CTBS EXAM 2026 SECTION H:
DISTRIBUTION AND DISPENSING
QUESTIONS AND ANSWERS WITH
COMPLETE SOLUTIONS 100%
CORRECT!!
Dispensing and Distribution SOPs
Question: In dispensing and distribution, there shall be Standard Operating
Procedures (SOPs) for which four operational areas?
Answer:
1. Receipt of tissue orders
2. Unit selection
3. Final container and/or package inspection
4. Shipping and transportation of tissue for transplantation
Veterinary Use Restrictions
Question: Human tissue intended for transplantation shall not be offered,
distributed, or dispensed for what specific use unless explicitly granted in a
Document of Gift/Authorization or in a record of informed consent?
Answer: Veterinary use
Authorized Entities for Distribution
Question: Provision of tissue for transplantation shall be restricted to which
specific facilities and professionals?
Answer:
Hospitals
, Free-standing medical facilities
Tissue banks
Tissue dispensing services
End-users for use in recipients (e.g., physicians, dentists, podiatrists, or other
medical professionals)
Tissue Distribution Intermediaries
Question: If tissue is provided to a tissue distribution intermediary, that
intermediary must meet the requirements of what specific section of the AATB
Standards?
Answer: Section M of AATB Standards
Verification and Documentation of Restrictions
Question: Controls must exist to ensure distribution restrictions are met. Where are
these restriction parameters typically found?
Answer: Document of Gift/Authorization or in a record of informed consent.
Question: Distribution restrictions must be communicated to distributors. What
must be documented periodically to verify the intermediary's compliance?
Answer: Periodic verification of activities performed by the tissue distribution
intermediary shall be documented (e.g., a paper audit, on-site audit, on-site
inspections, etc.).
Source Labeling and Consignment
Question: When a tissue bank distributes tissue obtained from another tissue bank
or tissue distribution intermediary, what must accompany the shipment?
Answer: Original labeling materials or other enclosures shall be distributed with
the tissue.
, Question: If tissue is provided on consignment, what dual assurances must the
distributing tissue bank's procedures maintain?
Answer: Traceability and that appropriate storage conditions are maintained during
consignment, transfer, or return.
Information Sharing and Traceability Records
Question: What types of information regarding donor status and processing details
must be made available to the end-user upon request, provided they do not infringe
on donor confidentiality?
Answer: Donor risk assessment, tissue-related information, and tissue processing
details.
Question: Records maintained by a tissue bank distributing tissue to other entities
(including unfinished or unreleased tissue) must be specifically designed to permit
what?
Answer: Designed to permit tissue to be traced from the donor to a consignee or
end-user and from a consignee or end-user back to the donor.
Required Content for Tissue Distribution Records
Question: Tissue distribution records shall include what 6 foundational items?
Answer:
1. Date of order placement
2. Name and address of consignee
3. Name of individual placing the order
4. Type and quantity of tissue ordered
5. Information pertaining to tissue shipped including: identification number of
tissue(s), collection and/or expiration date of tissue, date of shipment, type of
refrigerant, quantity of refrigerant, mode of transportation or courier, and
name of the staff member filling the order
6. Identifying information, if available, about the intended recipient
DISTRIBUTION AND DISPENSING
QUESTIONS AND ANSWERS WITH
COMPLETE SOLUTIONS 100%
CORRECT!!
Dispensing and Distribution SOPs
Question: In dispensing and distribution, there shall be Standard Operating
Procedures (SOPs) for which four operational areas?
Answer:
1. Receipt of tissue orders
2. Unit selection
3. Final container and/or package inspection
4. Shipping and transportation of tissue for transplantation
Veterinary Use Restrictions
Question: Human tissue intended for transplantation shall not be offered,
distributed, or dispensed for what specific use unless explicitly granted in a
Document of Gift/Authorization or in a record of informed consent?
Answer: Veterinary use
Authorized Entities for Distribution
Question: Provision of tissue for transplantation shall be restricted to which
specific facilities and professionals?
Answer:
Hospitals
, Free-standing medical facilities
Tissue banks
Tissue dispensing services
End-users for use in recipients (e.g., physicians, dentists, podiatrists, or other
medical professionals)
Tissue Distribution Intermediaries
Question: If tissue is provided to a tissue distribution intermediary, that
intermediary must meet the requirements of what specific section of the AATB
Standards?
Answer: Section M of AATB Standards
Verification and Documentation of Restrictions
Question: Controls must exist to ensure distribution restrictions are met. Where are
these restriction parameters typically found?
Answer: Document of Gift/Authorization or in a record of informed consent.
Question: Distribution restrictions must be communicated to distributors. What
must be documented periodically to verify the intermediary's compliance?
Answer: Periodic verification of activities performed by the tissue distribution
intermediary shall be documented (e.g., a paper audit, on-site audit, on-site
inspections, etc.).
Source Labeling and Consignment
Question: When a tissue bank distributes tissue obtained from another tissue bank
or tissue distribution intermediary, what must accompany the shipment?
Answer: Original labeling materials or other enclosures shall be distributed with
the tissue.
, Question: If tissue is provided on consignment, what dual assurances must the
distributing tissue bank's procedures maintain?
Answer: Traceability and that appropriate storage conditions are maintained during
consignment, transfer, or return.
Information Sharing and Traceability Records
Question: What types of information regarding donor status and processing details
must be made available to the end-user upon request, provided they do not infringe
on donor confidentiality?
Answer: Donor risk assessment, tissue-related information, and tissue processing
details.
Question: Records maintained by a tissue bank distributing tissue to other entities
(including unfinished or unreleased tissue) must be specifically designed to permit
what?
Answer: Designed to permit tissue to be traced from the donor to a consignee or
end-user and from a consignee or end-user back to the donor.
Required Content for Tissue Distribution Records
Question: Tissue distribution records shall include what 6 foundational items?
Answer:
1. Date of order placement
2. Name and address of consignee
3. Name of individual placing the order
4. Type and quantity of tissue ordered
5. Information pertaining to tissue shipped including: identification number of
tissue(s), collection and/or expiration date of tissue, date of shipment, type of
refrigerant, quantity of refrigerant, mode of transportation or courier, and
name of the staff member filling the order
6. Identifying information, if available, about the intended recipient
