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Traditional
TRADITIONAL OR TOTAL QUALITY
Acceptable quality
Total Quality
TRADITIONAL OR TOTAL QUALITY
Proactive system
Total Quality
TRADITIONAL OR TOTAL QUALITY
System process
Traditional
TRADITIONAL OR TOTAL QUALITY
Department focused
Traditional
TRADITIONAL OR TOTAL QUALITY
Quality as expense
Total Quality
TRADITIONAL OR TOTAL QUALITY
Us relationship
Total Quality
TRADITIONAL OR TOTAL QUALITY
Quality defined
Traditional
TRADITIONAL OR TOTAL QUALITY
Defects by workers
Traditional
TRADITIONAL OR TOTAL QUALITY
Management-controlled worker
Total Quality
TRADITIONAL OR TOTAL QUALITY
Manage by fact
Total Quality
TRADITIONAL OR TOTAL QUALITY
Continuous quality improvement
Traditional
TRADITIONAL OR TOTAL QUALITY
Status quo
Traditional
TRADITIONAL OR TOTAL QUALITY
Manage by intuition
Total Quality
TRADITIONAL OR TOTAL QUALITY
Empowered worker
Total Quality
TRADITIONAL OR TOTAL QUALITY
Defects by system
Traditional
TRADITIONAL OR TOTAL QUALITY
Intangible quality
Traditional
TRADITIONAL OR TOTAL QUALITY
We vs. they relationship
Total Quality
TRADITIONAL OR TOTAL QUALITY
Quality as means to lower cost
Total Quality
TRADITIONAL OR TOTAL QUALITY
Organization-focused
Traditional
TRADITIONAL OR TOTAL QUALITY
End-process focus
Total Quality
TRADITIONAL OR TOTAL QUALITY
Error-free quality
Traditional
TRADITIONAL OR TOTAL QUALITY
Reactive system
Quality Management System
All of laboratory’s policies, processes, procedures and resources needed to achieve quality testing.
Quality Assurance/Assessment
Process by which laboratory ensures quality results by close monitoring preanalytical, analytical, and postanalytical stages of testing.
Quality Control
Part of the analytical phase of Quality Assurance (QA)
Quality Control
process of monitoring results from control samples to verify accuracy of patient results.
QUALITY CONTROL
It is part of the process management component of the quality system that integrates good laboratory practices to ensure correct patient results.
QUALITY CONTROL
It is the process of ensuring that analytical results are correct by testing known samples that resemble patient’s sample and comparing their determined values with their expected values (control values).
Quality Assurance
QUALITY ASSURANCE OR QUALITY CONTROL
Process-oriented
Quality Control
QUALITY ASSURANCE OR QUALITY CONTROL
Product-oriented
Quality Control
QUALITY ASSURANCE OR QUALITY CONTROL
Try to find defects and correct them while making the product
Quality Control
QUALITY ASSURANCE OR QUALITY CONTROL
all about detection
Quality Assurance
QUALITY ASSURANCE OR QUALITY CONTROL
all about prevention
Quality Assurance
QUALITY ASSURANCE OR QUALITY CONTROL
Plan to avoid defect in the first place
Quality Assurance
QUALITY ASSURANCE OR QUALITY CONTROL
involves processes managing quality
Quality Control
QUALITY ASSURANCE OR QUALITY CONTROL
used to verify the quality of the product
machines, reagents, errors
OBJECTIVES OF QUALITY CONTROL
To check the stability of the __________
To check the quality of ________
To check technical ________
Control Solutions
Patient-like; should be tested in the same manner as patient samples
Control Solutions
The accuracy of any assay depends on this
Level I, Level II, Level III
In Clinical Chemistry, there are 3-Levels of Control solutions
normal
Level I of Control Solution means
abnormal low
Level II of Control Solution means
abnormal high
Level III of Control Solution means
Control Solutions
These are either Liquid or lyophilized
Control Solutions
Composed of one or more analytes of known concentration
Pooled serum, Commercial control
Types of Quality Control
Human, Bovine
Two types of pooled serum
Human
This pooled serum is more expensive but preferred
Bovine
This pooled serum is the most common animal source
Commercial control
Usually lyophilized for stability
Assayed, Unassayed
Two kinds of Commercial Control
Assayed
This commercial control is more expensive; company analyzed control and established reference range
Unassayed
This commercial control is without values; get reference range
Commercial controlI
Requires reconstitution
incorrect control values
Incorrect mixing of commercial control will lead to
Intralaboratory Quality Control, Interlaboratory Quality Control
Types of Quality Control
Intralaboratory Quality Control
This is also known as Internal Quality Control
External Quality Control
This is also known as Interlaboratory Quality Control
Random and Systematic Error
What does Internal Quality Control?
Daily
How often do we monitor Internal Quality Control?
External Quality Control
It involves the proficiency testing programs that periodically provide samples of unknown concentrations to participate in clinical laboratories.
External Quality Control
It is important in maintaining long-term accuracy of the analytical methods
College of American Pathologists Proficiency Program
The gold standard for clinical laboratory external QC testing
External Quality Control
A series of unknown samples are sent to the laboratory from the reference laboratory or authorized program provider
External Quality Control
Unknown samples must be tested by the laboratorians who regularly perform analysis of patient specimens using the same reagents and equipment for actual patient specimens, and the results are submitted to the program provider, preferably as soon as every analysis is done.
External Quality Control
Analysis of the unknown samples should be completed within the usual time as for the routine samples.
External Quality Control
Unknown accuracy samples should be treated like a patient specimen to determine the true essence of the accuracy.
testing period
Results of the proficiency testing must not be shared with their laboratories during
non-proficiency test scheme
If there is no available proficiency testing program for certain analyte, it is required to implement a what?
External Quality Control
If there is no available proficiency testing program for certain analyte, it is required to implement a non-proficiency test scheme.
every 6 months
Reference standards should be monitored how often?
Calibration
It is the process of verification by comparing the accuracy of the measuring instrument against a reference standard.
Reference Standards
This are substances with known concentration used
Primary, Secondary
Two types of standards
primary standard
Is an ultra high purity grade compound used in analysis involving assay, identification or purity tests.
Secondary standards
Also known as working standards
Secondary standards
These are also high purity grade materials which are quantified in relation to primary standards and put to routine use in laboratories.
Secondary standards
Limited validity depending on stability of the material and before expiry should be prepared for future use.
Levey-Jennings Chart
The most common intralaboratory quality control chart used in Clinical Chemistry laboratory; considered as the Gaussian Curve on its side.
falls with the control limits
When the observed value ____________, it can be interpreted that the method is performed adequately.
Points falling outside
________________ the control limits suggest that problems may be developing.
Multi-rules
These were formulized by the Western Electric Company and later applied to the clinical laboratory by Westgard and Groth.
Multi-rules
establish a criterion for judging whether an analytic process is out of control.
20
Prior to implementing a new lot number of QC material, both levels of QC material must be analyzed for ___ days.
Shift
abrupt change in analytic processes.
Trend
gradual change in analytic processes
12s
In Westgard Rules, one control observation exceeding the mean +-2s.
13s
In Westgard Rules, one control observation exceeding the mean +- 3s
22s
In Westgard Rules, two control observations consecutively exceeding the same +2s or -2s.
R4s
In Westgard Rules, one control exceeding the +2s and another exceeding the -2s.
41s
In Westgard Rules, four consecutive control observations exceeding +1s or -1s.
10x
Ten consecutive control observations falling on one side or the other of the mean (no requirement for SD size.)
12s
This westgard rule is a warning rule that initiates testing of control data by other rules.
13s
This westgard rule has high sensitivity to random error
22s
This westgard rule has high sensitivity to systematic error
R4s
This westgard rule has detection of random error
41s, 10x
This westgard rule/s has detection of systematic error
Random Error
No trend or means of predicting it.
Systematic Error
Will be seen as a trend in a data
Random Error
Occurs once; non-repeating.
Note
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