PRELIM LEC: Quality Assurance (TRANSES)
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Overall program that ensures that the final results reported by the laboratory are correct
Quality Assurance
It is concerned with all factors that affect the test results from preanalytic, analytic and post-analytic phases
Quality Assurance
System of ensuring accuracy and precision in the lab
Quality Control
Process of ensuring that analytical results are correct
Quality Control
QC samples are measured periodically in the same manner as clinical samples
Quality Control
Objectives of Quality Control:
• To check the stability of the machine • To check the quality of the reagent • To check for technical/clerical error
Types of Quality Control:
Intralab Interlab
AKA Internal Quality Control
Intralab
Analyses of control samples together with patient specimens
Intralab
Important in daily monitoring
Intralab
AKA External Quality Control
Interlab
Involves proficiency testing programs
Interlab
Ex.: National External Quality Assessment Scheme (NEQAS)
Interlab
Under RIPN
Interlab
Sends out specimen to labs to test, results are sent back, and results are compared
Interlab
Characteristics of an Ideal QC Material
• With known analyte concentrations • Inexpensive and stable for long periods • No communicable diseases • No matrix effect • Convenient packaging for easy dispensing and storage • Resembles human sample
Maintain long-term accuracy of methods
Interlab
TYPES OF REAGENTS
• Reagent Blank • Standard • Control
Value will tell the conc. of the unknown
Standard
Reagent without any analyte added
Reagent Blank
Most specific analytical solution
Standard
Only one analyte
Standard
Resembles patient sample
Control
Value will determine accuracy and precision
Control