How can the New York State Department of Health Clinical Laboratory Evaluation Program help you today?

Laboratory Standards

CLEP Program Guide

Apply for a Permit

Permit Modifications

Re-apply for a Permit

Health Commerce System (HCS)       

Limited Service Laboratories

Certificate of Qualification (CQ) Applications     

Cytotech Registrations

Lab Developed Test (LDT) Approval         

On-Site Survey Process / Facility Personnel Form (FPF)

If you need assistance with something else, we encourage you to use the purple menu to the right, or contact the program with a concern.

Program Updates

Test Approval

Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing on specimens originating from New York. Review of laboratory-developed tests (LDT) begins after the clinical laboratory permit application has been submitted.  Please refer to our Obtain a Permit page. LDT review is not offered as a stand-alone service. 

CLEP Releases LDT Review Data

There is national interest in the Laboratory-Developed Test (LDT) review process implemented by the Clinical Laboratory Evaluation Program (CLEP) of the New York State Department of Health.  CLEP has been reviewing LDTs since 1991.  Our review process has changed over the years, but our current review policy is described in detail on our website Under the current policy, a committee of sub