CLIA/COLA Compliance


When you work with Elite, you can feel confident about every laboratory certification and inspection because we know just about everything there is to know about CLIA and running a lab. With our 100% inspection passage rate our clients are quick to say how happy they are with their decision to hire Elite.

Before I hired Elite, my compliance effort was an absolute disaster. When the CLIA agent came by the first time, she stopped the inspection after about 30 minutes and told me not to run a single sample until I gave my lab a complete compliance overhaul.  I hired Elite the next day (literally). When the same CLIA agent came back a few weeks later, she couldn’t believe the difference.  Hiring Elite didn’t just make my lab run better, without Elite, I don’t think I’d even have a lab to speak of.

Randy T., Burlington NC - CEO of Regional Reference Laboratory

I'm not an expert in quality management and laboratory compliance.  But that’s OK because I found a partner in Elite that truly is. Hiring them allowed me to spend my time focused on my practice instead of trying to learn the ins and outs of all of those CLIA regulations and I’m so glad I hired Elite.

Dr. Felicia S., Charleston SC, Anesthesiologist Group

The first thing I did when I decided to open my own in-house lab in 2017 was hire Elite. I asked my lab director how the inspection went and he told me that Elite’s team knew more than the inspector.  After I saw the report without a single deficiency, I knew that I had made the right call bringing Elite onto my team.

Dr. Yemi O., Philadelphia, PA, Pain Management Practice


The Clinical Laboratory Improvement Amendments of 1988 (also known as CLIA) established a program to ensure that only quality laboratory testing was taking place around the country. And thanks to our Quality Management Team’s 100% success rate at preparing laboratories (and their personnel), Elite has rightfully earned a reputation with CLIA and COLA (the nation’s largest private accrediting body) as a nationwide leader in laboratory quality and compliance.

Let Elite use its expertise to complete all relevant applications (including the CMS-116) and prepare the laboratory team for the on-site inspection by a licensed CLIA agent.  We know the regulations inside and out – and we’re proud of that because there’s A LOT to know. You could spend thousands of dollars (and weeks on end) trying to get up to speed on everything (start with Subpart Q of the Code of Federal Regulations), with Elite by your side, Elite can handle it all for you and you can rest assured that a successful inspection is headed your way.

Elite’s Quality Management Team has led dozens of successful CLIA inspections and will have your lab ready to demonstrate unquestionable competence in the various aspects of the inspection including:

Preparing your team to accurately complete all phases of the testing process and perform all relevant laboratory procedures.

Preparing every member of the lab team for individual interviews.

Preparing the actual laboratory space with the relevant signage, safety equipment, and layout required by CLIA.

Preparing a package of data and records that can easily be turned over to the inspector, or its representatives, for review.

The above case-studies are for illustrative purposes only. Past performance is not indicative of future results, based on a variety of factors beyond our control or scope of services. We do not guarantee the accuracy or completeness of such information, and we assume no liability for damages resulting from or arising out of the use of such information. The performance numbers displayed herein may have been adversely or favorably impacted by events and economic conditions that will not prevail in the future.


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"These guys know tox. I spend about 40% less than I used to before I started running their method on my two LCMS instruments. When there’s a problem, I usually don’t even hear about it until after Elite has already fixed it.  I love that."

- Cody E., Reference Laboratory, Charleston, West Virginia