QA and QC Flashcards

(50 cards)

1
Q

What are pre-analytical errors

A

errors that affect specimens before the tests are performed

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2
Q

What analytes are effected by circadian and diurnal variation

A

electrolytes, glucose, urea, creatinine, uric acid, iron, cholesterol, albumin, total protein, AST, ALT and LD

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3
Q

What variables cause modifiable pre-analytical errors

A

circadian variation, menstrual cycle, fasting, alcohol, smoking, dietary supplements and drugs

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4
Q

What analytes are effected by eating before collection

A

glucose, GH, insulin, ionized calcium, triglycerides, total lipids, iron and LD are made higher

chloride, potassium and phosphate are lowered

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5
Q

What tests are effected by the ingestion of alcohol

A

blood glucose, GGT, lactate concentrations

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6
Q

What tests are effected by smoking tobacco

A

ammonia, blood gases, glucose and immunoglobulins

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7
Q

What is increased when collecting below an intravenous line

A

potassium and glucose

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8
Q

What tests are effected in ambulatory patients

A

albumin, calcium, lipoproteins, cholesterol, thyroxine, ALT, AST, amylase, and immunoglobulins A, G and M

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9
Q

What are the effects of prolonged venous occlusion

A

increased total protein, total lipids, iron, cholesterol, AST, and bilirubin

decreased potassium

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10
Q

What are the effects of fist pumping

A

accumulation of potassium, phosphate, lactate causing decreased blood pH and increased ionized calcium

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11
Q

What effects does hemolysis cause

A

increased LDH, potassium, magnesium, phosphate, asparate aminotransferase, total protein and ammonia

positive interference in cholesterol, triglyceride and creatine kinase assaus

negative interference in bilirubin, albumin and carotene assays

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12
Q

What specimens are photosensitive

A

serum bilirubin, carotene, methotrexate and urine bilirubin, urobilinogen and porphyrin

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13
Q

What specimens are temperature sensitive

A

ammonia, lactate and blood gases

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14
Q

What are delta checks

A

they can detect preanalytical errors comparing current value to previous values

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15
Q

Define accuracy

A

an estimate of non-random systematic error between samples of data. The agreement between the mean estimate of a quantity and its true value

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16
Q

Define central tendency

A

the value about which a population is centred. The mean, median and mode are all used to describe the central tendancy

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17
Q

Define coefficient of variance

A

a statistic that measures the distribution of data about the linear regression line

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18
Q

Define error

A

the difference between a single estimate of a quantity and its true value

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19
Q

Define mean

A

the arithmetic average of a data set

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20
Q

Define median

A

a middle value of the population

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21
Q

Define mode

A

the value of a population that occurs in the greatest frequency

22
Q

Define precision

A

a descriptor of random variation in a population of data

23
Q

Define proportional systematic error

A

an error that is always in one direction, the magnitude of which is a percentage of the concentration of the analyte

24
Q

Define random analytical error

A

an error that cannot be predicted

25
Define standard deviation
square root of variance, a measure of imprecision
26
Define systemic analytical error
an error that is always in one direction resulting in a loss of accuracy
27
Define variance
a statistic used to describe the distribution of data in a population
28
What do random error affect
the precision of an assay
29
What do systematic errors affect
the accuracy of an assay
30
What is a constant systemic error
results are consistently increased or decreased by the same amount regardless of concentration
31
What is a proportional systemic error
the analyte is consistently high or low in proportion to the analyte concentration
32
What are desirable properties for QC material
- material available commercially - long term stability - aliquots or vials available in convenient volumes - composed of the same matrix as test - contain a known concentration of analyte -should have concentration with in normal and abnormal reference ranges
33
What is the standard format for a QC graph
levey-jennings chart
34
What is a shift
an abrupt and sustained change in control values in a single direction
35
What is a trend
a gradual change over time to moving in a single direction
36
What is the 12S rule
one control value exceeds the mean +/-2SD a warning rule
37
What causes a break of the 12S rule
random or systematic error
38
What is the 13S rule
one control value exceeds the mean +/-3SD within run
39
What causes a break of the 13S rule
random error
40
What is the 22S rule
two consecutive controls exceed the same limit by atleast 2SD within run, across controls across runs, same controls
41
What causes a break of the 22S rule
systematic error
42
What is the R4S rule
one observation exceeds the mean plus 2SD and another exceeds the mean minus 2SD within run, across controls
43
What causes a break of the R4S rule
random error
44
What is the 41S rule
four consecutive controls exceed the same limit either mean plus 1SD or mean minus 1SD across runs, same control across runs, across controls
45
What causes a break of the 41S rule
systematic error
46
What is the 10X rule
ten consecutive control values fall on one side of the mean across runs, across controls across runs, same control
47
What causes a break of the 10X rule
systematic errror
48
What are calibrators
known concentrations of analytes used to set the relationship between the analyte concentration and detector response
49
When should calibration be performed
at least every six months, following replacement of reagents, following major maintenance, when QC demonstrates a shift or trend or is outside of limits
50
What are appropriate calibration materials
proficiency testing samples with known results, commercial calibrators, control materials with known results, patient specimens with known results