CTBS Documentation 2 — Questions and Answers
Question 1: Which document must accompany each tissue allograft at the time of distribution to a transplant facility?
- Donor informed consent
- Distributor invoice only
- Allograft package insert or label with required traceability information (Correct answer)
- Recipient medical record
Correct 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.
Question 2: How long must a tissue bank retain records related to infectious disease testing of donors?
- 1 year after distribution
- 5 years after distribution
- 10 years after distribution or the useful life of the tissue, whichever is longer (Correct answer)
- Indefinitely
Correct 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.
Question 3: What is the purpose of a Donor Eligibility Determination (DED) record in tissue banking?
- To authorize payment to the donor's family
- To document the formal conclusion that a donor meets or does not meet eligibility criteria for tissue donation (Correct answer)
- To schedule tissue processing workflows
- To record tissue storage temperatures
Correct 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.
Question 4: A tissue bank discovers a documentation error in a completed donor record. What is the correct procedure?
- Discard the record and create a new one
- White out the error and write the correction
- Draw a single line through the error, write the correction, date, and initial the change (Correct answer)
- Shred the record to avoid regulatory scrutiny
Correct 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.
Question 5: Which of the following is a required element on a tissue allograft label under FDA 21 CFR Part 1271?
- Recipient's name and date of transplant
- Donor risk assessment score
- Distinct identification code linking the allograft to the donor (Correct answer)
- Processing technician's signature
Correct 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.
Question 6: What does a Certificate of Analysis (COA) in tissue banking typically document?
- Financial cost of processing each tissue type
- Results of sterility testing and other quality tests performed on the allograft (Correct answer)
- Transplant surgeon's operative notes
- Insurance reimbursement codes
Correct 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.
Question 7: When must a tissue bank complete documentation of a quarantine hold on an allograft?
- Within 30 days of placing the hold
- At the time the hold is initiated (Correct answer)
- Only when the hold is lifted
- At the end of each fiscal quarter
Correct 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.
CTBS Documentation 2
Which document must accompany each tissue allograft at the time of distribution to a transplant facility?