Tag: clia 88

Why Theranos Is a Big Test for CMS and CLIA

By R. Lewis Dark, from the Volume XXIII, No. 8 – June 13, 2016 issue

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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National Lab Standards Coming For Patient Safety

By Robert Michel, from the Volume X No. 11 - August 18, 2003 issue

CEO SUMMARY: Because lab test data plays such an important role in medical decision-making, the Centers for Disease Control and Prevention (CDC) has launched a national effort to evaluate the quality of clinical and public health laboratories. In forming a Quality Institute, the goal is to issue a National Report on the Quality of Laboratory

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Volume XXV No. 17 – December 3, 2018

DID CONGRESS JUST PASS A LAW that makes innocent labs guilty of criminal acts? At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act -- a provision that makes common practices such as paying commissions to sales staff or placing phlebotomists in labs could be illegal. Worse: The experts are baffled by the language of the new law. Notes one of these experts in this issue, "Someone in the clinical lab industry may have to get prosecuted before we get some clarity, unless the Secretary of HHS issues clarifying regulations."

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Tag: clia 88

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