Define donation decision and consent from Australian Organ Donor Register

[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

Develop and publish an payload definition for R4 of donation decision and consent from Australian Organ Donor Register to provide an initial baseline as input a the piece of work to provide FHIR R4 endpoint for the exchange of digital health information recorded on the Australian Organ Donor Register between individuals, healthcare providers, and the My Health Record system infrastructure in Australia..

What it actually enables people to do

How awesome would it be?

Support transition from STU3 to R4 of digital health exchanges of an individual's information in relation to the Medicare program.

Workarounds

N/A

Additional context

Current implementation defined by:

• Medicare system to Clinical Information System via My Health Record system: My Health Record B2B Gateway Services v2.0 and Medicare - Australian Organ Donor Register v1.1
• Medicare system to My Health Record system for persistence: MDS REST Interfaces Specifications with reference to STU3 profile Consent Australian Organ Donor Register
• No supported access mechanism via My Health Record FHIR Gateway

[dtr-agency]

ADHA Extension Date of Initial Registration refactored for R4 ceb1dff

[dtr-agency]

Consent scope needs to be defined (mandatory) - existing values in core FHIR may not be suitable for organ donation. Query if ADR is suitable or if an additional concept should be defined.

There isn't anything suitable in SNOMED CT for consent scope, propose addition to HL7 AU if needed.

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Upon consultation, the use of adr is appropriate in R4 - the code is deprecated. Note in current draft of R5 scope is no longer present in the resource.

[dtr-agency]

CodeSystem: Consent Scope Codes included in the HL7 Terminology package is missing the concept 'adr' 'Advance Care Directive' as published in the ValueSet Consent Scope Codes bound in Consent.

See Zulip Consent Scope Codes stream and HL7 JIRA UP-255.

[dtr-agency]

Issue in supporting transition between the CDA or RIM format and the FHIR format (both STU3 and R4) of an Australian Organ Donor Register form.

The terminology that represents organ or tissue for donation doesn't have a defined transition from the NCTIS terminology supported in the original CDA (RIM) format and the SNOMED CT terminology supported in the FHIR format.

The CDA format supports the legacy value set NCTIS Organ Donation Consent Provision Type that uses concepts from NCTIS Data Components code system.

The FHIR format supports the value set Organ Donation Body Site that uses concepts from SNOMED CT.

Concept maps are required to define to define that transition but are not yet available.

[dtr-agency]

FHIR Architecture Review Outcomes on AODR set of profiles

• Add date constraint to at least day
• The remaining unflagged mandatory elements are meaningful and should have MS flagged
• remove MS flag from category: where a slice is used to impose fixed value constraints it does not require an MS flag set for that slice
• Update MS definition in the policy page to clarify this requirement
• Descriptions should be improved
• Shift invariants to be at site of element acted upon if min cardinality is 1
• Add known expectations of cardinality, and add comments to describe use case data.
• Shorten invariant descriptions - don't need to make them pseudo FHIRPath

Changes from FHIR Architecture Review complete.

[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

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Development and internal design architecture review is complete, internal unit testing is underway via AN-3, Clinical Informatics peer review is underway via AN-5, AN-6, AN-7, and AN-8.

[dtr-agency]

Testing completed with convention issue identified: Fixed via Testing 730d112

Clinical Informatics peer review changes: 42c4e01

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

[dtr-agency]

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

[dtr-agency]

Review and testing for this profile is complete. Next step is to mark as Active v1.0.0 and pass regression testing.

[dtr-agency]

NIO have advised Date of initial registration not provided in live feed - removed from Medicare Records FHIR IG via AuDigitalHealth/ci-medicare-records#23.

NIO have advised this data is present in 2018 and earlier content ingested via CDA. Need to retain this extension to support existing data. This extension may be refactored to have a correct R4 URL as the original STU3 extension was never implemented.

[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.