ASTM E2538-2006(2011) Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Archi.pdf

1、Designation: E2538 06 (Reapproved 2011)An 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 E2538; the numbe

2、r immediately following 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 () indicates an editorial change since the last revision or reapproval.1. Scope1.

3、1 This practice 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 impl

4、ementation standardbut, 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.

5、1.3 This practice 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 networkbounda

6、ries and the considerations 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 pract

7、ice is intended 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 informat

8、ion domains as 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

9、services througheffective 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 limitat

10、ions prior to use.2. Referenced Documents2.1 ASTM Standards:2E1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems forElectronic Health Record (EHR) SystemsE1340 Guide for Rapid Prototyping of Information SystemsE1384 Practice for Content and Struc

11、ture of the ElectronicHealth Record (EHR)E1578 Guide for Laboratory Information Management Sys-tems (LIMS)E1633 Specification for Coded Values Used in the Elec-tronic Health RecordE1714 Guide for Properties of a Universal HealthcareIdentifier (UHID)E1715 Practice for An Object-Oriented Model for Reg

12、istra-tion, Admitting, Discharge, and Transfer (RADT) Func-tions in Computer-Based Patient Record SystemsE1744 Practice for View of Emergency Medical Care in theElectronic Health RecordE1762 Guide for Electronic Authentication of Health CareInformationE1869 Guide for Confidentiality, Privacy, Access

13、, and DataSecurity Principles for Health Information Including Elec-tronic Health RecordsE1985 Guide for User Authentication and AuthorizationE1986 Guide for Information Access Privileges to HealthInformationE1987 Guide for Individual Rights Regarding Health Infor-mation31This practice is under the

14、jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the 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 approv

15、ed in 2006 as E2538 06. DOI:10.1520/E2538-06R11.2For 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 website.3Withdrawn. T

16、he last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.E1988 Guide for Training of Persons who have Access toHealth Information3E2017 Guide for Amendments to

17、Health InformationE2066 Guide for Validation of Laboratory InformationManagement SystemsE2084 Specification for Authentication of Healthcare Infor-mation Using Digital Signatures3E2085 Guide on Security Framework for Healthcare Infor-mation3E2086 Guide for Internet and Intranet Healthcare Security3E

18、2145 Practice for Information ModelingE2147 Specification for Audit and Disclosure Logs for Usein Health Information SystemsE2171 Practice for Rating-Scale Measures Relevant to theElectronic Health RecordE2457 Terminology for Healthcare InformaticsE2473 Practice for the Occupational/Environmental He

19、althView 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 610.12y 1990 (R2002) Standard Gl

20、ossary ofSoftware Engineering TerminologyANSI/IEEE 830y 1998 Software Requirements Specifica-tionANSI/IEEE 1058y 1998 Software Project ManagementPlansANSI/IEEE 1062y 1998 (R2002 includes 1062a) Recom-mended Practice for Software AcquisitionANSI/IEEE 1063y 2001 Software User DocumentationANSI/IEEE 10

21、73y 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)ANSI/IEEE 1073.4.1y 2001 Physical Layer-Cable Con-nected (redesignated 11073-4-1, Standard for MedicalDevice Communi

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

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

24、 1998 Guide for InformationTechnologySystem DefinitionConcept of OperationsDocumentANSI/IEEE 1490y 2003 IEEE Guide IEEEAdoption ofPMI StandardA Guide to Project Management Body ofKnowledge, 2000 Edition PMIANSI/IEEE 12207.0y 1996 Standard for InformationTechnologySoftware Life Cycle ProcessesANSI/IE

25、EE 12207.1y 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesLife CycleDataANSI/IEEE 12207.2y 1997 Guide for InformationTechnologySoftware Life Cycle ProcessesImplementation Considerations2.3 ANSI/HL7 Standards:5ANSI/HL7 Interface Standard v2.4, v2.5, v3.0HL7 Message Development Fram

26、ework v3.3, 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

27、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/ADA 1000.10 Health ServicesANSI/ADA 1000.11 Health Service ResourcesANSI/ADA 1000.12 Population Health FactsANSI/ADA 1

28、000.13 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 InvestigationANSI/ADA 1000.18 Comments Subject Area2.5 ISO Standards:5ISO/IEC TR 9789 Information TechnologyGuidelines forthe Org

29、anization and Representation of Data Elements forData Interchange-Coding Methods and PrinciplesISO 12200 Computer Applications in TerminologyMachine-Readable Terminology Interchange Format(MARTIF)Negotiated InterchangeISO 12620 Computer Applications in TerminologyDataCategoriesISO IS 12207 Informati

30、on TechnologySoftware LifeCycle ProcessesISO IS 15188 Project Management Guidelines for Termi-nology StandardizationISO 15189 Quality Management in the Clinical LaboratoryISO DIS 15193 Measurement of Quantities in Samples ofBiologic OriginReference MethodsISO DIS 15194 Measurement of Quantities in S

31、amples ofBiologic OriginReference Materials4Withdrawn 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)2ISO 15195 Requirements for Reference MeasurementLaboratoriesISO WD 15288 System Life Cycle Process

32、esISO 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 Processes6ANSI X125CEN ENV 1613 Medical InformaticsMessages for theexchange of laboratory information7CEN ENV 1614 Healt

33、hcare InformaticsStructure for no-menclature, 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. Borenstei

34、n, N Freed 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 Carrier8

35、CLSI AUTO2-A Laboratory Automation: Bar codes forSpecimen Container Identification8CLSI AUTO3-A Laboratory Automation: Communicationswith Automated Clinical Laboratory Systems, Instru-ments, Devices and Information Systems8CLSI AUTO4-A Laboratory Automation: Systems Opera-tional Requirements, Charac

36、teristics and Information El-ements8CLSI AUTO5-A Laboratory Automation: Electromechani-cal Interfaces8CLSI LIS-1A Specification for Low Level Protocol toTransfer Messages between Clinical Laboratory Instru-ments and Computer Systems8CLSI LIS-2A Specification for Transferring Informationbetween Clini

37、cal Instruments 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 Tu

38、bes in the Clinical Laboratory8CLSI LIS-8A Guide for Functional Requirements of Clini-cal Laboratory Information Management Systems8CLSI LIS-9A Guide for Coordination of Clinical Labora-tory Services in an Electronic Health Record Environmentand Networked Architectures8CLSI POCT1 Point of Care Conne

39、ctivity8DICOM Supplement 15 Visible Light Image, AnatomicFrame of Reference, Accession and Specimen for Endos-copy, Microscopy, and Photography9EIA/IEEE J-Std-016 Standard for Information Technology,Software Life Cycle Processes, Software Development,Acquirer-Supplier Agreement10IUPAC/IFCC Silver Bo

40、ok: Compendium of Terminologyand 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 C

41、linical Pharmacol-ogy and Toxicology11NCPDP SCRIPT v9.012RxNorm133. Terminology3.1 DefinitionsTerminology related to general informa-tion systems 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, Terminolog

42、yE2457, 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 Specific to This Standard:3.2.1 health information network, nset of data domains(nodes) and communications pathway

43、s (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 be associated with suchthings as data structures, data items, or program locations.3.2.3 practitioner, lice

44、nsed, 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 healthcareto a consumer. E13843.2.4.1 Dis

45、cussionThis term includes a professionallylicensed practitioner who is authorized to operate a healthcaredelivery facility.3.3 AcronymsThe following acronyms are used in thispractice and may also appear in other standards listed inSection 2.3.3.1 CAPCollege of American Pathologists6Available from th

46、e Association for Advancement of Medical Instrumentation,1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795.7Available from the European Committee for Standardization, 36 rue deStassart, B-1050 Brussels, Belgium.8Available from the Clinical and Laboratory Standards Institute, 940 West ValleyRd.,

47、 Suite 1400, Wayne, PA 19087-1898.9Available 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 Tr

48、ianglePark, NC 27709-3757.12Available 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)33.3.2 CDCCenters for Diseas

49、e 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 managementsystem3.3.6 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 commu