drowned up by the radiologist and experts belonging to the health system and the involved structure. Teleradiology should be submitted to assessments and agreements of the parties. The parties must commit to implementing it according to the instruction of guidelines, and must follow training and refresher courses. Teleradiology must have adequate financial resources to enable the proper implementation of all processes and medical work overall (implementation, interpretation, evaluation) whenever it is made. This guide intends to provide, not only to radiologists and technicians but also to other health practitioners involved, the elements of information and method for organizing the teleradiology, respecting the needs of medical ethics, patient safety, including informed consent, even with regard to radiation protection, privacy and quality. 1

16 DEFINITION Teleradiology is a medical procedure that may take place in different situations and it comprises in its field: distance learning, teleconference, teledistribution, teleconsultation, teleconsultancy and remote management. Teleconsultation, teleconsultancy and remote management are the tools aimed at the implementation of the radiological medical act, for clinical-diagnostic purpose, that uses the technology for remote transmission of images as well as the interaction between multiple professionals, dealing with each other. Distance learning and teleconference The term distance learning is a neologism used to denote any form of distance-teaching through telecommunications systems. The teleconference allows the exchange and distribution of medical data between multi-disciplinary team, and also between two or more structures. The patient residence data must be managed anonymously. Teledistribution Teledistribution allows the sending or the availability of diagnostic imaging exams to the patient or physician authorized by the patient, including the iconography and the report, that must be made available simultaneously to form a single document. Its use is justified in order to reduce the number of reproductions of the examinations of non-digital media (films), to rationalize the movement of people and to facilitate the supply of the report together with the images. Teleconsultation and teleconsultancy Teleconsultation is the collegial activities among multiple medical doctors who communicate with each other via computerized/telematics networks in order to establish the diagnosis and therapy planning. Teleconsultancy is a professional service request to the radiologist on a performed radiological medical procedure for a second opinion. It is formalized by a written report signed by the consultant. Teleconsultation and teleconsultancy can be classified as follow: according to the time depending on whether or not the two operating centres can share the image in real-time: - synchronous (interactive) - asynchronous (not interactive); according to the mode: - between two individuals - between two teams, even interdisciplinary. 2

17 They may be required by: the radiologist to another radiologist specialized in a specific field (e.g. neuroradiologist). This modality allows the radiologist located in decentralized locations, conducting the radiological exam, to use the specific experience of a consultant radiologist in selecting and conducting the examination, which is more suited to the clinical situation and to have a second reading of the images to clarify and/or confirm the diagnosis, in order to optimize the management of patient care. The interactive-synchronous tele-consultation between two radiologists is formalized in the written opinion validated by the signature of the consultant and the final report (digitally signed) of the radiologist asking the consultancy. other discipline specialist or general practitioner to a consultant radiologist about a radiological exam, for a second opinion; the second opinion has to be concluded by a written report signed digitally by the consultant. Teleconsultation, allowing the use of special expertise in some areas, can be considered the optimal application of teleradiology. It can compensate the inhomogeneous spatial distribution of resources and skills necessary to achieve the excellence. Remote management of diagnostic imaging Remote management of DI exams is the management of a radiological diagnostic examination by a radiologist, distant from the place of the examination, who collaborates with the referring physician (formal relationship between the two doctors) and technician present on the site of the exam, communicating in real time, by telephone and/or devices using informatics. The remote management is completed by the remote diagnosis, which is formalized by the report digitally signed by the radiologist. The remote diagnosis represents the last phase of the radiological medical act and the clinical diagnosis is made on radiological images from remote locations intra-or extra hospital site. The remote radiological diagnosis, pending a legislation enactment on the subject, must be specifically justified and should be performed only if the following safety and quality criteria have been met for: a) privacy; b) assurance that the images received are related to the patient for whom the examination is requested; c) consciousness to use established protocols for the execution of the exam; d) consciousness of having the equipment that allows the visualization techniques used without loss of image quality; e) full and formalized clinical-history information about the indication and consensus on the examination, the patient s clinical status, the diagnostic problem; f) easy and immediate communication with the centre that has carried out the examination. To this end, prior to the clinical use, it must be performed a proficiency test of the equipment on a regular basis and after any major maintenance or any upgrade of both software and hardware according to quality criteria. Furthermore, respecting the quality of clinical flow, the medical doctor asking the examination must inform the radiologist on the clinical development of the patient also about the diagnosis or about the formulated diagnostic hypothesis. The remote management can be performed for diagnostic imaging examinations that do not require the administration of 3

18 contrast medium trough a vascular or intracavitary access. It is mandatory that the remote management organization has a RIS-PACS (Radiology Information System Picture Archiving and Communication System) system (networked or with a single server) also for the availability of images of previous radiological examinations to the specialist doctor. 4

19 SCOPE AND CRITERIA FOR APPLICATION OF DIAGNOSTIC IMAGING EXAM REMOTE MANAGEMENT The remote management can be applied to different levels: a) within the department of radiology in the same hospital; b) among different radiological departments of the same hospital; c) in the screening programmes among different hospitals, in the case of the activity of first reader and or second reader based on a method of a double-blind reading, such as in screening; d) in research areas. To clarify the organizational context it should be noted that the remote control can be justified: a) in procedures within the same hospital when the activities of Operative Units of Radiology are located in different places, it is possible that the organization provides that part of the activity is carried out, in part of the day, in one of these locations by one or more RTs. The RT receives a formal delegation and the advice to execute some types of examinations from the radiologist, according to the procedures established by the remote management of DI for the information and justification policies. For the purposes of distance-reporting it is highly desirable that the organization has a RIS-PACS system, so that the radiologist that has to prepare the reports can also freely dispose of the entire iconographic documentation, recent or past, of the various patients. b) in procedures among different departments of the same hospital in the case of emergency/ non differential urgency when a local hospital unit cannot provide, temporarily and occasionally, the presence of a radiologist, it is possible to predict that the images are sent for immediate reporting to a radiologist sited in another corporate unit. It is clear that the radiological diagnosis of urgent delayed/emergency allows timely targeted and effective decisions, with significant and often decisive impact for the choice of the most appropriate treatment planning. The requirement that investigations with administration of intravascular or intracavitary contrast medium must be conducted by the radiologist physically present does not change. c) in procedures among different hospitals the only reasonable procedure at the moment seems to be the related to the activity of first reader in screening programs that provide a double-blind method of reading. Other uses of the remote management of DI are not justified, in particular the activity of remote and outsourced diagnosis in private professional activity, being limited to the reporting activity. According to the medical radiological act criteria, the laws in force and the provisions adopted by the National Committee for Bioethics (at the plenary session of 21 April 2006), which expressly states that the diagnosis should be done by the physician that visits physically the patient, telemedicine involves only the consultation of qualified professionals operators when necessary. See Appendices A and B. 5

20 QUALITY CONTROL Each project in order to be accepted must pass an installation test phase attested by a written report. The quality controls on a system of teleradiology concern not only the single component parts, but also the interconnection between them; in other words all that concerns the workflow. These controls are largely already included in the standard structural controls of a PACS system. In the quality control protocols of a system for teleradiology it should be noted that these systems are, ultimately, medical devices and not just computer. A not correct diagnostic image, in fact, may be correct computationally, but beyond the computerized point of view some errors on the images are not easily found. For this purpose Quality Control (QC) should always assure that the image will remain unchanged in its diagnostic content and constant between the various display devices, from production to the reporting time and finally to the storage, because based on the content of the images, the radiologist makes his report. The logic of QC, according to the requirements in Italian Legislative Decree 26 May 2000, n. 187 (on the implementation of the Directive 97/43/ EURATOM on health protection of individuals against the dangers of ionising radiation in relation to medical exposure) for medical equipment for diagnostic imaging, will include an acceptance test and periodic state and constancy tests. Quality control is an essential element for the optimization of radiological medical procedures, causing a direct impact on costs, risks and benefits. This is why every time relevant parts, additions of patches, new software releases, updates management program or other significant elements, will be replaced in the system, it will necessary to run a new quality control, certifying the reliability, the accuracy and the quality of the transmitted data. See Appendix C. 6