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Sigma Analysis: a new mid-volume lab
analyzer
We take a look at data from an abstract
that will be presented at the 2009 AACC/ASCLS/CSCC conference in
Chicago. Just because you buy a new chemistry instrument, does that
guarantee you'll get world class quality methods?
New Biodatabase from
Ricos
Dr. Carmen Ricos and her colleagues have
generously allowed us to post a new database on Biologic
Variation within subjects with disease. The previous databases have
relied on data from healthy patients. See how the variation changes
when you examine patients with different disease states.
Interview with Dr. Carmen
Ricos
in addition to letting us post another one
of her databases, Dr. Carmen Ricos agreed to answer a few questions
about the work, the results, and the meaning of all this biologic
variation.
EQC = Eliminated QC
A recent exchange of emails between POCT
users reveals the true effect of reducing QC frequency with EQC
options.
NEW Online
Course:
Quality Management and Design of Analytical Systems
(An Introduction)
Quality Planning and Design are part of a larger
systems approach to analytical management. in this new six lesson
course, participants will review current guidelines for quality and
learn to use QC Design tools to customize their procedures and achieve
the quality required by their tests.
As a bonus, register this month with coupon NEWIQMD and you'll save 25%
off the cost of registration (must use coupon at http://www.westgardqc.com )
The Risk Management
Process
A whole host of Risk Management tools,
techniques and terminology are headed for the laboratory. New standards
and guidelines will make heavy use of these concepts in coming
recommendations for laboratory conduct. Do you know what Risk really
is? Do you know what Risk Management really means? Dr. Westgard
explains some of the words and meanings of this new movement...
Guest Essay: A Manufacturer's
Perspective on Sigma-metrics
Dr. Ian Giles, Director of Scientific
Affairs for Sysmex America, shares their experiences with Sigma-metric
analysis and its impact upon their operations and customer relations.
Change is coming to Westgard
Web
We wanted to give you a heads-up on future
changes that will be made to the layout and operation of Westgard Web.
Don't Panic.
March Madness: Out-of-control in North
Dakota
Dr. Westgard returned to his birthplace in
March. Reflecting on events there more than half a century ago, as well
as those terrible floods of more recent times, Dr. Westgard writes that
both path and present call us to quality.
Westgard Sigma Analysis: Sysmex xt 1800i
Hematology
A poster at the IFCC conference applied
Sigma-metric analysis to a number of hematology methods, including
differential parameters, on the Sysmex xt 1800i. Interestingly, they
chose Biologic-based quality requirements, not the usual CLIA goals. We
review the data and generate some graphic analysis.
Westgard Sigma Analysis: What QC to do
for Hematology
Based on the Sigma-analysis of the Sysmex
xt 1800i, we apply QC Design and analyze the different QC procedures
appropriate for different quality requirement.s
First, Do No
Harm:
A Safety Net to Catch Analytic Errors
Risk Management standards are on the way.
Some of the old QC techniques are going to be replaced by these new
methods. That's all well and good, but in the end, you still need a way
to catch those errors that slip through. Dr. Westgard explains how to
balance the best of the old with the best of the new.
High
Reliability Testing: Sensitivity to Operations
In our next lesson on High Reliability, we
discuss the need for laboratories to treat "routine" tests as anything
but routine. How does your laboratory handle the crush of data and
detail in its daily operation - and still be sensitive to possible
signs of failure?
Westgard Sigma Analysis: 4 Glucose
methods
Tight Glycemic Control is one of the latest
trends in laboratory medicine - one that requires fast, frequent, and
precise testing. A recent paper studied four different glucose methods,
one POC, 2 blood gas, and one central laboratory hexokinase method. Can
you guess which methods performed the best, and what methods were good
enough to support TGC?
Interview:
Paul Epner and Labs are Vital™
The recently-retired head of the Labs Are Vital™
initiative talks about developing, launching, and growing the popular
laboratory community program.
Guest Essay:
Quality Requirements, QC Validation and Sigma Metrics for Veterinary
Laboratories
Dr. Freeman and Alison Farr talk more about their
2008 papers on veterinary quality requirements and the Sigma
performance metrics they calculated for their laboratory.
Westgard Sigma Analysis: 6 Hcy
methods
Elevated concentrations of homocysteine
(Hcy) are clinically associated with disorders and cardiovascular
disease. A recent paper compared six different methods for this
important analyte. But in the absence of a CLIA quality requirement,
how can we compare performance?
Happy Holidays 2008 and a Hopeful New
Year 2009
HbA1c for screening and diagnosis of
diabetes?
Recent coverage of estimated average
glucose (eAG) and the rise of HbA1c as the method for diagnosis of
diabetes raises an obvious question: Are HbA1c methods and results of
better quality than glucose methods and results? Dr. Westgard looks at
the numbers.
High
Reliability Testing: Reluctance to Simplify
In our next lesson on High Reliability, we
talk about a deceptively simple principle: the reluctance to simplify.
When everything about your organization is dedicated to streamlining
and making things more efficient, how do you maintain the ability to
know all the real complexity of your processes?
Quality
Requirements for Dogs, Cats, and Horses?
In a new paper, two scientists perform a
literature survey of the veterinary diagnostic literature and attempt
to calculate basic quality requirements for common analytes - for the
non-human species.
New Westgard Download:
Sigma-metrics Tool
On September 4th, 2008, Dr. Westgard spoke
as part of the AACC audioconference on "New Directions in Laboratory
QC" - which was subsequently quoted in the Clin
Lab News article on Risk and CLIA. We are pleased to make available
Dr. Westgard's complete presentation, as well as two Sigma-metrics
Charts and instructions on how to use them in QC Design.
Westgard Sigma Analysis: new HbA1c
method
At the 2008 AACC/ASCLS convention, a poster
was presented for a new direct enzymatic assay for %HbA1c. How does it
stack up against HPLC and immunoassay methods? How do you judge a
method when you've got multiple comparison methods and multiple quality
requirements?
A brief introduction to EP 15 -
interview with the CLSI committee chair, R. Neill Carey
We were fortunate enough to get R. Neill
Carey, PhD, the chair of the CLSI EP 15 committee, to present and
explain that new standard at the Chicago Method Validation workshop. He
also contributed a chapter to the new Basic Method Validation manual on
the same topic. But for those who have never heard of EP 15 before, we
conducted a short interview with Dr. Carey. This short introduction to
EP 15 may pique your interest in this new guideline.
Thinking about Three Sigma
In a previous lesson, we discussed some
possible actions to take when the Sigma-metric for a method is higher
than Six. But what about those methods with low Sigma-metrics? What do
you do when Sigma analysis delivers bad news?
Surpassing Six Sigma: 7 Thoughts on
Superior Quality
Recently, we've been seeing methods by some
instruments that perform well beyond Six Sigma. What are the
implications when a method is better than world class? Does this change
how we should operate those tests?
Westgard Sigma Analysis: Abbott
ARCHITECT c8000
At the 2008 AACC/ASCLS convention, Sten
Westgard was a co-author on a study examining multiple instruments on
multiple sites. When a large healthcare system has a lot of the same
instrument, how do the instruments perform?
High
Reliability Testing: Preoccupation with Failure
In the second lesson on High Reliability,
the first principle of HROs is discussed. Preoccupation with failure
sounds like a bad thing, so why is it a key behavior in highly reliable
organization?
Westgard Sigma Analysis: POC hematology
instrument
A recent evaluation paper in a prominent
journal took a look at a new POC hematology instrument. They concluded
that the performance was "within acceptable limits." When the bar is
that low, what's the actual Sigma performance?
Time to Engage
in Measurement Uncertainty
In the ongoing War of Words, it's time to
hear another voice. Dr. Dietmar Stockl, an expert from across the
Atlantic, provides us with a detailed essay explaining how measurement
uncertainty can be useful to the laboratory - and even co-exist with
Total Error.
Update on EP22, EP23 and "Alternate
QC"
The search for a different way to do QC
continues. And continues. Read the latest developments, from a meeting
at the AACC/ASCLS convention of the CLSI committees on EP 22 and
EP23.
A different approach: High Reliability
Testing
Lean, Six Sigma, ISO and Risk Management
aren't the only Quality management systems out there. There's at least
one other system called High Reliability Organiation (HRO) theory. A
recent report details how HRO can help improve healthcare
quality.
The Quality of Proficiency
Testing
A recently-released report from the CDC
dared to ask the big question: is Proficiency Testing effective? Not
only that, it dared to recommend a significant change in the CLIA
statutes.
Westgard Sigma Analysis: Roche cobas
c311
At the 2008 AACC/ASCLS convention, there is
a poster with performance data on the new Roche cobas c311. What's the
Sigma of these new methods?
New Edition! Basic Method
Validation
We're proud to announce the publication of
the third edition of this essential laboratory reference. This concise
guide to method validation has been revised, updated, and expanded.
We've added new chapters covering ISO, CLSI guidelines, and
Sigma-metrics. Download excerpts now and get an extra discount if you
place an online order.
New
Online Training in Method Validation
To coincide with the release of the third
edition, the online training course in method validation has also been
updated and expanded. New tools, new supplementary materials, even a
streaming video presentation on the "Secrets
of Method Validation." The most comprehensive course in method
validation just got better.
When Quality depends on the company you
keep
A recent report from the CDC identified a
number of problems with current proficiency testing. Among those
problems, the group SD quality requirement. What is it? Why is it a
problem? What can be done about it?
Westgard Sigma Analysis: a POC multitest
system
When a new POC instrument reports it has
great precision numbers, is that all you need to know about
performance?
CAP talks about ISO
15189:2007
Earlier this year, CAP announced that it
would offer ISO 15189:2007 certification to laboratories by the end of
this year. What does this mean for laboratories? Westgard Web asks the
CAP ISO staff.
Biologic Variation Database: the
2008 update
Dr. Carmen Ricos and her colleagues have
graciously provided us with the fifth edition of their
biological variation database. New data, new analytes, and new
desirable specifications - a most valuable contribution to the
field.
See the update highlights
See the References
See the Reference List
See the Desirable Specifications for
Imprecision, Inaccuracy, and TEa
Waiting on the FDA for alternate quality
control?
Earlier this year, CMS held out hope that
the FDA would create another option for quality control: Alternate QC
(AQC). Later, the FDA said it couldn't do that right now, but that it
remains open to the possibility. But, just how feasible is it
for today's FDA to tackle a new clearance option?
Westgard Sigma Analysis: GHb and cobas
6000
This month we take a Roche cobas 6000, we
apply the different analytical quality requirements for GHb and
evaluate its performance. What requirements should you pick? What rules
should you use?
The Skinny on QC? Are Quality
Requirements Lean?
In light of the publication of the fifth
edition of the Ricos et al biologic variation database, it's worth
contemplating one question: what's the quality of quality requirements?
In the parlance of the latest management trend, are quality
requirements "Lean"?
What we can learn from World Class
Methods
Over the past few months, Westgard Web has
performed several Sigma analyses of Abbott ARCHITECT methods, all with
superior results. We decided to go straight to the source and ask them
what they're doing that produces this level of quality. Turns out,
they're just doing all the things that we should be doing in the
laboratory...
Clinical
Chemistry Citation Classic (sub required)
In the March 2008 issue of Clinical
Chemistry, Dr. Westgard tells the story behind the seminal 1973
paper by Westgard and Hunt on the "Use and Interpretation of Common
Statistical Tests in Method Comparison Studies." This is the paper that
laid the foundation for method evaluation/validation studies for
laboratory tests.
New Year, New
Store
We've updated and upgraded our online
store. We're using Yahoo and Paypal to provide the store and payment
functionality. See the thumbnail below to get an idea of what the store
looks like, then Come check it out - at www.westgardqc.com - and let us
know what you think.
2008: The Year of EQC, AQC, or no QC at
all?
A recent audioconference explained how EQC,
despite its dubious scientific validity, was no longer educational, but
policy. The audioconference brought up the possibility once more that
the FDA will provide a QC clearance option for manufacturers. Don't get
your hopes up...
Sigma metrics of POC glucose
instruments
Scientists at the Mayo Clinic performend an
interesting study of multiple POC glucose methods to evaluate their
performance. Using this valuable data, we apply Westgard Sigma
analysis. Do you think there's world class performance at the point of
care?
Evaluating GHb quality
requirements
In the recent essay on Guidelines for GHb, a number of
different quality requirements were discussed and proposed. So what's
happening on the instrument? Taking an Abbott Architect c8000, we apply
the different analytical quality requirements and evaluate its
performance.
The Quality of Glycated Hemoglobin
(GHb)
Part Four of Dr. Westgard's series on the
War of Words in the Laboratory shows the impact of lax standards on one
of the most important tests in the laboratory. Guidelines for GHb have
been issued in 2002 and 2007 - but are they on target? Is there any
evidence in this evidence-based medicine guideline?
Equivocal QC: Coming to a Lab near
you
Despite universal complaints about the CMS
"EQC" options, despite the CMS admission that "we blew it", and despite
a complete lack of scientific validity, these policies are coming to a
laboratory near you. See how it's going to happen...
Guest Essay: Frequency of QC and Patient
Safety
We're delighted to present this guest essay
from Dr. Kent Dooley, an astute reader who has done serious thinking
about what patient safety implies for quality control. If labs are
serious about patient safety, should they be reducing their quality
control?
Sigma metrics: Abbott Architect
c16000
Using 2007 AACC poster data, we take
another look at Abbott's newest, biggest chemistry instrument. Does the
site evaluation corroborate the manufacturer's evaluation?
A War of Words in Laboratory
Terminology? Part III
Looking beyond the terminology of Trueness
and Uncertainty, Dr. Westgard examines the intended uses and customers
of these terms.
A War of Words in Laboratory
Terminology? Part II
Trueness. Uncertainty. Accuracy. Precision.
Why are there so many definitions for the same terms? Dr. Westgard
traces the history of metric concepts in the clinical laboratory. See
when and where ISO, IFCC, and CLSI began introducing new terminology
into the lab.
A War of Words in Laboratory
Terminology?
Have we reached the point where a "total
allowable error" is no longer acceptable? Shall we stop defining how
good a test should be - just so we can insist that tests shouldn't be
in error at all? The ISO terminology of trueness and uncertainty and
its passionate advocates might be saying just that.
"But...is it
reallyout?"
We get a lot of email at Westgard Web, and
a lot of it asks questions about specific situations where the theory
of QC might say a control is out, while the "real world" laboratory
believes that it's actually "in." This essay discusses why and where
there are the differences between the theory of QC and the practice of
QC.
Ten ways to do the Wrong QC
Wrong
Taking a cue from the previous, we look at
a "Top Ten" list of real world QC scenarios and see how laboratories
are getting their QC wrong.
Why We Write
After ten years of Westgard Web and more
than 100 essays written, Dr. Westgard reflects on the reasons for
writing for the Laboratory Professional audience on the Internet.
New "Westgard Rules" worksheets?
If the rules are 25 years old, why are we
offering "new" worksheets? Well, it came to our notice that the current
worksheet graphically describes the "classic" multirules, but no
similar worksheets exist for our other recommended multirule
combinations. Now we've remedied that - in one download, you can see
the "classic" rules, as well as modern recommendations for instruments
with 2 controls and 3 controls per run.
"Westgard Rules" at
25 years - an audio download
By some accounts, the "Westgard Rules"
turned 25 years old in 2007. In celebration of this anniversary, the
webmaster interviewed Dr. Westgard by phone about the past, present,
and future of multirules and QC. ( Please note this file is 13.5 MB.
Our apologies for the quality of the recording - Dr. Westgard was on
his way to South Africa at the time). In the future, we plan on
offering regular "podcasts" for your convenience.
Good Laboratory Practices, Part II
Some practical advice on the proper set up,
implementation and use of QC, as well as a discussion of "standard
deviations" from Good Laboratory Practice.
Good Laboratory Practices for
Statistical QC.
Did you know the ASCP held a teleconference
this year on " A How-Should-I guide to Laboratory Quality Control."
They cited the lack of "Good Laboratory Practice" standards for QC in
the laboratory. If only they had looked at the recent CLSI standards,
they would have found some. Dr. Westgard explains the new C24-A3
standard and how it can lead you to good laboratory practices in
quality control.
A Multichemistry analysis: 16 years
later
The unspoken assumption in laboratories and
diagnostics is that we're getting better all the time. Our new systems
are better than our old ones. But does the data show this? Just looking
at a Westgard et al. paper from 1990 and a collection of recent
instrument performance data provides a challenge to this thinking.
Are "Westgard Rules" efficient and cost
effective?
David Plaut, longtime friend of Dr.
Westgard, recently collaborated on a multisite evaluation of the
implementation of "Westgard Rules" in the laboratory. The poster,
originally at the 2005 AACC conference, is now available in an expanded
format online. And we thank David for it.
The War on Error: Complete Victory or a
Long, Hard Slog?
As part of our continuing series on Patient
Safety concepts, we explore the nature of Error, its varieties and
occurences in the lab, and consider the proposed changes in QC through
the perspective of Swiss cheese. No. We're not kidding. Swiss cheese.
Patient Safety: Can we get there from
here?
Our second lesson on Patient Safety
examines the traits of an ideal safety culture - and compares current
laboratory practices to those ideals. Does "lab culture" measure up to
"safety culture"? What prevents us from reaching the ideal safety
culture?
What are the risks of Risk
Management?
Risk Management is coming to laboratory
medicine, possibly to a regulation near you. As we learn about the
principles, tools, and processes of RM, let's also take time to
evaluate the risks.
Patient Safety: What's the culture in
the lab?
You may already know that Patient Safety is
an important "new" concept in healthcare. It's a hot topic in articles,
at conferences, and new institutions have been created and new laws
have been passed just to promote Patient Safety. So where does the lab
fit in?
The Quality of PT Sigma
metrics
In our series on the Quality of Laboratory
Testing, we've been looking at as many PT groups as possible. But the
questions arises, are some PT group estimates better than others? We
take a closer look at CAP PT Sigma metrics.
Multistage QC Design with EZ Rules
3
See how EZ Rules 3 makes
Multistage QC Design possible. The most advanced QC techniques are easy
to a sneak peak at a new version of EZ Rules we'll be releasing soon.
This new version combines the best features of Validator and EZ Rules,
and adds some new twists as well.
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