Spotting Quality Internationally: The Antwerp Meetings
This year's "Quality in the Spotlight" conference tackled the subject of auditing and inspections. Dr. Westgard reviews some of the highlights.
I’ve just returned from another stimulating conference on Quality in the Spotlight, an annual meeting organized by Dr. Henk Goldschmidt (pictured at right) from Holland and Dr. Jean-Claude Libeer (pictured at left) from Belgium. The meeting is held at a historic building near the center of Antwerp, which provides an ambiance that is hard to find here in the US. That, plus the fact that it is a small meeting of some one hundred people who are intensely interested in quality, makes it a unique conference.
This year’s topic was auditing and inspection, which brought me a new understanding of the differences between international accreditation programs vs the US regulatory approach. Given the problems with laboratory inspections in the US, we find our country moving to a more punitive and less educational approach. In contrast, much of the rest of the world utilizes inspections (or audits) to improve the quality of laboratories, rather than to regulate compliance with minimum standards for quality, as in the US. As a result, the laboratories in the rest of the world are making advances in quality while the US is at best standing still. In fact, the recent GAO report  suggests that the quality of US laboratories may be getting worse, rather than better! Nonetheless, the GAO report recommends changes that are meant to strengthen the regulatory application at the expense of education and improvements.
The highlight of the meeting was a presentation by Dr. David Burnett from the UK, who received this year’s Westgard Quality Award (pictured at left). A longtime champion of laboratory accreditation, Dr. Burnett is well-known for his book “A Practical Guide to Accreditation in Laboratory Medicine” , where he demonstrates the application of ISO guidelines in the laboratory at fictitious St. Elsewhere’s Hospital Trust. Dr. Burnett is very influential in international programs, particularly ISO 15189 guidelines for medical laboratories . He currently co-chairs (with Lucia Berte of the US) the committee that is preparing the next edition of 15189, which is scheduled to appear in 2008. His presentation, titled “ISO 15189: Is it fit for purpose?” reviewed the background, purpose, and content, and further discussed the changes that are being considered.
“Fit for purpose” is a phrase that has important meanings in quality management. One meaning relates to the guidelines being fit for application in a medical laboratory; another meaning has to do with laboratory tests being fit for their intended medical application. ISO 15189 is one of the only guidelines that directs laboratories to validate their measurement procedures (“examination procedures” in ISO terminology) for intended use and to design internal QC to verify that attainment of the intended quality of test results.
In contrast, CLIA’s purpose is to ensure that all laboratories comply with minimum standards, such as running two controls per day, rather than providing the QC that is necessary to verify the attainment of the intended quality of test results. With that single illustration you can understand why the quality of laboratory testing in the US is at a standstill, rather than improving. There’s no motivation to improve quality when compliance standards are set so low.
I asked Dr. Burnett whether the next edition of 15189 would maintain the language on “intended use” and “intended quality of test results” because I think that language is so critical for pointing laboratories in the right direction for managing quality. His answer was that those phrases may change, which I find troubling, particularly if they become more vague. “Intended use” gives clear direction, for example, a HbA1c test should distinguish between a value of 6.0 %Hb and 7.0%Hb because different clinical actions are prescribed by national and international treatment guidelines. Everyone can understand that the intended use here requires that laboratory methods ensure that a value of 6.0 %Hg should never be reported as 7.0 %Hb, or vice-versa, which means any and all sources of variation must be controlled, or limited, to less than 1.0 %Hb.
As you know if you follow this website, we have been discussing “intended use” along with “trueness” and “uncertainty.” You can expect the ISO 15189 concepts of “trueness” and “uncertainty” will remain, even though the estimation of uncertainty itself remains a serious problem in medical laboratories. Few laboratories find it practical to follow the ISO Guide to Expression of Uncertainty of Measurements, otherwise known as GUM . It is hoped that more practical guidance for the estimation of uncertainty will be provided by two new documents, one under development by CLSI  and the other by ISO . We will follow those developments because the concepts of trueness and uncertainty will most certainly make their way into the language and practices in US laboratories.
Another highlight of the Spotlight on Quality meetings is a dinner that takes place at some historic site in Antwerp. This year it was at the De Koninck Brewery, which is famous for its Belgian beers (see picture at left). For those of you who have never tried the dark Belgian brews, you are really missing something! As part of the evening activities, there is the presentation of the Jerry Ehrmeyer Award for the most Outstanding Poster. Those of you who knew Jerry (Sharon’s husband) will remember his wit and humor. He was always in charge of selecting the best poster, and while his criteria were never predictable (use of color, distance of author from Antwerp, etc.), his explanations were always entertaining. This feature continues and reminds us that, just as life is fleeting, so is quality and we should make the best of it every day.
Another activity at the dinner is a limerick contest. This proves to be a good way of generating interactions amongst people and usually leads to a winning entry from UK participants, most likely Roy Ward from Newcastle upon Tyne Hospitals. This year he was made the judge in order to level the playing field, eliminating a professional from the field of amateurs. The dinner guests are given a number of words that must be included, such as trueness, uncertainty, auditing, and De Koninck.
Here’s an example:
The uncertainty of trueness of uncertainty,
Puzzles laboratorians, most certainly;
But the trueness of uncertainty is inescapable,
Because trueness is metrologically traceable;
Which proves uncertainty, most certainly!
The certainty of trueness of uncertainty,
Makes auditing difficult, most certainly;
Because nobody knows,
What GUM should impose;
It’s very confusing, most certainly!
The certainty of trueness of uncertainty,
Challenged our discussion, most certainly;
After glass after glass of De Koninck,
With minds less sharp, unable to thinick;
We gave up on this limerick, most uncertainly!
I know, I know – it wouldn’t win the prize, but it gave me something to do on the long flight home.
Attendance at this meeting by US laboratory scientists has been disappointing. I hope some of you will put the March 10-11 2008 meeting on your calendar. Now that it is becoming more clear that CLIA has failed to ensure the quality of laboratory testing in the US, we must turn elsewhere for guidance on quality management and improvement. The Quality in the Spotlight meeting in Antwerp provides a good opportunity to keep up with what is happening internationally and also an opportunity to interact positively with the international community.
- US Government Accountability Office. Clinical Lab Quality: CMS and Survey Organization Oversight Should Be Strengthened. Report to Congressional Requesters. June 2006. www.gao.gov/new.items/d06416.pdf
- ISO/FDIS 15189 Medical laboratories – Particular requirements for quality and competence. 2002. International Organization for Standards, Geneva Switz.
- Burnett D. A Practical Guide to Accreditation in Laboratory Medicine. ABC Venture Publications. 2002.
- ISO Guide to Expression of Uncertainty in Measurements. 1993. www.gum.dk
- CLSI Project C51: Expression of Uncertainty of Measurement in Clinical Laboratory Medicine. Clinical Laboratory Standards Institute, Wayne PA.
- ISO Project 25680, Medical laboratories – Estimation and expression of measurement uncertainty, being developed by Working Group 2 (WG2) of ISO Technical Committee (TC) 212. Secretariat ANSI/CLSI, Wayne PA.
James O. Westgard, PhD, is a professor emritus 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.