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Basic QC PracticesOnline Course Description |
James O. Westgard, Ph.D.
|
 The course coordinator
and primary instructor is James O. Westgard, Ph.D., who is pictured
here with fellow instructors Trish Barry, BS, MT(ASCP), and Elsa
Quam, BS, MT(ASCP). |
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.
Participants who complete the lessons in this course will be able to:
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 analytical 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
classification 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,
analyte 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 analogy 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: How do you interpret control data
using a multirule QC procedure? Participants will 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 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. In QC
- The Multirule Interpretation, a common multirule procedure,
often known as "Westgard Rules", illustrates the application
and interpretation of multiple rules with multiple control materials
and multiple analytical runs.
Lesson 9: 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 reanalyzing
control materials and recommends alternative good practices for
solving control problems.
Lesson 10: 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 11: 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.
Participants will also be able to identify QC planning approaches
that are practical in service laboratories from Dr. Westgard's
discussion of QC - The Planning Process.
Lesson 12: What questions do you have about QC? Participants will be able to ask questions via e-mail or via an internet forum. In QC - The Frequently Asked Questions (FAQs), questions from current and past course participants are summarized and answers presented on-going "page" that is periodically updated.
Basic QC Practices is approved at the Intermediate Level of Instruction for 15 hours of PACE credit. Participants must register with the ASCLS and pass a final exam to receive the 15 PACE credits. The internet materials are being provided on this, the website of Westgard QC. Participants who wish to receive 12 ACCENT credits should contact the webmaster.
Comments, suggestions, and
feedback are invited!
