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Pathologist Paul A. Brown, MD, MetPath Founder, Dies at 85
EARLIER THIS YEAR, THE PATHOLOGY PROFESSION LOST one of what some call “the two Lions of Pathology.” On January 24, 2024, Paul A. Brown, MD, aged 85, died at his home in Palm Beach, Florida. In 1967, Brown was the founder of Metropolitan Pathology Laboratory, Inc., based in Ne…
Attorney Discusses Federal Cases Involving EKRA Violations by Labs
IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does…
Is There Evidence That Some Doctors Wish to Use Local Labs?
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Feds Bar Elizabeth Holmes from Government Health Programs
ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …
23andMe Says Big Data Breach Due to Customers’ ‘Negligence’
LAST OCTOBER, ONE HIGH PROFILE COMPANY THAT DOES GENETICS TESTING acknowledged it had experienced a data breach involving thousands of its customers. Then came an unexpected turn in this data breach event. In subsequent public statements during December, 23andMe stated that the or…
Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence
THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…
CLIA Lab Directors Must Watch Delegated Duties
CEO SUMMARY: Laboratory accredito…
Machine Learning Poised to Give Clinical Labs New Capabilities
“One of the first questions I ask the laboratory team is ‘do you want to continue to be a factory or do you want to be a change agent in healthcare?’ They all answer that they want contribute to positive change.” —Michael Simpson …
Clinisys CEO Discusses Strategic Changes Labs Need to Make
“Today, we predict that the next storm is about ready to happen, and it will involve clinical laboratories and anatomic pathology practices.” —Michael Simpson CEO SUMMARY: In this exclusive Q&A with The Dark Report, Clinisys CEO Michael Simpson describes the …
Outreach Nets Hospital Lab $2.5M in One Year
CEO SUMMARY: Tucson Medical Center had sold its outreach business to a commercial laboratory two decades earlier, but wanted to bring those services back to its in-house lab. Early work with the finance de…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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