USCDI Export for the Public

Information on the possible cause of the event

adverse events are mapped to MedDRA terminology

The AJCC Cancer Staging System describes the severity of an individual's cancer based on the magnitude of the original (primary) tumor as well as on the extent cancer has spread in the body. Understanding the stage of the cancer helps doctors to develop a prognosis and design a treatment plan for individual patients. The AJCC Cancer Staging System classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M), supplemented in recent years by evidence-based prognostic and predictive factors. There is a T,N,M staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The three categories—T, N, and M—and the prognostic factors collectively describe, with rare exceptions, the extent of tumor, including local spread, regional nodal involvement, and distant metastasis. It is important to stress that each component (T, N, and M) is referred to as a Category. The term stage is used when T, N, and M and cancer site–specific required prognostic factors are combined. The Criteria for T, N, and M are defined separately for cancers in different anatomic locations and/or for different histologic types.

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate.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.

For both Clinical (cT), Pathological (pT) and Neoadjuvant (ycT or ypT), the T Category is defined as the size and/or contiguous extension of the primary tumor. Note: The roles of the size component and the extent of contiguous spread are specifically defined for each cancer site. Primary Tumor (T) Categories: Primary tumor categories have specific notations to describe the existence, size, or extent of the tumor. TX: No information about the T category for the primary tumor, or it is unknown or cannot be assessed T0: No evidence of a primary tumor Tis: Carcinoma in situ T1, T2, T3, or T4: Primary invasive tumor, for which a higher category generally means • an increasing size • an increasing local extension, or • both

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.

The DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements. If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent. The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. 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

Date the beneficiary was discharged from the facility, or died. Matches the Statement Thru Date. When there is a discharge date, the Patient Discharge Status Code indicates the final disposition of the patient after discharge.

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

The knowledge and skills gained through education, the credentialing linked to the completion of various levels of schooling, and the quality of education. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 68 (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

For both Clinical (cN), Pathological (pN) and Neoadjuvant (ycN or ypN), the N Category is defined as Cancer in the regional lymph nodes as defined for each cancer site, including • absence or presence of cancer in regional node(s), and/or • number of positive regional nodes, and/or • involvement of specific regional nodal groups, and/or • size of nodal metastasis or extension through the regional node capsule, and/or • In-transit and satellite metastases, somewhat unique manifestations of nonnodal intralymphatic regional disease, usually found between the primary tumor site and draining nodal basins. Regional Lymph Node (N) Categories Categorizing regional lymph node involvement depends on its existence and extent. NX No information about the N category for the regional lymph nodes, or it is unknown or cannot be assessed N0 No regional lymph node involvement with cancer and for some disease sites, nonnodal regional disease as noted earlier N1, N2, or N3 Evidence of regional node(s) containing cancer, with • an increasing number, and/or • regional nodal group involvement, and/or • size of the nodal metastatic cancer deposit, or • non-nodal regional disease as noted earlier for melanoma and Merkel cell carcinoma, and for colorectal carcinoma

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.

Violence between individuals, subdivided into family and intimate partner violence and community violence. (World Health Organization, World Report on Violence and Health, p. 6 (2002).)

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

The date on which a device is manufactured. 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

Radiation dose delivered to the target volume in fulfilling the prescription (e.g. 7200 cGy).

For both Clinical (cM) and Pathological (pM) the M Category is defined as the absence or presence of distant metastases in sites and/or organs outside the local tumor area and regional nodes as defined for each cancer site. For some cancer sites, the location and volume or burden of distant metastases are included. Distant Metastasis (M) Categories: The distant metastasis category specifies whether distant metastasis is present. M0 No evidence of distant metastasis M1 Distant metastasis

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.

The patient's country of nationality.

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: Country of Nationality profile HL7
CDA: Country of Nationality template
SNOMED: 186034007 |Ethnicity / related nationality data (observable entity)|
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436

A subjective state that arises when an individual recognizes a situation as threatening, but dealing with the threat requires more resources than the individual has available. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 76 (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

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

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

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…

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…