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Title: Section 52-4.9 - Distribution of tissue products

Effective Date


52-4.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, cardiovascular tissue 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, HTLV-I or HCV; or

(2) the donor's blood reacts positively to approved tests for syphilis, unless confirmatory testing is negative.

(b) Cardiovascular tissue 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 tissue 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) Frozen cardiovascular tissue in transit from a tissue processing or storage facility to a tissue transplantation facility shall be maintained at a temperature of minus 70 degrees Celsius or lower. Tissue stored at a tissue transplantation facility shall be maintained at the appropriate storage temperature until immediately prior to transplantation.

(d) Cardiovascular tissue and its labeling and packaging shall be visually inspected prior to its distribution 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 tissue shall not be utilized for transplantation. In the case of frozen tissue, the period of time between thawing and use shall not exceed 24 hours if tissue is refrigerated at between one and 10 degrees Celsius, or four (4) hours if not refrigerated.

(e) Cardiovascular tissue shall be issued by the tissue transplantation facility only upon a written order by a licensed physician, or person authorized by law to order such issuance pursuant to section 52-4.11(b) of this Subpart. Documentation of such order shall be on a dedicated tracking record or on the recipient's medical record. Issuance of cardiovascular tissue shall be recorded in a disposition log and shall allow accurate tracking of tissue to each recipient.


VOLUME A-1 (Title 10)