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Title: Section 52-4.7 - Required laboratory tests on donor and donated tissue

Effective Date


52-4.7 Required laboratory tests on donors and donated tissue.

All required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state cardiovascular tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United State Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic cardiovascular tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I (HTLV-I), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, for purposes of donor selection.
(b) Testing of each cardiovascular tissue unit for aerobic and anaerobic contamination from each retrieval site shall be performed prior to final packaging, using standard laboratory procedures. Whenever fresh tissue is transplanted, the results of cultures shall be made available to the transplantation surgeon on a daily basis until the final reading has been completed.

(c) All cardiovascular tissue from living donors intended for allogeneic use shall be quarantined for six (6) months. After such time and prior to distribution of the tissue for transplantation, the donor shall be retested for HBsAg and antibodies to HCV, HIV-1 and HIV-2 and tested for antibodies to hepatitis B core antigen (anti-HBc).


VOLUME A-1 (Title 10)