1、Designation: E2522 07 (Reapproved 2013)Standard Guide forQuality Indicators for Health Classifications1This standard is issued under the fixed designation E2522; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi
2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () 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 class
3、ification. The 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 isapplicabl
4、e to all areas 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.Th
5、is standard explicitly 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 inc
6、orporatedinto a 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 requi
7、rements and the 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
8、goals. This standardwill 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 followin
9、g normative docu-ments contain provisions, which through reference in this text,constitute provisions of this Guide E2522. For datedreferences, subsequent amendments to, or revisions of, any ofthese publications do not apply. However, parties to agree-ments based on Guide E2522 are encouraged to inv
10、estigate thepossibility 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:2E1
11、238 Specification for Transferring Clinical ObservationsBetween Independent Computer Systems (Withdrawn2002)3E1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems forElectronic Health Record (EHR) SystemsE1284 Guide for Construction of a Clinical N
12、omenclaturefor Support of Electronic Health Records (Withdrawn2007)3E1384 Practice for Content and Structure of the ElectronicHealth Record (EHR)E1633 Specification for Coded Values Used in the ElectronicHealth Record2.3 ISO Standards:4ISO 704 Principles and Methods of TerminologyISO/DIS 860 Interna
13、tional Harmonization of Concepts andTermsISO 1087-2 TerminologyVocabularyPart 2: ComputerApplicationsISO 11179-3 TerminologyData RegistriesISO 12200 TerminologyComputer ApplicationsMachine Readable Terminology Interchange FormatISO 12620 TerminologyComputer ApplicationsDataCategoriesISO 15188 Projec
14、t Management for Terminology Standard-izationISO 2382-4 Information TechnologyVocabularyPart 4:Organization of Data1This guide is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of Subcommittee E31.35 on HealthcareData Analysis.Current edition a
15、pproved March 1, 2013. Published March 2013. DOI: 10.1520/E2522-07R13.2For 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 standards Document Summary page onthe ASTM
16、 website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohoc
17、ken, PA 19428-2959. United States1TR 9789 Guidelines for the Organization and Representationof Data Elements for Data InterchangeCoding Methodsand Principles2.4 CEN Standards:5ENV 12017 Medical InformaticsVocabulary3. Terminology3.1 For the purposes of this guide, the following terms anddefinitions
18、apply:3.1.1 canonical terma preferred atomic or pre-coordinated term for a particular medical concept.3.1.2 classificationcollection of 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 nomencl
19、ature. A classification is a terminologywhich aggregates data at a prescribed level of abstraction for aparticular domain. This fixing of the level of abstraction thatcan be expressed using the classification system is often fixedto enhance consistency when the classification is to be appliedacross
20、a diverse user group, such as is the case with some of thecurrent billing classification schemes. Examples are ICD9-CMand CPT.3.1.3 controlled health vocabularya terminology intendedfor clinical use. This implies enough content and structure toprovide a representation capable of encoding comparable
21、data,at a granularity consistent with that generated by the practicewithin the domain being represented, within the purpose andscope of 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 indicat
22、e the correct code to usefrom the classification. Such use is important for mapping fromthe way clinicians tend to speak to the classification. 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
23、 sense (forexample, clinical stage or severity of illness).3.1.6 nomenclaturethe canonical set of terms comprisinga given controlled vocabulary; their structure, relationshipsand, if existing, systematic and formal definitions; and thecode, meaning formal rules and general principles, guidinghow the
24、 controlled vocabulary may be changed.3.1.7 ontologyan organization of concepts by relation-ships for which one can make a rational argument.Colloquially, this term is used to describe a hierarchy con-structed for a specific purpose. For example, a hierarchy ofqualifiers would be a Qualifier Ontolog
25、y.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 example, “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 withi
26、n a specified domain.3.1.10.1 DiscussionThis implies a published purpose andscope from which one can determine the degree to which thisrepresentation adequately covers the domain specified.4. General4.1 BasicsBasic characteristics of a terminology influenceits utility and appropriateness in clinical
27、 applications.4.2 Concept OrientationThe basic unit of a terminologyshall be a concept, which is the embodiment of some specificmeaning 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 t
28、hatsame meaning (DIS 860). However, multiple terms (linguisticrepresentations) may have the same meaning if they areexplicit representations of the same concept. This impliesnon-redundancy, non-ambiguity, non-vagueness and internalconsistency.4.2.1 Non-RedundancyTerminologies shall be internallynorm
29、alized. There shall not be more than one concept identifierin the terminology with the same meaning (ISO 704, GuideE1284). This does not exclude synonymy; rather, it requiresthat this be explicitly represented.4.2.2 Non-AmbiguityNo concept identifier should havemore than one meaning. However, an ent
30、ry term (some authorshave referred to this as an “interface terminology”) can point tomore than one concept (for example, MI as MyocardialInfarction and Mitral Insufficiency).4.2.3 Non-VaguenessConcept names shall be context free(some authors have referred to this as “context laden”). Forexample, “d
31、iabetes mellitus” should not have the child concept“well controlled”; instead, the child concepts name should be“diabetes mellitus, well controlled.”4.2.4 Internal ConsistencyRelationships between con-cepts should be uniform across parallel domains within theterminology. For example, if heart valve
32、structures are speci-fied anatomically, the diagnosis related to each structure shouldalso be specified using the same relationships.4.3 Purpose and ScopeAny classification shall have itspurpose and scope clearly stated in operational terms so that itsfitness for particular purposes can be assessed
33、and evaluated(ISO 15188). Where appropriate, it may be useful to illustratethe scope by examples or use casesas in database models andother specification tools. Criteria such as coverage and com-prehensiveness can only be judged relative to the intended useand scope. For example, a classification mi
34、ght be comprehen-sive and detailed enough for aggregation of billing codes froma hospital admission (for example, DRGs), but inadequate 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 broa
35、d leafnode categories that lump specific clinical concepts together.For example, it is often important to distinguish specificdiagnosis from categories presently labeled “Not ElsewhereClassified” (NEC) or to differentiate disease severity such asindolent prostate cancer from widely metastatic diseas
36、e. The5Available from European Committee for Standardization (CEN), 36 rue deStassart, B-1050, Brussels, Belgium, http:/www.cenorm.be.E2522 07 (2013)2extent to which the depth of coverage is incomplete shall beexplicitly specified for each domain (scope) and purpose asindicated in 4.3. (1)64.3.2 Com
37、prehensivenessThe extent to which the degreeof 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 fin
38、dings, risk factors, or functional statusacross 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
39、Research and Quality guidelines, and the CMSmortality 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 t
40、o be mapped tothose classifications, such as ICD-9. This need for multiplegranularities is needed for clinical healthcare as well (ISO TR9789). For example, an endocrinologist may specify moredetail about a patients Diabetes Mellitus than a generalistworking in an urgent care setting or a nurse asse
41、ssing the extentto which the individual is coping 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 s
42、ame rules that are defined for theformation of 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 classificat
43、ion) developed are built fora specific purpose. 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 he
44、re is accomplished at the level of thereference 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 t
45、hevocabulary have assigned, these definitions will 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 cons
46、istentlyelevated Blood Pressure and not “BP 140/85.”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 exp
47、licitly stated. For example, the primaryhierarchical 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
48、parents). For example, stomach cancercan be viewed 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 anal
49、ysis) as a concept of interest can be foundby following 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
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