Deck 7: Quality Assurance and Quality Control

Question 1

Match the term with the definition.
Precision

A)How close a test result is to the true value
B)Highly purified substances of a known composition
C)Specimen with a known value that is similar in composition to the test specimen
D)How close the test results are to one another when repeated analyses of the same material are performed

Answer 1

How close the test results are to one another when repeated analyses of the same material are performed

Question 2

Match the term with the appropriate definition.
Mode

A)Middle value in a body of data
B)Value that occurs most frequently in a mass of data
C)Mathematical average calculated by dividing the sum of all individual values by the number of values

Answer 2

Value that occurs most frequently in a mass of data

Question 3

Using the Clinical and Laboratory Standards Institute (CLSI) protocol for a procedural format, insert the missing elements in the following written procedural protocol:
Procedure name
Name of test method
Specimen collection and storage

A)Quality control
B)Sources of error
C)Principle and purpose of the test
D)Procedural protocol

Answer 3

Principle and purpose of the test

Question 4

Sensitivity is defined as the

A)proportion of subjects with the specific disease or condition who have a positive test result.
B)proportion of subjects without the specific disease or condition who have a negative test result.
C)proportion of a population who have the disease.
D)number of patients with a normal test result who do not have the disease.

Question 5

Specificity is defined as the

A)proportion of subjects with the specific disease or condition who have a positive test result.
B)proportion of subjects without the specific disease or condition who have a negative test result.
C)proportion of a population who have the disease.
D)Number of patients with a normal test result who do not have the disease.

Question 6

Match the term with the definition.
Accuracy

A)How close a test result is to the true value
B)Highly purified substances of a known composition
C)Specimen with a known value that is similar in composition to the test specimen
D)How close the test results are to one another when repeated analyses of the same material are performed

Question 7

A control specimen should be

A)carried through the entire test procedure.
B)treated in exactly the same way as any patient specimen.
C)assayed at least once a week.
D)Both A and B.

Question 8

An example of a preanalytical error is

A)specimen obtained from the wrong patient.
B)lack of frequent preventive maintenance.
C)reporting of laboratory results by phone.
D)poorly trained phlebotomists.

Question 9

The reference range is

A)the range of values that includes 95% of the test results for a healthy reference population.
B)the term that replaces the term normal values or normal range.
C)stated as a range of values in terms of SD units.
D)All of the above.

Question 10

Using the Clinical and Laboratory Standards Institute (CLSI) protocol for a procedural format, insert the missing elements in the following written procedural protocol:
Procedure name
Name of test method
Expected or normal (reference) values

A)Quality control
B)Sources of error
C)Principle and purpose of the test
D)Procedural protocol

Question 11

Match the term with the definition.
Standard

A)How close a test result is to the true value
B)Highly purified substances of a known composition
C)Specimen with a known value that is similar in composition to the test specimen
D)How close the test results are to one another when repeated analyses of the same material are performed

Question 12

Required regulation of clinical laboratories is achieved by (the)

A)Clinical Laboratory Improvement Amendments of 1988.
B)The Joint Commission (TJC; formerly JCAHO).
C)College of American Pathologists (CAP).
D)American Hospital Association (AHA).

Question 13

Match the term with the definition.
Control

A)How close a test result is to the true value
B)Highly purified substances of a known composition
C)Specimen with a known value that is similar in composition to the test specimen
D)How close the test results are to one another when repeated analyses of the same material are performed

Question 14

Nonanalytical factors in quality assessment include

A)qualified personnel.
B)established laboratory policies.
C)quality control charts.
D)Both A and B.

Question 15

Match the term with the appropriate definition.
Mean

A)Middle value in a body of data
B)Value that occurs most frequently in a mass of data
C)Mathematical average calculated by dividing the sum of all individual values by the number of values

Question 16

Using the Clinical and Laboratory Standards Institute (CLSI) protocol for a procedural format, insert the missing elements in the following written procedural protocol:
Procedure name
Name of test method
Limitations

A)Quality control
B)Sources of error
C)Principle and purpose of the test
D)Procedural protocol

Question 17

For testing of moderate complexity, quality control requires

A)using fresh reagent daily.
B)performing control procedures monthly.
C)performing control procedures using at least two levels of control material for each day of testing.
D)Both A and C.

Question 18

Match the term with the appropriate definition.
Median

A)Middle value in a body of data
B)Value that occurs most frequently in a mass of data
C)Mathematical average calculated by dividing the sum of all individual values by the number of values

Question 19

Quality assessment programs include

A)patient identification.
B)specimen procurement.
C)specimen transportation and processing procedures.
D)All of the above.

Question 20

Using the Clinical and Laboratory Standards Institute (CLSI) protocol for a procedural format, insert the missing elements in the following written procedural protocol:
Procedure name
Name of test method
Reagents, supplies, and equipment

A)Quality control
B)Sources of error
C)Principle and purpose of the test
D)Procedural protocol

Question 21

Regarding the parallel testing of test kits, CLIA 88 treats high complexity, moderate complexity, and waived tests the same way when new test kits are put into use.

Question 22

If the control value in a determination is out of the acceptable range, lack of attention to timing or incubation temperature may be the factor responsible.

Question 23

If the control value in a determination is out of the acceptable range, faulty instrument or equipment may be the factor responsible.

Question 24

If the control value in a determination is out of the acceptable range, the deterioration of reagents or standards may be the factor responsible.

Question 25

If the control value in a determination is out of the acceptable range, use of poor technique by the technologist doing the test may be the factor responsible.