StructureDefinition - Statement of Vaccination to support exchange of digital health in Australia

[dtr-agency]

Prerequisites

• I have searched open and closed issues to make sure it isn't already requested or reported
• I have written a descriptive issue title

The issue / feature

Change description

Design and develop a set of materials that define a Clinical Information Object for Vaccination for the electronic exchange of vaccination and immunisation information between patients, healthcare providers, and between healthcare providers and the My Health Record system infrastructure in Australia.

What are the use cases we want to support?
TBD

What it actually enables people to do

Mockups

If applicable, add screenshots or mockups to help explain the issue / feature.

How awesome would it be?

TBD

Workarounds

TBD

Additional context

As part of the development of this profile we need to ensure:

• the R4 HL7 AU Base content used complete and correct - profile | extensions | terminology | namespaces
  • only necessary and sufficient content is present and it is all correct - is everything we need present; is there anything included that we DO NOT want in HL7 AU Base
  • issues that cannot be resolved quickly are raised in HL7 AU GitHub
  • QA for spelling and grammar,
  • ok against HL7 AU metadata conventions
  • tested invariant FHIRPath and tested the profile with examples
• design page(s) for R4 MedicationStatement profile(s) are established
• R4 Immunization profile is included in the applicable existing FHIR IGs in ci-fhir-r4 (currently only Event Summary)
  • the profile(s) conform to the metadata conventions
• R4 Immunization profile has at least 5 examples that conform to the profile
  • the examples conform to the contentions and principles for examples
  • the examples are linked to on the Examples tab for the applicable profiles in the FHIR IG(s)

[dtr-agency]

Confirmed with maintainer of HL7 AU Base to migrate the vaccine vial serial number extension into AU Base - pre-ballot as level 0 'potentially useful extension'.

ADHA Core Immunization development complete and ready for assurance.

[dtr-agency]

May 2022 QA Preview - http://build.fhir.org/ig/AuDigitalHealth/ci-fhir-r4/branches/2022May/package.tgz
Release 1.0.0 is limited to the FHIR R4 conformance artefacts that define the controls on data persistence for the following record types: Australian Immunisation Register, Australian Organ Donor Register, PBS/RPBS Claim Information, MBS/DVA Claim Information.

The FHIR R4 conformance artefacts are a set of StructureDefinitions that define the FHIR structures required, the data element definitions, and their associated rules of usage including the use of extensions and terminology. These conformance artefacts will be published in an Agency FHIR NPM package for use with FHIR and FHIR-aware tools. The FHIR package contains the validation form (JSON + SCH) of the conformance artefacts for direct use in validation operations and example resource instances that demonstrate use cases and conformance requirements.

While these artefacts and their package have been developed in conjunction with this Agency FHR implementation guide – publication and release of the implementation guide is not in scope. The implementation guide is provided to assist readers and users in understanding the Agency FHIR NPM package. See http://build.fhir.org/ig/AuDigitalHealth/ci-fhir-r4/branches/2022May/index.html

[dtr-agency]

Feedback raised during the assurance period from internal testing, CI SME design review, and NIO have been addressed. A new frozen QA Preview baseline is available.

Changes from internal assurance between v1.0.0-qa-preview and v1.0.0-qa-preview2 :

1. Applied copyright fixes AN-27, AN-25. See change in ADHA Core Flag, ADHA Australian Immunisation Register Notice, ADHA Record of Consent from Australian Organ Donor Register
2. Corrected to experimental flag to false AN-28. See change in ADHA Core Medication, ADHA Core Document Reference, ADHA Core Observation, ADHA Core Specimen, ADHA Core Substance
3. Refactored inv-dh-org-02 to be correctly evaluated AN-10. See change in ADHA Core Organization
4. Improved wording of inv-dh-obs-05 AN-40, AN-43, AN-44. See change in ADHA Core Observation, ADHA Pathology Result Observation, ADHA Diagnostic Result Observation, ADHA Imaging Result Observation
5. Typo in comment corrected AN-35 see change in ADHA Record of Claim against MBS or DVA
6. Typo in comment corrected AN-36 see change in ADHA Record of Claim against PBS or RPBS
7. Category slicing corrected to use pattern AN-21 See change in ADHA Record of Consent from Australian Organ Donor Register, ADHA Australian Immunisation Register Notice
8. Additional consent category LOINC code added (59284-0) AN-20 See change in ADHA Record of Consent from Australian Organ Donor Register
9. Added reference population constraints to Consent. Organization or Consent. Performer. See change in ADHA Record of Consent from Australian Organ Donor Register
10. Added information system device SNOMED CT binding to Device. Type FTR-1555. See change in ADHA System Device.
11. Typo in name corrected. See change in ADHA Core ServiceRequest.
12. Addition of Bundle example from SIT of AIR data to include Flag (bundle-air-02)

ADHA profiles amended (changes listed above):
• ADHA Record of Consent from Australian Organ Donor Register
• ADHA Record of Claim against MBS or DVA
• ADHA Record of Claim against PBS or RPBS
• ADHA Australian Immunisation Register Notice
• ADHA Core Document Reference
• ADHA Core Flag
• ADHA Core Medication
• ADHA Core Observation
• ADHA Core Organization
• ADHA Core ServiceRequest
• ADHA Core Specimen
• ADHA Core Substance
• ADHA Diagnostic Result Observation
• ADHA Imaging Result Observation
• ADHA Pathology Result Observation
• ADHA System Device

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June 2022 QA Preview - http://build.fhir.org/ig/AuDigitalHealth/ci-fhir-r4/branches/2022June/package.tgz
Release 1.0.0 is limited to the FHIR R4 conformance artefacts that define the controls on data persistence for the following record types: Australian Immunisation Register, Australian Organ Donor Register, PBS/RPBS Claim Information, MBS/DVA Claim Information.

The FHIR R4 conformance artefacts are a set of StructureDefinitions that define the FHIR structures required, the data element definitions, and their associated rules of usage including the use of extensions and terminology. These conformance artefacts will be published in an Agency FHIR NPM package for use with FHIR and FHIR-aware tools. The FHIR package contains the validation form (JSON + SCH) of the conformance artefacts for direct use in validation operations and example resource instances that demonstrate use cases and conformance requirements.

While these artefacts and their package have been developed in conjunction with this Agency FHR implementation guide – publication and release of the implementation guide is not in scope. The implementation guide is provided to assist readers and users in understanding the Agency FHIR NPM package. See http://build.fhir.org/ig/AuDigitalHealth/ci-fhir-r4/branches/2022June/index.html

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Cycle 1 clinical Informatics peer review AN-8 complete with no changes required.

Cycle 2 internal unit testing continues via AN-3. Cycle 2 clinical Informatics peer review continues via AN-5, AN-6, AN-7.

[dtr-agency]

Cycle 2 clinical Informatics peer review AN-5, AN-6, AN-7 complete with no changes required.

[dtr-agency]

The final baseline of the ADHA FHIR NPM package & IG is released for assurance as 1.0.0-qa-preview3. This version reflects final design agreements with NIO and Oracle and addresses feedback raised during the assurance period.

http://build.fhir.org/ig/AuDigitalHealth/ci-fhir-r4/branches/2022Aug/package.tgz

Changes from internal assurance between v1.0.0-qa-preview2 and v1.0.0-qa-preview3:

1. Applied release ready metadata in all structures e.g. status=active
2. Amended ADHA Record of Claim against MBS or DVA to remove support for ExplanationOfBenefit.referral and related profiles
3. Extension Date of Initial Registration refactored to use an R4 URL as the original STU3 extension was never implemented AN-467
4. Corrected id & url for ADHA Organ or Tissue for Donation BodyStructure AN-463
5. Amended ADHA Record of Consent from Australian Organ Donor Register in line with URL changes for Extension Date of Initial Registration AN-467 & ADHA Organ or Tissue for Donation BodyStructure AN-463
6. Corrected inv-dh-loc-03 in ADHA Core Location AN-462
7. Introduction of XPath expression for some invariants ci-fhir-r4/issues/150
8. Addition of condition attribute to elements impacted by invariants
9. Corrected ids in examples
10. Addition of Bundle example from of AIR to support new Bundling approach (bundle-air-03)
11. Amended body structure examples to update profile URL AN-463

ADHA profiles removed as part descoping ExplanationOfBenefit.referral:

• ADHA MBS Service Claim Item
• ADHA Core DiagnosticReport
• ADHA Core Media
• ADHA Core ServiceRequest
• ADHA Core Specimen
• ADHA Diagnostic Result Observation
• ADHA Imaging Result Observation
• ADHA Pathology Result Observation

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This version is undergoing internal release readiness and regression testing via AN-477, and publication readiness review via AN-431, Agency Governance review via Collaborate.

[dtr-agency]

Release readiness and regression testing AN-477 completed with no issues.
Publication readiness review AN-431 completed with informative documentation updates now complete.

Now progressing to publication in the Australian Digital Health Agency FHIR Implementation Guide v1.0.0.