Quality Management Flashcards

1
Q

The higher the SD result means

A

lower precision

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

a. lower precision
b. higher precision

A

A B

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3
Q

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

A

Coefficient Variation

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4
Q

Formula of CV

A

CV= SDx100/Mean

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5
Q

Limits between which we expect a specified

proportion of population to lie

A

Confidence limits

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6
Q

standard reference limit for normal distribution

A

95%

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7
Q

Normal Frequency Curve, Normal Distribution

Curve

A

Gaussian Curve

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8
Q

Also known as Bell-shaped curve

A

Gaussian Curve

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9
Q

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

A

Y-axis

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10
Q

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

A

X-axis

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11
Q

CUSUM data elements are centered around the mean

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

A

False

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12
Q

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

A

wider & shorter

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13
Q

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

A

Twin plot

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14
Q

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.

A

False

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15
Q

Calculates the difference between QC results

and the target means

A

Cumulative sum graph

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16
Q

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.

A

Shewart Levey-Jennings chart

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17
Q

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.

A

True

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18
Q

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

A

Cumulative sum graph

19
Q

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

A

Shewart Levey-Jennings chart

20
Q

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.

A

2 & 3

21
Q

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

A

Analytical method

22
Q

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.

A

Trend

23
Q

Causes of trend are improper calibration of

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

A

False

24
Q

Causes of shift are deterioration of reagents, light

source, control materials. TRUE OR FALSE.

A

False

25
Q

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.

A

Shift

26
Q

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

A

Westgard Control Rule

27
Q

Control rule to indicate if the analytical process

is “in control” or “out of control”

A

Westgard Control Rule

28
Q

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

A

True, 12s &13s

29
Q

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

A

True, 22s

30
Q

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?

A

False, 41s

31
Q

Difference between two consecutive

controls is greater than 4SD are responsive to random errors. TRUE OR FALSE. What error is that?

A

True, R4s

32
Q

Ten consecutive results are on the same

side of the target mean.

A

10x

33
Q

Set of control and patient specimens assayed,

evaluated and reported together

A

Analytical Run

34
Q

Current results compared to the previous/past

results

A

Delta Check

35
Q

Measured concentration is equal to the actual

concentration

A

Linear Range

36
Q

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

A

Point of care testing

37
Q

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

A

Interference testing

38
Q
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
A

F

39
Q

Studying those specific compounds affect the

accuracy of the laboratory test

A

Interference studying

40
Q

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

A

True

41
Q

Show whether a method measures all the

analytes or only part of it

A

Recovery Experiment

42
Q

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

A

Reference limit

43
Q

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

A

Recovery studies

44
Q

50th percentile

A

Median