HL7 FHIR Implementation Guide: SHR Core, Release 0.6 - US Realm (Draft for Comment 1)

HL7 FHIR Implementation Guide: SHR Core, Release 0.6 - US Realm (Draft for Comment 1) FHIR Profiles - Local Development build (v0.6.0). See the Directory of published versions

Primary logical models defined as part of this Implementation Guide

Name Definition
AbnormalBodyStructure

A body structure such as wound or tumor, observed to be present in a patient. The body structure is a condition that persists over time. The Code represents the body structure itself (the morphology), while the BodyLocation is the location of that structure. This corresponds to FHIR R4, where the BodyStructure resource has morphology (corresponding to Code) and a location. For example, the Code could be blunt force injury (SCT 3821009) and location left knee.

AdverseDrugReaction

A noxious and unintended response to a medicinal product. To be considered an ADR, a causal relationship must be at least suspected by the medical practitioner. The principal difference between an adverse drug reaction (ADR) an adverse event (AE) and is that a causal relationship is suspected for the ADR, but is not required for the AE. Adverse drug reactions are therefore a subset of adverse event reports.

AdverseEvent

A record of an untoward or unexpected event in a patient under treatment, and which does not necessarily have to have a causal relationship with that treatment. Adverse events may capture either a workflow breach that may or may not result in harm, but must be documented for quality improvement purposes, or an adverse finding whether or not it can be traceable to an actual workflow breach.

AllergyIntolerance

A finding related to the presence of an individual’s risk or sensitivity to a substance or class of substances. Per US Core specification, the result includes SNOMED codes representing ‘No known allergy’. In AllergyIntolerance, the reactions are included in-line, rather than referencing to conditions (in contrast to AdverseEvent).

Appointment

A booking of a healthcare event among patient(s), practitioner(s), related person(s) and/or device(s) for a specific date/time.

BloodPressure

The force of circulating blood on the walls of the arteries.

BodyHeight

Data structure for recording the body height, defined as the distance from the sole to the crown of the head.

BodyLength

The distance from the sole of the foot to the crown of the head, lying down (typically 0-2 years).

BodyMassIndex

A general indicator of the body fat an individual is carrying based upon the ratio of weight to height.

BodyTemperature

The measure of the level of heat in the body.

BodyWeight

Data structure for recording the body weight, defined as the mass or quantity of heaviness of the individual.

ClinicalNote

An entry concerning a patient where the result is a narrative text.

CodedLaboratoryObservation

A coded result from a laboratory test.

CodedNonLaboratoryObservation

The result of evaluations (measurements, tests, or questions) whose answer is expressed as a code.

ComorbidCondition

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.

ComponentOnlyNonLaboratoryObservation

An observation with components, but without a result value or panel members.

Composition

A composition represents a set of Entries sharing common provenance, a document such as an extract from a patient record, a knowledge artifact, or a catalog definition.

Condition

A condition that is or may be present in a subject. ‘Condition’ is interpreted broadly and could be a disorder, abnormality, problem, injury, complaint, functionality, illness, disease, ailment, sickness, affliction, upset, difficulty, disorder, symptom, worry, or trouble. The Observation-based class, ConditionAbsent, should be used to describe conditions that are not present or negative findings. SHR Condition uses the SHR BodyLocation structure that includes not only a code, but optional laterality, direction, clock direction, and distance. If included, the distance is measured from the location specified by the code, laterality, and direction.

CongenitalAbnormality

Any abnormality, genetic, anatomical, biochemical, evident at birth or during the neonatal period. Includes malformations, deformations, and chromosomal abnormalities.

Coverage

Health insurance coverage available (even if not used for payment for a given encounter).

Device

A specific durable physical device used in diagnosis or treatment. The value is the coding for a type of device, for example, a CPAP machine. The same device might be used on multiple patients. Device status cannot be reconciled between Argonaut and US-Core, each having different required value sets. Device type has extensible mappings to different value sets in Argonaut and US-Core, however both value sets have identical SNOMED content (descendants of 49062001 (Device). We adopt the US-Core value set, which is allowable because the binding is extensible.

DiagnosticImaging

Diagnostic imaging procedure performed.

DiagnosticReport
DocumentReference

A reference to a document, used to describe a document that is made available to a healthcare system. A document is some sequence of bytes that is identifiable, establishes its own context (e.g., what subject, author, etc. can be displayed to the user), and has defined update management. The DocumentReference resource can be used with any document format that has a recognized mime type and that conforms to this definition.

ECOGPerformanceStatus

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

Encounter

A description of an interaction between a patient and healthcare provider(s) for the purpose of providing healthcare service(s) or assessing the health status of a patient.

EpisodeOfCare

An association between a patient and an organization / healthcare provider(s) during which time encounters may occur. The managing organization assumes a level of responsibility for the patient during this time.

Group

A set of entities (personnel, material, or places) to be considered together. May be a pool of like-type resources, a team, or combination of personnel, material and places.

HeadCircumference

Circumference of the head (typically 0-2 years).

HeadlessLaboratoryPanel

A panel that does not have an overall value that summarizes the entire panel.

HeadlessPanel

A panel that does not have an overall value that summarizes the entire panel.

HeartRate

The number of times the heart ventricles contract per unit of time, usually per minute.

ImagingProcedure

Experimental class for an imaging procedure. This class is still incomplete at this time.

KarnofskyPerformanceStatus

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 [PMID: 23870327].

LaboratoryObservation

A coded finding based on a specimen, usually collected from a patient (but possibly from a location).

LaboratoryPanel

A set of independent but related observations that are often presented together to facilitate interpretation, such as a lipid panel.

LaboratoryProcedure

A procedure performed on a collected specimen such as a blood panel or a biopsy.

Location

Services and space and equipment provided for a particular purpose; a building or place that provides a particular service or is used for a particular industry. Could be a clinical site, community site, or a mobile facility.

Media

A photo, video, or audio recording acquired or used in healthcare. The actual content may be inline or provided by direct reference.

Medication

A type of prescription drug or over-the-counter drug that is used to prevent, treat, or relieve symptoms of a disease or abnormal condition, but excluding vaccines. In FHIR DSTU2 and STU3, Medication lacks the identifier attribute, which is included in SHR as an extension. DSTU2 lacks the status attribute, which is required by US-Core. Batch is 0..1 in FHIR R4, and accordingly is restricted here.

MedicationAdministration

A record of the use of a medication. If the medication is given as part of a course of treatment, the PartOf attribute should refer to the CourseOfTreatment. Although FHIR MedicationAdministration supports date of administration, information source, performer, it lacks common provenance elements, statement creation date, author, and recorder. These are supported as optional extensions. FHIR DSTU2 lacks a category attribute, which is provided as an extension in that version. SHR does not allow the ‘not given’ attributes from DSTU2 and STU3, since they are dropped in R4. The status element is used to document medications not given.

MedicationNonadherence

Information on the ability and cooperation of the patient in taking medicine or supplement as recommended or prescribed. This includes correct timing, dosage, and frequency. The FocalSubject can reference a specific medication.

Modeling note: MedicationAdherence could be attached to MedicationStatement directly as an extension, but modeling as an observation avoids creating an extension and allows this observation to be made at any time, independent of any specific medication.

MedicationRequest

An order for a medication to be dispensed and instructions for use. Value sets for status are in direct conflict between DSTU2 Argonaut and STU3 US-Core. Category does not exist in DSTU2 and is provided as an extension. Intent was added in STU3 and is provided as an extension with required binding.

MedicationStatement

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

FHIR Notes:

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.

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.

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.

NonLaboratoryObservation

An observation not based on a specimen.

Observation

Represents the result of evaluations (measurements, tests, or questions) that have been performed. Observation has a value representing the result (answer), or an DataAbsentReason indicating why the value is not present. Things observed about the subject can include social and behavioral factors, subjective and objective observations, and assessments. For an Observation, the Code describes the aspect or property of the subject being observed or measured. The Code is the ‘question code’ that pairs to the ‘answer’ contained in the Value.

Organization

A formally or informally recognized grouping of people or organizations formed for the purpose of achieving some form of collective action. Includes companies, institutions, corporations, departments, community groups, healthcare practice groups, payer/insurer, etc.

Organization type is restricted to 0..1 in FHIR DSTU2, similarly restricted here. Other required attributes come from STU 3 mapping to us-core-organization.

OxygenSaturation

Oxygen saturation in Arterial blood by Pulse oximetry.

Panel

A set of independent but related observations that are often presented together to facilitate interpretation, such as a lipid panel.

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.

SHR follows Argonaut and makes the value set binding on marital status required. 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.

Practitioner

A person who practices a healing art. HumanName is limited to one required value by US-Core. Gender is required by US-Core. US-Core required an identifier, either a NPI (preferred) or tax id.

Procedure

An action that is or was performed on or for a patient. This can be a physical intervention like an operation, or less invasive like long term services, counseling, or hypnotherapy.

ProcedureRequest

A request for a procedure to be performed. May be a proposal or an order.

Provenance

Describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance tracks information about the activity that created, revised, deleted, or signed a version of a resource, describing the entities and agents involved. This information can be used to form assessments about its quality, reliability, trustworthiness, or to provide pointers for where to go to further investigate the origins of the resource and the information in it.

QuantitativeLaboratoryObservation

A quantiative result from a laboratory test.

QuantitativeNonLaboratoryObservation

The result of evaluations (measurements, tests, or questions) whose answer is expressed as a code.

Questionnaire

A structured set of questions intended to guide the collection of answers from end-users. Questionnaires provide detailed control over order, presentation, phraseology and grouping to allow coherent, consistent data collection.

QuestionnaireResponse

A structured set of questions and their answers. The questions are ordered and grouped into coherent subsets, corresponding to the structure of the grouping of the questionnaire being responded to.

RadiationProcedure

A radiation oncology procedure. If the treatment is part of a larger course of treatment, the PartOf attribute should indicate that.

ReferralRequest

Used to record and send details about a request for referral service or transfer of a patient to the care of another provider or provider organization.

RelatedPerson

A person in a role defined in relationship to a patient

ResearchStudy

A clinical trial or similar research study. Reference: list of FDA data elements describing a research study: prsinfo.clinicaltrials.gov/definitions.html

ResearchSubject

Record of a subject’s enrollment and participation in a research study.

RespiratoryRate

The rate of breathing (inhalation and exhalation) measured within in a unit time, expressed as breaths per minute.

ServiceRequest

A record of a request for service such as diagnostic investigations, treatments, or operations to be performed.

SimpleCodedLaboratoryObservation

A coded result from a laboratory test without further panel members or components.

SimpleCodedNonLaboratoryObservation

An observation whose result is a code, and also having no components or panel members

SimpleLaboratoryObservation

A result from a laboratory test without panel members or components.

SimpleNonLaboratoryObservation

An observation having no components or panel members

SimpleQuantitativeLaboratoryObservation

An observation whose result is a quantity, with no components or panel members

Specimen

A specimen is a substance, physical object, or collection of objects, that the laboratory considers a single discrete, uniquely identified unit that is the subject of one or more steps in the laboratory workflow. A specimen may include multiple physical pieces as long as they are considered a single unit within the laboratory workflow. A specimen results from one to many specimen collection procedures, and may be contained in multiple specimen containers. Specimen may have one or more processing activities.

Substance

Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.

SurgicalProcedure
ValueSet

A set of codes drawn from one or more code systems

VitalSignsPanel

A summary of vital signs, including weight, height (or length), blood pressure, respiration rate, oxygen saturation, heart rate, and body temperature, BMI, and (optionally) head circumference. Each member of the panel is treated as a separate, independent observation. The panel is a grouping for convenience so all vitals can be retrieved using one LOINC code (85353-1).