Printable Update for Insertion Into Standards K2.210

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CHANGES TO AATB STANDARDS FOR TISSUE BANKING

SECTION K - QUALITY ASSURANCE


K2.000 QUALITY CONTROL PROGRAM


K2.200 Microbiological Tissue Culture


K2.210 Pre-Sterilization/Pre-Disinfection Cultures
(C, V, MS, OA, SB)

For each individually recovered or packaged tissue intended for transplantation, a qualitative pre-processing culture shall be obtained prior to exposing the tissue to antibiotics, Disinfectants, or Sterilizing agents. The culture results shall be documented in the donor’s record. The Medical Director or his/her physician designee shall review these pre-processing culture results prior to releasing the tissue for transplantation. Individual tissues with culture results yielding Clostridium or Streptococcus pyogenes (group A strep.) shall be discarded. Other individual tissues from the same donor that were recovered under conditions that could result in Cross-Contamination must also be discarded unless they can be treated with a validated Sterilization process. 

 

Except for Reproductive Tissue Banks and skin (S), each Tissue Bank shall establish appropriate Pre-Sterilization/Pre-Disinfection Culture methods and sampling strategies to represent all tissues received from a particular donor. The Pre-Sterilization/Pre-Disinfection Culture results shall be documented in the donor’s record. See AATB Interim Guidance Document No. 5, Standard K2.210 Pre-Sterilization/Pre-Disinfection Cultures for required expectations.

The Medical Director or his/her physician designee [see exception that follows for (S)] shall review these Pre-Sterilization/Pre-Disinfection Culture results prior to release of tissue for transplantation.



(MS, OA, SB)
Tissues with Pre-Sterilization/Pre-Disinfection Cultures positive for Clostridium, Streptococcus pyogenes (group A strep.), or any other microorganisms determined by the processor to be virulent or difficult to eliminate, shall be discarded unless treated
with a disinfection or sterilization process validated to eliminate the infectivity of such organisms. Other individual tissues from the same donor that were recovered under conditions that could result in Cross-Contamination must be discarded unless they will be treated with a disinfection or sterilization process validated to eliminate the infectivity of such organisms.

(C, V) Standard E1.040 Sterilization/Disinfection of Tissue (C, V) applies.

(S) Pre-processing skin cultures from representative anatomical areas shall be obtained prior to exposure of the tissue to antibiotic containing Processing solutions. Culture results shall be documented in the donor’s record. Individual anatomic areas yielding cultures positive forMicroorganisms considered pathogenic, and highly virulent must be discarded unless the tissue can be disinfected with a validated process (See E1.040 Sterilization/Disinfection of Tissue). The Medical Director or designee shall review all available pre-processing skin culture results prior to releasing the tissue for transplantation.  Skin Recovery shall be performed as a separate zone from other tissue types so that culture results can be independently reviewed.

Publication date: January 4, 2011 (AATB Bulletin No. 11-01)
Effective date: immediately