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Specification:

FHIR Core (FHIR)
Raised in Version:

R5
Work Group:

Orders & Observations
Related URL:
https://www.hl7.org/fhir/diagnosticreport.html
Related Artifact(s):

DiagnosticReport
Grouping:
- FDA-PQ/CMC
- eCTDM3
Resolution Description:
Hide

Add the following bullet to the scope and usage section (same as was added to Observation):

Product quality tests such as pH, Assay, Microbial limits, etc. on product and substance.
Show
Add the following bullet to the scope and usage section (same as was added to Observation): Product quality tests such as pH, Assay, Microbial limits, etc. on product and substance.
Resolution Vote:
Lorraine Constable/Peter Bomberg: 11-0-3
Change Category:
Enhancement
Change Impact:
Compatible, substantive
Applied for Version:

R5

PQ/CMC project is leveraging DiagnosticReport resources to capture the Product & Substance quality testing and stability reports.

Request broadening the the resource scope & Usage text to include PQ/CMC example. Suggested updates in red font below:-

The DiagnosticReport resource is suitable for the following kinds of diagnostic reports:
Laboratory (Clinical Chemistry, Hematology, Microbiology, etc.)
Pathology / Histopathology / related disciplines
Imaging Investigations (x-ray, CT, MRI, etc.)
Other diagnostics such as Cardiology, Gastroenterology, etc.
Product and Substance quality (batch analysis, stability)