ASTM E1712-97

Standard Specification for Representing Clinical Laboratory Test and Analyte Names (Withdrawn 2003)

SCOPE
1.1 This specification covers the construction of elected laboratory test and analyte names, because data concerning clinical laboratory tests must identify these tests in a common fashion if such data are to be transferable between databases or to be recognized in lookups or searches. It details the representations of test and analyte names as they are used in the clinical laboratory and in either the patient care record or the messages that exchange requests for those tests and analytes and return results to the requestor for insertion into the record. This specification details the form of the elected standard test name and resulting analytes in records and messages. It was written to unify several existing conventions that have been published for the identification of laboratory procedures or other billable or cost management items. It is intended to produce an explicit identifier not only of the test but also of each of the constituent results for each unique analyte. It is applicable to those situations that refer to the names of either the tests or the analytes resulting from clinical laboratory testing. These situations may include the following:Computer-based Patient Record Systems (CPR), Clinical Laboratory Information Management Systems (CLIMS), billing systems, cost identification and management systems, clinical decision support systems, epidemiologic registries and databases, and clinical research information management systems. The mnemonics of that name and the codes to be used as unique identifiers for the names of either the tests or resulting analytes are given as examples in a nonnormative appendix.

General Information

• Status: Withdrawn
• Publication Date: 09-Aug-1997
• Withdrawal Date: 11-Feb-2003
• ICS: 11.100 - Laboratory medicine
• Technical Committee: E31 - Healthcare Informatics

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: E 1712 – 97 An American National Standard
Standard Specification for
Representing Clinical Laboratory Procedure and Analyte
Names
This standard is issued under the fixed designation E 1712; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope tures of Systems of Concepts—Model for Representation
of Semantics, 1995
1.1 This specification covers the construction of elected
laboratory procedure and analyte names, because data concern-
3. Terminology
ing clinical laboratory tests must identify these procedures in a
3.1 Definitions of Terms Specific to This Standard:
common fashion if such data are to be transferable between
3.1.1 analyte name—the name of a single item or species
databases or to be recognized in lookups or searches. It details
identified or quantified by a laboratory procedure-denoted
the representations of procedure and analyte names as they are
component in the IUPAC/IFCC (1-6).
used in the clinical laboratory and in either the patient care
3.1.2 multiple analyte test—a single laboratory procedure
record or the messages that exchange requests for those
that results in a series of measurements, each relating to a
procedures and analytes and return results to the requestor for
separate identifiable entity. Separation and spectral techniques
insertion into the record. This specification details the form of
typically produce results of this type.
the elected standard procedure name and resulting analytes in
3.1.3 procedure battery—the generic clinical term for an
records and messages. It was written to unify several existing
aggregate of laboratory procedures requested by a single name
conventions that have been published for the identification of
and consisting of the names of both single procedures or
laboratory procedures or other billable or cost management
panels/profiles.
items. It is intended to produce an explicit identifier not only of
3.1.4 procedure name—the name of a laboratory analytical
the procedure but also of each of the constituent results for
procedure that leads to the identification or quantification, or
each unique analyte. It is applicable to those situations that
both, of one or more analytes.
refer to the names of either the procedures or the analytes
3.1.5 procedure panel/profile—an aggregate of clinical
resulting from clinical laboratory testing. These situations may
laboratory procedures requested by a single name, the constitu-
include the following: Computer-based Patient Record Sys-
ent procedures of which are single procedures.
tems (CPR), Clinical Laboratory Information Management
3.1.6 qualitative method precision— a procedure that re-
Systems (CLIMS), billing systems, cost identification and
sults only in an observable quantity, not a measurable property.
management systems, clinical decision support systems, epi-
3.1.7 quantitative method precision—a procedure resulting
demiologic registries and databases, and clinical research
in a measureable quantity that is governed by the chemical
information management systems. The mnemonics of that
measurement process defined in Ref (7) and containing a
name and the codes to be used as unique identifiers for the
measure of uncertainty (8).
names of either the procedures or resulting analytes are given
3.1.8 screen/semiquantitative method precision—a labora-
as examples in a nonnormative appendix.
tory procedure resulting in a measurable property that is
2. Referenced Documents categorized into an ordinal or nominal value without a measure
of uncertainty (8).
2.1 ASTM Standards:
3.1.9 single analyte procedure—a single laboratory proce-
E 1238 Specification for Transferring Clinical Observations
2 dure that results in one measurement that is characteristic of a
Between Independent Computer Systems
single entity.
E 1284 Guide for Nosologic Standards and Guides for
Construction of New Biomedical Nomenclature
4. Significance and Use
2.2 Cen Standards:
4.1 General:
CEN EN 12264 Medical Informatics—Categorical Struc-
4.1.1 The identification of procedure names used in the
clinical laboratory has traditionally relied on multiple sources,
This specification is under the jurisdiction of ASTM Committee E-31 on
each of which was created for a specific purpose. CPT-4 (9) is
Healthcare Informatics and is the direct responsibility of Subcommittee E31.13 on
Clinical Laboratory Systems.
Current edition approved Aug. 10, 1997. Published March 1998. Originally
published as E 1712 – 95. Last previous edition E 1712 – 95. The boldface numbers in parentheses refer to the list of references at the end of
Annual Book of ASTM Standards, Vol 14.01. this standard.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1712
currently used for fee-for-service payment and is being con- constraints on system implementors and laboratory profession-
sidered for prospective payment through an agreement between als to maintain the convention, during the growth of laboratory
the American Medical Association (AMA) and the Health Care science, in an upward compatible way. That is, new entries to
Financing Administration (HCFA). SNOMED terminology the lexicon must always be added in such a way that does not
(10) was developed for pathology reporting. The CAP Work- invalidate prior entries. New knowledge may require exten-
load reporting terminology (11) was devised for laboratory sions and additions but not deletions or modifications that will
management. The International Classification of Procedures change the meaning of prior entries.
(12) was produced for statistical purposes. A replacement for
4.1.3 The development of a classification and coding system
this document is being piloted based on previous work (13) and
for valid procedure names is being conducted by several
will be referred to as ICD-10 Procedure Coding System. CEN
mandating agencies. The principles for linking the naming
TC 251 WG 2 has developed terminology documents for
conventions to these schemes is given in Appendix X1, which
laboratory procedures (14, 15). When applied to the recording
is nonnormative at this time.
into the care record of specific results from testing, these prior
4.2 Structure of the Terms for Procedures and Analytes:
schemes in the United States have all had one common major
4.2.1 Terms for Procedure Names—Each procedure shall
deficiency: they were oriented toward identifying the general
have a full formal name based on the nomenclature principles
but not the specific process and not the specific results. This
of IUB/IUPAC (16, 19, 20) for chemical and biological
arrangement, although not able to keep up with the rapidly
substances, or on the International Non-Proprietary Names
changing number of new procedures, was adequate when
convention for drug products as mandated by USAN (14) and
dealing with single analyte procedures, but many procedures,
a structured formal representation of that name. Each proce-
and several commonly used ones, determined and reported
dure should also have a common name or short name. The first
multiple analytes. Three common examples of this are: the
part of the formal structured name is the primary analyte
“CBC,” or complete blood count, the differential white blood
measured. The name may have a species modifier separated
cell count, and the urine sediment microscopic count. Each of
from the analyte name by a “.” character. This analyte name
these procedures may have a variable number of specifically
may be modified by additional subattributes separated from the
identifiable analytes/species. Other procedures include separa-
primary analyte by one or more “,” characters (ASCII 44).
tion methods, such as chromatographic separations of amino
These subattributes are challenge, adjustment, and person, in
acids, in particular. It is well known that each result is a
that order. This name and additional modifiers shall be sequen-
separate and important measurement but that the emphasis of
tial: first, a procedure name, or one that invokes several
current naming systems is on the test method. Common
independent procedure names, shall be termed a “battery,” and
representation conventions have not yet been agreed upon for
this shall mean that the names included may be single
specifically identifying the analytes, although the European
procedure names or the names of either panels/profiles or other
EUCLIDES Foundation developed an analyte catalog.
batteries. An example is an admitting battery. There may be
4.1.2 This specification unifies the naming rules used in
just a list of single procedures that is given the category of
current separate terminologies and then adds to the unified list
panel/profile, but that circumstance is not required for the use
additional defined terms and representations for each analyte
of the term “battery.” Battery/profile/panel names shall begin
when these are different from the procedure name. It uses the
with a “*” (ASCII 42) character to uniquely visually identify
ideas stated in ISO general terminology standards as applied to
the procedure name aggregate. As a procedure name, the
health care in CEN EN 12264. It also includes conventions
battery name does not itself contain the constituent procedures
used by the IUPAC/IFCC Commission/Committee on Quanti-
of the battery. This list of names is an associated attribute of the
ties and Units in Clinical Chemistry (16) and the EUCLIDES
name in the same way that the various codes are associated
project of the European Standardization effort (17). A unique
attributes (see 4.3).
coding convention, which can be crossreferenced to the exist-
4.2.1.1 The challenge subattribute has the following form:<
ing coding conventions, for uniquely identifying each analyte
time delay> POST . The value sets for
can be specified from the nomenclature so determined and the
these sub-subattributes are given in Table 1. The adjustment
accompanying lexicon of terms. This unique coding conven-
subattribute is a phrase such as “Adj to pH 7.4,” again set off
tion can then be used whenever specific measurements are
by commas. The person subattribute has the following values:
reported for a particular specimen from an individual patient.
CONT 5 control, PAT 5 patient, DON 5 donor,
The coding convention is stated so that it, or specific variants
BPU 5 blood product unit, and FET 5 fetus. For example,
of it, can be specified for aggregating and storing results into,
GLUCOSE, 30M POST 100 GM GLUCOSE PO:MCNC:
or communicating laboratory procedure results from, transport- PT:SER:QN:.
able patient care records. It is based on the general principles
4.2.1.2 The formal procedure name shall also have levels of
set down in CEN EN 12264 and Ref (18). Because computer-
specificity beyond just the basic procedure name. In the
based records are longitudinal over the lifetime of the patient
following order, the additional major attributes of the proce-
and over the geographic locations where care may be deliv-
dure name shall uniquely identify the property observed or
ered, the naming and coding conventions must be adhered to
measured, timing of the specimen, source of the specimen,
within the specifications, if the recipient of the patient’s record degree of precision (qualitative, semiquantitative, quantita-
is to clearly, quickly, and unequivocally identify the laboratory
tive), and methodology or instrumentation, or both, for that
data recorded therein. The use of this convention places certain procedure, when required. The property observed or measured
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1712
(14, 15) shall be the second attribute, separated from the
TABLE 1 Continued
procedure/analyte name by a “:” (ASCII 58). The timing of the
PUS pus (UP)
specimen is the third attribute, which shall also always appear.
CALC calculus (TC)
SAL saliva (AL)
The source of the specimen shall always appear as the fourth
SKN skin (TK)
attribute of the name separated from the second by a “:”
SPT sputum, NOS (TS)
character. The degree of precision shall be the fifth attribute GAST gastric fluid (FG)
LIQ liquid (LQ)
separated from the fourth by a “:” and followed by a “:” and
BDY whole body (BY)
shall also always appear. These higher levels of specificity
USUB unknown substance
WAT water (ZW)
shall be organized as hierarchical extensions of the basic term
PRC packed red cells (RP)
in that order of priority. The method attribute is optional but, if
TISS tissue, NOS (TI)
absent, shall contain NS (meaning “not specified”) and shall be
DUFL duodenal fluid (FD)
PRT fluid, peritoneal (ascites) (FC)
the sixth attribute of the name. The list of attribute abbrevia-
PRL fluid pleural (FB)
tions used in components of the formal structured form of the
WNDE wound exudate (FE)
WNDD wound drainage (FI)
name are shown in Table 1. The source attribute may be broken
SWT sweat (SW)
into five subclasses, which are combined independently to
CVM cervical mucous (GM)
form the full source attribute. The five subclasses which appear
CVX cervix (GR)
EARW earwax
in that order are: specimen type, specimen origin, collection
CNJT conjunctiva
method, collection device, and pathologic condition. The first
ORH other
(specimen type) subattribute always appears. These subat-
PAFL pancreatic fluid
SWAB swab
tributes of the source apply in the priority order noted above
TUBE tube, NOS
and are separated by the delimiting ASCII character 44 “,”.
TUNK type unknown
TUNS type unspecified
Trailing delimiters shall be dropped if all of the remaining
ELCT electrode (ZE)
fields are empty; subattributes need not appear. Examples of
BPU blood product unit
the construction of procedure names are given in Appendix X1.
DIAF dialysis fluid
EHG exhaled gas
IHG inhaled gas
TABLE 1 Test Analyte Term Attribute and Subattribute
ENDC endocardium
A
Abbreviations
ENDM endometrium
MLK milk
A. Specimen Type
PPP platelet-poor plasma
PRP platelet-rich plasma
SER serum (SZ)
URNS urine sediment
UR urine (UZ)
UMED unknown medicine
PLAS plasma (PZ)
PAT patient
STL stool (LZ)
XXX specified at test time
AMN amniotic fluid (FA)
CSF cerebral spinal fluid (CZ)
B. Specimen Origin
BLD whole blood, NOS (BZ)
PLC placenta (PC)
BLDA blood arterial (BA)
ABS abscess
BLDV
...