Federal regulators have released a longer version of their report on their inspection of blood testing company Theranos that reveals that the startup has been dogged by quality control issues, the New York Times reports.
The report from the Centers for Medicare & Medicaid Services expands on the letter that it sent to Theranos in late January that said that it had uncovered "condition-level deficiencies" at the company's California lab as well as a deficiency in the company's hematology lab practice that posed an "immediate jeopardy to patient health and safety."
The new report says that Theranos relied on unqualified or not sufficiently trained personnel, stored samples in freezers that weren't at the proper temperatures, and reported the results of a blood clotting test despite quality control issues, according to the Times.
In addition, quality control checks of its proprietary Edison platform gave unpredictable results, the Wall Street Journal adds. For instance, it says that 29 percent of the QC checks of the Edison system performed in October 2014 fell outside of the range that the company deemed acceptable and, in February 2015, a hormone test run on Edison failed 87 percent of QC checks. Further, the Journal notes that inspectors found wide-ranging gap between the results that the Edison platform and traditional platforms provided when testing vitamin D.
Earlier this week, researchers from the Icahn School of Medicine at Mount Sinai reported in a paper in Journal of Clinical Investigation this week that tests performed by Theranos were more likely to show irregular results that those done by Quest Diagnostics or LabCorp.
A spokesperson for Theranos, Brooke Buchanan, says that the company is addressing the issues. "We've made mistakes in the past," she says in statement emailed to the Times, "but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures."
She notes at the Journal that the company has submitted a plan of correction to CMS. "Theranos shares the same goal as CMS does, which is to provide best quality care to our customers," Buchanan adds. "This has only made the company stronger and we are better for it today."
However, the Journal reports that the regulatory agency has found the plan to be inadequate and that it will likely impose sanctions against Theranos.