The U.S. Centers for Medicare and Medicaid Services, which regulates laboratories, noted in a 2016 letter to Holmes and its former Thiranos president, Sunny Balwani, that it had found serious flaws in the firm’s Bay Area laboratory, and that The response to the company’s alleged violations was insufficient or unreliable, the letter said, adding that patients using theranos blood tests were still at “immediate risk” of serious harm or death.
Holmes, who founded Theranos in 2003 at the age of 19, is accused of soliciting hundreds of millions of dollars from investors and defrauding doctors and patients that the company’s machines use only a few drops. Can take the full range of tests. Blood and Balwani, Holmes’ former romantic partner, are facing the same charges. Has denied the allegations
The letter informed Holmes and Balwani that the federal certification for the Newark lab would be revoked in two months, and that Theranos would be fined every day for failing to comply with federal laws.
The agency’s letter said that in 2015, it inspected and inspected Theranos’ Newark Lab, and found “numerous” examples of non-compliance with federal laws on more than 30 issues, including quality. Control, testing errors and abnormal results, operating procedures such as temperature control, and training of lab staff. Although Thiranos responded to the agency’s findings, CMS wrote that it found the company’s compliance claims to be “unreliable.”
Thiranos began commercial blood testing in 2013. The blood analyzer device made it impossible for federal investigators to assess the potential effects on patients.
The agency’s letter also stated that Theranos’ response did not explain why personnel were allowed to examine patient samples without full training, noting that when CMS inspectors visited the lab. So a Theranos staff member told her she was “informally trained.”
During the trial on Thursday, the judges were shown the exchange of text messages at Homes and Balwani while the agency was being inspected in New York. Balwani was in the lab. “There’s been a lot of animosity so far,” Balwani wrote. “They say they have complaints.” Holmes replied, “Stop praying literally.”
Dr. Sunil Dhawan-Balwani, a dermatologist and former director of Theranos Lab, who agreed to a short-term position overseeing the Newark Lab, said he spent a total of five to 10 hours working on the company in 2014 and 2015. Three days before the CMS inspection, he said, Balwani had asked him to approve reports confirming the company’s nearly 60 tests. Dhawan testified that he signed the reports even though he had never seen the Theranos machine being tested.
During an investigation by Holmes’ lawyer, Dhawan, a bald man in glasses wearing a dark blue blazer and black slip-on loafers, testified that he understood Balwani – a software businessman – Theranos. Was running a lab operation, and he only met Holmes once to greet him.
Holmes ‘legal team is fighting to prevent the prosecution from placing the CMS letter before the jury, arguing that the details of the sanctions against Therano would be biased, and “not related to Ms. Holmes’ intent.” ۔ ”
Holmes’ lawyers said in a filing Wednesday that “it is difficult for the criminal defendant to imagine anything more than the seemingly authoritative agency’s opinion about the ‘reputation’.”The filing claims that Thiranos appealed against the CMS ban but agreed with the agency. Theranos closed in 2018 before the appeal was resolved.
The Justice Department said Holmes faces up to 20 years in prison and a ڈالر 2.75 million fine if convicted.