Here are five highlights:
1. The CMS is giving Theranos 10 days to submit “acceptable evidence of correction.”
2. In the letter, the CMS lists problems with the laboratory director, the technical supervisor and hematology.
3. The CMS also cited issues with the lab’s analytics systems.
4. The details of these infractions are not clear as the CMS has not released the laboratory inspection report. However, the CMS labeled the determinations “condition-level deficiencies,” which are among the most serious CMS-issued levels.
5. If Theranos fails to take immediate action, the lab is at risk of losing certification.
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