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James O. Westgard, Ph.D.
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This course has been developed by Dr. James Westgard. Initial discussions with Dr. Chris Frings led to a proposal that was submitted to AACC President Dr. Larry Demers and the AACC Education Management Group chaired by Dr. Ishwarial Jialal. A detailed course review, conducted by Dr. Alan Wu and Dr. Robert Burnett, led to the final content and form of the materials. |
This new web-course represents the latest evolution of an approach to analytical quality management that has been undergoing development and improvement for nearly twenty years. The scientific basis of this approach is well-documented in the clinical chemistry literature, particularly in the Clincal Chemistry Journal published by AACC. In spite of this documentation, there is a need for a more user-friendly presentation that integrates the theory from the literature and the tools and technology needed to apply that theory. The development of the web-course makes it possible to use computer tools and technology to support and enhance the learning experience.
James O. Westgard, Ph.D. is the primary instructor for this
course and the author of nearly all the course material.
Other instructors wrote articles for the course in their area
of specialty:
This is not a course on how to do QC but how to PLAN QC! It's about figuring out what amount of QC is necessary to assure the desired quality will be achieved for the methods in your laboratory, i.e., selecting appropriate control rules and numbers of control measurements on the basis of the analytical or clinical quality requirement for the test and the imprecision and inaccuracy observed for the method.
This course is intended for clinical laboratory scientists
who have an interest in or responsibility for technical quality
management of laboratory testing processes. It should be especially
useful for directors and managers of healthcare laboratories,
clinical chemists, QC technologists and specialists, teachers
and students in Clinical Laboratory Science programs, instrument
developers, manufacturer's technical and field specialists, and
laboratory inspectors.
After completing this online course, you will be able to demonstrate the following skills:
Once registered, you will be able to link to a syllabus page which contains links to all assigned course materials. A link is a highlighted and underlined term that connects to new material. You use the computer mouse to click on that term and move to a new location, which may be on this website or any website world wide. You can return to your previous location by clicking the "back" button on your browser.
1. Is analytical quality still an issue
in laboratory testing? In Myths of Quality,
Dr. Westgard challenges the current thinking that analytical quality
is better than needed for medical care. He sets out the objective
of developing a quantitative quality planning approach to guarantee
that laboratory testing processes will achieve the necessary quality
in routine service. In Understanding Quality, Jerry
Ehrmeyer discusses the relative nature of quality and the need
for "standards" to compare and judge quality.
2. What quality is needed for a laboratory
test? In Quality Goals, Requirements, and Specifications,
Dr. Westgard discusses different terms and characteristics that
are used to describe quality and provides a systems perspective
to show the relationship between these different characteristics.
Per Hytloft Petersen provides a review of approaches to setting
analytical quality specifications in his discussion of European
Approaches to Analytical Goal-Setting. Tables provide
summaries of available CLIA analytical total error criteria,
clinical decision interval criteria, and European
biological goals.
3. How do you manage quality? In Assuring
Quality through Total Quality Management, Dr. Westgard
describes a framework for defining and implementing a quality
management process that provides continuous quality improvement.
This framework shows the synthesis of quality laboratory processes,
quality control, quality assessment, quality improvement, and
quality planning into a process centered on and guided by quality
requirements. The impact of laboratory regulations on quality
management is discussed by Dr. Sharon Ehrmeyer in her update,
What's New with CLIA'88, JCAHO, and CAP.
4. How do you build quality into a laboratory
testing process? In Putting Quality into Quality Control,
Dr. Westgard emphasizes the need for quality planning, with particular
attention to selecting statistical QC procedures that are appropriate
for detecting medically important errors. Four practical approaches
for QC planning are identified in Starting a QC Planning
Process. A detailed example of QC planning using analytical
quality requirements is provided for a Cholesterol test
that is subject to CLIA proficiency testing. Another example
considers a Cholesterol test and a clinical quality requirement
based on NCEP guidelines for interpretation of a screening test.
5. How can you do QC planning? In Tools
and Technology for QC Planning, Dr. Westgard describes
how to make QC planning practical using graphical tools, such
as power function graphs, critical-error graphs, and OPSpecs charts.
The QC Validator computer program is introduced
as an example of the kind of technology needed to provide these
graphical tools. An educational version of the program (QC Validator
2E) can be downloaded to provide these tools for the duration
of this course. A demo of the program can be downloaded
from the website and viewed to illustrate QC Validator's use.
Detailed tutorials are also available via download from the website.
FAQs about QC Validator provides additional discussion
of the use and application of this computer program.
6. QC Planning Tools - What are Power Function
Graphs? The performance of statistical QC procedures can be
characterized by determining the probabilities of rejecting analytical
runs that have different sizes of errors, as described in this
lesson on Power Function Graphs. An example of the
application of power functions considers Higher N QC Procedures
for Immunoassays. Additional discussion is provided by
FAQs for Power Function and Critical- Error Graphs.
7. QC Planning Tools - What are Critical-Error
Graphs? This lesson on Critical-Error Graphs demonstrates
the more quantitative use of power function graphs based on calculating
the size of medically important errors, then imposing these critical-errors
on the power curves to determine the probabilities for rejection.
The application of critical-error graphs is illustrated by QC
Selection for a Multitest Chemistry Analyzer that performs
18 different tests. A detailed application of the QC Validator
program is illustrated for albumin via downloading the Multi-test
Chemistry example.
8. QC Planning Tools - What are OPSpecs
Charts? Operating specifications describe the imprecision
and inaccuracy that are allowable for a method and the QC that
is necessary to assure the desired quality is achieved. The lesson
on OPSpecs Charts explains the origin of this powerful
QC planning tool. The cholesterol examples for analytical and
clinical quality requirements should be reviewed to understand
the application of this tool. FAQs about OPSpecs charts
provides further discussion to clarify their use and interpretation.
9. QC Planning Tools - What are Quality
Planning Models? The theoretical and conceptual basis of the
QC planning process and the QC planning tools are based on the
expected relationship between a quality requirement and the factors
that contribute to the variability of a test result. In this lesson
on Quality Planning Models, Dr. Westgard uses the
concept of an error budget to describe the relationships between
analytical total error criteria with analytical factors and clinical
decision criteria with preanalytical and analytical factors. Participants
should review the two cholesterol examples that represent applications
of these analytical and clinical error budgets (Cholesterol
with Analytical Quality Requirement, Cholesterol
with Clinical Quality Requirement).
10. What is a Total QC Strategy? The
appropriate balance between statistical and non-statistical QC
techniques depends on the performance available from the statistical
QC procedure. In this lesson on Total Quality Control (TQC)
Strategies, Dr. Westgard describes a flow chart that provides
guidance in developing TQC strategies for your own tests. A review
and summary of the QC planning process is provided by Dr. Westgard's
AACC Online article Strategies for Cost-Effective QC.
11. Applications - Can you really perform
QC planning quickly within one minute?This lesson focuses
on Normalized OPSpecs Charts and makes use of a
web-based calculator for normalized operating points
to provide a quick and easy way to apply the QC planning process.
You need to print a series of normalized OPSpecs charts,
then use the web calculator to determine the normalized operating
point to be plotted manually on these charts. A series of examples
are provided to give you enough practice to become proficient
in using these tools - proficient meaning that you should be able
to perform QC planning within one minute.
12. Applications - How do you assess the
performance of a recommended QC procedure? In The Myth
of Medical Decision Limits, the practices of using clinical
and fixed control limits are evaluated. The QC planning process
is used to first figure out what the actual statistical control
rule is, then to evaluate that rule's performance based on its
error detection and false rejection characteristics. A Glucose
Point-of-Care application illustrates the proper approach
for designing a QC procedure on the basis of a defined clinical
quality requirement.
13. Applications - How do you select acceptability
criteria to satisfy CLIA QC guidelines? In Selecting
QC procedures to satisfy CLIA requirements, a detailed
step-by-step procedure is described that begins with the definition
of quality according to the CLIA proficiency testing criteria
for acceptable performance and uses OPSpecs charts for selecting
controls rules and numbers of control measurements. Detailed applications
are discussed by Dr. Neill Carey in Tips on Managing the
Quality of Immunoassays.
14. Applications - How do you determine
the precision and accuracy needed for a test? In Quality
by Design, Dr. Westgard discusses how to use an OPSpecs
chart to establish precision and accuracy "specifications
for purchase." In the application QC planning using
European biologic goals, this approach is used to compare
the maximum allowable CVs for cholesterol and glucose testing
processes that are designed to assure the quality required by
clinical, analytical, and biological quality requirements.
15. Am I done with QC now? In Future
Directions in Quality Control, Dr. Westgard discusses
the expected evolution of quality systems and considers the needs
of total automation as well as point-of-care applications. In
Defect Rates, Quality and Productivity, Dr. Robert
Burnett describes the need to focus our future thinking on defect
rates to better manage the analytical quality of laboratory tests.
16. What else is happening in Quality Management? Trends in Quality Management describes the emerging interests in outcome measurements and utilization control. In Approaches to Clinical Laboratory Utilization, Dr. Arthur Eggert presents some strategies on how to get started managing the utilization of laboratory tests. These discussions will help you understand the importance of analytical quality management in the big picture.
Participant evaluation: A self-assessment exercise is
provided by the QC Planning Practice Test. The QC
Planning Test is preparation for a similar participant
exam that is used to award ACCENT continuing education credits.
Course evaluation: Participants must complete a course evaluation form that is supplied by AACC and must return that form to AACC to obtain continuing education credits.
