CTBS Tissue Banking Regulations & Standards 5 — Questions and Answers
Question 1: Under AATB Standards, the 'suitable' donor eligibility determination for a deceased musculoskeletal donor must be made by:
- Any certified tissue bank specialist (CTBS) on staff
- A licensed physician or medical director based on review of all required records (Correct answer)
- The procurement technician present at recovery
- An independent infectious disease specialist
Correct answer: A licensed physician or medical director based on review of all required records
AATB Standards require that donor suitability determination be made by a licensed physician, typically the medical director, after reviewing all required donor records.
Question 2: A tissue bank's SOP for cleaning and disinfecting processing rooms must be validated to demonstrate:
- That cleaning agents cost less than 5% of the processing budget
- That the procedures effectively reduce bioburden to acceptable levels (Correct answer)
- Compliance with EPA pesticide registration for all disinfectants used
- That cleaning is completed in under 30 minutes
Correct answer: That the procedures effectively reduce bioburden to acceptable levels
Cleaning and disinfection SOPs must be validated to confirm that they reduce microbial contamination to levels that protect tissue sterility.
Question 3: Which of the following is an example of a 'more than minimally manipulated' tissue under FDA's 21 CFR Part 1271 framework?
- Freeze-dried cortical bone cut to specific dimensions
- Demineralized bone matrix (DBM) formulated with a carrier substance that alters original characteristics (Correct answer)
- Cryopreserved femoral head stored at -80°C
- Cleaned and shaped amniotic membrane
Correct answer: Demineralized bone matrix (DBM) formulated with a carrier substance that alters original characteristics
Adding a carrier substance to DBM that alters its original relevant characteristics constitutes more than minimal manipulation, potentially requiring a BLA.
Question 4: A tissue bank is audited by AATB and cited for lack of documented temperature excursion responses in its cold chain records. This finding most directly relates to which AATB Standard area?
- Donor Eligibility
- Packaging and Labeling
- Storage and Transportation (Correct answer)
- Quality Systems
Correct answer: Storage and Transportation
Temperature excursion documentation is a core component of the Storage and Transportation standards, which require defined responses and records for cold chain deviations.
Question 5: FDA's 'tissue establishment registration' under 21 CFR 1271.21 must be completed:
- Within 5 days of first HCT/P distribution
- Before performing any manufacturing step with HCT/Ps, with updates within 30 days of changes (Correct answer)
- Annually at the start of each calendar year
- Only when the bank begins distributing to other states
Correct answer: Before performing any manufacturing step with HCT/Ps, with updates within 30 days of changes
Establishments must register with FDA before performing any manufacturing step and must update registration within 30 days of any changes to required information.
Question 6: Which scenario would most likely require a tissue bank to submit a Biological Product Deviation Report (BPDR) to the FDA?
- A minor label typo corrected before distribution
- A released allograft later found to have failed sterility testing after implantation (Correct answer)
- An SOP updated without completing a full change control review
- A donor chart received 2 hours later than the bank's internal target
Correct answer: A released allograft later found to have failed sterility testing after implantation
A sterility failure discovered after implantation represents a distributed HCT/P that may have caused serious injury, which must be reported as a BPDR under 21 CFR 1271.350.
Question 7: Under AATB Standards, a tissue bank's corrective action process (CAPA) must include which key element to be considered complete?
- Approval by the bank's board of trustees
- Verification that the corrective action was effective in preventing recurrence (Correct answer)
- Notification to all tissue recipients when any CAPA is opened
- Filing the CAPA with FDA within 15 business days
Correct answer: Verification that the corrective action was effective in preventing recurrence
An effective CAPA must include verification steps that confirm the corrective action resolved the root cause and prevented recurrence of the deviation.
CTBS Tissue Banking Regulations & Standards 5
Under AATB Standards, the 'suitable' donor eligibility determination for a deceased musculoskeletal donor must be made by: