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_[2] before the change occurs. An eCLEP Permit Materials Manual_[3] is available for reference. For indirect ownership changes or other owner changes, please contact the Program at CLEPCERT@health.ny.gov_[4]. 

Please note: all changes in director must be made through eCLEP.  A request to change the director role for the laboratory affiliation record using the HCS Coordinator Tools function does not constitute sufficient notification. 

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_[5]

To request changes in contact information, hours of operation, etc., access eCLEP on the Health Commerce System (HCS)_[6]. An eCLEP Permit Materials Manual_[7] is available for reference.

To report a laboratory closure, please notify the Program via email to CLEPCERT@health.ny.gov_[8].

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)_[9].  An  eCLEP Permit Materials Manual_[10] 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)_[11].  An  eCLEP Permit Materials Manual_[12] is available for reference.

A list of common tests/analytes and procedures_[13] cross-referenced with the Department's testing categories is available. Laboratories applying for or holding a New York State clinical laboratory permit must participate 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 2023 - 2024 Permit Category Descriptions_[14].

Laboratories holding a New York State clinical laboratory permit in the category appropriate to the testing performed may offer FDA-approved (PMA), FDA-cleared (510K), FDA-exempted tests; tests holding an FDA Emergency Use Authorization (EUA), Investigation Use Only tests that hold an FDA Investigational Device Exemption, standard methods and legacy assays. No notification is required.

A standard method is defined as an assay that has an established record of reliability and clinical validity, and which employs a standardized protocol that is universally applied in laboratories that employ the method for the analyte, such application being consistent with industry standards recognized by leading authorities in laboratory science. These are, in general, methods in use prior to FDA’s 1976 Medical Device Amendments.

A legacy assay is an assay that was in use in the laboratory prior to April 24, 2003. Laboratories are required to verify or establish performance specifications for any test system. However, submission for review of Standard Operating Procedures Manuals and validation for any test system used by the laboratory prior to April 24, 2003 is not required, unless specifically requested. This is in accordance with the CLIA interpretive guidelines published by the Centers for Medicare and Medicaid Services for the establishment and verification of performance standards (§493.1253(a)).

Laboratories adding any of the test types listed above  which necessitates the addition of a new permit category on the permit must submit both the category via eCLEP on the Health Commerce System_[15] (HCS).  An eCLEP Permit Materials Manual_[16] is available for reference. Please see above for Adding or Deleting a Permit Category. Note that the laboratory may not offer this testing on NYS specimens until an amended permit to include the new permit category is issued.

Laboratories adding a non-FDA-Approved/Cleared test, (aka Laboratory-developed test), please refer to the Test Approval_[17] page.

A list of common tests/analytes/procedures_[18], cross-referenced with the Department's testing categories is available.

Updates and additions to POCT locations within a facility can be made by accessing eCLEP on the Health Commerce System (HCS)_[19].  An eCLEP Permit Materials Manual_[20] is available for reference.