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1. CC 1 > Quality Control > Flashcards

Quality Control Flashcards

1
Q

A part of Quality assurance program (internal quality control).
It evaluates the validity of laboratory results before reporting.
Aims to identify and correct errors to ensure accuracy and precision.

A

QUALITY CONTROL (QC)

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2
Q

refers to closeness of measured value of an analyte to its true value.

A

ACCURACY

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3
Q

Also known as detection limit.
The lowest concentration of substance that can be detected by test method.
High sensitivity decrease false (-)
Desirable for screening test

A

Analytical sensitivity

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3
Q

proportion of population with disease who will be positive for result.
Also known as true POSITIVE RATE.

A

Diagnostic sensitivity

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3
Q

the degree of closeness or agreement among values between repeated measurements.

A

PRECISION/REPRODUCIBILITY

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4
Q

Ability of test method to measure only the target analyte and not the other related substances.
High specificity decreases false (+) and cross reactivity.
Desirable for confirmatory test.

A

Analytical specificity

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5
Q

proportion of population without disease who will be negative for result.
Also known as TRUE NEGATIVE RATE.

A

Diagnostic specificity

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6
Q

a set of values with upper and lower limits based on a healthy individual (120 person).

A

REFERENCE interval (normal values)

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7
Q

Use to compared with patient value for laboratory interpretation.

A

REFERENCE interval (normal values)

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8
Q

Also known as LINEARITY.

A

Reportable range

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9
Q

Range of values over which lab can verify accuracy of the test system.
Provided by the manufacturer and verify by testing 20 normal samples.

A

Reportable range

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10
Q

comparison of patient data with previous result (24-48 hours interval). It determine if the changes is due to medical or lab error.

A

Delta check-

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11
Q

test value that considered as life threatening. Glucose, electrolytes, total bilirubin and blood gases are list typically. Immediate notification to health care personnel should be done.

A

Critical values-

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12
Q

Internal quality control
Part of analytical phase of QA
the testing of control together with the patient sample.
Monitors the accuracy and precision of analytical method on a daily basis and detects any error

A

Intralab QC

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13
Q

External quality control
Testing of proficiency sample with unknown concentration.
Participated by different laboratories.
Maintain long term accuracy of the analytical method.
The gold standard for proficiency testing is the College of American pathologist (CAP).

A

Interlab QC

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14
Q

check the stability of the instrument/machine, quality of reagent, and technical error.

A

Quality control

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15
Q

a solution with precise known concentration used to identify and determine the concentration of the sample. Not serum or plasma based

A

STANDARD

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16
Q

a solution or device with known concentration or activity that is used to calibrate, adjust , or graduate measurement of an instrument to match a known input. Serum or plasma based.

A

CALIBRATOR

17
Q

a patient-like material made from human serum.
Used to run with patient samples.
Used to monitor the performance of an instrument after calibration.
Measure precision/reproducibility

A

Control

18
Q

used to evaluate overall precision of 2 different methods or instruments and reagents.

A

COEFFICIENT VARIATION

19
Q

used in external quality assessment program or a proficiency testing program.

A

Standard deviation index

20
Q

Types of Quality control chart

A

Gaussian normal distribution graph
Cumulative sum graph
Youden/twin plot
Shewhart Levey-Jennings chart

21
Q

Population probability distribution that is symmetric about the mean.
Also known as normal distribution curve.

A

Gaussian curve ( bell shape curve)

22
Q

It identifies the consistent problem and requires computer for implementation.

A

Cumulative sum graph (CUSUM)

22
Q

This plot is indicator of systemic error (trend) and can be used with the 1s rule.
Results are out of control when slopes exceeds 45 degrees.

A

Cumulative sum graph (CUSUM)

23
Q

The most widely used QC chart
Illustrate the overall distribution of QC values for interpretation.
Used to graph successive/ day to day control values. At least 20 measurements

A

Shewhart Levey-Jennings chart

23
Q

Used to compare results obtained on a high and low control serum from different laboratories.
Display the results of the analyses by plotting the mean value for one specimen on the y-axis and the other specimen for x-axis.
Points falling at the center within a 45 degree line- proportional error.
Points falling at center outside of 45 degree- constant error

A

Youden/twin plot

24
Q

a representation of vertically oriented Gaussian curve.

A

Shewhart Levey-Jennings chart

25
Q

approximation of distribution within a normal distribution.

A

Empirical Rule

26
Q

the midpoint or middle value of a distribution. To determine arrange the data in numerical order (ascending order).

A

Median

27
Q

is the frequent observation in a data set.

A

Mode

28
Q

expression of spread or distribution. To determine subtract the highest data to lowest data.

A

Range

29
Q

sudden change in data for several days. 6 or more consecutive values are observed only on one side of the mean. The main cause is improper calibration of instrument.

A

Shift (bias)-

30
Q

6 or more values move continuously in one direction. Hard to notice because it looks like a shift. Main cause is reagent deterioration.

A

Trend

31
Q

Any value outside established limit (+/-3s). It is significant if occurs more than once in 20 successive runs, caused by systematic or random error.

A

Outlier

32
Q

Uses two or more control rules to evaluate the QC data, and then rejects a run if any one of these is present.

A

Multi rule system

33
Q

a single value is outside ±2s limits. Indicate a systematic or random error.

A

12s

34
Q

any value outside ±3s limits. Indicates a random error

A

13s

35
Q

there is at least 4 differences between control values within a single run. Indicates a random error only.

A

R4s

36
Q

2 consecutive values outside the ±2s limits. Indicates systemic error.

A

22s

37
Q

3 consecutive values outside ±1s limits. Systematic error

A

31s

38
Q

4 consecutive values outside ±1s limits. Systematic error

A

41s

39
Q

10 control results on the same side of the mean regardless of SD which they are located. Systematic error.

A

10x

1. CC 1 (6 decks)

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