HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1 - Local Development build (v0.9.1). See the Directory of published versions

Primary profiles defined as part of this Implementation Guide

Name Based On Definition
BloodPressure Observation

Records blood pressure measurements, defined as the force of circulating blood on the walls of the arteries.

Conformance note: The blood pressure profile is based on the FHIR profile for blood pressure, and adds a set of optional elements that can help clinicians interpret the result. Because these additional elements are optional, any BloodPressure that conforms to the current profile also will conform to the FHIR profile, and vice versa.

BodyHeight Observation

Records the body height, defined as the distance from the sole to the crown of the head.

BodyWeight Observation

Records the body weight, defined as the mass or quantity of heaviness of the individual.

CBCWAutoDifferentialPanel DiagnosticReport

Complete blood count (CBC) with auto differential panel. Includes various measures of red blood cells, platelets, and various types of white blood cells and other related measures, such as hemoglobin. The components of this panel are not entirely standardized, so the definition of the CBC includes tests that are optional, or performed by certain laboratories but not others. Instances typically will include a subset of the listed panel members.

CancerDiseaseStatus Observation

A clinician’s qualitative judgment on the current trend of the cancer, e.g., whether it is stable, worsening (progressing), or improving (responding). The judgment may be based a single type or multiple kinds of evidence, such as imaging data, assessment of symptoms, tumor markers, laboratory data, etc.

CancerRelatedRadiationProcedure Procedure

A radiological treatment addressing a cancer condition. The scope of this profile has been narrowed to cancer-related procedures by constraining the ReasonReference and ReasonCode to cancer conditions.

Conformance note: If an ICD-10-PCS code is used in the code attribute, and there is a semantically equivalent SNOMED CT or CPT code, the resulting Procedure instance will not be compliant with US Core Profiles

CancerRelatedSurgicalProcedure Procedure

A surgical action addressing a cancer condition.

Conformance note: If an ICD-10-PCS code is used in the code attribute, and there is a semantically equivalent SNOMED CT or CPT code, the resulting Procedure instance will not be compliant with US Core Profiles.

ComorbidCondition Condition

A comorbidity refers to one or more diseases or conditions that occur along with another condition in the same person at the same time. Conditions considered comorbidities are often long-term or chronic conditions. Comorbidities are defined relative to an index disease and may be categorical, rather than described in full detail. The comorbid condition class provides comorbidity codes corresponding the Elixhauser Comorbidity Index.

Conformance note: If an ICD-10-CM code is used for the code attribute, and a semantically equivalent SNOMED code is available, the resulting instance will not be compliant with US Core Profiles.

ComprehensiveMetabolic2000SerumOrPlasmaPanel DiagnosticReport

Represents a comprehensive metabolic 2000 panel (CMP) from serum or plasma, which measures various components such as glucose, electrolytes, kidney function, and liver function. The components of this panel are not entirely standardized, so the definition of the CMP includes tests that are optional, or performed by certain laboratories but not others. Therefore, instances typically will include a subset of the listed panel members.

ECOGPerformanceStatus Observation

The Eastern Cooperative Oncology Group (ECOG) Performance Status represents the patient’s functional status and is used to determine their ability to tolerate therapies in serious illness, specifically for chemotherapy. Source: LOINC

GeneticVariantFound Observation

Records an alteration in the most common DNA nucleotide sequence. The term variant can be used to describe an alteration that may be benign, pathogenic, or of unknown significance. The term variant is increasingly being used in place of the term mutation. When reporting ‘Genetic Variant Found’, at least one element out of the following must be reported: ‘Variant Found Identifier’, ‘Variant Found HGVS Name’, and ‘Variant Found Description’.

GeneticVariantTested Observation

A test for a specific mutation on a particular gene. This profile is used to record whether a single discrete variant tested is present or absent (denoted as positive or negative respectively).

GenomicsReport DiagnosticReport

Genetic analysis summary report. The report may include one or more tests, with two distinct test types. The first type is a targeted mutation test, where a specific mutation on a specific gene is tested for. The result is either positive or negative for that mutation. The second type is a more general test for variants. This type of test returns the identity of variants found in a certain region of the genome.

The identity of non-genomic laboratory tests is typically represented by a LOINC code. However, many genetic tests and panels do not have LOINC codes, although some might have an identifier in NCBI Genetic Testing Registry (GTR), a central location for voluntary submission of genetic test information by providers. To identify the diagnostic report, the name of the report must be in the text sub-field of the code structure. If there is a coded identifier from GTR, LOINC, or other source, then it should be included into the the code sub-field of the code structure. If there is no suitable code, the code can be omitted.

Conformance note: To be conformant to US Core, the code attribute must be a LOINC code, if available. If there is no suitable code in LOINC, then a code from an alternative code system (such as GTR) can be used.

Implementation note: The performer of the test (organization or practitioner) should be included in the FHIR profile as the performer.actor.

Conformance note: The category for this profile is set to GE (Genetics), a code from http://hl7.org/fhir/ValueSet/diagnostic-service-sections. This is contrary to the Argonaut and US Core specifications, which require the category ‘LAB’ in diagnostic reports containing laboratory results. This is assumed to be an oversight in the US Core and Argonaut specifications.

KarnofskyPerformanceStatus Observation

The Karnofsky Performance Status (KPS) is a tool used to measure a patient’s functional status. It can be used to compare the effectiveness of different therapies and to help assess the prognosis of certain patients, such as those with certain cancers. The KPS score ranges from 0 to 100 in intervals of 10. Higher scores are associated with better functional status, with 100 representing no symptoms or evidence of disease, and 0 representing death.

MedicationStatement MedicationStatement

A record of the use of a medication (individual administration or entire course). The use may be reported by the patient or clinician and adminstration does not have to be directly observed.

Implementation note: Although FHIR supports the asserter (information source) and date asserted, it does not have a place for the author (who created and is responsible for the statement) and recorder (who entered the statement). Extensions are provided.

Conformance note: The treatment of ‘not taken’ has changed from DSTU2 and STU3 to R4. In R4, status and statusReason are used to indicate medications not taken. For upward compatibility, the ‘not taken’ attributes are profiled out. ReasonCode is a choice of CodeableConcept or ref(Condition) in DSTU2, and limited to one reason (pick a type). In STU3 and R4, there can be multiple reason codes, and multiple reason references, simultaneously.

Implementation note: Preference is given to using the National Library of Medicine (NLM) RxNorm terminology for medications. RxNorm is a coding standard established by the Office of the National Coordinator (ONC). However, RxNorm is restricted to FDA-approved drugs and does not include clinical trial drugs. MedicationStatement allows for the inclusion of other coding systems like the NCI Thesaurus (NCIT) to represent clinical trial oncology drugs.

Patient Patient

A person in the role of a patient. Sometimes, the patient is not the subject of information in a clinical statement where the Patient is the SubjectOfRecord.

Compatibility: Lies at the intersection of Argonaut and US Core Patient. MaritalStatus has a required binding in Argonaut, but an extensible binding in US-Core. To be feasible under both DSTU2 Argonaut and STU3 US-Core, the required binding strength is adopted.

PrimaryCancerCondition Condition

Records the history of the primary cancer condition, the original or first tumor in the body (reference https://www.cancer.gov/publications/dictionaries/cancer-terms/def/primary-tumor). Cancers that are not clearly secondary (i.e., of uncertain origin or behavior) should be documented as primary.

Cancer staging information summarized in this profile should reflect the most recent staging assessment on the patient, and should be updated if and when there is a new staging assessment. Past staging assessments will be preserved in instances of the TNMClinicalStageGroup and/or TNMPathologicalStageGroup, which refer back to PrimaryCancerCondition.

Conformance note: For the code attribute, to be compliant with US Core Profiles, SNOMED CT must be used unless there is no suitable code, in which case ICD-10-CM can be used.

SecondaryCancerCondition Condition

Records the history of secondary neoplasms, including location(s) and the date of onset of metastases. A secondary cancer results from the spread (metastasization) of cancer from its original site (reference: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/secondary-tumor).

Conformance note: For the code attribute, to be compliant with US Core Profiles, SNOMED CT must be used unless there is no suitable code, in which case ICD-10-CM can be used.

TNMClinicalDistantMetastasesCategory Observation

Category describing the presence or absence of metastases in remote anatomical locations, assessed using tests that are done before surgery. These include physical exams, imaging tests, laboratory tests (such as blood tests), and biopsies (definition adapted from NCI Dictionary of Cancer Terms).

TNMClinicalPrimaryTumorCategory Observation

Category of the primary tumor, based on its size and extent, assessed prior to surgery, based on evidence such as physical examination, imaging, and/or biopsy.

TNMClinicalRegionalNodesCategory Observation

Category of the presence or absence of metastases in regional lymph nodes, assessed using tests that are done before surgery. These include physical exams, imaging tests, laboratory tests (such as blood tests), and biopsies (definition adapted from NCI Dictionary of Cancer Terms).

TNMClinicalStageGroup Observation

The extent of the cancer in the body, according to the TNM classification system, based on information obtained prior to neoadjuvant treatment and surgery, e.g. based on evidence such as physical examination, imaging, and/or biopsy.

TNMPathologicDistantMetastasesCategory Observation

Category describing the presence or absence of metastases in remote anatomical locations, assessed through pathologic analysis of a specimen.

TNMPathologicPrimaryTumorCategory Observation

Category describing the primary tumor, based on its size and extent, assessed through pathologic analysis of a tumor specimen.

TNMPathologicRegionalNodesCategory Observation

Category describing the presence or absence of metastases in regional lymph nodes, assessed through pathologic analysis of a specimen.

TNMPathologicStageGroup Observation

The extent of the cancer in the body, according to the TNM classification system, based on examination of tissue samples removed during surgery, in addition to physical examination and imaging and potentially, other prognostic factors.

TumorMarkerTest Observation

The result of a tumor marker test. Tumor marker tests are generally used to guide cancer treatment decisions and monitor treatment, as well as to predict the chance of recovery and cancer recurrence. A tumor marker is a substance found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (noncancer) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer). Tumor markers differ from genetic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Source: Adapted from NCI Dictionary of Cancer Terms and Cancer.net)

Implementation note: The data value for TumorMarkerTest has cardinality is 0..1 (required if known) because when the test result is indeterminate, no quantitative data value will be reported. Instead, the reason for the null value will be reported in the DataAbsentReason field.