Section 52-7.9 - Distribution of tissue products

52-7.9 Distribution of tissue products.

(a) Except as specified in section 52-3.4 of this Part, ocular tissue shall not be made available for transplantation if the donor's blood tests repeatedly reactive in approved screening tests for HBsAg or antibodies to HIV-1, HIV-2 or HCV.

(b) The eye bank shall distribute tissue for transplantation only to another eye bank or to a licensed tissue transplantation facility in possession of a written order by a licensed physician.

(c) Tissue shall be transported by the eye bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the eye bank documenting the identification of tissue distributed, including the names of both the person(s) releasing the tissue and the person(s) receiving the tissue.

(d) Tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the appropriate storage temperature specified in section 52-7.8 of this Subpart. Tissue stored at a transplantation facility shall be maintained at the appropriate storage temperature until immediately prior to transplantation.

(e) Tissue shall be visually inspected prior to use by the transplant surgeon, who shall determine the suitability of the tissue for transplantation.

(f) Tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician or other person authorized by law to order tissue for transplant. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Documentation shall allow accurate tracking of tissue to each recipient.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete