MIDTERMS: L1 - QC AND QA

Question 1

MOTF
Quality
1. Conformance with the requirements of users or customers
2. It can be assessed and monitored. It can be improved

Answer 1

BOTH T

Question 2

T or F

Quality’s benefits exceed its cost

Answer 2

True

Question 3

MOTF

1. Improvements in quality (which requires cost) can lead to long-term reduction of cost
2. A balance must be obtained so that a net reduction in cost and an improved quality in services can be obtained

Answer 3

BOTH T

Question 4

How much money, time, personnel/work hours spend for quality

Answer 4

Quality Cost

Question 5

Cost conforming to the quality of the patients/clients

Answer 5

Cost of Conformance

Question 6

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

Answer 6

Only 3 is incorrect

PC and AC - are part of cost of conformance

Question 7

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

Answer 7

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

Question 8

MOTF

1. Wrong result - external failure costs
2. Not properly calibrated - internal failure costs

Answer 8

BOTH T

Note: External failure cost - more catastrophic

Question 9

MOTF:

1. Majority of errors are in the pre-analytic (32%-75%) and post-analytic (9-55%) phase
2. Analytic phase, which was the focus of earlier Quality Management schemes, accounts for only 4-32% of errors.

Answer 9

BOTH TRYE

Question 10

MOTF

1. Quantity over quality
2. Quantity is useless without quality

Answer 10

1 false, 2 true

• Must be quality over quantity

Question 11

Highest in the hierarchy - it encompasses all concepts of quality

Answer 11

Total Quality Management (TQM)

Question 12

Process improvement as a means to meet a set of standard

Answer 12

Total Quality Management (TQM)

Question 13

These are series of processes to improve your workflow as a means to meet a specific set of standard

Answer 13

Total Quality Management (TQM)

Question 14

5QS in Total Quality Management (TQM)

Answer 14

1. Quality Laboratory Process
2. Quality control
3. Quality assessment
4. Quality Improvement
5. Quality planning

Question 15

Includes analytical process and general guidelines on how the work is done

Answer 15

Quality Laboratory Process

Question 16

Serves as the general guidelines and procedures inside the lab, example of QLP

Answer 16

Standard Operating Procedures

Question 17

MOTF
Quality control
1. Detect and repair defects to prevent errors
2. Qc uses only statistical control procedures

Answer 17

1 true, 2 false

QC - uses both statistical and nonstatistical control procedures

Question 18

MOTF

1. Delta check -checking previous result in order for you to know if there are abrupt changes in the result (Statistical)
2. Westgard rules (statistical)

Answer 18

1 false, 2 true

Delta check - non-statistical

Question 19

T or F

Quality control is used only in the analytical phase

Answer 19

True

Question 20

1. Broader measures and monitors of lab performance

2. Encompasses preanalytical to postanalytical

Answer 20

Quality Assessment

Question 21

1. Determine and address root cause of problem

2. Structured problem-solving process

Answer 21

Quality Improvement

Question 22

Standardize the remedy and establish performance monitoring

Answer 22

Quality planning

Question 23

Identify what part of TQM:

Standard operating procedure

Answer 23

Quality Laboratory process

Question 24

Identify what part of TQM:

Checking temp of refrigerator if well maintained

Answer 24

Quality control

Question 25

Identify what part of TQM: | Failure mode and effects analysis

Answer 25

Quality Improvement

Question 26

Identify what part of TQM: | Problem tree analysis and Ishikawa or fishbone diagram

Answer 26

Quality Improvement

Question 27

T or F | 1. TQM is similar to PDCA (Plan Do Check Act)

Answer 27

True

Question 28

Quality from the perspective of end-user

Answer 28

Quality Assurance

Question 29

Planned and systematic activities to provide adequate confidence that requirements for quality will be met (ISO 8042,3,4; CLSI)

Answer 29

Quality Assurance

Question 30

Why is QA of testing important?

Answer 30

1. Public expects high quality 2. Defines quality goals & parameters 3. Evaluation & improvement system 4. Assures reliability and comparability of results 5. Cost-effective 6. Even the simplest of testing is not foolproof

Question 31

Benefits of Laboratory QA:

Answer 31

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

Question 32

Quality Assurance Model (Identify the 3)

Answer 32

- Staffing/personnel component - Quality control (QC) - Proficiency testing (PT) aka external quality assurance (EQA)

Question 33

T or F | The laboratory has a bigger role in clinical diagnosis

Answer 33

True

Question 34

MOTF 1. Transport and receive sample - analysis phase 2. Access result - post-analysis

Answer 34

1 false, 2 true | 1 - preanalysis

Question 35

MOTF 1. Load sample and add reagent - analysis phase 2. Repeat of test - postanalysis

Answer 35

1 true, 2 false | 2 - analysis

Question 36

MOTF 1. Centrifuge and Sorting - pre-analytical phase 2. Interpret result - postanalysis

Answer 36

Both true

Question 37

- 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)

Answer 37

Quality control

Question 38

Why do quality control?

Answer 38

Error detection, error prevention, measure performance, monitor performance, validate performance (most important)

Question 39

2 types of bias and define each

Answer 39

Positive bias - result is higher than normal Negative bias - result is lower than normal

Question 40

Imprecision can be computed by getting the _________

Answer 40

Standard deviation and by doing the Levey Jennings Chart

Question 41

________ are used to validate (confirm) whether the instrument is operating within pre-defined specifications, concluding that patient test results are reliable

Answer 41

``` Quality control (NOTE: QC should never be done last) ```

Question 42

MOTF 1. QC - setting the analyzer to give correct results 2. QC - If the analyzer (after calibration) is producing correct results (expected values)

Answer 42

1 false, 2 true | 1 - Calibration

Question 43

``` MOTF Calibration 1. Uses calibrators 2. Setting the analyzer 3. Example of calibration - use of standard in spectrophotometry ```

Answer 43

All are true

Question 44

``` MOTF Quality control 1. "Checking" 2. Done after calibration 3. Use of absorbance curve ```

Answer 44

3 is incorrect | AC - used in calibration

Question 45

MOTF 1. Calibrators are solutions that contain a known amount of concentration 2. Calibration is only done manually 3. 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

Answer 45

1,3 - correct 2 - incorrect 2 - can be done automatically via microprocessors controlling the instrument and manually

Question 46

MOTF 1. Controls - QC materials or solutions used to monitor the performance (precision and accuracy) 2. Controls - perform the testing of controls the same way you run the sample

Answer 46

Both T

Question 47

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

Answer 47

3 is incorrect QC materials are Lyophilized - dehydrated to powder - reconstitute to use by adding dh20 and mix

Question 48

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

Answer 48

1,3 - correct 2 - incorrect 2 - bought only at 1 to 5 ml

Question 49

MOTF 1. CC lab has atleast 2 levels of control - normal and abnormal 2. Contained in low actinic glass to prevent degradation from light

Answer 49

BOTH TRUE

Question 50

MOTF 1. Assayed - target values are predetermined 2. Assayed - verify and use 3. Unassayed - made by laboratory itself 4. Unassayed - pooled sera collected in laboratory

Answer 50

1,2 - true 3,4 - false 3 - Unassayed are manufacturer made 4 - In-house - pooled sera collected

Question 51

MOTF 1. Assayed - advisable since value is already made 2. Homemade - pool sera degrades over time

Answer 51

1 false, 2 true - Not advisable; must create your own values - use only as guides

Question 52

T OR F The International Organization of Standardization (ISO) recommend that at least 20 measurements should be made on “separate” days

Answer 52

False - Its the Clinical Laboratory Standard Institute (CLSI)

Question 53

MOTF 1. Accuracy - Describes the closeness of a test value to the actual/target/true value 2. Accuracy can measured in recovery study, interference study, comparison of methods study

Answer 53

Both True

Question 54

MOTF 1. Precision - closeness of the agreement between independent test results obtained under prescribed condition 2. Precision - consistency (degree of replication) of a series of tests results 3. Precision - TRUE VALUE is 100, results are 78, 89, 42, 123, 56

Answer 54

3 is incorrect | - must be near

Question 55

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

Answer 55

1 false, 2 true | 1 - close values, far from true value

Question 56

The capacity of a method to maintain both accuracy and precision over time

Answer 56

Reliability

Question 57

Repeatability or Practicability | - Capacity of the method to produce the same results on one sample again and again when performed by:

Answer 57

Same individual, same lot number, same instrument

Question 58

Reproducibility | - Capacity of the methods to produce the same results on one sample again and again when performed by

Answer 58

Different individuals on, Different days using, Different sets of reagents

Question 59

Ability of an analytical method to measure the smallest concentration of the analyte of interest

Answer 59

SENSITIVITY (ANALYTICAL SENSITIVITY)

Question 60

Ability of an analytical method to measure only the analyte of interest

Answer 60

SPECIFICITY (ANALYTICAL SPECIFICITY)

Question 61

T or F | Too high sensitivity is always better

Answer 61

False - can cause false positive and false negative

Question 62

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

Answer 62

All T

Question 63

MOTF 1. DIAGNOSTIC SENSITIVITY - ability of the test to detect the proportion of individuals with that disease who test positively with the test 2. DIAGNOSTIC SPECIFICITY - ability of the test to detect the proportion of individual without the disease who test negatively for the disease

Answer 63

Both T

Question 64

MOTF 1. The predictability of your result is more than just its sensitivity and specificity 2. Accuracy is not necessarily predictive

Answer 64

Both true

Question 65

Central organization sends out challenge specimens for testing

Answer 65

Proficiency testing (PT) aka external quality assurance (EQA)

Question 66

PT - Clin chem

Answer 66

Lung center of the Philippines

Question 67

PT - Hematology and Clin microscopy

Answer 67

National Kidney and Transplant Institute

Question 68

PT - HIV HEPA B AND SYPHILIS

Answer 68

San Lazaro Hospital

Question 69

PT - Microbio and Blood banking and Malaria

Answer 69

Research Institute For Tropical Medicine

Question 70

PT - Drug testing

Answer 70

East Avenue Medical Center

Question 71

Used for 1. early warning-system for problems 2. measure of laboratory quality valuable benchmarking tool 3. indicator of where to direct improvement efforts 4. monitor of changes in technology and testing practices

Answer 71

EQA or PT