CTBS Documentation 2

Question 1

Which document must accompany each tissue allograft at the time of distribution to a transplant facility?

Accepted Answer

Allograft package insert or label with required traceability information

Answer

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?

Accepted Answer

10 years after distribution or the useful life of the tissue, whichever is longer

Answer

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?

Accepted Answer

To document the formal conclusion that a donor meets or does not meet eligibility criteria for tissue donation

Answer

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?

Accepted Answer

Draw a single line through the error, write the correction, date, and initial the change

Answer

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?

Accepted Answer

Distinct identification code linking the allograft to the donor

Answer

FDA requires a distinct identification code on each label so the allograft can be traced back to the donor and all associated records.

(CTBS) Certified Tissue Bank Specialist Practice Test