1. Dual-Conformant C-CDA
Recommendations and options to resolve inconsistencies

2. Approach Identify required changes Identify difficulties
templates which cannot be dual-conformant
Consider errata on 2.0 to support older systems
Identify difficulties
Two SHOULD conformance statements with different vocabulary
Recommend following 1.1 conformance guidelines when creating dual- conformant documents
Identify confusion points where a 1.1 receiver expects information in a different location
Should not send duplicative information (data in both locations)

3. Vital Signs Organizer – Change Required 2. 16. 840. 1. 113883. 10. 20
C-CDA 1.1 – code required
C-CDA 2.0 – code optional, but if present, must be SNOMED
SHALL contain exactly one [1..1] code (CONF:19176).
This code SHALL contain exactly one Vital signs (CodeSystem: SNOMED-CT STATIC) (CONF:19177).
MAY contain zero or one [0..1] code (CONF: ).
The code, if present, SHALL contain exactly one Vital signs, weight, height, head circumference, oximetry, BMI, and BSA panel - HL7.CCDAr1.1 (CodeSystem: LOINC ) (CONF: ).
The code, if present, SHALL contain exactly one [1..1] @codeSystem=" " LOINC (CONF: ).

4. Vital Signs Organizer - Details
Vital Signs section requires a Vital Signs Organizer
Dual-conformant section
Requires a single code (per 1.1)
The code + codeSystem attributes cannot simultaneously be both LOINC and SNOMED
Suggested solution: Errata on C-CDA R2.0 to relax required binding to LOINC.
Source comment: 106 (Daniel Vreeman, Regenstrief Institute, Inc): The set of vital sign observations is drawn from LOINC, so the Organizer should at least allow for the LOINC panel code for this set to be used as the organizer code. I recommend that it be the required code because it means exactly this set of elements. (Persuasive 15/0/10 on Jan 21)

5. Vital Signs Organizer – Alternative options
Create errata on 2.0 template:
Add primitive constraint on & : If the organizer is not dual capable (does not contain a second templateId with root= and no extension), then require the LOINC code
Strongest constraint, testable with schematron
Simpler: make a branch: MAY contain zero or one [0..1] code such that it.
Essentially disables the verification; turns the whole conformance into a MAY
Alternative: Create a 2-code Value Set
Current 2.0 template
MAY contain zero or one [0..1] code (CONF: ).
The code, if present, SHALL contain exactly one Vital signs, weight, height, head circumference, oximetry, BMI, and BSA panel - HL7.CCDAr1.1 (CodeSystem: LOINC ) (CONF: ).
The code, if present, SHALL contain exactly one [1..1] @codeSystem=" " LOINC (CONF: ).

6. Tobacco Use – Change required 2. 16. 840. 1. 113883. 10. 20. 22. 4
C-CDA 1.1 – ASSERTION code
C-CDA 2.0 – LOINC code
SHALL contain exactly one [1..1] code (CONF:19174).
This code SHALL contain exactly one Assertion (CodeSystem: ActCode STATIC) (CONF:19175).
SHALL contain exactly one [1..1] code (CONF: ).
This code SHALL contain exactly one History of tobacco use (CONF: ).
This code SHALL contain exactly one [1..1] @codeSystem=" " (CodeSystem: LOINC ) (CONF: ).

7. Tobacco Use - Details
Both templates require the code element, but require different values for the code attribute
Suggested solution: Errata on C-CDA R2.0 to relax required binding to LOINC.
Source comment: 62 & 66 (Daniel Vreeman, Regenstrief Institute, Inc): LOINC is the HITSC-adopted vocabulary for observations about patient characteristics, including tobacco use. SNOMED CT for answer/response value. The observable code should be drawn from LOINC. (Persuasive 34/0/0 on Nov 21)

8. Tobacco Use – Alternative options
Create errata on 2.0 template:
Add primitive constraint on 19174: If the observation is not dual capable (does not contain a second templateId with root= and no extension), then require the LOINC code
Strongest constraint, testable with schematron
Alternative: Create a 2-code Value Set
Current 2.0 template:
SHALL contain exactly one [1..1] code (CONF: ).
This code SHALL contain exactly one History of tobacco use (CONF: ).
This code SHALL contain exactly one [1..1] @codeSystem=" " (CodeSystem: LOINC ) (CONF: ).

9. Smoking Status – Change required 2. 16. 840. 1. 113883. 10. 20. 22. 4
C-CDA 1.1
C-CDA 2.0
SHALL contain exactly one [1..1] code (CONF:19170).
This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CodeSystem: ActCode STATIC) (CONF:19171).
SHALL contain exactly one [1..1] statusCode (CONF:14809).
This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: ActStatus STATIC) (CONF:19116).
SHALL contain exactly one [1..1] effectiveTime (CONF:14814).
This effectiveTime SHALL contain exactly one [1..1] low (CONF:14818).
SHALL contain exactly one [1..1] value (CONF:14810).
This value SHALL contain exactly one which SHALL be selected from ValueSet Smoking Status STATIC (CONF:14817).
SHALL contain exactly one [1..1] code (CONF: ).
This code SHALL contain exactly one Tobacco smoking status NHIS (CONF: ).
This code SHALL contain exactly one [1..1] @codeSystem=" " (CodeSystem: LOINC ) (CONF: ).
SHALL contain exactly one [1..1] statusCode (CONF: ).
This statusCode SHALL contain exactly one Completed (CodeSystem: ActStatus STATIC) (CONF: ).
SHALL contain exactly one [1..1] effectiveTime (CONF: ). Note: This template represents a “snapshot in time” observation, simply reflecting what the patient’s current smoking status is at the time of the observation. As a result, the effectiveTime is constrained to just a time stamp, and will approximately correspond with the author/time.
SHALL contain exactly one [1..1] value (CONF: ).
This value SHALL contain exactly one which SHALL be selected from ValueSet Current Smoking Status STATIC (CONF: ).
If the patient's current smoking status is SHALL contain ' ' (Unknown if ever smoked) from ValueSet Current Smoking Status ( STATIC ) (CONF: ).
*Based on published version of 1.1

10. Smoking Status - Details
Code changed from ASSERTION to LOINC
effectiveTime changed from SHALL contain [1..1] low to a TS attribute instead of a low element)
Value Set added 2 new codes, but these were already being exchanged in 1.1 and allowed in MU2 validation tools

11. Smoking Status – Suggestion
Implement R1.1 Errata 596 (approved on 2/19/2015)
Update R1.1 to align with R2.0
Update text on smoking status template, and tobacco use template to match R2.
Update smoking status to no longer require effectiveTime/low. Update to TS.
Clarification on 4/23 the that 3 items above are just examples. Full alignment was intended.
Problem: MU2 validators are still requiring the low attribute and 1.1 ASSERTION code (as of 5/11/2015) – need to fix validator.

12. Discharge Summary Sections – Change Required
C-CDA 1.1
C-CDA 2.0
Hospital Discharge Diagnosis Section (SHALL) ( )
@code=“ ” Hospital Discharge Diagnosis (CONF: 15356)
Hospital Discharge Medications Section (entries optional) (SHALL) ( )
@code=" " Hospital Discharge Medications (CONF:15360).
Hospital Admission Diagnosis (MAY) ( )
@code=" " Hospital Admission Diagnosis (CONF:15480).
Hospital Admission Medications (MAY)
@code=" " Medications on Admission (CONF:15483)
Discharge Diagnosis Section (V2) (SHALL) ( : ) (SHALL)
@code="C-CDAV2-DDN" Prognosis LOINC (CONF: ).
Discharge Medications Section (entries optional) (V2) (SHOULD) ( : )
@code=" " Discharge medications (CONF: )
Admission Diagnosis (V2) (MAY) ( : )
@code=" " Admission diagnosis (CONF: ).
Admission Medications V2 (MAY)
@code=" " Medications on Admission (CONF: ).
Discharge Medications (entries required) (V2) (MAY) (same section code as entries optional)

13. Discharge Summary Sections - Details
Discharge Dx, Discharge Meds, Admission Dx changed section code
Discharge Dx V2 section code is not a proper LOINC code publication)
Admission Meds changed name but NOT section code
2.0 relaxed Discharge Meds (entries optional) from SHALL to SHOULD, but added Discharge Meds (entries required) as MAY
The two Discharge sections are required in R1.1 Discharge Summary document
Most sections were not ballot-able, the others were only versioned because their child templates were versioned
Source comment (several, this is an example) 41: (Larry Garber) This template could be used by Nursing Facilities and Home Health Agencies if the word "Hospital" was removed from the title. 216: (Jennie Harvell) Rename section because discharges aren't always from hospitals
Comments were made on all Hospital* templates; most were NOT updated in R2
Commenters did not request new LOINC codes; these were suggested by disposition comments

14. Discharge Summary Sections – Suggestion
Recommended: Create a Value Set for each section, containing the 1.1 and 2.0 section codes
When implementing a dual-conformant section, choose the 1.1 section code
Alternative: Undo section code changes via 2.0 errata
As implemented, C-CDA R2.0 does not completely meet the need requested by balloters anyway
Add guidance that existing Hospital* sections may still be used by non- hospital systems
Not Recommended: Send duplicate sections, one with the 1.1 code and one with the 2.0 code

15. Problem Type Value Set – Difference 2. 16. 840. 1. 113883. 10. 20. 22
C-CDA 1.1
C-CDA 2.0
SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type STATIC (CONF:8589).
SHALL contain exactly one [1..1] code, which SHOULD be selected from ValueSet Problem Type STATIC (CONF: ).
Value Set: Problem Type STATIC
Code System(s):
SNOMED CT
Description:
This value set indicates the level of medical judgment used to determine the existence of a problem.
Code
Code System
Print Name
SNOMED CT
Finding
Complaint
Diagnosis
Value Set: Problem Type
This value set indicates the level of medical judgment used to determine the existence of a problem.
Value Set Source:
Code
Code System
Code System OID
Print Name
LOINC
Problem HL7.CCDAR2
Symptom HL7.CCDAR2
Functional performance HL7.CCDAR2
Condition HL7.CCDAR2
Diagnosis
Complaint HL7.CCDAR2

16. Problem Type – Details
Conformance statement looks the same, pointing to the same Value Set OID with STATIC binding
1.1 Value Set are SNOMED codes
2.0 Value Set are LOINC codes
Value Set binding is a SHOULD
Suggestion: Use the 1.1 Value Set when creating a dual-conformant C-CDA
1.1 erroneously considers this SHOULD an error. See DSTU comment: 25

17. Advance Directives Type Value Set – Difference 2. 16. 840. 1. 113883
C-CDA 1.1
C-CDA 2.0
SHALL contain exactly one [1..1] code, where SHOULD be selected from ValueSet AdvanceDirectiveTypeCode STATIC (CONF:8651).
SNOMED Intubation SNOMED Tube Feedings SNOMED Other Directive SNOMED Life Support SNOMED CPR SNOMED IV Fluid & Support SNOMED Antibiotics SNOMED Resuscitation
SHALL contain exactly one [1..1] code (CONF: ).
This code SHALL contain exactly one Advance directive status (CONF: ).
This code SHALL contain exactly one [1..1] @codeSystem=" " (CodeSystem: LOINC ) (CONF: ).

18. Adv. Directive Type – Details
1.1 is SHOULD binding to a Value Set of SNOMED codes
2.0 is SHALL binding to one LOINC code
Suggestion: use the R2.0 LOINC in dual capable
1.1 Schematron erroneously considers this SHOULD an error. See DSTU comment (NIST TTT implemented correctly): 25

19. Goals updates
1.1 Goals were included in Plan of Care or Assessment & Plan section
Discretely via Plan of Care Activity Observation (no code or value restrictions)
2.0 introduced the Goals Section with a new Goals Template
Only required / listed in new Care Plan document template
Discretely via Goal Observation
Easily conformant with 1.1 Plan of Care Activity Observation
Also listed in the Plan of Treatment section as an optional entry
Recommendation
Unless implementing the 2.0 Care Plan document, continue to record goals in the Plan of Treatment section

20. Confusion – Functional / Cognitive / Mental
C-CDA 1.1 – Functional Status Section
Cognitive Status Problem Obs
Cognitive Status Result Obs
Cognitive Status Result Org
Functional Status Problem Obs
Functional Status Result Obs
Functional Status Result Org
Highest Pressure Ulcer Stage
Number of Pressure Ulcers
Pressure Ulcer Obs
C-CDA 2.0 – Mental Status Section
Mental Status Obs (fka Cognitive Result Obs)
Mental Status Org (fka Cognitive Result Org)
C-CDA 2.0 – Functional Status Section
Cognitive Status Problem Obs (Deprecated)
Functional Status Obs (V2) (fka Result Obs)
Functional Status Org (V2) (fka Result Org)
Functional Status Problem Obs (Deprecated)
Pressure Ulcer Obs (Deprecated)
Self-Care Activities (ADL & IADL) (New)
Sensory Status (New)

21. Functional / Mental Explanation
Many changes and restructuring will likely confuse 1.1 receivers
Cognitive status has moved from the Functional Status section in 1.1 to the Mental Status section in 2.0
Entries have been simplified, but slightly unclearly
1.1 Functional Status Result Organizer  2.0 Functional Status Organizer
1.1 Functional Status Result Observation  2.0 Functional Status Obsevation
1.1 Functional Status Problem Obs  Deprecated (use Status Obs)
1.1 Cognitive Status Result Organizer  2.0 Mental Status Organizer
1.1 Cognitive Status Result Observation  2.0 Mental Status Observation
1.1 Cognitive Status Problem Obs  Deprecated (use Status Obs)
Ulcer Observations have also wiggled around (may need new slide)