STP Quality Management 3 — Questions and Answers
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?
- Man (People)
- Machine (Equipment)
- Market (Competition) (Correct answer)
- Method (Process)
Correct answer: Market (Competition)
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?
- Pre-analytical phase only
- Analytical phase primarily, but also pre- and post-analytical (Correct answer)
- Post-analytical phase only
- Administrative and billing processes
Correct answer: Analytical phase primarily, but also pre- and post-analytical
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?
- Precision study
- Linearity study
- Method comparison / trueness study (Correct answer)
- Interference study
Correct answer: Method comparison / trueness study
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?
- High complexity testing
- Moderate complexity testing
- Waived testing (Correct answer)
- Provider-performed microscopy
Correct answer: Waived testing
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?
- Precision measures closeness to the true value; accuracy measures reproducibility
- Accuracy measures closeness to the true value; precision measures reproducibility of repeated measurements (Correct answer)
- They are interchangeable terms in modern metrology
- Precision applies to qualitative tests; accuracy applies to quantitative tests
Correct answer: Accuracy measures closeness to the true value; precision measures reproducibility of repeated measurements
Accuracy (trueness) reflects closeness to the true/reference value, while precision reflects the reproducibility or consistency of repeated measurements.
Question 6: In the context of the Plan-Do-Study-Act (PDSA) cycle, what happens during the 'Study' phase?
- A change is implemented on a small scale
- Data collected during the trial are analyzed to determine if the change worked (Correct answer)
- A new quality improvement hypothesis is developed
- Successful changes are standardized across the organization
Correct answer: Data collected during the trial are analyzed to determine if the change worked
The Study phase involves analyzing the data and results from the Do phase to determine whether the change produced the intended improvement.
Question 7: Which statistical measure is used to express the spread of IQC results and forms the basis for Levey-Jennings chart limits?
- Mean
- Median
- Standard deviation (Correct answer)
- Coefficient of variation
Correct answer: Standard deviation
Levey-Jennings chart warning and rejection limits (e.g., ±2SD, ±3SD) are calculated from the standard deviation of repeated control measurements.
STP Quality Management 3
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?