Quality problems surround Theranos' medical testing — 5 observations

Medical testing done by Theranos was plagued by quality control problems that could have led to inaccurate results for patients, according to an inspection report released by federal regulators and reported by The New York Times.

Here are five observations:

1. Among other findings in the report, which ran 121 pages, Theranos 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.

2. The report is from an inspection last fall of Theranos' laboratory in Newark, Calif., by CMS.

3. Earlier this week, researchers at the Icahn School of Medicine at Mount Sinai in New York City published the first independent assessment of Theranos, finding that it produced more irregular results than two more conventional laboratories.

4. Some of the most serious findings involve a test of blood clotting used on patients who take the blood thinner warfarin.

5. Theranos is a privately held health technology and medical-laboratory services company based in Palo Alto, Calif.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Patient Safety Tools & Resources Database

Featured Webinars

Featured Whitepapers

Featured Podcast