QC and QA Flashcards
a system that ensures accuracy and precision in the laboratory
Quality Control
The ability of an analytical method to measure the smallest concentration of the analyte of interest
Sensitivity
the ability of an analytical method to measure only the analyte of interest
Specificity
The nearness and closeness of the assayed value to the true or target value.
Accuracy
Used to assess presence of error (inaccuracy) in actual patient patient sample
Sample Comparison Study
Determines if specific compounds affect the laboratory test like hemolysis, turbidity and icteric
Interference study
Determines how much of the analyte can be identified in the sample
Recovery study
The ability of an analytical method to give repeated results on the same sample that agree with one another
Precision or Reproducibility
The ability of an analytical method to maintain accuracy and precision over an extended period of time
Reliability
The degree by which a method is easily repeated
Practicability
the ability of the analytically method to detect the proportion of individuals with the disease
Diagnostic Sensitivity
The ability of the analytical method to detect the proportion of individuals without the disease
Diagnostic Specificity
Control samples and px samples
Inside the lab
Daily monitoring of accuracy and precision
Random and systematic error
One week cycle
Intralab QC
Proficiency testing
Long term accuracy
Determines state of the art lab
College of American Pathology
Interlab QC
It is present in all measurements. It is due to chance.
Type of error which varies from sample to sample
Random Error
It is an error that influences observations consistently in one direction (constant difference)
Systematic error
It is the basis for varying differences between repeated measurements-variations in technique
Random error
It is a measure of the agreement between the measured quantity and the true value
Systematic error
Measure of central tendency
Mean
Used to observe values of control materials overtime to determine reliability of the analytical method
Quality Control Chart
Occurs when the data set can be accurately described by the SD and the mean
Gaussian Curve (Bell Shaped Curve)
Calculates the difference between QC and the target means. Earliest indication of systematic error
Cumulative Sum Graph (CUSUM)
Deterioration of reagents
Trend
Improper calibration of the instrument
Shift
The most widely used QC chart in the clinical laboratory
Shewhart Levey Jennings Chart
Use to compare results obtained on high and low control serum from different laboratories
Youdin/Twin Plot
A performance improvement program, in which the goal is to improve the process by eliminating variations or errors; improved performance,improved performance quality, improved bottom line
Six sigma
A system for reducing waste “Nonvalued activities “ esp in production or manufacturing processes
Lean system
The most common used patient based- QC technique
Delta check
Type of analytical testing performed outside the confines and central laboratory
POCT
