SECTION K - QUALITY ASSURANCE
K2.000 QUALITY CONTROL PROGRAM
K2.200 Microbiological Tissue Culture
Except for autologous and reproductive tissues, all tissue to be released for human transplantation shall have representative microbiological cultures obtained which includes testing to detect bacteria and fungi. and The_results must be documented in the donor record, unless Dosimetric Release has occurred by a validated process according to E1.044. Appropriate final packaging cultures (aerobic and anaerobic) shall be obtained and the results shall meet established parameters defining acceptable final packaging cultures before tissue is released for transplantation. The Director or his/her designee shall review all culture results prior to release of tissue for transplantation. Any variance in the culture results from the established parameters shall be reviewed and approved by the Medical Director or his/her designee prior to release. Except as described for skin below (S), no Allografts contained within the Processing Batch may be released for transplantation if post-processing final sterility test results show organism contamination. Allograft rework is permitted with an established program validated to eliminate the organism identified.
(A) Except for skin, if autologous tissue is being processed, microbiologic cultures, which includes testing to detect bacteria and fungi, should be obtained immediately prior to Processing.
(C, V) Representative cardiac and vascular tissue samples shall be cultured for fungal growth.
(MS, OA, SB, C, V)
Microbiologic testing of processed tissue, which includes testing to detect bacteria and fungi shall be performed on each donor Lot.
(S) Representative skin samples shall be cultured for the presence of fast-growing fungal organisms. Skin shall not be used for transplantation if any one of the following is noted at final culture:
2) Streptococcus pyogenes (group A strep.);
3) Enterococcus sp.;
4) gram-negative bacilli;
5) Clostridium; and
6) fungi (yeasts, molds).
Publication date: January 4, 2011 (AATB Bulletin No. 11-01)
Effective date: immediately