Quality Control & Process Improvement Flashcards
7 cards from real CLC 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 Control & Process Improvement flashcards as text
A laboratory is evaluating its QC strategy using the Total Analytical Error (TAE) model. Which formula correctly represents TAE?
Answer: TAE = |Bias| + 2CV
Total Analytical Error is calculated as the absolute bias plus two times the CV (representing the 95% confidence component of random error).
Which accreditation standard SPECIFICALLY requires laboratories to have a quality management system with defined quality indicators and a process for continuous improvement?
Answer: ISO 15189
ISO 15189 is the international standard for medical laboratory quality and competence that mandates a formal quality management system with continual improvement processes.
A scatter plot from a method comparison study shows data points that form a fan shape widening at higher concentrations. This pattern indicates:
Answer: Proportional random error
A fan-shaped scatter pattern in which variability increases with analyte concentration indicates proportional random error (imprecision that scales with concentration).
A laboratory director reviews a process capability study and finds a Cpk of 0.85 for a new automated pipetting system. What does this indicate?
Answer: The process is marginally capable and improvement is needed
A Cpk below 1.0 indicates the process does not meet minimum capability standards (target ≥1.33) and improvement actions are required.
During a continuous quality improvement (CQI) meeting, a laboratory team uses a '5 Whys' technique. This tool is BEST classified as a:
Answer: Root cause analysis technique
The '5 Whys' technique is a root cause analysis method that iteratively asks 'why' to drill down from a symptom to its underlying fundamental cause.
A laboratory's internal audit reveals that reference intervals have not been verified since the analyzer was replaced two years ago. According to CLIA and best practice, reference interval verification requires testing at least how many presumably healthy individuals?
Answer: 20 individuals
CLSI EP28-A3c recommends a minimum of 20 reference individuals to verify that a transferred reference interval is appropriate for the local population.
A laboratory consultant is asked to assess a quality improvement initiative's success six months after implementation. Which metric BEST demonstrates sustained process improvement?
Answer: Reduction in defect rate maintained over 6 months of control chart data
Sustained reduction in defect rates demonstrated on control charts over time provides objective evidence that a process improvement has been successfully embedded.