TAG:

clia requirements

After Two Decades, CMS Wants to Update CLIA Lab Regulations

IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…

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Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press

CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…

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Score for Theranos after AACC: Fail.

This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …

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Is Theranos Kowtowing To CMS over Pending CLIA Sanctions?

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 …

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December 7, 2015 Intelligence: Late Breaking Lab News

Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…

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Might Lawsuits Come Next in Theranos Story?

CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…

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Theranos: Many Questions, but Very Few Answers

CEO SUMMARY: Winston Churchill famously said that “Russia is a riddle wrapped in a mystery inside an enigma.” That description could apply to Theranos, the company that claims it is poised to disrupt the entire clinical laboratory testing industry. In Phoenix, where Theranos is r…

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Theranos: Many Questions, but Very Few Answers

WHEN A COMPANY THAT GOES PUBLIC WITH ITS GOALS, regularly and repeatedly declaring its lofty ambitions to do good for mankind by disrupting the status quo and replacing it with something new and wonderful, it invites itself to be judged by its actions and what it actually delivers. Since Thera…

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CMS Gives Deemed Status to A2LA under CLIA Law

CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…

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2012’s Top Ten Lab Stories Predict More Challenges

CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …

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