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The patient, or group of patients, location, or device this Observation is about and into whose record the observation is placed. Note: Additional structures are needed to handle situations where the actual focus of the Observation is different from the subject (or a sample of, part, or region of the subject). For example, a measurement on a fetus that is placed in the mother's record. Data Type: Reference (Patient, Group, Device, or Location). This data element is typically a pointer into a record in another table/structure that contains more metadata about the subject. Note: This Data Element (Observation.subject) would typically point to a record/instance of the Patient Demographics Data Class, though Observations can be recorded for other “units of analysis” (such as a geographic area, group of subjects, etc). The exact mechanism for specifying this linkage is not prescribed, but the purpose of this Data Element is to establish that the ability to communicate “who the observation is about” must be supported.

Vocabulary Standard: No single vocabulary covers the content necessary for representing all aspects of observation reporting (observation identifiers, coded observation values, computable units of measure, etc). Yet, the collection of core vocabularies needed are sufficiently mature. [Observation: Code] LOINC was specifically designed to fulfill the need for a freely available standard for identifying observations. More than 25 years later, it now contains a rich catalog of variables, answer lists, and the collections that contain them. [Observation: Value.units] UCUM was specifically designed to fulfill the need for a freely available standard of computable units of measure. [Observation: Value.code] • If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC. • If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc. • If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology • If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used Exchange and Analytic CDM specifications: HL7 Version 2: Chapter 7 C-CDA: Results Section (entries required): 2.16.840.1.113883.10.20.22.2.3.1 FHIR: Observation OMOP: Measurement, Observation PCORnet CDM: LAB_RESULT_CM, PRO_CM, OBS_CLIN, OBS_GEN

The time or time-period the observed value is asserted as being true. For biological subjects (e.g. human patients) this is typically called the "physiologically relevant time", which is usually either the time of the procedure or of specimen collection. Very often the source of the date/time information is not known, only the date/time itself. Data Type: variable. Allowable data types include: dateTime, Period, Timing, instant Note: An observation time is essential for understanding the context and clinical meaning of an observation. For nationwide interoperability, systems must support the ability to representing this time, even if it is not present for all observations.

Vocabulary Standard: No single vocabulary covers the content necessary for representing all aspects of observation reporting (observation identifiers, coded observation values, computable units of measure, etc). Yet, the collection of core vocabularies needed are sufficiently mature. [Observation: Code] LOINC was specifically designed to fulfill the need for a freely available standard for identifying observations. More than 25 years later, it now contains a rich catalog of variables, answer lists, and the collections that contain them. [Observation: Value.units] UCUM was specifically designed to fulfill the need for a freely available standard of computable units of measure. [Observation: Value.code] • If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC. • If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc. • If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology • If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used Exchange and Analytic CDM specifications: HL7 Version 2: Chapter 7 C-CDA: Results Section (entries required): 2.16.840.1.113883.10.20.22.2.3.1 FHIR: Observation OMOP: Measurement, Observation PCORnet CDM: LAB_RESULT_CM, PRO_CM, OBS_CLIN, OBS_GEN

A clinical note which narratively summarizes the patient encounter. LOINC code = 67781-5.

LOINC https://loinc.org/67781-5/ https://loinc.org/28636-9/ https;//loinc.org/34108-1/

The concept identifying what was tested, measured, or observed. Data Type: CodeableConcept Permissible Values: The observation identifier SHALL be from LOINC if the concept is present in LOINC.

Vocabulary Standard: No single vocabulary covers the content necessary for representing all aspects of observation reporting (observation identifiers, coded observation values, computable units of measure, etc). Yet, the collection of core vocabularies needed are sufficiently mature. [Observation: Code] LOINC was specifically designed to fulfill the need for a freely available standard for identifying observations. More than 25 years later, it now contains a rich catalog of variables, answer lists, and the collections that contain them. [Observation: Value.units] UCUM was specifically designed to fulfill the need for a freely available standard of computable units of measure. [Observation: Value.code] • If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC. • If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc. • If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology • If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used Exchange and Analytic CDM specifications: HL7 Version 2: Chapter 7 C-CDA: Results Section (entries required): 2.16.840.1.113883.10.20.22.2.3.1 FHIR: Observation OMOP: Measurement, Observation PCORnet CDM: LAB_RESULT_CM, PRO_CM, OBS_CLIN, OBS_GEN

The information determined as a result of making the observation. The information carried by Observation.value may take several forms, depending on the nature of the observation. For example, it could be a quantitative result, and ordinal scale value, nominal or categorial value, etc. Data Type: variable. Possible data types include: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Terminology Standards: The appropriate terminology depends on the observation. A few examples: • If the observation is quantitative, then Observation.value.units SHALL be drawn from UCUM. • If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC. • If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc. • If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology • If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used.

Vocabulary Standard: No single vocabulary covers the content necessary for representing all aspects of observation reporting (observation identifiers, coded observation values, computable units of measure, etc). Yet, the collection of core vocabularies needed are sufficiently mature. [Observation: Code] LOINC was specifically designed to fulfill the need for a freely available standard for identifying observations. More than 25 years later, it now contains a rich catalog of variables, answer lists, and the collections that contain them. [Observation: Value.units] UCUM was specifically designed to fulfill the need for a freely available standard of computable units of measure. [Observation: Value.code] • If the observation represents a validated assessment instrument (e.g. survey) item and the value is a CodeableConcept, then Observation.value.code SHALL be drawn from LOINC. • If the observation pertains to clinical genetics, then other terminologies or syntaxes may be used as appropriate, e.g. HGVS, ClinVar, etc. • If the observation represents a human phenotype, then the Observation.value MAY be drawn from the Human Phenotype Ontology • If the observation has a nominal or ordinal scale value and the Observation.value exists in SNOMED CT, then SNOMED CT MAY be used Exchange and Analytic CDM specifications: HL7 Version 2: Chapter 7 C-CDA: Results Section (entries required): 2.16.840.1.113883.10.20.22.2.3.1 FHIR: Observation OMOP: Measurement, Observation PCORnet CDM: LAB_RESULT_CM, PRO_CM, OBS_CLIN, OBS_GEN

The custodian is the organization that is in charge of maintaining and is entrusted with the care of the document.

Documentation of a clinical encounter that takes place via telehealth.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

NPPES assigns a unique number to each registered provider DEA assigns a number to each requesting and qualified healthcare professional.

Subject impacted by event - reference to Patient, Practitioner, Related Person, etc.

HL7.org FHIR R4 v4.0

Event or incident that occurred or was averted

HL7.org FHIR R4 v4.0

A synopsis of a patient’s admission and clinical course in one setting when being transferred to another setting.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

Documentation of a clinical encounter that takes place in an outpatient setting. Reason to consider separately (including this here because the "Reason" field for additional elements is truncating my text): This data element has some overlap with other existing and proposed Clinical Notes data elements Outpatient is a setting versus a type of service (Consultation, History & Physical, Discharge Summary, Transfer Summary, etc.). For example, Outpatient consultation notes span the “Consultation Note” and “Outpatient Note” data elements. However, we feel it is important to specify this particular setting because the vast majority of LOINC terms representing outpatient clinical notes aren’t captured in the data elements that represent particular types of service.

LOINC. We recommend adding the new data elements with a LOINC term representing the most generic term for that particular data element, along with information about how to access the value set of more specific LOINC terms available for each note type. The Regenstrief LOINC team can provide FHIR ValueSets with associated OIDs and/or webpages with downloadable content for each note type. Both of these resources would include the same set of LOINC terms. These resources do not exist yet but can easily be created if approved as additions to the USCDI. The benefit of hosting these resources on the LOINC website or providing them via LOINC FHIR terminology services compared to VSAC or other value set repositories is that the resources will be updated automatically with every LOINC release and would not require a separate process.

NPPES assigns a unique number to each registered provider DEA assigns a number to each requesting and qualified healthcare professional.

Outpatient note, LOINC code = 34108-1, and any LOINC LongName which has the phrase or concept 'outpatient note' within it.

LOINC https://loinc.org/67781-5/ https://loinc.org/28636-9/ https;//loinc.org/34108-1/

Initial evaluation note, LOINC code = 28636-9, and any LOINC LongName Note which has Initial Evaluation Note as a component.

LOINC https://loinc.org/67781-5/ https://loinc.org/28636-9/ https;//loinc.org/34108-1/

Encounter Status: FHIR Encounter Status: http://hl7.org/fhir/ValueSet/encounter-status Classification of Encounter: V3 Value SetActEncounterCode: http://hl7.org/fhir/ValueSet/v3-ActEncounterCode Encounter Type: FHIR Encounter type: http://www.ama-assn.org/go/cpt Encounter participant type: FHIR Participant type: http://hl7.org/fhir/ValueSet/encounter-participant-type Reason for the encounter: FHIR Encounter Reason Codes: http://hl7.org/fhir/ValueSet/encounter-reason Hospital encounter discharge disposition: FHIR Discharge disposition: http://hl7.org/fhir/ValueSet/encounter-discharge-disposition Expected source(s) of payment for this encounter: FHIR Coverage Type and Self-Pay Codes: http://hl7.org/fhir/R4/valueset-coverage-type.html Encounter chief complaint: FHIR DiagnosisRole: http://hl7.org/fhir/R4/valueset-diagnosis-role.html

Encounter Status: FHIR Encounter Status: http://hl7.org/fhir/ValueSet/encounter-status Classification of Encounter: V3 Value SetActEncounterCode: http://hl7.org/fhir/ValueSet/v3-ActEncounterCode Encounter Type: FHIR Encounter type: http://www.ama-assn.org/go/cpt Encounter participant type: FHIR Participant type: http://hl7.org/fhir/ValueSet/encounter-participant-type Reason for the encounter: FHIR Encounter Reason Codes: http://hl7.org/fhir/ValueSet/encounter-reason Hospital encounter discharge disposition: FHIR Discharge disposition: http://hl7.org/fhir/ValueSet/encounter-discharge-disposition Expected source(s) of payment for this encounter: FHIR Coverage Type and Self-Pay Codes: http://hl7.org/fhir/R4/valueset-coverage-type.html Encounter chief complaint: FHIR DiagnosisRole: http://hl7.org/fhir/R4/valueset-diagnosis-role.html

The way a tumor acts within the body, e.g., ability to grow, invade other areas and/or metastasize.

Tumor Histologic Type: International Classification of Diseases for Oncology 3.2, with additional values accepted by the WHO-IARC but not included in the official published documents. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, 2021 Release (month TBD) Tumor Behavior: International Classification of Diseases for Oncology 3.2 Tumor Primary Site: International Classification of Diseases for Oncology 3.2. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release Tumor Laterality: SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release – mCODE Laterality Value Set Tumor Clinical Grade: North American Association of Central Cancer Registries Grade Clinical

Data elements or description that provide a woman's pregnancy history at the time of death.

"LOINC: Summary of death note: 47046-8 Physician Summary of death note: 83796-3 Nurse Summary of death note: 84273-2 US Standard Certificate of Death Hepatitis C Case Report Form "LOINC Codes for death note summaries: https://loinc.org/47046-8/ https://loinc.org/83796-3/ https://loinc.org/84273-2/ US Standard Certificate of Death: https://www.cdc.gov/nchs/data/dvs/DEATH11-03final-ACC.pdf Pregnancy History - While a one to one relationship may not exist between the information in the EHR and what is needed in a state's electronic death registration system (EDRS), the information in the EHR (even if available in longhand), can help inform filling out the following in the EDRS. IF FEMALE: □ Not pregnant within the past year □ Pregnant at the time of death □ Not pregnant, but pregnant within 42 days of death □ Not pregnant, but pregnant 43 days to 1 year before death □ Unknown if pregnant within the past year Hepatitis C Case Report Form: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf"

"Clinical notes information for a newborn may include the Labor and delivery summary record under–Infant data, and maternal progress note. Example information will include breastfeeding information at time of discharge."

"LOINC codes exist for each of the proposed data elements The clinical notes of an new born should capture information such as: 73756-9 | Infant is being breastfed at discharge"