Module 4- Quality Control Flashcards

1
Q

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

A

True

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2
Q

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

A

Quality control

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3
Q

Prevents reporting of incorrect patient test results

A

Quality control

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4
Q

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

A

True

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5
Q

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

A

True

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6
Q

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

A

True

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7
Q

Specimens analyzed for quality control purposes

A

QC materials

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8
Q

Gold standard for clin. laboratory proficiency testing

A

CAP Program

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9
Q

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

A

Reference interval

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10
Q

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

A

As few as 20 study individuals

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11
Q

Reference interval applied to therapeutic drug

A

Therapeutic range

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12
Q

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

A

Negative bias

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13
Q

Ability of a test to detect a given disease or condition

A

Diagnostic sensitivity

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14
Q

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

A

Diagnostic specificity

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15
Q

______ Indicates test values are generally higher

A

Positive bias

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16
Q

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

A

Positive predictive value

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17
Q

Ability of a method to detect small quantities of an analyte

A

Analytic sensitivity

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18
Q

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

A

Negative predictive value

19
Q

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

A

Analytic specificity

20
Q

Ability of a method to measure only the analyte of interest

A

Specificity

21
Q

Error always in one direction

A

Systemic/systematic error

22
Q

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

A

Quality management

23
Q

Used for monitoring teat performance and quality control

A

Descriptive statistics

24
Q

Average

A

Mean

25
Q

Middle of data

A

Median

26
Q

Most frequently occurring

A

Mode

27
Q

Represent the relationship of all the data points to the mean

A

Spread

28
Q

Dispersion of values around the mean

A

Coefficient variation

29
Q

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

A

Inferential statistics

30
Q

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

A

T-test

31
Q

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

A

F-test

32
Q

May be caused by variations in techniques

A

Random error

33
Q

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

A

Systematic error

34
Q

Pioneered by shewhart in 1920s

A

Levey Jennings

35
Q

One control observation exceeding the mean ±2s

A

1 2s

36
Q

One control observation exceeding the mean ±3s

A

1 3s

37
Q

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

A

2 2s

38
Q

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

A

R 4s

39
Q

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

A

4 1s

40
Q

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

A

10x

41
Q

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.

A

True

42
Q

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

A

False

43
Q

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

A

True

44
Q

Most frequently used measure of variation

A

Standard deviation