Patients were in ‘immediate peril’ because of Theranos lab shortcomings, according to a 2016 federal audit.

SAN JOSE, CALIFORNIA – Kingshuk Das, the company’s lab director, claims that CEO Elizabeth Holmes ignored his frequent complaints about major problems with the start-blood-testing up’s equipment in the company’s final two years.

In her criminal fraud trial on Tuesday, Das, who joined Theranos in late 2015 and reported directly to Holmes, took the testimony.

He recalls trying to explain the inaccuracy difficulties to Holmes by using the example of female patients who had high levels of prostate-specific antigen, or PSA, a prostate test.

“Females should not have detectable PSA,” Das claimed, but he remembered Holmes offering an other explanation, citing “one article or two” saying that rare breast tumours may induce PSA results in women.

“Did you find that explanation satisfactory?” Assistant US Attorney Robert Leach inquired.

Das stated, “It felt preposterous.”

Federal prosecutors claim Holmes made false and misleading assertions about Theranos’ blood-testing technology to investors, patients, and doctors. If convicted, Holmes, who was once hailed the “next Steve Jobs,” faces up to 20 years in prison. She has denied all ten counts of wire fraud and two counts of conspiracy.

Das’ testimony could be detrimental since it reveals that Holmes was aware of the tests’ unreliability but continued to promote them anyhow. Holmes’ attorneys depicted her as a youthful, naive CEO who was unaware of the inaccuracy issues during opening arguments and cross interrogation of government witnesses.

Every test on the Edison devices from 2014 and 2015 was thrown out, and Das told Holmes that “these instruments were not performing from the start.”

Das explained, “I attempted to put it in a more accessible style.” “I seem to recall [Holmes] proposing a different interpretation.” Das testified that Holmes told him it wasn’t a problem with the device, but rather with quality control and quality assurance.

Das testified that his first responsibility as lab director was to respond to a finding made by the Centers for Medicare & Medicaid Services during an audit.

Following an onsite inspection of the Theranos laboratory in January 2016, CMS sent a deficiency notice to Sunil Dhawan, the previous lab director. “CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY,” the topic stated.

“On November 20, 2015, the onsite survey was completed,” the report stated. “As a result of the survey, it was found that your institution does not meet all of the CLIA program’s requirements for accreditation.”

“The laboratory’s inadequate practises pose urgent threat to patient health and safety,” CMS said.

Holmes’ lawyers have fought to prevent the CMS report from being presented to the jury. The judge overturned their objection. Das testified that he discussed the regulatory report’s issues with Holmes and other members of his staff.

In 2018, Das was laid off from the company. On Wednesday, he will continue his testimony.

Due to technology glitches in the courtroom, the trial was nearly two hours late. The television system that shows evidence to jurors and spectators on screens went down. The artefacts were projected onto a wall across from the jury box using an old-school projector and dimmed lights in the courtroom.

Judge Edward Davila of the United States District Court said, “I’m really humiliated our courtroom has had these difficulties.” “I’m sorry, but this isn’t meant to happen, and we shouldn’t be having these problems.” We’ve squandered vital time.”

Source: https://www.cnbc.com/2021/11/09/theranos-lab-problems-posed-immediate-jeopardy-to-patients-audit.html

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