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PROTECT-CHILD Pediatric Transplant Data Implementation Guide
0.1.0-ci-build -

PROTECT-CHILD Pediatric Transplant Data Implementation Guide
0.1.0-ci-build - ci-build

PROTECT-CHILD Pediatric Transplant Data Implementation Guide, published by Protect Child. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/protect-child/ and changes regularly. See the Directory of published versions

Worked Example — Liver

Worked Example — Liver

One complete PROTECT-CHILD record, end to end. The Model Maps show each entity alone and the Crosswalk lines up the three representations field by field; this page shows how the resources link together for one patient.

These records are illustrative: they exist to show how the profiles fit together, and are built to exercise the guide rather than to be clinically representative.

Bundle-ProtectChildRecipientJourneyExample

REC-1-0001 is Mila, nine years old, at La Paz University Hospital (centre 1), cirrhotic since March 2020. The transplant on 15 August 2023 is the index date every other record is positioned against.

Study centre and patients

The La Paz University Hospital as an Organization, then the two people: the recipient REC-1-0001 and the deceased donor DON-1-0001.

Study centre and patients Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Organization 1 study-centre Patient REC-1-0001 patient-transplant Patient DON-1-0001 donor

Catalogue entries

Study-wide definitions: the two immunosuppressant medications, the lab test and the instrumental investigation.

Catalogue entries (study-wide, no date of their own) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Medication IMM-0001 immunosuppressant Medication IMM-0002 immunosuppressant ObservationDefinition LBT-0001 lab-test ObservationDefinition INS-0001 instrumental-investigation

Recipient history — primary disease

The cirrhosis that brings her to transplant, as a Condition with the organ in bodySite. It predates every visit in the record.

Recipient history — primary disease Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Condition ExamplePatientLiverDiagnosis1 patient-primary-disease-diagnos…

Pre-transplant episode and transplant admission

One inpatient episode, VIS-1-0001, spanning work-up, surgery and the early post-operative period. Peak PRA is 80%, so rituximab is given while she is waitlisted — not donor-directed, since no organ has been offered — and full HLA typing follows with a negative pre-transplant DSA screen. The transplant itself, a split graft, is one linked set with its duct-to-duct biliary anastomosis and an intra-operative bleed; induction immunosuppression starts the same day. On day 5 she has acute kidney injury, a typed clinical event treated with sixteen days of dialysis.

Pre-transplant episode and transplant admission (2023-07-25 .. 2023-08-28) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Encounter VIS-1-0001 visit MedicationStatement PRM-1-0001 pre-medication context → VIS-1-0001 MedicationStatement PreMedicationChildExample1 pre-medication-child partOf → PRM-1-0001 Observation ExamplePatientImmunologyObser… patient-immunology-observation encounter → VIS-1-0001 Observation IMD-1-0001 immunological-data encounter → VIS-1-0001 Observation ExampleDonorAgeObservation1 patient-demographics-observation Observation ExampleDonorLiverType1 donor-liver-type-observation Observation ExamplePatientAgeObservation1 patient-demographics-observation Procedure TXP-1-0001 transplant encounter → VIS-1-0001 Procedure TransplantAnastomosisExample1 transplant-anastomosis encounter → VIS-1-0001 Condition IntraoperativeComplicationExa… intraoperative-complication encounter → VIS-1-0001 Observation TransplantDetailsExample1 transplant-details partOf → TXP-1-0001 MedicationStatement IMP-1-0001 imm-pat context → VIS-1-0001 Condition CLE-1-0001 clinical-event encounter → VIS-1-0001 Procedure ClinicalEventDialysisProcedur… clinical-event-procedure reasonReference → CLE-1-0001

1-month follow-up visit

VIS-1-0002: vitals, three analytes, a biospecimen for genomic analysis, and maintenance tacrolimus with its trough. EBV DNA at 2,450 copies/mL prompts a liver biopsy — EBER-positive nuclei, no bile duct damage or endothelialitis, so EBV hepatitis rather than rejection — and tacrolimus is cut 0.1 → 0.06 mg/kg in response. Hypertension appears here, on tacrolimus and steroids, and amlodipine starts the same day.

1-month follow-up visit (2023-09-15) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Encounter VIS-1-0002 visit Observation VIT-1-0001 vital-sign encounter → VIS-1-0002 Observation LBR-1-0001 lab-result-observation encounter → VIS-1-0002 Observation LBR-1-0002 lab-result-observation encounter → VIS-1-0002 Observation LBR-1-0003 lab-result-observation encounter → VIS-1-0002 Specimen BIO-1-0001 biosample ServiceRequest BioSampleGenomicRequest1 biosample-analysis-request encounter → VIS-1-0002 Observation CLV-1-0001 clinical-variable encounter → VIS-1-0002 Condition ConcomitantDiseaseExample1 concomitant-disease encounter → VIS-1-0002 Observation MIC-1-0001 microbiology encounter → VIS-1-0002 Condition MicrobiologyDiagnosisExample1 microbiology-diagnosis encounter → VIS-1-0002 MedicationStatement IMP-1-0002 imm-pat context → VIS-1-0002 Observation ImmPatPKObservationExample1 imm-pat-pk-observation partOf → IMP-1-0002 MedicationStatement IMP-1-0003 imm-pat context → VIS-1-0002 Observation IIV-1-0002 patient-instrumental-investigat… encounter → VIS-1-0002

Clinical-event visit — acute rejection episode

VIS-1-0003, unscheduled. The bloods bring her in: ALT 86 → 210 U/L, bilirubin 3.8 mg/dL, GGT 180. The biopsy shows C4d in the portal microvasculature with a de novo class I DSA. Treatment is a three-day methylprednisolone pulse at 10 mg/kg/day.

Clinical-event visit — acute rejection episode (2023-11-15) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Encounter VIS-1-0003 visit Condition CLE-1-0002 clinical-event encounter → VIS-1-0003 Observation IMD-1-0002 immunological-data encounter → VIS-1-0003 Observation ClinicalEventFlagObservationE… clinical-event-flag-observation focus → CLE-1-0002 Observation LBR-1-0007 lab-result-observation encounter → VIS-1-0003 Observation LBR-1-0008 lab-result-observation encounter → VIS-1-0003 Observation LBR-1-0009 lab-result-observation encounter → VIS-1-0003 MedicationStatement IMP-1-0004 imm-pat context → VIS-1-0003

6-month follow-up visit

VIS-1-0004: abdominal imaging, and the amlodipine reviewed — still running since September.

6-month follow-up visit (2024-02-15) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Encounter VIS-1-0004 visit MedicationStatement CMD-1-0001 concomitant-medication context → VIS-1-0004 Observation IIV-1-0001 patient-instrumental-investigat… encounter → VIS-1-0004

12-month follow-up visit

VIS-1-0005: vitals with 24-hour ABPM, and the three analytes repeated — creatinine 1.2 → 0.8 mg/dL, albumin 3.4 → 4.2 g/dL, ALT 86 → 31 U/L. Albumin and ALT track the graft; the creatinine tracks renal recovery from the early injury, and at 0.8 is still flagged high for a nine-year-old.

12-month follow-up visit (2024-08-15) Resources in the worked-example Bundle, grouped by the visit or phase they belong to, coloured by FHIR resource type. Each chip names the resource, its business identifier and its profile, and records the reference it makes to another entry. Encounter VIS-1-0005 visit Observation VIT-1-0002 vital-sign encounter → VIS-1-0005 Observation LBR-1-0004 lab-result-observation encounter → VIS-1-0005 Observation LBR-1-0005 lab-result-observation encounter → VIS-1-0005 Observation LBR-1-0006 lab-result-observation encounter → VIS-1-0005