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CC1 Lab > Quality Management > Flashcards

Quality Management Flashcards

1
Q

Systematic, integrated set of activities to establish and control the work process from preanalytical through postanalytical processes,

A

Quality management system

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2
Q

Preventive measure
Monitors performance starting from ordering to reporting

A

Quality assurance

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3
Q

Analytic phase-

A

Testing

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4
Q

Post analytic phase

A

Release of results

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5
Q

System of ensuring accuracy and precision in the laboratory

A

Quality control

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6
Q

Quality control is concerned only on the

A

Analytical phase

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7
Q

Process of ensuring that analytical results are correct by testing known samples that resemble patient samples→ known as

A

QC sample or control

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8
Q

both accurate and precise

A

Reliable

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9
Q

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

A

Sensitivity

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10
Q

It only measure the analyte of interest

A

Specificity

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11
Q

The nearness or closeness of the value to the true value or the target value

A

Accuracy

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12
Q

true value or the target value

A

Mean

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13
Q
  • The ability of an analytical method to give repeated results to the same sample that agree with one another
  • The values are near each other
A

Precision or reproducibility

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14
Q

The degree to which a method is easily repeated

A

Practicability

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15
Q

Able to maintain both accuracy and precision even over an extended period of time

A

Reliability

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16
Q

Ability of an analytical method to detect the proportion of individual’s WITH the disease

A

Diagnostic sensitivity

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17
Q

Ability of an analytical method to detect the proportion of individual’s WITHOUT the disease

A

Diagnostic specificity

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18
Q

Diagnostic specificity is able to detect

A

True negatives

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19
Q

Kinds of quality control

A

Interlab QC/ External QC
Intralab QC/ Internal QC

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20
Q

Involves proficiency testing (EQAS) programs that periodically provide samples of unknown concentration to participating clinical laboratories

A

Interlab QC/ External QC:

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21
Q

Proficiency testing

A

EQAS

22
Q
  • Analysis of control samples together with the patient specimens (within lab)
  • This type of QC is able to detect both random and systematic errors
A

Intralab QC/ Internal QC

23
Q

Intralab QC/ Internal QC can detect

A

Both random and systematic errors

24
Q

your internal QC is run everyday, minimum number of samples in a month should be

A

20

25
Q

Errors encountered in the collection, preparation and measurement of samples, including transcription and releasing of lab results

A

Variations

26
Q
  • Due to chance
    -Can vary for sample to sample
A

Random error

27
Q
  • detected as positive or negative bias
  • Often related to calibration problem, deteriorate reagent or control
A

Systematic error

28
Q

Human error

A

Clerical error

29
Q

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

A

Quality control chart

30
Q

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

A

Quality control chart

31
Q

This occurs when that data set is accurately described by your standard deviation
and your mean

A

Gaussian curve ( bell curve )

32
Q
  • Calculates the difference between QC results and your target means
  • It can identify consistent bias problems
  • Requires implementation computer
A

Cumulative sum graph

33
Q

Compare results obtained on
a high and low serum from different laboratories

A

Youden twin plot

34
Q
  • Most widely used QC chart in
    the laboratory
    -Can observe a trend or a
    shift or an outlier
A

Shewart Levey Jennings Chart

35
Q

Shewart Levey Jennings Chart errors

A

Trend, shift, outlier

36
Q

Is formed when control values increase or decrease for a minimum of 6 consecutive days

A

Trend

37
Q

Cause of trend

A

Deterioration of reagents

38
Q

This is formed when control values distribute themselves on one side of the mean for a minimum of 6 consecutive days

A

Shift

39
Q

Cause of shift

A

improper calibration of the instrument

40
Q

A control value that is far form the main set of values

A

outlier

41
Q

more accurate SD

A

low SD

42
Q
  • dispersion of values
  • how hey are far away from the mean, how close they are from each other (precision)
A

standard deviation

43
Q

data that cluster about one point

A

central tendency

44
Q

refers to raw data arranged in ascending (or descending) order

A

array

45
Q

refers to the the interval between the largest and smallest value in the data set

A

range

46
Q

tells how many times each value occurs

A

frequency distribution

47
Q

is the measure of the degree of variance from a mean value

A

standard deviation

48
Q

all the data are close to the mean

A

SD is small

49
Q

are values that fall within the preset acceptable limits

A

confidence limits

50
Q

is a substance with exact value and purity associated with it

A

standard

51
Q
  • is a substance with a particular value that has been determined by the manufacturer
  • often used to adjust an instrument to certain values prior to running samples
  • may be a standard or vice versa
A

calibrator

CC1 Lab (8 decks)

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