Quality review summary

Generated Tue Apr 01 09:45:42 CEST 2025, FHIR version 4.0.1 for hl7.fhir.us.mcode#4.0.0 (http://hl7.org/fhir/us/mcode)

IG Publisher Q/A summaryValidated against this.Radiotherapy Course Summary Profile
Quality checks summary
Domain Check=True Check=False
Pages and organization 7 0
Writing and narrative 5 0
Security and privacy considerations 0 1
Comparison capability statements / narrative summary
item Number of differences
resources 125
interactions 14
search parameters 46

Quality checks

Inspired by IG Best Practices described in Guidance for FHIR IG Creation

domain criteria check proof
Pages and organization Separate display of normative content True Pages: codesystems.html, capabilitystatements.html, conformance-profiles.html, profiles.html, extensions.html, conformance-uscdi-plus.html, conformance-general.html, conformance-patients.html, valuesets.html
Pages and organization Separate display of non-normative content True Pages: change_log.html, index.html, toc.html, dictionary.html, glossary.html, downloads.html
Pages and organization Presence of index page True Page: index.html
Pages and organization Presence of toc page True Page: toc.html
Pages and organization Presence of artifacts page True Page: artifacts.html
Pages and organization Presence of background page True Page: background.html
Pages and organization Presence of downloads page True Page: downloads.html
Writing and narrative Index page starts with a patient-friendly explanation of the purpose of the IG True Extract (page index.html): Cancer is among the leading causes of death worldwide. According to the National Cancer Institute, in the United States, 39.5 percent of men and women will be diagnosed with cancer at some point during their lifetimes. In 2020, an estimated 1,806,590 new cases of cancer will be diagnosed in the United States and 606,520 people will die from the disease. While these numbers are staggering, the silver lining in the wide prevalence of cancer is the potential to learn from the treatment of millions of patients. If we had research-quality data from all cancer patients, it would enable better health outcomes.
Writing and narrative Presence of a section that explains key information that needs to be understood prior to reading the IGTrue
  • Extract (page index.html): mCODE is a "Domain of Knowledge" implementation guide (IG). The purpose is to show how to represent clinical concepts generally, not to have a complete set of agreements for interoperable exchanges.
  • Extract (page group-genomics.html): mCODE assumes one is familiar with the GRIG content and uses this additional guidance to identify what is clinically actionable and minimal for the purpose of diagnosis, treatment, and monitoring of cancer patients.
  • Extract (page conformance-general.html): This section outlines requirements and recommendations for mCODE participants. The conformance verbs - SHALL, SHOULD, and MAY - are defined in FHIR Conformance Rules. MUST, MUST NOT, SHALL NOT, and REQUIRED are to be interpreted as described in RFC 2119.
  • Extract (page conformance-profiles.html): mCODE expresses requirements and expectations for implementers on the level of entire profiles and individual data elements within those profiles.
  • Extract (page conformance-uscdi-plus.html): The Assistant Secretary for Technology Policy (ASTP), formerly the Office of the National Coordinator (ONC), is developing the USCDI+ for Cancer data elements required for cancer reporting and the Enhancing Oncology Model (EOM). This is an important development that deserves early guidance on how mCODE can support this initiative as quickly as possible.
  • Extract (page capabilitystatements.html): Different Capability Statements in mCODE are associated with alternative methods of determining which patients are “in-scope” for mCODE (meaning cancer patients whose data is presented or exchanged with the intention of conforming to mCODE).
  • Extract (page dictionary.html): Please be aware of the following: Profiles not shown in the DD: Not all profiles used by mCODE are included in the Data Dictionary. mCODE uses external profiles for vital signs and routine laboratory results. These profiles are not included in the DD because they are defined externally to mCODE.
Writing and narrative Presence an explanation of what "mustSupport" means for different types of implementations of the IG True
  • Extract (page index.html): Only must-support (MS) data elements are included. These are elements that implementers could be expected to provide meaningful support for (see Profile Conformance for details).
  • Extract (page group-genomics.html): mCODE assumes one is familiar with the GRIG content and uses this additional guidance to identify what is clinically actionable and minimal for the purpose of diagnosis, treatment, and monitoring of cancer patients.
  • Extract (page conformance-general.html): mCODE Senders MUST be able to populate data elements Must-Support (MS) obligations, for all profiles they support (as declared in their CapabilityStatement). Receivers MUST be able to meaningfully process elements with MS obligations for each of the profiles they support (as declared in their CapabilityStatement).
  • Extract (page conformance-profiles.html): All mCODE profiles that have a top-level Must-Support (MS) flag SHALL be implemented. All profiles defined in mCODE SHOULD be implemented UNLESS the participant does not anticipate supplying or consuming a certain type of data, usually by virtue of playing a limited or specialized role in clinical or information workflows.
  • Extract (page artifacts.html): The only difference between CancerPatient and US Core Patient is that Patient.deceased is a must-support element in mCODE. Must-support is an instruction to implementers of FHIR clients and servers, rather than a constraint on data structure.
  • Extract (page dictionary.html): Only elements marked as "Must Support"(MS) are included in the Data Dictionary. These are elements that implementers may be expected to provide meaningful support for; see Profile-Level Conformance Expectations for more information.
Writing and narrative Presence of information on how to engage with the community True
  • Extract (page index.html): If you have questions or comments about this guide, you can join the conversation on chat.fhir.org, create an issue in the HL7 Jira, or reach out to any of the following individuals.
  • Extract (page codesystems.html): Propose a change
Writing and narrative Presence of an explanation of the relationship of the IG to any other guides True
  • Extract (page index.html): mCODE will serve as the basis for future implementation guides dealing with new use cases, particular types of cancer, or specific demographic groups using mCODE as a base.
  • Extract (page group-genomics.html): mCODE includes genomics-related data elements needed to inform cancer assessment and treatment options. The profiles directly derive from the HL7 CGWG Clinical Genomics Reporting Implementation Guide (GRIG) STU2 release.
  • Extract (page conformance-profiles.html): Most mCODE profiles are based on US Core profiles defined in the US Core Implementation Guide (v6.1.0). For example, CancerPatient is based on the US Core Patient profile. Because of the way profiles work in FHIR, any resource that validates against an mCODE profile that is based a US Core profile will automatically be in compliance with the US Core profile.
  • Extract (page conformance-uscdi-plus.html): At the time of mCODE STU4 IG development, USCDI+ for Cancer just completed its comment period, so the proposed data elements may still be subject to change. However, the current list of data elements suggests a higher priority should be applied to certain profiles within the mCODE data model.
  • Extract (page examples.html): The expectation is that mCODE will adopt those standards when they are completed.
  • Extract (page examples_pediatric.html): In addition to providing examples of mCODE profiles, this extended example demonstrates how to represent a clinically realistic scenario of a pediatric cancer patient. When information in the scenario does not map on to mCODE profiles, we provide examples using USCore or standard FHIR resources.
  • Extract (page downloads.html): Dependency Table IGPackageFHIRComment minimal Common Oncology Data Elements (mCODE) Implementation Guidehl7.fhir.us.mcode#4.0.0R4 HL7 Terminology (THO)hl7.terminology.r4#6.2.0R4Automatically added as a dependency - all IGs depend on HL7 Terminology FHIR Extensions Packhl7.fhir.uv.extensions.r4#5.2.0R4Automatically added as a dependency - all IGs depend on the HL7 Extension Pack Genomics Reporting Implementation Guidehl7.fhir.uv.genomics-reporting#2.0.0R4 US Core Implementation Guidehl7.fhir.us.core#6.1.0R4
Security and privacy considerationsPresence of a section focused on security or privacy False

Comparison capability statements / narrative

CapabilityStatementSenderConditionsThenPatients

Resource Resource difference Interactions differences Search parameters differences
RadiotherapyCourseSummary Not in CS
TumorMarkerTest Not in CS
CancerRelatedMedicationAdministrationNot in CS
MCODEPatientGroup Not in CS
CancerRelatedSurgicalProcedure Not in CS
CancerStage Not in CS
Tumor Not in CS
CancerPatient Not in CS
CancerRelatedMedicationRequest Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
HumanSpecimen Not in CS
SecondaryCancerCondition Not in CS
GenomicVariant Not in CS
Group Not in narrative
Condition Not in narrative
Patient
  • Not in CS: name, birthdate, active, gender, address, identifier

CapabilityStatementReceiverPatientsWithCancerCondition

Resource Resource difference Interactions differences Search parameters differences
CancerRelatedMedicationAdministrationNot in CS
Comorbidities Not in CS
ALLRiskAssessment Not in CS
CancerStage Not in CS
Tumor Not in CS
TumorSize Not in CS
HumanSpecimen Not in CS
ECOGPerformanceStatus Not in CS
LanskyPlayPerformanceStatus Not in CS
RhabdomyosarcomaRiskAssessment Not in CS
RadiotherapyCourseSummary Not in CS
TumorMarkerTest Not in CS
CancerRelatedSurgicalProcedure Not in CS
KarnofskyPerformanceStatus Not in CS
TumorMorphology Not in CS
CancerPatient Not in CS
CancerRelatedMedicationRequest Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
GenomicsReport Not in CS
SecondaryCancerCondition Not in CS
GenomicVariant Not in CS
Group Not in narrative
Patient
  • Not in CS: deceased, name, active, birthdate, gender, _id, telecom, identifier

CapabilityStatementReceiverPatientsAndCancerConditions

Resource Resource difference Interactions differences Search parameters differences
MCODEPatientGroup Not in CS
CancerStage Not in CS
MCODEPatientBundle Not in CS
CancerPatient Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
HumanSpecimen Not in CS
SecondaryCancerConditionNot in CS
Group Not in narrative
Condition Not in narrative
Patient
  • Not in CS: birthdate, gender, address, telecom, identifier, name

CapabilityStatementSenderPatientsWithCancerCondition

Resource Resource difference Interactions differences Search parameters differences
RadiotherapyCourseSummary Not in CS
TumorMarkerTest Not in CS
CancerRelatedMedicationAdministrationNot in CS
CancerRelatedSurgicalProcedure Not in CS
KarnofskyPerformanceStatus Not in CS
CancerStage Not in CS
Tumor Not in CS
CancerPatient Not in CS
CancerRelatedMedicationRequest Not in CS
PrimaryCancerCondition Not in CS
ECOGPerformanceStatus Not in CS
SecondaryCancerCondition Not in CS
GenomicVariant Not in CS
GenomicsReport Not in CS
Group Not in narrative
Patient
  • Not in CS: deceased, name, active, birthdate, gender, _id, telecom, identifier

CapabilityStatementReceiverPatientsInGroup

Resource Resource difference Interactions differences Search parameters differences
Bundle Not in CS
Procedure Not in CS
DiagnosticReport Not in CS
Observation Not in CS
HumanSpecimen Not in CS
Condition Not in CS
MedicationRequest Not in CS
MedicationAdministrationNot in CS
Group
  • Not in CS: member, _id
Patient
  • Not in CS: identifier

CapabilityStatementPatientBundle

Resource Resource difference Interactions differences Search parameters differences
GenomicRegionStudied Not in CS
CancerRelatedMedicationAdministrationNot in CS
CancerStage Not in CS
MCODEPatientBundle Not in CS
Tumor Not in CS
TumorSize Not in CS
HumanSpecimen Not in CS
Patient Not in CS
RadiotherapyVolume Not in CS
RadiotherapyCourseSummary Not in CS
TumorMarkerTest Not in CS
MCODEPatientGroup Not in CS
CancerRelatedSurgicalProcedure Not in CS
CancerPatient Not in CS
CancerRelatedMedicationRequest Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
GenomicsReport Not in CS
SecondaryCancerCondition Not in CS
GenomicVariant Not in CS

CapabilityStatementSenderPatientsInGroup

Resource Resource difference Interactions differences Search parameters differences
Procedure Not in CS
DiagnosticReport Not in CS
Observation Not in CS
Condition Not in CS
MedicationRequest Not in CS
MedicationAdministrationNot in CS
Group
  • Not in narrative: code
Patient
  • Not in CS: identifier

CapabilityStatementReceiverConditionsThenPatients

Resource Resource difference Interactions differences Search parameters differences
CancerStage Not in CS
MCODEPatientBundle Not in CS
CancerPatient Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
HumanSpecimen Not in CS
SecondaryCancerConditionNot in CS
Group Not in narrative
Condition Not in narrative
Patient
  • Not in CS: identifier

CapabilityStatementSenderPatientsAndCancerConditions

Resource Resource difference Interactions differences Search parameters differences
CancerRelatedMedicationAdministrationNot in CS
CancerStage Not in CS
MCODEPatientBundle Not in CS
TumorSize Not in CS
HumanSpecimen Not in CS
RadiotherapyCourseSummary Not in CS
TumorMarkerTest Not in CS
MCODEPatientGroup Not in CS
CancerRelatedSurgicalProcedure Not in CS
CancerPatient Not in CS
CancerRelatedMedicationRequest Not in CS
CancerDiseaseStatus Not in CS
PrimaryCancerCondition Not in CS
CancerDiseaseStatusEvidenceType Not in CS
SecondaryCancerCondition Not in CS
GenomicVariant Not in CS
Group Not in narrative
Condition Not in narrative
Patient
  • Not in CS: deceased, name, active, birthdate, gender, _id, telecom, identifier