Quality Control Flashcards

(33 cards)

1
Q

A gaussian distribution curve is usually

a. Rectangular
b. Bell shaped
c. Uniform
d. Skewed

A

B. Bell Shaped

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2
Q

The correlation coefficient

a. Indicates the strength of relationship in a linear regression.
b. Determines the regression type used to derive the slope and y-intercept.
c. Is always expressed as “b.”
d. Expresses method imprecision.

A

D. Expresses method imprecision.

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3
Q

Systematic error can best be described as consisting of

a. Constant and proportional error.
b. Constant error.
c. Proportional error.
d. Random error.
e. Syntax error.

A

a. Constant and proportional error.

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4
Q

Examples of typical reference interval data distribution
plots include all of the following except
a. ROC
b. Nonparametric
c. Parametric
d. Bimodal

A

a. ROC

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5
Q

A reference range can be verified by
a. Testing as few as 20 normal donor specimens.
b. Literature and vendor material review.
c. Using samples from previously tested hospital
patients.
d. Using pharmacy-provided plasmanate spiked
with target analyte concentrations.

A

a. Testing as few as 20 normal donor specimens.

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6
Q

Diagnostic specificity is the
a. Ability of a test to correctly identify the
absence of a given disease or condition.
b. Chance an individual does not have a given disease or condition if the test is within the reference interval.
c. Chance of an individual having a given disease or condition if the test is abnormal.
d. Ability of a test to detect a given disease or condition.

A

a. Ability of a test to correctly identify the

absence of a given disease or condition.

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7
Q

Interference studies typically use _______.

a. Hemolysed RBCs
b. Intralipids
c. Higly Icteric
d. AOTA

A

d. AOTA

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8
Q

Which Westgard rule detects random error.

a. 13s
b. 41s
c. 22s
d. 10x

A

a. 13s

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9
Q

The primary reason for implementing POCT

a. Reduced Testing cost
b. Enhanced outcomes of patient care
c. Lower central laboratory workload
d. use non-laboratorian analysts

A

b. Enhanced outcomes of patient care

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10
Q

Highest source of error in the Laboratory

a. Mislabeling
b. Patient Misidentification
c. Clerical Error
d. Pipetting

A

c. Clerical Error

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11
Q

Which are causes of Random Error

  1. Temperature of Analyzer
  2. Reagent Dispensing
  3. Instrument Instability
  4. Calibration Differences

a. 1 & 4
b. 2 & 3
c. 1, 2,3 & 4
d. 1, 2 and 3

A

d. 1, 2 and 3

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12
Q

Which are examples of Analytical Error

  1. Verbal reporting of results
  2. Oversight of Instruments
  3. Out of control QC
  4. Wrong assay performed

a. 2, 3, and 4
b. 3 and 4
c. 1, 2, and 3
d. 1 and 2

A

a. 2, 3, and 4

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13
Q

Which of the following quality control (QC) rules
would be broken 1 out of 20 times by chance alone?
A. 12s
B. 22s
C. 13s
D. 14s

A

A. 12s

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14
Q

Which of the following conditions is cause for
rejecting an analytical run?
A. Two consecutive controls greater than 2 s above
or below the mean
B. Three consecutive controls greater than 1 s above
the mean
C. Four controls steadily increasing in value but less
than ±1 s from the mean
D. One control above +1 s and the other below –1 s
from the mean

A

A. Two consecutive controls greater than 2 s above

or below the mean

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15
Q

One of two controls within a run is above +2s
and the other control is below –2s from the mean.
What do these results indicate?
A. Poor precision has led to random error (RE)
B. A systematic error (SE) is present
C. Proportional error is present
D. QC material is contaminated

A

A. Poor precision has led to random error (RE)

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16
Q

The term R4S means that:
A. Four consecutive controls are greater than ±1
standard deviation from the mean
B. Two controls in the same run are greater than
4s units apart
C. Two consecutive controls in the same run are
each greater than ±4s from the mean
D. There is a shift above the mean for four
consecutive controls

A

B. Two controls in the same run are greater than

4s units apart

17
Q
A trend in QC results is most likely caused by:
A. Deterioration of the reagent
B. Miscalibration of the instrument
C. Improper dilution of standards
D. Electronic noise
A

A. Deterioration of the reagent

18
Q

In most circumstances, when two controls within a
run are both greater than ±2s from the mean, what
action should be taken first?
A. Recalibrate, then repeat controls followed by
selected patient samples if quality control is
acceptable
B. Repeat the controls before taking any corrective
action
C. Change the reagent lot, then recalibrate
D. Prepare fresh standards and recalibrate

A

A. Recalibrate, then repeat controls followed by
selected patient samples if quality control is
acceptable

19
Q

When establishing QC limits, which of the
following practices is inappropriate?
A. Using last month’s QC data to determine
current target limits
B. Exclusion of any QC results greater than ±2s
from the mean
C. Using control results from all shifts on which the
assay is performed
D. Using limits determined by reference laboratories
using the same method

A

B. Exclusion of any QC results greater than ±2s

from the mean

20
Q
Which of the following plots is best for detecting
all types of QC errors?
A. Levy–Jennings
B. Tonks–Youden
C. Cusum
D. Linear regression
A

A. Levy–Jennings

21
Q
Which of the following plots is best for
comparison of precision and accuracy among
laboratories?
A. Levy–Jennings
B. Tonks–Youden
C. Cusum
D. Linear regression
A

B. Tonks–Youden

22
Q
Which plot will give the earliest indication of a
shift or trend?
A. Levy–Jennings
B. Tonks–Youden
C. Cusum
D. Histogram
23
Q

All of the following are requirements for a
QC material except:
A. Long-term stability
B. The matrix is similar to the specimens being
tested
C. The concentration of analytes reflects the clinical
range
D. Analyte concentration must be independent of
the method of assay

A

D. Analyte concentration must be independent of

the method of assay

24
Q
What is the minimum requirement for performing
QC for a total protein assay?
A. One level assayed every 8 hours
B. Two levels assayed within 8 hours
C. Two levels assayed within 24 hours
D. Three levels assayed within 24 hours
A

C. Two levels assayed within 24 hours

25
``` Which of the following statistical tests is used to compare the means of two methods? A. Student’s t test B. F distribution C. Correlation coefficient (r) D. Linear regression analysis ```
A. Student’s t test
26
When the magnitude of error increases with increasing sample concentration, it is called: A. Constant error B. Proportional error C. Random error D. Bias
B. Proportional error
27
A new tumor marker for ovarian cancer is evaluated for sensitivity by testing serum samples from patients who have been diagnosed by staging biopsy as having malignant or benign lesions. The following results were obtained: Number of malignant patients who are positive for CA 125 = 21 out of 24 Number of benign patients who are negative for CA 125 = 61 out of 62 What is the sensitivity of the new CA 125 test? A. 98.4% B. 95.3% C. 87.5% D. 85.0%
C. 87.5%
28
What measurement in addition to true negatives and prevalence is required to calculate the predictive value of a negative test result (PV–)? A. False negatives B. Variance C. True positives D. False positives
A. False negatives
29
A laboratory is establishing a reference range for a new analyte and wants the range to be determined by the regional population of adults age 18 and older. The analyte concentration is known to be independent of race and gender. Which is the most appropriate process to follow? A. Determine the mean and standard deviation of the analyte from 40 healthy adults and calculate the ±2s limit B. Measure the analyte in 120 healthy adults and calculate the central 95th percentile C. Measure the analyte in 120 healthy adults and use the lowest and highest as the reference range limits D. Measure the analyte in 60 healthy adults and 60 adults with conditions that affect the analyte concentration; calculate the concentration of least overlap
B. Measure the analyte in 120 healthy adults and | calculate the central 95th percentile
30
When comparing the laboratory’s monthly mean to its peer group to determine if bias is present, what statistic is most appropriate? A. F test B. Linear regression analysis C. Correlation coefficient D. Standard deviation index
D. Standard deviation index
31
Which of the following methods is most useful in order to detect sample misidentification? A. Cumulative summation B. Critical limit C. Delta limit D. Significant change limit
C. Delta limit
32
Which of the following total quality management tools can be used to calculate the analytical error rate for an analyte in the clinical laboratory? A. LEAN B. Six sigma C. ISO 9000 D. Laboratory information system
B. Six sigma
33
In which circumstances is a validation study (versus performing routine quality control) required? A. Instrument recalibration B. Source lamp or ion selective electrode change C. Change in reagent lot D. Change in calibrator lot
C. Change in reagent lot