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Your Instructor
Purpose
Audience
Course Goals
Course Materials
Lesson Descriptions
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Your
Instructor
James O. Westgard, Ph.D. is the
primary instructor for this course and the author of the course
material.
Purpose
Quality Control is not something
to be performed without thought. There is no single way to "do
QC", and the notion that 2 SD limits are the standard QC
practice is both out-dated and wasteful. Performing QC requires
careful consideration and planning. This course is concerned
with the establishment of logical specifications for precision
and accuracy of methods and with the selection of control rules
for statistical QC.
Audience
This minicourse is intended for
clinical laboratory scientists with responsibility for technical
quality management of laboratory testing processes. Directors
and managers of healthcare laboratories, clinical chemists, QC
technologists and specialists, teachers and students in Clinical
Laboratory Science programs will find it especially useful. Instrument
developers, manufacturer technical and field specialists, and
laboratory inspectors can also benefit greatly.
Course
Goals
- Learn the requirements for QC
by CLIA, JCAHO, and other agencies
- Define the quality required
and necessary for a laboratory test.
- Access resources for analytical,
clinical, and European quality requirements.
- Identify online tools for Quality
Planning
- Recognize the principles of
Quality Planning and their relationship to traditional QC.
Course
Materials
- A syllabus outlining the order
of the lessons
- 4 Lesson plans: each contains
a description of the lesson, along with links to the readings,
a list of things to do, and self-assessment questions
- Answers to the self-assessment
questions
- 4 online quizzes (which do not
count toward the final grade) to help prepare you for the final
exam.
- 1 online final exam (you must
pass with a score of > 70% to receive credit)
- Glossary of terms
- Archives of hundreds of supplemental
articles, essays, lessons, and applications for optional reading.
Lesson
Descriptions
1. Is Quality still an issue
in the new Millennium? Given the ongoing improvement of analytical
systems by manufacturers, many laboratories assume that analytical
quality is no longer a problem or even a responsibility of the
laboratory. In A Wake-Up call for Laboratory Quality Management,
Dr. Westgard provides a specific example of the FDA taking action
against a manufacturer for not following Quality System Regulations.
This example clearly illustrates the need for laboratories to
maintain the skills and capabilities to manage the quality of
their testing processes.
2. Why is Quality Planning
important? In this lesson,
Dr. Westgard reviews Total Quality Management (TQM) and identifies
the major components needed to manage the analytical quality
of laboratory testing processes. Quality planning is identified
as a critical component or activity in managing quality in the
laboratory.
3. What guidelines exist for
Quality Planning? In this lesson, Dr. Westgard covers the
rules that bear upon quality planning as well as recently published
QC practice guidelines. A review of US government regulations
(CLIA), accreditation guidelines (JCAHO), and consensus practice
guidelines from the National Committee for Clinical Laboratory
Standards (NCCLS). The NCCLS C24-A2 document provides quality-planning
guidelines for selecting QC procedures that are appropriate for
laboratory applications.
4. How is Quality Planning
performed? The NCCLS
guidelines for quality planning can be combined with available
quality-planning tools to devise a step-by-step planning process
that is practical in any laboratory.
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