QM Flashcards
- important to customers
- can be assessed and monitored
- can be improved
- quality’s benefits exceed its cost
Quality
3 Phases of the Testing Process
- Pre-analytic
- Analytic
- Post-analytic
ISO stands for:
International Organization for Standardization
“Planned and systematic activities to provide adequate confidence that requirements for quality will be met.”
Quality Assurance
Benefits of Quality Assurance
- QA provides evidence of good performance
- Laboratory mistakes are prevented
- Significant improvements in testing performance can be achieved
Why is Quality Assurance important?
- Public expects high quality
- Defines parameters & quality goals
- Evaluation & improvement system
- Assures reliability & comparability of results
- Cost effective
- Even the simplest of testing is not foolproof
Components of the Quality Assurance Model:
- Staff
- Proficiency Testing
- Quality Control
involves the systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results
Quality Control
A testing designed to assess the “health” of an analytical method
Quality Control
___________ results in the lab are used to validate (confirm) whether the instrument is operating within predefined specifications; concluding that patients test results are reliable.
Quality Control
3 events/processes after Quality Control
Patient Results > Physician > Treatment
Areas/Tests under Quality Control:
- Error Detection
- Error Prevention
- Measure Performance
- Monitor Performance: Bias, Imprecision, Total Error
- Validate Performance
Application of multi-rule systems
Westergard Rules
Plotting data
Levey-Jennings Chart
Central tendency, Range, SD, CV
Statistical Concepts
“Measurement of the broaden dimension of quality from the perspective of the end-user (client)”
Quality Assurance
Basic Quality Control Process
- Run a control sample
- Compare result with expected range of values
- Check to see if the result is right
Operator resulting action after QC Result: Yes
system is working → report good patient results
Operator resulting action after QC Result: No
system is not working → do not report any bad data
Operator resulting action after QC Result: Troubleshoot
Identify the problem & resolve it → Run again control material
According to CLSI, you should run QC at least ____ consecutive times (different days) in ____ month/s and use _________ and _________ after.
- 20
- 1
- statistical tools
- charts
Calibration or Quality Control?
“Setting” the analyzer to give correct results
- Uses calibrators
(standards)
Calibration
Calibration or Quality Control?
“Checking”
- If the analyzer is producing correct results
- The instrument’s calibration and other analytical processes
Quality Control
Calibration or Quality Control?
Solution that contains a known amount of an analyte used to calibrate an assay method
Calibration
Calibration or Quality Control?
Material or solutions used to monitor the performance (precision and accuracy) of an assay method once it has been calibrated
Quality Control
Calibration or Quality Control?
Run prior to QC manually by the laboratory analyst or automatically by the microprocessors controlling the instrument
Calibration
Calibration or Quality Control?
Run along-side patient samples and results are calculated from calibration data in the same manner that patient results are calculated.
Quality Control
Refers to the substance or base from which the control material is prepared. All of the characteristics of a sample (serum, plasma, urine)
Matrix
Control material that is dehydrated to powder
Lyophilized control material
3 Types of Control Material
- Assayed
- Unassayed
- In-house/Homemade
Describes the closeness of a test value to the actual/target/true value
Accuracy
Run same sample multiple times and find the mean to get the True Value
Accuracy
Accuracy can be measured in 3 ways:
- Recovery Study
- Interference Study
- 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
● HBA1C → Glycosylated Hemoglobin → HPLC is the gold standard method
Interference Study
● First method → Lab method
● Second method → Reference method/gold
standard method
● Accurate Machine → If lab result is close
to gold standard result
Comparison of Methods of Study
The consistency of a series of test results
Precision
Closeness of agreement between independent test results obtained under prescribed conditions.
Precision
- Degree of replication of data
- Ability of analytical methods to give repeated
results on the same sample that agree with one
another.
Precision
Capacity of a method to maintain both accuracy and precision
Reliability
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 one 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 (0.005 > 0.5)
Analytical Sensitivity
Ability of an analytical method to measure only the analyte of interest (1
test > 2 tests)
Analytical Specificity
Ability of the test to detect the proportion of individuals with that disease who test positively with the test
○ Focuses on true positives
Diagnostic Sensitivity
Ability of the test to detect the proportion of individual without the disease who test negatively for the disease
○ Focuses on true negatives
Diagnostic Specificity
NRL for Dengue, Influenza, TB, and other Mycobacteria
Research Institute for Tropical Medicine
NRL for Anatomic Pathology for Pulmonary Disease, Biochemistry, and Clinical Chemistry
Lung Center of the Philippines
NRL for Hematology, Immunohematology, Immunopathology, and Anatomic Pathology
National Kidney and Transplant Institute
NRL for Environmental and Occupational Health, Toxicology (drug testing), and Micronutrient Assay (confirmatory test for drug test)
East Avenue Medical Center
NRL for Pathology for Cardiac Disease
Philippine Heart Center
NRL for HIV/AIDS, Hepatitis, and Syphilis
San Lazaro Hospital/STD-AIDS Central Cooperative Laboratory
● Early warning-system for problems
● Measure of laboratory quality
● Valuable benchmarking tool (standardization and
traceability)
● Indicator of where to direct improvement efforts
● Monitor of changes in technology and testing
practices (evaluation component)
External Quality Assurance
What to do regularly before running sample and releasing official results?
Calibrate → Quality Control → Run Patient Sample = Release Patient Results
What to do if Quality Control is not within the range?
Troubleshoot
