Quality Control Flashcards

1
Q

An all inclusive / comprehensive system monitoring the accuracy of test results where all steps before, during and after the testing process are considered

A

Quality Assurance/Assessment (QA)

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2
Q

Provides a structure for achieving lab and hospital quality goals

A

Quality Assurance/Assessment

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3
Q

Processes considered in QA

A

pre-analytic, analytic and post analytic factors

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4
Q

monitor the analytical process; detect and minimize errors during the analysis and prevent reporting of erroneous test results.

A

Quality control

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5
Q

It uses statistical analysis of test system data

A

QC

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6
Q

example of published rules in Quality control

A

Westgard rules

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7
Q

TYPES OF QC: Daily

A

Internal

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8
Q

TYPES OF QC: Proficiency Testing

A

External

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9
Q

Determination of laboratory testing performance by means of intralaboratory comparisons

A

Proficiency testing

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10
Q

Must be integrated within routine workload and analyzed by personnel who are running the tests.

A

Proficiency testing

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11
Q

Used to access employee competency

A

Proficiency testing

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12
Q

Pre-Analytical & Analytical Causes of Error on 1. Samples under Sample Integrity

A

Lipemia
Hemolysis
Interfering Substances
Clotting
Incorrect tube

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13
Q

Post Anaytical Causes of Error

A

Incorrect reference ranges
Physician not notified of a panic or critical value
Incorrect interpretation of lab results by physician
Incorrect data entry of lab result

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14
Q

used to determine the lines of ‘normal’ and ‘acceptable’.

A

Statistic

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15
Q

a branch of mathematics that collects, analyzes, summarizes and presents information about “observations.”

A

Statistics

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16
Q

A statistical analysis of lab test data can help us define (2)

A

reference range for patients
Acceptable ranges for control specimen

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17
Q

the mathematical average of a group of numbers, determined by adding a group of numbers (events) and dividing the result by the number of events

A

Mean (x̄)

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18
Q

determined as the ‘middle’ of a group of numbers that have been arranged in sequential order. That is to say, there are an equal number of numbers on either side of the ‘middle’ number. In an odd # of observations, it is the _____ observation. In an even # of observations, average the ______.

A

Median - middle - two midde values

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19
Q

the number that appears most frequently in a group of numbers. There can be more than mode, or none at all.

A

Mode

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20
Q

Characteristic “bell-shaped” curve

A

Gaussian/Normal Distribution

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21
Q

All values are symmetrically distributed around the mean. This also assumed for all quality control statistic

A

Gaussian/Normal Distribution

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22
Q

refers to the ability to get the same (but not necessarily ‘true’) result time after time.

A

Precision

23
Q

An accurate result is one that is the ‘true’ result.

A

accuracy

24
Q

The degree of fluctuation in the measurements is indicative of the ___ of the assay.

A

precision

25
Q

The closeness of measurements to the true value is indicative of the ______ of the assay

A

accuracy

26
Q

Systematic change in the test system resulting in a displacement of the mean from the original value

A

Systematic error

27
Q

Imprecision of the test system causing a scatter or spread of control values around the mean

A

Random Error

28
Q

the amount by which an analysis varies from the correct result.

A

Bias

29
Q

Is a mathematical expression of the dispersion of a group of data around a mean.

A

Standard deviation

30
Q

expression of dispersion

A

SD

31
Q

+/- 1 SD

A

68.2% OF THE TIME

32
Q

+/- 2 SD

A

95.5% of the time

33
Q

+/- 3 SD

A

99.7% of the time

34
Q

Indicates what percentage of the mean is represented by the standard deviation

A

Coefficient of Variation

35
Q

Reliable means for comparing the precision or SD at different units or concentration levels

A

Coefficient of Variation (CV)

36
Q

Formula for CV%

A

Standard deviation X 100
mean

37
Q

CV should be less than ___?

A

5%

38
Q

Useful in comparing 2 or more analytical methods

A

CV

39
Q

a material or preparation used to monitor the stability of the test system within predetermined limits

A

CONTROL

40
Q

how many levels of control materials are used in establishment of qc system

A

2 to 3

41
Q

Run assay on control sample & manually enter control results on chart

A

Collecting data

42
Q

a graph that plots QC values in terms of how many standard deviations each value is from the mean

A

levey jennings chart

43
Q

Most labs make use of

A

± 2 SD or 95% confidence limit.

44
Q

QC data results are distributed on one side of the mean for 6-7 consecutive days

A

Shifts

45
Q

Consistent increase or decrease of QC data points over a period of 6-7 days

A

Trend

46
Q

means that there is too much dispersion in your result compared with the rest of the results

A

out of control

47
Q

Range of analyte values that a method can directly measure on the specimen without any dilution, concentration or other pretreatment

A

AMR= Analytical Measurement Range

48
Q

Range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration, or other pretreatment used to expand the direct AMR.

A

CRR= Clinical Reportable Range

49
Q

Comparison of individual patient results throughout the day or week with computer detection of changes from earlier individual patient results

A

delta check

50
Q

The normal or expected value for patients

A

reference ranges

51
Q

Are defined as being within +2 Standard Deviations from the mean

A

Reference ranges

52
Q

Each lab must establish its own reference ranges based on _____

A

local population

53
Q

Values that indicate a life-threatening situation for the patient

A

Critical values and read back of results