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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

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Logical Models

These define data models that represent the domain covered by this implementation guide in more business-friendly terms than the underlying FHIR resources.

BioSample logical model

Logical model representing the PROTECT-CHILD data model entity bio_sample.

ClinicalVariable logical model

Logical model representing the PROTECT-CHILD data model entity clinical_variable.

ConcomitantDisease logical model

Logical model representing the PROTECT-CHILD data model entity concomitant_disease.

ConcomitantEpisode logical model

Logical model representing the PROTECT-CHILD data model entity concomitant_episode.

ConcomitantMedication logical model

Logical model representing the PROTECT-CHILD data model entity concomitant_medication.

Donor logical model

Logical model representing the PROTECT-CHILD data model entity donor.

EpigenomeStudy logical model

Logical model representing the PROTECT-CHILD data model entity epigenome_study.

GenomicTest logical model

Logical model representing the PROTECT-CHILD data model entity genomic_test.

ImmIndPat logical model

Logical model representing the PROTECT-CHILD data model entity imm_ind_pat.

ImmMainPat logical model

Logical model representing the PROTECT-CHILD data model entity imm_main_pat.

Immunosuppressant logical model

Logical model representing the PROTECT-CHILD data model entity immunosuppressant.

InstrumentalInvestigation logical model

Logical model representing the PROTECT-CHILD data model entity instrumental_investigation.

LabResult logical model

Logical model representing the PROTECT-CHILD data model entity lab_result.

LabTest logical model

Logical model representing the PROTECT-CHILD data model entity lab_test.

MarkImmFunc logical model

Logical model representing the PROTECT-CHILD data model entity mark_imm_func.

MethylomicStudy logical model

Logical model representing the PROTECT-CHILD data model entity methylomic_study.

Microbiology logical model

Logical model representing the PROTECT-CHILD data model entity microbiology.

Outcome logical model

Logical model representing the PROTECT-CHILD data model entity outcome.

OutcomeType logical model

Logical model representing the PROTECT-CHILD data model entity outcome_type.

PatInstInv logical model

Logical model representing the PROTECT-CHILD data model entity pat_inst_inv.

Patient logical model

Logical model representing the PROTECT-CHILD data model entity patient.

PostEvent logical model

Logical model representing the PROTECT-CHILD data model entity post_event.

PostEventType logical model

Logical model representing the PROTECT-CHILD data model entity post_event_type.

PreMedication logical model

Logical model representing the PROTECT-CHILD data model entity pre_medication.

ReferenceGenome logical model

Logical model representing the PROTECT-CHILD data model entity reference_genome.

TargetRegion logical model

Logical model representing the PROTECT-CHILD data model entity target_region.

Transplant logical model

Logical model representing the PROTECT-CHILD data model entity transplant.

Unit logical model

Logical model representing the PROTECT-CHILD data model entity unit.

VariantAnnotation logical model

Logical model representing the PROTECT-CHILD data model entity variant_annotation.

VariantOccurrence logical model

Logical model representing the PROTECT-CHILD data model entity variant_occurrence.

Visit logical model

Logical model representing the PROTECT-CHILD data model entity visit.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

ABO group observation

ABO blood group as an Observation (LOINC 883-9). Reusable for both recipients and donors.

Biological Sample

Biological sample linked to transplant patients and omics studies, aligned with the bio_sample table.

Clinical Variable

Clinical variables and vital signs recorded for a transplant patient.

Concomitant Disease

Relevant concomitant diseases associated to a subject or record.

Concomitant Episode

Clinical episode related to a concomitant disease for a transplant patient.

Concomitant Medication

Concomitant medication records associated with a concomitant episode.

Donor liver graft type observation

Type of liver graft (complete vs partial) captured as an Observation (LOINC 74836-8).

Donor pre-KTX dialysis type observation

Dialysis method prior to kidney transplantation (LOINC 70958-4).

Epigenome Study

Epigenome (e.g. methylation array) study metadata and platform details.

Genomic Test

Definition of a genomic test / sequencing platform and pipeline configuration.

HLA Class I typing observation

HLA Class I (A, B, C) typing as an Observation panel (LOINC 96629-1).

HLA Class II typing observation

HLA Class II (DP, DQ, DR) typing as an Observation panel (LOINC 96640-8).

Histological diagnosis date observation

Date of histological diagnosis captured as an Observation date result (LOINC 77975-1).

Immunosuppressant

Immunosuppressive drug definition used in initial or maintenance therapy.

Immunosuppressant Induction to Patient

Record of immunosuppressive induction treatment given to a transplant patient.

Immunosuppressive Maintenance to Patient

Maintenance immunosuppressive therapy given to the transplant patient, aligned with the immunosuppressive_maintenance_patient table.

Instrumental Investigation

Catalogue of instrumental investigation tests, aligned with the instrumental_investigation table.

Lab Result

Individual laboratory result for a transplant recipient, aligned with the lab_result table.

Lab Test

Definition of a laboratory test, including its name and unit.

Laboratory DiagnosticReport

Laboratory report grouping one or more lab result observations for a transplant recipient.

Liver disease diagnosis observation

Primary liver disease diagnosis. Use effectiveDateTime as the diagnosis date and valueCodeableConcept as the diagnosis.

Marker of Immune Function

Markers of immune function including HLA and non-HLA antibodies for a transplant patient.

Methylomic Study

Methylomic study / locus-level methylation metrics.

Microbiology

Microbiology results related to transplant recipients and/or donors, aligned with the microbiology table.

Outcome

Outcome information for transplant patients, linked to multiple clinical domains.

Outcome Type

Definition of an outcome type used to categorize outcome records.

PRA observation

Panel reactive antibody / cPRA as an Observation (LOINC 80737-0). Use Observation.method to mark max vs last.

Patient Instrumental Investigation

Instrumental investigation performed on a transplant patient, aligned with the patient_instrumental_investigation table.

Patient observations

A curated list of patient-level observations (ABO, Rh, PRA, HLA typing, diagnoses, etc.) that reference a transplant recipient.

Post Event

Clinical events occurring after transplant, associated with a patient and event type.

Post Event Type

Definition of a post-transplant event type.

Pre-transplant Medication

Pre-transplant medication record aligned with the pre_medication table.

Reference Genome

Reference genome definition used by genomic tests, including build_name and FASTA path.

Renal disease diagnosis observation

Primary renal disease diagnosis. Use effectiveDateTime as the diagnosis date and valueCodeableConcept as the diagnosis.

Rh factor observation

Rh type as an Observation (LOINC 10331-7). Reusable for both recipients and donors.

Target Region

Target gene / genomic region associated with a genomic test platform.

Transplant

Encounter profile representing a transplant, linking the transplant recipient and donor and aligned with the transplant table.

Transplant Donor

Transplant donor profile based on the FHIR Patient resource, aligned with the donor table.

Transplant Recipient

Transplant recipient profile based on the FHIR Patient resource, aligned with the patient table.

Variant Annotation

Annotation of a variant occurrence using external databases and classifications.

Variant Occurrence

Variant occurrence information within a target region.

Visit

Encounter profile representing a visit in the transplant follow-up schedule, aligned with the visit table.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

2h post-dose drug level (C2)

csa2h_post_dose_level – drug level measured 2 hours after dosing (commonly cyclosporine C2).

AECA / other non-HLA antibodies

Anti-endothelial cell antibodies or other non-HLA antibodies not captured above.

AT1R antibody result

Angiotensin II type-1 receptor (AT1R) antibody result.

Adenovirus serology IgG

adenovirus_igg – presence of IgG antibodies to adenovirus; false=Negative, true=Positive.

Adenovirus serology IgM

adenovirus_igm – presence of IgM antibodies to adenovirus; false=Negative, true=Positive.

Age at DNA extraction

Age (in years) of the subject at the time of DNA extraction.

Alignment tools

Name and version of the alignment tool.

Allele frequency

Allele frequency for the variant.

Alternate allele

Variant allele sequence (e.g., C).

Annotation database

Database used for this variant annotation.

Annotation databases

Information about the databases used for annotation.

Annotation tools

Information about the tool used for annotation.

Anti-MICA antibody result

Anti-MICA (MHC class I–related chain A) antibody result.

Anti-MICB antibody result

Anti-MICB (MHC class I–related chain B) antibody result.

Antihypertensive treatment

antihypertensive_treatment – blood-pressure–lowering drug(s) used pre-transplant.

Antiviral prophylaxis pre-medication

antiviral_phrophylaxis – preventive antiviral medication(s) given to reduce risk of viral infection or reactivation (Kidney only).

Area under the concentration–time curve (AUC)

auc – pharmacokinetic area under the curve for the immunosuppressant.

Array date

Date when the array was run.

BKV FISH on kidney biopsy

bkv_fish_kidney_biopsy – BK virus FISH on kidney biopsy; false=Negative, true=Positive.

BKV-DNA on kidney biopsy

bkv_dna_kidney_biopsy – detection of BK virus DNA on kidney biopsy; false=Negative, true=Positive.

Beta value

Beta value representing methylation level.

BioSample ID relationship

Reference to the primary biosample collected at this visit (bio_sample_id).

Bisulfite date

Date of bisulfite conversion.

Bisulfite reference kit

Bisulfite conversion kit used in the epigenome experiment.

Blood BKV-DNA

blood_bkv_dna – detection of BK virus DNA in blood; false=Negative, true=Positive.

Blood CMV-DNA

cmv_dna – CMV nucleic acid test result (false=Negative, true=Positive).

Blood EBV-DNA

ebv_dna – EBV nucleic acid test result (quantitative, float).

Blood Parvovirus B19-DNA

parvovirus_b19_dna – detection of parvovirus B19 DNA in blood; false=Negative, true=Positive.

CMV serology IgG

cmv_igg – presence of IgG antibodies against CMV; false=Negative, true=Positive.

CMV serology IgM

cmv_igm – presence of IgM antibodies against CMV; false=Negative, true=Positive.

CNV locus

Locus information for CNV.

Chip type

Type of chip used for the epigenome array.

Chromosome ID

Chromosome identifier (e.g. 1–22, 23=X, 24=Y, 25=MT).

Chromosome coordinate

Coordinate system for numbering the chromosomes.

Clinical variable ID relationship

Reference to clinical variable/vital signs information associated with this outcome.

Clinical variable ID relationship

Reference to clinical variables recorded at this visit (clinical_variable_id).

Cold ischaemia time (minutes)

Cold ischaemia time for the graft in minutes (cold_ischemia_time).

Concomitant disease ID relationship

Reference to the concomitant disease record associated with this episode.

Concomitant disease name(s)

Set of relevant concomitant diseases.

Concomitant episode ID relationship

Reference to the concomitant episode this medication belongs to.

Concomitant episode ID relationship

Reference to concomitant episode information associated with this outcome.

Concomitant episode ID relationship

Reference to a concomitant episode associated with this visit (concomitant_episode_id).

Copy number

Copy number value for CNV data.

DNA concentration

dna_concentration – DNA concentration for the sample (float).

Date

Date when vital signs were measured.

Date of instrumental investigation

Date on which the instrumental investigation was performed.

Detection p-value

Detection p-value for the methylation measurement.

Diastolic blood pressure

Diastolic blood pressure in mmHg.

Donor ID relationship

donor_id – reference to the donor associated with this microbiology record.

Donor type

Whether the donor is living or deceased.

Donor-specific antibody (DSA)

Donor-specific antibody flag for the HLA antibody above (yes/no).

Donor/recipient weight ratio

Ratio of donor graft weight to recipient body weight (d_r_weight_ration).

Dose of immunosuppressant

dose – maintenance dose of the immunosuppressant.

EBV serology IgG EBNA

ebv_igg_ebna – presence of IgG antibodies against EBV Nuclear Antigen (EBNA); false=Negative, true=Positive.

EBV serology IgG anti-VCA

ebv_igg_anti_vca – presence of IgG antibodies against EBV Viral Capsid Antigen (VCA); false=Negative, true=Positive.

EBV serology IgM anti-EA

ebv_igm_anti_ea – presence of IgM antibodies against EBV Early Antigen (EA); false=Negative, true=Positive.

EBV serology IgM anti-VCA

ebv_igm_anti_vca – presence of IgM antibodies against EBV Viral Capsid Antigen (VCA); false=Negative, true=Positive.

ETAR antibody result

Endothelin receptor type-A (ETAR) antibody result.

End date of maintenance therapy

Date when this maintenance immunosuppressant regimen was stopped (if applicable).

End position

End position of the target region (genomic coordinate).

Epigenome Study ID Relationship

epigenome_study_id – reference to epigenome study linked to this sample.

Episode date

Date of the concomitant episode.

Episode description

Description of the concomitant episode.

Event description

Free-text description of the post-transplant event.

Event end date

Date when the post-transplant event resolved or ended.

Event onset date

Date when the post-transplant event started.

First warm ischaemia time (minutes)

First warm ischaemia time for the graft in minutes (1_warm_ischemia_time).

Fusion breakpoint

Genomic position where a fusion variant occurs.

Fusion supporting reads

Supporting read count of the fusion.

Genetic origin

Somatic or germline origin of the variant.

Genomic Test ID Relationship

genomic_test_id – reference to the genomic test configuration used for this sample.

Genomic Test Name

Name of the platform using sequencing, assigned by the institution.

Genomic Test Version

Version of the platform using sequencing, assigned by the institution.

Genomic test ID relationship

Reference to the genomic test used in this epigenome study.

Genomic test ID relationship

Reference to the genomic test (platform) containing this target region.

Genotype

Allele state.

HGNC ID

Gene ID based on HGNC nomenclature.

HGNC symbol

Gene symbol given by HGNC nomenclature.

HGVS c. notation

Nomenclature for the sequence variant at the DNA level (HGVS c. notation).

HGVS p. notation

Nomenclature for the sequence variant at the protein level (HGVS p. notation).

HLA antibody class or locus

Class or locus of the HLA antibody being recorded.

HSV serology IgG

hsv_igg – presence of IgG antibodies to HSV; false=Negative, true=Positive.

HSV serology IgM

hsv_igm – presence of IgM antibodies to HSV; false=Negative, true=Positive.

Heart rate

Pulse rate in beats per minute.

Height

Patient’s height/length in centimeters.

Immunosuppressant ID relationship

Reference to the immunosuppressant drug used for induction.

Immunosuppressant ID relationship

immunosuppressant_id – reference to the immunosuppressant drug used for maintenance.

Immunosuppressant dose

Dose of the selected immunosuppressant used for induction.

Immunosuppressant name

Name/type of the immunosuppressant drug.

Immunosuppressive induction ID relationship

Reference to immunosuppressive induction treatment associated with this visit (imm_ind_pat_id).

Immunosuppressive maintenance ID relationship

Reference to immunosuppressive maintenance treatment associated with this visit (imm_main_pat_id).

Instrumental investigation ID relationship

instrumental_investigation_id – reference to the catalogue entry describing the test performed.

Instrumental investigation name

Name of the instrumental investigation test conducted.

Intraoperative complications

Whether and which complications occurred during surgery (intraoperative_complications).

Kidney side

Transplanted kidney side (kidney_side).

Lab result ID relationship

Reference to laboratory results associated with this visit (lab_result_id).

Lab result patient reference

patient_id – reference to the transplant recipient for whom this lab result is recorded.

Lab test ID relationship

Reference to lab test definition associated with this outcome.

Lab test name

Name of the laboratory test conducted.

Lab test reference

lab_test_id – reference to the lab test definition (LabTest catalog row) associated with this lab result.

M value

M-value transformation of the beta value.

MFI value

Median Fluorescence Intensity (MFI) for the HLA antibody listed in hla_antibody_class.

Manifest number

Manifest number for the array.

Mean target coverage

Mean target coverage.

Medication

Type of concomitant medication applied.

Medication

Medication(s) relevant to this variant annotation.

Methylated reads

Number of reads showing methylation.

Methylomic Study ID Relationship

methylomic_study_id – reference to methylomic study linked to this sample.

Microbiology ID relationship

Reference to microbiology results associated with this outcome.

Microbiology ID relationship

Reference to microbiology results associated with this visit (microbiology_id).

Nephrectomy of original kidney

Whether the patient’s native kidney was surgically removed before the transplant (nephrectomy_original_kidney).

Other intraoperative complications (free text)

Specification of other types of complications during surgery (intraoperative_complications_other).

Other pre-transplant medications

other_medications – any other relevant pre-transplant medications.

Outcome ID relationship

Reference to the outcome record associated with this visit (outcome_id).

Outcome date

Date associated with the outcome (e.g. assessment date).

Outcome type ID relationship

Reference to the type/category of outcome.

Outcome type name

Name of the outcome type.

Oxygen saturation

Oxygen saturation at rest, in percent.

Parvovirus B19 serology IgG

parvovirus_b19_dna_igg – presence of IgG antibodies to parvovirus B19; false=Negative, true=Positive.

Parvovirus B19 serology IgM

parvovirus_b19_dna_igm – presence of IgM antibodies to parvovirus B19; false=Negative, true=Positive.

Patient ID relationship

Reference to the patient for whom clinical variables are recorded.

Patient ID relationship

Reference to the patient for whom the concomitant episode is recorded.

Patient ID relationship

Reference to the patient receiving immunosuppressive induction.

Patient ID relationship

Reference to the patient for whom the immune function markers are recorded.

Patient ID relationship

patient_id – reference to the transplant recipient associated with this microbiology record.

Patient ID relationship

Reference to the patient for whom the outcome is recorded.

Patient ID relationship

patient_id – reference to the transplant recipient for whom the instrumental investigation was performed.

Patient ID relationship

Reference to the patient who experienced the post-transplant event.

Patient instrumental investigation ID relationship

Reference to patient instrumental investigation associated with this outcome.

Patient instrumental investigation ID relationship

Reference to a patient instrumental investigation associated with this visit (pat_inst_inv_id).

Per target base cover x100

Percentage of selected bases covered at ≥100x.

Pool ID

Identifier of the sample pool.

Post event ID relationship

Reference to post-transplant event associated with this outcome.

Post event type ID relationship

Reference to the type/category of the post-transplant event.

Post event type name

Name of the post-transplant event type.

Post-event ID relationship

Reference to a post-transplant event (e.g. rejection episode) occurring at this visit (post_event_id).

Pre-dose drug level

pre_dose_level – drug level measured immediately before dosing (trough level).

Pre-medication ID relationship

Reference to pre-transplant medication information associated with this outcome.

Pre-medication ID relationship

Reference to pre-medication information associated with this visit (pre_medication_id).

Pre-medication patient reference

patient_id – reference to the transplant recipient for whom the pre-medication is recorded.

Raw data

Link or identifier to raw data files.

Read count

Total number of reads for this locus.

Read length

Information about the length of the read.

Read type

Information about the method of sequence reading.

Recipient patient reference

patient_id – reference to the transplant recipient for whom maintenance therapy is recorded.

Reference Genome ID relationship

Reference to the reference genome used for this genomic test.

Reference allele

Reference allele sequence (e.g., A).

Reference genome FASTA path

Filesystem or URI path of the reference genome FASTA file.

Reference genome ID relationship

Reference to the reference genome used in this methylomic study.

Reference sequence

Transcript ID based on a protein-coding RNA (mRNA), including accession and version number.

Result of the instrumental investigation

result – result of the instrumental investigation test conducted (Normal / Abnormal).

Rituximab pre-medication

rituximab – any rituximab given pre-transplant.

SNP reader device

Device used as SNP reader.

Sample ID

Sample identifier used in the epigenome study.

Sample send to INGEMM date

send_ingemm_date – date when the sample was sent to INGEMM.

Sample type

Type of sample used in the epigenome study (Blood, Saliva, Other tissues).

Scan date

Date when the array was scanned.

Second warm ischaemia time (minutes)

Second warm ischaemia time for the graft in minutes (2_warm_ischemia_time, kidney only).

Sentrix barcode array

Sentrix array barcode.

Sentrix position

Position on the Sentrix array.

Sequence alteration

Structural variant type.

Sequencing device

Sequencer machine information.

Start date of maintenance therapy

Date when this maintenance immunosuppressant regimen was started.

Start position

Start position of the target region (genomic coordinate).

Systolic blood pressure

Systolic blood pressure in mmHg.

Target capture

Information about the capture method of examined and targeted region.

Target disease ID

Identifier of the target disease for this epigenome study.

Target region ID

Identifier of the target region for which methylation information is recorded.

Target region ID relationship

Reference to the target region (gene/region) for which the variant information is recorded.

Temperature

Body temperature in degrees Celsius.

Time from diagnosis to transplant (months)

Months between disease diagnosis and transplant date (time_diag_to_tx).

Transplant ID relationship

Reference to the transplant associated with this visit (transplant_id).

Transplant donor reference

Reference to the donor associated with this transplant.

Type of surgical biliary anastomosis

Type of biliary reconstruction used (type_surgical_biliary_anastomosis).

Unit ID relationship

Reference to the unit definition associated with this lab test.

Urine BKV-DNA

urine_bkv_dna – detection of BK virus DNA in urine; false=Negative, true=Positive.

VZV serology IgG

vzv_igg – presence of IgG antibodies to varicella–zoster virus; false=Negative, true=Positive.

VZV serology IgM

vzv_igm – presence of IgM antibodies to varicella–zoster virus; false=Negative, true=Positive.

Variant calling tools

Name and version of the variant calling tool.

Variant class level

Classification level for the variant.

Variant exon number

Exon number in which the variant occurred.

Variant feature

Functional variant type.

Variant occurrence ID relationship

Reference to the variant occurrence this annotation refers to.

Variant origin

Origin of the variant (e.g., inherited, de novo, somatic).

Variant pathogenicity

Pathogenicity assessment (e.g., pathogenic, likely pathogenic, VUS, benign).

Variant read depth

Variant depth divided by read depth.

Variant tier level

Tier level for the variant (e.g., Tier 1, Tier 2).

Vascular anomalies

Presence of relevant arterial/venous anatomical variants (vascular_anomalies).

Vessel mismatch (donor-recipient)

Whether there is a vessel size/configuration mismatch requiring tailoring (vessel_mismatch_d_r).

Weight

Patient’s weight in kilograms.

dbSNP rsID

dbSNP reference ID (rsID) maintained by NCBI.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

ABO Group ValueSet

ABO blood groups for transplant recipients and donors.

BioSample Tissue Type ValueSet

Allowed tissue types for BioSample.tissue_type.

Concomitant Disease Category ValueSet

ValueSet of relevant concomitant diseases.

Concomitant Medication Category ValueSet

ValueSet of concomitant medication categories.

Dialysis method ValueSet

Dialysis method values expressed using LOINC Answer codes (aligned with LOINC answer list LL2102-3 for 70958-4).

Donor Liver Type ValueSet

Allowed values for donor liver type (Complete, Partial).

Donor type value set

Allowed values for donor type (Living, Deceased).

Immunosuppressant Drug Type

ValueSet of immunosuppressive drug types.

Immunosuppressive Maintenance to Patient Type ValueSet

Allowed types for immunosuppressive maintenance records.

Instrumental Investigation Name

ValueSet of instrumental investigation tests conducted.

Intraoperative Complications ValueSet

Allowed intraoperative complications during liver transplantation.

Kidney Side ValueSet

Allowed values for kidney side.

Lab Result Unit ValueSet

Allowed UCUM units of measurement for lab result values (unit column).

Lab Test Name

ValueSet of laboratory tests conducted.

Outcome Type Name

ValueSet of post-transplant outcome types.

PRA Observation Type ValueSet

Allowed values for Observation.method when reporting maximum vs most recent PRA.

Patient Instrumental Investigation Result ValueSet

Allowed results for the instrumental investigation test (Normal, Abnormal).

Post Event Type Name

ValueSet of post-transplant event types.

Pre-medication Antihypertensive Drug ValueSet

Allowed antihypertensive drugs for antihypertensive_treatment.

Pre-medication Type ValueSet

Allowed type(s) for pre-medication records.

Reference Genome Build ValueSet

Allowed reference genome build names (GRCh38, GRCh37).

Rh Factor ValueSet

Allowed Rh factor values for transplant recipients and donors.

Transplant Type ValueSet

Allowed transplant types.

Type of surgical biliary anastomosis ValueSet

Allowed types of biliary anastomosis in liver transplant.

Visit Type ValueSet

Allowed types of visits in the transplant follow-up schedule.

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

ABO Group CodeSystem

ABO blood groups for transplant recipients and donors.

BioSample Tissue Type CodeSystem

Tissue types for biological samples (from the bio_sample table).

Concomitant Disease Category

Categories of relevant concomitant diseases.

Concomitant Medication Category

Categories of concomitant medications.

Donor Liver Type CodeSystem

Type of liver donation (complete vs partial).

Donor type

Living vs deceased donor classification.

Immunosuppressant Drug Type

Types of immunosuppressive drugs used in the transplant setting.

Immunosuppressive Maintenance to Patient Type CodeSystem

Type of immunosuppressive maintenance record.

Instrumental Investigation Name

Types of instrumental investigation tests conducted.

Intraoperative Complications CodeSystem

Intraoperative complications during liver transplantation.

Kidney Side CodeSystem

Side of the kidney for nephrectomy / transplant context.

Lab Test Name

Types of laboratory tests conducted.

Outcome Type Name

Types of clinical outcomes after transplant.

PRA Observation Type CodeSystem

Distinguishes maximum (historical) vs most recent PRA measurements.

Patient Instrumental Investigation Result CodeSystem

Result of the instrumental investigation test conducted (Normal / Abnormal).

Post Event Type Name

Types of post-transplant events.

Pre-medication Antihypertensive Drug CodeSystem

Antihypertensive drugs used as pre-transplant medication.

Pre-medication Type CodeSystem

Type of pre-transplant medication record.

Reference Genome Build CodeSystem

Reference genome build names.

Rh Factor CodeSystem

Rh factor for transplant recipients and donors.

Transplant Type CodeSystem

Type of solid-organ transplant (liver, kidney, combined liver-kidney).

Type of surgical biliary anastomosis CodeSystem

Types of biliary anastomosis used in liver transplantation.

Visit Type CodeSystem

Type of visit in the transplant follow-up schedule.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Example Biological Sample

Example biological sample used in Visit example.

Example Clinical Variables

Example set of clinical variables for a transplant patient.

Example Concomitant Disease

Example record of a concomitant disease.

Example Concomitant Episode

Example concomitant episode for a transplant patient.

Example Concomitant Medication

Example concomitant medication for a concomitant episode.

Example Epigenome Study

Example epigenome (methylation array) study record.

Example Genomic Test

Example genomic test / sequencing platform configuration.

Example Immunosuppressant

Example immunosuppressant drug definition.

Example Immunosuppressant Induction to Patient

Example record of immunosuppressive induction therapy given to a patient.

Example Immunosuppressive Maintenance to Patient

Example record of maintenance immunosuppressive therapy for a transplant recipient.

Example Instrumental Investigation

Example imaging/instrumental investigation for a transplant patient.

Example Lab Result Observation

Example creatinine result for a transplant recipient.

Example Lab Test

Example definition of a lab test (Albumin).

Example Laboratory Report

Example lab report grouping a single creatinine result.

Example Marker of Immune Function

Example immune function marker record for a transplant patient.

Example Methylomic Study

Example methylomic record for a locus.

Example Microbiology record

Example microbiology panel for a transplant recipient.

Example Outcome

Example outcome record for a transplant patient.

Example Outcome Type

Example outcome type: Chronic renal failure after pLTx.

Example Patient Instrumental Investigation

Example of a patient instrumental investigation linked to InstrumentalInvestigation catalogue.

Example Post Event Type

Example post-transplant event type: Episodes of AKI after LTx.

Example Post-Transplant Event

Example of a post-transplant event (e.g., infection episode).

Example Pre-medication

Example record of pre-transplant medications.

Example Reference Genome GRCh38

Example GRCh38 reference genome used for genomic tests.

Example Target Region

Example target region linked to a genomic test.

Example Variant Annotation

Example annotation for a variant occurrence.

Example Variant Occurrence

Example variant occurrence linked to a target region.

Example donor ABO observation

ABO group for the transplant donor.

Example donor HLA class I typing

Example HLA class I typing result (A, B, C) for the donor.

Example donor HLA class II typing

Example HLA class II typing result (DP, DQ, DR) for the donor.

Example donor PRA observation

Example PRA (%) recorded for the donor (if available).

Example donor Rh observation

Rh type for the transplant donor.

Example donor liver graft type

Example donor liver graft type.

Example donor observations list

An example List that links the donor to donor-level Observations.

Example donor pre-KTX dialysis type

Example donor dialysis method prior to kidney transplant.

Example histological diagnosis date

Example date of histological diagnosis.

Example liver disease diagnosis

Example liver diagnosis and diagnosis date.

Example patient ABO observation

ABO group for the transplant recipient.

Example patient HLA class I typing

Example HLA class I typing result (A, B, C).

Example patient HLA class II typing

Example HLA class II typing result (DP, DQ, DR).

Example patient Rh observation

Rh type for the transplant recipient.

Example patient last PRA observation

Most recent PRA (%).

Example patient max PRA observation

Maximum PRA (%).

Example patient observations list

An example List that links the transplant recipient to their patient-level Observations.

Example renal disease diagnosis

Example renal diagnosis and diagnosis date.

Example transplant

Example transplant instance mapped from the transplant table.

Example transplant donor

Example Patient instance conforming to Donor.

Example transplant recipient

Example Patient instance conforming to PatientTransplant.

Example visit

Example visit instance mapped from the visit table.