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
Which document must accompany each tissue allograft at the time of distribution to a transplant facility?
Answer: Allograft package insert or label with required traceability information
Each allograft must be accompanied by a label or package insert containing required traceability and usage information per AATB standards.
How long must a tissue bank retain records related to infectious disease testing of donors?
Answer: 10 years after distribution or the useful life of the tissue, whichever is longer
FDA regulations require records related to donor testing to be retained for 10 years or the useful life of the tissue, whichever is longer.
What is the purpose of a Donor Eligibility Determination (DED) record in tissue banking?
Answer: To document the formal conclusion that a donor meets or does not meet eligibility criteria for tissue donation
The DED record formally documents the conclusion of the eligibility review, including all relevant screening and testing results.
A tissue bank discovers a documentation error in a completed donor record. What is the correct procedure?
Answer: Draw a single line through the error, write the correction, date, and initial the change
Corrections must be made by drawing a single line through the error, then adding the correction, date, and initials to maintain an auditable trail.
Which of the following is a required element on a tissue allograft label under FDA 21 CFR Part 1271?
Answer: Distinct identification code linking the allograft to the donor
FDA requires a distinct identification code on each label so the allograft can be traced back to the donor and all associated records.
What does a Certificate of Analysis (COA) in tissue banking typically document?
Answer: Results of sterility testing and other quality tests performed on the allograft
A COA summarizes the quality and safety test results for a specific tissue lot, confirming it meets release specifications.
When must a tissue bank complete documentation of a quarantine hold on an allograft?
Answer: At the time the hold is initiated
Quarantine holds must be documented at the time they are placed to ensure proper tracking and prevent inadvertent release.