Sections 1215 and 1250 say that they don&#x27;t follow manual procedure requirements.  Not surprising, given that the focus of the enterprise is automating laboratory procedures.<p>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.<p>I find the outrage a bit outrageous.