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I looked up what those laws referred to are, and... this is very very serious and Theranos is unlikely to survive it. The first two laws they are cited as havi

I looked up what those laws referred to are, and... this is very very serious and Theranos is unlikely to survive it. The first two laws they are cited as having broken are about quality control standards. The next two laws they are cited as having broken are about qualifications that must be held by the laboratory director and technical supervisor. The last law they are cited as having broken is about qualifications that must be held by technicians. They have ten days to come into compliance, but in order to address these violations they will have to either hire new staff for key leadership and other positions, or pull their product from the market. They will do the latter. This same company was previously forced to pull their "nanotainer" testing system from the market because when regulators sent them control samples, they fraudulently tested them on different equipment and with different procedures than they used with patient samples. I will be surprised if no criminal charges are brought against Theranos CEO Elizabeth Holmes.

aczerepinski 11y ago
They aren't laws, and they have ten days to submit a plan, not to execute the plan. Are you sure you know enough about this sector to weigh in on whether survival is likely?
- apsec112 11y ago
  Federal regulations (created by the executive) are technically different from statutes (created by legislators), but there can certainly be criminal penalties for violating them. I wouldn't be at all surprised if that were the case here, given the public safety implications of medical testing. The letter says that Theranos must provide "acceptable evidence of correction documenting that the immediate jeopardy has been removed". "Has been" is past tense, so Theranos really is required to fix the problems (at least the most serious ones) in ten days, not just plan to fix them.
- jimrandomh 11y ago
  Not laws? Those are section numbers from the US Code of Federal Regulations. Are you trying to point at the distinction between civil and criminal law?
  - michaelhoffman 11y ago
    The CFR is made up of regulations. Usually when people refer to "laws" in a U.S. context they are referring to statutes.
    - tannhauser23 11y ago
      No no no, regulations have the force of law, and if you violate them you can be fined, jailed, banned from the industry, etc. This is serious.
      - aczerepinski 11y ago
        I'm really not sure about that. There are so many conditions spanning when documents need to be signed, how to clean a nursing bag, when to hold meetings, what credentials personnel need to hold, how close to the floor/ceiling supplies can be stored. What are some examples of COP violations leading to jail time?
        hguant 11y ago
        Law - what is put together by Congress and signed by the President. This can involve tasking Federal agencies to do a specific task, referred to as a mandate. Regulation - How the Agency turns its mandate, which is often broadly stated and sometimes nebulous, into concrete actions and policies. An example - I worked at the DOJ as an intern. There was a law passed to provide benefits to the families of public safety officers who died in the line of duty. What those benefits are? Who qualifies as a public safety officer? If a fire fighter gets in a car crash on his was home from a shift, does that qualify? The answers to these questions are determined by lawyers and experts in equal measure - the experts to determine what should be done to solve the problem, the lawyers to make sure the agency actually has the power to enact the policies the experts recommend. To put it in OOP terms, regulations are instances of law. The stuff you mentioned - who is allowed to sign form 22a, minimum size of cleaning closets - is still law. The agencies also have the power to determine penalties for breaking regulations, not all of which involve going to jail. This power is again derived from what powers Congress assigns them when it writes the law.
dnautics 11y ago
Limiting personal liability is the purpose for incorporation... She can't have criminal charges brought against her unless she commits an SEC violation and uses corporate resources for personal or unrelated purposes in conflict with the best interests of investors, which is what they are claiming shkreli did, for example.

aczerepinski 11y ago

They aren't laws, and they have ten days to submit a plan, not to execute the plan. Are you sure you know enough about this sector to weigh in on whether survival is likely?

apsec112 11y ago
Federal regulations (created by the executive) are technically different from statutes (created by legislators), but there can certainly be criminal penalties for violating them. I wouldn't be at all surprised if that were the case here, given the public safety implications of medical testing. The letter says that Theranos must provide "acceptable evidence of correction documenting that the immediate jeopardy has been removed". "Has been" is past tense, so Theranos really is required to fix the problems (at least the most serious ones) in ten days, not just plan to fix them.
jimrandomh 11y ago
Not laws? Those are section numbers from the US Code of Federal Regulations. Are you trying to point at the distinction between civil and criminal law?
- michaelhoffman 11y ago
  The CFR is made up of regulations. Usually when people refer to "laws" in a U.S. context they are referring to statutes.
  - tannhauser23 11y ago
    No no no, regulations have the force of law, and if you violate them you can be fined, jailed, banned from the industry, etc. This is serious.
    - aczerepinski 11y ago
      I'm really not sure about that. There are so many conditions spanning when documents need to be signed, how to clean a nursing bag, when to hold meetings, what credentials personnel need to hold, how close to the floor/ceiling supplies can be stored. What are some examples of COP violations leading to jail time?
      - hguant 11y ago
        Law - what is put together by Congress and signed by the President. This can involve tasking Federal agencies to do a specific task, referred to as a mandate. Regulation - How the Agency turns its mandate, which is often broadly stated and sometimes nebulous, into concrete actions and policies. An example - I worked at the DOJ as an intern. There was a law passed to provide benefits to the families of public safety officers who died in the line of duty. What those benefits are? Who qualifies as a public safety officer? If a fire fighter gets in a car crash on his was home from a shift, does that qualify? The answers to these questions are determined by lawyers and experts in equal measure - the experts to determine what should be done to solve the problem, the lawyers to make sure the agency actually has the power to enact the policies the experts recommend. To put it in OOP terms, regulations are instances of law. The stuff you mentioned - who is allowed to sign form 22a, minimum size of cleaning closets - is still law. The agencies also have the power to determine penalties for breaking regulations, not all of which involve going to jail. This power is again derived from what powers Congress assigns them when it writes the law.

dnautics 11y ago

Limiting personal liability is the purpose for incorporation... She can't have criminal charges brought against her unless she commits an SEC violation and uses corporate resources for personal or unrelated purposes in conflict with the best interests of investors, which is what they are claiming shkreli did, for example.