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More Than Just a Number

Published May 2, 2016 1:07 PM by Stephanie Noblit

To work in the clinical laboratory profession is to be someone that upholds the highest standards of quality and patient safety, right? I think the majority of my colleagues would agree with that.

Working in our profession, we do have the ability to say honestly that we save lives every day, but there is something about that statement that goes unsaid. We don’t feel the need to say, “When I do my job correctly, I save lives.” Most of us would never feel the need to say it like that because we don’t see any other way of doing our job. We result accurate results or we result nothing. We run QC morning, noon and night; we fill out log sheets; we study trends, graphs and means; and we run every calibration and proficiency that comes our way. Many labs even have at least one person that oversees quality.

Now, truth be told, many laboratorians and QC don’t always get along. I think it would be fair to say that everyone working in the clinical lab has a few QC horror stories, but despite all of that, we still run QC! And as I’m sitting here writing this, I’m thinking about how silly this all sounds. What I’m thinking in my head and what you are probably thinking too is, “Of course I still run QC, why wouldn’t I?”

I can’t imaging reporting something out without first insuring my QC was acceptable, so I was shocked to read about some of the QC practices (or lack thereof) that were occurring at Theranos. In an article1 by Sten Westgard of Westgard Rules, he detailed some of the QC issues that were cited by CMS. Theranos had many Westgard Rules in place in their SOP’s, but did not follow them. CMS also cited Theranos for repeating QC multiple times after it was out without performing a calibration or troubleshooting. On one day, CMS noted that Theranos ran a control 12 times without obtaining an acceptable value.

What’s scary about this is that QC is the only way we know our patient values are correct. I’ve heard this phrase many times from many laboratorians, “Without proper QC a result is just a random number.” When we do our jobs correctly, we do have the power to save lives, but if we do it incorrectly, we can really harm someone. I’m very concerned about the wellbeing of the patients whose lab tests were run at Theranos during these times of poor QC, but I’m also worried that Theranos’ mistakes will cause people to have a distrust of all labs.

We go into the lab every day and do everything we can to insure our tests and instruments are accurate. We work to insure patient safety and quality assurance every day, and we must make an effort to inform our patients of that. True lab professions get accurate results!

 

References:

1. http://james.westgard.com/the_westgard_rules/2016/04/another-thing- about-theranos.html

1 comments

Well stated, Stephanie.

Laboratorians are taught the importance of QC at the start of their clinical training.  Throughout months of training in all the various laboratory departments QC stands at the forefront again and again.  We must carry this with us from graduation day throughout our careers.  This is what gives us the confidence, trust and piece of mind needed to meet the challenges in the ever changing world of laboratory medicine.

Ed Beitz, Medical Lab Science - MLS Prog Dir, WellSpan Health September 2, 2016 7:50 AM
York PA

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