PHCR eICR R2 STU1.1 Update Comments

November 2016 - HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 1, STU Release 1.1 - US Realm - Available for Comment

This wiki page will support review and feedback for proposed updates to the HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 1, STU Release 1.1 - US Realm.

This IG consists of two volumes:

• Volume 1 provides narrative introductory and background material pertinent to this implementation guide, including information on how to understand and use the templates in Volume 2.
• Volume 2 contains the Clinical Document Architecture (CDA) templates for this guide along with lists of templates, code systems, and value sets used.

For commenting prior to reconciliation and publication, the STU update Implementation Guide and its related files are available to HL7 members here: Update_for_Comment_CDAR2_IG_PHCASERPT_R2_D1.1_2016DEC.

As an STU update, this new version will not go through the usual HL7 balloting process but will use the STU Update Process with industry review on the HL7 wiki.

The changes in this update can be summarized as follows:

Volume 1 Typo corrections, non-substantive wording changes were made throughout the document but these changes will not be detailed.

• New chapters/sections/appendices (only the top heading-level of the addition is noted):
  • 1.3 Organization of the Guide
  • 1.6 Current Project
  • 3 CDA R2 Background
  • 5.2 Stand-Alone Templates
  • 5.4 Trigger Code Templates
  • Appendix A — Acronyms and Abbreviations
  • Appendix B — High Level Change Log
  • Appendix C — Extensions to CDA R2
• Updated chapters/sections:
  • 4 Using This Implementation Guide
    • replaced "Conventions used in this implementation guide" section
  • 4.1 Conformance Conventions Used in This Guide
  • 4.2 Templates and Conformance Statements
  • 4.3 XML Conventions Used in This Guide
    • Split chapter "Data Requirements and IG Template Specifications Organization" into the following two chapters:
  • 5 eICR IG Specific Conformance Guidance
  • 6 eICR Data Requirements
    • Updated tables and diagrams to reflect new data elements and added sections (see above)

Volume 2

• Document-Level Templates
  • No new document-level templates were added.
  • Initial Public Health Case Report Document (eICR) was versioned to V2:
    • Added containment for C-CDA R2.1: Plan of Treatment (V2) Section
    • Added containment for Birth Sex Observation
    • Added @sdtc:deceasedInd
    • Updated constraint for @sdtc:deceasedTime
    • Added guidance for using county in an address
    • Updated examples
• Section-Level Templates
  • One new section-level template was added:
    • C-CDA R2.1: Plan of Treatment (V2) Section
  • Entry-Level Templates
    • Five new entry-level templates were added:
    • C-CDA R2.1 Companion Guide: Birth Sex Observation
    • C-CDA R2.1 Based: Initial Case Report Trigger Code Lab Test Order
    • C-CDA R2.1 Based: Initial Case Report Trigger Code Problem Observation
    • C-CDA R2.1 Based: Initial Case Report Trigger Code Result Observation
    • Travel History
• Value Sets
  • Seven new value sets were added:
    • Initial Case Report Trigger Code Result Status
    • ONC Administrative Sex
    • Reportable Conditions Trigger Code Value set
    • Trigger code for condition name (RCTC subset)
    • Trigger code for laboratory test names (RCTC subset)
    • Trigger code for laboratory test orders (RCTC subset)
    • Trigger code for organism or substance (RCTC subset)

Review Note: Travel History template: As this is a new template and not based on any existing template, we encourage detailed review and feedback around the utility and design of this template

During the one week comment period running from November xx-xx, 2016, please submit your comments below including at least your name, item, existing wording, proposed wording, and comment.

Thank you.

Enter your comments below this line by clicking on the Comments (edit) link.

Comments

Example comment:

Name: HL7 Commenter

Item: Volume 2, Template XXXX

Existing wording: CONF: xxxxx-xx SHOULD contain exactly 1..1

Proposed wording: CONF: xxxxx-xx SHALL contain exactly 1..1

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Name: Sarah Gaunt

Item: Volume 1: 4.1 Templates and Conformance Conventions

Existing wording: This heading is at the wrong level - it needs to be indented on level so that it is nested under 4.1 Conformance Conventions Used in this Guide

Proposed wording: Indent 4.1 Templates and Conformance Conventions one level so that it is 4.1.1 Templates and Conformance Conventions

Preliminary Disposition: Will fix heading as suggested.

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Name: George Cole

Item: Volume 2: Section 3.14 Travel History

Existing wording: The participant contains a location (either an address or a coded location)

ii. This participantRole MAY contain zero or one [0..1] code, which SHOULD be selected from ValueSet Geographical location history urn:oid:2.16.840.1.114222.4.11.3201 DYNAMIC (CONF:3284-263). Note: Coded value of the location

Figure 52: Travel History - Coded Location Example

Proposed wording: The participant may contain a location as an address.

Reason for proposal: The coding and exchange is simplified with only one approach for travel location, and we suggest using addr and removing the coded location text, constraints, and example.

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Name: George Cole

Item: Volume 2: Section 3.14 Travel History

Existing wording: ....ValueSet Geographical location history... (the hyperlink points to a nonexistent bookmark)

Proposed wording: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=9CE75E17-176B-DE11-9B52-0015173D1785

Preliminary Disposition: Persuasive, will update hyperlink to that suggested.

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Name: George Cole

Item: Volume 2: Section 3.14 Travel History

Existing wording: 7. SHALL contain exactly one [1..1] effectiveTime (CONF:3284-295). Note: Date(s) spent in the location

Proposed wording: 7. SHALL contain exactly one [1..1] effectiveTime (CONF:3284-295). Note: Date(s) spent in the location, using any format for effectiveTime that is supported by CDA. See Figure 54: effectiveTime Examples

Reason for proposal: Until we saw the examples, we wondered whether or not there were missing constraints on effectiveTime.

Preliminary Disposition: Sarah Gaunt: Persuasive, will change wording to that suggested.

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Name: George Cole

Item: Volume 2: Section 3.14 Travel History

Existing wording: The participant contains a location

Question (not suggested change): We were a bit surprised to see Travel as an act with participants containing locations. It is a bit hard to see a country as a participant of an act. So, we just have to ask if other constructs were considered. For example, was coded observation with location as a value considered?

Preliminary Answer: Sarah Gaunt: We based this modeling on a SD listserv discussion from 2014 and a subsequent Kieth Boone blog post (http://motorcycleguy.blogspot.com.au/2014/10/on-process-for-rapid-template.html ). I'll send you the listserv discussion for your reference (hard to reference it here!)

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Name: George Cole

Item: Volume 2: Section 3.11.1 3.11.1 Initial Case Report Trigger Code Result Observation, Figure 45: Initial Case Report Trigger Code Result Observation - Final Result Example

Existing wording: The example shows template ID's with and without extensions, as would be required for C-CDA R2.1

<templateId root="2.16.840.1.113883.10.20.22.4.2" />

<templateId root="2.16.840.1.113883.10.20.22.4.2" extension="2015-08-01" />

Question (not suggested change): Since this guide publishes Result Observation (V3), and other templates, without the C-CDA R2.1 requirement to have both templateId elements (with and without extension), does that mean that there is no requirement in this guide to publish both templateId elements?

Could Figure 45, and the example file distributed with the guide, be published with only <templateId root="2.16.840.1.113883.10.20.22.4.2" extension="2015-08-01" /> ? What is the thinking on inclusion or not of the unversioned templateId?

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Name: Justine Maxwell, TN Dept of Health

Item: 1.9 Contents of Package, Volume 1, (Table 2.)

Question: Should the table include an additional column that list the exact chapter and section the normative or informative material is located throughout volumes 1 and volumes 2? In Release 1.0 of the Implementation Guide, it clearly stated what chapters/sections were normative (e.g. “The examples and comments in Chapters 2 and 3, are not normative and any conflict between content therein and Chapters 1 or 4 should be favor the specifications in Chapters 1 and 4.”).

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, 4.1 Conformance Conventions Used in This Guide

Existing wording: Only the title of the section is included. There is actually nothing in 4.1. It looks like the language starts in 4.2.

Proposed wording: Either include language conformance conventions used in this guide section under 4.1, or remove this section.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, 4 Using this Implementation Guide

Existing wording:

Suggestion/Proposed wording: Include a statement somewhere in Section 4 stating that “The reader of this implementation guide is expected to have available and use the Clinical Document Architecture, Release 2 (CDA R2) US Realm Standard and the Consolidated CDA (C-CDA) DSTU Release 2.1 Templates Standard” An example of why the reader may need to know that they need to go back to the base standards is this: For the “id” data element, the implementation guides only states that it “SHALL be a globally unique identifier for the document.” Does the “id” have to contain an extension, or is just a “root” without an “extension” sufficient? A reader may not realize that they have to go back to the base standards in order to figure out this information.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 2, 1.1.1.5 informant (Assigned Healthcare Provider, volume 2, page 26) The example for the Assigned Health Care Provider Informant (volume 2, Figure 5, page 48) has data elements telecom and representedOrganization. However, there are no numbered list of constraints used in the eICR IG under Assigned Health Care Provider Informant that include conformance statements and cardinality indicators and identifiers. Is this missing information intentional? What constraints are used to generate the example (Figure. 5)

Existing Wording:

iii. This assignedEntity SHALL contain at least one [1..*] US Realm Address (AD.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.2) (CONF:1198-8220).

iv. This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:1198-8221).

1. This assignedPerson SHALL contain at least one [1..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.1.1) (CONF:1198-8222).

Proposed wording:

iii. This assignedEntity SHALL contain at least one [1..*] US Realm Address (AD.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.2) (CONF:1198-8220). iv. This assignedEntity SHALL contain at least one [1..*] telecom (CONF:1198-****).

1. Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) urn:oid:2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:1198-****).

v. This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:1198-8221).

1. This assignedPerson SHALL contain at least one [1..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.1.1) (CONF:1198-8222).

vi. This assignedEntity SHALL contain exactly one [1..1] representedOrganization (CONF:2218-**).

i. This representedOrganization SHALL contain exactly one [1..1] name (CONF:2218-**).

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 2, 1.1.1.15 Performer (volume 2, page 31) The example for the Performer (volume 2, Figure 14, page 53) has data elements telecom and representedOrganization. However, there are no numbered list of constraints used in the eICR IG under Perfomer that include conformance statements and cardinality indicators and identifiers. Is this missing information intentional? What constraints are used to generate the example (Figure. 14)?

Existing Wording:

ii. This serviceEvent SHOULD contain zero or more [0..*] performer (CONF:1198-14839).

1. The performer, if present, SHALL contain exactly one [1..1] @typeCode, which SHALL be selected from ValueSet x_ServiceEventPerformer urn:oid:2.16.840.1.113883.1.11.19601 STATIC (CONF:1198-14840).

2. The performer, if present, MAY contain zero or one [0..1] functionCode (CONF:1198-16818).

a. The functionCode, if present, SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet ParticipationFunction urn:oid:2.16.840.1.113883.1.11.10267 STATIC (CONF:1198-32889).

3. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-14841).

a. This assignedEntity SHALL contain at least one [1..*] id (CONF:1198-14846).

i. Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:1198-14847).

b. This assignedEntity SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) urn:oid:2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:1198-14842).

Proposed wording:

ii. This serviceEvent SHOULD contain zero or more [0..*] performer (CONF:1198-14839).

1. The performer, if present, SHALL contain exactly one [1..1] @typeCode, which SHALL be selected from ValueSet x_ServiceEventPerformer urn:oid:2.16.840.1.113883.1.11.19601 STATIC (CONF:1198-14840).

2. The performer, if present, MAY contain zero or one [0..1] functionCode (CONF:1198-16818).

b. The functionCode, if present, SHOULD contain zero or one [0..1] @code, which SHOULD be selected from ValueSet ParticipationFunction urn:oid:2.16.840.1.113883.1.11.10267 STATIC (CONF:1198-32889).

3. The performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-14841).

a. This assignedEntity SHALL contain at least one [1..*] id (CONF:1198-14846).

i. Such ids SHOULD contain zero or one [0..1] @root="2.16.840.1.113883.4.6" National Provider Identifier (CONF:1198-14847).

b. This assignedEntity SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Healthcare Provider Taxonomy (HIPAA) urn:oid:2.16.840.1.114222.4.11.1066 DYNAMIC (CONF:1198-14842).

c. This assignedEntity SHALL contain at least one [1..*] US Realm Address (AD.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.2) (CONF:1198-8220). d. This assignedEntity SHALL contain at least one [1..*] telecom (CONF:1198-****).

1. Such telecoms SHOULD contain zero or one [0..1] @use, which SHALL be selected from ValueSet Telecom Use (US Realm Header) urn:oid:2.16.840.1.113883.11.20.9.20 DYNAMIC (CONF:1198-****).

e. This assignedEntity SHALL contain exactly one [1..1] assignedPerson (CONF:1198-****).

1. This assignedPerson SHALL contain at least one [1..*] US Realm Person Name (PN.US.FIELDED) (identifier: urn:oid:2.16.840.1.113883.10.20.22.5.1.1) (CONF:1198-****).

f. This assignedEntity SHALL contain exactly one [1..1] representedOrganization (CONF:2218-**).

i. This representedOrganization SHALL contain exactly one [1..1] name (CONF:2218-**).

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 2, Figure 27, page 104, Example for No Known Problems Section

Question: The example for No Known Problems Section (volume 2, Figure 27, page 104) has a templateID for “Problem Section with Coded Entries Optional” and “Problem Section with Coded Entries Required,” however the implementation guidance (volume 2, page 102) only has a conformance statement and cardinality indicator for one templateID. Is having two templateIDs in the example intentional or is this an error?

Existing wording:

1. Conforms to Problem Section (entries optional) (V3) template (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.2.5:2015-08-01). 2. MAY contain zero or one [0..1] @nullFlavor="NI" No information (CodeSystem: HL7NullFlavor urn:oid:2.16.840.1.113883.5.1008) (CONF:1198-32864). 3. SHALL contain exactly one [1..1] templateId (CONF:1198-9179) such that it a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.2.5.1" (CONF:1198-10441). b. SHALL contain exactly one [1..1] @extension="2015-08-01" (CONF:1198-32510).

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Name: HL7 Commenter

Item: Volume 2, 1.1.1.2, record Target (volume 2, page 21) in regards to Reported Age of the Patient

Existing Wording: 3. This patient SHALL contain exactly one [1..1] birthTime (CONF:1198-5298). a. SHALL be precise to year (CONF:1198-5299). b. SHOULD be precise to day (CONF:1198-5300).

For cases where information about newborn's time of birth needs to be captured.

c. MAY be precise to the minute (CONF:1198-32418).

Proposed wording/suggestion: In the recordTarget there is a data element for the patient’s birth time, however, the implementation guide does not include the “Reported Age” of the patient. Is this data element missing intentionally? Having reported age of the patient would be useful if birth time is not available. This has been modeled previously in death reporting. It might be helpful to consult with the authors of the CDA Vital Records Death Reporting Implementation Guide for details on how to report age as an observation.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 2, Encounter Diagnosis (volume 2, page 127)

Existing Wording:

4. SHALL contain exactly one [1..1] code (CONF:1198-19182).

a. This code SHALL contain exactly one [1..1] @code="29308-4" Diagnosis (CONF:1198-19183).

b. This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.6.1" (CodeSystem: LOINC urn:oid:2.16.840.1.113883.6.1) (CONF:1198-32160).

5. SHALL contain at least one [1..*] entryRelationship (CONF:1198-14892) such that it

a. SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-14893).

b. SHALL contain exactly one [1..1] Problem Observation (V3) (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.4:2015-08-01) (CONF:1198-14898).

Question/suggestion:

The implementation guidance for the Encounter Diagnosis, does not have any conformance statements or cardinality indicators for statusCode or effectiveTime. However, the Encounter Diagnosis (V3) example (volume 2, Figure 33, page 128) includes a statusCode data element and an effectiveTime data element. Is this intentional that these two data elements are missing from the implementation guidance but are included in the example?

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, page 64, Appendix C-Extensions to CDA –R2

In Appendix C it says the sdtc:deceasedInd is used to indicate if a family member is deceased. Should it also include in the table that the sdtc:deceasedInd is also can be used to indicate that the patient, in addition to a family member, in the recordTarget is deceased too? It looks like the sdtc:deceasedInd was added to the recordTarget in the conformance statement, but was not updated in this table. This also applies for deceasedTime.

Existing Wording:

The references to the extension for the deceasedInd are not consistent. In the Appendix C of volume 1 it is referenced in the table as the deceasedIndextension. The deceasedIndextension (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased. Then in the recordtTarget on page 61, its referenced as sdtc:deceasedInd. This patient SHALL contain exactly one [1..1] sdtc:deceasedInd (CONF:3284-306).

Proposed wording/suggestion:

Be consistent with how extensions are referenced and documented throughout the text. We would suggest referencing this extension as always sdtc:deceasedInd. This could be a simple typo of a missing space in the table description. The deceasedInd extension (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, page 64, Appendix C-Extensions to CDA –R2

There seems to be a problem with consistency. In the Appendix C table from volume 1, the sdtc:deceasedInd is described as the extension for (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased. However, in volume 2, on page 61, in the recordTarget, the same extension is listed for the patient. We couldn’t find any reference to this extension elsewhere in volume 2. So the use of this extension as described in volume 1 is not consistent with the conformance statements using this extension in volume 2. This also applies for deceasedTime.

Existing Wording:

The deceasedIndextension (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased.

Proposed wording/suggestion:

The deceasedIndextension (= “true” or “false”) in the family history organizer on the related subject is used inside to indicate if a family member is deceased. This same extension is also used in the recordTarget. There should also probably be a conformance statement using this extension in the family history organizer of the related subject for the family member.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, page 64, Appendix C-Extensions to CDA –R2

Question:

The sdtc:raceCode in the table in Appendix C of volume 1 says that the extension should only be under the patient. However, the sdtc:ethnicGroupCode is listed as falling under the record target or subjectPerson. Why the difference? Is this correct?

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, Table 10, page 56-Mapping of Data Elements to Data Model

Question:

In Table 10, the class attribute name for the “Date of Diagnosis” data element is effectiveDate. Is this intentional or should it be effectiveTime? In volume 2, effectiveTime is used.

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Name: Justine Maxwell, TN Dept of Health

Item: Volume 1, Figure 24, page 52-eICR Data Model

Question:

In Figure 24 (eICR Data Model), the Encounter Diagnosis box includes effectiveDate. Is this intentional or should it the effectiveTime data element? In volume 2, effectiveTime is used.

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