Title: Section 52-3.4 - Selection and testing requirements for tissue donors
52-3.4 Selection and testing requirements for tissue donors.
(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 or 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 pre-transfusion 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 immunodeficiency virus (HIV) infection, including:
(i) nontherapeutic injected drug use within the preceding five (5) years;
(ii) men who have engaged in anal intercourse or oral sex with another man at any time within the preceding five (5) 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 seventy-two (72) consecutive hours or longer within the preceding twelve (12) months;
(vii) individuals who, within the preceding twelve (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 (5) years, and individuals who have been their heterosexual partners within the past twelve (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 twelve (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 proceding six (6) months, receipt of a bite from an animal suspect of rabies; and (12) for living donors, receipt of a blood transfusion within the preceding twelve (12) months. (b) Individuals with suspected rabies or evidence of HIV infection shall not be accepted as donors under any circumstances.
(c) All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state tissue acquisitions by New York State-licensed banks, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration or by the department.
(1) Blood samples from all allogeneic donors of tissue for clinical use, except oocyte donors tested in accordance with section 52-8.6(h) of this Part shall be tested for evidence of infection with HIV-1, HIV-2, hepatitis B virus (HBV), including hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) and, except for donors of eye tissue or tissue to be virally inactivated, human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection. If available, aliquots of residual serum or plasma shall be frozen for retrospective testing of donors in the event that new or improved tests become available prior to the distribution of donated tissue.
(2) All laboratory testing and donor medical history reports shall be reviewed and approved by the medical director or by the medical director's designee, according to criteria determined by the medical director, prior to release of tissue for distribution.
(3) Results of required testing shall be affixed to the final tissue product container or included in a product circular for tissue intended for clinical use.
(4) Except in a life-threatening emergency documented and approved by the medical director and the director of the tissue transplantation service using the tissue, tissue shall not be made available for clinical use unless the donor's blood reacts negatively to approved tests for HIV-1, HIV-2, HBsAg, HCV and, except for eye tissue or tissue to be subjected to viral inactivation, HTLV-I.
VOLUME A-1 (Title 10)