This problem affects the following products:
HealthShare Unified Care Record:
- version 2020.2 and higher
- any installation on a version earlier than 2020.2 for which the original negation indicator patch was applied (Alert HS2020-04-01: HSIEC-2030, HSIEC-2219; Alert HS2020-08-01: SKK1046, SKK1047, SKK1048, SRF709)
Clinical Document Architecture (CDA) documents can contain clinical data that is “negated” to represent a clinical concept that is known to be absent or untrue:
- Negation may apply to general concepts, such as documenting that a patient does not have any known drug allergies or did not receive any medications during an encounter.
- Negation may also apply to specific concepts, such as documenting that a patient did not receive a specific vaccination.
Because the meaning can be unclear, Unified Care Record (UCR) skips negated concepts when it transforms CDA to SDA on import.
When UCR processes CDA documents, it performs a negationInd check at the
<component>
<section>
<entry>
level for all the sections in CDA.
If the transformation code encounters negationInd=true anywhere within the <entry>, the entire entry is skipped.
This behavior is incorrect in the case of some sections like Family History, Results, and Vital Signs because these sections may contain an entry <organizer> where a single <entry> represents multiple exclusive data points, for example:
<entry … >
<organizer … >
…
<component>
<observation … negationInd="true">
…
</observation>
</component>
<component>
<observation>
…
</observation>
</component>
Skipping import for the complete <entry> in these sections means that some data which is not negated and could be imported is erroneously skipped, like the second observation in the example above.
Omitting clinical data that could be imported into Unified Care Record represents a clinical safety risk.
A correction for C32, CCDAv11 and CCDAv21 inbound transformations changes the behavior so that UCR excludes only the <component> within an <entry> when negationInd=true is encountered within the component for sections that, as per CCDAv21 specifications, can have an entry x-path like <ClinicalDocument> -> <structuredBody> -> <component> -> <section> -> <entry> -> <organizer> -> <component> where each <component> within an <organizer> represents a new data point.
This correction is implemented for:
- Family History
- Results
- Vital Signs
To correct this issue you may request an ad hoc patch for HSIEC-7942. If you have any questions regarding this advisory, please contact the Worldwide Response Center (WRC).