CMS lab inspectors decided to revoke blood-testing company Theranos' lab certificate after identifying multiple deficiencies at its Newark, Calif., lab. The revocation, which became effective Sept. 5, would also force the shutdown of Theranos' Scottsdale lab, but more than two weeks later the company continues to test patients' blood at the lab, according to AZ Central.
Palo Alto, Calif.-based Theranos is able to continue operating its Scottsdale lab because it is appealing the lab certificate revocation, according to the report, which effectively stalls the lab's shutdown. It could be months or even years before the appeal is settled, as a review of past case documents on the HHS website indicate some certificate-revocation appeals have dragged on for more than three years, AZ Central reported.
Meanwhile, Theranos officials said they amended the company's lab operations to address the deficiencies that led to sanctions by CMS. The company said it "has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership, enhancing Theranos' clinical policies and procedures and revamping training programs," according to the report.
Company officials added Theranos plans to continue talks with federal lab regulators "regarding the possibility of reaching a mutually agreeable resolution to this matter," according to the report.