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CCLEC QM > QM > Flashcards

QM Flashcards

1
Q
  • important to customers
  • can be assessed and monitored
  • can be improved
  • quality’s benefits exceed its cost
A

Quality

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2
Q

3 Phases of the Testing Process

A
  • Pre-analytic
  • Analytic
  • Post-analytic
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3
Q

ISO stands for:

A

International Organization for Standardization

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4
Q

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

A

Quality Assurance

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5
Q

Benefits of Quality Assurance

A
  1. QA provides evidence of good performance
  2. Laboratory mistakes are prevented
  3. Significant improvements in testing performance can be achieved
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6
Q

Why is Quality Assurance important?

A
  • 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
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7
Q

Components of the Quality Assurance Model:

A
  1. Staff
  2. Proficiency Testing
  3. Quality Control
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8
Q

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

A

Quality Control

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9
Q

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

A

Quality Control

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10
Q

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

A

Quality Control

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11
Q

3 events/processes after Quality Control

A

Patient Results > Physician > Treatment

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12
Q

Areas/Tests under Quality Control:

A
  1. Error Detection
  2. Error Prevention
  3. Measure Performance
  4. Monitor Performance: Bias, Imprecision, Total Error
  5. Validate Performance
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13
Q

Application of multi-rule systems

A

Westergard Rules

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14
Q

Plotting data

A

Levey-Jennings Chart

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15
Q

Central tendency, Range, SD, CV

A

Statistical Concepts

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16
Q

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

A

Quality Assurance

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17
Q

Basic Quality Control Process

A
  1. Run a control sample
  2. Compare result with expected range of values
  3. Check to see if the result is right
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18
Q

Operator resulting action after QC Result: Yes

A

system is working → report good patient results

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19
Q

Operator resulting action after QC Result: No

A

system is not working → do not report any bad data

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20
Q

Operator resulting action after QC Result: Troubleshoot

A

Identify the problem & resolve it → Run again control material

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21
Q

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

A
  1. 20
  2. 1
  3. statistical tools
  4. charts
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22
Q

Calibration or Quality Control?

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

A

Calibration

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23
Q

Calibration or Quality Control?

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

A

Quality Control

24
Q

Calibration or Quality Control?

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

A

Calibration

25
Q

Calibration or Quality Control?

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

A

Quality Control

26
Q

Calibration or Quality Control?

Run prior to QC manually by the laboratory analyst or automatically by the microprocessors controlling the instrument

A

Calibration

27
Q

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.

A

Quality Control

28
Q

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

A

Matrix

29
Q

Control material that is dehydrated to powder

A

Lyophilized control material

30
Q

3 Types of Control Material

A
  1. Assayed
  2. Unassayed
  3. In-house/Homemade
31
Q

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

A

Accuracy

32
Q

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

A

Accuracy

33
Q

Accuracy can be measured in 3 ways:

A
  1. Recovery Study
  2. Interference Study
  3. Comparison of Methods of Study
34
Q

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

A

Recovery Study

35
Q

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

A

Interference Study

36
Q

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

A

Comparison of Methods of Study

37
Q

The consistency of a series of test results

A

Precision

38
Q

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

A

Precision

39
Q
  • Degree of replication of data
  • Ability of analytical methods to give repeated
    results on the same sample that agree with one
    another.
A

Precision

40
Q

Capacity of a method to maintain both accuracy and precision

A

Reliability

41
Q

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.

A

Repeatability/Practicability

42
Q

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.

A

Reproducibility

43
Q

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

A

Analytical Sensitivity

44
Q

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

A

Analytical Specificity

45
Q

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

A

Diagnostic Sensitivity

46
Q

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

A

Diagnostic Specificity

47
Q

NRL for Dengue, Influenza, TB, and other Mycobacteria

A

Research Institute for Tropical Medicine

48
Q

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

A

Lung Center of the Philippines

49
Q

NRL for Hematology, Immunohematology, Immunopathology, and Anatomic Pathology

A

National Kidney and Transplant Institute

50
Q

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

A

East Avenue Medical Center

51
Q

NRL for Pathology for Cardiac Disease

A

Philippine Heart Center

52
Q

NRL for HIV/AIDS, Hepatitis, and Syphilis

A

San Lazaro Hospital/STD-AIDS Central Cooperative Laboratory

53
Q

● 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)

A

External Quality Assurance

54
Q

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

A

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

55
Q

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

A

Troubleshoot

CCLEC QM (1 decks)

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