The 5 Most Common CLIA Citations — And How to Avoid Them

I spent 7 years walking into laboratories as a CLIA surveyor for the Arkansas Department of Health. In that time, I surveyed hundreds of labs — physician office labs, hospital labs, reference labs, you name it. And here's what surprised me most: the labs that got cited weren't full of people who didn't care. Almost every single one genuinely wanted to do things right.

They just didn't know where the gaps were until I pointed them out.

So today, I'm pointing them out to you — before a surveyor has to.

Here are the 5 citations I saw most often, and exactly what to do about each one.

1. Quality Control Documentation Gaps

This is the one I saw constantly, and it almost never had anything to do with the actual testing being wrong. It was the paperwork.

I'd walk in, watch a tech run QC flawlessly, and then ask to see the records — and find missing initials, gaps in dates, or corrective action that was never documented even though I could tell something had clearly gone sideways at some point.

Here's the thing: surveyors can't cite what they can't see, but they also can't ignore what your records show — even if the real-world practice was fine.

How to avoid it: Review your QC logs at least monthly. Notice any results that were repeated and ask yourself: if a surveyor saw this today, would it tell the full story? Would corrective actions be documented every single time a control was out? Were patient results reviewed any time a change occurred to the test system — like a calibration or a new reagent lot? 

2. Personnel Competency Assessment — Missing or Incomplete

CLIA requires documented competency assessments for ALL personnel, and this is one of the easiest things to let slip when everyone's busy.

What I saw most often: competency assessments not performed twice in the first year of employment, no assessments for clinical or technical consultants, or missed altogether. Even worse were assessments that were technically done, but the documentation didn't clearly show all six required elements were actually evaluated.

How to avoid it: Build competency assessments into your calendar — annually, without exception, for every laboratory person. Use a form that maps directly to the required elements so nothing gets missed in the documentation, even if it was done in practice.

3. Proficiency Testing — Unsuccessful Results Not Investigated

PT is one of the most visible parts of your compliance program, which is exactly why surveyors look closely at it. The citation isn't just "you failed PT." It's "you failed PT and didn't document what you did about it."

An unsuccessful PT result requires a documented investigation — even if you already know exactly what happened. I saw plenty of labs that fixed the issue immediately but never wrote down the why or the corrective action.

How to avoid it: Create a simple PT investigation template now, before you need it. When an unsuccessful result comes in, you should be able to fill it out in 10 minutes rather than scrambling to remember what happened weeks later.

4. Procedure Manual Not Current

Your procedure manual is supposed to be a living document — updated when methods or equipment change, signed off by your current laboratory director.

What I found again and again: manuals that were clearly written years ago, with no documented review by the current laboratory director, and procedures that no longer matched what was actually happening at the bench. Procedures for old methods or equipment that had not been removed. No new procedures for the testing that replaced them.

How to avoid it: Set a recurring annual reminder to have you and staff review the manual for any outdated procedures. If your testing process changes mid-year, update the relevant section immediately rather than waiting for the annual review to catch up.

5. Temperature Monitoring and Equipment Maintenance Logs

This one feels small until it isn't. Refrigerator and freezer temperature logs with gaps. Equipment maintenance that was performed but never logged. Corrective action for an out-of-range temperature that isn't documented anywhere. Reagents stored in the wrong conditions because the acceptable range on your chart doesn’t match the manufacturer’s storage requirements. 

It's tedious, routine work — which is exactly why it's where things slip.

How to avoid it: If you're not already using automated temperature monitoring with alerts, it's worth the investment. If you're still doing manual logs, build a habit of a daily 5-minute check rather than trying to fill in gaps after the fact. Regularly compare the manufacturer’s requirements for the reagents or supplies stored in a refrigerator or freezer with the acceptable range on the log.

Key Takeaways

• Most CLIA citations come from documentation gaps, not bad practice

• Surveyors evaluate what your records show — not just what actually happened

• The fix for all five of these is the same: build small, consistent habits now instead of trying to recreate documentation later

• None of this requires fear or panic — it requires a system

Want a tool that helps you catch these gaps before a surveyor does?

Grab my free Top 10 CLIA Deficiencies Checklist — it walks through these citations and more. [Download it here]

That Lab Chic is an educational resource and does not constitute legal or regulatory advice.