New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-3 - General Technical Standards For Tissue Banks › Section 52-3.4 - Selection and testing requirements for tissue donors

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Except as specifically approved by the
					 medical director of the comprehensive tissue procurement service and in
					 conformance with generally accepted standards of practice, allogeneic tissue
					 for clinical use shall not be released from donors with any of the following
					 conditions:
(1) evidence of infection at the
					 site of donation or generalized sepsis on physical examination, by history or
					 by autopsy;
(2) except for donors
					 of eye tissue, evidence of autoimmune disease or malignant disease;
(3) history of hepatitis B or C, or hepatitis
					 of unknown etiology;
(4) history of
					 a confirmed positive test or treatment for syphilis within the past 12
					 months;
(5) degenerative or
					 infectious neurological disease, such as Creutzfeldt-Jacob disease, multiple
					 sclerosis and Alzheimer's disease, or encephalitis of unknown
					 etiology;
(6) history of receipt of
					 pituitary-derived human growth hormone;
(7) transfusion within 48 hours, with four or
					 more units of blood or blood components in adults, or any transfusions within
					 48 hours in children under 12 years of age, unless:
(i) a pretransfusion blood sample is
					 available for testing;
(ii) a
					 testing technology unaffected by plasma dilution and approved by the department
					 is used for all analytes; or
(iii)
					 plasma dilution is determined to be insufficient to alter test results,
					 according to an algorithm submitted to and approved by the
					 department;
(8) history
					 of behavior or factors which place the donor at high risk for human
					 immunodificiency virus (HIV) infection, including:
(i) nontherapeutic injected drug use within
					 the preceding five years;
(ii) men
					 who have engaged in anal intercourse or oral sex with another man at any time
					 within the preceding five years;
(iii) recipients of factor VIII or factor IX
					 concentrate which was not heat-treated or otherwise virally
					 inactivated;
(iv) individuals with
					 evidence of HIV infection;
(v)
					 individuals who have engaged in other behavior determined as high risk for HIV
					 infection by the United States Public Health Service (USPHS);
(vi) individuals who have been inmates of
					 correctional facilities for 72 consecutive hours or longer within the preceding
					 12 months;
(vii) individuals who,
					 within the preceding 12 months, have been heterosexual partners of HIV-positive
					 individuals or of individuals who fit within any of the above categories;
					 and
(viii) men and women who have
					 engaged in prostitution at any time within the preceding five years, and
					 individuals who have been their heterosexual partners within the past 12
					 months;
(9) except for
					 donors of eye tissue, significant exposure to a substance that may be
					 transferred in toxic doses, such as lead, mercury and gold;
(10) acquisition, within the previous 12
					 months, of a tattoo or other skin piercing in which shared instruments which
					 were not sterilized between uses are known to have been used;
(11) within the preceding six months, receipt
					 of a bite from an animal suspect of rabies; and
(12) for living donors, receipt of a blood
					 transfusion within the preceding 12 months.