A Centers for Medicare & Medicaid Services inspection of Theranos' California lab has uncovered a number of "condition-level deficiencies," according to a letter sent by CMS to the company. The inspection also found a deficiency in the company's hematology lab practice that poses an "immediate jeopardy to patient health and safety."
The "immediate jeopardy" finding is rare and severe, according to the Wall Street Journal. "It means they've got a major issue in that lab," Timothy Hamill, vice chairman of the University of California, San Francisco's department of laboratory medicine, tells the Journal.
The letter adds that the lab is not in compliance with all conditions needed for Clinical Laboratory Improvement Amendments (CLIA) certification. Theranos has 10 days to respond with its plan to fix the issues. If it doesn't address the problems, the company may lose its certification and be subject to fines.
The blood-testing company has come under increased scrutiny following multiple reports in the Wall Street Journal that questioned the company's technology, testing procedures, and approach to proficiency testing.
While the report associated with the CMS letter isn't yet available and the details of the problems unearthed aren't clear, The Verge notes that 'condition-level deficiencies' are also "among the most serious" findings CMS can make.
In the letter, CMS says uncovered problems with lab personnel as well as with analytic systems at Theranos' Newark, Calif., lab, in addition to the deficiencies in hematology. The company's other lab in Arizona was not part of the inspection.
In a statement, Theranos says that the CMS inspection began months ago and "does not reflect the current state of the lab." The spokesperson, Brooke Buchanan, adds in the emailed statement that the company has already begun to address these issues, particularly the personnel-related problems.
For instance, she says the company has brought on a new lab director, Kingshuk Das, a board-certified pathologist and associate medical director of the University of California, Los Angeles' clinical labs, and that it has hired a clinical consultant, Waldo Concepcion, the chief of clinical transplantation and professor of surgery at Stanford University Medical Center.
Buchanan also notes that CMS didn't issue findings related to earlier reports of alleged cheating on proficiency testing or data manipulation.
"We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards," she adds. "We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action."
Theranos will submit its full plan of corrective actions to CMS within days, according to Buchanan.