The Dark Report

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 …

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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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2020’s Top 10 Lab Stories Are Without Precedent!

CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In …

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UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy

IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day.  Inaccurate early results from a newly-launched, same-day, at-home COVID-19 lateral-flow test caused officials to …

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