CTBS Quality Assurance 4 — Questions and Answers
Question 1: Which sterilization validation parameter refers to the probability that a single unit is NOT sterile?
- Sterility Assurance Level (SAL) (Correct answer)
- Bioburden Reduction Factor
- D-value
- Z-value
Correct answer: Sterility Assurance Level (SAL)
SAL (Sterility Assurance Level) expresses the probability of a viable microorganism being present on a product after sterilization, typically expressed as 10⁻⁶.
Question 2: When reviewing supplier qualifications, which document provides assurance that a critical material supplier has been evaluated and approved?
- Approved Supplier List (ASL) (Correct answer)
- Material Safety Data Sheet (MSDS)
- Product Catalog
- Purchase Order
Correct answer: Approved Supplier List (ASL)
An Approved Supplier List (ASL) documents that critical suppliers have been formally evaluated and approved based on quality criteria.
Question 3: In tissue banking, what is a 'deviation' from a standard operating procedure?
- An intentional permanent change to an SOP
- An unplanned departure from an approved procedure during execution (Correct answer)
- A scheduled equipment calibration
- A planned process improvement
Correct answer: An unplanned departure from an approved procedure during execution
A deviation is an unplanned, unintentional departure from an approved SOP that occurs during the execution of a process.
Question 4: What is the purpose of incoming inspection for tissue processing supplies?
- To reduce the cost of supplies by returning damaged items
- To verify that received materials meet specifications before use in processing (Correct answer)
- To train new employees on supply chain management
- To comply with FDA export regulations
Correct answer: To verify that received materials meet specifications before use in processing
Incoming inspection verifies that supplies and materials received from vendors meet the quality specifications required before they are used in tissue processing.
Question 5: Which metric is used to measure the effectiveness of a sterilization process by calculating the time required to reduce a microbial population by 90%?
- F-value
- D-value (Correct answer)
- Z-value
- SAL
Correct answer: D-value
The D-value (decimal reduction time) is the time required at a given temperature or radiation dose to reduce a microbial population by 90% (one log reduction).
Question 6: A tissue bank implements a new software system for tracking tissue inventory. According to QA principles, what must be completed before the system is used for production?
- Employee satisfaction survey about the new system
- Computer system validation (CSV) (Correct answer)
- Approval from all transplant surgeon customers
- A comparison with competitor software systems
Correct answer: Computer system validation (CSV)
Computer system validation (CSV) must be completed before a software system is used in production to demonstrate it performs as intended and produces reliable results.
Question 7: Under 21 CFR Part 1271, how long must human tissue establishments retain donor eligibility records?
- 5 years
- 10 years
- At least 10 years after the date of transplantation or distribution (Correct answer)
- Indefinitely
Correct answer: At least 10 years after the date of transplantation or distribution
21 CFR 1271.270 requires that donor eligibility determination records be maintained for at least 10 years after the date of transplantation, distribution, disposition, or expiration.
CTBS Quality Assurance 4
Which sterilization validation parameter refers to the probability that a single unit is NOT sterile?