Tietz Fundamentals of Clinical

Chemistry and Molecular Diagnostics

7th Edition Burtis Test Bank
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Chapter 07: Quality Management
Test Bank

MULTIPLE CHOICE

1. If alerted to a control problem when using Westgard multirules, an analyst should first:
a. assess the analytical method, equipment, reagents, and specimens.
b. rerun controls several times until the values finally are acceptable.
c. call the laboratory manager.
d. call the manufacturer’s repair hotline.
ANS: A
When alerted to a control problem, the analyst first should conduct an inspection of the
analytical method, equipment, reagents, and specimens to ensure that the test is performing
correctly.

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2. Upon examination of the week’s analytical run of plasma glucose tests, you notice that four
consecutive normal control values are +1 s (standard deviation) from the mean. In your QC
report, you note that Westgard multirule _____ has been broken and realize that this rejection
rule is sensitive to _____ error.
a. 14s; random
b. 41s; systematic
c. R4s; systematic
d. 4Rs; random
ANS: B
The multirule 41s indicates that four consecutive control observations have exceeded the mean
plus 1 s or the mean minus 1 s. This multirule is sensitive to systematic error.

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3. Upon examination of the week’s analytical run of plasma glucose tests, you notice that four
consecutive normal control values are +1 s (standard deviation) from the mean. In your QC
report, you note that a Westgard multirule has been broken and realize that this rejection rule
is sensitive to a specific type of error. An example of this type of error would be:
a. poor pipetting technique.
b. incubator temperature change.
c. improper calibrator preparation.
d. unstable photometer.
ANS: C
Systematic errors often related to calibration problems are listed in Box 7-7. Random errors
more likely are due to (1) lack of reproducibility in the pipetting of samples and reagents, (2)
dissolving of reagent tablets and mixing of sample and reagents, and (3) lack of stability of
temperature baths, timing regulation, and photometric and other sensors.

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4. Preparation of a CLSI-defined procedure document of an analytical protocol is a means of
controlling which one of the following types of variables?
a. Analytical
b. Preanalytical
c. Postanalytical
d. Reproducibility
ANS: A
Certain variables specifically affect individual analytical methods, and these require the
development of procedures to deal specifically with the characteristics of the methods. A
procedure document provides step-by-step instructions that a single individual needs to take to
successfully complete one activity in the process. Such a procedure is critical if a method is to
provide the same results when used by different analysts over a long period of time.

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5. Which one of the following would be considered a postanalytical variable in regard to

laboratory services?
a. Test ordering
b. Specimen acquisition
c. Test procedures
d. Result reporting
ANS: D
A variable that affects patient outcomes after laboratory analysis is considered a postanalytical
variable. In this case, the only choice that occurs after analysis is reporting results.

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6. The Westgard multirules for quality control were designed to interpret control data and to aid
in troubleshooting. The rule stated as 22s is interpreted as meaning:
a. one control value has exceeded ±2 s from the mean.
b. two consecutive control values have exceeded the mean ±2 s.
c. two consecutive control values have exceeded the mean ±1 s.
d. four consecutive controls have exceeded the mean ±2 s.
ANS: B
Multirule 22s indicates that two consecutive control observations exceed the same mean plus 2
s or the same mean minus the 2 s limit.

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7. Lean Production:
a. involves use of simulated patient specimens made from a common pool to
determine the “quality” of a laboratory’s performance using standard deviation
calculations.
b. is a quality performance goal that requires a specific number of standard deviations
of process variation to fit within the tolerance limits for the process.
c. is a quality process that focuses on creating more value by eliminating activities
that are considered wasteful.
d. is a set of international standards for quality management produced by the
 International Organization for Standardization.
ANS: C
In the quality process of Lean Production, to increase efficiency any inefficient activity or
process that consumes resources or adds cost or time without creating value is revised or
eliminated.

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8. Which one of the following would be considered a cost of nonconformance?

a. Performing preventive maintenance on analyzers
b. Employee training
c. Repeating an analytical run because the QC is out of range
d. Sending an employee to a fire safety class
ANS: C
Costs of nonconformance consist of internal and external failure costs. A repeat run is an
internal failure cost for poor analytical performance, and repeat requests for tests—because of
poor analytical quality—constitute an external failure cost.

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9. Six Sigma processes:

a. use simulated patient specimens made from a common pool to determine the
“quality” of a laboratory’s performance using standard deviation calculations.
b. are quality performance goals that require a specific number of standard deviations
of process variation to fit within the tolerance limits for the process.
c. are focused on creating more value by eliminating activities that are considered
waste.
d. are international standards for quality management produced by the International
Organization for Standardization.
ANS: B
The principle of Six Sigma involves the performance goal that “6 sigmas or 6 standard
deviations of process variation should fit within the tolerance limits for the process.” Six
Sigma provides a more quantitative framework for evaluating process performance and more
objective evidence for process improvement.

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10. Upon examination of the control chart of the week’s analytical run of serum creatinine, you
notice that 10 consecutive level II control values lie on the same side of the mean. In your QC
report, you note that Westgard multirule _____ has been broken and realize that this rejection
rule is sensitive to _____ error.
a. 10; random
b. 10; systematic
c. X10; random
d. X10; systematic
ANS: B
 Westgard multirule 100 indicates that 10 consecutive control observations have fallen on one
side of the mean (above or below, with no other requirement on size of the deviations). This
rule is sensitive to systematic error.

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11. Upon examining a Levey-Jennings control chart for analyte X, you notice that on day 6 the
one control was −2.5 s from the mean and the duplicate control was +3.3 s from the mean.
Which of the following Westgard control rules was/were broken?
a. 41s and 22s
b. R4s and 13s
c. R4s and 22s
d. 22s only
ANS: B
Multirule R4s indicates that one observation exceeds the mean plus 2 s and another exceeding
the mean minus 2 s, while 13s indicates that one control observation has exceeded the mean ±
3 s.

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12. Which one of the following statements concerning the use of internal control materials is
incorrect?
a. Use of control materials can aid in the identification of assay malfunctions that
lead to unreliable data.
b. Serum controls are prepared from human serum pools and are analyzed in
analytical runs that are separate from patient samples.
c. QC data are collected over a period of time and statistically analyzed using
measures of central tendency.
d. Controls that exceed specific limits are examined with the Westgard rules to
determine what kind of error is present and what actions are to be taken.
ANS: B
Serum controls are always included in the same analytical runs with patient samples and are
treated in a similar fashion to the patient samples.

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13. In regard to a Gaussian distribution, ±2 s from the mean encompasses _____ of values.
a. 99.7%
b. 98.0%
c. 95.5%
d. 68.2%
ANS: C
Error distribution of an analytical method is assumed to be Gaussian. The control limits are
set to include most of the control values, usually 95% to 99.7%, which correspond to the mean
± 2 or 3 s.

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14. Random error would be caused by:
a. contaminated reagents.
b. pipetting errors.
c. inappropriate preparation of calibrators.
d. low volume reagent blanks.
ANS: B
Random errors more likely are due to (1) lack of reproducibility in the pipetting of samples
and reagents, (2) dissolving of reagent tablets and mixing of sample and reagents, and (3) lack
of stability of temperature baths, timing regulation, and photometric and other sensors.

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15. According to CLIA regulations, a score of _____ must be attained on three consecutive
external proficiency test challenges for a laboratory to be accredited and continue patient
testing.
a. 50%
b. 60%
c. 70%
d. 80%
ANS: D
To succeed in a given category, a laboratory must produce correct results on four of five
specimens for each of the analytes in that category and score overall at least 80% on three
consecutive challenges.

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16. You have received your proficiency test results from the accrediting agency and note that your
creatinine result was unacceptable at greater than 2 SDI from the group mean. The value that
was entered on your survey report form was 15 mg/dL. The group method mean was 1.3
mg/dL, with a method standard deviation of 0.3 mg/dL. You realize that your laboratory made
an error in entering the result. If you had entered 2.0 mg/dL as the result on your survey
report, what would the correct SDI be?
a. 45.6 SDI
b. 4.56 SDI
c. 1.08 SDI
d. 0.67 SDI
ANS: D
The standard deviation interval (SDI) is calculated by subtracting the group method mean
from the laboratory result and dividing this by the group standard deviation. In this case, (2.0
− 1.3)/0.3 = 0.67 (SDI). Differences greater than 2 indicate that a laboratory is not in
agreement with the rest of the laboratories in the program.

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17. You have received your proficiency test results from the accrediting agency and note that your
creatinine result was unacceptable at greater than 2 SDI from the group mean. The value that
was entered on your survey report form was 15 mg/dL. The group method mean was 1.3
mg/dL with a method standard deviation of 0.3 mg/dL. You realize that your laboratory made
an error in entering the result. If you had entered 2.0 mg/dL as the result on your survey
report, would the recalculated SDI now be in agreement with the rest of the laboratories in the
testing program?
a. Yes
b. No
c. Cannot determine from information given
ANS: A
Differences greater than 2 indicate that a laboratory is not in agreement with the rest of the
laboratories in the program; the value 0.67 is less than 2, so the SDI is acceptable.

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18. Two types of error may be encountered during chemical analysis of a substance. The type of
error that occurs as a result of contaminated calibrating solutions would be _____ error.
a. systematic
b. random
c. analytical
d. calibration
ANS: B
See Box 7-7. Systematic errors are often related to calibration problems.

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19. You arrive at the clinical chemistry laboratory one morning and discover that personnel from
the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The
technician has circled the level I TSH control values, and you realize that all six of the level I
control values are +3 s from the mean. No results have been released. Now it’s your decision
regarding what to do next. First, which Westgard rule(s) has (have) been violated?
a. 22s
b. 41s
c. 13s
d. All of the above rules have been broken.
ANS: D
In this case, the values are all on one side of the mean by at least +1 s (41s), at least two
consecutive controls have exceeded the mean by +2 s (22s), and at least one control has
exceeded the mean by +3 s (13s).

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20. You arrive at the clinical chemistry laboratory one morning and discover that personnel from
the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The
technician has circled the level I TSH control values, and you realize that all six of the level I
control values are +3 s from the mean. No results have been released. Now it’s your decision
regarding what to do next. What is your decision regarding the release of results in the
problem stated in the preceding question?
a. Hold all results, reject the run, and troubleshoot.
b. Release results and do nothing else.
c. Release all results and troubleshoot.
d. Call the manufacturer’s representative and ask him what to do.
ANS: A
When one of the control observations exceeds a 2 s limit, the patient results are held and
additional rules applied. In this case, the control data are inspected using the 13s, 22s, and 41s
rules. When any of the rules indicates the run is out of control, the analytical run is rejected
and the patient results are not reported.

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21. You arrive at the clinical chemistry laboratory one morning and discover that personnel from
the third shift left you the QC sheet from the thyroid-stimulating hormone (TSH) run. The
technician has circled the level I TSH control values, and you realize that all six of the level I
control values are +3 s from the mean. No results have been released. Now it’s your decision
regarding what to do next. What kind of error is most likely occurring?
a. Random error due to pipetting errors
b. Systematic error due to calibration issues
ANS: B
All three of the broken multirules are sensitive to systematic error, which many times is
caused by improper calibration.

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22. According to the five-Q framework, the “QP” refers to quality:

a. programming.
b. planning.
c. processes.
d. precision.
ANS: B
Quality assessment requires that causes of problems be identified through QI and eliminated
through quality planning (QP).

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23. What is the role of quality planning in the five-Q framework of quality?
a. To monitor the laboratory as a whole for result quality
b. To monitor the statistical analysis of results
c. To ensure that the laboratory's performance satisfies quality requirements
d. To identify the cause of a problem and find a remedy for that problem
ANS: C
 If a problem exists and is remedied through quality improvement, QP is necessary to (1)
standardize the remedy, (2) establish measures for performance monitoring, (3) ensure that the
performance achieved satisfies quality requirements, and (4) document the new QLP.

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24. The first step in the development of an in-service training program using an instructional
system for employee competency in the laboratory is:
a. direct observation of routine patient test performance.
b. preparation of a written procedure.
c. implementation of a schedule.
d. a needs assessment or gap analysis.
ANS: D
Design of an in-service training program based on instructional systems design includes the
following elements: (1) analysis, (2) design, (3) implementation, and (4) evaluation. It begins
with a needs assessment or gap analysis to determine employee performance requirements,
identify deficiencies, and evaluate existing education and training resources.

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