ASTM E2538-06(2011)

Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020)

SIGNIFICANCE AND USE
Health information networks (HINs) have arisen in recent years as a way to share common information within organizational arrangements among those healthcare facilities that have been formed into large, more comprehensive integrated delivery systems (IDS) and managed care organizations (MCO) offering a full range of healthcare services, both inpatient and ambulatory.  
The specific organizational structures to which the MCO term was originally applied most probably have evolved into something quite different. Furthermore, IDS organizations are contracting with other organizations that have a market larger than a single IDS itself and are buying such services for themselves rather than offering them internally.
These organizations will need a frame of reference for the global information needed to provide all of the services required during patient care. For a global Concept Model consult ADA Specification 1000.0–1000.18 and TR 1039.
Pharmacotherapy will require a number of these services, including those of the clinical laboratory for therapeutic drug monitoring as well as pharmacy services of both resident and nonresident care organizations and stand-alone pharmacies to ensure freedom from medication errors and conduct ongoing investigations of both the outcomes of care and the management of resources related to pharmacotherapy.  
Pharmacotherapy functions include prescribing (clinical orders), dispensing, administering, and monitoring, which support “pharmaceutical care” defined as “provision of drug therapy to achieve desired therapeutic outcomes that improve a patient’s quality of life.” These functions address patients’ needs that require information support as noted in Table 1.
Another aspect of the monitoring function is the development of instrumentation for testing at point of care (POCT) for high-value immediate-benefit services that support pharmacotherapy. POCT, however, needs supervision and training from skilled laboratorians for the actual per...
SCOPE
1.1 This practice applies to the process of defining and documenting the capabilities, logical data sources, and pathways of data exchange regarding pharmacotherapy information services within a given network architecture serving a set of healthcare constituents.
1.2 This practice is not a technical implementation standard but, rather, describes how the implementation methods and techniques can be used to coordinate pharmacotherapy services logically within an electronic health record (EHR) systems environment involving participating organizations and sites connected by a networked communication system.  
1.3 This practice covers the content of the nodes and arcs of the resulting logical network involving EHR, pharmacy, and clinical laboratory-capable sites. This practice also considers the various purposes and organizational arrangements for coordinating pharmacotherapy services within the network boundaries and the considerations for connections among external networks.  
1.4 This practice refers to other standards for conventions within various data domains, such as pharmacy systems, clinical laboratory information management systems (CLIMS), and EHR systems, and for messaging conventions.  
1.5 This practice is intended to outline how integration of pharmacy, CLIMS, and EHR information systems can be undertaken to result in a transparent pharmacotherapy clinical decision support environment, regardless of the underlying implementation architecture, by describing the logical interoperability of information domains as facilitated by information and communications technology (ICT).  
1.6 This practice is directed at pharmacists, clinical pharmacologists, clinical laboratorians, information system managers, and information systems vendors for use in planning and implementing coordinated pharmacotherapy services through effective dialog.
1.7 This standard does not purport to address all of the safety concerns, if ...

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2011
• Withdrawal Date: 08-Jan-2020
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: E31 - Healthcare Informatics
• Drafting Committee: E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy

Relations

• Replaces: ASTM E2538-06 - Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures
• Effective Date: 01-May-2011

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:E2538 −06 (Reapproved 2011)
Standard Practice for
Defining and Implementing Pharmacotherapy Information
Services within the Electronic Health Record (EHR)
Environment and Networked Architectures
This standard is issued under the fixed designation E2538; 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 and implementing coordinated pharmacotherapy services
through effective dialog.
1.1 This practice applies to the process of defining and
1.7 This standard does not purport to address all of the
documenting the capabilities, logical data sources, and path-
safety concerns, if any, associated with its use. It is the
waysofdataexchangeregardingpharmacotherapyinformation
responsibility of the user of this standard to establish appro-
services within a given network architecture serving a set of
priate safety and health practices and determine the applica-
healthcare constituents.
bility of regulatory limitations prior to use.
1.2 This practice is not a technical implementation standard
1.8 This international standard was developed in accor-
but, rather, describes how the implementation methods and
dance with internationally recognized principles on standard-
techniquescanbeusedtocoordinatepharmacotherapyservices
ization established in the Decision on Principles for the
logically within an electronic health record (EHR) systems
Development of International Standards, Guides and Recom-
environment involving participating organizations and sites
mendations issued by the World Trade Organization Technical
connected by a networked communication system.
Barriers to Trade (TBT) Committee.
1.3 This practice covers the content of the nodes and arcs of
the resulting logical network involving EHR, pharmacy, and
2. Referenced Documents
clinical laboratory-capable sites. This practice also considers
2.1 ASTM Standards:
the various purposes and organizational arrangements for
E1239 Practice for Description of Reservation/Registration-
coordinating pharmacotherapy services within the network
Admission, Discharge, Transfer (R-ADT) Systems for
boundaries and the considerations for connections among
Electronic Health Record (EHR) Systems (Withdrawn
external networks.
2017)
1.4 This practice refers to other standards for conventions
E1340 Guide for Rapid Prototyping of Information Systems
within various data domains, such as pharmacy systems,
(Withdrawn 2017)
clinicallaboratoryinformationmanagementsystems(CLIMS),
E1384 Practice for Content and Structure of the Electronic
and EHR systems, and for messaging conventions.
Health Record (Withdrawn 2017)
E1578 Guide for Laboratory Informatics
1.5 This practice is intended to outline how integration of
E1633 SpecificationforCodedValuesUsedintheElectronic
pharmacy, CLIMS, and EHR information systems can be
Health Record (Withdrawn 2017)
undertaken to result in a transparent pharmacotherapy clinical
E1714 Guide for Properties of a Universal Healthcare Iden-
decision support environment, regardless of the underlying
tifier (UHID)
implementation architecture, by describing the logical interop-
E1715 Practice for An Object-Oriented Model for
erability of information domains as facilitated by information
Registration,Admitting, Discharge, and Transfer (RADT)
and communications technology (ICT).
Functions in Computer-Based Patient Record Systems
1.6 This practice is directed at pharmacists, clinical
(Withdrawn 2017)
pharmacologists, clinical laboratorians, information system
E1744 Practice for View of Emergency Medical Care in the
managers,andinformationsystemsvendorsforuseinplanning
1 2
This practice is under the jurisdiction ofASTM Committee E31 on Healthcare For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Data Management, Security, Confidentiality, and Privacy. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved May 1, 2011. Published June 2011. Originally the ASTM website.
approved in 2006. Last previous edition approved in 2006 as E2538 06. DOI: The last approved version of this historical standard is referenced on
10.1520/E2538-06R11. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2538−06 (2011)
Electronic Health Record (Withdrawn 2017) Device Communications—Physical Layer Interface—
E1762 Guide for Electronic Authentication of Health Care Cable Connection)
Information (Withdrawn 2017) ANSI/IEEE 1074™ 2006 Standard for Developing Life
E1869 Guide for Confidentiality, Privacy, Access, and Data Cycle Processes
SecurityPrinciplesforHealthInformationIncludingElec- ANSI/IEEE 1074.1™ 1995 Guide for Developing Life
tronic Health Records (Withdrawn 2017) Cycle Processes
E1985 Guide for User Authentication and Authorization ANSI/IEEE 1220™ 2005 Standard for Application and
(Withdrawn 2017) Management of the System Engineering Process
E1986 Guide for Information Access Privileges to Health ANSI/IEEE 1233™ 1998 (R2002 includes 1233a) Guide to
Information (Withdrawn 2017) Preparing System Requirements Specifications
E1987 Guide for Individual Rights Regarding Health Infor- ANSI/IEEE 1320.1™ 1998 (R2004) Standard for Concep-
mation (Withdrawn 2007) tual Modeling Language—Syntax and Semantics for
E1988 Guide for Training of Persons who have Access to IDEF0
Health Information (Withdrawn 2007) ANSI/IEEE 1320.2™ 1998 (R2004) Standard for Concep-
E2017 Guide forAmendments to Health Information (With- tual Modeling Language—Syntax and Semantics for
drawn 2017) IDEF1X97 (IDEF Object)
E2066 Guide forValidation of Laboratory Information Man- ANSI/IEEE 1362™ 1998 Guide for Information
agement Systems (Withdrawn 2015) Technology—System Definition—Concept of Operations
E2084 Specification for Authentication of Healthcare Infor- Document
mation Using Digital Signatures (Withdrawn 2009) ANSI/IEEE 1490™ 2003 IEEE Guide IEEE—Adoption of
E2085 Guide on Security Framework for Healthcare Infor- PMI Standard—AGuide to Project Management Body of
mation (Withdrawn 2009) Knowledge, 2000 Edition PMI
E2086 Guide for Internet and Intranet Healthcare Security ANSI/IEEE 12207.0™ 1996 Standard for Information
(Withdrawn 2009) Technology—Software Life Cycle Processes
E2145 Practice for Information Modeling (Withdrawn ANSI/IEEE 12207.1™ 1997 Guide for Information
2017) Technology—Software Life Cycle Processes—Life Cycle
E2147 Specification for Audit and Disclosure Logs for Use Data
in Health Information Systems (Withdrawn 2017) ANSI/IEEE 12207.2™ 1997 Guide for Information
E2171 Practice for Rating-Scale Measures Relevant to the Technology—Software Life Cycle Processes—
Electronic Health Record (Withdrawn 2017) Implementation Considerations
E2457 Terminology for Healthcare Informatics
2.3 ANSI/HL7 Standards:
E2473 Practice for the Occupational/Environmental Health
ANSI/HL7 Interface Standard v2.4, v2.5, v3.0
View of the Electronic Health Record
HL7 Message Development Framework v3.3, Dec. 1999
P110 Proposed Guide to Assist in the Defining, Procuring,
2.4 ANSI/ADA Standards:
Installing, and Implementing of a Computerized Hospital
ANSI/ADA TR 1039 2005 Clinical Content Data Model
Pharmacy System
ANSI/ADA 1000.0 Introduction, Model Architecture, and
2.2 ANSI/IEEE Standards:
Specification Framework
ANSI X3.172 American National Dictionary for Informa-
ANSI/ADA 1000.1 Individual Identification
tion Systems
ANSI/ADA 1000.2 Codes and Nomenclature
ANSI/IEEE 610.12™ 1990 (R2002) Standard Glossary of
ANSI/ADA 1000.3 Individual Characteristics
Software Engineering Terminology
ANSI/ADA 1000.4 Population Characteristics
ANSI/IEEE 830™ 1998 Software Requirements Specifica-
ANSI/ADA 1000.5 Organization
tion
ANSI/ADA 1000.6 Location
ANSI/IEEE 1058™ 1998 Software Project Management
ANSI/ADA 1000.7 Communication
Plans
ANSI/ADA 1000.8 Healthcare Event
ANSI/IEEE 1062™ 1998 (R2002 includes 1062a) Recom-
ANSI/ADA 1000.9 Health Materiel
mended Practice for Software Acquisition
ANSI/ADA 1000.10 Health Services
ANSI/IEEE 1063™ 2001 Software User Documentation
ANSI/ADA 1000.11 Health Service Resources
ANSI/IEEE 1073™ 1996 Framework and Overview
ANSI/ADA 1000.12 Population Health Facts
ANSI/IEEE 1073.3.1™ 2001/Amd1-2001 Transport Profile
ANSI/ADA 1000.13 Patient Health Facts
(redesignated 11073-3-1, Standard for Medical Device
ANSI/ADA 1000.14 Health Condition Diagnosis
Communications-Transport Profile-Connection Mode)
ANSI/ADA 1000.15 Health Service Plan
ANSI/IEEE 1073.4.1™ 2001 Physical Layer-Cable Con-
ANSI/ADA 1000.16 Patient Health Service
nected (redesignated 11073-4-1, Standard for Medical
ANSI/ADA 1000.17 Clinical Investigation
ANSI/ADA 1000.18 Comments Subject Area
2.5 ISO Standards:
Withdrawn 1988.
ISO/IEC TR 9789 Information Technology—Guidelines for
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. the Organization and Representation of Data Elements for
E2538−06 (2011)
Data Interchange-Coding Methods and Principles fer Messages between Clinical Laboratory Instruments
ISO 12200 Computer Applications in Terminology— and Computer Systems
Machine-Readable Terminology Interchange Format CLSI LIS-2A Specification for Transferring Information be-
(MARTIF)—Negotiated Interchange tween Clinical Instruments and Computer Systems
ISO 12620 Computer Applications in Terminology—Data CLSI LIS-3A Guide for Procurement of a Clinical Labora-
Categories tory Information Management System (CLIMS)
ISO IS 12207 Information Technology—Software Life CLSI LIS-5A Specification for Transferring Clinical Obser-
Cycle Processes vations between Independent Computer Systems
ISO IS 15188 Project Management Guidelines forTerminol- CLSI LIS-7A Specification for Use of Bar Codes on Speci-
ogy Standardization men Tubes in the Clinical Laboratory
ISO 15189 Quality Management in the Clinical Laboratory CLSILIS-8A GuideforFunctionalRequirementsofClinical
ISO DIS 15193 Measurement of Quantities in Samples of Laboratory Information Management Systems
Biologic Origin—Reference Methods CLSILIS-9A GuideforCoordinationofClinicalLaboratory
ISO DIS 15194 Measurement of Quantities in Samples of Services in an Electronic Health Record Environment and
Biologic Origin—Reference Materials Networked Architectures
ISO 15195 Requirements for Reference Measurement Labo- CLSI POCT1 Point of Care Connectivity
ratories DICOM Supplement 15 Visible Light Image, Anatomic
ISO WD 15288 System Life Cycle Processes Frame of Reference, Accession and Specimen for
ISO 15440 Guide for Life Cycle Processes Endoscopy, Microscopy, and Photography
ISO 17511 Traceability of Calibration and Control Materials EIA/IEEE J-Std-016 Standard for Information Technology,
Software Life Cycle Processes, Software Development,
2.6 Other Standards:
Acquirer-Supplier Agreement
AAMI SW68:2001 Medical Device Software-Software Life
IUPAC/IFCC Silver Book: Compendium of Terminology
Cycle Processes
and Nomenclature of Properties in Clinical Laboratory
ANSI X12
Sciences
CEN ENV 1613 Medical Informatics—Messages for the
IUPAC/IFCC Properties and Units in Clinical Laboratory
exchange of laboratory information
Sciences X Properties and Units in General Clinical
CEN ENV 1614 Healthcare Informatics—Structure for
Chemistry
nomenclature, classification and coding of properties in
IUPAC/IFCC Properties and Units in Clinical Laboratory
clinical laboratory sciences
Sciences XII Properties and Units in Clinical Pharmacol-
CEN EN 12017 Medical Informatics Vocabulary (MIVoc)
ogy and Toxicology
CEN EN 12264 Categorical Structures of Systems of
NCPDP SCRIPT v9.0
Concepts—Model for Representation of Semantics
RxNorm
(MOSE)
Internet RFC 1521 N. Borenstein, N Freed MIME [Multi-
3. Terminology
purposeInternet Mail Extensions] Purpose: Mechanisms
3.1 Definitions—Terminologyrelatedtogeneralinformation
for Specifying and Designating the Format of Internet
systems appears in ANSI X3.172 and ANSI/IEEE 610.12.
Message Bodies Bellcore Innosoft Sept. 1993
Terminology relating generally to healthcare information ap-
ANSI/CLSI ASTP2 Point of Care In-vitro Diagnostic Test-
pears in CEN EN 12264 and CEN EN 12017, Terminology
ing
E2457, and Unified Medical Language System (UMLS). The
CLSI AUTO1-A Laboratory Automation: Specimen
terms used frequently from these sources appear here, in
Container/Specimen Carrier
addition to those terms specific to this practice.
CLSI AUTO2-A Laboratory Automation: Bar codes for
Specimen Container Identification
3.2 Definitions of Terms Specific to This Standard:
CLSI AUTO3-A Laboratory Automation: Communications
3.2.1 health information network, n—set of data domains
with Automated Clinical Laboratory Systems,
(nodes) and communications pathways (arcs) serving a health-
Instruments, Devices and Information Systems
care constituency with information management services.
CLSI AUTO4-A Laboratory Automation: Systems Opera-
3.2.2 identifier, n—symbol used to name, indicate, or locate.
tional Requirements, Characteristics and Information El-
ANSI/IEEE 610.12
ements
3.2.2.1 Discussion—Identifiers may be associated with such
CLSIAUTO5-A LaboratoryAutomation:Electromechanical
things as data structures, data items, or program locations.
Interfaces
CLSILIS-1A SpecificationforLowLevelProtocoltoTrans-
Available from NEMA, Suite 1752, 1300 N. 17th St., Rosslyn, VA 22209.
Available from the Institute of Electrical and Electronics Engineers, Inc., 1828
L St., NW, Suite 1202, Washington, DC 20036-5104.
Available from the Association for Advancement of Medical Instrumentation, AvailablefromtheIUPACSecretariat,POBox13757,ResearchTrianglePark,
1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795. NC 27709-3757.
AvailablefromtheEuropeanCommitteeforStandardization,36ruedeStassart, Available from the National Council for Prescription Drug Programs, 9240 E.
B-1050 Brussels, Belgium. Raintree Dr., Scottsdale, AZ 85260-7518.
8 13
AvailablefromtheClinicalandLaboratoryStandardsInstitute,940WestValley Available from Reference and Web Services, National Library of Medicine,
Rd., Suite 1400, Wayne, PA 19087-1898. 8600 Rockville Pike, Bethesda, MD 20894.
E2538−06 (2011)
3.2.3
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