CTBS EXAM PREP COURSE ALL FLASH CARDS
1. Recovery: Obtaining tissue other than reproductive tissue from a donor that is intended for use in human
transplantation, therapy, research, or education
2. May: an acceptable method that is recognized but NOT essential
3. Must: Use to indicate a MANDATORY requirement. The same as SHALL.
4. Shall: Use to indicate a MANDATORY standard. The same as MUST.
5. Should: Indicated a recommendation; advisory, indicating a commonly accepted activity for which there may be
ettective alternatives.
6. Container: An enclosure for ONE finished unit of transplantable tissue (1 unit of tissue)
7. Package: A labeled box, carton, receptacle, or wrapper containing tissue and ,ay contain one or more containers
and accompanying label materials
8. Container Label: Contains 10 items including reference to package insert. Includes Tissue Identification
number and 9 listed items)
9. Transport Package Label: Domestic: 6 items
International: Same as domestic + receiving federal country needs receiving country needs and federal government
additions.
10. Package Insert: All packages have 21 items; DV Donors add 11 more items for a total of 32.
11. Packaging System: Combination of primary package, secondary package, and additional protective pack-
aging, as deemed necessary.
12. Primary Packaging: Layer of packaging in direct contact with tissue
13. Secondary Package: Barrier surrounding primary package (e.g. tissue can be sterile inside, aseptically
processed tissue, recovered, or acquired tissues)"
14. Error: Deviation from SOPM, Standards, or applicable laws or regulations.
15. Accident: Any occurrence, not associated with a deviation from SOPs, standards, or or applicable laws or
regulations during donor screening or testing. or issue recovery, collection or acquisition, processing, quarantining,
,labeling, storage, quarantining, or dispensing that may ettect:
-the performance
-biocompatibility
-freedom from transmissible pathogens of tissues
-Ability to trave tissues to the Donor
16. Variance: A departure from Standards that is pre-approved but the AATB Board of Governors PRIOR to
implementation.
17. Deviation: An event that is a departure from a procedure or normal practice (Can be intentional)
,18. Physical Assessment: An examination of a deceased donor's body. Ante-mortem or Post-mortem; ID
evidence of High Risk behavior, signs of HIV or HB, viral or bacterial infections, an trauma to recover sites
19. Physical Examination: An examination of a living donor's body to determine evidence of high risk
behavior, to determine overall general health; examination after DRAI should encompass a directed examination (if
history is suspect)
20. Acquisition: The point after delivery at which tissue is under the control of the tissue bank
21. You are comparing the DRAI and learn that the potential donor lived with
a relative who was HCV positive at the time of death. According to AATB
standards for Tissue Banking you must:: Defer the case
22. Nucleic Acid Test, or NAT, detect what?: Viral DNA and RNA
23. What document must be included in the donor record if no third party
records are available?: The death certificate.
24. In the United States, which agency provides regulatory oversight of tissue
banking?: FDA
25. Tissue banks wishing to implement practices differing from AATB standards
for Tissue Banking must:: Request a variance to standards
26. In tissue processing, the "lot" refers to:: The tissue/grafts produced from one donor in a specific
processing session.
27. Which of the following is required by AATB standards for tissue banking of
all tissue establishments?: Tissue establishments shall have a governing body.
28. Which anatomical landmark denotes the point at which the recovery of the
great saphenous vein should stop?: The saphenofemoral junction
29. Why is screening, medical record review, and DRAI review in evaluating in-
creased risk behaviors, such as drug use, in addition to testing so important?: To
ID the risk of a negative screen due to the window period, the potential for a false negative screening, a non-reactive test
due to viral suppression.
, 30. The donor risk assessment (DRAI) should be completed with the:: Most knowl-
edgeable person
31. Persons who have for a non-medical reason, included intravenous,
intramuscular, and subcutaneous injections are excluded from donation.: Injected
drugs within the preceding five years
32. Which of the following tendons inserts at the tibia?: The Gracilis tendon.
1. Recovery: Obtaining tissue other than reproductive tissue from a donor that is intended for use in human
transplantation, therapy, research, or education
2. May: an acceptable method that is recognized but NOT essential
3. Must: Use to indicate a MANDATORY requirement. The same as SHALL.
4. Shall: Use to indicate a MANDATORY standard. The same as MUST.
5. Should: Indicated a recommendation; advisory, indicating a commonly accepted activity for which there may be
ettective alternatives.
6. Container: An enclosure for ONE finished unit of transplantable tissue (1 unit of tissue)
7. Package: A labeled box, carton, receptacle, or wrapper containing tissue and ,ay contain one or more containers
and accompanying label materials
8. Container Label: Contains 10 items including reference to package insert. Includes Tissue Identification
number and 9 listed items)
9. Transport Package Label: Domestic: 6 items
International: Same as domestic + receiving federal country needs receiving country needs and federal government
additions.
10. Package Insert: All packages have 21 items; DV Donors add 11 more items for a total of 32.
11. Packaging System: Combination of primary package, secondary package, and additional protective pack-
aging, as deemed necessary.
12. Primary Packaging: Layer of packaging in direct contact with tissue
13. Secondary Package: Barrier surrounding primary package (e.g. tissue can be sterile inside, aseptically
processed tissue, recovered, or acquired tissues)"
14. Error: Deviation from SOPM, Standards, or applicable laws or regulations.
15. Accident: Any occurrence, not associated with a deviation from SOPs, standards, or or applicable laws or
regulations during donor screening or testing. or issue recovery, collection or acquisition, processing, quarantining,
,labeling, storage, quarantining, or dispensing that may ettect:
-the performance
-biocompatibility
-freedom from transmissible pathogens of tissues
-Ability to trave tissues to the Donor
16. Variance: A departure from Standards that is pre-approved but the AATB Board of Governors PRIOR to
implementation.
17. Deviation: An event that is a departure from a procedure or normal practice (Can be intentional)
,18. Physical Assessment: An examination of a deceased donor's body. Ante-mortem or Post-mortem; ID
evidence of High Risk behavior, signs of HIV or HB, viral or bacterial infections, an trauma to recover sites
19. Physical Examination: An examination of a living donor's body to determine evidence of high risk
behavior, to determine overall general health; examination after DRAI should encompass a directed examination (if
history is suspect)
20. Acquisition: The point after delivery at which tissue is under the control of the tissue bank
21. You are comparing the DRAI and learn that the potential donor lived with
a relative who was HCV positive at the time of death. According to AATB
standards for Tissue Banking you must:: Defer the case
22. Nucleic Acid Test, or NAT, detect what?: Viral DNA and RNA
23. What document must be included in the donor record if no third party
records are available?: The death certificate.
24. In the United States, which agency provides regulatory oversight of tissue
banking?: FDA
25. Tissue banks wishing to implement practices differing from AATB standards
for Tissue Banking must:: Request a variance to standards
26. In tissue processing, the "lot" refers to:: The tissue/grafts produced from one donor in a specific
processing session.
27. Which of the following is required by AATB standards for tissue banking of
all tissue establishments?: Tissue establishments shall have a governing body.
28. Which anatomical landmark denotes the point at which the recovery of the
great saphenous vein should stop?: The saphenofemoral junction
29. Why is screening, medical record review, and DRAI review in evaluating in-
creased risk behaviors, such as drug use, in addition to testing so important?: To
ID the risk of a negative screen due to the window period, the potential for a false negative screening, a non-reactive test
due to viral suppression.
, 30. The donor risk assessment (DRAI) should be completed with the:: Most knowl-
edgeable person
31. Persons who have for a non-medical reason, included intravenous,
intramuscular, and subcutaneous injections are excluded from donation.: Injected
drugs within the preceding five years
32. Which of the following tendons inserts at the tibia?: The Gracilis tendon.
