MIDTERMS: L1 - QC AND QA Flashcards
MOTF
Quality
1. Conformance with the requirements of users or customers
2. It can be assessed and monitored. It can be improved
BOTH T
T or F
Quality’s benefits exceed its cost
True
MOTF
- Improvements in quality (which requires cost) can lead to long-term reduction of cost
- A balance must be obtained so that a net reduction in cost and an improved quality in services can be obtained
BOTH T
How much money, time, personnel/work hours spend for quality
Quality Cost
Cost conforming to the quality of the patients/clients
Cost of Conformance
MOTF
1. Prevention costs - Costs that are associated with
activities designing to prevent defects
2. Appraisal costs - Related to the detection of those defects
3. These two are part of cost of nonconformance
4. These two work hand in hand
Only 3 is incorrect
PC and AC - are part of cost of conformance
MOTF
1. Internal failure cost - Costs that are associated with errors after the
patients receive the test results
2. External failure costs - Associated with errors found before the customer receives the product/service
BOTH F
1. External failure cost - Costs that are associated with errors after the
patients receive the test results
2. Internal failure costs - Associated with errors found before the customer receives the product/service
MOTF
- Wrong result - external failure costs
- Not properly calibrated - internal failure costs
BOTH T
Note: External failure cost - more catastrophic
MOTF:
- Majority of errors are in the pre-analytic (32%-75%) and post-analytic (9-55%) phase
- Analytic phase, which was the focus of earlier Quality Management schemes, accounts for only 4-32% of errors.
BOTH TRYE
MOTF
- Quantity over quality
- Quantity is useless without quality
1 false, 2 true
- Must be quality over quantity
Highest in the hierarchy - it encompasses all concepts of quality
Total Quality Management (TQM)
Process improvement as a means to meet a set of standard
Total Quality Management (TQM)
These are series of processes to improve your workflow as a means to meet a specific set of standard
Total Quality Management (TQM)
5QS in Total Quality Management (TQM)
- Quality Laboratory Process
- Quality control
- Quality assessment
- Quality Improvement
- Quality planning
Includes analytical process and general guidelines on how the work is done
Quality Laboratory Process
Serves as the general guidelines and procedures inside the lab, example of QLP
Standard Operating Procedures
MOTF
Quality control
1. Detect and repair defects to prevent errors
2. Qc uses only statistical control procedures
1 true, 2 false
QC - uses both statistical and nonstatistical control procedures
MOTF
- Delta check -checking previous result in order for you to know if there are abrupt changes in the result (Statistical)
- Westgard rules (statistical)
1 false, 2 true
Delta check - non-statistical
T or F
Quality control is used only in the analytical phase
True
- Broader measures and monitors of lab performance
2. Encompasses preanalytical to postanalytical
Quality Assessment
- Determine and address root cause of problem
2. Structured problem-solving process
Quality Improvement
Standardize the remedy and establish performance monitoring
Quality planning
Identify what part of TQM:
Standard operating procedure
Quality Laboratory process
Identify what part of TQM:
Checking temp of refrigerator if well maintained
Quality control
Identify what part of TQM:
Failure mode and effects analysis
Quality Improvement
Identify what part of TQM:
Problem tree analysis and Ishikawa or fishbone diagram
Quality Improvement
T or F
1. TQM is similar to PDCA (Plan Do Check Act)
True
Quality from the perspective of end-user
Quality Assurance
Planned and systematic activities to provide adequate confidence that requirements for quality will be met (ISO 8042,3,4; CLSI)
Quality Assurance
Why is QA of testing important?
- Public expects high quality
- Defines quality goals & parameters
- Evaluation & improvement system
- Assures reliability and comparability of results
- Cost-effective
- Even the simplest of testing is not foolproof
Benefits of Laboratory QA:
- Provides evidence of good performance
- Laboratory mistakes are prevented
- Significant improvements in testing performance can be achieved
Quality Assurance Model (Identify the 3)
- Staffing/personnel component
- Quality control (QC)
- Proficiency testing (PT) aka external quality assurance
(EQA)
T or F
The laboratory has a bigger role in clinical diagnosis
True
MOTF
- Transport and receive sample - analysis phase
- Access result - post-analysis
1 false, 2 true
1 - preanalysis
MOTF
- Load sample and add reagent - analysis phase
- Repeat of test - postanalysis
1 true, 2 false
2 - analysis
MOTF
- Centrifuge and Sorting - pre-analytical phase
- Interpret result - postanalysis
Both true
- Involves the systematic monitoring of analytic processes to detect analytic errors and to ultimately prevent the reporting of incorrect patient test results
- A testing designed to assess the “health” of an analytical method (Henry’s)
Quality control
Why do quality control?
Error detection, error prevention, measure performance, monitor performance, validate performance (most important)
2 types of bias and define each
Positive bias - result is higher than normal
Negative bias - result is lower than normal
Imprecision can be computed by getting the _________
Standard deviation and by doing the Levey Jennings Chart
________ are used to validate (confirm) whether the instrument is operating within pre-defined specifications, concluding that patient test results are reliable
Quality control (NOTE: QC should never be done last)
MOTF
1. QC - setting the analyzer to give correct results
2. QC - If the analyzer (after calibration) is producing correct
results (expected values)
1 false, 2 true
1 - Calibration
MOTF Calibration 1. Uses calibrators 2. Setting the analyzer 3. Example of calibration - use of standard in spectrophotometry
All are true
MOTF Quality control 1. "Checking" 2. Done after calibration 3. Use of absorbance curve
3 is incorrect
AC - used in calibration
MOTF
- Calibrators are solutions that contain a known amount of concentration
- Calibration is only done manually
- Calibration is done only once every after opening a new batch of reagents to make sure that your instrument is well-calibrated with respect to the new batch of reagen
1,3 - correct
2 - incorrect
2 - can be done automatically via microprocessors controlling the instrument and manually
MOTF
- Controls - QC materials or solutions used to monitor the performance (precision and accuracy)
- Controls - perform the testing of controls the same way you run the sample
Both T
MOTF
Quality control materials
1. Closely mimic (same matrix) the characteristics of the patient’s sample being tested
2. Stable for prolonged period (at least a year) with interfering preservatives of special storage needs
3. Bought in a liquid form - to be stable for prolonged periods
3 is incorrect
QC materials are
Lyophilized
- dehydrated to powder
- reconstitute to use by adding dh20 and mix
MOTF
Quality control materials
1. Available in aliquots convenient for daily use
2. Bought in 1 L
3. Will destabilize if the temperature changes so frequently
1,3 - correct
2 - incorrect
2 - bought only at 1 to 5 ml
MOTF
- CC lab has atleast 2 levels of control - normal and abnormal
- Contained in low actinic glass to prevent degradation from light
BOTH TRUE
MOTF
- Assayed - target values are predetermined
- Assayed - verify and use
- Unassayed - made by laboratory itself
- Unassayed - pooled sera collected in laboratory
1,2 - true
3,4 - false
3 - Unassayed are manufacturer made
4 - In-house - pooled sera collected
MOTF
- Assayed - advisable since value is already made
- Homemade - pool sera degrades over time
1 false, 2 true
- Not advisable; must create your own values
- use only as guides
T OR F
The International Organization of Standardization (ISO) recommend that at least 20 measurements should be made on “separate” days
False
- Its the Clinical Laboratory Standard Institute (CLSI)
MOTF
- Accuracy - Describes the closeness of a test value to the actual/target/true value
- Accuracy can measured in recovery study, interference study, comparison of methods study
Both True
MOTF
- Precision - closeness of the agreement between independent test results obtained under prescribed condition
- Precision - consistency (degree of replication) of a series of tests results
- Precision - TRUE VALUE is 100, results are 78, 89, 42, 123, 56
3 is incorrect
- must be near
MOTF
1. Inaccurate but precise results: far values to each other but close from
the true value
2. Precision can be easily related to the standard deviation
1 false, 2 true
1 - close values, far from true value
The capacity of a method to maintain both accuracy and precision over time
Reliability
Repeatability or Practicability
- Capacity of the method to produce the same results on one sample again and again when performed by:
Same individual, same lot number, same instrument
Reproducibility
- Capacity of the methods to produce the same results on one sample again and again when performed by
Different individuals on, Different days using, Different sets of reagents
Ability of an analytical method to measure the smallest concentration of the analyte of interest
SENSITIVITY (ANALYTICAL SENSITIVITY)
Ability of an analytical method to measure only the analyte of interest
SPECIFICITY (ANALYTICAL SPECIFICITY)
T or F
Too high sensitivity is always better
False - can cause false positive and false negative
MOTF
1. Analytic - Focuses on the test itself
2. Analytic - Focuses on the ways the analytes are detected
by the test
3. Diagnostic - Pertains to how the disease is detected by the test itself
All T
MOTF
- DIAGNOSTIC SENSITIVITY - ability of the test to detect the proportion of individuals with that disease who test positively with the test
- DIAGNOSTIC SPECIFICITY - ability of the test to detect the proportion of individual without the disease who test negatively for the disease
Both T
MOTF
- The predictability of your result is more than just its sensitivity and specificity
- Accuracy is not necessarily predictive
Both true
Central organization sends out challenge specimens for testing
Proficiency testing (PT) aka external quality assurance (EQA)
PT - Clin chem
Lung center of the Philippines
PT - Hematology and Clin microscopy
National Kidney and Transplant Institute
PT - HIV HEPA B AND SYPHILIS
San Lazaro Hospital
PT - Microbio and Blood banking and Malaria
Research Institute For Tropical Medicine
PT - Drug testing
East Avenue Medical Center
Used for
- early warning-system for problems
- measure of laboratory quality valuable benchmarking tool
- indicator of where to direct improvement efforts
- monitor of changes in technology and testing practices
EQA or PT
