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CLINICAL CHEMISTRY 1 - LECTURE > MIDTERMS: L1 - QC AND QA > Flashcards

MIDTERMS: L1 - QC AND QA Flashcards

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1
Q

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

A

BOTH T

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2
Q

T or F

Quality’s benefits exceed its cost

A

True

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3
Q

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
A

BOTH T

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4
Q

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

A

Quality Cost

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5
Q

Cost conforming to the quality of the patients/clients

A

Cost of Conformance

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6
Q

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

A

Only 3 is incorrect

PC and AC - are part of cost of conformance

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7
Q

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

A

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

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8
Q

MOTF

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

BOTH T

Note: External failure cost - more catastrophic

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9
Q

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.
A

BOTH TRYE

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10
Q

MOTF

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

1 false, 2 true

  • Must be quality over quantity
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11
Q

Highest in the hierarchy - it encompasses all concepts of quality

A

Total Quality Management (TQM)

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12
Q

Process improvement as a means to meet a set of standard

A

Total Quality Management (TQM)

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13
Q

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

A

Total Quality Management (TQM)

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14
Q

5QS in Total Quality Management (TQM)

A
  1. Quality Laboratory Process
  2. Quality control
  3. Quality assessment
  4. Quality Improvement
  5. Quality planning
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15
Q

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

A

Quality Laboratory Process

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16
Q

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

A

Standard Operating Procedures

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17
Q

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

A

1 true, 2 false

QC - uses both statistical and nonstatistical control procedures

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18
Q

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)
A

1 false, 2 true

Delta check - non-statistical

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19
Q

T or F

Quality control is used only in the analytical phase

A

True

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20
Q
  1. Broader measures and monitors of lab performance

2. Encompasses preanalytical to postanalytical

A

Quality Assessment

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21
Q
  1. Determine and address root cause of problem

2. Structured problem-solving process

A

Quality Improvement

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22
Q

Standardize the remedy and establish performance monitoring

A

Quality planning

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23
Q

Identify what part of TQM:

Standard operating procedure

A

Quality Laboratory process

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24
Q

Identify what part of TQM:

Checking temp of refrigerator if well maintained

A

Quality control

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25
Q

Identify what part of TQM:

Failure mode and effects analysis

A

Quality Improvement

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26
Q

Identify what part of TQM:

Problem tree analysis and Ishikawa or fishbone diagram

A

Quality Improvement

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27
Q

T or F

1. TQM is similar to PDCA (Plan Do Check Act)

A

True

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28
Q

Quality from the perspective of end-user

A

Quality Assurance

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29
Q

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

A

Quality Assurance

30
Q

Why is QA of testing important?

A
  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
31
Q

Benefits of Laboratory QA:

A
  1. Provides evidence of good performance
  2. Laboratory mistakes are prevented
  3. Significant improvements in testing performance can be achieved
32
Q

Quality Assurance Model (Identify the 3)

A
  • Staffing/personnel component
  • Quality control (QC)
  • Proficiency testing (PT) aka external quality assurance
    (EQA)
33
Q

T or F

The laboratory has a bigger role in clinical diagnosis

A

True

34
Q

MOTF

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

1 false, 2 true

1 - preanalysis

35
Q

MOTF

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

1 true, 2 false

2 - analysis

36
Q

MOTF

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

Both true

37
Q
  • 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)
A

Quality control

38
Q

Why do quality control?

A

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

39
Q

2 types of bias and define each

A

Positive bias - result is higher than normal

Negative bias - result is lower than normal

40
Q

Imprecision can be computed by getting the _________

A

Standard deviation and by doing the Levey Jennings Chart

41
Q

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

A 
Quality control
(NOTE: QC should never be done last)
42
Q

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

A

1 false, 2 true

1 - Calibration

43
Q 
MOTF
Calibration 
1. Uses calibrators
2. Setting the analyzer
3. Example of calibration - use of standard in spectrophotometry
A

All are true

44
Q 
MOTF
Quality control
1. "Checking"
2. Done after calibration
3. Use of absorbance curve
A

3 is incorrect

AC - used in calibration

45
Q

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
A

1,3 - correct
2 - incorrect

2 - can be done automatically via microprocessors controlling the instrument and manually

46
Q

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
A

Both T

47
Q

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

A

3 is incorrect

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

48
Q

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

A

1,3 - correct
2 - incorrect

2 - bought only at 1 to 5 ml

49
Q

MOTF

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

BOTH TRUE

50
Q

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
A

1,2 - true
3,4 - false

3 - Unassayed are manufacturer made
4 - In-house - pooled sera collected

51
Q

MOTF

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

1 false, 2 true

  • Not advisable; must create your own values
  • use only as guides
52
Q

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

A

False

  • Its the Clinical Laboratory Standard Institute (CLSI)
53
Q

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
A

Both True

54
Q

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
A

3 is incorrect

- must be near

55
Q

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

A

1 false, 2 true

1 - close values, far from true value

56
Q

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

A

Reliability

57
Q

Repeatability or Practicability

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

A

Same individual, same lot number, same instrument

58
Q

Reproducibility

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

A

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

59
Q

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

A

SENSITIVITY (ANALYTICAL SENSITIVITY)

60
Q

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

A

SPECIFICITY (ANALYTICAL SPECIFICITY)

61
Q

T or F

Too high sensitivity is always better

A

False - can cause false positive and false negative

62
Q

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

A

All T

63
Q

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
A

Both T

64
Q

MOTF

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

Both true

65
Q

Central organization sends out challenge specimens for testing

A

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

66
Q

PT - Clin chem

A

Lung center of the Philippines

67
Q

PT - Hematology and Clin microscopy

A

National Kidney and Transplant Institute

68
Q

PT - HIV HEPA B AND SYPHILIS

A

San Lazaro Hospital

69
Q

PT - Microbio and Blood banking and Malaria

A

Research Institute For Tropical Medicine

70
Q

PT - Drug testing

A

East Avenue Medical Center

71
Q

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
A

EQA or PT

CLINICAL CHEMISTRY 1 - LECTURE (4 decks)

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