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Obtain a Permit

Applicants begin by completing these 4 documents:

Notes:

  • Include Identification of an acceptable director to be responsible for the testing who holds a Certificate of Qualification in all the categories proposed by the laboratory
  • Include complete list of proposed test offerings.
  • Incomplete or incorrectly completed applications or failure to submit additional forms as required below will result in a delay in processing.
  • Fees: Total fees due at time of application are $1,100.00. This includes a non-refundable $100 application fee and a $1,000 Inspection and Reference fee. This is payable by check made out to the New York State Department of Health.  Credit card payments are not accepted. Checks drawn on banks located outside the United States are not accepted. Laboratories located outside the United States must contact CLEP at clep@health.ny.gov to determine an acceptable alternate payment method. 
  • Laboratories located out-of-state must also pay any travel costs associated with the on-site survey. These fees are mandated by New York State Public Health Law. Checks should be made payable to the New York State Department of Health. Credit card payments are not accepted. Checks drawn on banks located outside the United States are not accepted. Laboratories located outside the United States must contact CLEP at clep@health.ny.gov to determine an acceptable alternate payment method

Optional documents, as applicable to the laboratory:

Supporting documents:

Mailing the Permit Application

Postal Service Address Courier Mail Service Address
Clinical Laboratory Evaluation Program
Wadsworth Center
New York State Department of Health
Empire State Plaza, P.O. BOX 509
Albany, New York 12201-0509
Clinical Laboratory Evaluation Program
Wadsworth Center
New York State Department of Health
P1 South, Loading Dock J
Albany, New York 12237

Notification of changes in the laboratory name, owner, director, or location, and requests for new categories or analytes must be submitted, prior to the effective date of the change, via eCLEP. At a minimum, the laboratory director must have completed the HCS account creation process prior to submitting changes via eCLEP. Please call CLEP at (518) 485-5378 if changes must be made before the laboratory director has been granted access to HCS.

Please be advised that Article 5, Title V, Section 575 of New York State Public Health Law stipulates that a laboratory permit is automatically void upon a change of director, owner or location. Proper and timely notification of these changes is required to stay this void.

Please review the relevant Laws and Regulations pertaining to clinical laboratories.

A clinical laboratory permit will be issued when:

  1. The laboratory director and any assistant directors have been issued Certificates of Qualification in all applicable categories relevant to the laboratory permit application.
  2. The laboratory participates in an On-site Survey  by a CLEP clinical laboratory consultant(s) and any deficiencies have been corrected.
  3. The laboratory has successfully participated in Proficiency Testing (or alternate assessment, as applicable) for all permit categories sought on the application.
  4. The laboratory has received Test Approval, as applicable.
  5. The laboratory director has obtained a Health Commerce System account and affiliated that account with the laboratory.
  6. All applicable fees have been paid.

Laboratories applying for a New York State clinical laboratory permit may not begin testing on NYS specimens until all requirements have been met and a permit is issued. Clinical laboratory permits are valid for one year, commencing on July 1 of each year (initial permits can be issued at any time during the permit cycle of July 1 through June 30) and extending through June 30 of the following year.