USCDI V4 Smoking Status Validator Failure Using Example Reference Section

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Chara McMunn

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Aug 18, 2026, 7:44:01 PMAug 18
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Validation Failure using C-CDA USCDI V4 Validator
https://site.healthit.gov/c-cda/uscdi-v4

Example entry for template Id 2.16.840.1.113883.10.20.22.4.511 from https://hl7.org/cda/us/ccda/3.0.0/Binary-social-history-section-example.html

Validation Error 
Result Description: The 'SmokingStatusUSCDISmokingStatusUSCDICode' invariant is violated on 'org.openhealthtools.mdht.uml.cda.consol.impl.SmokingStatusUSCDIImpl@638da43d{http:///resource14248.xml#//@clinicalDocument/@component/@structuredBody/@component.11/@section/@entry.0/@observation}'
XPath: /ClinicalDocument/component/structuredBody/component[12]/section/entry/observation
Line Number: 394

See attached results and xml document. Please advise as it does not appear that we are violating structural definition. If known issue, ETA on release. 
SQAFC6120_RemoveTemplate2.xml
CCDA_USCDIV4_Results.pdf

Prahbu Shankar

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Aug 20, 2026, 11:46:54 AMAug 20
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Hello,

Use correct template for smoking status. Instead of 2.16.840.1.113883.10.20.22.4.511  use 2.16.840.1.113883.10.20.22.4.78


Thanks,
-Prabhu

Kyle Meadors

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Aug 22, 2026, 4:25:19 PMAug 22
to Prahbu Shankar, Edge Test Tool (ETT)
I think the issue that Chara is raising is that USCDI v4 in the CCDA moves to the Consolidated CCDA vs 3.0 IG standard which now combines the base CCDA IG spec with the old CCDA Companion Guide - we now just have 1 document to follow instead of two. 

In vs 3.0 for the CCDA IG ( https://hl7.org/cda/us/ccda/3.0.0/uscdi.html), the Smoking Status template (2.16.840.1.113883.10.20.22.4.511:2024-05-01) is combination and replacement of the two previous templates Smoking Status - Meaningful Use ( 2.16.840.1.113883.10.20.22.4.78 ) and Tobacco Use, and it aligns with the US Core Smoking Status profile in USCDI v4 and going v5, v6, etc.

However, the SITE test tool is still using the previous vs 2.1 CCDA IG but trying to fit USCDI v4 in it, but that is not the right approach to my understanding. We now need to move to vs 3.0 of the CCDA IG to support USCDI v4 because we don't have a separate CCDA Companion Guide to instruct us on how to map USCDI data elements uniformly into the CCDA. 

In this situation, I think the USCDI v4 CCDA validator is still following the old rules for USCDI v3/CCDA vs 2.1 IG/CCDA Companion Guide vs 4.1 and expecting smoking status to be in the 2.16.840.1.113883.10.20.22.4.78 template, but that template is now retired in USCDI v4/CCDA vs 3.0.

I know this is something of a condundrum in that we are in-between regulations with only USCDI v3/CCDA IG 2.1 required (although we do have SVAP). I do think the tool will eventually get updated to align with the spec, but I understand SITE developer may not be authorized yet to do that. 

Anyway, I think the error Chara sees in the USCDI v4 validator is a false negative - her file looks corrected - but until tool is updated to support vs 3.0 we may be stuck with this error. 




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Kyle Meadors
@kylemeadors

Chara McMunn

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Aug 26, 2026, 8:27:43 AMAug 26
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Prahbu Shankar  - Kyle is correct. Can you please update?
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