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 2 Medications

Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Negation Rationale

Medications (including medications with dose): RxNORM Medication Route: SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.222) Negation Rationale (reason codes): SNOMED (i.e. OID: 2.16.840.1.113883.3.117.1.7.1.93) https://vsac.nlm.nih.gov/valueset/expansions?pr=ecqm Negation Rationale: https://www.hl7.org/fhir/valueset-reason-medication-not-given-codes.html , http://hl7.org/fhir/us/qicore/ValueSet-qicore-negation-reason.html

Joel Andress CMS
Level 2 Health Insurance Information

Data related to an individual’s insurance coverage for health care.

Policy Number

The unique identifier for a specific insurance policy that defines a set of covered benefits and services along with other information that is necessary to administer the policy (e.g. financial obligations for both parties)

Member, subscriber, group, and plan identifiers are assigned by healthcare insurer. The coverage period is a standard date range during which the coverage is in effect. There is currently no standard Healthcare Payer Identifier (e.g. HPID) but frequently the NAIC identifier is used but not required.

Robert C Dieterle On behalf of the Da Vinci Project
Level 2 Facility Information

Physical place of available services or resources.

Facility Contact Information

Various: FHIR DSTU2, 3 and 4, CDA Release 2.0, HL7 V2 PL Data Type

Keith W. Boone Audacious Inquiry
Level 2 Facility Information

Physical place of available services or resources.

Facility Address Keith W. Boone Audacious Inquiry
Level 2 Biologically Derived Product

Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Processing Facility

Provides details on the processing location of the product

ISBT-128 Processing Facility Identification Number

Barbee Whitaker Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)
Level 2 Biologically Derived Product

Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Product Code

Provides a description of and supports traceability for a product

ISBT-128 Product Description Code

Barbee Whitaker Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)
Level 2 Biologically Derived Product

Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Unique Identifier

Provides a globally unique identifier code for an individual product.

Medical Product of Human Origin Unique Identifier
UNOS UNet TransNet Labeling System

Barbee Whitaker Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)
Level 2 Health Insurance Information

Data related to an individual’s insurance coverage for health care.

Coverage Period

The time frame in which the policy is in force.

Member, subscriber, group, and plan identifiers are assigned by healthcare insurer. The coverage period is a standard date range during which the coverage is in effect. There is currently no standard Healthcare Payer Identifier (e.g. HPID) but frequently the NAIC identifier is used but not required.

Robert C Dieterle On behalf of the Da Vinci Project
Level 2 Social History Sexual Activity

Information on the sexual activity of the patient

SNOMED CT: (Parent code and all children codes in the hierarchy) 414254005 - Finding of frequency of sexual activity (finding) 162171002 - Currently not sexually active (finding) 228453005 - Sexually active (finding) *LOINC 64728-9 - Have you ever had vaginal intercourse [PhenX] *Note Montana's Department of Public Health and Human Services (DPHHS) includes SNOMED CT codes in their “Adolescent Wellness” Registry, addressing the “STI Screening” measure, together with the “Chlamydia Screening in Women” measure.

Raymonde Uy National Association of Community Health Centers (NACHC)
Level 2 Facility Information

Physical place of available services or resources.

Facility Managing Organization Identifier

Various: FHIR DSTU2, 3 and 4, CDA Release 2.0, HL7 V2 PL Data Type

Keith W. Boone Audacious Inquiry
Level 2 Biologically Derived Product

Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Source Identifier

Provides details on collections and pooled products such as donation identifier

ISBT-128 Donation Identification Number

Barbee Whitaker Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)
Level 2 Biologically Derived Product

Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Division

Provides details on aliquots or when a donation event involves more than one collection

ISBT-128 Division Identifier

Barbee Whitaker Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)
Level 1 Work Information Retirement Date

Retirement Date is a self-reported date (at least year) that a person considers themselves to have ‘retired’. A person can have more than one Retirement Date. A person can be both employed and retired, so these data are independent of one another.

An information model of the Work Information data elements, called Occupational Data for Health (ODH), has been published ( https://doi.org/10.1093/jamia/ocaa070) and the data are represented in the Federal Health Information Model (FHIM; https://fhim.org/). An HL7 informative EHR-S Functional Profile has been published (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=498). A Guide to Collection of Occupational Data for Health (ODH) is in preparation. Logical Observation Identifiers Names and Codes (LOINC) codes are available for each Work Information Data Element and each component of the data elements, including Retirement Date (https://loinc.org/). Interoperability standard formats for all of the Work Information Data Elements are published as aligned HL7 CDA, V2, and FHIR ODH templates as well as an IHE CDA profile ODH template. Related References: HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes; Occupational Data for Health, Release 1 – US Realm; STU. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=522 IHE Patient Care Coordination (PCC) Technical Framework Supplement: CDA Content Modules, Revision 2.6 – Trial Implementation. https://www.ihe.net/resources/technical_frameworks/#pcc HL7 FHIR Release 4.0.1 Profile: Occupational Data for Health (ODH), Release 1.0 STU. http://hl7.org/fhir/us/odh/STU1/ HL7 Version 2.9 Messaging Standard – An Application Protocol for Electronic Data Exchange in Healthcare Environments, Normative. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=516. Chapter 3, Patient Administration: Retirement Date is included in the PD-1 segment.

Genevieve Luensman PhD Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH)
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 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
SNOMED CT: https://www.snomed.org/

Kevin Jung University of California San Francisco Breast Care Center
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 Provenance

The metadata, or extra information about data, regarding who created the data and when it was created.

Author Id

An identifier of the person or device who authored the document.

Sarah Gaunt The Association of Public Health Laboratories (APHL)
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
SNOMED CT: https://www.snomed.org/

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
SNOMED CT: https://www.snomed.org/

Kevin Jung University of California San Francisco Breast Care Center
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