.COVID-19 and the Rise of Digital Pathology

USCAP Interactive Webcast, October 21, 2020 11:00 PDT.

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A week after the declaration of a national emergency, the Centers for Medicare and Medicaid Services (CMS) temporarily lifted the CLIA license requirement for the sign-out of pathology cases at remote locations. The FDA also exercised regulatory enforcement discretion regarding how digital pathology systems could be marketed. Many pathologists took advantage of the sign-out flexibility to minimize COVID-19 exposure risks and provide timely diagnoses.

Digital pathology rose to the occasion and delivered on its promise of performing diagnoses from anywhere. But even in the face of a pandemic, it is important that digital pathology systems be properly implemented and validated. This session will review the regulatory issues around remote sign-out and then dive into the digital pathology system components and laboratory operation considerations to initiate a digital workflow.

We will also explore the clinical validation that was performed at Memorial Sloan Kettering Cancer Center that allowed pathologists to offer remote clinical reporting. Finally, we’ll emphasize the importance of actively engaging with our clinical and surgical colleagues, especially when working remotely.

 

Source: USCAP

 

 

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