The thread installs the Newark Theranos lab as a case in which three paths could diverge: the public story (Edison, finger stick, a full menu at Walgreens), the proficiency-testing path CLIA already required to match patients, and the assay that actually produced the reported number (often a commercial analyzer, sometimes a modified one, sometimes Edison). The unresolved question is which repair would have closed that split in 2014. Binding proficiency testing to the named primary method, and printing the instrument on the report, is already 42 C.F.R. § 493.801(b); CMS's 2016 letter is what enforcement of that rule looks like after the fact. Requiring a device clearance for each advertised test before a retail menu is a different first statute. Giving the retail partner the live instrument list, not a demonstration room, is a third. Those are not substitutes. The SEC complaint already says Pharmacy A would not have accelerated its innovation fee had it known third-party analyzers ran most of the tests. Holmes's jury already separated investor fraud from patient fraud. The live question is which of those three, if required in 2014, would have turned a CLIA certificate and a two-hundred-test menu back into a named assay.