Tools, Technologies and Training for Healthcare Laboratories

Guest Essay

The Quality in the Spotlight Conference

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.

(and the Westgard Awards)
A decade of quality conferences organized in Antwerp, Belgium on a yearly basis: from 1995 until 2005.

Dr. H.M.J. Goldschmidt, Foundation DCT, P.O. box 4201, 5004 JE Tilburg, The Netherlands. Tel: +31 13 4672745, Fax: +31 13 4676280, Website:

Prof. Dr. J.C. Libeer, Institute of Public Health, Juliette Wytmanstraat 14, 1050 Brussels, Belgium.Tel: +32 2 6425527, Fax: +32 2 6425645

A Conference on Quality

In the spring of 1994 the initiative was taken to organize a series of meetings considering quality in medical laboratories. Being a private initiative of a small bureau organizing a variety of scientific conferences, no ties with formal societies were looked for. A panel of experts was gathered to organize, on a yearly basis, a European conference with the sole purpose to discuss quality in laboratory medicine. The general feeling was that in science as well as in industry and within governmental agencies a growing number of people would be interested in this field. At that time quality considered quality control rules, the concept of total quality control was only known from industry and the field was only of limited interest. Although many had the feeling that great things were coming some. This feeling was reflected in the conference title: Quality [R]evolution in Clinical Laboratories. In the beginning it was difficult to obtain a solid mailing list and to bring the message to the right people. Because on the one hand the purpose was to spread the knowledge on quality models in laboratory medicine to as many as possible people, while on the other hand the conference tried to serve as a high level discussion platform for the experts attending as well as lecturing. Each and every year approximately 130 participants from approximately 25 countries attend the conference. The percentage of people attending for the next time as well is as high as 30 % and there is a large variety of affiliations present. The industrial support is modest but solid. The first conference was organized in 1995, the year 2002 was skipped due to the interference with the global IFCC meeting and therefore in 2005 the conference will be organized for the 10th time. Antwerp was chosen as the hosting city because it fitted the atmosphere looked for perfectly. The sudden death of the initial organizer of the conference, Leo Hoonhout, caused a crisis in 1998. However after the founding of an independent, non-profit organization named `The Quality Meetings`, the conferences were smoothly created and organized.

From the start a few goals were set. We tried to create an informal atmosphere. As many as possible different parties, depending on the subject under discussion were involved. The format was that of guided discussions between lectures, workshops and drawing of consensus statements. The number of invited lectures from the USA was substantial. An extensive conference book was provided and all conferences were published as proceedings in Journal of Accreditation and Quality Assurance. A peer reviewed scientific journal published by Springer Verlag.

Over the years all kind of subjects were touched upon, ranging from European directives, to new software and to the American CLIA laws. High level political lectures but also very practical examples of implementing quality control systems. One should bear in mind with all of this that the level of quality delivered by laboratory medicine should be increased and guaranteed.

The Westgard Award

In a way to get this particular field more recognized, The Westgard Quality Award was issued. During the yearly conference this award is given to a person that has made a special contribution to the field of quality within laboratory medicine. His / her contribution must mark a positive difference in the way the quality issue in laboratory medicine is handled. This award is granted to medical laboratory scientists whose efforts in improving the quality of medical laboratory tests have made a significant impact. The awardee is invited to give a keynote speech to give his / her ideas about quality in laboratory medicine. A plaquette as well as a very modest amount of money are given to honor of the chosen scientist.

Over the years the following persons have received the award: Dr. Rene Dybkaer (1998), Dr. Adam Uldall (1999), Prof. Dr. Alain Truchaud (2000), Dr. Per Hylftoft Petersen (2001), Dr. Carmen Ricós (2003), Dr. Carl C. Garber (2004), and, next year, Prof. Dr. Sverre Sandberg (2005).

The award was given the name ´The Westgard Quality Award´ due to the fact that Prof. Dr. Jim Westgard can be regarded as the global icon on the quality issue in laboratory medicine. His papers in clinical chemistry, based upon the work of Shewart et al., set the trends in clinical chemistry. The "Westgard Rules" are still a cornerstone in quality thinking in laboratory medicine. But his ongoing work reflected in many books, computer programs, courses and lectures, is on the cutting edge of this field. Professor Westgard has given many lectures at the Antwerp meeting, giving a yearly update of his ongoing work. On top of that he often comments on the specific subjects of each particular Antwerp conference.

The awardees have, of course, in common their passion for quality within laboratory medicine. But all of them have achieved remarkable contributions to this specific field.

Dr. Rene Dybkaer has written a number of papers and books on quantities and units, reference values, reference materials, systems engineering, effectiveness of results, quality assurance, continuous quality improvement, and decentralized clinical measurements. He served as IFCC President and President of the European Confederation of Laboratory Medicine and as Convenor of ISO and CEN working groups on Reference systems (in metrology for laboratory medicine). His keynote lecture was titled ´From total allowable error via traceability to uncertainty of unbiased result´.

Dr. Adam Uldall is heavily involved in EQA as an integrated professional quality assurance activity of medical laboratories. Most challenges of the laboratories applies also for EQA, e.g. metrology, laboratory accreditation, aspects of laboratory organization and education, changing test menu, and proper use of laboratory results. New technology, e.g., electronic information technology, can improve EQA, however, it also can provide new challenges (e.g., point of care testing and self testing). EQA: Quo Vadis?

Prof. Dr. Alain Truchaud quoted from his article in Clinical Chemistry (43:9, 1709-1715, 1997): “The question today for laboratory professionals is, ‘To be or not to be in the future of the in vitro diagnostic service network’. The only way to adapt ourselves is to use new management methods to reengineer our profession and select emerging technologies with a global quality-assurance approach issued from our analytical know-how, directed towards the patient”.

Dr. Per Hylftoft Petersen was a laureate of the Jim Westgard quality award for the year 2001 of the Quality in the Spotlight Foundation as a distinguished scientist in laboratory medicine. His scientific work deals with the many aspects of quality within clinical biochemistry in interpretation of laboratory data, both data from patients and from reference individuals, as well as control and method validation data. A characteristic aspect of the majority of his publications is the application of various models (biological, clinical, analytical, and statistical), designed, selected, and adapted to the specific situation, attempting to optimize the signal-to-noise ratio in order to obtain maximum information from data. His main work during the last twenty years is the creation and evaluation of 'analytical quality specifications' (quality goals, performance goals). Here, he has been strongly involved in development of models for evaluation of these specifications, both general models for the quality needed for establishing common reference intervals, and specific models for well defined clinical settings for monitoring situations and for diagnosis and classifications, e.g., evaluation of the new WHO and ADA criteria for the diagnosis of diabetes mellitus. Lately, he has been in the front of creation of a model for describing and evaluating the theoretical difficult handling of measurements performed on 'ordinal scale’ (semi quantitative tests), which also allows for evaluation of analytical quality specifications, optimizing and control, and further on validation of these types of tests.

Dr. Carmen Ricós fondly declares that Biological Variation is a pillar for managing quality in laboratory medicine. Her lectures was titled ´Integration of data derived from biological variation into the quality management system´. Data on within- and between-subject biological variation (BV) are available for around 250 analytes commonly used in medical laboratories. Integration of this data into the quality system occurs at all three levels of laboratory activity: - Preanalytical process – Biological Variation provides the basis for selecting the most appropriate specimen for analysis, for defining sample stability and for deciding suitable timing between samplings, - Analytical process – Biological Variation-derived goals are fundamental for designing internal QC procedures, and for evaluating laboratory performance - Postanalytical process - delta checks based on within-subject Biological Variation Values are used for validating results and for interpreting serial results from a patient.

Dr. Carl C. Garber has his roots in American industry. He is an lecturer on the Six Sigma approach to Laboratory Quality: within the daily practice of The Quest Diagnostics, the effect of the Six Sigma approach on laboratory performance, internally as well as externally, were found. He is well aware of the resources needed, the risks involved, and the outcomes realized.

Prof. Dr. Sverre Sandberg is head of a quality improvement organization (NOKLUS in Norway) especially designed for laboratory activity in primary health care. He has a keen interest in Evidence Based Laboratory Medicine (C-EBLM). He combines his conceptual views with day to day practical problems, all focusing on quality in laboratory medicine.

Quality in the spotlight 2005
Conference at the Elzenveld in Antwerp, Belgium

7th and 8th of March 2005
with focus on an integral quality concept NEXUS

This is the 10th conference on quality in medical laboratories in a row. We are now seeking for a coherent view on quality within laboratory medicine. Ten years ago some of us regarded hospitals as factories. Industrial like thinking was introduced in health care: work flow analysis, activity based costing and other industrial techniques were introduced, implemented and applied. We said that it was wise to take these cha(llen)ges step by step:

The Quality [r]Evolution.

But where has this evolution taken us? What is the current status? Is it still a patchwork of all kind of ideas or is a general new setup emerging, which is specific to healthcare?

After wandering around for a decade it is now time to make up our minds and reach for a coherent, structural view on the quality in laboratory medicine. We discussed and used the "Westgard Rules," requirements for analytical quality, reference values, target values, the CE label, metrological traceability and uncertainty and so on. How about an integral view, an integrated model? Clinical chemistry, laboratory medicine needs a new model, a new doctrine.

´Nexus´ is Latin for ´cohesion´; ´coherence´; ´context´.

Quality in laboratory medicine goes far beyond the boundaries of the medical laboratory. We have the obligation to define and garantee the quality of laboratory medicine test results.

Laboratory medicine needs to reach for the next level of quality awareness and achievement. With a focus on the NEXUS vision, we will discuss and design a comprehensive vision for quality requirements in laboratory medicine. We will begin with post-analytical quality, take (perhaps mistakenly) analytical quality for granted and then reason our way back toward pre-analytical quality. Concepts, such as metrological traceability, measurement uncertainty, and total quality systems are all incorporated in the NEXUS vision. The tools and technology are ready to use. The NEXUS vision states: the diagnostic environment of any patient should be totally digitalised, humanly supervised at predetermined times and in full through continuous interaction with databases containing relevant, well-defined information. All these are conditions “to obey” the ideal test requirements that lead towards a total error budget of ¼ BVii for analytical variability. The NEXUS concept suggests that the laboratory's responsibilities in the future will be to support the answering of clinical questions in the context of the patient's needs. "Context" here also means that quality goes beyond getting the “right” answer on the “right” patient that can be interpreted against “right” reference values. Quality ultimately means being sure the patient is treated correctly.

In addition a variety of industrial High Park presentations will shed light on their contribution to the NEXUS vision and the future of laboratory medicine.

As in previous years: an extensive conference book will be presented at the conference itself. It contains not only the information with regard to the actual presentations but also a lot of background information on the subjects covered. In addition the proceedings will be published in the peer reviewed scientific literature: i.e. ‘Accreditation and Quality Assurance’ from Springer Verlag, Heidelberg, Germany.

Conference address:
Conference Center ‘t Elzenveld
Lange Gasthuisstraat 45
B-2000 Antwerp, Belgium

Visit the Quality in the Spotlight Conference website for more information

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