The Centers for Medicare and Medicaid Services, one of the federal bodies that regulates laboratory blood tests, sent the company a letter released Wednesday (uploaded by The Verge) that showed that it violated at least five clinical laboratory regulations.
For hematology, "It was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety," the agency wrote in a letter dated January 25.
Other violations included: analytic systems and three instances of laboratory personnel problems.
The controversial blood-testing startup ran into trouble late in 2015 after The Wall Street Journal launched a series of pieces that questioned the company's finger-prick blood-testing technology.
On Sunday, The Journal originally reported that CMS found problems with Theranos' laboratory in Newark, California. The report doesn't have anything to do with Theranos' Arizona lab, which Theranos says runs more than 90% of its tests.
In a statement regarding the report, Theranos wrote:
"This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory's systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action."
Theranos has 10 days to show the agency that it's working to fix the problems. The company said it plans to submit a correction plan to CMS "within days." If need be, CMS can sanction Theranos up to $10,000 for every day it's not compliant, the letter reads.
Read the full letter: CMS
CMS.gov
.jpg)
CMS.gov
.jpg)
CMS.gov