USCDI Export for the Public

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SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate.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

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.

When the event occurred

adverse events are mapped to MedDRA terminology

Information on the possible cause of the event

adverse events are mapped to MedDRA terminology

Type of the event itself in relation to the subject

adverse events are mapped to MedDRA terminology

The suspected agent causing the adverse event

adverse events are mapped to MedDRA terminology

The NIAAA Single-Item Screener is a single question that may be used to screen men and women (separately) for unhealthy alcohol use. It has been validated in primary care settings; the specific language for men and women appears below. Men: How many times in the past year have you had five or more drinks in a day? Women: How many times in the past year have you had four or more drinks in a day?

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 AUDIT-C is a three-item measure to screen for alcohol-related problems. Questions and answers include: 1. How often do you have a drink containing alcohol? (Response choices: Never/Monthly or less/2-4 times per month/2-3 times per week/4 or more times per week) 2. How many standard drinks containing alcohol do you have on a typical day? (Response choices: 1-2/3-4/5-6/7-9/10 or more) 3. How often do you have six or more drinks on one occasion? (Response choices: Daily or almost daily/Weekly/Monthly/Less than monthly/Never)

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 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

Location where action was taken and/or where dataset or data element was collected (captured, sourced). Location should include room (within) building (within) organization. Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Physical Location is part of “where”. Physical Location 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 Physical Location 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 State, in context of data lifecycle. States should include: origination (capture, collection), update (from previous content/value), verification (of data sourced by others (e.g., transcriptionist, scribe, student) or from automated device), transformation (e.g., from source system internal representation to exchange artifact (such as HL7 message, CDA document or FHIR resource), from exchange artifact to receiver internal representation). Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Data State is part of “what”. Data State 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 Data State 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.

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.

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.

(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)

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

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.

This data element includes whether an individual has received a diagnosis of alcohol abuse or dependence, as per the DSM-IV nosology

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 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

This data element captures the Alcohol Use Disorder (AUD) diagnosis, which reflects the current nosology for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

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