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CLIA Quality System Regulations
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Last month, I started a new job.

Those of you who follow my blog might find this funny. A few months ago I wrote about being "The New Kid in Town." When I wrote that blog, I had no idea I would be living in just a few months later. But I will save that story for a future month. 

One week before starting, I received a call from the owner asking for technical assistance. A customer was concerned because a high percentage of their patients we’re being reported as having abnormal white cell differential counts.  With no Laboratory Manager on-site, she was hoping I could assist with this concern. 

I took the customers information along with the patient information so that I could fully research they concerned. I figured that would buy me some time. Having only been in the lab for interviews, I was not familiar with this customer nor with our analyzers and reference ranges.

I referred to my tried-and-true troubleshooting skills; the ones that I train every new tech in my lab. 

The key "Start at the beginning."


I needed to find out what I could about this customer. They were a new customer of ours and that was part of the reason for their concern. Our reference ranges were different from their previous lab period so one of the first things noted was this customer is located 2000 miles from my laboratory. (I work in a national reference lab) Geographically, they are in a very different area than my laboratory.


I needed to look at the results. Having wasted an immeasurable amount of time in my career researching errant concerns, I learned,always verify the concern.  Simply put, you cannot fix that which is not broken. I researched a few of the examples that were given to me.  Upon review I discovered that all of the examples provided were reported as having an abnormal white cell differential. The concern is valid.


I needed to evaluate the correctness of the results.  Where they accurate? Was this variation significant?  What should I do from here?

All of these questions, and more will be answered at CRI®’s Symposium for Clinical Laboratories, April 5 – 8 at the Tropicana in Las Vegas, Nevada. Where attendees will participate in EDUCATION FOR LABORATORY EXCELLENCE – making a positive impact for quality patient care. 

I hope to see you there.

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