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 implements a new analyzer and finds the coefficient of variation (CV) for a high-concentration QC material is 2.5% but 8.1% for a low-concentration QC material. This pattern MOST likely indicates:
Answer: Constant random error
High CV at low concentrations with acceptable CV at high concentrations is characteristic of constant (absolute) imprecision, which has proportionally more impact near the detection limit.
Which document type in a laboratory quality management system describes the step-by-step instructions for performing a specific analytical procedure?
Answer: Standard operating procedure (SOP)
Standard operating procedures (SOPs) provide detailed, step-by-step instructions for performing specific laboratory tasks or analytical procedures.
A Pareto analysis of laboratory errors reveals that specimen labeling errors, centrifugation problems, and wrong tube type together account for 78% of all pre-analytical errors. This finding supports which principle?
Answer: The 80/20 rule
The Pareto principle (80/20 rule) states that approximately 80% of effects come from 20% of causes, guiding prioritization of improvement efforts.
During proficiency testing (PT), a laboratory's result for a serum sodium sample is flagged as unacceptable. The FIRST action the laboratory director should take is:
Answer: Investigate the cause through root cause analysis
Root cause analysis must be performed first to identify why the PT failure occurred before corrective action can be appropriately targeted.
In a laboratory QC program, what is the PRIMARY purpose of using two levels of controls (normal and abnormal)?
Answer: To detect errors across the analytical measurement range
Running QC at both normal and abnormal concentrations verifies method performance across clinically relevant portions of the analytical measurement range.
A laboratory's turnaround time data shows a normal distribution with mean 45 minutes and SD 8 minutes. What percentage of results will be reported within 29–61 minutes?
Answer: 95%
The range 29–61 minutes spans ±2 SD from the mean (45 ± 16), which encompasses approximately 95% of values in a normal distribution.
Which quality indicator is MOST useful for monitoring laboratory pre-analytical errors related to sample integrity?
Answer: Hemolysis index tracking
Tracking hemolysis index rates identifies pre-analytical problems with blood collection, transport, and processing that compromise specimen integrity.