Tuesday, April 26, 2016

CMS Releases "Only Lightly Redacted" Versions of Theranos Audits

Truncated or heavily redacted versions of Theranos inspection reports have circulated in recent weeks, and have been posted at Wall Street Journal and elsewhere.

On April 25, the Wall Street Journal posted newly released, only lightly redacted documents.   A November 2015 inspection report is here.   A March 2016 letter describing potentially very severe sanctions is here.

The second letter carries the headline, "Important Notice - Please Read Carefully."

The WSJ writes in part,
Theranos ran tests on the [Siemens Advia 1800] by diluting small samples of blood pricked from patients’ fingers to increase the samples’ volume to fit Advia’s volume requirements, according to former employees. Ms. Holmes denied in October that Theranos diluted blood samples before running them on traditional machines. Since then, the company has declined to comment on the matter.
For additional links to Theranos journalism online, see www.tinyurl.com/theranoslinks