Digital Pathology in the United States during a Pandemic Highlights from Covid-19 and the Rise of Digital Pathology Webinar
The COVID-19 pandemic wreaked havoc worldwide, and many pathologists experienced a dramatic fall in case volume due to the reduction of surgical and endoscopic procedures.1
Recognizing the urgency created by the COVID-19 pandemic, on March 26, 2020, the Centers for Medicare & Medicaid Services (CMS) exercised an enforcement discretion to allow pathologists to review slides and sign out remotely. This discretion temporarily waived the requirement for remote locations to have separate CLIA licenses, provided that the designated primary site or primary laboratory has a Clinical Laboratory Improvement Amendments (CLIA) certificate.2
A few days later, the FDA also issued a guidance document. This policy expanded the availability of remote review and reporting devices using scanned digital images of pathology slides during the pandemic by allowing non-FDA cleared digital pathology systems for primary diagnosis. The FDA emphasized that these systems must be validated (even if validated in the hospital, the system must go through some form of validation to ensure it will perform in a remote location).3 Many pathologists can now safely sign out digital or glass slides from outlying areas such as a home office.4
The Digital Pathology Journey for Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center is a cancer treatment and research institution in New York City and a big proponent of digital pathology. Over a decade ago, the first whole slide scanner came to the laboratory during the implementation of barcoding, tracking, and laboratory information system integration. Dr. Matthew Hanna is the Director of Digital Pathology informatics at Memorial Sloan Kettering Cancer Center (MSKCC) and led the charge during the COVID19 pandemic. He explains, "The novel coronavirus impacted the world in unprecedented ways; however, it has shown how valuable digital pathology can be in the present state and very likely in the future."
Social Distancing Challenges in the MSKCC Laboratory during the Pandemic
While outpatient visits across the country dropped during the initial COVID-19 pandemic, there was a short-lived decline in volume for a few months; the MSKCC laboratory continued operating at a relatively regular cadence. Memorial Sloan Kettering had to adapt and quickly pivot to increase digital pathology operations and develop a new digital workflow to help support and protect their pathologists and provide continuous patient care. Since the pandemic started, the center has maintained scanning with over 100,000 slides/month in 2020 while continuously increasing volume.
The discussion of new workflows during COVID-19 required involving all stakeholders across the department and the institution, specifically, hospital and departmental leadership, pathology informatics groups, faculty and trainees, histology laboratory staff, and the digital scanning team. It was indeed an all-hands-on-deck approach to quickly transform the daily workflows. All of this, of course, occurred while maintaining social distancing. However, not everyone could work remotely. Laboratory staff and digital scanning team shifts were staggered to accommodate onsite work and minimize exposure to various teams. Some staff is still required to be in the laboratory to process the specimens, generate the glass slides and scan them.
The social distancing mandate also impacted other resources, such as space. With over 40 trainees, there was an impact on desk space and relocation of fellows across open areas in the department, such as sign-out rooms, to ensure social distancing requirements. Educational activities (fellowship training, daily didactic, conference meetings, digital sign-outs, feedback to trainees, and validation of frozen section telepathology) essentially went entirely online.
Before undertaking the digital pathology transformation for clinical and surgical pathology for primary diagnosis at a remote site, the department completed remote validation. This validation had three aims:
- Analyze the operational workflow from the point of specimen accession to clinical sign-out in reporting using digital pathology
- Evaluate if pathologists had adequate remote access performance while at a remote site when reviewing their clinical cases, and
- Technical evaluation of the digital pathology system, as implemented clinically.
This remote validation study during COVID-19 appeared in Modern Pathology June 2020, https://www.nature.com/articles/s41379-020-0601-5.5 Validation showed remote digital sign-out is feasible and safe for patients seeking care during this time. As a result of the study and provisional approval from the New York State Department of Health, the MSK pathologists commenced remote digital pathology review.
Program Enhancement Opportunities
Once remote review and sign-out were in place, the team evaluated volumes and staffing to maintain the glass slide digital scanning operations. They also assessed turnaround times, finding no delay even with the added step of scanning the glass slides before distribution by scanning the slides during downtime when the biopsies would have been awaiting review overnight. Other enhancements to the program included:
- Development of a work from home task force - to take a deep dive and review technical as well as cultural changes that will need to take place to support a work from home environment
- Creation of a calendar schedule - to scan various subspecialties each day and allow pathologists the option for digital and remote review on a given day to support the different surgical pathology specialties and the current volume
- Implementation of a digital education portal - to be used to develop educational materials, conferences, and sharing of de-identified cases
- Agreement to develop a global consultation portal - to provide digital consultation services, especially during these times for those labs worldwide who have digital means and can submit digital pathology slides to the institution for review
- Participation in the collection of real-world data - to influence regulations pertaining to clearance of digital pathology systems and, more importantly, will prove the safety and efficacy of these technologies for patient care and provide a novel care delivery model for pathologists to leverage in their clinical practice
- Expansion plan - to digital cytology solutions and other cellular specimen materials
Dr. Hanna states, "From our experience at Memorial Sloan Kettering, I have no doubt digital pathology will become a new standard of care to support our pathologists and continue to provide high-quality care for our patients."
Dr. Glassy explains that "Digital pathology has undoubtedly proved its worth during the pandemic but cautions pathologists that working in a remote location should not mean disengaging. The pathologist should be as visible as possible by reaching out to the medical staff, administration, and other health care team members, as needed, actively engaging when attending virtual meetings, and being an actual participant on the patient care team."
Want to hear more about the adoption of Digital Pathology from Dr. Glassy and Dr. Hanna?
Watch the webinar COVID-19 and the Rise of Digital Pathology to learn more https://www.leicabiosystems.com/resources/covid-19-and-the-rise-of-digital-pathology/.
- Bracey T, Arif S, Ralte AM, Shaaban AM, Ganesan R. Histopathology during the COVID-19 pandemic: resilience through adaptation and innovation. Diagnostic Histopathology. Published online December 2020. doi:10.1016/j.mpdhp.2020.12.003
- Remote Sign-out FAQs. Accessed January 4, 2022. https://documents.cap.org/documents/Remote-Sign-Out-FAQs-FINAL.pdf
- Health C for D and R. Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. U.S. Food and Drug Administration. Published April 24, 2020. Accessed January 4, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-remote-digital-pathology-devices-during-coronavirus-disease-2019-covid-19-public
- Search. College of American Pathologists. https://www.cap.org/search?q=Remote-Sign-Out-FAQs-FINAL.pdf
- Hanna MG, Reuter VE, Ardon O, et al. Validation of a digital pathology system including remote review during the COVID-19 pandemic. Modern Pathology. 2020;33(11):2115-2127. doi:10.1038/s41379-020-0601-5
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