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Ask the Expert - Do I need a CLIA license if I perform a lab test even if I’m not billing for it?

Thursday, February 01, 2018


The landscape for lab testing is changing and we must be able to adapt or go up in a puff of smoke! All is not doom and gloom, we can prevail.

Here are some tips related to testing, billing, etc.

Do I need a CLIA license if I perform a lab test even if I’m not billing for it? 

YES. Billing or not billing for a test has nothing to do with compliance. CLIA does not care if you get paid, they only care if the test is being performed correctly. You must have a CLIA license and any state required license (if applicable) to perform even one test.

I must be billing the right code for my lab testing because I am getting paid for it.

Just because insurance is paying you, does not mean you are billing the correct codes, it just means you haven’t got caught or audited yet. If you face an audit, they can take back the incorrect payment revenue. Double check you coding each year to make sure you are billing correctly.

We have a CLIA Certificate of Waiver so we really don’t have any requirements and aren’t going to be inspected.

WRONG. CLIA requires that for all waived testing performed, you must follow the manufacturer’s guidelines for running that test. The package insert that comes with the test outlines how the test is to be performed, stored, and the controls that must be run.

CLIA inspects about 5% of Waived labs each year. You can have your lab testing shut down if they feel you are putting your patients in jeopardy by not following the guidelines.

For kit tests, I just buy whatever is cheapest when I reorder.

Bad idea. Let’s look at Strep A tests for example. When you switch brands, the way the test is performed may change (i.e. different incubation times, numbers of drops of reagent, etc). If you change, does everyone get documented on training for the new method? Also the accuracy of kit tests can vary greatly. Check the package inserts and buy the ones with the highest accuracy to get the best results for your patients.

CLIA and the accrediting agencies are focusing on employee competency and training.

CLIA expects the following six items to be part of any competency evaluation for an employee.  Some items may not be applicable to kits tests, but most items apply.

  1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing
  2. Monitoring the recording and reporting of test results
  3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
  4. Direct observation of performance of instrument maintenance and function checks
  5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples 
  6. Assessment of problem solving skills


I Hope these tips help out. To stay up to date on all CLIA regulations visit:







Expert Contributor for Physicians Office Resource