ASTM E2538

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.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents

E1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems
E1340 Guide for Rapid Prototyping of Information Systems
E1384 Practice for Content and Structure of the Electronic Health Record (EHR)
E1578 Guide for Laboratory Information Management Systems (LIMS)
E1633 Specification for Coded Values Used in the Electronic Health Record
E1714 Guide for Properties of a Universal Healthcare Identifier (UHID)
E1715 Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
E1744 Practice for View of Emergency Medical Care in the Electronic Health Record
E1762 Guide for Electronic Authentication of Health Care Information
E1869 Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records
E1985 Guide for User Authentication and Authorization
E1986 Guide for Information Access Privileges to Health Information
E1987 Guide for Individual Rights Regarding Health Information
E1988 Guide for Training of Persons who have Access to Health Information
E2017 Guide for Amendments to Health Information
E2066 Guide for Validation of Laboratory Information Management Systems
E2084 Specification for Authentication of Healthcare Information Using Digital Signatures
E2085 Guide on Security Framework for Healthcare Information
E2086 Guide for Internet and Intranet Healthcare Security
E2145 Practice for Information Modeling
E2147 Specification for Audit and Disclosure Logs for Use in Health Information Systems
E2171 Practice for Rating-Scale Measures Relevant to the Electronic Health Record
E2457 Terminology for Healthcare Informatics
E2473 Practice for the Occupational/Environmental Health View of the Electronic Health Record
P110 Proposed Guide to Assist in the Defining, Procuring, Installing, and Implementing of a Computerized Hospital Pharmacy System
AAMI SW68:2001 Medical Device Software-Software Life Cycle Processes
ANSI X12
ANSI X3.172 American National Dictionary for Information Systems
ANSI/ADA 1000.0 Introduction, Model Architecture, and Specification Framework
ANSI/ADA 1000.1 Individual Identification
ANSI/ADA 1000.10 Health Services
ANSI/ADA 1000.11 Health Service Resources
ANSI/ADA 1000.12 Population Health Facts
ANSI/ADA 1000.13 Patient Health Facts
ANSI/ADA 1000.14 Health Condition Diagnosis
ANSI/ADA 1000.15 Health Service Plan
ANSI/ADA 1000.16 Patient Health Service
ANSI/ADA 1000.17 Clinical Investigation
ANSI/ADA 1000.18 Comments Subject Area
ANSI/ADA 1000.2 Codes and Nomenclature
ANSI/ADA 1000.3 Individual Characteristics
ANSI/ADA 1000.4 Population Characteristics
ANSI/ADA 1000.5 Organization
ANSI/ADA 1000.6 Location
ANSI/ADA 1000.7 Communication
ANSI/ADA 1000.8 Healthcare Event
ANSI/ADA 1000.9 Health Materiel
ANSI/ADA TR 1039 2005 Clinical Content Data Model
ANSI/CLSI ASTP2 Point of Care In-vitro Diagnostic Testing
ANSI/HL7 Interface Standard v2.4, v2.5, v3.0
ANSI/IEEE 1058 1998 Software Project Management Plans
ANSI/IEEE 1062 1998 (R2002 includes 1062a) Recommended Practice for Software Acquisition
ANSI/IEEE 1063 2001 Software User Documentation
ANSI/IEEE 1073 1996 Framework and Overview
ANSI/IEEE 1073.3.1 2001/Amd1-2001 Transport Profile (redesignated 11073-3-1, Standard for Medical Device Communications-Transport Profile-Connection Mode)
ANSI/IEEE 1073.4.1 2001 Physical Layer-Cable Connected (redesignated 11073-4-1, Standard for Medical Device Communications-Physical Layer Interface-Cable Connection)
ANSI/IEEE 1074 2006 Standard for Developing Life Cycle Processes
ANSI/IEEE 1074.1 1995 Guide for Developing Life Cycle Processes
ANSI/IEEE 1220 2005 Standard for Application and Management of the System Engineering Process
ANSI/IEEE 12207.0 1996 Standard for Information Technology-Software Life Cycle Processes
ANSI/IEEE 12207.1 1997 Guide for Information Technology-Software Life Cycle Processes-Life Cycle Data
ANSI/IEEE 12207.2 1997 Guide for Information Technology-Software Life Cycle Processes-Implementation Considerations
ANSI/IEEE 1233 1998 (R2002 includes 1233a) Guide to Preparing System Requirements Specifications
ANSI/IEEE 1320.1 1998 (R2004) Standard for Conceptual Modeling Language-Syntax and Semantics for IDEF0
ANSI/IEEE 1320.2 1998 (R2004) Standard for Conceptual Modeling Language-Syntax and Semantics for IDEF1X97 (IDEF Object)
ANSI/IEEE 1362 1998 Guide for Information Technology-System Definition-Concept of Operations Document
ANSI/IEEE 1490 2003 IEEE Guide IEEE-Adoption of PMI Standard-A Guide to Project Management Body of Knowledge, 2000 Edition PMI
ANSI/IEEE 610.12 1990 (R2002) Standard Glossary of Software Engineering Terminology
ANSI/IEEE 830 1998 Software Requirements Specification
CEN EN 12017 Medical Informatics Vocabulary (MIVoc)
CEN EN 12264 Categorical Structures of Systems of Concepts-Model for Representation of Semantics (MOSE)
CEN ENV 1613 Medical Informatics-Messages for the exchange of laboratory information
CEN ENV 1614 Healthcare Informatics-Structure for nomenclature, classification and coding of properties in clinical laboratory sciences
CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier
CLSI AUTO2-A Laboratory Automation: Bar codes for Specimen Container Identification
CLSI AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices and Information Systems
CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics and Information Elements
CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces
CLSI LIS-1A Specification for Low Level Protocol to Transfer Messages between Clinical Laboratory Instruments and Computer Systems
CLSI LIS-2A Specification for Transferring Information between Clinical Instruments and Computer Systems
CLSI LIS-3A Guide for Procurement of a Clinical Laboratory Information Management System (CLIMS)
CLSI LIS-5A Specification for Transferring Clinical Observations between Independent Computer Systems
CLSI LIS-7A Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
CLSI LIS-8A Guide for Functional Requirements of Clinical Laboratory Information Management Systems
CLSI LIS-9A Guide for Coordination of Clinical Laboratory Services in an Electronic Health Record Environment and Networked Architectures
CLSI POCT1 Point of Care Connectivity
DICOM Supplement 15 Visible Light Image, Anatomic Frame of Reference, Accession and Specimen for Endoscopy, Microscopy, and Photography
EIA/IEEE J-Std-016 Standard for Information Technology, Software Life Cycle Processes, Software Development, Acquirer-Supplier Agreement
HL7 Message Development Framework v3.3, Dec. 1999
Internet RFC 1521 N. Borenstein, N Freed MIME [MultipurposeInternet Mail Extensions] Purpose: Mechanisms for Specifying and Designating the Format of Internet Message Bodies Bellcore Innosoft Sept. 1993
ISO 12200 Computer Applications in Terminology-Machine-Readable Terminology Interchange Format (MARTIF)-Negotiated Interchange
ISO 12620 Computer Applications in Terminology-Data Categories
ISO 15189 Quality Management in the Clinical Laboratory
ISO 15195 Requirements for Reference Measurement Laboratories
ISO 15440 Guide for Life Cycle Processes
ISO 17511 Traceability of Calibration and Control Materials
ISO DIS 15193 Measurement of Quantities in Samples of Biologic Origin-Reference Methods
ISO DIS 15194 Measurement of Quantities in Samples of Biologic Origin-Reference Materials
ISO IS 12207 Information Technology-Software Life Cycle Processes
ISO IS 15188 Project Management Guidelines for Terminology Standardization
ISO WD 15288 System Life Cycle Processes
ISO/IEC TR 9789 Information Technology-Guidelines for the Organization and Representation of Data Elements for Data Interchange-Coding Methods and Principles
IUPAC/IFCC Properties and Units in Clinical Laboratory Sciences XII Properties and Units in Clinical Pharmacology and Toxicology
IUPAC/IFCC Properties and Units in Clinical Laboratory Sciences X Properties and Units in General Clinical Chemistry
IUPAC/IFCC Silver Book: Compendium of Terminology and Nomenclature of Properties in Clinical Laboratory Sciences
NCPDP SCRIPT v9.0
RxNorm

Index Terms

EHR; electronic health record; information domain; network architecture; pharmacotherapy information services; ICS Number Code 35.240.80

Citing ASTM Standards

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