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Title: Section 52-6.9 - Distribution of tissue products

Effective Date


52-6.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, skin shall not be made available for allogeneic transplantation if: (1) the donor's blood tests repeatedly reactive in approved screening tests for HBsAg, or antibodies to HIV-1, HIV-2, HCV or, unless the tissue is to be virally inactivated, antibodies to HTLV-I; or (2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.

(b) Skin shall be transported by the tissue bank or its agents, or by staff or agents of the tissue transplantation facility. A signed form shall be kept on file at the skin 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.

(c) Skin in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at the applicable storage temperature specified in section 52-6.8 of this Subpart. Tissue stored at a tissue transplantation facility shall be maintained at a target temperature of minus 40 degrees Celsius or lower until immediately prior to transplantation. Storage shall be in a freezer or liquid nitrogen tank reserved for skin or other tissue intended for transplantation, or blood reserved for transfusion.

(d) Skin and its labeling and packaging shall be visually inspected prior to its release by the tissue processing facility. The tissue shall be inspected by the tissue transplantation facility immediately upon receipt and again after thawing, if frozen. If the physical appearance is abnormal, or there is indication or suspicion of overt microbial contamination, the skin shall not be utilized for transplantation.

(e) Skin 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. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of skin shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.


VOLUME A-1 (Title 10)