CTBS Quality Assurance 5 — Questions and Answers
Question 1: What is the primary purpose of a 'hold' or 'quarantine' label placed on tissue or materials in a tissue bank?
- To indicate the tissue is ready for distribution
- To prevent use of potentially nonconforming tissue or materials pending investigation or disposition (Correct answer)
- To identify tissue belonging to a specific surgeon
- To flag tissue that has been sold but not yet shipped
Correct answer: To prevent use of potentially nonconforming tissue or materials pending investigation or disposition
Quarantine labeling prevents inadvertent use of tissue or materials that are under investigation or pending disposition for a potential nonconformance.
Question 2: Which type of audit involves an assessment of a tissue bank's quality system by an external accreditation organization?
- Internal audit
- First-party audit
- Second-party audit
- Third-party audit (Correct answer)
Correct answer: Third-party audit
A third-party audit is conducted by an independent external organization, such as AATB, to assess compliance with accreditation standards.
Question 3: In tissue banking quality systems, what does 'lot release' testing refer to?
- Testing performed to select tissue donors from a waiting list
- Quality testing completed on a batch of tissue before it is released for distribution (Correct answer)
- A regulatory review before FDA clearance is granted
- Testing of packaging materials after sterilization
Correct answer: Quality testing completed on a batch of tissue before it is released for distribution
Lot release testing is the set of quality tests that must be completed and meet acceptance criteria before a batch of tissue is approved for distribution.
Question 4: What distinguishes a 'critical' control point from a 'non-critical' step in a tissue processing procedure?
- Critical steps require more staff to perform
- Critical steps are those where failure could directly compromise tissue safety or quality (Correct answer)
- Non-critical steps are not documented in SOPs
- Critical steps are performed only by the QA Director
Correct answer: Critical steps are those where failure could directly compromise tissue safety or quality
Critical control points are process steps where a deviation could directly compromise the safety, sterility, or quality of the tissue, making them subject to stricter controls and monitoring.
Question 5: Which of the following best describes 'risk-based thinking' as applied in tissue bank quality management?
- Avoiding all activities that carry any level of risk
- Identifying, assessing, and prioritizing quality controls based on the potential impact of failures (Correct answer)
- Delegating all risk decisions to regulatory authorities
- Using only validated processes that have never had a deviation
Correct answer: Identifying, assessing, and prioritizing quality controls based on the potential impact of failures
Risk-based thinking involves systematically identifying potential failures, assessing their likelihood and impact, and allocating quality controls proportional to the level of risk.
Question 6: A tissue bank technician notices that a critical piece of processing equipment is past its scheduled calibration date. What is the appropriate QA response?
- Continue using the equipment and schedule calibration for the next available date
- Immediately remove the equipment from service, quarantine products processed since last calibration, and initiate an investigation (Correct answer)
- Notify the FDA immediately before taking any other action
- Re-calibrate the equipment in-house without documentation
Correct answer: Immediately remove the equipment from service, quarantine products processed since last calibration, and initiate an investigation
Equipment past its calibration due date must be taken out of service, and all products processed since the last valid calibration should be quarantined pending investigation of potential impact.
Question 7: What is the function of a 'change control' process in a tissue bank quality management system?
- To manage financial budget changes within the organization
- To provide a systematic process for evaluating, approving, and implementing changes to controlled documents, equipment, or processes (Correct answer)
- To track personnel changes and staff turnover
- To approve changes to donor eligibility criteria requested by physicians
Correct answer: To provide a systematic process for evaluating, approving, and implementing changes to controlled documents, equipment, or processes
Change control ensures that any modifications to controlled processes, equipment, or documents are formally evaluated for quality and compliance impact before being implemented.
CTBS Quality Assurance 5
What is the primary purpose of a 'hold' or 'quarantine' label placed on tissue or materials in a tissue bank?