CTBS EXAMS TEST PAPER QUESTIONS AND ANSWERS
SURE A+
✔✔OSTEOARTICULAR GRAFT - ✔✔A weight bearing allograft with intact articular
surfaces, consisting of a joint with associated soft tissue and bone.
✔✔PATCH GRAFT (C) - ✔✔A segment of cardiac allograft conduit to be used in
cardiovascular repair, replacement, construction, or reconstruction
✔✔PERFUSION SOLUTION (V) - ✔✔A room temperature, sterile isotonic solution such
as tissue culture media or PlasmaLyte® utilized to gently perfuse veins at recovery. This
solution may also contain an antithrombotic agent (i.e., sodium heparin)
✔✔POOLING - ✔✔The physical contact or mixing of tissue from two or more donors in
a single receptacle.
✔✔PROCESSING - ✔✔- 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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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) - ✔✔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 - ✔✔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 - ✔✔A condensed version of the donor testing and
eligibility determination records. This can be combined with the package insert.
✔✔SURGICAL BONE (SB) - ✔✔Any bone from a living donor for allogeneic use such
as a femoral head removed during surgery.
✔✔TERMINAL STERILIZATION - ✔✔A validated process used to render a product
(e.g., tissue) within its final sterile barrier system (e. g., package, container) sterile
✔✔TISSUE - ✔✔A functional group of cells. The term is used collectively in Standards
to indicate both cells and tissue.
✔✔TOTAL ISCHEMIC TIME (C, V) - ✔✔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) - ✔✔The placement of human reproductive tissue into a human
recipient (R).
✔✔WARM ISCHEMIC TIME (C) - ✔✔The time interval from asystole to subjecting
cardiac tissue to cold rinse (or transport) solution at recovery
✔✔WARM ISCHEMIC TIME (V) - ✔✔The time interval from asystole to subjecting
vascular tissue to transport solution and wet ice temperatures at recovery.
✔✔WET ICE TEMPERATURES - ✔✔Temperatures ranging from above freezing (0°C)
to 10°C.
✔✔What two things must organizations have in their structure? - ✔✔A governing body
and Person(s) designated as Management with Executive responsibility (MWER)
✔✔Purchasing Controls - ✔✔Establish and maintain procedures to ensure all
purchases of products or services conform to requirements established by each tissue
bank
✔✔What documents/types must be maintained by Quality(5) - ✔✔Master copy of
current SOPM • Archived documents • Master list of preprinted labels • Records of
names, signatures, initials or identification codes and inclusive date of employment for
those authorized to perform of review tasks • Reports and conclusions of process
validations and equipment qualification studies
SURE A+
✔✔OSTEOARTICULAR GRAFT - ✔✔A weight bearing allograft with intact articular
surfaces, consisting of a joint with associated soft tissue and bone.
✔✔PATCH GRAFT (C) - ✔✔A segment of cardiac allograft conduit to be used in
cardiovascular repair, replacement, construction, or reconstruction
✔✔PERFUSION SOLUTION (V) - ✔✔A room temperature, sterile isotonic solution such
as tissue culture media or PlasmaLyte® utilized to gently perfuse veins at recovery. This
solution may also contain an antithrombotic agent (i.e., sodium heparin)
✔✔POOLING - ✔✔The physical contact or mixing of tissue from two or more donors in
a single receptacle.
✔✔PROCESSING - ✔✔- 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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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) - ✔✔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 - ✔✔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 - ✔✔A condensed version of the donor testing and
eligibility determination records. This can be combined with the package insert.
✔✔SURGICAL BONE (SB) - ✔✔Any bone from a living donor for allogeneic use such
as a femoral head removed during surgery.
✔✔TERMINAL STERILIZATION - ✔✔A validated process used to render a product
(e.g., tissue) within its final sterile barrier system (e. g., package, container) sterile
✔✔TISSUE - ✔✔A functional group of cells. The term is used collectively in Standards
to indicate both cells and tissue.
✔✔TOTAL ISCHEMIC TIME (C, V) - ✔✔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) - ✔✔The placement of human reproductive tissue into a human
recipient (R).
✔✔WARM ISCHEMIC TIME (C) - ✔✔The time interval from asystole to subjecting
cardiac tissue to cold rinse (or transport) solution at recovery
✔✔WARM ISCHEMIC TIME (V) - ✔✔The time interval from asystole to subjecting
vascular tissue to transport solution and wet ice temperatures at recovery.
✔✔WET ICE TEMPERATURES - ✔✔Temperatures ranging from above freezing (0°C)
to 10°C.
✔✔What two things must organizations have in their structure? - ✔✔A governing body
and Person(s) designated as Management with Executive responsibility (MWER)
✔✔Purchasing Controls - ✔✔Establish and maintain procedures to ensure all
purchases of products or services conform to requirements established by each tissue
bank
✔✔What documents/types must be maintained by Quality(5) - ✔✔Master copy of
current SOPM • Archived documents • Master list of preprinted labels • Records of
names, signatures, initials or identification codes and inclusive date of employment for
those authorized to perform of review tasks • Reports and conclusions of process
validations and equipment qualification studies
