USCDI Export for the Public

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

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

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

The Source of information received by an organization. The Source defines at a high level the standard used to exchange the information.

The Da Vinci Project has developed a code system and value set to represent the Source of information as represented in an extension to the FHIR R4.0.1 Provenance resource. It is available as part of the Payer Data Exchange FHIR Implementation Guide

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.

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.

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.

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.

A PACP may contain a person’s quality of life priorities based on their personal values for what is important to them in order to have a good quality of life. They may value such things as being able to take care of themselves without needing physical help from loved ones, or being able to live without depending on machines to keep them alive, or living as long as possible by receiving all the medical care doctors believe will help them. The intent of the quality of life priorities is to provide guidance to the future care team, in a situation where the person is unable to communicate for his or her self, that informs their healthcare agent as to what is important to them and provides guidance to the care team when treatment decisions need to be made on the person’s behalf.

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.

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.

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.

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.

This data element is the self-reported date range(s) when a person worked in what is considered a combat zone. Both civilian workers, such as Department of Defense contractors, and military service members could have worked in combat zones.

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.

This element is used to describe how intense or severe the sensation of pain is on a 1-10 scale.

LOINC: 38208-5 Pain severity – Reported

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)

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

A record of the patient’s authorizations and directions regarding disclosure and use of the patient’s SDOH data.

Yes, structural standards exist for each of these six elements in current HL7 standards. Specifically, in FHIR, (1) Assessments are Observation resources; (2) Problems/Health Concerns are Condition resources; (3) Goals are Goal resources; (4) Interventions are ServiceRequest and Procedure resources; (5) Outcomes are represented by the status on any of the previously mentioned resources or creation of new Observation resources; and (6) Consent is represented by the Consent resource. Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems For the respective SDOH domains: For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value sets in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5) Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project. • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The details of the domains and specific consensus-approved value sets for each of the activities will be externally maintained as part of a hierarchy of LOINC panels and, where necessary, VSAC value sets referenced by the LOINC panels. The proposed structure is as follows: Survey (Panel) LOINC code a. Food Insecurity Domain (Panel) (LOINC code) i. Food Insecurity Assessment (Panel) (LOINC code) 1. Value set (LOINC codes) ii. Food Insecurity Health Concerns (Panel) (LOINC code) 1. Value set (SNOMED-CT and ICD-10-CM) iii. Food Insecurity Goals (Panel) (LOINC code) 1. Value set (LOINC codes) iv. Food Insecurity Interventions (Panel) (LOINC code) 1. Value set (SNOMED-CT, HCPCS, CPT, LOINC) v. Food Insecurity Outcomes (Panel) (LOINC code) 1. Value set (LOINC codes) b. Domain: Housing Instability and Homelessness c. Etc.

The amount of the discount.

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.

Total amount for each category (i.e., submitted, eligible, etc.)

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.

The reduction in the payment amount to reflect the current carrier as a secondary, teritary, etc, payer. May be multiple occurrences if the current carrier is a teritary, etc. carrier.

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.