Theranos, the blood testing startup based in Palo Alto, Calif., ran a hematology test on 81 patients in a six-month period despite erratic results from quality-control checks, according to The Wall Street Journal, which cited a federal inspection report.
Although the federal report hasn't been publicly released, people familiar with the report told WSJ it is more detailed than the January letter from CMS that outlined deficiencies at Theranos' lab in Newark, Calif.
In January, CMS said "deficient practices" in hematology at the Theranos lab posed "immediate jeopardy to patient health and safety."
People who have seen the federal inspection report told WSJ it indicates Theranos ignored quality-control checks while administering a blood test that measures how long it takes blood to clot. The result of this test repeatedly deviated from the lab's typical result by more than two standard deviations.
Despite the erratic quality-control results, which occurred between April 1 and Sept. 23 last year, Theranos sent blood test results to 81 patients.
"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," Kingshuk Das, director of Theranos' lab in California, told WSJ.
However, Timothy Hamill, MD, professor emeritus at the University of California, San Francisco's department of laboratory medicine, disagrees. He said physicians who received the blood-clotting test, called "prothrombin time," from the Theranos lab during the six-month period shouldn't rely on the results. "Those results are not worth anything," he told WSJ.
More articles on Theranos:
CMS findings could put Theranos at risk of losing certification: 10 things to know
Walgreens seeks ways to ax Theranos partnership for good
What other startups can learn from Theranos' story