N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-5.10

Current through Register Vol. 46, No. 50, December 11, 2024

Section 58-5.10 - Compliance with standards

(a) Hematopoietic progenitor cell procurement services and/or processing facilities shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating operating procedures, equipment and records, including financial records and lists of physicians or facilities to whom or to which hematopoietic progenitor cells are released, to determine compliance with the standards in this Subpart. If the commissioner determines that a significant likelihood exists that adequate safeguards are not implemented, the department may require that cells not be released pending a hearing. Such hearing shall commence within 15 days of any suspension pursuant to this section.

(b) Whenever requested, a hematopoietic progenitor cell bank shall submit to the department reports containing such information and data concerning the bank's activities as may be required by this Subpart. Such reports shall be signed by the director of the hematopoietic progenitor cell bank.