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Evidence that Theranos may have returned potentially faulty results to patients have been documented in a government investigation, the Wall Street Journal reports.
Citing people familiar with the documents, The Journal’s John Carreyou and Christopher Weaver report that the blood-testing company gave results even though they were aware of quality-control issues.
The documents came from a report from the Centers for Medicare and Medicaid Services, the federal agency responsible for regulating laboratory tests. The documents are not yet publicly available.
CMS, which also issued a warning letter to Theranos in January, cited laboratory personnel problems, issues with analytics systems and hematology concerns for the blood-testing company’s Newark, California lab. Theranos has since submitted a plan of correction to CMS.
In the hematology category, the letter read “it was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.”
The Journal reports that between April and September 2015, Theranos sent blood-test results back to 81 people on blood thinners for a test called PT/INR. Having accurate results for the amounts of blood thinners in the body is crucial, because too much can cause fatal bleeding while too little could cause clots to form that could lead to stroke or other complications.
Blood thinners are particularly tricky to test for, so most laboratories use a deviation rule that helps make sure the test is within certain parameters that would make it accurate. The investigation found that the results fell outside that deviation rule, The Journal says.
“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’ new California lab director Dr. Kingshuk Das said in a statement emailed to Business Insider. “At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab.”
Theranos has since notified any patients who could have been affected, Theranos Vice President Brooke Buchanan told Business Insider. The issues with the results are not due to the company’s proprietary finger-prick technology, but rather from traditional blood samples run on standard blood-testing devices.
“The new lab director approved enhanced reagent management procedures, as well as improved quality control procedures, to address issues raised by CMS concerning the PT/INR test, such as accounting for a third party manufacturer’s changes to parameters of particular reagent lots,” Buchanan said in a statement. “The lab investigated all PT/INR issues raised by CMS, has notified any potentially affected patients, and has no reason to believe that these issues have affected patients’ health. The PT/INR issues identified by CMS related to tests run on conventional equipment using venipuncture samples.”
More evidence of lab missteps have come out against Theranos – Business Insider