As a medical laboratory professional I can shed some light: The Immediate Hazard Hematology citation comes from an expired reagent being used on a Hematology

As a medical laboratory professional I can shed some light: The Immediate Hazard Hematology citation comes from an expired reagent being used on a Hematology analyzer (clearly a standard Siemens analyzer, not the mysterious new technology they won't disclose). This is easily fixable, but reveals a great deal about what is ACTUALLY going on in that lab The Laboratory Director and Technical Consultant citations are standard when you have an Immediate Hazard citation. But they also reveal how poorly organized this lab is and how whomever is responsible for the laboratory leadership at a directorship level knows NOTHING about CMS laboratory regulations, or tried to pull a fast one on CMS/CLIA by hiring a patently unqualified Dermatologist to be a part-time director of a CLIA high-complexity lab. This is a MASSIVE glaring error in leadership and quality assurance at the very highest level. The executive leadership of this company appears to know nothing about the business they seek to upend. I am sure the Cleveland Clinic is wondering WTH they got themselves involved with. Also very telling that Holmes was at Cleveland Clinic the day after this letter was released. They are clearly operating as a bog-standard lab doing conventional testing to be able to report patient results and be a traditional CLIA-certified lab (except may be one test they have - the HSV) This significant fact seems to have escaped everyone. They can't report any tests performed by their top-secret technology because it ain't FDA approved. For a conventional refererence lab like Quest or Labcore, their inspection faults would be embarrasing but fixable. For Theranos, it's likely fixable but the PR fiasco may be ultimately fatal. Someone shoukd really have studied the industry they seek to upturn and worked with real professionals rather than pusing global dominance and glossy PR. The cart is miles ahead of the horse at Theranos