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Clinical Chemistry (SEM1) > QMS, QA, QC > Flashcards

QMS, QA, QC Flashcards

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1
Q

Classify if random error or systematic error:
- error in pipetting
- change in incubation period

A

Random error

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2
Q

Classify if random error or systematic error:
- variation in incubation temperature
- change in reagent batch
- modifications in testing methods

A

Systematic Error

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3
Q

What is a trend?

A

Trend indicates a gradual loss of reliability in the test system.

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4
Q

What is a shift?

A

It is an abrupt change in control mean.

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5
Q

Trend or Shift: Deterioration of instrument light source

A

Trend

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6
Q

Trend or Shift: Accumulation of debris in sample/reagent tubing

A

Trend

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7
Q

Trend or Shift: Accumulation of debris on electrode surfaces

A

Trend

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8
Q

Trend or Shift: Aging of reagents

A

Trend

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9
Q

Trend or Shift: Deterioration of control materials

A

Trend

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10
Q

Trend or Shift: Deterioration of incubation chamber temps (enzymes only)

A

Trend

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11
Q

Trend or Shift: Deterioration of light filter integrity

A

Trend

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12
Q

Trend or Shift: Calibration deterioration

A

Trend

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13
Q

Trend or Shift: QC data represents a sudden and dramatic positive or negative change in test system performed

A

Shift

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14
Q

Trend or Shift: Sudden failure or change in light source

A

Shift

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15
Q

Trend or Shift: Change in reagent formulation and reagent lot

A

Shift

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16
Q

Trend or Shift: Major instrument maintenance

A

Shift

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17
Q

Trend or Shift: Sudden change in incubation temperature (enzyme only)

A

Shift

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18
Q

Trend or Shift: Room temp or humidity change

A

Shift

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19
Q

Trend or Shift: Failure in sampling system

A

Shift

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20
Q

Trend or Shift: Failure in reagent dispense system

A

Shift

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21
Q

Trend or Shift: Inaccurate calibration/recalibration

A

Shift

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22
Q

This encompasses all endeavors, procedures, and activities directed towards ensuring that a specified quality or product is maintained.

Includes pre-, analytical, and post-analytical.

A

Quality Assurance

23
Q

Concerned with analytical phase of quality assurance

Internal (Intralab)
External (Interlab)

A

Quality Control

24
Q

This compares observed control values with the control limits and provide a visual display that is easy to inspect and review.

A

Quality Control Chart

25
Q

Most commonly used QC chart

A

Levey-Jennings Chart

26
Q

Independent variable of Levey-Jennings Plot

A

X-Axis (Day/Time)

27
Q

Analyte concenrtation of Levey-Jennings

A

Y-axis

28
Q

Uses series of control rules to interpret data. This chart detects errors.

A

Westgard Multirule Chart

29
Q

Systematic Errors of Westgard Rules

A

EVEN NUMBERS
- 2 2s
- 4 1s
- 10x

30
Q

Random Errors of Westgard Rules

A

ODD numbers
-1 2s
- 1 3s
- R 4s

31
Q

This westgard rule is a warning rule where one of the two controls falls outside 2SD

A

1 2s

32
Q

Westgard rule: EITHER of the two control falls outside of 3SD. Run must be rejected

A

1 3s

33
Q

Westgard rule: 2 consecutive values for the same level falls outside of 2SD in the same direction or both controls in the same run exceed 2SD

A

2 2s Rule

34
Q

One control exceeds the mean by -2SD, and the other control exceeds the mean by +2SD. The range between two results will therefore exceed 4SD.

A

R 4s

35
Q

Required control data from previous run. Four consecutive QC results for one level of control are outside 1SD or both levels of control have consecutive results outside SD

A

4 1s

36
Q

Requires control data from previous runs. Ten consecutive QC result for one level of control are on one side of the mean or both levels of control have five consecutive results that are on the same side of the mean.

A

10x

37
Q

Indicator of dispersion

A

Standard Deviation

38
Q

Relative indicator of precision / Index of Precision

A

CV

39
Q

Interpret a high CV

A

Results are highly variable. Poor precision.I

40
Q

Interpret a low CV

A

Good precision

41
Q

Indicate percentages of the following inside the curve:

1SD, 2SD, 3SD

A

1SD = 68.3%
2SD = 95.5%
3SD = 99.7%

42
Q

Chart “earliest indicator of systematic errors”

A

CUSUM

43
Q

Chart: increased and decreased serum error.
45 degree angle is dependent systematic error

A

Youden-Twin

44
Q

Diagnostic specificity formula?

A

TN/TN+FN x 100

45
Q

Diagnostic sensitivity formula?

A

TP/TP + FN x 100

46
Q

PPV formula?

A

TP/TP + FP x 100

47
Q

NPV Formula?

A

TN/TN+FN x 100

48
Q

This method of analysis has the ability to detect the SMALLEST AMOUNT OF ANALYTE

A

Analytical Sensitivity

49
Q

This method of analysis has the ability to detect ONLY the analyte of interest

A

Analytical Specificity

50
Q

This is the ability of assay to maintain both accuracy and precision over an extended period of time

A

Reliability

51
Q

Type of reliability: closeness of values to the repeated values after repeating during SAME CONDITIONS

A

Repeatability

52
Q

Type of reliability: closeness of value to the reported value after repeating during CHANGED CONDITIONS

A

Reproducibility

53
Q

This effect is due to improper product manufacturing

A

Matrix Effect

54
Q

Define a standard

A

Solutions of known PURE CONCENTRATION

Clinical Chemistry (SEM1) (14 decks)

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