14th Edition AATB Standards Definitions

Questão	Responda
ACCIDENT	Any 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.
ADEQUATE INFORMATION	Information 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" (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	An undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation.
ALLOGENEIC	Used as an adjective to modify donation, tissue, donor or recipient when transplantation is intended for a genetically different person.
ALLOGRAFT	Tissue intended for transplantation into a genetically different person.
AORTOILIAC GRAFT (C)	The distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries.
ARTERIAL GRAFT (V)	A segment of peripheral artery that is recovered, processed and preserved.
ASEPTIC PROCESSING	The 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	The recovery of tissue using methods that restrict or minimize contamination with microorganisms from the donor, environment, recovery personnel, and/or equipment.
ASYSTOLE	The 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, PEA). If a death was not witnessed, asystole must be determined by the LTKA. Asystole will be "cross-clamp time" if tissue donor was also a solid organ donor.
AUDIT	A 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	A 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.
AUTHORIZATION	Permission given after adequate information concerning the donation, recovery and use of tissues is conveyed.
AUTHORIZING PERSON	Upon death of the donor, the person, other than the donor, authorized by law to make an anatomical gift.
AUTOGRAFT (A)	Tissue intended for implantation, transplantation, or infusion into the living donor from whom it was recovered.
AUTOLOGOUS	Used as an adjective to modify donation, tissue, donor or recipient when donation is intended only from him/herself and transplantation is intended only to him/herself.
BATCH	A specific quantity of tissue produced according to a single processing protocol during the same processing cycle.
BIOBURDEN	The number of contamination organisms found on a given amount of material.
BLOOD COMPONENT	Any part of a single-donor unit of blood separated by physical or mechanical means.
CARDIAC TISSUE (C)	Tissue type that includes, but is not limited to, valved conduits, non-valved conduits, aortoiliac grafts, and patch grafts.
CELLULAR TISSUE (CT)	Viable cells that are autologous or allogeneic, committed or uncommitted, and non-expanded.
CERTIFIED COPY	Relating to a death certificate, an original, authenticated form produced by a governing authority.
CLAIM	Any written or oral communication alleging the quality, durability, reliability, infectious disease risk, or performance of tissue.
COLD ISCHEMIC TIME (C)	The time interval from subjecting cardiac tissue to cold rinse (or transport) solution at recovery to the beginning of disinfection.
COLD ISCHEMIC TIME (V)	The time interval from subjecting vascular tissue to transport solution and wet ice temperatures at recovery to the beginning of disinfection.
COLLOID	A protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment such as albumin, dextran, hetastarch, or certain blood components, such as plasma and platelets.
COMPLAINT	Any written or oral communication concerning the dissatisfaction with the identity, quality, packaging, durability, safety, effectiveness, or performance of tissue.
COMPETENCY	The ability of an employee to acceptably perform tasks for which he/she has been trained.
COMPETENCY ASSESSMENT	The evaluation of the ability of an employee to acceptably perform tasks for which he/she has been trained.
CONSIGNEE	Any tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user (whether individual, agency, institution, or organization) that receives finished tissue.
CONTRACT SERVICES	Those functions pertaining to the recovery, screening, testing, processing, storage, and/or distribution of human tissue that another establishment agrees to perform.
CONTROLLED AREAS	Restricted work areas of low microbial and particulate content in which non-sterile materials are prepared.
CORRECTION	Related to conformity, remedial action to eliminate a detected nonconformity.
CORRECTIVE ACTION	Action to eliminate the cause and prevent recurrence of a nonconformity or other undesirable situation; may be performed in conjunction with preventive action(s).
CRITICAL	Classification of a supply, reagent, material, instrument or equipment that can affect the quality and/or safety of tissue.
CRITICAL AREAS	Restricted work areas where cells, tissue, containers and/or closures are exposed to the environment.
CROSS-CONTAMINATION	The transfer of infectious agents from one tissue to another from either the same donor or a different donor.
CRYOPRESERVED	Frozen with the addition of, or in a solution containing, a cryoprotectant agent such as glycerol or dimethylsulfoxide.
CRYSTALLOID	A balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume, such as saline solution, Ringer's lactate solution, or 5% dextrose in water, or total parenteral nutrition.
DECOMTAMINATION	Cleaning the environment, facilities, and/or surfaces (sanitation), or instruments, supplies, and equipment (sanitization), with intent to remove or reduce pathogenic microbes.
DEHYDRATION	The removal of water from tissue. For example, dehydration methods may include chemical (alcohol), critical/supercritical drying, simple air drying, or drying in a dehydrator.
DESSICATION	The removal of water from tissue. For example, dessication methods may include chemical (alcohol), critical/supercritical drying, simple air drying, or drying in a dessicator.
DEVIATION	An event that is a departure from a procedure or a normal practice.
DISINFECTANT	An agent (e.g. heat or chemical) capable of reducing the number of viable microorganisms. A disinfectant might not kill spores. Use of antimicrobials in tissue processing is included here.
DISINFECTION	A process that reduces the number of viable microorganisms on tissue, but may not destroy all microbial forms, such as spores and viruses. Use of antimicrobials in tissue processing is included here.
DISINFECTION TIME (C, V)	The time interval between subjecting tissue to disinfection solution and transferring tissue to rinsing solutions in preparation for preservation.
DISPENSING SERVICE	A facility responsible for the receipt, maintenance and delivery to the ultimate user (e.g., transplanting surgeon, surgical center or research facility) of tissue for transplantation or research.
DISPOSITION	The final destination of tissue, e.g., use for transplantation, therapy research, education, or discard; also, the final destination of critical supplies, reagents, materials or equipment that can affect the quality and/or safety of tissue, e.g., release for use or discard.
DISTRIBUTION	A process that includes receipt of a request for tissue, selection of appropriate finished tissue, preparation for transport, any required inspections, and subsequent shipment and delivery of tissue to another tissue bank, tissue distribution intermediary, tissue dispensing service, or end-user.
DOCUMENT OF AUTHORIZATION	Legal record of the gift of tissue, permitting and defining the scope of the postmortem

Próximo

14th Edition AATB Standards Definitions

Descrição

Resumo de Recurso

Semelhante

	Criado por Mallory Uzzel mais de 6 anos atrás