Distribution of cryopreserved skin without review of bacterial test results.

Record number: 
MPHO Type: 
Alerting signals, symptoms, evidence of occurrence: 
Tissue establishment A recovered skin, sampled it for bacteriologic testing (“recovery cultures”) and provided it to tissue establishment B who stored it in antibiotics at 5°C until processing it. After refrigerated storage for 1-7 days, tissue establishment B performed bacterial testing again immediately prior to cryopreservation in the final package and distributed the skin after reviewing the final bacterial testing results.
Demonstration of imputability or root cause: 
For many months neither tissue bank reviewed recovery culture results. Through miscommunication both tissue establishments had assumed that the other was reviewing the recovery culture results prior to distribution whereas neither was. Several allograft recovery cultures showed virulent pathogens ordinarily not accepted for use. A recall of over 100 skin allografts was performed and burn surgeons contacted. No disease transmissions were found (from tissue bank adverse event files)