"But a more than 100-page report published Thursday says the lab was struggling with basic procedures, had poorly trained staff, and gave patients test results even when the company knew they could be wrong."
"Although some tests were in good agreement across all three providers, such as triglycerides and red blood cell counts, others diverged -- "good" HDL cholesterol and white blood cell counts, for example. Theranos was 1.6 times as likely to report abnormal results as Quest Diagnostics and Laboratory Corporation of America Holdings.
Wonkblog Study raises questions about accuracy of some Theranos blood tests By Carolyn Y. Johnson March 28
A new study has found that the proprietary technology behind the embattled blood-testing startup Theranos was substantially more likely to flag results as abnormally high or low compared with other companies -- a difference that raises concerns about the accuracy of those Theranos tests. Theranos also rejected samples, requiring they be redrawn, 12 times as often as the two dominant blood testing laboratories in the United States and reported consistently lower cholesterol numbers.
The study, published in the Journal of Clinical Investigation, drew concern from specialists in clinical testing. Although some tests were in good agreement across all three providers, such as triglycerides and red blood cell counts, others diverged -- "good" HDL cholesterol and white blood cell counts, for example. Theranos was 1.6 times as likely to report abnormal results as Quest Diagnostics and Laboratory Corporation of America Holdings.
"People know if your cholesterol is over 200, perhaps you need to do something about that. And they know that because a '200' is a '200,' pretty much anywhere you get your testing done," said Patricia Jones, the president of the American Association for Clinical Chemistry. "The fact that Theranos's results are significantly different, I find concerning. There is allowable error in diagnostics, but according to the paper, Theranos exceeded the total allowable error in that test."
"Despite not having completed the proper training, members of Theranos' Newark, California laboratory staff ran and reported test results to patients over a period of months in 2015. The document also reveals that Theranos put its customers at risk when it failed to have a manual on hand that outlined the actions staff needed to take when quality control results didn't meet the lab's own criteria. In addition, Theranos failed to document calibration of the machine it uses for hematology tests. It also didn't ensure proper quality control for a test used to determine how long blood takes to clot before reporting results to patients. A CMS spokesperson declined to elaborate on the contents of the document."
As I stated yesterday, there are other criminal investigations underway that are unrelated to the securities law issues - they are serious and people IMO will likely go to prison for the East Bay lab. And those that avoid prison will be banned for life from any meaningful position in a company subject to FDA regulation (lifetime debarment - lawyers gett 'disbarred' butt the FDA 'debars' people from working in FDA-regulated entities).
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