Proposed Sanctions
Accordingly, pursuant to 42 C.F.R. §§ 493.1806, 493.1814, and 493.1840(a)(3), based on the finding of immediate jeopardy and the laboratory's failure to meet all CLIA Condition-level requirements, and based on the failure by the owners and director of the laboratory to comply with certificate requirements and performance standards as evidenced by the deficiencies cited during the CLIA recertification and complaint survey completed on December 23, 2015, CMS is proposing the following sanctions against the CLIA certificate of Theranos, Inc.:
- 42 U.S.C. § 263a(i), and 42 C.F.R. §§ 493.1806, 493.1840(a)(3), and 493.1840(e)—Principal Sanction: Revocation of the laboratory's CLIA certificate effective 60 calendar days from the notice of imposition. If imposed the laboratory has 60 calendar days to appeal the determination to revoke the laboratory's CLIA certificate. If a timely hearing request is received, revocation of the laboratory's CLIA certificate will become effective following the administrative hearing decision, if our determination of non-compliance is upheld.
- 42 C.F.R. §§ 493.1806, 493.1812, 493.1840(a)(3), and 493.1840(d)(2)(i)—Principal Sanction: Limitation of the laboratory's CLIA certificate for the specialty of hematology effective eight calendar days from the notice of imposition based on the finding of immediate jeopardy. The limitation will take effect regardless of whether a hearing request is filed and will remain in effect until the laboratory's CLIA certificate is revoked.
- 42 C.R.R. §§ 493.1806(c)(3), 493.1810(c)(2)(ii), 493.1810(d), and 493.1834—Alternative Sanction: Civil Money Penalty (CMP) in the amount of $10,000 per day for each day of non-compliance effective five calendar days from the notice of imposition. If the laboratory requests a hearing, the CMP will not be collected until after the hearing decision is rendered. However, the $10,000/day will begin to accrue five (5) days from the notice of imposition and will continue to accrue until it can be verified that all the cited deficiencies have been corrected and the laboratory is in compliance with all Condition-level requirements or the laboratory's CLIA certificate is limited. In determining the amount of the penalty, CMS has taken into account the following factors: (1) the laboratory was found to be out of compliance with five CLIA Condition-level requirements as well as numerous Standard-level CLIA requirements during the survey completed on December 23, 2015; (2) the deficiencies cited during the survey, specifically related to the Condition-level requirement set forth 42 C.F.R. § 493.1215, Hematology, were so serious as to result in the determination of immediate jeopardy to patient health and safety; (3) the laboratory failed to remove the jeopardy after being provided an opportunity to do so; (4) the laboratory failed to come into Condition-level compliance after being provided ample opportunity to do so; (5) the laboratory failed to meet all hematology requirements specified in 42 C.F.R. §§ 493.1230 through 493.1256, § 493.1269, and §§ 493.1281 through 493.1299, as is required by 42 C.F.R. 493.1215 for a laboratory providing services in the specialty of hematology; (6) the laboratory failed to meet all analytic system requirements specified in 42 C.F.R. §§ 493.1251 through 493.1283; (7) the laboratory failed to meet all requirements for a
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