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)
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