The blood testing startup Theranos got a little more time, Friday.
The Centers for Medicare & Medicaid Services sent this statement today:
“At the request of the laboratory’s director, Theranos was granted an extension until February 12 to submit their response to the CMS inspection report. This is a routine procedure in oversight of clinical labs.”
A CMS inspection of the lab, in Newark, California, had found deficiencies that “pose immediate jeopardy to patient health and safety,” according to a CMS letter sent to Theranos.
Immediate jeopardy, as defined by CMS, means “a situation in which immediate corrective action is necessary because the laboratory’s non-compliance … has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”
Originally, Theranos had been given 10 days from receipt of the letter to correct the deficiencies. That deadline was today.
CMS also directed the company to take “corrective action” for affected patients.
Theranos sent this statement about the extension:
“We are working to submit our plan of correction to CMS, addressing every issue raised in the audit report regarding the Newark, CA lab and will continue to actively work with them. CMS has granted an extension to February 12 for submission of our plan of correction, to allow our new Lab Director, Dr. Das, additional time to review our comprehensive response.”
So … what should people whose blood has been tested by Theranos do in the meantime?
I asked a CMS spokesperson if the agency had any advice for those folks; she declined to respond.
Theranos did not respond to two queries asking the same question.
Medical Ethicist Weighs In
What does an expert in medical ethics think?
Hank Greely is the director of Stanford’s Center for Law and the Biosciences. He said in an email that “it wouldn’t shock” him if CMS’ assertion of potential fatal consequences wasn’t literal.
He said the language “is enough to at least raise serious questions about getting customers/patients to get new tests.”
Greely said the haste in which Theranos should be obligated to contact potentially affected patients would be determined by the substance and frequency of the errors CMS found.
“If they got substantial error rates on a particular kind of test (I don’t know – total cholesterol), I would think they need to tell the customers who got that test. If instead they had a relatively low error rate (though still too high) scattered across all their testing, figuring out who to tell what is trickier. And some kinds of lab tests are going to be more critical than others.”
Greely said he thought it would behoove Theranos to offer affected patients or even every patient a free retest, if it was able to do so.
“Good PR, good for the patients (if the retests are accurate), and, if their tests are as cheap as they say they are, not expensive.”
Greely said though the details of disclosure are complicated and depend on many factors, “the idea that you should not let your customers rely on test results you have reason to think had a good chance of being inaccurate is not [complicated].”