The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #1
The submission references "Ex. A, Tab 9, F-1" and "Ex. A, Tab 10, F-1." We found no such references in the materials provided to CMS.
Throughout Ex. E, Tab 1, the laboratory provided lists of patient specimen accession numbers for which the laboratory intended to issue corrected test reports. The laboratory provided no documentation to indicate corrected reports were generated and issued.
We found no information addressing how the laboratory will ensure the accurate review of test method validation documentation, the issue cited in the deficiency.
The laboratory failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information set forth above and in our January 25, 2016 letter.
Finding #2
The submission references "Ex. H, Tabs 1, 2-5, 16, 17 - 20, 21, 22 - 25, 26, 27 - 30, 36, 37-40, 46, 47 - 50, 56, and 57 - 60." We found no such references in the materials provided to CMS.
Ex. H contains lists of patient specimen accession numbers for which the laboratory intended to issue corrected test reports. The laboratory provided no documentation to indicate corrected reports were generated and issued.
At the time of the onsite survey, the laboratory's protocol "Master Validation Plan for Routine Chemistry Assays on Theranos Devices," stated: ". . .for establishing the trueness or comparability to two procedures. . .at least 50% of samples should be outside the reference interval."
For five validation documents (ALT, BUN, calcium, glucose, and sodium testing using the b 4 b 4, a review of the test results used by the laboratory to establish "the trueness or comparability of two procedures" showed that the laboratory did not follow its established protocol and use "at least 50% of samples. . .outside the reference interval."
The submission includes the protocol "Method Validation," at Ex. A, Tab 9, Section 8.1.1.1 ("A method comparison and bias estimation design"), which states: "If the analyte has a critical medical decision level, at least 50% of the specimens must have analyte levels below this value and the remaining 50% above."
We are unclear as to the laboratory's definition of "critical medical decision level." No definition of this phrase was found in Section 3—Definitions of the "Method Validation" protocol or in Ex. H.
In Ex. H of the submission, the laboratory provided the following "assay validation" summary:
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