CLC Laboratory Operations & Quality Management 3 — Questions and Answers
Question 1: A laboratory's turnaround time (TAT) for STAT troponin consistently exceeds its target of 60 minutes. Which quality improvement tool would best identify the root causes of delays?
- Pareto chart (Correct answer)
- Levey-Jennings chart
- Scatter diagram
- Run chart showing TAT trend over time only
Correct answer: Pareto chart
A Pareto chart ranks the most frequent causes of delay in descending order, helping prioritize which factors contribute most to TAT failures.
Question 2: Which CLSI guideline specifically addresses laboratory method comparison and bias estimation?
- EP5-A3 (Evaluation of Precision)
- EP9-A3 (Measurement Procedure Comparison and Bias Estimation) (Correct answer)
- EP15-A3 (User Verification of Precision and Estimation of Bias)
- EP6-A (Evaluation of the Linearity of Quantitative Measurement)
Correct answer: EP9-A3 (Measurement Procedure Comparison and Bias Estimation)
CLSI EP9-A3 provides guidelines for comparing patient sample results between two measurement procedures to estimate bias.
Question 3: Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which control measure has the highest priority in the hierarchy of controls?
- Use of personal protective equipment such as gloves and gowns
- Engineering controls such as needleless systems and sharps containers (Correct answer)
- Administrative controls such as work practice procedures
- Housekeeping controls such as regular decontamination of surfaces
Correct answer: Engineering controls such as needleless systems and sharps containers
Engineering controls are the highest-priority control measure under the Bloodborne Pathogens Standard because they eliminate or isolate the hazard at the source.
Question 4: A laboratory consultant is asked to evaluate a new point-of-care glucose meter for use in an ICU. Which factor is LEAST relevant to the regulatory assessment?
- Whether the meter is CLIA-waived or non-waived
- The color of the meter casing and display screen (Correct answer)
- Operator training and competency requirements
- Quality control frequency requirements per manufacturer labeling
Correct answer: The color of the meter casing and display screen
Physical appearance has no regulatory relevance; CLIA complexity classification, QC requirements, and training are all regulatory considerations.
Question 5: When calculating the sigma metric for a laboratory test, which four parameters are used?
- Mean, SD, CV%, and Z-score
- Bias, CV, allowable total error (TEa), and the formula: (TEa − |Bias|) / CV (Correct answer)
- Precision, accuracy, sensitivity, and specificity
- Reference range, linearity, carryover, and reproducibility
Correct answer: Bias, CV, allowable total error (TEa), and the formula: (TEa − |Bias|) / CV
Sigma = (TEa − |Bias|) / CV, where TEa is the allowable total error, Bias is the systematic error, and CV is the imprecision expressed as a coefficient of variation.
Question 6: A laboratory is accredited by the College of American Pathologists (CAP). How often must the laboratory participate in CAP proficiency testing surveys for regulated analytes?
- Once per year per analyte
- Twice per year with at least five challenges per event (Correct answer)
- Quarterly with three challenges per event
- Monthly with one challenge per event
Correct answer: Twice per year with at least five challenges per event
CLIA regulations require laboratories to participate in PT at least twice per year with a minimum of five challenges per event for regulated analytes.
Question 7: A CLC is reviewing a laboratory's corrective action log and notices that the same QC failure has been documented three times in six months with the same root cause. What does this pattern indicate?
- The corrective actions implemented were effective and the problem is being properly monitored
- The root cause analysis was superficial and the corrective action did not address the underlying problem (Correct answer)
- Three occurrences in six months is within acceptable limits for random laboratory error
- The QC material is of poor quality and should be replaced with a different lot
Correct answer: The root cause analysis was superficial and the corrective action did not address the underlying problem
Recurring failures with the same root cause indicate that previous corrective actions were ineffective and a deeper systemic investigation is needed.
CLC Laboratory Operations & Quality Management 3
A laboratory's turnaround time (TAT) for STAT troponin consistently exceeds its target of 60 minutes.
Which quality improvement tool would best identify the root causes of delays?