Federal officials released a report showing the inspection of a Newark, California Theranos' facility last fall. The startup company which offers finger prick blood testing services, faces problems that are sure to raise more questions on the results of its tests.
The 121-page report made by the Centers for Medicare and Medicaid Service (CMS) found issues like having unqualified employees who failed to keep freezers at the proper temperatures and other issues showing the company failed to meet the company's own standards.
Unlicensed personnel worked in the company's laboratory to review patient test results. The company also failed to follow manufacturer's instructions on equipment use and it doesn't have a written protocol on how to calibrate the machines to make sure they give accurate results.
The $9 billion-valued company faced scrutiny after the credibility and accuracy of its results were questioned. The federal officials found [pdf] that the company's machines produced inaccurate test results including one for cancer diagnosis.
There were frequent inconsistent blood test results when tested in July 2014, including those from February to June of 2015 on the company's test machine, Edison. For instance, a test measuring the levels of a hormone which affects testosterone levels failed about 87 percent of the time when Edison was used.
According to the inspection, 29 percent of the quality-control checks performed on the proprietary blood-testing devices in October 2014 gave out results that are outside the criteria considered acceptable by Theranos.
Theranos released its official statement in response to the latest result that added to the burden of the company's reputation.
The company's Vice President of Communications, Brooke Buchanan, said that patient safety and quality is their top priority. She added that though they made mistakes in their Newark laboratory, the company remedied the flaws.
The company already hired a registered pathologist to head the laboratory. The company's two co-laboratory directors are also physicians.
"We will continue to work with CMS to ensure every issue has been fixed completely. We recognize the critical role they play in the laboratory industry, and will continue our work to implement best-in-class policies and procedures," she said.
"Theranos shares the same goal as CMS, which is to provide best quality care to our patients," she added.
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