Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

January 2021

CAP Loses CLIA Accreditation Clients to Joint Commission

This is an excerpt of a 1,790-word article in the January 19, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College …

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2021 Opens with a Major Story … and It’s Not COVID!

On the pages that follow, you will learn about a major story in the clinical laboratory industry that has gone unreported and publicly unremarked by the lab profession at large. This story is how three large health systems that own 372 hospitals have switched to a different CLIA (Clinical Laboratory Improvement Amendments) accreditation organization over …

2021 Opens with a Major Story … and It’s Not COVID! Read More »

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CAP Loses Accreditation Clients to Joint Commission

CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hundreds of hospital laboratories. Such a shift in the market for CLIA accreditation …

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Why Are Health Systems Changing CLIA Accreditors?

CEO SUMMARY: It is uncommon for a major health system to switch its CLIA lab accreditation business from one accrediting body to another. Yet, just in the past 18 months, that decision was made by the Veterans Administration, Ascension Health, and Providence Health. This is an important development for the entire clinical laboratory profession, because …

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Understanding Differences Between 2 CLIA Accreditors

MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation requirements of the federal Clinical Laboratory Improvement Amendment (CLIA) statute. Such a movement of …

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Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance

“We believe the ability to work with just two drops of blood, plus the fast time-to-results and the reduction in operator overhead provided by our FDA-cleared moderate-complexity analyzer, will be highly attractive to providers.” —Yossi Pollak, CEO, Sight Diagnostics, Ltd. CEO SUMMARY: For 70 years, the Coulter Principle has been a bedrock technology in hematology. …

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Digital Pathology Launched in the ‘Era of COVID-19’

CEO SUMMARY: Is it smart to initiate digital pathology (DP) systems and whole-slide imaging just as a novel coronavirus upends healthcare and society at large? That was the question asked at Poplar Healthcare, a pathology lab in Memphis. Senior management proceeded with the implementation, despite the uncertainty that accompanied the SARS-CoV-2 pandemic. Nine months later, …

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January 19, 2021 Intelligence: Late-Breaking Lab News

Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 molecular tests, 68 antibody tests, and …

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