Single Use Permits | New York State Department of Health, Wadsworth Center

The Single Use Permit application process has replaced the Non-Permitted Laboratory Test Request process effective immediately.

The Single Use Permit application process serves as a pathway to authorize testing at laboratories that offer unique testing that is not available from permit-holding laboratories or has not yet received full approval from the Department as a laboratory-developed test. All laboratories performing testing, however, must hold a valid CLIA number in accordance with federal regulations.

Key Takeaways:

Application for a Single Use Permit must be made by the TESTING LABORATORY using a new module of eCLEP called eCLEP-SUP. We will no longer be accepting applications from the ordering source/referring provider/referring laboratory.
Single Use Permits will be issued to the TESTING LABORATORY ONLY via a new module of eCLEP called eCLEP-SUP. We will no longer be faxing copies of the approval to ordering source/referring provider/referring laboratory.

Access to eCLEP-SUP requires a Health Commerce System (HCS) account. Follow instructions on our Health Commerce System webpage to create and affiliate Director, HCS Coordinator and other User accounts (e.g., CLRS Single Use Permit/Test Entry Coordinator and Delegated Submitter).

An HCS User does not need eCLEP Delegated Submitter status to access eCLEP-SUP. Instead, your laboratory’s HCS Coordinator can assign the role of CLRS Single Use Permit/Test Entry Coordinator using their ‘Coordinator’s Update Tool’ on HCS.

eCLEP-SUP Access Quick Start Guide Oct 2025

More information on the Health Commerce System:

The Health Commerce System (HCS) is the secure website for web-based interactions with the New York State Department of Health. Every individual accessing the Health Commerce System must have their own HCS account. Sharing of an account user ID and password is a violation of the security user agreement, which will result in a termination of your HCS account privileges and possible prosecution if data security is compromised because of the violation.

Each laboratory must define an HCS Director who assumes responsibility and authority to request and manage HCS accounts for laboratory staff and manage roles in the HCS Communications Directory.

For a laboratory holding, or has applied for, a New York clinical laboratory permit, the HCS director must be the Laboratory Director named on the permit.
For a laboratory that does not hold, nor has applied for, a New York clinical laboratory permit, the HCS director must be the laboratory director named on the CLIA certificate.

WHEN IS A SINGLE USE PERMIT REQUIRED?

A Single Use Permit (SUP) is required to perform testing on a specimen originating from New York if:

The testing laboratory does not hold a New York State clinical laboratory permit and offers a novel assay, or
The testing laboratory holds a New York State clinical laboratory permit but does not hold approval to perform a novel assay.

TYPES OF SINGLE USE PERMITS

Patient-specific: Required for clinical, diagnostic, or prognostic testing of a New York specimens. A separate application must be submitted for each specimen. Each specimen may be examined using more than one test. Laboratories performing serial testing on the same patient must apply for each specimen collected.

Test-specific (clinical trial): Required for laboratories that do not hold a NYS permit to perform testing to support a clinical trial. A valid clinical trial number, IRB or IDE number is required for consideration of a test-specific SUP. A separate application must be submitted for each test. The test-specific SUP covers a Department-defined time period.

APPLYING FOR A SINGLE USE PERMIT

LABS WITHOUT A NYS CLINICAL LABORATORY PERMIT

Initial Requests:

Complete the Initial Single Use Permit form the first time your laboratory applies for a single use permit.
Fax to 518-449-6917
Await email from clepsup@health.ny.gov with instructions on obtaining Health Commerce System (HCS) Accounts.
Await fax transmission of Single Use Permit, if approved.
Subsequent requests may continue being faxed until the HCS Account for the laboratory director has been affiliated. From that point forward, subsequent requests must be made using eCLEP on the HCS.
The HCS Account creation and affiliation process must be completed within three weeks of the initial test request.

Subsequent Requests:

Subsequent applications for a Single Use Permit (SUP) require a Health Commerce System (HCS) account. Please see the HCS Account Section below for information on obtaining an HCS Account.

User must be assigned the role “CLRS Single Use Permit/Test Entry Coordinator”
Login to the Health Commerce System
Click on eCLEP under My Applications
Click on Single Use Permit.
- If Single Use Permit does not appear, click on Permit Materials and then choose Single Use Permit from the tabs at the top.
Answer the questions and enter the required information.
Click Submit.
The Single Use Permit (or denial letter) will be posted to eCLEP-SUP when a decision is made.

LABS WITH A NYS CLINICAL LABORATORY PERMIT

User must be assigned the role “CLRS Single Use Permit/Test Entry Coordinator” or be an eCLEP Delegated Submitter.
Login to the Health Commerce System
Click on eCLEP under My Applications
Click on Single Use Permit.
- If Single Use Permit does not appear, click on Permit Materials and then choose Single Use Permit from the tabs at the top.
Answer the questions and enter the required information.
Click Submit.
The Single Use Permit (or denial letter) will be posted to eCLEP when a decision is made.