CTBS Quality Assurance 2

Question 1

Which document type describes the step-by-step instructions for performing a specific tissue bank task?

Accepted Answer

Standard Operating Procedure (SOP)

Answer

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?

Accepted Answer

To eliminate the root cause of a nonconformance

Answer

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?

Accepted Answer

The reagent meets specified quality criteria for identity, purity, and potency

Answer

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?

Accepted Answer

FDA

Answer

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:

Accepted Answer

A critical nonconformance

Answer

A missing required signature on a donor consent form is a critical nonconformance because it violates regulatory and accreditation requirements for donor eligibility documentation.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Quality Assurance 2