Guest Essays This page contains a list of all the Guest Essays (35+). You can access every public Guest Essay by clicking the green button. To see a preview of all the essay, click the blue preview buttons.

Go read it!	Guest Essay Title	Preview	Availability
	The Skinny on QC: Are Quality Requirements "Lean"? Sten Westgard		Public
	Biologic Variation and Desirable Specifications for QC, 2008 Update Dr. Carmen Ricos, Ph.D.		Public
	Frequency of QC - Implications for Patient Safety Dr. Kent Dooley, Ph.D., FACB		Public
	Quality Goal Index Dr. David Parry, Ph.D.		Public
	Multisite Validation that "Westgard Rules" are cost-efficient and effective David Plaut et al		Public
	Biologic Variation and Desirable Specifications for QC, 2006 Update Dr. Carmen Ricos, Ph.D.		Public
	What are the Risks of Risk Management? Sten Westgard		Public
	Quality Management Cocktail: ISO, Lean and Six Sigma Sten Westgard		Public
	The Quality in the Spotlight Conference (and the Westgard Awards) Dr. HMJ Goldschmidt, Dr JC Libeer		Public
	The Nordic Reference Interval Project (NORIP) Dr. Pål Rustad		Public
	The Latest on Reference Values and Reference Intervals Dr. Per Hyltoft Petersen		Public
	Biologic Variation and Desirable Specifications for QC, 2004 Update Dr. Carmen Ricos, Ph.D.		Public
	It's not Rocket Science: Lessons from the Columbia and Challenger Disasters Sten Westgard and James O. Westgard.		Public
	Is GUM Injurious - or just superfluous? Dr. Per Hyltoft Petersen, Ph.D.		Public
	Are Scientific Statements the Scientific Truth? Dr. Callum Fraser, Ph.D.		Public
	Quality Requirements Update Dr. Sharon Ehrmeyer, Ph.D.		Public
	Biodatabase Update Dr. Carmen Ricos, Ph.D.		Public
	Pre-, Post- & Analytical Errors David Plaut, Sten Westgard & James O. Westgard		Public
	Biologic Variation: Principles and Practice Dr. Callum Fraser, Ph.D.		Public
	CLS: Victims of our own success? Diana Maas, MA, CLS(NCA)		Public
	Biologic Variation and Desirable Specifications for QC Dr. Carmen Ricos, Ph.D.		Public
	Good Laboratory Practice versus CLIA Janine Denis Cook, Ph.D.		Public
	Trueness and Uncertainty Dr Xavier Fuentes Arderiu Ph.D. Pharm.D.		Public
	Report of the Norwegian EQA Validator Workshop Dr. Heidi Steensland		Public
	QC Validation in Veterinary Laboratories Kathleen P. Freeman, DVM, MS, Ph.D.		Public
	Biological variation data for setting quality specifications Callum G. Fraser, Ph.D.		Public
	MV - The Regulations Sharon Ehrmeyer, Ph.D.		Public, BMV
	Total Quality Management for Medical Laboratories: A European point of view Dr. Pharm. J.C. Libeer, Ph.D., Ph.D.		Public
	QC - The Regulations Sharon Ehrmeyer, Ph.D.		Public, BQC
	European Approaches to Analytical Goal-Setting Dr. Per Hyltoft Petersen		Public
	What's New with CLIA'88, JCAHO & CAP Sharon Ehrmeyer, Ph.D.		Public
	Defect rates, quality and productivity Robert Burnett, Ph.D.		Public
	Tips on managing the quality of immunoassays R. Neill Carey, Ph.D.		Public
	Approaches to Clinical Laboratory Utilization Art Eggert, Ph.D.		Public
	Understanding Quality Jerry Ehrmeyer		Public

Understanding Quality

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. Read the essay Back to Top

Approaches to Clinical Laboratory Utilization

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. Read the essay Back to Top

Tips on Managing the Quality of Immunoassays

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. Read the essay Back to Top

Defect Rates, Quality and Productivity

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. Read the essay Back to Top

What's New with CLIA'88, JCAHO, & CAP?

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 CLIA’88, the Joint Commission on Healthcare Organizations (JCAHO), and the College of American Pathologists (CAP) regulatory and accreditation guidelines. CLIA’88 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. Read the essay Back to Top

European approaches to analytical goal-setting

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. Read the essay Back to Top

QC - The Regulations

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! Read the essay Back to Top

Total Quality Management for Medical Laboratories: A European POV

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. Read the essay Back to Top

MV - The Regulations

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. Read the essay Back to Top

Biological variation data for setting quality specifications

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. Read the essay Back to Top

QC Validation in Veterinary Laboratories

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?) Read this essay Back to Top

Report of the Norwegian EQA Validator Workshop

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. Read this essay Back to Top

Trueness and Uncertainty

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. Read this essay Back to Top

Good Laboratory Practice versus CLIA

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. Read this essay Back to Top

Biologic Variation and Desiriable Specifications for QC

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 Back to Top

Clinical Laboratory Sciences: Victims of our own Success?

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. Read this essay Back to Top

Biologic Variation: Prinicples and Practice

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 Back to Top

Pre-, Post- and Analytical Errors

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." Read this essay Back to Top

Biodatabase Update

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 Back to Top

Regulation Update

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. Read this essay Back to Top

Are scientific statements the scientific truth?

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. Read this essay Back to Top

Is GUM Injurious - or just superfluous?

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. Read this essay Back to Top

It's not Rocket Science: Lessons from the Columbia and Challenger Disasters

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? Read this essay Back to Top

Ricos Biologic Variation Database: 2004 update

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

The Latest on Reference Values and Reference Intervals

Dr. Per Hyltoft-Petersen discusses why reference values and reference intervals are still an issue and are still important. Read this essay Back to Top

The Nordic Reference Interval Project (NORIP)

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 Back to Top

The Quality in the Spotlight Conference (and the Westgard Awards)

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 Back to Top

Quality Management Cocktail: ISO, Lean and Six Sigma

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 Back to Top

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, Sten Westgard reminds us to take time to evaluate the risks. Read this essay Back to Top

Ricos Biologic Variation Database: 2006 update

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

Multisite Evaluation that "Westgard Rules" are cost-effective and efficient

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. Read this essay Back to Top

Benchmarking Quality with the Quality Goal Index

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. Read this essay Back to Top

Frequency of QC: A Patient Safety Perspective

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? Read this essay Back to Top

Ricos Biologic Variation Database: 2006 update

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 Back to Top

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, Sten Westgard contemplates another question: what's the quality of quality requirements? In the parlance of the latest management trend, are quality requirements "Lean"? Read this essay Back to Top

Your submissions are encouraged!! Please send them in to westgard@westgard.com or mail them to the address below. While we can't guarantee that all guest articles can be published, we regularly post guest essays here that are important to the field of laboratory quality control and our website audience.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.