Module 6 Flashcards

1
Q

What is total quality management?

A

Overall management with the goal of long term customer satisfaction.

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2
Q

What is the hierarchical structure of TQM?

A
TQM
Quality management
Quality system
Quality assurance
Quality control
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3
Q

What is quality assurance?

A

The planned and systematic activities to provide confidence that an organization fulfills quality requirements.

Monitors QC data to identify and correct problems.

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4
Q

What is quality control?

A

Regular operational activities that ensure high quality test results.

What we do everyday to ensure valid results.

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5
Q

What are the types of QC?

A

Statistical- monitors the performance of analytical methods by analyzing controls and comparing the know a and unknowns, quantitative/qualitative controls.

Nonstatistical- procedures to maintain and improve analytical system performance, maintenance procedures and monitoring.

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6
Q

What is an analytical system?

A

Everything it takes to produce a result.

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7
Q

What is preventative maintenance?

A

Done to prevent the development of problems.

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8
Q

What is calibration?

A

Analyzing known samples to develop a curve with which we can read unknowns.

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9
Q

What is accuracy?

A

Nearness to the true value.

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10
Q

What is precision?

A

Reproducibility over time.

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11
Q

What is error?

A

Difference between true and measured values.

Positive- higher

Negative- lower

Random- unpredictable, imprecision

Systematic- consistent bias, inaccuracy

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12
Q

What is sensitivity?

A

The ability to measure low concentrations of an analyte.

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13
Q

What is specificity?

A

The ability to accurately measure one analyte without interference from others.

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14
Q

What are the different measures of central tendency?

A

Mean- average of a data set

Mode- the value that occurs the most frequently

Median- the middle number in a data set

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15
Q

What do measures of central tendency relate to?

A

Accuracy

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16
Q

What does standard deviation describe?

A

The spread of values about the mean.

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17
Q

What does SD measure?

A

Imprecision/error

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18
Q

What is the formula for calculating SD?

A

SD = square root(sum(X-x)2/n-1)

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19
Q

What is the coefficient of variation?

A

The SD expressed as a percentage.

Description of spread/variance/error

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20
Q

What is the benefit of using %CV?

A

Independent of units so can compare data between sets.

21
Q

How is %CV calculated?

A

%CV = SD/x(mean) x 100%

22
Q

What is normal/Gaussian distribution?

A

A frequency curve whose shape is symmetrical about the mean.

Mean, median and mode is the same.

Assume normal distribution of error.

23
Q

What is non-Gaussian distribution?

A

The mean, median and mode aren’t the same value so the curve isn’t symmetrical.

Skewed data/bias

24
Q

What are controls?

A

Prepared samples with known concentration used to detect errors.

Compared to an expected range of values.

25
Q

What matrix are controls prepared in?

A

Same as the patient samples.

26
Q

In what ways are controls available?

A

Lyophilized- freeze dried

Liquid

27
Q

How many levels of control are there normally?

A

Usually more than one.

Low, normal, high or 1, 2, 3

28
Q

What types of controls are available?

A

Single analyte- contains one analyte of known concentration

Multianalyte- contains a number of analytes at known concentration

29
Q

What is the benefit of multianalyte controls?

A

Can run one set for multiple assays.

30
Q

What is an analytical run?

A

A set interval for which the performance of a system can be expected to remain stable.

Set time or number of specimens.

Both controls and samples.

31
Q

What is the max time for an analytical run?

A

24hrs

32
Q

What are control limits?

A

Defined ranges of expected results that if exceeded warn of an error in the analytical system.

Usually run a min of 20x over the period of a month.

33
Q

How is the control range determined?

A

By adding and subtracting multiples of the SD (usually 2SD) from the mean.

34
Q

What does a control range of 2SD encompass?

A

95% of values

35
Q

What is a control chart?

A

Graphical representation of control range.

Y- control value

X- time

36
Q

What is the most common type of control chart?

A

Levey-Jennings

37
Q

What are control charts labelled with?

A

Test name

Units

Analytical system

Name, level and lot no. of control

Mean and SD

Time period

38
Q

How many control charts are required?

A

One for each level.

39
Q

Why must control charts be retained?

A

For accreditation

40
Q

What controls are reported?

A

All of them

41
Q

What is looked for monthly in control charts?

A

Trends/shifts

Missing records

Values used to calculate the control ranges for the next month

42
Q

What is a trend?

A

Consistent pattern of systemic error.

Long term change.

43
Q

What is a shift?

A

Change centred around a new point.

Dramatic change.

44
Q

What is the purpose of the lab?

A

Provide high quality patient results.

They must be valid, applicable and timely

45
Q

When are controls accepted? When are they rejected?

A

If values fall within the control range (+/-2SD) they are accepted.

If they fall out of the control range they’re rejected, further investigation needed.

46
Q

What rules do most labs use?

A

Multi-rule QC/Westgard rules

47
Q

What is troubleshooting?

A

Detailed procedures to be followed in case of QC failure.

48
Q

What is the steps for troubleshooting?

A
Figure out what's going on
Isolate the cause (reagents, instrument, technologist, environment)
Resolve the issue
Evaluate the resolution
Document the steps and outcomes