N.Y. Comp. Codes R. & Regs. Tit. 10 § 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.
Notes
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