CMS Letter States Theranos Lab Poses An “Immediate Jeopardy” To Patient Safety

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On Sunday of this week, the Wall Street Journal broke yet another story on Theranos, this time suggesting that a damaging report on a CMS inspection conducted in one of its testing facilities late last year was days from being released to the public. While the full report has yet been made public, CMS published a scathing public letter to Theranos this week broadly outlining deficiencies it found while inspecting Theranos’ California lab facility. Those deficiencies, CMS says, “pose immediate jeopardy to patient health and safety,” and require correction within 10 days if the lab is to avoid losing its license to perform Medicare tests. 

The CMS letter outlines five major deficiencies found during its inspection, the most serious of which was found during the inspection of its hematology test process. Hematology is a broad category of lab tests that includes blood cell counts and measuring how long it takes for blood to clot, a common test used to monitor patients taking blood thinners. These are routine tests by any measure, yet CMS indicated that it was here that deficiencies were found that posed “immediate jeopardy” to patient safety. News of the letter made immediate headlines, as Theranos has been the subject of intense media scrutiny since a series of investigative reports published in October questioned the company’s core technology, as well as its accountability and ethics.

Theranos responded to the CMS letter in a statement published on its website that explains that it has “already addressed many of the observations” and that it will “submit a full plan of correction to CMS within days.” As per usual, Theranos deflected much of the criticism, noting that the inspection “was conducted months ago and is not a reflection of the current state of our lab,” and that the inspection of its California lab does not implicate “our Arizona lab, where we currently process over 90 percent of our tests.” The company notes that since the inspection, it has made policy changes within its California lab, and has hired a new clinical lab director.

Walgreens, one of Theranos’ largest corporate customers, has been publically distancing itself from the imploding startup since October, and has now taken one step further in announcing that it is closing its Theranos testing center in Palo Alto and has stopped sending samples to the company’s California lab, noting that no samples would be sent to the lab “until all issues raised by (regulators) have been fully resolved.”


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