TAG:

Polsinelli

Balwani Guilty! Sentencing Is Next for Theranos Execs

CEO SUMMARY: The trial of former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani ended with convictions by a jury on 12 counts of wire fraud and conspiracy. Now all eyes are looking ahead to the sentencing of Balwani and Elizabeth Holmes, the founder and fo…

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Labs Can Expect COVID-19 Test Audits, Investigations

  CEO SUMMARY: Billions of federal …

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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 question…

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CLIA Lab Director Testimony Shows Risks to Pathologists

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…

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CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’

CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…

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