Consumer technology healthcare firm Theranos Inc. faces another challenge.
U.S. regulators from the Centers for Medicare and Medicaid Services (CMS) has released a letter saying Theranos lab practices in one of its facilities pose immediate jeopardy to patient health.
The facility in question is the Newark, California laboratory, which was inspected as part of the agency's Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Regulators were able to complete the on-site survey on Nov. 20, 2015, but the investigation officially concluded on Dec 23, when the lab sent critical information to the agency.
"As a result of the survey, it was determined that your facility is not in compliance with all of the Conditions required for certification in the CLIA program," the letter says (PDF).
Aside from the lack of compliance, the agency also states that the facility has deficient practices than can result in immediate jeopardy to patient health and safety.
Immediate jeopardy is defined as a situation that needs prompt corrective action because it has already caused, is causing or will likely cause serious hazards or death to the recipients of the lab's services and to the public.
The agency found that the lab did not meet the required conditions for hematology, analytic systems and labs performing high complexity testing.
CMS requires labs that pose immediate jeopardy to perform actions to eliminate the jeopardy and exhibit condition-level compliance. Facilities that are not able to do so may not be certified under the CLIA certification program.
CMS now requires Theranos to submit a credible allegation of compliance statement and an acceptable evidence of correction. These documentations should show what corrective interventions were performed on patients who have been affected by the deficient practice.
The laboratory should also show how the it was able to identify other patients who could potentially get harmed because of their deficient practice.
Theranos must also enumerate the measures it has included in its system to ensure that the incident will not happen again.
If the requirements are not met, CMS will have to pose sanctions against Theranos' CLIA certificate. The agency's corrective actions may include Civil Money Penalty that may reach up to $10,000 per day, suspension, and limitation or termination of CLIA certificate.
Theranos Inc. said it has made changes to its policies and personnel, even hiring a new consultant, Dr. Waldo Concepcion, from Stanford University.
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