A lab at Cleveland Clinic was placed in Immediate Jeopardy status a few months ago. They voluntarily stopped some services temporarily and were fined $600,000.
Whether or not regulations are technically "laws" is beside the point, and arguing about it so much is pedantic. The feds show up with a gun and have full authority to fine you or even padlock your lab (which has happened plenty of times). Theranos is in plenty of legal (or regulatory, who cares) hot water right now, whatever you call it.
Thanks for posting (and to seanccox who posted a similar link). I'm wrong, and it appears the lab business is different from other health care businesses where most surveys contain deficiencies and everybody just keeps working.
http://www.beckershospitalreview.com/quality/cms-fines-cleve...
Whether or not regulations are technically "laws" is beside the point, and arguing about it so much is pedantic. The feds show up with a gun and have full authority to fine you or even padlock your lab (which has happened plenty of times). Theranos is in plenty of legal (or regulatory, who cares) hot water right now, whatever you call it.