Title: Section 52-5.7 - Required laboratory tests on donors and donated tissue

Effective Date

11/01/2000

52-5.7 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 musculoskeletal tissue procurements, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulatory authority, the United States Health Care Financing Administration, or by the department.

(a) Blood samples from all allogeneic musculoskeletal tissue donors shall be tested for antibodies to human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), and hepatitis C virus (HCV), as well as for hepatitis B surface antigen (HBsAg) and for syphilis, and, unless the tissue is to be virally inactivated, antibodies to human T-lymphotropic virus type I (HTLV-I), for purposes of donor selection.

(b) Testing of each musculoskeletal tissue unit for aerobic and anaerobic contamination 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 musculoskeletal 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

VOLUME A-1 (Title 10)

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