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CC LEC MIDTERM > LQMS > Flashcards

LQMS Flashcards

1
Q

is a standardized procedure and
practice contributing to the overall quality
of laboratory test results.

A

Laboratory Quality Management System

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2
Q

Involves systematic monitoring of analytic
processes to detect analytic errors and to
prevent reporting of inaccurate test results

A

Quality control

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3
Q

medical laboratory
requires quality in all steps. The test results must be accurate and reliable, and reports must be produced on time without tampering.

A

Quality Management System

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4
Q

quality of a testing
result does not depend on a single step.

A

Laboratory Quality Management System

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5
Q

an international standard that specifies the requirements for quality and competence in medical laboratories.

A

ISO 15189:2022

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6
Q

Quality of process

A

Quality assurance

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7
Q

Quality of product

A

Quality control

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8
Q

requires quality in individual processes, resources, and overall
organizational structure.

A

Laboratory Quality Management System

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9
Q

Laboratory functions that require quality practices

A
  • Environment
  • Quality procedures
  • Record keeping
  • Expert human resource
  • Quality reagents
  • Quality equipment and instruments
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10
Q

more on the process/procedure orientation

A

Quality assurance

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11
Q

More on product orientation

A

Quality control

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12
Q

The practice that encompasses all procedures and activities
directed toward ensuring that a specified quality of product is
achieved and maintained.

A

quality assurance

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13
Q

It is the ability of an analytical
method to measure the smallest concentration
of the analyte of interest.

A

sensitivity

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14
Q

It is the ability of an analytical
method to measure only the analyte of interest.

A

Specificity

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15
Q

Part of the overall goal of quality assurance

A

quality control

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16
Q

It is the nearness or closeness of the assayed value to the true or target
value.

A

Accuracy

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17
Q

It is a process of ensuring that analytical results
are correct by testing known samples that resemble
patient samples.

A

QC

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18
Q

It is one component of the quality assurance
system, and is part of the performance
monitoring that occurs after a test has been
established.

A

QC

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19
Q

three types of accuracy

A

recovery, interference and
patient sample comparison

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20
Q

determines if specific compounds affect the
laboratory tests like hemolysis, turbidity and icteric

A

interference study

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21
Q

determines how much of the analyte can be
identified in the sample

A

Recovery study

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22
Q

study is used to assess presence of error
(inaccuracy) in actual patient sample.

A

Sample comparison

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23
Q

It is the ability of an analytical method to give
repeated results on the same sample that
agree with one another.

A

Precision or reproducibility

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24
Q

It is the ability of an analytical
method to maintain accuracy and precision
over an extended period of time during
which equipment, reagents and personnel
may change.

A

Reliability

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25
Q

It is the degree by which a
method is easily repeated.

A

Practicability

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26
Q

It is the ability of the analytical method to
detect the proportion of individuals with
the disease.

A

Diagnostic sensitivity

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27
Q

It is the ability of the analytical method
to detect the proportion of individuals
without the disease.

A

Diagnostic specificity

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28
Q

Screening tests require high sensitivity so
that no case is missed.

A

Diagnostic sensitivity

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29
Q

Confirmatory tests require high
specificity to be certain of the diagnosis.

A

Diagnostic specificity

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30
Q

It reflects the ability of the method to
detect true-negatives with very few false-
positives.

A

Diagnostic specificity

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31
Q

It indicates the ability of the test to generate
more true-positive results and few false-
negative.

A

Diagnostic sensitivity

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32
Q

Formula of diagnostic sensitivity

A

Diagnostic Sensitivity (%)= true positive divided by true positive + false negative x 100

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33
Q

Formula of diagnostic specificity

A

Diagnostic Specificity (%) = true negative divided by true negative + false positive x 100

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34
Q

meaning of ATM

A

Accuracy
T-test
Mean

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35
Q

measured using t-test by comparison of the mean of the value

A

Accuracy

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36
Q

meaning of SPF

A

Standard deviation
Precision
F-test

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37
Q

measured by f-test by comparison of Standard deviation

A

Precision

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38
Q

The likelihood/probability of the test

A

Predictive value

39
Q

the percentage of people with
positive test results who have the disease

A

Positive Predictive Value

40
Q

the percentage of people with
negative test results who do not have the disease.

A

Negative Predictive Value

41
Q

Formula of PPV

A

PPV = True positive divided by true positive + false positive x 100

42
Q

Formula of NPV

A

NPV = True negative divided by true negative + false negative x 100

43
Q

KINDS OF QUALITY CONTROL

A

Intralab Quality Control (Internal QC)
Interlab Quality Control (External QC)

44
Q

It is important for the daily monitoring of accuracy
and precision of analytical methods. DAY TO DAY control

A

Intralab Quality Control (Internal QC)

45
Q

It is important in maintaining long-term
accuracy of the analytical methods.

A

Interlab Quality Control (External QC)

46
Q

It involves proficiency testing programs
that periodically provide samples of
unknown concentrations to participating
clinical laboratories.

A

Interlab Quality Control (External QC)

47
Q

It involves
the analyses of control samples together with the
patient specimens.

A

Intralab Quality Control (Internal QC)

48
Q

It is also used to determine state-of-the-art
interlaboratory performance.

A

Interlab Quality Control (External QC)

49
Q

A series of unknown samples are sent to the
laboratory from the reference laboratory or
authorized program provider.

A

External QC Testing

50
Q

allows each laboratory to compare and
evaluate test results or outcomes with those laboratories
that use the same methods (reagents and equipment)

A

Proficiency testing

51
Q

random error

A

precision

52
Q

systematic error

A

accuracy

53
Q

considered as a gold standard or confidence limit

A

+- 2 SD or standard deviation

54
Q

Who check the stability of the machine?

A

calibrator

55
Q

Who check the quality of reagents?

A

Quality control reagents

56
Q

What are the 2 levels of controls?

A
  • normal
  • high
57
Q

What are the 3 levels of immunoassays

A
  • normal
  • high
  • low
58
Q

Characteristics of an Ideal QC Material

A
  1. Resembles human sample.
  2. Inexpensive and stable for long periods .
  3. No communicable diseases.
  4. No matrix effects/known matrix effects.
  5. With known analyte concentrations (assayed control).
  6. Convenient packaging for easy dispensing and
    storage
59
Q

What is matrix effect

A

errors caused by manufacturer

60
Q

The test method must be compared always with a
method of acceptable accuracy such as____________

A

Gold standard or reference method

61
Q

Are errors encountered in the collection,
preparation and measurement of samples,
including transcription and releasing of
laboratory results.

A

VARIATIONS

62
Q

It is present in all measurements; it
is due to chance.

A

Random Error

63
Q

example of random error

A
  • due to instrument
  • due to environment
  • due to operator
64
Q

It is an error that influences observations consistently in one
direction (constant difference).

A

systematic error

65
Q

Example of systematic error

A
  • calibration problems
  • deterioration of reagents
    and control materials
  • improperly made standard
    solutions
  • contaminated solutions
  • unstable and
    inadequate reagent blanks
  • leaky ion selective electrode
66
Q

what are the three types of systematic error

A
  • Constant Error
  • Proportional/Slope/Percent Error
  • Clerical Error
67
Q

it refers to a difference between the target value
and the assayed value.

A

constant error

68
Q

problem with standard deviation

A

proportional/slope/percent error

69
Q

problem with mean

A

constant error

70
Q

it results in greater deviation
from the target value due to higher sample concentration.

A

proportional/slope/percent error

71
Q

It is the highest frequency of clerical errors occurs with
the use of handwritten labels and request forms.

A

clerical error

72
Q

It is based on the quantity of error that will negatively affect
clinical decisions.

A

allowable error

73
Q

Indicators of analytic performance

A
  1. internal QC,
  2. proficiency testing,
  3. accreditation,
  4. quality assurance monitoring and
  5. laboratory utilization
74
Q

What type of error is Replication study

A

Random Error

75
Q

What test is used to determine Constant error

A

Interference study

76
Q

Systemic error

A

Comparison of methods

77
Q

Proportional error

A

Recovery study

78
Q

Replication and comparison

A

Total error

79
Q

Pre-analytical Errors:

A
  1. Incorrect patient identification
  2. Improper patient preparation
  3. Incorrect specimen collection
  4. Mislabeled specimen
  5. Incorrect order of draw
  6. Incorrect used of tubes for blood collection
  7. Incorrect anticoagulant to blood ratio (short draw)
  8. Improper mixing of blood and anticoagulant
  9. Incorrect specimen preservation
  10. Mishandled specimen (transport and storage)
  11. Incorrectly interpreted/ordered laboratory test
  12. Incomplete centrifugation
  13. Incorrect data log-in
80
Q

Analytical Errors:

A
  1. Incorrect sample and reagent volume
  2. Incorrect incubation of solution
  3. Equipment/instrument malfunction
  4. Improper calibration of
    equipment/calibration error
81
Q

Post-analytical Errors:

A
  1. Unavailable or delayed laboratory results
  2. Long turnaround time
  3. Incomplete laboratory results
  4. Wrong transcription of the patient’s data and
    laboratory results
  5. Missing laboratory results
  6. Laboratory results submitted to the wrong
    physician/doctors who did not request for the lab
    tes
82
Q

Who developed Six Sigma business management strategy?

A

Motorola, Inc

83
Q

seeks to improve the performance of
a process by identifying and eliminating
causes of defects and errors, resulting in
eliminating variation in the process.

A

LEAN SIX SIGMA METHODOLOGY

84
Q

to eliminate the waste,
such as streamlining a process to reduce wait times
or modifying a process to reduce cost.

A

lean principles work

85
Q

they are being increasingly used to reduce
error and waste within the health care system.

A

lean six sigma

86
Q

reduction of the committed error

A

six sigma

87
Q

examples of six sigma

A
  • error in the billing
  • reducing blood wastage in the blood bank
88
Q

example of lean (more on waste in the time)

A
  • turnaround time
    -wait times
  • ## flow or cycle times
89
Q

What are the 5S in lean principle?

A
  • Set
  • Sort
  • Shine
  • Standardize
  • Sustain
90
Q

What is the 6S in lean principle

A
  • Set
  • Sort
  • Shine
  • Standardize
  • Sustain
  • Safety
91
Q

methodology of six sigma

A
  • Define
  • Measure
  • Analyze
  • Improve
  • Control
92
Q

Applications of Lean Six Sigma

A

-1. A universally accepted framework for QI
-2. Common language throughout the
organization
-3. A checklist to guide the process
-4. Control measures to sustain improvements and
offer long-term monitoring

93
Q

Six Sigma metrics measured using

A

Defects (errors) per million
opportunities (DPMO).

CC LEC MIDTERM (3 decks)

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