Method Validation Projects Course Information

Method Validation Projects is a 2-credit course that provides a laboratory application of the principles of Method Validation. Method Validation Basics is a prerequisite course, and if not completed already, must be taken concurrently with the Method Validation Projects course.

Method Validation Projects provides real-world experiences in validating the performance of a laboratory method. The student must have access to a diagnostic testing laboratory that will cooperate in a method validation project. This cooperation involves providing access to a new test method to be studied, a comparative method, specimens for testing, space and resources to carryout the validation experiments, and a mentor who will participate in the project.

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 instructor, 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

Analytical methods must be evaluated to demonstrate that their performance characteristics are valid for the diagnostic application of interest. Characteristics of interest usually include working range, limit of detection, within-run replication, recovery, interference, day-to-day replication, comparison with an established method, and verification of reference intervals. Such experimental studies are required in US healthcare laboratories to satisfy regulatory requirements of the Clinical Laboratory Improvement Amendments, or CLIA-88. Experience in performing a method validation study will help students integrate method validation principles with practice, adapt statistical theory to practical tools for data analysis, and gain practical skills in performing real studies in a working laboratory.

The student will demonstrate the skills to:

• Organize a method validation study
• Define the quality required for the tests being studied
• Develop an experimental plan appropriate for the analytical method
• Carry out the necessary experiments
• Calculate the experimental data appropriately
• Determine the acceptability of the method for the intended purpose
• Prepare a report of the evaluation study and results

The student is responsible for arranging an evaluation project in a laboratory. The participating laboratory is responsible for providing a mentor and giving access to the necessary materials and resources to carry out the method validation study.

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 Method Validation Basics are accessible via the Internet through links provided in the lesson plans.

• 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.