TISSUE BANKING SPECIALIST 2026 EXAM
SCRIPT TEST PAPER QUESTIONS AND
ANSWERS VERIFIED PASS
◉ PROCESSING. Answer: - Any activity performed on tissue other
than donor screening, donor testing, tissue recovery, collection, or
acquisition functions, storage, distribution or dispensing. It includes
but is not limited to (i) disinfecting, (ii) sterilizing, (iii) packaging in
primary package as defined in Guidance Document No.9, (iv)
packaging in secondary package, when used, as defined in Guidance
Document No9, (v) labeling, and (vi) testing tissue.
◉ QUARANTINE. Answer: The identification of tissue, reagents,
supplies, materials and equipment as not suitable for use, or that has
not yet been characterized as being suitable for use.
◉ RECALL. Answer: A field correction or removal of distributed
tissue initiated to reduce a risk to health posed by the tissue or to
remedy a violation of regulatory requirements that may present a
risk to health.
◉ SKIN PREP. Answer: The application of antiseptic solution to
decontaminate the skin. This is a continuous process that is
performed without delay between steps; it does not include shaving
hair, although this can be done if preferred.
,◉ STATIC. Answer: At-rest condition during aseptic processing
where the controlled environment is complete with equipment
installed and operating in a manner agreed upon, but with no
personnel present
◉ STERILE and Sterility assurance level (SAL). Answer: The absence
of detectable, viable, microorganisms (refer to ANSI/AAMI
ST67:2011) including spores. SAL= The probability of a single viable
microorganism occurring on a product after sterilization
◉ STOCK RECOVERY. Answer: Retrieval of tissue that has not left the
direct control of the tissue bank (manufacturer), i.e., the tissue is
located on the premises owned, or under the control of, the tissue
bank (manufacturer), and no portion of the affected tissue has been
released for use.
◉ SUMMARY OF RECORDS. Answer: A condensed version of the
donor testing and eligibility determination records. This can be
combined with the package insert.
◉ SURGICAL BONE (SB). Answer: Any bone from a living donor for
allogeneic use such as a femoral head removed during surgery.
, ◉ TERMINAL STERILIZATION. Answer: A validated process used to
render a product (e.g., tissue) within its final sterile barrier system
(e. g., package, container) sterile
◉ TISSUE. Answer: A functional group of cells. The term is used
collectively in Standards to indicate both cells and tissue.
◉ TOTAL ISCHEMIC TIME (C, V). Answer: The time interval from
asystole to subjecting tissue to disinfection solution. This is the sum
of warm ischemic time and cold ischemic time.
◉ TRANSFER (R). Answer: The placement of human reproductive
tissue into a human recipient (R).
◉ WARM ISCHEMIC TIME (C). Answer: The time interval from
asystole to subjecting cardiac tissue to cold rinse (or transport)
solution at recovery
◉ WARM ISCHEMIC TIME (V). Answer: The time interval from
asystole to subjecting vascular tissue to transport solution and wet
ice temperatures at recovery.
◉ WET ICE TEMPERATURES. Answer: Temperatures ranging from
above freezing (0°C) to 10°C.
SCRIPT TEST PAPER QUESTIONS AND
ANSWERS VERIFIED PASS
◉ PROCESSING. Answer: - Any activity performed on tissue other
than donor screening, donor testing, tissue recovery, collection, or
acquisition functions, storage, distribution or dispensing. It includes
but is not limited to (i) disinfecting, (ii) sterilizing, (iii) packaging in
primary package as defined in Guidance Document No.9, (iv)
packaging in secondary package, when used, as defined in Guidance
Document No9, (v) labeling, and (vi) testing tissue.
◉ QUARANTINE. Answer: The identification of tissue, reagents,
supplies, materials and equipment as not suitable for use, or that has
not yet been characterized as being suitable for use.
◉ RECALL. Answer: A field correction or removal of distributed
tissue initiated to reduce a risk to health posed by the tissue or to
remedy a violation of regulatory requirements that may present a
risk to health.
◉ SKIN PREP. Answer: The application of antiseptic solution to
decontaminate the skin. This is a continuous process that is
performed without delay between steps; it does not include shaving
hair, although this can be done if preferred.
,◉ STATIC. Answer: At-rest condition during aseptic processing
where the controlled environment is complete with equipment
installed and operating in a manner agreed upon, but with no
personnel present
◉ STERILE and Sterility assurance level (SAL). Answer: The absence
of detectable, viable, microorganisms (refer to ANSI/AAMI
ST67:2011) including spores. SAL= The probability of a single viable
microorganism occurring on a product after sterilization
◉ STOCK RECOVERY. Answer: Retrieval of tissue that has not left the
direct control of the tissue bank (manufacturer), i.e., the tissue is
located on the premises owned, or under the control of, the tissue
bank (manufacturer), and no portion of the affected tissue has been
released for use.
◉ SUMMARY OF RECORDS. Answer: A condensed version of the
donor testing and eligibility determination records. This can be
combined with the package insert.
◉ SURGICAL BONE (SB). Answer: Any bone from a living donor for
allogeneic use such as a femoral head removed during surgery.
, ◉ TERMINAL STERILIZATION. Answer: A validated process used to
render a product (e.g., tissue) within its final sterile barrier system
(e. g., package, container) sterile
◉ TISSUE. Answer: A functional group of cells. The term is used
collectively in Standards to indicate both cells and tissue.
◉ TOTAL ISCHEMIC TIME (C, V). Answer: The time interval from
asystole to subjecting tissue to disinfection solution. This is the sum
of warm ischemic time and cold ischemic time.
◉ TRANSFER (R). Answer: The placement of human reproductive
tissue into a human recipient (R).
◉ WARM ISCHEMIC TIME (C). Answer: The time interval from
asystole to subjecting cardiac tissue to cold rinse (or transport)
solution at recovery
◉ WARM ISCHEMIC TIME (V). Answer: The time interval from
asystole to subjecting vascular tissue to transport solution and wet
ice temperatures at recovery.
◉ WET ICE TEMPERATURES. Answer: Temperatures ranging from
above freezing (0°C) to 10°C.
