Pathways to Excellence remote diagnostics permanently approved after push by nation’s pathologists

The pandemic changed the way we all accomplish things, both in personal lives and professional roles. The impact is no greater than in health care, where we have reinvented how we care for patients and keep them and ourselves safe.

The forced change has in many cases created improved procedures that may not have been realized otherwise. For pathologists, one newly approved process – long debated even prior to 2020 – has evolved and is here to stay.

No Longer Exceptional Use

Aaron R. Huber, D.O., Director of Surgical Pathology, and Christa Whitney-Miller, M.D., Vice Chair of Anatomic Pathology and Interim Department Chair, were among 76 authors from medical centers across the nation who last fall asked the U.S. Congress to permanently legalize remote diagnostics for patient care. The open letter, published in Nature Medicine, pointed to the effectiveness of remote diagnostics and asked lawmakers to extend a regulatory exemption that allowed pathologists to review and diagnose patient specimens remotely during the pandemic. The authors called for this change to be permanently written into the federal Clinical Laboratory Improvement Amendments (CLIA), which was last updated 34 years ago.

Although no one can claim the letter was the sole reason the change was granted, the voices of so many respected, experienced pathologists are thought to have certainly played a role.

“We are all pleased with the decision,” Huber said. “We expected

Continued on page 2 it eventually, of course, but the speed with which Congress acted is appreciated.”

Technology Here To Stay

Due to the need to isolate beginning in 2020 and with so many people working from home, the temporary waiver was welcome, allowing remote sign-out of pathology cases using digital pathology or glass slide review without obtaining a separate CLIA number. The exception preserved continuity of patient care, ensuring ongoing quality by involving pathologists where subspecialty review is required.

Vektra L. Casler, M.D., joined the URMC faculty in 2021, well after the initial scramble to shift all processes to accommodate the pandemic. Part of her role is to coordinate technology – and specifically whole-slide scanning – to build an infrastructure that allows for many more slides to be imaged at one time, rather than only a handful, as had been the capability until recently.

“We had low-throughput scanners scattered in various labs, which hold only 12 or so slides,” Casler said. “Our highthroughput scanner is designed to scan much more quickly and hold hundreds of slides, operating autonomously after a tech loads it. This frees up tech time and produces a much larger number of near giga-pixel-sized specimen images approved for remote review and diagnosis.”

Over the next several years, the department will begin to secure additional whole-slide scanners, Casler said. The new technology not only will be able to process the health system’s specimens, but it also will be able to eventually provide support for other institutions that will reimburse for imaging and consultation services.

More Than Clinical Implications

Surgical Pathologist Sarah K. Findeis, M.D., said the impact of remote sign-out is significant for patient care, and it goes beyond that, as well.

“Remote work provides not only more flexibility and a better work-life balance for our faculty and trainees, it also allows us to optimize our work processes so that we can provide better, more timely patient care,” Findeis said.

“COVID-19 accelerated the need for clinical remote work, and we’ve also learned from the early adopter institutions that there are wide-reaching, unexpected, positive ripple effects in the education and research fields. Discovering even more of those ripple effects would be a game-changer for the field of pathology.”

HIGH-QUALITY RESULTS, REGARDLESS

The outcomes resulting from the clinical use of the new technology and remote sign-outs during the pandemic were as pathologists nationwide had predicted: the quality of work being conducted remotely remained extremely high. Ohio State and Memorial Sloane Kettering did much of their work remotely during the pandemic, too, Huber said. MSK studied its onsite versus remote cases, confirming that location didn’t matter and neither did the device – phone, tablet, computer monitor – used for evaluation.

“We are in a digital age, no matter what,” Huber said, adding that specialists such as radiologists have for years been looking at films remotely. “For pathologists, it was the legislation that needed to catch up.”

Smoller Steps Down As Department Chair

Bruce Smoller, M.D., announced in September he was stepping down as department chair. He remains on faculty as a practicing dermatopathologist and teacher. Christa L. Whitney-Miller, M.D., vice chair of Anatomic Pathology, is serving as interim chair while a national search is conducted.

As its leader since 2014, Smoller oversaw many of Pathology’s key achievements, including the opening of a centralized lab facility offsite on Bailey Road. The 130,000-squarefoot facility consolidated the majority of testing and created consistent standards and cost-efficiency. The facility was a pivotal ingredient in the department’s rapid and progressive COVID response; as of 2022, the lab had conducted more than 1 million COVID tests.

Smoller pursued new processes to ensure the highest levels of patient care by having all results read and reviewed by subspecialists, and he developed training programs in Medical Technology, Phlebotomy and Histotechnology. He also championed academic excellence through the creation of five fellowships and expansion of residencies by 20 percent. A strong advocate for diversity and inclusion efforts, Smoller is leaving the department with a more diverse and gender-balanced leadership team.

Ihopeyour 2023 is off to a great start! This is, of course, my first Pathways to Excellence newsletter as interim chair.

First and foremost, I’d like to thank Dr. Smoller for his service. The department grew substantially under his stewardship: We consolidated services across the UR Medicine enterprise, with much of that work now going to the Central Lab at Bailey Road; the number of faculty has increased; our molecular lab is now performing panels of next-generation, sequencing-based mutational analysis for myeloid and solid tumor malignancies; the microbiology lab has performed more than 1 million COVID tests; and Anatomic Pathology has a new high-throughput whole slide scanner… to name a few clinical accomplishments.

We have increased the number of residents and our fellowship offerings; we have medical technology and phlebotomy training programs, and a histotechnology training program in the works. Our academic productivity has increased – we had 33 posters and one platform presentation at USCAP this year, along with three short courses/interactive microscopy sessions led by our faculty!

Congratulations to Archibald S. Perkins, M.D., Ph.D., who received funding from the U.S. Department of Defense; Benjamin J. Frisch, Ph.D., whose American Cancer Society Award started in January, and Rajnish Bharadwaj, M.B.B.S., Ph.D., who recently received notice of funding from the NBIADA – congratulations!

Congratulations to Xiaoyan Liao, M.D., Ph.D., as well, who was recently promoted to associate professor.

As we look to this new year, planning for the move of Anatomic Pathology to Bailey Road is underway. Their move also will be a phased one, with the Histology and Immunohistochemistry labs moving first, followed subsequently by the Gross Room and then the faculty. Recruiting for faculty and residents continues in earnest; and the search for a permanent chair has begun.

As always, many thanks to all the faculty and staff, for all you do to support the patients we touch across Upstate New York. Here’s to 2023!

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We are grateful for your continued support.

To make a tax-deductible gift to Pathology & Laboratory Medicine, visit www.pathology.urmc.edu and click "Make a Gift." You can also contact Melissa Head at (585) 273-2890 or melissa.head@rochester.edu.