Sec. 52-2.10. Compliance with standards

Tissue banks, including tissue transplantation facilities, insemination/implantation sites, human milk transfer stations and nontransplant anatomic banks, shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating the operating procedures, equipment and records, including financial records and lists of physicians or facilities to whom or to which human tissue is released, to determine compliance with the standards in this Part. No tissue bank or nontransplant anatomic bank may acquire, process, store or distribute tissue or nontransplant anatomic parts in New York State unless the bank has been issued a license by the department, or as otherwise specified in this Part. If the commissioner determines that a bank's failure to comply with the standards set forth in this Part creates a significant likelihood that the health, safety and welfare of potential patients and other persons in contact with tissue or nontransplant anatomic parts from the bank is in jeopardy, the department may require that tissue not be released pending a hearing. The hearing shall commence within 15 days of any suspension pursuant to this section.