CMS to Theranos: Deficient lab practices pose 'immediate jeopardy to patient health'

The investigation into Theranos by the Centers for Medicare & Medicaid Services has been completed, and the findings are not good, with CMS saying that "the deficient practices of the laboratory pose immediate jeopardy to patient health and safety."

In its letter on the findings to Theranos, CMS adds that it is requiring Theranos to take action immediately to fix the deficiencies and "come into Condition-level compliance."

For a lab to perform testing, there are requirements it must follow, CMS notes in its letter. The conditions that were not met by Theranos include hematology, analytic systems and labs performing high-complexity testing by the lab director, technical supervisor and testing personnel.

Theranos has been given 10 days by CMS to show it has complied with the requirements.

In addition, on Thursday Walgreens announced it will close its Palo Alto, California-based Theranos Wellness Center and stop lab services at its store in the city. Walgreens said it also will not send any patient samples to Theranos' lab until "all issues raised by CMS have been fully resolved."

The troubles at Theranos were brought to light last fall, when the Wall Street Journal published a series of reports questioning the use and accuracy of the lab testing company's technology.

Theranos disputed those claims, but a few weeks later, the U.S. Food and Drug Administration released a report saying the company did not properly validate its technology. The FDA determined that Theranos' collection containers were "uncleared medical devices" being used for interstate commerce.

In a statement regarding CMS's findings, Theranos said "the survey ... does not reflect the current state of the lab."

"As the survey took place we were simultaneously conducting a comprehensive review of our laboratory's systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards," Theranos spokeswoman Brooke Buchanan said.

To learn more:
- here's the CMS letter (.pdf)
- read Theranos' statement

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