CTBS Quality Control & Risk Management in Tissue Banking 3

Question 1

When validating a new sterility testing method for tissue, which organism is most commonly used as a positive control for anaerobic conditions?

Accepted Answer

Clostridium sporogenes

Answer

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?

Accepted Answer

Preventive Action

Answer

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?

Accepted Answer

Unique Donor Identification Number (UDIN)

Answer

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?

Accepted Answer

Current practices versus regulatory requirements or standards

Answer

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?

Accepted Answer

At least 10 years after distribution or disposal

Answer

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.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Quality Control & Risk Management in Tissue Banking 3