DEPARTMENT OF HEALTH & HUMAN SERVICES |
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Refer to: WDSC-GKY
IMPORTANT NOTICE - PLEASE READ CAREFULLY
July 7, 2016
Sunil Dhawan, M.D., Director CLIA Number: 05D2025714
Elizabeth Holmes, Owner
Ramesh Balwani, Owner
Theranos, Inc.
7333 Gateway Boulevard
Newark, CA 94560
RE:IMPOSITION OF SANCTIONS
Dear Dr. Dhawan, Ms. Holmes, and Mr. Balwani:
We are writing to notify you of the determination by the Centers for Medicare & Medicaid Services (CMS) that Theranos, Inc. ("Theranos" or "the laboratory") located at the above address is not in compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) Condition-level requirements, has not removed the finding of immediate jeopardy, and of the consequent imposition of the following sanctions:
- Revocation of the laboratory's CLIA certificate
- 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
CLIA Survey
CMS conducted a CLIA recertification and complaint survey at Theranos in 2015. The onsite portion of the survey was completed on November 20, 2015; however, the survey concluded with the receipt of critical information received from the laboratory on December 23, 2015. Based on this survey, the laboratory was found to be out of compliance with five CLIA Condition-level requirements, in addition to numerous CLIA Standard-level requirements.
By letter dated January 25, 2016, CMS provided Theranos with a listing of all deficiencies identified during the survey on Form CMS-2567, Statement of Deficiencies. The January 25, 2016 letter also notified the laboratory that the seriousness of the deficiencies cited under 42 C.F.R. § 493.1215 resulted in the finding of immediate jeopardy to patient health and safety, and requested
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