Federal inspection report reveals major problems at Theranos lab
- The Centers for Medicare and Medicaid (CMS) have released a 121-page partially-redacted report revealing a long list of deficiencies at Theranos' Newark, CA lab. The report reveals Theranos failed to meet some of its own quality-control checks as well as improperly storing blood samples.
- Other deficiencies included incomplete documentation, running tests with unqualified personnel, and failure to notify patients and physicians when results were flawed, according to the Wall Street Journal.
- A CMS letter sent to Theranos in February warned that deficiencies in the Newark, CA lab posed “immediate jeopardy to patient health and safety.” The report released on Thursday details those violations.
The CMS report revealed that 29% of quality-control checks on Theranos' proprietary testing device, known as Edison provided results which were out of range of the company’s own standards. This included blood tests for prolactin, prostate-specific antigen (PSA), vitamin D, and vitamin B12.
The Edison testing device was supposed to be a game-changer for blood testing, allowing pin-prick blood samples collected via Theranos' nanotainers to be used for fast, accurate test results. A round of venture-capital funding in 2014 affirmed this vision, leading to a valuation of $9 billion for the Palo Alto, CA-based company.
A spokesperson from Theranos, Brooke Buchanan, told the Wall Street Journal that Theranos has made mistakes, but has "dedicated every resources to remedy these failures." She also said that Theranos has a plan to correct the deficiencies.
In October 2015 a bombshell article in the Wall Street Journal revealed Theranos had been misrepresenting its lab-testing business and that the company was using the Edison to handle roughly 10% of their total testing.
Now, the recently released CMS report, based on federal inspections that took place between September and November 2015, shows the company frequently produced out-of-range test results using their proprietary technology as well as conventional technology. Based on the report, Theranos’ Newark, CA lab ran about 890,000 tests a year.
Regulators used test samples of stored blood plasma to assess testing accuracy and ensure that results were within two standard deviations of the accepted norm. They determined that a large percentage of the results were out of the acceptable range.
Theranos has taken steps to remedy these deficiencies and also hired a new lab manager, Kingshuk Das, who has implemented extensive new procedures. However, restoring Theranos' credibility in the eyes of customers and insurers will take time. The negative publicity surrounding Theranos’ tests have already had an effect. Capital BlueCross of Pennsylvania, for example, has suspended their use of Theranos until the shortcomings are addressed.
There is a possibility CMS will take punitive action against Theranos for the lab's failures due to its findings. In CMS’ February letter, the regulator warned continued noncompliance could result in civil money fines, or suspension/revocation of the lab’s certificate.