ASTM E2522-07
(Guide)Standard Guide for Quality Indicators for Health Classification
Standard Guide for Quality Indicators for Health Classification
ABSTRACT
This guide is intended to document principal ideas which are necessary and sufficient to assign value to health classification. This guide shall serve governments, funding agencies, terminology developers, terminology integration organizations, and the purchasers and users of this classification system toward improved terminological development and recognition of value in classification. This international standard will also provide classification developers and authors with the quality guidelines needed to construct useful, maintainable classifications. It is applicable to all areas of health about which information is kept or utilized, and is intended to complement and utilize those notions already identified by other national and international standards bodies. These tenets do not attempt to specify all of the richness which can be incorporated into a classification. However, this standard does specify the minimal requirements, which if not adhered to will assure that the classification will have limited generalizability and will be very difficult if not impossible to maintain.
SCOPE
1.1 This international standard is intended to document principal ideas which are necessary and sufficient to assign value to a classification. The standard will serve as a guide for governments, funding agencies, terminology developers, terminology integration organizations, and the purchasers and users of classification systems toward improved terminological development and recognition of value in a classification. It is applicable to all areas of health about which information is kept or utilized. Appropriately, classifications should be evaluated within the context of their stated scope and purpose. It is intended to complement and utilize those notions already identified by other national and international standards bodies. This standard explicitly refers only to classifications. This international standard will also provide classification developers and authors with the quality guidelines needed to construct useful, maintainable classifications. These tenets do not attempt to specify all of the richness which can be incorporated into a classification. However, this standard does specify the minimal requirements, which if not adhered to will assure that the classification will have limited generalizability and will be very difficult if not impossible to maintain. We have used the word "Shall" to indicate mandatory requirements and the word "Should" to indicate those requirements which we feel are desirable but may not be widely achievable in current implementations. Classifications, which do not currently meet these criteria, can be in compliance with this standard by putting in place mechanisms to move toward these goals. This standard will provide classification developers with a sturdy starting point for the development of useful classifications. This foundation serves as the basis from which classification developers will build robust concept systems.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:E2522 −07
StandardGuide for
Quality Indicators for Health Classifications
This standard is issued under the fixed designation E2522; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope these publications do not apply. However, parties to agree-
ments based on Guide E2522 are encouraged to investigate the
1.1 This international standard is intended to document
possibility of applying the most recent editions of the norma-
principal ideas which are necessary and sufficient to assign
tive documents indicated below. For undated references, the
value to a classification. The standard will serve as a guide for
latest edition of the normative document referred to applies.
governments, funding agencies, terminology developers, ter-
Members of ISO and IEC maintain registers of currently valid
minology integration organizations, and the purchasers and
International Standards.
users of classification systems toward improved terminological
development and recognition of value in a classification. It is 2.2 ASTM Standards:
applicabletoallareasofhealthaboutwhichinformationiskept E1238 Specification for Transferring Clinical Observations
or utilized. Appropriately, classifications should be evaluated Between Independent Computer Systems (Withdrawn
within the context of their stated scope and purpose. It is 2002)
intended to complement and utilize those notions already E1239 Practice for Description of Reservation/Registration-
identified by other national and international standards bodies. Admission, Discharge, Transfer (R-ADT) Systems for
This standard explicitly refers only to classifications. This Electronic Health Record (EHR) Systems
international standard will also provide classification develop- E1284 Guide for Construction of a Clinical Nomenclature
ers and authors with the quality guidelines needed to construct for Support of Electronic Health Records (Withdrawn
useful, maintainable classifications. These tenets do not at- 2007)
tempt to specify all of the richness which can be incorporated E1384 Practice for Content and Structure of the Electronic
into a classification. However, this standard does specify the Health Record (EHR)
minimal requirements, which if not adhered to will assure that E1633 SpecificationforCodedValuesUsedintheElectronic
the classification will have limited generalizability and will be Health Record
very difficult if not impossible to maintain. We have used the 2.3 ISO Standards:
word “Shall” to indicate mandatory requirements and the word
ISO 704 Principles and Methods of Terminology
“Should” to indicate those requirements which we feel are ISO/DIS 860 International Harmonization of Concepts and
desirable but may not be widely achievable in current imple-
Terms
mentations. Classifications, which do not currently meet these ISO 1087-2 Terminology—Vocabulary—Part 2: Computer
criteria, can be in compliance with this standard by putting in
Applications
place mechanisms to move toward these goals. This standard ISO 11179-3 Terminology—Data Registries
will provide classification developers with a sturdy starting
ISO 12200 Terminology—Computer Applications—
point for the development of useful classifications. This foun- Machine Readable Terminology Interchange Format
dation serves as the basis from which classification developers
ISO 12620 Terminology—Computer Applications—Data
will build robust concept systems. Categories
ISO 15188 Project Management for Terminology Standard-
2. Referenced Documents
ization
ISO 2382-4 Information Technology—Vocabulary—Part 4:
2.1 Normative References—The following normative docu-
Organization of Data
ments contain provisions, which through reference in this text,
constitute provisions of this Guide E2522. For dated
references, subsequent amendments to, or revisions of, any of
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare the ASTM website.
Informatics and is the direct responsibility of Subcommittee E31.35 on Healthcare The last approved version of this historical standard is referenced on
Data Analysis. www.astm.org.
Current edition approved April 1, 2007. Published May 2007. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
E2522-07. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2522−07
TR9789 GuidelinesfortheOrganizationandRepresentation 3.1.10 terminology—set of terms representing a system of
of Data Elements for Data Interchange—Coding Methods concepts within a specified domain.
and Principles
3.1.10.1 Discussion—This implies a published purpose and
scope from which one can determine the degree to which this
2.4 CEN Standards:
representation adequately covers the domain specified.
ENV 12017 Medical Informatics—Vocabulary
4. General
3. Terminology
4.1 Basics—Basic characteristics of a terminology influence
3.1 For the purposes of this guide, the following terms and
its utility and appropriateness in clinical applications.
definitions apply:
3.1.1 canonical term—a preferred atomic or pre-
4.2 Concept Orientation—The basic unit of a terminology
coordinated term for a particular medical concept.
shall be a concept, which is the embodiment of some specific
3.1.2 classification—collection of terms grouped by a com-
meaning and not a code or character string. Identifiers of a
mon characteristic. Usually not intended to represent the full Concept shall correspond to one and only one meaning and in
content of a knowledge domain. Classifications are an aggre-
a well-ordered vocabulary only one concept may have that
gation of a nomenclature. A classification is a terminology same meaning (DIS 860). However, multiple terms (linguistic
which aggregates data at a prescribed level of abstraction for a
representations) may have the same meaning if they are
particular domain. This fixing of the level of abstraction that explicit representations of the same concept. This implies
can be expressed using the classification system is often fixed
non-redundancy, non-ambiguity, non-vagueness and internal
to enhance consistency when the classification is to be applied consistency.
acrossadiverseusergroup,suchasisthecasewithsomeofthe
4.2.1 Non-Redundancy—Terminologies shall be internally
current billing classification schemes. Examples are ICD9-CM
normalized.Thereshallnotbemorethanoneconceptidentifier
and CPT.
in the terminology with the same meaning (ISO 704, Guide
E1284). This does not exclude synonymy; rather, it requires
3.1.3 controlled health vocabulary—a terminology intended
that this be explicitly represented.
for clinical use. This implies enough content and structure to
provide a representation capable of encoding comparable data, 4.2.2 Non-Ambiguity—No concept identifier should have
more than one meaning. However, an entry term (some authors
at a granularity consistent with that generated by the practice
within the domain being represented, within the purpose and havereferredtothisasan“interfaceterminology”)canpointto
more than one concept (for example, MI as Myocardial
scope of the terminology.
Infarction and Mitral Insufficiency).
3.1.4 index term—a pointer to a concept in a classification.
4.2.3 Non-Vagueness—Concept names shall be context free
This can be a synonym, abbreviation, acronym or some
(some authors have referred to this as “context laden”). For
mnemonicwhichcanbeusedtoindicatethecorrectcodetouse
example, “diabetes mellitus” should not have the child concept
fromtheclassification.Suchuseisimportantformappingfrom
“well controlled”; instead, the child concept’s name should be
the way clinicians tend to speak to the classification. These
“diabetes mellitus, well controlled.”
have been referred to as Entry terms by some authors.
4.2.4 Internal Consistency—Relationships between con-
3.1.5 modifier—a string which, when added to a term,
cepts should be uniform across parallel domains within the
changes the meaning of the term in the Clinical sense (for
terminology. For example, if heart valve structures are speci-
example, clinical stage or severity of illness).
fiedanatomically,thediagnosisrelatedtoeachstructureshould
3.1.6 nomenclature—the canonical set of terms comprising
also be specified using the same relationships.
a given controlled vocabulary; their structure, relationships
4.3 Purpose and Scope—Any classification shall have its
and, if existing, systematic and formal definitions; and the
purpose and scope clearly stated in operational terms so that its
code, meaning formal rules and general principles, guiding
fitness for particular purposes can be assessed and evaluated
how the controlled vocabulary may be changed.
(ISO 15188). Where appropriate, it may be useful to illustrate
3.1.7 ontology—an organization of concepts by relation-
the scope by examples or ‘use cases’as in database models and
ships for which one can make a rational argument. Colloqui-
other specification tools. Criteria such as coverage and com-
ally, this term is used to describe a hierarchy constructed for a
prehensiveness can only be judged relative to the intended use
specific purpose. For example, a hierarchy of qualifiers would
and scope. For example, a classification might be comprehen-
be a Qualifier Ontology.
sive and detailed enough for aggregation of billing codes from
3.1.8 qualifier—a string which, when added to a term,
a hospital admission (for example, DRGs), but inadequate for
changes the meaning of the term in a Temporal or Adminis-
specifying the indication for a surgical procedure.
trative sense (for example, “History of” or “Recurrent”).
4.3.1 Coverage—Each segment of the healthcare process
3.1.9 term—a word or words corresponding to one or more
shall have explicit in-depth coverage and not rely on broad leaf
concepts.
node categories that lump specific clinical concepts together.
For example, it is often important to distinguish specific
diagnosis from categories presently labeled “Not Elsewhere
Classified” (NEC) or to differentiate disease severity such as
Available from European Committee for Standardization (CEN), 36 rue de
Stassart, B-1050, Brussels, Belgium, http://www.cenorm.be. indolent prostate cancer from widely metastatic disease. The
E2522−07
extent to which the depth of coverage is incomplete shall be links/relations/attributes should be explicitly defined. If a
explicitly specified for each domain (scope) and purpose as looser meaning such as “broader than/narrower than” is used,
indicated in 4.3. (1) it should be explicitly stated. For example, the primary
4.3.2 Comprehensiveness—The extent to which the degree hierarchical relation should be subsumption as exemplified by
of comprehensiveness is incomplete shall be explicitly speci- logicalimplication:“BisakindofA”means“AllB’sareA’s.”
fied for each domain (scope) and purpose as indicated in 4.3.
4.7 Multiple Hierarchies—Concepts should be accessible
Within the scope and purpose, all aspects of the healthcare
through all reasonable hierarchical paths (that is, they shall
process shall be addressed for all related disciplines, such as
allowmultiplesemanticparents).Forexample,stomachcancer
physical findings, risk factors, or functional status—across the
can be viewed as a neoplasm or as a gastrointestinal disease.A
breadth of medicine, surgery, nursing, and dentistry. This
balancebetweennumberofparents(assiblings)andnumberof
criterion applies because decision support, risk adjustment,
children in a hierarchy should be maintained. This feature
outcomes research, and useful guidelines require more than
assumes obvious advantages for natural navigation of terms
diagnoses and procedures. Examples include existing Agency
(forretrievalandanalysis)asaconceptofinterestcanbefound
for Healthcare Research and Quality guidelines, and the CMS
by following intuitive paths (that is, users should not have to
mortality model. (2)
guess where a particular concept was instantiated). (4)
4.4 Mapping:
4.8 Consistency of View—A concept in multiple hierarchies
4.4.1 Government and payers mandate the form and classi-
shall be the same concept in each case. Our example of
fication schema for much clinical data exchange. Thus, com-
stomach cancer shall not have changes in nuance or structure
prehensive and detailed representations of patient data within
when arrived at via the cancer hierarchy as opposed to GI
computer-based patient records should be able to be mapped to
diseases. Inconsistent views could have catastrophic conse-
those classifications, such as ICD-9. This need for multiple
quences for retrieval and decision support by inadvertently
granularities is needed for clinical healthcare as well (ISO TR
introducing variations in meaning which may be unrecognized
9789). For example, an endocrinologist may specify more
and therefore be misleading to users of the system. (5)
detail about a patient’s Diabetes Mellitus than a generalist
4.9 Explicit Uncertainty—Notions of “probable,” “sus-
workinginanurgentcaresettingoranurseassessingtheextent
pected,” “history of,” or differential possibilities (that is, a
to which the individual is coping with their disorder, even
Differential Diagnosis list) shall be supported. The impact of
though all may be caring for the same patient. The degree to
certain versus very uncertain information has obvious impact
whichtheterminologyismappabletootherclassificationsshall
ondecisionsupportandothersecondarydatauses.Similarly,in
be explicitly stated. (3)
the case of incomplete syndromes, clinicians should be able to
4.4.2 The rules for mapping from a classification to a
record the partial criteria consistent with the patient’s presen-
nomenclature are the same rules that are defined for the
tation. This criterion is listed separately as many current
formation of compositional expressions from the reference
terminological systems fail to address this adequately.
terminology and therefore are by definition terminology de-
pendent. As a well-formed classification is defined as a 4.10 Representational Form—The representational form of
pre-coordination from the reference terminology, different
the identifiers within the terminology should be meaningless.
constructs (codes in the classification) deve
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