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What I Need To Do Labs In The Office with Dr. Heather Signorelli

The Private Medical Practice Academy

What I Need To Do Labs In The Office with Dr. Heather Signorelli

December 20, 2022

What I Need To Do Labs In The Office with Dr. Heather Signorelli

You never know when your mother-in-law will turn out to be a valuable asset to your practice. Mine was a lab technologist who had started up and ran multiple medical labs.  When we told her that I had decided to start my own practice, one of her first questions was “what labs are you planning to do?” followed by you need a CLIA Waiver.

Say what? 

I had no idea what that was or how to get one. The test said was CLIA Waived. Doesn’t that mean that you don’t need a CLIA?

A CLIA Waived test just means that there are fewer associated rules to follow. You still need to apply for and get a CLIA Waiver. Even for real simple stuff like doing point-of-care lab tests in the office. You want to do a UA or a rapid strep test. Or maybe a urine drug screen or pregnancy test. 

In this episode of The Private Medical Practice Academy, I chat with Dr. Heather Signorelli, a pathologist who has started and ran multiple labs. We discuss CLIA (Clinical Laboratory Improvement Amendments–in case you were wondering) and the different CLIA programs and their requirements.

Apply for a CLIA: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories

How to get a CLIA waiver: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf

CLIA Waived tests: https://www.cdc.gov/clia/docs/tests-granted-waived-status-under-clia.pdf

If you are doing any labs in your office or are thinking about adding them, you won’t want to miss this episode! Also, remember–you can earn 1 AMA PRA Category 1 CME for completing the reflection after listening to the podcast. Click here to reflect and unlock credits & more.  

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