Health IT Standards for Health Information Management

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Integrating the Healthcare Enterprise

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IHE IT Infrastructure (ITI) White Paper Health IT Standards for Health Information Management Practices

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(HIT Standards for HIM Practices) Revision 1.1

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Date:

September 18, 2015

Author:

ITI Planning Committee

Email:

[email protected]

Please verify you have the most recent version of this document. See here for Published versions and here for Public Comment versions.

Copyright © 2015: IHE International, Inc.

IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

Foreword

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Integrating the Healthcare Enterprise (IHE) is an international initiative to promote the use of standards to achieve interoperability among health information technology (HIT) systems and effective use of electronic health records (EHRs). IHE provides a forum for care providers, HIT experts and other stakeholders in several clinical and operational domains to reach consensus on standards-based solutions to critical interoperability issues. The primary output of IHE is system implementation guides, called IHE Profiles. IHE publishes each profile through a well-defined process of public review and trial implementation and gathers profiles that have reached final text status into an IHE Technical Frameworks.

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This white paper is published on September 18, 2015. Comments are invited and can be submitted at http://www.ihe.net/ITI_Public_Comments. For on-going development work, see http://wiki.ihe.net/index.php?title=HIT_Standards_for_HIM_Practices

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General information about IHE can be found at: http://ihe.net. Information about the IHE IT Infrastructure domain can be found at: http://ihe.net/IHE_Domains.

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Information about the organization of IHE Technical Frameworks and Supplements and the process used to create them can be found at: http://ihe.net/IHE_Process and http://ihe.net/Profiles. The current version of the IHE IT Infrastructure Technical Framework can be found at: http://ihe.net/Technical_Frameworks/.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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CONTENTS 1 Acknowledgement...................................................................................................................... 4 2 Introduction ................................................................................................................................ 6 2.1 Need, Goal and Objectives, Scope and Outcome ............................................................... 7 2.2 Intended Audience .............................................................................................................. 9 3 Methodology ............................................................................................................................ 10 3.1 Method .............................................................................................................................. 10 3.2 Project Participants ........................................................................................................... 11 3.3 Project Tasks, Timeline and Deliverables ........................................................................ 12 4 Overview of Health Information Management ........................................................................ 14 4.1 HIM Professionals (Actors) .............................................................................................. 14 4.2 HIM Practices (Actions) ................................................................................................... 15 4.3 Health Information (Products) .......................................................................................... 16 4.4 Information Governance ................................................................................................... 19 4.4.1 Principle of Information Availability: Business Requirements ................................. 21 4.4.2 Principle of Information Integrity: Business Requirements ...................................... 22 4.4.3 Principle of Information Protection: Business Requirements ................................... 23 4.5 HIM Practice CheckList ................................................................................................... 24 4.6 HIM Practice Use Cases ................................................................................................... 24 4.7 Glossary ............................................................................................................................ 25 5 Gap Analysis of HIT Standards to Support HIM Practices ..................................................... 26 6 Recommendations .................................................................................................................... 27 7 Roadmap .................................................................................................................................. 30 Appendix A: HIM Practice Checklist ........................................................................................... 32 Appendix B: HIM Practice Use Cases .......................................................................................... 39 B.1 Use Case A1.1: All documents are accounted for within a specific time period post completion of the episode of care ..................................................................................... 39 B.2 Use Case A1.2: Record is closed as complete within a specific time period post completion of the episode of care ..................................................................................... 43 B.3 Use Case A2.1: Documents within the record can be viewed by or released to the external requestor ............................................................................................................................ 45 B.4 Use Case A3.1: An audit log of the episode of care record .............................................. 47 B.5 Use Case A3.2: An audit log of requests for release of information and accounting of disclosures ......................................................................................................................... 48 Appendix C: Glossary ................................................................................................................... 49 Appendix D: HIT Standards for HIM Practices ........................................................................... 53

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

1 Acknowledgement 90

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This white paper was developed with the support from the American Health Information Management Association (AHIMA) - the not-for-profit membership-based healthcare association representing more than 101,000 health information management (HIM) and informatics professionals who work in more than 40 different types of entities related to our nation’s public health and healthcare industry. AHIMA is committed to advancing information governance in the healthcare industry to ensure the quality and integrity of all types of information necessary to safe, high quality, cost effective care and the improvement of the health of individuals and populations. This white paper was developed as a part of a new globally-focused AHIMA initiative on Information Governance (IG) 1, 2, 3 – an organization-wide framework for managing information throughout its lifecycle and supporting the organization’s strategy, operations, regulatory, legal, risk, and environmental requirements. 4 This IG Initiative is a key component of AHIMA's overall strategy to develop guidelines, operating rules and standards for healthcare documentation practices. AHIMA formed a Task Force of HIM professionals – subject matter experts (SMEs) – to provide expertise for aligning HIM practices and capabilities of health information systems through health information technology (HIT) standards. Their work was facilitated by the AHIMA Standards Team. Table 1 presents the list of the Task Force members.

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American Health Information Management Association (AHIMA). Information Governance Principles for Healthcare (IGPHC). Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Principles.ashx 2 American Health Information Management Association (AHIMA). Information Governance (IG) Infographic – What is IG? Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Infographic.ashx 3 Cohasset Associates and American Health Information Management Association (AHIMA). Professional Readiness and Opportunity. Information Governance in Healthcare White Paper. Minneapolis, MN. 2015. URL: http://www.ahima.org/~/media/AHIMA/Files/HIM-Trends/IGSurveyWhitePaperCR_7_27.ashx?la=en 4 American Health Information Management Association (AHIMA). Information Governance. Glossary. URL: http://www.ahima.org/topics/infogovernance/ig-glossary HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Table 1: AHIMA-IHE White Paper Task Force Members

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Name

(in alphabetical order) Affiliation

Kathleen Addison

Alberta Health Services

Linda Bailey-Woods

Bailey Woods Advisors

Kevin Baldwin

UCLA

Alane Combs

Coastal Healthcare

Funmilola Daniel

Quest Diagnostics

Vicki Delgado

Kindred Hospital Albuquerque

Elisa Gorton

St. Vincent's Medical Center

Sandra Huyck

Beaumont Health System

Satyendra Kaith

Kaplan Higher Education Group

Susan Lucci

Just Associates

Amber Martinez

Precyse

Lori McNeil Tolley

Boston Children's Hospital

Denese Miller

Kennestone Regional Medical Center

Megan Munns

Just Associates

Neysa Noreen

Children's Hospitals and Clinics of Minnesota

Michael Nusbaum

M.H. Nusbaum & Associates Ltd.

Deane Stillar

Alberta Health Services

DeAnn Tucker

Owensboro Health

Lee Wise

Summit Medical Center

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Copyright © 2015: IHE International, Inc.

IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

2 Introduction 115

This document, the IHE Information Technology Infrastructure (ITI) White Paper “HIT Standards for HIM Practices,” describes the need for, value and an approach for aligning HIM business practices (HIM practices) with capabilities of standards-based HIT products to support information governance in healthcare. The white paper provides: 1. An overview of HIM practices related to information governance

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2. Detailed analysis of HIM business requirements and best practices checklist related to information availability, integrity and protection – three of the information governance principles selected out of a total of eight principles 5, 6, 7 3. Five Use Cases derived from these business requirements and best practices for the information availability – in order to guide the development of the functional requirements for HIT standards

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4. Glossary – definitions of terms, participants (actors), processes (actions) and outcomes of HIM practices related to the Use Cases 5. An initial gap analysis of existing HIT standards to support HIM business requirements under selected three IG principles (information availability, integrity and protection) and

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6. Recommendations for HIM community and standards development organizations (SDOs) for further standardization of both HIM practices as well as capabilities of HIT products to support these practices. 135

The white paper describes an approach (methodology) and a roadmap for expanding the list of Use Cases to support business requirements for HIM practices under other information governance principles in the future. Our effort is aimed to advance the use of standardized interoperable health information and communication technology (HICT) in healthcare for improving patient safety and quality of care.

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American Health Information Management Association (AHIMA). Information Governance Principles for Healthcare (IGPHC). Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Principles.ashx 6 American Health Information Management Association (AHIMA). Information Governance (IG) Infographic – What is IG? Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Infographic.ashx 7 Cohasset Associates and American Health Information Management Association (AHIMA). Professional Readiness and Opportunity. Information Governance in Healthcare White Paper. Minneapolis, MN. 2015. URL: http://www.ahima.org/~/media/AHIMA/Files/HIM-Trends/IGSurveyWhitePaperCR_7_27.ashx?la=en HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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2.1 Need, Goal and Objectives, Scope and Outcome NEED. In the past decade HIM professionals have been working on implementing health information and communication technology including various health information systems (HIS) such as Electronic Health Record Systems (EHRS), Laboratory Information Management Systems (LIMS) and other HICT products in healthcare and public health organizations. Based on the literature review 8, 9, 10, 11, 12, 13, 14, 15, 16 we identified the following challenges with HICT adoption: 1. HIS design flaws 2. Poor HIS usability and improper HICT use 3. Inappropriate documentation capture in HIS 4. Errors related to design and use of clinical decision support

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5. Errors related to faulty support of HIM practices in HIS 6. Outdated organizational policies to support information capture, management, sharing and use in electronic environment because these policies were developed for the paperbased environment 8

Bowman S. Impact of electronic health record systems on information integrity: Quality and safety implications. Perspectives in Health Information Management. 2013. URL: http://perspectives.ahima.org/impact-of-electronichealth-record-systems-on-information-integrity-quality-and-safety-implications/#.VU0OLPm6e00 9 Nguyen L, Bellucci E, and Nguyen LT. Electronic health records implementation: An evaluation of information system impact and contingency factors. International Journal of Medical Informatics. 2014. 83(11): 779-796. 10 Kuhn T, Basch P, Barr M and Yackel T. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Annals of Internal Medicine. 2015. URL: http://scholar.google.com/scholar?hl=en&q=Clinical+Documentation+in+the+21st+Century%3A+Executive+Summ ary+of+a+Policy+Position+Paper+From+the+American+College+of+Physicians&btnG=&as_sdt=1%2C14&as_sdt p= 11 Bouamrane M and Mair, FS. A study of general practitioners' perspectives on electronic medical records systems in NHS Scotland. BMC Medical Informatics and Decision Making. 2013. 13: 58 URL: http://search.proquest.com.library.capella.edu/docview/1399741170?pq-origsite=summon 12 Walker JM etal. EHR safety: the way forward to safe and effective systems. JAMA. 2008. 15(3): 272-277. URL: http://jamia.oxfordjournals.org/content/15/3/272.short 13 Health Level Seven (HL7). Electronic Health Records System Usability Conformance Criteria, Release 1. 2015. Health Level Seven (HL7). Comment-only Ballot. URL: http://wiki.hl7.org/index.php?title=EHR_USABILITY 14 Terry AL etal. Implementing electronic health records. Key factors in primary care. Canadian Family Physician. 2008. 54(5): 730–736. URL: http://www.cfp.ca/content/54/5/730.short 15 Holroyd-Leduc JM etal. The impact of the electronic medical record on structure, process, and outcomes within primary care: a systematic review of the evidence. JAMA. 2011. 18(6): 732-737. URL: http://scholar.google.com/scholar?hl=en&q=The+impact+of+the+electronic+medical+record+on+structure%2C+pr ocess%2C+and+outcomes+within+primary+care%3A+a+systematic+review+of+the+evidence.&btnG=&as_sdt=1 %2C14&as_sdtp= 16 Cleveland S and Ellis TJ. Toward a model for customer-driven release management. Proceedings of the Nineteenth Americas Conference on Information Systems, Chicago, IL. August 2013. URL: http://scholar.google.com/scholar?hl=en&q=Toward+a+model+for+customerdriven+release+management.&btnG=&as_sdt=1%2C14&as_sdtp= HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ 155

7. Inadequate training for HIM personnel and clinicians to operate HIS and 8. Errors related to vendor’s upgrades of HIS systems (i.e., HICT release cycle management).

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To address challenges that HIM professionals documented while transitioning from the paperbased to an electronic environment, there is a need to establish cross-collaboration between HIM professionals, standards developers and HIT vendors focusing on the following three efforts to assure that: Effort 1: Functional requirements for HIM practices have been communicated to standards developers for creating HIT standards Effort 2: Standards are adopted in the HIT products and

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Effort 3: Standards-based HIT products support HIM practices. GOALS AND OBJECTIVES. The goals of the white paper are two-fold: (a) inform HIT standards developers about HIM practices; and (b) to outline a methodology for aligning HIM practices with the capabilities of HIT products through standards.

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The following are the white paper objectives: 1. Demonstrate the alignment between HIM practices (business requirements, practice checklists, use cases), and capabilities of HICT products to support these practices 2. Inform IHE development process by defining Profile Specifier checklist (i.e., functional requirements for HIT standards) aligned with the HIM practice checklist

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3. Inform the development of national and international HIT interoperability standards for HICT products for identified HIM practices and 4. Create the roadmap for the development of these standards.

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SCOPE. The white paper is focused on HIM practices related to electronic health information capture, management, sharing and use. This year (Year 1), we developed a methodology for cross-collaboration between HIM professionals and HIT standards developers concentrating on Effort 1 - a systematic approach for specifying functional requirements for HIM practices via use cases in order to validate existing HIT standards and to guide the development of new standards. In the future, we anticipate working with the IHE community on expanding our approach to focus on HIT standards adoption in HIT products (Effort 2) and providing feedback on capabilities of standards-based HIT products to support HIM practices (Effort 3). In Year 1, we focused on the three information governance principles out of a total of eight principles as indicated in bold, italic font below:

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ 190

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1. 2. 3. 4. 5. 6. 7. 8.

Information availability Information integrity Information protection Information accountability Information compliance Information transparency Information retention and Information disposition.

This white paper presents: 200

1. HIM business requirements under the three principles (information availability, integrity and protection) 2. Results of literature review for the best HIM practices under these three principles aligned with the business requirements and 3. Five Use Cases for information availability (focused on inpatient care settings).

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In the future, we anticipate continuing the development of additional Use Cases under information availability, other IG principles and healthcare settings. OUTCOME. We established methodology (a systematic approach) for continuing collaboration between HIM professionals and standards developers via specifying

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a. Business requirements by information governance principle (information availability, integrity and protection) b. HIM practice checklist based on the analysis of the business requirements and HIM practices documented in the literature and c. Use Cases and functional requirements to support HIM practices in HIT products.

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This methodology is described in detail in the correspondent section below. Six specific deliverables listed in the Introduction section above are also described in details in the white paper.

2.2 Intended Audience 220

The intended audience of the white paper includes HIM professionals, HIM educators, standards developers, HIT and ICT vendors for all types of clinical, public health and research information systems and HICT products, and other stakeholders involved in current or planned implementation of HICT in healthcare, public health and research organizations.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

3 Methodology 3.1 Method 225

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In this project, we deployed requirement elicitation method to specify HIM needs for the standard-based HICT products as follows. Derived from the on-going AHIMA work on the information governance principles in healthcare, 17, 18, 19, 20 we specified HIM business requirements by information availability, integrity and protection principles. Further we conducted literature review on the HIM best practices supporting these business requirements and developed HIM checklists by principle. Drawn from the checklist’s items, we developed Use Cases to specify functional requirements for HIT standards. We further conducted initial analysis of existing standards from various standard development organizations (SDOs) by business requirements/HIM practice checklist/Use Cases. Figure 1 presents overview of method deployed. Numbers (#=XX) on Figure 1 show the number of items developed by each step of the project.

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Figure 1: Project Method: Requirements Elicitation

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American Health Information Management Association (AHIMA). Information Governance Principles for Healthcare (IGPHC). Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Principles.ashx 18 American Health Information Management Association (AHIMA). Information Governance (IG) Infographic – What is IG? Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Infographic.ashx 19 Cohasset Associates and American Health Information Management Association (AHIMA). Professional Readiness and Opportunity. Information Governance in Healthcare White Paper. Minneapolis, MN. 2015. URL: http://www.ahima.org/~/media/AHIMA/Files/HIM-Trends/IGSurveyWhitePaperCR_7_27.ashx?la=en 20 American Health Information Management Association (AHIMA). Information Governance in Healthcare. Pilot Projects. Work in progress. 2015. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

3.2 Project Participants 240

The project was conducted under the IHE ITI Planning Committee. HIM professionals – subject matter experts - were recruited via the Call for Participation 21 among those serving on AHIMA volunteer initiatives as follows: 1. AHIMA Enterprise Information Management Practice Council (EIMPC) 2. Health Information Exchange Practice Council (HIEPC) 3. Privacy/Security Practice Council (PSPC)

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4. Data and Information Analysis Task Force (DIATF) 5. Clinical Documentation Improvement Task Force (CDITF) 6. Coordination of Care Task Force (CCTF) 7. Consumer Engagement Task Force (CETF) 8. AHIMA IG Advisory Group

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A total of 19 HIM SMEs were recruited (Table 1). Table 2 describes types of organizations and HIM roles of volunteers who participated in the Task Force. Table 2: Task Force Members: Organizations and Roles Organization Hospital

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HIM Role

Number of Volunteers

Senior Provincial Director

1

Director, Enterprise Information Management

1

Director/Manager/Assistant Director

3

Director/Assistant Director, Privacy

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Data Integrity and Applications Manager

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Compliance Audit Specialist

1

HIM Consultant

2

Consultant Entity

HIM Consultant

3

Higher Education

Faculty

1

Laboratory

Senior Customer Service Representative

1

Vendor

Associate Identity Manager

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Consultant, Chief Privacy Officer

1

Consultant, Information Systems

1

The overall work on the project was facilitated by the AHIMA Standards Team. 21

Integrating the Healthcare Enterprise (IHE). Information Technology Infrastructure (ITI) Planning Committee. HIT Standards for HIM Practices White Paper. Call for Participation. January 15, 2015.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

3.3 Project Tasks, Timeline and Deliverables

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This project was conducted during September 2014 – September 2015. Table 3 describes projects tasks, timeline and deliverables. Project activities were conducted via biweekly conference calls of the HIM Task Force members. Representatives from the Task Force and AHIMA Staff also participated in the biweekly meetings of the IHE ITI Planning Committee to review and critique Use Cases and functional requirements for HIT standards developed by the HIM volunteers. The AHIMA staff attended 3 in-person IHE meetings (November 2014, April and July 2015) to provide progress reports on the project activities.

265 Table 3: Tasks, Timeline and Deliverables Task

Timeframe

Deliverable

Develop and defend proposal to the IHE ITI Committee

Sept.-Nov. 2014

Proposal for the 2014-15 IHE development cycle

Develop project infrastructure

Dec. 2014

Wiki Pages

Assemble AHIMA HIM SME Task Force

Jan. 2015

Call for Participation

Develop project methodology

Jan. 2015

Methodology

Document business requirements and HIM best practices by selected IG principle: availability, protection and integrity

Jan.-April 2015

Business Requirements Literature Review HIM Practice Checklist

Define Use Cases for selected HIM best practices

Feb.-April 2015

HIM Use Case List

Conduct gap analysis of HIT standards to assess their relevance to supporting HIM practice

Mar.-Apr. 2015

Standards Gap Analysis Table

Develop recommendations and roadmap for addressing identified gaps in HIM practices and HIT standards

Mar.-Apr. 2015

Recommendations and Roadmap

Publish draft white paper for public comments

May 2015

Draft white paper

Publish final white paper

Sept. 2015

Final white paper

Communication, outreach and marketing

May-Sept. 2015

Spotlight in HIMSS Media Article in Journal of AHIMA Presentation at AHIMA Convention

Develop proposal for the IHE 2015-16 development cycle

Sept. 2015

Proposal for the 2015-16 IHE development cycle

Figure 2 presents summary of the project activities.

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Figure 2: Project Activities

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HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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4 Overview of Health Information Management 4.1 HIM Professionals (Actors) 275

HIM professionals are responsible for ensuring the availability, integrity, and protection of information that is needed to deliver healthcare and population health services and to make appropriate healthcare and health promotion-related decisions. Table 4 presents a sample of current roles of HIM professionals in healthcare organizations. 22 Table 4: Roles of HIM Professionals in Healthcare Organizations

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HIM Roles Data Capture, Validation, and Maintenance Chart correction analyst

Data architect

ICD-10 implementation specialist

Classification editor and exchange expert

Data capture design specialist

Information workflow designer

Clinical coding validator

Data dictionary manager

Patient identity manager

Clinical content manager

Data integrity and transition specialist/auditor

Registrar (birth, cancer, device, bone marrow, tissue)

Clinical documentation improvement specialist/supervisor

Data mapper/translator

Research coordinator/associate

Coder

Data quality manager/analyst

Research data abstractor

Coding compliance coordinator/supervisor/manager

Documentations/EHR trainer

Terminology asset manager

Computer-assisted coding validation practice leader

EHR content manager

Voice capture specialist

Privacy Officer

Enterprise patient master index, data integrity analyst

Data/Information Analysis, Decision Support and Informatics Business analyst/data analyst

Data integration manager/analyst

Decision support officer

Claims data analyst

Data integrity and transactions specialist/auditor

Health data analyst/manager/director

Clinical content analyst

Data quality manager/analyst

Health data statistician

Data abstractor/coordinator

Data repository architect/manager/analyst

Health outcomes analyst

Data architect

Decision support analyst

Health data quality engineer

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LaTour K. etal, Health Information Management. Chicago, IL: AHIMA Press. 2013. p. 50.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ The emerging roles for HIM professionals in the new interoperable electronic data sharing environment include Standards setters, Standards developers, Educators, Chief information governance officers, Consumer information advocates, Brokers of information. 23 285

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4.2 HIM Practices (Actions) HIM practices are focused on collecting health information, ensuring complete documentation, maintaining and protecting health data, and appropriately sharing authorized information through electronic as well as paper-based release of information. 24 Thus HIM practices include various activities aimed to support basic HIM functions: Capture, Process, Use, Store, and Dispose health information as depicted in Figure 3 to present an overview of the high level functions to support information lifecycle.

Figure 3: HIM Functions to Support Information Lifecycle 295

Table 5 presents HIM activities under these functions. 25 Table 5: HIM Activities by HIM Function Capture Create Enter Record Dictate Write Receive Interface Update Capture

Process Classify Validate Analyze QC/QA Compliance Integrate Prove Maintenance

Use Code Examine Analytics Business Intelligence Release Discover Hold Retain Export Transmit Exchange Share

Store Store Preserve Archive Protect

Dispose Delete Deprecate Destroy Permanent Store Discover Permanent Archive Transition

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Van Dolan P. Reframing Roles. American Health Information Management Association (AHIMA) Leadership Symposium, Chicago, IL July 11-12, 2014. 24 LaTour, K. etal, Health Information Management. Chicago, IL: AHIMA Press, 2013, p.50. 25 American Health Information Management Association (AHIMA). Information Governance in Healthcare. Maturity Model. Work in Progress. 2015 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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4.3 Health Information (Products) 300

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Quality health information is a product of activity(ties) involved clinician, patient and HIM professionals. It is comprised of all types of health data generated in the process of care delivery within an episode of care and assembled/presented/stored/exchanged in records that include documents/data quires/screens/images/readings, etc. (i.e., all that describes the episode of care). Relevant paper-based documents provided by patient, caregiver and/or clinicians during the episode of care can be scanned and become part of the record of the episode of care. An episode of care consists of various functions, e.g., registration, triage, assessment, testing, care plan, registries, reporting, etc. The order of performing these functions is determined by the type of encounter and specified by organizational policies or jurisdictional law. Each of these functions is associated with capturing/producing/sharing/using specific information in the records. Table 6 shows the examples of episode of care’s functions and correspondent information. Table 6: Functions of the Episode of Care and Examples of Health Information in the Record Episode of Care’s Functions

Examples of Information in the Record

Visit Registration/Admission

Patient and Facility Demographics, Billing, Consent for Information Exchange (opt-out/opt-in)

Triage

Triage Notes and Vital Signs

Assessment

History and Physical, Problem List, Medication Reconciliation, Preliminary Diagnosis and Care Plan

Laboratory and Diagnostic Testing

Consent for Procedure, Test Orders and Test Result Reports

Diagnosis and Care Plan

Confirmed Diagnosis and Updated Care Plan

Prescription

Medication Order and Dispense Report

Progress notes

Daily Notes, Treatments, Interventions, Procedures, etc.

Summary of Care

Transfer Summary or Discharge Summary

Discharge/Transfer/Disposition (ADT)

ADT Record

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Figure 4 presents the hierarchy of the record content such as: Level 1 – Lifetime Record – longitudinal record that includes records from all episodes of care over the patient’s lifetime (prenatal care – birth – life – death) Level 2 – Episode of Care Record – multiple information components (records, documents, forms, etc.) generated within various functions of the episode of care (Table 6)

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Level 3 – Function’s Record Component – specific record(s) (e.g., registration record, admission record, test order record, test result reports record, etc.) generated within a specific function of the episode of care (Table 6) Level 4 – Data Entry Record (record at data entry level) – representation of data in a record component associated with a specific function (e.g., test order document/form, care plan document/form, public health report/form, etc.). Standardized representation of data entry in the document/form is achieved by using Health Level Seven (HL7) Continuity Care Document (CCD)/Clinical Document Architecture (CDA) standard, 26 HL7 Fast Health Interchange Resource (FHIR) standard 27 and/or other information content standards.

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Figure 4: Record Content Hierarchy

26

Health Level 7 (HL7). Clinical Documentation Architecture (CDA) Release 2. 2005. URL: http://wiki.hl7.org/index.php?title=Structured_Documents 27 Health Level 7 (HL7). Fast Healthcare Interoperability Resources (FHIR). 2014. URL: http://www.hl7.org/fhir/ HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Figure 5 presents the examples of the Episode of Care’s functions and record components generated at a specific function in the process of care.

a

b

340

Figure 5: Examples of Episode of Care’s Functions and Records/Documents:

a – High level view of the episode of care functions and documentation and b – Detailed view of episode of care functions and documentation. 345

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4.4 Information Governance

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Information governance is described as an accountability framework that “includes the processes, roles, standards, and metrics that ensure the effective and efficient use of information in enabling an organization to achieve its goals.” 28 In short, information governance defines the rules imposed on the information as a product. According to the ARMA International (formerly the Association of Records Managers and Administrators), 29 generally accepted recordkeeping principles include: 1. Accountability 2. Transparency

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3. Protection

Record Attributes

4. Integrity 5. Compliance 6. Availability 7. Retention

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Record States

8. Disposition Please note that principles 1-5 represent the attributes of the record, principles 6-8 represent the states of the record lifecycle. 365

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In 2014 AHIMA launched Information Governance Initiative to adopt these IG principles for healthcare - IGPHCTM . 30, 31 The eight principles are broad and comprehensive and coincide with one another in many instances. The principles operate in tandem to establish trust by clinicians, patients, regulators, and others with whom the organization interacts. 32 Figure 6 presents AHIMA framework for information governance that enables organizational policies and processes to support information lifecycle. 33 28

ARMA International (formerly the Association of Records Managers and Administrators). Generally Accepted Recordkeeping Principles. Information Governance Maturity Model. 2013. URL; http://www.arma.org/principles 29 Same 30 American Health Information Management Association (AHIMA). Information Governance Principles for Healthcare (IGPHC). Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Principles.ashx 31 Cohasset Associates and American Health Information Management Association (AHIMA). Professional Readiness and Opportunity. Information Governance in Healthcare White Paper. Minneapolis, MN. 2015. URL: http://www.ahima.org/~/media/AHIMA/Files/HIM-Trends/IGSurveyWhitePaperCR_7_27.ashx?la=en 32 Datskovsky G, Hedges R, Empel S, Washington L. Evaluating the information governance principles for healthcare: compliance and availability. JAHIMA 86, no.6 (June 2015): 54-55. 33 Green D. Information Governance Update. Presentation at the Health Information Management and Systems Society (HIMSS) Annual Convention. Chicago IL, April 12-16, 2015. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Figure 6: AHIMA Information Governance Framework: Organizational Policies, Processes and Roles for Information Lifecycle 34 375

The authority on establishing organizational policies and processes as well as specific documentation generated via these policies and processes and/or mandated by regulatory bodies falls on a Committee comprised of representatives from clinical, business and technology departments within the healthcare facility. 35, 36 380

These representatives may include: •

385

390

Patient care providers •

Clinicians (MDs, PA, RNs, residents, other credentialed providers) and



Staff who supports ancillary services (laboratory, radiology, pharmacy, etc.



Practice administrators (physician’s assistants, medical group administration)



Health information services directors/medical informatics officers (Chief Medical Informatics Officer (CMIO))



Health information technology department (Chief Information Officer (CIO))



Health information directors (HIM, Clinical Documentation Improvement (CDI), Release of Information (ROI))



Compliance officers (legal and regulatory support) (Chief Legal Officer (CLO), Auditor)

34

Green D. Information Governance Update. Presentation at the Health Information Management and Systems Society (HIMSS) Annual Convention. Chicago IL, April 12-16, 2015. 35 Forms Management. Hospital Policy. University of Vanderbilt, Nashville TN. June 12, 2000 36 Quinsey CA. Managing forms and legal electronic health records. JAHIMA, July 2007, p.58-59 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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405



Purchasing and financial managers (Chief Financial Officer (CFO)) and



Vendors (document scanning, master patient index (MPI)/EMPI, diagnostic imaging, EHR, laboratory, etc.) and



Other.

Please note that this Committee may have various titles (Form Management Committee, HIT Committee, etc.) and carry out different responsibilities in different organizations. Further efforts are needed to assure standardization of Committee’s efforts in defining HIM practices and documentation when implementing information governance within an organization. This is specifically important because in the interoperable, electronic information sharing environment, a lack of sound organizational policies and practices on HIM may compromise shared data, information and knowledge. Our suggestions regarding standardization of the Committee’s efforts are presented in the Recommendation section below. To carry out project activities, in Year 1 we selected 3 information governance principles (information availability, integrity and protection). Sections that follow provide definitions and business requirements for the selected principles based on the AHIMA information governance principles in healthcare (IGPHC). 37 4.4.1 Principle of Information Availability: Business Requirements

410

Information Availability is defined as the ability of an organization to maintain information in a manner that ensures timely, accurate, and efficient retrieval of information by authorized entity, 38 i.e., information shall be available upon request of authorized entity. This information may be used by:

415



The healthcare team, patients, and other caregivers



Authorized members of the workforce and others authorized users consistent with regulations



Legal and compliance authorities for discovery and regulatory review purposes and



Internal and external reviewers for purposes including but not limited to payer audit, financial audit, case management, and quality assurance.

Table 7 presents HIM business requirements under Principle of Information Availability to retrieve, use, audit, and manage information. 420

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American Health Information Management Association (AHIMA). Information Governance Principles for Healthcare (IGPHC). Chicago, IL. 2014. URL: http://www.ahima.org/~/media/AHIMA/Files/HIMTrends/IG_Principles.ashx= 38 Same. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Table 7: HIM Business Requirements: Health Information Availability Health Information Availability: Business Requirements 1. Ability to capture and maintain information in a manner that ensures timely, accurate (complete and correct), and efficient access and retrieval. 2. Ability to search, identify, locate and retrieve patient specific information in continually expanding volumes of information and across multiple systems including various electronic HIS and manual systems (paper-based document locations, storages, etc.). This requirement is focused on tracking sources where information resides (HISs, other HICT products and manual systems). 3. Ability to access information across various systems (electronic and manual) and across patient populations. This includes the abilities to search, identify, locate, and retrieve the information required to support organization’s ongoing activities via queries. This requirement is focused on how information from various sources is accessed. 4. Ability to assemble information from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization. 5. Ability to address multiple demands for having the right information available at the right time for the right requestor. 6. Ability to access information created with legacy hardware and software systems. In case of impending system obsolescence, information with organizational value should be migrated to currently supported hardware and/or converted into a machinereadable format. 7. Ability to maintain metadata services across all participating systems assigning structural and descriptive characteristics to information including data provenance information (authors and dates of creation, modification, sending, receipt, access, etc.). 8. Ability to ensure levels of redundancy, failover, contingencies and other risk management practices to minimize risks of nonavailability of information due to a disaster, system malfunction, or data corruption. 9. Ability to maintain the workforce capabilities on the most current methods to capture, maintain and access information assuring the work processes consistencies despite of workforce turnover. 10. Ability to enable trust of requestor in information by ensuring the timeliness, accuracy (completeness and correctness), and efficiency of information availability based on implementation of business requirements 1-9 above.

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We further used business requirements on health information availability to (a) identify HIM best practices Checklist via literature review, (b) develop Use Cases specifying functional requirements for HIT standards, and (c) conduct preliminary gap analysis of existing standards supporting these business requirements (please see below Appendices A, B and D, respectively). 4.4.2 Principle of Information Integrity: Business Requirements

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Information integrity – the state of being whole or unimpaired – is defined as the ability of data to maintain its structure and attributes to assure representation of intended content and meaning. 39 Table 8 presents HIM business requirements under Principle of Information Integrity.

39

In formulating this definition we revised the original definition of information integrity in AHIMA Pocket Glossary, 2013. We will work to update AHIMA definition in the future as needed. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Table 8: HIM Business Requirements: Health Information Integrity Health Information Integrity: Business Requirements 1. Ability to maintain information in a manner that ensures confidence in its authenticity, timeliness, accuracy, and completeness. 2. Ability to maintain integrity of information to comply with safety, quality of care, and compliance with applicable voluntary, regulatory and legal requirements. 3. Ability to maintain integrity of information in adherence to the organization’s policies and procedures. 4. Ability to provide appropriate workforce training on information management and governance to support integrity of information. 5. Ability to enable trust of requestor in the integrity of information by ensuring the authenticity, timeliness, accuracy, and completeness, admissibility of records for litigation purposes. 6. Ability to ensure integrity of information through reliable system controls that support the organization’s ongoing activities across various systems. 7. Ability to manage integrity of information received from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization. 8. Ability to demonstrate oversight by senior management of adherence to approved policies and procedures necessary to maintain reliability of information. 9. Ability to ensure reliability of data and information based on the nature and type of healthcare organization processes and systems for creation and capture, processing, and other applicable stages of the information’s lifecycle. 10. Ability to implement ongoing quality control measures to include field-specific data edits built into systems/applications; monitoring and correction of patient identity errors; monitoring and correction of documentation completeness and data accuracy; and ongoing data quality controls, and monitoring and correction in adherence to existing standards. 11. Ability to prove reliability and integrity of information through audit process to validate measures for ensuring the reliability and integrity of information. 12. Ability to monitor hardware, network infrastructure, software, storage, and other system components for reliability of performance. 13. Ability to maintain formal change control processes as part of a reliable information environment. 14. Ability to test HIS capabilities to support business requirements 1-13 including validation of data and all appropriate metadata.

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4.4.3 Principle of Information Protection: Business Requirements Information Protection is defined as guarding against “(1) inappropriate acquisition, access, disclosure or use of protected health information as well as (2) loss, tampering, and corruption of health information.” 40 Thus part 1 of this definition relates to protection of Information Availability and part 2 – to protection of Information Integrity.

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Table 9 presents HIM business requirements under Principle of Information Protection.

40

American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p.134

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Table 9: HIM Business Requirements: Health Information Protection Health Information Protection: Business Requirements 1. Ability to ensure appropriate levels of protection from breach, corruption and loss of information that is private, confidential, classified and essential to business continuity or otherwise requires protection. 2. Ability to consistently apply and enforce levels of protection to information, regardless of medium, from the moment the information is created until the moment it reaches or exceeds its retention period and is appropriately disposed. This specifically includes adherence to security, privacy and confidentiality requirements (rules, regulations, policies) when determining a method for the final disposition of information, regardless of source or media. This applies whether the disposition is archival, transfer to another organization, preservation for permanent storage, or destruction. 3. Ability to establish an audit program that defines a clear process for verifying whether sensitive secure information is being handled in accordance with the organization’s policies and procedures. 4. Ability to manage and balance compliance with the varying degrees of protection, mandated by laws, regulations, and/or organizational policies for information generated and managed by an organization. 5. Ability to provide security, business continuity, and disaster recovery processes that will ensure continued operation and continued protection, during and after periods of failure or disruption. 6. Ability to assign and manage appropriate levels of information access and security clearance to all members of the workforce and other authorized parties relevant to their roles or duties. 7. Ability to maintain appropriate security safeguards, clearly defined and enforced by organizational policies, designed to protect electronic information from being inappropriately viewed, e-mailed, downloaded, uploaded, or otherwise proliferated— intentionally or inadvertently, even by individuals with legitimate access to the system. 8. Ability to provide physical security safeguards of computing and access devices or any equipment containing private, secret, or confidential information or intellectual property of the organization.

4.5 HIM Practice CheckList 445

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Based on the literature review we developed HIM Practices Checklist of best practices used in HIM for information availability, integrity and protection. We aligned this Checklist with the business requirements described in Tables 7-9 above. Appendix A presents the HIM Practice Checklist by business requirements under selected information governance principles: availability, integrity and protection. Appendix A also reveals the gaps between the business practices, best practices and the use cases. These identified gaps outline where additional business requirements and use cases need to be developed.

4.6 HIM Practice Use Cases

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We further used the HIM Practices Checklist (Appendix A) to develop five Use Cases under information availability principle. We utilized an iterative development, vetting and validation approach working both with the HIM SMEs and IHE ITI experts. The following are the Use Cases developed to date: Use Case 1: All documents are accounted for within a specific time period post completion of the episode of care Use Case 2: Record is closed as complete within a specific time period post completion of the episode of care Use Case 3: Documents within the record can be viewed by or released to the external requestor HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Use Case 4: An audit log of the episode of care record Use Case 5: An audit log of requests for release of information and accounting of disclosures 465

These Use Cases are limited to the inpatient care settings. Detailed description of the Use Cases is provided in Appendix B.

4.7 Glossary

470

To assure the use of consistent terms and definitions across Use Cases we developed a Glossary of terms and concepts used in HIM practices (Appendix C). In some cases we used definitions from the AHIMA HIM Glossary; 41 in others, we developed our own definition. We anticipate updating the AHIMA HIM Glossary by revising current definitions and/or adding new definitions as needed.

41

American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014

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5 Gap Analysis of HIT Standards to Support HIM Practices 475

Based on the business requirements, we conducted a high level analysis of HIT standards developed by standards development organizations which may be applicable to HIM practices. Initially, we focused on identifying standards from the following SDOs: •

International Organization for Standardization (ISO)



American Society for Testing and Materials (ASTM) and



Health Level Seven (HL7).

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485

Appendix D presents the framework for the gap analysis of HIT standards that we used. It contains examples of ISO, ASTM and HL7 standards by HIM business requirements under the selected three IG principles. In the future, we anticipate carrying out the detailed analysis of these and other standards by Use Case. This analysis will include the detailed review and selection of IHE standards (integration and content profiles) by Use Case. Please note that Appendix D contains only the standard’s identification number (ID) from the correspondent SDO not the title of the standard or its description. On the project wiki pages, 42 we developed supporting table that contains the ID, title and abstract for the standards listed in Appendix D.

42

IHE-AHIMA White Paper HIT Standards for HIM Practices. Project Wiki Page. URL: ftp://ftp.ihe.net/IT_Infrastructure/iheitiyr13-20152016/Planning_Cmte/WorkItems/HIM_Practices/Standards_Table_0507/ HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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495

500

6 Recommendations Working on the analysis of the HIM business requirements (Tables 7-9), HIM Practices Checklist (Appendix A) and Use Cases (Appendix B), we identified gaps in both HIM practices as well as standards development. For example, Table in Appendix A contains cells with the statement of “Additional alignment between Business Practice and Checklist item is needed” that indicates the gap between best practices described in the literature and business requirements statements from Tables 7-9. We will work to address these gaps in the future. The list of recommendations was developed to improve alignment between HIM practices and HIT standards. These recommendations were aimed to (1) HIM professionals and (2) Standards developers. Table 10 presents our recommendations for affected stakeholders to better align HIM practices and capabilities of HIT products through standards. Table 10: Recommendations to HIM Professionals and SDOs Recommendations for HIM Professionals

A. Standardize policies for organizations’ Form Management Committee 43 including 1. Standardize/harmonize scope and operations of the Committee according with the information governance principles 2. Harmonize/standardize Committees’ policies across healthcare organizations 3. Develop a template of organizational policy related to documentation development and management 4. Define standardized set of documentation for the Episode of Care a. Collect applicable documents that are available for a complete Episode of Care b. Define policies on the Open and Closed Records and the processes and timeliness of the record completion. This includes finalizing definitions on Open records, e.g., Incomplete, Lost, Delinquent, Cancelled c. Define policy that outlines how clinicians are notified of Open and Closed records when i. Procedures ordered but not performed ii. Documentation components are missing or iii. Signatures are missing. 44 5. Define a minimum set of content to be analyzed for timeliness and completeness in the legal record 6. Define data provenance of content and source a. Metadata tags such as the who, what, when, where, why B. Designate HIM representatives to participate at HL7 Working Groups including 1. HL7 Community-based Collaborative Care (CBCC) Workgroup a. Review Patient Friendly Consent Directive standard ballot 45, 46 43

Please see note that the name of this Committee may vary in different organizations. American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p.77 45 Health Level Seven (HL7). Patient Friendly Consent Directive. URL: http://wiki.hl7.org/index.php?title=HL7_Patient_Friendly_Consent_Directive_Project 44

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ b. Review Data Provenance Model 47 – key concerns include: i. ensuring confidence/authenticity/reliability of information for clinical decision-making by knowing who, what, when, where, why ii. capturing who, what, when, where, why for auditing, accounting of disclosure and accesscontrols iii. re-use of clinical information for research purposes (who, what, when, where, why) iv. legal issues related to data provenance in healthcare 2. HL7 EHR Workgroup a. Normalize definitions for records/document lifecycle. Specific examples of statements from the HL7 EHR Functional Model standard 48 are provided in italic below. (Strikethrough text and underlined italics are the proposed changes). “Record Infrastructure RI. 1.4, Function; Record Completeness, Conformance Criteria: Statement: Manage Record Completeness. Description: The EHR-S must provide the ability for an organization to define minimum elements and timeframes for completion at the report level and at the record level.” 1. Discuss and define the use of terms: minimum element, report level, record level. “Provide a report that identifies completion and timeliness status by patient/ health record number or other specified parameters.” 2. Is this Audit trail report? “Prior to disclosure for legal proceedings or other official purposes, an organization analyzes the health record for completeness. EHR systems must provide the ability to define capture a minimum set of content to be analyzed for timeliness and completeness and provide a report of the status.” 3. EHR system will not define a minimum set of content prior to release of information (ROI). This is the work of the Form Management Committee (see above). 3.1 Propose to change “define” to “capture”. 3.2 Define a report of status? “Care Provision Support (CPS) 3.3.12: The system SHOULD provide the ability to render an indicator that a patient record is incomplete (e.g., not finalized or authenticated/signed) when a discharge or transfer order is entered into the system. 4. Replace the term “incomplete” with the “open” throughout the standard.

46

HL7 Community-based Collaborative Care (CBCC) Workgroup. Patient Friendly Consent Directive.URL: http://wiki.hl7.org/index.php?title=Community-Based_Collaborative_Care 47 Health Level Seven (HL7). HL7 Data Provenance Project. URL: http://wiki.hl7.org/index.php?title=HL7_Data_Provenance_Project_Space 48 Health Level Seven (HL7). Electronic Health Record Functional Model Release 2. 2014. URL: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=269 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ 3. HL7 FHIR (Fast Healthcare Information Resources) Workgroup a. Normalize definitions for records/document lifecycle. Review of EHR System Functional Model Record Lifecycle Events Implementation Guide ballot 49. 1. Replace “Record Amendment” with “Record Retraction” that includes Record Amendment and Record Addendum. C. Review documentation on Provenance from the World Wide Web Consortium (W3C) 50, 51 1. Review W3C documents addressing Provenance that can be summarized as follows: “Provenance of a resource is a record that describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance.” Recommendations for Standards Development Organizations

A. Health Level Seven (HL7) 1. HL7 Community-based Collaborative Care (CBCC) Workgroup a. Enable review of the Patient Friendly Consent Directive and Data Provenance Model to incorporate recommendation from HIM professionals (above) 2. HL7 EHR Workgroup a. Enable review of the HL7 EHR Functional Model standard to incorporate recommendation from HIM professionals (above) 3. HL7 FHIR (Fast Healthcare Information Resources) Workgroup a. Enable review of EHR System Functional Model - Record Lifecycle Events Implementation Guide ballot 52 to incorporate recommendation from HIM professionals (above) B. Integrating the Healthcare Enterprise 1. Enable review of the IHE profiles with HIM professionals for developed Use Cases.

49

Health Level Seven (HL7).Electronic Health Record System Functional Model - Record Lifecycle Events Implementation Guide. URL: http://hl7-fhir.github.io/ehrs-rle.html 50 World Wide Web Consortium (W3C). Provenance. URL: http://www.w3.org/standards/techs/provenance 51 World Wide Web Consortium (W3C). Provenance XG Final Report. URL: http://www.w3.org/2005/Incubator/prov/XGR-prov-20101214/ 52 Health Level Seven (HL7).Electronic Health Record System Functional Model - Record Lifecycle Events Implementation Guide. URL: http://hl7-fhir.github.io/ehrs-rle.html

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7 Roadmap 505

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The ultimate goal of our efforts described in this white paper was to have the HIM principles and practices to be supported by interoperable standards-based HICT products. The HIM principles and practices represent a missing component in the collaboration between HIT vendors, professional associations, and government to craft a portfolio of interoperable HIT standards for electronic document sharing. We believe that we demonstrated that our work fills this missing component. The deliverables presented in this White paper – Business requirements for Information Availability, Integrity and Protection (Tables 7-9), HIM Practice Checklist (Appendix A), Use Cases (Appendix B) and examples of HIT standard gap analysis by business requirements (Appendix D) as well as the consensus-based process employed to develop these deliverables – outline the overall methodology for aligning the HIM practices needs with the capabilities of HIT products to support these needs. Through this effort we built the foundation for the amalgamation of the HIM and HIT universes (Figure 7).

Figure 7: Amalgamation of HIM and HIT Universes

520

Based on our productive experience of HIM professionals working together with IHE experts we are determined to continue this effort in the future. We will focus on the following efforts for our future collaboration: 525

2015-2016 1. Continue to elicit business requirements for additional 5 information governance principles using the format of Tables 7-9: Accountability, Transparency, Compliance, Retention and Disposition

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2. Continue to populate HIM Practice Checklist for additional principles based on the literature review of the best HIM practices (Appendix A) HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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3. Continue to develop Use Cases for the HIM practices under Information Availability, Integrity and Protection (Appendix B). Specific examples of Use Cases for the 2015-16 development cycle will include: Use Case 6: Data Quality Use Case 7: Copy and Paste Use Case 8: Patient Registration Use Case 9: Patient Matching Use Case 10: Transition of Care 4. Undertake detailed gap analysis of HIT standards by Use Case starting with those developed in Year 1 based on the preliminary analysis conducted for the business requirements (Appendix D) 5. Define the timeline for the completion of the development of the HIM practice Use Cases based on the experience from Years 1and 2 to expedite requirement gathering for new HIT standards

545

6. Define the maintenance process for developed Use Cases and 7. Identify automated tools to assist in the development and maintenance of the Use Cases.

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Based on the outcomes from efforts 1-7, we anticipate developing a comprehensive Roadmap (milestones, partners, outcomes, metrics for success, supporting infrastructure, i.e., automated tools, and training) for enabling standardization of HIM practices and HICT products to support these practices. We will further work with IHE to transition from our current Effort 1: functional requirements for HIM practices have been communicated to standards developers for creating HIT standards; to launching activities in support of the Effort 2: standards are adopted in the HIT products and Effort 2: standards-based HIT products support HIM practices.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Appendix A: HIM Practice Checklist Business Requirements

HIM Practice Checklist Examples

53

Use Case

Health Information Availability (A) 1. Ability to capture and maintain information in a manner that ensures timely, accurate (complete and correct), and efficient access and retrieval.

A1. All documents can be accounted for and the record closed as complete within a specific time period post patient discharge in accordance with governmental regulations, accreditation organizations, or organizational policy.

A1.1. All documents can be accounted for within a specific time period post completion episode of care/encounter. A1.2. Record is closed as complete within a specific time period post completion of the episode of care/encounter

2. Ability to search, identify, locate and retrieve patient specific information in continually expanding volumes of information and across multiple systems including various electronic HIS and manual systems (paper-based document locations, storages, etc.). This requirement is focused on tracking sources where information resides (HISs, other HICT products and manual systems).

A2.Single or multiple groups of documents within the electronic medical record can be viewed by or released to the requestor.

A2.1. Single and multiple (submission sets) documents within the electronic medical record can be viewed by or released to the requestor for treatment, payment, and healthcare operations use and disclosure. A2.2. Single and multiple (submission sets) groups of documents within the electronic medical record can be viewed by or released to the requestor for use and disclosure requiring a signed authorization.

3. Ability to access information across various systems (electronic and manual) and across patient populations. This includes the abilities to search, identify, locate, and retrieve the information required to support organization’s ongoing activities via queries. This requirement is focused on how information from various sources is accessed.

A2.Single or multiple groups of documents within the electronic medical record can be viewed by or released to the requestor.

A2.1 and A2.2 (above)

4. Ability to assemble information from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization.

A2.Single or multiple groups of documents within the electronic medical record can be viewed by or released to the requestor.

A2.1 and A2.2 (above)

5. Ability to address multiple demands for having the right information available at the right time for the right requestor.

A2.Single or multiple groups of documents within the electronic medical record can be viewed by or released to the requestor.

A2.1 and A2.2 (above)

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Grzybowski, D. Strategies for electronic document and health record management. AHIMA, Chicago, IL. 2014. pp. 31, 40, 47, 159 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Business Requirements

HIM Practice Checklist Examples

6. Ability to access information created with legacy hardware and software systems. In case of impending system obsolescence, information with organizational value should be migrated to currently supported hardware and/or converted into a machine-readable format.

A2.Single or multiple groups of documents within the electronic medical record can be viewed by or released to the requestor.

A2.1 and A2.2 (above)

Use Case

7. Ability to maintain metadata services across all participating systems assigning structural and descriptive characteristics to information including data provenance information (authors and dates of creation, modification, sending, receipt, access, etc.).

To be developed (TBD)

TBD

8. Ability to ensure levels of redundancy, failover, contingencies and other risk management practices to minimize risks of non-availability of information due to a disaster, system malfunction, or data corruption.

TBD

TBD

9. Ability to maintain the workforce capabilities on the most current methods to capture, maintain and access information assuring the work processes consistencies despite of workforce turnover.

TBD

TBD

10. Ability to enable trust of requestor in information by ensuring the timeliness, accuracy (completeness and correctness), and efficiency of information availability based on implementation of business requirements 1-9 above.

A1. All documents can be accounted for and the record closed as complete within a specific time period post patient discharge in accordance with governmental regulations, accreditation organizations, or organizational policy.

A1.1 and A1.2 (above)

11. Additional alignment between Business Practice and Checklist item is needed

A3. A log of all requests and accounting of disclosures is kept as an audit trail and can be referenced as needed.

TBD

12. Additional alignment between Business Practice and Checklist item is needed

A5. Maintenance of an inventory of discontinued (retired), archived, and disposed, revised, current forms according to governmental regulations. Maintaining an inventory that is complete, accurate and continually updated based on the organizational policy. Legal health record definition and records retention policy.

TBD

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Business Requirements

HIM Practice Checklist Examples

13. Additional alignment between Business Practice and Checklist item is needed

A8. Focus on system interoperability and integration requires that information and service quality be added as a new health information dimension. Key considerations become accuracy and completeness of data, excellent information access, continued availability of data, supported overall by data provenance, privacy and security safeguards.

TBD

Use Case

14. Additional alignment between Business Practice and Checklist item is needed

A9. Disclosing of records require written authorization by the patient and approval by the compliance officer if not otherwise allowed by law. A written record is kept by the compliance officer and available for audits.

TBD

Health Information Integrity (I) 1. Ability to maintain information in a manner that ensures confidence in its authenticity, timeliness, accuracy, and completeness.

A4. Full chart management functionality (i.e., Record Lifecycle Management) to verify the identification of location of the source of the release, completeness of the documents being released, and destination for the release or review are available in the release of information software.

TBD

2. Ability to maintain integrity of information to comply with safety, quality of care, and compliance with applicable voluntary, regulatory and legal requirements.

I5. Accurate capture of patient data by electronic health record system. Reduction of medical errors that cause inaccurate recording of patient data such as allergies and medications, compromising quality of care and patient safety.

TBD

3. Ability to maintain integrity of information in adherence to the organization’s policies and procedures.

I1. Performance of a daily duplicate medical record number and account number validity checking process in place. Enterprise-wide process exists for notification of duplications. Process of merging paper and electronic records

TBD

4. Ability to provide appropriate workforce training on information management and governance to support integrity of information.

I2. Proper training and support of system user is paramount to preventing system errors that can potentially contribute to suboptimal healthcare quality.

TBD

5. Ability to enable trust of requestor in the integrity of information by ensuring the authenticity, timeliness, accuracy, and completeness, admissibility of records for litigation purposes.

A1. All documents can be accounted for and the record closed as complete within a specific time period post patient discharge in accordance with State and Federal regulations, accreditation organizations (e.g., Joint Commission, Det Norske Veritas Healthcare - ISO 9000), or organizational policy.

A1.1. All documents can be accounted for within a specific time period post completion episode of care/encounter. A1.2. Record is closed as complete within a specific time period post completion of the episode of care/encounter.

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Use Case

6. Ability to ensure integrity of information through reliable system controls that support the organization’s ongoing activities across various systems.

TBD

TBD

7. Ability to manage integrity of information received from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization.

A6. Standard and complete capture of patient data by electronic health record system. For example; normal laboratory results with a normal reference range, 24 hour clock, pain scale with reference, with appropriate references (case definitions) for all results, findings, interpretations, care plans, standards of care (clinical pathways) allergies, and medications. To ensure integrity of patient data (prevent inaccurate recording of patients data and protect against compromising quality of care, and patient safety), see reference to integrity. A7. Operate (maintain, monitor, test, update, verify, validate) timely system interfaces that ensure accurate interchange of data using a validated (trusted) information exchange system (sender-receiver interfaces). System interface problems can lead to poor decisions, delays, data loss, errors, unnecessary testing, and system downtime.

A3.1. An audit log of the episode of care record

8. Ability to demonstrate oversight by senior management of adherence to approved policies and procedures necessary to maintain reliability of information.

I3. Improved information quality (integrity) is perceived by providers as a result of electronic health record implementation; demonstrated by the following attributes, accuracy, timeliness, accessibility to current data, and availability. 54

TBD

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Nguyen L, Bellucci E and Nguyen LT Electronic health records implementation: An evaluation of information system impact and contingency factors. International Journal of Medical Informatics. 2014. 83(11): 779-796.

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Use Case

9. Ability to ensure reliability of data and information based on the nature and type of healthcare organization processes and systems for creation and capture, processing, and other applicable stages of the information’s lifecycle.

A6. Standard and complete capture of patient data by electronic health record system. For example; normal laboratory results with a normal reference range, 24 hour clock, pain scale with reference, with appropriate references (case definitions) for all results, findings, interpretations, care plans, standards of care (clinical pathways) allergies, and medications. To ensure integrity of patient data (prevent inaccurate recording of patients data and protect against compromising quality of care, and patient safety), see reference to integrity. A7. Operate (maintain, monitor, test, update, verify, validate) timely system interfaces that ensure accurate interchange of data using a validated (trusted) information exchange system (sender-receiver interfaces). System interface problems can lead to poor decisions, delays, data loss, errors, unnecessary testing, and system downtime.

TBD

10. Ability to implement ongoing quality control measures to include field-specific data edits built into systems/applications; monitoring and correction of patient identity errors; monitoring and correction of documentation completeness and data accuracy; and ongoing data quality controls, and monitoring and correction in adherence to existing standards.

A6 and A7 above.

TBD

11. Ability to prove reliability and integrity of information through audit process to validate measures for ensuring the reliability and integrity of information.

TBD

TBD

12. Ability to monitor hardware, network infrastructure, software, storage, and other system components for reliability of performance.

TBD

TBD

13. Ability to maintain formal change control processes as part of a reliable information environment.

TBD

TBD

14. Ability to test HIS capabilities to support business requirements 1-13 including validation of data and all appropriate metadata.

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Business Requirements

HIM Practice Checklist Examples

15. Additional alignment between Business Practice and Checklist item is needed

I4. Appropriate workforce education and training on information management and governance and ongoing technical support has been proven to support improved electronic health record system proficiency resulting in successful adoption and use. 55

TBD

Use Case

16. Additional alignment between Business Practice and Checklist item is needed

I5. Accurate capture of patient data by electronic health record system. Reduction of medical errors that cause inaccurate recording of patient data such as allergies and medications, compromising quality of care and patient safety. 56

TBD

17. Additional alignment between Business Practice and Checklist items is needed

P1. To support information integrity, MPI services for matching patient should be aligned with EDMS where episode of care records are managed. “MPI contain the correct number of entries in the right sequence, so that it has episode of care integrity within its account number.”

Future Patient Matching Use Case

Health Information Protection (P) 1. Ability to ensure appropriate levels of protection from breach, corruption and loss of information that is private, confidential, classified and essential to business continuity or otherwise requires protection.

TBD

TBD

2. Ability to consistently apply and enforce levels of protection to information, regardless of medium, from the moment the information is created until the moment it reaches or exceeds its retention period and is appropriately disposed. This specifically includes adherence to security, privacy and confidentiality requirements (rules, regulations, policies) when determining a method for the final disposition of information, regardless of source or media. This applies whether the disposition is archival, transfer to another organization, preservation for permanent storage, or destruction.

P3. Full release of information functionality, including tracking receipts for requests, gathering electronic medical records from all facilities, and processing those files, the billing and collections associated with the release, and the actual distribution of the copies for the records.

TBD

55

Nguyen L, Bellucci E and Nguyen LT Electronic health records implementation: An evaluation of information system impact and contingency factors. International Journal of Medical Informatics. 2014. 83(11): 779-796. 56 Bowman S. Impact of electronic health record systems on information integrity: Quality and safety implications. Perspectives in Health Information Management. 2013. pp. 2, 3, 7. URL: http://perspectives.ahima.org/impact-ofelectronic-health-record-systems-on-information-integrity-quality-and-safety-implications/#.VU0OLPm6e00. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Use Case

3. Ability to establish an audit program that defines a clear process for verifying whether sensitive secure information is being handled in accordance with the organization’s policies and procedures.

P6. Employ a break-the-glass emergency access methodology to override access control measures designed to protect patient privacy and confidentiality. Utilize audit trails to monitor compliance with organization privacy policy and procedures.

TBD

4. Ability to manage and balance compliance with the varying degrees of protection, mandated by laws, regulations, and/or organizational policies for information generated and managed by an organization.

P2. Global or universal authorization can be filed at the enterprise (medical record number) vs. individual episode of care.

TBD

5. Ability to provide security, business continuity, and disaster recovery processes that will ensure continued operation and continued protection, during and after periods of failure or disruption.

TBD

TBD

6. Ability to assign and manage appropriate levels of information access and security clearance to all members of the workforce and other authorized parties relevant to their roles or duties.

P4. Enforce a need to know (minimum necessary) privacy and security policy for all users of patient-protected information and records as opposed to open access.

TBD

7. Ability to maintain appropriate security safeguards, clearly defined and enforced by organizational policies, designed to protect electronic information from being inappropriately viewed, e-mailed, downloaded, uploaded, or otherwise proliferated—intentionally or inadvertently, even by individuals with legitimate access to the system.

P3. Full release of information functionality, including tracking receipts for requests, gathering electronic medical records from all facilities, and processing those files, the billing and collections associated with the release, and the actual distribution of the copies for the records.

TBD

8. Ability to provide physical security safeguards of computing and access devices or any equipment containing private, secret, or confidential information or intellectual property of the organization.

P5. Limit clinician documentation entry to only those practitioners who are associated with a specific patient within the system.

TBD

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Appendix B: HIM Practice Use Cases

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Sections below describe Use Cases developed from the harmonized HIM business requirements and HIM practices Checklist (Appendix A) under information availability (A) principle as follows: Use Case A1.1: All documents are accounted for within a specific time period post completion of the episode of care Use Case A1.2: Record is closed as complete within a specific time period post completion of the episode of care Use Case A2.1: Documents within the record can be viewed by or released to the external requestor

570

Use Case A3.1: An audit log of the episode of care record Use Case A3.2: An audit log of requests for release of information and accounting of disclosures. 575

The following numbering convention was used to manage the Use Cases: B.1 Use Case A1.1: B – Appendix B 1 – order number in which Use Case is listed in Appendix B A – Availability principle 1 – HIM Practice #1 as listed in the Checklist (Appendix A)

580

1 – number of the Use Case under HIM Practice #1(Appendix A). Information Governance Principle: Health Information Availability 585

HIM Practice A1. All documents are accounted for and the record closed as complete within a specific time period post patient discharge in accordance with State and Federal regulations, accreditation organizations (e.g., US Joint Commission, 57 Det Norske Veritas Healthcare - ISO 9000 58), or organizational policy. 59

B.1 Use Case A1.1: All documents are accounted for within a specific time period post completion of the episode of care

57

The Joint Commission. URL: http://www.jointcommission.org/ Det Norske Veritas Healthcare. URL: http://dnvglhealthcare.com/ 59 Grzybowski, D. Strategies for electronic document and health record management. AHIMA, Chicago, IL. 2014. p.40 58

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This Use Case is focused on inpatient encounter. Other types of encounter (outpatient, long-term care and others) are out of scope and will be addressed in the future. The statement “all documents” is referred to open and closed records generated within the episode of care (Figures 5 and 8). Please see Use Case A1.2 for the description of open and closed records states.

595

The term “record” is used in the context of the episode of care, i.e., level 2 of the record hierarchy depicted in Figure 4 above. The term "accounted for" means that the EHR system shall support all types of medical documentation, i.e., records (paper and electronic) generated during a specified timeframe of an episode of care.

600

605

The list of records and personnel involved in defining and maintaining these records are specified by organizational policies. 60 The authority on establishing organizational policies and processes as well as specific documentation (records) generated via these policies and processes and/or mandated by regulatory bodies falls on a Committee (Form Management Committee or other name may be used for this Committee) comprised of representatives from clinical, business and technology departments within the facility. 61, 62 If other facilities are involved in providing services, data sharing agreements between two facilities shall define the policies on how documentation will be accounted for when shared. The custodian of the records within the facility is the health information management (HIM) department (former medical records department).

610

615

Figure 8 presents the episode of care record lifecycle that include various functions (registration/admission, triage, assessment, testing, diagnosis confirmation and care plan, prescription, discharge/transfer) performed in the context of a clinical pathway; records generated within each function; as well as record sharing between EHR and ancillary systems (diagnostic testing, pharmacy) involved in the clinical pathway. Examples of these functions and records generated by function are presented in Table 5 above. Figure 8 also presents various HIT applications (APP) – technical actors – involved in documenting clinical pathway within the episode of care. Specific examples of participating information systems (technical actors) include: 1. EHR System – Record Originator 2. Ancillary System 1 (e.g., Laboratory, Radiology, etc.) – Record Receiver (order) and Record Originator (result report)

620

3. Ancillary System 2 (Pharmacy) – Record Receiver (prescription) and Record Originator (prescription dispense report). 60

Forms Management. Hospital Policy. University of Vanderbilt, Nashville TN. June 12, 2000 Same 62 Quinsey CA. Managing forms and legal electronic health records. JAHIMA, July 2007. p.58-59 61

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Please note that every participating technical actor in addition to function-specific records also exchange the following documentation: 1. Notification of Document Availability (Sender to Receiver) 2. Acknowledgement of Document Receipt (Receiver to Sender).

630

The time period for documentation/record completion depends on the record type as defined by each specific function/event/step within the episode of care, i.e., function-specific workflow steps and sub-steps (Figure 8).

Figure 8: Example of Episode of Care and Various Information Systems (Technical Actors) Involved in Documenting Clinical Pathway 635

640

The “Start and the End” of each function/event/step within the episode of care are defined by the creation and completion of the correspondent record related to the specific function/event/step. More specifically, the start of the episode of care is defined by the initial interaction of the patient with the healthcare facility (e.g., present at the facility, e-mail, phone or other). This initial interaction sets into motion the chain of functions/events/steps defined by the clinical pathway of activities for a specific episode of care. This initial interaction acts as a trigger of a specific clinical pathway (Table 11). HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Table 11: Relationship between Episode of Care’s Flow of Events and Documents Episode of Care Clinical Pathway by Flow of Events

Records

Initial interaction with healthcare facility (visit, e-mail, phone)

645

650

Step 1

Record 1 – output for Step 1 and input /trigger for Step 2

Step 2

Record 2 – output for Step 2 and input/trigger for Step 3

Step 3

Record 3 – output for Step 3

For example, for patient registration, the start of the registration process is triggered by the patient presenting at the facility in person or contacting the facility by phone or via e-mail. Registration staff initiates the command “Register a New Patient” or “Look up Existing Patient” in the facility’s EHR system to initiate the specific record for Step 1. This record may contain several documents/forms (Patient Registration Form, Medical and Social History Update Form, Information Exchanges Consent Form, patient’s privacy and confidentiality protection forms, etc.). For the functions that follow the registration (Step 1), the completed set of documents/forms for Patient Registration in EHR (Record 1) serves as a trigger to begin the next step, e.g., triage (Step 2) that triggers the Record 2 set of documents/forms (e.g., the history and physical form) to be completed.

655

660

Patient’s registration, admission, disposition, and discharge/transfer define the status (states) of the patient’s interaction within the healthcare facility. EHR system must support the document flow across all patient states within the episode of care (Figure 8 and Table 11). EHR system must also capture change in these states via the Open and Closed record status associated with each state. (Please see Use Case A1.2 for Open and Closed records as well as Use Case A3.1 for the Audit log of the records in the episode of care). In EHR system the patient status (state) is typically monitored in the Capacity/Bed Management application. For example, under disposition when patient is moved to another floor for testing, all previous documents in the record that triggered this new state (input documents) and new documents generated by this new state (output documents) must be captured in EHR.

665

670

Please note that Patient Status (data element, field) was traditionally used for billing. Now this field may be used as a trigger to determine the corresponding documentation in the record. The end of a specific function as well as the episode of care, at large, is defined by providing capabilities to electronically sign the output document. This action is called “Verified by Authentication” and includes the time stamp (date and time) of verification for each output document. The completion of this capability is done by obtaining signature of an authorized person including digital signature on a specific document. Furthermore, within each document there can be multiple authentications as defined by organizational policy. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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B.2 Use Case A1.2: Record is closed as complete within a specific time period post completion of the episode of care 675

680

There are two states of the record/document - Open and Closed - that represent the state of the record. Open record is a record (one document) or a set of record components (several documents/forms) that is/are created to begin a new function (level 3 in the record hierarchy, Figure 4). This includes open records for patient care, as well as incomplete and delinquent records. An open record has to be completed within a defined timeframe for a specific function. The Committee (Forms Management Committee) defines policies on the processes and timeliness of the record completion, e.g., 30 days for discharge summary as per the requirements of the US Joint Commission and US Medicare conditions of participation.

685

EHR system must support capabilities to notify the clinician 1. When the record is open 3. When the record is outside of the time limits set for a specific function 4. Ready to be signed, i.e., verified by authentication, and 5. When the record is closed.

690

The record remains open until all its components are assembled and the appropriate documents are authenticated according to organizational policies. 63 Record completion is the process defined by the organizational policy. This process specifies activities of the authorized personnel to be able to 1. Open (initiate the new record)

695

2. Access existing record to contribute new information 3. Access existing record to modify/correct existing information and 4. Close a specific component of the record and/or the full record. 64 700

In order to close the record, each activity (1-4) has to be verified by authentication (i.e., signed) by authorized personnel involved in this activity. In the paper-based environment the term “retraction” (go back) was used to access the record for correcting information that was inaccurate, invalid, or made in error. Retraction is aimed to modify the Open record 65 (see activity 3 above). The term retraction is used in HIM to modify 63

American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p. 32 64 Same, p. 126 65 Same, p. 130 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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existing information in the record through record amendment or addendum, i.e., modification of the original record entry. Whenever, changes are made to the record (e.g., new document was added, the part of the record was revised, etc.) the changes/revisions must be reviewed and approved by the authorized person in accordance with organizational policy and jurisdictional law.

710

An audit trail must capture all modifications done to the record. (Please see Use Case 3.1 below about audit trail for retraction.) Closed record is the record that 1. Contains all necessary clinical information to substantiate the care rendered 2. Verified by authentication by the authorized clinician or other designated personnel

715

3. Meets the requirements of the legally defensible health record as defined by organizational policies and/or 4. Administratively closed record, i.e., closed based on the administrative decision with documentation supporting this decision.

720

EHR system must have capabilities to assure the completion of the records by the authorized personnel, as follows: 1. Generate a list of Open records for all patients of a clinician on a daily basis upon opening the EHR 2. Generate notifications about the record for which the timeframe is expiring, so clinician could act upon this notification as follows:

725

a. Close the record supplying appropriate description for the reason of the record closure b. Sending reminder to the:

730

i.

Patient via phone, e-mail, etc.

ii.

Ancillary system(s)

c. Other. 3. Generate audit reports on records generation, retraction for modification (amendment or addendums) and completion. (Please see Use Case 3.1 below about audit trail for retraction).

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HIM Practice A.2. Documents within the electronic medical record can be viewed by or released to the external requestor.

B.3 Use Case A2.1: Documents within the record can be viewed by or released to the external requestor 740

This Use Case is focused on effective delivery of the release of information (ROI) by a facility according to organizational policies defined by the facility’s Committee. 66, 67, 68 Release of information (ROI) is defined as the process of disclosing patient identifiable information from the health record to another party. 69 ROI function is based on 1. Availability of all documentation that comprises a current and accurate Legal Health Record (LHR) and Designated Records Set (DRS) in EHR system (see Use Case A1.1)

745

2. Ability of the record custodian (HIM department) to maintain LHR and DRS in EHR system 3. Ability to assemble all records in a timely manner in LHR and DRS and 4. Ability to provide LHR and DRS to the authorized external requestor. 750

Examples of information that may be requested by external requestor 70, 71 may include, but are not limited to:

755

760



Disclosures of protected health information (PHI) that are not for treatment, payment, or delivery of healthcare operations



Disclosures for research purposes



Disclosures to government agencies (excluding intelligence/national security)



Disclosures to public health authorities (public health reporting including vital statistics records reporting)



Disclosures on adverse event reporting, e.g., to US Food and Drug Administration (FDA)



Disclosures for specialized government functions



Disclosures to employers

66

Forms Management. Hospital Policy. University of Vanderbilt, Nashville TN. June 12, 2000 Same 68 Quinsey CA. Managing forms and legal electronic health records. JAHIMA, July 2007. p. 58-59 69 American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p. 128 70 Stuard S. Developing a plan of action – How to conduct an accounting of disclosures. JAHIMA 2003. 211(7): 4-5. 71 Downing K and McLendon K. Checking in on accounting of disclosures. JAHIMA 2013. 84(11): 50-52. 67

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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765



Disclosures to health oversight agencies



Disclosures to law enforcement, e.g., suspected domestic and child violence and abuse reporting



Disclosures to employers



Disclosures regarding deceased persons



Disclosures for specialized government functions and



Disclosures for workers' compensation purposes.

ROI function is supported by the electronic document management system (EDMS) application, designed to serve as a platform from which release of information is managed. 72 770

Basic ROI workflow consists of at least the following steps: 1. Capture the request for information from the requestor 2. Verify that the request for information is not in violation of the privacy, confidentiality and security rules, jurisdictional law and organizational policies 3. Verify the requestor’s rights to view information requested 4. Assemble information that was requested

775

5. Verify the assembled information by authorized person 6. Authorize the release of assembled information to the requestor 7. Release information to the requestor 8. Record information requests and releases in the audit trail. 780

Each step in the ROI workflow may have additional sub-steps. Involvement of specific actors (both business actors (facility’s personnel) and technical actors (information systems including both internal and external (ancillary) systems) in these steps has to be further defined/modeled. Each of these steps is associated with specific data content. For example, data for Step 1 – capture the request for information from the requestor – shall at least include 1. Patient’s Full Name

785

2. Medical Record Number 3. Other Patient Information, e.g., date of birth, address, etc. 4. Date(s) of Service Requested 5. Expiration Date of Authorization 72

Kohn D. How information technology supports virtual HIM departments. JAHIMA. 2009. 80(3). URL: http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_043005.hcsp?dDocName=bok1040035

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

______________________________________________________________________________ 46 Rev. 1.1 – 2015-09-18

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ 6. Requestor Name

790

7. Requestor Address 8. Request Date of Request 9. Request Purpose 10. Timeframe for Request, i.e., when requestor anticipates to receive the information 11. Date When Information Was Released

795

12. Charge for Information Release

800

805

Please note that, specification of the data content is out of scope of this white paper. To define data content for specific requests, in the future, we will work with the IHE Content Committees, e.g., Patient Care Coordination (PCC), Quality, Research and Public Health (QRPH) and others as needed. Risk mitigation procedures for ROI must be supported by the EHR system. Examples of these procedures may include (a) recording of all requests for information, (b) accounting of all disclosures, and other. Please see Use Case A3.1 below regarding audit trail that may be applicable to enabling these procedures.

HIM Practice A.3. A log of all requests and accounting of disclosures is kept as an audit trail and can be referenced as needed 73

B.4 Use Case A3.1: An audit log of the episode of care record 810

This Use Case is focused on the maintenance of logs for the episode of care records for clinical documentation improvement and audit purposes. The retention of these logs will be done according to the federal and state regulation and organizational policies defined by the facility’s Committee. The following states of the record can be recorded in the audit log:

815



Record Creation – Record is Open



Record Retraction for Corrections, Modification, Amendments and Addenda



Record Completion – Record is Closed



Record Access by Authorized Users •

Clinicians involved in patient care and



Patient or Caregiver

73

Grzybowski, D. Strategies for electronic document and health record management. AHIMA, Chicago, IL. 2014. p. 40. HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Copyright © 2015: IHE International, Inc.

IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ 820



Record Assembled for the Release of Information (See Use Case A2.1 above)

Please note that, specification of the data content is out of scope of this white paper. In the future, we anticipate collaborating with IHE Content Committees to define data content for these states of the record.

825

B.5 Use Case A3.2: An audit log of requests for release of information and accounting of disclosures

830

This Use Case is focused on the maintenance ROI and information disclosure logs for risk mitigation and audit purposes. The retention of these logs should be done according with the organizational policies defined by the facility’s Committee. There is a need to review existing IHE and HL7 standards that could potentially provide examples of audit log use cases for ROI and disclosures similar to the ones specified in Use Case A2.1 above.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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Appendix C: Glossary Term Clinical pathway

Definition A flow of activities and documentation derived from the clinical guidelines as related to a specific episode of care (Figures 5 and 8). Clinical pathway is a tool designed to coordinate multidisciplinary care planning for specific diagnoses and treatments. 74 Clinical pathway – also known as a clinical workflow document (specification or checklist) – is developed by physicians (medical informaticians) at the facility. It serves as a practice management protocol. This protocol defined information and data requirements (forms, documents) associated with the episode of care. The information and data requirements (forms, documents content) are also called case definitions, i.e., specific instructions on how to document specific activity within the function based on the clinical guidelines. 75

Designated record set

The oversight of the correct recording of information according to the clinical pathway protocol and case definition is conducted by the facility’s Clinical Documentation Improvement (CDI) team of the HIM department. CDI team is also involved in developing templates (standardized formats) for forms and documents used in the clinical pathway to document the episode of care/encounter. 76 Organizations may be required to identify their designated record set, which is defined as a group of records maintained by or for a covered entity that is: The record of what you acted upon to treat the patient. 1.

The medical records and billing records about individuals maintained by or for a covered healthcare provider

2.

The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan 77

Disclosure Electronic document management system (EDMS)

3. Used, in whole or part, by or for the covered entity to make decisions about individuals.” With the definition of the designated record set in mind, the organization must identify the content and data sets specific to their facility. Once the necessary information for the designated record set has been determined, it is required that this information and content be defined and documented within organizational policies. Defined by federal regulations disclosure as “the release, transfer, provision of, access to, or divulging in any other manner of information outside the entity holding the information.” 78 A multi-component health information technology system designed to serve as a single central platform from which release of information is managed. 79

74

American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p. 28 75 Children’s Medical Center. Guide to clinical documentation improvement. 2nd Edition. Dallas, TX. 2015. 76 Solicit from SMEs the samples of such templates and/or provide the link to the examples of these templates. 77 American Health Information Management Association (AHIMA). Release of Information Toolkit. May 2013. URL: http://library.ahima.org/xpedio/groups/secure/documents/ahima/bok1_050184.pdf. 78 United States Department of Health and Human Services (HHS). National Institutes of Health (NIH). How can covered entities use and disclose protected health information for research and comply with the privacy rule? URL: http://privacyruleandresearch.nih.gov/pr_08.asp 79 Kohn, D. How information technology supports virtual HIM departments. JAHIMA. 2009, 80(3): URL: http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_043005.hcsp?dDocName=bok1040035 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Term Form/Document /Screen

Definition The terms “Form”, “Document” and “Screen” are used interchangeably in this white paper. This is a broad category that is being used for input modes. Form/document/screen is the representation of knowledge assembled from data collected during the Episode of care/Encounter or Function/Record Entry. Formal definitions of these terms are the following: Forms are pages that allow users to fill in and submit information 80 Document is any analog or digital, formatted and preserved “container” of data or information. 81Screen prototype is a sketch of the user interface of each screen that is anticipated in a project. 82 Information in the Form/Document/Screen can be delivered as scanned document, pdf, structured text (based on HL7 CDA or FHIR standards) or message (string of data).

Episode of care/ Encounter

The content for specific forms/documents generated under the episode of care/encounter’s functions such as patients demographic, assessment notes, test orders and results, care plans, medication prescriptions and other (Table 1) is out of scope for this white paper. It may be developed under the IHE Content Profiles in the future. In this White paper, the episode of care/encounter is referred to a visit or multiple visits or interaction(s) between patient and provider and/or ancillary services within the facility. The type of episode of care/encounter is defined by the service type (e.g., inpatient, outpatient, emergency department (ED), long-term care and others). Additional discussions are needed to align the terms for episode of care/encounter/ and visit with terminology used by other countries. The term “episode of care” is also the unit of payment under the home health prospective payment system (HHPPS) 83

Function, event, step

Term interaction includes phone calls, e-mail communication, telemedicine sessions, e-visits and other. Specific states of the interaction (registration, admission, disposition, discharge or transfer) are the states of the patient’s interaction, as described under Start and the End of the Episode of Care/Encounter below. The episode of care/encounter is comprised of functions/events/steps. The Function of the episode of care/encounter is defined as entity or the activity that involve a single healthcare department, service area or discipline, 84 e.g., visit registration/admission; triage; nurse's and physician's assessment; laboratory and diagnostic testing; diagnosis and care plan; prescription; discharge/transfer/disposition and other (Figure 5). The Event is defined as an action or activity that occurs within a system and/or network, inclusive of its boundaries. 85

Legal health record (LHR)

The Step is defined as a sub-action or sub-activity that occurs within a specific event of care. The subset of all patient specific data created or accumulated by a healthcare provider that constitutes the organization’s official business record, and is typically used when responding to formal requests for information for legal and legally permissible purposes 86

80

McGraw H. Dictionary of Scientific and Technical Terms. 2003 American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p. 49 82 Same, p.133 83 Same, p. 55 84 American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. 2014. p.62 85 Health Information Management and Systems Society (HIMSS). Dictionary of Healthcare Information Technology Terms, Acronyms and Organizations. 2010. p.49 86 Servais CE. The legal health record. AHIMA, Chicago, IL 81

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Term Data provenance

Record

Definition This is a very broad topic that has many meanings in different contexts. The W3C Provenance Incubator Group developed a working definition of provenance as: ”Provenance of a resource is a record that describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance.” 87 According to HIMSS, record is defined as a document stating results achieved or providing evidence of activities preformed. 88 Our record definition analysis showed the need to define further the relationship between records generated throughout healthcare delivery in the context of record lifecycle for the lifetime record, episode of care record, function record and record entry. We proposed the following record hierarchy and definitions: Lifetime Record (prenatal, birth-death) is defined as longitudinal health record, i.e., a permanent, coordinated patient record of information that was acted upon to treat the patient, listed in chronological order and maintained across time from birth to death. 89 Record of Episode of Care (admission-discharge) is defined as full medical documentation generated during the episode of care, i.e., in a period of continuous medical care performed by healthcare professionals in relation to a particular clinical problem or situation. This period may include one or more healthcare services given by a provider. (For our purposes we are limiting the definition to inpatient status.) Documentation: The recording of pertinent healthcare findings, interventions, and responses to treatment as a business record and form of communication among caregivers. 90 Record at the Function Level or Record Entry is defined as full medical documentation generated during the activities performed under a function. It is defined as the notation made in a patient's health record, whether paper or electronic, by the responsible healthcare practitioner to document an event or observation associated with healthcare services provided to the patient. 91 For some functions, this can be one document, e.g., registration form; for other functions, in which several documents may comprise the record entry, e.g., testing: consent for procedure, test order, test result report. Please note that in the standards development organizations (HL7, ISO), the term Record Entry is used for a single document only. Record at Data Entry Level is defined as a collection of parts that are related to, or associated with, a record for a specific activity. Using the terminology of the HL7 Clinical Document Architecture (CDA) standards, these parts follow the following hierarchy: record’s Sections, Templates and Data Fields. Using terminology of HL7 Fast Healthcare Information Resource (FHIR) standard, these parts can be represented as record’s “resources.” These parts of the record can be completed by various business actors.

87

World Wide Web Consortium (W3C). Provenance XG final report, 2010. URL http://www.w3.org/2005/Incubator/prov/XGR-prov-20101214/ 88 Health Information Management and Systems Society (HIMSS). Dictionary of Healthcare Information Technology Terms, Acronyms and Organizations. 2010. p. 101 89 American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p.88 HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Term

Definition 92

Release of information (ROI)

The process of disclosing patient identifiable information from the health record to another party.

Use

Under federal regulations; use of PHI is “the sharing, employment, application, utilization, examination, 93 or analysis of such information within an entity that maintains such information.”

90

Same, p.50 Same, p.70 92 American Health Information Management Association (AHIMA). Pocket Glossary of Health Information Management and Technology. Chicago, IL. 2014. p.128 93 United States Department of Health and Human Services (HHS). Administrative Data Standards and Related Requirements: Definitions 91

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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835

Appendix D: HIT Standards for HIM Practices Standards Development Organizations

Business Requirements

HL7

ISO

ASTM

Health Information Availability 1. Ability to capture and maintain information in a manner that ensures timely, accurate (complete and correct), and efficient access and retrieval.

EHRS FM R2

2. Ability to search, identify, locate and retrieve patient specific information in continually expanding volumes of information and across multiple systems including various electronic HIS and manual systems (paper-based document locations, storages, etc.). This requirement is focused on tracking sources where information resides (HISs, other HICT products and manual systems).

ISO/HL710781 ISO/IEEE IS 11073-10101 2004 ISO/IEEE IS 11073-10103 2014 ISO/IEEE IS 11073-10201 2004 ISO/IEEE IS 11073-10404 2010 ISO/IEEE IS 11073-10407 2010 ISO/IEEE IS 11073-10408 2010

E1633 08a

ISO/TS TS 14265 2011

E2369-12

3. Ability to access information across various systems (electronic and manual) and across patient populations. This includes the abilities to search, identify, locate, and retrieve the information required to support organization’s ongoing activities via queries. This requirement is focused on how information from various sources is accessed.

E1384-07

4. Ability to assemble information from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization.

CDA R2

E2369-12

5. Ability to address multiple demands for having the right information available at the right time for the right requestor.

EHRS FM R2

ISO/HL710781 ISO IS 13606-1 2008 ISO IS 13606-2 ISO IS 13606-3 2009 ISO/TS TS 14265 2011

E1744-04 E2369-12 E2473

EHRS FM R2

ISO/TS TS 17948 2014

E1384-07

6. Ability to access information created with legacy hardware and software systems. In case of impending system obsolescence, information with organizational value should be migrated to currently supported hardware and/or converted into a machine-readable format. 7. Ability to maintain metadata services across all participating systems assigning structural and descriptive characteristics to information including data provenance information (authors and dates of creation, modification, sending, receipt, access, etc.).

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

______________________________________________________________________________ 53 Rev. 1.1 – 2015-09-18

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Standards Development Organizations

Business Requirements

HL7

ISO

ASTM

8. Ability to ensure levels of redundancy, failover, contingencies and other risk management practices to minimize risks of non-availability of information due to a disaster, system malfunction, or data corruption. 9. Ability to maintain the workforce capabilities on the most current methods to capture, maintain and access information assuring the work processes consistencies despite of workforce turnover. 10. Ability to enable trust of requestor in information by ensuring the timeliness, accuracy (completeness and correctness), and efficiency of information availability based on implementation of business requirements 1-9 above.

EHRS FM R2 CDA R2

ISO/HL710781 ISO IS 13606-1 2008 ISO IS 13606-2 ISO IS 13606-3 2009

E1633 08a E2369-12

Health Information Integrity 1. Ability to maintain information in a manner that ensures confidence in its authenticity, timeliness, accuracy, and completeness.

EHRS FM R2

ISO/HL710781 ISO/IEEE IS 11073-10101 2004 ISO/IEEE IS 11073-10103 2014 ISO/IEEE IS 11073-10201 2004 ISO/IEEE IS 11073-10404 2010 ISO/IEEE IS 11073-10407 2010 ISO/IEEE IS 11073-10408 2010

2. Ability to maintain integrity of information to comply with safety, quality of care, and compliance with applicable voluntary, regulatory and legal requirements.

EHRS FM R2

ISO/HL710781

3. Ability to maintain integrity of information in adherence to the organization’s policies and procedures.

EHRS FM R2

ISO/HL710781 ISO IS 22600-1 2014

5. Ability to enable trust of requestor in the integrity of information by ensuring the authenticity, timeliness, accuracy, and completeness, admissibility of records for litigation purposes.

EHRS FM R2

ISO/HL710781

6. Ability to ensure integrity of information through reliable system controls that support the organization’s ongoing activities across various systems. 7. Ability to manage integrity of information received from disparate electronic systems, both internal and external to the actual or virtual location(s) of the organization.

EHRS FM R2

ISO/HL710781 ISO IS 22600-1 2014

EHRS FM R2

ISO/HL710781 ISO/IEEE IS 11073-10101 2004 ISO/IEEE IS 11073-10103 2014 ISO/IEEE IS 11073-10201 2004 ISO/IEEE IS 11073-10404 2010 ISO/IEEE IS 11073-10407 2010 ISO/IEEE IS 11073-10408 2010 ISO IS 13606-3 2009

E1633 08a

4. Ability to provide appropriate workforce training on information management and governance to support integrity of information.

E1384-07 E2369-12 E2473

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

______________________________________________________________________________ 54 Rev. 1.1 – 2015-09-18

Copyright © 2015: IHE International, Inc.

IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________ Standards Development Organizations

Business Requirements

HL7

ISO

ASTM

8. Ability to demonstrate oversight by senior management of adherence to approved policies and procedures necessary to maintain reliability of information. 9. Ability to ensure reliability of data and information based on the nature and type of healthcare organization processes and systems for creation and capture, processing, and other applicable stages of the information’s lifecycle.

EHRS FM R2

ISO/HL710781 ISO/IEEE IS 11073-10101 004 ISO/IEEE IS 11073-10103 2014 ISO/IEEE IS 11073-10201 2004 ISO/IEEE IS 11073-10404 2010 ISO/IEEE IS 11073-10407 2010 ISO/IEEE IS 11073-10408 2010 ISO/TS TS 21547 2010

10. Ability to implement ongoing quality control measures to include field-specific data edits built into systems/applications; monitoring and correction of patient identity errors; monitoring and correction of documentation completeness and data accuracy; and ongoing data quality controls, and monitoring and correction in adherence to existing standards. 11. Ability to prove reliability and integrity of information through audit process to validate measures for ensuring the reliability and integrity of information.

E2117- 06

EHRS FM R2

ISO/HL710781 ISO IS 22600-1 2014

E2147-01

12. Ability to monitor hardware, network infrastructure, software, storage, and other system components for reliability of performance. 13. Ability to maintain formal change control processes as part of a reliable information environment. 14. Ability to test HIS capabilities to support business requirements 1-13 including validation of data and all appropriate metadata.

Health Information Protection 1. Ability to ensure appropriate levels of protection from breach, corruption and loss of information that is private, confidential, classified and essential to business continuity or otherwise requires protection.

EHRS FM R2

ISO/HL710781 ISO IS 27799 2008

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

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IHE IT Infrastructure White Paper – Health IT Standards for Health Information Management Practices (HIT Standards for HIM Practices) ______________________________________________________________________________

Business Requirements

Standards Development Organizations HL7

ISO

2. Ability to consistently apply and enforce levels of protection to information, regardless of medium, from the moment the information is created until the moment it reaches or exceeds its retention period and is appropriately disposed. This specifically includes adherence to security, privacy and confidentiality requirements (rules, regulations, policies) when determining a method for the final disposition of information, regardless of source or media. This applies whether the disposition is archival, transfer to another organization, preservation for permanent storage, or destruction.

EHRS FM R2

ISO/HL710781 ISO IS 27799 2008

3. Ability to establish an audit program that defines a clear process for verifying whether sensitive secure information is being handled in accordance with the organization’s policies and procedures.

EHRS FM R2

ISO/HL710781

4. Ability to manage and balance compliance with the varying degrees of protection, mandated by laws, regulations, and/or organizational policies for information generated and managed by an organization.

EHRS FM R2

ISO/HL710781 ISO IS 22600-1 2014 ISO IS 27799 2008

5. Ability to provide security, business continuity, and disaster recovery processes that will ensure continued operation and continued protection, during and after periods of failure or disruption.

EHRS FM R2

ISO/HL710781

6. Ability to assign and manage appropriate levels of information access and security clearance to all members of the workforce and other authorized parties relevant to their roles or duties.

EHRS FM R2

ISO/HL710781 ISO IS 17090-1 2013 ISO IS 17090-2 2008 ISO IS 22600-1 2014 ISO IS 27799 2008

7. Ability to maintain appropriate security safeguards, clearly defined and enforced by organizational policies, designed to protect electronic information from being inappropriately viewed, e-mailed, downloaded, uploaded, or otherwise proliferated— intentionally or inadvertently, even by individuals with legitimate access to the system.

EHRS FM R2

ISO/HL710781 ISO IS 17090-1 2013 ISO IS 17090-2 2008

ASTM

E2147-01

8. Ability to provide physical security safeguards of computing and access devices or any equipment containing private, secret, or confidential information or intellectual property of the organization.

HL7®, HEALTH LEVEL SEVEN®, CCD®, CDA®, and FHIR® are trademarks owned by Health Level Seven International and are registered with the United States Patent and Trademark Office.

______________________________________________________________________________ 56 Rev. 1.1 – 2015-09-18

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Health IT Standards for Health Information Management

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