Quality Assurance Projects Course Information

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

Quality Assurance Projects provides real-world experiences investigating and developing laboratory QA practices. The student must have access to a diagnostic testing laboratory that will cooperate in the review and assessment of the ongoing quality assurance practices. This cooperation involves providing access to QA plans, policies and procedures. The laboratory must provide a mentor who will support and participate in the projects.

Sharon S. Ehrmeyer, Ph.D. is the instructor for this course. Dr. Ehrmeyer is a Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School and Director of the Clinical Laboratory Science Program.

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 evaluating and developing quality assurance policies and practices to ensure quality testing. This will require the student to critique current testing protocols and practices to determine whether they are appropriate and adequate for a particular testing situation. Students also will develop new QA policies and procedures for selected units studied in the Quality Assurance Basics course that both address the needs of a specific testing situation and ensure compliance with the mandated CLIA requirements and/or applicable accreditation standards (JCAHO, CAP, or COLA).

Goals

The student will demonstrate the skills to:

• Define and apply the appropriate quality requirements (from CLIA and, when appropriate, an accreditation agency, such as JCAHO or CAP) for each of the units discussed in the QA Basics Course;
• Evaluate and critique current laboratory QA policies and practices as to their effectiveness and adequacy in meeting the needs of a specified testing situation and mandated regulatory requirements;
• Develop policies and procedures for units discussed in the QA Basics Course to address pre-analytical, analytical and post-analytical errors while adhering to CLIA and/or accreditation mandates.
• Devise strategies for passing inspections;
• Identify opportunities for quality improvement.

Materials

The student is responsible for arranging with a laboratory the completion of the assignments included in Quality Assurance Projects. The participating laboratory is responsible for providing a mentor and access to appropriate information, such as the current QA plan and various policies and procedures for assuring quality throughout the testing process.

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 Assurance 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 assignments are to be carried out.
• An electronic forum is available for discussion of the steps of the QA projects 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.
• Discussions with the course instructor are scheduled as part of monitoring progress through the assignments. Additional discussions can be scheduled at the discretion of the participant.