Theranos has received a report from the US Government’s Centers for Medicare & Medicaid Services (CMS) citing non-compliance of the firm’s Newark facility with the regulations of clinical laboratory improvement amendments of 1988 (CLIA).
CMS has conducted a CLIA recertification and compliant survey in the laboratory and determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.
Laboratories that do not satisfy the conditional-level requirements of CLIA will not be allowed to carry out laboratory testing under its programme.
CMS has provided ten days of time to the firm to provide compliance and evidence of correction confirming that the immediate jeopardy has been removed and action has been taken to correct all of the condition-level deficiencies.
The authority will impose sanctions on the laboratory, if jeopardy is not removed and does not come into condition-level compliance.
Theranos is claimed to have developed a blood-testing device called Edison that uses a few drops of blood obtained through a finger-stick, rather than vials of blood obtained via traditional venipuncture, utilizing microfluidics technology.