Note that any automated lab today still requires many manual procedures, and the staff have to conform. It's totally inexcusable, within the current legal environment, to not satisfy those conditions. Their lab isn't some gleaming, hermetically sealed iLab with only mechanics and computers inside.

I will note that I placed a caveat that I didn't know the magnitude of the violations, but be aware, this is an extremely serious problem for Theranos, they have no excuses, they would have known what to do ahead of time, and they certainly wouldn't use the reasoning that their lab is partially automated so they don't need to comply with manual procedure requirements.