CTBS Quality Control & Risk Management in Tissue Banking 3 — Questions and Answers
Question 1: When validating a new sterility testing method for tissue, which organism is most commonly used as a positive control for anaerobic conditions?
- Staphylococcus aureus
- Candida albicans
- Clostridium sporogenes (Correct answer)
- Pseudomonas aeruginosa
Correct answer: Clostridium sporogenes
Clostridium sporogenes is a standard positive control organism for anaerobic sterility testing due to its obligate anaerobic nature.
Question 2: A tissue bank's internal audit reveals that calibration records for a critical balance are missing for the past 3 months. Which CAPA element should address preventing recurrence?
- Corrective Action
- Preventive Action (Correct answer)
- Root Cause Analysis
- Effectiveness Check
Correct answer: Preventive Action
Preventive Action addresses systemic changes to prevent recurrence of the identified gap in calibration documentation.
Question 3: Which labeling requirement for HCT/Ps mandates that the donor ID be traceable from the donor to the recipient?
- Chain of custody documentation
- Unique Donor Identification Number (UDIN) (Correct answer)
- Distinct processing lot number
- Biohazard labeling protocol
Correct answer: Unique Donor Identification Number (UDIN)
The Unique Donor Identification Number (UDIN) must appear on all tissue labels and enables complete traceability from donor to recipient.
Question 4: In a gap analysis performed before a regulatory inspection, what is being compared?
- Current practices versus competitor tissue bank practices
- Current practices versus regulatory requirements or standards (Correct answer)
- Current tissue inventory versus projected demand
- Current staff competency versus national certification rates
Correct answer: Current practices versus regulatory requirements or standards
A gap analysis compares the tissue bank's current practices against applicable regulatory requirements, standards, or accreditation criteria.
Question 5: What is the minimum required retention period for donor records under 21 CFR Part 1271?
- 5 years
- 10 years
- At least 10 years after distribution or disposal (Correct answer)
- Indefinitely
Correct answer: At least 10 years after distribution or disposal
21 CFR Part 1271 requires donor records to be retained for at least 10 years after the date of administration or the expiration date of the HCT/P.
Question 6: Which type of contamination control measure involves physical separation of different processing stages to prevent cross-contamination?
- Temporal separation
- Spatial segregation (Correct answer)
- Chemical decontamination
- Personnel gowning protocols
Correct answer: Spatial segregation
Spatial segregation physically separates clean and dirty areas or different processing stages to prevent cross-contamination between tissue types or processing steps.
Question 7: During a tissue bank's management review meeting, which metric would BEST indicate the effectiveness of the CAPA system?
- Number of CAPAs opened in the past quarter
- Percentage of CAPAs closed on time with verified effectiveness (Correct answer)
- Total cost spent on corrective actions
- Number of regulatory inspections passed
Correct answer: Percentage of CAPAs closed on time with verified effectiveness
The percentage of CAPAs closed on time with verified effectiveness measures whether quality problems are actually being resolved, not just documented.
CTBS Quality Control & Risk Management in Tissue Banking 3
When validating a new sterility testing method for tissue, which organism is most commonly used as a positive control for anaerobic conditions?