Module 4- Quality Control

Question 1

True/False: majority of medical decisions are made using laboratory data

Answer 1

True

Question 2

_____ involves the systematic monitoring of analytic processes in order to detect analytic errors that occur during analysis

Answer 2

Quality control

Question 3

Prevents reporting of incorrect patient test results

Answer 3

Quality control

Question 4

True/False: expected values are represented by intervals of accepted values with upper and lower limits

Answer 4

True

Question 5

True/False: Expected values falls within control limits = correct values

Answer 5

True

Question 6

True/False: when values fall outside control limits, further analysis is done to avoid erroneous reporting of patient results

Answer 6

True

Question 7

Specimens analyzed for quality control purposes

Answer 7

QC materials

Question 8

Gold standard for clin. laboratory proficiency testing

Answer 8

CAP Program

Question 9

A pair of medical decision points that span the limits of results expected for a given condition

Answer 9

Reference interval

Question 10

How many study individuals are required in verifying a reference interval (transference)?

Answer 10

As few as 20 study individuals

Question 11

Reference interval applied to therapeutic drug

Answer 11

Therapeutic range

Question 12

_____ Indicates that test values tend to be lower than the reference value

Answer 12

Negative bias

Question 13

Ability of a test to detect a given disease or condition

Answer 13

Diagnostic sensitivity

Question 14

Ability of a test to correctly identify the absence of a given disease or condition

Answer 14

Diagnostic specificity

Question 15

______ Indicates test values are generally higher

Answer 15

Positive bias

Question 16

Chance of an individual having a given disease or condition if the test is abnormal

Answer 16

Positive predictive value

Question 17

Ability of a method to detect small quantities of an analyte

Answer 17

Analytic sensitivity

Question 18

Chance of an individual does not have a given disease or condition if the test is within tje reference interval

Answer 18

Negative predictive value

Question 19

Ability of a method to detect only the analyte it is designed to determine

Answer 19

Analytic specificity

Question 20

Ability of a method to measure only the analyte of interest

Answer 20

Specificity

Question 21

Error always in one direction

Answer 21

Systemic/systematic error

Question 22

Approach focusing on process improvement as a means to meet a set standard

Answer 22

Quality management

Question 23

Used for monitoring teat performance and quality control

Answer 23

Descriptive statistics

Question 24

Average

Answer 24

Mean

Question 25

Middle of data

Answer 25

Median

Question 26

Most frequently occurring

Answer 26

Mode

Question 27

Represent the relationship of all the data points to the mean

Answer 27

Spread

Question 28

Dispersion of values around the mean

Answer 28

Coefficient variation

Question 29

Attempt to apply conclusions that have been obtained from one experimental study to more general population

Answer 29

Inferential statistics

Question 30

Analyses if the means of two data sets are greatly different from each other

Answer 30

T-test

Question 31

______ is performed when it is not known whether the two populations have the same variance

Answer 31

F-test

Question 32

May be caused by variations in techniques

Answer 32

Random error

Question 33

May be due to several factors, including poorly made standards, reagents, instrumentation problems, etc.,

Answer 33

Systematic error

Question 34

Pioneered by shewhart in 1920s

Answer 34

Levey Jennings

Question 35

One control observation exceeding the mean ±2s

Answer 35

1 2s

Question 36

One control observation exceeding the mean ±3s

Answer 36

1 3s

Question 37

Two control observation consecutively exceeding the same +2s or -2s

Answer 37

2 2s

Question 38

One control exceeding the +2s and another exceeding -2s

Answer 38

R 4s

Question 39

Four consecutive control observations exceeding +1s or -1s.

Answer 39

4 1s

Question 40

Ten consecutive control observations falling on one side or the other side of the mean

Answer 40

10x

Question 41

True/False: all proficiency failures and significanys shifts and trends musy be reviewed, investigated, and resolved with 30 days of final receipt of proficiency results.

Answer 41

True

Question 42

True/False: acceptability criteria for proficiency testing are not provided by the proficiency program

Answer 42

False

Question 43

True/False: proficiency testing program must demonstrate a dynamic and real-time review time of all proficiency test results by the laboratory director and delegated management personnel

Answer 43

True

Question 44

Most frequently used measure of variation

Answer 44

Standard deviation