1、Designation: E 2522 07Standard Guide forQuality Indicators for Health Classifications1This standard is issued under the fixed designation E 2522; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number i
2、n parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This international standard is intended to documentprincipal ideas which are necessary and sufficient to assignvalue to a classification. The
3、standard will serve as a guide forgovernments, funding agencies, terminology developers, ter-minology integration organizations, and the purchasers andusers of classification systems toward improved terminologicaldevelopment and recognition of value in a classification. It isapplicable to all areas
4、of health about which information is keptor utilized. Appropriately, classifications should be evaluatedwithin the context of their stated scope and purpose. It isintended to complement and utilize those notions alreadyidentified by other national and international standards bodies.This standard exp
5、licitly refers only to classifications. Thisinternational standard will also provide classification develop-ers and authors with the quality guidelines needed to constructuseful, maintainable classifications. These tenets do not at-tempt to specify all of the richness which can be incorporatedinto a
6、 classification. However, this standard does specify theminimal requirements, which if not adhered to will assure thatthe classification will have limited generalizability and will bevery difficult if not impossible to maintain. We have used theword “Shall” to indicate mandatory requirements and the
7、 word“Should” to indicate those requirements which we feel aredesirable but may not be widely achievable in current imple-mentations. Classifications, which do not currently meet thesecriteria, can be in compliance with this standard by putting inplace mechanisms to move toward these goals. This sta
8、ndardwill provide classification developers with a sturdy startingpoint for the development of useful classifications. This foun-dation serves as the basis from which classification developerswill build robust concept systems.2. Referenced Documents2.1 Normative ReferencesThe following normative doc
9、u-ments contain provisions, which through reference in this text,constitute provisions of this Guide E 2522. For dated refer-ences, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreementsbased on Guide E 2522 are encouraged to investigate thep
10、ossibility of applying the most recent editions of the norma-tive documents indicated below. For undated references, thelatest edition of the normative document referred to applies.Members of ISO and IEC maintain registers of currently validInternational Standards.2.2 ASTM Standards:2E 1238 Specific
11、ation for Transferring Clinical ObservationsBetween Independent Computer Systems3E 1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT)Systems for Electronic Health Record (EHR) SystemsE 1284 Guide for Construction of a Clinical Nomenclaturefor Support of
12、Electronic Health Records3E 1384 Practice for Content and Structure of the ElectronicHealth Record (EHR)E 1633 Specification for Coded Values Used in the Elec-tronic Health Record2.3 ISO Standards:4ISO 704 Principles and Methods of TerminologyISO/DIS 860 International Harmonization of Concepts andTe
13、rmsISO 1087-2 TerminologyVocabularyPart 2: ComputerApplicationsISO 11179-3 TerminologyData RegistriesISO 12200 TerminologyComputer ApplicationsMachine Readable Terminology Interchange FormatISO 12620 TerminologyComputer ApplicationsDataCategoriesISO 15188 Project Management for Terminology Standard-
14、izationISO 2382-4 Information TechnologyVocabularyPart 4:Organization of DataTR 9789 Guidelines for the Organization and Representa-tion of Data Elements for Data InterchangeCoding1This guide is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of
15、 Subcommittee E31.35 on HealthcareData Analysis.Current edition approved April 1, 2007. Published May 2007.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the stand
16、ards Document Summary page onthe ASTM website.3Withdrawn.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.M
17、ethods and Principles2.4 CEN Standards:5ENV 12017 Medical InformaticsVocabulary3. Terminology3.1 For the purposes of this guide, the following terms anddefinitions apply:3.1.1 canonical terma preferred atomic or pre-coordinated term for a particular medical concept.3.1.2 classificationcollection of
18、terms grouped by a com-mon characteristic. Usually not intended to represent the fullcontent of a knowledge domain. Classifications are an aggre-gation of a nomenclature. A classification is a terminologywhich aggregates data at a prescribed level of abstraction for aparticular domain. This fixing o
19、f the level of abstraction thatcan be expressed using the classification system is often fixedto enhance consistency when the classification is to be appliedacross a diverse user group, such as is the case with some of thecurrent billing classification schemes. Examples are ICD9-CMand CPT.3.1.3 cont
20、rolled health vocabularya terminology intendedfor clinical use. This implies enough content and structure toprovide a representation capable of encoding comparable data,at a granularity consistent with that generated by the practicewithin the domain being represented, within the purpose andscope of
21、the terminology.3.1.4 index terma pointer to a concept in a classification.This can be a synonym, abbreviation, acronym or somemnemonic which can be used to indicate the correct code to usefrom the classification. Such use is important for mapping fromthe way clinicians tend to speak to the classifi
22、cation. Thesehave been referred to as Entry terms by some authors.3.1.5 modifiera string which, when added to a term,changes the meaning of the term in the Clinical sense (forexample, clinical stage or severity of illness).3.1.6 nomenclaturethe canonical set of terms comprisinga given controlled voc
23、abulary; their structure, relationshipsand, if existing, systematic and formal definitions; and thecode, meaning formal rules and general principles, guidinghow the controlled vocabulary may be changed.3.1.7 ontologyan organization of concepts by relation-ships for which one can make a rational argu
24、ment. Colloqui-ally, this term is used to describe a hierarchy constructed for aspecific purpose. For example, a hierarchy of qualifiers wouldbe a Qualifier Ontology.3.1.8 qualifiera string which, when added to a term,changes the meaning of the term in a Temporal or Adminis-trative sense (for exampl
25、e, “History of” or “Recurrent”).3.1.9 terma word or words corresponding to one or moreconcepts.3.1.10 terminologyset of terms representing a system ofconcepts within a specified domain.3.1.10.1 DiscussionThis implies a published purpose andscope from which one can determine the degree to which thisr
26、epresentation adequately covers the domain specified.4. General4.1 BasicsBasic characteristics of a terminology influenceits utility and appropriateness in clinical applications.4.2 Concept OrientationThe basic unit of a terminologyshall be a concept, which is the embodiment of some specificmeaning
27、and not a code or character string. Identifiers of aConcept shall correspond to one and only one meaning and ina well-ordered vocabulary only one concept may have thatsame meaning (DIS 860). However, multiple terms (linguisticrepresentations) may have the same meaning if they areexplicit representat
28、ions of the same concept. This impliesnon-redundancy, non-ambiguity, non-vagueness and internalconsistency.4.2.1 Non-RedundancyTerminologies shall be internallynormalized. There shall not be more than one concept identifierin the terminology with the same meaning (ISO 704, GuideE 1284). This does no
29、t exclude synonymy; rather, it requiresthat this be explicitly represented.4.2.2 Non-AmbiguityNo concept identifier should havemore than one meaning. However, an entry term (some authorshave referred to this as an “interface terminology”) can point tomore than one concept (for example, MI as Myocard
30、ialInfarction and Mitral Insufficiency).4.2.3 Non-VaguenessConcept names shall be context free(some authors have referred to this as “context laden”). Forexample, “diabetes mellitus” should not have the child concept“well controlled”; instead, the child concepts name should be“diabetes mellitus, wel
31、l controlled.”4.2.4 Internal ConsistencyRelationships between con-cepts should be uniform across parallel domains within theterminology. For example, if heart valve structures are speci-fied anatomically, the diagnosis related to each structure shouldalso be specified using the same relationships.4.
32、3 Purpose and ScopeAny classification shall have itspurpose and scope clearly stated in operational terms so that itsfitness for particular purposes can be assessed and evaluated(ISO 15188). Where appropriate, it may be useful to illustratethe scope by examples or use casesas in database models ando
33、ther specification tools. Criteria such as coverage and com-prehensiveness can only be judged relative to the intended useand scope. For example, a classification might be comprehen-sive and detailed enough for aggregation of billing codes froma hospital admission (for example, DRGs), but inadequate
34、 forspecifying the indication for a surgical procedure.4.3.1 CoverageEach segment of the healthcare processshall have explicit in-depth coverage and not rely on broad leafnode categories that lump specific clinical concepts together.For example, it is often important to distinguish specificdiagnosis
35、 from categories presently labeled “Not ElsewhereClassified” (NEC) or to differentiate disease severity such asindolent prostate cancer from widely metastatic disease. Theextent to which the depth of coverage is incomplete shall beexplicitly specified for each domain (scope) and purpose asindicated
36、in 4.3. (1)65Available from European Committee for Standardization (CEN), 36 rue deStassart, B-1050, Brussels, Belgium, http:/www.cenorm.be.6The boldface numbers in parentheses refer to the list of references at the end ofthis standard.E25220724.3.2 ComprehensivenessThe extent to which the degreeof
37、comprehensiveness is incomplete shall be explicitly speci-fied for each domain (scope) and purpose as indicated in 4.3.Within the scope and purpose, all aspects of the healthcareprocess shall be addressed for all related disciplines, such asphysical findings, risk factors, or functional statusacross
38、 thebreadth of medicine, surgery, nursing, and dentistry. Thiscriterion applies because decision support, risk adjustment,outcomes research, and useful guidelines require more thandiagnoses and procedures. Examples include existing Agencyfor Healthcare Research and Quality guidelines, and the CMSmor
39、tality model. (2)4.4 Mapping:4.4.1 Government and payers mandate the form and classi-fication schema for much clinical data exchange. Thus, com-prehensive and detailed representations of patient data withincomputer-based patient records should be able to be mapped tothose classifications, such as IC
40、D-9. This need for multiplegranularities is needed for clinical healthcare as well (ISOTR 9789). For example, an endocrinologist may specify moredetail about a patients Diabetes Mellitus than a generalistworking in an urgent care setting or a nurse assessing the extentto which the individual is copi
41、ng with their disorder, eventhough all may be caring for the same patient. The degree towhich the terminology is mappable to other classifications shallbe explicitly stated. (3)4.4.2 The rules for mapping from a classification to anomenclature are the same rules that are defined for theformation of
42、compositional expressions from the referenceterminology and therefore are by definition terminology de-pendent. As a well-formed classification is defined as apre-coordination from the reference terminology, differentconstructs (codes in the classification) developed are built fora specific purpose.
43、 Therefore, if a classification is useful for apurpose and it is fully specified, then by definition it iscoordinate with the reference terminology. Two classificationsdefined by the same reference terminology are coordinate andinteroperable. Mapping here is accomplished at the level of thereference
44、 terminology and therefore is correct at the lowestlevel of computable meaning.4.5 Systematic DefinitionsIn order for users of the termi-nology to be certain that the meaning that they assign toconcepts is identical to the meaning which the authors of thevocabulary have assigned, these definitions w
45、ill need to beexplicit and available to the users. Further, as relationships arebuilt into vocabularies, multiple authors will need these defi-nitions to ensure consistency in authorship. For example, theconcept “Hypertension” might be defined as a consistentlyelevated Blood Pressure and not “BP 140
46、/85.”4.6 Explicitness of RelationsThe logical definition ofsubsumption should be defined. The formal behavior of alllinks/relations/attributes should be explicitly defined. If alooser meaning such as “broader than/narrower than” is used,it should be explicitly stated. For example, the primaryhierarc
47、hical relation should be subsumption as exemplified bylogical implication: “B is a kind ofA” means “All Bs areAs.”4.7 Multiple HierarchiesConcepts should be accessiblethrough all reasonable hierarchical paths (that is, they shallallow multiple semantic parents). For example, stomach cancercan be vie
48、wed as a neoplasm or as a gastrointestinal disease. Abalance between number of parents (as siblings) and number ofchildren in a hierarchy should be maintained. This featureassumes obvious advantages for natural navigation of terms(for retrieval and analysis) as a concept of interest can be foundby f
49、ollowing intuitive paths (that is, users should not have toguess where a particular concept was instantiated). (4)4.8 Consistency of ViewA concept in multiple hierarchiesshall be the same concept in each case. Our example ofstomach cancer shall not have changes in nuance or structurewhen arrived at via the cancer hierarchy as opposed to GIdiseases. Inconsistent views could have catastrophic conse-quences for retrieval and decision support by inadvertentlyintroducing variations in meaning which may be unrecognizedand therefore be misleading to
