One of them was Elizabeth’s Wall Street Journal interview, which stated that Theranos’s tests were “more accurate than the conventional methods” and called that improved accuracy a scientific advance. When they met again a few days later, Daniel allowed that the statements in the Journal piece were too sweeping but argued that they had been made by the writer, not by Elizabeth herself. Tyler found this argument a little too convenient. Surely the writer hadn’t made up these claims on his own; he must have heard them from Elizabeth. A faint smile briefly crossed Daniel’s lips.
“Well, sometimes Elizabeth exaggerates in an interview setting,” he said.
There was something else that was bothering Tyler—something he’d just gotten wind of from Erika—and he decided to bring that up too. All clinical laboratories must submit three times a year to something called “proficiency testing,” an exercise designed to ferret out labs whose testing isn’t accurate. Accredited bodies like the College of American Pathologists send laboratories samples of preserved blood plasma and ask them to test them for various analytes.
During its first two years of operation, the Theranos lab had always tested proficiency-testing samples on commercial analyzers. But since it was now using the Edisons for some patient tests, Alan Beam and his new lab codirector had been curious to see how the devices fared in the exercise. Beam and the new codirector, Mark Pandori, had ordered Erika and other lab associates to split the proficiency-testing samples and run one part on the Edisons and the other part on the lab’s Siemens and DiaSorin analyzers for comparison. The Edison results had differed markedly from the Siemens and DiaSorin ones, especially for vitamin D.
When Sunny had learned of their little experiment, he’d hit the roof. Not only had he put an immediate end to it, he had made them report only the Siemens and DiaSorin results. There was a lot of chatter in the lab that the Edison results should have been the ones reported. Tyler had looked up the CLIA regulations and they seemed to bear that out: they stated that proficiency-testing samples must be tested and analyzed “in the same manner” as patient specimens “using the laboratory’s routine methods.” Theranos tested patient samples for vitamin D, PSA, and the two thyroid hormones on the Edisons, so it followed that the proficiency-testing results for those four analytes should have come from the Edisons.
Tyler told Daniel he didn’t see how what Theranos had done could be legal. Daniel’s response followed a tortuous logic. He said a laboratory’s proficiency-testing results were assessed by comparing them to its peers’ results, which wasn’t possible in Theranos’s case because its technology was unique and had no peer group. As a result, the only way to do an apples-to-apples comparison was by using the same conventional methods as other laboratories. Besides, proficiency-testing rules were extremely complicated, he argued. Tyler could rest assured that no laws had been broken. Tyler didn’t buy it.
* * *
—
AT 9:16 A.M. on Monday, March 31, 2014, the email Tyler had been waiting for all weekend landed in his Yahoo in-box—or rather in the in-box of Colin Ramirez, an alias he had made up to remain anonymous. The email was from Stephanie Shulman, director of the Clinical Laboratory Evaluation Program at the New York State Department of Health. She was responding to a query Tyler had submitted the previous Friday under the cover of his new fictional identity.
Tyler had reached out to the New York health department because it ran one of the proficiency-testing programs Theranos had participated in. He still suspected that the way the company conducted proficiency testing was improper and he wanted an expert opinion. After exchanging a few emails with Shulman, Tyler had his answer. In response to a description he gave her of Theranos’s practices, she wrote back that they amounted to “a form of PT cheating” and were “in violation of the state and federal requirements.” Shulman gave Tyler two options: he could give her the name of the offending laboratory, or he could file an anonymous complaint with New York State’s Laboratory Investigative Unit. He chose to do the latter.
Armed with the knowledge that he was correct about his proficiency-testing suspicions, Tyler went to see his grandfather. They sat down together in the dining room of George’s big house, and Tyler tried to explain to the former secretary of state the concepts of precision, sensitivity, quality control, and proficiency testing and to show him why he thought Theranos’s