SIST EN 14136:2004
(Main)Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-Diagnostik
Diese Europäische Norm gilt für externe Qualitätssicherungsprogramme, nachfolgend als EQAS (External Quality Assessment Schemes) bezeichnet, die in ihre Funktionen die Beurteilung und Bewertung der Leistung bestimmter in vitro diagnostischer Verfahren (einschließlich der In vitro Diagnostika, nachfolgend als IVD bezeichnet) einbeziehen. Sie legt die Anforderungen dar, die erforderlich sind, damit die EQAS diese Funktion in Beziehung auf Folgendes erfüllen können:
3 die Struktur und die Organisation des Programms;
3 die Identitätsfestlegung der vom Teilnehmer verwendeten Verfahren bzw. IVD;
3 die Gliederung und Bewertung der Daten.
ANMERKUNG Die entsprechend diesen Kriterien gewonnenen externen Qualitätssicherungsdaten helfen Herstellern, Anwendern oder zuständigen Behörden, die Leistung von IVD nach deren Markteinführung unabhängig zu überwachen.
Diese Europäische Norm legt weder die Art und Weise fest, nach denen die EQAS ihrerseits organisiert werden, noch wie die einzelne oder gemeinsame Leistung klinischer Laboratorien bewertet wird.
Utilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitro
La présente Norme européenne s'applique aux programmes d'évaluation externe de la qualité, désignés ci-apres PEEQ, qui incluent dans leurs fonctions l'évaluation de la performance de procédures spécifiées de diagnostic in vitro (y compris les dispositifs médicaux de diagnostic in vitro, désignés ici DM DIV). Elle établit les exigences nécessaires pour permettre aux PEEQ de remplir cette fonction, relatives a :
3 la conception et l'organisation du programme ;
3 l'identification des procédures (DM DIV) utilisées par le participant ;
3 la classification et l'évaluation des données.
NOTE Les données d'évaluation externe de la qualité générées selon ces criteres peuvent aider les fabricants, les utilisateurs et les autorités compétentes a contrôler de maniere indépendante la performance post-commercialisation des DM DIV.
La présente Norme européenne ne précise pas la maniere dont les PEEQ sont eux-memes organisés, ni comment la performance individuelle ou collective des laboratoires d'analyses de biologie médicale est évaluée.
Uporaba shem zunanje ocene kakovosti za oceno delovanja postopkov diagnostičnih preiskav in vitro
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-DiagnostikUtilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitroUse of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN 14136:2004SIST EN 14136:2004en,fr,de01-november-2004SIST EN 14136:2004SLOVENSKI
STANDARD
SIST EN 14136:2004
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14136May 2004ICS 11.100English versionUse of external quality assessment schemes in the assessmentof the performance of in vitro diagnostic examination proceduresUtilisation des programmes d'évaluation externe de laqualité dans l'évaluation de la performance des procéduresde diagnostic in vitroVerwendung externer Qualitätssicherungsprogramme beider Bewertung der Durchführung vonUntersuchungsverfahren in der In-vitro-DiagnostikThis European Standard was approved by CEN on 2 March 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14136:2004: ESIST EN 14136:2004
EN 14136:2004 (E)2ForewordThis document (EN 14136:2004) has been prepared by Technical Committee CEN/TC 140 “In vitro diagnosticmedical devices”, the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by November 2004, and conflicting national standards shall be withdrawn at the latestby November 2004.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.This document includes a Bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.SIST EN 14136:2004
EN 14136:2004 (E)3IntroductionExternal quality assessment schemes (EQAS) are an essential feature of mechanisms designed to maintain andimprove the analytical quality and medical appropriateness of clinical laboratory data. EQAS are most highlydeveloped in fields in which mostly quantitative, numerical data are generated; notably in clinical chemistry,haematology, immunology, etc. However, EQAS can also be extended to qualitative or more subjectiveinvestigations such as in microbiology and parasitology, as well as in histo- or cytopathology.Participation and acceptable performance in EQAS serve a valuable function in raising standards in laboratorymedicine and in educating providers and users about the potential benefits and limitations of laboratoryexaminations. Objective data provided by EQAS are an essential component of efforts to relate the current state ofthe art of laboratory performance to medical needs.EQAS are already essential parts of laboratory accreditation systems, whether mandatory or not, in member statesof the European Union. Good clinical laboratory practice includes both external quality assessment and internalquality control as complementary components of quality assurance.In addition to the major objectives of EQAS (see ISO/IEC Guide 43-1), data from EQAS can also provide avaluable resource in enabling comparisons to be made between alternative new or established analyticalprocedures (including in vitro diagnostic medical devices hereafter called IVD MDs), or in demonstrating thetransferability of procedures between laboratories, or in disclosing difficulties or deficiencies in their operation thatcan only become apparent during long-term and widespread use. An EQAS in which the survey samples havereference procedure values can provide evidence of the trueness of results obtained by using different procedures;an EQAS in which the same survey samples are circulated repeatedly and frequently can demonstratereproducibility and, e. g., the possible effects of changes in the properties of an IVD MD.The major objectives of individual EQAS differ, ranging from those that are directed principally towards ensuringcompliance with specific proficiency targets, to those that are aimed at a general survey and improvement ofparticular services: e. g., in developing a network of participation, or in establishing criteria for evaluatingperformance of more subjective investigations. Thus, details of schemes such as organisation (e.g., by regulatoryauthorities, professional societies or industrial concerns), nature and frequency of sample distribution, andassessment of results, differ from one scheme to another.Because of the differing functions and objectives of EQAS, it is neither possible nor desirable to impose a singlepattern of organisation on all such schemes, and this European Standard does not intend to do so. The generalprinciples for the design and the operation of EQAS are outlined in ISO/IEC Guide 43-1 and include:¾ use of appropriate survey samples;¾ effective distribution to participants (e. g. laboratories and/or point-of-care testing sites);¾ rapid processing of survey data ;¾ return to participants of reports that are clearly interpreted with respect to stated criteria;¾ mechanisms for follow-up of unsatisfactory performance (e.g. through advice services).In order to enable EQAS to provide data that are useful in monitoring the analytical performance of specificprocedures (including IVD MDs), additional features are used. For example, EQAS should unequivocallyidentify individual procedures (devices) used in statistically significant numbers, and above all, theyshould be able to distinguish performance characteristics inherent in a particular procedure (device) fromthose attributable to its users.This European Standard specifies ways in which EQAS can meet these procedure (device)-related criteria. Thus,EQAS is able to contribute to the post-marketing monitoring of IVD MDs as mentioned in Directive 98/79/EC on invitro diagnostic medical devices to the benefit of both their manufacturers and users.SIST EN 14136:2004
EN 14136:2004 (E)41 ScopeThis European Standard applies to external quality assessment schemes, hereafter called EQAS, that include intheir functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures(including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that arenecessary to enable EQAS to fulfil this function relating to:¾ scheme design and organisation;¾ identification of procedures (IVD MDs) used by the participant;¾ classification and evaluation of data.NOTEExternal quality assessment data generated according to these criteria will help manufacturers, users or competentauthorities to monitor independently the post-marketing performance of IVD MDs.This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual orcollective performance of clinical laboratories is evaluated.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use.EN 12286:1998, In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin —Presentation of reference measurement procedures.EN 45003:1995, Calibration and testing laboratory accreditation system — General requirements for operation andrecognition.EN ISO 15195, Laboratory medicine - Requirements for reference measurement laboratories (ISO/FDIS15195:2003).EN ISO 17511, In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrologicaltraceability of values assigned to calibrators and control materials (ISO 17511:2003).EN ISO 18153, In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrologicaltraceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO18153:2003).ISO 3534-1:1993, Statistics — Vocabulary and symbols — Part 1: Probability and general statistical terms.International Vocabulary of Basic and General Terms in Metrology (VIM), 2nd edition, Geneva: ISO, 19933 Terms and definitionsFor the purposes of this European Standard, the terms and definitions given in EN 375:2001, EN 12286:1998,EN ISO 17511:2003, EN 45003:1995, ISO 3534-1:1993, the International Vocabulary of Basic and General Termsin Metrology (VIM) and the following apply.SIST EN 14136:2004
EN 14136:2004 (E)53.1assigned valuevalue attributed to a particular quantity and accepted, sometimes by convention, as having an uncertaintyappropriate for a given purpose [ISO/IEC Guide 43-1:1997]3.2external quality assessmentEQAdetermination of individual and collective laboratory performance, and performance characteristics of examinationprocedures by means of interlaboratory comparisonNOTEThe primary objectives of EQA are educational, and can be supported by additional elements.3.3nominal scalescale with a set of possible values, for a given kind-of-property, that are each designated by a word or symbolwithout any relation to magnitudeEXAMPLEBlood group (A, B, AB, 0)NOTEThe values can be listed in any arbitrary order according to practical considerations and convention.3.4ordinal scalescale with an ordered set of possible values, for properties of a given kind-of-property, that are each designated bya word or symbol used for ranking according to magnitude, but where differences or ratios between values have noarithmetic meaningEXAMPLESWording such as "not detected", "weakly positive"," "positive", "strongly positive" or figures such as 0, 1, 2, 3.3.5target valueaccepted reference valueNOTEExamples of target values are assigned values, reference procedure values, and consensus values.3.6reference measurement procedurethoroughly investigated measurement procedure shown to yield values having an uncertainty of measurementcommensurate with its intended use, especially in assessing the trueness of other measurement procedures for thesame quantity and in characterizing reference materials [EN 12286:1998, 3.7]3.7reference procedure valuevalue obtained by a reference measurement procedure3.8survey samplesample sent to participants for selected examination, where the result is returned to the EQAS organisation forindependent assessment of performance4 Design requirements for EQAS4.1The EQAS organisation shall formulate the objectives of its surveys at its start.4.2The EQAS organisation shall provide survey samples composed in such a way that they simulate as closelyas possible the relevant properties of the samples on which the examination procedures are intended to be used.NOTE 1For assigning target values to survey samples see EN ISO 17511.SIST EN 14136:2004
EN 14136:2004 (E)6NOTE 2For some evaluations it can be appropriate to use a set of survey samples with different target values.NOTE 3The responsibility of the EQAS organisation for providing survey samples with appropriate properties is set out inISO/IEC Guide 43-1.NOTE 4EQAS organisations should not select survey samples containing unphysiological additives which maydisadvantage an individual IVD MD.4.3The frequency of surveys shall be appropriate for
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