Quality Planning Projects Course Information

Quality Planning Projects is a 2-credit course that provides laboratory applications of the principles and approach for selecting and designing statistical QC procedures. Quality Planning Basics is a prerequisite course; if not completed already, Quality Planning Basics must be taken at the same time as Quality Planning Projects.

Quality Planning Projects provides real-world experiences investigating laboratory QC practices. The student must have access to a diagnostic testing laboratory that will cooperate in the review and assessment of its ongoing quality control practices. This cooperation involves providing access to QC policies and procedures, method validation data, routine QC data, and proficiency testing results. The laboratory must provide a mentor who will support and participate in the projects.

Dr. James O. Westgard is responsible for developing the contents of this course and serves as one of the course instructors. Dr. Westgard is a Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School, Co-Director of the Graduate Certificate in Laboratory Quality Management, Director of Quality Management Services in the Clinical Laboratories at the University of Wisconsin Hospital & Clinics, and President of Westgard QC, Inc.

Other faculty and laboratory scientists may also serve as course instructors, particularly when projects involve special areas of laboratory testing where their expertise will be helpful to the students in carrying out the projects they have selected.

Purpose

This course is intended to provide practical experience in selecting statistical QC procedures that are appropriate for a diagnostic test and a laboratory method. The selection of statistical QC procedures is important to maximize the detection of medically important errors and to minimize the false rejections of the QC procedure. Statistical QC is the backbone of a sound quality program in any service laboratory, assuming the technique is properly implemented and the QC data is properly collected, calculated, and interpreted. This course is intended to help students select and implement appropriate statistical QC procedures.

Goals

The student will demonstrate the skills to:

• Define quality requirements for diagnostic tests
• Assess method imprecision and inaccuracy from method validation data
• Assess method imprecision and inaccuracy from QC and PT data
• Utilize quality-planning tools, such as the chart of operating specifications
• Select appropriate statistical control rules and numbers of control measurements
• Formulate an appropriate Total Quality Control strategy
• Identify opportunities for quality improvement

Materials

The student is responsible for arranging a quality-planning project in a laboratory. The participating laboratory is responsible for providing a mentor and providing access to the method validation data, routine QC data, and proficiency testing or peer-comparison results.

Course materials and project guidelines are available on the Internet.

• A syllabus is provided to identify the project assignments and the points at which materials must be submitted for review and approval.
• Assignments provide detailed guidelines for the steps of the project and the materials that must be submitted.
• Instructional materials for Quality Planning Basics are accessible via the Internet through links provided in the lesson plans.

Interactive Components

• Each student must find a mentor who is available in the laboratory in which the project is carried out.
• An electronic forum is available for discussion of the steps of the project with other students who are also performing projects.
• The course instructor is available for questions and discussion via e-mail.
• Reports from assignments must be transmitted as Word, Powerpoint, or Excel documents via e-mail for review and feedback from the instructor.
• Five discussions must be scheduled with the course instructor as part of monitoring progress through the assignments.