Quality Control Flashcards
Method is easily repeated
Practicability
Maintain accuracy and precision
Reliability
Daily monitoring of accuracy and precision
Intralab/Interlab QC
Proficiency testing (Reference lab)
Long-term accuracy
Difference of >2: not in agreement w/ other lab
Interlab/External QC
Available for a min. of 1 yr
QC materials
Graphic representation of the acceptable limits of variation
Shewhart Levey-Jennings Chart
V-mask
Earliest indication of systematic errors (trend)
Cumulative Sum Graph (CUSUM)
SD of 2 groups of data
F-test
Means of 2 groups of data
T-test
Improper product manufacturing
Unpurified analyte
Altered protein
Matrix effect
Degree of flatness or sharpness
Kurtosis
Control rules + Control chart
Multirule Shewhart procedure
Westgard: at least 40 samples
Test method
Westgard: preferably 100 samples
Reference method
Tripod:
Program development
Assessment and monitoring
Quality improvement
Quality Assurance
Referred to as absurd value
Physiologic Limit
Control and patient specimens assayed, evaluated, and report together
Analytical Run
Causes:
- Improper calibration
- Deterioration of reagents
- Contaminated solution
- Sample instability/unstable reagent blanks
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- Incorrect sample and
Systematic error (Inaccuracy/Determinate)
29% of errors (lab results)
Nonlab. personnel
Preferred (Human: biohazard)
Not for immunochem, dye-binding and bilirubin
Bovine control materials