Theranos可能Have Run Blood Tests Despite Quality IssuesEighty one patients in a six-month period received hematology results that were not adequately controlled for quality.
This story originally appeared onFortune Magazine
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 theWall Street Journallearned about despite not yet being released to the public, found that Theranos continued to run the tests on patients despite erratic quality control results. Eighty one 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 theJournal.
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 astatementon 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 -- theSilicon Valley Unicornthat's been valued at around $9 billion -- has fallen under scrutiny after aJournalinvestigation in Octoberfound that the startup was using its own machines for only a small fraction of blood tests.
Fortunehas reached out to Theranos for further comment and will update this story if the company responds.
