CMS conducted a survey of Theranos’ Newark, California, lab previous year.
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The Centers for Medicare and Medicaid Services says the lab run by Theranos in Newark poses “immediate danger to patient safety”.
Furthermore, the findings did not reflect operations at ifs Scottsdale lab, where the company performs 90 percent of tests and processes almost all samples collected at its testing centers inside area Walgreens stores.
Its hematology lab, lab director, technical director and testing staffing were all cited, and the Palo Alto company has just 10 days to prove its compliance or it will be effectively shut down.
“We are still reviewing the report, but we addressed numerous observations during the survey and are actively continuing to take corrective action”, the company said. Inspectors would verify the fixes through a follow-up inspection. If the agency does not deem the jeopardy to have been removed, it may receive onsite monitoring or a $10,000 fine per day, the letter states. Other penalties could include suspending or revoking the lab’s certificate and making the lab ineligible for Medicare payments.
Even without knowing the details (the complete CMS report has not yet been released), this kind of language “implies serious infractions that require immediate remedy”, Jerry Yeo, the director of clinical chemistry laboratories at the University of Chicago, told Tech Insider.
Theranos has been hit with yet another major setback after a USA government health agency described its blood-testing technology as posing “immediate jeopardy” to the public. The blood-testing company’s stated ability “to quickly process the full range of laboratory tests from a few drops of blood” pricked from a finger helped garner it a valuation of $9 billion from private investors in 2014 and vaulted founder Elizabeth Holmes to fame.
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In addition, the FDA revealed that following an inspection of Theranos facilities in August and September, it found that the company’s design for its capillary tube nanotainer blood collection devices was “not validated under actual or simulated use conditions”. She speaks at the WSJDLive 2015 conference in Laguna Beach, Calif.
