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Purpose
This course provides the background for understanding QC Design, with emphasis on available guidelines, quality goals, QC Design tools, and practical directions concerning the information needed to perform QC Design.
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.
All materials covered by the final exam are entirely online.
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
Participants who complete the lessons in this course will be able to:
- Locate the sources for quality goals and requirements, including CLIA, JC, CAP, ISO, CLSI, etc.
- Define the quality required and necessary for a laboratory test.
- Access resources for analytical, clinical, and European quality requirements.
- Identify tools for Quality Design and Planning
- Use tools to design and select appropriate QC procedures for different methods
- Recognize the principles of Quality Design and Planning.
Instructor
Dr. James O. Westgard, Ph.D. is the primary author of the course materials. He is an internationally recognized expert on QC and the originator of multirule QC (popularly known as the "Westgard Rules").
Dr. Westgard is an Emeritus Professor in Pathology and Laboratory Medicine at the University of Wisconsin Medical School and President of Westgard QC, Inc. He has over 40 years experience in laboratory quality management.
Dr. Westgard has lectured and given workshops on five continents, in dozens of cities; published hundreds of abstracts, papers, chapters, and numerous books; provided QC consulting and advice to manufacturers, hospitals, and government agencies; received awards and honors from the AACC, ASCLS, NACB, the British Association of Clinical Biochemists, and the Australian Association of Clinical Biochemists. Most recently, he received the 2004 Laboratory Public Service National Leadership Award for Lifetime Achievement from the Washington G2 Lab Institute, and the 2005 Improved Quality Processes Award from the Institute for Quality in Laboratory Medicine.
Syllabus
Design and Management of Quality Control systems
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| Lesson |
Materials |
| 1. Guidance for Analytical Quality Systems |
- Participants will identify the sources of advice on Quality, including industrial practices, CLIA, CLIA Final Rule, ISO 15189, and CLSI. They will also recognize the responsibility of the laboratory to aggregate different recommendations and make professional judgments when advice is in conflict.
- In Guidance for Quality Systems, Dr. Westgard discusses different sources of advice on Quality: industry, management experts, regulations, standards and guidelines.
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| 2. What Quality is required? |
- Participants will be able to define the three approaches for standards of quality, apply a Systems perspective to quality goals, and explain the differences in the terminology for quality goal, quality standard, quality specification, etc. Participants will, on a more practical level, be able to translate quality goals into Operating Specifications .
- In Quality Goals, Requirements and Operating Specifications, Dr. Westgard explains the different approaches to quality goals, as well as the many different terms used in quality design, planning, and control.
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| 3. Tools for Analytical System Planning and Quality Control Design |
- Participants identify the different QC Design and Planning tools, recognizing the advantages and disadvantages of each tool. Using the Sigma-metrics tools, participants will evaluate method performance. Using the Normalized OPSpecs tool, Participants will select appropriate QC procedures for their methods.
- In Evolution of Tools for Analytical Quality System Planning, Dr. Westgard describes the history development of different tools for Quality Design. Strengths and weaknesses are detailed. Participants will download copies of the Sigma-metrics chart and the Normalized OPSpecs chart
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| 4. Gathering data for Quality Design |
- Participants will define rational quality requirements, identify critical decision levels of laboratory methods, determine the imprecision and inaccuracy of methods, and calculate imprecision (CV) and inaccuracy (bias) from appropriately gathered data .
- In Getting the Data for Quality Design, Dr. Westgard provides step-by-step directions for defining quality requirements and critical decision levels, as well as the proper way to gather data and calculate imprecision and inaccuracy.
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| 5. The Sigma-metrics QC Selection Chart |
- Participants will calculate method Sigma-metrics, draw performance lines on a Sigma-metric charts, and evaluate error detection and false rejection characteristics of QC procedures.
- In Using the Sigma-metrics QC Selection tool, Dr. Westgard explains how to calculate the Sigma-metric of a method, draw the line on the chart, and use that line to determine the best QC procedure for a method. In example applications, this process is demonstrated for a number of different tests and levels of performance.
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| 6. The Normalized OPSpecs Chart Design Tool |
- Participants will be able to state the scientific thinking behind an OPSpecs chart. Participants will identify the elements of an OPSpecs chart, plot "operating points" on OPSpecs charts and interpret the meaning of those points. Finally, they will select appropriate QC procedures for tests based on the operating points.
- InUsing a Normalized OPSpecs chartDr. Westgard reviews the scientific theory behind the OPSpecs chart, then gives step-by-step instructions on how to use it. In Example Applications, the Normalized OPSpecs chart is used in a number of examples with different levels of performance.
- Finally, participants will take the Final Exam. A score of 70% or higher is necessary in order to pass the course.
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