Blood testing upstart Theranos failed to follow its own established procedures and make certain that all patients who may have received potentially inaccurate blood test results were notified, according to the Wall Street Journal.
Those are just some of the deficiencies listed in a lab inspection report obtained by the Journal via a public records request. Federal inspectors found that the Silicon Valley firm, once considered a rising star, also neglected to ensure its devices’ accuracy hewed to its manufacturer’s instructions on key tests such as blood-glucose monitoring and pregnancy tests. In fact, even conventional blood testing machines (as opposed to the “nano-prick” blood test technology that CEO Elizabeth Holmes had claimed would revolutionize the diagnostics industry) were improperly operated by Theranos employees, according to the report.
Theranos eventually shut down the Scottsdale, Ariz., laboratory where the various deficiencies were cited, and says it plans to continue discussions with the government over the issues. The firm also argues that the accuracy problems wouldn’t have ultimately affected clinical decision-making.
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Although Theranos began as a diagnostics firm, its mounting woes and regulatory scrutiny — including multiple lawsuits and an ugly legal battle with former partner Walgreens (WBA) — eventually led the company to shift its focus. In fact, the company has decided to leave the blood testing game altogether, instead focusing on a new device called the “miniLab,” which it plans to sell to health care providers.
Holmes is currently appealing a Centers for Medicare and Medicaid Services (CMS) sanction that bans her from working in the medical lab field for two years.
