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QC Delta PV PPT Student 09
QC Delta PV PPT Student 09
Objectives
1. Discuss the use of quality control in ensuring the validity of laboratory test results 2. Define the acceptable range as it relates to quality control and how this range is determined.
Objectives
3. Define the terms as they relate to quality control: a. Accuracy b. Precision c. Reliability 4. Explain the use of delta checks to assure accurate patient test results
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Objectives
5. Define the following terms: a. Test sensitivity b. Test specificity c. Predictive value 6. Discuss how sensitivity, specificity and predictive value are used to assess the diagnostic usefulness of a test
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
Analytical Run
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
Accuracy refers to the closeness of a measurement to the true value Precision refers to the reproducibility of a measurement Reliability refers to the accuracy and precision of a measurement
Analytical Run: plasma glucose 1. Level I control 2. Level II control 3. John Smother 4. Gomer Pyle 5. Jayne Sealess
Analytical Run: plasma glucose 1. Level I control 2. Level II control 3. John Smother 4. Gomer Pyle 5. Jayne Sealess
Quality Control Acceptable Limits Mean +/- 2SD Level I Level II 70 +/- 4 mg/dl 180 +/- 9 mg/dl Acceptable Range 62 78 mg/dl 162 198 mg/dl
Expected Reference Range and Critical Limits Fasting plasma glucose: 70-99 mg/dl Critical low: Critical high: < 45 mg/dl > 450 mg/dl
Quality Control Acceptable Limits Mean +/- 2SD Level I Level II 70 +/- 4 mg/dl 180 +/- 9 mg/dl Acceptable Range 62 78 mg/dl 162 198 mg/dl
Expected Reference Range and Critical Limits Fasting plasma glucose: 70-99 mg/dl Critical low: Critical high: < 45 mg/dl > 450 mg/dl
Is level I control within acceptable limits? Is level II control within acceptable limits?
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Analytical Run: plasma glucose 1. Level I control 2. Level II control 3. John Smother 4. Gomer Pyle 5. Jayne Sealess
Quality Control Acceptable Limits Mean +/- 2SD Level I Level II 70 +/- 4 mg/dl Acceptable Range 62 78 mg/dl
Delta Check
Another tool used by the laboratory to assure accurate patient test results for specific analytes The most recent test result for a particular patient is compared to the most previous test result for that patient
Expected Reference Range and Critical Limits Fasting plasma glucose: 70-99 mg/dl Critical low: Critical high: < 45 mg/dl > 450 mg/dl
Can patient test results be reported? Why/why not? No; the validity of the analytical run is questioned because control level II is outside of acceptable limits. All testing must be repeated and when all controls are within acceptable limits, 23 the patient test results may be reported.
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
Delta Check
If the test result has changed significantly from the last time the test was done, a delta check failure occurs The delta check failure means the change in test results is not physiologically possible The allowable difference is predetermined by various investigators and clinicians
Delta Check
The technologist is now responsible to determine the cause of the delta check failure before releasing test results
Test sample may have been compromised
Test interference: hemolyzed, lipemic, icteric Sample not handled properly Drawn at incorrect time: trough, peak, tolerance Drawn in incorrect sample tube: B-R-G-P-G Treatment?
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Jan.8 95
Jan.12 105
Jan. 13 22*
Jan.2 3.6
Jan.3 4.1
Jan.4 6.9*
*Delta check failure What is a likely cause for this failure? Should test results be reported?
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*Delta check failure What is a likely cause for this failure? Should test results be reported?
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Diagnostic Efficacy
Diagnostic sensitivity Diagnostic specificity Positive predictive value Negative predictive value
Ideal
All persons with disease will test positive (referred to as diagnostic sensitivity) All persons without disease will test negative (referred to as diagnostic specificity) Test results would be: 100% sensitive 100% specific
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
Reality
All methods have an inherent amount of error that will affect test results No method is able to detect all persons with disease accurately -andNo method is able to detect all persons without disease accurately
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Patients with disease Positive test result Negative test result Test sensitivity: Test specificity: + (TP) - (FN)
Hypothetical Example
A total of 3000 patients were assessed for acute myocardial infarction (AMI) with Troponin I (cTnI) measurements: 1000 patients tested positive for cTnI and of those, 980 had diagnostic AMI; 2000 patients tested negative for cTnI and of those, 30 had diagnostic AMI 34
Pos predictive value: TP/(TP + FP) x 100 Neg predictive value: TN/(TN + FN) x 100
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture
Disease Prevalence
Using PSA cut off value of 4.0 ng/ml: Sensitivity = 79%; Specificity = 46%; +PV = 33%; -PV = 87%)
Prevalence of disease 0.001 (0.1% of population) 0.01 (1% of pop) 0.1 (10% of pop) 0.2 (20% of pop) 0.5 (50% of pop)
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CLS 500 Application and Interpretation of Clinical Laboratory Data QC, Delta Check and Predictive Value Lecture