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CLINICAL CHEMISTRY > QUALITY CONTROL > Flashcards

QUALITY CONTROL Flashcards

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1
Q

Is a system of ensuring accuracy & precision in the laboratory by including quality control reagents in every series of measurements

A

Quality Control

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2
Q

is a systematic action necessary to provide adequate confidence that laboratory services will satisfy the given medical needs for patient care

A

Quality Assurance

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3
Q

material of known concentration used in developing a standard curve and/or instrument calibration

A

Standard

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4
Q

sample of known quantity with several analytes present

A

Control

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5
Q

2 Types of Quality Control

A
  1. Interlab QC

2. Intralab QC

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6
Q

2 Levels of control solutions in General Chemistry

A
  1. Pathologic

2. Non-Pathologic

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7
Q

QC done within the Laboratory

A

Intralab Quality Control

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8
Q

Maintaining long term quality control

Involves proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical laboratories

Determine state-of-the-art of the analytical methods

A

Interlab quality control

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9
Q

Internal QC

A

Intralab Quality Control

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10
Q

External QC

A

Interlab quality control

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11
Q

Gold standard for clinical laboratory external QC testing

A

College of American Pathologists (CAP)

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12
Q

Intralab QC Is done every ______

A

Everyday

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13
Q

Immuno Assays QC Level

A
  1. Low QC
  2. Normal QC
  3. HIgh QC
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14
Q

Ability of an analytical method to measure the smallest concentration

A

Sensitivity

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15
Q

Is the Ability of an analytical method to measure ONLY the analyte of Interest

A

Specificty

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16
Q

Is the Nearness or Closeness of the Assayed value to the true or target value

A

Accuracy

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17
Q

The ability of an analytical method to give repeated results on the same sample that agree with one another

A

Precision

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18
Q

The degree by w/c a method is easily repeated.

A

Practicability

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19
Q

The ability of an analytical method to maintain accuracy & precision over an extended period of time during w/c equipment, reagents, & personnel may change

A

Reliability

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20
Q

Other name for precision

A

Reproducibility

21
Q

The Ability of an analytical method to detect the proportion of individuals with the disease. (Screening tests require high sensitivity)

A

Diagnostic Sensitivity

22
Q

The Ability of an analytical method to detect the proportion of individuals without the disease. (Confirmatory tests require high specificity)

A

Diagnostic Specificity

23
Q

highest frequency occurs with the use of handwritten labels and request forms

A

Clerical Error

24
Q

Random Error Vs. Systematic Error

A

Random Error>Varies from sample to sample
>Present in all measurement
>Due to chance

Systematic Error> Error that influences observations consistently in one directions

25
Q

Example of random error

A

> Pipetting error
Mislabeling of samples
Temperature fluctuations
Improper mixing of sample and reagent

26
Q

Example of Systematic error

A 
>Calibration problems
>Deterioration of reagents and control materials
>Improper made of standard solutions
>Contaminated Solutions
>Unstable and inadequate reagent blanks
27
Q

measure of central tendency; measure of accuracy; AVERAGE

A

Mean

28
Q

measure of dispersion of values from the mean; measure of precision; most frequently used measure of variation

A

Standard deviation

29
Q

index of precision; percentile expression of the mean

A

Coefficient variation

30
Q

measure of variability

A

Variance

31
Q

determines whether there is a statistically significant difference between the standard
deviations of two groups of data

A

F-Test

32
Q

determines whether there is a
statistically significant difference between the means of
two groups of data

A

T-Test

33
Q

MIDPOINT of the distribution;
value of the observation that divides the observation into
two equal groups of data

A

Median

34
Q

most FREQUENT observation

A

Mode

35
Q

is the difference between the

highest and lowest score in data

A

Range

36
Q

data element are centered around the mean with most elements close to the mean

A

Gaussian Curve

37
Q

provides the earliest
indication of systematic error (trend); requires computer
implementation

A

Cumulative Sum Graph

38
Q

compare results obtained on

a high and low control serum from different laboratories

A

Youden/Twin Plot

39
Q

most widely used QC chart in the clinical laboratory; allows laboratorians to apply multiple rules without the aid of computer;
identifies both random and systematic error

A

Shewhart Levey-Jennings Chart

40
Q

Trend Vs. Shift

A

TREND>Main cause: deterioration of reagents
>Control values either increase or decrease for six consecutive days

SHIFT> Main caused:Improper calibration
> Control values that distribute themselves on one side or either side of the mean for six consecutive days

41
Q

Westgard Rule Random Error

A

12s
1 3s
R 4s

42
Q

Westgard rule Systematic errors

A

2 2s
4 1s
10x rule

43
Q

1 control value exceeds +/- 2SD; rejection or warning rule

A

1 2s

44
Q

1 control value exceeds +/- 3SD

A

1 3s

45
Q

Range/difference etween the highest and lowest control result within an analytical run is 4SD

A

R 4s

46
Q

2 consecutive control values exceed either +/-2SD

A

2 2s

47
Q

4 consecutive control values exceed +/-1SD

A

4 1s

48
Q

10 consecutive control values fall on 1 side or the other side of the mean

A

10x Rule

49
Q

Interlab qc proficiency testing is done every______

A

6 months

CLINICAL CHEMISTRY (3 decks)

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