Why do Q.A.? Physician’s Expectations Diagnosis Therapy Technology Physician’s Expectations Diagnosis Therapy Technology.

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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