UPDATE: Feds give Theranos one more week to respond to damaging CMS inspection
UPDATE 2: Theranos on Friday, February 5 announced that CMS has given the company a one-week extension to respond to the deficiencies it outlined in a letter on January 25.
"CMS has granted an extension to February 12 for submission of our plan of correction, to allow our new Lab Director, Dr. [Kingshuk] Das, additional time to review our comprehensive response," Theranos spokeswoman Brooke Buchanan said in a statement, according to Bloomberg.
UPDATE: In response to the CMS report described below, pharmacy giant Walgreens has decided to temporarily shut down one of the Theranos "Wellness Centers" in Palo Alto, California and said that it would stop sending blood samples to the laboratory in Newark, California cited in regulators' report.
Walgreens will suspend the use of this site until the relevant issues "have been fully resolved," the Wall Street Journal reports. Theranos has 10 days to solve the issues called out by CMS, one of which includes a hematology-related concern which the agency says poses an "immediate jeopardy to patient health and safety."
- Federal regulators at the Centers for Medicare and Medicaid Services sent "nanotainer" blood testing firm Theranos a letter on Monday warning that deficiencies at one of the company's laboratories in Newark, California posed "immediate jeopardy to patient health and safety." The letter was released on Wednesday.
- Theranos has 10 days to correct the deficiencies cited by CMS and risks sanctions and loss of certification if it is unable to do so. The company said in a statement that it will release a full plan of correction to CMS "within days."
- The Wall Street Journal first reported that these deficiencies had been identified on Sunday.
Here's the full letter from CMS:
While the CMS letter identifies a number of deficiencies, the one cited as an "immediate jeopardy to patient health and safety" relate to hematology.
"This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab," said Theranos in its response to the letter. "We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action." The firm has also installed a new lab director and clinical consultant.
From a practical standpoint, the deficiencies shouldn't put too much of a damper on the Theranos' ability to conduct its tests since much of it is conducted in its Arizona facilities. But this does add to a slew of critical reports and allegations that have been lobbed against the firm in the last year, as well as the FDA's warning to the company that it considered Theranos' proprietary tests unapproved medical devices and that the company had to stick to its single cleared herpes test when using the finger-prick tech.
One major question is whether or not this latest revelation will affect Theranos' relationship with the pharmacy giant Walgreens, which has reportedly been mulling its options when it comes to the two firms' business arrangements. Theranos has a deal in which it provides testing services in 41 Walgreens "Wellness Centers" in California and Arizona. (UPDATED ABOVE)
The CMS letter did not mention the other allegations that have centered on Theranos, all of which the firm has vehemently denied. That includes complaints from former employees claiming that the company told workers to continue conducting the nanotainer tests despite risks of inaccuracies; allegations that the firm tried to shield its proprietary tech from scrutiny; and allegations that Theranos diluted its finger-prick blood samples.