There has been significant expansion and development in clinical laboratory sciences and, in particular, metrological concepts, definitions and terms since the previous edition of this book was published in 1995. It is of prime importance to standardize laboratory reports for reliable exchange of patient examination data without loss of meaning or accuracy. New disciplines have appeared and the interrelationships between different disciplines within clinical laboratory sciences demand a common structure and language for data exchange, in the laboratory and with the clinicians, necessitating additional coverage in this book. These new sections will be based upon recommendations published by various national, regional, and international bodies especially IUPAC and IFCC. This book groups and updates the recommendations and will be appropriate for laboratory scientists, medical professionals and students in this area.
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Compendium of Terminology and Nomenclature of Properties in Clinical Laboratory Sciences
By Georges Férard, René Dybkaer, Xavier Fuentes-Arderiu
The Royal Society of ChemistryCopyright © 2017 International Union of Pure and Applied Chemistry
All rights reserved.
History of Recommendations on Properties in Clinical Laboratory Sciences
The beginnings of the work on quantities and units in clinical laboratory sciences illustrate the catalytic interplay of international organizations, national societies and critical individuals with novel ideas.
In 1954, the 10th General Conference on Weights and Measures (CGPM) met and resolved that: "In accordance with the wish expressed by the 9th CGPM (of 1948) in its Resolution 6 concerning the establishment of a practical system of units of measure for international use, the 10th CGPM decides to adopt as base units ... metre, kilogram, second, ampere, degree Kelvin [renamed kelvin in 1962], candela." In 1960, that system became known as the International System of Units, SI. In 1971, the mole was added to the system on the advice of IUPAC, IUPAP, and ISO.
In the late 1950s, probably most chemists and certainly most scientists in biologically oriented disciplines dismissed the recommendations on weights and measures as irrelevant, of concern only to physicists and engineers. As parts of ISO Recommendation 31 (the forerunner of ISO 31:1992) on quantities and units were being published up to 1960 on 'periodic and related phenomena', 'mechanics' and 'heat', the opinion of biologists about its irrelevance would probably have been confirmed. The titles suggested that such recommendations were not interdisciplinary.
In 1952, a IUPAC Commission on Clinical Chemistry had been formed to coordinate national groups. A professor from Geneva, Manuel C. Sanz, predecessor at the University of Geneva of another active worker for IFCC, Marc Roth, encountered a group of young medical graduates during a visit to Copenhagen. The group was pursuing further studies in biochemistry, including analytical, inorganic, organic and physical chemistry. Sanz became aware of the local ideas on working towards a unified "presentation of results" in clinical chemistry and took immediate steps to bring their ideas to the attention of the international scientific community.
In 1957, Rene Dybkaer had been invited by the Danish Society for Clinical Chemistry and Clinical Physiology to give a paper entitled "Standardisering af enheds-betegnelser i klinisk-kemisk laboratoriearbejde" (Standardizing unit symbols in work of the clinico-chemical laboratory). The paper was subsequently published in the journal Nordisk Medicin. It was a plea for implementation in clinical chemistry of the recommendations of the IUPAC Commission on Symbols and Physicochemical Terminology and of ISO Technical Committee 12 on quantities and units.
The strength of the beginnings in Denmark was the realization that the recommendations of BIPM and ISO, despite their orientation to physical sciences, had an interdisciplinary element that needed to be sought out and applied. The Danish society appointed a committee (R. Dybkaer, N. S. C. Heilskov, J. Jorgensen, K. Jorgensen, and E. Praetorius), which presented a proposal in 1960 to the other Scandinavian societies of clinical chemistry and also translated it as a proposal to the Fourth International Congress on Clinical Chemistry in Edinburgh in 1960. The IUPAC Commission on Clinical Chemistry referred the proposal to the Fifth International Congress on Clinical Chemistry in Detroit in August 1963. Meanwhile, ideas were developing further in Scandinavia. The relevance of molecular quantities (§7.1.2), although not then part of the International System of Units, was stressed.
The Committee on Standards and Control of the American Association of Clinical Chemistry discussed the proposal in 1963 and its comments formed part of the subsequent recommendation. The situation as seen from the United States is described by N. Radin: "A system of units for clinical chemists was proposed by the Danish Society for Clinical Chemistry and Clinical Physiology. This system was transmitted to the IUPAC Commission on Clinical Chemistry in June 1963. A Subcommittee on Nomenclature and Usage of the Committee on Standards and Controls of the American Association of Clinical Chemistry was assigned the task of studying the problem with a view to agreement upon a set of rational and internally consistent objectives for nomenclature reform. The recommendations of the subcommittee were in close agreement with those of the original Danish proposals as being desirable objectives."
The proposal was accepted as a basis for a recommendation at the Fifth International Congress (1963), where a symposium was held on 'Nomenclature and standard units'. The draft recommendation, prepared by Dybkaer and Jorgensen, was presented to the IUPAC Commission on Clinical Chemistry in 1964.
At the IUPAC General Assembly in Paris in 1965, the Commission resolved to recommend the cubic metre as the preferred denominator unit in expression of concentrations (§5.10.2) and appointed a Subcommission for Standards and Units in Clinical Chemistry consisting of Jean-Emile Courtois (Paris), Rene Dybkaer, Per Lous (Copenhagen), Noel F. Maclagan (London), Martin Rubin (Washington, DC) and Manuel C. Sanz. At the first meeting of the Subcommission in Copenhagen in November 1965, Poul Astrup and Kjeld Jorgensen attended as 'experts'. The draft, based on 'A primer of quantities and units in clinical chemistry', 1966, was finalized and approved by the IUPAC Commission on Clinical Chemistry and by the Council of IFCC during the Sixth International Congress of Clinical Chemistry in Munich in 1966. It was included as a Recommendation 1966 in a monograph by Dybkaer and Jorgensen, and published in 1967 under the title "Quantities and units in clinical chemistry".
The change in title and in emphasis is remarkable. Superficially the problem seemed to be units and their representation. Evolution from 1957 to 1967 perhaps reflects the realization that a unified way of naming and specifying the quantities was more fundamental; standardization of measurement units was a secondary issue.
The principle of preference for amount-of-substance rather than mass in describing chemical amounts was approved in 1966 by the clinical chemists and ratified in 1972 by the International Committee (now Council) for Standardization in Haematology (ICSH), IFCC and the World Association of Societies of Anatomic and Clinical Pathology (WASP). The recommendation was published in 1973, together with one on preference for the litre in expression of concentrations, under the title "Use of SI in clinical laboratory measurements". Concurrently, the mole had been accepted by CGPM in 1971 as an SI base unit for amount of substance.
Two proposals in the 1966 primer failed to reach approval: 'Whole number measurement of quantities' and 'Qualitative measurement of quantities'. These issues have continued to plague the reporting of analytical data and have surfaced again in discussions in recent years (§4.1).
In 1971, the IUPAC Commission and IFCC Expert Panel (which became a Committee in the 1980s) published two of the most useful guides on the reporting of biological and chemical data, the IUPAC 'Yellow Appendices' Nos 20 and 21 of 1972, which were provisional abridged revisions of the 1967 Recommendations. Revision of them started during the IUPAC General Assembly at Munich in 1973.
The group met at Munich again in 1974: Rene Dybkaer, Bernard H. Armbrecht from the US Food & Drug Administration in Washington, DC, Kjeld Jorgensen, Pierre Metais from the University of Strasbourg, Roland Herrmann from the University of Giessen and J. Christopher Rigg from Wageningen. Besides the revision of the 1967 publication, of which the Yellow Appendices Nos. 20 and 21 were the first stage, drafts were discussed on fluid mechanics (little of which has seen the light of day), on spectroscopy (initiated by Metais and Herrmann) and on activities and pH. The discussions were extremely thorough.
In contrast to the rapid progress towards agreement among clinical laboratory scientists on ways of expressing concentrations, the problems of expressing enzymological data (§7.6) were just being realized for the first time. Dybk^r had a seemingly endless itinerary in the early 1970s discussing enzyme activity and catalytic amount and their units, the enzyme unit and the katal, with ISO Technical Committee 12, IUPAC, the International Union of Biochemistry (IUB) Joint Committee on Biochemical Nomenclature, and the authorities of IUPAC and IFCC. The problems were resolved by the IUPAC Commission on Quantities and Units in Clinical Chemistry (CQUCC), the IFCC Expert Panel on Quantities and Units (EPQU) and the IFCC Expert Panel on Enzymes at a joint meeting at Strasbourg in 1975 chaired by Donald Moss. The results of the negotiations with the IUPAC-IUB Joint Committee on Biochemical Nomenclature were published in 1978. A revised version of the recommendation of the commission and expert panel was at last published in 1979. The IFCC, through IUPAC, had asked the Consultative Committee for Units (CCU) of the International Committee for Weights and Measures (CIPM) to support a petition to the CGPM for a special term "katal" for the SI coherent unit 'mole per second' in expressing 'catalytic activity'. The CCU was not convinced of the need, although in the same period radiologists managed to win approval of special terms for the derived units becquerel, gray and sievert (§5.8.2, Table 5.2) with similar arguments about human safety.
At the IUPAC General Assembly at Madrid in September 1975, there were joint meetings with the two spectroscopic commissions of IUPAC, who (quite rightly) tore to pieces an early draft on quantities and units in spectroscopy: current nomenclature was a mess, but logical and user-friendly answers were still needed. The discussion with the physical chemists yielded permission to introduce the term substance concentration instead of the long-winded amount-of-substance concentration. However, discussion on whether the unit of catalytic amount, termed the katal, was a base unit or a derived unit was extremely irate, with Max L. McGlashan, the then chairman of the IUPAC Interdivisional Committee on Nomenclature and Symbols (IDCNS) addressing the members of the CQUCC in hortatory fashion as "naughty" for trying to introduce new nomenclature without proper discussion. The members of the Commission were sent away with instructions to introduce the new nomenclature properly (§5.4). At times, that project was extremely frustrating, despite the encouragement of a subsequent chairman of IDCNS, Norman Jones, who prophesied that it would take at least another 10 years.
It is gratifying to note that when IFCC approached the CIPM in 1998 with the proposal for the special term "katal", it was this time supported by CCU and the Consultative Committee for Amount of Substance (CCQM). This led to acceptance by Resolution 12 of the 21st CGPM in 1999, meaning that katal is a bona fide SI unit term in the relevant circumstances. In the 1970s, metrologists and the physical chemists at Madrid looked askance at the distinction Dybkaer and Jorgensen had made in 1967 between quantity and kind-of-quantity. By contrast, three past members of IUPAC-CQUCC and IFCC-EPQU participated in the committee of an ISO task group responsible for producing the second edition of the 'International Vocabulary of Metrology (VIM)' and clinical chemists also sat in the group that made significant changes to the third edition, including adoption of the concept 'kind of quantity'. Clinical laboratory sciences are now being taken seriously as a branch of metrology.
The need for clarity of intergovernmental policy on SI in the medical professions led to the preparation by WHO of 'A guide to international recommendations on names and symbols for quantities and on units of measurement', in which the group provided considerable information about IUPAC and IFCC recommendations. This led on to a resolution of the 30th World Health Assembly (WHA) at Geneva in May 1977. The group, in particular its chairman Robert Zender (La Chaux-de-Fonds, Switzerland), advised on the formulation of the recommendation and on the subsequent publication by WHO of a booklet on 'The SI for the health professions', as requested by the 30th WHA. There had been strong requests, notably from cardiologists, for clarification of policy on units for blood pressure and that issue was clarified for the time being in a resolution of the 34th WHA in 1981 (§9.41U, Note 2).
A continuing issue has been the metrological status of WHO International Units (IU) (§10.3) and the problems of using biological reference materials (§6.11.6) as standards in biological, immunological and chemical measurements.
Introduction of the general language of metrology into a biologically oriented discipline has been a two-way process. One example was the deficiencies found in the terms of spectrometric quantities. The resulting thorough critique seriously delayed the publication of a recommendation on absorption spectrometry, which was finalized jointly with the IUPAC Commission on Molecular Structure and Spectroscopy. However, it did force the clinical chemists to initiate a separate project on nomenclature of derived quantities, which was finalized by H. Peter Lehmann (Louisiana State University), who took over as chairman in 1979. That recommendation considerably influenced the nomenclature of ISO 31H992.
Some of the ideas debated in the commission and expert panel have proved too contentious or too theoretical for publication as recommendations. After Robert Zender took over as chairman of the group from Dybkær in 1975, his attempt to tighten up the definitions of basic concepts such as system and component in terms of set theory foundered because they were felt to be too theoretical. Some of his ideas have been publishedand have been taken account of in drafting §4.3.1 and 5.1. Section 5.1 also takes account of discussions in IFCC on 'semiquantitative' and 'qualitative tests', which were published as position papers by Dybkær and Jorgensen and by Dybkaer who pursued the matter further in a thesis in 2004 and an updated text in 2009.
Another area where the group has done pioneering work, although unpublishable as recommendations, was logarithmic quantities (§8.10), which were examined by Ben Visser (Maastricht, the Netherlands). Some of his ideas were published in papers of the IFCC Expert Panel on pH and Blood Gases. His wisdom on the wider issues of the unit one has not yet been fully exploited (§5.13), although it has influenced the revision of ISO 31-6 on acoustic quantities and units.
Less contentious was the work on physicochemical quantities (§7.2), including chemical activity and pH, which was later organized jointly with the IFCC Committee on pH under the chairmanship of Ole Siggaard-Andersen, also from Copenhagen. Nevertheless, symbolic notation in that area raised objections on aesthetic grounds.
At the IUPAC General Assembly in Hamburg in 1991, it was suggested that the time was ripe to consolidate the recommendations from the Division of Clinical Chemistry. Several of the initial members of the group on quantities and units in clinical chemistry were still active and could still be consulted. Several of a new generation of recommendations were near to finalization. Two key members of the group from the early 1970s had died: Roland Herrmann, who initiated the work on spectrometric quantities, in 1980; Pierre Metais, who did much to standardize nomenclature and use of quantities in the French-speaking world, in November 1987.
The task was completed by the publication in 1995 of the IFCC-IUPAC Recommendations 'Compendium of Terminology and Nomenclature of Properties in Clinical Laboratory Sciences'.
Developments in metrological terminology and the necessity to expand the subject field from quantity to property, thus including nominal properties, as well as comments received on the first edition, has led to this second edition, prepared as a joint project under the aegis of the IFCC Committee and IUPAC Subcommittee on Nomenclature for Properties and Units.
The work on a coding scheme for clinical laboratories was initiated in 1987 by Henrik Olesen (Copenhagen), newly elected chairman of the Commission on Quantities and Units (C-QU) of IFCC and IUPAC. With Olesen as convener of Working Group 2 on Healthcare Terminology, Semantics and Knowledge Bases of the Technical Committee 251 on Standards in Healthcare Informatics and Telemetric of European Committee for Standardisation (CEN/TC251/WG2), inter alia, two European Norms were elaborated that closely followed the guidelines worked out by C-QU. These standards have been combined with rules for the use of international nomenclature, e.g. CAS codes and terms. This has resulted in the NPU terminology, so far comprising definitions of more than 16 000 dedicated kinds-of-property for use in laboratory data transmission systems. Since 2012, IFCC has published the terminology, which is updated regularly. It has been elaborated in cooperation with relevant scientific organizations in each of the subjects: properties and units in thrombosis and haemostasis, IOC prohibited drugs, clinical microbiology, trace elements, general clinical chemistry, clinical pharmacology and toxicology, reproduction and fertility, clinical allergology, clinical molecular biology, transfusion medicine and immunohaematology, and environmental human toxicology.
Excerpted from Compendium of Terminology and Nomenclature of Properties in Clinical Laboratory Sciences by Georges Férard, René Dybkaer, Xavier Fuentes-Arderiu. Copyright © 2017 International Union of Pure and Applied Chemistry. Excerpted by permission of The Royal Society of Chemistry.
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Table of Contents
History of recommendations on properties and units in clinical laboratory sciences; Definitions of some disciplines applied in the clinical laboratory; Conventions and instructions for use; Fundamental concepts in communication of clinical laboratory data; Principles and practice of kinds-of-quantity and units; Requesting, generating, and transmitting clinical laboratory data; Choice and use of kinds-of-quantity for different examination purposes; Kinds-of-quantity of dimension one: SI unit 1; Kinds-of-quantity of dimension other than one; Kinds-of-property without dimensions of the ISQ; Index of abbreviations used for institutions and committees; Index of symbols for kinds-of-quantity and corresponding coherent SI units in clinical laboratory sciences.