CTBS Exam 2022 Section M Tissue
Distribution Intermediaries questions
with solutions
An agent who acquires distributed tissue for storage and further distribution shall? -
answersEstablish policies and procedures to ensure the safety and traceability of tissue
from receipt through storage, clinical use, further distribution, or destruction.
the definition of a tissue distribution intermediary and responsibilities include? -
answers1) designing, creating, maintaining, or controlling the specifications for finished
tissue, relevant parts of Section E apply
2) designing, creating, specifying, or maintaining responsibility for the contents of the
label for finished tissue, relevant parts of Section G apply
3) performing any labeling functions to include the physical application of a label to
finished tissue, relevant parts of Section G apply
4) final review for tissue release, relevant parts of Section F apply
When any tissue banking activities are performed beyond the few functions that identify
an entity as a tissue distribution intermediary (i.e., an agent that only acquires and
stores tissue for further distribution)? - answersAll standards apply, and compliance is
required for accreditation.
The difference in relabeling for tissue dispensing service and tissue distribution
intermediaries are? - answersTissue shall not be relabeled. Existing labels shall not be
altered. Additional labels shall not be applied unless pre-approved by the tissue bank
processor that applied the original label
When a tissue distribution intermediary further distributes tissue? - answersall
accompanying labeling materials or other enclosures shall be forwarded with the tissue.
Provision of tissue for transplantation shall be restricted to? - answershospitals, free-
standing medical facilities, tissue banks, tissue dispensing services, another tissue
distribution intermediary, and end-users (e.g., physicians, dentists, podiatrists or other
medical professionals) for use in recipients
Tissue distribution intermediaries shall have procedures that describe ? -
answersevaluation of requests from new customers for tissue.
, Human tissue by tissue distribution intermediaries dispensed for transplantation shall
not be offered or distributed for veterinary use? - answersunless such use is specifically
granted in a document of gift/authorization or in a record of informed consent. Controls
must exist to ensure distribution restrictions are met such as those found on the
document of gift/authorization or informed consent.
Donor risk assessment, tissue condition(s), and tissue processing details, with the
exception of information that may infringe upon the confidentiality of donor information,
shall be? - answersmade available to the transplanting physician upon request.
If tissue is provided on consignment, the tissue distribution intermediary shall? -
answersmaintain procedures to ensure traceability and that appropriate storage
conditions are maintained during consignment, further distribution or return
Prior to shipping, packages shall be inspected to ensure the external packaging and
labels? - answersare undamaged, the tissue is not expired, and the tissue being
shipped is consistent with the tissue requested. The exterior of the transport package
shall be inspected to verify that requirements in G3.310 are met. These inspections
shall be documented, including identification of staff conducting inspections
If tissue to be shipped requires specific environmental conditions other than ambient
temperature, the capability of the transport package? - answersto maintain the required
environmental conditions shall be demonstrated and documented in a validation study.
The length of time those conditions can be maintained by the packaging (assuming
normal handling) shall also be determined. Expiration dates of the packaging shall be
noted on the outside of the transport package
The mode of transportation selected shall be? - answersdetermined by any special
shipping and handling requirements of the tissue and/or shipping refrigerants, shipping
restrictions of commercial carriers, and the urgency of the tissue request.
The transport package label shall include the following information? - answers1) name,
address and telephone number of the tissue distribution intermediary
2) name and address of the consignee or end-user
3) telephone number of the organization to whom issues related to shipping should be
communicated
4) prominent identification of contents as ''DONATED HUMAN TISSUE.''
5) recommended storage conditions and transport expiration date (if applicable)
6) type and quantity of refrigerant or other hazardous materials enclosed in the transport
package
7) transport (shipping) expiration date (if applicable)
8) any special handling instructions, when applicable (ex "DO NOT FREEZE," "DO NOT
X-RAY," "DO NOT IRRADIATE")
Distribution Intermediaries questions
with solutions
An agent who acquires distributed tissue for storage and further distribution shall? -
answersEstablish policies and procedures to ensure the safety and traceability of tissue
from receipt through storage, clinical use, further distribution, or destruction.
the definition of a tissue distribution intermediary and responsibilities include? -
answers1) designing, creating, maintaining, or controlling the specifications for finished
tissue, relevant parts of Section E apply
2) designing, creating, specifying, or maintaining responsibility for the contents of the
label for finished tissue, relevant parts of Section G apply
3) performing any labeling functions to include the physical application of a label to
finished tissue, relevant parts of Section G apply
4) final review for tissue release, relevant parts of Section F apply
When any tissue banking activities are performed beyond the few functions that identify
an entity as a tissue distribution intermediary (i.e., an agent that only acquires and
stores tissue for further distribution)? - answersAll standards apply, and compliance is
required for accreditation.
The difference in relabeling for tissue dispensing service and tissue distribution
intermediaries are? - answersTissue shall not be relabeled. Existing labels shall not be
altered. Additional labels shall not be applied unless pre-approved by the tissue bank
processor that applied the original label
When a tissue distribution intermediary further distributes tissue? - answersall
accompanying labeling materials or other enclosures shall be forwarded with the tissue.
Provision of tissue for transplantation shall be restricted to? - answershospitals, free-
standing medical facilities, tissue banks, tissue dispensing services, another tissue
distribution intermediary, and end-users (e.g., physicians, dentists, podiatrists or other
medical professionals) for use in recipients
Tissue distribution intermediaries shall have procedures that describe ? -
answersevaluation of requests from new customers for tissue.
, Human tissue by tissue distribution intermediaries dispensed for transplantation shall
not be offered or distributed for veterinary use? - answersunless such use is specifically
granted in a document of gift/authorization or in a record of informed consent. Controls
must exist to ensure distribution restrictions are met such as those found on the
document of gift/authorization or informed consent.
Donor risk assessment, tissue condition(s), and tissue processing details, with the
exception of information that may infringe upon the confidentiality of donor information,
shall be? - answersmade available to the transplanting physician upon request.
If tissue is provided on consignment, the tissue distribution intermediary shall? -
answersmaintain procedures to ensure traceability and that appropriate storage
conditions are maintained during consignment, further distribution or return
Prior to shipping, packages shall be inspected to ensure the external packaging and
labels? - answersare undamaged, the tissue is not expired, and the tissue being
shipped is consistent with the tissue requested. The exterior of the transport package
shall be inspected to verify that requirements in G3.310 are met. These inspections
shall be documented, including identification of staff conducting inspections
If tissue to be shipped requires specific environmental conditions other than ambient
temperature, the capability of the transport package? - answersto maintain the required
environmental conditions shall be demonstrated and documented in a validation study.
The length of time those conditions can be maintained by the packaging (assuming
normal handling) shall also be determined. Expiration dates of the packaging shall be
noted on the outside of the transport package
The mode of transportation selected shall be? - answersdetermined by any special
shipping and handling requirements of the tissue and/or shipping refrigerants, shipping
restrictions of commercial carriers, and the urgency of the tissue request.
The transport package label shall include the following information? - answers1) name,
address and telephone number of the tissue distribution intermediary
2) name and address of the consignee or end-user
3) telephone number of the organization to whom issues related to shipping should be
communicated
4) prominent identification of contents as ''DONATED HUMAN TISSUE.''
5) recommended storage conditions and transport expiration date (if applicable)
6) type and quantity of refrigerant or other hazardous materials enclosed in the transport
package
7) transport (shipping) expiration date (if applicable)
8) any special handling instructions, when applicable (ex "DO NOT FREEZE," "DO NOT
X-RAY," "DO NOT IRRADIATE")
