Recommendations for Implementing Encounter Summary Documents with Clinical Notes in C-CDA, Lecture notes of Product Development

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Concise Consolidated CDA:

Deploying Encounter Summary CDA

Documents with Clinical Notes

June 2018

Executive Summary

In the Fall of 2017, the independent Car e quality and CommonWell Content Work Groups were attempting to solve a set of common issues: unacceptably large C-CDA documents, an absence of clinical notes in exchanged documents, support for encounter summary documents, and the need for document version management. The initiatives agreed to launch a Joint Document Content Work Group (JDCWG) in January 2018 with participants that included clinicians, vendor representatives, and standards development representatives. This white paper defines a path to improve the content in C-CDA exchange, while acknowledging the realities of present day documentation and exchange practices. The intended audience of this guidance is C-CDA implementers, product development teams, and software developers. The recommendations resulting from this joint effort include the following:

• Implementers should support Encounter Summary Documents in addition to Patient Summary Documents
• Encounter Summary Documents should be based upon the C-CDA template for Progress Note (Outpatient/Ambulatory) or Discharge Summary (Inpatient/Hospital)
• Implementers should incorporate Clinical Notes in C-CDA implementations
• Content in Encounter Summary Documents should only reflect information at the time of the encounter
• Implementers should only include a subset of the ONC Common Clinical Data Set by default in an Encounter Summary Document, and only if that data was validated during the encounter
• Implementers should include a Section Time Range Observation for each section in an Encounter Summary Document
• Implementers should construct C-CDAs that reflect the scope of document query parameters The next steps related to these recommendations are for Car e quality and CommonWell representatives to present them to their respective Steering Divisions to determine how to encourage implementation. Additionally, these recommendations will be shared with HL7 for possible inclusion in a future version of C-CDA.

• 1 Introduction
  • 1.1 Purpose
  • 1.2 Audience
  • 1.3 Background and Development Approach
    • 1.3.1 Sources and Process
• 2 Encounter Summary Documents
  • 2.1 Document Body Guidance
    • 2.1.1 Section Time Range
  • 2.2 Outpatient/Ambulatory Summary (Progress Note Document)
  • 2.3 Inpatient/Hospital Summary (Discharge Summary Document)
  • 2.4 Clinical Notes
    • 2.4.1 Common Clinical Note Types
    • 2.4.2 Sending Clinical Notes in C-CDA
      • 2.4.2.1 Note directly attached to the associated act
      • 2.4.2.2 Note is in an appropriate section
      • 2.4.2.3 Note in stand-alone Notes Section
    • 2.4.3 Encounter Linking for Clinical Notes
      • 2.4.3.1 Clinical Note Best Practices
• 3 Patient Summary Documents
  • 3.1 Honor time parameters in Query for Documents
  • 3.2 Missing Time parameters
  • 3.3 USCDI within TEFCA
• 4 Smart Senders and Resilient Receivers
  • 4.1 Smart Senders
    • 4.1.1 Maintain proper references between coded values and narrative
    • 4.1.2 Maintain act/observation IDs across documents
    • 4.1.3 Document Versioning
      • 4.1.3.1 Encounter Summary Document Version Management Guidance
    • 4.1.4 Reconciliation flag
  • 4.2 Resilient Receivers
    • 4.2. 1 Document Display Guidance
    • 4.2.2 Receive and display any valid CDA document
• 5 Appendix
  • 5.1 Additional education material
  • 5.2 Document Generation Timing and Content
  • 5.3 Future Work
• Deploying Encounter Summary CDA Documents with Clinical Notes June
• Figure 1 – Sample display of Section Time Range....................................................................................... Table of Figures
• Figure 2 – Progress Note Document Section Requirements
• Figure 3 – Discharge Summary Document Section Requirements
• Figure 4 – Example of Note Attached to an Act..........................................................................................
• Figure 5 – Example of Note Added to an Appropriate Section
• Figure 6 – Example of Stand-alone Notes Section
• Figure 7 – Example of Encounter Linking with entryReference
• Figure 8 – Example of Encounter Linking with entryReference
• Figure 9 – Timespan Elements in the Query Transaction
• Figure 10 – VA Section Timespan Filters
• Figure 11 – ONC Draft USCDI
• Figure 12 – Example id root only
• Figure 13 – Example id root + extension.....................................................................................................
• Figure 14 – Discharge Summary with no Hospital Course information
• Figure 15 – Replacement Discharge Summary document with Hospital Course Information
• Figure 16 – Document Query
• Figure 17 – Document Retrieval
• Figure 18 - Document Information Available during the IHE Query and in the stored C-CDA
• Figure 19 - Sample Document List Display

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018

Acknowledgements

This guide was developed through a joint effort of Car e quality and CommonWell. The editors appreciate the collaborative efforts and commitment from all participants to improve the quality of C-CDA documents. Work Group participants included: Primary Editor Organization Brett Marquard DoD / VA Interagency Program Office (IPO) / WaveOne Ed Donaldson OneRecord / Ready Computing Contributor Organization Alan Swenson Kno Anand Prabhu Mediportal Ava Spetalnick Athenahealth Becky Shoemaker Dignity Health Benjamin Flessner Redox Christopher Dickerson Carequality Christopher J. Hills DoD / VA Interagency Program Office (IPO) Corey Parker Greenway Health Dana Grove Cerner Dave Cassel Carequality David Camitta MD, MS Dignity Health David Parker MD DoD / VA Interagency Program Office (IPO) / Defined IT Didi Davis eHealth Exchange Elizabeth R. Ames Sutter Health Eric Heflin The Sequoia Project Farah Saeed eClinicalWorks Holly Miller MD, MBA MedAllies Jason Goldwater Cedar Bridge Group Jitin Asnaani CommonWell Health Alliance Joe Wall MEDITECH Justin Ware Epic Kelly Bundy Surescripts Leanna Evans Cerner Lisa R. Nelson MaxMD Lizz Restat athenahealth Luke Doles NY eHealth Collaborative Madhav Darji eClinicalWorks Margaret Donahue, MD US Department of Veterans Affairs Marie Swall US Department of Veterans Affairs / JP Systems Marty Prahl Social Security Administration

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018

1 Introduction

Car e quality and the CommonWell Health Alliance are two industry initiatives committed to the seamless exchange of healthcare information. This guide is the result of a joint development effort of the Content Workgroups within each initiative to improve the content of Consolidated CDA exchange.

1.1 Purpose

This document provides guidance for including Clinical Notes, and guidance for exchanging Encounter Summary CDA Documents. A Clinical Note is narrative text a clinician wrote, dictated, or copied from other portions of the patient’s chart. An Encounter Summary CDA document will include this Clinical Note (required) plus other relevant sections with discrete data as generated by the system and/or included per clinician instructions. This document complements the Health Level Seven (HL7) CDA® R2 IG: C-CDA Templates for Clinical Notes STU Release 2.1. It is also not a replacement for the C-CDA Templates for Clinical Notes R Companion Guide, which primarily supports the requirements of the ONC 2015 Edition Certification Criteria (2015 Edition) Certified Electronic Health Record Technology requirements. The guidance provided here will be considered in a future update to C-CDA.

1.2 Audience

The primary audience of this guide is C-CDA implementers, product development teams, and software developers. This guide provides detailed guidance for placement of clinical information in C-CDA and best practices for system generators and receivers. Software architects, business analysts, and policy managers can also benefit from understanding the preferred approach of supporting Encounter Summary documents in addition to Patient Summary documents.

1.3 Background and Development Approach

In the fall of 2017, independent Car e quality and CommonWell Content Work Groups were attempting to solve a set of common issues: unacceptably large C-CDA documents, an absence of clinical notes in exchanged documents, support for encounter summary documents, and the need for document version management. Participants from both content work groups approached the Directors of Car e quality and CommonWell to consider a single joint effort to tackle these common issues. The Joint Work Group launched in January 2018. Participants in the Joint Content Work Group included clinicians, vendor representatives and participants involved in standards development. The principles of the Joint Content Work Group were as follows:

1. Maintain an initiative agnostic perspective
2. The product of the work group should be a best practices document
   1. Exact format to be determined
   2. Car e quality and CommonWell may reference document or incorporate into their material

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018

3. All final material will have joint branding or none
4. Development will occur in single content work group
5. Initiatives will independently review and approve guidance
6. Any guidance developed may be transitioned over to HL7 for balloting and maintenance The Joint Work Group set clinical and technical priorities in the first call as follows: Clinical
7. Require Encounter specific document support
8. Outpatient/Ambulatory Summary (Progress Note Document) with defined sections
9. Inpatient/Hospital Summary (Discharge Summary Document) with defined sections
10. Determine most frequently used Clinical Note types^1 - develop examples for each to include in encounter specific documents
11. Develop guidance on Note placement within documents for generator and consumer
12. Require Patient Summary
13. Define patient-level (not encounter specific) sections to always include
14. Future – Define default time ranges for each section Technical
15. Develop guidance for document versioning Prior to the launch of the Joint Content Work Group each individual content work group discussed tackling the size of exchanged CCDs by discussing appropriate content restriction by section. It became clear, that even improved filtering of a single patient CCD wouldn’t solve the information overload for clinicians reviewing documents that could sometimes be over 1,000 pages in length. The group focused on the importance of providing focused information to the clinician at the time they need it. The group identified encounter specific document support, including clinical notes, as the top priority. Members felt that the information provided by clinical notes would provide critical supplemental context to the discrete data they were currently getting in Patient Summary CCD documents. They also felt that these notes should not be added to the already long Patient Summary CCD documents they were receiving. After the Joint Content Work Group finalized priorities, weekly calls were scheduled to develop and review design approaches. Decisions were made through discussion and consensus without the implementation of formal voting.

1.3.1 Sources and Process

The Joint Content Work Group considered the C-CDA R2.1, and Companion Guide as the baseline for all discussions. As a guiding principle, the Joint Content Work Group focused on providing complementary, (^1) With support from our Argonaut colleagues!

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018

2 Encounter Summary Documents

An encounter summary document is primarily a clinician authored collection of information specific to a single patient interaction with a clinician, care team or hospitalization. The document may be provided to a patient immediately upon, or soon after, the conclusion of their visit even if all the information related to that visit is not yet available. For example, an encounter may have pending laboratory results or may lack a finalized clinician note or discharge summary when a patient departs. However, an encounter summary document may be updated when additional encounter specific data is available (i.e. finalized). A complete encounter summary includes any information that may have been updated after the conclusion of the encounter. See Document Versioning section for guidance on how to manage documents versions and updates. For the purposes of document exchange, this guide focuses on two Encounter Summary Document types: ● Outpatient/Ambulatory Encounter Summary ● Inpatient/Hospital Encounter Summary It is important to note these two broad categories may not perfectly align with patient billing classes. This guide does not define exact scenarios of when to use each type of encounter summary. The group consensus was to use the outpatient/ambulatory encounter summary for office visits, and use the inpatient/hospital encounter summary for overnight stays in hospitals. For hospital outpatient services (ambulatory surgery, etc.) or inpatient rehabilitation the provider/organization may need to determine which encounter summary document type is most appropriate. This supplement provides guidance for generating the C-CDA Progress Note Document to exchange information associated with an Outpatient/Ambulatory Encounter, and the C-CDA Discharge Summary Document to exchange information associated with an Inpatient/Hospital Encounter. The Joint Content Work Group selected these information exchange documents because they were designed to support the most generic, encounter level documents currently available. After systems support the Progress Note Document, and the Discharge Summary Document, implementers are encouraged to implement additional document types that support specific use cases, for example Consultation Note Document. Implementation of the Encounter Summary Documents complements the existing Patient Summary document exchanged by systems today. Encounter Summary Documents provide information about the patient used or generated during the encounter. Patient Summary Documents provide the current and historical information about a patient. The Joint Content Work Group decided that in order for systems to provide a complete picture of a patient's history, they SHALL provide access to, at a minimum, one Encounter Summary Document for each available encounter and a current Patient Summary Document. To help understand this decision, the Joint Content Work Group considered the following scenario:

1. A clinician requests a patient’s historical visits from 9/1/201 7 - 12/1/2017.

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018

2. The patient had 3 visits during this time, so the system returns 3 individual Encounter Summary Documents.
3. Each Encounter Summary Document includes the information (e.g. Medication List) at the conclusion of the encounter. Systems that are unable to report information that is accurate to the time of the encounter SHALL NOT include current information instead. If a system provided the current Medication list with each Encounter Summary, rather than the encounter specific list, all of the documents would have the same information making it impossible for the clinician to determine the state of the patient at the time of the encounter. Thus, systems without the ability to produce a Medication list that accurately reflected the Medications at the end of the encounter, SHALL NOT include a Medication list in the Encounter Summary Document.

2.1 Document Body Guidance

The CDA document body communicates clinical content through sections. C-CDA R2.1 includes robust recommendations for required and optional sections for the C-CDA Progress Note Document and the C- CDA Discharge Document which were determined by the review of thousands of clinical documents. The additional guidance here complements this prior work. When HL7 considers a new ballot, members of the Joint Content Work Group will submit these recommendations for inclusion. The content work group selected sections for the Progress Note Document and Discharge Summary Document using these guidelines:

1. Include all sections required in the base C-CDA document template
2. Include a priority subset of clinical data drawn from the ONC Common Clinical Data Set (CCDS) and draft US Core Data for Interoperability (USCDI).
3. Systems SHOULD send a ‘No information’ assertion template if nothing is available^2 for one of the priority subset data elements.
4. Systems MAY send additional data elements, beyond the priority subset, if relevant to the encounter. For these additional data elements, systems should not send a ‘No information’ template if nothing is available. Many systems include the data required in the Common Clinical Data Set (CCDS) in every C-CDA document even if that data is not updated, or relevant, to an encounter. The participants in the Joint Content Work Group recommended that only a priority subset of such data elements always be included (listed below), and only if they were reviewed or reconciled during an encounter. This approach is consistent with ONC’s requirement that systems must support sending all CCDS for certification purposes, but also allows the clinician to determine what is relevant for a particular encounter document. The Joint Content Work Group recognizes that reconciliation does not occur the same way in (^2) See HL7 Approved C-CDA Example No Information

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 The Joint Content Work Group recommends all sections include this observation and corresponding text. The text should be included underneath the section header and state either: ● The section includes all information for this encounter ● Or, the section includes information corresponding to a time range with a low and a high value Figure 1 – Sample display of Section Time Range

2.2 Outpatient/Ambulatory Summary (Progress Note Document)

The content work group selected the C-CDA Progress Note document template^6 to support Outpatient/Ambulatory Encounter Summary Document exchange. The Progress Note is a generic document which supports any outpatient visit. It is a first step towards systems exchanging more specific document types per encounter type. The preferred LOINC document type code is 11506-3, Provider-unspecified Progress note, although systems may send more specific codes from the ProgressNoteDocumentTypeCode urn:oid:2.16.840.1.113883.11.20.8.1 value set. Figure 2 – Progress Note Document Section Requirements, below, identifies the sections the Joint Content Work Group recommends be required for implementations of the Progress Note document type intended to serve as an Outpatient/Ambulatory Summary. (^6) C-CDA R2.1 Progress Note templateId: 2.16.840.1.113883.10.20.22.1.9:2015- 08 - 01

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 Required Required if Reviewed^7 Outpatient/Ambulatory Summary (Progress Note Document) Assessment and Plan Section (V2) Allergies and Intolerances Section (entries required) (V3) Clinical Notes^8 (may include Subjective) Medications Section (entries required) (V2) Encounter Section (V3) with encounter diagnoses for the specific encounter Immunizations Section (entries required) (V3) Figure 2 – Progress Note Document Section Requirements The Progress Note Document is not restricted to these sections. Clinicians, or specific sites, may choose to include other sections relevant to the encounter (Results, Vital Signs, etc.).

2.3 Inpatient/Hospital Summary (Discharge Summary Document)

The content work group selected the C-CDA Discharge Summary document template^9 to support Inpatient/Hospital Encounter Summary Document exchange. The Discharge Summary is a key document for patients transitioning from the hospital to a new care setting. The preferred LOINC document type code is 18842-5, Discharge Summary note, although systems may send more specific codes from the DischargeSummaryDocumentTypeCode value set urn:oid:2.16.840.1.113883.11.20.4.1. Figure 3 – Discharge Summary Document Section Requirements, below, identifies the sections the Joint Content Work Group recommends be required for implementations of the Discharge Summary document type intended to serve as an Inpatient/Hospital Summary. (^7) Only include if the system is confident a user has reviewed or reconciled the list and is current to the Encounter Summary Document. On generation, systems may include the IHE Reconciliation template to record an explicit reconciliation act. (^8) C-CDA R2.1 Companion Guide Notes Section 2.16.840.1.113883.10.20.22.2.65:2016- 11 - 01 (^9) C-CDA R2.1 Discharge Summary templateId: 2.16.840.1.113883.10.20.22.1.8:2015- 08 - 01

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 exchanging in the HL7 C-CDA companion guide^15 using the new Notes Section^16 and Notes Activity^17. The HL7 guidance provided a baseline for the additional guidance here.

2.4.1 Common Clinical Note Types

The LOINC terminology includes thousands of different note types. To focus the industry, the Argonaut participants and the Department of Veterans Affairs contributed their most commonly used note types to develop the following list of top notes: ● Discharge documentation (8648-8 and/or 18842-5) ● Consultation (11488-4) ● Imaging narrative (18726-0) ● Lab/path narrative ● History & Physical (34117-2) ● Progress note ● Procedures note (28570-0) The list is not in a priority order, nor does it represent the exclusive list of what systems can and will support. All systems are encouraged to support this list and additional notes from the Note Types value set. Any future standards publications should not be restricted to this list.

2.4.2 Sending Clinical Notes in C-CDA

The introduction of the Notes Section and Notes Activity entry templates in the HL7 C-CDA companion guide provided structure and guidance for sending notes. Depending on the clinician workflow, and the discrete information available at time of document creation, the participants agreed on three potential approaches in priority order:

1. Include Note(s) directly attached to the associated act
2. Include Note(s) in an appropriate standard section
3. Include Note(s) in a stand-alone notes section

2.4.2.1 Note directly attached to the associated act

When a note is specifically about an action a clinician performed, the note should reference that action. For example, a Procedure Note is linked, or nested within, the procedure it documents. When direct attribution is possible (as an entryRelationship), the clinical note should be included in the appropriate section where the act is included. Receiving systems should be prepared for Clinical Notes directly embedded in an act and provide a control to display, at minimum, and be able to expand or collapse the note. For example, if the Procedure section had 5 procedures, it is preferable to display the 5 procedures in a flat list or table, with an option, possibly a ‘+’ sign, to allow the user to expand and read each individual Procedure note. (^15) HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 1 (^16) C-CDA R2.1 Companion Guide Notes Section 2.16.840.1.113883.10.20.22.2.65:2016- 11 - 01 (^17) C-CDA R2.1 Companion Guide Note Activity 2.16.840.1.113883.10.20.22.4.202:2016- 11 - 01

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 Figure 4 – Example of Note Attached to an Act

Procedure	Date
Appendectomy	January 25, 2018
Operative Note - Dr. Surgeon - 01/25/2018 Patient repositioned with arms extended on arm boards...

... ...

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 for which there are many consultation notes, may choose to put those notes in a standalone Notes Section to avoid cluttering up the Encounter Section. Figure 6 – Example of Stand-alone Notes Section

2.4.3 Encounter Linking for Clinical Notes

Clinical Notes are written by a clinician in the context of an encounter. Every Clinical Note must have an Author and should be linked to an Encounter, whether a short telephone encounter or a lengthy Hospital Encounter. Encounter linking is important since some systems parse entries and may not properly retrieve header information. When the C-CDA is an ‘Encounter Summary’ the Clinical Note should use an entryReference to the

Dr. Specialist - September 8, 2016 Dear Dr. Henry Leven: Thank you for referring Ms. Everywoman for evaluation. As you know... ...

Deploying Encounter Summary CDA Documents with Clinical Notes June 2018 encompassingEncounter/id^18. Figure 7 below provides an XML example for how this should be done. Figure 7 – Example of Encounter Linking with entryRelationship reference When C-CDA is ‘Patient Summary’ each Note must have explicit encounter reference within the entry. If the document contains an Encounters section with the associated encounter, the Note Activity can reference the encounter ID as demonstrated in Figure 7. Otherwise, the entire encounter should be included in the Note Activity as demonstrated in Figure 8 below. Figure 8 – Example of Encounter Linking with encounter nested

2.4.3.1 Clinical Note Best Practices

The best practices for clinical note exchange will evolve as exchange of this type of information becomes more common. For a start, these are suggested best practices:

1. Prioritize human authored content. Text generated from structured entries are not considered ‘Notes’ (^18) The companion guide published in March 2017 restricted to only encounters in the encounter section. SDWG approved errata 1522 on 1/29/2018 to additionally allow linking to encompassingEncounter/id.

... **…** ... **…**