The Legal Health Record

1
The Legal Health Record

• Virginia Health Information Management
  Association
• April 23, 2008
• Cheryl Servais, MPH, RHIA
• Precyse Solutions, LLC

2
Presentation Goals

• Basis for Defining the Legal Health Record (LHR)
• Electronic Health Record (EHR) vs LHR
• Practical Tips for Defining and Maintaining the
  LHR in Your Facility

3
Patient Information is Exploding

• Moving from paper to electronic information
  expands boundaries
• More information available, databases merged,
  expanded capabilities
• Requires providers to clearly define their legal
  health record

4
Definition of Legal Health Record

• The subset of all patient-specific data created
  or accumulated by a healthcare provider that may
  be released to third parties in response to
  legally permissible requests.
• Properly authorized requests for ROI
• Subpoenas
• Court orders

5
Legal Caveats

• This presentation is not legal advice
• Its purpose is to guide practitioners on how to
  define and maintain documents and data elements
  that serve as the LHR for the provider and are
  used to respond to routine requests

6
Legal Caveats

• Seek legal counsel anytime, but especially when
• Patient information beyond the LHR definition is
  requested, subpoenaed, or ordered for production
  by a court or administrative agency
• Records are requested in suits involving the
  provider
• A provider receives an atypical request

7
Legal Caveats

• If an item is not part of LHR content, it still
  can be created, maintained or shared for
  treatment, payment or operations
• LHR content definition attempts to identify
  documents/data to be kept in legal manner
• Assist staff with processing of routine requests

8
HIM Role in LHR Content Definition

• Assist the provider or provider organization with
  defining LHR content
• Consider
• Laws, regulations, standards
• Physician/institutions needs
• Legal counsel guidance
• Community practice
• 3rd party payer documentation requirements

9
LHR Definition - General

• Important to any healthcare organization
• Applies to all types of patients and patient
  services
• Includes PHI stored in any medium that is
  collected and used in delivering healthcare or
  assessing health status

10
LHR Definition - General

• Data/documents included in LHR definition do not
  need to be stored in one location or system, but
  must be linked through
• MPI
• Pointers
• Other notations

11
Steps to Defining LHR Content

• Start with universe of all possible data about a
  patient
• Select items that are required by regulation or
  statute to be retained
• Make sure items meet business record standard
• There is no one size fits all standard for all
  providers

12
Legal Basis of LHR Content

• Federal Rules of Evidence (FRE)
• (aka Business Record Rule)
• Article VIII, Rule 803(6) exception to hearsay
  rule
• Article VIII, Rule 902(11) requires business
  record to be accompanied by an affidavit by
  Custodian certifying the record meets the
  requirements of Rule 803(6)

13
Legal Basis of LHR Content

• Business Record Definition
• Documentation made at or near the time of the
  event by a person with knowledge of the event
  kept in the ordinary course of business and made
  as a part of the regular practice of the activity

14
Legal Basis of LHR Content

• Federal Rules of Civil Procedure (FRCP)
• Relates to the production of electronic data
• Must be in usable format
• May require direct access to system
• Access cannot be prohibited by claim of cost
• Sanctions may be imposed if data are lost

15
Legal Basis of LHR Content

• State rules of evidence
• Many adopted Uniform Rules of Evidence Act with
  language similar to the FRE
• State licensing regulations or other regulations
  on health record content

16
Legal Basis of LHR Content

• Medicare Conditions of Participation (COP)
• Medicare Billing Guidelines

17
Legal Basis of LHR Content

• HIPAA Designated Record Set
• Medical Record Contents
• Computer data bases with patient information
• Billing/patient accounting databases
• Research databases/files
• Registry data

18
Legal Basis of LHR Content

• LHR is a subset of the Designated Record Set
• Select subset based on FRE, FRCP, State laws and
  other standards
• Record made in normal course of business
• Validate author of notation, date and time
• Record made at or near the time of the event

19
Legal Basis of LHR Content

• Exceptions to Business Record Definition
• Note or email written by patients family member
• Computer audit trails
• Registry data
• Research data

20
Other Basis of LHR Content

• Accrediting Body Standards (e.g. Joint
  Commission)
• Payer documentation requirements
• Words may refer to record requirements in paper
  terms
• e.g. Medication sheets vs MAR
• but still pertain to information formerly
  contained in paper format

21
Other Basis of LHR Content

• Other standards to watch
• HL7 EHR TC
• Legal EHR-S Functional Profile Workgroup
• Legal Electronic Health Record-System
• Functional Profile
• Registration Release 1 (v 1.0) June 1, 2007
• Co-Facilitators
• Michelle Dougherty, RHIA, CHP
• Harry Rhodes, MBA, RHIA, CHPS, CPHIMS

22
Other Basis of LHR Content

• American Society for Testing and Materials (ASTM)
  subcommittee E31.25, E1384-02a Standard
  Practice for Content and Structure of the EHR
• Other groups defining Core Data Sets for EHR
• AHIMA COP and Practice Briefs

23
Metadata

• Data about Data
• File/author name
• Date created/modified/accessed
• Document version numbers
• Revision history
• Date created by system (document ID, job number,
  etc)

24
Metadata

• Can be fully discoverable in civil litigation
• e-discovery
• If metadata removed from systems/files can face
  sanctions, fines for not having this information

25
Source of LHR Content- Issues

• Consider issues
• Current practice
• State laws/regulations
• Advice of legal counsel
• Document decisions
• Revisit as laws and practices change

26
Source of LHR Content - Issues

• Originating Systems Lab, Radiology, PACS,
  Pharmacy, Cardiology, CPOE, Transcription, Fetal
  Monitoring
• Secondary Systems Results reporting, EHR,
  Clinical Data Repository
• Data may be duplicated which system will be
  used for LHR?

27
Source of LHR Content Issues

• Source systems can also include administrative
  data or billing data
• Exclude these elements?
• E.g. time of patient arrival to department
• Charge code
• Time of test
• Time of interpretation
• Techs assisting with procedure

28
Sources of LHR Content - Issues

• Detail vs summary data
• Summary report vs EKG or tracing
• X-ray report and/or film
• Raw data vs interpretation
• Tables created from multiple sources
• Medication dosage vs lab value
• Lab values trended over time in graphic format

29
LHR Issues Notes

• Assess how information is used
• Determine if it is pertinent to documentation of
  patient care
• Are there other sources for data (e.g. dictated
  reports, diagnostic study data)?

30
LHR Issues Notes

• Working notes in preparation of final report
• Data gathering tools (questionnaires, worksheets)
• Psychotherapy notes
• Printed documents from EHR with notations
• BUT, notes in separate systems may still be part
  of LHR

31
Sources of LHR Content - Issues

• Paper documents vs scanned images
• Some states may still require paper
• Uniform Photographic Copies of Business and
  Public Records as Evidence Act adopted by many
  states

32
LHR Content Whats Out?

• Administrative Data or Documents
• Audit trails (maybe)
• ROI authorization forms
• Birth/death certificate worksheets
• Correspondence
• Notice of privacy practice
• Incident reports
• Insurance forms

33
LHR Content Whats Out?

• Derived data
• Aggregated data
• Registry data
• Abstracted elements
• Research data
• OASIS, Core Measures, MDS data

34
LHR Content To Be Determined

• Decision Support Documents
• Pop-up notices, alerts, reminders
• Notices/communication with patients or family
• Email, voice mail, regular mail
• Data from other providers
• Meet FRE standard?

35
LHR Issues Alerts, Pop-ups, Reminders

• Alerts, Pop-ups and Reminders are tools to aid in
  clinical decision making
• Tools themselves are NOT part of the medical
  record BUT
• Documented response to a tool is a part of the
  LHR along with the tool

36
LHR Content To Be Determined

• Personal Health Records
• Meet FRE standard?
• May be the basis of a diagnosis or treatment
  decision
• e.g. insulin/glucose tracking
• Medical diaries

37
LHR Content To Be Determined

• Picture Archiving and Communication System (PACS)
  images
• Routinely provide or only upon specific request?
• Preliminary vs final reports
• Include all versions?

38
LHR Content Definition Grid
39
LHR Content Definition

• NOTE Just because a document or data element is
  included in the definition of the LHR does not
  mean it must be included in response to a request
  for information
• Tailor response to needs of requestor

40

• Maintaining The LHR

41
Accuracy

• Documentation should reflect care given
• Author of entry responsible for accuracy
• Provider needs P/P to govern documentation
  requirements
• Define data elements
• Standardize between systems

42
Addenda, Amendments, Alterations

• Provider needs P/P for handling addenda,
  amendments, corrections and deletions including
  time frames
• Review HL7 Standards for Legal Health Record for
  suggestions on performing and tracking
  alterations
• Systems must clearly identify original
  information as well as the changes

43
Addenda, Amendments, Alterations

• Never obliterate or alter an original entry
• Do not need to present original version to end
  user, but it must be available for viewing when
  necessary
• Critical if information has been used to support
  clinical decisions
• Clearly indicate versions and linkage among
  versions when reviewing any entry

44
Addenda, Amendments, Alterations

• Document
• Date and time of change
• Identify as addendum or correction
• Indicate why change or addendum is being made
• Provide link to original entry in EHR
• Notify end-users of change or addendum

45
Patient Requested Amendments

• Process required by HIPAA 45 C.F.R 164.526(a)
• Amendment should refer back to original
  information
• Include correct information with date and time
• Do not remove or change original information

46
Late Entries

• Identify as late entry
• Record current date and time of entry
• Refer to date and time of original event
• Indicate reason for late entry

47
Cut and Paste Functionality

• Risks
• Copying to wrong patient or wrong encounter
• Inadequate identification of original author and
  date
• May be illegal or unethical in some
  circumstances, e.g. clinical trials, pay for
  performance, quality assurance data

48
Cut/Paste Functionality in EHR

• May be acceptable if
• Appropriate attribution and source made in new
  entry
• Organizational policy states when it can and
  cannot be used
• Methods exist to cross check accuracy of entry in
  correct patient record/encounter

49
Audit Trails

• Include date, time and nature of each transaction
  or activity surrounding a document or data
  element
• Identify the individual performing the
  transaction (additions, changes, deletions,
  viewing, printing, etc)
• Support the legal integrity of the record by
  documenting all activity

50
Authorship

• Who may create information in the EHR?
• Permission granted according to organizational
  policy based on state/federal laws
• Document in medical staff bylaws/rules
  regulations policies and procedures

51
Authentication

• Process that indicates authorship and completion
  by the individual who is legally responsible for
  the entry
• Must comply with applicable statutes and regs,
  which may vary substantially
• Should be addressed in organizational
  policy-meaning, responsibility, timeliness,form
  and format

52
Methods of Authentication

• Hand-written signatures
• Rubber stamps
• Computer keys
• Electronic/digital signature

53
Authentication Issues

• Auto-authentication generates computerized
  authentication for any entry that requires one
  often without reviewing the entry
• Entries completed by multiple individuals can
  EHR accommodate these types of entries so each
  separate entry is separately authenticated
• Authenticating care provided by colleagues
  countersignatures/co-signatures

54
Considerations for Electronic Authentication

• Faxed signatures faxed document legal vs
  original signed document?
• Message integrity does signing an entry lock
  it down? No further changes after signature
• Non-repudiation identify person entering
  signature as author of entry. Author cant deny
  entry later

55
Digital vs. Digitized Signatures

• Check state laws to see if electronic signatures
  are acceptable
• Digitized signature is a handwritten signature
  from a pen-pad (like in stores)
• Digital signature embed a character string into
  an entry using public key encryption technology
• Ensures message is unaltered and signer is
  authentic

56
Custodians of Record

• Typically a member of the HIM Department
• With EHR other professionals may become
  custodians
• Database managers or system administrators
• IT Professionals
• Software vendors
• Legal counsel (when provider party to action)
  for purposes of responding to subpoena

57
Data Transmission or Translation

• Data often transmitted from one system to another
  (e.g. lab to CPR)
• Have process in place to ensure transmissions are
  complete (no records truncated or lost or
  corrupted)
• Determine process for mis-matched files

58
Disaster Recovery

• Type of disaster doesnt matter
• Provider must protect patient information from
  loss or suspicion of tampering
• Required by HIPAA Security Standards and Joint
  Commission
• Develop disaster recovery plan to protect health
  information, minimize disruption of healthcare
  operations, and provide for orderly recovery

59
Downtime Documentation

• Information generated during must be part of LHR
• Most will use paper or stand-alone systems during
  downtime
• When EHR system is restored, how will this data
  be incorporated into the LHR?
• Data entry Scanning
• These documents should carry the same weight as
  an original

60
Document Imaging

• Determine the source of information to be
  provided in response to a request for
  information
• Printout of imaged documents
• Retain original paper documents
• If the imaged documents will be used, be sure the
  process to image and index the documents is
  monitored for quality and accuracy

61
Mergers and Acquisitions

• Record sets from both providers need to be
  brought together
• Standardize document names data elements
• Standardize LHR content and processes for
  maintaining the record
• Standardize the source of truth e.g. lab
  system, EHR, results reporting
• Map data elements carefully

62
Divestitures

• One provider may lose clinical systems or EHR
• How retain patient information?
• Paper printout
• Data storage can it be read?
• Transfer to a new system interoperability/compat
  ibility of old data and new system

63
Retention and Destruction

• Those documents/data elements included in the LHR
  content definition must be preserved for the
  length of time specified by the providers
  retention schedule (based on legal requirements)
• If the same date is in multiple systems, only
  need to preserve the date in that system
  designated as the source for the LHR

64
Retention and Destruction

• Develop task force to review where patient
  information is located
• What is on-line
• What is stored in other media
• Develop Retention schedule
• Develop a destruction schedule and process

65
Role-based Access

• Determine the right of access to patient
  information based on individuals right to know
• Also determine
• Who can print or fax patient information
• Who can download information
• Who can change or delete information

66
Role-based Access

• Establish information to be released to certain
  types of requestors a subset of the LHR
• Researchers
• Payers
• Students
• Physician office staff

67
Role-based Access

• Establish monitoring procedures/audit trails for
  those with high levels of access
• HIM Staff
• IT Staff
• Nurses and other care givers
• UR/QA staff

68
Retraction

• Retraction removing a document from one record
  and placing it into another record
• Need to keep documentation on situation and date
  of retraction
• May need to notify users of both records

69
Reassignment

• Involves moving a document from one episode of
  care to another
• Need explanatory note in patients file

70
Questions
71
THANK YOU

• Cheryl Servais, MPH, RHIA
• VP Compliance and Privacy
• cservais_at_precysesolutions.com

72
LHR Definition Discussion Group 1

• Print documents?
• Keep Paper as legal health record?
• Keep Paper as back-up?
• State laws
• End user preference
• Work station availability
• Who can print?
• How control paper copies?

73
LHR Definition Discussion Group 2

• Include documents from outside facility?
• Physicians/hospitals
• Ambulance services
• Diagnostic tests
• Alternative medical care (acupuncture, herbalists)

74
LHR Definition - Discussion Group 3

• Other items to consider as part of LHR
• Audio files (dictation)
• Recordings of provider/patient calls
• Emails
• End of shift reports
• Videos of visits, procedures, telemedicine
  consults