Topic - Group Discussion - Week 7 - Quality Management PDF

10/5/2020 Topic: Group Discussion: Week 7 - Quality Management
This is a graded discussion: 10 points possible

due -
Group Discussion: Week 7 - Quality Management
1. Differentiate the three phases of Clinical Chemistry testing process in clear and concise form.
2. Explain thoroughly the differences of Quality Assurance and Quality Control.
3. What are the solutions used as tools for Quality Assurance and Quality Control?
Discussion: Quality Management
Quality Management
A management philosophy and approach that focuses on processes and their improvement as
the means to satisfy customer needs and requirements.
As defined by CLSI and ISO, it is coordinated activities to direct and control an organization
with regard to quality.
Quality management ensures that an organization, product or service is consistent. It has four
main components: quality planning (https://en.wikipedia.org/w/index.php?
title=Quality_planning&action=edit&redlink=1) , quality assurance
(https://en.wikipedia.org/wiki/Quality_assurance) , quality control
(https://en.wikipedia.org/wiki/Quality_control) and quality improvement
(https://en.wikipedia.org/wiki/Quality_improvement) . Quality management is focused not only
on product and service quality (https://en.wikipedia.org/wiki/Service_quality) , but also on
the means to achieve it. Quality management, therefore, uses quality assurance and control of
processes as well as products to achieve more consistent quality
(https://en.wikipedia.org/wiki/Quality_(business)) .
Quality Assurance and Quality Control
QUALITY CONTROL
It is a system of ensuring precision and accuracy in the laboratory by using quality control
reagents in every series of measurements.
It is a system of techniques to ensure with a specified degree of confidence that the result
obtained from each series of analysis is true and correct.
https://olfu.instructure.com/courses/51624/discussion_topics/785193?module_item_id=4069647 1/5
Three phases of quality assurance
Pre-analytical phase
Preparation
e.g. labeling of tubes
Analytical phase
Main focus of quality control
Should be done properly and correctly
Post-analytical phase
Implications of Quality Control
Sensitivity
The ability of a method to detect and measure even the smallest amount of the particular
substance tested for.
Analytical sensitivity – able to measure minute concentration of the analyte
it also refers to the test's ability to correctly detect ill patients who do have the condition
Diagnostic sensitivity – the test must always give a (+) result in the presence of the disease
True (+)
= ------------------------------- x 100
True (+) + False (-)
Specificity
The ability of a method to measure only the component desired without the interference of some
other substances present in the same sample.
Analytical specificity – able to measure only one unknown substance

Diagnostic specificity – the test must always give a negative result in the absence of disease
True (-)
= ------------------------------- x 100
True (-) + False (+)
Accuracy
The ability of a method to determine the exact value of the substance of interest in the sample.
It is the closeness or the nearness of a test value (value obtained) to the original value (pre-
determined value)
Precision and Reproducibility
The ability of a method to give repeated results on the same sample that agrees with one another.
Practicality
The degree by which a method is easily repeated.
Reliability
The ability of an analytical method to maintain accuracy &precision over an extended period of
time during which equipment, reagents, & personnel may change.
Other purposes of Quality Control
1. To check the stability of the machine

2. To check the quality of reagents
3. To check for technical error if any was committed by the operator
Tools of Quality Assurance and Quality Control
Standard solution
For accuracy
A solution of known characteristics and of known value or whose concentration is accurately
known
It is composed of one known constituent only and used as a basis of reference for the
calculation of the value of the unknown.
100% pure
Serve as a reference for unknown
Choose the standard nearest to the unknown
Control solution
For precision
A solution (either commercially or non-commercially prepared) composed of several known

constituents which can be run simultaneously with the test to check the accuracy of the
results.
Derived from human blood
Pooled serum (1yr)
Blank
Solution without the specimen

With reagent
Set the reading to zero
For accuracy
Two kinds of Quality Control reagents
Commercially prepared
Manufactured by different companies which may come in the lyophilized (pulverized or

powdered) and the non-lyophilized
Types:
Assayed – values are known and given
Unassayed – values are known but not given
Non-commercially prepared
Sources for the preparation of non-commercially prepared QC reagents

Left-over sera (pooled sera)
References:
Rifai, Nader (2019) Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics 8th
Edition
Bishop, Michael L., (2018) Clinical Chemistry: Principles, Techniques and Correlations 8th
Edition
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10/5/2020 Topic: Group Discussion: Week 7 - Quality Management

This is a graded discussion: 10 points possible

Group Discussion: Week 7 - Quality Management

2. Explain thoroughly the differences of Quality Assurance and Quality Control.

Discussion: Quality Management

Quality Assurance and Quality Control

Three phases of quality assurance

e.g. labeling of tubes

Main focus of quality control

Should be done properly and correctly

Implications of Quality Control

Analytical sensitivity – able to measure minute concentration of the analyte

True (+) + False (-)

Analytical specificity – able to measure only one unknown substance

True (-) + False (+)

Precision and Reproducibility

The degree by which a method is easily repeated.

Other purposes of Quality Control

1. To check the stability of the machine

Tools of Quality Assurance and Quality Control

A solution (either commercially or non-commercially prepared) composed of several known

Solution without the specimen

Two kinds of Quality Control reagents

Manufactured by different companies which may come in the lyophilized (pulverized or

Assayed – values are known and given

Unassayed – values are known but not given

Sources for the preparation of non-commercially prepared QC reagents

Search entries or author Unread  

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