ASTM E1384-2007 Standard Practice for Content and Structure of the Electronic Health Record (EHR)《电子健康记录(EHR)的内容和结构用标准实施规程》.pdf

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1、Designation: E 1384 07An American National StandardStandard Practice forContent and Structure of the Electronic Health Record(EHR)1This standard is issued under the fixed designation E 1384; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re

2、vision, 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. Scope*1.1 This practice covers all types of healthcare services,including those given in ambulatory care,

3、hospitals, nursinghomes, skilled nursing facilities, home healthcare, and spe-cialty care environments. They apply both to short termcontacts (for example, emergency rooms and emergency medi-cal service units) and long term contacts (primary care physi-cians with long term patients). The vocabulary

4、aims to encom-pass the continuum of care through all delivery models. Thispractice defines the persistent data needed to support ElectronicHealth Record system functionality.1.2 This practice has four purposes:1.2.1 Identify the content and logical data structure andorganization of an Electronic Hea

5、lth Record (EHR) consistentwith currently acknowledged patient record content. Therecord carries all health related information about a person overtime. It may include history and physical, laboratory tests,diagnostic reports, orders and treatments documentation, pa-tient identifying information, le

6、gal permissions, and so on. Thecontent is presented and described as data elements or asclinical documents. This standard is consistent with eXtensibleMarkup Language (XML). See Document Type Definition(DTD) 2.1 and W3CXML Schema 1.01.2.2 Explain the relationship of data coming from diversesources (

7、for example, clinical laboratory information manage-ment systems, order entry systems, pharmacy informationmanagement systems, dictation systems), and other data in theElectronic Health Record as the primary repository for infor-mation from various sources.1.2.3 Provide a common vocabulary for those

8、 developing,purchasing, and implementing EHR systems.1.2.4 Provide sufficient content from which data extractscan be compiled to create unique setting “views.”1.2.5 Map the content to selected relevant biomedical andhealth informatics standards.2. Referenced Documents2.1 ASTM Standards:2E 1238 Speci

9、fication for Transferring Clinical ObservationsBetween Independent Computer Systems3E 1239 Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT)Systems for Electronic Health Record (EHR) SystemsE 1633 Specification for Coded Values Used in the Elec-tronic Health

10、 RecordE 1639 Guide for Functional Requirements of ClinicalLaboratory Information Management Systems3E 1714 Guide for Properties of a Universal HealthcareIdentifier (UHID)E 1715 Practice for An Object-Oriented Model for Regis-tration, Admitting, Discharge, and Transfer (RADT) Func-tions in Computer-

11、Based Patient Record SystemsE 1769 Guide for Properties of Electronic Health Recordsand Record SystemsE2118 Guide for Coordination of Clinical Laboratory Ser-vices within the Electronic Health Record Environmentand Networked Architectures3E 2369 Specification for Continuity of Care Record (CCR)E 247

12、3 Practice for the Occupational/Environmental HealthView of the Electronic Health RecordE 2538 Practice for Defining and Implementing Pharmaco-therapy Information Services within the Electronic HealthRecord (EHR) Environment and Networked ArchitecturesASTM/HL7 Continuity of Care Document, 20072.2 Ot

13、her Health Informatics Standards:1This 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 Privacy.Current edition approved Oct. 15, 2007. Published Nove

14、mber 2007. Originallyapproved in 1991. Last previous edition approved in 2002 as E 1384 02a.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 S

15、ummary page onthe ASTM website.3Withdrawn.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.HL7 Health Level Seven (HL7) Version 2.2 19944(Version2.4 and 2.5)NCPDP Natio

16、nal Council for Prescription Drug Programs(NCPDP) Telecommunication Standard Format Version3 Release 2, 19925ANSI ASC X12: Version 3, Release 3 (1992)6X12.84 Healthcare Enrollment and Maintenance Transac-tion Set (834)7X12.85 Healthcare Claim Payment Transaction Set (835)7X12.87 Healthcare Claim Tra

17、nsaction Set (837)72.3 ANSI Standards:7HL7 EHR TC Electronic Health Record-System FunctionalModel, Release 1 February, 2007Health Information Management and Technology: Glossary,American Health Information Management Association,20063. Terminology3.1 Definitions of Terms Specific to This Standard:3.

18、1.1 admitting diagnosisa provisional description of thereason why a patient requires care in an inpatient hospitalsetting.3.1.2 ambulatory carepreventive or corrective healthcareservices provided on a nonresident basis in a providers office,clinic setting, or hospital outpatient setting. The term am

19、bula-tory usually implies that the patient has come to a location andhas departed that same day. (Ambulatory care includes medi-cine such as acupuncture, specialty clinics for consultationservices and retail care centers used for short term immediateservices.)3.1.3 ancillary service visitappearance

20、of an outpatient ina unit of a hospital or outpatient facility to receive service(s),test(s), or procedures; it is ordinarily not counted as anencounter for healthcare services.3.1.4 clinican outpatient facility providing a limited rangeof healthcare services, and assuming overall healthcare respon-

21、sibility for the patients. See also ambulatory care.3.1.5 clinic patienta patient who is registered for thepurpose of diagnosis or treatment or follow-up on an ambula-tory basis.3.1.6 continuing care retirement communityan organiza-tion established to provide housing and services, includinghealthcar

22、e, to people of retirement age.3.1.7 electronic health record (EHR)an electronic healthrecord is any information related to the past, present or futurephysical/mental health, or condition of an individual. Theinformation resides in electronic system(s) used to capture,transmit, receive, store, retri

23、eve, link and manipulate multime-dia data for the primary purpose of providing health care andhealth related services.3.1.8 emergency patienta patient admitted to emergencyroom service of a hospital for diagnosis and therapy requiringimmediate healthcare services.3.1.9 emergency servicesimmediate ev

24、aluation andtherapy rendered in urgent clinical conditions, sustained untilthe patient can be referred to his or her personal practitioner forfurther care.3.1.10 encounter(1) the direct personal contact between apatient and a physician or other person who is authorized bystate licensure law and, if

25、applicable, by medical staff bylawsto order or furnish healthcare services for the diagnosis ortreatment of the patient. (2) A contact between a patient and apractitioner who has primary responsibility for assessing andtreating the patient at a given contact, exercising independentjudgment. Contact

26、may be via an electronic visit.3.1.11 episodeone or more healthcare services receivedby an individual during a period of relatively continuous careby healthcare practitioners in relation to a particular clinicalproblem or situation.3.1.11.1 episode of care (EOC reimbursement)a categoryof payments ma

27、de as lump sums to providers for all healthcareservices delivered to a patient for a specific illness or over aspecified time period or both; also called bundled paymentsbecause they include multiple services and may include mul-tiple providers of care.3.1.12 free standing ambulatory surgery centera

28、) A freestanding outpatient surgical facility is a separate facility thatexists primarily to provide services in connection with surgicalprocedures that do not require inpatient hospitalization. b) Anoutpatient surgical facility that has its own national identifier;is a separate entity with respect

29、to its licensure, accreditation,governance, professional supervision, administrative functions,clinical services, record keeping, and financial and accountingsystems; has as its sole purpose the provision of services inconnection with surgical procedures that do not require inpa-tient hospitalizatio

30、n; and meets the conditions and require-ments set forth in the Medicare Conditions of Participation.3.1.13 health maintenance organizationan organizationthat provides health coverage to voluntary enrollees in returnfor prepayment of a set fee, regardless of the services used.3.1.14 home healtha) An

31、umbrella term that refers to themedical and non-medical services provided to patients andtheir families in their places of residence. b) The provision ofmedical and non-medical care in the home or place ofresidence to promote, maintain, or restore health or to mini-mize the effect of disease or disa

32、bility.3.1.15 hospicean interdisciplinary program of palliativecare and supportive services that addresses the physical,spiritual, social and economic needs of terminally ill patientsand their families.3.1.16 hospitalan establishment with an organized medi-cal staff with permanent facilities that in

33、clude inpatient bedsand continuous medical/nursing services and that providesdiagnostic and therapeutic services for patients as well asovernight accommodations and nutritional services.4Available from HL7, Mark McDougall, Executive Director, 900 Victors Way,Suite 122, Ann Arbor, MI 48108.5Available

34、 from NCPDP, 4201 North 24th Street, Suite 365, Phoenix,AZ 85016.6Available from DISA (Data Interchange Standards Association).7Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.E13840723.1.17 hospital-based outpatient carea subset of ambula-to

35、ry care utilizing the hospital staff, equipment, and resourcesto render diagnostic, preventive or corrective healthcare, orboth.3.1.18 inpatient admissionthe formal acceptance by ahospital of a patient who is to be provided with room, board,and continuous nursing service in an area of the hospital w

36、herepatients generally stay overnight.3.1.19 intermediate care facility (ICF)an institutionwhich primarily provides health-related care and services toindividuals who do not require the degree of care or treatmentwhich a hospital or skilled nursing facility is designated toprovide, but who, because

37、of their physical or mental condi-tion, require care and services.3.1.20 length of stay (LOS)the total number of patientdays for an inpatient episode, calculated by subtracting the dateof admission from the date of discharge. If a patient is admittedand discharged on the same date, the LOS is one da

38、y.3.1.21 licensed practitionersan individual at any level ofprofessional specialization who requires a public license/certification to practice the delivery of care to patients. Apractitioner can also be a provider.3.1.22 longitudinal patient recorda permanent, coordi-nated patient record of signifi

39、cant information, in chronologi-cal sequence. It may include all historical data collected or beretrieved as a user designated synopsis of significant demo-graphic, genetic, clinical and environmental facts and eventsmaintained within an automated system.3.1.23 long-term carehealthcare rendered in a

40、 non-acute-care facility and to a patient in resident or nonresident status tochronically ill, aged, disabled or mentally handicapped indi-viduals who are in need of continual supervision and assistanceby healthcare practitioners.3.1.24 non-licensed practitioneran individual without apublic license/

41、certification who is supervised by a licensed/certified individual in delivering care to patients.3.1.25 outpatient caresee ambulatory care.3.1.26 observationany aspect or attribute of a patient thatcan be described at a particular time. Examples include serumglucose finding, a chest x-ray impressio

42、n, a bone density scanresult, vital signs and a progress note.3.1.27 partial hospital programfacilities of the hospitalare regularly used on a scheduled basis for care during asubstantial number of daytime or nighttime hours.3.1.28 patient health recordthe primary legal recorddocumenting the healthc

43、are services provided to a person, inany aspect of healthcare delivery. This term is synonymouswith: medical record, health record, patient care record (pri-mary patient record), client record, resident record. The termincludes routine clinical or office records, records of care in anyhealth-related

44、 setting, preventive care, life style evaluation,research protocols, special study records and various clinicaldatabases.3.1.28.1 DiscussionAs the repository of informationabout a single patient, this information is generated by health-care professionals as a direct result of interaction with a pati

45、entor with individuals who have personal knowledge of the patient(or with both). The record contains information about thepatient and other individuals as they relate to the health of thepatient, for example, family history, caregiver support.3.1.28.2 Personal health recordAn electronic or paperreco

46、rd of health information compiled and maintained by thepatient or others for patient use (5).3.1.29 patient record systemthe set of components thatform the mechanism by which patient records are created,used, stored, and retrieved. A patient record system is usuallylocated within a healthcare provid

47、er/practitioner setting. Itincludes people, data, rules and procedures, processing andstorage devices (for example, paper and pen, hardware andsoftware), and communications and support functions.3.1.30 primary diagnosisthe diagnosis of the conditionthat is primarily responsible for the patients symp

48、toms andsigns and has the greatest impact on the patients health, or isthe most resource-intensive to treat.3.1.31 principal diagnosisa statement of the conditionestablished after study to be chiefly responsible for occasioningthe admission of the patient to the hospital for care.3.1.32 providera bu

49、siness entity which furnishes health-care to a consumer; it includes a professionally licensedpractitioner who is authorized to operate a healthcare deliveryfacility.3.1.33 referred (patient)registered exclusively for specialdiagnostic/therapeutic service of the hospital for diagnosis/treatment on an ambulatory basis. Responsibility remains withthe referring practitioner.3.1.34 resident care facilitya residential facility that pro-vides regular and emergency health services, when needed, andappropriate supporting services on a regular basis.3.1.