By - May 02, 2023
During the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) —at the urging of the American Society for Clinical Pathology (ASCP), the Society for Pathology Informatics, and others—temporarily allowed pathologists and laboratory professionals to read slides remotely without requiring a separate Clinical Laboratory Improvement Amendments (CLIA) certificate.
ASCP would like that to be permanent. The Society recently sent CMS a letter with that request and received a response from CLIA stating that it has no intention of changing this policy. However, CMS indicated it is reviewing the matter.
Prior to the new CMS policy allowing pathologists and laboratory professionals to perform remote reads, pathologists needed a separate CLIA certificate for the site at which they would perform them. And because the Food and Drug Administration (FDA) also has certain requirements about signing out slides remotely, such as specific requirements for the computer monitor, a secure telecommunications line, and other requirements that comply with the Health Insurance Portability and Accountability Act (HIPAA), this generally meant that remote reviews would occur in a specific location, such as an office or home location. CMS’s new policy of not requiring a separate CLIA certificate for remote review allows pathologists and laboratory personnel to review slides almost anywhere, provided it is not for the purposes of primary sign out of cases (per the FDA requirements).
“Being able to review slides remotely would be a game changer for both anatomical and clinical pathologists,” says Anil Parwani, MD, PHD, FASCP, MBA, professor of Pathology and Biomedical Informatics at The Ohio State University and chair of the Society for Pathology Informatics. “Allowing pathologists to review slides remotely would provide patients access to care services without any interruption or delay, thereby enhancing the timeliness for patients to receive a quality diagnosis.”
How might remote access reduce the interruptions? Pathologists, Dr. Parwani notes, might not have the same work schedule as a colleague who needs a second opinion on a slide interpretation. Say a pathologist subspecialist has ended their workday at the hospital at 5 p.m. and has gone home. That might cause a delay if the subspecialist is unavailable until the following morning to interpret the slide. In his practice, Dr. Parwani does provide overnight consultations.
“If you are able to read slides remotely, you can offer your assistance to help consult on a case,” Dr. Parwani says. “For example, a colleague wants you to take a quick look at a specimen to help determine if a patient has cancer. You are offering quality review on a case or providing education or providing biomarker interpretation remotely.”
“If I don’t have remote access to review slides, it would not allow the best patient care,” he explains.
ASCP Chief Officer of Medical Quality Ali Brown, MD, FASCP, concurs that allowing pathologists to review slides remotely can expand access to pathology services, particularly in rural or underserved regions. “Say I have a colleague in a small town in rural Alabama, and he’ll send me a slide to read on TEAMS,” she explains. “I am the secondary read, so for quality assurance or consultation, it is a great tool. That is an example where we are using common everyday technology. He has a camera installed on his microscope to show the slide, which I can read over his screenshare.”
However, to do the primary sign out, for example, where a pathologist’s name is on the diagnostic report, the pathologist needs to follow the FDA specifications, which includes using an FDA approved computer and monitor.
Allowing pathologists and laboratory professionals to remotely review slides could also be a boon for hospitals, even for those in nonrural areas. “Let’s say you are having a hard time finding a neuropathologist, you could potentially supplement the consultation with a remote read. There are shortages of some subspecialty pathologists,” Dr. Brown says.
Will allowing pathologists and laboratory professionals to read slides remotely on a permanent basis open Pandora’s Box to a host of new challenges? Dr. Parwani says it is important to ensure that pathologists are using this privilege in the correct way.
“It doesn’t mean a pathologist who can review slides remotely can do it whatever way they want,” he says. “But, the fact that you can do it without getting another license makes it less burdensome. You still need to follow all the regulations, such as complying with HIPAA, having the proper internet connection, signing out remotely in a secure location.”
Another challenge is that many pathologists and laboratory professionals do not understand these compliance issues. “When you sign out from home, you need to know the rules of education. How do you do it? What is the best way? The last thing we want is for a few pathologists to do it the wrong way. We need to promote safe practices,” Dr. Parwani says.
“Advocacy is important,” he adds, “It’s important to go to CMS and other places to promote this. Overall, there are compelling reasons to allow remote reading of slides as it does help to advance patient care.”
ASCP also recognizes and appreciates the essential dyad of pathologists and cytologists who care for patients. The focus of a future article will incorporate the cytologists’ role in remote review of slides, along with workflow considerations.
ASCP communications writer