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
