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Government report details Theranos quality control issues

TechCrunch TechCrunch 31/03/2016 Sarah Buhr

A government report released late Thursday accuses Theranos of producing inaccurate test results, of failing to meet its own lab standards and hiring unqualified personnel.

The Centers for Medicare and Medicaid Service visited Theranos’ main facilities in Newark, California last November and found the one drop blood test startup’s machines produced wildly inaccurate test results – including one for cancer detection, according to a redacted version of the report put out by the Wall Street Journal.

Between June 1st and September 21st, Theranos failed to properly hire and train qualified people to run the machines, allowed unlicensed workers to review patient test results, failed to follow manufacturer’s instructions on equipment and did not have a proper, written protocol in place to calibrate the machines to maintain accuracy, according to the full 121-page document obtained by the WSJ.

There weren’t many details at the time of the federal health agency’s inspection last fall. CMS declared at the time Theranos’ “deficient practices … pose immediate jeopardy to patient health and safety” at the time of the inspection last fall, giving it 10 days to take action and fix the problems or face a fine of up to $10,000 per day.

These new details provide an inside look at some very real issues surrounding Theranos’ code named Edison technology – the supporting reason for the company’s $9 billion valuation.


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