CTBS Terms And Quality: Complete Study Guide
Recovery Right Ans - Obtaining tissue other than reproductive tissue from
a donor that is intended for use in human transplantation, therapy, research
or education
Container Right Ans - An enclosure for 1 finished unit of transplantable
tissue. (1 unit of tissue)
Package Right Ans - A labeled box, carton, receptacle, or wrapper
containing tissue and may contain one or more containers and accompanying
labeling materials.
Packaging system Right Ans - The combination of primary package,
secondary package, and additional protective packaging, as deemed
necessary.
Primary package Right Ans - Layer of packaging in direct contact with
tissue
Secondary package Right Ans - -The barrier that surrounds the primary
package (e.g., the tissue can be sterile tissue inside, aseptically processed
tissue, recovered, or acquired tissue.)
Error Right Ans - A deviation from SOPM, Standards, or applicable laws or
regulations.
Accident Right Ans - Any occurrence, not associated with a deviation from
SOPs, standards, or applicable laws or regulations, during donor screening or
testing, or tissue recovery, collection or acquisition, processing, quarantining,
labeling, storage, distribution, or dispensing that may affect:
●the performance,
●biocompatability, or
●freedom from transmissable pathogens of the tissue or the ●ability to trace
tissue to the donor.
Variance Right Ans - A departure from Standards that is PRE-APPROVED
by the AATB Board of Governors PRIOR to implementation
, Deviation Right Ans - An event that is a departure from a procedure or
normal practice (Can be intentional)
Physical Assessment Right Ans - An examination of a deceased donor's
body.
- Ante-mortem or post-mortem
- identify evidence of: HR behavior, signs of HIV or Hep, viral or bacterial
infections, trauma to recovery sites
Physical examination Right Ans - An examination of a living donor's body
to:
- determine evidence of HR behavior (and)
- determines overall general health
- examination after DRAI should encompass a directed examination (if history
is suspect)
Acquistion (BT)- Right Ans - The point after delivery at which tissue is
under the control of the tissue bank
Organ Procurement Organization (OPO) ,Tissue Recovery Organization, Birth
Tissue Acquisition Organization Right Ans - Responsible for the recovery
and/or acquisition of donated tissues and "front-and" functions.
Tissues recovered for tissue bank/tissue processor.
Criteria defined by the tissue processor/bank provides the final decision on
tissue use for transplant.
May approach the family or may have standing agreements in place. (e.g.,
processor, OPO, eye bank)
Tissue Bank or Processor Right Ans - May also function as a tissue
recovery/acquisition organization. My also function as a tissue distributor.
Stores tissue and completes and (or) verifies all necessary testing outcomes.
Processes and packages tissue for distribution.
Responsible for the release of tissue for transplant.
Establishes traceability through all steps.
Tissue Distributor Right Ans - May be tissue bank/tissue processor.
May work directly with end users.
Stores and distributes tissue for use.
Facilitates recalls and returns, as necessary.
Recovery Right Ans - Obtaining tissue other than reproductive tissue from
a donor that is intended for use in human transplantation, therapy, research
or education
Container Right Ans - An enclosure for 1 finished unit of transplantable
tissue. (1 unit of tissue)
Package Right Ans - A labeled box, carton, receptacle, or wrapper
containing tissue and may contain one or more containers and accompanying
labeling materials.
Packaging system Right Ans - The combination of primary package,
secondary package, and additional protective packaging, as deemed
necessary.
Primary package Right Ans - Layer of packaging in direct contact with
tissue
Secondary package Right Ans - -The barrier that surrounds the primary
package (e.g., the tissue can be sterile tissue inside, aseptically processed
tissue, recovered, or acquired tissue.)
Error Right Ans - A deviation from SOPM, Standards, or applicable laws or
regulations.
Accident Right Ans - Any occurrence, not associated with a deviation from
SOPs, standards, or applicable laws or regulations, during donor screening or
testing, or tissue recovery, collection or acquisition, processing, quarantining,
labeling, storage, distribution, or dispensing that may affect:
●the performance,
●biocompatability, or
●freedom from transmissable pathogens of the tissue or the ●ability to trace
tissue to the donor.
Variance Right Ans - A departure from Standards that is PRE-APPROVED
by the AATB Board of Governors PRIOR to implementation
, Deviation Right Ans - An event that is a departure from a procedure or
normal practice (Can be intentional)
Physical Assessment Right Ans - An examination of a deceased donor's
body.
- Ante-mortem or post-mortem
- identify evidence of: HR behavior, signs of HIV or Hep, viral or bacterial
infections, trauma to recovery sites
Physical examination Right Ans - An examination of a living donor's body
to:
- determine evidence of HR behavior (and)
- determines overall general health
- examination after DRAI should encompass a directed examination (if history
is suspect)
Acquistion (BT)- Right Ans - The point after delivery at which tissue is
under the control of the tissue bank
Organ Procurement Organization (OPO) ,Tissue Recovery Organization, Birth
Tissue Acquisition Organization Right Ans - Responsible for the recovery
and/or acquisition of donated tissues and "front-and" functions.
Tissues recovered for tissue bank/tissue processor.
Criteria defined by the tissue processor/bank provides the final decision on
tissue use for transplant.
May approach the family or may have standing agreements in place. (e.g.,
processor, OPO, eye bank)
Tissue Bank or Processor Right Ans - May also function as a tissue
recovery/acquisition organization. My also function as a tissue distributor.
Stores tissue and completes and (or) verifies all necessary testing outcomes.
Processes and packages tissue for distribution.
Responsible for the release of tissue for transplant.
Establishes traceability through all steps.
Tissue Distributor Right Ans - May be tissue bank/tissue processor.
May work directly with end users.
Stores and distributes tissue for use.
Facilitates recalls and returns, as necessary.
