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Advisory: Advance Directive Status Value Derived from CDA and C-CDA May Be Misleading

This problem affects the following products:

  • HealthShare Unified Care Record, all versions
  • HealthShare Clinical Viewer, all versions
  • HealthShare Health Connect, all versions
  • InterSystems IRIS for Health, all versions

The Advance Directive streamlet in the SDA data model contains a Status property which is populated by CDA and C-CDA transformations. The Status is derived as “Active” or “Inactive” depending upon data in the CDA or C-CDA document.
In a C-CDA 1.1 or C-CDA 2.1 document:

  • if the Advance Directive observation entry has an effectiveTime set in the past or the entry's effectiveTime/high is null or absent, the SDA Advance Directive Status property will be set to “I” for “Inactive”.
  • If the entry's effectiveTime is in the future, the SDA  Status property will be set to “A” for “Active”.

Unless updated data is later received, this value will not be updated when the effectiveTime has passed.

For example, in the following Advance Directive entry in a C-CDA 1.1 or C-CDA 2.1 document, the value for effectiveTime/high is in the future. This will be derived as an SDA Status equal to “A”. When the effectiveTime/high date passes, the SDA Status value will not be updated unless updated data is received by the system.

<entry>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.48"/>
<!-- ** Advance Directive Observation ** -->
<id root="9b54c3c9-1673-49c7-aef9-b037ed72ed27"/>
<code code="304251008" codeSystem="2.16.840.1.113883.6.96" displayName="Resuscitation"/>
<statusCode code="completed" />
<effectiveTime>
<low value="20210101"/>
<high value="20230101"/>
</effectiveTime>
...
</entry>

NOTE: the C-CDA 1.1 and 2.2 specifications require that statusCode is always equal to “completed”. Therefore, it is not meaningful to determine whether the Advance Directive is active or not.

Within the out-of-the-box Clinical Viewer, Advance Directives are displayed as part of the Alert profile page and include the data items Alert Category, Alert, Message, External ID, Entered On and Create User Role. Prior to Clinical Viewer version 2022.1, Status and End Date were not available in the Alert profile page.

This may pose a clinical safety risk as the Advance Directive is inappropriately represented as active when it has expired or is inappropriately represented as inactive when it is in effect. In either situation, the Advance Directive may be improperly applied, resulting in potential harm to the patient. Within the Clinical Viewer, users may not be aware that the information being displayed has expired.

The following mitigating factors have been identified:

  • The “Active” Status value is accurate at the time the data is ingested.
  • If the document is reprocessed, the Status value will be updated using the current date.
  • If an updated document is received, the Status value will be updated using the current date.
  • The effectiveTime values are retained. They are stored in the SDA AdvanceDirective streamlet ToTime and FromTime properties. 
  • This issue does not affect data from CDA C32 documents. See the Additional Information section of this advisory for more information.
  • The out-of-the-box Clinical Viewer 2022.1 displays both the Status (Status) and End Date (ToTime) data items. Users may reference both values to better assess the status of the information. 

Who is Affected by This Issue

  • HealthShare customers are affected by this issue if they ingest C-CCDA 1.1 or C-CDA 2.1 documents containing Advance Directive data.
  • Health Connect and IRIS for Health customers are affected by this issue if they ingest C-CCDA 1.1 or C-CDA 2.1 documents containing Advance Directive data and they store that data in SDA.
  • Within Clinical Viewer, HealthShare customers are affected by this issue if the standard display for alerts within the Clinical Viewer is used.

A fix is not yet available for the core issue affecting the validity over time of Status values within HealthShare. A fix is available for Clinical Viewer to display the Status and End Date data items in the Alert display. The Clinical Viewer fix is included in the 2022.1 release and can be requested as an ad hoc patch in HSCV-10983.
InterSystems recommends that customers apply the Clinical Viewer fix and notify their users and recipients of outbound data that Advance Directive Status information should not be relied upon for clinical decision making.

Additional Information

InterSystem's CDA C32 document transformation is not affected by this issue. It derives the SDA Status value differently than the C-CDA 1.1 and 2.1 transformations. The CDA C32 specification permits the usage of an Advance Directive Status Observation which has a required ValueSet 2.16.840.1.113883.1.11.20.1 AdvanceDirectiveStatusCode. This ValueSet is detailed in the table below. Note that the displayName values for these codes have evolved over time, the table below shows the displayName values as they are documented in the CDA C32 specification.

AdvanceDirectiveStatusCode:

code
displayName
codeSystem
Code System Name
425392003
Current and Verified
2.16.840.1.113883.6.96
SNOMED CT
425394002
Supported By Healthcare Will
2.16.840.1.113883.6.96
SNOMED CT
425393008
Supported By Durable Power of Attorney for Healthcare
2.16.840.1.113883.6.96
SNOMED CT
425396000
Verified With Family Only
2.16.840.1.113883.6.96
SNOMED CT
310305009
Verified By Medical Record Only
2.16.840.1.113883.6.96
SNOMED CT

The InterSystems CDA C32 data transformation will derive a value of “A” for “Active” if the Advance Directive Status Observation has a value matching one of the codes above or the additional SNOMED codes 425397009 (Active advance directive with verification by healthcare professional (finding)) and 425395001 (Active living will). All other values, or null values, will be derived as “I” for “Inactive”.

Reference Information

The core data issue is identified as HSIEC-4365.

The Clinical Viewer fix is identified as HSCV-10983. HSCV-10983 is included in the Clinical Viewer 2022.1 release and can be requested as an ad hoc patch from the Worldwide Response Center (WRC).

If you have any questions regarding this alert, please contact the WRC.