Basic QC Practices is an online course intended for professionals
in Clinical Laboratory Science (CLS).
Dr. Westgard is the course coordinator and primary instructor.
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.
This course is intended to provide education and training in
quality control (QC) to a broad audience of healthcare practicioners
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 analysts and operators, assuming the technique
is properly implemented and the QC data is properly interpreted.
This course should help healthcare practictioners implement and
operate valid statistical QC procedures.
Basic QC Practices Syllabus |
| Lesson |
Materials |
| 1. What's the idea behind statistical quality control? |
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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.
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| 2. How do you plot and interpret control results on a Levey-Jennings chart? |
- Participants will learn to construct Levey-Jennings control charts with appropriate control limits, plot example control data, and interpret the control results.
- In QC - The Levey-Jennings Control Chart, Patricia L. Barry, BS MT(ASCP) shows how to do this for a cholesterol example.
|
| 3. Isn't there a simpler way to do QC? |
- Participants will be able to assess the efficacy of electronic checks for monitoring the performance of a testing process.
- In QC - Electronic Checks and the Total Testing Process, Dr. Westgard describes the role of electronic checks in a Total QC system. Using the analogy to compare the total testing process to the "total driving process," Dr. Westgard shows that electronic QC can be seen as part of a bigger system, essential but not sufficient by itself.
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| 4. What regulations govern the practice of QC? |
- Participants will be able to identify the US CLIA regulations for quality control, as well as accreditation standards, guidelines, and checklists from the Joint Commission, CAP, and COLA.
- In QC - The Regulations, Dr. Sharon Ehrmeyer describes the US regulatory and accreditation requirements that apply to all laboratory testing, with examples of rules and guidelines from the deemd providers and accreditation agencies.
|
| 5. What are control materials and what characteristics are important? |
- Participants will learn to select control materials that are appropriate for tests of interest.
- In QC - The Materials, Elsa F. 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, analyte levels, and pre-treatement steps.
- In QC - DOs and DON'Ts, Dr. Westgard provides a summary of laboratory QC practice advice.
|
| 6. How do you interpret control data using a multirule QC procedure? |
- Participants will be able to interpret control results with a series of rules to determine if patient test results should be reported and, if not, what type of analytical errors are likely occurring in out-of-control runs.
- In QC - "The Westgard Rules," Dr. Westgard defines the rules commonly included in multirule procedures and provides the rationale for using multiple control rules to interpret control rules.
|
| 7. How do you interpret multilevel QC data? |
- Participants will be able to interpret control results when multiple levels of control materials are being analyzed.
- In QC - the Multirule and Multilevel Interpretation, Dr. Westgard illustrates the interpretation of multiple rules with multiple control materials and multiple analytical runs.
|
| 8. What are the chances of run rejection? |
- Participants will be able to identify the problem of false rejections caused by narrow control limits, such as commonly-used 2 SD control limits.
- In QC - Rejection Characteristics and Power Curves, Dr. Westgard explains the concepts of error detection and false rejection using the analogy of a smoke detector.
|
| 9. How do you solve out-of-control problems? |
- Participants will learn to distinguish between good and bad habits for responding to out-of-control signals.
- In QC - The Out-of-control Problem, Elsa F. Quam, BS , MT(ASCP), identifies the bad habits of repeating control measurements and reanalyzing control materials and recommends alternative good practices for solving control requirements.
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| 10. What are some common problems encountered while performing QC? |
- Participants will learn to distinguish between good and bad habits for responding to out-of-control signals.
- In "But...Is it really out?" Doing the Wrong QC Wrong, Dr. Westgard and Sten Westgard discuss common "real world" situations with QC, out-of-control events, and errors in QC Design.
- In Ten Ways to do the Wrong QC Wrong, Sten Westgard examines user-submitted out-of-control scenarios and explains where the QC went wrong.
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| 11. What documentation and QC records are required? |
- Participants will learn to specify the parameters and information that need to be documented to make QC records useful for trouble-shooting and problem-solving.
- In QC - The Records, Patricia L. Barry, BS, MT(ASCP), describes the importance of documenting the "history" of a method to learn from past experiences. Good record-keeping is the ability to identify changes that may be the cause of problems.
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| 12. What is external quality assessment? |
- Participants will learn the characteristics of quality assessment programs like peer groups and proficiency testing.
- In QC - External Quality Assessment, David Plaut, BA, and James O. Westgard, PhD discuss the features of peer groups, proficiency testing, and the advantages and disadvantages of these programs.
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| 13. What calculations do you have to perform? |
- Participants will learn to calculate monthly QC statistics (mean, standard deviation or SD, coefficient of variation or CV) and control limits, as well as the cumulative statistics and cumulative control limits.
- In QC - The Calculations describes the equations used for calculating QC statistics.
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| 14. Review of Basic QC Practices and Final Exam |
- Participants will be able to perform a critical review of their own laboratory's practices for planning, implementing, and operating a QC procedure
- Dr. Westgard provides a review of previous lessons, explaining how a real world laboratory incorporates QC into their daily routine with QC - The Practice.
- Dr. Westgard summarizes key QC points in QC - Do's and Don'ts
- In QC - The Frequently Asked Questions (FAQs), Dr. Westgard provides answers to questions from current and past course participants.
- Participants take a Final Exam. Those who pass with a score of 70% or higher are elligible for continuing education credits.
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