Graduate Certificate in Laboratory Quality Management - Clinical Laboratory Science Program

Quality Control Basics Course Information

Quality Control Basics is a 1-credit introductory course that is part of the required study in the area of Quality Control. It is a prerequisite to the course Quality Control Projects, a 2-credit course that can be taken concurrently.

Quality Control Basics provides the essentials for performing statistical QC procedures in service laboratories. It covers the principles, terminology, and practices of common QC procedures, such as the Levey-Jennings control chart and the Westgard multirule technique.

Your instructors

Dr. Westgard is the primary instructor and is responsible for the contents of the course. 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 in the Clinical Laboratory Science Program, Director of Quality Management Services in the Clinical Laboratories at the University of Wisconsin Hopsital & Clinics, and Principle in Westgard QC, Inc.

Other instructors include Patricia L. Barry, BS, MT(ASCP) and Elsa F. Quam, BS, MT(ASCP), who are Quality Specialists in the Clinical Laboratories at the University of Wisconsin Hospital, and Sharon S. Ehrmeyer, PhD, MT(ASCP), who is CLS Program Director and Professor of Pathology and Laboratory Medicine at the University of Wisconsin Medical School.

Purpose

This course is intended to provide education and training in quality control (QC) to a broad audience of healthcare practitioners who perform laboratory tests in central laboratories, clinic or outpatient laboratories, and point-of-care settings.

The emphasis is on statistical QC because this is the backbone of any good laboratory QC program, regardless of the setting where the tests are being performed. Statistical QC is a widely applicable technique that is very powerful for detecting problems with test performance and very quantitative for demonstrating proficiency of xxxxysts and operators, assuming the technique is properly implemented and the QC data is properly interpreted. This course will help healthcare practitioners implement and operate valid statistical QC procedures.

Goals

Students who complete these lessons will be able to:

Access internet resources to support continuing education and training in xxxxytical quality management;
Assess individual needs for QC training and education on the basis of responsibilities for laboratory tests;
State the basic idea of statistical QC in terms of the variation expected in a measurement process;
Identify the regulatory and accreditation requirements for QC for tests of interest;
Select control materials that are appropriate for tests of interest;
Calculate monthly QC statistics (mean, standard deviation or SD, coefficient of variation or CV) and control limits, as well as cumulative statistics and cumulative control limits;
Construct Levey-Jennings control charts with appropriate control limits, plot example control data, and interpret the control results;
Recognize problems with false rejections caused by narrow control limits, such as commonly used 2 SD control limits;
Interpret control results with a series of rules to determine if patient test results can be reported and, if not, what type of xxxxytical errors are likely occurring in out-of-control runs;
Distinguish between good and bad habits for responding to out-of-control problems;
Specify the parameters and information needed to make QC records useful for trouble-shooting and problem-solving;
Perform a critical review of laboratory practices for planning, establishing, and operating a QC procedure; and
Identify QC planning approaches that are practical in service laboratories.

Materials

All the materials for this course are available via the Internet. A hardcopy manual and a CD version of the course are also available for those who have limited access to the Internet.

This course description provides a summary of each of the lessons.

The syllabus lists the different units and provides links to individual lesson plans. YOU SHOULD BOOKMARK THE SYLLABUS AS THE STARTING PAGE FOR YOUR STUDIES.
Each lesson plan provides the goal of the lesson, specific objectives, links to course materials for that lesson, a list of things to do, and some questions for self-assessment.
Selected reference papers are provided in PDF format and can be read (and printed) using the Adobe Acrobat Reader.

Interactive Components

An electronic discussion forum is available to all participants in the course. This forum allows discussion among students as well as comments from the instructors. Participants are encouraged to submit questions by e-mail. These questions will be summarized and answers will be posted. Each participant is encouraged to find a mentor who will be available to discuss the lessons and assessment questions.

Study Units

Lesson 1. What QC training is necessary? In this introduction, participants will assess their own needs for QC training and education. In QC - Back to Basics, Dr. Westgard explains why everyone needs to be concerned about quality control, even in this age of high technology and improved xxxxytical testing processes, and provides guidelines for the basic training needed by personnel who have different levels of responsibility for laboratory testing.

Lesson 2. What's the idea behind statistical quality control? Participants will be able to describe the basic idea of statistical QC in terms of the variation expected in a measurement process. In QC - The Idea, Dr. Westgard shows how a histogram representing measurement variation is the basis for the QC chart.

Lesson 3. What regulatory and accreditation guidelines influence the practice of QC? Participants will identify the regulatory and accreditation requirements for QC for their tests of interest. In QC - The Regulations, Dr. Sharon Ehrmeyer reviews the USA regulatory and accreditation guidelines that influence current QC practices, describes the classifications of tests based on complexity, and identifies the QC requirements for those different classes of tests.

Lesson 4. What are control materials and what characteristics are important? Participants will be able to select control materials that are appropriate for their tests of interest. In QC - The Materials, Elsa Quam, BS, MT(ASCP) reviews the purpose of statistical QC and describes the important characteristics of control materials, such as matrix, stability, vial-to-vial variability, assayed vs unassayed, xxxxyte levels, and pretreatment steps. A summary table of clinical decision levels is provided courtesy of Dr. Bernard Statland.

Lesson 5. What calculations do you have to perform? Participants will calculate monthly QC statistics (mean, standard deviation or SD, coefficient of variation or CV) and control limits, as well as cumulative statistics and cumulative control limits. QC - The Calculations describes the equations used for calculating QC statistics. A problem set is provided, along with an interactive web-based calculator, for practice in performing these calculations.

Lesson 6. How do you plot and interpret control results on a Levey-Jennings chart? Participants will construct Levey-Jennings control charts with appropriate control limits, plot example control data, and interpret the controls results. In QC - The Levey-Jennings Control Chart, Patricia Barry BS, MT(ASCP) shows how to do this for a cholesterol example.

Lesson 7. What are the chances of rejecting a run with different QC procedures? Participants will recognize problems with false rejections caused by narrow control limits, such as commonly used 2 SD control limits. In QC - Chances for Rejection, Dr. Westgard uses the xxxxogy between a fire alarm and an error detector is used to describe the performance of a detector in terms of false alarms and true alarms (or false rejections and true rejections).

Lesson 8. What is multirule QC and what are "Westgard rules?" Participants will learn to use a series of control rules to determine if patient test results should be reported and, if not, what type of xxxxytical errors are likely occurring in out-of-control runs. In QC - The Multirule Procedure, Dr. Westgard defines the rules commonly included in multirule procedures and provides the rationale for using multiple control rules to interpret control data.

Lesson 9. How do you interpret control data using "Westgard rules?" An example set of control data is examined in detail to illustrate the multirule interpretation. QC - The Multirule Interpretation describes the application and interpretation of multiple rules with multiple control materials and multiple xxxxytical runs.

Lesson 10. How do you solve out-of-control problems? Participants will distinguish between good and bad habits for responding to out-of-control problems. In QC - The Out-of-Control Problem, Elsa Quam, BS, MT(ASCP) identifies the bad habits of repeating control measurements and rexxxxyzing control materials and recommends alternative good practices for solving control problems.

Lesson 11. What documentation and QC records are required? Participants will be able to specify the parameters and information that needs to be documented to make QC records useful for trouble-shooting and problem-solving. In QC - The Records, Patricia Barry, BS, MT(ASCP) describes the importance of documenting the "history" of a method to learn from past experiences. While documentation and paper work often elicit a negative feeling, the positive side of good record-keeping is the ability to identify changes that may be the cause of problems.

Lesson 12. What's the overall process for establishing a QC procedure? Participants will be able to perform a critical review of their own laboratory's practices for planning, implementing, and operating a QC procedure, with reference to the steps identified in QC - The Practice.

Lesson 13. What approaches are available to plan or select QC procedures? Participants will be able to identify QC planning approaches that are practical in service laboratories from Dr. Westgard's discussion of QC - The Planning Process.

Lesson 14. How do you use charts of operating specifications to select QC procedures? A simple QC planning tool � the OPSpecs chart � is used to select control rules and numbers of control measurements that are appropriate for the quality required by the test and the performance observed for the method. In QC � Mapping the Road to xxxxytical Quality, Dr. Westgard uses the xxxxogy of a map to help students locate an appropriate QC procedure with the aid of OPSpecs charts.

Lesson 15. What questions do you have about QC? A review of critical points in the lessons is provided by QC - The Frequently Asked Questions (FAQs), which is a list of questions compiled from current and past course participants.

Unit 16. On-line Exam.