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Chemical Pathology > Basic lessons in quality control > Flashcards

Basic lessons in quality control Flashcards

1
Q

Define ‘abnormal control’

A

A control product which contains a physiologically high or low concentration of a particular analyte

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2
Q

Define ‘analyte’

A

The constituent or characteristic of the sample to be measured (includes any element, ion, compound, substance, factor, infectious agent, cell, organelle, activity, property, presence or absence, concentration, intensity)

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3
Q

Define ‘analytical method’

A

The means by which an analyte is measured

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4
Q

Define ‘analytical process’

A

A series of steps taken in the analysis or testing of patient specimens/samples

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5
Q

Define ‘analytical range’

A

The span over which an analysis provides results of specified characteristics

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6
Q

Define ‘assay’

A

Noun - determination of the amount, activation or potency of a constituent; a quantitative assessment of an analyte
Verb - to analyse a sample of a specimen to determine the amount, activity or potency of a specific analyte or substance

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7
Q

Define ‘between run precision’

A

Precision calculated from data collected from separate runs

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8
Q

Define ‘bias’

A

The difference between the true value and the value obtained

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9
Q

Define ‘clinically relevant decision level’

A

That concentration of analytical which would define a patient as normal or abnormal

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10
Q

Define ‘coefficient of variation’

A

The ratio of the standard deviation to the mean expressed as a percentage

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11
Q

Define ‘coefficient of variation ratio’

A
  1. The ratio obtained by dividing the laboratory monthly coefficient of variation by the peer group monthly coefficient variation
  2. A peer based estimate of precision
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12
Q

Define ‘concentration’

A

A measure of the amount of dissolved substance per unit of volume

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13
Q

Define ‘constituent’

A
  1. A component of a sample
  2. Analyte
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14
Q

Define ‘in control’

A

Indicates that the analysis of patient samples is reliable

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15
Q

Define ‘interlaboratory QC program’

A

A program which accepts laboratory QC data at regular intervals (usually monthly) for statistical analysis and comparison to other laboratories

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16
Q

Define ‘ISO’

A

International Organisation for Standardisation - an international body of experts that sets general standards of performance

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17
Q

Define ‘Levey-Jennings chart’

A

A graphical chart used to plot successive quality control results (day to day or run to run)

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18
Q

Define ‘lyophilised’

A

Freeze-dried

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19
Q

Define ‘matrix’

A

All the components of a control product except the analyte

20
Q

Define ‘matrix effect’

A

The physiochemical effect or interference of the matrix on the analytical method’s ability to accurately measure an analyte

21
Q

Define ‘mean’

A
  1. The sum of values divided by the number of values
    In QC - the best estimate of an analyte’s true value
22
Q

Define ‘method curve’

A

A mathematically derived linear or non-linear curve specific to a particular analytical method used to quantify the measurement of an analyte by comparison to a standard of known concentration

23
Q

Define ‘normal control’

A

A control product which contains a physiologically normal concentration of a particular analyte

24
Q

Define ‘open-vial stability’

A

The amount of time expressed in hours of days a control product or analyte is considered stable and reliable after the control vial is opened or reconstituted

25
Q

Define ‘out of control’

A

Indicates that the analysis of patient samples is unreliable

26
Q

Define ‘precision’

A

The closeness of agreement between independent test results

26
Q

Define ‘peer group’

A

A group that uses the same instrument, analytical method, reagent, unit of measure and lot of control

27
Q

Define ‘ QC log’

A

A written or computerised listing of successive quality control results

28
Q

Define ‘proficiency survey’

A
  1. A program in which multiple blind specimens are periodically sent to members of a group of laboratories for analysis. Each laboratory’s results are then compared with those of other laboratories in the group and reported to the participating laboratory and others.
  2. Proficiency testing
  3. External quality assessment
29
Q

Define ‘quality control products’

A

Liquid or freeze-dried materials of human, animal or chemical origin that are used to monitor the quality and consistency of the analytical process

30
Q

Define ‘quality control’

A

A statistical process that monitors and evaluates the analytical process using data collected from testing of quality control products

31
Q

Define ‘random error’

A

Any random deviation from the laboratory mean

32
Q

Define ‘range’

A

The difference between the largest and smallest observed value of a quantitative characteristic or statistical limit

33
Q

Define ‘reportable range’

A

The functional range of an assay over which concentrations of an analyte can be measured with accuracy and precision

34
Q

Define ‘run’

A

A period to time or series of measurements within which accuracy and precision of the measuring system are expected to be stable

34
Q

Define ‘shift’

A
  1. A sudden and eventually stable change in control values and possibly stable values
  2. A type of systematic error
35
Q

Define ‘shelf life’

A

The amount of time an unopened control product is considered reliable when stored properly

36
Q

Define ‘standard deviation’

A

A statistic which quantifies the dispersion of values within a specified set of values

37
Q

Define ‘SDI’

A

Standard Deviation Index - a peer based estimate of accuracy

38
Q

Define ‘statistical limits’

A

Define range of data calculated from quality control data using the mean and standard deviation used to differentiate an analytical process that is in control from one that is not in control

39
Q

Define ‘statistical process’

A

A series of steps that results in production of one or more statistics

40
Q

Define ‘statistical process control’

A

A set of rules which use statistics to monitor and evaluate a process

41
Q

Define ‘systematic error’

A

A trend or shift away from the laboratory mean

42
Q

Define ‘trend’

A
  1. A gradual, often subtle, increase or decrease in control values and possibly patient values
  2. A type of systematic error
43
Q

Define ‘Westgard rules’

A

A set of 6 statistical rules with multiple applications when used separately or in concert with each other are used to verify the reliability or lack of reliability for patient test results

44
Q

Define ‘within run precision’

A

Precision calculated from data collected from a single run

45
Q
A

Chemical Pathology (2 decks)

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