As noted in our March 18, 2016 letter, the laboratory again failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information as set forth in our January 25, 2016 letter.
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The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
In the second submission, the laboratory states that "the job description for TP 14 has been revised to be consistent with the job description of a Clinical Laboratory Associate [CLA] in the laboratory's personnel procedures (Ex. HH, Tab 7B)." We note this job description is essentially unchanged from the laboratory's February 12, 2016 submission and still contains CLIA regulatory responsibilities for testing personnel, and as such TP 14 is required to meet the educational requirements. This job description was not signed by TP14. On April 17, 2016, CMS received an additional exhibit, Ex. PP, which states that "the laboratory had revised the job description for clinical laboratory associates and . . . TP14 subsequently executed the new job description form (Ex. PP, Tab 5)." Ex. PP, Tab 5 includes a job description (CL JOB-03027, Rev. A) for CLA's and was signed by TP14 on April 15, 2016. The job description in Ex. PP, Tab 5 is different than the job description submitted in Ex. HH, Tab 7B. We are unclear if the job description submitted in both Exs. HH and PP is specific to TP14 or intended for all CLAs, nor are we clear which job description is currently being used for CLAs.
The laboratory's submission does not provide any additional documentation to show that TP14 is qualified to perform high complexity testing. Based on the information provided to CMS, TP 14 remains unqualified to perform high complexity testing. The laboratory's second submission states "that TP14 has not performed any test analyses between November 2015 and his execution of this revised job description (Ex. HH, Tab 7 A);" however, the laboratory still has not addressed any patient impact for testing performed by TP14 prior to November 2015.
The laboratory again failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information as set forth in our January 25, 2016 and March 18, 2016 letters.
Imposed Sanctions
Accordingly, pursuant to 42 C.F.R. §§ 493.1806, 493.1812, 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 taking action to impose the following sanctions against the CLIA certificate of Theranos, Inc.:
- 42 C.F.R. §§ 493.1806(b), 493.1840(a)(3), and 493.1840(e) - Principal Sanction: Revocation of the laboratory's CLIA certificate effective September 5, 2016. The laboratory has sixty (60) calendar days to appeal the determination to revoke the laboratory's CLIA certificate. If
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