PALO ALTO, CA (January 27, 2016) – We received a report from CMS documenting its findings from a scheduled survey in our Newark, CA lab that took place last fall. We are currently reviewing the report, but have already addressed many of the observations during the survey. We are continuing to take corrective action and will submit a full plan of correction to CMS within days.
First and foremost, we value engagement with our regulators, which helps us build best-in-class systems, and we are committed to ensuring that all our labs operate at the highest standards. Theranos remains the sole company to call for – and voluntarily submit itself to – stronger regulatory oversight.
It’s important to note this particular survey was conducted months ago and is not a reflection of the current state of our lab in Newark, CA. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems.
CMS’ findings included standard and condition-level deficiencies, and one finding at the “immediate jeopardy” level, based on a condition-level deficiency in one specific area – hematology. To be clear, that finding does not apply to the whole lab, and none of these findings relate to our Arizona lab, where we currently process over 90 percent of our tests.
Three of the condition-level deficiencies are related to personnel, such as documentation and oversight; one is related to analytic systems; and the one referenced above to hematology. CMS found that within hematology, certain policies, procedures, and associated events did not meet the relevant standards.
As part of our review, we have made policy and personnel changes in our Newark, CA lab, including adding a new CLIA lab director with the conclusion of our lab director search. Our new lab director, Dr. Kingshuk Das, is a board-certified pathologist and M.D. and, among other accomplishments, an Associate Medical Director of UCLA’s Clinical Laboratories. We have also brought on a new clinical consultant, Dr. Waldo Concepcion, the Chief of Clinical Transplantation and Professor of Surgery at Stanford University Medical Center.
We were grateful to have our regulators directly review our alternative proficiency testing processes for our proprietary technologies and related operations. CMS issued no findings on the following allegations mentioned in recent media coverage:
· An allegation of proficiency testing “cheating”
· An allegation that management “instructed lab employees to keep testing patients” despite indications of purported problems
· An alleged complaint to CMS in which an R&D employee allegedly “deleted” QC data
· An allegation that Theranos improperly hid the existence of its lab holding its proprietary technologies
· An allegation that Theranos manipulated data to make its proprietary machines seem more accurate
· An allegation of a “dilution” protocol causing inaccurate results
· An allegation regarding the handling of a purported “proficiency-testing sample” in February 2014
Theranos has voluntarily committed to FDA review of its laboratory-developed tests and publishing its prices, lab proficiency testing pass rate, customer satisfaction scores, guest visit times, and more, to realize a system in which individuals become more engaged with their health, and early detection and prevention of disease become realities.