Clinical Laboratory Evaluation Program

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. 

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 https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/test-approval. Under the current policy, a committee of sub

Revisions to the New York State Clinical Laboratory Standards of Practice are now available, including: Current Standards General Systems Standards Effective May 5th, 2021 Specialty Requirements by Category with Microbiology and Pathology Standards of Practice, effective May 2021  Standard Revisions

What can this tool do for me? It can tell you which labs perform a certain test, the name of the labs and where they are located. You can find tests performed within a given category for each approved lab and which sample type those tests can be performed on. Explore the new laboratory developed test search tool.

A new search tool is available to help laboratories find providers and products that meet NYS proficiency testing (PT) requirements for analytes described in 42 CFR Subparts H and/or I. Laboratories are required to notify CLEP of their PT enrollment choices each year in the Fall and whenever adding a new analyte to the test menu that is described in CLIA subparts H and/or I.