Quality Management Flashcards
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Regulates labs and ensures accurate and reliable test results
Hemolysis
Destruction of red blood cells
Proficiency Testing
testing unknown specimens sent to a third party for evaluation
Quality
Meeting expectations and providing accurate results
Quality Control
Identify problems and maintain performance
Reference Range
Includes upper and lower limits of a lab test
Standard Operating Procedure (SOP)
Instructions on how to perform lab processes
Total Quality Management
Approach to long term success through customer satisfaction
Total Testing Process
Includes Preanalytical, Analytical, and Postanalytical
What does CLIA define as a clinical lab?
A facility that performs tests on human specimens
Waived Test
Simple examinations
Non-waived Test
More complex, more stringent
Quality Management System
Quality Planning
Quality Processes (QLP’s)
Quality Control
Quality Assessment
Quality Improvement
Peter Parker Can Always Intervene
What is a QC sample?
Solution that mimics a patients specimen
How do we treat Proficiency tests?
Like patient samples
How much success does a lab need to continue operation?
Correct on 4/5 specimens and overall score of 80%
What must a SOP include?
Title page
Effective Date
Purpose
Control Chart
View changes over time
Levey-Jennings Chart
A graph to represent lab data
Measured in Standard Deviation
Mean
Sum of a group of numbers divided by the number of numbers
Median
Measurements from lowest to highes
Mode
Most frequently occurring measurement
Precision
Closeness of two or more measurement to each other
Accuracy
How close a measurement comes to the true value
Standard Deviation
Measures how widely spread data points are
Trend
Values in one direction over six or more analytical runs
Westgard Procedure
Series of control rules to interpret data
When do we reject patient results?
When the run is out of control
Random Error
Statistical Fluctuation
Systematic Error
Always in one direction and are predictable
Analyte
Sample being analyzed
Coefficient of Variation
Dispersion of data points in a data series around the mean
Why are statistical descriptions useful in the lab?
Data Distribution
Random Variation
What are the three most common descriptions of the center of a dataset?
Mean
Median
Mode
What are the three most common descriptions of Spread?
Range
Standard Deviation
Coefficient of Variation (CV)
How do we find varience?
Mean divided by number of measurements minus 1
How do we find Standard Deviation?
Square root varience
How do we find CV?
SD divided by mean x 100
What is the most common shape of a dataset?
Gaussian Distribution (Bell Curve)
68 - 95 - 99 rule
68% falls between +- 1SD
95% falls between +- 2SD
99% falls between +- 3SD
Sensitivity
Percentage of True positives
Specificity
Percentage of True negatives
Why do we use a new testing method?
Reduce Costs
Improve Quality
Client Satisfaction
Improve Efficiency
Close Quarters Saves Everyone
How many individuals does CLSI allow for a study?
20 subjects
