Yes, 2 year bans have been imposed on other clinical blood testing labs but available data also suggest sanctions such as those imposed on Theranos, and on Elizabeth Holmes as its CEO, may be extremely rare.

Sanctions Were Imposed By Centers for Medicare and Medicaid Services (CMS), Not FDA

Sanctions on Theranos, and on Elizabeth Holmes as its CEO, weren’t imposed by the FDA.

CMS is the US federal regulator that oversees Clinical Laboratory Improvement Amendments (see below from 1).

‘CLIA applies to all laboratories that examine “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” (see 42 U.S.C. § 263a(a)).’

This is why CMS has oversight over the laboratory activities of a CLIA-accredited clinical blood testing lab like Theranos. Such labs draw blood samples from patients, perform a bunch of tests on them and report results either back to them or to the physicians who requested those tests.

CMS Sanctions Imposed On Theranos In Letter Dated July 7, 2016

Next, what exactly were the sanctions imposed by CMS on Theranos, and on Elizabeth Holmes as its CEO?

The relevant sanctions in CMS’ 33-page report were (see below from 2)

How Frequent Are CMS Sanctions On CLIA-Accredited Labs? Apparently Extremely Rare

A 2004 assessment (see below from 3) of sanctions imposed by CMA shows that they’re extremely rare.


1. https://www.cms.gov/Regulations-…

2. https://sqps.onstreamsecure.com/…

3. Ehrmeyer, Sharon S., and Ronald H. Laessig. “Has compliance with CLIA requirements really improved quality in US clinical laboratories?.” Clinica chimica acta 346.1 (2004): 37-43. https://www.researchgate.net/pro…