CTBS Quality Control & Risk Management in Tissue Banking 2

Question 1

Which document type is used to formally record a deviation from an established SOP during tissue processing?

Accepted Answer

Nonconformance Report

Answer

A Nonconformance Report (NCR) documents any deviation from established SOPs or specifications during tissue banking operations.

Question 2

In tissue banking, what is the purpose of a 'hold' status applied to a tissue lot?

Accepted Answer

To prevent distribution pending investigation or testing

Answer

A 'hold' status prevents distribution of tissue while an investigation, additional testing, or quality review is completed.

Question 3

What statistical tool uses upper and lower control limits to monitor process variability over time?

Accepted Answer

Control chart

Answer

Control charts plot process data with calculated upper and lower control limits to detect trends and out-of-control conditions.

Question 4

Which FDA regulation requires tissue establishments to maintain a list of all suppliers of critical materials?

Accepted Answer

21 CFR Part 1271

Answer

21 CFR Part 1271 governs human cells, tissues, and cellular and tissue-based products (HCT/Ps) and requires supplier qualification records.

Question 5

A tissue bank discovers a processing error that may have affected 12 tissue units already distributed. What is the FIRST action required?

Accepted Answer

Contact consignees to quarantine or retrieve affected tissue

Answer

The immediate priority is contacting consignees to quarantine or retrieve potentially affected tissue to prevent patient harm.

(CTBS) Certified Tissue Bank Specialist Practice Test