When Quality Management Fails, the Consequences Can Be Dire

In your job, do you ever lose sight of the big picture?

It’s easy to do. As we go about our workdays, checking items off the list, we’re often so focused on the what that we forget to take a breath and reflect on the why.

Quality management is not for the faint of heart. This profession can hold lives in the balance, whether you’re a supplier quality manager for an aviation company, an auditor for a pharmaceutical brand, or a quality-control expert for a laboratory.

The why of what you do is critical: you prevent disasters from happening. That’s huge, although not necessarily something you think about every day.

Theranos: A Cautionary Tale

But every so often, a story pops up in the news that reminds us of why quality management is so valuable. It’s not just about protecting the bottom line, or issuing NCRs, or filling out forms. It’s about making the world a better place, making people a little bit safer, one inspection at a time.

The rise and fall of California-based Theranos—the sexy start-up laboratory that promised to revolutionize blood testing—is a cautionary tale that highlights the importance of quality control, and the real life consequences that poor quality management practices can have. People were harmed because of Theranos’s failure to maintain even the most basic safeguards.

Here’s how bad it was: an inspection from the federal Centers for Medicare and Medicaid Services (CMS) revealed that 29% of the quality-control checks run in October 2014 exceeded Theranos’s threshold of two standard deviations from its average result. 80 percent of these red flag QC checks were more than three standard deviations from its average—these numbers don’t exactly inspire confidence.

The results are devastating, both for financial and human reasons. Patients have filed at least 10 federal class-action lawsuits against Theranos in Arizona and California, and the federal government revoked the company’s California lab license in July 2016. Theranos Founder and CEO Elizabeth Holmes has been banned from the blood testing business for at least two years. Ouch.

It’s Not Just About the Bottom Line—It’s About People

The human devastation, as you can imagine, is both serious and hard to quantify. Each bogus test result was delivered to an unsuspecting patient, taking a massive emotional toll. Imagine being told you have diabetes or a cancerous tumor when you don’t: your life is turned upside down.  And the physical tolls are no less significant—many patients altered their treatment plans due to the results they received.

Of course, no laboratory is perfect—inaccurate tests can happen at any lab, but not on this scale. Theranos failed to implement a rigorous and disciplined quality management process, and thousands of patients suffered as a result. Theranos, once the darling of the lab-tech space, now finds itself in freefall, with no bottom in sight.

Quality professionals, we invite you to read more about the patients hurt by Theranos as you reflect on what a meaningful job you have. We at ARMATURE think about it often—the software we build supports quality management in a range of key industries, and there are people whose lives are safer, healthier, and richer as a result of our collective focus on quality.