Documentation Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation flashcards as text
What is the significance of a 'chain of custody' document in tissue banking?
Answer: It tracks possession and handling of tissue from recovery through distribution to ensure accountability
Chain of custody documentation establishes accountability by recording each transfer of possession and the condition of tissue at each step.
Under AATB standards, what must be documented when a tissue bank receives a customer complaint about an allograft?
Answer: The complaint details, investigation findings, and any corrective actions taken
AATB requires tissue banks to document the nature of the complaint, the investigation process, findings, and any corrective or preventive actions.
Which document type is used to formally approve a change to a tissue bank's standard operating procedure?
Answer: Change control record
Change control records document the review, approval, and implementation of changes to SOPs, ensuring changes are authorized before use.
A tissue bank must document the identity of personnel who performed each critical processing step primarily to:
Answer: Enable traceability and accountability if a quality issue arises
Documenting personnel identity at each critical step allows investigators to trace actions back to specific individuals if a quality or safety problem is identified.
What type of document communicates a temporary authorized departure from a standard operating procedure during tissue processing?
Answer: Approved deviation or variance
An approved deviation (or variance) formally authorizes and documents a temporary departure from an SOP for a specific situation.
Which information is essential on a donor record to satisfy AATB traceability requirements back to the original recovery?
Answer: The recovery agency's unique donor identifier and recovery date
AATB traceability requires linking every allograft to a unique donor identifier and recovery date so the full chain can be reconstructed.
How should electronic records in a tissue bank be protected to ensure data integrity?
Answer: Backed up regularly with access controls, audit trails, and secure authentication
FDA 21 CFR Part 11 and AATB standards require electronic records to have access controls, audit trails, and regular backups to ensure integrity.