Data Analysis & Reporting Techniques Flashcards

A Youden plot is used during an external quality assurance survey. What information does it simultaneously display?

Answer: Both systematic error (bias) and random error (imprecision) across two different analyte concentrations

A Youden plot plots two control levels against each other, revealing systematic bias (diagonal shift) and random error (scatter) in a single graphic.

A laboratory consultant identifies that 15% of stat results are delivered outside the 60-minute TAT goal. Which process improvement methodology provides a structured data-driven framework to reduce this defect rate?

Answer: DMAIC (Define, Measure, Analyze, Improve, Control)

DMAIC is the structured Six Sigma improvement cycle used to reduce defects in an existing process, making it ideal for TAT improvement projects.

In reporting immunoassay results, a high-dose hook effect can cause a false low result. Which laboratory practice best mitigates this risk for suspected very high-concentration specimens?

Answer: Perform a 1:10 dilution and repeat the assay; if diluted result is significantly higher, report the diluted result with dilution factor applied

Diluting a specimen suspected of causing a hook effect and retesting reveals the true elevated concentration; a paradoxically higher diluted result confirms the hook effect.

Which type of uncertainty contributes to Type A uncertainty in laboratory measurement, according to ISO/IEC 17025 guidance?

Answer: Statistically evaluated uncertainty derived from repeated measurements under the same conditions

Type A uncertainty is evaluated using statistical methods applied to a series of repeated observations under defined conditions (e.g., repeatability studies).

A laboratory is required to report HbA1c results traceable to the IFCC/NGSP reference system. Which term best describes this requirement?

Answer: Metrological traceability

Metrological traceability means results are linked to a reference standard through an unbroken chain of calibrations, ensuring results are comparable across methods and laboratories.

A CLC is asked to calculate the number needed to diagnose (NND) for a new screening test with a sensitivity of 80% in a population with 5% disease prevalence. What does a high NND indicate?

Answer: Many individuals must be screened to identify one true positive case, suggesting the test may be inefficient for mass screening

A high NND means a large number of screenings are needed to detect one true case, indicating lower efficiency — especially relevant in low-prevalence populations.

Which reporting practice is required under CLIA '88 for laboratory test reports sent to authorized persons?

Answer: Reports must include the name and address of the laboratory, the test performed, the result, and appropriate reference intervals

CLIA '88 mandates that laboratory reports include the laboratory's name and address, test name, result, and reference intervals (where applicable) to ensure actionable and auditable reporting.