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Missing Namespace OID in Null Flavor tag and incorrect value outputs for D.1.1.x in E2B (R3) (Doc ID 2424566.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.1.1 to 8.1.2 [Release 8.1]
Oracle Life Sciences Argus Safety - Version 8.1.1 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Symptoms

There are some incorrect outputs for Patient Information tags D.1.1.1 - D.1.1.4 in E2B (R3)

1) Namespaces OID in Null Flavor tag does not populate

2) In "Code" tag, the value (eg, investigation) displays instead of code (eg, 4)

 

Here is the sample HL7 output 

<!--D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) -->
<asIdentifiedEntity classCode="IDENT">
<id nullFlavor="MSK" />
<code code="investigation" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="2.0" />
</asIdentifiedEntity>


Expected output is:

<!--D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) -->
<asIdentifiedEntity classCode="IDENT">
<id nullFlavor="MSK" root="2.16.840.1.113883.3.989.2.1.3.10" />
<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="2.0" />
</asIdentifiedEntity>

 

 

According to the regulations, the following Namespaces OID supposed to display in each element.

D.1.1.1 --- 2.16.840.1.113883.3.989.2.1.3.7
D.1.1.2 --- 2.16.840.1.113883.3.989.2.1.3.8
D.1.1.3 --- 2.16.840.1.113883.3.989.2.1.3.9
D.1.1.4 --- 2.16.840.1.113883.3.989.2.1.3.10

 


---------------------------------------------
STEPS
---------------------------------------------
1. Open the case
2. Go to the patient tab and set the patient ID if this is the study case
3. Go to the additional information tab
4. Set the value of "E2B GP Medical No" in the reference section
5. Set the value of "E2B Hospital Record No" in the reference section
6. Set the value of "E2B Specialist No" in the reference section
7. Enter the mandatory value for E2B (R3)
8. Save the case

9. Go to the regulatory report tab and schedule E2B (R3)
10. Click Draft link
11. Change the view format to "HL7 View"



Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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