Issue: Volume XXVIII, Number 16 - November 29, 2021

VALID Act vs. VITAL Act: Day of Reckoning for LDTs

TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests.  One bill is called the Verifying Accurate Leading-Edge IVCT …

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Florida Laboratory Owner Gets 82-Month Jail Term

CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who violate the federal anti-kickback statute. Morever, this case is …

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In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role

CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys questioned four of Theranos’ former lab directors about inaccurate test results and failures to comply …

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Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility

MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab?  This question is being asked after the California Department of Public Health (CDPH) finally made public the CLIA inspection report by state officials after they visited the state-owned Valencia Branch Laboratory last winter.  ‘Scathing …

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November 29, 2021 Intelligence: Late-Breaking Lab News

Pathologists interested in ways to automate the various manual steps in the histology laboratory may want to watch the progress of an emerging company. Clarapath of Hawthorne, N.Y., says it is “automating processes around the way tissue is processed onto glass slides via ‘sectioning,’ or cutting a cross-section of the tissue specimen.” The company just …

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