USCDI Export for the Public
| Classification Level Sort descending | Data Class | Data Class Description | Data Element | Data Element Description | Applicable Standards | Submitter Name | Submitter Organization | Submission Date |
|---|---|---|---|---|---|---|---|---|
| Level 1 | Facility Information | Physical place of available services or resources. |
Facility GPS Coordinates | Various: FHIR DSTU2, 3 and 4, CDA Release 2.0, HL7 V2 PL Data Type |
Keith W. Boone | Audacious Inquiry | ||
| Level 1 | Genomics | Variant Interpretation | The categorical or clinical assessment of the genetic variant data, where interpretation is necessary to fully understand the significance. |
* SNOMED CT LINKS: SNOMED CT LOINC HGNC Notation HGVS Nomenclature COSMIC ISCN |
Steve Bratt | CodeX (Common Oncology Data Elements eXtensions), a member-driven HL7 FHIR Accelerator | ||
| Level 1 | Genomics | Variant Type | The data representing the type of genetic variation. Some examples of variant types include DNA, protein, chromosome. |
* SNOMED CT LINKS: SNOMED CT LOINC HGNC Notation HGVS Nomenclature COSMIC ISCN |
Steve Bratt | CodeX (Common Oncology Data Elements eXtensions), a member-driven HL7 FHIR Accelerator | ||
| Level 1 | Biologically Derived Product | Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity. |
Biologically Derived Product Storage information | This set of data elements describe the product’s storage information within the blood bank or other appropriate entity storing the product: a. Description (FHIR R4: description): this is a free-text field for describing how the product is stored. b. Temperature (FHIR R4: temperature): temperature used for storage. c. Temperature Units (FHIR R4: scale): units for temperature used for storage (e.g. Celsius or Fahrenheit). d. Storage Duration (FHIR R4: duration): duration of storage before administration. |
ISBT-128 for biologically derived products of human origin (blood components, fluid, cells, tissues, or organs), and NDC/RxNorm for productized biologics such as blood derived products (e.g. IVIGs, clotting factors, and others). Links URLs (added here to enable sharing multiple): - ISBT: http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2 - RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html - NDC: https://www.fda.gov/drugs/drug-approvals-and-databases/nati |
Barbee Whitaker | FDA Center for Biologics Evaluation and Research | |
| Level 1 | Health Status Assessments | Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition. |
PROMIS (Patient-Reported Outcomes Measurement Information System) survey score result | Patient-Reported Outcomes Measurement Information System (PROMIS) program created new paradigms for how clinical research information is collected, used, and reported. PROMIS addressed a need in the clinical research community for a rigorously tested patient reported outcome (PRO) measurement tool that uses recent advances in information technology, psychometrics, and qualitative, cognitive, and health survey research to measure PROs such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. |
ICD-10 : https://www.cms.gov/Medicare/Coding/ICD10 |
Kevin Jung | University of California San Francisco Breast Care Center | |
| Level 1 | Health Status Assessments | Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition. |
Promise Preference (PROPr) Utility Score | PROPr is a score for the PROMIS measurement system. PROPr combines scores from 7 PROMIS domains into a single preference-based score (also called a health utility score). This score captures the preferences of the general adult US population. |
ICD-10 : https://www.cms.gov/Medicare/Coding/ICD10 |
Kevin Jung | University of California San Francisco Breast Care Center | |
| Level 1 | Health Status Assessments | Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition. |
Two-item PROMIS®️ global physical and mental health scales | Two-item PROMIS®️ global physical and mental health scales: Global health items provide synoptic information that can be utilized as predictive indictors of health care utilization and mortality. |
ICD-10 : https://www.cms.gov/Medicare/Coding/ICD10 |
Kevin Jung | University of California San Francisco Breast Care Center | |
| Level 1 | Outcomes | Adverse Event Severity | Degree to which an an unfavorable or unintended disease, sign, or symptom that is temporally associated with the use of a medical treatment or procedure, affects the health and wellbeing of the subject. Usage Note: Adverse event may or may not be directly caused by the medical treatment or procedure. Severity may be represented by several scales or descriptions. | The use of NCI CTCAE and SNOMED CT. The severity value sets of the adverse event are part of an existing FHIR CodeSystem: AdverseEventSeverity |
Vulcan | Vulcan | ||
| Level 1 | Laboratory | Analysis of clinical specimens to obtain information about the health of a patient. |
Instrument Unique Identifier | Uniquely identifies the type of instrument that was used in conjunction with the Test kit (at minimum by using instrument name and manufacturer (similar to the make and model of a car)) to obtain the Test Result Value. When a testkit is used on an instrument it is the combination of kit and instrument, that qualify the Performed Test. |
Riki Merrick | Association of Public Health Laboratories | ||
| Level 1 | Patient Demographics/Information | Data used to categorize individuals for identification, records matching, and other purposes. |
Patient Social Security Number | Records patient’s social security number. |
Social Security Administration: https://www.ssa.gov/history/ssn/geocard.html Medicare Beneficiary Identifiers (MBIs): https://www.cms.gov/Medicare/New-Medicare-Card PHIN VADS: Patient Marital Status: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=DB54A32E-D583-4A24-BD9C-234B0C7BD0FD Gender Identity - Gender harmony project definitions: https://www.jointcommission.org/-/media/deprecated-unorganized/imported-assets/tjc/system-folders/topics-library/lgbtfieldguidepdf.pdf?db=web&hash=224B46C31193399359B8113698971F26 FHIR patient extension: birthplace: http://hl7.org/fhir/R4/extension-patient-birthplace.html FHIR patient address.period: http://hl7.org/fhir/us/core/StructureDefinition-us-core-patient.html LOINC pregnancy status: https://loinc.org/82810-3/ Patient Vital Status: PHIN VADS, SNOMED-CT: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=6EA795D5-5C5D-E511-81F8-0017A477041A Patient vital status:CCDA uses Value Set - HealthStatus urn:oid:2.16.840.1.113883.1.11.20.12 Value Set Source: https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.1.11.20.12/expansion |
Maria Michaels | CDC | |
| Level 1 | Patient Demographics/Information | Data used to categorize individuals for identification, records matching, and other purposes. |
Patient Marital Status | Patient marital status at the time of documentation. |
Social Security Administration: https://www.ssa.gov/history/ssn/geocard.html Medicare Beneficiary Identifiers (MBIs): https://www.cms.gov/Medicare/New-Medicare-Card PHIN VADS: Patient Marital Status: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=DB54A32E-D583-4A24-BD9C-234B0C7BD0FD Gender Identity - Gender harmony project definitions: https://www.jointcommission.org/-/media/deprecated-unorganized/imported-assets/tjc/system-folders/topics-library/lgbtfieldguidepdf.pdf?db=web&hash=224B46C31193399359B8113698971F26 FHIR patient extension: birthplace: http://hl7.org/fhir/R4/extension-patient-birthplace.html FHIR patient address.period: http://hl7.org/fhir/us/core/StructureDefinition-us-core-patient.html LOINC pregnancy status: https://loinc.org/82810-3/ Patient Vital Status: PHIN VADS, SNOMED-CT: https://phinvads.cdc.gov/vads/ViewValueSet.action?id=6EA795D5-5C5D-E511-81F8-0017A477041A Patient vital status:CCDA uses Value Set - HealthStatus urn:oid:2.16.840.1.113883.1.11.20.12 Value Set Source: https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.1.11.20.12/expansion |
Maria Michaels | CDC | |
| Level 1 | Cancer Care | NCI Patient Reported Outcomes (PRO)-Common Terminology for Criteria for Adverse Events (CTCAE) | PRO-CTCAE (NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events) was developed to evaluate symptomatic toxicities by self-report in adults, adolescents and children participating in cancer clinical trials. It is designed to be utilized in comparison to the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer trials. |
ICD-10 : https://www.cms.gov/Medicare/Coding/ICD10 |
Kevin Jung | University of California San Francisco Breast Care Center | ||
| Level 1 | Patient Demographics/Information | Data used to categorize individuals for identification, records matching, and other purposes. |
Patient's Primary Care Provider | Patient's nominated care provider. [Knowing this at the patient level can help answer the question at the encounter level whether the pt. was seen by PCP.] |
Medicare Beneficiary Identifiers (MBIs) |
Nedra Garrett | Centers for Disease Control and Prevention | |
| Level 1 | Advance Directives | Durable Medical Power of Attorney | A person uses a durable medical power of attorney to appoint one or more people to serve as advocates or “healthcare agents” empowered to make medical treatment decisions on behalf of that person if the person is incapacitated and cannot communicate with medical personnel. |
HL7 CDA® R2 Implementation Guide: Personal Advance Care Plan (PACP) Document, Release 1 - US Realm STU Release 2 The PACP document is a CDA document template designed to share information created by an individual to express his or her care and medical treatment goals, preferences, and priorities for some future point in time, under certain circumstances when the individual cannot make medical treatment decisions or communicate his or her goals, preferences, and priorities with the care team. The purpose of the PACP document is to ensure that the information created by the individual is available and considered in clinical care planning, and the focus of the standard is sharing patient generated information. It should not matter if the source information is documented on a piece of paper, in a video recording, or in a consumer-controlled application that exists for this purpose. The standard provides a means to share this information in a standard way with a system that maintains a clinical record for the person. It is not intended to be a legal document or a digitization of a legal document. However, a PACP can reference a legal document, and it can represent information contained in a legal document such as the appointment of healthcare agents and the identity of witnesses or a notary. |
Matt Elrod on behalf of ADVault, Inc. | ADVault, Inc. | ||
| Level 1 | Patient Demographics/Information | Data used to categorize individuals for identification, records matching, and other purposes. |
Variation in Sex Characteristics | Were you born with a variation in your physical sex characteristics? (This is sometimes called being intersex or having a Difference in Sex Development, or DSD.) |
LOINC has an intersex response option, 99502-7, for Recorded sex or gender. LOINC has an intersex response option. We do not endorse the way LOINC conceptualizes intersex (as corresponding to an X response to a sex or gender question). |
Sean Cahill | Fenway Health | |
| Level 1 | Security Label | Security Label Purpose of Use (POU) Tag | A POU tag is the 0..* component of a Security Label that conforms to follows the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to indicate the circumstances under which an authorized recipient is permitted to perform an activity such as create, collect, access, use, or disclose. For HL7 POU codes, see POU value set at: https://build.fhir.org/ig/HL7/UTG/ValueSet-v3-PurposeOfUse.html We recommend creating a value set of POU codes to value the POU tag, which are specific to priority US policies as discussed in the HL7 Cross-Paradigm US Regulatory Security Labeling Implementation Guide, which is under development. |
HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative. |
TICIA Louise GERBER | Health Level Seven International | ||
| Level 1 | Security Label | Security Label Confidentiality Tag | A Confidentiality tag is the 1..1 component of a Security Label that conforms to the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 (HCS) syntax to represent the level of protection prescribed by a policy governing the information to which a label is assigned. The HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 (HCS) can be found at: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=345 HL7 recommends creating a value set of Confidentiality codes specific to priority US policies as discussed in the HL7 Cross-Paradigm US Regulatory Security Labeling Implementation Guide, which is under development and can be found at: https://build.fhir.org/ig/HL7/us-security-label-regs/branches/master/index.html For v3 HL7 Confidentiality Codes, see the Confidentiality value set at: https://build.fhir.org/ig/HL7/UTG/ValueSet-v2-0952.html For background on use of Confidentiality codes, see https://confluence.hl7.org/display/SEC/Use+of+Confidentiality+Codes+in+HL7+Security+Labeling . For use of Confidentiality codes in CDA, see HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1. For use of Confidentiality codes in FHIR see http://hl7.org/fhir/uv/security-label-ds4p/2020May/background.html For use of Confidentiality codes in HL7 Version 2, see v2.9 ARV Segment. |
HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative. |
TICIA Louise GERBER | Health Level Seven International | ||
| Level 1 | Biologically Derived Product | Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity. |
Biologically Derived Product | This resource is defined by HL7 FHIR as "a material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.” See HL7 FHIR R4 specification for additional details (http://hl7.org/fhir/biologicallyderivedproduct.html). The major components of the BiologicallyDerivedProduct data class are comprised of the following components below: 1. Product information 2. Storage information |
ISBT-128 for biologically derived products of human origin (blood components, fluid, cells, tissues, or organs), and NDC/RxNorm for productized biologics such as blood derived products (e.g. IVIGs, clotting factors, and others). Links URLs (added here to enable sharing multiple): - ISBT: http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2 - RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html - NDC: https://www.fda.gov/drugs/drug-approvals-and-databases/nati |
Barbee Whitaker | FDA Center for Biologics Evaluation and Research | |
| Level 1 | Biologically Derived Product | Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity. |
Biologically Derived Product information | This set of data elements describes information related to the biologically derived product: a. Product Code (productCode): this is the data element which can store 1 to many codable concepts describing the product. We propose the ability to use the following product codes to identify biologically derived products: a.i. ISBT-128 Product Code: identifies the biologically derived product type, such as blood components, fluids, tissues, organs, or cells. a.ii. ISBT-128 Donation Identification Number: uniquely identifies a biologic product donation, such as blood components, fluids, tissues, organs, or cells. a.iii. NDC or RxNorm codes can be used for biologically derived products that are manufactured and labeled with an NDC, such as blood derived products (e.g. IVIG’s, clotting factors). Vaccines shall use the Immunization Data Class resource. b. Product Type/Category (FHIR R4: productCategory): this element identifies the product type (e.g. organ | tissue | fluid | cells | biologicalAgent). c. Collector (FHIR R4: collector): identifies the collection entity practitioner resource instance, if appropriate. d. Source (FHIR R4: source): linkage to Patient or Organization resource identifying the biologically derived product donation source. e. Collected date/time (FHIR R4: collected): date and time of biologic product collection. f. Quantity (FHIR R4: quantity): quantity of biologic product identified in the resource instance. |
ISBT-128 for biologically derived products of human origin (blood components, fluid, cells, tissues, or organs), and NDC/RxNorm for productized biologics such as blood derived products (e.g. IVIGs, clotting factors, and others). Links URLs (added here to enable sharing multiple): - ISBT: http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2 - RxNorm: https://www.nlm.nih.gov/research/umls/rxnorm/index.html - NDC: https://www.fda.gov/drugs/drug-approvals-and-databases/nati |
Barbee Whitaker | FDA Center for Biologics Evaluation and Research | |
| Level 1 | Advance Directives | Living Will | In a living will, a person specifies whether he or she wants (or does not want) “life-sustaining treatments” (e.g., artificial nutrition or hydration, dialysis or the use of a ventilator to help with breathing), external cardiac compression (CPR), the application of an electric current to the heart (defibrillation), or the use of a tube placed into the windpipe through the mouth or nose to help the person breathe, should that person suffer a medical emergency and be unable to communicate with the care team. A living will includes information that helps the healthcare agent make treatment decisions on the person’s behalf, and is used by medical professionals to inform their treatment plans. |
HL7 CDA® R2 Implementation Guide: Personal Advance Care Plan (PACP) Document, Release 1 - US Realm STU Release 2 The PACP document is a CDA document template designed to share information created by an individual to express his or her care and medical treatment goals, preferences, and priorities for some future point in time, under certain circumstances when the individual cannot make medical treatment decisions or communicate his or her goals, preferences, and priorities with the care team. The purpose of the PACP document is to ensure that the information created by the individual is available and considered in clinical care planning, and the focus of the standard is sharing patient generated information. It should not matter if the source information is documented on a piece of paper, in a video recording, or in a consumer-controlled application that exists for this purpose. The standard provides a means to share this information in a standard way with a system that maintains a clinical record for the person. It is not intended to be a legal document or a digitization of a legal document. However, a PACP can reference a legal document, and it can represent information contained in a legal document such as the appointment of healthcare agents and the identity of witnesses or a notary. |
Matt Elrod on behalf of ADVault, Inc. | ADVault, Inc. |