Quality Management Flashcards
7 cards from real STP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Management flashcards as text
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?
Answer: 10x rule
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.
What does 'measurement uncertainty' represent in a laboratory result?
Answer: A quantitative estimate of the doubt associated with a measurement result
Measurement uncertainty is a parameter characterizing the dispersion of values that could reasonably be attributed to the measurand, reflecting doubt about the result.
Which document type in a quality management system describes WHAT to do and WHY, rather than HOW to do it step by step?
Answer: Policy
A policy states high-level intentions and direction (what and why), while SOPs and work instructions describe the detailed steps (how).
In laboratory accreditation, what is an 'audit finding' classified as a 'major non-conformance'?
Answer: A systemic failure likely to affect the validity of results or patient safety
A major non-conformance indicates a systemic breakdown or significant failure that directly threatens the reliability of results or patient/staff safety.
A laboratory's turnaround time (TAT) for STAT troponin results has increased. Which quality tool would BEST help map the workflow to identify bottlenecks?
Answer: Process flow diagram (value stream map)
A process flow diagram or value stream map visually represents each step in the workflow, making it easy to identify delays, redundancies, and bottlenecks.
What is the purpose of a 'blank' in analytical chemistry quality control?
Answer: To assess background signal and ensure no contamination contributes to results
A blank (containing no analyte) measures background absorbance or signal, confirming that reagents and matrix do not contribute false positive readings.
Under ISO 15189, which of the following is a requirement for the post-examination phase?
Answer: Systematic review of results before authorization and release
ISO 15189 requires that results be reviewed for plausibility and clinical consistency before authorization, forming part of the post-examination phase.