81 patients got results that could be questionable.
A federal inspection report may offer new evidence that Theranos ran blood tests despite questionable results.
The Centers for Medicare and Medicaid Services (CMS) report, which the Wall Street Journal learned about despite not yet being released to the public, found that Theranos continued to run the tests on patients despite erratic quality control results. 81 patients in a six-month period received hematology results that were not adequately controlled for quality.
The unreleased report follows a letter that the CMS sent to Theranos in January. That letter was short on specific issues with the startup’s methods, but it cited five major infractions that “pose immediate jeopardy to patient health and safety,” according to the Journal.
The blood test that Theranos continued to perform despite quality issues measured the ability of blood to clot—an important test that doctors use to adjust patients’ dosages of blood thinners.
In a statement on the company’s website, Theranos’ newly hired California lab director Kingshuk Das said that the problems identified in the report are no longer present: “We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health.”
Theranos—the Silicon Valley Unicorn that’s been valued at around $9 billion—has fallen under scrutiny after a Journal investigation in October found that the startup was using its own machines for only a small fraction of blood tests.
Fortune has reached out to Theranos for further comment and will update this story if the company responds.