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Clinical Chemistry (CC 1) > (M) Lec 1: Quality Management in Clinical Chemistry > Flashcards

(M) Lec 1: Quality Management in Clinical Chemistry Flashcards

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1
Q

Refers to over all program or system that ensures that the final results
generated by the laboratory has achieved and maintained a specified quality

A

Quality assurance

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2
Q

3 phases of quality assurance

A

Pre-analytical, Analytical, Post-analytical

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3
Q

These refer to which phase of QA:

 Requisition of laboratory test
 Patient preparation
 Specimen collection
 Specimen handling, processing, storage

A

Pre-ana

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4
Q

These refer to which phase of QA:
 Specimen analysis
 Quality of reagent
 Efficiency of instrument
 Analytical skill proficiency of MedTech

A

Analytical

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5
Q

These refer to which phase of QA:

 Interpolation of results
 Reporting of Results
 Recording of Results

A

Post-ana

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6
Q

Process of monitoring the characteristics of the analytical processes and detect analytical errors during testing

A

Quality control

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7
Q

What does QC aims to ensure?

A

Precision and accuracy

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8
Q

The objective of this is to:
 Check quality of reagents
 Monitor stability of machine
 Monitor personnel errors/technical errors

A

QC

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9
Q

T or F:

Quality control is defined as the overall program that ensures that final results reported by the laboratory are correct

A

False (QA)

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10
Q

T or F:

Quality control refers to the measures that must be included during each test run to verify that the test is working properly

A

True

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11
Q

This aims to ensure that the results generated by the tests are correct

A

Quality control

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12
Q

What is the overall program that ensures that final results reported by the laboratory are correct?

A

QA

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13
Q

What are the types of QC?

A
  1. Internal/ Intralaboratory Quality Control
  2. External/ Interlaboratory Quality Control
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14
Q

Refers to:

 Precision of laboratory tests
 Applied to all work processes and to every test done in the laboratory
 Based on the results of control specimens and patient `specimens

A

Internal/Intralaboratory QC

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15
Q

These refer to:

 Pattern recognition
 Delta Check
 Randomized duplicate specimens
 Average of normals

A

 Internal/Intralaboratory QC

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16
Q

Refers to:

 Accuracy of laboratory tests
 Proficiency testing programs

A

External/Interlaboratory QC

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17
Q

Ability to recognize pattern

A

Pattern recognition

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18
Q

Compares past and present result

A

Delta check

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19
Q

One patient sample is divided into two; requires that the result of the two specimen must be the same to ensure precision

A

Randomized duplicate specimens

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20
Q

In external QC, where is the sample coming from?

A

Reference lab

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21
Q

Ref lab for CC

A

Lung Center of the Philippines

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22
Q

T or F:

Difference of >1 in external QC means not agreement with other lab

A

False (diff of >2)

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23
Q

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

A

Analytical sensitivity

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24
Q

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

A

Analytical specificity

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25
Q

T or F:

Analytical sensitivity and analytical specificity are the same as diagnostic specificity and sensitivity

A

False

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26
Q

Nearness or closeness of the assayed value to the true or target value

A

Accuracy

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27
Q

Ability of an analytical method to give repeated results on the same sample

A

Precision

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28
Q

Reflects reproducibility

A

Precision

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29
Q

T or F:

In theory: It is impossible to have a method that is accurate but imprecise, but the overall average of repeat values is near the true value

A

False (possible)

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30
Q

T or F: In Practice: If a method is
imprecise, it is usually also
inaccurate

A

True

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31
Q

Degree by which a method is easily repeated

A

Practicabiltiy

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32
Q

Ability to maintain accuracy and precision over an extended period of time

A

Reliability

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33
Q

Ability to detect the proportion of individuals with a disease who test positively with the test

A

Diagnostic Sensitivity

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34
Q

Ability to detect the proportion of individuals without the disease who test negatively with the test

A

Diagnostic Specificity

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35
Q

Difference between the measured value and the mean expressed as a number of SD

A

SD Index

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36
Q

What are the three SD Index?

A

SDI of O- accurate/100% agreement
SDI of 3- inaccuracy
SDI of 2- investigate action

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37
Q

SDI that refers to accurate/100% agreement

A

SDI of O

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38
Q

SDI that refers to inaccuracy

A

SDI of 3

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39
Q

SDI that refers to investigate action

A

SDI of 2

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40
Q

These refer to:

 Resembles human sample
 Inexpensive and stable for long periods
 No communicable disease
 No matrix effects/known matrix effects
 With known analyte concentrations
 Convenient packaging for easy dispensing and storage
 Preferrable lyophilized

A

Characteristics of a QC material

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41
Q

Lyophilized control solution must be stored in which temperature?

A

Room temp

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42
Q

T or F:

Control solution is a sample of known quantity of all analytes

A

False (several analytes only)

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43
Q

What is run alongside patient samples?

A

Control solution

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44
Q

2 levels control solution

Level I

A

Normal

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45
Q

2 levels control solution

Level II

A

Abnormal

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46
Q

3 levels control solution

Level I

A

Low normal

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47
Q

3 levels control solution

Level II

A

High normal

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48
Q

3 levels control solution

Level III

A

Very abnormal

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49
Q

T or F:

Control solution can be commercially and noncommercially prepared

A

True

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50
Q

Familiarize the sources of control slution

A

 Fasting donor
 Blood bank plasma
 Left-over sera
 Abbatoir blood

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51
Q

Refers to:

 Contains a known amount of
analyte
 A specific analyte is present
 Used for calibrating an assay
method

A

Standard solution

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52
Q

Ussed to read out any absorbance caused by reagent or serum

A

Blank solution

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53
Q

Types of blank solution

A

Test or Serum blank
Reagent blank
Water blank

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54
Q

Variations/types of errors

A

Random Error
Systematic Error
Clerical Error

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55
Q

Also called as interdeterminate error

A

Random error

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56
Q

› Measures “imprecision”
› Errors that occurs without any real pattern
› Causes: due to instrument, operator, and environmental conditions

A

Random error

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57
Q

The following causes which type of error?

 Pipetting errors
 Mislabeling of samples
 Temperature fluctuation
 Improper mixing of sample and reagent
 Dirty optics
 Voltage fluctuations

A

Random error

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58
Q

Also called determinate error

A

Systematic error

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59
Q

› Measures “ Inaccuracy”
› Error that is continuous and affects all results equally
› Measure of agreement between the measured quantity and
true value

A

Systematic error

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60
Q

The following causes which type of error?

 Calibration problems
 Deterioration of reagents and control materials
 Unstable and inadequate reagent blanks
 Contaminated solutions
 Failing instrumentation
 Poorly written procedures

A

Systematic error

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61
Q

Two variations/types of systematic error

A

Constant error
Proportional error

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62
Q

Systematic error that is not dependent on the amount of analyte present

A

Constant error

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63
Q

Systematic error that is dependent on analyte concentration

A

Proportional error

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64
Q

Type of error that includes handwritten labels and request forms

A

Clerical error

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65
Q

T or :

Clerical errors occur in pre-analytical, analytical, and post-analytical phase

A

True

66
Q

Refers to:

› Measure of central tendency
› Average of all the data points or values

A

Mean

67
Q

Middle data point observed once data are arrange in descending or ascending order

A

Median

68
Q

Value that occurs with the greatest frequency

A

Mode

69
Q

Difference between the highest and lowest values in a set of data

A

Range

70
Q

Measure of variability

A

Variance

71
Q

Measure of the average squared distance of data points from the mean

A

Variance

72
Q

Measure of precision

A

Standard dev

73
Q

Measure of the dispersion of values from the mean

A

Standard dev

74
Q

Percentile expression of the mean

A

Coefficient of Variation

75
Q

Total Percent Error

A

Coefficient of Variation

76
Q

Index of precision

A

Coefficient of Variation

77
Q

Limits between which we expect a specified proportion of
population to lie

A

Confidence intervals or limits

78
Q

Familiarize the usual confidence limits

A

68.2%= +/- 1SD
95.5 %= +/- 2SD
99.7%= +/- 3SD

79
Q

T or F:

To be precise, the mean should be near the individual results

A

False (accurate)

80
Q

T or F:

To be precise, the individual results should be near each other

A

True

81
Q

What are the measures of precision?

A

SD, CV and variance

82
Q

Relationship between SD and precision

A

Inversely proportional (the higher the SD, the less precise it is)

83
Q

Relationship between variance and precision

A

Inversely proportional (the higher the variance, the less precise it is)

84
Q

Relationship between COV and precision

A

Inversely proportional (the higher the COV, the less precise it is)

85
Q

What are the quality control charts?

A

Gaussian Curve
Cumulative Sum Graph
Youden/Twin Plot
Shewhart Levey-Jennings Char

86
Q

Refers to Normal Frequency Curve, Normal Distribution Curve

A

Gaussian Curve

87
Q

The curve that results from the data that have a
normal distribution forming a bell-shape

A

Gaussian Curve

88
Q

Other name for Gaussian Curve

A

Bell-shaped Curve

89
Q

Population of subject of Gaussian Curve

A

At least 100

90
Q

T or F: In the Gaussian Curve, data elements are centered around the mean with most elements close to the mean

A

True

91
Q

Refers to a probability distribution that is symmetric about the mean, showing that data near the mean are more frequent in occurrence than data far from the mean, and is also known as the Gaussian distribution

A

Normal Distribution

92
Q

This gives the earliest indication of systematic error

A

Cumulative Sum Graph

93
Q

This calculates the difference between Qc results and the target means and is done by subtracting the mean from the individual values and the cumulative differences are plotted

A

CUMSUM

94
Q

Refers to:

 Twin Chart
 Used to compare results
 Used to compare method using different samples or one sample using two different methods

A

Youden/Twin Plot

95
Q

Refers to:

 Most widely used system in clinical laboratories
 Allows laboratorian to apply multiple rules without the aid
of computer

A

Shewart Levey-Jennings Chart

96
Q

A graphic representation of the acceptable limits of variation in the results of an analytical method

A

Shewhart Levey-Jennings Chart

97
Q

What error is being detected in Shewart Levey-Jennings Chart?

A

Both random and systematic error

98
Q

System that allows good visual representation of precision and
relative accuracy, easy to interpret

A

Shewhart Levey-Jennings Chart

99
Q

Error detected by Youden Chart?

A

Systematic error

100
Q

Error detected by CUMSUM

A

Systematic error

101
Q

A Shewhart Control Chart depend on the use of how many QC specimen?

A

1

102
Q

Familiarize how Shewhart Control Chart is being developed

A

 Put up the 1QC specimen for atleast 20 or more assay runs and record down readings
 Calculate the mean and standard deviations (SD)
 Make a plot with the running day on the x axis and readings on the y axis
 Draw the lines across the y axis for the following:
Mean, +/- 1SD, +/- 2SD, +/- 3SD
 Plot the reading obtained for the 1 QC specimen for `subsequent assay run

103
Q

What are the errors that ca be observed on LJ Chart?

A

Trend, Shift, Oulier

104
Q

Error on LJ Chart that refers to:

 Gradual change in the mean that proceed in one direction
 Control values either increases or decreases for six consecutive days
 Causes: Deterioration of reagents, light source, control materials

A

Trend

105
Q

How many days can control values increase or decrease for it to be considered a trend?

A

Six consecutive days

106
Q

Causes of trend as an error on LJ Chart?

A

Deterioration of reagents, light source, control
materials

107
Q

Error on LJ Chart that refers to:

 An abrupt change in the mean that becomes continuous
 Control values that distribute themselves on one side or either side of the mean for six consecutive days
 Causes: improper calibration of instrument, new lots of standards and reagents

A

Shift

108
Q

How many days can control values distribute themselves on the sides of the mean for it to be considered as a shift error on LJ Chart?

A

Six consecutive days

109
Q

Causes of shift as an error on LJ Chart?

A

improper calibration of instrument, new lots of
standards and reagents

110
Q

Error on LJ Chart that refers to:

 Control values that are far from the main set of values
 Highly deviating values
 Random or Systematic errors

A

Outlier

111
Q

Set of control and patient specimens assayed, evaluated and reported together

A

Analytical Run

112
Q

Current results compared to the previous/past result

A

Delta Check

113
Q

Measured concentration is equal to the actual concentration

A

Linear Range/Dynamic Range

114
Q

Analytical testing performed outside the confines of the central lab usually by non-laboratorian personnel

A

Point of care Testing

115
Q

Used to measure systematic errors or inaccuracy caused by substances other than the analyt

A

Interference Experiments

116
Q

Example of substances that can cause inaccuracy in Interference Experiments

A

Hemoglobin, Lipids, bilirubin, anti-coagulants

117
Q

This experiment shows wether a method measures all the analytes or only part of it

A

Recovery Experiment

118
Q

This refers to the usual values for a healthy population that represents 95% central tendency

A

Reference Limit, Reference Interval, Reference Value

119
Q

Its purpose is to determine how much of analyte can be detected in presence of all other compounds in the matrix

A

Recovery studies

120
Q

T or F: Recovery studies determine if the method is able to accurately measure an analyte

A

True

121
Q

T or F: In Reference Value, specific measurement are performed on a large number of healthy individuals (age and sex)

A

True

122
Q

How many patients do you need each age and sex category to establish a Reference Value/Reference Interval?

A

100/120

123
Q

Familiarize the factors that affect establishing Reference Values

A

 Analytical method used
 Specimen collection procedure
 Composition of reference population
 Criteria of exclusion and inclusion
 Physiologic and environmental factpr

124
Q

Refers to:

A new method is evaluated by comparing it with a reference method

A

Comparison of Methods

125
Q

T or F:

Westgard recommends that at least 30 samples and preferrably 120 samples should be run by both method

A

False (40 - 100)

126
Q

What are the measures of accuracy?

A

 Recovery experiment
 Interference studies
 Patient sample
comparison

127
Q

Enumerate the measures of precision.

A

 CV
 SD
 Variance

128
Q

Multiple quality control

A

Westgard’s Multirule System

129
Q

In Westgard’s Multirule System, this is to indicate if the analytical process is “in
control” or “out of control”

A

Control rule

130
Q

What are the control rules in Westgard’s Multirule System?

A

1-2s
1-3s
2-2s
4-1s
R-4s
10x

subscript yang after ng hyphen idk asan subscript dito

131
Q

Westgard Control Rules

One control result exceeds the mean by
more than +/- 2SD
Warning or rejection rule
Detects random error

A

1-2s

132
Q

Westgard Control Rules

One control result exceeds the mean by
more than +/- 3SD
Detects random error

A

1-3s

133
Q

Westgard Control Rules

Two consecutive control results exceed the
mean by 2 more than 2SD
Response most often to systematic errors
Must lie in the same direction from the mea

A

2-2s

134
Q

Westgard Control Rules

Four consecutive control results exceeds the
mean by more than 1SD
Must lie in the same direction from the mean
Responsive to systematic error

A

4-1s

135
Q

Westgard Control Rules

Difference between two consecutive controls is greater than 4SD
Assay values in opposite direction from each other
Responsive to random errors or increased imprecision

A

R-4s

136
Q

Westgard Control Rules

Ten consecutive results are on the same side of `the target mean
Systematic error

A

10-x

137
Q

T or F:

If QC is out of control, you can still fix it by testing and testing again

A

False (stop testing)

138
Q

T or F:

Each part of the gaussian curve is the percentage per SD

A

True

139
Q

In Gaussian curve/bell curve, what could it mean if it lies between 2-3 SD?

A

Potential error

140
Q

In Gaussian curve/bell curve, what could it mean if it lies more than 3 SD from the mean?

A

Needs corrective action

141
Q

T or F: If the curve becomes wider or skewed, it’s still in normal distribution

A

False (there is an error)

142
Q

Disadvantage of Shewart Levey Jennings Chart

A

Time consuming

143
Q

Other name for Shewart Levey

A

Dot/shoe chart

144
Q

How many directions does the trend proceed to?

A

One

145
Q

Trend and shift are example of (random/systematic) errors

A

Systematic

146
Q

T or F: A change in the control value for 10 days can be considered either a trend or shift depending whether it’s abrupt or gradual and its direction

A

False (does not follow 10 x rule)

147
Q

T or F: A change in the control value for 5 days can be considered either a trend or shift depending whether it’s abrupt or gradual and its direction

A

False (does not follow the 6 day rule)

148
Q

In what manner should Confidence limits should be reported?

A

By range

149
Q

Which systematic error does CUSUM specifically detect?

A

Trend

150
Q

Most common method of CUSUM

A

VMAS

151
Q

Which systematic error does Twin Plot specifically detect?

A

None (not specific)

152
Q

Most important statistical parameters under LJ Chart

A

Mean, SD, and CL

153
Q

In LJ Chart, running day is plotted on (X/Y axis)

A

X axis

154
Q

In LJ Chart, reading is plotted on (X/Y axis)

A

Y axis

155
Q

In LJ Chart, what are calculated?

A

Mean and SD

156
Q

In LJ Chart, what are drawn across the y axis?

A

Mean, +/- 1SD, +/- 2SD, +/- 3SD

157
Q

LJ Chart is mostly done with what curve on the side?

A

Gaussian curve (to check if may bell shape pa rin)

158
Q

T or F: You cannot use different kinds of lines to differentiate mean from 1SD, 2SD, etc

A

False (up to you)

159
Q

T or F: Shift passes the mean in LJ chart

A

False (papuntang gilid lang)

160
Q

T or F: Trend goes on sides of the mean in LJ chart

A

False (Shift ‘yun)

161
Q

A value must pass how many SD from the mean for it to be considered as outlier usually?

A

+/- 3SD

Clinical Chemistry (CC 1) (22 decks)

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