Quality Management

Question 1

The higher the SD result means

Answer 1

lower precision

Question 2

1. SD result of >2 indicates
2. SD result should be <2

a. lower precision
b. higher precision

Answer 2

A B

Question 3

Percentile expression of the mean. Aka Total Percent Error. Index of precision.

Answer 3

Coefficient Variation

Question 4

Formula of CV

Answer 4

CV= SDx100/Mean

Question 5

Limits between which we expect a specified

proportion of population to lie

Answer 5

Confidence limits

Question 6

standard reference limit for normal distribution

Answer 6

95%

Question 7

Normal Frequency Curve, Normal Distribution

Curve

Answer 7

Gaussian Curve

Question 8

Also known as Bell-shaped curve

Answer 8

Gaussian Curve

Question 9

this is where you plot the result, where SD are placed

Answer 9

Y-axis

Question 10

this is where you plot the frequency, where DAYS are placed

Answer 10

X-axis

Question 11

CUSUM data elements are centered around the mean

with most elements close to the mean. TRUE OR FALSE.

Answer 11

False

Question 12

If a random error is present the curve in gaussian curve becomes

Answer 12

wider & shorter

Question 13

Used to compare results using different
samples or one sample using two different
methods and for systematic error detection

Answer 13

Twin plot

Question 14

In bell-shaped curve, one specimen will be plotted to the Y axis and the other specimen will be plotted to the X axis. TRUE OR FALSE.

Answer 14

False

Question 15

Calculates the difference between QC results

and the target means

Answer 15

Cumulative sum graph

Question 16

Most widely used system in clinical laboratories. A graphic representation of the acceptable limits
of variation in the results of an analytical method. Detects both random and systematic error.

Answer 16

Shewart Levey-Jennings chart

Question 17

Levey-Jennings Chart: Before plotting this chart, you have first to compute for the 8 statistical parameters
specifically, the SD and the Mean. TRUE OR FALSE.

Answer 17

True

Question 18

Done by subtracting the mean from the
individual values and the cumulative differences
are plotted. Give the earliest indication of systematic error.

Answer 18

Cumulative sum graph

Question 19

The mean should be written in one solid line
whereas the confidence limit should be written
using broken lines when making

Answer 19

Shewart Levey-Jennings chart

Question 20

Control values that lies in _SD and _SD and beyond is a sign of potential problem. You have to run a new
control and repeat specimen testing.

Answer 20

2 & 3

Question 21

is considered in control when
there is symmetrical distribution of control values
about the mean and there are only few control
values outside the 2SD control limit

Answer 21

Analytical method

Question 22

Errors which can be observed on LJ chart: Gradual change in the mean that proceed in one direction. Control values either increases or decreases for six consecutive days.

Answer 22

Trend

Question 23

Causes of trend are improper calibration of

instrument, new lots of standards and reagents. TRUE OR FALSE.

Answer 23

False

Question 24

Causes of shift are deterioration of reagents, light

source, control materials. TRUE OR FALSE.

Answer 24

False

Question 25

An abrupt change in the mean that becomes continuous. Control values that distribute themselves on one side or either side of the mean but do not pass the mean for six consecutive days.

Answer 25

Shift

Question 26

Also known as “Multirule Quality Control” used in the laboratory for internal and external QC.

Answer 26

Westgard Control Rule

Question 27

Control rule to indicate if the analytical process | is “in control” or “out of control”

Answer 27

Westgard Control Rule

Question 28

One control result exceeds the mean by more than +/- 2SD & 3SD should be rejected (random error). TRUE OR FALSE. What error is that?

Answer 28

True, 12s &13s

Question 29

Two consecutive control results/days exceed the mean by 2 more than 2SD is a systematic error. TRUE OR FALSE. What error is that?

Answer 29

True, 22s

Question 30

Four consecutive control results/days exceeds the mean by more than 1 SD should not be rejected (systematic error). TRUE OR FALSE. What error is that?

Answer 30

False, 41s

Question 31

Difference between two consecutive | controls is greater than 4SD are responsive to random errors. TRUE OR FALSE. What error is that?

Answer 31

True, R4s

Question 32

Ten consecutive results are on the same | side of the target mean.

Answer 32

10x

Question 33

Set of control and patient specimens assayed, | evaluated and reported together

Answer 33

Analytical Run

Question 34

Current results compared to the previous/past | results

Answer 34

Delta Check

Question 35

Measured concentration is equal to the actual | concentration

Answer 35

Linear Range

Question 36

Analytical testing performed outside the confines of the central lab usually by non-laboratorian personnel (nurses)

Answer 36

Point of care testing

Question 37

Used to measure systematic errors or inaccuracy caused by substances other than the analyte

Answer 37

Interference testing

Question 38

``` Most common interference that could affect the result a. Hemoglobin b. Lipids, c. bilirubin d. anticoagulants e. a and b f. all of the above g. none ```

Answer 38

F

Question 39

Studying those specific compounds affect the | accuracy of the laboratory test

Answer 39

Interference studying

Question 40

Interference is equal to concentration with interference added divided by the concentration without interference. TRUE OR FALSE

Answer 40

True

Question 41

Show whether a method measures all the | analytes or only part of it

Answer 41

Recovery Experiment

Question 42

Results obtained from a single individual or group. Requires 100 or 120 patients.

Answer 42

Reference limit

Question 43

Method is able to accurately measure an analyte. Patient sample (matrix) and aliquot of concentration analyte (spiked). Determine how much of analyte can bedetected in presence of all other compounds in the matrix

Answer 43

Recovery studies

Question 44

50th percentile

Answer 44

Median