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Go read it! |
Guest Essay Title |
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The Skinny on QC:
Are Quality Requirements "Lean"? Sten Westgard |
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Public |
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Biologic Variation and Desirable Specifications for QC, 2008 Update
Dr. Carmen Ricos, Ph.D. |
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Public |
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Frequency of QC - Implications for Patient Safety Dr. Kent Dooley, Ph.D., FACB |
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Public |
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Quality Goal Index
Dr. David Parry, Ph.D. |
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Public |
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Multisite Validation that "Westgard Rules" are cost-efficient and effective
David Plaut et al |
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Public |
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Biologic Variation and Desirable Specifications for QC, 2006 Update
Dr. Carmen Ricos, Ph.D. |
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Public |
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What are the Risks of Risk Management?
Sten Westgard |
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Public |
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Quality Management Cocktail:
ISO, Lean and Six Sigma
Sten Westgard |
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Public |
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The Quality in the Spotlight Conference (and the Westgard Awards)
Dr. HMJ Goldschmidt, Dr JC Libeer |
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Public |
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The Nordic Reference Interval Project (NORIP)
Dr. Pål Rustad |
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Public |
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The Latest on Reference Values and Reference Intervals
Dr. Per Hyltoft Petersen |
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Public |
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Biologic Variation and Desirable Specifications for QC, 2004 Update
Dr. Carmen Ricos, Ph.D. |
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Public |
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It's not Rocket Science: Lessons from the Columbia and Challenger Disasters
Sten Westgard and James O. Westgard. |
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Public |
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Is GUM Injurious - or just superfluous? Dr. Per Hyltoft Petersen, Ph.D. |
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Public |
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Are Scientific Statements the Scientific Truth? Dr. Callum Fraser, Ph.D. |
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Public |
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Quality Requirements Update Dr. Sharon Ehrmeyer, Ph.D. |
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Public |
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Biodatabase Update
Dr. Carmen Ricos, Ph.D. |
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Public |
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Pre-, Post- & Analytical Errors
David Plaut, Sten Westgard & James O. Westgard |
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Public |
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Biologic Variation: Principles and Practice
Dr. Callum Fraser, Ph.D. |
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Public |
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CLS: Victims of our own success?
Diana Maas, MA, CLS(NCA) |
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Public |
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Biologic Variation and Desirable Specifications for QC
Dr. Carmen Ricos, Ph.D. |
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Public |
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Good Laboratory Practice versus CLIA
Janine Denis Cook, Ph.D. |
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Public |
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Trueness and Uncertainty
Dr Xavier Fuentes Arderiu Ph.D. Pharm.D. |
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Public |
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Report of the Norwegian EQA Validator Workshop
Dr. Heidi Steensland |
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Public |
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QC Validation in Veterinary Laboratories
Kathleen P. Freeman, DVM, MS, Ph.D. |
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Public |
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Biological variation data for setting quality specifications
Callum G. Fraser, Ph.D. |
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Public |
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MV - The Regulations
Sharon Ehrmeyer, Ph.D. |
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Public, BMV |
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Total Quality Management for Medical Laboratories:
A European point of view
Dr. Pharm. J.C. Libeer, Ph.D., Ph.D. |
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Public |
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QC - The Regulations
Sharon Ehrmeyer, Ph.D. |
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Public, BQC |
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European Approaches to Analytical Goal-Setting
Dr. Per Hyltoft Petersen |
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Public |
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What's New with CLIA'88, JCAHO & CAP
Sharon Ehrmeyer, Ph.D. |
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Public |
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Defect rates, quality and productivity
Robert Burnett, Ph.D. |
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Public |
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Tips on managing the quality of immunoassays
R. Neill Carey, Ph.D. |
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Public |
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Approaches to Clinical Laboratory Utilization
Art Eggert, Ph.D. |
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Public |
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Understanding Quality
Jerry Ehrmeyer |
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Public |
Understanding Quality
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What does the word "Quality" mean,
anyway? Is it an absolute or relative term? Jerry Ehrmeyer, a
frequent speaker at AACC conventions, discusses what "quality"
really means, using everyday examples from the quality of wine
to the quality of maps.
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Approaches to Clinical Laboratory
Utilization
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Dr. Art Eggert discusses the evolution of
clinical laboratory utilization. Do you remember back when laboratories
used to be a profit center instead of a cost center? Dr. Eggert
traces the history of laboratory testing and its costs, and discusses
how to optimize laboratory testing benefits while minimizing
the expense.
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Tips on Managing the Quality of Immunoassays
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Dr. R. Neill Carey shows how to derive quality
requirements for immunoassays from the proficiency testing criteria.
Theophylline, cortisol, thyroxine, and folate examples are illustrated.
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Defect Rates, Quality and Productivity
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Dr. Robert Burnett describes the need to focus
our future thinking on defect rates to better manage the analytical
quality of laboratory tests. In the midst of our preoccupation
with the profound changes that are taking place in health care
delivery in general, and laboratory medicine in particular, it
might be of some comfort to realize that there are some fundamental
things that have remained the same. Two management objectives
that have not changed in organizations, including clinical laboratories,
are the need for high quality and the need for high productivity.
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What's New with CLIA'88, JCAHO, &
CAP?
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Dr. Sharon Ehrmeyer, a frequent speaker on
government regulations, graces our website with a timely essay
on the newest developments in CLIA, JCAHO, & CAP. This article
is an update of CLIA88, the Joint Commission on Healthcare
Organizations (JCAHO), and the College of American Pathologists
(CAP) regulatory and accreditation guidelines. CLIA88 establishes
minimum performance standards for all clinical laboratories;
JCAHO and CAP are professional organizations which have received
deemed status from the Healthcare Financing Administration (HCFA).
Both voluntary organizations inspect their members using standards
that meet or exceed those of CLIA.
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European approaches to analytical
goal-setting
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In the US, when it comes to quality requirements,
we have CLIA and clinical decision criteria and a whole host
of other choices (many of them bad). But, if you can believe
it, the situation in Europe is even more complicated! Dr. Per
Hyltoft-Petersen discusses external quality assurance schemes,
ISO, analytical goal-setting, and finally biological goal-setting.
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QC - The Regulations
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Dr. Sharon Ehrmeyer returns with an section
for our Basic QC Practices series. If you're operating a laboratory
in the U.S., there's a government agency out there that wants
to regulate you - do you know which one? In this article, Dr.
Ehrmeyer details all the various bureaucracies and their regulations.
See which rules apply to you!
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Total Quality Management for Medical
Laboratories:
A European POV
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Dr J.C. Libeer, Ph.D., Ph.D, joins us from
Belgium, where he has put together a comprehensive survey of
the European quality schemes and programmes, noting their strengths
and weaknesses. A must for those who want to learn about and
keep current with laboratory quality management in Europe.
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MV - The Regulations
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Dr. Sharon Ehrmeyer is back again! You may
remember her article on regulations in our Basic QC Practices
series. In this article, she explains which regulations and standards
and agencies are involved with Method Validation. A must-read
reference.
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Biological variation data for setting
quality specifications
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Dr. Callum G. Fraser, one of the leading experts
in defining quality goals, has provided us with an article based
on his presentation at the 1998 Fourth European Conference Quality
[r]evolution in Clinical Laboratories in Antwerp. Dr. Fraser
provides a detailed discussion of biologic goals and describes
the process as well as the sources of data. Links in the essay
are provided to tables on this webiste that contain the data.
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QC Validation in Veterinary Laboratories
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Kathleen P. Freeman DVM, Ph.D., offers a testimonial
on how she used the Westgard QC Planning Process to improve the
quality of her laboratory. Hey, even pets need QC! (And if your
dog's blood tests are performed with better QC than your own
lab tests, shouldn't you do something about it?)
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Report of the Norwegian EQA Validator
Workshop
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Dr. Heidi Steensland, head of the the Norwegian
EQA, presents us with the results of a QC Validator workshop.
Over 40 QC Validator users from more than 25 laboratories in
Norway gathered to discuss the use and application of the QC
Validator program. They shared their results with us, and now
we share them with you.
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Trueness and Uncertainty
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From accuracy to working standard, ISO plans
to redefine all the terminology used in the laboratory. Dr. Xavier
Fuentes-Arderiu, who provided us with the Biological Data Bank,
now presents an essay on the proposed changes. See
also Dr. Westgard's comments on the usefulness of these proposals.
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Good Laboratory Practice versus CLIA
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This guest essay by Dr. Janine Cook details
the obligations of Good Laboratory Practice and the government
requirements of CLIA. Find out where the two mesh and where they
conflict.
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Biologic Variation and Desiriable
Specifications for QC
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Dr. Carmen Ricos provides us with a comprehensive
database of biologic variation for over 300 quantities, based
on a review of over 140 articles in the scientific literature.
The accompanying database includes the observed between- and
within-subject biologic variation for these quantities, as well
as desirable specifications for imprecision, bias and total allowable
error. This is a fantastic wealth of information for those seeking
more guidance on quality requirements.
Read this essay
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Clinical Laboratory Sciences: Victims
of our own Success?
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Diana Mass, from Arizona State University,
shares her thoughts on how the continuing success of laboratories
may have contributed to their downfall. As laboratories continue
to do "more with less" management seems to expect them
to do even more with even less. What can labs do to prevent this
downward spiral? Diana has a few remedies.
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Biologic Variation: Prinicples and
Practice
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Dr. Callum Fraser is recognized as the international
expert on biologic variation. His new book from the AACC press:
Biologic Variation: Principles and Practice is now the definitive
reference on the subject. Luckily, Dr. Fraser has let us post
the Foreword to this book on our website.
Read this essay
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Pre-, Post- and Analytical Errors
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Which improvements should be made first? Unfortunately,
we seem to be arguing that some errors are more important (i.e.
worse) than others. But rather than make a Chicken-or-Egg choice,
David Plaut, Dr. Westgard, and the webmaster urge an analysis
of these types of errors. The answer to the question of which
improvements come first need not be "pre" or "post"
or "analytical" - it should be "all three at once."
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Biodatabase Update
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Dr. Carmen Ricos and her colleagues
have provided us with an update to their 2000 Biological Variation
Database. New analytes have been added, figures have been updated
and in some cases, corrected. This article summarizes all the
changes made to the desirable specifications for total error,
bias, and imprecision (derived from biological variation) for
hundreds of analytes.
Read this essay
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Regulation Update
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CLIA, JCAHO, CAP, CMMS....This festival of
acronyms can only mean one thing: Dr. Sharon Ehrmeyer, our highly
esteemed and frequent contributor, is updating us on the latest
in quality regulations. See the latest rules you need to know.
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Are scientific statements the scientific truth?
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Callum G. Fraser, Ph.D., the noted expert on biologic variation, takes an in-depth look at new guidelines for hsCRP. While the AHA/CDC has produced a scientific statement, sadly, he finds they have not found the scientific truth.
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Is GUM Injurious - or just superfluous?
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What is GUM? Well, it's not something you chew. It's the ISO Guide to Uncertainty in Measurements. And as ISO standards become more widely used for accreditation of laboratories worldwide, GUM will become more widely used by both laboratories and manufacturers. But is GUM useful? superfluous? injurious? Recently, a panel of seven Scandinavian scientists examined GUM and evaluated its usefulness. We are pleased to share their findings.
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It's not Rocket Science: Lessons from the Columbia and Challenger Disasters
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The loss of the Columbia and Challenger Shuttles were not just technical failures - they were also a result of a culture at NASA that devalued safety. As we look at the Shuttle failures, how can we be sure that labs aren't doing the same thing?
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Ricos Biologic Variation Database: 2004 update
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Dr. Carmen Ricos and her colleagues have provided us with an update to their Biological Variation Database. New analytes have been added, figures have been updated and in some cases, corrected. This article summarizes all the changes made to the desirable specifications for total error, bias, and imprecision (derived from biological variation) for hundreds of analytes.
Read this essay
Back to Top
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The Latest on Reference Values and Reference Intervals
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Dr. Per Hyltoft-Petersen discusses why reference values and reference intervals are still an issue and are still important.
Read this essay
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The Nordic Reference Interval Project (NORIP)
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Dr. Pål Rustad explains how more than 100 laboratories in the Nordic countries collaborated to produce common reference intervals for 25 quantities in serum/plasma and 8 hematology quantities.
Read this essay
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The Quality in the Spotlight Conference (and the Westgard Awards)
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Dr. HMJ Goldschmidt and Dr JC Libeer explain the history of the Quality in the Spotlight conference, an annual event in Europe that is devoted to the topic of quality. Also, a list of "Westgard Award" winners is given.
Read this essay
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Quality Management Cocktail: ISO, Lean and Six Sigma
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Sten Westgard provides a report on a presentation from three experts on three different quality management trends. Different approaches are discussed, areas of convergence are described.
Read this essay
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What are the Risks of Risk Management?
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Risk Management is coming to laboratory medicine, possibly to a regulation near you. As we learn about the principles, tools, and processes of RM, Sten Westgard reminds us to take time to evaluate the risks.
Read this essay
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Ricos Biologic Variation Database: 2006 update
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Dr. Carmen Ricos and her colleagues have provided us with an update to their Biological Variation Database. New analytes have been added, figures have been updated and in some cases, corrected. This article summarizes all the changes made to the desirable specifications for total error, bias, and imprecision (derived from biological variation) for hundreds of analytes.
Read this essay
Back to Top
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Multisite Evaluation that "Westgard Rules" are cost-effective and efficient
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David Plaut, longtime friend and colleague 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.
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Benchmarking Quality with the Quality Goal Index
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Dr. David Parry of St. Boniface General Hospital in Winnipeg, provides us with data on Sigma metrics in two laboratories. Dr. Parry's innovation is a Quality Goal Index, a metric that can distinguish between precision and accuracy problems, as well as techniques to deal with calibrator lot changes.
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Frequency of QC: A Patient Safety Perspective
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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 how often they run controls?
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Ricos Biologic Variation Database: 2006 update
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Dr. Carmen Ricos and her colleagues have provided us with the fifth edition of their Biological Variation Database. New analytes have been added, figures have been updated and in some cases, corrected. This article summarizes all the changes made to the desirable specifications for total error, bias, and imprecision (derived from biological variation) for hundreds of analytes.
Read this essay
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The Skinny on QC: Are Quality Requirements "Lean"?
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In light of the publication of the fifth edition of the Ricos et al biologic variation database, Sten Westgard contemplates another question: what's the quality of quality requirements? In the parlance of the latest management trend, are quality requirements "Lean"?
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