STP Quality Management 4

Question 1

A laboratory notices that IQC results for a glucose assay have gradually shifted upward over 10 days without breaching ±2SD limits. Which Westgard rule flags this trend?

Accepted Answer

10x rule

Answer

The 10x (10 consecutive) rule flags when ten successive control results fall on the same side of the mean, indicating a systematic shift or trend.

Question 2

What does 'measurement uncertainty' represent in a laboratory result?

Accepted Answer

A quantitative estimate of the doubt associated with a measurement result

Answer

Measurement uncertainty is a parameter characterizing the dispersion of values that could reasonably be attributed to the measurand, reflecting doubt about the result.

Question 3

Which document type in a quality management system describes WHAT to do and WHY, rather than HOW to do it step by step?

Accepted Answer

Policy

Answer

A policy states high-level intentions and direction (what and why), while SOPs and work instructions describe the detailed steps (how).

Question 4

In laboratory accreditation, what is an 'audit finding' classified as a 'major non-conformance'?

Accepted Answer

A systemic failure likely to affect the validity of results or patient safety

Answer

A major non-conformance indicates a systemic breakdown or significant failure that directly threatens the reliability of results or patient/staff safety.

Question 5

A laboratory's turnaround time (TAT) for STAT troponin results has increased. Which quality tool would BEST help map the workflow to identify bottlenecks?

Accepted Answer

Process flow diagram (value stream map)

Answer

A process flow diagram or value stream map visually represents each step in the workflow, making it easy to identify delays, redundancies, and bottlenecks.

(STP) Scientist Training Programme Practice Test

(STP) Scientist Training Programme Practice Test

STP Quality Management 4