Quality Control/ Quality Assurance 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 sample in resemble patient sample

A

Quality Control

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3
Q

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

A

Sensitivity

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4
Q

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

A

Specificity

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5
Q

It is the ability of an analytical method to maintain accuracy and precision over an extended period of time during which equipment

A

Realibility

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6
Q

It is an ability of an analytical method to detect the proportion of individual without the disease

A

Diagnostic specificity

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7
Q

It is an ability of an analytical method to detect the proportion of individual with the disease

A

Diagnostic sensitivity

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8
Q

Require high sensitivity so that no case is missed

A

Screening test

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9
Q

Require high specificity to be certain of the diagnosis

A

Confirmatory test

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10
Q

It involves the analyses control samples together with the patient specimen; detects both random and systematic error in a daily basis

A

Internal QC

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11
Q

It is important in maintaining long term accuracy of the analytical method

A

External QC

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12
Q

The gold standard for clinical elab external QC testing

A

College of American Pathologist

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13
Q

To ensure clinicians that patient results are accurate

A

Proficiency testing

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14
Q

Objectives of quality control

A
  • To check the stability of the machine
  • To check the quality of reagents
  • To check technical operator errors
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15
Q

The accuracy of any assay depends on ____

A

Control solutions (QC materials)

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16
Q

General chemistry assay used ___ of control solutions

A

2 levels

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17
Q

Immuno assay used ___ of control solutions

A

3 levels

18
Q

___ are calculated from mean and SD

A

Control limits

19
Q

Ideal control limits is between ___

A

+/- 2 SD

20
Q

Characteristics of an Ideal QC material

A
  • Resembles human sample
    -Inexpensive and stable for long period
  • No communicable disease
  • with known analyte concentration
21
Q

Present in all measurements; type of error that varies from sample to sample; Known as imprecision

A

Random Error

22
Q

Error that influences observation consistently in one direction; known as inaccuracy

A

Systematic error

23
Q

Pre analytical error

A
  • incorrect patient identification
    -improper patient preparation
  • mislabeled spicemen
  • incorrect order of draw
24
Q

Analytical Error (During)

A
  • incorrect sample and reagent volume
  • incorrect incubation of solutions and timing
  • equipment malfunction
25
Q

Post analytical error

A
  • unavailable or delayed lab results
  • long TAT
  • incomplete lab result
26
Q

Is a measured central tendency; average

A

Mean

27
Q

It is a measured of dispersion of values from the mean; most frequently used measure of variation

A

Standard Deviation

28
Q

Percentile expression of the mean; measure of random error

A

Coefficient of variation

29
Q

The standard deviation squared; measures variability; represent the difference between each value and the average of the data

A

Variance

30
Q

Used to determine whether there is a statistically significant difference between the SD of 2 groups of data

A

F test

31
Q

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

A

T test

32
Q

Used to observe values of control materials over time to determine reliability of the analytical method

A

Quality Control Chart

33
Q

Occurs when the data set can be accurate, it describe by the SD and the mean; centered around the mean with most elements close to the mean

A

Gaussian curve( bell shaped curve)

34
Q

Calculate the difference between QC results an the target means; common method : V-mask

A

Cumulative sum graph (CUSUM)

35
Q

It is used to compare results obtained on a high and low control serum from different labs

A

Youden/ twin plot

36
Q

Most widely used QC chart in the clinical lab; easily identifies random and systematic errors

A

Shewart levey Jenning chart

37
Q

Formed by control values that either increase or decrease for six consecutive days

A

Trend

38
Q

Formed by control value that distribute themselves on one side or either side of the mean for six consecutive days

A

Shift

39
Q

These are control values that are far from the main set values; highly deviating values

A

Outliers

40
Q

Can increase without increasing the false rejection rate

A

Westgard control chart

41
Q

Indicate if the analytical process is out of control

A

Control rule