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

1、Designation: E 2538 06An American National StandardStandard Practice forDefining and Implementing Pharmacotherapy InformationServices within the Electronic Health Record (EHR)Environment and Networked Architectures1This standard is issued under the fixed designation E 2538; the number immediately fo

2、llowing the designation 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 (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice

3、 applies to the 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 stan

4、dardbut, rather, 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 practi

5、ce covers the 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 co

6、nsiderations for 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

7、 to outline how 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

8、facilitated by informationand communications technology (ICT).1.6 This practice is directed at pharmacists, clinical phar-macologists, clinical laboratorians, information system manag-ers, and information systems vendors for use in planning andimplementing coordinated pharmacotherapy services throug

9、heffective dialog.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 u

10、se.2. Referenced Documents2.1 ASTM Standards:2E 1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT)Systems for Electronic Health Record (EHR) SystemsE 1340 Guide for Rapid Prototyping of Information Sys-temsE 1384 Practice for Content and Structure of the

11、 ElectronicHealth Record (EHR)E 1578 Guide for Laboratory Information ManagementSystems (LIMS)E 1633 Specification for Coded Values Used in the Elec-tronic Health RecordE 1714 Guide for Properties of a Universal HealthcareIdentifier (UHID)E 1715 Practice for An Object-Oriented Model for Regis-tratio

12、n, Admitting, Discharge, and Transfer (RADT) Func-tions in Computer-Based Patient Record SystemsE 1744 Practice for View of Emergency Medical Care in theElectronic Health RecordE 1762 Guide for Electronic Authentication of Health CareInformationE 1869 Guide for Confidentiality, Privacy,Access, and D

13、ataSecurity Principles for Health Information Including Elec-tronic Health RecordsE 1985 Guide for User Authentication and AuthorizationE 1986 Guide for Information Access Privileges to HealthInformationE 1987 Guide for Individual Rights Regarding Health In-formationE 1988 Guide for Training of Pers

14、ons who have Access toHealth InformationE 2017 Guide for Amendments to Health Information1This practice is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of Subcommittee E31.25 on HealthcareData Management, Security, Confidentiality, and Privac

15、y.Current edition approved Dec. 1, 2006. Published January 2007.2For referenced ASTM standards, 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 websi

16、te.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.E 2066 Guide for Validation of Laboratory InformationManagement SystemsE 2084 Specification for Authentication of Healthcare In-formation Using Digital SignaturesE 2085 Guide on Secu

17、rity Framework for Healthcare Infor-mationE 2086 Guide for Internet and Intranet Healthcare SecurityE 2145 Practice for Modeling in Health InformaticsE 2147 Specification for Audit and Disclosure Logs for Usein Health Information SystemsE 2171 Practice for Rating-Scale Measures Relevant to theElectr

18、onic Health RecordE 2457 Terminology for Healthcare InformaticsE 2473 Practice for the Occupational/Environmental HealthView of the Electronic Health RecordP110 Proposed Guide to Assist in the Defining, Procuring,Installing, and Implementing of a Computerized HospitalPharmacy System32.2 ANSI/IEEE St

19、andards:4ANSI X3.172 American National Dictionary for Informa-tion SystemsANSI/IEEE 610.12y 1990 (R2002) Standard Glossary ofSoftware Engineering TerminologyANSI/IEEE 830y 1998 Software Requirements Specifica-tionANSI/IEEE 1058y 1998 Software Project ManagementPlansANSI/IEEE 1062y 1998 (R2002 includ

20、es 1062a) Recom-mended Practice for Software AcquisitionANSI/IEEE 1063y 2001 Software User DocumentationANSI/IEEE 1073y 1996 Framework and OverviewANSI/IEEE 1073.3.1y 2001/Amd1-2001 Transport Profile(redesignated 11073-3-1, Standard for Medical DeviceCommunications-Transport Profile-Connection Mode)

21、ANSI/IEEE 1073.4.1y 2001 Physical Layer-Cable Con-nected (redesignated 11073-4-1, Standard for MedicalDevice CommunicationsPhysical Layer InterfaceCable Connection)ANSI/IEEE 1074y 2006 Standard for Developing LifeCycle ProcessesANSI/IEEE 1074.1y 1995 Guide for Developing LifeCycle ProcessesANSI/IEEE

22、 1220y 2005 Standard for Application andManagement of the System Engineering ProcessANSI/IEEE 1233y 1998 (R2002 includes 1233a) Guide toPreparing System Requirements SpecificationsANSI/IEEE 1320.1y 1998 (R2004) Standard for Concep-tual Modeling LanguageSyntax and Semantics forIDEF0ANSI/IEEE 1320.2y

23、1998 (R2004) Standard for Concep-tual Modeling LanguageSyntax and Semantics forIDEF1X97 (IDEF Object)ANSI/IEEE 1362y 1998 Guide for InformationTechnologySystem DefinitionConcept of OperationsDocumentANSI/IEEE 1490y 2003 IEEE Guide IEEEAdoption ofPMI StandardA Guide to Project Management Body ofKnowl

24、edge, 2000 Edition PMIANSI/IEEE 12207.0y 1996 Standard for InformationTechnologySoftware Life Cycle ProcessesANSI/IEEE 12207.1y 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesLife CycleDataANSI/IEEE 12207.2y 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesImplement

25、ation Considerations2.3 ANSI/HL7 Standards:4ANSI/HL7 Interface Standard v2.4, v2.5, v3.0HL7 Message Development Framework v3.3, Dec. 19992.4 ANSI/ADA Standards:4ANSI/ADA TR 1039 2005 Clinical Content Data ModelANSI/ADA 1000.0 Introduction, Model Architecture, andSpecification FrameworkANSI/ADA 1000.

26、1 Individual IdentificationANSI/ADA 1000.2 Codes and NomenclatureANSI/ADA 1000.3 Individual CharacteristicsANSI/ADA 1000.4 Population CharacteristicsANSI/ADA 1000.5 OrganizationANSI/ADA 1000.6 LocationANSI/ADA 1000.7 CommunicationANSI/ADA 1000.8 Healthcare EventANSI/ADA 1000.9 Health MaterielANSI/AD

27、A 1000.10 Health ServicesANSI/ADA 1000.11 Health Service ResourcesANSI/ADA 1000.12 Population Health FactsANSI/ADA 1000.13 Patient Health FactsANSI/ADA 1000.14 Health Condition DiagnosisANSI/ADA 1000.15 Health Service PlanANSI/ADA 1000.16 Patient Health ServiceANSI/ADA 1000.17 Clinical Investigation

28、ANSI/ADA 1000.18 Comments Subject Area2.5 ISO Standards:4ISO/IEC TR 9789 Information TechnologyGuidelines forthe Organization and Representation of Data Elements forData Interchange-Coding Methods and PrinciplesISO 12200 Computer Applications in TerminologyMachine-Readable Terminology Interchange Fo

29、rmat(MARTIF)Negotiated InterchangeISO 12620 Computer Applications in TerminologyDataCategoriesISO IS 12207 Information TechnologySoftware LifeCycle ProcessesISO IS 15188 Project Management Guidelines for Termi-nology StandardizationISO 15189 Quality Management in the Clinical LaboratoryISO DIS 15193

30、 Measurement of Quantities in Samples ofBiologic OriginReference MethodsISO DIS 15194 Measurement of Quantities in Samples ofBiologic OriginReference Materials3Withdrawn 1988.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.or

31、g.E2538062ISO 15195 Requirements for Reference MeasurementLaboratoriesISO WD 15288 System Life Cycle ProcessesISO 15440 Guide for Life Cycle ProcessesISO 17511 Traceability of Calibration and Control Materi-als2.6 Other Standards:AAMI SW68:2001 Medical Device Software-Software LifeCycle Processes5AN

32、SI X124CEN ENV 1613 Medical InformaticsMessages for theexchange of laboratory information6CEN ENV 1614 Healthcare InformaticsStructure for no-menclature, classification and coding of properties inclinical laboratory sciences6CEN EN 12017 Medical Informatics Vocabulary (MIVoc)6CEN EN 12264 Categorica

33、l Structures of Systems ofConceptsModel for Representation of Semantics(MOSE)6Internet RFC 1521 N. Borenstein, N Freed MIME Multi-purposeInternet Mail Extensions Purpose: Mechanismsfor Specifying and Designating the Format of InternetMessage Bodies Bellcore Innosoft Sept. 19935ANSI/CLSI ASTP2 Point

34、of Care In-vitro Diagnostic Test-ing4CLSI AUTO1-A Laboratory Automation: SpecimenContainer/Specimen Carrier7CLSI AUTO2-A Laboratory Automation: Bar codes forSpecimen Container Identification7CLSI AUTO3-A Laboratory Automation: Communicationswith Automated Clinical Laboratory Systems, Instru-ments, D

35、evices and Information Systems7CLSI AUTO4-A Laboratory Automation: Systems Opera-tional Requirements, Characteristics and Information El-ements7CLSI AUTO5-A Laboratory Automation: Electromechani-cal Interfaces7CLSI LIS-1A Specification for Low Level Protocol toTransfer Messages between Clinical Labo

36、ratory Instru-ments and Computer Systems7CLSI LIS-2A Specification for Transferring Informationbetween Clinical Instruments and Computer Systems7CLSI LIS-3A Guide for Procurement of a Clinical Labora-tory Information Management System (CLIMS)7CLSI LIS-5A Specification for Transferring Clinical Obser

37、-vations between Independent Computer Systems7CLSI LIS-7A Specification for Use of Bar Codes on Speci-men Tubes in the Clinical Laboratory7CLSI LIS-8A Guide for Functional Requirements of Clini-cal Laboratory Information Management Systems7CLSI LIS-9A Guide for Coordination of Clinical Labora-tory S

38、ervices in an Electronic Health Record Environmentand Networked Architectures7CLSI POCT1 Point of Care Connectivity7DICOM Supplement 15 Visible Light Image, AnatomicFrame of Reference, Accession and Specimen for Endos-copy, Microscopy, and Photography8EIA/IEEE J-Std-016 Standard for Information Tech

39、nology,Software Life Cycle Processes, Software Development,Acquirer-Supplier Agreement9IUPAC/IFCC Silver Book: Compendium of Terminologyand Nomenclature of Properties in Clinical LaboratorySciences10IUPAC/IFCC Properties and Units in Clinical LaboratorySciences X Properties and Units in General Clin

40、icalChemistry10IUPAC/IFCC Properties and Units in Clinical LaboratorySciences XII Properties and Units in Clinical Pharmacol-ogy and Toxicology10NCPDP SCRIPT v9.011RxNorm123. Terminology3.1 DefinitionsTerminology related to general informa-tion systems appears in ANSI X3.172 and ANSI/IEEE 610.12.Ter

41、minology relating generally to healthcare information ap-pears in CEN EN 12264 and CEN EN 12017, TerminologyE 2457, and Unified Medical Language System (UMLS). Theterms used frequently from these sources appear here, inaddition to those terms specific to this practice.3.2 Definitions of Terms Specif

42、ic to This Standard:3.2.1 health information network, nset of data domains(nodes) and communications pathways (arcs) serving a health-care constituency with information management services.3.2.2 identifier, nsymbol used to name, indicate, or lo-cate. ANSI/IEEE 610.123.2.2.1 DiscussionIdentifiers may

43、 be associated with suchthings as data structures, data items, or program locations.3.2.3 practitioner, licensed, nindividual at any level ofprofessional specialization who requires a public license/certification to practice the delivery of care to patients.E 13843.2.3.1 DiscussionA practitioner may

44、 also be a provider.3.2.4 provider, nbusiness entity that furnishes healthcareto a consumer. E 13843.2.4.1 DiscussionThis term includes a professionallylicensed practitioner who is authorized to operate a healthcaredelivery facility.3.3 AcronymsThe following acronyms are used in thispractice and may

45、 also appear in other standards listed inSection 2.5Available from the Association for Advancement of Medical Instrumentation,1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795.6Available from the European Committee for Standardization, 36 rue deStassart, B-1050 Brussels, Belgium.7Available from

46、 the Clinical and Laboratory Standards Institute, 940 West ValleyRd., Suite 1400, Wayne, PA 19087-1898.8Available from NEMA, Suite 1752, 1300 N. 17th St., Rosslyn, VA 22209.9Available from the Institute of Electrical and Electronics Engineers, Inc., 1828L St., NW, Suite 1202, Washington, DC 20036-51

47、04.10Available from the IUPAC Secretariat, PO Box 13757, Research TrianglePark, NC 27709-3757.11Available from the National Council for Prescription Drug Programs, 9240 E.Raintree Dr., Scottsdale, AZ 85260-7518.12Available from Reference and Web Services, National Library of Medicine,8600 Rockville

48、Pike, Bethesda, MD 20894.E25380633.3.1 CAPCollege of American Pathologists3.3.2 CDCCenters for Disease Control and Prevention,Department of Health and Human Services3.3.3 CDIMCommon domain information model3.3.4 CDSSClinical decision support systems3.3.5 CLIMSClinical laboratory information manageme

49、ntsystem3.3.6 CMSCenters for Medicare/Medicaid Services3.3.7 CPRComputer-based patient record3.3.8 DHHSDepartment of Health and Human Services3.3.9 DIMDomain information model3.3.10 ECElectronic commerce3.3.11 EDIElectronic data interchange3.3.12 EHRElectronic health record3.3.13 HINHealth information network3.3.14 ICTInformation and communication technology3.3.15 IDSIntegrated delivery systems3.3.16 ISAInformation systems architecture3.3.17 LASLaboratory automation system3.3.18 LIMSLaboratory information management system3.3.19 MDSS