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