4 ms·

Sections 1215 and 1250 say that they don't follow manual procedure requirements. Not surprising, given that the focus of the enterprise is automating laborator

Sections 1215 and 1250 say that they don't follow manual procedure requirements. Not surprising, given that the focus of the enterprise is automating laboratory procedures. The remaining sections cited are requirements on the staff operating the lab. The letter infers that the staff do not conform to regulatory requirements. Again, this is not surprising given that the function of the enterprise is to remove humans from the process. I find the outrage a bit outrageous.

dekhn 11y ago
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.
epistasis 11y ago
That is a very odd whitewashing. Even if its all automated, you still need a lab director with qualifications to run the lab. And somebody has to fill reagent bottles. People are involved. That they fail when so few people are involved is a lot worse.
- aminorex 11y ago
  I doubt there is any meat here. The real complaint should be their failure to anticipate and accomodate the perverse but very real requirements of regulatory compliance in the near term. In the long run, the regulations will have to change in light of technological reality, but investors don't usually care about the long run.
  - LevyJenningsSD2 11y ago
    There IS meat here, but it isn't the hematology problem. It's that their medical director is unqualified to direct this lab. CLIA is very stringent about what qualifications are needed for a lab doing high-complexity testing. This is such a huge mistake by Theranos that I have to truly believe they do not know what they are doing, or perhaps felt they were above these laws. CLIA is indeed the law, passed by Congress many years ago. Even Kissinger can't throw his weight around and bypass it. Duh

dekhn 11y ago

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.

epistasis 11y ago

That is a very odd whitewashing. Even if its all automated, you still need a lab director with qualifications to run the lab. And somebody has to fill reagent bottles. People are involved. That they fail when so few people are involved is a lot worse.

aminorex 11y ago
I doubt there is any meat here. The real complaint should be their failure to anticipate and accomodate the perverse but very real requirements of regulatory compliance in the near term. In the long run, the regulations will have to change in light of technological reality, but investors don't usually care about the long run.
- LevyJenningsSD2 11y ago
  There IS meat here, but it isn't the hematology problem. It's that their medical director is unqualified to direct this lab. CLIA is very stringent about what qualifications are needed for a lab doing high-complexity testing. This is such a huge mistake by Theranos that I have to truly believe they do not know what they are doing, or perhaps felt they were above these laws. CLIA is indeed the law, passed by Congress many years ago. Even Kissinger can't throw his weight around and bypass it. Duh