USCDI Export for the Public

This data element provides a measure of an individual’s average daily alcohol intake, i.e., how many drinks per day someone has

Most of the requested data elements are in LOINC, as per the codes below. We have requested the addition of the NIAAA Single-Item Screener and the diagnosis of Alcohol Use Disorder to LOINC. AUDIT-C : 72109-2 Ethanol in blood: 5640-8 Ever drink alcohol: 69721-9 Average daily alcohol intake: 74013-4 Alcohol binge episodes/month: 11286-2 Alcohol abuse or dependence: 74043-1 Alcohol help during pregnancy: 64718-0

This data element denotes whether an individual currently consumes alcohol or not

Most of the requested data elements are in LOINC, as per the codes below. We have requested the addition of the NIAAA Single-Item Screener and the diagnosis of Alcohol Use Disorder to LOINC. AUDIT-C : 72109-2 Ethanol in blood: 5640-8 Ever drink alcohol: 69721-9 Average daily alcohol intake: 74013-4 Alcohol binge episodes/month: 11286-2 Alcohol abuse or dependence: 74043-1 Alcohol help during pregnancy: 64718-0

The 2020 Interoperability Standards Advisory (ISA) includes the concept of “patient preference/consent” in the content and structure section. (https://www.healthit.gov/isa/section/patient-preferenceconsent) The proposed data element, Obligation or Prohibition Instruction for Life-Sustaining Treatment, is loosely related to both the data class of “patient instructions” and the data element of “care experience preference”. A patient preference regarding a treatment for which the patient has provided consent to perform (obligation) or not to perform (prohibition) is aligned with the notion of a Patient Instruction. Episodic patient instruction records a patient’s consent to have or not have a particular medical treatment under certain circumstances during an episode of care. These consents provide the patient’s care team with information needed to establish the patient’s plan of care. When a person is about to undergo a medical procedure where he or she will be sedated, or about to have an inpatient stay, or a stay at a nursing or rehab care facility, care providers may ask the patient to make episode-of-care-specific decisions about medical treatments he or she does or does not want should a circumstance arise when this choice would need to be taken into consideration. A patient may make these decisions for himself or herself, or if the patient cannot make these decisions, the surrogate decision-maker may decide. These consents are made in the present and apply to the current episode of care. They are instructions provided by the patient or a surrogate decision-maker. The patient makes these decisions by himself or herself and communicates them to the care team. There is no requirement for the patient to make decisions which are consistent with the goals, preferences, and priorities they may have previously documented in advance directives or their PACP, but it is possible their prior thoughts may influence their current choices. If the patient is unable to communicate, then a patients previously appointed healthcare agent or a surrogate decision-maker if a healthcare agent was not appointed may make these decisions on the patient’s behalf. Ideally, these decisions are informed by the values, beliefs, and quality of life priorities documented previously by the patient as advance directives or PACP. Episodic patient instructions are closely related to advance directives, in that they say, for this episode of care if x happens, then do y. Or, if x happens, do not do y. For this reason, episodic patient instructions are often recorded in the clinical record along with a person’s advance directives. However, episodic patient instructions are not advance directives because they represent actual treatment decisions not input to inform potential treatment decisions. A set of recognized obligation or prohibition instructions that a patient or his or her surrogate decision-maker may make is documented in the value set Obligation or Prohibition Instruction Type urn:oid:2.16.840.1.113883.11.20.9.69.17. This value set 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/2.16.840.1.113883.11.20.9.69.17/expansion/Latest

HL7 CDA® R2 Implementation Guide: C-CDA R2.1; Advance Directives Templates, Release 1 - US Realm 2.4 Obligation Instruction [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.205:2018-01-01 (open)] Draft as part of Advance Directives - Template Revisions The Obligation Instruction template is designed to be used within the Advance Directives Section. However, this information also may be relevant within an Interventions Section or a Plan of Treatment Section. It is an adaptation of the Instruction V2 template. It follows the structure of an instruction template, but modifies the semantics in two ways. First, the code element comes from a value set containing concepts that are types of Obligation Instructions that a patient, or a patient's healthcare agent or other type of surrogate decision-maker may decide to make when the patient is unable to communicate. Second, the author of this template is the person who made the decision documented in the Obligation Instruction. The Obligation Instruction template and Prohibition Instruction template are designed as a "matched pair" to permit either prohibitions or obligations to be clearly expressed in an unambiguous way. The use of negation is explicitly expressed, and the semantic design of the recommended value sets takes into consideration the logical meaning of an obligation versus a prohibition. The Obligation Instruction template explicitly prohibits the use of negationInd. It always expresses activities that care providers have been instructed to perform. Coded concepts used in this template express activities in the positive. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template. 2.5 Prohibition Instruction [act: identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.206:2018-01-01 (open)] Draft as part of Advance Directives - Template Revisions The Prohibition Instruction template is designed to be used within the Advance Directives Section. However, this information also may be relevant within an Interventions Section or a Plan of Treatment Section. It is an adaptation of the Instruction V2 template. It follows the structure of an instruction template, but modifies the semantics in several ways. First, the code element comes from a value set containing concepts that are types of care instructions about activities that a patient, or a patient's healthcare agent or other type of surrogate decision-maker (when the patient is unable to communicate) does not want care providers to perform. Second, the author of this template is the person who made the decision documented in the Prohibition Instruction. The Prohibition Instruction template and Obligation Instruction template are designed as a "matched pair" to permit either prohibitions or obligations to be clearly expressed in an unambiguous way. The use of negation is explicitly expressed, and the semantic design of the recommended value sets takes into consideration the logical meaning of an obligation versus a prohibition. . The Prohibition Instruction template explicitly requires the use of negationInd=”true”. It always expresses activities that care providers have been instructed not to perform. Coded concepts used in this template express activities in the positive and add sematics for negation through the structural negationInd attribute. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template. For decisions that establish prohibition instructions, refer to the Prohibition Instruction.

The degree of abnormality of cancer cells; or the extent to which cancer cells are similar in appearance and function to healthy cells of the same tissue type before any treatment (surgical resection or initiation of any treatment including neoadjuvant).

Tumor Histologic Type: International Classification of Diseases for Oncology 3.2, with additional values accepted by the WHO-IARC but not included in the official published documents. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, 2021 Release (month TBD) Tumor Behavior: International Classification of Diseases for Oncology 3.2 Tumor Primary Site: International Classification of Diseases for Oncology 3.2. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release Tumor Laterality: SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release – mCODE Laterality Value Set Tumor Clinical Grade: North American Association of Central Cancer Registries Grade Clinical

The side of a paired organ, or the side of the body on which the tumor originated.

Tumor Histologic Type: International Classification of Diseases for Oncology 3.2, with additional values accepted by the WHO-IARC but not included in the official published documents. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, 2021 Release (month TBD) Tumor Behavior: International Classification of Diseases for Oncology 3.2 Tumor Primary Site: International Classification of Diseases for Oncology 3.2. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release Tumor Laterality: SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release – mCODE Laterality Value Set Tumor Clinical Grade: North American Association of Central Cancer Registries Grade Clinical

The location in the body where the cancer first developed.

Tumor Histologic Type: International Classification of Diseases for Oncology 3.2, with additional values accepted by the WHO-IARC but not included in the official published documents. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, 2021 Release (month TBD) Tumor Behavior: International Classification of Diseases for Oncology 3.2 Tumor Primary Site: International Classification of Diseases for Oncology 3.2. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release Tumor Laterality: SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release – mCODE Laterality Value Set Tumor Clinical Grade: North American Association of Central Cancer Registries Grade Clinical

A person's stated observation of how often in the past year they used medications, from identified opiate pain relievers, sedatives, stimulants or sleeping medications, just for the feeling, to get high, or more often or in larger doses than prescribed, using a 5 point Likert scale. TAPS Tool: In the PAST 12 MONTHS, how often have you used any prescription medications just for the feeling, more than prescribed or that were not prescribed for you? Prescription medications that may be used this way include: Opiate pain relievers (for example, OxyContin, Vicodin, Percocet, Methadone) Medications for anxiety or sleeping (for example, Xanax, Ativan, Klonopin) Medications for ADHD (for example, Adderall or Ritalin). Value: 1. Daily or almost daily (displayed as "0"): a subjective response that something happens daily or almost daily 2. Weekly (displayed as "1"): Every week 3. Monthly (displayed as "2"): Every month 4. Less than Monthly (displayed as "3"): An event that occurs less frequently than once a month 5. Never (displayed as "4"): Not ever, at no time in the past (or future).

Elements were recently submitted for inclusion in LOINC.

The microscopic structure of biological tissues in which the cancer originates.

Tumor Histologic Type: International Classification of Diseases for Oncology 3.2, with additional values accepted by the WHO-IARC but not included in the official published documents. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, 2021 Release (month TBD) Tumor Behavior: International Classification of Diseases for Oncology 3.2 Tumor Primary Site: International Classification of Diseases for Oncology 3.2. SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release Tumor Laterality: SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2020 Release – mCODE Laterality Value Set Tumor Clinical Grade: North American Association of Central Cancer Registries Grade Clinical

(Per https://www.hl7.org/fhir/provenance.html): “Provenance.signature: A digital signature on the target Reference(s). The digital signature, inclusive of a hash on the resource being signed (Provenance.signature.type = 1.2.840.10065.1.12.1.14), will ensure that the integrity of the particular electronic health information (EHI) is maintained and not altered in any way. This allows recipients of this EHI to trust the integrity of the content regardless of its most recent origin. • As patient-mediated EHI becomes more prevalent, maintaining the chain of trust via this digital signature will be instrumental in patient-provided health information exchange.

HL7 FHIR R4 (v4.01: R4 – Mixed Normative and STU)

Author Credential(s), in context of action taken and/or in context of USCDI dataset or data element authorship. Should allow credentials such as MD, DO, RN, DDS, PharmD...

Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Author Credential(s) are part of “who”.

Author Credential(s) must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed.

Note that Author Credential(s) are intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

Action Taken, in context of the real-world occurrence (activity or event) that included collection of the USCDI dataset or data element. Actions include: assessment, history and physical, admission, discharge, transfer, order (e.g., for diagnostic test, for care, for therapy, for medications), result or interpretation (e.g., of diagnostic test), referral, consultation, care planning, observation... Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Action Taken is part of “what”. Action Taken must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Action Taken is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

Data element capturing seasonal or migrant farm work status.

Veteran Status: Z56.82 Military deployment status Farmworker Status: ICD: Z57.2 Occupational exposure to dust Z57.3 Occupational exposure to other air contaminants Z57.4 Occupational exposure to toxic agents in agriculture Z57.6 Occupational exposure to extreme temperature Z57.8 Occupational exposure to other risk factors Agricultural/animal husbandry worker (occupation) - SNOMED: 106390009 Refugee Status: Refugee family (social concept) - SNOMED: 413323004 Refugee (person) - SNOMED: 446654005 Are you a refugee? - LOINC: 93027-1 Refugee - LOINC: LA29153-6

The globally unique identifier for each blood or biologic product identified using the ISBT 128 international standard.

ISBT 128

A telecom of the custodian organization.

An identifier that is common across all document revisions.

The area of social risk documented for a patient (e.g., housing insecurity, alcohol use, transportation security). When exchanging a domain, the following constituent data components should be included: - Source/Assessment: The specific survey, questionnaire, or question set(s) used to calculate the patient’s risk value for the domain, if applicable. If a particular assessment was not used to calculate the patient’s risk value, just the risk value may be exchanged. - Risk Value: The category of risk that applies to a patient for the domain (e.g., “high risk,” “moderate risk,” “low risk,” or “unknown”). - Date: The date the assessment was completed.

LOINC can be used to express a number of assessments used to evaluate a patient’s social determinants of health. SNOMED CT can be used to document a clinical observation stemming from an assessment when it is appropriate.

Data element capturing the refugee status of a patient

Veteran Status: Z56.82 Military deployment status Farmworker Status: ICD: Z57.2 Occupational exposure to dust Z57.3 Occupational exposure to other air contaminants Z57.4 Occupational exposure to toxic agents in agriculture Z57.6 Occupational exposure to extreme temperature Z57.8 Occupational exposure to other risk factors Agricultural/animal husbandry worker (occupation) - SNOMED: 106390009 Refugee Status: Refugee family (social concept) - SNOMED: 413323004 Refugee (person) - SNOMED: 446654005 Are you a refugee? - LOINC: 93027-1 Refugee - LOINC: LA29153-6

Device ID where dataset or data element was originated (collected, captured, sourced), updated, verified, attested, transformed... Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Device ID is part of “where”. Device ID must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Device ID is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

A Sensitivity tag is the 0..* component of a Security Label that conforms to the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to represent the type of information deemed by policy to require a specified level of Confidentiality protection. HL7 recommends creating a value set of Sensitivity codes to value the Sensitivity 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. For HL7 v3 Sensitivity codes see _ActInformationSensitivityPolicy in the ActCode value set. For background on the use of Sensitivity codes, see Sensitive Information Security Label Privacy Tag Used if required by governing policy in HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1, in the HL7 Version 2.9 BHS, FHS, MSH, and ARV Segments, and in the FHIR Data Segmentation for Privacy IG.

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.

Military service in the armed forces of the United States or other nations, including the length and branch of service, the military occupation, the location and type of duty (e.g., in the United States or abroad with combat, combat support, or noncombat duties), and any ongoing illness, injury, limitation, or disability that began during military service. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 297 (2014).)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set 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 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