Health Agency Says Theranos Lab Practices Pose “Immediate Jeopardy” To Patient Safety

More bad news for Theranos: A federal health agency has declared that the blood test company’s “deficient practices … pose immediate jeopardy to patient health and safety.”

In a letter sent to Theranos on January 25, the Centers for Medicare & Medicaid Services said it identified deficiencies related to hematology and analytic systems, and with the lab’s laboratory director, technical supervisor and testing personnel. (The deficiencies causing “immediate jeopardy” were in the area of hematology.) The letter states that Theranos has 10 days to provide “acceptable evidence of correction” or face penalties.

In response, Theranos sent out this statement:

This survey of our Newark, CA lab began months ago [the CMS says the “onsite survey” was completed on November 20] and 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. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.

More specifically, Theranos said that the findings were not related to the company’s Arizona lab “where we currently process over 90 percent of our tests” and that the Newark lab has a new director and clinical consultant.

Theranos also said the CMS did not issue findings about many of the allegations (like whether Theranos was “cheating” the proficiency tests that are necessary to certify its instruments’ accuracy) that surfaced in a Wall Street Journal report last fall.