ASTM E2522-07(2013)
(Guide)Standard Guide for Quality Indicators for Health Classifications (Withdrawn 2022)
Standard Guide for Quality Indicators for Health Classifications (Withdrawn 2022)
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.
WITHDRAWN RATIONALE
This international standard is intended to document principal ideas which are necessary and sufficient to assign value to a classification.
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this guide was withdrawn in January 2022 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E2522 −07 (Reapproved 2013)
Standard Guide 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This international standard is intended to document
principal ideas which are necessary and sufficient to assign
2. Referenced Documents
value to a classification. The standard will serve as a guide for
2.1 Normative References—The following normative docu-
governments, funding agencies, terminology developers, ter-
ments contain provisions, which through reference in this text,
minology integration organizations, and the purchasers and
constitute provisions of this Guide E2522. For dated
users of classification systems toward improved terminological
references, subsequent amendments to, or revisions of, any of
development and recognition of value in a classification. It is
these publications do not apply. However, parties to agree-
applicabletoallareasofhealthaboutwhichinformationiskept
ments based on Guide E2522 are encouraged to investigate the
or utilized. Appropriately, classifications should be evaluated
possibility of applying the most recent editions of the norma-
within the context of their stated scope and purpose. It is
tive documents indicated below. For undated references, the
intended to complement and utilize those notions already
latest edition of the normative document referred to applies.
identified by other national and international standards bodies.
Members of ISO and IEC maintain registers of currently valid
This standard explicitly refers only to classifications. This
International Standards.
international standard will also provide classification develop-
2.2 ASTM Standards:
ers and authors with the quality guidelines needed to construct
E1238 Specification for Transferring Clinical Observations
useful, maintainable classifications. These tenets do not at-
Between Independent Computer Systems (Withdrawn
tempt to specify all of the richness which can be incorporated
2002)
into a classification. However, this standard does specify the
E1239 Practice for Description of Reservation/Registration-
minimal requirements, which if not adhered to will assure that
Admission, Discharge, Transfer (R-ADT) Systems for
the classification will have limited generalizability and will be
Electronic Health Record (EHR) Systems (Withdrawn
very difficult if not impossible to maintain. We have used the
2017)
word “Shall” to indicate mandatory requirements and the word
E1284 Guide for Construction of a Clinical Nomenclature
“Should” to indicate those requirements which we feel are
for Support of Electronic Health Records (Withdrawn
desirable but may not be widely achievable in current imple-
2007)
mentations. Classifications, which do not currently meet these
E1384 Practice for Content and Structure of the Electronic
criteria, can be in compliance with this standard by putting in
Health Record (Withdrawn 2017)
place mechanisms to move toward these goals. This standard
E1633 SpecificationforCodedValuesUsedintheElectronic
will provide classification developers with a sturdy starting
Health Record (Withdrawn 2017)
point for the development of useful classifications. This foun-
2.3 ISO Standards:
dation serves as the basis from which classification developers
ISO 704 Principles and Methods of Terminology
will build robust concept systems.
ISO/DIS 860 International Harmonization of Concepts and
1.2 This international standard was developed in accor-
Terms
dance with internationally recognized principles on standard-
ISO 1087-2 Terminology—Vocabulary—Part 2: Computer
ization established in the Decision on Principles for the
Applications
Development of International Standards, Guides and Recom-
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
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare Standards volume information, refer to the standard’s Document Summary page on
Informatics and is the direct responsibility of Subcommittee E31.35 on Healthcare the ASTM website.
Data Analysis. The last approved version of this historical standard is referenced on
Current edition approved March 1, 2013. Published March 2013. Originally www.astm.org.
approved in 2007. Last previous edition approved in 2007 as E2522–07. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/E2522-07R13. 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 (2013)
ISO 11179-3 Terminology—Data Registries structed for a specific purpose. For example, a hierarchy of
ISO 12200 Terminology—Computer Applications— qualifiers would be a Qualifier Ontology.
Machine Readable Terminology Interchange Format
3.1.8 qualifier—a string which, when added to a term,
ISO 12620 Terminology—Computer Applications—Data
changes the meaning of the term in a Temporal or Adminis-
Categories
trative sense (for example, “History of” or “Recurrent”).
ISO 15188 Project Management for Terminology Standard-
3.1.9 term—a word or words corresponding to one or more
ization
concepts.
ISO 2382-4 Information Technology—Vocabulary—Part 4:
3.1.10 terminology—set of terms representing a system of
Organization of Data
concepts within a specified domain.
TR9789 GuidelinesfortheOrganizationandRepresentation
3.1.10.1 Discussion—This implies a published purpose and
of Data Elements for Data Interchange—Coding Methods
scope from which one can determine the degree to which this
and Principles
representation adequately covers the domain specified.
2.4 CEN Standards:
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:
4.2 Concept Orientation—The basic unit of a terminology
3.1.1 canonical term—a preferred atomic or pre-
shall be a concept, which is the embodiment of some specific
coordinated term for a particular medical concept.
meaning and not a code or character string. Identifiers of a
3.1.2 classification—collection of terms grouped by a com-
Concept shall correspond to one and only one meaning and in
mon characteristic. Usually not intended to represent the full
a well-ordered vocabulary only one concept may have that
content of a knowledge domain. Classifications are an aggre-
same meaning (DIS 860). However, multiple terms (linguistic
gation of a nomenclature. A classification is a terminology
representations) may have the same meaning if they are
which aggregates data at a prescribed level of abstraction for a
explicit representations of the same concept. This implies
particular domain. This fixing of the level of abstraction that
non-redundancy, non-ambiguity, non-vagueness and internal
can be expressed using the classification system is often fixed
consistency.
to enhance consistency when the classification is to be applied
4.2.1 Non-Redundancy—Terminologies shall be internally
acrossadiverseusergroup,suchasisthecasewithsomeofthe
normalized.Thereshallnotbemorethanoneconceptidentifier
current billing classification schemes. Examples are ICD9-CM
in the terminology with the same meaning (ISO 704, Guide
and CPT.
E1284). This does not exclude synonymy; rather, it requires
that this be explicitly represented.
3.1.3 controlled health vocabulary—a terminology intended
4.2.2 Non-Ambiguity—No concept identifier should have
for clinical use. This implies enough content and structure to
more than one meaning. However, an entry term (some authors
provide a representation capable of encoding comparable data,
havereferredtothisasan“interfaceterminology”)canpointto
at a granularity consistent with that generated by the practice
more than one concept (for example, MI as Myocardial
within the domain being represented, within the purpose and
Infarction and Mitral Insufficiency).
scope of the terminology.
4.2.3 Non-Vagueness—Concept names shall be context free
3.1.4 index term—a pointer to a concept in a classification.
(some authors have referred to this as “context laden”). For
This can be a synonym, abbreviation, acronym or some
example, “diabetes mellitus” should not have the child concept
mnemonicwhichcanbeusedtoindicatethecorrectcodetouse
“well controlled”; instead, the child concept’s name should be
fromtheclassification.Suchuseisimportantformappingfrom
“diabetes mellitus, well controlled.”
the way clinicians tend to speak to the classification. These
4.2.4 Internal Consistency—Relationships between con-
have been referred to as Entry terms by some authors.
cepts should be uniform across parallel domains within the
3.1.5 modifier—a string which, when added to a term,
terminology. For example, if heart valve structures are speci-
changes the meaning of the term in the Clinical sense (for
fiedanatomically,thediagnosisrelatedtoeachstructureshould
example, clinical stage or severity of illness).
also be specified using the same relationships.
3.1.6 nomenclature—the canonical set of terms comprising
4.3 Purpose and Scope—Any classification shall have its
a given controlled vocabulary; their structure, relationships
purpose and scope clearly stated in operational terms so that its
and, if existing, systematic and formal definitions; and the
fitness for particular purposes can be assessed and evaluated
code, meaning formal rules and general principles, guiding
(ISO 15188). Where appropriate, it may be useful to illustrate
how the controlled vocabulary may be changed.
the scope by examples or ‘use cases’as in database models and
3.1.7 ontology—an organization of concepts by relation-
other specification tools. Criteria such as coverage and com-
ships for which one can make a rational argument.
prehensiveness can only be judged relative to the intended use
Colloquially, this term is used to describe a hierarchy con-
and scope. For example, a classification might be comprehen-
sive and detailed enough for aggregation of billing codes from
a hospital admission (for example, DRGs), but inadequate for
Available from European Committee for Standardization (CEN), 36 rue de
Stassart, B-1050, Brussels, Belgium, http://www.cenorm.be. specifying the indication for a surgical procedure.
E2522−07 (2013)
4.3.1 Coverage—Each segment of the healthcare process built into vocabularies, multiple authors will need these defi-
shall have explicit in-depth coverage and not rely on broad leaf nitions to ensure consistency in authorship. For example, the
node categories that lump specific clinical concepts together. concept “Hypertension” might be defined as a consistently
For example, it is often important to distinguish specific elevated Blood Pressure and not “BP > 140/85.”
diagnosis from categories presently labeled “Not Elsewhere
4.6 Explicitness of Relations—The logical definition of
Classified” (NEC) or to differentiate disease severity such as
subsumption should be defined. The formal behavior of all
indolent prostate cancer from widely metastatic disease. The
links/relations/attributes should be explicitly defined. If a
extent to which the depth of coverage is incomplete shall be
looser meaning such as “broader than/narrower than” is used,
explicitly specified for each domain (scope) and purpose as
it should be explicitly stated. For example, the primary
indicated in 4.3. (1)
hierarchical relation should be subsumption as exemplified by
4.3.2 Comprehensiveness—The extent to which the degree
logicalimplication:“BisakindofA”means“AllB’sareA’s.”
of comprehensiveness is incomplete shall be explicitly speci-
4.7 Multiple Hierarchies—Concepts should be accessible
fied for each domain (scope) and purpose as indicated in 4.3.
through all reasonable hierarchical paths (that is, they shall
Within the scope and purpose, all aspects of the healthcare
allowmultiplesemanticparents).Forexample,stomachcancer
process shall be addressed for all related disciplines, such as
can be viewed as a neoplasm or as a gastrointestinal disease.A
physical findings, risk factors, or functional status—across the
balancebetweennumberofparents(assiblings)andnumberof
breadth of medicine, surgery, nursing, and dentistry. This
children in a hierarchy should be maintained. This feature
criterion applies because decision support, risk adjustment,
assumes obvious advantages for natural navigation of terms
outcomes research, and useful guidelines require more than
(forretrievalandanalysis)asaconceptofinterestcanbefound
diagnoses and procedures. Examples include existing Agency
by following intuitive paths (that is, users should not have to
for Healthcare Research and Quality guidelines, and the CMS
guess where a particular concept was instantiated). (4)
mortality model. (2)
4.8 Consistency of View—A concept in multiple hierarchies
4.4 Mapping:
4.4.1 Government and payers mandate the form and classi- shall be the same concept in each case. Our example of
stomach cancer shall not have changes in nuance or structure
fication schema for much clinical data exchange. Thus, com-
prehensive and detailed representations of patient data within when arrived at via the cancer hierarchy as opposed to GI
diseases. Inconsistent views could have catastrophic conse-
computer-based patient records should be able to be mapped to
those classifications, such as ICD-9. This need for multiple quences for retrieval and decision support by inadvertently
introducing variations in meaning which may be unrecognized
granularities is needed for clinical healthcare as well (ISO TR
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,”
workinginanurgentcaresettingoranurseassessingtheextent
“suspected,” “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
whichtheterminologyismappabletootherclassificatio
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.