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 The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.

See our reviews of D5403, D5407, D5413, D5421, D5423, D5429, D5437, D5447, D5449, D5469, D5477, D5481, D5775, D5779, D5787, D5791, and D5793.

D5403

The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.

Finding #1

Although the laboratory addressed the inclusion in its procedure manual of corrective actions to be taken when calibration or quality control (QC) results failed to meet the laboratory's criteria for acceptability when using the Siemens Advia 2120i instrument, in its submission the laboratory failed to address how it will ensure its procedure manuals include applicable components as required by 42 C.F.R. § 493.1251(b).

We also note that to ensure appropriate and required calibration or QC corrective actions were taken, the laboratory indicated that quarterly audits will be performed and suggested that the audits results would be reviewed within the laboratory's QMPI Program. However, the laboratory did not establish the procedure by which these quarterly audits are to be conducted. In its submission, the laboratory indicates that a "tracer audit may [emphasis added] be used," but did not provided a protocol for a "tracer audit," the means by which a "tracer audit" would be documented, and whether the results of a "tracer audit" would be the information reviewed by the QMPI Program.

The laboratory failed to address and provide acceptable evidence of correction consisting of: what measure has been put in place or what systemic changes have been made to ensure the deficient practice does not recur; and, how the corrective action(s) is being monitored to ensure the deficient practice does not recur.

Finding #2

The laboratory was cited for not having a QC procedure for the "Edison 3.5 Theranos System" prior to 5/15/14. The laboratory's submission states that it performed QC before and after 5/15/14; however, it did not address the citation. While the data submitted did show that QC was run prior to 5/15/14, the laboratory provided no information regarding any investigation as to what procedure the laboratory was using to determine number, type, frequency and acceptability criteria for QC. The laboratory indicated that systemic errors using QC and patient test distribution over time as well as random errors were used to evaluate patient impact. Specifically, the laboratory indicated that "QC data was reviewed to identify >2SD failure and periods of elevated CV. Namely, batches of 10 consecutive QC data points were analyzed and the CV was calculated for each QC level during this period. If the CV was >30%, then all patient results run during that time period will be voided." Ex E, Tab 1. The laboratory did not indicate how "periods of elevated CV" were identified or what time periods were reviewed. The summary also included a specific number of patient "reports [that] were identified" for each analyte that may have been affected by the laboratory's QC errors, but did not include any documentation to indicate whether corrected reports were generated and issued.

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