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Quality Control Flashcards

1
Q

It Is a system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series of measurements.

A

Quality Control

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2
Q

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

A

Quality Control

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3
Q

It involves the process of monitoring the characteristics of the analytical processes” and detects analytical errors during testing, and ultimately prevent the reporting of inaccurate patient test
results.

A

Quality Control

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4
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

Quality Control

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5
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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6
Q

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

A

Specificity

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7
Q

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

A

Accuracy

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8
Q

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

A

Recovery study

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9
Q

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

A

interference study

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10
Q

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

A

Patient sample comparison study

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11
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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12
Q

It is the degree by which a method is easily repeated

A

Practicability

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13
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

Practicability

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14
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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15
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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16
Q

Screening tests require high sensitivity so that no case is missed

A

Diagnostic sensitivity

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17
Q

Formula in Diagnostic sensitivity

A

Sensitivity (%) = 100 x the number of diseased individuals with a positive test /
Total number of diseased individuals tested

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18
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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19
Q

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

A

Diagnostic specificity

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20
Q

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

A

Diagnostic specificity

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21
Q

Formula for Diagnostic specificity

A

Sensitivity (%) = 100 x the number of individuals without a negative test /
Total number of individuals tested without the disease

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22
Q

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

A

lntralab Quality Control (Internal QC)

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23
Q

It detects changes In performance between the present operation and the “stable” operation.

A

lntralab Quality Control (Internal QC)

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24
Q

It is important for the-daily monitoring of accuracy and precision of analytical methods

A

lntralab Quality Control (Internal QC)

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25
Q

It detects both random and systematic errors in a daily basis.

A

lntralab Quality Control (Internal QC)

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26
Q

It allows identification of analytic errors within a one:Week cycle

A

lntralab Quality Control (Internal QC)

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27
Q

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

A

Interlab Quality Control (External QC)

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28
Q

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

A

Interlab Quality Control (External QC)

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29
Q

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

A

Interlab Quality Control (External QC)

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30
Q

In Interlab Quality Control (External QC) the proficiency program is the gold standard for clinical laboratory external QC testing.

A

The College of American Pathologists (CAP)

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31
Q

should resemble human sample and be, available for a minimum of one year (same lot number) - different lot numbers of the same material have different concentrations which requires new estimates of the mean and standard deviation.

A

Quality control materials

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32
Q

are preferred but because of limited sources and biohazard considerations, bovine control materials are used.

A

Human control materials

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33
Q

is not the choice for immunochemistry, dye-binding and certain bilirubin assays.

A

Bovine-based QC material

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34
Q

should be the same matrix as the specimens being tested, for example, measurement

A

QC materials

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35
Q

are results of improper product. manufacturing, use of unpurified human and nonhuman analyte additives and altered protein components.

A

Matrix effects

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36
Q

can be purchased with or without assayed values

A

Control materials

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37
Q

are more expensive but can be used as external-.checks for accuracy

A

Assayed controls

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38
Q

must be properly done- to -avoid incorrect control values.

A

Reconstitution of lyophilized control materials

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39
Q

do_not_require reconstitution but may have different characterizations compared-to actual patient specimens

A

Stabilized frozen controls

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40
Q

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

A

Variation

41
Q

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

A

Random Error

42
Q

It is a type of error which varies from sample to sample.

A

Random Error

43
Q

It is the basis for varying differences between repeated measurements— variations in technique.

A

Random Error

44
Q

It is due to instrument, operator and environmental conditions
pipetting error, mislabeling of samples, temperature fluctuation, and improper Mixing of sample and reagent.

A

Random Error

45
Q

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

A

Systematic Error

46
Q

It is detected as either positive or negative bias - often related to calibration problems, deterioration of reagents and control materials, improperly made standard solutions, contaminated solutions, unstable and inadequate reagent blanks, leaky ion selective electrode (ISE), failing instrumentation and poorly written procedures.

A

Systematic Error

47
Q

It is a measure of the agreement between the-measured quantity and the true value.

A

Systematic Error

48
Q

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

A

Constant Error

49
Q

it is independent of sample concentration.

A

Constant Error

50
Q

it exists when there is a continual difference between the comparative method and the test method regardless of the concentration.

A

Constant Error

51
Q

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

A

Proportional/Slope/Percent Error

52
Q
  • it exists when the difference between the test method and the comparative method values is proportional to the analyte concentration.
A

Proportional/Slope/Percent Error

53
Q

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

A

Clerical Error

54
Q

internal QC, proficiency testing, accreditation, quality assurance monitoring and laboratory utilization

A

indicators of analytic performance

55
Q

The first step in method evaluation? which estimates the random error.

A

precision study

56
Q

refers to all the activities that take place before testing, such as test ordering and sample collection.

A

Preanalysis

57
Q

The most frequent preanalytic errors

A

improperly filling the sample tube, placing specimens in the wrong containers or preservatives, and selecting the incorrect test.

58
Q

> consists of the laboratory activities that actually produce a result, such as running a sample on an automated analyzer.

A

analysis stage

59
Q

comprises patient reporting and result
interpretation.

A

Postanalysis

60
Q

> is the most error-free means of requesting laboratory tests.

A

Online computer input

61
Q

> Most laboratory errors occur in the

A

preanalytic and postanalytic stages.

62
Q

It is determined for each test method and is expressed either in measurement units of the
analyte (mmol/L) or percentages.

A

Allowable error

63
Q

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

A

Allowable error

64
Q

The total error (random, proportional, constant and systematic error) must be less than they or fixed limits for a method to be considered acceptable.

A

Allowable error

65
Q

if the total error is greater than Ea, corrections must be made to reduce the error or the method
be rejected.

A

Allowable error

66
Q

The determination of whether long-term precision is sufficient is based on the total imprecision
being less than one-third of the allowable error.

A

Allowable error

67
Q

it is the science of-gathering, analyzing, interpreting and presenting data.

A

Statistics

68
Q

is a measure of-central tendency. It is associated with symmetrical or normal distribution

A

Mean

69
Q

is a measure of the dispersion of values from the mean. It helps describe the normal curve. A measure of the distribution range. lt is the ‘most frequently used measure of.variation

A

Standard Deviation,(SD)

70
Q

is percentile expression of the ‘mean; an Index of precision

A

Coefficient of Variation (CV)

71
Q

is called the standard deviation squared; a measure of variability. It represents the difference between each value and the average of the data

A

Variance

72
Q

are used to compare the means or standard deviations of two grpups of the data

A

Inferential statistics

73
Q

is used to determine whether there is a statistically significant difference between the standard deviatiopns pf two groups pf data

A

F-test

74
Q
  • is the value of the observation that divides the observations into two groups, each
    containing equal number of observations. It is the midpoint of a distribution; 50th centile
A

Median

75
Q

is the most frequent observation; it is used to describe data with two centers (bimodal).

A

Mode

76
Q

is the simplest expression of spread or distribution; it is the difference between the and lowest score in a data

A

Range

77
Q

is the difference between the value o f a data point and the mean value divided by the group’s SD

A

Standard deviation index (SDI)

78
Q

is used to determine whether there is a statistically significant difference between the means of two groups of data

A

t-test

79
Q

it is used to observe values:of control materials,over time to-determine reliability of the
analytical method.

A

QUALITY CONTROL CHART

80
Q

it is utilized to observe and detect analytical errors such as inaccuracy and impercision

A

QUALITY CONTROL CHART

81
Q

It occurs when the data set can be accurately described by the SD and the mean

A

Gaussian Curve (Bell-Shaped Curve)

82
Q

it is obtained by-plotting the valueS from multiple analyses of a sample.

A

Gaussian Curve (Bell-Shaped Curve)

83
Q

It is a population probability distribution that is symmetric about the Mean.

A

Gaussian Curve (Bell-Shaped Curve)

84
Q

It occurs when data elements are centered around the mean with most element’s close to the
mean.

A

Gaussian Curve (Bell-Shaped Curve)

85
Q

It focuses on the distribution of errors from the analytical method rather than the values from a healthy or patient population.

A

Gaussian Curve (Bell-Shaped Curve)

86
Q
A

Gaussian Curve (Bell-Shaped Curve)

87
Q

In Gaussian Curve (Bell-Shaped Curve) The total area under the curve is

A

1.0 or 100%.

88
Q

It calculates the difference between QC results and the target means.

A

Cumulative Sum Graph (CUSUM)

89
Q

in Cumulative Sum Graph (CUSUM) the Common method:

A

V-mask

90
Q

It identifies consistent bias problems; it requires computer implementation.

A

Cumulative Sum Graph (CUSUM)

91
Q

This plot will give the earliest indication of systematic errors (trend) and can be used with the 13s rule.

A

Cumulative Sum Graph (CUSUM)

92
Q

nIt is very sensitive to small, persistent errors that commonly occur in the modern, low calibration-frequency analyzer.

A

Cumulative Sum Graph (CUSUM)

93
Q

Results are out of control when the slope exceeds 45° or a decision (± 2.7 SD) is exceeded.

A

Cumulative Sum Graph (CUSUM)

94
Q

It is used to compare results obtained on a Kith and low control serum from afferent laboratories.

A

Youden/Twin Plot

95
Q

it allows the laboratorians to apply multiple rules without the aid of a computer.

A

Shewhart Levey-Jennings Chart

96
Q

nIt is the most widely used QC chart in the clinical laboratory.

A

Shewhart Levey-Jennings Chart

97
Q

nIt easily identifies random and systematic errors.

A

Shewhart Levey-Jennings Chart

98
Q

It is a graphic representation of the acceptable limits of variation in the results of an analytical method.

A

Shewhart Levey-Jennings Chart

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