CMS Rebukes Theranos for Deficiencies at California Laboratory

The once-hot startup Theranos has received a lot of blows, including a letter from the Centers for Medicare & Medicaid Services.

In the letter, CMS details several deficiencies at Theranos’ Newark, Calif., laboratory, following a Nov. 20, 2015, onsite survey.

Of particular note is a finding of “immediate jeopardy” level in hematology. As a result, the company needs to take corrective action immediately, as the laboratory’s noncompliance poses risks to patient health and safety.

Further, there are three condition-level deficiencies related to personnel, such as documentation and oversight. One of the deficiencies is related to analytic systems. CMS found that within hematology, certain policies, procedures and associated events did not meet the relevant standards.

Theranos has fought back. “To be clear, that finding does not apply to the whole lab, and none of these findings relate to our Arizona lab, where we currently process over 90 percent of our tests,” Theranos says in response to the CMS report.

“It’s important to note this particular survey … is not a reflection of the current state of our lab in Newark, CA. 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,” Theranos explains.

The company says that it has made policy and personnel changes at the Newark lab, including adding a new Clinical Laboratory Improvement Amendments lab director and a new clinical consultant.

CMS issued no findings covering certain allegations that were mentioned in recent media coverage, Theranos points out, including proficiency testing “cheating,” manipulating data to make proprietary machines seem more accurate, and improperly hiding the existence of the lab holding its proprietary technologies.

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