N.Y. Comp. Codes R. & Regs. Tit. 10 § 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 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.
(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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.