CTBS Quality Control & Risk Management in Tissue Banking 4

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?

Accepted Answer

Assign a complaint number and begin investigation

Answer

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?

Accepted Answer

Viable and non-viable particle counts

Answer

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?

Accepted Answer

Process revalidation demonstrating equivalent or superior microbial reduction

Answer

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'?

Accepted Answer

Mitigation reduces probability or impact; acceptance acknowledges residual risk as tolerable

Answer

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?

Accepted Answer

Certificate of Analysis

Answer

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.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Quality Control & Risk Management in Tissue Banking 4