CTBS Quality Assurance 2 — Questions and Answers
Question 1: Which document type describes the step-by-step instructions for performing a specific tissue bank task?
- Standard Operating Procedure (SOP) (Correct answer)
- Quality Manual
- Policy Statement
- Audit Report
Correct answer: Standard Operating Procedure (SOP)
SOPs provide detailed, step-by-step instructions for performing specific tasks consistently and correctly.
Question 2: In a tissue bank QA system, what is the primary purpose of a corrective action?
- To penalize staff for errors
- To eliminate the root cause of a nonconformance (Correct answer)
- To document that a deviation occurred
- To notify regulators of a problem
Correct answer: To eliminate the root cause of a nonconformance
Corrective actions are designed to identify and eliminate the root cause of a nonconformance to prevent recurrence.
Question 3: What does a Certificate of Analysis (COA) for a processing reagent typically confirm?
- The reagent's shelf life has expired
- The reagent meets specified quality criteria for identity, purity, and potency (Correct answer)
- The reagent was manufactured in the US
- The reagent has been approved by the FDA for human use
Correct answer: The reagent meets specified quality criteria for identity, purity, and potency
A COA confirms that a reagent lot meets pre-established specifications for identity, purity, potency, and other relevant quality attributes.
Question 4: Which regulatory body publishes the Good Tissue Practice (GTP) regulations applicable to human tissue establishments in the US?
- AATB
- CDC
- FDA (Correct answer)
- CMS
Correct answer: FDA
The FDA publishes 21 CFR Part 1271, which establishes Good Tissue Practice (GTP) requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Question 5: During a QA audit of donor records, a tissue bank specialist finds that a donor consent form is missing a required signature. This is an example of:
- A preventive action
- A critical nonconformance (Correct answer)
- An acceptable deviation
- A routine variance
Correct answer: A critical nonconformance
A missing required signature on a donor consent form is a critical nonconformance because it violates regulatory and accreditation requirements for donor eligibility documentation.
Question 6: What is the purpose of environmental monitoring in a tissue processing cleanroom?
- To measure employee productivity
- To verify that bioburden levels remain within acceptable limits (Correct answer)
- To track equipment maintenance schedules
- To monitor tissue storage temperatures
Correct answer: To verify that bioburden levels remain within acceptable limits
Environmental monitoring verifies that air quality, surface bioburden, and other parameters stay within limits that protect tissue sterility.
Question 7: Which of the following best describes a 'trend analysis' in tissue bank quality assurance?
- A one-time review of a single nonconformance event
- Ongoing monitoring of quality data over time to detect patterns (Correct answer)
- A regulatory inspection of facility records
- A comparison of two different tissue processing methods
Correct answer: Ongoing monitoring of quality data over time to detect patterns
Trend analysis involves continuously monitoring quality metrics over time to identify patterns that may indicate emerging problems before they become critical.
CTBS Quality Assurance 2
Which document type describes the step-by-step instructions for performing a specific tissue bank task?