C-CDA R2.1 Comment Submission

SDWG completed an update to Consolidated CDA R2.0 to enable a C-CDA 2.1 instance to be created that can be used without requiring change to the product supporting C-CDA 1.1. A full description of the project is available on Project Insight Consolidated CDA DSTU 2013 Update (1014). The C-CDA R2.1 20150701_Review_Posting is available to HL7 members for review prior to reconciliation and publication. As a minor DSTU update, this new version will not go through the usual HL7 balloting process but will use the DSTU Update process with industry review on the HL7 wiki.

Before submitting comments, please review the C-CDA R2.1 Approved Compatibility Principles

Updates open for comment are identified by yellow highlighting.

• Volume 1 - If the heading is highlighted, the entire section is open for comment.
• Volume 2 - The specific conformance statements updated are highlighted. Templates that are only updated to reference a contained template that has been versioned (extension="2015-08-01") are not open for comment. Figures with updated conformance statements are open for review.

3 approaches to find edits: Word advanced find - highlight search, High-level change-log Volume 1 (page 43), Excel comparison files (CDA R1.1 vs 2.0 Reviews) included in the review zip.

During the comment period 7/1/2015 - 7/13/2015, please submit your comments on this wiki page using the table below. A template for adding a row is available at the top of the wiki table when in edit mode. Thank you.

Comments submitted on 7/13 - (all in excel above)

CONF#	Name	Summary of Issue	Existing Wording	Proposed Wording	Comments
9045	Example Person	Short problem statement	This text is how the issue is currently documented in the IG	This text is the proposal for how the issue could be documented differently in the IG	This is why the issue is important or tells why the proposed wording is beneficial
1198-9045, 1198-32848	Sarah Gaunt	Example needs fixing	Example has the LOINC code in the code and the SNOMED code in the translation	Constraints state this should be the other way round
1198-7504, 1198-10085	Sarah Gaunt	Missing open brackets	SHALL contain 1..1] low (CONF:1198-7504), SHALL contain 1..1] high (CONF:1198-10085)	SHALL contain [1..1] low (CONF:1198-7504), SHALL contain [1..1] high (CONF:1198-10085)	You probably need to escape those brackets like "[[]"
1198-5402	VK	Mis-match on conformance Cardinality	If country is US, this addr SHALL contain zero to one [1..1] state, which SHALL be selected from ValueSet StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC (CONF:1198-5402). Note: A nullFlavor of ' UNK' may be used if the state is unknown.	If country is US, this addr SHALL contain exactly one [1..1] state, which SHALL be selected from ValueSet StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC (CONF:1198-5402). Note: A nullFlavor of ' UNK' may be used if the state is unknown.	Cardinality specified in the statement is not matching with the notation specified in the bracket
1198-8651	VK	Missing ValueSet table definition	SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet AdvanceDirectiveTypeCode urn:oid:2.16.840.1.113883.1.11.20.2 STATIC 2006-10-17 (CONF:1198-8651).		Hyperlink for the ValueSet AdvanceDirectiveTypeCode is not working
1198-8558	VK	Missing Social History Type ValueSet table definition	SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Social History Type urn:oid:2.16.840.1.113883.3.88.12.80.60 STATIC 2008-12-18 (CONF:1198-8558).		Hyperlink for the ValueSet Social History Type is not working
N/A	Dan Brown	Duplicate/invalid type for template in High-Level Change Log.	Section Consultation Note (V3) 2.16.840.1.113883.10.20.22.1.4:2015-08-01	None	The template is a document not a section. It is listed with the documents as well so was not missed. It is a duplicate in an incorrect location and should be removed
N/A	Dan Brown	Missing template in High-Level Change Log.	None	Hospital Admission Diagnosis (V3) 2.16.840.1.113883.10.20.22.4.34:2015-08-01 Updated to reference a contained template that has been versioned.	The template was versioned in R.2.1 (V2 -> V3) but is missing from the High-Level Change log. It should be added.
N/A	Dan Brown	Minor template name change in High-Level Change Log.	Admissions Medications Section (entries optional) (V3) 2.16.840.1.113883.10.20.22.2.44:2015-08-01	Admission Medications Section (entries optional) (V3) 2.16.840.1.113883.10.20.22.2.44:2015-08-01	Listed as Admissions Medications Section (plural) instead of Admission (singular).
N/A	Dan Brown	Extra/incorrect template should be removed in High-Level Change Log.	Hospital Admission Diagnosis Section (V3) 2.16.840.1.113883.10.20.22.4.34:2015-08-01	None	The template is an R1.1 original template name. The V2 version in R2.0 does not include the 'Hospital' prefix and is instead 'Admission Diagnosis Section (V2)'. This is why it is not listed as a template in either the 2.0 or 2.1 'Template Ids in This Guide'. This was an erratum confusing the refactor to remove 'Hospital' as there is an Admission Diagnosis Section (V2) in R2.0 / urn:hl7ii:2.16.840.1.113883.10.20.22.2.43:2014-06-09 and an Admission Diagnosis Section (V3) in R2.1 / urn:hl7ii:2.16.840.1.113883.10.20.22.2.43:2015-08-01. Since Admission Diagnosis Section (V3) is listed already (first section template in the table), the 'Hospital' version can be removed. In addition, the templateID root given (.34) is for Hospital Admission Diagnosis (V3) which is for an entry, not a section, and is already listed in the entries part of the table. Proposing to remove the (Hospital Admission Diagnosis Section (V3) 2.16.840.1.113883.10.20.22.4.34:2015-08-01) template from the table altogether.
1198-10085	HL7 PCWG	It is not rare for a patient to have a resolution of an allergic condition therefore recommend the removal of the note due to clinical inaccuracy. It is generally accepted in the field of allergy practice that most childhood food allergies are outgrown by adulthood. Approximately 10% of the US Population has documentation in their medical record of penicillin allergy. The references at the two links that follow suggest that approximately 90% of those individuals with a documentation of penicillin allergy in their record have no reaction to penicillin on evaluation and challenge. [1][2]	"Note: It is clinically rare for an allergy to be "resolved", and therefore for the Concern to be resolved, even for patients undergoing allergy desensitization. As a result, effectiveTime/high will generally not be present."		This statement is not correct and should be removed.
1198-32835	HL7 PCWG	"C-CDAV2-DDN" Prognosis - this code does not exist in LOINC	i.SHALL contain exactly one [1..1] @code="C-CDAV2-DDN" Prognosis (CONF:1198-32835).		What does this code mean and where is it defined? The translation has a code that in not currently in LOINC database but has LOINC as code system - "C-CDAV2-DDN" Prognosis
1198-32847; 1198-32848	HL7 PCWG	Values seem to be missing in the LOINC list of values	Table 283: Problem Type values	Value set need to have cognitive function type for the patient. Need to support backwards compatibility for the SNOMED equivalent for Cognitive Function code for the patient (not just family member)	Can 75275-8 Cognitive Function be used? Can it be added to table 283: Problem Type list of values?
1198-32853	HL7 PCWG	Need a value set for the LOINC values used in translation	a.This code SHALL contain at least one [1..*] translation, which SHOULD be selected from CodeSystem LOINC (urn:oid:2.16.840.1.113883.6.1)CONF:1198-32853.		Please provide a value set for social history type with the applicable LOINC codes to support semantic interoperability.
N/A	Matthew Rahn	Clarification	This will enable implementers of systems conforming to this guide to produce documents that can be understood by systems which only support the C-CDA Release 1.1 specification.	Add clarifying sentence or two on what it means for a new system that only implements R2.1. If they only implement 2.1, will they be capable of receiving a R1.1 document?
Errata re criticality	Patient Care WG	See letter from Patient Care WG to Structured Docs WG: Patient Care WG Letter to Structured Docs WG 2015-6-30 and presentation to Structured Docs WG: Presentation to Structured Docs WG Re Criticality 2015-6-25	Existing wording: Currently the severity template links to both the reaction as well as the allergy/intolerance templates.	Proposed wording: Add new criticality template and associate with the allergy and intolerance condition. Remove conformance linking severity template to allergy and intolerance condition. New LOINC and SNOMED CT codes will be provided.
Various	Keith W. Boone	Several issues in attached spreadsheet File:Kwbcomments.xlsx	See spreadsheet	See spreadsheet	Will refactor into this format when I have time.
Allergy/Adverse Event Value Set Name (Errata)	HL7 Patient Care WG	Current Allergy and Intolerance Event value set name does not accurately reflect the concepts in the value set.	Value Set: Allergy/Adverse Event Type urn:oid:2.16.840.1.113883.3.88.12.3221.6.2 (SNOMED CT terms populate this value set: Allergy to substance (disorder) Drug allergy (disorder); Drug intolerance (disorder); Food allergy (disorder); Food intolerance (disorder); Propensity to adverse reactions (disorder); Propensity to adverse reactions to drug (disorder); Propensity to adverse reactions to food (disorder); Propensity to adverse reactions to substance (disorder); Dander (animal) allergy	Rename Value Set "Allergy and Intolerance Type Value Set" with the following definition: This value set includes concepts that represent a type of adverse sensitivity, allergy or intolerance.	Current definition includes the concept of adverse event. Concepts in the value set relate to adverse reactions, not adverse events. Therefore the name is misleading. Note this same name is carried through to VSAC. <NA>
NA	David Tao	Volume 1, section 3.3, 2nd bullet: Erroneous wording "records what was one..."	Generally, an act in EVN (event) mood is a discrete event (a user looks, listens, measures; records what was one),	Generally, an act in EVN (event) mood is a discrete event (a user looks, listens, measures; records what was done or observed),	I'm not sure what words were intended, but suggest an improvement above
NA	David Tao	Volume 1 Appendix B High Level Change Log, Volume 1 Summary of Changes: Typo on second bullet	New section describing the compatibilty principles for Release 2.1	New section describing the compatibility principles for Release 2.1
NA	David Tao	Volume 1 Appendix B, Volume 2 Summary of Changes: Typo on US Realm Header	Added R1.1 value set requirement for languageCommuncation	Added R1.1 value set requirement for languageCommunication
NA	David Tao	Volume 1 Appendix B, Volume 2 Summary of Changes: Question on Result Observation (V3)	Added R1.1 requirement to include organizer/code. The R2.0 organizer/code is optional.	Not sure, but the change log does not match the change actually made in Volume 2.	The highlighted text on page 779 (CONF 1198-7143) is about value, not code. There is no mention of organizer/code. It mentions that "b. A coded or physical quantity value MAY contain zero or more [0..*] translations..."
Vol. 1 Ch 3	Benjamin Flessner	Backwards compatibility by default or just enabled?	The new compatible template versions contain constraint modifications, which enables compatibility with C-CDA 1.1.	The new compatible template versions contain constraint modifications, which enables compatibility with C-CDA 1.1. Note that to produce a C-CDA 1.1-compatible document a document creator must still add secondary C-CDA 1.1 template IDs where appropriate.	Early on in the project we discussed whether 2.1 would have two modes (2.0-only and backwards-compatible) or be only for compatibility purposes. Since we settled on the latter (compatibility only), I thought that wherever possible, implementing only the 2.1 rules would automatically enable backwards-compatibility with 1.1. But in order to do this, you would have to require both the 1.1 templateId and the 2.1 templateId on sections which could be backwards compatible. Since this wording mentions "enabling" backwards compatibility, I would recommend clarifying that in order to actually be backwards compatible, the 1.1 templateIds need to be included.
Col. 1 Ch 3	Benjamin Flessner	Clarification on backwards compatibility	Support for specifications with dependencies on C-CDA Release 2.0		Do we make any recommendation to content creators C-CDA which specification they should use when creating documents for consumers they know can receive C-CDA2.0? Do we recommend they follow C-CDA2.0 rules or do we recommend they follow C-CDA2.1 rules but omit the backwards-compatible 1.1 templateIds? Re: the one vs two "modes" of C-CDA R2.1, the latter sounds a bit like the dual-mode option.
1198-5402	Corey Spears	Cardinality mismatch (zero to one and [1..1])	If country is US, this addr SHALL contain zero to one [1..1] state, which SHALL be selected from ValueSet StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC (CONF:1198-5402).	If country is US, this addr SHALL contain exactly one [1..1] state, which SHALL be selected from ValueSet StateValueSet 2.16.840.1.113883.3.88.12.80.1 DYNAMIC (CONF:1198-5402).	Should be the same requirement as in R1.1
1198-9501	Corey Spears	Unclear wording	SHALL include an Assessment and Plan Section, or an Assessment Section and a Plan of Treatment Section (CONF:1198-9501).	SHALL include an Assessment and Plan Section, or both an Assessment Section and a Plan of Treatment Section (CONF:1198-9501).	Should be worded clearer.
1198-9501	Corey Spears	Constraint negation	SHALL include an Assessment and Plan Section, or an Assessment Section and a Plan of Treatment Section (CONF:1198-9501).		This constraint negates the need for CONF:1198-28938, which states that these sections may be present.
1198-32835	Corey Spears	Invalid code	SHALL contain exactly one [1..1] @code="C-CDAV2-DDN" Prognosis (CONF:1198-32835).		C-CDAV2-DDN is not a valid LOINC code. Also, if this code translation is meant to represent prognosis, it is not a valid translation of the code="11535-2" Hospital Discharge Diagnosis
1198-8651	Corey Spears	invalid link	SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet AdvanceDirectiveTypeCode urn:oid:2.16.840.1.113883.1.11.20.2 STATIC 2006-10-17 (CONF:1198-8651).		The link for AdvanceDirectiveTypeCode is not valid
1198-7504	Corey Spears	typo	If statusCode/@code="active" Active, then effectiveTime SHALL contain 1..1] low (CONF:1198-7504).	If statusCode/@code="active" Active, then effectiveTime SHALL contain [1..1] low (CONF:1198-7504).	missing begin bracket "["
1198-8985	Corey Spears	Invalid requirement	SHALL contain exactly one [1..1] @negationInd (CONF:1198-8985).	MAY contain zero or one [0..1] @negationInd (CONF:1198-8985).	There is no reason for the @negationInd to be present if the activity is not being negated
1198-8558	Corey Spears	invalid link	SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Social History Type urn:oid:2.16.840.1.113883.3.88.12.80.60 STATIC 2008-12-18 (CONF:1198-8558).		The link for Social History Type is not valid
1198-14842	Corey Spears	Relaxation of constraint	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).		R1.1 requires @code
1198-8520	Corey Spears	Relaxation of constraint	This serviceEvent SHALL contain at least one [1..*] performer (CONF:1198-8520)		R1.1 requires exactly 1 performer (with its following constraints)
N/A	Corey Spears	Missing constraint			Missing R1.1 constraint "SHALL contain exactly one [1..1] author/assignedAuthor (CONF:7640)."
N/A	Corey Spears	Missing constraint			Missing R1.1 constraint "his author/assignedAuthor SHALL contain exactly one [1..1] addr (CONF:7641)."
N/A	Corey Spears	Missing constraint			Missing R1.1 constraint "This author/assignedAuthor SHALL contain exactly one [1..1] telecom (CONF:7642)."
N/A	Corey Spears	Missing constraint			Missing R1.1 constraint "This custodian/assignedCustodian/representedCustodianOrganization SHALL contain exactly one [1..1] id (CONF:7648)."
NA	Emma Jones	Table 38:NUBC UB-04 FL17 Patient Status	Code 01 Discharged/transferred to a Short-Term General Hospital for Inpatient Care	Code 02 Discharged/transferred to a Short-Term General Hospital for Inpatient Care	The second code 01 is incorrect. Code should be 02
*	*	*	End of Comments	*	*