Laboratory Quality Control and Management Flashcards
7 cards from real CMT 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 Quality Control and Management flashcards as text
What is the analytical measurement range (AMR) of a laboratory test?
Answer: The range of analyte concentrations that can be measured directly without specimen modification
The analytical measurement range (AMR) is the range of analyte concentrations that an instrument can directly measure without dilution, concentration, or other specimen modification.
Which Westgard rule is triggered when four consecutive QC values all fall on the same side of the mean beyond ±1 SD, indicating a systematic shift?
Answer: 4₁s rule
The 4₁s rule is triggered when four consecutive QC values all exceed ±1 SD on the same side of the mean, indicating a systematic shift or trend.
In laboratory management, what does 'turnaround time' (TAT) measure?
Answer: The total time from specimen collection to result reporting to the clinician
Turnaround time (TAT) measures the total time from specimen collection (or receipt in the lab) to when the result is available to the ordering clinician, and is a key performance indicator.
What is the purpose of establishing reference ranges in a clinical laboratory?
Answer: To define the interval of values expected in a healthy reference population
Reference ranges define the expected interval of values found in a healthy reference population, helping clinicians interpret whether a patient's result is within normal limits.
Which document provides the legally binding minimum quality standards for laboratory testing in the United States?
Answer: CLIA (Clinical Laboratory Improvement Amendments) regulations
CLIA regulations are federal law that establish legally binding minimum standards for laboratory quality, personnel, and testing procedures, enforced by CMS.
A laboratory notices that glucose QC results are consistently 5% above the target value for multiple consecutive days. This pattern most likely indicates:
Answer: Systematic positive bias, possibly due to reagent lot or calibrator issues
A consistent positive shift from the target value over multiple days indicates systematic bias, often caused by reagent lot changes, calibration drift, or calibrator concentration issues.
What is the primary purpose of performing method validation before implementing a new laboratory test?
Answer: To demonstrate that the method performs as expected for its intended clinical use
Method validation demonstrates that a new or modified laboratory test meets required performance specifications (accuracy, precision, linearity, reference range) for its intended clinical use before patient testing begins.