In a letter sent to Ms. Holmes, three members of the committee outlined the regulatory lapses discovered at Palo Alto, Calif.-based Theranos since August 2015, including use of an unapproved medical device, failures to keep records and failure to conduct quality audits, among others.
“Given our ongoing concerns about Theranos’s compliance with federal statutes and regulations and the quality and accuracy of Thernaos’s testing, we are requesting that you provide a briefing to committee staff,” according to the letter.
In particular, the committee seeks information on how Theranos plans to work with regulators to become compliant with federal law, how Theranos has changed internal policies to prevent future compliance issues, whether Theranos is conducting an internal investigation to determine a root cause of “widespread compliance failures” and steps Theranos is taking to assist those potentially harmed by inaccurate test results.
In a statement to Becker’s Hospital Review, Theranos said, “Patient safety and clinical quality are our top priorities. We look forward to answering the members’ questions and explaining the significant actions we have taken with new operational leadership and quality standards at our laboratories. We are committed to the highest standards of excellence across all our labs and look forward to continuing constructive engagement with our regulators and working to bring access to high-integrity, affordable health information to every person.”
The committee asked Ms. Holmes to respond to its request no later than July 14.
Editor’s note: This story was updated July 5 at 4:10 pm CT to include a statement from Theranos.
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