Published on New York State Department of Health, Wadsworth Center (

Obtain a Permit

Apply for a Clinical Laboratory Permit

A clinical laboratory permit will be issued when:

  1. The laboratory director and any assistant directors have been issued Certificates of Qualification[16] in all applicable categories relevant to the laboratory permit application.
  2. The laboratory participates in an On-site Survey[17]  by a CLEP clinical laboratory consultant(s) and any deficiencies have been corrected.
  3. The laboratory has successfully participated in Proficiency Testing[18] (or alternate assessment, as applicable) for all permit categories sought on the application. *NOTE: THE LABORATORY MUST AUTHORIZE THEIR PT PROVIDER TO RELEASE PT RESULTS TO NY IN ORDER TO BE ELIGIBLE FOR A PERMIT. Instructions are available in our Proficiency Testing Guide on our PT webpage. 
  4. The laboratory has received Test Approval[19], as applicable.
  5. The laboratory director has obtained a Health Commerce System[20] account and affiliated that account with the laboratory. 
  6. All applicable fees[21] have been paid.