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Theranos certificate to operate revoked by U.S. regulators
Lenay Ruhl//July 8, 2016//
Listen to this articleTheranos is a lab company that had been testing patients at a midstate location through a partnership with Harrisburg-based Capital BlueCross.
The Centers for Medicare and Medicaid Services, or CMS, revoked the certification for Theranos’ Newark lab and cancelled the laboratory’s approval to receive Medicare and Medicaid payments.
Back in January, CMS had cited Theranos for several clinical deficiencies, and its laboratory services at a Capital BlueCross retail store in Hampden Township have been suspended since then.
“Theranos is no longer a provider for Capital BlueCross,” Capital BlueCross spokesperson Kirsten Page said today. “Their draw site that briefly operated in our Enola retail store was removed in January of 2016.”
CMS’s recent ruling on Theranos goes into effect in 60 days, but the laboratory agreed not to do any more patient testing in Newark until further notice.
In the meantime, Theranos will continue to work with CMS to address the issues found in its Newark lab, and its Arizona laboratory will still operate, a Theranos news release said.
“We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions,” Elizabeth Holmes, Theranos founder and CEO said. “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.”
