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Clinical Laboratory Evaluation Program

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

CLEP Releases LDT Review Data

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...
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Polarized light image of glucose. Richard Cole, Wadsworth Center

The Permit Reapplication Period Opens April 03, 2023

It is now time to re-apply for your clinical laboratory permit. Please review the attached Reapplication Instructions.

Additional reference documents:

  • ...
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Revised Standards are now available

Revised Standards are now available

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...
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Laboratory Developed Tests Search Tool

New Tool to Search Laboratory Developed Tests

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.


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CLEP Program Update

CLEP Announces New PT Survey 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...

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