Quality Assurance Flashcards
1
Q
Importance of Quality Control
A
- for accurate lab results
- efficient lab operations
- timely reporting of info
- customer’s needs and satisfaction
2
Q
Phases of QC
A
Pre-analytical phase
Analytical phase
Post-analytical phase
3
Q
- serum indices
- monitor the ability of an instrument to detect hemolyzed, icteric, or lipemic samples
A
Pre-analytical phase
4
Q
- quality control
- comprehensive line of independent QC products to monitor precision
actual measurement of the analyte in a specimen
A
Analytical phase
5
Q
Informatics
- QC Data management and analysis
- Unity Software Solutions
- Interlaboratory peer group comparison program
A
Post-analytical phase
6
Q
- refers to all the processes a lab takes to ensure quality of test results
- result of all such processes
A
Quality Assurance
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
8
Q
establishment of quality requirements to satisfy customers
A
Quality Assurance Program or Quality Management Framework
9
Q
encompasses the creation, selection, and validation of methods and processes in the lab
A
Quality Planning
10
Q
result from quality planning and describe the means by which work is conducted in the laboratory
A
Quality Laboratory Process (QLP)
11
Q
personnel policies, standard operating procedures, specimen collection guidelines
A
QLP
12
Q
represent the best way work is done in the lab
A
QLP
13
Q
all actions done to measure & monitor performance of the lab processes
A
Quality Assessment
14
Q
- verification of the quality of sample collected
- sample processing
- reporting of results
- competency & adequacy of lab staff
A
Quality Assessment
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
16
Q
provides tools to detect problems early and prevent errors from exceeding established quality requirements
A
Quality Control
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
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
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
20
Q
In what phase does QC apply to?
A
Analytical phase
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
22
Q
What are the ISO 9001 quality indicators?
A
- customer satisfaction
- conformity to customer requirement
- a count of preventive actions addressed
- quality materials provided by suppliers
23
Q
ISO standard for the particular requirements for quality and competence
A
ISO 15189 Med Lab 2007
24
Q
ISO standard for the general requirements for competence of testing and calibration labs
A
ISO/IBC 17025, 2005
25
ISO standard that requires labs to implement quality indicators to systematically monitor & evaluate the lab's contribution to patient care
ISO 15189
26
What are the characteristics of a good quality control?
SPARPS
- Specificity
- Precision
- Accuracy
- Reliability
- Practicability
- Sensitivity
27
the closeness of an analytical result to the true value
Accuracy
28
- reproducibility
- the degree to which repeated result agree
the closeness of test results to each other
Precision
29
How is precision expressed?
by standard deviation
30
True or False
| - the larger the standard deviation, the precise the values are
False, smaller sd
31
the ability of the method to detect even the smallest amount of the substance tested
Sensitivity
32
the ability of a method/instrument to detect a particular substance w/o the interference of some other substances present in the sample
Specificity
33
the ability of a method/instrument to maintain its accuracy & precision even at an extended period of time or under different variables
Reliability
34
the degree to which the method/instrument is easily repeated
Practicability
35
What are the purposes of Quality Control?
To check:
1. the stability of the equipment
2. the quality of the reagent
3. technical errors
4. the lab results
36
What are the 2 major divisions of QC Program?
- External QC (Interlaboratory)
| - Internal QC (Intralaboratory)
37
DOH Memo No. 2009-0086
Implementation of External Quality Assessment Program as Regulatory Requirement for Licensing of Clinical Laboratories
38
a substance/chemical of known exact value used to calibrate an assay method
Standard
39
substances of the highest possible quality and accuracy
Primary Standards
40
controls developed in comparison with primary standards
Secondary Standards
41
- 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
Calibrator
42
- 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
QC Sera (QCS/QCM)
43
What is assayed together with QCS? What is the purpose?
the unknown sample, to measure precision
44
Choices of QCS is dependent on:
1. availability of QCS that contains the analyte
| 2. nature of liquid matrix (of the source)
45
2 Sources of QCS
Human and Animal
46
Most common animal QCS source
Bovine
47
Types of QCS
1. In-House/Non Commercial
| 2. Commercial QCS
48
Examples of Non commercial QCS
- pooled sera
- fasting donor sera
- blood bank plasma
49
2 Kinds of Commercial QCS
Assayed QCS
| Unassayed QCS
50
Commercial QCS with a control value/known concentration that has been pretested using analytical procedures by the manufacturer, usually more expensive and used frequently
Assayed WCS
51
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
Unassayed QCS
52
2 Forms of Commercial QCS
```
Lyophilized form (powdered)
Non-lyophilized form (liquid)
```
53
True or False
| QC samples must be analyzed with patient samples using the same method and conditions but different reagents.
False, the same reagents
54
True or False
| QC samples should be run once a day, if possible routinely in each analytical run
True
55
True or False
| QC samples need not be run after an instrument has already been calibrated
False, should be run after calibration
56
True or False
| QC samples should be evaluated during a 30-40 day period
False, 20-30
57
True or False
| QCS results are used to create a Quality Control Chart
True
58
a statistical tool which is a typical representative value of a set of observations
Mean
59
True or False
| Mean is the best way of expressing the validity of a series of results
False, it's a poor way
60
- the measurement of variation of a single result from the mean
- the spread of any value from the mean
Standard deviation
61
- 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
Coefficient of Variation
62
statistical tool used to determine precision from one test method to the other
Coefficient of Variation
63
True or False
| Precise methods have a CV of < 5%
True
64
statistical tool used to distinguish between normal and abnormal values at the borderlines of the normal range
Allowable Limits of Error (ALE)
65
True or False
| The ALE concentration units must be lesser than half of the normal range
False, greater than 1/4 of the normal range
66
Types of Graphical Displays
Bar graphs
Pie graphs
Line Graph
67
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
Control Chart
68
Examples of control charts
1. Yuoden Plot/Twin Plot Chart
| 2. Levey-Jennings/Shewhart Chart/Dot Chart
69
labelled with the mean and appropriate SD values at line intersection points on the Dot Chart
Y-axis
70
labelled from left to right in time unites that reflects the sequence of control measurements on the Dot Chart
X-axis
71
a technique with a set of criteria as useful as the Levey-Jennnings Chart for monitoring performance
Westgard "Multirule" Technique
72
Purposes of the Westgard rule
1. to improve quality monitoring
2. to minimize subjectivity in data analysis
3. to provide help or guide in trouble shooting
73
technique that can be performed on quality control data using the L-J graph
Trend Analysis
74
True or False
| Lean optimizes space, time, & activity to improve chemical paths of workflow/
False, physical
75
Lean Processes
1. identify the value
2. map the value stream
3. create flow
4. establish pull
5. seek perfection
76
technique that uses a formal project planning structure that moves the process of reducing error to the lowest levels in the organization
Six Sigma
77
5 Steps Cycle of Six Sigma
```
Define
Measure
Analyze
Improve
Control
```
78
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)
True
79
2 methods of Six Sigma
- measure outcomes by inspection
| - measure variation & predict process performance
80
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
Gaussian Curve
81
percentage of values that falls within ± 2SD in a normal distribution curve
95.5%
82
percentage of values that falls within ± 1SD in a normal distribution curve
68.3%
83
If the values are farther from the mean, the curve would be _____ compared to the normal distribution curve
Lower
84
If the values are closer to the mean, the curve would be _____ compared to the normal distribution curve
Higher or more pointed
85
A good rule of thumb is that data sets should contain at least ___ points.
20
86
a graph wherein quality control data is plotted on to give a visual indication whether a lab test is working well
Levey-Jennings Chart
87
When the QC values obtained are within ±2SD, you are ___ control
In
88
the gradual change, increase or decrease, of 4 or more consecutive QC values from the mean
Trend
89
a change that becomes systematic & continuous which occurs when 4 or more consecutive QC values point apart on the same side of the mean
Shift
90
an increased frequency of both high and low outliers
Dispersion
91
When does an increased dispersion occur?
When there is imprecision
92
a QC value that exceeds ±3SD
Outlier
93
an imprecision/random variance error due to chance and does not cause a change of accuracy
Random Error
94
True or False
| a random error source is easy to identify through QC, however specific problems are hard to pinpoint
True
95
an inaccuracy/variance error which may influence results to be consistently higher or lower than the real value
Systematic Error
