CMS findings could put Theranos at risk of losing certification: 10 things to know

Emily Rappleye (Twitter) - Print  | 

CMS found "deficient practices" at a Theranos laboratory in Newark, Calif., some of which "pose immediate jeopardy to patient health and safety," following a completion of a November inspection, a letter released Wednesday said, according to The Wall Street Journal.

Theranos is a blood testing startup based out of Palo Alto, Calif., that has been under scrutiny since October, when The Wall Street Journal published an intensive critical report of the company's processes.

Here are 10 things to know about CMS' findings, Theranos' response and the repercussions.

1.CMS found Theranos' Newark lab had five major infractions that violate federal standards that involve a range of issues, including its hematology practices, analytic systems and personnel issues, according to the report.

2. Detailed descriptions of the infractions are not available to the public currently, but according to The Wall Street Journal, should be available within the next few months.

3. What is known about the five infractions is they range from standard and condition-level deficiencies to severe and "likely to cause, at any time, serious injury or harm, or death to individuals served by the laboratory or to the health and safety of the general public," the CMS letter said, according to the report. "Condition-level" deficiencies are the most serious level of infraction, Robert Fitzgerald, PhD, professor of pathology and director of toxicology at the University of California, San Francisco, told The Wall Street Journal.

4. Theranos' hematology practices are what resulted in findings of "immediate jeopardy," a rare and severe finding, according to The Wall Street Journal.

5. In an emailed statement, Theranos responded to CMS' findings, stating the lab was undergoing a self-review at the time of the investigation. "This survey of our Newark, Calif., lab began months ago and does not reflect the current state of the lab... We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action," the statement says. As for the hematology finding at the "immediate jeopardy" level, Theranos underscored that it neither applies to the whole lab, nor every location.

6. Theranos also noted the findings do not apply to its Arizona lab, where 90 percent of its tests are processed, according to the emailed statement.

7. It also called out several media allegations that were not part of CMS' findings, including allegations it manipulated data to make its proprietary machines seem more accurate, or that it diluted test samples, causing inaccurate results.

8. Theranos has 10 days from the date on the letter, Jan. 25, to come up with a solution for the problems found by CMS, according to the report. "A full plan of correction will be submitted to CMS within days," Theranos' statement said.

9. If Theranos is unable to address the issues, it could lose its certification and be subject to fines of up to $10,000 per day, according to the report.

10. In light of CMS' findings, Walgreens announced Thursday it would suspend use of all Theranos testing in the 40 Arizona stores where it was being used, according to The Chicago Tribune.

 

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