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

Laboratory Compliance / By Robert Michel

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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CMS CLIA Sanction Letter Sent To Theranos Raises Questions

Laboratory Compliance / By Joseph Burns

CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab company’s founder and CEO Elizabeth Holmes from the operating a clinical laboratory for …

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Why Theranos Is a Big Test for CMS and CLIA

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc., and force the lab to close? Or will it soften its …

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions against Theranos, including revocation of the Theranos CLIA certificate. An expanded scientific advisory …

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Did Theranos Turn Over its CLIA Lab Director?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy needed to disrupt the clinical lab testing marketplace.

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Pathologist Sues Hulu Over Depiction in Theranos TV Series

Clinical Laboratory, People / By Scott Wallask

THERE IS AN INTRUGUING NEW TWIST IN THE LONG-RUNNING SAGA of the now-defunct Theranos. Pathologist and former Theranos CLIA lab director Adam Rosendorff, MD, is taking Hulu to court. Rosendorff, the federal government’s star witness during the fraud trial of former Theranos CEO Elizabeth Holmes, recently issued a court summons to Hulu over the streaming …

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Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director

Lab Risk & Compliance, Laboratory Compliance / By Scott Wallask

TANTALIZING DETAILS ABOUT FORMER THERANOS CEO ELIZABETH HOLMES’ purchase of a one-way plane ticket to Mexico prior to her conviction grabbed headlines following the filing of a motion to appeal her conviction. However, for clinical laboratory directors, the relevant information in the latest motion filed by Holmes’ lawyers centers on Adam Rosendorff, MD, a pathologist …

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Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud

Lab Risk & Compliance, Laboratory Compliance / By Scott Wallask

SENTENCING OF ELIZABETH HOLMES AND RAMESH “SUNNY” BALWANI in federal court caps the strange, yet captivating, saga of Theranos and its flawed blood testing technology. For laboratory professionals, the four years of legal wranglings that surrounded the Theranos fraud case may be remembered for shining a spotlight on the responsibilities of laboratory directors under the …

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Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request

Lab Risk & Compliance, The Dark Report / By Scott Wallask

Keeping with the unexpected and odd circumstances surrounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the government’s star witness in Holmes’ 2021 trial—a pathologist—visiting her home in August to speak with the disgraced former Theranos CEO. As …

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Balwani Guilty! Sentencing Is Next for Theranos Execs

Clinical Laboratory / By Robert Michel

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 former CEO of Theranos, who was found guilty on …

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