CMS Report On Theranos Details Lack Of Quality Control, Use Of Unqualified Personnel
The blood testing startup says its new lab director has implemented extensive new procedures to improve on the failures, and that those who were in leadership during the period the federal government was investigating are no longer with the lab.
The Wall Street Journal:
Theranos Devices Often Failed Accuracy Requirements
The blood-testing devices that Theranos Inc. touted as revolutionary often failed to meet the company’s own accuracy requirements for a range of tests, including one to help detect cancer, according to a federal inspection report. A redacted version of the report was released late Thursday. A full version was reviewed by The Wall Street Journal. The 121-page document details deficiencies found by the Centers for Medicare and Medicaid Services during its inspection of the closely held company’s Newark, Calif., laboratory last fall. (Carreyrou and Weaver, 3/31)
The New York Times:
Report Shows Theranos Testing Plagued By Problems
Among other findings in the report, which ran 121 pages, the company used unqualified or inadequately trained personnel and stored samples in freezers that were not at the proper temperature. It also failed to ensure that the quality control for an important blood-clotting test was acceptable before reporting results for patients. (Pollack, 3/31)
Bloomberg:
Theranos Inspection Report Details Quality-Control Failures
The document also includes Theranos’s plans for corrections, saying the new lab director, Kingshuk Das, has implemented extensive new procedures to improve the facility’s operations. “The lab directors during the period covered by the survey no longer hold any position with the lab,” Theranos wrote in the document. ... “We have no reason to believe that the issues raised by CMS have affected patients health,” company spokeswoman Brooke Buchanan said Thursday in an e-mail. “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.” (Chen and Tracer, 3/31)
The Arizona Republic:
Report On Theranos Cites Quality, Accuracy Issues
It was unclear whether CMS has accepted a proposed "plan of correction" that Theranos submitted as part of the inspection report. CMS officials declined to comment after releasing the report. A separate inspection of the company's Scottsdale lab found minor infractions that the company addressed. (Alltucker, 3/31)
