New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.3 - Hematopoietic progenitor cell procurement

Current through Register Vol. 46, No. 28, July 10, 2024
(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 60 days to at least two written requests
					 for such consent sent at least 30 days apart. Documentation of such written
					 requests shall be maintained.