STP Quality Management 3

Question 1

During a root cause analysis, a fishbone (Ishikawa) diagram is constructed. Which of the following is NOT a standard 'bone' category used in laboratory settings?

Accepted Answer

Market (Competition)

Answer

Standard fishbone categories for laboratories include Man, Machine, Method, Material, Environment, and Measurement — market/competition is not a standard category.

Question 2

External Quality Assessment (EQA) primarily evaluates which phase of the total testing process?

Accepted Answer

Analytical phase primarily, but also pre- and post-analytical

Answer

EQA (proficiency testing) primarily assesses analytical performance but modern schemes also evaluate pre- and post-analytical elements such as interpretation.

Question 3

A laboratory introduces a new analyzer. Which validation study is designed to assess the closeness of agreement between results from the new method and a reference method?

Accepted Answer

Method comparison / trueness study

Answer

A method comparison or trueness study compares patient sample results from the new method against a reference or comparative method to assess bias.

Question 4

Under CLIA '88 regulations in the US, which category of testing has the fewest regulatory requirements?

Accepted Answer

Waived testing

Answer

Waived tests are simple, low-risk tests cleared by the FDA; laboratories performing only waived tests face minimal CLIA regulatory requirements.

Question 5

What is the primary difference between 'precision' and 'accuracy' in analytical measurement?

Accepted Answer

Accuracy measures closeness to the true value; precision measures reproducibility of repeated measurements

Answer

Accuracy (trueness) reflects closeness to the true/reference value, while precision reflects the reproducibility or consistency of repeated measurements.

(STP) Scientist Training Programme Practice Test

(STP) Scientist Training Programme Practice Test

STP Quality Management 3