Disability Status and Functional Status Observation validations

Danny Wise

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Sep 2, 2025, 6:58:58 PMSep 2

to Edge Test Tool (ETT)

I see in the Release Notes for V4.1.7 that was deployed over the weekend:

Updated Functional Status validation to enforce Disability Status and Functional Status Observations in content validation

A couple comments / questions:

The validator now enforces the specific CUBS Disability Status answer indicated in several USCDI V3 scenarios, e.g. "170.315_b1_toc_amb_svap_uscdiv3_sample1_v1:"

Please be aware that CUBS (Comprehensive Universal Behavior Screen) is technically 3rd-party IP that requires licensing fees for implementers to incorporate it into their systems. Particularly for systems that do not support the ability for users to enter their own screening questionnaires, these licensing fees may be a barrier to some developers for system-delivering the CUBS-specific question. Note that the C-CDA Companion Guide R4.1 only indicates a "MAY" binding for the CUBS answer set in the Disability Status Observation template. We had been using a nullFlavor for observation/value in the Disability Status Observation template and it passed the validator successfully, but today that is now causing an error:

Result Description: The scenario requires Patient's Disability Status Observation data but the submitted C-CDA does not contain Disability Status Observation data.

FYI -- I also recently logged an STU Jira comment for the Companion Guide about similar concerns for the Disability Status Observation template definition: https://jira.hl7.org/browse/CDA-21379
I'm now getting errors about the Functional Status Observation for several of the USCDI V3 scenarios, e.g. "170.315_b1_toc_amb_svap_uscdiv3_sample1_v1" (for what it's worth, the same functional status was also specified in the USCDI V1 scenario "170.315_b1_toc_amb_sample1_v2"):

Result Description: The scenario requires Patient's Functional Status Observation data but the submitted C-CDA does not contain Functional Status Observation data.

I am not seeing what about our current implementation is causing this error, however -- what specifically is the validator looking for now? We currently generate Functional Status Observation entries like below directly in the Functional Status section (i.e., not in an organizer):

<entry>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.67"/>
<templateId root="2.16.840.1.113883.10.20.22.4.67" extension="2014-06-09"/>
<id root="2.16.840.1.113883.3.3388.1.1.1.996261.3.948556577.1.3.2" extension="860b4f3e-b1ae-4018-b640-36d1092367d0"/>
<code code="54522-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Functional status"/>
<text>
<reference value="#functional-860b4f3e-b1ae-4018-b640-36d1092367d0"/>
</text>
<statusCode code="completed"/>
<effectiveTime xsi:type="IVL_TS">
<low value="20050501"/>
</effectiveTime>
<value xsi:type="CD" code="105504002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Dependence on walking stick"/>
</observation>
</entry>

Nagesh Bashyam

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Sep 3, 2025, 8:07:23 AMSep 3

to Danny Wise, Edge Test Tool (ETT)

Functional Status Observations are being validated to be present within the /entry/organizer/component/observation.

We will consult internally if we can relax it and just use it as /entry/observation.

With respect to CUBS, is there are different set of questionnaires that you are using. Any insights would be useful for us to provide the data to ASTP for recommendations.

From: 'Danny Wise' via Edge Test Tool (ETT) <edge-te...@googlegroups.com>
Date: Tuesday, September 2, 2025 at 6:59 PM
To: Edge Test Tool (ETT) <edge-te...@googlegroups.com>
Subject: Disability Status and Functional Status Observation validations

I see in the Release Notes for V4.1.7 that was deployed over the weekend:

Updated Functional Status validation to enforce Disability Status and Functional Status Observations in content validation

A couple comments / questions:

The validator now enforces the specific CUBS Disability Status answer indicated in several USCDI V3 scenarios, e.g. "170.315_b1_toc_amb_svap_uscdiv3_sample1_v1:"

Please be aware that CUBS (Comprehensive Universal Behavior Screen) is technically 3rd-party IP that requires licensing fees for implementers to incorporate it into their systems. Particularly for systems that do not support the ability for users to enter their own screening questionnaires, these licensing fees may be a barrier to some developers for system-delivering the CUBS-specific question. Note that the C-CDA Companion Guide R4.1 only indicates a "MAY" binding for the CUBS answer set in the Disability Status Observation template. We had been using a nullFlavor for observation/value in the Disability Status Observation template and it passed the validator successfully, but today that is now causing an error:

Result Description: The scenario requires Patient's Disability Status Observation data but the submitted C-CDA does not contain Disability Status Observation data.

FYI -- I also recently logged an STU Jira comment for the Companion Guide about similar concerns for the Disability Status Observation template definition: https://jira.hl7.org/browse/CDA-21379

I'm now getting errors about the Functional Status Observation for several of the USCDI V3 scenarios, e.g. "170.315_b1_toc_amb_svap_uscdiv3_sample1_v1" (for what it's worth, the same functional status was also specified in the USCDI V1 scenario "170.315_b1_toc_amb_sample1_v2"):

Result Description: The scenario requires Patient's Functional Status Observation data but the submitted C-CDA does not contain Functional Status Observation data.

I am not seeing what about our current implementation is causing this error, however -- what specifically is the validator looking for now? We currently generate Functional Status Observation entries like below directly in the Functional Status section (i.e., not in an organizer):

<entry>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.67"/>
<templateId root="2.16.840.1.113883.10.20.22.4.67" extension="2014-06-09"/>
<id root="2.16.840.1.113883.3.3388.1.1.1.996261.3.948556577.1.3.2" extension="860b4f3e-b1ae-4018-b640-36d1092367d0"/>
<code code="54522-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Functional status"/>
<text>
<reference value="#functional-860b4f3e-b1ae-4018-b640-36d1092367d0"/>
</text>
<statusCode code="completed"/>
<effectiveTime xsi:type="IVL_TS">
<low value="20050501"/>
</effectiveTime>
<value xsi:type="CD" code="105504002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Dependence on walking stick"/>
</observation>
</entry>

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Danny Wise

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Sep 4, 2025, 7:50:19 AMSep 4

to Edge Test Tool (ETT)

Thank you Dragon,

Regarding Functional Status Observations, I’ll note:

The Functional Status Section definition allows them to be present as independent entries (i.e., outside of any Functional Status Organizers)
The Functional Status Organizer template requires that at least one “Self Care Activities (ADL and IADL)” component observation (templateId 2.16.840.1.113883.10.20.22.4.128) also be present. Supporting that additional template would add data capture scope that is not specified in the test scenario documentation – that doesn’t seem to be strictly necessary for the USCDI “Functional Status” data element, nor is it explicitly required by US Core for representing Functional Status via FHIR.

For those reasons, I fully support and encourage updating the validator to accept a “stand-alone” Functional Status Observation entry outside of any Functional Status Organizer.

Regarding Disability Status, we are supporting the 6 yes/no disability status questions from the American Community Survey (https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/43681/index.pdf#page=7) since they are in the public domain. As suggested in the Disability Status Observation template definition, these are represented via Assessment Scale Supporting Observations, but we have been using a nullFlavor for the CUBS-specific value element in the “parent” Disability Status Observation – see the full example below:

</text>
<statusCode code="completed"/>
<effectiveTime xsi:type="IVL_TS">

<templateId root="2.16.840.1.113883.10.20.22.4.69"/>
<templateId root="2.16.840.1.113883.10.20.22.4.69" extension="2022-06-01"/>
<id root="2.16.840.1.113883.3.3388.1.1.1.996261.3.1730205414.1.3.2" extension="assessment-scale-observation-e64d46d8-c3e8-42dc-bc7a-1c91e49beb92"/>
<code code="69919-9" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Race, ethnicity, sex, primary language, disability - Health and Human Services (HHS) panel "/>
<statusCode code="completed"/>
<effectiveTime value="20250902162907+0000"/>
<value xsi:type="CD" nullFlavor="NA"/>
<author>
<templateId root="2.16.840.1.113883.10.20.22.4.119"/>
<time value="20250902162907+0000"/>
<assignedAuthor>
<id root="2.16.840.1.113883.4.6" extension="1122334455"/>
<id root="2.16.840.1.113883.3.3388.3.9" extension="ad7d4adb-5b90-41a2-9050-11600de0af20"/>
<assignedPerson>
<name>
<prefix>Dr</prefix>
<given>Albert</given>
<family>Davis</family>
</name>
</assignedPerson>
<representedOrganization>
<name>Neighborhood Physicians Practice</name>
</representedOrganization>
</assignedAuthor>
</author>
<entryRelationship typeCode="COMP">

Nagesh Bashyam

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Sep 4, 2025, 7:53:49 AMSep 4

to Danny Wise, Edge Test Tool (ETT)

Danny

We are also leaning towards supporting both, just waiting on confirmation before we make the change.

Thanks

Dragon

Please be aware that CUBS (Comprehensive Universal Behavior Screen) is technically 3rd-party IP that requires licensing fees for implementers to incorporate it into their systems. Particularly for systems that do not support the ability for users to enter their own screening questionnaires, these licensing fees may be a barrier to some developers for system-delivering the CUBS-specific question. Note that the C-CDA Companion Guide R4.1 only indicates a "MAY" binding for the CUBS answer set in the Disability Status Observation template. We had been using a nullFlavor for observation/value in the Disability Status Observation template and it passed the validator successfully, but today that is now causing an error:

Result Description: The scenario requires Patient's Disability Status Observation data but the submitted C-CDA does not contain Disability Status Observation data.

FYI -- I also recently logged an STU Jira comment for the Companion Guide about similar concerns for the Disability Status Observation template definition: https://jira.hl7.org/browse/CDA-21379

I'm now getting errors about the Functional Status Observation for several of the USCDI V3 scenarios, e.g. "170.315_b1_toc_amb_svap_uscdiv3_sample1_v1" (for what it's worth, the same functional status was also specified in the USCDI V1 scenario "170.315_b1_toc_amb_sample1_v2"):

Result Description: The scenario requires Patient's Functional Status Observation data but the submitted C-CDA does not contain Functional Status Observation data.

I am not seeing what about our current implementation is causing this error, however -- what specifically is the validator looking for now? We currently generate Functional Status Observation entries like below directly in the Functional Status section (i.e., not in an organizer):

<entry>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.67"/>
<templateId root="2.16.840.1.113883.10.20.22.4.67" extension="2014-06-09"/>
<id root="2.16.840.1.113883.3.3388.1.1.1.996261.3.948556577.1.3.2" extension="860b4f3e-b1ae-4018-b640-36d1092367d0"/>
<code code="54522-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Functional status"/>
<text>
<reference value="#functional-860b4f3e-b1ae-4018-b640-36d1092367d0"/>
</text>
<statusCode code="completed"/>
<effectiveTime xsi:type="IVL_TS">
<low value="20050501"/>
</effectiveTime>
<value xsi:type="CD" code="105504002" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Dependence on walking stick"/>
</observation>
</entry>

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br...@waveoneassociates.com

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Sep 4, 2025, 11:37:53 AMSep 4

to Edge Test Tool (ETT)

Hi, Danny!

HL7 Structured Documents reviewed your tracker (https://jira.hl7.org/browse/CDA-21379) in detail this morning. The committee agreed that C-CDA requiring a potentially IP-restricted code is not best practice.

During the discussion, one vendor reported that they have been using the 89556-5 code for both CUBS and other general disability assessments, since they did not consider the code to be restricted to CUBS alone.

This topic will remain on the agenda next week. If you’re able to join, the call is Thursday from 10:00 AM - 12:00 PM ET.

Best

Brett

Danny Wise

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Nov 20, 2025, 11:55:38 AM (yesterday) Nov 20

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Brett / Dragon,

Are there still plans for (or at least conversations around) updating the validator for the following?

Accept Functional Status Observation as either its own Functional Status Section entry or nested inside a Functional Status Organizer (C-CDA allows both)
Not require CUBS IP for Disability Status Observation value (e.g., LA29243-5 "I'm Vulnerable - I sometimes or periodically have acute or chronic symptoms affecting housing, employment, social interactions, etc.")

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