Theranos CEO Elizabeth Holmes is at risk of being barred from the blood-testing business for two years as a result of some serious missteps at her startup.
And she says those missteps have made her feel “devastated.”
In an interview with the Today Show’s Maria Shriver, Holmes claimed responsibility for the shortcomings that the Centres for Medicare and Medicaid Services cited in their inspection reports.
“I feel devastated that we did not catch and fix these issues faster,” she said.
A March 18 letter reported by The Wall Street Journal stated that the Centres for Medicare and Medicaid Services said it plans to revoke Theranos’ California lab’s licence based on its failure to comply with the agency’s safety and performance standards. Another document cited by The Journal detailed the potential two-year suspension of Holmes and Theranos president Sunny Balwani, which would, if put into place, bar them from owning or operating any lab for the next two years.
Regarding the letters as well as the six months of controversy over the accuracy of Theranos’ tests, Holmes told Shriver that as the founder and CEO, the responsibility for the problems is hers alone.
“Anything that happens in this company is my responsibility at the end of the day,” she said. “We stopped testing and have taken the approach of saying, ‘Let’s rebuild this entire lab from scratch so that we can ensure it never happens again.'”
The sanctions outlined in the March 18 letter were based on two main problems. First, the finding of “immediate jeopardy” and Theranos’ “failure to meet all CLIA condition-level requirements,” and, second, the failure by the lab’s owner and director to “comply with certificate requirements and performance standards” outlined during the survey that the agency conducted in December 2015. Theranos had responded to the original concerns outline by CMS in February, though that response wasn’t a sufficient fix.
“Probably the most devastating part of this is that I thought we did,” Holmes told Shriver.
Theranos has responded to the March 18 letter, so it remains to be seen if these updates are what CMS was looking for.