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Resources and Reagents/Acids and Bases/ Quality Management > Quality Management > Flashcards

Quality Management Flashcards

1
Q

Clinical Laboratory Improvement Amendments of 1988 (CLIA)

A

Regulates labs and ensures accurate and reliable test results

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2
Q

Hemolysis

A

Destruction of red blood cells

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3
Q

Proficiency Testing

A

testing unknown specimens sent to a third party for evaluation

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4
Q

Quality

A

Meeting expectations and providing accurate results

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5
Q

Quality Control

A

Identify problems and maintain performance

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6
Q

Reference Range

A

Includes upper and lower limits of a lab test

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7
Q

Standard Operating Procedure (SOP)

A

Instructions on how to perform lab processes

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8
Q

Total Quality Management

A

Approach to long term success through customer satisfaction

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9
Q

Total Testing Process

A

Includes Preanalytical, Analytical, and Postanalytical

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10
Q

What does CLIA define as a clinical lab?

A

A facility that performs tests on human specimens

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11
Q

Waived Test

A

Simple examinations

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12
Q

Non-waived Test

A

More complex, more stringent

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13
Q

Quality Management System

A

Quality Planning
Quality Processes (QLP’s)
Quality Control
Quality Assessment
Quality Improvement
Peter Parker Can Always Intervene

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14
Q

What is a QC sample?

A

Solution that mimics a patients specimen

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15
Q

How do we treat Proficiency tests?

A

Like patient samples

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16
Q

How much success does a lab need to continue operation?

A

Correct on 4/5 specimens and overall score of 80%

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17
Q

What must a SOP include?

A

Title page
Effective Date
Purpose

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18
Q

Control Chart

A

View changes over time

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19
Q

Levey-Jennings Chart

A

A graph to represent lab data
Measured in Standard Deviation

20
Q

Mean

A

Sum of a group of numbers divided by the number of numbers

21
Q

Median

A

Measurements from lowest to highes

22
Q

Mode

A

Most frequently occurring measurement

23
Q

Precision

A

Closeness of two or more measurement to each other

24
Q

Accuracy

A

How close a measurement comes to the true value

25
Q

Standard Deviation

A

Measures how widely spread data points are

26
Q

Trend

A

Values in one direction over six or more analytical runs

27
Q

Westgard Procedure

A

Series of control rules to interpret data

28
Q

When do we reject patient results?

A

When the run is out of control

29
Q

Random Error

A

Statistical Fluctuation

30
Q

Systematic Error

A

Always in one direction and are predictable

31
Q

Analyte

A

Sample being analyzed

32
Q

Coefficient of Variation

A

Dispersion of data points in a data series around the mean

33
Q

Why are statistical descriptions useful in the lab?

A

Data Distribution
Random Variation

34
Q

What are the three most common descriptions of the center of a dataset?

A

Mean
Median
Mode

35
Q

What are the three most common descriptions of Spread?

A

Range
Standard Deviation
Coefficient of Variation (CV)

36
Q

How do we find varience?

A

Mean divided by number of measurements minus 1

37
Q

How do we find Standard Deviation?

A

Square root varience

38
Q

How do we find CV?

A

SD divided by mean x 100

39
Q

What is the most common shape of a dataset?

A

Gaussian Distribution (Bell Curve)

40
Q

68 - 95 - 99 rule

A

68% falls between +- 1SD
95% falls between +- 2SD
99% falls between +- 3SD

41
Q

Sensitivity

A

Percentage of True positives

42
Q

Specificity

A

Percentage of True negatives

43
Q

Why do we use a new testing method?

A

Reduce Costs
Improve Quality
Client Satisfaction
Improve Efficiency
Close Quarters Saves Everyone

44
Q

How many individuals does CLSI allow for a study?

A

20 subjects

45
Q
A

Resources and Reagents/Acids and Bases/ Quality Management (3 decks)

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