CTBS Quality Control & Risk Management in Tissue Banking 4 — Questions and Answers
Question 1: A tissue bank receives a complaint that a bone allograft had an unusual odor upon opening. Under the AATB Standards, what is the FIRST documented step?
- Issue an immediate voluntary recall
- Assign a complaint number and begin investigation (Correct answer)
- Notify the recipient's surgeon
- Test the remaining tissue from the same lot
Correct answer: Assign a complaint number and begin investigation
AATB Standards require every complaint to be logged with a unique identifier and investigated, with documentation of all findings and actions.
Question 2: Which environmental monitoring parameter is most critical to verify in a Class 10,000 (ISO 7) cleanroom used for tissue processing?
- Temperature and relative humidity only
- Viable and non-viable particle counts (Correct answer)
- Carbon dioxide levels
- Noise and lighting levels
Correct answer: Viable and non-viable particle counts
Both viable (microbial) and non-viable (total particle) counts must be monitored to confirm cleanroom classification and contamination control.
Question 3: When a tissue bank changes its antibiotic cocktail formulation, which validation activity is MANDATORY before implementing the change?
- Staff retraining only
- Process revalidation demonstrating equivalent or superior microbial reduction (Correct answer)
- FDA pre-approval submission
- Retrospective review of past sterility results
Correct answer: Process revalidation demonstrating equivalent or superior microbial reduction
Any change to a critical process component like antibiotic formulation requires revalidation to confirm the new formulation achieves equivalent microbial reduction.
Question 4: In risk management terminology, what is the difference between 'risk mitigation' and 'risk acceptance'?
- Mitigation eliminates risk entirely; acceptance ignores it
- Mitigation reduces probability or impact; acceptance acknowledges residual risk as tolerable (Correct answer)
- Mitigation requires FDA approval; acceptance does not
- Mitigation applies to clinical risks only; acceptance applies to operational risks
Correct answer: Mitigation reduces probability or impact; acceptance acknowledges residual risk as tolerable
Risk mitigation implements controls to reduce likelihood or severity, while risk acceptance formally acknowledges that remaining residual risk is within acceptable limits.
Question 5: Which document formally authorizes the release of a tissue lot for distribution after all QC checks are complete?
- Certificate of Analysis (Correct answer)
- Batch Release Record
- Distribution Authorization
- Final Inspection Report
Correct answer: Certificate of Analysis
A Certificate of Analysis (CoA) documents the results of all required testing and quality checks and serves as the formal release authorization for a tissue lot.
Question 6: What is the purpose of a 'lookback' procedure in tissue banking?
- Reviewing donor demographics for research purposes
- Investigating previously distributed tissue when new donor risk information emerges (Correct answer)
- Auditing historical SOP compliance
- Retrospectively validating past processes
Correct answer: Investigating previously distributed tissue when new donor risk information emerges
A lookback procedure investigates tissue already distributed when new information—such as a subsequent reactive test result—suggests potential donor risk.
Question 7: An employee reports that a colleague skipped the required 30-minute antibiotic soak step to meet a production deadline. This should be handled FIRST as:
- A personnel disciplinary matter only
- A nonconformance requiring quarantine of affected tissue and CAPA (Correct answer)
- A verbal warning with no formal documentation
- An optional deviation since the tissue appeared normal
Correct answer: A nonconformance requiring quarantine of affected tissue and CAPA
Skipping a validated critical processing step is a nonconformance requiring formal documentation, quarantine of affected tissue, investigation, and corrective action.
CTBS Quality Control & Risk Management in Tissue Banking 4
A tissue bank receives a complaint that a bone allograft had an unusual odor upon opening.
Under the AATB Standards, what is the FIRST documented step?