answers
ACCIDENT - answersany occurrence not associated with a deviation from standard
operating procedures, 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 - 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.
ALLOGENIC - 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 - answersA reproductive donor of tissue whose identity is
unknown to the recipient (R).