Section 58-5.3 - Hematopoietic progenitor cell procurement

58-5.3 Hematopoietic progenitor cell procurement.

(a) Facilities where allogeneic or autogeneic hematopoietic progenitor cells are collected shall be adequately lighted, ventilated and equipped, and be operated in a manner which conforms to current medical standards generally accepted by leading authorities in transplantation medicine.

(b) Each hematopoietic progenitor cell procurement service, except for such facilities collecting cord blood only, shall document association with a hematopoietic progenitor cell transplantation facility and compliance with the procedures, protocols and recordkeeping requirements for collection as established by the transplantation facility, as well as all requirements of this Subpart.

(c) All required clinical laboratory testing shall meet the standards of Article 5 Title V of the Public Health Law.

(d) For bone marrow harvesting procedures, adequate facilities shall be available for the administration of anesthesia and for emergency resuscitation. A qualified anesthesiologist shall be on the premises at all times during harvesting procedures.

(e) Emergency services shall be immediately available to any donor who manifests an adverse reaction.

(f) A physician shall explain the hazards of the donation procedure to the donor in such a manner that the donor is offered an opportunity to refuse consent. The donor shall be advised of the risks of hematopoietic progenitor cell donation and of the anesthesia method to be used, the potential need for transfusional support and possible side effects of each procedure, and options for disposition of hematopoietic progenitor cells no longer needed by the intended recipient. All this information shall be provided to each prospective donor in written form. The written informed consent of the prospective donor shall then be obtained. Autogeneic donors shall also be informed of the risks associated with hematopoietic progenitor cell collection. (g) Informed consent for collection of cord blood shall be obtained from the donor's mother before stem cells are placed in inventory. In all cases of in utero cord blood collection, consent shall be obtained prior to collection. (h) Hematopoietic progenitor cells from autogeneic donors shall not be destroyed or released for purposes other than infusion into the intended patient without written authorization from the director of the facility storing the hematopoietic progenitor cells and; (1) if the donor/patient is deceased, written documentation of death; or (2) if the donor/patient is living, written authorization from the physician currently responsible for treating the patient for the underlying disorder for which the hematopoietic progenitor cells were collected; and documented informed consent from the donor/patient or donor/patient's guardian, unless it is documented that no response was received within sixty (60) days to at least two (2) written requests for such consent sent at least thirty (30) days apart. Documentation of such written requests shall be maintained. (i) Hematopoietic progenitor cells from allogeneic donors shall not be destroyed or released for purposes other than transplantation into the originally intended recipient without the written authorization of the intended recipient's physician and documentation that the intended recipient, if living, has been notified that the cells will not be available.

Effective Date: 
Wednesday, July 21, 2004
Doc Status: 
Complete