For New York Specimens

New York State Non-Permitted Laboratory Test Request

Under New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58-1.10 (g) of 10NYCRR), laboratories performing testing for any specimens collected in the State of New York must hold a New York State clinical laboratory permit or have test request approval for specific tests.

Because of the rarity of many genetic conditions, testing may not be available through a permit-holding laboratory, or there may be justification for sending to a non-permitted laboratory. New York State approval must be obtained before sending the specimen to a non-permitted laboratory. The ordering provider requesting testing must document that the patient or legal guardian was informed that the laboratory performing the testing does not hold a New York State laboratory permit or that the test is not approved by the Department.

Our laboratory does not yet hold a New York State license. Therefore, you must first submit a completed Non-Permitted Laboratory Test Request Approval Form to the New York State Health Department and receive approval for any patient specimen collected in New York that you wish to send to our laboratory for testing. Upon approval, you may send the patient specimen, test requisition form, and a copy of the approval letter for testing to commence.

Notification of approval or rejection will be sent in writing for each request to use a non-permitted laboratory. If rejected, the reason(s) for denial will be explained in the written response. Please contact the Clinical Laboratory Evaluation Program at (518) 485-5378 with any questions.

Please also complete Genetic Testing Healthcare Provider Statement for any tests submitted for testing.

For Genetic Tests:

Genetic Testing Quality Assurance Program

Wadsworth Center, NYSDOH

Ph: (518) 474-6271

Fax: (518) 486-2693

For Cytogenetic Tests:

Cytogenetics Quality Assurance Program

Wadsworth Center, NYSDOH

Ph: (518) 474-6796

Fax: (518) 486-4921