Theranos’ proprietary blood-testing devices failed to meet the company’s own accuracy standards for an array of tests, according to a 121-page government report released Thursday and obtained by The Wall Street Journal.
The deficiencies were documented by the Centers for Medicare and Medicaid Services during its inspection of the controversial blood-testing startup’s Newark, California, laboratory last fall.
The listed deficiencies include flawed quality-control tests, failure to establish written policies for blood collection and storage processes, using unqualified staff members to conduct tests, and failing to notify patients of their flawed test results for extended periods of time.
The report’s findings are the first time performance records have been made public for the company’s proprietary blood-testing devices, according to The Journal.
The technology, code-named Edison, produced quality-control check results outside Theranos’ acceptable range 29% of the time in February 2014. In February 2015, quality checks for an Edison test that measured a hormone affecting testosterone levels failed 87% of the time.
“This is the first time that we’ve actually seen data from the Theranos instrument, and it’s as bad as one would have worried it would be,” Stephen Master, associate professor of pathology at Weill Cornell Medical College in New York, told The Journal.
All references to the Edison machines have been redacted in the report.
The company, which is valued at $9 billion, has been mired in controversy for months.
The controversial blood-testing startup first ran into trouble late in 2015 after The Journal launched a series of articles that raised questions about the company’s finger-prick blood-testing technology.
Theranos has also had issues with quality control of tests run on the standard blood-testing devices that Theranos uses for most of its tests.
In March, The Journal reported that from last April to September, Theranos sent blood-test results back to 81 people on blood thinners for a test called PT/INR. Having accurate results for the amount of blood thinners in the body is crucial, because too much can cause fatal bleeding while too little can cause clots to form that could lead to stroke or other complications.
Theranos has since notified any patients who could have been affected by the flawed test results, Theranos Vice President Brooke Buchanan told Business Insider in early March.
“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.”