The blood-testing company Theranos last night announced that the Centers for Medicare & Medicaid Services had revoked the company’s license to operate its Newark, California lab and barred Theranos founder and CEO Elizabeth Holmes from owning, operating or directing a lab for two years. CMS also cancelled the Newark lab’s approval to receive payments from Medicare and Medicaid.
The harsh, even crippling federal sanctions resulted from an inspection of the lab last November. That inspection found numerous deficiencies in the lab’s operation, including problems with a blood-clotting test that were potentially life-threatening.
The government agency had threatened the penalties in April but had given Theranos a chance to respond. In the interim, Theranos voided or corrected tens of thousands of blood tests, sending notices to doctors and patients in May.
“We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions, ” said Holmes in a statement. “Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures.
“While we are disappointed by CMS’ decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.”
Theranos has two rounds of administrative appeals available to it, which could delay some of the sanctions, including the revocation of the Newark lab’s license. Theranos said the revocation does not take effect for 60 days. The company still operates a lab in Arizona.
Last month, the drugstore chain Walgreens pulled out of its partnership with Theranos.
Source:: Future of You
