Data Integrity and Theranos: Lessons from the Extreme Non-Compliance 
[Posted on: Thursday, 05 May , 2016]

When we hear about data integrity issues these days, the obvious perception is of a facility in India or another foreign country getting caught trying to manipulate results. However, for a change (pun intended) this week we are talking about Theranos, a diagnostic lab in California with branches in Arizona and New Jersey, with serious data integrity issues. Last week the CMS released lightly redacted reports of its audits at Theranos. These findings will not come as surprise to those following news about the company since last Oct when FDA auditors found many issues with the documentation, training, and compliance at Theranos’ labs in New Jersey and California. Since then there have been a steady stream of negative news about Theranos. Popular media is filled with tales about how secretive the CEO of the company was that she won’t tell their own investors about how their “famed” platform technology works or how all major venture capitalists shunned the company, or how almost everyone on the Board of the company was barely knowledgeable about the science of the company. Theranos has used the LDT process to offer a unique blood test where it claimed to provide most blood chemistry tests from a pin drop of blood. On the surface the technology would involve a major scientific breakthrough in detection technology. CMS audit confirmed what was hinted by the FDA auditors last year, in that the Theranos device, called Capillary Tube Nanotainer, was not accurate, validated or even used a lot by the company. The company did not follow several critical SOPs, did not document all the results, did not investigate deviations, did not get the SOPs approved by the qualified lab directors, did not validate vendors, and did not store records adequately. The 45 page report from CMS provides a scathing list of violations by Theranos, mostly related to integrity and reliability of data generated at the lab. The findings were so severe that CMS threatened to ban the CEO of the company from operating any lab for 2 years. There is also a criminal investigation in the works to find if the company deceived its investors and risked the lives of patients with erroneous results. There are several lessons here for the regulated industry. Data integrity issues can happen everywhere. Training and independent audits of facilities are necessary to avoid data integrity issues. Regulated industry has to focus on complete documentation. Many of the findings against Theranos came from the discrepancies between what personnel told the auditors and what was written down. Approval of processes must happen before they are implemented. Several critical SOPs at the labs, which were supposed to be signed by the lab director, were signed many months after they were implemented. All deviations must be investigated and appropriate CAPA undertaken. Unfortunately, these findings are not unique to Theranos, but are widely seen at many CLIA labs which are not audited by FDA. According to FDA, CLIA certification is not a sufficient standard for diagnostic tests and this case is a good example in support of FDA’s argument. This news should be a wake-up call to all regulated labs to revisit their processes to evaluate existing processes and need for improvement.