SPL Mapping FHIR R5 Implementation Guide
0.2.0 - Build CI United States of America flag

SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Organziation-Based Use Cases

Page standards status: Informative

Organization Use Cases

This page details the following use cases that all use profiles based on the Organization resource:

  1. UC01 - Request an NDC Labeler Code
    • 51726-8 NDC Labeler Code Request
    • 69968-6 NDC Labeler Code Inactivation
  2. UC02 - Register or updated the information of an Establishment
    • 51725-0 Establishment Registration
    • 70097-1 Establishment De-Registration
    • 53410-7 No Change Notification
    • 53411-5 Out of Business Notification
  3. UC03 - Submit GDUFA Facility Self-Identification
    • 71743-9 Generic Drug Facility Identification Submission
    • 72090-4 Identification of CBER-regulated generic drug facility

Here is a high level diagram that shows the generic use of the profiles for these use cases:

Organization Profiles diagram
Figure 2.1 - Organization Profiles

Labeler Code Use Case

Here are the profiles used in the Labeler Code Request action:

Labeler Code Request Profiles diagram
Figure 2.2 - Labeler Code Request Profiles

Here are the profiles used in the Labeler Code Inactivation action:

Labeler Code Inactivation Profiles diagram
Figure 2.3 - Labeler Inactivation Profiles

Establishment Registration Use Cases

Here are the profiles used in the Establishment Registration action:

Establishment Registration Profiles Part 1 diagram
Figure 2.4 - Establishment Registration Profiles (Part 1)
Establishment Registration Profiles Part 2 diagram
Figure 2.5 - Establishment Registration Profiles (Part 2)

Here are the profiles used in the Establishment Inactivation action:

Establishment Inactivation Profiles diagram
Figure 2.6 - Establishment Inactivation Profiles

Generic Drug Facility Use Cases

Here are the profiles used in the Generic Drug Facility Identification action:

Generic Drug Facility Identification Profiles diagram
Figure 2.7 - Generic Drug Facility Identification Profiles

Here are the profiles used in the Generic Drug Facility Inactivation action:

Generic Drug Facility Inactivation Profiles diagram
Figure 2.8 - Generic Drug Facility Inactivation Profiles

Out of Business Use Case

Here are the profiles used in the Out of Business Notification action. This action is used for Establishments and Generic Drug Facilities.

Out of Business Notification Profiles diagram
Figure 2.9 - Out of Business Notification Profiles