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Regulations and Guidance

Regulations

Physician office laboratories are regulated by federal regulations.

Public Health Law

In New York State, there are 2 programs that issue CLIA certificates based on the exception in the Public Health Law (§579.1) that dictates to which Program the facility will submit an application.  In order to meet the POL exception, the facility must be entirely owned and operated by a physician or group of physicians, perform laboratory tests, personally or through their own employees, solely as an adjunct to the treatment of their own patients.  

To read this law, please follow the link, then click "PBH", then "Article V", then "Title 5" and finally "579".

Guidance

Brochures