Federal Regulators Find Conditions at Theranos Lab That Pose "Immediate Jeopardy to Health"

January 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PALO ALTO, Calif. – Federal regulators warned blood-testing company Theranos this week that its Newark, Calif. Laboratory has “deficient practices” that “pose immediate jeopardy to patient health and safety,” the Washington Post reported this morning.

The warning letter from the Centers for Medicare and Medicaid Services is another setback for the company, which has faced its share of scrutiny over its equipment and practices from the media and federal regulators on multiple occasions over the past year. Following a Nov. 20 inspection, the letter, which was released this week, told Theranos that its laboratory practices at the Newark site were not in compliance with conditions set forth by the federal Clinical Laboratory Improvement Amendment (CLIA). The letter said the company’s hematology practices at that site “posed immediate jeopardy to the health and safety” of patients. The letter defined immediate jeopardy a situation in which corrective action is necessary due to the laboratory's non-compliance, which “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 the health and safety of the general public."

The letter noted deficiencies in Theranos’ hematology practices, its analytic systems and also issues with three employees. Theranos has 10 days to comply with the issues raised by regulators, which Theranos said it will do.

In an email sent to BioSpace by Brooke Buchanan, vice president of communications at Theranos, the company said the deficiencies found in November do not reflect the current state of the Newark lab. It also noted it has made some personnel changes, including the hiring of a new CLIA lab director.

“As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems,” Theranos said.

Theranos said the deficiencies found in Newark does not reflect the whole of the site, it does not include the company’s Arizona facility, where it says more than 90 percent of its testing is done.

To quell any concerns about the state of the company’s laboratory practices, Buchanan said “Theranos has voluntarily committed to FDA review of its laboratory-developed tests and publishing its prices, lab proficiency testing pass rate, customer satisfaction scores, guest visit times, and more, to realize a system in which individuals become more engaged with their health, and early detection and prevention of disease become realities.”

Buchanan also pointed out what she said have been some inaccurate allegations mentioned in some media reports. She said the Centers for Medicare and Medicaid Services found nothing to support allegations of proficiency testing “cheating”; an allegation that management “instructed lab employees to keep testing patients” despite indications of purported problems; an allegation that Theranos improperly hid the existence of its lab holding its proprietary technologies; and an allegation of a “dilution” protocol causing inaccurate results.

This is not the first time Theranos, a $9 billion company, has been criticized for its laboratories. Following an inspection of its labs earlier this summer by the U.S. Food and Drug Administration, federal regulators called the company’s proprietary Nanotainer tubes an uncleared medical device. Regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary Nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. As a result, the FDA said Theranos is “currently shipping this uncleared medical device in interstate commerce between California, Arizona and Pennsylvania.” Other observations made by FDA inspectors include a criticism that a method for addressing complaints regarding a possible failure of the device to meet its specifications were not “reviewed, evaluated and investigated where necessary.”