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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 …

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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…

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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…

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CLIA Lab Directors Must Watch Delegated Duties

CEO SUMMARY: Laboratory accredito…

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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 …

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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 …

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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…

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Don’t Automate Bad Work Processes in Microbiology

CEO SUMMARY: Automation is not always right for every lab’s microbiology department, according to consultants from bioMérieux. When evaluating automated instruments, it is necessary to review wo…

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Actions Pathologists Can Take to Protect Their Income

CEO SUMMARY: Pathology groups may feel their income is under attack from lower Medicare reimbursement rates and rising practice costs. But steps to protect that income can include carefully determin…

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Competency Assessments Prove To Be a Nagging CLIA Deficiency

CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…

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