Exam 5 Quality Management – Flashcards
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| Quality Management |
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| The process of ensuring accurate lab results |
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| Descriptive Statistics |
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| Summarize important features of a group of data |
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| Mean |
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| Sum of the data points divided by the number of data points |
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| Median |
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| Middle data point in a set |
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| Mode |
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| The most frequent data point in a set |
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| Range |
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| Largest # - Smallest # |
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| Standard Deviation |
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| Dispersion; how data is spread around the mean |
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| What is SD used to set? |
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| Limits of acceptability (confidence limits) |
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| Coefficient of Variation |
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| Way of expressing SD in % |
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| What is CoV good for comparing? |
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| Tests reported in different units and concentrations |
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| %CV = ? |
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| (SD/X) x 100 |
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| Gaussian Distribution |
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| Visual representation of the distribution of values around an established mean |
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| What % of data falls between +/= 1 SD? |
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| 68% |
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| What % of data falls between +/= 2 SD? |
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| 95% |
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| What % of data falls between +/= 3 SD? |
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| 99% |
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| Reference Interval Study |
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| CAP requires that every lab either establish or verify reference intervals for any new test |
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| How many volunteers are needed for Establishing a Reference Interval? |
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| 120+ |
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| How many volunteers are needed for Verifying a Reference Interval? |
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| 20+ |
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| When Verifying a Reference Interval, No more than what percent of the tested subjects must fall outside the vendor's limits? |
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| 10% |
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| When Establishing a Reference Interval, how do you determine the reference interval? |
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| Mean +/= 2 SD |
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| Diagnostic Efficiency |
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| How good is a test at detecting or predicting the presence of a disease? |
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| Diagnostic Sensitivity |
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| proportion of persons with a disease who test positive |
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| Diagnostic Specificity |
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| proportion of persons without the condition who test negative |
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| Precision Study |
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| Detects any problems with test reproducibility |
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| Describe Precious Study |
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| 2 controls Run Twice a day 10 Days |
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| Accuracy Study |
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| Often use patient samples spiked with known analyte |
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| Comparison-of-Methods Studies |
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| Comparing patient results of new method with patient results of out-going method |
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| What are some reasons for changing methods? |
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| Cost, efficiency, TAT, personnel, safety, disposal, etc. |
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| When performing Comparison-of-Methods Studies what is the recommended # of specimens to run by each method? |
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| 40-100 |
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| When performing Comparison-of-Methods Studies, specimens should be run by each method within how many hours of each other? |
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| 4 hours |
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| When performing Comparison-of-Methods Studies,it is recommended that you spread the testing out over how many days? |
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| 8-20 |
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| With Linear Regression Analysis, Values by the current method are plotted on which axis? |
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| X axis |
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| With Linear Regression Analysis, Values by the new method are plotted on which axis? |
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| Y axis |
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| True or False: Linear Regression Analysis - The agreement between the two methods is estimated from the best straight line between the points |
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| True |
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| What does the Linear Regression Analysis provide? |
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| Measures of Dispersion |
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| Quality Control |
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| The lab's system for recognizing errors and to prevent reporting of incorrect patient values |
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| Controls |
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| Purchased materials that are tested and compared to the manufacturer’s predetermined target ranges |
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| You should have a sufficient quantity of controls to last a minimum of how long? |
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| 1 year |
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| For New Lots, Controls must be analyzed for at least how many days? |
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| 20 days |
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| Confidence Limits |
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| A control should fall within the 95% (2SD) Range |
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| QC Charts: Levey-Jennings |
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| Graphically show the values of a control over time |
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| What are the 3 Types of Analytic Errors |
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| Systematic/Systemic Error Random Error Dispersion |
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| Dispersion |
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| Wide scattering of control values |
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| Dispersion may be caused by what 2 things? |
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| System failure Operator error |
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| Random error |
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| Unexpected error that affects precision |
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| Can Random error be predicted? |
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| No |
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| What are 2 causes of Random Error? |
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| Environmental Operator error |
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| Shift |
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| Abrupt change in the analytical process |
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| Trend |
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| Gradual change in the analytical process |
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| What is the following considered: 6 or more data points all falling above or all falling below the mean |
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| Shift |
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| What is the following considered: Data points take either an upward or a downward direction |
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| Trend |
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| Systematic/Systemic Error |
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| A factor that causes a constant error, either + or = |
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| What are some causes of Systematic/Systemic Error |
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| Poorly made standards or reagents Failing instrumentation Deteriorating reagents Improper blanking Poorly written procedure |
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| Which type of Analytic Error Affects all samples in the run? |
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| Systematic/Systemic Error |
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| Westgard Rules |
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| What to do when a control is out of range. |
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| What is Westgard Rules based on? |
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| @ Least 2 controls per run |
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| 1 2S |
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| Warning |
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| 1 3S |
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| 1 control value falls outside +/= 3SD (random error) |
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| Which 2 Westgard Rules are Random Error |
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| 1 3S & R 4S |
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| 2 2S |
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| 2 consecutive values fall outside +/= 2 SD on the same side of X |
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| R 4S |
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| 1 control is >+2SD, the other is >-2SD |
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| 4 1S |
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| 4 Consecutive values that fall outside +/= 1 SD on the same side of X |
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| 10X |
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| 10 Consecutive values that fall on one side of the mean |
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| Which 3 Westgard Rules are Systemic Errors? |
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| 10X, 4 1S, & 2 2S |
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| Delta Check |
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| A patient's most recent test result is compared with a previous test result |
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| What does Delta Check Detect? |
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| Mislabeling, test errors, contamination, or a change in patient |
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| What is it called when there is External Quality Control? |
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| Proficiency Testing |
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| Proficiency Testing |
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| Designed to detect testing errors in a lab. Your lab results are graded and compared to all other participants in the program |
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| True or False: Proficiency Testing is required to maintain accreditation with TJC, CLIA, & CAP |
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| True |
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| What do Discrepant results require? |
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| Investigation |
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| If discrepancies aren't fixed, what can happen? |
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| The lab may lose the authority to perform patient testing to the analyte in question |
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| Quality Improvement |
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| A program designed to develop new, improved levels of performance |
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| Lean |
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| An idea designed to eliminate non-value adding steps; |
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| Six Sigma |
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| An idea designed to reduce variation |
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| Which Quality Improvement is used to Reduce Cycle Time? |
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| Lean |
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| Which Quality Improvement is used to Reduce Error? |
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| Six Sigma |
