QMS, QA, QC

Question 1

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

Answer 1

Random error

Question 2

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

Answer 2

Systematic Error

Question 3

What is a trend?

Answer 3

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

Question 4

What is a shift?

Answer 4

It is an abrupt change in control mean.

Question 5

Trend or Shift: Deterioration of instrument light source

Answer 5

Trend

Question 6

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

Answer 6

Trend

Question 7

Trend or Shift: Accumulation of debris on electrode surfaces

Answer 7

Trend

Question 8

Trend or Shift: Aging of reagents

Answer 8

Trend

Question 9

Trend or Shift: Deterioration of control materials

Answer 9

Trend

Question 10

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

Answer 10

Trend

Question 11

Trend or Shift: Deterioration of light filter integrity

Answer 11

Trend

Question 12

Trend or Shift: Calibration deterioration

Answer 12

Trend

Question 13

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

Answer 13

Shift

Question 14

Trend or Shift: Sudden failure or change in light source

Answer 14

Shift

Question 15

Trend or Shift: Change in reagent formulation and reagent lot

Answer 15

Shift

Question 16

Trend or Shift: Major instrument maintenance

Answer 16

Shift

Question 17

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

Answer 17

Shift

Question 18

Trend or Shift: Room temp or humidity change

Answer 18

Shift

Question 19

Trend or Shift: Failure in sampling system

Answer 19

Shift

Question 20

Trend or Shift: Failure in reagent dispense system

Answer 20

Shift

Question 21

Trend or Shift: Inaccurate calibration/recalibration

Answer 21

Shift

Question 22

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

Includes pre-, analytical, and post-analytical.

Answer 22

Quality Assurance

Question 23

Concerned with analytical phase of quality assurance

Internal (Intralab)
External (Interlab)

Answer 23

Quality Control

Question 24

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

Answer 24

Quality Control Chart

Question 25

Most commonly used QC chart

Answer 25

Levey-Jennings Chart

Question 26

Independent variable of Levey-Jennings Plot

Answer 26

X-Axis (Day/Time)

Question 27

Analyte concenrtation of Levey-Jennings

Answer 27

Y-axis

Question 28

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

Answer 28

Westgard Multirule Chart

Question 29

Systematic Errors of Westgard Rules

Answer 29

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

Question 30

Random Errors of Westgard Rules

Answer 30

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

Question 31

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

Answer 31

1 2s

Question 32

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

Answer 32

1 3s

Question 33

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

Answer 33

2 2s Rule

Question 34

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.

Answer 34

R 4s

Question 35

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

Answer 35

4 1s

Question 36

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.

Answer 36

10x

Question 37

Indicator of dispersion

Answer 37

Standard Deviation

Question 38

Relative indicator of precision / Index of Precision

Answer 38

CV

Question 39

Interpret a high CV

Answer 39

Results are highly variable. Poor precision.I

Question 40

Interpret a low CV

Answer 40

Good precision

Question 41

Indicate percentages of the following inside the curve: 1SD, 2SD, 3SD

Answer 41

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

Question 42

Chart "earliest indicator of systematic errors"

Answer 42

CUSUM

Question 43

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

Answer 43

Youden-Twin

Question 44

Diagnostic specificity formula?

Answer 44

TN/TN+FN x 100

Question 45

Diagnostic sensitivity formula?

Answer 45

TP/TP + FN x 100

Question 46

PPV formula?

Answer 46

TP/TP + FP x 100

Question 47

NPV Formula?

Answer 47

TN/TN+FN x 100

Question 48

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

Answer 48

Analytical Sensitivity

Question 49

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

Answer 49

Analytical Specificity

Question 50

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

Answer 50

Reliability

Question 51

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

Answer 51

Repeatability

Question 52

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

Answer 52

Reproducibility

Question 53

This effect is due to improper product manufacturing

Answer 53

Matrix Effect

Question 54

Define a standard

Answer 54

Solutions of known PURE CONCENTRATION