Qual Control Flashcards
involves the SYSTEMATIC MONITRING OF ANALYICAL PROCESSES to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results
QUALITY CONTROL
Application of multirule systems
WESTERGARD RULE
Plotting data
LEVEY JENNINGS CHART
“Setting” the analyzer to give correct results
CALIBRATION
Checking”
- If the analyzer is producing correct results
QUALITY CONTROL
Run along-side patient samples and results
QUALITY CONTROL
Run prior to QC manually
CALIBRATION
Refers to the substance or base from which the control material is prepared.
MATRIX
3 TYPES OF CONTROL MATERIALS
ASSAYED
UNASSAYED
HOME MADE OR IN HOUSE
Target value PREDETERMINED
ASSAYED
- Commonly used in the laboratory
- Manufacturer gives CONTROL MATERIAL AND RANGE for comparison
ASSAYED
● Target values not PREDETERMINED
● Full assay to be established
UNASSAYED
Manufacturer gives CONTROL MATERIAL W/O RANGE
UNASSAYED
● Pooled sera collected in the laboratory
● Full assay, validation needed
○ No manufacturer
HOME MADE OR INHOUSE
Describes the CLOSENESS of a test value to the actual/target/true valu
ACCURACY
ACCURACY can be measured in 3 ways
(RIC)
Recovery study
Interference method
Comparison of methods of study
● Patient sample is added concentrated analyte of interest
● Accurate machine → INCREASED RESULT even if sample has other analytes present
Recovery study
Interfering substances REFLECT/ABSORB light and REACT with reagents.
● Accurate Machine → Machine WON’T CHANGE RESULTS with the presence of interfering substances
INTERFERENCE STUDY
Gold standard method
HPLC
Accurate Machine → If lab result (recovery study) is CLOSE to gold standard (interference study) result
COMPARISON OF METHODS OF STUDY
Degree of REPLICATION of data
PRECISION
Ability of analytical methods to give REPEATED results on the same sample that agree with one another.
PRECISION
Capacity to produce the SAME RESULTS ON ONE SAMPLE again and again when performed by the SAME individual using the SAME lot numbers on the SAME instruments..
REPEATABILITY/PRACTICABILITY
Capacity of the method to produce the SAME RESULTS ON THE SAME SAMPLE again and again when performed by DIFFERENT individuals on DIFFERENT days using DIFFERENT sets of reagents.
REPRODUCIBILITY
Ability of ANALYTICAL method
to measure the SMALLEST CONCENTRATION of the analyte of interest
ANALYTICAL SENSITIVITY
Ability of an ANALYTICAL
method to measure ONLY the analyte of interest
ANALYTICAL SPECIFICITY
Ability of the test to detect the proportion of individuals W/ THAT DISEASE who test POSITIVELY with the test
DIAGNOSTIC SENSITIVITY
Ability of the test to detect
the proportion of individual W/O THE DISEASE who test NEGATIVELY for the disease
DIAGNOSTIC SPECIFICITY
NRL for Dengue, Influenza, TB, and other Mycobacteria.
Research Institute for Tropical Medicine
NRL for
- Anatomic Pathology for Pulmonary Disease
- Biochemistry, Clinical Chemistry
Lung Center of the Philippines
NRL for
- Hematology, Immunohematology
- Immunopathology, Anatomic Pathology
National Kidney and Transplant Institute
NRL for
- Environmental and Occupational Health
- Toxicology (drug testing)
- Micronutrient Assay (confirmatory test for
drug test)
East Avenue Medical Center
NRL for Pathology for Cardiac Disease
Philippine Heart Center
NRL for
a. HIV/AIDS
b. Hepatitis
c. Syphilis
San Lazaro Hospital/STD-AIDS Central Cooperative Laboratory
Valuable benchmarking tool
External quality assurance
