Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences.

Recommendations for clinical laboratory science reports regarding properties, units, and symbols: the NPU format.

The document describes the Nomenclature for Properties and Units (NPU) format developed by the joint committee on Nomenclature for Properties and Units of the IFCC and IUPAC. Basic concepts, in particular system, component, kind-of-property, and unit are defined. Generalities concerning quantities and units, and terminological rules are recalled.

Properties and units in the clinical laboratory sciences, Part XXIII. The NPU terminology, principles and implementation -a user's guide (Technical Report 2011) (IFCC-IUPAC).

This document describes the application of the syntax, semantic rules and format of the NPU terminology for coded dedicated kinds-of-property in the various subject fields of the clinical laboratory sciences. The document sums up considerations and reasoning by the C-SC-NPU and collects the experience with the system through some 8 years of application in electronic health communication. Access to the NPU terminology in English is currently at www.

An outline for a vocabulary of nominal properties and examinations--basic and general concepts and associated terms.

Scientists of disciplines in clinical laboratory sciences have long recognized the need for a common language for efficient and safe request of investigations, reporting of results, and communication of experience and scientific achievements. Widening the scope, most scientific disciplines, not only clinical laboratory sciences, rely to some extent on various nominal examinations, in addition to measurements. The 'International vocabulary of metrology--Basic and general concepts and associated terms' (VIM) is designed for metrology, science of measurement.

Clinical laboratory sciences data transmission: the NPU coding system.

In health care services, technology requires that correct information be duly available to professionals, citizens and authorities, worldwide. Thus, clinical laboratory sciences require standardized electronic exchanges for results of laboratory examinations. The NPU (Nomenclature, Properties and Units) coding system provides a terminology for identification of result values (property values).

Properties and Units in the Clinical Laboratory Sciences.

This document describes the introduction of the concept of property in the field of clinical and environmental human toxicology for the presentation of results of clinical laboratory investigations. It follows the IFCC-IUPAC systematic terminological rules and attempts to create a common base for communication between the clinical chemist, the medical practitioner, the human toxicologist, and the environmental toxicologist. The term designating a substance being a toxicant may be an international nonproprietary name (INN), a generic name, a registered trade name, a fantasy name, or other.

An ontology on property for physical, chemical, and biological systems.

Current metrological literature, including the International vocabulary of basic and general terms in metrology (VIM 1993), presents a special language slowly evolved without consistent use of the procedures of terminological work; furthermore, nominal properties are excluded by definition. Both deficiencies create problems in fields, such as laboratory medicine, which have to report results of all types of property, preferably in a unified systematic format. The present text aims at forming a domain ontology around "property", with intensional definitions and systematic terms, mainly using the terminological tools--with some additions--provided by the International Standards ISO 704, 1087-1, and 10241.

The tortuous road to the adoption of katal for the expression of catalytic activity by the General Conference on Weights and Measures.

Background: The "unit" for "enzymic activity" (U = 1 micromol/min) was recommended by the International Union of Biochemistry and Molecular Biology (IUB) in 1961 and is widely used in medical laboratory reports. The general trend in metrology, however, is toward global standardization through defining units coherent with the International System of Units (SI).

Approach: Several proposals were advanced from the IFCC, International Union of Pure and Applied Chemistry, and IUB regarding the definition for enzymic activity as well as the terms for kind-of-quantity, units, symbol, and dimension.

Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine.

When describing the performance of procedures and the reliability of their results, ISO terminology should be used. Results should be universally comparable and this requires metrological traceability. The concomitant uncertainty (inversely) indicating reliability should be obtained in a universal and transparent fashion, and should be combinable.

Terminological problems around "accuracy" and "uncertainty".

The consistent description and treatment of metrological data in laboratory medicine are hampered by the lack of a systematic, universally accepted nomenclature and by variations in the conceptual understanding of uncertainty. The differences between the classical approach to a result as consisting of a true value plus errors and the new approach of a measured corrected value with uncertainty based on a detailed uncertainty budget are discussed. The various definitions of some relevant concepts, including "accuracy", the new concept "trueness", and "precision", are contrasted, and proposed modification are presented.

Clinical laboratory work--concepts and terms.

An appropriate term is sought for the concept embracing the different types of clinical laboratory work. The defining characteristics of the concept are therefore described, i.e.

Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine.

The preparation of written records of measurement procedures and descriptions of reference materials requires order, scientific and practical expertise, exactness, and completeness. Realizing the importance of adequate documentation in science, practice, and industrial development, the European Committee for Standardization (CEN) has drafted two European Standards on the two subjects, presenting the structure and contents of such documents. The standards, however, do not provide guidance to the proper use of quantities, units, equations, numerical values, and terminology.

Quantities and units for biological reference materials used with in vitro diagnostic measuring systems for antibodies.

The WHO International Reference Materials (IRM), whether International Biological Standards (IS) (formerly International Reference Preparations (IRP)) or International Biological Reference Reagents (IRR), have served a good purpose in standardizing bioprocedures by defining international units of bioactivity or potency where dimensions seem difficult to establish. Especially for in vitro diagnostic procedures, the trend is towards measuring biochemically informative molecular-based quantities (involving the unit mole) when some chemical entity of a component can be defined. The use of a standard, with a value assigned by any procedure, as a calibrant in other procedures does not assure traceability and valid diagnostic results if the component (analyte) is microheterogeneous to a varying degree or there are varying matrix effects.

Properties and units in the clinical laboratory sciences. V. Properties and units in thrombosis and haemostasis: ISTH-IUPAC-IFCC recommendations 1995.

For historical reasons, the terms used in the nomenclature for properties in thrombosis and haemostasis differ according to 'school' of thought. This hampers communication. In collaboration, The Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis and the Committee (Commission) of Quantities and Units (in Clinical Chemistry) have prepared a set of recommended systematic names for properties in that domain.

Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems.

Reliability of clinical laboratory results is obtained through quality assurance in both their production and transmission. The former involves a reference measurement system of reference materials and reference measurement procedures with metrological and statistical verification of results. The latter requires that sender and receiver have access to a common terminology.

Application of IUPAC-IFCC recommendations on quantities and units to WHO biological reference materials for diagnostic use. International Union of Pure and Applied Chemistry (IUPAC) and International Federation of Clinical Chemistry (IFCC).

This document deals with the nature of WHO biological reference materials, their development for the control of therapeutic substances and recommendations to improve their application in diagnosis. The nature of international units specified by WHO biological reference materials is contrasted with that of SI units, and the method for assigning values in international units to such reference materials is described. The document recommends the use of SI units (mole) with existing and proposed WHO biological reference materials whenever the elementary entity of the stated component can be recognized.

Result, error and uncertainty.

Several recent documents, from international standardization bodies, present the philosophical and statistical background for understanding the components of a measured value and its uncertainty, as well as the relevant nomenclature for their description. The value is the output of a function relating values from reading, calibrator, corrections and influence quantities. The corrected value may be regarded as the sum of a true value, bias of measurement procedure, laboratory deviation, and random error; in some cases there are also biases from aberrant sample and undetected mistakes.

Quality assurance, accreditation, and certification: needs and possibilities.

Demonstrable quality of laboratory services entails two parts. First, one needs a quality policy statement, identification of user needs, choice of measurement procedures, reference measurement system to provide traceability, control materials, and proficiency testing with materials having reference-measurement-assigned values. Second, it may be useful to obtain recognition of competence in addition to the director's certificate, such as Good Laboratory Practice (when studying toxicity of chemicals), ISO 9000 certification of a self-defined quality system, nongovernmental professional accreditation, or, most demanding, governmental accreditation according to European Standard EN 45,001 with some modifications.

Application of IUPAC-IFCC recommendations on quantities and units to WHO biological reference materials for diagnostic use: recommendations 1994.

This document deals with the nature of WHO biological reference materials, their development for the control of the therapeutic substances, and recommendations to improve their application in diagnosis. The nature of international units specified by WHO biological reference materials is contrasted with that of SI units, and the method for assigning values in international units to such reference materials is described. The document recommends the use of SI units (mole) with existing and proposed WHO biological reference materials whenever the elementary entity of the stated component can be recognized.

A quality manual for the clinical laboratory including the elements of a quality system. Proposed guidelines.

Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual.