Q&A with Chris Garcia, MD
Assistant Professor of Pathology
Medical College of Wisconsin
MedicalLab Management: Where do we currently stand regarding the permissible use of digital pathology technology?
Chris Garcia: Digital pathology tools have been in use in some form for several years now with numerous applications in pathology practice. In the education and research realms, digital whole slide imaging (WSI) has, in some cases, supplanted the use of microscopes for instructive purposes. In the clinical space, WSI is now openly used for frozen section interpretation without FDA restriction. It also is successfully used for digital image analysis of HER2 and ER/PR stains, for example. The use of WSI for intrapractice consultation is certainly permissible and beneficial, and it delivers substantial value to archiving. Given the nature of digital elements, these images can easily be integrated into reports and diagnosis documentation. Further, the use of telepathology and WSI for second opinion consultation has shown promise at several institutions. One area that could benefit from further investigation is leveraging WSI for quality assurance activities, which falls within current use guidelines as well.
Clinical conferences benefit from the use of digital pathology tools, particularly tumor boards or pathology education conferences, as the technology lends itself easily to presentations and interaction with other digital media.
MLM: What are the primary obstacles to greater adoption of digital pathology tools in clinical practice?
Garcia: Certainly a traditional obstacle has been the management of large digital files within a health care institution. Many laboratories have no experience working with a large-scale digital file server. That said, as clinical labs continue to join together within the larger trend of health care consolidation, the management of digital files would likely be subsumed by dedicated information technology departments well versed in such tasks. Proper storage of large digital images is no longer technically limited, but facilities looking to expand digital pathology practices must ensure the proper infrastructure is in place to both handle and manage what eventually could become massive digital storage requirements.
Another challenge is the question of how to interface information with the laboratory information system (LIS). Depending on what vendor or type of LIS is in use, there may be technological conflicts that make the sharing of information difficult if not impossible. Assuming an interface can be created, which system will manage digital images? Are all cases going to be taken from the digital pathology equipment and then into the LIS or will patient information travel from the LIS into the digital pathology system? As pathologists handle a large number of cases, requiring the use of additional new platforms is not always welcome. These are some of the current issues impacting digital pathology adoption—determining the system by which to interact with WSI and ensuring proper integration with other dependent systems in the lab.
The primary question the lab should be asking is: How do we want to use digital pathology? For many practices, it would be very difficult to transition from an entirely glass-slide-based workflow to a digital workflow. For example, there are very few scanners that can handle whole-mount slides, which can make it difficult for practices that use these in their workflow. Whole-mount slides are much larger than the majority of traditional pathology glass slides. The robotics required to scan these huge slides would need to be highly sophisticated, and the resulting file sizes would be enormous. That said, the production of whole-mount slides creates a significantly sized tissue sample, which can be highly beneficial to certain disciplines, such as prostate pathology.
Additional questions include: What areas of our pathology practice do we plan to convert to digital? How will this generate a positive return on investment? As with all health care technology, the facility must look at ROI. While there are studies pointing out the practical benefits, there is a lack of clear consensus on the financial ROI digital pathology can enable.
MLM: How is digital pathology technology currently utilized in your practice?
Garcia: At this point, the Medical College of Wisconsin primarily uses digital pathology tools for educational purposes. This use is not universal and the system itself is not highly sophisticated, but as we establish our goals for the next 5-10 years and look at our capability roadmap and the systems necessary to meet those goals, digital pathology is a significant part of the equation. At this stage, we are planning to use digital pathology tools to augment our outreach services, assist in archiving, and support intrapractice consultation.
MLM: Are the steps you are taking now in preparation for reduced regulatory restrictions on digital imaging in pathology?
Garcia: Yes, and this is part of a larger business model for the laboratory. The expansion of digital information exchange in health care is only increasing and laboratories must look at what their plans are for the next several years in terms of growth and the retention and acquisition of business. We see the adoption of digital pathology tools as essential and the approval of this technology for primary diagnosis is on the horizon. However, this issue requires a dynamic view. If you look at this simply as transition from a glass-slide workflow to a digital workflow, it is not unlike the transition from paper medical records to electronic health records (EHRs); certainly there are benefits, but the full capabilities of EHRs are far more dynamic than paper systems. The same holds true for digital pathology.
The institutions that gradually, yet purposely, incorporate digital pathology tools into their workflow will have a competitive advantage in the health care market. As a regional academic medical center, we need to determine our place in that market, and we believe the flexibility offered by digital pathology will greatly enhance the services we are able to provide to both our internal and external clients.
MLM: Should primary read and diagnosis classification be granted, what would be the best first steps facilities could take to begin adopting digital pathology tools?
Garcia: Without a doubt, the first step is to ensure to every extent possible that your lab is operating in a well-run state. Digital pathology shows great promise, but if the lab is not well run, well managed, and predictable in terms of quality and results, the lab will not reap significant benefits from this technology.
As far as the actual adoption of digital tools, the lab must become familiar with a digital workflow. Many pathology labs are still working with a largely paper-based workflow, and switching to a digital version requires more than adding hardware and software; it requires a working understanding and a full embrace of digital information systems. If the impression of your current LIS is that it is “good enough” for operations to proceed, it likely does not offer the capabilities necessary for a fully digital workflow. While many, especially larger, health care facilities already have certain digital workflows in place throughout the hospital, there seems to be a lack of a dominant, proven workflow demonstrating the full integration of digital pathology technology.
MLM: How do you see the practice of pathology changing for the better with the expanded permissible use of digital and automated systems?
Garcia: If digital tools are well planned for and well implemented, they can be a terrific benefit to pathologists and other disciplines and clinicians who rely on pathology. The potential is there for greatly facilitating case management and refining and standardizing overall pathology workflow. In addition, digital tools enable more in-depth collaboration in the form of review boards and second opinions. The technology would allow facilities to better address underserved communities and centers of excellence to grow in their capabilities and services in managing difficult cases. Ideally, digital tools can raise the bar of practice for all pathologists.
Christopher A. Garcia, MD, is an assistant professor of pathology at the Medical College of Wisconsin, where he is the director of pathology informatics. His research focuses on the digital transformation of medical diagnosis and the emergence and intersection of digital imaging, machine learning, decision support, health care delivery, and complex sociotechnical systems. Chris earned his BS in biology at Arizona State University, his MD at the University of Illinois, completed a joint residency in anatomic and clinical pathology at the University of Utah, and recently completed his fellowship at Mass General Hospital in pathology informatics. Currently, he is a fellow in the MIT Systems Design and Management Masters Degree Program with an estimated completion in 2017.