Realizing the promise of digital pathology

Shortly after COVID-19 was declared a national emergency in the U.S., the Centers for Medicare & Medicaid Services (CMS) issued a memorandum on March 26, 2020, waiving the pre-pandemic requirement for remote sites to have a CLIA certificate when reviewing histopathology slides for primary diagno...

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Bibliographic Details
Published inMLO. Medical laboratory observer Vol. 53; no. 11; pp. 24 - 26
Main Author McClintock, David
Format Magazine Article Trade Publication Article
LanguageEnglish
Published Nashville Endeavor Business Media 01.11.2021
Subjects
Algorithms
Artificial intelligence
Automation
Biomedical laboratories
Clinical pathology
Company business management
Coronaviruses
COVID-19
Decision making
Digitization
Efficiency
Government regulation
Immunohistochemistry
Laws, regulations and rules
Management
Medical laboratories
Methods
Pandemics
Pathology
Scanners
Software
Technology application
United States
United States > US
Online AccessGet full text
ISSN0580-7247

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Summary:Shortly after COVID-19 was declared a national emergency in the U.S., the Centers for Medicare & Medicaid Services (CMS) issued a memorandum on March 26, 2020, waiving the pre-pandemic requirement for remote sites to have a CLIA certificate when reviewing histopathology slides for primary diagnosis.1 The U.S. Food and Drug Administration (FDA) soon followed on April 24, 2020, with a guidance document relaxing enforcement policies that effectively allowed the interim use of digital pathology devices intended for"reviewing and reporting of digital pathology slides from remote locations"without a premarket notification submission.2 The guidance covered automated digital image microscopes, whole slide imaging (WSI) systems, image viewing and management software, and digital pathology displays - typically used in healthcare facilities, but also key components for reviewing and reporting of digital pathology slides from remote settings. [...]automated slide imaging can translate into faster, more accurate results and expedited clinical decision-making, resulting in better patient care. [...]WSI technology comprises not just the slide scanner, but also the software applications and server hardware to manage and display images, and in some cases, algorithms to assist the pathologist or technologist with image interpretation. At this early stage, it is also important to determine where you will incorporate slide scanning into the laboratory workflow: before microscopic analysis, after sign-out but before archiving, on demand after archiving, or maybe a combination of these options?
ISSN:0580-7247