| D6168: 42 C.F.R. § 493.1487 | Condition: Laboratories performing high complexity testing; testing personnel. |
In addition, CMS determined that various CLIA Standard-level requirements were not met.
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 that the laboratory take immediate action to remove the jeopardy and bring any unmet Condition-level requirements into compliance. CMS gave the laboratory 10 calendar days from the date of receipt of the January 25, 2016 letter to submit a credible allegation of compliance and acceptable evidence of correction for the cited deficiencies. On February 4, 2016, a Theranos representative requested an extension until February 12, 2016 to provide a submission, which CMS granted. CMS received a submission from the laboratory in response to the January 25, 2016 letter on February 12, 2016.
After careful review, we have determined that the laboratory's submission does not constitute a credible allegation of compliance and acceptable evidence of correction for the deficiencies cited during the CLIA recertification and complaint survey completed on December 23, 2016, and does not demonstrate that the laboratory has come into Condition-level compliance and abated immediate jeopardy. In general, we find that the statements made in the allegation of compliance and evidence of correction: 1) failed to adequately address the deficient practice cited; 2) are incomplete and failed to meet the criteria of acceptable evidence of correction; 3) do not ensure sustained compliance; and 4) show a lack of understanding of the CLIA requirements.
As the laboratory was advised in our January 25, 2016 letter, a credible allegation of compliance, as defined by regulation (42 C.F.R. § 493.2), is a statement or document that is:
1) Made by a representative of a laboratory with a history of having maintained a commitment to compliance and taking corrective action when required;
2) Realistic in terms of the possibility of the corrective action being accomplished between the date of the survey and the date of the allegation; and
3) Indicates resolution of the problem.
It is important to note that for it to be credible, the allegation of compliance must be complete and address each of the deficiencies cited in the Statement of Deficiencies. For each deficiency, the allegation of compliance must include a corrective action date that is realistic in terms of the action being accomplished between the date of the survey and the planned date of completion.
As Theranos was also advised in our January 25, 2016 letter, the laboratory's allegation of compliance must be substantiated by acceptable evidence of correction which must include:
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