Why do Q.A.?Why do Q.A.?
• Physician’s Expectations
• Diagnosis
• Therapy
• Technology
• Physician’s Expectations
• Diagnosis
• Therapy
• Technology
Physician’s ExpectationsPhysician’s Expectations
DiagnosisDiagnosis
• Specificity – True Positive in Disease
• Sensitivity – True Negative
• Specificity – True Positive in Disease
• Sensitivity – True Negative
TherapyTherapy
• Adjustment of Medication• Adjustment of Medication
TechnologyTechnology
• Complex Instruments
• Complex Reagents
• Micro Techniques
• Complex Instruments
• Complex Reagents
• Micro Techniques
What is Q.A.?What is Q.A.?
• Samples
• Control Material
• Assay Conditionsa. Reagentsb. Instruments
• Daily Review
• Retrospective Peer Review
• Samples
• Control Material
• Assay Conditionsa. Reagentsb. Instruments
• Daily Review
• Retrospective Peer Review
ControlsControls
• Similar to patient samples• Respond like samples• Stability like samples
• Similar to patient samples• Respond like samples• Stability like samples
Daily ReviewDaily Review
• Decision Rules• Random Error• Systematic Error
• Decision Rules• Random Error• Systematic Error
CalculationsCalculations
Gaussian DistributionGaussian Distribution
Abnormal DistributionAbnormal Distribution
Graphing – Levey-Jennings ChartsGraphing – Levey-Jennings Charts
NormalNormal
Westgard RulesWestgard Rules
1 – 3s
2 – 2s
R – 4s
4 – 1s
10x
1 – 3s
2 – 2s
R – 4s
4 – 1s
10x
1 – 3s1 – 3s
2 – 2s2 – 2s
2 – 2s2 – 2s
R – 4sR – 4s
4 – 1s4 – 1s
10x10x
Retrospective Peer ReviewRetrospective Peer Review
• Measurement of Peer Precision
• Method Comparisons
• Proficiency Surveys and Routine Q.C.
• Measurement of Peer Precision
• Method Comparisons
• Proficiency Surveys and Routine Q.C.
SDI-Standard Deviation IndexSDI-Standard Deviation Index
SDI InterpretationSDI Interpretation
• Like Signs
• Spread of 1 SDI
• Reproducibility
• Like Signs
• Spread of 1 SDI
• Reproducibility
SDISDI
E = mcE = mc
Excellence =Methods x Controls x Calculations
Excellence =Methods x Controls x Calculations
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