Canadian Licensure for the Use of Digital Pathology for Routine Diagnoses: One More Step Toward a New Era of Pathology Practice Without Borders

Abstract

On April 22, 2013, GE Healthcare (Mississauga, Ontario, Canada) announced that the Omnyx Integrated Digital Pathology system, developed jointly with the University of Pittsburgh Medical Center (Omnyx LLC, Pittsburgh, Pennsylvania), had obtained a Health Canada Class II Medical Device License for creating, managing, storing, annotating, measuring, and viewing digital whole-slide images for routine pathology use. On May 9, a similar clearance was announced by Leica Biosystems (Vista, California). The University Health Network (UHN) Laboratory Medicine Program (Toronto, Ontario, Canada), one of the largest diagnostic labs in Canada, is one of several beta and clinical test sites for the Omnyx Integrated Digital Pathology system, generated the data that led to the Health Canada licensure, and has used Aperio ePathology (Vista, California) solutions since 2006.These announcements are major breakthroughs in terms of helping to promote wider adoption of whole-slide imaging (WSI) telepathology for diagnostic purposes. Although in Canada the decision of using WSI for diagnostic purposes is mainly the responsibility of pathologists, who must make sure they have appropriate assistance in case of medicolegal difficulties, such a decision by a national certification agency confirms that this technology can be used safely for routine diagnostic work. It also emphasizes Canada's role as a world leader in the implementation of digital pathology to improve the quality of care. The College of American Pathologists (CAP) also recently released a guideline on validating WSI for diagnostic purposes, representing another important step in preparing the broader pathology community to adopt digital imaging technology.1 In the United States, the Food and Drug Administration currently has not granted approval to any digital pathology vendor to market WSI systems for primary diagnosis. It remains to be seen whether Health Canada licensure, along with the growing use of WSI systems for diagnostic purposes in Canada and other countries, will have any impact on the time course of the approval process at the Food and Drug Administration.Digital pathology has been successfully implemented around the world for education, clinical pathologic conferences, and research. Its adoption for diagnostic purposes is increasing but has been primarily limited to specific, generally low-volume niches, such as second opinions and frozen sections. Its use for primary diagnoses on a routine clinical basis remains limited to a few experiences, particularly in European countries.There are several strong arguments in favor of using WSI for primary diagnosis. With this technology, pathologists have access to high-resolution digital images that can be viewed over a full range of magnification as per light microscopy. Diagnostic-quality images can be expected so long as good-quality histologic sections are placed in the slide scanners. These images can be annotated, stored for future use, and repeatedly viewed by multiple users independent of their location in a digital pathology network. Experiences from abroad demonstrate an overall diagnostic accuracy comparable with that of conventional microscopy.1,2 Based on the literature and our personal experience, the main advantages of WSI include: the ability to work anywhere and anytime; enhanced access to expert opinions from subspecialist colleagues; and the ability to collect multiple opinions simultaneously and obtain more precise measurements on parameters such as lesion size, extent of invasion, and distance from resection margins through the use of digital analysis tools. Furthermore, in situations where pathologists are separated from glass slides by great distances, digital pathology enables improved turnaround times; up-front case prioritization; improved collaboration between pathologists, surgeons, and laboratory technologists; equitable workload distribution; reduced isolation for pathologists working in remote regions; and enhanced access for education and quality assurance activities. For the health care system and the patient, it favors increased efficiencies, reduced transportation-related loss or damage to slides, reduced costs for pathologist travel and/or specimen transportation, diminished interruption of service due to the unavailability of pathologists, decreased patient transfers and 2-step surgeries, and enhanced recruitment and retention of local surgeons and/or pathologists in remote regions. In short, digital pathology facilitates improved quality and continuity of care.The Health Canada licensure announcement and the release of the CAP validation guideline address 2 previously identified barriers to greater adoption of digital pathology, namely, a lack of regulatory approval and a lack of standards or guidelines on how to implement the technology for diagnostic work. Several major issues, technologic and human, nonetheless remain to be addressed before widespread use of digital pathology in daily practice becomes a reality. Digital pathology has not yet reached the same level of maturity as that of digital radiology. Specific challenges that have been repeatedly identified include: image archiving and retrieval, scanner throughput, and the speed of user interfaces that many feel are inadequate to support pathology workflow in a high-volume practice environment. Further, most commercially available digital pathology solutions do not offer streamlined integration with local laboratory information systems, making their use seem laborious in high-volume situations. The inability to efficiently carry out real-time multiplanar focus adjustments to accommodate for variations in tissue thickness, especially for cytology slides, represents another technologic challenge for WSI systems. However, WSI technology is rapidly evolving, and it is expected that these technical limitations will be overcome.2Both the inertia associated with changing from light microscopy and the acceptance of digital technology as a reliable diagnostic modality by pathologists are among the biggest human factors to be addressed. Well-executed validation studies, such as those performed by Bauer and colleagues,3 showing that diagnostic review by WSI is not inferior to microscope slide review are crucial in this regard. A highly coordinated effort between teams working in different sites is required if a telepathology network based on WSI is to be successful. Pathologists and surgeons as well as pathologists and laboratory staff working at different sites must learn to work together during and after implementation. It has been our experience that strong medical leadership, effective management of expectations concerning the deployment process, dedicated and experienced biomedical and information technology teams, and frequent communication between all participants are the keys to successful implementation of a telepathology network.4 Furthermore, a coordinating center capable of providing training, technical, and logistic support to the different institutions is also of utmost importance. Finally, legal, jurisdictional/licensure, and credentialing issues as well as reimbursement issues must be addressed early in the process.Canada has been a world leader in the adoption of telepathology thanks to the initiative of a few leading pathologists and the financial support of provincial governments and Canada Health Infoway, a federal telehealth funding agency. The large geographic size of the country, its relatively small population, its extreme disparities in population density, and its shortage of anatomic pathologists are major elements driving the adoption of telepathology in Canada.5 The pioneering experience of the UHN in Toronto has demonstrated since 2004 the feasibility and advantages of using virtual microscopy to cover intraoperative consultations between 2 hospitals separated by 1 mile.6 The UHN has since expanded its telepathology program to provide both subspecialty support for its transplant pathology programs and subspecialty services to several other hospitals, including a cluster of hospitals in northeastern Ontario. In addition, the UHN provides consultation services to pathologists in Kuwait. The Eastern Quebec Telepathology Network was designed to provide intraoperative consultations and second opinions to smaller community hospitals in a huge territory in the province of Québec. The network involves 21 sites, of which 6 are devoid of a pathology laboratory, 4 have no pathologist, and 4 have only 1 pathologist on site.4 The province of Newfoundland and Labrador is also implementing a provincial telepathology solution and expects to connect with pathology services in the province of Manitoba and the UHN in Toronto. Finally, the province of British Columbia has developed expertise in standards and is using digital microscopy for consultations, education, and quality assurance, and the Eastern Ontario Regional Laboratory Association in Ottawa, Ontario, is also implementing a 17-hospital network. In September 2012, the Canadian Association of Pathologists approved a collaborative document prepared by Canadian pathologists entitled, “Guidelines for Establishing a Telepathology Service for Anatomic Pathology Using Whole Slide Imaging.”7An exciting and realistic target during the next few years will be the development of a pan-Canadian telepathology network, resulting in something resembling a nationwide virtual pathology department. A recent survey in Canada demonstrated a significant interest in digital pathology and telepathology among Canadian anatomic pathologists, residents, and fellows.5In conclusion, the announcement of Health Canada licensure for GE Healthcare and Leica Biosystems is a major step toward the wider adoption of digital technology in the daily practice of pathologists. Our view, which is also shared by a growing number of pathologists, is that the day when light microscopes will no longer be needed in pathology laboratories is not far off. It is the responsibility of the pathology profession to see that this transition occurs in a safe and orderly manner. As Dr Ronald S. Weinstein, a world leader in digital pathology, wrote in one of his recent publications2: “Twenty-five years from now, the initiation of the creation of telepathology diagnostic networks. . .may be recognized as having been transformative for global healthcare and an enabler of the implementation of patient-centered healthcare throughout the world. Ultimately, the responsibility for the success of patient-centered healthcare will rest on the shoulders of diagnosticians, hopefully pathologists.”

Ähnliche Arbeiten