The Monitor Daily (U.S.) – Theranos faces regulatory troubles yet again, with federal regulators having sent the blood testing startup a letter pointing out deficient practices in the Newark laboratory.
If the terming ‘deficient practices’ sounds vague, that’s because it is. The letter, signed and sealed by the Centers for Medicare and Medicaid Services (CMS) contains a five-point list of complaints Theranos should address in 10 days time. If the Silicon Valley company fails to comply with the federal regulator requests, it faces a 10,000 dollars fine per day.
Theranos was a market sensation when the company was announced. When it promised the revolutionizing of blood testing with new technology and fingerprick blood tests, everybody was on board. The Silicon Valley company had the most diverse board, ranging from government officials to former military officials. Elizabeth Holmes was in the limelight for a lengthy period of time. Her company, Theranos, shared the limelight in an unexpected feat of glory.
The aim of Theranos is to revolutionize blood testing. Federal regulators seem bent on making this journey as difficult as possible. Of course both sides’ positions must be taken with a pinch of salt. Nonetheless, a routine check at the Theranos Newark laboratory in California has revealed that the blood testing laboratory employes practices which are deficient. As such, they pose a threat to patients’ safety and health.
The ‘deficient practices’ as they are called in the CMS letter were found during the survey conducted in November, aiming at certifying the laboratory. On December 23rd Theranos send additional information to the federal regulator. Now, on January 25th, Theranos was served the CMS letter.
The deficiencies listed in the five-point list relate to the Newmark laboratory’s analytic systems, the personnel, the laboratory’s supervisor as well as its leadership. The most attention-grabbing point of the five-point list is hematology. This is the only point that might endanger the Newmark laboratory.
According to Brooke Buchanan, Theranos spokeswoman, the CMS survey did not reflect the state of the laboratory. While Theranos officials are reviewing the CMS survey results, most of the points have been addressed. Theranos faces regulatory troubles yet again. Still, the company is taking all steps necessary to correct the deficiencies pointed out by the federal regulator.
In addition, Brooke Buchanan drew attention to the fact that the CMS letter is directed exclusively at the Newmark laboratory and does not reflect on the entire company. The Arizona laboratory is the hot spot for blood testing. It is in the Arizona laboratory that Theranos processes over 90 percent of the tests.
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