According to an as-of-yet-unreleased federal inspection report, blood-testing firm Theranos continued to conduct a blood test on patients despite inconsistent quality control testing results, the Wall Street Journal reports.
In late January, the Centers for Medicare & Medicaid Services sent Theranos a letter that said its inspection had uncovered a deficiency in the company's hematology lab practice that posed "immediate jeopardy to patient health and safety" as well as other "condition-level deficiencies."
According to the Journal, this report sheds further light on the issues that inspection uncovered. It says that quality control checks run between April 1 and September 23 of last year yielded results that fell two standard deviations outside the usual result and that Theranos sent results for that hematology test to 81 patients, the issue notwithstanding. The blood-clotting test is often used to tweak dosages for patients taking warfarin.
Lab directors tell the Journal that varying results are common and that labs set their own threshold for what amount of variation is tolerable, though most follow the two-standard-deviation criterion.
The Journal adds that the report found that the California Theranos lab also relied on expired reagents for the test.
"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's lab in California, tells the Journal. He adds that the report does not reflect the current state of the lab.
The Journal notes that CMS currently is reviewing a plan of correction Theranos submitted last month in response to the letter.