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Question:

The provider wants to bill toxicology tests for his patients. Are there any requirements for this?

 

Answer: 

If you are doing any on-site laboratory testing using test devices, you need to obtain a license from the NYS Department of Health. 

 You will need to register as either a Limited Service Laboratory or a NYS Clinical Laboratory depending on the testing performed, and the devices used to do that testing. 

Limited Service Laboratory

Providers interested in performing on-site laboratory testing using test devices categorized by the Food and Drug Administration (FDA) as Waived must apply for a Limited Service Laboratory Registration Certificate

NYS Clinical Laboratory

Providers interested in performing on-site laboratory testing using test devices categorized by the FDA as Non-Waived (Moderate or High complexity) must apply for a NYS Clinical Laboratory Permit

 

Thanks to JenyaY.

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September 2018