Basic QC Practices

SECOND EDITION
Training in Statistical Quality Control
for Healthcare Laboratories
James O. Westgard, PhD

with contributions from

Patricia L. Barry, BS, MT(ASCP)
Elsa F. Quam, BS, MT(ASCP)
Sharon S. Ehrmeyer, PhD
David Plaut BA
Bernard E. Statland, MD, PhD

Copyright 2002
7614 Gray Fox Trail, Madison WI 53717
Phone 608-833-4718 HTTP://WWW.WESTGARD.COM

Library of Congress Control Number 2002102704

ISBN 1-886958-17-3
Published by Westgard QC, Inc.
7614 Gray Fox Trail
Madison, WI 53717
Phone 608-833-4718
Copyright 2002 by Westgard QC, Inc. (WQC). All rights reserved. No part of this publication may be reproduced, stored in a
retrieval system, or transmitted in any form or by any means,
electronic, mechanical, photocopying, recording, or otherwise,
without prior written permission of Westgard QC, Inc..

Westgard QC, Inc, Copyright 2002

Table of Contents
1. Whats the idea behind statistical quality control? ............... 1
QC The Idea .......................................................................... 3
2. How do you plot and interpret control results on a LeveyJennings chart? .......................................................................... 15
QC The Levey-Jennings Control Chart ............................ 17
Levey-Jennings QC practice exercise ................................... 28
3. Isnt there a simpler way to do QC? ........................................ 37
QC Electronic Checks and the Total Testing Process ...... 39
4. What is the minimum QC? ......................................................... 49
QC Point-of-Care Testing and Physician Office Laboratories,
Sharon S. Ehrmeyer, PhD ..................................................... 51
5. Are QC improvements still needed? ........................................ 63
QC DOs and DONTs .......................................................... 65
6. How do you interpret control data using a multirule QC
procedure? ................................................................................... 75
QC The Westgard Rules ................................................... 77
7. How do you interpret multilevel QC data? ........................... 91
QC The Multirule and Multilevel Interpretation ............. 93
8. How do you solve out-of-control problems? ........................ 105
QC The Out-of-Control Problem ....................................... 107
9. What documentation and QC records are required? ........ 115
QC The Records ................................................................. 117
10. What is external quality assessment? ................................. 123
QC External Quality Assessment ..................................... 125
11. What regulatory guidelines influence QC? ....................... 141
QC The Regulations, Sharon S. Ehrmeyer, PhD ............ 143
12. What are control materials and what characteristics are
important? ................................................................................. 155
QC The Materials .............................................................. 157
Medical Decision Levels, Bernard E. Statland, MD, PhD 164
13. What calculations do you have to perform? ...................... 169
QC The Calculations ......................................................... 171

Basic QC Practices, 2 nd Edition

14. What are the chances of run rejection? .............................. 185

QC Rejection Characteristics and Power Curves ............ 187
15. Whats wrong with Quality Control? .................................. 199
QC Complaints and Solutions .......................................... 201
16. What does doing the right QC right mean? ................... 207
Repeated, Repeated, Got Lucky .......................................... 209
17. What is the right QC? .............................................................. 215
Mapping the Road to Quality .............................................. 217
18. Whats the right way to select the right QC? .................... 227
QC Computer Technology for Selecting the Right QC ... 229
19. Whats the right way to implement the right QC? ........... 241
QC Computer Technology for Implementing QC Right . 243
20. Whats in the future for laboratory QC? ............................ 261
QC Sage Advice on New QC Approaches ......................... 263
21. Basic QC Glossary ................................................................... 273
22. References and Online Resources ....................................... 291
23. Self-Assessment Answers ....................................................... 299
Appendix 1: CLIA88 Quality Requirements ............................ 327
Appendix 2: Normalized OPSpecs Charts ................................ 331

Foreword to the 2nd Edition

James O. Westgard, PhD
I heard this story from a Medical Technologist who was inspecting a laboratory. She
observed a method that was in very good control in fact, the control was too good
because all the points on the control charts were within plus or minus just one
standard deviation of the means for the control materials. She asked how the control
limits were set and learned that the laboratory used the manufacturer's
recommended range to estimate the standard deviation(s), then computed 3s
control limits. A quick calculation from real control data showed that the actual
standard deviations were about 1/3 of those used in calculating the control limits,
which meant that the nominal 3s control limits corresponded to actual statistical
control limits of 9s! The lab was using a 19s control rule on this method. It's no
wonder the laboratory never had any control problems! It would take a systematic
error of 10 to 15 times the size of the standard deviation to trigger an out-of-control
signal. The method would probably have to run out of reagents before the QC
procedure would detect something was wrong.
This story shows that plotting points on control charts does not constitute
quality control. There's a right way to do QC if the purpose is to assure that test
results provide the quality necessary for patient care. Somehow in this highly
advanced medical industry, in this age of high technology, in this era of making
healthcare an efficient business, and with today's focus on "the bottom line," the
basics are being forgotten. That's why we've written this book. The most basic and
fundamental expectation of a laboratory is that it provides correct test results.
Statistical QC practices are critical for assuring test results are correct.

QC is Safety
QC practices, like safety practices, are recognized as important if something bad
happens, but they seem to be a waste of time and effort when things are working
okay. The key to their success is advance planning, anticipation of what might go
wrong, warnings when things are going wrong, and a planned course of action to
respond to a problem and minimize the damage. The similarity between quality and
safety processes provides a useful analogy: think of a QC problem as a fire and think
of a QC procedure as a smoke detector. Many people agree that a smoke detector
is necessary, but still think it's a waste of time to have an evacuation plan, fire drills,
and training with fire extinguishers, at least until a real fire occurs. Then it
suddenly becomes relevant, and hopefully its not too late to read the emergency
response guide posted in the laboratory.
Safety is part of basic training in the laboratory. So is quality control. We need
to keep at it to maintain a good program, prevent unfortunate events, detect
problems, and respond quickly when they occur. We must periodically review our
safety procedures and participate in planned drills. We also need to review our QC
procedures and be sure they accomplish what they're supposed to they're supposed
to detect errors, without a lot of false alarms that waste time and effort.

QC Basic Training 101 is the minimum training for anyone who

performs a laboratory test, including personnel in point-of-care settings.
QC The Idea presents the concept of measurement variation and its
use to monitor method performance with the aid of a control chart.
QC The Levey-Jennings Control Chart describes the construction of a
control chart, plotting of control data, and interpretation of control results.
QC Electronic QC and the Total Testing Process deals with the specific
issue of using electronic checks as part of a QC system.
QC Point-of-Care Testing and Physician Office Laboratories describes
the overall QC system that is needed in a POC setting.
QC DOs and DONTs provides a summary of good and bad QC
practices.

QC Basic Training 102 adds the following for analysts who work
under supervision in a laboratory testing site.
QC The "Westgard Rules" describes the use of multiple decision rules,
or multirule QC, to make judgments about the acceptance and rejection of
analytical runs.
QC The Multirule and Multilevel Interpretation illustrates the
application of multiple control rules with multiple control materials.
QC The Out-of-Control Problem provides some guidelines on how to
respond to control rule violations, with emphasis on identifying and solving the
problem causing the rejection signal.
QC The Records describes the importance of having a good system of
documentation to aid in solving control problems.
QC External Quality Assessment describes the use of external quality
assessment information to further support the evaluation of performance and
identification of problems.

QC Basic Training 103 adds the following for analysts who work
independently, have responsibilities for managing specific instruments and
systems, or responsibilities for supervising other laboratory personnel.
QC The Regulations provides a summary of guidelines from government and accreditation organizations, particularly CLIA, CAP, and JCAHO.
QC The Materials discusses the selection of control materials and
factors that affect their usefulness for monitoring laboratory methods.
QC The Calculations explains how to calculate the mean and standard
deviation from control data and how to calculate monthly and cumulative
control limits.
QC Rejection Characteristics and Power Curves describes the performance characteristics of QC procedures in terms of probabilities of false rejection and error detection (false alarms and true alarms, resp.) and introduces the

power function graph as a tool for evaluating and comparing the performance of
different control rules.
QC Complaints and Solutions discusses the changes and improvements that will provide better QC systems.

QC Basic Training 104 provides guidance for analysts, supervisors,

managers, and directors who are responsible for establishing and implementing
QC procedures in laboratories.
Repeated, Repeated, Got Lucky describes a common problem in many
laboratories due to poor planning of QC procedures.
Mapping the Road to Quality describes a step-by-step procedure for
selecting control rules and numbers of control measurements on the basis of the
quality required for a test and the imprecision and bias observed for a method.
QC Computer Technology for Selecting the Right QC demonstrates
how to implement an efficient planning process with the aid of a QC design
program.
QC Computer Technology for Implementing QC Right demonstrates
the features that are important when selecting software to implement real-time
data checking.
Sage Advice on New QC Approaches provides a summary of the stateof-the-art in laboratory QC and the future directions for development of
improved QC systems.
Basic QC Practices, 2nd Edition is part of a trilogy of back to basics
books that deal with analytical quality management. Basic Method Validation considers the experimental and statistical techniques needed to characterize the precision and accuracy of a method. Basic Planning for Quality
provides a set of manual tools for selecting control rules appropriate for a test
and method. A more advanced Quality-Planning approach that describes in
detail the application of computer tools can be found in our book Six Sigma
Quality Design and Control.
We hope that readers of the 2nd edition will find Basic QC Practices
even more useful than the 1st edition.

Foreword to the 1st Edition

The 1990s will probably be remembered as the "re-decade" in healthcare
reorganizing, restructuring, and reengineering to reduce costs. The management
strategy of "doing more with less" has meant that laboratories end up with less staff
with less education, less experience, and less training. Given the major changes in
organization and processes, it would be expected that quality control efforts should
have increased to guard against the dangers of doing more with less, i.e., doing more
tests less well. But laboratory inspections continue to cite QC practices as one of
the most frequent and serious deficiencies, suggesting more tests are being done
with less quality control. This outcome is defended by arguments that there are
more and bigger problems elsewhere in the total testing process, therefore analytical quality is no longer a concern.
This book is part of a counter-attack against the notion that we should assume
analytical quality is okay. While it may be simple to perform tests with today's
analytical systems, it is also simple-minded to assume that the test results are
automatically okay and that nothing can go wrong with the testing process. Does
anyone believe the test result given by a bathroom scale? Will anyone settle for a
single measurement, or does it take a series of measurements to convince them of
the correctness of their weight? Laboratory measurements are certainly much more
complicated and should not be assumed to be correct! We owe it to our patients and
physicians to assure, rather than assume, that the test results are correct.
In the sports vernacular of this decade, there is always talk about the need to
get "back to the basics" whenever performance isn't what it's supposed to be. Forget
about the razzle-dazzle and be sure everyone understands the fundamentals. We
have a similar message for anyone who does laboratory tests. Forget about the
razzle-dazzle of the automatic instrument with its digital readout and its computer
interface: be sure the test results are correct. Basic QC Practices is about the
fundamentals of performing statistical QC to assure the quality of laboratory tests.
We hope this book will help you serve your patients better.
The production of this book came about in a different manner than usual.
Before these words were put down on paper, they were first published on the
Internet. That's right! This was a virtual book, in a sense, before it was remade in
its present form. Literally thousands of people have had a chance to preview many
of the lessons presented here, from over 40 different countries around the world.

Acknowledgments
This book would not exist without the help of others. Sten Westgard provided
the inspiration for our website, guided its development, and managed the publication of these materials.
Elsa Quam and Trish Barry continue to be my sounding board for new ideas,
concepts, theories, and approaches. The practicality of these materials are mainly
the result of their insights on how to relate theory to practice. I've been privileged
to work with many capable technologists during my career and Elsa and Trish are
certainly two of the best.
Sharon Ehrmeyer always steps in to help me with the government angle on
regulations. I confess I don't really get very excited by publications in the Federal
Register and am glad that Sharon does and is willing to keep me up to date on what's
happening. Bernie Statland saved us a lot of time and effort by allowing us to
present a summary of his recommendations on medical decision levels. That
information fills what otherwise would have been a real void in these materials.
David Plaut suggested the reorganization of these materials and contributed
to the expansion of coverage to make this a better and more complete manual for
teaching and training.
James O. Westgard
Madison Wisconsin

About the authors and contributors

James O. Westgard, PhD, is a Professor in the Department of Pathology and
Laboratory Medicine at the University of Wisconsin Medical School, where he
teaches in the Clinical Laboratory Sciences program. He is also Director of Quality
Management Services at the Clinical Laboratories, University of Wisconsin Hospital & Clinics, and the President of Westgard QC, Inc.
David S. Plaut, BA, is a Scientific Specialist with more than 30 years of
experience in clinical chemistry. He is a fixture at national, regional, and local
meetings, where his presentations regularly attract standing-room-only crowds.
Elsa F. Quam, BS, MT(ASCP), is a Quality Specialist in the Clinical
Laboratories at the University of Wisconsin Hospital and Clinics.
Patricia L. Barry, BS, MT(ASCP), is a Quality Specialist in the Clinical
Laboratories at the University of Wisconsin Hospital and Clinics.
Sharon S. Ehrmeyer, PhD, MT(ASCP), is a Professor in the Department
of Pathology and Laboratory Medicine and Director of the Clinical Laboratory
Sciences Program at the University of Wisconsin Medical School.
Bernard E. Statland, MD, PhD, is Director, Office of Device Evaluation,
Center for Devices and Radiological Health, US Food and Drug Administration.

Author's Note:
I have spent the last 25 years of my career advocating the improvement of
quality control in the healthcare laboratory. During that time, Ive discovered that
its not enough to talk about the need for quality improvement; people need tools and
techniques to make improvements. So I developed statistical tools to help identify
poor quality control practices and I also developed planning processes to guide
quality improvements. Then I discovered it wasnt enough to demonstrate those
quality improvement tools; people needed these tools to be practical, fast, and easy
to use. So I collaborated with others on the creation of software that automated the
tools and techniques and provided a simple, graphic interface for users. Even then,
I discovered that having the theory and tools and software wasnt enough; people
need a quick and convenient way to learn and access these things. So I started
publishing books, offering online courses, and posting articles on the Internet.
Throughout this book, youll see that I mention Westgard QC products in the
lessons. You may be tempted to say this book is therefore commercially biased. I
admit to several biases: I am biased against the status quo compliance mentality
of current QC practices in healthcare. I am biased against the idea that we should
abandon statistical QC for unproven, less capable QC techniques. I am biased
against the short-sighted, short-term impulse to slash costs in every area of
healthcare laboratories and eliminate any investment in quality control. These very
biases, and my unwillingness to accept the decline of quality control practices, led
me to found a company that would create products to enable and enhance the
improvement of quality control.
Im happy to admit that Im proud of every book that has been published by
Westgard QC and that Im proud of all the software packages weve released. In the
text, where possible, I note some of the other products available on the market that
provide the same quality improvement tools or techniques. In many cases, however,
there is no other software or book out there on the market for instance, our
software may remain the only software in the world that provides automatic QC
selection for quite some time. I look forward to the day when this market is crowded
with competitors and I have to provide a third edition of this book.
As a final note, I have structured Basic QC Practices, 2nd edition, so it stands
alone. You do not need to buy anything further to start improving the quality of your
laboratory. The book has links to free Internet tools on our website that will allow
you to plot and interpret control results on a Levey-Jennings chart. The last
appendix contains a series of normalized OPSpecs charts that you can use to start
a manual quality improvement process. All you need to do is read this book and start
taking action.

Westgard QC, Inc. Copyright 2002

1: What's the idea behind statistical

quality control?
Learn 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.

Objectives:
m Explain the basis of a statistical QC chart.
m Review the QC terminology.
m Preview the application of QC for laboratory tests.

Lesson materials:
m QC The Idea, by James O. Westgard, PhD

Things to do:
m Study the lesson.
m Select an example laboratory test that is of interest to you.
m Review your laboratorys description for doing QC for this test.

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Basic QC Practices, 2 nd Edition

Self-Assessment Questions:
m What is the basic principle of statistical QC?
m What is a control rule?
m What is the meaning of 12s and 13s?
m What is an analytical run?
m What information is needed to calculate control limits?

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Westgard QC, Inc. Copyright 2002

QC The Idea
James O. Westgard, PhD

The Need for QC

The product of a testing process is a numerical result. Unlike a
physical product that can be inspected to assess whether it looks
good or bad, you can't look at a test result and tell whether it's valid.
247 what do you think? If this is a patient sample, do you think
the test result is of good quality (meaning the correct value)?
If the value of 247 is measured on a sample that has been
analyzed before and has the values shown in the accompanying
histogram, do you think the test
result is of good quality? Because
values between 240 and 260 have
often been observed in past measurements, it is expected that
this new value should also fall in
that range if everything is working okay, therefore, the patient
test results included in this run
of measurements are also most
likely correct.

X
XX
XX
XX
XXX
XXXX
XXXX
XX245XX255X 265X
235
240

250

260

A simple graphical tool the QC chart

In the laboratory, control charts are used to make it simple to
compare today's observed value with what is expected based on past
history. As shown in the second figure, by turning the histogram
sideways and spreading the results out according to the time they
were collected, it is easy to see how each observation compares to
the expected distribution of past observations, which are shown by
the central line and certain limits calculated from the mean and
standard deviation (SD) of the past control data. In this figure, the
limit lines correspond to the mean 1 SD, 2 SD, and 3 SD.

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Basic QC Practices, 2 nd Edition

The IDEA of a
QC Chart

X
XX
XX
XX
XXX
XXXX
XXXX
XX
XX255X 265X
235
245
240

250

260

Determine the expected

distribution of control values
Calculate mean and SD from
control data to establish control
limits for control chart
Expect control values to fall with
certain control limits
95% within 2 SD
99.7% within 3 SD
Plot control values versus time to
provide control chart
Identify unexpected values

Very Unexpected
X
265
260

X
X
X
X
X
255 X
X
X X X
XX
250
X
X
X
X
X
X
X
245
X
X
X
240
X
Somewhat Unexpected
235
1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 20 1 2 3 4

Run Number (or Time, Date)

Assuming a Gaussian or normal distribution, it would be

expected that about 68% of the points fall within 1 SD of the mean,
95% within 2 SD of the mean and 99.7% within 3 SD of the mean.
Therefore, it would be very unexpected (0.3% chance) to observe a
control value greater than 3 SD from the mean and such an
observation usually indicates there is a problem with the method.
It is somewhat unexpected to observe a control value greater than
2 SD from the mean, but this will happen at least 5% of the time
when analyzing 1 control per run, so it may indicate a real problem
or it may be a false alarm. It is very common (32% chance) to see
individual values beyond 1 SD from the mean, therefore this
control limit is of no value for making a judgment about method
performance based on a single control value.

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Westgard QC, Inc. Copyright 2002

That's the idea behind statistical quality control. See if you

can get the right answer for a sample with known values. The right
answer is actually a range of values that are calculated from the
mean and standard deviation of past results. That mean and control
limits can be shown on a control chart to make it simple to plot new
control measurements and see how they compare with the expected
range of values.

In the beginning, there was Shewhart

Walter A. Shewhart was a statistician at Bell Telephone Laboratories
who developed the scientific basis for statistical process control.
Shewhart stated that "the object of industry is to set up economic
ways of satisfying human wants and in so doing to reduce everything
possible to routines requiring a minimum amount of human effort.
Through the use of the scientific method, extended to take account
of modern statistical concepts, it has been found possible to set up
limits within which the results of routine efforts must lie if they are
to be economical. Deviations in the results of a routine process
outside such limits indicate that the routine has broken down and
will no longer be economical until the cause of trouble is removed."
Shewhart made this statement in the preface to his book on the
"Economic Control of Quality of Manufactured Product" that was
published in 1931.[1]
Statistical process control, from the beginning, has been concerned with achieving the desired quality (satisfying human wants)
at minimum cost (economic control). Shewhart identified critical
elements such as the expected variation of a routine process, a way
to set limits that will identify when the routine has broken down,
and the need to eliminate causes of trouble when the process was
observed to exceed those limits.
Almost twenty years passed before Levey and Jennings introduced statistical control methods in clinical laboratories in 1950 [2].
Shewhart's original recommendations called for making a group of
measurements, calculating the average and range (maximum difference), then plotting the average and the range on two different
control charts. Levey and Jennings proposed making duplicate
measurements on a patient specimen. Because the actual level of

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Basic QC Practices, 2 nd Edition

the measured constituent varied from specimen to specimen, this

was a more difficult application. Henry and Segalove [3] developed
an alternative procedure in which a stable reference sample was
analyzed repeatedly and individual measurements were plotted
directly on a control chart. This reference sample type of QC in
which individual values or single values are plotted directly is
commonly known today as a Levey-Jennings chart.
Since that time, industry has developed stable control products that mimic patient samples, thus today there are safe QC
materials readily available for most established tests. A better
understanding of the performance characteristics of QC procedures
has been developed [4], which has led to refinements such as the
multirule procedure for evaluating and interpreting control data
[5]. Strategies for cost-effective operation have been further refined
[6]. Computer programs have been developed to implement statistical control procedures by performing the necessary calculations,
preparing graphical displays, applying the desired control rules,
and alerting analysts to problem situations. Today, support for
handling control results is provided by most automated analyzers,
information systems, and even point-of-care devices.

Learning the QC lingo

Statistical process control is the general term used to describe those
aspects of a control system in which statistics are applied to
determine whether observed performance is within the expected
variation of the process, in contrast to other components of a total
control system such as preventive maintenance, instrument function
checks, operator training, etc., that are included in CLIA's broad
definition of quality control.
Quality control procedure is used here to refer to a specific protocol
for analyzing a specific number of control materials and interpreting
a specific number of test results. In healthcare laboratories, a
control procedure is usually implemented by collecting test results
on stable control materials, then plotting those control observations
on a control chart that has specified control limits, or by evaluating
those control results by data calculations employing specified decision
criteria or control rules.

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Westgard QC, Inc. Copyright 2002

Control chart is a graphical method for displaying control results

and evaluating whether a measurement procedure is in-control or
out-of-control. Control results are plotted versus time or sequential
run number; lines are generally drawn from point to point to accent
any trends, systematic shifts, and random excursions.
Control limits are lines drawn on a control chart to provide graphic
criteria for assessing whether a measurement procedure is incontrol or out-of-control. These control limits are usually calculated
from the mean and standard deviation (SD, or s) determined for a
given control material. Typically the interpretation is based on a
specified number of results or points exceeding a certain control
limit. When in-control, patient test results are reported. When outof-control, the run is rejected and no test results can be reported.
Control rule means a decision criterion for judging whether an
analytical run is in-control or out-of-control. It is commonly defined
by a symbol of the form AL, where A is an abbreviation for a statistic
or represents a number of control measurements, and L identifies
the control limits, often specified as the mean a multiple of the
standard deviation (s) or sometimes by a specified probability for
false rejection (Pfr). Some examples follow:

13s refers to a control rule

+3s
that is commonly used with a
+2s
Levey-Jennings chart when
+1s
the control limits are set as Mean
the mean +3s and the mean -1s
3s. A run is rejected when a -2s
single control measurement -3s
exceeds the mean +3s or the
mean 3s control limit.

13s
3s rule
violation

1 2 3 4

5 6 7 8 9 10

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Basic QC Practices, 2 nd Edition

12s refers to the control rule

+3s
that is commonly used with a
+2s
Levey-Jennings chart when
+1s
the control limits are set as Mean
the mean 2s. In the original -1s
Westgard multirule QC -2s
procedure, this rule is used -3s
as a warning rule to trigger
careful inspection of the
control data by other rejection
rules.
22s refers to the control rule
that is used with a Levey- +3s
Jennings chart when the +2s
control limits are set as the +1s
mean 2s. In this case, Mean
-1s
however, the run is rejected -2s
when 2 consecutive control -3s
measurements exceed the
same mean +2s or the same
mean 2s.

12s
2s rule
violation

1 2 3 4

5 6 7 8 9 10

22s
2s rule
violation

1 2 3 4

5 6 7 8 9 10

+3s

R4s refers to a control rule

+2s
where a reject occurs when 1
+1s
control measurement in a Mean
group exceeds the mean +2s -1s
and another exceeds the -2s
mean 2s.
-3s

R4s rule
violation
1 2 3 4

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5 6 7 8 9 10

Westgard QC, Inc. Copyright 2002

Run, analytical run, or run length refers to the interval, which

could be a period of time or group of samples, for which a decision
on control status is to be made. CLIA defines a maximum run length
of 24 hours for chemistry analytes and 8 hours for hematology tests.
Many laboratories define a shorter period based on changes that
may affect the performance of the testing process, such as changing
operators, changing reagents, recalibration, or other factors that
may make the process susceptible to problems. Run length varies
from system to system and laboratory to laboratory. For random
access automated systems, a run is usually defined as the time
interval at which controls are reanalyzed. For manual systems and
batch instruments, a run is often defined as a group (or batch) of
samples that are all analyzed at the same time.

Doing the deed

The idea is simple, but doing QC for real can become complicated.
In this book, weve divided the materials into four study areas that
are appropriate for operators and analysts who have different
levels of interest and responsibility.

Basic Training 101 Doing QC. Not everyone needs to

understand everything in this book, but everyone should study the
first group of lessons. These initial lessons are concerned with
doing QC and understanding its importance. They assume that the
testing application is overseen by someone who takes care of the
more technical details discussed later on in this book.
The lesson QC The Levey-Jennings Control Chart
provides detailed directions on how to prepare control charts, plot
control values, and interpret control data. Because QC can be
complicated (and unfamiliar to non-laboratory personnel), many
manufacturers today recommend the use of electronic QC instead
of statistical QC for Point-of-Care (POC) applications. The lesson
QC Electronic QC and the Total Testing Process discusses
the need and usefulness of both approaches. The minimum requirements that must be satisfied are discussed in the lesson QC
Point-of-Care Testing and Physician Office Laboratories. A
summary of good and bad practices is provided in the lesson QC
DOs and DONTs.

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Basic QC Practices, 2 nd Edition

Basic Training 102: Understanding the Results. Analysts

working in a production laboratory need better skills in interpreting
QC data from internal and external programs. Decisions about
accepting or rejecting test results on the basis of QC should be
straight-forward. However, it is still difficult to know what to do
when there is a problem. Problem-solving requires a more in-depth
understanding and interpretation of QC data, QC records, and
peer-comparison results.
The use of multiple control rules provides one source of
information about the type of error that might be occurring. The
lesson QC The Westgard Rules reviews commonly-used
multirule QC procedures. The lesson QC The Multirule and
Multilevel Interpretation focuses on identifying the type of error
occurring in complex applications where there are multiple control
measurements from multiple control materials. The lesson QC
The Out-of-Control Problem provides general guidance for
trouble-shooting QC problems. An important resource in troubleshooting is good documentation of the history and changes with a
method, as discussed in QC The Records. Finally, an important
source of information for understanding how your method is
performing relative to other methods in the field is described in QC
External Quality Assessment.

Basic Training 103: Maintaining Proper Procedures.

Analysts who have responsibility for particular methods and
systems, or work independently with little supervision, need to
understand many of the fine details of QC. QC actually seems easy
when everything is properly set up and maintained. But thats not
the situation in many laboratories. You need to calculate control
limits properly, select appropriate control rules and numbers of
control measurements, and define when controls will be analyzed.
These are complicated issues that are influenced by both legal
requirements and scientific principles.
First, consider professional practice guidelines and government regulations that influence the practice of QC in laboratory
settings today. See the lesson on QC The Regulations for a
summary of legal and accreditation requirements. To start setting
up a QC procedure, you first select control materials that are

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appropriate for the tests of interest and methods in use. Manufacturers may supply these materials along with their test systems,
but it is also good practice to have at least one control material that
is from a different manufacturer. The selection of materials should
consider important factors, such as matrix effects, stability, vial-to
-vial variation, assayed versus unassayed materials, analyte levels, pre-treatment problems, and cost. See the lesson QC The
Materials for more details.
Next you must assay the selected control materials under
routine operating conditions to characterize the variation expected
in your own situation. This usually involves making at least 20
measurements, then calculating the mean and standard deviation.
There are many pitfalls from using bottle values and estimates of
the mean and standard deviation that dont represent the variation
in your own setting. See the lesson QC The Calculations for
more information about data calculations.
Even with good materials and proper calculations, there may
be false alarms or false rejections that cause much confusion for
analysts, particularly when certain control rules are utilized. The
lesson QC Rejection Characteristics and Power Curves
describes the rejection characteristics of commonly-used control
rules and introduces an important evaluation and planning tool
the Power Function Graph. Finally, the lesson QC Complaints
and Solutions describes the changes and improvements that will
lead to better QC systems in any laboratory setting.

Basic Training 104: Implementing Effective QC

Procedures. Someone probably you since youre the one
interested enough to be reading this book needs to define what QC
procedures are to be used for the tests in your laboratory. This
responsibility often resides with directors, managers, supervisors,
or QC specialists, but someone needs to know what QC to do. The
question often arises when old methods or systems are replaced by
newer ones that have better stability and performance, but should
also be part of the annual review of laboratory procedures. Many
laboratories continue to do the same old QC because they dont
know how to plan QC procedures to account for the quality required
for a test and the performance observed for the method.

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The problems due to poor planning of QC are highlighted in

Repeated, Repeated, Got Lucky. The essays title comes from a
real experience with a common problem in many laboratories. That
problem can be solved by implementing a systematic, step-by-step
planning process to select control rules and the number of control
measurements in an objective way. See the lesson Mapping the
Road to Quality for a description of an approach for selecting
control rules and numbers of control measurements on the basis of
the quality required for a test and the imprecision and inaccuracy
observed for a method. Practical tools are described in Computer
Technology for Selecting the Right QC.
What remains is to provide an effective way for implementing
a well-designed QC procedure. See Computer Technology for
Implementing QC Right for a discussion of the software features
that are needed to implement both simple and advanced QC
designs. Finally, some perspective on future directions in QC is
provided in the lesson QC Sage Advice on New QC Approaches.

References
1. Shewhart WA. Economic Control of Quality of Manufactured
Product. New York; D. Van Hostrand Company, Inc., 1931.
2. Levey S, Jennings ER. The use of control charts in the clinical
laboratory. Am J Clin Pathol 1950;20:1059-66.
3. Henry RJ, Segalove M. The running of standards in clinical
chemistry and the use of the control chart. J Clin Pathol
1952;27:493-501.
4. Westgard JO, Groth T, Aronsson T, Falk H, deVerdier C-H.
Performance characteristics of rules for internal quality control:
probabilities for false rejection and error detection. Clin Chem
1977;23:1857-67.
5. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart
chart for quality control in clinical chemistry. Clin Chem
1981;27:493-501.

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6. Westgard JO, Barry PL. Cost-Effective Quality Control: Managing

the Quality and Productivity of Analytical Processes. Washington,
DC:AACC Press, 1986.

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