AATB TERMS 14TH EDITION Exam 2024

AATB TERMS 14TH EDITION Exam 2024 ACCIDENT - answerAny occurrence, not associated with a deviation from standard operating procedures (SOPs), standards, or applicable laws and regulations, during donor screening or testing, or recovery, collection or acquisition, processing, quarantine, labeling, storage, distribution, or 2 dispensing that may affect the performance, biocompatibility, or freedom from transmissible pathogens of the tissue or the ability to trace tissue to the donor Acquisition (BT) - answerthe point after delivery at which tissue is under the control of the tissue bank ADEQUATE INFORMATION - answerinformation sufficient for the donor, the authorizing person if the living donor to make a voluntary decision regarding the gift of tissues for transplantation, therapy, research and/or education. The parameters or what constitutes adequate information must include "Core Elements" contained in D2.400 or D3.400, and such additional information as the donor, authorizing person or living donor should know. When the donor is authorizing the gift of tissue, publicly available information concerning the scope and use of the gift shall be deemed adequate information ADVERSE OUTCOME - answeran undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation ALLOGENEIC - answerused as an adjective to MODIFY donation, tissue, donor or recipient when transplantation is intended for a GENETICALLY DIFFERENT PERSON ALLOGRAFT - answerTissue intended for transplantation into a genetically different person AORTOILIAC GRAFT (C) - - answerThe distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries. ARTERIAL GRAFT (V) - answerA segment of peripheral artery that is recovered, processed and preserved. ASEPTIC PROCESSING - answerThe processing of tissue using the aseptic techniques where tissue, containers and/or devices are handled in a controlled environment in which the air supply, materials, equipment and personnel are regulated to prevent microbial contamination of tissue ASEPTIC RECOVERY - answerThe recovery of tissue using methods that restrict or minimize contamination with microorganisms from the donor, environment, recovery personnel, and/or equipment ASYSTOLE - answerThe reference time for cardiac death. A documented pronounced time of death is used as asystole when life-saving procedures have been attempted and there were signs of, or documentation of, recent life (e.g., witnessed event, agonal respirations, pulseless electrical activity). If a death was not witnessed, asystole must be determined by the last time known alive. Asystole will be 'cross clamp time' if the tissue donor was also a solid organ donor AUDIT - answerA documented review of procedures, records, personnel functions, equipment, materials, facilities, and/or suppliers to evaluate adherence to the written SOPM, standards, applicable laws and regulations. AUDIT TRAIL - answera process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the course of such details relating to the electronic record. (FDA Guidance for Industry, Computerized Systems Used in Clinical Investigations, May 2007) AUTHORIZATION - answerPermission given after Adequate Information concerning the donation, recovery and use of tissues is conveyed. AUTHORIZING PERSON - answerUpon the death of the Donor, the person, other than the Donor, authorized by law to make an anatomical gift.