N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-5.4 - Donor qualifications
(a)
Except in the case of an autogeneic donation, a complete donor history shall be
obtained prior to hematopoietic progenitor cell donation. A summary of the
donor history obtained by a hematopoietic progenitor cell procurement service
shall be provided to the physician performing the transplant for a
determination of the cells' suitability for transplantation. The donor history,
or in the case of cord blood donation, the history of the donor's biologic
mother and, if available, the donor's biologic father, shall include, but not
be limited to, information concerning:
(1) any
acute respiratory disease;
(2) any
infectious skin disease that creates a risk of contamination of the
hematopoietic progenitor cells;
(3)
any disease transmissible by hematopoietic progenitor cells insofar as can be
determined by donor history;
(4)
active tuberculosis or history of therapy therefor;
(5) history of malaria or travel to or
residence in malarially endemic areas for periods of time considered to bear
increased risks for malaria exposure, as determined by criteria established by
the procurement or collection facility, consistent with criteria developed by
the United States Public Health Service;
(6) known coagulation of platelet
disorders;
(7) any medical
condition, which may be affected adversely by the collection
procedure;
(8) any medical
condition, including a malignancy, that would adversely affect the quality of
the hematopoietic progenitor cells collected;
(9) receipt of an organ transplant or a
transfusion of blood or blood components within the past 12 months;
(10) indications of drug or alcohol abuse;
and
(11) other medical conditions
or circumstances as determined by the medical advisory committee and medical
director of the procurement service.
(b) Except in the case of an autogeneic
donation or cord blood donation, a complete physical examination of the donor
shall be performed by the medical director of the procurement service or
another qualified physician.
(c)
For autogeneic donations, testing for syphilis, hepatitis B surface antigen
(HBsAg), antibody to human immunodeficiency virus type 1 (anti-HIV-1) and
antibody to human immunodeficiency virus type 2 (anti-HIV-2) shall be
performed, unless already performed within the previous 30 days, or unless the
hematopoietic progenitor cells are collected, processed and transfused at the
same facility and a system is in place to ensure disposition to the intended
recipient.
(d) For allogeneic
hematopoietic progenitor cell donations in New York State, specimens of blood
shall be collected from the donor, or in the case of umbilical cord blood, from
the donor's mother, and the following tests shall be performed in a clinical
laboratory under permit by the department. For out-of-state donations, all
required clinical laboratory testing shall be performed by a laboratory which
is approved by the regulatory authority in the state or jurisdiction where the
laboratory is located, or by the department:
(1) within 30 days prior to or 72 hours after
donation, and prior to initiation of the transplant conditioning regimen in the
recipient:
(i) direct tests for indicators of
infection with syphilis and cytomegalovirus (CMV);
(ii) HbsAg;
(iii) antibody to hepatitis B core antigen
(anti-HBc), antibody to hepatitis C virus (anti- HCV), anti HIV-1, anti-HIV-2,
and antibody to human T-cell lymphotropic virus type 1 (anti-HTLV-1);
and
(iv) except for cord blood
donation, peripheral blood cell enumeration (red, white and platelet) and
differential blood smear evaluation;
(2) prior to ablation of the recipient, major
histocompatibility antigens (HLA-A,B and DR) and other minor histocompatibility
antigens, including mixed lymphocyte culture or DNA typing, as
indicated.
(e) Except
for allogeneic donors confirmed positive for any indicator of HIV infection,
the decision as to the acceptability of hematopoietic progenitor cells shall be
made by the hematopoietic progenitor cell transplantation service director.
Hematopoietic progenitor cells from allogeneic donors confirmed positive for
any indicator of HIV infection may not be used in any case.
Notes
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