Theranos CEO Elizabeth Holmes should be banned from holding a diagnostic business, federal regulators propose.
Following a series of controversies over faulty and erratic blood test results, Holmes or Sunny Balwani, Theranos's chief operating officer, will be prohibited from owning or running a laboratory for two years, a letter dated March 18 from the Centers for Medicare and Medicaid Services (CMS) said.
Federal health regulators proposed the sanctions after concluding that the company failed to address the major problems seen in a Theranos laboratory in California. These deficiencies may pose serious threats to patient health and safety.
The company's certification will also be revoked which covers its California-based lab, all its operations and suspension from receiving payments from insurance under Medicare.
Holmes, the 31-year-old founder of a biotech blood testing firm, Theranos, once promised to revolutionize the diagnostic industry with her finger-prick tests. Now, her career may be going down the drain as she may be banned from the industry completely.
CMS, however, will reconsider the sanctions if the company heads can provide good evidence on why they should not be closed or banned from the industry. A 10-day leeway was given to the company to provide its response. Though the company has responded, a final decision hasn't been made.
"The whole thing is hypothetical; if sanctions are imposed, we could appeal and the process could take months," said Brooke Buchanan, a Theranos spokeswoman.
"The fact is we have not received sanctions," she added.
Most of the concerns were brought into attention after an inspection report of the laboratory was released in March. The report detailed the company's shortcomings, which included failure to meet quality-control standards that the company itself has established.
For instance, the company failed to keep freezers at the required temperatures by manufacturers, failure to document properly, missing documentary signatures and hiring unqualified personnel.
Buchanan said that the company was in daily contact with the regulators and described the continued questions as part of the ordinary process. The spokeswoman, however, said that they do not expect the process to be over in three months, especially now that the company already made changes in order to address the concerns raised by the regulators.
"We've taken comprehensive corrective measures over the past several months," she said.
Photo: Steve Jurvetson | Flickr
