– Revocation of the [Newark, California] laboratory’s CLIA [Clinical Laboratory Improvement Amendments] certificate which, as dictated by the regulations, includes a prohibition on owners and operators of the lab from owning, operating or directing a lab for at least two years from the date of revocation
– Limitation of the laboratory’s CLIA certificate for the specialty of hematology
– A Civil Money Penalty
– A Directed Portion of a Plan of Correction
– Suspension of the laboratory’s approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology
– Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services
These penalties represent serious blows to Theranos.
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