3 QUALITY ASSESSMENT AND QUALITY CONTROL IN THE CLINICAL LABORATORY

Question 1

The abbreviation TJC stands for an organization that:
a. Accredits hospitals and inspects clinical laboratories
b. Accredits physician laboratories
c. Determines waived and nonwaived categories of assays
d. Accredits only hospital laboratories

Answer 1

a. Accredits hospitals and inspects clinical laboratories

Question 2

The abbreviation CAP stands for an organization that:
a. Accredits hospitals and inspects clinical laboratories
b. Accredits physician laboratories
c. Determines waived and nonwaived categories of assays
d. Accredits only hospital laboratories

Answer 2

d. Accredits only hospital laboratories

Question 3

The abbreviation COLA stands for an organization that:
a. Accredits hospitals and inspects clinical laboratories
b. Accredits physician laboratories
c. Determines waived and nonwaived categories of assays
d. Accredits only hospital laboratories

Answer 3

b. Accredits physician laboratories

Question 4

The abbreviation CLIA stands for an organization that:
a. Accredits hospitals and inspects clinical laboratories
b. Accredits physician laboratories
c. Determines waived and nonwaived categories of assays
d. Accredits only hospital laboratories

Answer 4

c. Determines waived and nonwaived categories of assays

Question 5

An example of a preanalytical (preexamination) error is:
a. Malfunction of a microprocessor that affects accuracy in testing
b. Incorrect identification of a patient
c. Transposition of a numeric critical value in transmitting a report
d. Verbally reporting a laboratory result over the telephone

Answer 5

b. Incorrect identification of a patient

Question 6

An example of an analytical (examination) error is:
a. Malfunction of a microprocessor that affects accuracy in testing
b. Incorrect patient identification
c. Transposition of a numeric critical value in transmitting a report
d. Use of the wrong anticoagulant in the patient sample tube

Answer 6

a. Malfunction of a microprocessor that affects accuracy in testing

Question 7

An example of a postanalytical (postexamination)
error is:
a. Malfunction of a microprocessor that affects accuracy in testing
b. Incorrect patient identification
c. Transposition of a numeric critical value in transmitting a report
d. Use of the wrong anticoagulant in the patient sample tube

Answer 7

c. Transposition of a numeric critical value in transmitting a report

Question 8

Blood from the wrong patient is an example of a/an:
a. Preanalytical (preexamination) error
b. Analytical (examination) error
c. Postanalytical (postexamination) error
d. Either a or b

Answer 8

a. Preanalytical (preexamination) error

Question 9

Specimen collected in the wrong tube is an example of a/
an:
a. Preanalytical (preexamination) error
b. Analytical (examination) error
c. Postanalytical (postexamination) error
d. Either a or b

Answer 9

a. Preanalytical (preexamination) error

Question 10

Quality control outside of acceptable limits is an example of a/an:
a. Preanalytical (preexamination) error
b. Analytical (examination) error
c. Postanalytical (postexamination) error
d. Either a or c

Answer 10

b. Analytical (examination) error

Question 11

Accuracy is defined as:
a. How close results are to one another
b. How close a test result is to the true value
c. Specimen that is similar to patient’s blood; known
concentration of constituent
d. Comparison of an instrument measure or reading to a known physical constant

Answer 11

b. How close a test result is to the true value

Question 12

Calibration is defined as:
a. How close results are to one another
b. How close a test result is to the true value
c. Specimen that is similar to patient’s blood; known
concentration of constituent
d. Comparison of an instrument measure or reading to a known physical constant

Answer 12

d. Comparison of an instrument measure or reading to a known physical constant

Question 13

A control is defined as:
a. How close a test result is to the true value
b. Specimen that is similar to patient’s blood; known concentration of constituent
c. Comparison of an instrument measure or reading to a known physical constant
d. Measurement of a highly purified substance of known
composition

Answer 13

b. Specimen that is similar to patient’s blood; known concentration of constituent

Question 14

Precision is defined as:
a. How close results are to one another
b. How close a test result is to the true value
c. Comparison of an instrument measure or reading to a known physical constant
d. Measurement of a highly purified substance of known
composition

Answer 14

a. How close results are to one another

Question 15

Standards are defined as:
a. How close a test result is to the true value
b. Specimens that are similar to patient’s blood; known concentration of constituent
c. Comparison of an instrument measure or reading to a known physical constant
d. Highly purified substances of known composition

Answer 15

d. Highly purified substances of known composition

Question 16

Sensitivity is:
a. Cases with a specific disease or condition that produce a positive result
b. Cases without a specific disease or condition that produce a negative result
c. Cases with a specific disease or condition that produce a negative result
d. Cases without a specific disease or condition that
produce a positive result

Answer 16

a. Cases with a specific disease or condition that produce a positive result

Question 17

Specificity is:
a. Cases with a specific disease or condition that produce a positive result
b. Cases without a specific disease or condition that produce a negative result
c. Cases with a specific disease or condition that produce a negative result
d. Cases without a specific disease or condition that produce a positive result

Answer 17

d. Cases without a specific disease or condition that produce a positive result

Question 18

The mean is:
a. Another term for the average
b. Most frequently occurring number in a group of values
c. Number that is midway between the highest and lowest values
d. A representation of a true analyte value

Answer 18

a. Another term for the average

Question 19

The median is:
a. Another term for the average
b. Most frequently occurring number in a group of values
c. Number that is midway between the highest and lowest values
d. A representation of a true analyte value

Answer 19

c. Number that is midway between the highest and lowest values

Question 20

The mode is:
a. Another term for the average
b. Most frequently occurring number in a group of values
c. Number that is midway between the highest and lowest values
d. A representation of a true analytic value

Answer 20

b. Most frequently occurring number in a group of values

Question 21

The standard deviation is:
a. Equal to SD divided by the mean
b. Measure of variability
c. The same as the mean value
d. An exact measurement of an analytic value

Answer 21

b. Measure of variability

Question 22

The coefficient of variation is:
a. Equal to SD divided by the mean
b. Measure of variability
c. The same as the mean value
d. An exact measurement of an analytic value

Answer 22

a. Equal to SD divided by the mean

Question 23

Levey-Jennings plots:
a. Show values on a chart
b. Have three warning rules
c. Have three mandatory rules
d. All the above

Answer 23

a. Show values on a chart

Question 24

Macy works within the Chemistry department in her first job out of a Medical Laboratory Science program. Today has been a typically busy day for her as she loads samples into instruments and checks results. Macy loaded two levels of quality control (QC) materials prior to a large run of patients and on checking the results for the QC, she noticed that one of the levels was outside the range that had been
established.

What is Macy’s next step?
a. Testing should be suspended until the issue is resolved.
b. This depends on how far “out” the QC level is.
c. There are a number of stat tests in the run, and she should report them “out.”
d. She should repeat running the QC level that is out until it falls within range.

Answer 24

b. This depends on how far “out” the QC level is.

Question 25

Macy works within the Chemistry department in her first job out of a Medical Laboratory Science program. Today has been a typically busy day for her as she loads samples into instruments and checks results. Macy loaded two levels of quality control (QC) materials prior to a large run of patients and on checking the results for the QC, she noticed that one of the levels was outside the range that had been established.

As part of Macy’s investigation into the QC issue, she notices that a scheduled preventive maintenance (PM) activity was not performed yesterday. Macy completes the PM and then recalibrates the test that is having QC issues. After recalibration, the QC level is now in range. Macy documents the missed PM and her resolution within the binder kept with that machine.

Are Macy’s actions considered part of a quantitative QC
program?
a. No; a quantitative QC program involves the use of only two levels of control material for each day of testing.
b. Yes; a quantitative QC program encompasses both equipment and reagents.
c. No; the most important aspect of a quantitative QC program is the assurance of reliability.
d. Yes; calibration is the most important part of a quantitative QC program.

Answer 25

b. Yes; a quantitative QC program encompasses both equipment and reagents.