ANSI ASTM E2538-2006 Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Archit.pdf

1、Designation: E2538 06 (Reapproved 2011)Standard Practice forDefining and Implementing Pharmacotherapy InformationServices within the Electronic Health Record (EHR)Environment and Networked Architectures1This standard is issued under the fixed designation E2538; the number immediately following the d

2、esignation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice applies to th

3、e process of defining anddocumenting the capabilities, logical data sources, and path-ways of data exchange regarding pharmacotherapy informationservices within a given network architecture serving a set ofhealthcare constituents.1.2 This practice is not a technical implementation standardbut, rathe

4、r, describes how the implementation methods andtechniques can be used to coordinate pharmacotherapy serviceslogically within an electronic health record (EHR) systemsenvironment involving participating organizations and sitesconnected by a networked communication system.1.3 This practice covers the

5、content of the nodes and arcs ofthe resulting logical network involving EHR, pharmacy, andclinical laboratory-capable sites. This practice also considersthe various purposes and organizational arrangements forcoordinating pharmacotherapy services within the networkboundaries and the considerations f

6、or connections amongexternal networks.1.4 This practice refers to other standards for conventionswithin 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 ho

7、w integration ofpharmacy, CLIMS, and EHR information systems can beundertaken to result in a transparent pharmacotherapy clinicaldecision support environment, regardless of the underlyingimplementation architecture, by describing the logical interop-erability of information domains as facilitated by

8、 informationand communications technology (ICT).1.6 This practice is directed at pharmacists, clinicalpharmacologists, clinical laboratorians, information systemmanagers, and information systems vendors for use in planningand implementing coordinated pharmacotherapy servicesthrough effective dialog.

9、1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.8 This intern

10、ational standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Co

11、mmittee.2. Referenced Documents2.1 ASTM Standards:2E1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems forElectronic Health Record (EHR) Systems (Withdrawn2017)3E1340 Guide for Rapid Prototyping of Information Systems(Withdrawn 2017)3E1384 Practi

12、ce for Content and Structure of the ElectronicHealth Record (Withdrawn 2017)3E1578 Guide for Laboratory InformaticsE1633 Specification for Coded Values Used in the ElectronicHealth Record (Withdrawn 2017)3E1714 Guide for Properties of a Universal Healthcare Iden-tifier (UHID)E1715 Practice for An Ob

13、ject-Oriented Model forRegistration, Admitting, Discharge, and Transfer (RADT)Functions in Computer-Based Patient Record Systems(Withdrawn 2017)3E1744 Practice for View of Emergency Medical Care in the1This practice is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the

14、direct responsibility of Subcommittee E31.25 on HealthcareData Management, Security, Confidentiality, and Privacy.Current edition approved May 1, 2011. Published June 2011. Originallyapproved in 2006. Last previous edition approved in 2006 as E2538 06. DOI:10.1520/E2538-06R11.2For referenced ASTM st

15、andards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.

16、Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of Inter

17、national Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1Electronic Health Record (Withdrawn 2017)3E1762 Guide for Electronic Authentication of Health CareInformation (Withdrawn 2017)3E1869 Guide for Confidentiality, Privacy,

18、Access, and DataSecurity Principles for Health Information Including Elec-tronic Health Records (Withdrawn 2017)3E1985 Guide for User Authentication and Authorization(Withdrawn 2017)3E1986 Guide for Information Access Privileges to HealthInformation (Withdrawn 2017)3E1987 Guide for Individual Rights

19、 Regarding Health Infor-mation (Withdrawn 2007)3E1988 Guide for Training of Persons who have Access toHealth Information (Withdrawn 2007)3E2017 Guide for Amendments to Health Information (With-drawn 2017)3E2066 Guide for Validation of Laboratory Information Man-agement Systems (Withdrawn 2015)3E2084

20、 Specification for Authentication of Healthcare Infor-mation Using Digital Signatures (Withdrawn 2009)3E2085 Guide on Security Framework for Healthcare Infor-mation (Withdrawn 2009)3E2086 Guide for Internet and Intranet Healthcare Security(Withdrawn 2009)3E2145 Practice for Information Modeling (Wit

21、hdrawn2017)3E2147 Specification for Audit and Disclosure Logs for Usein Health Information Systems (Withdrawn 2017)3E2171 Practice for Rating-Scale Measures Relevant to theElectronic Health Record (Withdrawn 2017)3E2457 Terminology for Healthcare InformaticsE2473 Practice for the Occupational/Enviro

22、nmental HealthView of the Electronic Health RecordP110 Proposed Guide to Assist in the Defining, Procuring,Installing, and Implementing of a Computerized HospitalPharmacy System42.2 ANSI/IEEE Standards:5ANSI X3.172 American National Dictionary for Informa-tion SystemsANSI/IEEE 610.12 1990 (R2002) St

23、andard Glossary ofSoftware Engineering TerminologyANSI/IEEE 830 1998 Software Requirements Specifica-tionANSI/IEEE 1058 1998 Software Project ManagementPlansANSI/IEEE 1062 1998 (R2002 includes 1062a) Recom-mended Practice for Software AcquisitionANSI/IEEE 1063 2001 Software User DocumentationANSI/IE

24、EE 1073 1996 Framework and OverviewANSI/IEEE 1073.3.1 2001/Amd1-2001 Transport Profile(redesignated 11073-3-1, Standard for Medical DeviceCommunications-Transport Profile-Connection Mode)ANSI/IEEE 1073.4.1 2001 Physical Layer-Cable Con-nected (redesignated 11073-4-1, Standard for MedicalDevice Commu

25、nicationsPhysical Layer InterfaceCable Connection)ANSI/IEEE 1074 2006 Standard for Developing LifeCycle ProcessesANSI/IEEE 1074.1 1995 Guide for Developing LifeCycle ProcessesANSI/IEEE 1220 2005 Standard for Application andManagement of the System Engineering ProcessANSI/IEEE 1233 1998 (R2002 includ

26、es 1233a) Guide toPreparing System Requirements SpecificationsANSI/IEEE 1320.1 1998 (R2004) Standard for Concep-tual Modeling LanguageSyntax and Semantics forIDEF0ANSI/IEEE 1320.2 1998 (R2004) Standard for Concep-tual Modeling LanguageSyntax and Semantics forIDEF1X97 (IDEF Object)ANSI/IEEE 1362 1998

27、 Guide for InformationTechnologySystem DefinitionConcept of OperationsDocumentANSI/IEEE 1490 2003 IEEE Guide IEEEAdoption ofPMI StandardA Guide to Project Management Body ofKnowledge, 2000 Edition PMIANSI/IEEE 12207.0 1996 Standard for InformationTechnologySoftware Life Cycle ProcessesANSI/IEEE 1220

28、7.1 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesLife CycleDataANSI/IEEE 12207.2 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesImplementation Considerations2.3 ANSI/HL7 Standards:5ANSI/HL7 Interface Standard v2.4, v2.5, v3.0HL7 Message Development Framework v3.

29、3, Dec. 19992.4 ANSI/ADA Standards:5ANSI/ADA TR 1039 2005 Clinical Content Data ModelANSI/ADA 1000.0 Introduction, Model Architecture, andSpecification FrameworkANSI/ADA 1000.1 Individual IdentificationANSI/ADA 1000.2 Codes and NomenclatureANSI/ADA 1000.3 Individual CharacteristicsANSI/ADA 1000.4 Po

30、pulation CharacteristicsANSI/ADA 1000.5 OrganizationANSI/ADA 1000.6 LocationANSI/ADA 1000.7 CommunicationANSI/ADA 1000.8 Healthcare EventANSI/ADA 1000.9 Health MaterielANSI/ADA 1000.10 Health ServicesANSI/ADA 1000.11 Health Service ResourcesANSI/ADA 1000.12 Population Health FactsANSI/ADA 1000.13 Pa

31、tient Health FactsANSI/ADA 1000.14 Health Condition DiagnosisANSI/ADA 1000.15 Health Service PlanANSI/ADA 1000.16 Patient Health ServiceANSI/ADA 1000.17 Clinical InvestigationANSI/ADA 1000.18 Comments Subject Area2.5 ISO Standards:5ISO/IEC TR 9789 Information TechnologyGuidelines forthe Organization

32、 and Representation of Data Elements for4Withdrawn 1988.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.E2538 06 (2011)2Data Interchange-Coding Methods and PrinciplesISO 12200 Computer Applications in TerminologyMachine-R

33、eadable Terminology Interchange Format(MARTIF)Negotiated InterchangeISO 12620 Computer Applications in TerminologyDataCategoriesISO IS 12207 Information TechnologySoftware LifeCycle ProcessesISO IS 15188 Project Management Guidelines for Terminol-ogy StandardizationISO 15189 Quality Management in th

34、e Clinical LaboratoryISO DIS 15193 Measurement of Quantities in Samples ofBiologic OriginReference MethodsISO DIS 15194 Measurement of Quantities in Samples ofBiologic OriginReference MaterialsISO 15195 Requirements for Reference Measurement Labo-ratoriesISO WD 15288 System Life Cycle ProcessesISO 1

35、5440 Guide for Life Cycle ProcessesISO 17511 Traceability of Calibration and Control Materials2.6 Other Standards:AAMI SW68:2001 Medical Device Software-Software LifeCycle Processes6ANSI X125CEN ENV 1613 Medical InformaticsMessages for theexchange of laboratory information7CEN ENV 1614 Healthcare In

36、formaticsStructure fornomenclature, classification and coding of properties inclinical laboratory sciences7CEN EN 12017 Medical Informatics Vocabulary (MIVoc)7CEN EN 12264 Categorical Structures of Systems ofConceptsModel for Representation of Semantics(MOSE)7Internet RFC 1521 N. Borenstein, N Freed

37、 MIME Multi-purposeInternet Mail Extensions Purpose: Mechanismsfor Specifying and Designating the Format of InternetMessage Bodies Bellcore Innosoft Sept. 19936ANSI/CLSI ASTP2 Point of Care In-vitro Diagnostic Test-ing5CLSI AUTO1-A Laboratory Automation: SpecimenContainer/Specimen Carrier8CLSI AUTO2

38、-A Laboratory Automation: Bar codes forSpecimen Container Identification8CLSI AUTO3-A Laboratory Automation: Communicationswith Automated Clinical Laboratory Systems,Instruments, Devices and Information Systems8CLSI AUTO4-A Laboratory Automation: Systems Opera-tional Requirements, Characteristics an

39、d Information El-ements8CLSIAUTO5-A LaboratoryAutomation: ElectromechanicalInterfaces8CLSI LIS-1A Specification for Low Level Protocol to Trans-fer Messages between Clinical Laboratory Instrumentsand Computer Systems8CLSI LIS-2A Specification for Transferring Information be-tween Clinical Instrument

40、s and Computer Systems8CLSI LIS-3A Guide for Procurement of a Clinical Labora-tory Information Management System (CLIMS)8CLSI LIS-5A Specification for Transferring Clinical Obser-vations between Independent Computer Systems8CLSI LIS-7A Specification for Use of Bar Codes on Speci-men Tubes in the Cli

41、nical Laboratory8CLSI LIS-8A Guide for Functional Requirements of ClinicalLaboratory Information Management Systems8CLSI LIS-9A Guide for Coordination of Clinical LaboratoryServices in an Electronic Health Record Environment andNetworked Architectures8CLSI POCT1 Point of Care Connectivity8DICOM Supp

42、lement 15 Visible Light Image, AnatomicFrame of Reference, Accession and Specimen forEndoscopy, Microscopy, and Photography9EIA/IEEE J-Std-016 Standard for Information Technology,Software Life Cycle Processes, Software Development,Acquirer-Supplier Agreement10IUPAC/IFCC Silver Book: Compendium of Te

43、rminologyand Nomenclature of Properties in Clinical LaboratorySciences11IUPAC/IFCC Properties and Units in Clinical LaboratorySciences X Properties and Units in General ClinicalChemistry11IUPAC/IFCC Properties and Units in Clinical LaboratorySciences XII Properties and Units in Clinical Pharmacol-og

44、y and Toxicology11NCPDP SCRIPT v9.012RxNorm133. Terminology3.1 DefinitionsTerminology related to general informationsystems appears in ANSI X3.172 and ANSI/IEEE 610.12.Terminology relating generally to healthcare information ap-pears in CEN EN 12264 and CEN EN 12017, TerminologyE2457, and Unified Me

45、dical Language System (UMLS). Theterms used frequently from these sources appear here, inaddition to those terms specific to this practice.3.2 Definitions of Terms Specific to This Standard:3.2.1 health information network, nset of data domains(nodes) and communications pathways (arcs) serving a hea

46、lth-care constituency with information management services.3.2.2 identifier, nsymbol used to name, indicate, or locate.ANSI/IEEE 610.123.2.2.1 DiscussionIdentifiers may be associated with suchthings as data structures, data items, or program locations.6Available from the Association for Advancement

47、of Medical Instrumentation,1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795.7Available from the European Committee for Standardization, 36 rue de Stassart,B-1050 Brussels, Belgium.8Available from the Clinical and Laboratory Standards Institute, 940 West ValleyRd., Suite 1400, Wayne, PA 19087-1

48、898.9Available from NEMA, Suite 1752, 1300 N. 17th St., Rosslyn, VA 22209.10Available from the Institute of Electrical and Electronics Engineers, Inc., 1828L St., NW, Suite 1202, Washington, DC 20036-5104.11Available from the IUPAC Secretariat, PO Box 13757, Research Triangle Park,NC 27709-3757.12Av

49、ailable from the National Council for Prescription Drug Programs, 9240 E.Raintree Dr., Scottsdale, AZ 85260-7518.13Available from Reference and Web Services, National Library of Medicine,8600 Rockville Pike, Bethesda, MD 20894.E2538 06 (2011)33.2.3 practitioner, licensed, nindividual at any level ofprofessional specialization who requires a public license/certification to practice the delivery of care to patients. E13843.2.3.1 DiscussionA practitioner may also be a provider.3.2.4 provider, nbusiness entity that furnishes healthcare