AATB Test questions with accurate
answers
Accident - answersAny occurrence, not associated with a deviation from standard
operating procedures (SOPs), standards, or applicable laws and regulations, during
donor screening or testing, or tissue recovery, collection or acquisition, processing,
quarantining, labeling, storage, distribution, or
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) - answersThe point after delivery at which tissue is under the control of
the tissue bank.
adequate information - answersInformation sufficient for the donor, the authorizing
person or the living donor to make a voluntary decision regarding the gift of tissues for
transplantation, therapy, research and/or education. The parameters of 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
requests or which the donation coordinator reasonably believes 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 - answersAn undesirable effect or untoward complication in a
recipient consequent to or reasonably related to tissue transplantation.
ALLOGENEIC - answersUsed as an adjective to modify donation, tissue, donor or
recipient when transplantation is intended for a genetically different person.
ALLOGRAFT - answersTissue intended for transplantation into a genetically different
person.
ANNUAL - answersA frequency of activity defined by each tissue bank as 12 months
including reasonable tolerance limits (up to 3 months). Justification for the tolerance
limits shall be documented by the tissue bank with consideration for the risk associated
with the specific activity scheduled.
, ANONYMOUS DONOR (R) - answersA reproductive donor of tissue whose identity is
unknown to the recipient (R).
AORTOILIAC GRAFT (C) - answersThe distal segment of the abdominal aorta including
the bifurcation and proximal segments of both the left and right common iliac arteries.
ARTERIAL GRAFT (V) - answersA segment of peripheral artery that is recovered,
processed and preserved.
ARTIFICIAL INSEMINATION (R) - answersThe placement of semen within the
reproductive tract of a recipient (R).
ASEPTIC PROCESSING - answersThe processing of tissue using 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 - answersThe recovery of tissue using methods that restrict or
minimize contamination with microorganisms from the donor, environment, recovery
personnel, and/or equipment.
ASSISTED REPRODUCTIVE TECHNOLOGY PROCEDURE (R) - answersA medical
procedure intended to result in conception, including, but not limited to, therapeutic
insemination, in-vitro fertilization (including intracytoplasmic sperm injection), and
gamete intrafallopian transfer.
ASYSTOLE - answersThe 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 - answersA 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 - answersA 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 - answersPermission given after adequate information concerning
the donation, recovery and use of tissues is conveyed.
