USCDI Export for the Public

Does the radiation field for the current course overlap with radiation fields from prior courses of therapy?

For each Cancer Patient - Provider Reported Toxicity record the Toxicity Measure specifies what value is measured. For example if CTCAE v5.0 (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…) is used then the Toxicity Measure would correspond to CTCAE Term (e.g. Dry Mouth, or Dry Mouth)

The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) identified this as a high priority element supporting patient care, outcomes research and public policy

Common Terminology Criteria for Adverse Events
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…

Identify targets and overall doses treated with the radiation therapy course. This supports systematic reporting what was done for treatment summaries. For example it enables identifying that the prostate received a dose of 7200 cGy. Where the prescription reflects intent, this element reflects what was delivered.

Medical orders guide what medical interventions providers will perform for a patient. A portable medical order is a type of medical order. Portable medical orders are not authored by patients. They are authored by practitioners in the context of an electronic medical record system. The medical orders are provided to the patient in the form of a document so the orders can travel with the patient and be exchanged with other care providers who do not have access to the EMR where the orders originated. Medical orders regarding life-sustaining treatments are established by a practitioner regarding treatments that restore, sustain or prolong a patient’s life. These types of medical orders are intended to be consistent with the patient’s instructions and wishes. Orders to perform or not perform specific types of life-sustaining treatments are documented by physicians as medical orders within the EMR system used by the organization providing medical interventions or the practitioner’s EMR. When medical orders regarding life-sustaining treatment are produced in a portable format, they are portable medical orders for life-sustaining treatment. Currently, there is no national standard for the expected content in a portable medical order for life-sustaining treatments, as the content can vary by State and EMR system. All doctors, emergency medical professionals, and other healthcare professionals, must follow these medical orders as the patient moves from one location to another (hospital, care facility, home, etc.), unless a treating physician examines the patient, reviews the medical order for life-sustaining treatment, and through conversation with the patient detects the need for a replacement order or as a result of their own clinical judgement creates a replacement order. In an emergency situation, characterized by a life-threatening health crisis, if the patient is unable to speak for themselves, life-sustaining treatments and procedures that are legally required of medical and emergency personnel can be overridden by a valid portable medical order. Depending on the state, a portable medical order may go by any of the following names: • MOLST (Medical Orders for Life-Sustaining Treatment) • POLST (Physician Orders for Life-Sustaining Treatment) • MOST (Medical Orders for Scope of Treatment) • POST (Physician Orders for Scope of Treatment) • TPOPP (Transportable Physician Orders for Patient Preferences) • Out-of-hospital Do Not Resuscitate (DNR) Orders The above forms have historically been paper-based and siloed in EMRs that might contain a scanned image, or a clinical note that details the decisions documented in the portable medical order. Emergency and treating care teams do not have mechanisms for establishing that the copy they are provided is the most current version and that another, more recent portable medical order doesn’t exist that would contradict the order they are reviewing. These uploaded copies of the portable medical order for life-sustaining treatment are considered to be just as valid as the original paper medical order that was provided by a physician to the patient for whom it was written. The currently supported digital interchange format for portable medical orders is a pdf document, as there are not standard interoperable data elements. The pdf document can be represented as a C-CDA Unstructured Document or a FHIR DocumentReference to enable key administrative information to be processed.

Portable Medical Orders for Life Sustaining Treatment The currently supported digital interchange format for portable POLST orders is a pdf document. The pdf document can be represented as a C-CDA Unstructured Document or a FHIR DocumentReference to enable key administrative information to be processed. There is no standard guidance about the expected content in a portable medical order for life sustaining treatments. The content varies by state and by EMR system. Portable Medical Orders for Life Sustaining treatment are a type of Medical Order. Data Element Code Definition Portable medical order form 93037-0 LOINC urn:oid:2.16.840.1.113883.6.1 Physician Order for Scope of Treatment which encompasses Physician Orders for Life-Sustaining Treatment (POLST) or Medical Orders for Life-Sustaining Treatment (MOLST). MOLST Observation In the context of a Patient Summary or Encounter Summary authored by a clinician or assembled by clinician’s EMR system, observations verifying a patient’s advance directive information and medical orders for life sustaining treatments using established standards for recording this type of information documented by providers. If a person has a medical order or physician order for life sustaining treatment (MOLST or POLST). This observation does not indicate what orders are included in the MOLST or POLST. It indicates if a MOLST or POLST exists. If a MOLST or POLST exists, the template includes a reference structure that can be used to point to the MOLST or POLST document. The vocabulary and structure needed to express this observation is provided in the HL7 CDA® R2 Implementation Guide: Personal Advance Care Plan (PACP) Document, Release 1 - US Realm STU Release 2 August 2020 Volume 2 – Templates. This observation can be used to document a patient authored statement about portable medical orders for life sustaining treatments or physician authored statements about there being portable medical orders for life sustaining treatments. Note that a physician’s own medical orders placed for life sustaining treatments are documented as medical orders placed within the physician’s own EMR.

The Karnofsky Performance Status (KPS) is a tool used to measure a patient's functional status. It can be used to compare the effectiveness of different therapies and to help assess the prognosis of certain patients, such as those with certain cancers. The KPS score ranges from 0 to 100 in intervals of 10. Higher scores are associated with better functional status, with 100 representing no symptoms or evidence of disease, and 0 representing death.

LOINC, SNOMED-CT, and FHIR see: https://search.loinc.org/searchLOINC/search.zul?query=functional+status http://hl7.org/fhir/us/mcode/ https://browser.ihtsdotools.org/?perspective=full&conceptId1=273472005&edition=MAIN/2020-07-31&release=&languages=en

Currently consistently housed, but experiencing any of the following circumstances in the past 12 months: being behind on rent or mortgage, multiple moves, homelessness; or currently living in a shelter, motel, temporary or transitional living situation, scattered site housing, or not having a consistent place to sleep at night; or lacking a fixed, regular, and adequate nighttime residence. (Richard Sheward, Allison Bovell-Ammon, Nayab Ahmad, Genevieve Preer, Stephanie Ettinger de Cuba & Megan Sandel, Promoting Caregiver and Child Health Through Housing Stability Screening in Clinical Settings, 39 Zero to Three J. 52, 52-53 (Mar. 2019); Megan Sandel, Richard Sheward, Stephanie Ettinger de Cuba, Sharon M. Coleman, Deborah A. Frank, Mariana Chilton, Maureen Black, Timothy Heeren, Justin Pasquariello, Patrick Casey, Eduardo Ochoa & Diana Cutts, Unstable Housing and Caregiver and Child Health in Renter Families, 141 Pediatrics e20172199, p. 3 (2018); McKinney-Vento Homeless Assistance Act of 1987, Pub. L. 100-77, § 103(a)(1), 101 Stat. 482, 485 (July 22, 1987).) Currently under consideration by and in process with the Gravity community.

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

In the past year whether patient has been able to unable to find affordable or pay for childcare. (LOINC) LA30127-7 Synonyms: (ICD-10-CM) Z59.68 (Unable to pay for child care)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

FHIR Resource: HL7 FHIR R4 MedicationStatement, aka R5 MedicationUsage Data element: MedicationStatement.status; MedicationUsage.takenAsOrdered Values in http://hl7.org/fhir/CodeSystem/medication-statement-status: {active | completed | entered-in-error | intended | stopped | on-hold | unknown | not-taken} These are defined in terms of taking; i.e., “active” in MedicationRequest means that the prescription can be filled, but in MedicationStatement, means that the patient is taking it. FHIR R5 target is to remove “status” and create “use,” with values { Taking | Taking as directed | Taking not as directed | Not Taking | Unknown (unable to obtain)} AVS/PVS system uses “I am taking this med {As written | Differently | Not taking | Unsure}”

For each Cancer Patient - Provider Reported Toxicity record the Toxicity Value corresponding to the Toxicity Measure specified indicates the severity of the toxicity using the standardized table. specifies what value is measured. For example if CTCAE v5.0 (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…) the values in the standardized set are 0,1,2,3,4,5

The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) identified this as a high priority element supporting patient care, outcomes research and public policy

Common Terminology Criteria for Adverse Events
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/doc…

A condition in which one is unable to regularly move from place to place in a safe and timely manner because one lacks the material, economic or social resources necessary for transportation. (Alix Gould-Werth, Jamie Griffin & Alexandra K. Murphy, “Developing a New Measure of Transportation Insecurity: An Exploratory Factor Analysis,” 11(2) Survey Practice , p. 1 (2018).) Currently under consideration by and in process with the Gravity community.

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

Cancer patients with similar prognoses are grouped by using prognostic stage group tables. Clinical and pathological stage groups are defined for each case as appropriate. These disease-specific groups are composed of the following categories: • cT, cN, and cM or pM • pT, pN, and cM or pM • factors for both groups, if applicable Rules for assigning prognostic stage groups: Prognostic stage groups are based on combinations of T, N, M, and relevant prognostic factors and usually define groups of patients with similar outcomes to help define prognosis and appropriate treatment, as well as to enable comparisons of similar groups of patients between institutions and over time.

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

This data element comprises how many alcohol binge episodes an individual has per month

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

Use of the tobacco plant leaf or its products. The predominant use of tobacco is by smoke inhalation of cigarettes, pipes, and cigars. Smokeless tobacco refers to a variety of tobacco products that are either sniffed, sucked, or chewed. An electronic cigarette is a vaporizer device that simulates smoking by providing some of the aspects of smoking that includes nicotine but without combusting tobacco. These products include psychoactive ingredient, nicotine. Question Prompt: Any use of tobacco (or nicotine-containing) products? Permissible Values: o Never (SNOMED: 702979003) An individual who has never consumed tobacco products in their lifetime. o Former (SNOMED: 702975009) An individual who has consumed tobacco products in his or her lifetime but who had quit consumption at the time of question. o Current - Daily (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, and who does so every day. o Current - Occasionally (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, who uses now, but does not use every day. o Unknown (SNOMED: TBD) An individual for whose tobacco product use is unknown.

There are SNOMED and LOINC Codes for most of the data elements but new codes will be requested for eCigarette use.

The Distince Identification code (aka Donation Identification Number (DIN)) is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

Financial resource strain encompasses both the subjective sense of strain as the result of economic difficulties and specific sources of strain. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 1, p. 58 (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

Whether or not the patient asserts they have verifiable vaccine credentials.

HL7 FHIR: Vaccine Credential Patient Assertion Observation profile

HL7 CDA: Vaccine Credential Patient Assertion Observation

LOINC: 11370-4 "Immunization status - Reported"

The number that allows for the identification of a device, indicating its position within a series.Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

In the past year whether patient has been unable to afford or access a phone. (LOINC) LA30129-3 LA13918-0 (With little difficulty), 3; LA13920-6 (with some difficulty), 2; LA13919-8 (With much difficulty) Synonyms: (SNOMEDCT) 5501000175107 Lack of telephone in home environment (ICD-10-CM) Z59.65 (Unable to pay for phone)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

Total number of sessions in the treatment course. A session is the period between when the patient enters the treatment room and when they leave it.

Score for the molecular test result identified. For example Pathology Molecular Test Name is ProMark, Result could be 30

American Joint Committee on Cancer e.g. AJCC8