Erin Griffith Das testifies that he had to respond to CMS with a patient impact assessment out of a regulatory, professional and ethical obligation. Erin Griffith Das testifies that he explained the issues to Holmes using the example of female patients returning abnormal PSA levels (a prostate test) because “females should generally not have PSA detectable.” Erin Griffith The CMS report shows that in numerous months between 2014 and 2015, a number of types of tests showed that 15 percent of tests were violating a common quality control rule. Erin Griffith There’s a list of “conditions” that were not met, including “analytic systems,” meaning the instruments and methods used. Das testifies that he discussed the issues with Holmes and the Theranos team. Erin Griffith In Nov 2015, CMS did an onsite survey of Theranos’s CLIA lab. In January 2016, CMS sent Theranos a notice with the heading: CONDITION LEVEL DEFICIENCIES – IMMEDIATE JEOPARDY Erin Griffith Dr. Das was working on a CMS audit while at Theranos. We discuss a “statement of deficiencies” that was 121 pages long. Erin Griffith (He joined officially in March 2016, long after Theranos had publicly launched.) Erin Griffith Wow, Das testifies that when he started as lab director, he was not aware that of Theranos performing any tests that it had developed in-house. No tests on Edison, Minilab or TSPU. No tests on finger stick samples. Erin Griffith Defense is chiming in along the way in opposition of this document; the judge shoots it down as it is already in evidence. Erin Griffith Kingshuk Das, a Theranos lab director, has taken the stand. Lowering the lights to show exhibits on a projector in the courtroom feels a bit like a Junior High science class. We see CLIA Lab rules that shows CMS (fed …
