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Quality Assurance Flashcards

1
Q

Importance of Quality Control

A
  1. for accurate lab results
  2. efficient lab operations
  3. timely reporting of info
  4. customer’s needs and satisfaction
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2
Q

Phases of QC

A

Pre-analytical phase
Analytical phase
Post-analytical phase

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3
Q
  • serum indices

- monitor the ability of an instrument to detect hemolyzed, icteric, or lipemic samples

A

Pre-analytical phase

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4
Q
  • quality control
  • comprehensive line of independent QC products to monitor precision
    actual measurement of the analyte in a specimen
A

Analytical phase

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5
Q

Informatics

  • QC Data management and analysis
  • Unity Software Solutions
  • Interlaboratory peer group comparison program
A

Post-analytical phase

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6
Q
  • refers to all the processes a lab takes to ensure quality of test results
  • result of all such processes
A

Quality Assurance

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7
Q

How is QA achieved?

A

by planning, assessment, monitoring tools to pledge, guarantee, and assure that the results produced are correct and reliable

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8
Q

establishment of quality requirements to satisfy customers

A

Quality Assurance Program or Quality Management Framework

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9
Q

encompasses the creation, selection, and validation of methods and processes in the lab

A

Quality Planning

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10
Q

result from quality planning and describe the means by which work is conducted in the laboratory

A

Quality Laboratory Process (QLP)

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11
Q

personnel policies, standard operating procedures, specimen collection guidelines

A

QLP

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12
Q

represent the best way work is done in the lab

A

QLP

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13
Q

all actions done to measure & monitor performance of the lab processes

A

Quality Assessment

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14
Q
  • verification of the quality of sample collected
  • sample processing
  • reporting of results
  • competency & adequacy of lab staff
A

Quality Assessment

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15
Q

thorough assessment of what the problem is and the use of quality planning to modify and/or create lab processes to eliminate the problem

A

Quality Improvement

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16
Q

provides tools to detect problems early and prevent errors from exceeding established quality requirements

A

Quality Control

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17
Q

What are the 5 Q’s of the Quality Assurance Program?

A 
Quality Planning
Quality Laboratory Processes
Quality Control
Quality Assessment
Quality Improvement
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18
Q

component of QAP which is comprised of all systematic actions needed to produce adequate confidence that lab services will give the medical needs for patient care

A

Quality Control

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19
Q
  • the process of monitoring lab analyses to ensure accuracy of results
  • system set to ensure that certain limits for test results are maintained
A

Quality Control

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20
Q

In what phase does QC apply to?

A

Analytical phase

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21
Q

ISO standard that requires labs to create measurable objectives that can be assessed to determine the success of the quality system

A

ISO 9001

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22
Q

What are the ISO 9001 quality indicators?

A
  1. customer satisfaction
  2. conformity to customer requirement
  3. a count of preventive actions addressed
  4. quality materials provided by suppliers
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23
Q

ISO standard for the particular requirements for quality and competence

A

ISO 15189 Med Lab 2007

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24
Q

ISO standard for the general requirements for competence of testing and calibration labs

A

ISO/IBC 17025, 2005

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25
Q

ISO standard that requires labs to implement quality indicators to systematically monitor & evaluate the lab’s contribution to patient care

A

ISO 15189

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26
Q

What are the characteristics of a good quality control?

A

SPARPS

  • Specificity
  • Precision
  • Accuracy
  • Reliability
  • Practicability
  • Sensitivity
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27
Q

the closeness of an analytical result to the true value

A

Accuracy

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28
Q
  • reproducibility
  • the degree to which repeated result agree
    the closeness of test results to each other
A

Precision

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29
Q

How is precision expressed?

A

by standard deviation

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30
Q

True or False

- the larger the standard deviation, the precise the values are

A

False, smaller sd

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31
Q

the ability of the method to detect even the smallest amount of the substance tested

A

Sensitivity

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32
Q

the ability of a method/instrument to detect a particular substance w/o the interference of some other substances present in the sample

A

Specificity

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33
Q

the ability of a method/instrument to maintain its accuracy & precision even at an extended period of time or under different variables

A

Reliability

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34
Q

the degree to which the method/instrument is easily repeated

A

Practicability

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35
Q

What are the purposes of Quality Control?

A

To check:

  1. the stability of the equipment
  2. the quality of the reagent
  3. technical errors
  4. the lab results
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36
Q

What are the 2 major divisions of QC Program?

A
  • External QC (Interlaboratory)

- Internal QC (Intralaboratory)

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37
Q

DOH Memo No. 2009-0086

A

Implementation of External Quality Assessment Program as Regulatory Requirement for Licensing of Clinical Laboratories

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38
Q

a substance/chemical of known exact value used to calibrate an assay method

A

Standard

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39
Q

substances of the highest possible quality and accuracy

A

Primary Standards

40
Q

controls developed in comparison with primary standards

A

Secondary Standards

41
Q
  • a substance w/ a particular value that has been determined/assigned by the manufacturer
  • used to adjust an instrument to certain values prior to running samples
A

Calibrator

42
Q
  • a substance which contains the same analyte that is being tested for and assayed by he usual clinical lab methods
  • has a certain nominal range and is treated like a patient sample
A

QC Sera (QCS/QCM)

43
Q

What is assayed together with QCS? What is the purpose?

A

the unknown sample, to measure precision

44
Q

Choices of QCS is dependent on:

A
  1. availability of QCS that contains the analyte

2. nature of liquid matrix (of the source)

45
Q

2 Sources of QCS

A

Human and Animal

46
Q

Most common animal QCS source

47
Q

Types of QCS

A
  1. In-House/Non Commercial

2. Commercial QCS

48
Q

Examples of Non commercial QCS

A
  • pooled sera
  • fasting donor sera
  • blood bank plasma
49
Q

2 Kinds of Commercial QCS

A

Assayed QCS

Unassayed QCS

50
Q

Commercial QCS with a control value/known concentration that has been pretested using analytical procedures by the manufacturer, usually more expensive and used frequently

A

Assayed WCS

51
Q

Commercial QCS which is less costly and the values are known but not given, usually have target values w/ actual results falling near the target value

A

Unassayed QCS

52
Q

2 Forms of Commercial QCS

A 
Lyophilized form (powdered)
Non-lyophilized form (liquid)
53
Q

True or False

QC samples must be analyzed with patient samples using the same method and conditions but different reagents.

A

False, the same reagents

54
Q

True or False

QC samples should be run once a day, if possible routinely in each analytical run

55
Q

True or False

QC samples need not be run after an instrument has already been calibrated

A

False, should be run after calibration

56
Q

True or False

QC samples should be evaluated during a 30-40 day period

A

False, 20-30

57
Q

True or False

QCS results are used to create a Quality Control Chart

58
Q

a statistical tool which is a typical representative value of a set of observations

59
Q

True or False

Mean is the best way of expressing the validity of a series of results

A

False, it’s a poor way

60
Q
  • the measurement of variation of a single result from the mean
  • the spread of any value from the mean
A

Standard deviation

61
Q
  • statistical tool used to compare the relative variability between 2 or 3 different sets of values
  • degree of dispersion of data points relative to the mean
A

Coefficient of Variation

62
Q

statistical tool used to determine precision from one test method to the other

A

Coefficient of Variation

63
Q

True or False

Precise methods have a CV of < 5%

64
Q

statistical tool used to distinguish between normal and abnormal values at the borderlines of the normal range

A

Allowable Limits of Error (ALE)

65
Q

True or False

The ALE concentration units must be lesser than half of the normal range

A

False, greater than 1/4 of the normal range

66
Q

Types of Graphical Displays

A

Bar graphs
Pie graphs
Line Graph

67
Q

chart that displays the control observation/calculated statistic as a function of time (date, run number) and uses a rectangular coordinate paper to plot values

A

Control Chart

68
Q

Examples of control charts

A
  1. Yuoden Plot/Twin Plot Chart

2. Levey-Jennings/Shewhart Chart/Dot Chart

69
Q

labelled with the mean and appropriate SD values at line intersection points on the Dot Chart

70
Q

labelled from left to right in time unites that reflects the sequence of control measurements on the Dot Chart

71
Q

a technique with a set of criteria as useful as the Levey-Jennnings Chart for monitoring performance

A

Westgard “Multirule” Technique

72
Q

Purposes of the Westgard rule

A
  1. to improve quality monitoring
  2. to minimize subjectivity in data analysis
  3. to provide help or guide in trouble shooting
73
Q

technique that can be performed on quality control data using the L-J graph

A

Trend Analysis

74
Q

True or False

Lean optimizes space, time, & activity to improve chemical paths of workflow/

A

False, physical

75
Q

Lean Processes

A
  1. identify the value
  2. map the value stream
  3. create flow
  4. establish pull
  5. seek perfection
76
Q

technique that uses a formal project planning structure that moves the process of reducing error to the lowest levels in the organization

77
Q

5 Steps Cycle of Six Sigma

A 
Define
Measure
Analyze
Improve
Control
78
Q

True or False

Six Sigma is any process that can be evaluated in terms of sigma metric (how many sigma’s fit within tolerance limits)

79
Q

2 methods of Six Sigma

A
  • measure outcomes by inspection

- measure variation & predict process performance

80
Q

a symmetrical bell shaped curve generated when plotting samples values on a graph wherein the assay values are on the x-axis and the frequency of each value are on the y-axis

A

Gaussian Curve

81
Q

percentage of values that falls within ± 2SD in a normal distribution curve

82
Q

percentage of values that falls within ± 1SD in a normal distribution curve

83
Q

If the values are farther from the mean, the curve would be _____ compared to the normal distribution curve

84
Q

If the values are closer to the mean, the curve would be _____ compared to the normal distribution curve

A

Higher or more pointed

85
Q

A good rule of thumb is that data sets should contain at least ___ points.

86
Q

a graph wherein quality control data is plotted on to give a visual indication whether a lab test is working well

A

Levey-Jennings Chart

87
Q

When the QC values obtained are within ±2SD, you are ___ control

88
Q

the gradual change, increase or decrease, of 4 or more consecutive QC values from the mean

89
Q

a change that becomes systematic & continuous which occurs when 4 or more consecutive QC values point apart on the same side of the mean

90
Q

an increased frequency of both high and low outliers

A

Dispersion

91
Q

When does an increased dispersion occur?

A

When there is imprecision

92
Q

a QC value that exceeds ±3SD

93
Q

an imprecision/random variance error due to chance and does not cause a change of accuracy

A

Random Error

94
Q

True or False

a random error source is easy to identify through QC, however specific problems are hard to pinpoint

95
Q

an inaccuracy/variance error which may influence results to be consistently higher or lower than the real value

A

Systematic Error

Clinical Chemistry (2 decks)

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