January 29, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – Walgreens, which has partnered with Theranos to provide blood testing in its stores, does not want the company to send any tests to its Newark, Calif. facilities following a scathing report showing “deficient practices” that “pose immediate jeopardy to patient health and safety.”
Walgreens is suspending Theranos laboratory services at its Palo Alto, Calif., store, effective immediately, the company said in a statement issued Thursday. Their actions came within hours of a scathing report from the U.S. Centers for Medicare & Medicaid Services.
“Walgreens informed Theranos that tests collected at 40 Theranos Wellness Centers located at stores in Arizona must be sent only to Theranos’ certified lab in the Phoenix area or to an accredited third-party lab for analysis. No patient samples will be sent to the Newark lab until all issues raised by CMS have been fully resolved,” Walgreens said.
Additionally, Walgreens has toyed with the idea of closing its 40 Theranos centers at stores across Arizona, Reuters reported this morning, citing unnamed sources who spoke to the Wall Street Journal.
The warning letter from the Centers for Medicare and Medicaid Services 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 warning letter from the Centers for Medicare and Medicaid Services 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.
This morning Brooke Buchanan, vice president of communications at Theranos, said the company is working to fix the issues identified at the Newark facility. She also said the company continues to work with Walgreens to provide access to “reliable, high quality, and low-cost lab testing services.” Buchanan added Theranos remains confident in its technologies.
“This is an issue that many other labs have faced, and we have been and will fix it quickly and completely, working with our regulators as we always do,” Buchanan said.
Theranos said the deficiencies found in Newark does not reflect the whole of the site, nor does it include the company’s Arizona facility, where it says more than 90 percent of its testing is done. However, Buchanan told CNN that Theranos will shut down its Newark lab until the issues are addressed.
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.”
