SECTION D - ACQUISITION OF TISSUE: CONSENT, DONOR SCREENING, AND
TISSUE RECOVERY AND COLLECTION
D4.000 DONOR SUITABILITY
D4.300 Disease Screening
D4.355 Interpretation of Infectious Disease Test Results
Disposition of allogeneic tissue shall be based upon the interpretation of all infectious disease test results and shall be as follows:
1) Human tissue shall be determined not to be suitable for transplantation if from a donor whose specimen has tested repeatedly reactive on an FDA-licensed, approved, or cleared donor screening test for anti-HIV-1, anti-HIV-2, HBsAg, anti-HBc, or anti-HCV, anti-HTLV-I or anti-HTLV-II. When a birth mother’s specimen is used for testing, these same rules apply.
2) Viable leukocyte-rich tissue (e.g., semen) shall be determined not to be suitable for transplantation if from a donor whose specimen has tested repeatedly reactive (RR) on an FDAlicensed, approved, or cleared donor screening test for anti-HTLV-I or anti-HTLV-II.
The suitability of other human tissue for transplantation from donors whose specimens test RR for anti-HTLV-I or anti-HTLV-II shall be determined by the Medical Director.
Note: Law and/or regulation, including, where applicable, foreign laws and/or regulations, may differ in regard to a RR HTLV antibody test result and how this impacts the suitability of the donor’s tissues for transplantation.
2)3) Human tissue shall be determined not to be suitable for transplantation if from a donor whose specimen had a final test result of positive, repeat reactive, or repeatedly reactive on a screening test using a NAT assay. When a birth mother’s specimen is used for testing, these same rules apply.
3)4) If a laboratory that performs organ donor testing performs the initial testing in duplicate or triplicate, the Tissue Bank must obtain and review the results of all individual tests performed. If any one of those initial tests is reactive or positive, the tissue shall be determined not suitable for transplantation.
4)5) Tissue from a donor reactive for syphilis using an FDA-licensed, cleared, or approved non-treponemal screening assay may be used for transplantation only if the sample is found to be negative using an FDA-licensed, cleared or approved treponemal-specific confirmatory assay. If initial testing was performed using an FDA-licensed, cleared, or approved treponemal-specific confirmatory assay and was reactive, the tissue shall not be used for transplantation.
5) 6) If results of additional infectious disease testing are received for tests that are not required, such test results must be included in the donor’s medical record and any results from those tests must be considered when determining donor suitability. Procedure(s) shall be established for the interpretation of additional infectious disease test results.
NOTE: For international members that do not export tissues to the U.S., applicable requirements of the government/competent authority regarding test kit licensing/approval apply.
(A) Determination of the final Disposition of tissue in which a donor’s blood sample tests positive is the responsibility of the donor-patient’s licensed physician. If tissue from a donor who tests positive is to be stored in a tissue bank, refer to E4.400 Segregation of Tissue.
(R) Determination of the use of Client Depositor and/or Directed Donor reproductive tissues in cases where required test results are positive or repeatedly reactive must be documented according to protocols described at F2.200 Special Circumstances in Release of Reproductive Tissues (see note for CMV below).
Tissue from an anonymous Semen Donor who tests reactive for an active acute infection with cytomegalovirus (CMV) shall not be deemed suitable for use. Tissue from an anonymous Semen Donor determined to be in a latent CMV status may be acceptable. Each individual bank shall develop a procedure for determining suitability for both anonymous and Directed Donors. Procedures must also include provisions for communicating CMV status to the end user physician such that a decision can be made regarding use of a CMV positive (total IgG plus IgM) donor.
Tissue from a donor testing positive for chlamydia or gonorrhea shall not be suitable for use.
Published date: November 11, 2009 (AATB News Release)
Effective date: At the discretion of the Tissue Bank