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Exam 5 Quality Management
QA & QC = QM Uunit 5 Lecture 7
76
Chemistry
Undergraduate 3
04/15/2015

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