# Quality Assurance Flashcards

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1
Q

Parameter

A

The whole population

2
Q

Statistic

A

Sample of the population

3
Q

Population

A

set of homogeneous items or events that is of interest for some question or experiment.

4
Q

Sample

A

A sample is a smaller group of members of a population selected as a representative of the population.

Sample is biased

5
Q

Random Sample

A

Randomly means that every member of the target population has an identical chance of being included in the sample. In other words, the method you use for selecting your sample can not be biased.

6
Q

quality

A

Documented data use of statisticial calculations to compare lab data against other confirmed means of testing

7
Q

what are the 2 medicine statistical tests

A
```Reference test (Gold standard)
Comparison test (Procedure to be validated)```
8
Q

when does a test become gold standard?

A

When it is the most consistent and most accurate test for a particular disease

9
Q

What is a comparison test

A

Any other testing procedure, competing technology or variation from the gold standard

10
Q

Making statistical indices more intuitive

A

Realize that all indices start with a presumption that the Gold Standard is perfect
Pay particular attention to the English of the statistical terminology
Pay close attention to the labels and layout of any table of data

11
Q

Golden rule

A

For all purposes of statistical indices, the assumption is that the gold standard s perfect

12
Q

If the results of a test match the results of a gold standard

A

Test=true

13
Q

If the results of a test do not match the results of a gold standard test

A

Test=false

14
Q

Both comparison and gold standard test are attempting to do what?

A

Predict the presence of disease

15
Q

If the result is positive

A

it means that the test predicted the presence of disease

16
Q

If the result was negative

A

Test predicted the absence of disease

17
Q

True

A

is when the test results match the gold standard

18
Q

False

A

is when the test results do not match the gold standard

19
Q

True Positive

A

The test is correct (T) because it matches the gold standard and the test is positive for disease (P)

20
Q

True Negative

A

The test is correct (T) because it matches the gold standard and the test is negative for disease (N)

21
Q

False Positive

A

The test is incorrect (F) because it does not match the gold standard and the test is positive for disease (P)

22
Q

False negative

A

The test is incorrect (F) because it does not match the gold standard and the test is negative for disease (N)

23
Q

Gold standard

A

Assumed to be perfect

24
Q

Number of tested Patients with disease

A

Have disease=TP+FN

25
Q

Patients without disease

A

No disease=TN+FP

26
Q

Number of tested patients in the population that the test predicts to have the disease

A

Test positive: TP+FP

27
Q

Number of tested patients in the population that the test predicts do not have the disease

A

Test negative: TN+FN

28
Q

Sensitivity

A

Implies the ability of a test to detect disease

Times the test correctly predicted disease divided by al of the the times the disease really does exist

29
Q

Sensitivity equation

A

TP/TP+FN (*100%)

30
Q

Specificity

A

Refers to the ablity of a test to detect the absence of disease relative to the number of people who in reality do not have disease

31
Q

Specificity equation

A

TN/TN+FP (*100%)

32
Q

Accuracy

A

Percentage of times the test is correct relative to the gold standard

33
Q

Accuracy equation

A

TP+TN/TP+FN+TN+FP (*100%)

34
Q

positive predictive value

A

Is a value of how often the test is correct when positive for disease as a percentage of the total times the test is positive for disease

35
Q

Positive predictive value equation

A

PPV = TP/TP+FP (x100%) - notice only positive terms

36
Q

Negative predictive value

A

is a measure of how often the test is correct when negative for disease as a percentage of the total times the test is negative for disease

37
Q

Negative predictive value equation

A

NPP = TN/TN+FN (x100%) - notice only negative terms

38
Q

Accuracy defintion

A

Overall measure includes both a cacualtion for when the test was correct when positive for disease and when the test was correct when negative for the disease

39
Q

Accuracy must be….

A

Between the sensitivity and specificity

40
Q

The accuracy must also be between

A

Negative predictive value and positive predictive value

41
Q

Sensitivity is…

A

The ability of a test to detect disease

42
Q

Specificity is…

A

Ability of a test to detect the absence of disease

43
Q

Accuracy is

A

The percentage of times the test is correct

Accuracy=TP+TN/All tests

44
Q

Positive predictive value is

A

Percentage of times the test was correct when it predicted presence of disease

45
Q

how is positive predictive value determined

A

How many times the test correctly predicted the presence of disease divided by the total number of times the test predicted that there was disease.

46
Q

negative predictive value is…

A

Percentage of times the test was correct when it predicted absence of disease

47
Q

How is negative predictive value determined

A

How many times the test correctly predicted the absence of disease divided by the total number of times the test predicted that there was no disease

48
Q

The perfect test….

A

Sensitivity, specificity, accuracy, positive predictive value and negative predictive value would all be 100%

49
Q

In the real world

A

-No garuntee that the gold standard is perfect

50
Q

Good match to good standard

A

Good test

51
Q

A

52
Q

bad match to a good standard

A

53
Q

A

Not a whole lot of information

54
Q

Testing can be preformed by the

A

Ultrasound manufacture, regulatory bodies or within the ultrasound lab

55
Q

Purpose of testing

A

To assess performance differences between different ultrasound system designs

To assess a system’s performance and/or manufacturing

To minimize artifacts

56
Q

what does testing include

A
• Routine maintenance of ultrasound equipment
• Routine maintenance of lab equipment
• Individual certification
• Accreditation
• Statistical processing to compare a testing procedure against the gold standard
• QA meetings
• Overall accuracy of studies
• peer review
57
Q

Why is testing needed

A

Make certain that the system performance is adequate

58
Q

How do we test the system?

A

Use of test objects and test phantoms is an attempt to provide a constant reference frame so that a standard can be developed and so that changes over time can be identified

59
Q

Certain phantoms

A

Stable means by which to calibrate and compare performance over time

60
Q

Ability to mimic characteristics and complexities of tissues….

A

Limited

61
Q

Part of the system most likely to break/degrade

A

Transducer

62
Q

Getting repeatable test results

A

Take careful preparation and great system knowledge

63
Q

Transducer Care

A

Don’t drop the probe

No kinks, crimps or excessive force should be placed on the cord (RUNNING OVER CORD WITH MACHINE)

64
Q

probe leakage tests

A

Determine the mechanical integrity and ensure patient safety

65
Q

Why are probe leakage tests done

A

Mechanical discontinuities and fissures represent a potential electrical safety hazard
Small mechanical deformities can reduce efficacy of cleaning and disinfecting procedures with microbial formation in breaches

66
Q

Transducer general cleaning

A

Soap and water with a soft cloth to remove residual gel or biological related residues

Disinfecting Wipes after each use

67
Q

Transducer disinfection and sterilization

A

Sterilization
High-level disinfection
Intermediate-level disinfection
Low-level disinfection

68
Q

Sterilization

A

Complete elimination of all forms of microbial life including spores and viruses

Required when using a device considered ‘critical’-penetrates the skin or mucous membrane and is used without protective covering or if it is compromised
NOT AUTOCLAVING

69
Q

Low level disinfection

A

Destruction of most bacteria, some viruses and some fungi

Low level disinfection=not enough to inactivate TB or spores

Use of germicide

Transducer is sprayed or immersed in germicide nd then rinsed with sterile water

General cleaning should be employed prior to this type of care

70
Q

High level disinfection

A

Destruction/removal of all micro-organisms except bacterial spores

Intended for probes which makes the spread of disease more likely because of contact with blood or other bodily fluids

Trans-esophageal
Trans-rectal
Trans-vaginal

71
Q

Process for high level disinfection

A

Perform general cleaning
Ensure compatibility of disinfecting solution with transducer
Immerse transducer following specific disinfecting guidelines (20 minutes in CIDEX)
Rinse with sterile water (10 minutes)
Allow probe to dry
Examine probe for structural damage

72
Q

what are the two groups of 2D/Doppler testing

A

Those that measure the acoustic output of the instrument

Those that test the operation of the instrument

73
Q

Those that measure the acoustic output of the instrument

A

This group considers only the beam former and the transducer acting together as a source of ultrasound

74
Q

Those that test the operation of the instrument (anatomic images and flow evaluation performance):

A

This group takes into account the operation of the entire instrument. Imaging and Doppler performance are important for evaluating the instrument as a diagnostic tool. The acoustic output of an instrument is important when considering bioeffects and safety

75
Q

Doppler testing

A

Doppler testing presents extraordinary challenges since mimicking the properties of blood in a consistent fashion is extremely difficult. As a result, many different types of Doppler phantoms have been created

76
Q

Doppler Phantoms

A

Flow phantoms
Non-flow/String phantoms
Vibrating Plate (sensitivity) phantoms

77
Q

Blood mimicking fluids

A

Flow phantoms may provide continuous or pulsatile flow

Water based suspension fluid

78
Q

Doppler flow phantom consists of

A
```an imaging face
a medium
a flow conduit
a pump
Reservoir
a blood mimicking fluid```
79
Q

Non-flow/String phantoms

A

-Created because of difficulty creating a stable flow pattern

-