CMS Theranos Report 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)