Title: Section 58-5.4 - Donor qualifications.

Effective Date

07/21/2004

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 cell's 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 or 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 twelve (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 thirty (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 thirty (30) days prior to or seventy-two (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-I; 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,m 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.

Volume

VOLUME A-1 (Title 10)

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