Summary of Design Decisions

![](https://hackmd.io/_uploads/rkzPgbe03.png) <style>.markdown-body { max-width: 1500px; }</style>  source: https://hackmd.io/@erichaas/BJXs2R672 # Summary of US Core V7 Design for USCDI R4 Note: MS = Must Support --- ### Allergies and Intolerance DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S) Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. If a cell is empty, an applicable vocabulary standard has not been identified.|US Core V7 Proposal ---|---|--- **Substance (Non-Medication)** Non-pharmacologic agent believed to cause a harmful or undesired physiologic response following exposure. Examples include but are not limited to latex, eggs, pollen, and peanuts| Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, March 2023 Release|**No Change**: US Core`AllergyIntolerance.code` binding to [Common substances for allergy and intolerance documentation including refutations](https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1186.8/expansion) already includes "Non-pharmacologic agent" For Design Notes see [Allergies and Intolerance](/vdnc6ek3RP-n9c7mOSIJCA) --- ### Encounter DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V7 Proposal ---|---|--- **Encounter Identifier** Sequence of characters by which an encounter is known.||**No Change**: US Core`Encounter.identifier` is a Must Support element For Design Notes see [Encounter](/WksTXCjiR7KQT1HfH-nJ8g) --- ### Procedures DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V7 Proposal ---|---|--- **Time of Procedure** Time and/or date a procedure or other action is performed. Examples include but are not limited to vaccine or medication administration times, surgery start time, and time ultrasound performed.|| **No Change**: - US Core Procedure Profile (surgery start time) `Procedure.performed[x]` is a Must Support element - US Core DiagnosticReport Profile (time ultrasound performed) `DiagnosticReport.effective[x]` is a Must Support element - US Core Immunization Profile (vaccine administration time) `Immunization.occurrence[x]` is a Must Support element  For Design Notes see [Procedures](/NhGJEbDVT3G3PcBzJ_FIJA) --- ### Vital Signs DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V7 Proposal ---|---|--- **Average Blood Pressure** Arithmetic average of systolic and diastolic components of two of more blood pressure readings in a specified time period or according to a specified algorithm or protocol. Examples include but are not limited to 3-day morning and evening home monitoring, clinical encounter repeat average, and 24-hour ambulatory measurement.|Both standards are required. Logical Observation Identifiers Names and Codes (LOINC) version 2.74 The Unified Code of Units for Measure, Revision 2.1|:new: US Core Mean Blood Pressure Profile* using [Vital Signs with Qualifying Elements (CIMI):Average Blood Pressure](http://hl7.org/fhir/us/vitals/STU1/StructureDefinition-average-blood-pressure.html) as a blueprint \*US Core Mean Blood Pressure Profile Details - Blood pressure panel mean (e.g., N BPs/N) systolic and mean diastolic ([LOINC 96607-7](https://loinc.org/96607-7)) - Add implementation guidance on protocol: e.g., *Information about the protocol used to determine averages SHOULD be supplied in Observation.note.text (for example, ‘ 24-hour ambulatory measurement.’)* - Add implementation guidance on CIMI and Card-X extensions ##### :arrow_right: [Average Blood Pressure Profile and Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#average-blood-pressure) For Design Notes see [Vital Signs](/Z9WsUlwfTHy6yrnZXXdzLw) --- ### Facility Information DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S) Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. If a cell is empty, an applicable vocabulary standard has not been identified.|US Core V7 Proposal ---|---|--- **Facility Identifier** Sequence of characters representing a physical place of available services or resources.||:new: : US Core`Location.identifier` 0..* Must Support **Facility Type** Category of service or resource available in a location. Examples include but are not limited to hospital, laboratory, pharmacy, ambulatory clinic, longterm and post-acute care facility, and food pantry||:new:: US Core`Location.type` 0..* Must Support, Binding: [ServiceDeliveryLocationRoleType](http://terminology.hl7.org/5.0.0/ValueSet-v3-ServiceDeliveryLocationRoleType.html) (extensible) **Facility Name** Word or words by which a facility is known.||**No Change**: US Core`Location.name` is a Must Support element To support links to the facility via Encounter add `.encounter` (or`.context`) as a MS elements (or`.context`) to the US Core Profiles listed below. These links indirectly reference the location via Encounter. - Add `.location` as a MS element to the US Core Immunization Profile to address the special circumstance with vaccinations at pop-up sites and Pharmacies. - Add implementer guidance that if the actual event location is different from Encounter.location SHOULD use that resource's `.location` element if present. Note: Current Must Support/USCDI Requirements are listed in **bold** text |US Core Resource|Reference to Encounter|Reference to Location |--- |--- |--- | |DiagnosticReport (Lab)|DiagnosticReport.encounter|None| |DiagnosticReport (Notes)|**DiagnosticReport.encounter (MS)**|None| |Encounter|Encounter.partOf|**Encounter.location (MS)**| |Immunization|Immunization.encounter|Immunization.location| |MedicationDispense|MedicationDispense.context|MedicationDispense.location| |Observation (Lab)|Observation.encounter|Not included - potential extension| |Procedure|Procedure.encounter|Procedure.location| |ServiceRequest|ServiceRequest.encounter|ServiceRequest.locationCodeServiceRequest.location ##### :arrow_right: [Location Profile and Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#facility_information) For Design Notes see [Facility Information](/xmpbtnmxSzK0m2_fdm2dcA) --- ### Laboratory DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S) Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. If a cell is empty, an applicable vocabulary standard has not been identified.|US Core V7 Proposal ---|---|--- **Result Unit of Measure** Unit of measurement to report laboratory test results|The Unified Code of Units for Measure, Revision 2.1|**No Change**: US Core Laboratory Result Observation Profile`Observation.valueQuantity` 0..1 *Must Support* us-core-3: SHALL use UCUM for coded quantity units. **Result Reference Range** Upper and lower limit of test values expected for a designated population of individuals. Usage note: reference range values may differ by patient characteristics, laboratory test manufacturer and laboratory test performer.||:new: US Core Laboratory Result Observation Profile`Observation.referenceRange` 0..* *Must Support* **Result Interpretation** Categorical assessment of a laboratory value, often in relation to a test's reference range. Examples include but are not limited to high, low, critical, and normal.|Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, March 2023 Release* Optional: HL7 Code System ObservationInterpretation|:new: US Core Laboratory Result Observation Profile`Observation.interpretation` 0..* *Must Support* Binding: [ObservationInterpretationCodes](http://hl7.org/fhir/R4/valueset-observation-interpretation.html) (extensible) **Specimen Source Site** Body location from where a specimen was obtained. Examples include but are not limited to right internal jugular, left arm, and right eye.|Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, September 2022 Release|:new: US Core Specimen Profile`Specimen.collection.bodySite` 0..1 *Additional USCDI Requirement* Binding: [SNOMED CT Body Structures](http://hl7.org/fhir/ValueSet/body-site) (extensible) **Specimen Identifier** Sequence of characters assigned by a laboratory for an individual specimen.||:new: US Core Specimen Profile`Specimen.identifier` 0..* Must Support **Specimen Condition Acceptability** Information regarding a specimen, including the container, that does not meet a laboratory’s criteria for acceptability. Examples include but are not limited to hemolyzed, clotted, container leaking, and missing patient name. Usage note: This may include information about the contents of the container, the container, and the label.|Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, March 2023 Release*|:new: US Core Specimen Profile`Specimen.condition` 0..1 *Additional USCDI Requirement* Binding: [hl7VS-specimenCondition](http://terminology.hl7.org/5.0.0/ValueSet-v2-0493.html) (extensible) \* :exclamation: Issue with ONC vs HL7 terminology requirements ##### :arrow_right: [Laboratory and Specimen Profiles and Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#laboratory) For Design Notes see [Laboratory](/Ed2-9T2QQNihYUksWs55TQ) --- ### Health Status Assessments DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V7 Proposal ---|---|--- **Physical Activity** Evaluation of a patient's current or usual exercise. Examples include but are not limited to Exercise Vital Sign.||Base it on US Core's [Screening and Assessments](http://hl7.org/fhir/us/core/screening-and-assessments.html) In other words, reused Simple Observations/US Core Condition Problems and Health Concerns, The US Core Observation Screening Assessment Profile,The SDC Base Questionnaire/US Core QuestionnaireResponse Profile with recommendation to use value sets from [Physical activity IG](http://hl7.org/fhir/us/physical-activity/2023May) **Alcohol Use** Evaluation of a patient's consumption of alcohol. Examples include but are not limited to history of alcohol use, alcohol use disorder identification test and alcohol intake assessment.||Same as above with recommended domain specific value set from (TAPS or SDOH) **Substance Use** Evaluation of a patient's reported use of drugs or other substances for non-medical purposes or in excess of a valid prescription. Examples include but are not limited to substance use disorder score, and substance use knowledge assessment.||Same as above with recommended domain specific value set from (TAPS or SDOH) Provide implementer Guidance on appropriate terminology and Assessment Tools - Physical Activity IG - TAPS : The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool ###### :arrow_right: [Physical Activity Examples Based on US Core Screenings and Assessements](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#physical-activity) ###### :arrow_right: [Substance Use Examples Based on US Core Screenings and Assessements](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#substance-use) ###### :arrow_right: [Alcohol Use Examples Based on US Core Screenings and Assessements](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#alcohol-use) For Design Notes see [Health Status Assessments](/3J_QYnLGSKSx2YoawRUmBA) --- ### Medications DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)|US Core V7 Proposal ---|---|--- **Medication Instructions** Directions for administering or taking a medication. Examples include but are not limited to prescription directions for taking a medication, and package instructions for over-the-counter medications. Usage notes: May include route, quantity, timing/frequency, and special instructions(PRN, sliding scale, taper).||**No Change**: US Core`MedicationRequest.dosageInstruction` is a Must Support element **Medication Adherence** Statement of whether a medication has been consumed according to instructions. Examples include but are not limited to taking as directed, taking not as directed, and not taking.| Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) U.S. Edition, March 2023 Release*|:new: 0..* *Additional USCDI Requirement* MedicationAdherance extension on MedicationRequest \*Use SNOMED CT vs MedicationStatement Adherence Codes Extensible |Code (SCT ID)|Preferred Term|Available Acceptable Term (Synonym)|Available Acceptable Term (Synonym)| ---|---|---|---| 1156699004|Complies with drug therapy (finding)| Adheres to drug therapy|Adheres to medication regime| 702565001|Non-compliance of drug therapy (finding)| Drug therapy non adherence|Medication therapy non-adherence| 275928001|Drugs - partial non-compliance (finding)||| 275927006|Drugs - total non-compliance (finding)||| 457831000124109|Medication therapy compliance variable (finding) | Medication therapy compliance variable| Medication adherence variable| 26166500*|Unknown (Qualifier) \* Note: No more specific unknown code vs FHIR DAR code??? ##### :arrow_right: [MedicationRequest with Adherance Extension Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#medication) For Design Notes see [Medications](/B94huB65SnSIA5GuG28WNQ) --- ### Goals DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S) Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. If a cell is empty, an applicable vocabulary standard has not been identified.|US Core V7 Proposal ---|---|--- **Treatment Intervention Preference** Person's goals, preferences, and priorities for care and treatment in case that person is unable to make medical decisions because of a serious illness or injury. Examples include but are not limited to thoughts on cardiopulmonary resuscitation, mental health treatment preferences, and thoughts on pain management.|Logical Observation Identifiers Names and Codes (LOINC) version 2.74|:new: Observation derived from US Core Simple Observation using [PACIO'a ADI Personal Intervention Preference Profile](https://build.fhir.org/ig/HL7/fhir-pacio-adi/branches/master/StructureDefinition-ADI-PersonalInterventionPreference.html) as a blueprint. **Care Experience Preference** Person's goals, preferences, and priorities for overall experiences during their care and treatment. Examples include but are not limited to religious beliefs, dislikes and fears, and thoughts and feelings to be shared.|Logical Observation Identifiers Names and Codes (LOINC) version 2.74|:new: Observation derived from US Core Simple Observation using [PACIO's ADI Care Experience Preference Profile](https://build.fhir.org/ig/HL7/fhir-pacio-adi/branches/master/StructureDefinition-ADI-CareExperiencePreference.html) as a blueprint. \* Details. - derived from US Core Simple Observation - add 2 new category codes to [US Core Category](https://build.fhir.org/ig/HL7/fhir-pacio-adi/branches/master/StructureDefinition-adi-contextualValue-extension.html) - constrain code extensible binding to either :thinking_face: - a single code - PACIO code sets - Must Support or USCDI requirement for `derivedFrom` DocumentReference :thinking_face: - Simplified version of the PACIO Profiles. - no mandatory Narrative - no Must Support text elements for codes - no [PACIO Context Extension](https://build.fhir.org/ig/HL7/fhir-pacio-adi/branches/master/StructureDefinition-adi-contextualValue-extension.html) - no fixed status to "complete" - adds effective[x] and performer as MustSupports. ##### :arrow_right: [Care Experience and Treatment Intervention Preference Profile and Examples](https://healthedata1.github.io/USCDI4-Sandbox/artifacts.html#goals-and-preferences) For Design Notes see [Goals](/a3eMn2mMRm6fj_y1lw9MSA) --- ### Next Steps 1. Presentation of our decisions ( alongside CCDA decision) at the Sept WGM Wed Q3-4 1. Apply updates to US Core CI Build 1. Host a series of public HL7 calls to review these updates and address US Core Trackers (HL7 CGP Calls every Thursday 1 PM Eastern) starting Sept 21st. - Change requests for existing US Core content (JIRA trackers) are due by Sept 30th to be considered for US Core v7.0.0-ballot version. Trackers after that will only be considered if they are technical corrections or solely at the editor's discretion, otherwise, they will be considered after the Jan 2024 Ballot. 1. Publication of US Core v7.0.0-ballot in Jan 2024 Ballot 1. Ballot Reconciliation Jan-April 2024 1. Publication of US Core v7.0.0 in May 2024 --- # :question:

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