QM

Question 1

• important to customers
• can be assessed and monitored
• can be improved
• quality’s benefits exceed its cost

Answer 1

Quality

Question 2

3 Phases of the Testing Process

Answer 2

• Pre-analytic
• Analytic
• Post-analytic

Question 3

ISO stands for:

Answer 3

International Organization for Standardization

Question 4

“Planned and systematic activities to provide adequate confidence that requirements for quality will be met.”

Answer 4

Quality Assurance

Question 5

Benefits of Quality Assurance

Answer 5

1. QA provides evidence of good performance
2. Laboratory mistakes are prevented
3. Significant improvements in testing performance can be achieved

Question 6

Why is Quality Assurance important?

Answer 6

• 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

Question 7

Components of the Quality Assurance Model:

Answer 7

1. Staff
2. Proficiency Testing
3. Quality Control

Question 8

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

Answer 8

Quality Control

Question 9

A testing designed to assess the “health” of an analytical method

Answer 9

Quality Control

Question 10

___________ results in the lab are used to validate (confirm) whether the instrument is operating within predefined specifications; concluding that patients test results are reliable.

Answer 10

Quality Control

Question 11

3 events/processes after Quality Control

Answer 11

Patient Results > Physician > Treatment

Question 12

Areas/Tests under Quality Control:

Answer 12

1. Error Detection
2. Error Prevention
3. Measure Performance
4. Monitor Performance: Bias, Imprecision, Total Error
5. Validate Performance

Question 13

Application of multi-rule systems

Answer 13

Westergard Rules

Question 14

Plotting data

Answer 14

Levey-Jennings Chart

Question 15

Central tendency, Range, SD, CV

Answer 15

Statistical Concepts

Question 16

“Measurement of the broaden dimension of quality from the perspective of the end-user (client)”

Answer 16

Quality Assurance

Question 17

Basic Quality Control Process

Answer 17

1. Run a control sample
2. Compare result with expected range of values
3. Check to see if the result is right

Question 18

Operator resulting action after QC Result: Yes

Answer 18

system is working → report good patient results

Question 19

Operator resulting action after QC Result: No

Answer 19

system is not working → do not report any bad data

Question 20

Operator resulting action after QC Result: Troubleshoot

Answer 20

Identify the problem & resolve it → Run again control material

Question 21

According to CLSI, you should run QC at least ____ consecutive times (different days) in ____ month/s and use _________ and _________ after.

Answer 21

1. 20
2. 1
3. statistical tools
4. charts

Question 22

Calibration or Quality Control?

“Setting” the analyzer to give correct results
- Uses calibrators
(standards)

Answer 22

Calibration

Question 23

Calibration or Quality Control?

“Checking”
- If the analyzer is producing correct results
- The instrument’s calibration and other analytical processes

Answer 23

Quality Control

Question 24

Calibration or Quality Control?

Solution that contains a known amount of an analyte used to calibrate an assay method

Answer 24

Calibration

Question 25

Calibration or Quality Control? Material or solutions used to monitor the performance (precision and accuracy) of an assay method once it has been calibrated

Answer 25

Quality Control

Question 26

Calibration or Quality Control? Run prior to QC manually by the laboratory analyst or automatically by the microprocessors controlling the instrument

Answer 26

Calibration

Question 27

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.

Answer 27

Quality Control

Question 28

Refers to the substance or base from which the control material is prepared. All of the characteristics of a sample (serum, plasma, urine)

Answer 28

Matrix

Question 29

Control material that is dehydrated to powder

Answer 29

Lyophilized control material

Question 30

3 Types of Control Material

Answer 30

1. Assayed 2. Unassayed 3. In-house/Homemade

Question 31

Describes the closeness of a test value to the actual/target/true value

Answer 31

Accuracy

Question 32

Run same sample multiple times and find the mean to get the True Value

Answer 32

Accuracy

Question 33

Accuracy can be measured in 3 ways:

Answer 33

1. Recovery Study 2. Interference Study 3. Comparison of Methods of Study

Question 34

Patient sample is added concentrated analyte of interest ● Accurate machine → increased result even if sample has other analytes present

Answer 34

Recovery Study

Question 35

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

Answer 35

Interference Study

Question 36

● First method → Lab method ● Second method → Reference method/gold standard method ● Accurate Machine → If lab result is close to gold standard result

Answer 36

Comparison of Methods of Study

Question 37

The consistency of a series of test results

Answer 37

Precision

Question 38

Closeness of agreement between independent test results obtained under prescribed conditions.

Answer 38

Precision

Question 39

- Degree of replication of data - Ability of analytical methods to give repeated results on the same sample that agree with one another.

Answer 39

Precision

Question 40

Capacity of a method to maintain both accuracy and precision

Answer 40

Reliability

Question 41

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.

Answer 41

Repeatability/Practicability

Question 42

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.

Answer 42

Reproducibility

Question 43

Ability of analytical method to measure the smallest concentration of the analyte of interest (0.005 > 0.5)

Answer 43

Analytical Sensitivity

Question 44

Ability of an analytical method to measure only the analyte of interest (1 test > 2 tests)

Answer 44

Analytical Specificity

Question 45

Ability of the test to detect the proportion of individuals with that disease who test positively with the test ○ Focuses on true positives

Answer 45

Diagnostic Sensitivity

Question 46

Ability of the test to detect the proportion of individual without the disease who test negatively for the disease ○ Focuses on true negatives

Answer 46

Diagnostic Specificity

Question 47

NRL for Dengue, Influenza, TB, and other Mycobacteria

Answer 47

Research Institute for Tropical Medicine

Question 48

NRL for Anatomic Pathology for Pulmonary Disease, Biochemistry, and Clinical Chemistry

Answer 48

Lung Center of the Philippines

Question 49

NRL for Hematology, Immunohematology, Immunopathology, and Anatomic Pathology

Answer 49

National Kidney and Transplant Institute

Question 50

NRL for Environmental and Occupational Health, Toxicology (drug testing), and Micronutrient Assay (confirmatory test for drug test)

Answer 50

East Avenue Medical Center

Question 51

NRL for Pathology for Cardiac Disease

Answer 51

Philippine Heart Center

Question 52

NRL for HIV/AIDS, Hepatitis, and Syphilis

Answer 52

San Lazaro Hospital/STD-AIDS Central Cooperative Laboratory

Question 53

● 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)

Answer 53

External Quality Assurance

Question 54

What to do regularly before running sample and releasing official results?

Answer 54

Calibrate → Quality Control → Run Patient Sample = Release Patient Results

Question 55

What to do if Quality Control is not within the range?

Answer 55

Troubleshoot