Module 6 Flashcards

(48 cards)

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
What matrix are controls prepared in?
Same as the patient samples.
26
In what ways are controls available?
Lyophilized- freeze dried Liquid
27
How many levels of control are there normally?
Usually more than one. Low, normal, high or 1, 2, 3
28
What types of controls are available?
Single analyte- contains one analyte of known concentration Multianalyte- contains a number of analytes at known concentration
29
What is the benefit of multianalyte controls?
Can run one set for multiple assays.
30
What is an analytical run?
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
What is the max time for an analytical run?
24hrs
32
What are control limits?
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
How is the control range determined?
By adding and subtracting multiples of the SD (usually 2SD) from the mean.
34
What does a control range of 2SD encompass?
95% of values
35
What is a control chart?
Graphical representation of control range. Y- control value X- time
36
What is the most common type of control chart?
Levey-Jennings
37
What are control charts labelled with?
Test name Units Analytical system Name, level and lot no. of control Mean and SD Time period
38
How many control charts are required?
One for each level.
39
Why must control charts be retained?
For accreditation
40
What controls are reported?
All of them
41
What is looked for monthly in control charts?
Trends/shifts Missing records Values used to calculate the control ranges for the next month
42
What is a trend?
Consistent pattern of systemic error. Long term change.
43
What is a shift?
Change centred around a new point. Dramatic change.
44
What is the purpose of the lab?
Provide high quality patient results. They must be valid, applicable and timely
45
When are controls accepted? When are they rejected?
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
What rules do most labs use?
Multi-rule QC/Westgard rules
47
What is troubleshooting?
Detailed procedures to be followed in case of QC failure.
48
What is the steps for troubleshooting?
``` Figure out what's going on Isolate the cause (reagents, instrument, technologist, environment) Resolve the issue Evaluate the resolution Document the steps and outcomes ```