CTBS EXAM SECTION M: TISSUE DISTRIBUTION
INTERMEDIARIES
1. An agent who acquires distributed tissue for storage and further distribution shall?:
Establish policies and procedures to ensure the safety and traceability of tissue from receipt through storage, clinical use,
further distribution, or destruction.
2. the definition of a tissue distribution intermediary and responsibilities in-
clude?: 1) 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
3. 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)?: All standards apply, and compli-
ance is required for accreditation.
4. The difference in relabeling for tissue dispensing service and tissue distribu-
tion intermediaries are?: Tissue 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
5. When a tissue distribution intermediary further distributes tissue?: all accompa-
nying labeling materials or other enclosures shall be forwarded with the tissue.
6. Provision of tissue for transplantation shall be restricted to?: hospitals, 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
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, 7. Tissue distribution intermediaries shall have procedures that describe ?: eval-
uation of requests from new customers for tissue.
8. Human tissue by tissue distribution intermediaries dispensed for transplanta-
tion shall not be offered or distributed for veterinary use?: unless 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.
9. 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?: made available to the transplanting physician upon request.
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INTERMEDIARIES
1. An agent who acquires distributed tissue for storage and further distribution shall?:
Establish policies and procedures to ensure the safety and traceability of tissue from receipt through storage, clinical use,
further distribution, or destruction.
2. the definition of a tissue distribution intermediary and responsibilities in-
clude?: 1) 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
3. 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)?: All standards apply, and compli-
ance is required for accreditation.
4. The difference in relabeling for tissue dispensing service and tissue distribu-
tion intermediaries are?: Tissue 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
5. When a tissue distribution intermediary further distributes tissue?: all accompa-
nying labeling materials or other enclosures shall be forwarded with the tissue.
6. Provision of tissue for transplantation shall be restricted to?: hospitals, 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
1/9
, 7. Tissue distribution intermediaries shall have procedures that describe ?: eval-
uation of requests from new customers for tissue.
8. Human tissue by tissue distribution intermediaries dispensed for transplanta-
tion shall not be offered or distributed for veterinary use?: unless 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.
9. 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?: made available to the transplanting physician upon request.
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