CTBS Quality Assurance 4

Question 1

Which sterilization validation parameter refers to the probability that a single unit is NOT sterile?

Accepted Answer

Sterility Assurance Level (SAL)

Answer

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?

Accepted Answer

Approved Supplier List (ASL)

Answer

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?

Accepted Answer

An unplanned departure from an approved procedure during execution

Answer

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?

Accepted Answer

To verify that received materials meet specifications before use in processing

Answer

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%?

Accepted Answer

D-value

Answer

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).

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Quality Assurance 4