Quality Planning Basics Course Information

Quality Planning Basics 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 Clinical Chemistry journal published by AACC. In spite of this documentation, there is a need for a more user-friendly presentation that provides tools and technology that make it easy to apply the scientific theory. This course provides Internet calculation tools 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.

This is not a course on how to do QC or perform a method validation study! Those topics are covered in our courses on Quality Control Basics and Method Validation Basics. Quality Planning Basics is concerned with establishing the specifications for the precision and accuracy of a method and selecting the control rules and numbers of control measurements for statistical QC. 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.

Participants who complete the lessons in this course will be able to:

• Define the quality required for a laboratory test.
• Access Internet sources of information for analytical, clinical, or European quality requirements.
• Utilize the "OPSpecs chart" (i.e., chart of operating specifications) for quality planning applications.
• Establish purchase specifications for the imprecision and inaccuracy needed for analytical methods.
• Select control rules and numbers of measurements appropriate for the imprecision and inaccuracy of your methods and the quality required in your laboratory.
• Select an appropriate Total QC strategy for methods in your laboratory.
• Utilize Internet calculator tools to support quality planning.

All the materials for this course are available via the Internet.

• The Course Syllabus outlines the order of the lessons and provides links to individual lesson plans.
• Each Lesson Plan provide a summary of the lesson, specific learning objectives, a list of materials, a list of things to do, and self-assessment exercises.
• A Lesson may involve text material, Internet calculation tools, and a PC computer program.
• Course tools are provided to facilitate the learning process, simplify data handling and calculations, and demonstrate specific applications.
• A Glossary of Terms is available and can be accessed from any lesson.
• A Reference List identifies the scientific papers that are the basis of the approach and the background for the course materials.

1. Why is quality still an issue in the new millennium? 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 action is a sentinel event calling for independent analytical quality management in healthcare laboratories.
2. Why is quality planning important? In Assuring Quality through Total Quality Management, Dr. Westgard identifies the critical role of quality planning in a laboratory quality management process.
3. What guidelines exist for quality planning? Complying with Regulations, Standards, and Practice Guidelines reviews US government regulations (CLIA), accreditation guidelines JCAHO), and consensus practice guidelines (NCCLS) to provide a complete picture of how quality should be managed. 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? In Devising a Practical Process, Dr. Westgard combines the existing quality-planning guidelines with available tools to devise a detailed step-by-step quality-planning process that is practical for your use.
5. How are quality requirements defined for a laboratory test? Defining Quality Requirements first identifies the difficulties with current recommendations in order to set the stage for a "systems" view of quality standards. This system shows the relationship between the various recommendations and the operating specifications that are needed to manage testing processes in a service laboratory. Internet sources of recommendations on quality requirements are also identified.
6. How do you use the OPSpecs quality-planning tool? Adopting the OPSpecs Chart as Your Quality-Planning Tool provides detailed information about how to use a chart of operating specifications.
7. What do you do when quality isn't good enough? The appropriate balance between statistical and non-statistical QC techniques depends on the performance available from the statistical QC procedure. In Formulating a Total Quality Control Strategy, Dr. Westgard provides a flow chart to guide the development of TQC strategies for individual tests.
8. Can you do quality planning by hand? This lesson on Implementing a Manual Process using Normalized OPSpecs Charts provides everything you need to start a quality- planning process for your own applications. The approach described here is the "manual kit method" for quality planning using pre-printed charts of operating specifications. The use of normalized OPSpecs charts for selecting QC procedures is illustrated for glucose, cholesterol, calcium, hemoglobin, leukocyte count, and erythrocyte count.
9. How do you become proficient at quality planning? Practice makes Proficient provides an overview of the quality-planning process and sets the stage for your own applications. The remaining lessons deal with applications in different areas of testing, such as routine chemistry, toxicology, hematology, endocrinology, and immunology.
10. Automated Chemistry Applications. CLIA quality requirements are reviewed and example applications provided for cholesterol, glucose, chloride, and calcium tests that are performed by an automated multitest analytical system.
11. Blood Gas Applications. A situation is examined where blood pH, pCO2, and pO2 are measured by a Point-of-Care instrument.
12. Immunoassay Applications. CLIA quality requirements are reviewed and example applications are provided for thyroxine, cortisol, and thyroid stimulating hormone (TSH).
13. Coagulation Applications. CLIA quality requirements are reviewed and example applications provided for prothombin time, activated partial thromboplastin time, and fibrinogen. Internet quality-planning tools are introduced and utilized to select QC procedures for these applications.
14. Should statistical QC be improved or abandoned? In What's Wrong with Statisticall Quality Control, many of the frequently-made-complaints (FMC's) about statistical quality control are examined and quality planning is shown to be the answer to many of the current problems with statistical quality control.
15. What questions do you have about quality planning? Frequently asked questions (FAQs) provide a review of the fine points of quality planning.
16. Examination