1.1.7 Basic Principles and Techniques (Quality Assurance: Analytical Variation) Flashcards

1
Q

Due to chance and not recur

a. Random error
b. Systematic error

A

a

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2
Q

Predictable pattern that may recur

a. Random error
b. Systematic error

A

b

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3
Q

Random Error Affects?

a. Precision
b. Accuracy

A

a

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4
Q

Systematic error affects

a. precision
b. Accuracy

A

b

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5
Q

Random error Violates what westgard rules?

A

12S
13S
R4S

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6
Q

Systematic error causes shift, trend and violates what Westguard rule?

A

22s
42s
81s
10mean

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7
Q

Instrument instability

a. Random error
b. Systematic error

A

a

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8
Q

Temp and voltage

a. Random error
b. Systematic error

A

a

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9
Q

Deterioration of reagents

a. Random error
b. Systematic error

A

b

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10
Q

Unstable blanks and calibration error

a. Random error
b. Systematic error

A

b

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11
Q

Dirty glassware, sampling error

a. Random error
b. Systematic error

A

a

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12
Q

Improper mixing of sample and reagent

a. Random error
b. Systematic error

A

a

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13
Q

Operator variability

a. Random error
b. Systematic error

A

a

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14
Q

Contaminated control

a. Random error
b. Systematic error

A

b

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15
Q

Changes in standard concentration

a. Random error
b. Systematic error

A

b

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16
Q

Gradual change in the distribution of control values such that they continue to increase or decrease over a period of 6 consecutive days

a. Shift
b. Trend
c. Outliers

A

b

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17
Q

Gradual change in the distribution of control values such that they accumulate on one side of the mean for 6 consecutive days

a. Shift
b. Trend
c. Outliers

18
Q

Highly deviating control values caused by random or systematic errors

a. Shift
b. Trend
c. Outliers

19
Q

The major cause of shift?

a. Instrument instability
b. Standard preparation error
c. Calibration error
d. Deteriorating reagent

20
Q

The major cause of trend?

a. Instrument instability
b. Standard preparation error
c. Calibration error
d. Deteriorating reagent

21
Q

In calculating analyte concentration (Cu = (Au x Cs) / As), If the standard is diluted, the concentration of the unknown is Falsely ________

A

High

Ex:

Standard solution is Serum while the concentration of the unknown is Bacterial antigen, if the Serum is diluted then the antigens is more concentrated which results to falsely High which is an example of UPWARD SHIFT

22
Q

Most commonly used QC chart?

A

Shewhart LEvel-Jennings chart (LJ chart)

23
Q

X in LJ chart indicates?

a. days or runs
b. mean, SD limits

24
Q

Y in LJ chart indicates?

a. days or runs
b. mean, SD limits

25
Q

Which among the following causes Random error?

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

26
Q

Which among the following causes Systematic error?
a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

27
Q

Error detected:

Imprecision; warning rule

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

28
Q

Decision: accept the run and release the result

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

29
Q

Error detected: Imprecision or systematic bias and reject the run

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

30
Q

Error detected: Imprecision that reject the run

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

31
Q

Error detected: Bias TREND
a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

32
Q

Error detected: Bias

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

33
Q

Initiates testing of other error rules

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

34
Q

Ten consecutive control values are on the same side of the mean

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

A

g

Across runs (10 runs) / Across Control (5 runs, 5 controls)

35
Q

Two consecutive values or values for TWO QC sample exceed 2 SDs from the target value in the same Direction

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

A

d

Across runs (2 runs) / Across control (1 runs and 1 control)

36
Q

One control value exceeds 2 SDs from the target value

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

37
Q

One control value exceeds 3SDs from the target value
a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

38
Q

Four consecutive contol values exceed 1 SD from the target value

a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

A

e

Across runs (4 runs) / Across control (2 runs, 2 Control)

39
Q

Eight consecutive values for the same QC sample exceed 1 SD in the same direction
a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

40
Q

Range between two levels of control within a run exceeds 4SDs
a.12s
b.13s
c. R4s
d. 22s (2.55)
e. 41s
f. 81s
g. 10mean

41
Q

NOTE: PLEASE REFER IN TRANS/RECORDING FOR THE GRAPH and EXAMPLE