ASTM E2017-1999(2005) Standard Guide for Amendments to Health Information《健康信息修订的标准指南》.pdf

1、Designation: E 2017 99 (Reapproved 2005)An American National StandardStandard Guide forAmendments to Health Information1This standard is issued under the fixed designation E 2017; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 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 guide addresses the criteria for amendingindividually-identifiable health information. Certain criteria

3、 foramending health information is found in federal and state laws,rules and regulations, and in ethical statements of professionalconduct. Although there are several sources for guidance, thereis no current national standard on this topic.2. Referenced Documents2.1 ASTM Standards:2E 1762 Guide for

4、Electronic Authentication of Health CareInformationE 1869 Guide for Confidentiality, Privacy,Access, and DataSecurity Principles for Health Information Including Elec-tronic Health Records3. Terminology3.1 Definitions:3.1.1 amendment, nalteration of health information bymodification, correction, add

5、ition, or deletion.3.1.2 authentication, nprovision of assurance of theclaimed identity of an entity, receiver, or object.(E 1869, E 1762, CPRI3)3.1.3 author, nperson(s) who is (are) responsible andaccountable for the health information creation, content, accu-racy, and completeness for each documen

6、ted event or healthrecord entry.3.1.4 commission, nact of doing, performing, or commit-ting something. (Websters 1993)3.1.5 confidential, adj(1) status accorded to data or infor-mation indicating that it is sensitive for some reason and needsto be protected against theft, disclosure, or improper use

7、, or allthree, and must be disseminated only to authorized individualsor organizations with an approved need to know; (2) privateinformation, which is entrusted to another with the confidencethat unauthorized disclosure that will be prejudicial to theindividual will not occur. (E 1869)3.1.6 delete,

8、v(1) to eliminate by blotting out, cutting outor erasing; (2) to remove or eliminate, as to erase data from afield or to eliminate a record from a file, a method of erasingdata. (Websters 1993, Websters New World Dictionaryof Computer Terms, 1994)3.1.7 error, nact involving an unintentional deviatio

9、nfrom truth or accuracy.3.1.8 health information, nany information, whether oralor recorded, in any form or medium (1) that is created orreceived by a health care practitioner; a health plan; healthresearcher, public health authority, instructor, employer, schoolor university, health information ser

10、vice or other entity thatcreates, receives, obtains, maintains, uses or transmits healthinformation; a health oversight agency, a health informationservice organization, or (2) that relates to the past, present, orfuture physical or mental health or condition of an individual,the provision of health

11、 care to an individual, or the past, presentor future payments for the provision of health care to aprotected individual; and, (3) that identifies the individual withrespect to which there is a reasonable basis to believe that theinformation can be used to identify the individual.(HIPAA4, E 1869)3.1

12、.9 information, ndata to which meaning is assigned,according to context and assumed conventions(E 1869)3.1.10 omission, nsomething neglected or left undone, theact of omitting. (Websters 1993)3.1.11 permanence, nquality of being in a constant, con-tinuous state.4. Significance and Use4.1 The purpose

13、 of this guide is to assure comparabilitybetween paper-based and computer-based amendments. Paper-based and computer-based amendments must have comparablemethods, practices and policies, in order to assure an unam-biguous representation of the sequence and timing of docu-mented events. Original and

14、amended health informationentries and documents must both be displayed and must beconsistent across both domains. Comparability does not rule1This guide is under the jurisdiction of ASTM Committee E31 on HealthcareInformatics and is the direct responsibility of Subcommittee E31.25 on HealthcareManag

15、ement, Security, Confidentiality, and Privacy.Current edition approved May 10, 1999. Published September 1999.2For 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 st

16、andards Document Summary page onthe ASTM website.3CPRI (Computer-Based Record Institute), 4915 Saint Elmo Ave., Suite 401,Bethesda, MD 20814 (http:/www.cpri.org).4HIPAA (Health Insurance Portability and Accountability Act), 1996 (http:/www.hcfa.gov/hipaa/hipaahm.htm).1Copyright ASTM International, 1

17、00 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.out, however, the use of capabilities specific to the electronicworld, which do not have paper-based counterparts, for ex-ample, displaying the amended text with a pop-up window,which can show the text prior to its am

18、endment.4.2 Traditional paper-based health records and policies sup-port the need of authorized authors of health information toamend entries and documents in the health record underappropriate circumstances. In a paper-based health record,amending entries is accomplished by drawing a line throughth

19、e erroneous entry, writing in the correct information, andauthenticating the amendment by signing and dating thechange. Such corrections always display the original documen-tation along with the amendment. This procedure is used toassure an unambiguous representation of the sequence andtiming of doc

20、umented events and any appropriate amendments.4.3 Current and emerging technologies for health records,including, but not limited to, computer-based health records,employ different input and display methodologies than thetraditional paper-based record and, therefore, different amend-ment alternative

21、s for health record or health informationentries, or both. Health information may be entered directlyinto an automated, electronic, or computer-based health recordsystem, for example, by voice, keyboard (either by the carepractitioner, transcriptionist, or other intermediary), mouse,pen, tablet, a p

22、ersonal digital assistant, or through the use ofstructured data entry. Unlike a written record, which essentiallyis always viewed in its original handwritten or typewrittenform, the presentation and display of electronic and computer-based health information often is transformed. This transfor-matio

23、n occurs when information is transferred from onecomputerized system to another system or filtered by differentdisplay characteristics or views of the data. In addition, incontrast to the paper-based record, computers and computersystems can modify display of the data directly, for example, innonchr

24、onological order or filtering through queries. Amendedelectronic records should display a distinct and obvious nota-tion of their amended state. Access to the original healthinformation should be immediately available, that is, prioramendments back to and including the original record.5. Authenticat

25、ion of Authorship5.1 Under this guide, authentication is used to prove author-ship of each documented event or health record entry.5.1.1 For handwritten records under this guide, authentica-tion of the author is provided through the act of signing orinitialing an entry.5.1.2 For computer-based healt

26、h information systems underthis guide, authentication of the author is provided through theuse of a digital signature (see Guide E 1762).6. Health Information Permanence6.1 Health information attains permanence when it is au-thenticated by its author(s) as a complete and final document,as establishe

27、d by organizational policies and procedures. Or-ganizational policies and procedures, regulations from regula-tory, accreditation, and standards organizations and agencies,professional associations, as well as legislative and legalrequirements, define explicit rules as to what constitutes apermanent

28、 entry into a health record and whether or not thatentry or document must be authenticated by the author.6.2 Once an entry is complete, final and authenticated by itsauthor(s), permanent health information can be altered onlythrough the process of amendment.6.3 Organizational policies and procedures

29、 that define per-manence must consider the following:6.3.1 Authenticated or unauthenticated health informationin paper or electronic form is permanent when it becomesavailable for viewing or reading by any health care practitionerother than the author for concurrent or subsequent direct careof the p

30、atient about whom the health information is docu-mented.6.3.2 Unauthenticated health information used in the directprovision of health care or in the process of health caredecision making, must be marked clearly, legibly, and obvi-ously as unauthenticated or defined and clearly understood asunauthen

31、ticated. Examples of unauthenticated health informa-tion are as follows:6.3.2.1 Dictated or Transcribed ReportsNotes, historiesand physicals, discharge summaries, consult reports, letters,procedure notes and reports, diagnostic study reports.6.3.2.2 Preliminary ReportsDiagnostic studies, labora-tory

32、 values, images and image reports.6.3.2.3 Unsigned handwritten, typed, copied, facsimile,printed or computer-based health information.6.3.2.4 Handwritten notes or documents that also have beendictated and eventually will be transcribed.7. Amending Health Information7.1 Amending health information is

33、 appropriate when anexplicit error is recognized, information is disputed, or there isan error of omission or commission in documentation. Anyrequest to amend or modify health information must bedocumented and retained as part of the health record, includingacceptance or denial of the request.7.2 An

34、 amendment may be appropriate when the followingoccurs:7.2.1 An explicit error is detected while reviewing healthinformation, for example, when an image technician reviewshealth information and determines the abnormal mammogramactually belongs to the patients mother who has the same lastname.7.2.2 T

35、he author determines further health informationneeds to be added to an existing document, which constitutesan error of omission, for example, the dictating physicianrealizes that he or she left something out during the originaldictation.7.2.3 The author determines that the entry or documentcontains

36、information that does not actually apply to what hastranspired with a patient and about whom the information hasbeen entered or documented, which constitutes an error ofcommission, for example, when a physician realizes that he orshe has documented a more complete physical exam than wasactually perf

37、ormed on the patient.7.2.4 A health care practitioner who is responsible forsupervising or overseeing another health care practitionerdetermines there is an error in the record, for example, anE 2017 99 (2005)2attending physician reviewing the work of a student, resident,physician assistant or advan

38、ced practice registered nurse.7.2.5 A patient requests the opportunity to amend personalhealth information, which he or she deems to be in error, forexample, a patient disagrees with the health care practitionersstatement of his or her use of alcohol.7.2.6 A system programmed for possible error dete

39、ctiondetects a possible data error or questions the reasonableness ofdata, for example, laboratory values that are impossible for thestated test.7.3 Individuals authorized to request an amendment tohealth information may include the following:7.3.1 The author of a health information entry or documen

40、t.7.3.2 The individual ordering, providing service or evaluat-ing care that is documented in that health care entry.7.3.3 An individual supervising, responsible for or evaluat-ing another health care practitioners care of a patient.7.3.4 A patient or guardian who requests an amendment tohis or her o

41、wn personal health information.7.3.5 A human or system-process that flags an error in thehealth information entry.7.4 Policies and procedures must be established to accu-rately track the process from error identification, or request foramendment, through the completion of the amendment. Ifamendments

42、 are requested but deemed unsuitable upon review,organizational policies and procedures should be in place todelineate when this denial should itself be documented. Theamendment process to health information should include thefollowing:7.4.1 Possible error is detected by human or system-processor a

43、request for amendment is made.7.4.2 If appropriate, as defined by organizational policiesand procedures, an authorized entity, that is, person, device, orprocess, makes the amendment.7.4.3 The entity making the amendment is identified andrecorded and is associated directly with the amended entry and

44、is readily apparent to anyone who views or reviews thatamended entry.7.4.4 The date and time of the amendment is recorded.Inclusion of the date and time that the amendment is made alsoshould be associated directly with the amended entry andreadily apparent to anyone who views or reviews that amended

45、entry.7.5 Organizational policy should state that amendment(s)must be made in a timely fashion and must be able to be linkedto the original document(s).7.6 For all amendments to health information, the originalentry, handwritten, printed, facsimile, copied, electronic orcomputer-generated, must be r

46、etained during and after theamendment process. The original entry must remain accessible,be clearly readable, and retain its original meaning. Acceptablemethods for meeting this requirement are as follows:7.6.1 For handwritten amended entries, the use of a cleanline drawn through the original entry

47、is acceptable, as long asthe original entry still is readable and clearly and unmistakablydecipherable.7.6.2 For amended entries in computer-based informationsystems where information has been deleted or modified, theuse of strike-through characters is acceptable, as long as theoriginal entry still

48、is readable and clearly and unmistakablydecipherable. For amended entries where information has beeninserted at a later date, this text must be identified clearly byappropriate convention (for example, right quadrant).7.7 If more than one copy of the original entry or documentexists, known recipient

49、s should be notified of the amendment,whether the amendment is handwritten, on a printout, a copy,facsimile, electronic, or computer-based. This includes datatransferred from one enterprise system to another system,including smart cards, which requires notification on the part ofthe sender that the recipient of the data must ensure thatappropriate amendments and destruction are carried out.7.8 Any amendment of a previous amendment is subject tothe exact same rules and procedures as an amendment to theoriginal document.7.9 The presence of amended entries and docume