Adding new test

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Adding new test Posted: Thu Mar 24, 2016 11:58 am
I have recently added a new test in my laboratory. Do I need to notify CLIA of this addition to my test menu?
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Re: Adding new test Posted: Mon Mar 28, 2016 6:14 am
When ever you add or delete a test in your test menu you must notify CLIA within 60 days of the change by sending a letter to your local CLIA office. Be sure to include your CLIA ID number. If the test is non-waived you will need to perform proficiency testing. Contact your PT provider as well to make sure you have the correct test module. In addition if your new test is a different specialty than what you currently have on your CLIA certificate you will need to fill out CMS form 116 to add this specialty.

If you are a COLA lab you must contact COLA within 30 days.
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