Article 5, Title V of the New York State Public Health Law specifies that a laboratory permit is void upon a change in laboratory director, owner, or location.

All changes in laboratory name, owner name, director, assistant director, direct ownership, or location must be submitted to the Clinical Laboratory Evaluation Program via eCLEP on the Health Commerce System before the change occurs. An eCLEP Permit Materials Manual is available for reference. For indirect ownership changes or other owner changes, please contact the Program at CLEPCERT@health.ny.gov.

Submission of change in eCLEP is considered a new permit application. All changes are subject to Department approval. For example, an on-site survey may be required for a change in location, and approvals for changes in director are subject to review of the proposed director's commitments at other facilities and the performance of other laboratories under his or her direction.

A new laboratory permit will be issued for approved changes in director, location, owner or name of the laboratory once requirements have been met.

Disclosure of Ownership, Controlling Interest, and Corporate Membership Statement Form and Supporting Instructions

To request changes in contact information, hours of operation, etc., access eCLEP on the Health Commerce System (HCS). An eCLEP Permit Materials Manual is available for reference.

To report a laboratory closure, please notify the Program via email to CLEPCERT@health.ny.gov.

The following information must be included in the email:

• Laboratory PFI
• Effective date of the closure
• Location where laboratory records and specimens will be retained to comply with Part 58.1-11 (Title 10 of the New York Codes, Rules and Regulations)

Request to add or delete an assistant director by accessing eCLEP on the Health Commerce System (HCS).  An eCLEP Permit Materials Manual is available for reference. You must have the CQ Code for the individual in order to request this change.

Requests to add or delete a permit category by accessing eCLEP on the Health Commerce System (HCS).  An eCLEP Permit Materials Manual is available for reference.

A list of common tests/analytes and procedures, cross-referenced with the Department's testing categories is available here. Laboratories applying for or holding a New York State clinical laboratory permit must particpate in proficiency testing with a CMS-approved provider for all tests described in 42 CFR 493 subpart H and/or subpart I.

Add Category requests are reviewed by Program Staff upon receipt.  If requirements are met, the laboratory will be placed in “Applied” status for the category. The laboratory must successfully participate in required proficiency testing, on-site survey and method approval, as applicable, before an amended permit to include the requested category will be issued.

For a list of NYS Permit Categories please refer to our Permit Category Descriptions (2018 - 2019).

Laboratories adding an FDA-Approved/Cleared test under an existing permit category must submit the request via eCLEP on the Health Commerce System (HCS). An eCLEP Permit Materials Manual is available for reference. Upon notification, the laboratory may begin offering this test to clients.

Laboratories adding an FDA-Approved/Cleared test which necessitates the addition of a new permit category on the permit must submit both the category and test via eCLEP on the Health Commerce System (HCS).  An eCLEP Permit Materials Manual is available for reference. Please see above for Adding or Deleting a Permit Category.

Laboratories adding a non-FDA-Approved/Cleared test, please refer to the Test Approval page.

A list of common tests/analytes and procedures, cross-referenced with the Department's testing categories is available here. 

Updates and additions to POCT locations within a facility can be made by accessing eCLEP on the Health Commerce System (HCS).  An eCLEP Permit Materials Manual is available for reference.