Federal inspection finds Theranos devices often failed its own quality tests: 6 things to know

A CMS report released Thursday with details from a federal inspection shows Palo Alto, Calif.-based Theranos' proprietary blood-testing devices frequently missed the mark for accuracy on a range of tests, according to The Wall Street Journal.

Only a redacted version of the report is available publicly due to the company's wish to protect trade secrets, but WSJ was provided a full version for review. Here are six takeaways from the federal inspection report, based on the WSJ review.

1. The company's blood-testing devices failed its own quality-control checks by significant margins. In October 2014, almost a third (29 percent) of the results of the quality-control checks on Theranos blood-testing devices were outside of what Theranos considered acceptable, according to the report. Quality-control checks performed January 2015 on a Vitamin B12 test using the company's proprietary device, Edison, showed 34.3 percent to 48.5 percent of variability from the average result, according to the report. This measurement of variability from the average result, called a coefficient of variation, should not be more than 15 percent by Theranos standards.

2. At this time the company had scaled back the use of its Edison device. It also considerably scaled down the tests performed on its proprietary blood testing device in 2014 and since last fall has only used it for one type of test for herpes, according to the report.

3. Federal inspectors also found that when a sample was tested on both Theranos' proprietary blood testing device, Edison, and a traditional machine, the results varied greatly. Based on a random sampling of tests that measure Vitamin D, the difference between the results of the two different machines was anywhere from 21 percent to 130 percent. This gap should be no more than 20 percent based on Theranos' own procedures, according to WSJ.

4. The lab was cited for performing tests with unqualified personnel. The inspectors noted blood samples were not stored at the correct temperatures and patients were not promptly notified of faulty test results, according to the report.

5. Theranos says it has "dedicated every resource to remedy those failures [in its Newark lab]." Spokeswoman Brooke Buchanan provided the remarks to WSJ but did not answer specific questions. She also told the paper Theranos has submitted a plan of correction and evidence it has addressed operational issues. The company has also said it has notified patients affected by erroneous results.

6. CMS did not provide a comment. However, WSJ allegedly heard from sources familiar with the matter that CMS has called this correction plan inadequate.

 

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