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Title: Section 58-3.8 - Out-of-state laboratory seeking permit

58-3.8 Out-of-state laboratory seeking permit.

(a) Prior to any onsite inspection, an out-of-state laboratory possessing or seeking a New York State permit shall pay to the department, by certified check, bank check, teller's check or money order, a fee calculated by the department and consisting of the following components:

(1) a transportation expense, which shall be either the actual travel expense if travel is by common carrier, or a mileage expense at the rate negotiated between the State and the union representing the employees scheduled to conduct the inspection; and

(2) a per diem expense as specified by the New York State Comptroller for the inspecting employees, multiplied by the number of additional days estimated by the department to be necessary for travel and the actual inspection.

(b) In calculating this fee, the department shall estimate the total cost of the components specified in paragraph (a)(1) of this section and divide it equally among the laboratories inspected on any trip.

(c) In the event the department underestimates any of the above expenses, the laboratory shall pay any difference between the estimate and the actual expense.

(d) Fees collected shall be credited to the Clinical Laboratory Reference Fee Account. In the event the department overestimates any of the above expenses, the laboratory shall be notified of the difference between the estimate and the actual expense, and its account shall be credited that amount unless a refund is requested.

(e) Failure to pay the fee for out-of-state inspection will result in suspension or nonrenewal of the laboratory permit.


VOLUME A-1 (Title 10)