Government report details Theranos quality control issues

A government report released late Thursday accuses Theranos of producing inaccurate test results, of failing to meet its own lab standards and hiring unqualified personnel.

The Centers for Medicare and Medicaid Service visited Theranos’ main facilities in Newark, California last November and found the one drop blood test startup’s machines produced wildly inaccurate test results – including one for cancer detection, according to a redacted version of the report put out by the Wall Street Journal.

The newly released 121-page report, obtained in full by the WSJ details quality control issues – including the failure to meet Theranos own standards.

According to the report, erratic test results were frequent when tested in July 2014, and from February to June of 2015 on Theranos’ proprietary blood test machine Edison. One example – a test to measure a hormone affecting testosterone levels failed 87 percent of the time when run on Edison.

Between June 1st and September 21st, Theranos failed to properly hire and train qualified people to run the machines, allowed unlicensed workers to review patient test results, failed to follow manufacturer’s instructions on equipment and did not have a proper, written protocol in place to calibrate the machines to maintain accuracy, according to the report.

It is unfathomable Theranos would be allowed to run test results for the public during this time. and these new details provide an inside look at some very real issues surrounding Theranos as a company, particularly around its code-named Edison technology – the supporting reason for the company’s $9 billion valuation.

But there weren’t many details released at the time of the federal health agency’s inspection last fall. CMS declared at the time Theranos’ practices posed “immediate jeopardy to patient health and safety,” and gave it 10 days to fix the problems or face a fine of up to $10,000 per day.

Safeway has since pulled out of a potential partnership with the company and Walgreens has stopped testing at its Palo Alto, California location and is reportedly working to cut ties with Theranos at its 40 clinic locations in Arizona.

We also found Theranos had stopped using its “nanotainer” technology for its sole FDA-approved Herpes test though it had advertised differently. And we found the blood test startup was outsourcing lab work to several other places, including ARUP in Salt Lake City, Utah.

Theranos has submitted a plan to CMS to correct the problems, including hiring a new lab director in its Newark facility and says it will be taking “corrective action” for test results not meeting the standard.

“We’ve made mistakes in the past in the Newark, CA lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures,” Theranos spokesperson Brooke Buchanan told TechCrunch in a statement.

Buchanan also says Theranos will “continue to work with CMS to ensure every issue has been fixed completely.”