The Centers for Medicare and Medicaid Services has decided that Theranos’ Newark, Calif., facility poses “immediate jeopardy to patient health and safety.” A letter sent to the company on January 25th says that the lab has been given 10 days to provide “acceptable evidence of correction.”
Theranos Lab Poses ‘Immediate Jeopardy to Patient Health,’ Says U.S. Agency
If Theranos doesn’t take immediate action, the lab could lose its certification.
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Specifically, the document cites problems with the laboratory director, the technical supervisor, hematology and the lab’s analytic systems. CMS has not released the laboratory inspection report that led to this letter, so the details of these infractions remain unclear. But the level assigned to these determinations — “Condition-level deficiencies” — are among the most serious that CMS can make. They mean that Theranos’ Newark lab was found to be in violation of accepted professional standards. CMS declined to comment on the letter.
This article originally appeared on Recode.net.
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