Laboratory Operations & Quality Management 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 Laboratory Operations & Quality Management flashcards as text
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?
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.
Which CLSI guideline specifically addresses laboratory method comparison and bias estimation?
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.
Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which control measure has the highest priority in the hierarchy of controls?
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.
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?
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.
When calculating the sigma metric for a laboratory test, which four parameters are used?
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.
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?
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.
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?
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.