PALO ALTO, CA (March 31, 2016) – Quality and patient safety is our top priority. Theranos submitted a Plan of Correction to CMS and related evidence that addressed how the company has actively ensured that our lab operates at the highest standard. We’ve made mistakes in the past in the Newark, CA lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures. As part of that comprehensive review and our review of CMS’s survey findings we have taken the following actions:
· Made personnel changes in our Newark, California lab, including hiring a new full time lab director who is an M.D. and board certified pathologist, and two co-lab directors who are also M.D. and board certified pathologists, to run the lab.
· We have adopted enhanced quality systems, policies and procedures, and provided expert support to the lab
· Proactively suspended testing associated with any affected areas last year after learning of the issues, which allowed us to ensure comprehensive resolution of any issues identified by CMS, or identified in our own reviews, before patients are tested on any of the instruments impacted
· Voided results associated with any findings that were not consistent with the quality standards the lab holds itself to today, under our lab’s new leadership
We will continue to work with CMS to ensure every issue has been fixed completely. We recognize the critical role they play in the laboratory industry, and will continue our work to implement best-in-class policies and procedures. Theranos shares the same goal as CMS, which is to provide best quality care to our patients.
This has only made the company stronger and we are better for it today.
Vice President of Communications