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154 Cards in this Set
- Front
- Back
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AAMI
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Association for the Advancement of Medical Instrumentation
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ACCIDENT
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Any occurrence, not associated with a deviation from Standard Operating Procedures
(SOPs), standards, or applicable government laws and regulations, during donor screening or testing, or tissue recovery or collection, 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. |
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ADVERSE OUTCOME
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An undesirable effect or untoward complication in a recipient consequent to or
reasonably related to tissue transplantation. |
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ALLOGRAFT
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Tissue intended for transplantation into another individual of the same species.
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ANONYMOUS DONOR (R)
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A reproductive donor of cells or tissue whose identity is unknown to the
recipient. |
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ANSI
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American National Standards Institute
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AORN
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Association of periOperative Registered Nurses
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ART
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Assisted Reproductive Technology—All clinical treatments and laboratory procedures that include
the handling of both human oocytes and sperm, or embryos, with the intent of establishing a pregnancy |
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ARTERIAL GRAFT (V)
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A segment of artery that is recovered, processed and preserved
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ARTIFICIAL INSEMINATION (R)
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placement of semen within the reproductive tract of a
recipient. |
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ASEPTIC PROCESSING
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The processing of tissue using methods to prevent, restrict or minimize
contamination with microorganisms from the environment, processing personnel, and/or equipment |
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ASEPTIC RECOVERY
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The recovery of tissue using methods that restrict or minimize contamination
with microorganisms from the donor, environment, recovery personnel, and/or equipment. |
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ASSISTED REPRODUCTIVE TECHNOLOGY PROCEDURE
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A 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. |
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ASYSTOLE
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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., 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. |
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AUDIT
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A documented review of procedures, records, personnel functions, equipment, materials,
facilities, and/or vendors to evaluate adherence to the written SOPM, standards, or federal, state and/or local laws and regulations. |
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AUTOGRAFT (A)
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Tissue intended for implantation, transplantation or infusion into the individual
from whom they were recovered. |
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BATCH
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A specific quantity of tissue that is intended to have a uniform character and quality, within
specific limits, which is produced according to a single processing protocol during the same processing cycle, precluding mixing of tissue from two or more donors. |
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BIOBURDEN
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The number of contaminating organisms found on a given amount of material prior to
undergoing a sterilizing procedure. |
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BLOOD COMPONENT
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Any part of a single-donor unit of blood separated by physical or mechanical
means. |
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CDC
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Centers for Disease Control and Prevention, Atlanta, Georgia
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CERTIFIED COPY
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relating to a death certificate, an original, authenticated form produced by a
governing authority. |
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CFR
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Code of Federal Regulations. Published by the Office of the Federal Register, National Archives
and Records Administration, Washington, DC. |
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CLAIM
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Any written or oral communication alleging the quality, durability, reliability, infectious disease
risk, or performance of tissue. |
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CLEAN ROOM
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A room in which the concentration of airborne particles is monitored and controlled
to defined specification limits. |
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CLIENT DEPOSITOR (R)
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A person, or persons, who store(s) reproductive cells or tissues for future
use in artificial insemination or assisted reproductive technology procedures for themself(ves) or a sexually intimate partner; not considered a reproductive tissue donor. |
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COLD ISCHEMIC TIME (C)
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The time interval from subjecting cardiac tissue to cold rinse (or
transport) solution at recovery to the beginning of disinfection. |
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COLD ISCHEMIC TIME (V)
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The time interval from subjecting vascular tissue to transport solution
and wet ice temperatures at recovery to the beginning of disinfection. |
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COLLECTION
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The acquisition of semen or retrieval of oocytes from a donor or Client Depositor by
surgical or non-surgical procedures. |
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COLLOID
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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. |
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COMPLAINT
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Any written or oral communication concerning dissatisfaction with the identity, quality,
packaging, durability, reliability, safety, effectiveness, or performance of tissue. |
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COMPETENCY
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The ability of an employee to acceptably perform tasks for which he/she has been
trained. |
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COMPETENCY ASSESSMENT
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The evaluation of the ability of an employee to acceptably perform
tasks for which he/she has been trained. |
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CONSIGNEE
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Any Tissue Bank, Tissue Distribution Intermediary or Tissue Dispensing Service
(whether individual, agency, institution, or organization) that receives tissue and assumes responsibility for the processing, storage, distribution and/or dispensing of such tissue. |
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CONTAINER
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An enclosure for one finished unit of transplantable tissue.
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CONTRACT SERVICES
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Those functions pertaining to the recovery, screening, testing, processing,
storage, and/or distribution of human tissue that another establishment agrees to perform for a tissue establishment. |
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CONTROLLED AREAS
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Restricted work areas of low microbial and particulate content in which nonsterile
materials are prepared. |
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CRITICAL AREAS
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Restricted work areas where cells, tissue, containers and/or closures are exposed to
the environment. |
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CROSS-CONTAMINATION
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The transfer of infectious agents from tissue to other tissue from the
same donor or from one donor’s tissue to another donor’s tissue. |
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CRYOPRESERVED
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Tissue frozen with the addition of, or in a solution containing, a cryoprotectant
agent such as glycerol or dimethylsulfoxide. |
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CRYOPROTECTANT
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An additive that serves to minimize osmotic imbalances that occur with the
progression of freezing fronts through a substance, and is intended to limit the amount of cell damage caused by cell shrinkage and intracellular ice formation. |
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CRYSTALLOID
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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 percent dextrose in water, or total parenteral nutrition (TPN). |
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DEHYDRATION
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The removal of water from tissue.
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DEVIATION
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An event that is a departure from a procedure or normal practice.
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DIRECTED DONOR (R)
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A reproductive cell or tissue donor who is known to the recipient but is not
her sexually intimate partner. |
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DISINFECTANT
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An agent that reduces the number of viable cellular microorganisms.
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DISINFECTION
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A process that reduces the number of viable cellular microorganisms, but does not
necessarily destroy all microbial forms, such as spores and viruses. |
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DISINFECTION TIME (C, V)
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The time interval between subjecting tissue to disinfection solution and
transferring tissue to rinsing solutions in preparation for preservation. |
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DISPENSING SERVICE
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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. |
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DISPOSITION
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The final destination of tissue, including use for transplantation, research, or discard.
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DISTRIBUTION
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A process that includes receipt of a request for tissue, selection and inspection of
appropriate tissue, and inspection, and subsequent shipment and delivery of tissue to another Tissue Bank, Tissue Distribution Intermediary, or Tissue Dispensing Service. |
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DONATED EMBRYO
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An embryo designated for implantation into a recipient other than the oocyte
donor. |
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DONATED HUMAN TISSUE
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For the purposes of labeling, this is tissue provided for storage or
transplantation, either allogeneic or autologous. |
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DONOR
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A living or deceased individual who is the source of tissue for transplantation in accordance
with established medical criteria and procedures. |
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DONOR RISK ASSESSMENT INTERVIEW
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A documented dialogue in person or by telephone with
an individual or individuals who would be knowledgeable of the donor’s relevant medical history and social behavior. For example this may be: the donor, if living; the next of kin; the nearest available relative; a member of the donor’s household; other individual with an affinity relationship (e.g., caretaker, friend, significant life partner); and/or the primary treating physician. Alternatively, a living donor may complete a written questionnaire. The relevant social history is elicited by questions regarding certain activities or behaviors that are considered to place such an individual at increased risk for a relevant communicable disease agent or disease (RCDAD). |
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DONOR REFERRAL SOURCES
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Entities such as hospitals, medical examiners, coroners and individual
allied health care professionals who identify potential tissue donors and refer them, or their next of kin, to tissue banks. |
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DONOR SUITABILITY ASSESSMENT
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The evaluation of all available information about a potential
donor to determine whether the donor meets qualifications specified in the SOPM and Standards. This includes, but is not limited to: medical, social, and sexual histories; laboratory test results; physical assessment or physical examination; and autopsy findings (if performed). |
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DOSIMETRIC RELEASE
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Tissue release based on dosimetry instead of sterility testing.
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DURA MATER (DM)
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A type of soft tissue that includes the pachymeninx (thick, membranous) tissue
covering the brain. |
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EMBRYO
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Pre-implantation, reproductive tissue resulting from the combination of oocyte and sperm.
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EMBRYO BANK
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A facility that performs cryopreservation or storage of embryos intended for use in
creating pregnancy. |
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EMBRYO CLIENT DEPOSITOR (R)
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A woman and/or man who provides gametes or contracts with a
gamete donor(s) responsible for creation of an embryo(s) intended for transfer. |
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EMBRYO DONOR (R)
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Embryo client depositor(s) who choose(s) to donate her (their) embryos.
Ownership of the embryos is transferred to a new client depositor(s) who was (were) not gamete providers. |
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END-USER
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A health care practitioner who performs transplantation procedures.
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EQUIPMENT QUALIFICATION STUDIES
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Protocols designed to adequately evaluate, prior to use,
whether pieces of equipment will perform to expectations, and normally function within the required tolerance limits. |
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ERROR
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A departure, whether or not intentional, from the SOPM, standards, or applicable federal,
state, and/or local laws and/or regulations during donor screening, testing, recovery, processing, quarantine, labeling, storage, distribution, or dispensing of tissues that may cause infectious disease transmission, adversely affect the clinical performance of tissue, and/or interfere with the ability to trace tissue to the donor. |
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FDA
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The United States Food and Drug Administration.
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FETAL TISSUE
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Tissue recovered during embryonic or fetal stages of development.
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FINISHED TISSUE
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Tissue that has been fully processed, enclosed in its final container, labeled, and
released to distribution inventory. |
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FREEZE DRIED/LYOPHILIZED
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Tissue dehydrated for storage by conversion of the water content of
frozen tissue to a gaseous state under vacuum that extracts moisture |
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GAMETE
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Mature human germ cell, whether an oocyte or sperm.
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GESTATIONAL CARRIER (R)
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A woman contracted by the embryo client depositor(s) for pregnancy
gestation under the supervision of the embryo client depositor’s(s’) physician. |
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INFORMED CONSENT
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A procedure whereby information concerning the donation process is
presented to the donor or donor’s next of kin with an opportunity for them to ask questions, after which specific approval is documented. |
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IN-PROCESS CONTROLS
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Any tests, samples, evaluations, monitoring, or measurements performed
during processing or preservation that are designed to evaluate the processing or preservation procedure of the tissue subjected to processing or preservation for conformance to specifications in the SOPM |
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IN-PROCESS MATERIAL
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Any material that is used in the processing of tissue, including, but not
limited to, incoming tissue, water, alcohol, acid, containers, and closures. |
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LABEL
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Any written, printed, or graphic material on or affixed to a container or package of cells or
tissue. |
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LABELING MATERIAL
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Any printed or written material, including labels, advertising, and/or
accompanying information (e.g., package insert, brochures, and pamphlets), related to the tissue |
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LIVING DONOR (LD)
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a donor whose heart is beating at the time of tissue donation. For all Living
Donors, (LD) standards apply, then tissue-specific standards apply. |
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LOT
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Tissue produced from one donor at one time using one set of instruments and supplies. Also refers
to a quantity of reagents, supplies, or containers that is processed or manufactured at one time and identified by a unique identification number |
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MAY
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Used to reflect an acceptable method that is recognized but not essential
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MICROORGANISM
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a microscopic organism; viruses, while sometimes included in this classification,
are not included here. |
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MUST
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Used to indicate a mandatory requirement
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NEXT OF KIN
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The person(s) most closely related to a deceased individual as designated by applicable
law such as the Uniform Anatomical Gift Act. |
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NON-TERMINAL IRRADIATION
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Ionizing radiation used to reduce microbes prior to processing
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NON-VALVED CONDUIT (C)
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A length of cardiac outflow tract (aortic or pulmonic) from which the
valve structure has been removed or intentionally rendered completely non-functional. |
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OOCYTE DONOR (R)
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One who donates oocytes for use in assisted reproductive technology
procedures. An oocyte donor can be further categorized as a directed donor or an anonymous donor. |
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OSTEOARTICULAR GRAFT
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A large weight bearing allograft with intact articular surfaces, consisting
of a joint with associated soft tissue and bone. |
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PACKAGE
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A labeled carton, receptacle, or wrapper containing one or more containers and
accompanying labeling material. |
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PACKAGE INSERT
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The written material accompanying tissue allograft or autograft bearing further
information about the tissue, directions for use, and any applicable warnings. |
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PATCH GRAFT (C)
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A segment of cardiac allograft conduit to be used in cardiovascular repair,
construction, or reconstruction |
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PERFUSION SOLUTION (V)
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A room temperature, sterile isotonic solution such as tissue culture
media or PlasmaLyte utilized to gently perfuse veins at recovery. This solution is amended with an appropriate smooth muscle relaxant (i.e., papaverine) and may also contain an antithrombotic agent (i.e., sodium heparin). |
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PERFUSION TIME (V)
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The time interval from asystole to subjecting the vascular tissue to perfusion
solution. |
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PHYSICAL ASSESSMENT
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a recent ante-mortem or post-mortem documented evaluation of a deceased
donor’s body that can identify evidence of: high-risk behavior and signs of HIV infection or hepatitis infection; other viral or bacterial infections; or, trauma to the potential recovery sites. |
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PHYSICAL EXAMINATION
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a recent documented evaluation of a living donor’s body to determine
whether there is evidence of high risk behavior and that determines overall general health of the donor. After a donor risk assessment interview is completed and if any history is suspect, the physical examination should also encompass a directed examination (of a body part or region). |
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PLASMA DILUTION
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A decrease in the concentration of the donor’s plasma proteins and circulating
antigens or antibodies resulting from the transfusion of blood or blood components and/or infusion of fluids, e.g., colloid(s) and/or crystalloid(s). |
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POLICIES AND PROCEDURES MANUAL
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See Standard Operating Procedures Manual (SOPM).
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POOLING
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The physical contact or mixing of tissue from two or more donors in a single receptacle.
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PRESERVATION
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The use of chemical agents, alterations in environmental conditions or other means
during processing to prevent or retard biological or physical deterioration of tissue. |
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PROCEDURE
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A series of steps, which when followed, is designed to result in a specific outcome.
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PROCESS CONTROLS
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A system of checks and balances incorporated into standard operating
procedures involving critical operations to prevent errors. |
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PROCESS VALIDATION STUDIES
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The process of demonstrating that a specific process or procedure
will consistently produce expected results within predetermined specifications. |
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PROCESSING
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Any activity performed on tissue, other than tissue recovery or collection, including
preparation, preservation for storage, and/or removal from storage, to assure the quality and/or sterility of human tissue. Processing includes steps to inactivate and/or remove adventitious agents |
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PROCUREMENT
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See RECOVERY
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PROFICIENCY
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An evaluation of laboratory methods and test results that assesses the quality of
standard operating procedures, equipment, supplies, and reagents, as well as the skill of the personnel performing the testing |
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QUALIFICATION
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The process of establishing confidence that equipment, reagents, and ancillary
systems are capable of consistently operating within established limits and tolerances. Process performance qualification is intended to establish confidence that the process is effective and reproducible. |
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QUALITY
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The conformance of tissue or a process with pre-established specifications or standards
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QUALITY ASSURANCE (QA) PROGRAM
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A program that defines the policies and environment that
are required to meet standards of quality and safety and that provides confidence that the processes and tissue consistently conform to requirements for quality. Dimensions of QA may include quality control, auditing and process control, standards for personnel, facilities, procedures, equipment, testing, and record keeping activities. |
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QUALITY CONTROL (QC)
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Specific tests defined by the QA Program to be performed to monitor
recovery, processing, preservation and storage, tissue quality, and test accuracy. These may include but are not limited to, performance evaluations, inspection, testing, and controls used to determine the accuracy and reliability of the tissue bank’s equipment and operational procedures, as well as the monitoring of supplies, reagents, equipment, and facilities. |
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QUARANTINE
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The identification of human tissue as not suitable for transplantation, including human
tissue that has not yet been characterized as being suitable for transplantation. Quarantine includes the storage of such tissue in an area clearly identified for such use, or other procedures, such as automated designation, to prevent the release of this tissue for transplantation. |
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RECALL
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An action taken by a tissue bank to locate and retrieve tissue from distribution and dispensary
inventories. |
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RECIPIENT
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An individual into whom tissue is transplanted
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RECIPIENT (R)
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A woman undergoing an assisted reproductive technology procedure
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RECOVERY
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Obtaining tissue from a donor that is intended for use in human transplantation.
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RECOVERY SITE
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The immediate area or room where a tissue recovery takes place (e.g., dedicated
tissue recovery suite, healthcare facility operating room, autopsy suite). |
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RELEVANT MEDICAL RECORDS
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a collection of documents including a current donor risk
assessment interview, a physical assessment/physical examination of the donor, laboratory test results (in addition to results of testing for required relevant communicable disease agents), relevant donor records, existing coroner and autopsy reports, as well as information obtained from any source or records which may pertain to donor suitability regarding high risk behaviors, and clinical signs and symptoms for any relevant communicable disease agent or disease (RCDAD), and/or treatments related to medical conditions suggestive of such risk. |
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REPRODUCTIVE TISSUE
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Any cells and/or tissue from the reproductive tract intended for use in
assisted reproductive technology procedures. This includes, but is not limited to: oocytes, ovarian tissue, embryos, semen, spermatozoa, spermatids, testicular tissue, and epididymal tissue. |
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REPRODUCTIVE TISSUE BANK
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A tissue bank that collects, processes, stores, and/or distributes
human reproductive tissue for use in assisted reproductive technology procedures |
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RESOLUTION
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Adjustment, clarification, and/or correction of practices and/or procedures that results
in compliance with the SOPM and/or standards. |
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RESPONSIBLE PERSON
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A person who is authorized to perform designated functions for which he or
she is trained and qualified. |
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SAFETY
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A quality of tissue indicating handling according to standards and substantial freedom from the
potential for harmful effects to recipients |
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SATELLITE FACILITY
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An establishment in a physically separate location where any activities occur
that contribute to recovery, transport, processing, storage, packaging, labeling or distribution of human tissue under the management or direct supervision of the same corporate entity or its employee(s). |
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SEMEN (R)
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The fluid of man’s reproductive system consisting of spermatozoa and secretions of
accessory glands |
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SEMEN BANK (R)
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A tissue bank that collects, processes, stores, and/or distributes semen for use in
artificial insemination or assisted reproductive technology procedures. |
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SERVICES TO DONOR FAMILIES
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A defined policy or program describing tissue donation follow-up
that is offered to the Consenting Person (or Party). These may include written communications regarding: potential uses of tissue; recovery outcome information; bereavement support; provision of a copy of the Document of Consent: and/or guidance describing how to contact the tissue bank if any questions arise regarding the donation. Frequency of follow-up and program maintenance is at the discretion of the Director |
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SHALL
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The same as MUST
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SHOULD
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Used to indicate a recommendation; advisory, indicating a commonly accepted activity for
which there may be effective alternatives. |
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STANDARD OPERATING PROCEDURES MANUAL (SOPM)
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A group of standard operating
procedures (SOPs) detailing the specific policies of a tissue bank and the procedures used by the staff/ personnel. This includes, but is not limited to, procedures to: assess donor suitability; recovery; processing; quarantine; release to inventory; labeling; storage; distribution; and recalling tissue. |
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STANDARDS
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AATB Standards for Tissue Banking
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STERILE
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The absence of detectable, viable, Microorganisms (refer to ANSI/AAMI ST67:2003).
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STERILITY ASSURANCE LEVEL (SAL)
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The probability of a single viable microorganism occurring
on a product after Sterilization (refer to ANSI/AAMI ST67:2003). |
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STERILIZATION
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A validated process used to render tissue free from viable microorganisms (refer to
ANSI/AAMI ST67:2003) including spores. |
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STORAGE
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The maintenance of tissue for future use.
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STRUCTURAL SUPPORT
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Those tissue grafts that contribute biomechanical strength to a surgical
construct. |
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SUMMARY OF RECORDS
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A condensed version of the donor testing and suitability determination
records. This can be combined with the package insert. |
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TERMINAL STERILIZATION
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A validated process whereby tissue within its primary package is
sterilized (refer to ANSI/AAMI ST67:2003). |
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THIRD PARTY RECORDS
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records produced by an entity not involved in tissue recovery or donor
screening. Examples of third party records include: hospital medical records; emergency medical services records; coroner/medical examiner records; and police reports. |
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TISSUE
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A functional group of cells. The term is used collectively in Standards to indicate both cells and
tissue. |
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TISSUE BANK
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An entity that provides or engages in one or more services involving tissue from living
or deceased individuals for transplantation purposes. These services include assessing donor suitability, recovery, processing, storage, labeling, and distribution of tissue. |
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TISSUE DISPENSING SERVICE
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Any entity that receives, stores, and provides tissue directly to an
end-user for immediate transplantation. Tissue dispensing services may or may not be tissue banks, depending on what other functions they perform. |
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TISSUE DISTRIBUTION INTERMEDIARY
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An intermediary agent who acquires and stores tissue for
further distribution and performs no other tissue banking functions |
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TISSUE IDENTIFICATION NUMBER
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Any unique combination of letters, numbers, and/or symbols
assigned to tissue and linked to a donor, from which the complete history of the collection, processing, packaging, quarantine, labeling, storage, and distribution of tissue can be traced. Identical tissue processed under the criteria defined in ‘‘lot’’ may be assigned the same tissue identification number. |
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TOLERANCE LIMITS
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The limits that define a range of acceptable values that are established for each
testing procedure which, when exceeded, require the implementation of corrective actions designed to produce results within the acceptable range in future tests. |
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TOTAL ISCHEMIC TIME (C, V)
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The time interval from asystole to subjecting tissue to disinfection
solution. This is the sum of warm ischemic time and cold ischemic time. |
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TRACEABILITY
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The ability to locate tissue during any step of its donation, collection or recovery,
processing, testing, storage, distribution or disposition. It implies the capacity to identify the medical facility receiving the tissue and, at the medical facility, the ability to identify the recipient. |
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TRANSFER (R)
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The placement of human reproductive tissue into a human recipient.
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TRANSPLANTATION
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The transfer of allograft tissue to a recipient. This includes musculoskeletal,
skin, cardiovascular, and fetal tissue, as well as reproductive tissue used in assisted reproductive procedures. |
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TRANSPORT MEDIUM
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Any microbiological medium capable of maintaining cellular viability during
the transport of a culture from field to laboratory. |
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VALIDATION
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The process of establishing documented evidence that provides a high degree of
assurance that a specific process will consistently produce the predetermined outcome. |
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VALVED CONDUIT (C)
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An allograft heart valve with an attached length of cardiac outflow tract
(aortic or pulmonic). |
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VARIANCE
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A departure from Standards that is pre-approved by the AATB Board of Governors prior to
implementation. |
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VEIN GRAFT (V)
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A segment of vein that is recovered, processed and preserved.
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VERIFICATION
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The confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled. |
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WARM ISCHEMIC TIME (C)
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The time interval from asystole to subjecting cardiac tissue to cold
rinse (or transport) solution at recovery |
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WARM ISCHEMIC TIME (V)
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The time interval from asystole to subjecting vascular tissue to
transport solution and wet ice temperatures at recovery. |
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WET ICE TEMPERATURES
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Temperatures ranging from 1-10°C.
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