Exam 5 Quality Management

 Quality Management
 The process of ensuring accurate lab results
 Descriptive Statistics
 Summarize important features of a group of data
 Mean
 Sum of the data points divided by the number of data points
 Median
 Middle data point in a set
 Mode
 The most frequent data point in a set
 Range
 Largest # – Smallest #
 Standard Deviation
 Dispersion; how data is spread around the mean
 What is SD used to set?
 Limits of acceptability (confidence limits)
 Coefficient of Variation
 Way of expressing SD in %
 What is CoV good for comparing?
 Tests reported in different units and concentrations
 %CV = ?
 (SD/X) x 100
 Gaussian Distribution
 Visual representation of the distribution of values around an established mean
 What % of data falls between +/= 1 SD?
 68%
 What % of data falls between +/= 2 SD?
 95%
 What % of data falls between +/= 3 SD?
 99%
 Reference Interval Study
 CAP requires that every lab either establish or verify reference intervals for any new test
 How many volunteers are needed for Establishing a Reference Interval?
 120+
 How many volunteers are needed for Verifying a Reference Interval?
 20+
 When Verifying a Reference Interval, No more than what percent of the tested subjects must fall outside the vendor’s limits?
 10%
 When Establishing a Reference Interval, how do you determine the reference interval?
 Mean +/= 2 SD
 Diagnostic Efficiency
 How good is a test at detecting or predicting the presence of a disease?
 Diagnostic Sensitivity
 proportion of persons with a disease who test positive
 Diagnostic Specificity
 proportion of persons without the condition who test negative
 Precision Study
 Detects any problems with test reproducibility
 Describe Precious Study
 2 controlsRun Twice a day10 Days
 Accuracy Study
 Often use patient samples spiked with known analyte
 Comparison-of-Methods Studies
 Comparing patient results of new method with patient results of out-going method
 What are some reasons for changing methods?
 Cost, efficiency, TAT, personnel, safety, disposal, etc.
 When performing Comparison-of-Methods Studies what is the recommended # of specimens to run by each method?
 40-100
 When performing Comparison-of-Methods Studies, specimens should be run by each method within how many hours of each other?
 4 hours
 When performing Comparison-of-Methods Studies,it is recommended that you spread the testing out over how many days?
 8-20
 With Linear Regression Analysis, Values by the current method are plotted on which axis?
 X axis
 With Linear Regression Analysis, Values by the new method are plotted on which axis?
 Y axis
 True or False:Linear Regression Analysis – The agreement between the two methods is estimated from the best straight line between the points
 True
 What does the Linear Regression Analysis provide?
 Measures of Dispersion
 Quality Control
 The lab’s system for recognizing errors and to prevent reporting of incorrect patient values
 Controls
 Purchased materials that are tested and compared to the manufacturer’s predetermined target ranges
 You should have a sufficient quantity of controls to last a minimum of how long?
 1 year
 For New Lots, Controls must be analyzed for at least how many days?
 20 days
 Confidence Limits
 A control should fall within the 95% (2SD) Range
 QC Charts: Levey-Jennings
 Graphically show the values of a control over time
 What are the 3 Types of Analytic Errors
 Systematic/Systemic ErrorRandom ErrorDispersion
 Dispersion
 Wide scattering of control values
 Dispersion may be caused by what 2 things?
 System failureOperator error
 Random error
 Unexpected error that affects precision
 Can Random error be predicted?
 No
 What are 2 causes of Random Error?
 EnvironmentalOperator error
 Shift
 Abrupt change in the analytical process
 Trend
 Gradual change in the analytical process
 What is the following considered:6 or more data points all falling above or all falling below the mean
 Shift
 What is the following considered:Data points take either an upward or a downward direction
 Trend
 Systematic/Systemic Error
 A factor that causes a constant error, either + or =
 What are some causes of Systematic/Systemic Error
 Poorly made standards or reagentsFailing instrumentation Deteriorating reagentsImproper blankingPoorly written procedure
 Which type of Analytic Error Affects all samples in the run?
 Systematic/Systemic Error
 Westgard Rules
 What to do when a control is out of range.
 What is Westgard Rules based on?
 @ Least 2 controls per run
 1 2S
 Warning
 1 3S
 1 control value falls outside +/= 3SD (random error)
 Which 2 Westgard Rules are Random Error
 1 3S & R 4S
 2 2S
 2 consecutive values fall outside +/= 2 SD on the same side of X
 R 4S
 1 control is >+2SD, the other is >-2SD
 4 1S
 4 Consecutive values that fall outside +/= 1 SD on the same side of X
 10X
 10 Consecutive values that fall on one side of the mean
 Which 3 Westgard Rules are Systemic Errors?
 10X, 4 1S, & 2 2S
 Delta Check
 A patient’s most recent test result is compared with a previous test result
 What does Delta Check Detect?
 Mislabeling, test errors, contamination, or a change in patient
 What is it called when there is External Quality Control?
 Proficiency Testing
 Proficiency Testing
 Designed to detect testing errors in a lab. Your lab results are graded and compared to all other participants in the program
 True or False:Proficiency Testing is required to maintain accreditation with TJC, CLIA, & CAP
 True
 What do Discrepant results require?
 Investigation
 If discrepancies aren’t fixed, what can happen?
 The lab may lose the authority to perform patient testing to the analyte in question
 Quality Improvement
 A program designed to develop new, improved levels of performance
 Lean
 An idea designed to eliminate non-value adding steps;
 Six Sigma
 An idea designed to reduce variation
 Which Quality Improvement is used to Reduce Cycle Time?
 Lean
 Which Quality Improvement is used to Reduce Error?
 Six Sigma
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