Title: Section 52-5.9 - Distribution of tissue products

52-5.9 Distribution of tissue products.

(a) Except as provided in section 52-3.4 of this Part, musculoskeletal 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, 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) Freeze-dried processed musculoskeletal tissue distributed by a processing or storage facility shall be visually inspected for cracks, contamination, or extraneous material prior to distribution. If tissue container seals are broken or there is evidence that proper temperature has not been maintained, tissue shall not be distributed for transplantation. Container vacuums shall be determined to be satisfactory by testing with a spark generator.

(c) Musculoskeletal 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.

(d) Musculoskeletal tissue 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 52-5.8. Tissue stored at a tissue transplantation facility shall be maintained, until immediately prior to transplantation, at minus 20 degrees Celsius or lower for a maximum of six (6) months, and minus 40 degrees Celsius for longer periods. Storage shall be in a freezer reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfusion.

(e) Musculoskeletal 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.

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