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 Work Information Employment Status

This data element includes a coded concept, Employment Status, with time and date stamp and/or start date and end date. A person can be both employed and retired, and can have a different employment status for each job. Employment Status is a person's self-reported, coded relationship to working for pay, family earnings, or training (e.g. having one or more jobs, searching for work, etc.). A person’s Employment Status is independent of Job characteristics, e.g., not “full-time work” or “part-time work,” because many people have more than one job.

An information model of the Patient Work 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; https://loinc.org/) codes are available for each Patient Work Data Element, including Employment Status. The ODH code set (https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.114222.4.5.327) provides a value set for Employment Status as well as other Patient Work Data Elements (https://phinvads.cdc.gov/vads/SearchValueSets_search.action?searchOptions.searchText=ODH). The PHIN VADS ODH Hot Topics section provides downloadable files with Preferred Concept Names and Easy Read Descriptions for Employment Status values (https://phinvads.cdc.gov/vads/SearchVocab.action). Interoperability standard formats for all of the Patient Work 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 2C, Tables, Tables 0954-0959 provide the Patient Work Data Element component value sets. Chapter 3, Patient Administration, sections 3.4.15 and 3.4.18 describe the Patient Work Data Elements Employment Status and Combat Zone Period as Occupational Health (OH) segments; Retirement Date is included in the PD-1 segment.

Genevieve Luensman Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health
Level 1 Advance Directives Personal Advance Care Plan

Advance care plan is a general term for any documentation or other recordation of a person’s 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. An advance care plan places an emphasis on communication, as opposed to legal formalities. A PACP is a term specifically defined by HL7 as a template to facilitate the sharing of information expressed in advance care plans. A PACP may include the type of information contained in a living will and/or a durable medical power of attorney, and it also may include other medical interventions experience preference and instructions that help a healthcare agent make treatment decisions on the person’s behalf, and can be used by medical professionals to inform their medical interventions and treatment planning for the patient. Within the family of documents that have been defined under Consolidated CDA, the PACP document can be classified as a type of patient-generated document. The PACP document facilitates digital exchange of information previously and currently captured and shared using paper documents. Digital exchange of this type of data has become particularly critical within the context of COVID-19. To reduce the spread of disease, hospitals have disallowed patient family members and/or representatives to be present when the patient is admitted and as medical interventions are rendered, while also prohibiting acceptance of paper documents due to concerns of contagion. A PACP may include information relating to the appointment of a healthcare agent and alternate agents and establishing their authorized powers and limitations. It also may include information relating to any or all of the following: goals, preferences, and priorities for medical interventions (e.g., palliative and/or hospice care), including medical treatment preferences, based on the patient’s individual values, spiritual and religious beliefs, and personal definitions of quality of life; instructions to be followed after death (e.g., organ donation and autopsy); and information about who has signed, witnessed, and notarized the information authored by the individual, if available and appropriate. The set of recognized kinds of advance directive documents include concepts from the value set: Advance Directives Categories urn:oid:2.16.840.1.113883.11.20.9.69.4 which is openly available for reference in the National Library of Medicine’s Value Set Authority Center. It can be referenced using this url: https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.69.4/definition

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.

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 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 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 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s authorized representative, 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 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 authorized representative, 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 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 Medications

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

Medication Treatment Intent

The purpose of a treatment, or the desired effect or outcome resulting from the treatment. For example, a treatment may be intended to completely or partially eradicate a disease process by disrupting its underlying physiological processes, resulting in improvement in health; or a treatment may have no expectation of eradication but rather may be intended simply to delay the onset of more severe symptoms; or may be intended to prolong life without any expectation of cure. NOTE: Treatment Intent has also been submitted under the Procedures data class

SNOMED CT codes for therapeutic intent (qualifier value)

Andre Quina MITRE
Level 1 Patient Demographics/Information

Data used to categorize individuals for identification, records matching, and other purposes.

Patient Birth Place

The city, state, county and country or location in which the patient was born.

FHIR patient extension: birthplace FHIR patient address.period

Adam Bazer, MPD Integrating the Healthcare Enterprise USA (IHE USA)
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 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s authorized representative, 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
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 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.)
 No
 Yes, my chromosomes, genitals, reproductive organs, or hormone functions were observed to be different from the typical female/male binary at birth and/or I have been diagnosed with an intersex variation or Difference of Sex Development
 I don’t know
Source: Intersex Data Collection: Your Guide to Question Design. interACT: Advocates for Intersex Youth. 2020. Accessed September 29, 2022. https://interactadvocates.org/intersex-data-collection/

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 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 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 Exposure/Contact Information Exposure/Contact Date The date or period on which the possible exposure/contact occurred.

HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) based on FHIR R4 HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) HL7 FHIR: US Public Health Exposure Contact Information profile (Observation.component) HL7 CDA: Exposure/Contact Information Observation template (observation/participant)

Laura Conn
Level 1 Medications

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

Medication Module

The medication module is concerned with resources and functionality in 3 main domains: (1) the ordering, dispensing, administration of medications and recording statements of medication use, (2) Recording of Immunizations given (or not given), evaluation of given immunizations and recommendations for an individual patient at a point in time, and (3) The creation or querying for medications as part of drug information or drug knowledge. https://www.hl7.org/fhir/medications-module.html

RxNorm and SNOMED CT

Shelly Spiro Pharmacy HIT Collaborative
Level 1 Exposure/Contact Information Exposure/Contact agent The possible agent of concern in the exposure/contact.

HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) based on FHIR R4 HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) HL7 FHIR: US Public Health Exposure Contact Information profile (Observation.component) HL7 CDA: Exposure/Contact Information Observation template (observation/participant)

Laura Conn